Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Background PRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system. Methods Participants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0–4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed. Results 103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55–0.90); tablet vs paper: 0.81 (0.62–0.96); IVRS vs paper: 0.78 (0.60–0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = −0.04 [−0.16–0.22]; tablet vs paper = −0.02 [−0.11–0.14]; IVRS vs paper = 0.02 [−0.07–0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/−0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported “no problems” responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper. Conclusions Mode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration. Trial registration NCT Clinicaltrials.gov identifier: NCT0215863

Vitamin D status in irritable bowel syndrome and the impact of supplementation on symptoms: what do we know and what do we need to know?

BACKGROUND: Low vitamin D status is associated with risk of colorectal cancer and has been implicated in inflammatory bowel disease. Irritable bowel syndrome (IBS) is a chronic, relapsing, functional bowel disorder. A nascent literature suggests a role for vitamin D in IBS, but this has not been collated or critiqued. To date, seven studies have been published: four observational studies and three randomised controlled trials (RCTs). All observational studies reported that a substantial proportion of the IBS population was vitamin D deficient. Two intervention studies reported improvement in IBS symptom severity scores and quality of life (QoL) with vitamin D supplementation. There are limited data around the role of vitamin D in IBS. CONCLUSIONS: The available evidence suggests that low vitamin D status is common among the IBS population and merits assessment and rectification for general health reasons alone. An inverse correlation between serum vitamin D and IBS symptom severity is suggested and vitamin D interventions may benefit symptoms. However, the available RCTs do not provide strong, generalisable evidence; larger and adequately powered interventions are needed to establish a case for therapeutic application of vitamin D in IBS

Microbiota and neurologic diseases : potential effects of probiotics

Background: The microbiota colonizing the gastrointestinal tract have been associated with both gastrointestinal and extra-gastrointestinal diseases. In recent years, considerable interest has been devoted to their role in the development of neurologic diseases, as many studies have described bidirectional communication between the central nervous system and the gut, the so-called "microbiota-gut-brain axis". Considering the ability of probiotics (i.e., live non-pathogenic microorganisms) to restore the normal microbial population and produce benefits for the host, their potential effects have been investigated in the context of neurologic diseases. The main aims of this review are to analyse the relationship between the gut microbiota and brain disorders and to evaluate the current evidence for the use of probiotics in the treatment and prevention of neurologic conditions. Discussion: Overall, trials involving animal models and adults have reported encouraging results, suggesting that the administration of probiotic strains may exert some prophylactic and therapeutic effects in a wide range of neurologic conditions. Studies involving children have mainly focused on autism spectrum disorder and have shown that probiotics seem to improve neuro behavioural symptoms. However, the available data are incomplete and far from conclusive. Conclusions: The potential usefulness of probiotics in preventing or treating neurologic diseases is becoming a topic of great interest. However, deeper studies are needed to understand which formulation, dosage and timing might represent the optimal regimen for each specific neurologic disease and what populations can benefit. Moreover, future trials should also consider the tolerability and safety of probiotics in patients with neurologic diseases

Functional Dyspepsia in Review: Pathophysiology and Challenges in the Diagnosis and Management due to Coexisting Gastroesophageal Reflux Disease and Irritable Bowel Syndrome

Functional dyspepsia is a common disorder which imposes significant diagnostic and treatment challenges for patients and physicians. The most recent update of the diagnostic criteria subdivides functional dyspepsia into two subcategories based on the main symptom of epigastric pain or postmeal fullness. As we discuss in this review, several studies have shown significant overlap in symptoms and pathophysiology between functional dyspepsia, irritable bowel syndrome, and the spectrum of reflux disorders. This overlap in symptoms can be informative in helping us to understand the underlying pathophysiology, diagnostic approaches, and treatment strategies. The addition of diagnostic testing such as pH impedance manometry of the distal esophagus to the current common diagnostic tests might be helpful in distinguishing between functional dyspepsia and reflux disease. Importantly, various treatment modalities may be more effective than others if the main symptom is burning rather than pain or postmeal fullness rather than early satiation

Development of a decision support system tool to predict the pulmonary function using artificial neural network approach

