Utility of irritable bowel syndrome subtypes and most troublesome symptom in predicting disease impact and burden.

BACKGROUND: Little is known about the characteristics of individuals with irritable bowel syndrome (IBS) according to stool subtype or the most troublesome symptom reported by the individual, or whether these are useful in predicting the impact of IBS. METHODS: We collected demographic, gastrointestinal, and psychological symptoms, healthcare usage and direct healthcare costs, impact on work and activities of daily living, and quality of life data from individuals with Rome IV-defined IBS. KEY RESULTS: We recruited 752 people with Rome IV IBS. Individuals with IBS-D reported a poorer disease-specific quality of life than those with IBS-C or IBS-M (mean (SD) IBS-QOL 45.3 (23.0) for IBS-D, vs. 52.3 (19.9) for IBS-C, vs. 49.4 (22.0) for IBS-M, p = 0.005). Mean (SD) IBS-QOL scores were also lower amongst those who reported diarrhea (44.8 (22.3)) or urgency (44.6 (22.3)) as their most troublesome symptom, compared with those reporting abdominal pain (52.2 (22.9)), constipation (49.5 (21.8)), or abdominal bloating or distension (50.4 (21.3)). However, there were no differences in mean EQ-5D scores, IBS severity, levels of anxiety, depression, somatoform symptom-reporting, or gastrointestinal symptom-specific anxiety. Direct healthcare costs of IBS were similar across all subtypes and all most troublesome symptom groups, although some differences in work productivity and social leisure activities were detected. CONCLUSIONS AND INFERENCES: There appears to be limited variation in the characteristics of individuals with Rome IV IBS based on both stool subtypes and most troublesome symptom reported, suggesting that gastrointestinal symptoms alone have limited ability to predict disease impact and burden.

Novel Symptom Subgroups in Individuals With Irritable Bowel Syndrome Predict Disease Impact and Burden.

BACKGROUND & AIMS: Current classification systems based on bowel habit fail to capture the multidimensional nature of irritable bowel syndrome (IBS). We previously derived and validated a classification system, using latent class analysis, incorporating factors beyond bowel habit. We applied this in another cohort of people with IBS to assess its ability to capture the impact of IBS on the individual, the health care system, and society. METHODS: We collected demographic, symptom, and psychological health data from adults in the community self-identifying as having IBS, and meeting Rome IV criteria. We applied our latent class analysis model to identify the 7 subgroups (clusters) described previously, based on overall gastrointestinal symptom severity and psychological burden. We assessed quality of life, health care costs (£1 = $1.20), employment status, annual income, work productivity, and ability to perform work duties in each cluster. RESULTS: Of 1278 responders, 752 (58.8%) met Rome IV criteria. The 7-cluster model fit the data well. The patients in the 4 clusters with the highest psychological burden, and particularly those in cluster 6 with high overall gastrointestinal symptom severity and high psychological burden, showed lower educational levels, higher gastrointestinal symptom-specific anxiety, were more likely to have consulted a gastroenterologist, and used more drugs for IBS. IBS-related and generic quality of life were impaired significantly in these 4 clusters and significantly fewer individuals reported earning ≥£30,000 per year. Productivity and the ability to work, manage at home, engage in social and private leisure activities, and maintain close relationships all were impacted significantly, and IBS-related health care costs over the previous 12 months were highest in these 4 clusters. In those in cluster 6, costs were more than £1000 per person per year. CONCLUSIONS: Our clusters identify groups of individuals with significant impairments in quality of life, earning potential, and ability to work and function socially, who are high utilizers of health care.

The future of clinical trials-is it virtual?

