OBJECTIVES: Chronic idiopathic constipation (CIC) is characterized by unsatisfactory defecation and difficult or infrequent stools. CIC affects 9%–20% of adults in the United States, and although prevalent, gaps in knowledge remain regarding CIC healthcare seeking and medication use in the community. We recruited a population-based sample to determine the prevalence and predictors of (i) individuals having discussed their constipation symptoms with a healthcare provider and (ii) the use of constipation therapies. METHODS: We recruited a representative sample of Americans aged 18 years or older who had experienced constipation. Those who met the Rome IV criteria for irritable bowel syndrome and opioid-induced constipation were excluded. The survey included questions on constipation severity, healthcare seeking, and the use of constipation medications. We used multivariable regression methods to adjust for confounders. RESULTS: Overall, 4,702 participants had experienced constipation (24.0% met the Rome IV CIC criteria). Among all respondents with previous constipation, 37.6% discussed their symptoms with a clinician (primary care provider 87.6%, gastroenterologist 26.0%, and urgent care/emergency room physician 7.7%). Age, sex, race/ethnicity, marital status, employment status, having a source of usual care, insurance status, comorbidities, locus of control, and constipation severity were associated with seeking care (P < 0.05). Overall, 47.8% of respondents were taking medication to manage their constipation: over-the-counter medication(s) only, 93.5%; prescription medication(s) only, 1.3%; and both over-the-counter medication(s) and prescription medication(s), 5.2%. DISCUSSION: We found that 3 of 5 Americans with constipation have never discussed their symptoms with a healthcare provider. Furthermore, the use of prescription medications for managing constipation symptoms is low because individuals mainly rely on over-the-counter therapies.

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Background: Chronic idiopathic constipation (CIC) is a functional gastrointestinal disorder with an estimated prevalence of 16% in the USA; however, the humanistic and economic burden of CIC is poorly characterized. Aim: This systematic literature review aimed to assess the humanistic and economic burden of CIC in adults in the USA. Methods: Two systematic literature searches of English-language publications on the humanistic and economic burden of CIC in adults in the USA were conducted using electronic databases and other resources. Both searches included the terms "chronic idiopathic constipation" and "functional constipation". Specific terms used in the search on humanistic burden included "quality of life", "SF-36", "SF-12", and "PAC-QOL"; search terms for economic burden included "cost", "resource use", "absenteeism", and "productivity". Results: Overall, 16 relevant articles were identified. Health-related quality of life (HRQoL) appeared to be reduced in patients with CIC compared with controls and the general US population. Abdominal (r=0.33-0.49), stool (r=0.23-0.33), and rectal symptoms (r=0.53) appeared to be associated with reduced HRQoL. Younger age and female sex were associated with reduced overall HRQoL and greater symptom severity. Direct outpatient costs were higher in patients with CIC than those without CIC (US$6284 vs US$5254). Patients with CIC and abdominal symptoms reported more days of disrupted productivity per month than those without abdominal symptoms (3.2 days vs 1.2 days). The overall prevalence of complementary and alternative medicine use by patients with CIC was similar to that in the general US population. Conclusion: The reduced HRQoL and increased costs associated with CIC indicate unmet therapeutic need in this disorder. Further research is required to better understand the humanistic and economic burden of CIC in the USA.

Crohn disease (CD) is a chronic inflammatory condition without a permanent medical cure and commonly requiring a lifetime of care. This article discusses the impact of natalizumab induction and maintenance therapy on the health-related quality of life (HRQoL) of CD patients. Two natalizumab phase III studies were evaluated: the Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) study evaluated the HRQoL of CD patients during 12 weeks of natalizumab induction therapy, and the Evaluation of Natalizumab As Continuous Therapy (ENACT-2) trial evaluated the effect of natalizumab maintenance therapy on HRQoL for a period of 48 weeks past a 12-week induction period (ENACT-1). HRQoL assessments were made with the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form-36 (SF-36). In the ENCORE study, induction therapy with natalizumab was demonstrated to significantly increase HRQoL scores at 12 weeks when compared with patients on placebo. During the ENACT-2 trial, IBDQ and SF-36 scale scores of patients who responded to natalizumab induction remained stable whereas those on placebo worsened. At week 60, the mean change from baseline on all scales of the IBDQ and the SF-36 were significantly higher for those who continued to receive natalizumab as compared to those who received placebo (p

The ratio of controller to total medications dispensed for COPD is a measure that can easily be calculated using only pharmacy claims data. A CTR of greater than or equal to 0.3 can potentially be used as a quality-of-care measurement for prevention of exacerbations.