The spirometry is considered a preclinical tool for the evaluation of the respiratory system. The formal lung volumes measurement and health status lung system are made using spirometry. Artificial neural network (ANN) has been introduced in solving complex problems in a large number of different settings, including medical diagnosis support system as predictive power. An objective of this research was intended to investigate the development of a new decision support system (DSS) using ANN modeling approaches and algorithms to predict pulmonary function in people. The spirometry data and general characteristics, anthropometric data, and body composition parameters (N = 130) were obtained from subjects. The classification of pulmonary function was performed by the multi-layer perceptron (MLP) model. Findings show that the MLP model is capable of classifying respiratory abnormalities in different people. The ANN model was totally 93.6, 92.3, 84.6, and 91.5 successful in correctly classified in training, validation, test, and all data, respectively. Also, a DSS tool was created that allows the evaluation and classification of the results of spirometry data. It appears that ANNs are useful in classification pulmonary function. © 2021 John Wiley & Sons Ltd

HPV infection among patients with high grade cervical intraepithelial neoplasia and squamous cell carcinoma of cervix

Background: Cervical cancer is the second most common cancer of the women worldwide. It is also an important cause of cancer-related mortality in women, after breast cancer. Nearly half million of new cases are identified yearly. The incidence rate in developing countries is greater than the developed countries. Epidemiologic studies have shown that the association of genital human papilloma virus (HPV) with cervical cancer is strong, independent of other risk factors, and consistent in several countries. The aim of this study was to determine the frequency of HPV in patients with high grade cervical intraepithelial neoplasia (CINIII, CIN II) and squamous cell carcinoma (SCC) of cervix.Methods: Hundred specimens from patients with SCC and CINIII, CIN II, confirmed by histological review, referring to Mirza Koochak Khan Hospital from 1999-2004 were enrolled in a cross sectional study. Polymerase chain reaction was utilized for identification and typing of HPV DNA.  To increase the sensitivity of HPV detection, nested PCRs were performed using MY09/MY11 as outer and GP5/GP6 as inner primers.Results: It was possible to extract 77 of 100 specimens that HPV DNA was detected in 47 of 77 specimens. Infection with HPV was present in 32 specimens (86.5%) among SCC patients and in 15 specimens (37.5%) among CINIII, CIN II patients. The most frequent HPV types in SCC patients were HPV 16 and 18 (59.38%) and then 33 (34.38%) and in CINIII, CIN II patients was 16 (53.33%) and 18 (40%). the most frequent co-infection in both groups was HPV 16 and 18 which was present in 40.62% and 26.7% of cases respectively. Conclusions: The most frequent HPV types in patients with SCC and CINIII, CIN IIwas 16 and 18 that is identical to many other countries infection pattern

Quality of life and fecal incontinence after transanal endoscopic microsurgery for benign and malignant rectal lesions.

To access publisher's full text version of this article click on the hyperlink at the bottom of the pageTransanal endoscopic microsurgery (TEM) is a minimally invasive treatment used to excise a variety of rectal lesions. Potential overstretching of the sphincter's musculature due to dilation of the anal canal to allow placement of a 40-mm-wide scope combined with partial resection of the rectum and subsequent loss of rectal volume creates a concern regarding anorectal function postoperatively. Data regarding patient satisfaction with anorectal function and quality of life after TEM are scant. This report presents data on patient satisfaction gathered during a period of 10 years.A prospectively maintained database of patients undergoing TEM from 1997 to 2007 was queried to identify patients to survey using the Fecal Incontinence Quality of Life Scale questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) questionnaire version 3, and a questionnaire designed by the authors to assess satisfaction with quality of life. From a group of 86 patients, 57 (66 %) responded to the questionnaires. Patient satisfaction outcomes were determined by age, preoperative diagnosis, tumor level in the rectum, excision method, and radiation treatment.Most of the patients (94.7 %) preferred TEM to having a stoma. Age (p = 0.03) and nature of the lesion (p = 0.03) were the only factors that affected coping. Depression was affected only by the presence of malignancy (p = 0.001). Excision method was the only factor that significantly influenced overall lifestyle (p = 0.002). Neither tumor level (p = 0.8) nor radiation therapy (p = 0.9) affected patient satisfaction with lifestyle after TEM. The presence of malignancy (p = 0.004) and full-thickness excision (p = 0.02) were related to more problems with fecal incontinence.Satisfaction with fecal continence generally is high after TEM. Tumor level, size of tumor, and radiation therapy do not affect the level of satisfaction after TEM. Younger age and benign nature of the lesion help patients to cope better with lifestyle changes and reduce depression. Patients with submucosal excision have a significantly higher level of satisfaction