INTRODUCTION: Participant recruitment to clinical trials is often sub-optimal. Decentralized clinical trials have the potential to address challenges in traditional site-based clinical trial recruitment. SOURCES OF DATA: This review is based on recently published literature and the experience of running a large industry-sponsored interventional trial using both traditional and decentralized methods. AREAS OF AGREEMENT: Efficient delivery of clinical trials is essential to continue to provide therapeutic improvements in a timely and cost-efficient way. Clinical trial designs are constantly evolving to achieve effective trial delivery, manage the complexity of new therapeutic algorithms and conform to cultural developments. AREAS OF CONTROVERSY: Digitally innovative decentralized clinical trials may be a solution to improve recruitment and retention. Although many trials incorporate digital innovations to reduce patient burden, decentralized clinical trials allow remote access to clinical research, potentially enhancing geographical diversity as well as reducing participant burden. GROWING POINTS: Areas for development currently being discussed are developing a 'recruitment platform' that exploits the reach of digital connectivity, automated identification of eligible participants from volunteers, employing technology for remote interaction and exploring the logistic process of delivering the interventions. AREAS TIMELY FOR RELEVANT RESEARCH: The focus of development must ensure that the overall impact will widen participation and reduce inequalities in healthcare.

Willingness to pay for medications among patients with Rome IV Irritable Bowel Syndrome.

BACKGROUND: Little is known about willingness to pay for medications among individuals with irritable bowel syndrome (IBS). METHODS: We collected demographic, gastrointestinal symptom, psychological health, quality of life, and healthcare usage data from 752 adults with Rome IV-defined IBS. We examined willingness to pay for a hypothetical medication in return for improvement in IBS symptoms using a contingent valuation method, according to these variables. RESULTS: The median amount of money individuals was willing to pay was £1-£50 (IQR £0-£100) per month for a medication with a 100% chance of improving IBS symptoms. Women, compared with men, (92.7% willing to pay "£0," 89.8% "£1-£50," 87.3% "£51-£100," 78.9% "£101-£200," and 78.5% "more than £200," p = 0.008) were less likely to be willing to pay for a pill with a 100% chance of improving IBS symptoms whilst those with an annual income of £30,000 or more (12.2% willing to pay "£0," 25.2% "£1-£50," 33.5% "£51-£100," 40.2% "£101-£200," and 35.1% "more than £200," p = 0.002) were more likely. We observed a higher willingness to pay among those with lower IBS-related quality of life (p = 0.002 for trend). Of all 752 individuals, 92.7%, 74.5%, and 58.0% would be willing to pay for a medication that would give them a 100%, 50%, or 30% chance of improving IBS symptoms, respectively. CONCLUSION: Patients with IBS are willing to pay for medications which improve IBS symptoms. Future studies should investigate the relative importance of medication pricing, efficacy, and side effect profile among individuals with IBS.

Impact of Rome IV irritable bowel syndrome on work and activities of daily living.

BACKGROUND: Few studies have demonstrated the impact of irritable bowel syndrome (IBS) on work and activities of daily living. METHODS: We collected demographic, gastrointestinal symptom, psychological health and quality of life data from 752 adults with Rome IV-defined IBS. We used the work productivity and activity impairment questionnaire for irritable bowel syndrome and the work and social adjustment scale to examine the degree of both impairment at work and in activities of daily living, as well as factors associated with these. RESULTS: Of 467 individuals who were employed, 133 (28.5%) reported absenteeism, 373 (85.6%) presenteeism and 382 (81.8%) overall work impairment. A mean of 1.97 hours of work per week was lost due to IBS. Extrapolating this across the entire UK, we estimate that between 72 and 188 million hours of work are lost per year due to IBS in individuals of working age. Among all 752 participants, 684 (91.0%) reported any activity impairment with 220 (29.3%) reporting impairment in home management, 423 (56.3%) in social leisure activities, 207 (27.5%) in private leisure activities, and 203 (27.0%) in maintaining close relationships. Severe IBS, higher levels of anxiety, depression, somatization and gastrointestinal symptom-specific anxiety, and lower levels of IBS-related quality of life were associated with impairment in both work and activities of daily living. CONCLUSION: Patients with IBS experience a substantial impact on their work and activities of daily living because of their IBS. Future studies should assess the impact of medical interventions on the ability to work and participate in social activities.

Direct healthcare costs of Rome IV or Rome III-defined irritable bowel syndrome in the United Kingdom.

