Development and validation of algorithms to identify acute diverticulitis.

PURPOSE: The objectives of this study were to develop and validate algorithms to accurately identify patients with diverticulitis using electronic medical records (EMRs). METHODS: Using Kaiser Permanente Southern California's EMRs of adults (≥18 years) with International Classification of Diseases, Clinical Modifications, Ninth Revision diagnosis codes of diverticulitis (562.11, 562.13) between 1 January 2008 and 31 August 2009, we generated random samples for pilot (N = 692) and validation (N = 1502) respectively. Both samples were stratified by inpatient (IP), emergency department (ED), and outpatient (OP) care settings. We developed and validated several algorithms using EMR data on diverticulitis diagnosis code, antibiotics, computed tomography, diverticulosis history, pain medication and/or pain diagnosis, and excluding patients with infections and/or conditions that could mimic diverticulitis. Evidence of diverticulitis was confirmed through manual chart review. Agreement between EMR algorithm and manual chart confirmation was evaluated using sensitivity and positive predictive value (PPV). RESULTS: Both samples were similar in socio-demographics and clinical symptoms. An algorithm based on diverticulitis diagnosis code with antibiotic prescription dispensed within 7 days of diagnosis date, performed well overall. In the validation sample, sensitivity and PPV were (84.6, 98.2%), (95.8, 98.1%), and (91.8, 82.6%) for OP, ED, and IP, respectively. CONCLUSION: Using antibiotic prescriptions to supplement diagnostic codes improved the accuracy of case identification for diverticulitis, but results varied by care setting.

The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX ® formulated delayed-release mesalamine.

PURPOSE: Ulcerative colitis (UC) is associated with impaired health-related quality of life (HRQL) and work-related outcomes (WRO). This analysis examined correspondences among measures of HRQL and WRO in patients with UC, as well as the magnitude of each measure's responsiveness to disease activity and treatment. METHODS: An open-label, prospective trial of delayed-release mesalamine tablets formulated with MMX(®) technology included 8 weeks of treatment for patients with active mild-to-moderate UC (n = 137) and 12 months of maintenance treatment for patients with quiescent UC (n = 206). Spearman correlations (ρ) measured inter-domain associations across measures of generic HRQL [12-item Short-Form Health Survey (SF-12v2)], disease-specific HRQL [Short Inflammatory Bowel Disease Questionnaire (SIBDQ)], and disease-specific WRO [Work Productivity and Activity Impairment for Specific Health Problems (WPAI:SHP)]. Responsiveness to disease activity and treatment was assessed for each instrument. RESULTS: Changes in scores from baseline to week 8 were moderately correlated across all instrument domains: 65 of 80 (81 %) between-instrument inter-domain correlations were of moderate magnitude (0.30 < ρ < 0.70), with an average magnitude of 0.42 [95 % confidence interval (CI) 0.38-0.46]. Associations between symptom measures were stronger for SIBDQ (|average ρ| = 0.41; 95 % CI 0.34-0.48) and WPAI:SHP (0.40; 0.30-0.47) than SF-12v2 (0.30; 0.27-0.34). SIBDQ was most sensitive to treatment [effect size (d z ) for change from baseline to week 8 = 0.62; 95 % CI 0.35-0.89], followed by WPAI:SHP (d z = 0.43; 0.32-0.54) and SF-12v2 (d z = 0.33; 0.27-0.39). CONCLUSION: While the SIBDQ showed the greatest overall responsiveness to disease activity and treatment, all three patient-reported outcomes instruments provided complementary interpretive information regarding the impact of UC treatment.

Development and validation of a disease-targeted quality of life instrument for chronic diverticular disease: the DV-QOL.

