Impact of study design on adenoma detection in the evaluation of artificial intelligence-aided colonoscopy: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Randomized controlled trials (RCTs) have reported that artificial intelligence (AI) improves endoscopic polyp detection. Different methodologies-namely, parallel and tandem designs-have been used to evaluate the efficacy of AI-assisted colonoscopy in RCTs. Systematic reviews and meta-analyses have reported a pooled effect that includes both study designs. However, it is unclear whether there are inconsistencies in the reported results of these 2 designs. Here, we aimed to determine whether study characteristics moderate between-trial differences in outcomes when evaluating the effectiveness of AI-assisted polyp detection. METHODS: A systematic search of Ovid MEDLINE, Embase, Cochrane Central, Web of Science, and IEEE Xplore was performed through March 1, 2023, for RCTs comparing AI-assisted colonoscopy with routine high-definition colonoscopy in polyp detection. The primary outcome of interest was the impact of study type on the adenoma detection rate (ADR). Secondary outcomes included the impact of the study type on adenomas per colonoscopy and withdrawal time, as well as the impact of geographic location, AI system, and endoscopist experience on ADR. Pooled event analysis was performed using a random-effects model. RESULTS: Twenty-four RCTs involving 17,413 colonoscopies (AI assisted: 8680; non-AI assisted: 8733) were included. AI-assisted colonoscopy improved overall ADR (risk ratio [RR], 1.24; 95% confidence interval [CI], 1.17-1.31; I2 = 53%; P < .001). Tandem studies collectively demonstrated improved ADR in AI-aided colonoscopies (RR, 1.18; 95% CI, 1.08-1.30; I2 = 0%; P < .001), as did parallel studies (RR, 1.26; 95% CI, 1.17-1.35; I2 = 62%; P < .001), with no statistical subgroup difference between study design. Both tandem and parallel study designs revealed improvement in adenomas per colonoscopy in AI-aided colonoscopies, but this improvement was more marked among tandem studies (P < .001). AI assistance significantly increased withdrawal times for parallel (P = .002), but not tandem, studies. ADR improvement was more marked among studies conducted in Asia compared to Europe and North America in a subgroup analysis (P = .007). Type of AI system used or endoscopist experience did not affect overall improvement in ADR. CONCLUSIONS: Either parallel or tandem study design can capture the improvement in ADR resulting from the use of AI-assisted polyp detection systems. Tandem studies powered to detect differences in endoscopic performance through paired comparison may be a resource-efficient method of evaluating new AI-assisted technologies.

Enhancing Self-Management of Percutaneous Endoscopic Gastrostomy Tubes Through the Implementation of a Standardized Education and Assessment Pathway: A Quality Improvement Initiative.

Intraduodenal infusion of levodopa-carbidopa intestinal gel by percutaneous endoscopic gastrostomy tube with jejunal extension is a treatment option to reduce motor and nonmotor complications in patients with advanced Parkinson's disease when oral therapy no longer provides sufficient benefit. Medication management is of central focus; however, there was no standardized patient education on stoma-site care and tube maintenance, leading to the development of stoma-site complications. As a quality improvement (QI) initiative, a standardized education and assessment pathway was developed and implemented in an urban academic outpatient clinic to enhance patient self-management and reduce stoma-site complications. A retrospective chart review was conducted to establish baseline incidence of cutaneous stoma-site complications. QI interventions were implemented using a rapid-cycle improvement model. Routine stoma assessments by a nurse who specializes in wound, ostomy, and continence care were implemented at set points, and patient education on PEG tube care and maintenance was reinforced at each session. Results demonstrated a significant reduction in moderate-to-severe tube and stoma-site-related complication. Implementation of a similar standardized education and assessment pathway in patients with percutaneous endoscopic gastrostomy tubes may lead to a decrease in stoma-site-related complications and overall better patient self-management.

Variable or Fixed? Exploring Entrustment Decision Making in Workplace- and Simulation-Based Assessments.

