A Descriptive Study of Quality of Life Following Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma.

BACKGROUND: Patients with oropharyngeal squamous cell carcinoma (OPSCC) treated with radiation-based therapy suffer from short- and long-term toxicities that affect quality of life (QOL). Transoral robotic surgery (TORS) has an established role in the management of early OPSCC but adjuvant treatment is often indicated postoperatively due to the high incidence of nodal metastasis associated with advanced human papillomavirus (HPV)-related OPSCC. To overcome the need for adjuvant radiation therapy (RT), neoadjuvant chemotherapy followed by TORS and neck dissection (ND) is proposed. This study aimed to assess if QOL in HPV-associated OPSCC receiving neoadjuvant chemotherapy followed by TORS and ND returns to baseline within 12 months of completing treatment. METHODS: A 12 month longitudinal study was carried out at McGill University Health Centre in Montreal, Canada, among a convenience sample of patients with American Joint Committee on Cancer Seventh Edition stage III and IVa HPV-related OPSCC who were treated with neoadjuvant chemotherapy followed by TORS and ND. QOL data were obtained pretreatment and at 1, 3, 6, and 12 months following treatment completion using the European Organisation for Research and Treatment of Cancer Core and Head and Neck extension modules. Paired t tests and mixed models for repeated measures analysis were used to assess changes in QOL from baseline to 12 months postoperatively and over time, respectively. RESULTS: Nineteen of 23 patients (median age 58 years) who received the study treatment fulfilled the eligibility criteria. OPSCC subsites were palatine tonsil (n = 12) and base of tongue (n = 7). All 19 patients were treated per protocol and none required adjuvant RT as per pathology review and protocol requirements at a postoperative multidisciplinary team tumor board discussion. No significant differences were found when comparing 12 month QOL follow-up scores to pretreatment scores in measures that would likely be affected by RT [eg, swallowing (P = .7), social eating (P = .8), xerostomia (P = .9)]. CONCLUSION: In HPV-related OPSCC, neoadjuvant chemotherapy followed by TORS and ND as definitive treatment is associated with excellent QOL outcomes. Postoperative QOL scores returned to baseline by 3 months and were maintained for all measures, indicating a return to normal function.

Patient Experiences in the Management of Inflammatory Bowel Disease: A Qualitative Study.

Background: Inflammatory bowel disease (IBD) can lead to substantial impairments of quality-of-life. Clinical guidelines and quality indicators aid physicians in practice but may not reflect the perspectives and experiences of patients with IBD. To address this, the objectives of this study were to understand patient experiences with IBD care and to explore priorities. Methods: Based on a convenience sample of 36 participants, five focus groups were completed at four sites across Canada. Data were analyzed using a deductive thematic analysis approach to assess emergent themes and variability in participants' experiences. Results: Our results are organized by themes of structure, process and outcomes to illustrate common issues with respect to how care is organized in the healthcare system, how patients receive and experience care and how patients perceive the outcomes of their care. Our results frame a health systems quality approach that signal needed improvements in access to care, the need for innovation with respect to virtual medicine, the potential expansion of multidisciplinary team-based care and the importance of addressing the psychosocial dimensions for patients with IBD and their caregivers in order to better deliver patient-centred care. Conclusions: The issues identified have the potential to impact priority areas in the system, IBD care delivery, and how outcomes can be improved by focusing on 'lived experience' and patient-centred care. The differing values and perspectives of all those involved in caring for patients with IBD underscore the importance of good communication with patients, caregivers and family members, as well as staying responsive to evolving needs.

Health Care Perspectives of Adult Patients with Lower Educational Attainment in Inflammatory Bowel Disease: A Qualitative Study.

Patients with lower educational attainment are underrepresented in inflammatory bowel disease (IBD) research. To increase our understanding of the health care perspectives of patients with less than a university degree, semi-structured interviews were conducted among 23 outpatients at the McGill University Health Centre IBD Centre (Montreal, Canada). Thematic analysis was used to analyze the qualitative data. Perspectives focused on communication with health care professionals, access to care, symptoms and treatment, and outside support. Access to an IBD specialist was the most important aspect of care. Good care, kind and receptive staff, and a lengthy delay to diagnosis were frequently reported experiences. IBD specialists, nurses, and family and friends were most helpful in managing disease. Physical and emotional symptoms, reduced social engagement, and medications were difficult aspects of living with IBD. An ideal IBD clinic would provide access to traditional and non-traditional services and assist with obtaining support to help patients engage in social activities, increase affordability of care, and maintain employment. Study findings may be helpful in designing equitable models of health care delivery.