BACKGROUND: Colonic diverticular disease is typically conceived as acute diverticulitis attacks surrounded by periods of clinical silence. However, evolving data indicate that many patients have persistent symptoms and diminished health-related quality of life (HRQOL) long after acute attacks. We developed a disease-targeted HRQOL measure for symptomatic uncomplicated diverticular disease (SUDD)-the diverticulitis quality of life (DV-QOL) instrument. METHODS: We conducted a systematic literature review to craft a conceptual model of SUDD HRQOL. This was complemented by three focus groups including 45 SUDD patients. We developed items based on our literature search, focus groups, and cognitive debriefings. We administered the items to SUDD patients with persistent symptoms following a confirmed diverticulitis event. We created scales based on factor analysis and evaluated the scales for reliability and validity. RESULTS: Concept elicitation revealed a range of illness experiences attributed to SUDD. Coding of 20,490 transcribed words yielded a 52-code network with four primary, condition-related concepts: (1) physical symptoms (e.g., bloating); (2) behaviors (e.g., restrictions); (3) cognitions and concerns (e.g., fear); and (4) impact and consequences (e.g., absenteeism, anxiety). Based on patient language, we developed the 17-item DV-QOL instrument. In a cross-sectional validation sample of 197 patients, DV-QOL discriminated between patients with recent versus distant diverticulitis events and correlated highly with Short Form 36 and hospital anxiety and depression scores. CONCLUSIONS: Patients with SUDD attribute a wide range of negative psychological, social, and physical symptoms to their condition, both during and after acute attacks; DV-QOL captures these symptoms in a valid, reliable manner.

Increased risk for irritable bowel syndrome after acute diverticulitis.

BACKGROUND & AIMS: Individuals with diverticulosis frequently also have irritable bowel syndrome (IBS), but there are no longitudinal data to associate acute diverticulitis with subsequent IBS, functional bowel disorders, or related emotional distress. In patients with postinfectious IBS, gastrointestinal disorders cause long-term symptoms, so we investigated whether diverticulitis might lead to IBS. We compared the incidence of IBS and functional bowel and related affective disorders among patients with diverticulitis. METHODS: We performed a retrospective study of patients followed up for an average of 6.3 years at a Veteran's Administration medical center. Patients with diverticulitis were identified based on International Classification of Diseases, 9th revision codes, selected for the analysis based on chart review (cases, n = 1102), and matched with patients without diverticulosis (controls, n = 1102). We excluded patients with prior IBS, functional bowel, or mood disorders. We then identified patients who were diagnosed with IBS or functional bowel disorders after the diverticulitis attack, and controls who developed these disorders during the study period. We also collected information on mood disorders, analyzed survival times, and calculated adjusted hazard ratios. RESULTS: Cases were 4.7-fold more likely to be diagnosed later with IBS (95% confidence interval [CI], 1.6-14.0; P = .006), 2.4-fold more likely to be diagnosed later with a functional bowel disorder (95% CI, 1.6-3.6; P < .001), and 2.2-fold more likely to develop a mood disorder (CI, 1.4-3.5; P < .001) than controls. CONCLUSIONS: Patients with diverticulitis could be at risk for later development of IBS and functional bowel disorders. We propose calling this disorder postdiverticulitis IBS. Diverticulitis appears to predispose patients to long-term gastrointestinal and emotional symptoms after resolution of inflammation; in this way, postdiverticulitis IBS is similar to postinfectious IBS.

Long-term risk of acute diverticulitis among patients with incidental diverticulosis found during colonoscopy.

BACKGROUND & AIMS: Colonic diverticulosis is the most common finding during routine colonoscopy, and patients often question the significance of these lesions. Guidelines state that these patients have a 10% to 25% lifetime risk of developing acute diverticulitis. However, this value was determined based on limited data, collected before population-based colonoscopy, so the true number of cases of diverticulosis was not known. We measured the long-term risk of acute diverticulitis among patients with confirmed diverticulosis discovered incidentally on colonoscopy. METHODS: We performed a retrospective study using administrative and clinical data from the Veterans Affairs Greater Los Angeles Healthcare System, collecting data on patients who underwent colonoscopies from January 1996 through January 2011. We identified patients diagnosed with diverticulosis, determined incidence rates per 1000 patient-years, and analyzed a subgroup of patients with rigorously defined events confirmed by imaging or surgery. We used a Cox proportional hazards model to identify factors associated with the development of diverticulitis. RESULTS: We identified 2222 patients with baseline diverticulosis. Over an 11-year follow-up period, 95 patients developed diverticulitis (4.3%; 6 per 1000 patient-years); of these, 23 met the rigorous definition of diverticulitis (1%; 1.5 per 1000 patient-years). The median time-to-event was 7.1 years. Each additional decade of age at time of diagnosis reduced the risk for diverticulitis by 24% (hazard ratio, 0.76; 95% confidence interval, 0.6-0.9). CONCLUSIONS: Based on a study of the Veterans Affairs Greater Los Angeles Healthcare System, only about 4% of patients with diverticulosis develop acute diverticulitis, contradicting the common belief that diverticulosis has a high rate of progression. We also found that younger patients have a higher risk of diverticulitis, with risk increasing per year of life. These results can help inform patients with diverticulosis about their risk of developing acute diverticulitis.