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Objectives To develop tools for identifying and addressing medication adherence barriers so that they are asthma‐specific, to assess pharmacists’ perspectives on the use of the tools and their implementation in the community pharmacy practice. Methods Development of asthma adherence tools involved analysis of available tools that focused on identifying and resolving asthma‐specific barriers to adherence, followed by selection and modification of tools. Semi‐structured interviews were conducted with practicing community pharmacists on pharmacists’ experiences in addressing adherence for patients with asthma, barriers, special concerns and perceptions regarding the proposed tools and their implementation in practice. Audio‐recorded interviews were transcribed. Thematic analysis was conducted to describe pharmacists’ feedback. Key findings Three asthma‐specific tools, which were adapted from the Adherence Starts with Knowledge‐12 adherence tool and the Drug Adherence Work‐up tool, were utilized in this study, including: (1) a patient questionnaire to identify asthma medication adherence barriers, (2) a pharmacist ‘Conversation Starter’ document to efficiently facilitate identification and resolution of barrier(s), and (3) a patient pamphlet entitled ‘Breathe Easier’ to address and educate patients regarding identified barrier(s). Pharmacists’ (N = 5) overall perspectives on the approach and proposed tools were positive. All pharmacists acknowledged high patient need for asthma education and adherence support. Most of the interviewees agreed that common adherence barriers were addressed in the tools and that the main barrier regarding program implementation was time. Providing focused counselling by utilizing tools that identify specific patient issues and offer possible solutions may help overcome the time barrier. Conclusions The proposed tools can enhance patient–pharmacist communication and have the potential to improve adherence and overall asthma management, which can lead to a decreased asthma burden.

Background Ulcerative colitis (UC) and Crohn’s disease (CD) are associated with a range of symptoms that adversely affect health-related quality of life. This research aimed to develop and validate two patient-reported outcome (PRO) tools to assess signs and symptoms in patients with moderate-to-severe UC or CD. Methods PRO-UC and PRO-CD Diaries were developed in accordance with US Food and Drug Administration (FDA) recommendations. Data were collected from concept elicitation interviews (in which patients described their symptoms and experience of the disease) and further refined through cognitive interviews (in which patients assessed the relevance and clarity of questions in the tools). Results Interviews were conducted with 12 patients for each indication. Five symptoms (urgent bowel movements, abdominal pain, frequent bowel movements, bloody stools, diarrhea/watery stools) were reported by 83–100% of participants with UC and were included in the final 6-item PRO-UC Diary: stool frequency, rectal bleeding (2 items), diarrhea, rectal urgency, and abdominal pain. For CD, seven symptoms (abdominal pain, diarrhea/loose stools, urgent bowel movements, fatigue/tiredness/weakness, frequent bowel movements, bloody stools, nausea) were reported by 50–100% of participants. These, together with vomiting and incontinence (reported by 42% and 33% of participants, respectively), were included in the final 10-item PRO-CD Diary, covering abdominal pain (2 items), stool frequency, liquid/very soft stool frequency, rectal bleeding, rectal urgency, nausea, vomiting, bowel incontinence, and general well-being. Symptoms were consistently cited across both indications to have an impact on quality of life, with frequent complaints being the need to always be near a toilet and inability to leave home, as well as general pain, discomfort, and nausea. For both tools, questions were accurately interpreted, with at least 67% of participants in both indications stating that items were easy to answer/relevant to their condition and symptoms were easy to recall over the last 24 h. Conclusions Both the PRO-UC and PRO-CD Diaries were developed and validated in accordance with FDA recommendations, providing two new tools for use in clinical trials to assess response to treatment in patients with UC or CD. Psychometric analyses are warranted to fully evaluate their properties and value for use in clinical trials.