Mobile health technologies supporting colonoscopy preparation: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Mobile health (mHealth) technologies are innovative solutions for delivering instructions to patients preparing for colonoscopy. OBJECTIVE: To systematically review the literature evaluating the effectiveness of mHealth technologies supporting colonoscopy preparation on patient and clinical outcomes. METHODS: MEDLINE, EMBASE, CINAHL and CENTRAL were searched for randomized controlled trials (RCTs) that evaluated the effectiveness of mHealth technologies for colonoscopy preparation on patient and clinical outcomes. Two reviewers independently assessed study eligibility, extracted data, and appraised methodological quality using the Cochrane Risk-of-Bias tool. Data were pooled using random effects models and when heterogeneity, assessed using I2, was statistically significant, a qualitative synthesis of the data was performed. Publication bias was assessed using a funnel plot. RESULTS: Ten RCTs (3,383 participants) met inclusion criteria. MHealth interventions included smartphone apps, SMS text messages, videos, camera apps, and a social media app. Outcomes were bowel cleanliness quality, user satisfaction, colonoscopy quality indicators (cecal intubation time, withdrawal time, adenoma detection rate), adherence to diet, and cancellation/no-show rates. MHealth interventions were associated with better bowel cleanliness scores on the Boston Bowel Preparation Scale [standardized mean difference (SMD) 0.57, 95%CI 0.37-0.77, I2 = 60%, p = 0.08] and the Ottawa Bowel Preparation Scale [SMD -0.39, 95%CI -0.59-0.19, I2 = 45%, p = 0.16], but they were not associated with rates of willingness to repeat the colonoscopy using the same regimen [odds ratio (OR) 1.88, 95%CI 0.85-4.15, I2 = 48%, p = 0.12] or cancellations/no-shows [OR 0.96, 95%CI 0.68-1.35, I2 = 0%]. Most studies showed that adequate bowel preparation, user satisfaction and adherence to diet were better in the intervention groups compared to the control groups, while inconsistent findings were observed for the colonoscopy quality indicators. All trials were at high risk of bias for lack of participant blinding. Visual inspection of a funnel plot revealed publication bias. CONCLUSIONS: MHealth technologies show promise as a way to improve bowel cleanliness, but trials to date were of low methodological quality. High-quality research is required to understand the effectiveness of mHealth technologies on colonoscopy outcomes.

Association between Smoking and 30-Day Outcomes in Otologic Surgery.

OBJECTIVE: To determine the effect of current smoking status on 30-day postoperative adverse events in patients undergoing otologic surgery. STUDY DESIGN: Retrospective cohort study. SETTING: Database of the American College of Surgeons National Surgical Quality Improvement Program from 2006 to 2016. SUBJECTS AND METHODS: Adult patients undergoing middle ear and mastoid surgery were included. Preoperative smoking status was determined, and adverse events within 30 days of surgery were recorded. Descriptive statistics were used to characterize the study sample. Multivariable logistic regression was performed to identify the association between sociodemographic and clinical variables and postoperative adverse events. Population-attributable fractions were then calculated. RESULTS: A total of 10,684 patients who underwent otologic surgery were included, of whom 2036 (19.1%) were smokers. The most commonly performed surgery was tympanoplasty with and without ossicular chain reconstruction, followed by canal wall up tympanomastoidectomy. Adverse events occurred in 221 (2.1%) patients; the most common was superficial wound infections (n = 99, 0.9%). In smokers, the odds ratio for any adverse event was 1.97 (95% CI, 1.42-2.71). The odds ratios (95% CIs) for superficial wound infections, wound dehiscence, and 30-day readmission among smokers were 1.89 (1.32-2.86), 3.92 (1.26-11.60), and 1.84 (1.15-2.87), respectively. The population-attributable fraction for any adverse event in smokers was 15.5%. CONCLUSIONS: In patients undergoing otologic surgery, smokers are more likely than nonsmokers to have postoperative adverse events-in particular, wound infections, wound dehiscence, and readmission to hospital.

What Patients Want in a Smartphone App That Supports Colonoscopy Preparation: Qualitative Study to Inform a User-Centered Smartphone App.