Medication adherence and persistence in the treatment of Canadian ulcerative colitis patients: analyses with the RAMQ database.

BACKGROUND: Although high non-adherence to medication has been noticed for ulcerative colitis (UC), little is known about adherence to mesalamine treatments and determinants that can predict adherence. The objective of this study was to assess adherence and persistence to mesalamine treatments and their potential determinants in mild to moderate UC patients in a real-life setting in Quebec, Canada. METHODS: A retrospective prescription and medical claims analysis was conducted using a random sample of mesalamine users with UC. For inclusion, patients were required to initiate an oral mesalamine treatment between January 2005 and December 2009. Patients with a diagnosis of Crohn's disease were excluded. Treatment adherence (medication possession ratio [MPR]) and persistence were evaluated over a 1-year period after the index prescription using the Kaplan-Meier method with log-rank test and stepwise regression to identify potential determinants. RESULTS: A sample of 1,681 of the new oral mesalamine users (mean age = 55.3) patients was obtained. Overall, the percentage of patients with a MPR of 80% or greater at 12 months was 27.7%, while persistence was 45.5%. Among patients treated with mesalamine delayed/extended-release tablets (Mezavant®), adherence and persistence were 40.9% and 71.9%, respectively. Predictors of high adherence included, male gender (OR=1.3; 95% confidence interval [CI]=1.1-1.6), older age (>60 years; OR=1.6; 95% CI=1.3-2.0) and current use of corticosteroids (OR=1.4; 95% CI=1.1-1.8). Predictors of high persistence included male sex (OR=1.4; 95% CI=1.1-1.7), current use of corticosteroids (OR=1.4; 95% CI=1.1-1.7) and presence of hypertension or respiratory diseases (OR=1.2; 95% CI=1.01-1.55). CONCLUSIONS: The majority of patients with UC exhibited low adherence and persistence to mesalamine treatments. Various determinants of improved adherence and persistence were identified.

Association between oral 5-ASA adherence and health care utilization and costs among patients with active ulcerative colitis.

BACKGROUND: Observational cohort study to assess the association between adherence to oral 5-aminosalicylates (5-ASAs) and all-cause costs and health care utilization among patients with active ulcerative colitis (UC) in the United States. METHODS: Retrospective analysis of insurance claims from June 1997 to August 2006 in the LifeLink Database. Patient criteria: aged 18 or older with one or more claim(s) between June 1997 and August 2005 for a UC diagnosis and at least one oral 5-ASA prescription on or after the first observed UC diagnosis; continuous enrollment for at least 6 months prior to and 12 months following 5-ASA initiation (index date). As a proxy for active disease, patients needed to have at least two UC-specific non-pharmacy claims, at least 30 days of 5-ASA treatment and at least one corticosteroid prescription within the 12-month post-index period. Cumulative exposure to oral 5-ASAs over the 12-month period was calculated using the medication possession ratio (MPR). Patients with an MPR of at least 0.80 were classified as adherent. All-cause medical and pharmacy resource utilization and costs were computed over the 12-month post-index period and compared between adherent and nonadherent patients. RESULTS: 1,693 UC patients met study inclusion criteria: 72% were nonadherent to 5-ASA treatment (n=1,217) and 28% were adherent (n=476) in the 12-month study period. Compared with nonadherent patients, adherent patients had 31% fewer hospitalizations (P=0.0025) and 34% fewer emergency department admissions (P=0.0016). Adherent patients had 25% more pharmacy prescriptions overall (P <0.0001) and 71% more UC-related pharmacy prescriptions (P <0.0001) than did nonadherent patients. Total all-cause health care utilization was 1.13 times higher for adherent patients than for nonadherent patients (P=0.0002). After adjusting for covariates, total all-cause costs were 29% higher for nonadherent patients than for adherent patients (mean [95% confidence interval]: $13,465 [$13,094, $13,835] vs $17,339 [$17,033, $17,645]). CONCLUSIONS: Approximately three-quarters of patients with active UC were not adherent with their prescribed doses of oral 5-ASA. Nonadherence was associated with higher total all-cause costs. The key driver of decreased costs among adherent patients was inpatient hospitalizations, which more than offset these patients' expected higher pharmacy costs.