PURPOSE: Many models of competency-based medical education (CBME) emphasize assessing entrustable professional activities (EPAs). Despite the centrality of EPAs, researchers have not compared rater entrustment decisions for the same EPA across workplace- and simulation-based assessments. This study aimed to explore rater entrustment decision making across these 2 assessment settings. METHOD: An interview-based study using a constructivist grounded theory approach was conducted. Gastroenterology faculty at the University of Toronto and the University of Calgary completed EPA assessments of trainees' endoscopic polypectomy performance in both workplace and simulation settings between November 2019 and January 2021. After each assessment, raters were interviewed to explore how and why they made entrustment decisions within and across settings. Transcribed interview data were coded iteratively using constant comparison to generate themes. RESULTS: Analysis of 20 interviews with 10 raters found that participants (1) held multiple meanings of entrustment and expressed variability in how they justified their entrustment decisions and scoring, (2) held personal caveats for making entrustment decisions "comfortably" (i.e., authenticity, task-related variability, opportunity to assess trainee responses to adverse events, and the opportunity to observe multiple performances over time), (3) experienced cognitive tensions between formative and summative purposes when assessing EPAs, and (4) experienced relative freedom when using simulation to formatively assess EPAs but constraint when using only simulation-based assessments for entrustment decision making. CONCLUSIONS: Participants spoke about and defined entrustment variably, which appeared to produce variability in how they judged entrustment across participants and within and across assessment settings. These rater idiosyncrasies suggest that programs implementing CBME must consider how such variability affects the aggregation of EPA assessments, especially those collected in different settings. Program leaders might also consider how to fulfill raters' criteria for comfortably making entrustment decisions by ensuring clear definitions and purposes when designing and integrating workplace- and simulation-based assessments.

Development and prospective validation of a scoring system for the Basic Endoscopic Skills Training (BEST) box.

AIMS: The increased use of endoscopy as a minimally invasive therapeutic technique has created a great demand for endoscopic training. The Basic Endoscopic Skills Training (BEST) box provides a low-cost solution by adapting the Fundamentals of Laparoscopic Surgery (FLS) box for flexible endoscopic simulation. The BEST box consists of six endoscopic tasks with a 5-min time limit per task. This study aims to develop a scoring system for objective evaluation of user performance. METHODS: A total of 165 participants were tested on the BEST box. Participants were divided into two groups: retrospective analysis (n = 100) and prospective analysis (n = 65). From the retrospective group, 55 individuals were also scored on the Global Assessment of Gastrointestinal Endoscopic Skills-Upper Endoscopy (GAGES-UE). Linear regression between user performance on BEST box and GAGES-UE was performed to develop the scoring system. Receiver Operating Characteristic curve was used to determine a threshold score to help users appreciate their endoscopic expertise. Prospective scoring of 65 individuals was then performed using the formula developed (20 experts and 45 trainees). RESULTS: The minimum and maximum possible scores are 30 and 110, respectively. Retrospective analysis showed that the scoring system was able to distinguish between experts and trainees (p < 0.001), correlated with GAGES-UE (p < 0.001), and had a reliability constant of r = 0.765 (p < 0.001). On prospective testing using the scoring system the expert group received a final average score of 92, whereas the average score for the trainee group was 61 (p < 0.001). CONCLUSIONS: The developed BEST box scoring system correlates with the experience level of the test taker as well as with the GAGES-UE scoring system. The results of this study add further evidence to the validity of the BEST box as an effective, low-cost endoscopic simulator with the scores used by trainees to track their performance level overtime.

Meeting the Motility Educational Requirements of the Gastroenterology Trainee in the 21st Century.

BACKGROUND: Gastrointestinal (GI) motility and functional disorders comprise over two-third of referrals to GI specialists yet training programs are disproportionately focused on endoscopy, inflammatory bowel disease and liver disease. Trainees at many centres receive minimal or no formal training in motility disorders and have little or no exposure to motility testing. Our purpose was to develop an educational intervention to address this learning need. METHODS: We designed a formal training program comprised of didactic sessions, workshops and hands-on motility sessions with live demonstrations designed to be held over the course of a weekend. Faculty for the course were experienced GI motility experts from across Canada. Resident trainees from all Canadian GI fellowship programs were invited to attend. Pre- and post-tests were administered to measure the baseline learning needs and the impact of the program. Course evaluations were completed by attendees. RESULTS: Three annual courses were offered over the past 3 years. Both adult and paediatric gastroenterology trainees attended the programs. The majority of training programs from Canada were represented. Baseline testing of attendees revealed a fundamental lack of understanding of GI motility concepts and their clinical implications. Postcourse test scores demonstrated a significant improvement in motility knowledge. Course evaluations of the content and faculty presentations received uniformly positive reviews. CONCLUSIONS: There is a pervasive lack of clinical knowledge of GI motility among Canadian GI subspecialty trainees. A focused weekend intensive course is one step in addressing this learning need.