BACKGROUND: The preparation for colonoscopy is elaborate and complex. In the context of colorectal cancer screening, up to 11% of patients do not keep their colonoscopy appointments and up to 33% of those attending their appointments have inadequately cleansed bowels that can delay cancer diagnosis and treatment. A smartphone app may be an acceptable and wide-reaching tool to improve patient adherence to colonoscopy. OBJECTIVE: The aim of this qualitative study was to employ a user-centered approach to design the content and features of a smartphone app called colonAPPscopy to support individuals preparing for their colonoscopy appointments. METHODS: We conducted 2 focus group discussions (FGDs) with gastroenterology patients treated at the McGill University Health Centre in Montreal, Canada. Patients were aged 50 to 75 years, were English- or French-speaking, and had undergone outpatient colonoscopy in the previous 3 months; they did not have inflammatory bowel disease or colorectal cancer. FGDs were 75 to 90 min, conducted by a trained facilitator, and audiotaped. Participants discussed the electronic health support tools they might use to help them prepare for the colonoscopy, the content needed for colonoscopy preparation, and the features that would make the smartphone app useful. Recordings of FGDs were transcribed and analyzed using thematic analysis to identify key user-defined content and features to inform the design of colonAPPscopy. RESULTS: A total of 9 patients (7 male and 2 female) participated in one of 2 FGDs. Main content areas focused on bowel preparation instructions, medication restrictions, appointment logistics, communication, and postcolonoscopy expectations. Design features to make the app useful and engaging included minimization of data input, reminders and alerts for up to 7 days precolonoscopy, and visual aids. Participants wanted a smartphone app that comes from a trusted source, sends timely and tailored messages, provides reassurance, provides clear instructions, and is simple to use. CONCLUSIONS: Participants identified the need for postcolonoscopy information as well as reminders and alerts in the week before colonoscopy, novel content, and features that had not been included in previous smartphone-based strategies for colonoscopy preparation. The ability to tailor instructions made the smartphone app preferable to other modes of delivery. Study findings recognize the importance of including potential users in the development phase of building a smartphone app.

Reporting quality of randomized controlled trials in otolaryngology: review of adherence to the CONSORT statement.

BACKGROUND: Randomized controlled trials are the gold standard in medical and surgical research to assess the efficacy of therapeutic interventions. The reporting of these trials should be of high quality to allow readers' appropriate interpretation and application. METHODS: The objectives of our study were to assess the extent to which the recent Otolaryngology - Head and Neck Surgery (ORL-HNS) randomized control trials in the top nine journals and in the top Canadian journal comply with the Consolidated Standards of Reporting Trials (CONSORT) statement, and to identify the CONSORT items most in need of improvement. Based on the impact factor and circulation number of 2014, the top nine Otolaryngology journals and the top Canadian Otolaryngology journal were selected and were searched to identify RCTs published in English and between 2010 and 2014. Two authors independently reviewed and extracted data using a standardized data extraction form constructed with the help of a medical librarian. Our outcome was to assess the adherence of articles reporting to the CONSORT items. Descriptive statistics were used. RESULTS: One hundred and eighty-two Otolaryngologic RCTs were identified in the top nine international journals and in the top Canadian journal. The inter-rater reliability between two raters was 0.32. The extent of adherence to CONSORT Statement ranged from 25 to 93.5% with a mean of 59.0% and a median of 59.4%. Only 6.5% of RCTs described the individual responsible for enrolling and assigning subjects and method of randomization; 32.4% reported the estimated effect size and precision; 40.6% reported a sample size calculation and 32.4% mentioned external validity or implications of the findings. CONCLUSION: Findings revealed that the reporting of RCTs in the top nine ORL-HNS journals and in the top Canadian ORL-HNS journal is suboptimal. The quality of reporting can be improved by addressing the three CONSORT items found most deficient in this study namely, sample size calculations, estimated effect size and precision, and external validity.

Screening Indication Associated With Lower Likelihood of Minor Adverse Events in Patients Undergoing Outpatient Colonoscopy.