Cost effectiveness of ulcerative colitis treatment in Germany: a comparison of two oral formulations of mesalazine.

BACKGROUND: The treatment of ulcerative colitis (UC) can place a substantial financial burden on healthcare systems. The anti-inflammatory compound 5-aminosalicylic acid (5-ASA; mesalazine) is the recommended first-line treatment for patients with UC. In this analysis, the incremental cost effectiveness ratio (ICER) of two oral formulations of 5-ASA (Mezavant® and Asacol®) is examined in the treatment of patients with mild-to-moderate, active UC in Germany. METHODS: A Markov cohort model was developed to assess the cost effectiveness of Mezavant compared with Asacol over a 5-year period in the German Statutory Health Insurance (SHI). Drug pricing details for 2009 were applied throughout the model, and overall resource use was determined and also fitted to 2009 from published results of a large cross sectional study of German SHI patients. Cost per quality adjusted life year (QALY) was the primary endpoint for this study. Remission rates were obtained using data from a randomised, phase III trial of Mezavant with an active Asacol reference arm and a long-term, open label, safety and tolerability trial of Mezavant. Uncertainty in the study model was assessed using one-way and probabilistic sensitivity analyses applying a Monte Carlo simulation. RESULTS: Over a 5-year period, healthcare costs for patients receiving Mezavant were 624 Euro lower than for patients receiving Asacol. Additionally, patients receiving Mezavant gained 0.011 QALYs or 18 more days in remission compared with Asacol. One-way sensitivity analyses suggest that these results are driven by both differences in the acquisition cost between mesalazine formulations and differences in treatment efficacy. Furthermore, sensitivity analyses suggest a probability of 76% for cost savings and higher QALYs with Mezavant compared with Asacol. If adherence and its influence on the remission rates and the risk of developing colorectal cancer were included in the model, the results might have even been more favorable to Mezavant due to its once daily dosing regimen. CONCLUSIONS: This model suggests that patients treated with Mezavant may achieve increased time in remission and higher QALYs, with lower direct costs to the SHI when compared with Asacol. Mezavant may therefore be a suitable first-line option for the induction and maintenance of remission in UC.

Barriers to mesalamine adherence in patients with inflammatory bowel disease: a qualitative analysis.

BACKGROUND: The causes for nonadherence to mesalamine in patients with inflammatory bowel disease (IBD) have been characterized using mostly indirect methods. Patient-reported barriers are lacking in this population. OBJECTIVE: To identify patient-reported barriers to mesalamine adherence through direct interviews. METHODS: Focus groups and one-on-one interviews were undertaken in adult patients with IBD. Transcripts from the focus groups and interviews were analyzed to identify themes and links between these themes, assisted by qualitative data software MaxQDA. RESULTS: Of 27 patients participating, 21 (78%) had ulcerative colitis, and 6 (22%) had Crohn's disease. Their self-reported adherence ranged from complete adherence (n = 3) to intermittent nonadherence (n = 24). Patients frequently indicated that they were resistant to taking medications for their condition. The barriers to adherence that emerged from interviews could be categorized under a number of themes: competing priorities, social stigma, refill inconvenience, costs, efficacy values, side effects, and pill characteristics. Efficacy values reported to influence adherence included doubts about efficacy, consequences of missed doses, and doubts about need for maintenance medication. Pill characteristics reported as barriers included pill size and pill frequency. Despite use of electronic prescribing, obtaining refills was reported as an obstacle to adherence in this cohort. Decanting of pills to multiple containers to increase accessibility was also reported. CONCLUSIONS: Patients with both ulcerative colitis and Crohn's disease report a number of common barriers to mesalamine adherence. Factors in medication-taking behavior and beliefs were reported in this study that may have implications for strategies to improve adherence by health care providers.

The burden of inflammatory bowel disease: a patient-reported qualitative analysis and development of a conceptual model.