Optical Biopsy of the Upper GI Tract Using Fluorescence Lifetime and Spectra.

Screening and surveillance for gastrointestinal (GI) cancers by endoscope guided biopsy is invasive, time consuming, and has the potential for sampling error. Tissue endogenous fluorescence spectra contain biochemical and physiological information, which may enable real-time, objective diagnosis. We first briefly reviewed optical biopsy modalities for GI cancer diagnosis with a focus on fluorescence-based techniques. In an ex vivo pilot clinical study, we measured fluorescence spectra and lifetime on fresh biopsy specimens obtained during routine upper GI screening procedures. Our results demonstrated the feasibility of rapid acquisition of time-resolved fluorescence (TRF) spectra from fresh GI mucosal specimens. We also identified spectroscopic signatures that can differentiate between normal mucosal samples obtained from the esophagus, stomach, and duodenum.

Efficacy of Biofeedback Therapy in Clinical Practice for the Management of Chronic Constipation and Fecal Incontinence.

BACKGROUND: Chronic constipation (CC) and fecal incontinence (FI) are often secondary to pelvic floor neuromuscular sensory or motor dysfunction. Biofeedback therapy (BFT) uses visual and verbal feedback to improve anorectal coordination, strength and sensation. In clinical trials, BFT demonstrated response rates between 70% and 80%. The purpose of this study is to determine the effectiveness of BFT in clinical practice. METHODS: In this retrospective observational cohort study, the charts of all patients who completed BFT at our centre were reviewed. A positive response to BFT was defined as improvement in ARM profile from baseline or subjective symptom improvement or both. Descriptive statistics were used to analyze the data. RESULTS: One hundred thirty patients with an average age of 57.5 ± 16.4 years and 79.2% female were included. Of all patients, 43.1% were referred for CC, 37.7% for FI, 16.9% for alternating CC and FI, and 2.3% for rectal pain. The overall response rate to BFT was 76.2% (n=99). Of those that responded, 64.6% (n=64) demonstrated both ARM and symptom improvement, 27.3% (n=27) had ARM improvement but no symptom improvement, and 8.1% (n=8) had symptom improvement but no ARM improvement. In patients with FI, the overall response rate was 79.6% (n=39) with symptom improvement in 67.3% (n=33). In those with CC with dyssynergic defecation (n=53), the overall response rate was 69.8% (n=37); however, only 45.3% (n=24) had symptomatic improvement. CONCLUSION: In our clinical practice, although overall response rates to BFT are similar to published reports, patients with CC with dyssynergic defecation are less likely to have symptomatic response compared with those with FI.

Efficacy and Safety of Eluxadoline in Patients With Irritable Bowel Syndrome With Diarrhea Who Report Inadequate Symptom Control With Loperamide: RELIEF Phase 4 Study.

OBJECTIVES: Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder with limited effective treatment options. We evaluated the efficacy and safety of eluxadoline in patients with IBS-D who reported inadequate symptom control with prior loperamide. METHODS: Three hundred forty-six adults with IBS-D (Rome III criteria) were randomly assigned to placebo or eluxadoline 100 mg twice daily for 12 weeks. Patients recorded daily IBS-D symptoms, including worst abdominal pain (WAP) and stool consistency (through Bristol Stool Scale). The primary endpoint was proportion of composite responders, defined as patients who met daily composite response criteria (≥40% WAP improvement and <5 Bristol Stool Scale score) for at least 50% of treatment days, and recorded ≥60 days of diary entries over the 12-week period. RESULTS: Over 12 weeks, a significantly greater proportion of eluxadoline patients achieved the primary composite responder endpoint compared to placebo (22.7% vs 10.3%, P = 0.002), and component endpoints of improvements in stool consistency (27.9% vs 16.7%, P = 0.01) and WAP (43.6% vs 31.0%, P = 0.02). Additionally, a greater proportion of eluxadoline patients met the composite responder endpoint assessed at monthly intervals compared to placebo (weeks 1-4: 14.0% vs 6.9%, P = 0.03; weeks 5-8: 26.7% vs 14.9%, P = 0.006; weeks 9-12: 30.8% vs 16.7%, P = 0.002). Rates of adverse events were comparable in both groups (37.4% vs 35.3%); no treatment-related serious adverse event, cases of sphincter of Oddi spasm, or pancreatitis were reported. DISCUSSION: Eluxadoline appears safe and effective for treating IBS-D symptoms in patients with an intact gallbladder reporting inadequate relief with prior loperamide use.