We sought to determine, among outpatients at one university hospital endoscopy center, rates of self-reported minor adverse events (MAEs) at 2, 14, and 30 days postcolonoscopy and to identify predictors of MAEs at Day 2 postcolonoscopy. A single-center longitudinal cohort study with follow-ups at Days 2, 14, and 30 postcolonoscopy was conducted in Montreal, Canada. Baseline self-report data included patient age, gender, gastrointestinal discomforts and other discomforts in the preceding month, and comorbidity. Intracolonoscopy procedures and the method of insufflation were obtained from endoscopy reports. Minor adverse event data were obtained by either phone or Internet survey. Multivariate logistic regression was used to identify predictors of MAEs at Day 2. Of 705 individuals approached, 420 (mean age = 58.7 years; SD = 8.4, 45.7% female) were eligible and consented to study participation, and 378 (90%) participated in at least one follow-up. At Days 2, 14, and 30, 86 (25.1%), 46 (13.7%), and 13 (3.1%) patients, respectively, experienced at least one MAE. At the Day 30 follow-up, 2 (0.53%) patients reported having experienced a serious adverse event. The multivariable analysis results showed that screening compared with nonscreening colonoscopy was protective for MAEs at 2 days (OR = 0.5, 95% CI [0.3, 0.9]). We found that 25% of patients experienced at least one MAE at 2 days postcolonoscopy, and screening compared with nonscreening colonoscopy patients were half as likely to experience these early MAEs. Nurses may use these findings to educate and reassure patients about colonoscopy risks. Large, longitudinal multicenter studies are needed to corroborate our findings.

Vitamin B12 deficiency in inflammatory bowel disease: a prospective observational pilot study.

BACKGROUND AND AIM: Diagnostic and management guidelines for vitamin B12 (cobalamin, Cbl) deficiency in inflammatory bowel disease (IBD) are lacking. True deficiency is defined as Cbl concentrations below reference range combined with elevated methylmalonic acid (MMA) concentrations. Studies analyzing Cbl status in IBD use only Cbl concentrations without confirmatory MMA. This study aims to determine the proportion of IBD patients with Cbl concentrations below reference range and their predisposing clinical and genetic characteristics. We then compared this to the proportion with true deficiency. PATIENTS AND METHODS: In a prospective observational pilot study of adult IBD outpatients, Cbl concentrations, MMA levels, and fucosyltransferase 2 mutations were measured at clinic visits. RESULTS: A total of 66 Crohn's disease (CD) and 30 ulcerative colitis (UC) patients were recruited. Mean Cbl concentrations (pmol/l) in CD (253.7) were not significantly lower than UC (320.5, P=0.24). Serum Cbl below reference range (<148) was observed in 7.6 and 10% of CD and UC patients, respectively (P=0.70). True deficiency in CD and UC was 3 and 3.3%, respectively (P=1.0). Patients with ileal resections more than 30 cm had lower mean Cbl concentrations (177, P=0.02) and a trend toward higher proportions with Cbl levels below reference range (40%, P=0.06), but not increased deficiency rates (0%, P=1.0). Disease location, severity, and fucosyltransferase 2 mutations were not associated with altered Cbl status. CONCLUSION: True Cbl deficiency was rare in IBD patients in this study. A disparity in Cbl status exists when confirmatory MMA levels are used compared with Cbl concentrations alone. Asymptomatic IBD patients with low serum Cbl require confirmatory tests to guide management and avoid unnecessary treatment.

Intratympanic dexamethasone in sudden sensorineural hearing loss: A systematic review and meta-analysis.

OBJECTIVE: Systemic dexamethasone has demonstrated conclusive benefits in reversing sudden sensorineural hearing loss (SSNHL) despite considerable number of potential side effects. In contrast, the intratympanic route of steroid administration averts several possible complications. This study aims to examine the literature to delineate the efficacy and side effect of intratympanic dexamethasone (ITD) injection for the treatment of SSNHL. DATA SOURCE: Cochrane, Embase, and MEDLINE electronic databases from January 1950 to August 2014, with an update performed on November 10, 2014. REVIEW METHODS: Systematic review and meta-analysis of randomized controlled clinical trials (RCCTs), using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram and guidelines. Quality assessment was performed using The Cochrane Collaboration Tool for Assessing Risk of Bias. RESULTS: Eight RCCTs on SSNHL were included Three of the eight studies had high risk of bias. Substantial heterogeneity was found. The meta-analysis failed to detect statistically significant difference between ITD and alternative treatment (odds ratio = 0.39, 95% credible intervals = 0.11-1.27). The side-effects profile was favorable for ITD. No serious adverse events were recorded. CONCLUSION: There is no sufficient scientific evidence to support a difference between ITD and alternative therapy for SSNHL. We recommend larger RCCTs to determine the effectiveness of ITD compared to oral steroid therapy. We encourage a shift in study design selection toward noninferiority or superiority studies. Avoiding systemic corticotherapy, especially in vulnerable populations, should be the rationale for future research in the field. Laryngoscope, 127:1897-1908, 2017.