BACKGROUND: The aim of this study was to describe the impacts of inflammatory bowel disease (IBD) from the patients' perspective and to inform the development of a conceptual model. METHODS: Focus groups and one-on-one interviews were undertaken in adult patients with IBD. Transcripts from the focus groups and interviews were analyzed to identify themes and links between themes, assisted by qualitative data software MaxQDA. Themes from the qualitative research were supplemented with those reported in the literature and concepts included in IBD-specific patient-reported outcome measures. RESULTS: Twenty-seven patients participated. Key physical symptoms included pain, bowel-related symptoms such as frequency, urgency, incontinence, diarrhea, passing blood, and systemic symptoms such as weight loss and fatigue. Participants described continuing and variable symptom experiences. IBD symptoms caused immediate disruption of activities but also had ongoing impacts on daily activities, including dietary restrictions, lifestyle changes, and maintaining close proximity to a toilet. More distal impacts included interference with work, school, parenting, social and leisure activities, relationships, and psychological well-being. The inconvenience of rectal medications, refrigerated biologics, and medication refills emerged as novel burdens not identified in existing patient-reported outcome measures. CONCLUSIONS: IBD symptoms cause immediate disruption in activities, but patients may continue to experience some symptoms on a chronic basis. The conceptual model presented here may be useful for identifying target concepts for measurement in future studies in IBD.

Medical resource utilization and associated costs in patients with ulcerative colitis in the UK: a chart review analysis.

OBJECTIVE: Limited evidence is available on the economic burden of ulcerative colitis (UC) in the UK, particularly relating to the impact of relapse frequency on direct medical costs. This study identifies and assesses medical resource utilization (MRU) and associated direct costs in mild and moderate UC patients in the UK. PATIENTS AND METHODS: A retrospective chart review of patients with mild-to-moderate UC diagnosed at least 1 year before the study was performed. From 33 general practitioner (GP) and 34 gastroenterologist sites, charts of the last three UC patients fulfilling the inclusion criteria were reviewed. Descriptive statistics were calculated for MRU and 2011 costs (GB£) by number of relapses. RESULTS: The study population included 201 patients with a mean age of 39.9 years; 44% were women and the mean disease duration was 7.4 years. UC-related costs of each MRU category increased with the number of relapses. Comparing patients without relapse with those with more than two relapses, the mean annual UC-related costs were £14 versus £2556 for hospitalizations; £218 versus £988 for visits (including nurse, GP, specialist, and other visits); £21 versus £1303 for procedures; £17 versus £188 for diagnostics; and £1168 versus £6660 for all-cause total costs. Age, sex, and site of data reporting (GP vs. gastroenterologist) were not associated with MRU or costs. CONCLUSION: Patients with mild-to-moderate UC incurred considerable costs that increased markedly with the number of relapses. These findings support the importance of maintenance therapies in UC that reduce or prevent relapses. Quantifying the relationship between relapse rate and costs will inform future health economic studies.

Acute colonic diverticulitis: diagnostic evidence, demographic and clinical features in three practice settings.

BACKGROUND AND AIMS: Diverticulitis is often diagnosed in outpatients, yet little evidence exists on diagnostic evidence and demographic/clinical features in various practice settings. We assessed variation in clinical characteristics and diagnostic evidence in inpatients, outpatients, and emergency department cases and effects of demographic and clinical variables on presentation features. METHODS: In a retrospective cohort study of 1749 patients in an integrated health care system, we compared presenting features and computed tomography findings by practice setting and assessed independent effects of demographic and clinical factors on presenting features. RESULTS: Inpatients were older and more often underweight/normal weight and lacked a diverticulitis past history and had more comorbidities than other patients. Outpatients were most often Hispanic/Latino. The classical triad (abdominal pain, fever, leukocytosis) occurred in 78 (38.6%) inpatients, 29 (5.2%) outpatients and 34 (10.7%) emergency department cases. Computed tomography was performed on 196 (94.4%) inpatients, 110 (9.2%) outpatients and 296 (87.6%) emergency department cases and was diagnostic in 153 (78.6%) inpatients, 62 (56.4%) outpatients and 243 (82.1%) emergency department cases. Multiple variables affected presenting features. Notably, female sex had lower odds for the presence of the triad features (odds ratio [95% CI], 0.65 [0.45-0.94], P<0.05) and increased odds of vomiting (1.78 [1.26-2.53], P<0.01). Patients in age group 56 to 65 and 66 or older had decreased odds of fever (0.67 [0.46-0.98], P<0.05) and 0.46 [0.26-0.81], P<0.01), respectively, while > / =1 co-morbidity increased the odds of observing the triad (1.88 [1.26-2.81], P<0.01). CONCLUSION: There was little objective evidence for physician-diagnosed diverticulitis in most outpatients. Demographic and clinical characteristics vary among settings and independently affect presenting features.