BACKGROUND: Previous studies have demonstrated a substantial economic impact of irritable bowel syndrome (IBS). AIMS: To provide contemporaneous estimates of direct healthcare costs of IBS in the United Kingdom. METHODS: We collected demographic, gastrointestinal and psychological symptoms, quality of life and healthcare usage data from adults with Rome IV or Rome III IBS in the United Kingdom. We calculated the mean annual direct healthcare costs of IBS per person and used contemporaneous IBS prevalence data, together with census data, to estimate annual direct costs of IBS. We also examined predictors of higher costs. RESULTS: The mean annual direct cost of IBS per person among 752 individuals with Rome IV IBS was £556.65 (SD £1023.92) and £474.16 (SD £897.86) for 995 individuals with Rome III IBS. We estimate the annual direct healthcare cost of IBS in the United Kingdom is £1.27 billion if the Rome IV criteria are used to define IBS, and £2.07 billion using Rome III. Among individuals with Rome IV IBS, mean annual costs were higher in those with opiate use (£907.90 vs £470.58, p < 0.001), more severe symptoms (p < 0.001 for trend), a shorter duration of IBS (1 year, £1227.14 vs >5 years £501.60, p = 0.002), lower quality of life (p < 0.001 for trend), and higher depression, somatisation and gastrointestinal symptom-specific anxiety scores (P < 0.001 for trend for all). CONCLUSION: We estimate annual direct healthcare costs of IBS of between £1.3 and £2 billion in the United Kingdom.

Willingness to accept risk with medication in return for cure of symptoms among patients with Rome IV irritable bowel syndrome.

BACKGROUND: Some drugs for irritable bowel syndrome (IBS) have serious side effects. AIMS: To examine the willingness of individuals with IBS to accept risks with medication in return for symptom cure. METHODS: We collected demographic, gastrointestinal symptoms, psychological health, quality of life and impact on work and daily activities data from 752 adults with Rome IV-defined IBS. We examined median willingness to accept death in return for cure with a hypothetical medication using a standard gamble, according to these variables. RESULTS: Participants would accept a median 2.0% (IQR 0.0%-9.0%) risk of death in return for a 98.0% (IQR 91.0%-100.0%) chance of permanent symptom cure. The median accepted risk of death was higher in men (5.0% vs 2.0%, P < 0.001), those with continuous abdominal pain (4.0% vs 1.0%, P < 0.001), more severe symptoms (P = 0.005 for trend), abnormal depression scores (P < 0.001 for trend), higher gastrointestinal symptom-specific anxiety (P < 0.001 for trend), and lower IBS-related quality of life (P < 0.001 for trend). Those willing to accept above median risk of death were more likely to be male (17.1% vs 9.1%, P < 0.001), take higher levels of risks in their daily life (P = 0.008 for trend), and report continuous abdominal pain (53.1% vs 39.4%, P < 0.001), and had higher depression (P = 0.004 for trend) and lower quality of life (P < 0.001 for trend) scores. CONCLUSION: Patients are willing to accept significant risks in return for cure of their IBS symptoms.

Atypical breasts cancers.

INTRODUCTION: With increasing incidence of breast cancers there are now a larger number of cases diagnosed with rare malignancies. These can be diagnostic dilemmas and management strategy can be different by various breast multi-disciplinary teams (MDT). We aim to discuss the evidence-based approach for management of these atypical breast cancers which were identified in patients from a single breast screening unit. METHOD: Patient with unusual breast malignancies (all types except invasive ductal and lobular) treated under the care of a single surgeon were identified during the breast multi-disciplinary discussion from 2011 to 2015. The histology and management of these cases were reviewed and literature search of electronic databases via PubMed and the search engines Google/Google Scholar was performed. Emphasis on keywords based on the histology type was used to limit search. Search was focused on the diagnosis, management and prognosis of these unusual breast cancers. CONCLUSION: This series aims to focus on the evidence-based management of these rare breast malignancies; the diagnosis of which is crucial as it affects the overall treatment and prognosis.

Left gastric artery aneurysm rupture: a rare cause of retroperitoneal bleeding: a case report.