Adaptation of the fundamentals of laparoscopic surgery box for endoscopic simulation: performance evaluation of the first 100 participants.

BACKGROUND: The paucity of readily accessible, cost-effective models for the simulation, practice, and evaluation of endoscopic skills present an ongoing barrier for resident training. We have previously described a system for conversion of the Fundamentals of Laparoscopic Surgery box (FLS) for flexible endoscopic simulation. Six endoscopic tasks focusing on scope manipulation, and other clinically relevant endoscopic skills are performed within a 5-min time limit per task. This study describes our experience and validation results with the first 100 participants. METHODS: A total of 100 participants were evaluated on the simulator. Thirty individuals were classified as experts (having done over 200 endoscopic procedures), and 70 were classified as trainees (39 individuals reported having no prior endoscopy experience). Of the 100 participants, 55 individuals were retested on the simulator within a period of 4 months. These 55 individuals were also evaluated using the "Global Assessment of Gastrointestinal Endoscopic Skills" (GAGES). T-tests and Pearson correlations were used where appropriate, values less than 0.05 were considered significant. RESULTS: Experts completed all six tasks significantly faster than trainees. For the 55 participants who were retested on the simulator, all tasks demonstrated evidence of test-retest reliability for both experts and trainees who did not practice in between tests. Moderate correlations between lower completion times and higher GAGES scores were observed for all tasks except the clipping task. CONCLUSIONS: The results from the first 100 participants provide evidence for the simulator's validity. Based on task completion times, we found that experts perform significantly better than trainees. Additionally, preliminary data demonstrate evidence of test-retest reliability, as well as GAGES score correlation. Additional studies to determine and validate a scoring system for this simulator are ongoing.

Feasibility of adapting the fundamentals of laparoscopic surgery trainer box to endoscopic skills training tool.

BACKGROUND: The fundamentals of laparoscopic surgery (FLS) training box is a validated tool, already accessible to surgical trainees to hone their laparoscopic skills. We aim to investigate the feasibility of adapting the FLS box for the practice and assessment of endoscopic skills. This would allow for a highly available, reusable, low-cost, mechanical trainer. METHODS: The design and development process was based on a user-centered design, which is a combination of the design thinking method and cognitive task analysis. The process comprises four phases: empathy, cognitive, prototyping/adaptation, and end user testing. The underlying idea was to utilize as many of the existing components of FLS training to maintain simplicity and cost effectiveness while allowing for the practice of clinically relevant endoscopic skills. A sample size of 18 participants was calculated to be sufficient to detect performance differences between experts and trainees using a two tailed t test with alpha set at 0.05, standard deviation of 5.5, and a power of 80%. RESULTS: Adaptation to the FLS box included two fundamental attachments: a front panel with an insertion point for an endoscope and a shaft which provides additional support and limits movement of the scope. The panel also allows for mounting of retroflexion tasks. Six endoscopic tasks inspired by FLS were designed (two of which utilize existing FLS components). Pilot testing with 38 participants showed high user's satisfaction and demonstrated that the trainer was robust and reliable. Task performance times was able to discriminate between trainees and experts for all six tasks. CONCLUSIONS: A mechanical, reusable, low-cost adaptation of the FLS training box for endoscopic skills is feasible and has high user satisfaction. Preliminary testing shows that the simulator is able to discriminate between trainees and experts. Following further validation, this adaptation may act as a supplement to the FES program.

Clinical Practice Guidelines for the Assessment of Uninvestigated Esophageal Dysphagia.

BACKGROUND AND AIMS: Our aim is to review the literature and provide guidelines for the assessment of uninvestigated dysphagia. METHODS: A systematic literature search identified studies on dysphagia. The quality of evidence and strength of recommendations were rated according to the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. Statements were discussed and revised via small group meetings, teleconferences, and a web-based platform until consensus was reached by the full group. RESULTS: The consensus includes 13 statements focused on the role of strategies for the assessment of esophageal dysphagia. In patients presenting with dysphagia, oropharyngeal dysphagia should be identified promptly because of the risk of aspiration. For patients with esophageal dysphagia, history can be used to help differentiate structural from motility disorders and to elicit alarm features. An empiric trial of proton pump inhibitor therapy should be limited to four weeks in patients with esophageal dysphagia who have reflux symptoms and no additional alarm features. For patients with persistent dysphagia, endoscopy, including esophageal biopsy, was recommended over barium esophagram for the assessment of structural and mucosal esophageal disease. Barium esophagram may be useful when the availability of endoscopy is limited. Esophageal manometry was recommended for diagnosis of esophageal motility disorders, and high-resolution was recommended over conventional manometry. CONCLUSIONS: Once oropharyngeal dysphagia is ruled out, patients with symptoms of esophageal dysphagia should be assessed by history and physical examination, followed by endoscopy to identify structural and inflammatory lesions. If these are ruled out, then manometry is recommended for the diagnosis of esophageal dysmotility.