Impact of MMX® mesalamine on improvement and maintenance of health-related quality of life in patients with ulcerative colitis.

BACKGROUND: Ulcerative colitis (UC) substantially reduces patients' health-related quality of life (HRQoL). The current study examined the burden of disease and the impact of daily multimatrix (MMX®) mesalamine treatment on HRQoL for patients with active or quiescent mild-to-moderate UC. METHODS: Data were from a two-phase, multicenter, open-label study with mild-to-moderate UC patients. In the acute phase, 132 patients with active disease received MMX mesalamine 2.4-4.8 g/day QD for 8 weeks. In the maintenance phase, 207 patients with quiescent disease received MMX mesalamine 2.4 g/day QD for 12 months. The Short Form-12 (version 2) (SF-12v2) measured HRQoL during each phase. Disease burden was examined by comparing acute-phase baseline scores with a U.S. general population sample. Repeated-measures analyses assessed change in SF-12v2 scores for each phase. Correspondence between HRQoL and disease activity was examined through correlations between SF-12v2 scores with patient-reported symptom measures. RESULTS: Baseline SF-12v2 scores for patients with UC were generally much lower than for the general population sample, indicating a broad disease burden. In the acute phase, significant improvement was observed for most SF-12v2 scores at week 8; a comparison with the matched norms showed a complete elimination of burden. No changes in SF-12v2 scores were observed during the maintenance phase. Changes in symptom measures and SF-12v2 scores were moderately correlated. CONCLUSIONS: The sizeable burden of active mild-to-moderate UC on HRQoL was eliminated following 8 weeks' treatment with MMX mesalamine 2.4-4.8 g/day. HRQoL remained stable over 12 months of maintenance treatment in patients with quiescent UC.

Medication use patterns and predictors of nonpersistence and nonadherence with oral 5-aminosalicylic acid therapy in patients with ulcerative colitis.

BACKGROUND: 5-aminosalicylic acid (5-ASA) is the recommended first-line treatment for active mild-to-moderate ulcerative colitis (UC) and for maintenance of UC remission. However, persistence and adherence to prescribed 5-ASAs are often suboptimal. OBJECTIVE: To evaluate 5-ASA medication use patterns and assess risk factors associated with nonpersistence and nonadherence to oral 5-ASA medications in UC patients. METHODS: IMS LifeLink Health Plan claims data (January 2007 to June 2011) were analyzed. We identified adult patients (18 years or older) with at least 1 diagnosis of UC (ICD-9-CM code = 556.x [ulcerative colitis]) and at least 1 pharmacy claim for an oral 5-ASA (balsalazide disodium, sulfasalazine, mesalamine delayed-release, and Multi-Matrix System mesalamine) during the study period. Patients were required to have continuous eligibility on both health and pharmacy plans for 6 months pre- and 12 months post-initial pharmacy claim (index date). Medication use patterns (discontinuation, time to discontinuation [days], switch, and nonadherence) in the 12 months following the index date were evaluated. Nonpersistence or discontinuation with the index medication was defined as a treatment gap ≥ 60 days. Switch was identified as patients changing to another 5-ASA product after discontinuing the index medication. Nonadherence to index medication was determined by medication possession ratio (MPR) less than 0.8 for the index medication. Nonadherence to any 5-ASA treatment was determined by a proportion of days covered (PDC) less than 0.8 for any 5-ASA. A Cox model was used to assess the relative hazards associated with discontinuation. Multiple logistic regression models were used to assess risk factors associated with nonadherence to either the index or any 5-ASA medications. RESULTS: A total of 5,664 patients met selection criteria. The median time to discontinuation of index drug differed significantly across index medications (range, 98.5 days [sulfasalazine] to 177.5 days [Multi-Matrix System mesalamine], P less than 0.0001). Patients on Multi-Matrix System mesalamine were less likely to discontinue (63.3% vs. ≥ 68.6%, P = 0.001) and more likely to adhere to their medication (MPR ≥ 0.8; 23.1% vs. ≤ 17.4%, P less than 0.0001) than patients on other medications. Patients on mesalamine delayed-release (13.8%) or Multi-Matrix System mesalamine (14.3%) had lower switch rates than the patients on balsalazide (17.2%) or sulfasalazine (17.8%), P = 0.01. Significant predictors of nonpersistence included index medication versus Multi-Matrix System mesalamine (balsalazide disodium: HR = 1.21, 95% CI = 1.07-1.36; mesalamine delayed-release: HR = 1.21, CI = 1.11-1.32; sulfasalazine: HR = 1.40, CI = 1.25-1.57), female gender (HR = 1.16, CI = 1.09-1.23), never receiving specialist care (HR = 1.14, CI = 1.07-1.21), preferred provider organization (PPO) versus health maintenance organization (HR = 1.14, CI = 1.04-1.24), and Medicare fee for service or self-insured health plan versus commercial plan (HR = 1.29, CI = 1.10-1.52). Significant variables associated with nonadherence with 5-ASA treatment (PDC less than 0.8) included not switching medication (OR = 1.90, CI = 1.58-2.29), age less than 65 (OR = 1.90, CI = 1.56-2.31), index medication as compared with Multi-Matrix System mesalamine (balsalazide disodium: OR = 1.43, CI = 1.10-1.85; mesalamine delayed-release: OR = 1.41, CI = 1.19-1.68; sulfasalazine: OR = 1.66, CI = 1.30, 2.12), female gender (OR = 1.33, CI = 1.17-1.52), residing in different regions as compared with the Midwest region (the South [OR = 1.40, CI = 1.20-1.64] and Northeast [OR = 1.29, CI = 1.05-1.58]), no use of rectal forms during the post-index period (OR = 1.28, CI = 1.08-1.50), no use of immunosuppressive/biologic agents during the post-index period (OR = 1.70, CI = 1.35-2.14), never receiving specialist care (OR = 1.25, CI = 1.08-1.44), and Medicaid/Medicare versus commercial plan (OR = 1.48, CI = 1.03-2.13). CONCLUSIONS: Patients on once-daily dosed Multi-Matrix System mesalamine had the lowest risk of discontinuation and the highest adherence rate. Multiple factors were associated with either nonpersistence or nonadherence, including multiple-daily dosed index medication, younger age, female gender, residing in the South region, PPO plan, noncommercial payer, not using immunosuppressive/biologic agents, not using rectal 5-ASA, and never receiving specialist care.