INTRODUCTION: Visceral artery aneurysms are very rare. Patients usually present as emergency secondary to the sudden rupture of the aneurysm or as an incidental finding on ultrasound, MRI or abdominal computed tomography. Among these, splenic artery aneurysms are the most common ones accounting for 60% of all splanchnic aneurysms and gastric and gastroepiploic aneurysms account for only about 4%. CASE PRESENTATION: We present a 61-year-old Caucasian male previously fit and well, presenting with sudden onset epigastric pain due to retroperitoneal haemorrhage secondary to ruptured left gastric artery aneurysm. Apart from a tender epigastrium, there were no other obvious signs elicited on abdominal examination. He had persistent tachycardia and haemoglobin drop from 10 g/dl to 6.7 g/dl. He underwent a contrast computed tomography which identified the ruptured left gastric artery. The aneurysm was controlled successfully with coil embolisation of the left gastric artery. At three-month follow-up, there was no evidence of the aneurysm. CONCLUSION: Clinical presentations that do not correlate with examination finding should prompt immediate extensive investigation. The aid of contrast computed tomography and minimally invasive radiological interventional is the key to a fruitful outcome for this very rare entity.

Porcine acellular dermis-based breast reconstruction: complications and outcomes following adjuvant radiotherapy.

BACKGROUND: Acellular dermal matrices (ADM) such as StratticeTM are increasingly used in UK during implant-based reconstruction. However, there are mixed opinions regarding the compatibility of radiotherapy treatment in pre- and post-reconstructed breasts. The aims of this study are to audit the rates of radiation induced complications in patients who underwent breast reconstruction using StratticeTM and establish whether there is an association between timing of radiotherapy and complication rates. METHODS: Retrospective data collection was performed for all patients who underwent skin-sparing mastectomy and immediate or delayed StratticeTM-based reconstruction, and received pre- or post-reconstruction radiotherapy from July 2010 to November 2014. RESULTS: The age ranged from 33 to 78 years (mean age 51 ± 10.6) with a mean follow-up time of 21 months. There were 25 StratticeTM-based reconstructions performed. Sixteen had delayed reconstruction, and 9 had skin-sparing mastectomy and immediate reconstruction. There were 4 (16 %) abandoned procedures due to inability to stretch the mastectomy flap secondary to poor skin compliance. Two women (8 %) presented 4 and 9 months later with wound breakdown. One case (4 %) developed severe capsular contracture following radiotherapy post-reconstruction and 1 case (4 %) of implant rupture. There were no episodes of extrusion or implant infection. Overall complication rates were 32 %. The majority (75 %) of complications occurred in breasts reconstructed post-radiotherapy; however, this is not significant when analysed using chi-square (p = 0.43). CONCLUSIONS: Our evidence suggests that there is no difference in complication rates in pre- and post-radiation individuals; this would suggest that implant-based reconstruction using StratticeTM should not be an absolute contraindication in pre- or post-radiotherapy patients. However, when planning these procedures, it is paramount that the increased risks are emphasised to patients in order to better manage patient expectation in cases where complications arise. Level of Evidence: Level III, risk / prognostic study.

Rectal metastasis from Breast cancer: A rare entity.

INTRODUCTION: Breast cancer metastases occurs in around 50% of all presentation. It is the second most common type of cancer to metastasise to the GI tract but this only occurs in less than 1% of cases. PRESENTATION OF CASE: We report a case that underwent treatment for invasive lobular cancer (ILC) of the breast and 5 years later was found to have rectal and peritoneal metastasis. She is currently receiving palliative management including chemotherapy in the form of weekly Paclitaxel (Taxol(®)) and stenting to relieve obstruction. CONCLUSION: There should be high clinical suspicion of bowel metastasis in patients presenting with positive faecal occult blood with or without bowel symptoms even if the incidence is less <1% of metastases, particularly in cases where the initial breast tumour was large, with positive axillary nodes.

Rare breast malignancies and review of literature: A single centres experience.

INTRODUCTION: Breast cancer is a heterogeneous condition, with variants which are less common but still very well defined by the World Health Organization (WHO) classification. With the small number of cases each year large trials are difficult to perform. This series aims to discuss the rare breast malignancies encountered within a breast department and the evidence based approached to their management. METHOD: Literature search of electronic databases via PubMed and the search engines Google/Google Scholar were used. Emphasis on keywords: breast cancer and the type of histology used to limit search. Searches were screened and those articles suitable had full text versions retrieved. The references to all retrieved texts were searched for further relevant studies. CONCLUSION: Due to the rarity of some of these breast cancers, systematic evaluation of patient with detailed histopathology will aid accurate diagnosis and management. The series hopes to add the existing understanding of this small percentage of cases.