The Use of Standardized Questions in Identifying Patients with Dyssynergic Defecation.

BACKGROUND: Dyssynergic defecation (DD) is present in approximately 30% of patients with idiopathic chronic constipation (CC). Diagnostic criteria for DD require objective testing such as anorectal manometry (ARM); yet, ARM remains a limited resource in Canada. The aim of this study is to determine the predictability of DD in patients with CC using a standardized self-reported symptom questionnaire. METHOD: In this study, 166 consecutive English-speaking patients with CC who were referred for ARM completed a symptom questionnaire. DD was diagnosed if pelvic floor dyssynergy was demonstrated by ARM and balloon expulsion time was more than one minute. Likelihood ratios (LRs) were calculated for individual symptoms and prespecified symptom combinations. Likelihood ratios greater than five or less than 0.2 were considered significant. A recursive partitioning tree was used to find the symptoms best able to predict DD. RESULTS: No single constipation symptom was sufficient to predict a diagnosis of DD. Patients who reported sometimes feeling an urge to defecate and a prolonged straining duration of greater than five minutes were more likely to have DD (LR = 7.74). In patients who reported straining often or always and had a short straining duration of less than two minutes, the diagnosis of DD was less likely (LR = 0.04). The recursive partitioning tree analysis similarly identified a sense of urge with a prolonged straining duration as predictor for DD, as well as an incomplete evacuation as another potential predictor. CONCLUSION: Questions regarding need to strain, duration of straining, urge to defecate, and incomplete evacuation are useful to predict the presence of DD in patients with CC. These questions will enable clinicians to make a clinical diagnosis of DD to guide treatment.

Treatment Algorithm for Chronic Idiopathic Constipation and Constipation-Predominant Irritable Bowel Syndrome Derived from a Canadian National Survey and Needs Assessment on Choices of Therapeutic Agents.

Background. Chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome (IBS-C) are common functional lower gastrointestinal disorders that impair patients' quality of life. In a national survey, we aimed to evaluate (1) Canadian physician practice patterns in the utilization of therapeutic agents listed in the new ACG and AGA guidelines; (2) physicians satisfaction with these agents for their CIC and IBS-C patients; and (3) the usefulness of these new guidelines in their clinical practice. Methods. A 9-item questionnaire was sent to 350 Canadian specialists to evaluate their clinical practice for the management of CIC and IBS-C. Results. The response rate to the survey was 16% (n = 55). Almost all (96%) respondents followed a standard, stepwise approach for management while they believed that only 24% of referring physicians followed the same approach. Respondents found guanylyl cyclase C (GCC) agonist most satisfying when treating their patients. Among the 69% of respondents who were aware of published guidelines, only 50% found them helpful in prioritizing treatment choices and 69% of respondents indicated that a treatment algorithm, applicable to Canadian practice, would be valuable. Conclusion. Based on this needs assessment, a treatment algorithm was developed to provide clinical guidance in the management of IBS-C and CIC in Canada.

The role and structure of the multidisciplinary team in the management of advanced Parkinson's disease with a focus on the use of levodopa-carbidopa intestinal gel.

A multidisciplinary team (MDT) approach is increasingly recommended in Parkinson's disease (PD) treatment guidelines, but no standard of care exists for such an approach, and the guidelines do not provide clarification on how it should be implemented. This paper reviews evidence of MDT interventions in people with PD and provides expert clinical perspectives for an MDT approach, with a focus on advanced PD and levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension in the USA). The key recommendations are to enable the best possible treatment of people with PD locally by facilitating a close structured collaboration of different health care professionals working in a fixed network structure; to refer people with PD to established MDT centers in a timely manner; to establish regular meetings for the MDT enabling interdisciplinary exchange and learning; to optimize individual treatment and carefully evaluate available treatment options; to ensure treatment decisions are agreed jointly between people with PD, their caregivers, family, and health care professional; and to include specialists outside of neurology from adjuvant medical departments as necessary when implementing advanced therapies.