Patient preferences for first-line oral treatment for mild-to-moderate ulcerative colitis: a discrete-choice experiment.

BACKGROUND: Patients with ulcerative colitis (UC) frequently require long-term therapy to prevent relapse. Treatments such as 5-aminosalicylic acid (5-ASA [mesalazine]) are efficacious and well tolerated, but adherence to treatment is often poor. OBJECTIVE: This discrete-choice experiment (DCE) was conducted to estimate differences in patient preferences for 5-ASA treatment in mild-to-moderate UC based on levels of self-reported adherence. Inclusion of patients residing in the US, UK, Germany, and Canada allowed for assessment of possible cultural differences in patient preferences. METHODS: DCE attributes were determined through literature review, clinician consultation, and patient interviews. Six treatment attributes were identified: ease of swallowing, time of day, quantity, extent of flare resolution, likelihood of flare occurrence, and cost. A total of 400 patients in four countries completed the DCE and adherence (Modified Morisky Scale) surveys. Data were analyzed using generalized estimating equations to estimate patient preference and willingness to pay (WTP) by levels of self-reported adherence and country of residence. RESULTS: All attributes had expected polarity and were significant predictors of patient preference. Self-reported 'good' versus 'poor' adherers significantly preferred symptom control (p = 0.0108) and mucosal healing (p = 0.0190) attributes. All patients stated preference for symptom control/mucosal healing and flare risk attributes; the latter attribute was significantly preferred across all countries. Country differences in patient preference for convenience versus clinical attributes were found. Overall, patients were willing to pay £29.24 ($US46.27) per month for symptom control and mucosal healing, and an additional £78.81 ($US124.70) per month for reduction in flare risk to 10% per year (WTP costs were equalized between each country using the published 2008 purchasing power parity). Those with flares in the past year significantly preferred avoiding future flares (p < 0.0001) versus other attributes, as well as lower risk of flares (10%, likelihood ratio: 0.64-0.70). CONCLUSIONS: Findings indicate that self-reported adherers to UC therapy have a stronger preference for clinical benefits over other treatment attributes, suggesting that positive patient assessment of effectiveness may influence adherence. Ongoing clinician assessment of patient preferences for treatment attributes, as well as education on the importance of adherence, may help improve treatment outcomes in UC.