Establishing Clinically Significant Patient-reported Outcomes for Diverticular Disease.

BACKGROUND: Diverticular disease can undermine health-related quality of life. The diverticulitis quality of life (DV-QOL) instrument was designed and validated to measure patient-reported burden of diverticular disease. However, values reflecting meaningful improvement (i.e., minimal clinically important difference [MCID]) and the patient acceptable symptom state (PASS) have yet to be established. We sought to establish the MCID and PASS of the DV-QOL and describe the characteristics of those with DV-QOL above the PASS threshold. MATERIALS AND METHODS: We performed a prospective cohort study of adults with diverticular disease from seven centers in Washington and California (2016-2018). Patients were surveyed at baseline, then quarterly up to 30 mo. To determine the MCID and PASS for DV-QOL, we applied various previously established distribution- and anchor-based approaches and compared the resulting values. RESULTS: The study included 177 patients (mean age 57 y, 43% women). A PASS threshold of 3.2/10 distinguished between those with and without health-related quality of life-impacting diverticulitis with acceptable accuracy (area under the curve 0.76). A change of 2.2 points in the DV-QOL was the most appropriate MCID: above the distribution-based MCIDs and corresponding to patient perception of importance of change (AUC 0.70). Patients with DV-QOL ≥ PASS were more often men, younger, had Medicaid, had more serious episodes of diverticulitis, and had an occupational degree or high-school education or less. CONCLUSIONS: Our study is the first to define MCID and PASS for DV-QOL. These thresholds are critical for measuring the impact of diverticular disease and the evaluation of treatment effectiveness.

Quality of life in uncomplicated recurrent diverticulitis: surgical vs. conservative treatment.

Elective sigmoid colectomy for recurrent uncomplicated diverticulitis remains controversial and is decided on an individual basis. Eighty patients treated conservatively (44 patients) or by elective surgery (36 patients) for recurrent uncomplicated diverticulitis were contacted and assessed for quality of life. The mean difference in quality of life scores was greater after surgery (overall + 2.14%, laparoscopic resection +4.95%, p = 0.36 and p = 0.11, respectively) as compared to conservative management. Female patients undergoing laparoscopic resection had statistically significantly higher quality of life scores than women treated conservatively (+8.98%; p = 0.049). Twenty-eight of 29 responding patients stated that they were highly satisfied and would have the operation done again. Elective sigmoidectomy is a valid treatment option for recurrent uncomplicated diverticulitis in terms of quality of life. Quality of life improved most if surgery was performed laparoscopically, especially in women.

The influence of rifaximin on diverticulitis rate and quality of life in patients with diverticulosis.

Diverticulosis, its associated symptoms and complications are one of the most common pathologies of the gastrointestinal tract in more economically developed countries. Presence of diverticuli and their clinical consequences can be divided into four categories: 1) diverticulosis, i.e. an asymptomatic presence of diverticuli that are usually found by accident 2) symptomatic uncomplicated diverticulosis 3) diverticulitis (acute uncomplicated diverticulitis) 4) complications of diverticulitis (conditions requiring hospital stay). The aim of this study was to retrospectively analyze the efficacy of rifaximin in preventing diverticulitis in patients visiting proctology clinics. The diagnostic criterium for diverticulosis was confirmation by colonoscopy, barium enema or CT colography (virtual colonoscopy) as well as history of at least one documented episode of diverticulosis. History of diverticulosis was evaluated based on medical records, clinical symptoms, elevated level of CRP (>5.0) and/or diagnostic imaging (ultrasound, CT). After setting strict exclusion criteria, 248 patients were qualified for the study out of 686, and they were later divided into two groups: control group (group I - 145 patients) and studied group (group II - 103 patients receiving rifaximin prophylaxis). Diverticulitis rate was comparable in both groups over a period of 6 months before study (p = 0.1306) and 6 months of treatment (p=0.3044). Between the 6th and 12th month of treatment, a significantly lower rate of diverticulitis was noted in the group receiving rifaximin compared to control group (p<0.0001). Patients receiving rifaximin reported higher quality of life (which was assessed using the VAS scale) compared to control group after 12 months. The results confirmed the efficacy of riaximin in prevention of diverticulitis, even in the scheme of repeated courses every 3 months. Not only did application of rifaximin lower the rate of diverticulitis and its complications in patients after an episode of diverticulitis, but also it improved the patients' quality of life. It seems that diverticulitis prophylaxis based on rifaximin can be economically efficient, however, it requires further research.

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.

Quality of life outcomes in 599 cancer and non-cancer patients with colostomies.

BACKGROUND: A colostomy is known to impact negatively on a patient's quality of life (QOL). Concerns include incontinence, rectal discharge, gas, difficulties in returning to work, decreased sexual activity, and travel and leisure challenges. Reports have described QOL outcomes in cancer patients with colostomies and inflammatory bowel syndrome with colostomies, but little has been written regarding a comparison of cancer and non-cancer populations. The purpose of this study was to describe QOL issues of colostomy patients and compare these issues in cancer and non-cancer participants. MATERIALS AND METHODS: A QOL-ostomy questionnaire was mailed to 2455 California members of the United Ostomy Association. RESULTS: Of the 1457 respondents (59%), 599 had a colostomy. Most were results from cancer (517/599), with colorectal cancer being the most common diagnosis. The most common benign diagnoses were inflammatory bowel disease and diverticulitis. Demographics were similar, except for more females in the non-cancer group (76%), and increased length of time with colostomy from the cancer group (mean 135.9 versus 106.4 months, P = 0.03). Common QOL problems included sexual problems, gas, constipation, travel difficulties, and dissatisfaction with appearance. Overall, cancer patients had less difficulty adjusting to their colostomies. CONCLUSIONS: Results confirmed the negative impact of a colostomy on QOL. While patients with cancer had a better overall QOL than those with benign processes, concerns were common to all colostomy patients. These results provide health care practitioners with information useful in discussing QOL concerns during pre-operation treatment decisions and post operative teaching and follow-up care.

[Correlation between colonoscopy and histopathology of the colon in diverticular disease and the irritable colon syndrome]. / Correlacão entre colonoscopia e histopatologia do cólon na doenca diverticular e na síndrome do cólon irritável.

In this study 29 patients were carriers of diverticular disease of the colons (DDC) and 29 patients with irritable bowel syndrome (IBS). The patients were diagnosed by means of a directed anamnesis standardized by the radiologic study of the colons. The methodology included, radiologic study of the colons, endoscopic examination of the colon (colonoscopy with biopsy) and anatomic pathologic examination of the fragments obtained in the endoscopy. It was tried, by means of colonoscopy with biopsy and anatomic pathological examination, to demonstrate, classify and relate, in agreement with pre-established criterion, the degree of intensity of the inflammatory process in the colic mucosa. According to the results we may conclude that: 1) colonoscopy in the studied inflammatory diseases is important for diagnosis, evaluation of the inflammatory process, identification of associated illness and material obtention for the anatomic pathological examination; 2) there is always a chronic inflammatory process, in variable degrees, of the colic mucosa in DDC and in IBS; 3) colonoscopy with biopsy and the anatomic pathological examination are adequate to diagnose with precision the degree of intensity of the chronic inflammatory process of the colic mucosa and the presence of associated disease in DDC and in IBS.