Safety and efficacy of POEM for treatment of achalasia: a systematic review of the literature.

INTRODUCTION: Peroral endoscopic myotomy (POEM) is a novel intervention for the treatment of achalasia, which combines the advantages of endoscopic access and myotomy. The purpose of this study was to perform a systematic review of the literature to evaluate the efficacy and safety of POEM. METHODS: The systematic review was conducted following the PRISMA guidelines. Evidence-Based Medicine Reviews, Cochrane Central Register of Controlled Trials, Ovid MEDLINE (R) including in-process and non-indexed citations were searched for POEM studies using the keywords: esophageal achalasia, POEM, endoscopy, natural orifice surgery, laparoscopic Heller myotomy (LHM), and related terms. Eckardt score, lower esophageal sphincter (LES) pressure, and reported complications were the main outcomes. Two authors reviewed the search result independently. A third reviewer resolved all disagreements. Data abstraction was pilot-tested and approved by all authors. Data were examined for clinical, methodological, and statistical heterogeneity with the aim of determining whether evidence synthesis using meta- analysis was possible. RESULTS: The search strategy retrieved 2894 citations. After removing duplicates and applying the exclusion criteria, 54 studies were selected for full-text review of which a total of 19 studies were considered eligible for further analysis. There were 10 retrospective and 9 prospective studies, including 1299 POEM procedures. No randomized control trial (RCT) was identified. Overall, the pre- and post-POEM Eckardt scores and LES pressure were significantly different. The most frequently reported complications were mucosal perforation, subcutaneous emphysema, pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion, and pneumonia. The median follow-up was 13 months (range 3-24). CONCLUSION: POEM is a safe and effective alternative for the treatment of achalasia. However, only short-term follow-up data compared with LHM are available. RCTs and long-term follow-up studies are needed to establish the efficacy and safety of POEM in the management of patients with achalasia.

Domperidone Prescribing Practices Exposed Patients to Cardiac Risk despite a "Black Box" Warning: A Canadian Tertiary Care Center Study.

Background. In 2012, Health Canada released a warning regarding domperidone use, based on associations with life-threatening arrhythmias and death. Objective. This study aimed to compare the appropriateness of domperidone prescribing patterns before the advisory to those afterward. Methods. Two retrospective reviews were conducted for patients prescribed domperidone during quarters in 2005 and 2012. Outcomes included appropriateness of indication, dosing regimens, monitoring of electrolytes, baseline electrocardiogram performance and characteristics, presence of left ventricular dysfunction, and coprescription of QT-prolonging medications. Univariable and multivariable logistic regression analyses were performed. p values < 0.05 were considered significant. Results. 290 and 287 patients were analyzed in 2005 and 2012, respectively. Domperidone initiation in hospital decreased from 2005 to 2012 (71.4% versus 39.4%, p < 0.0001) as did prescriptions for nonapproved indications (84.8% versus 58.2%, p < 0.0001). In-hospital initiation predicted prescription for nonapproved indications (OR = 7.01, 95% CI 4.52-10.87, p < 0.0001). Use of domperidone as the sole GI drug predicted nonapproved indications (OR = 2.51, 95% CI 1.38-4.55, p = 0.002). Conclusions. The advisory was associated with more appropriate domperidone initiation and compliance with recommended dosages. Our study suggests the need for increased awareness of the dosing and monitoring of domperidone to ensure patient safety.

Valid and reliable techniques for measuring fibrosis in patients with head and neck cancer postradiotherapy: A systematic review.

BACKGROUND: Fibrosis is a common side effect of radiotherapy for head and neck cancer. Although treatments for fibrosis have been developed, valid and reliable measurement tools are needed to verify their efficacy. The purpose of this review was to identify and appraise tools used to measure head and neck fibrosis. METHODS: Electronic databases were searched for primary research published through April 2014. Main search terms included head and neck cancer, radiotherapy, fibrosis, validity, and reliability. Methodological quality was assessed using Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). Two blinded raters conducted all assessments. Discrepancies were resolved by consensus. RESULTS: The search retrieved 534 unique citations. Nine studies met our inclusion criteria, representing 9 different tools. Only 1 tool was assessed for reliability and validity. QUADAS-2 revealed that all studies were at risk for bias. CONCLUSION: To date, there are no valid and reliable techniques for measuring fibrosis postradiotherapy for head and neck cancer, especially within the suprahyoid and pharyngeal regions. © 2015 Wiley Periodicals, Inc. Head Neck 38: E2322-E2334, 2016.