Pilot Validation Study: Canadian Global Rating Scale for Colonoscopy Services.

Background. The United Kingdom Global Rating Scale (GRS-UK) measures unit-level quality metrics processes in digestive endoscopy. We evaluated the psychometric properties of its Canadian version (GRS-C), endorsed by the Canadian Association of Gastroenterology (CAG). Methods. Prospective data collection at three Canadian endoscopy units assessed GRS-C validity, reliability, and responsiveness to change according to responses provided by physicians, endoscopy nurses, and administrative personnel. These responses were compared to national CAG endoscopic quality guidelines and GRS-UK statements. Results. Most respondents identified the overarching theme each GRS-C item targeted, confirming face validity. Content validity was suggested as 18 out of 23 key CAG endoscopic quality indicators (78%, 95% CI: 56-93%) were addressed in the GRS-C; statements not included pertained to educational programs and competency monitoring. Concordance ranged 75-100% comparing GRS-C and GRS-UK ratings. Test-retest reliability Kappa scores ranged 0.60-0.83, while responsiveness to change scores at 6 months after intervention implementations were greater (P < 0.001) in two out of three units. Conclusion. The GRS-C exhibits satisfactory metrics, supporting its use in a national quality initiative aimed at improving processes in endoscopy units. Data collection from more units and linking to actual patient outcomes are required to ensure that GRS-C implementation facilitates improved patient care.

Screening polypectomy rates below quality benchmarks: a prospective study.

AIM: To estimate and compare sex-specific screening polypectomy rates to quality benchmarks of 40% in men and 30% in women. METHODS: A prospective cohort study was undertaken of patients aged 50-75, scheduled for colonoscopy, and covered by the Québec universal health insurance plan. Endoscopist and patient questionnaires were used to obtain screening and non-screening colonoscopy indications. Patient self-report was used to obtain history of gastrointestinal conditions/symptoms and prior colonoscopy. Sex-specific polypectomy rates (PRs) and 95%CI were calculated using Bayesian hierarchical logistic regression. RESULTS: In total, 45 endoscopists and 2134 (mean age = 61, 50% female) of their patients participated. According to patients, screening PRs in males and females were 32.4% (95%CI: 23.8-41.8) and 19.4% (95%CI: 13.1-25.4), respectively. According to endoscopists, screening PRs in males and females were 30.2% (95%CI: 27.0-41.9) and 16.6% (95%CI: 16.3-28.6), respectively. Sex-specific PRs did not meet quality benchmarks at all ages except for: males aged 65-69 (patient screening indication), and males aged 70-74 (endoscopist screening indication). For all patients aged 50-54, none of the CI included the quality benchmarks. CONCLUSION: Most sex-specific screening PRs in Québec were below quality benchmarks; PRs were especially low for all 50-54 year olds.

Rates of minor adverse events and health resource utilization postcolonoscopy.

BACKGROUND: Little is known about minor adverse events (MAEs) following outpatient colonoscopies and associated health care resource utilization. OBJECTIVE: To estimate the rates of incident MAE at two, 14 and 30 days postcolonoscopy, and associated health care resource utilization. A secondary aim was to identify factors associated with cumulative 30-day MAE incidence. METHODS: A longitudinal cohort study was conducted among individuals undergoing an outpatient colonoscopy at the Montreal General Hospital (Montreal, Quebec). Before colonoscopy, consecutive individuals were enrolled and interviewed to obtain data regarding age, sex, comorbidities, use of antiplatelets/anticoagulants and previous symptoms. Endoscopy reports were reviewed for intracolonoscopy procedures (biopsy, polypectomy). Telephone or Internet follow-up was used to obtain data regarding MAEs (abdominal pain, bloating, diarrhea, constipation, nausea, vomiting, blood in the stools, rectal or anal pain, headaches, other) and health resource use (visits to emergency department, primary care doctor, gastroenterologist; consults with nurse, pharmacist or telephone hotline). Rates of incident MAEs and health resources utilization were estimated using Bayesian hierarchical modelling to account for patient clustering within physician practices. RESULTS: Of the 705 individuals approached, 420 (59.6%) were enrolled. Incident MAE rates at the two-, 14- and 30-day follow-ups were 17.3% (95% credible interval [CrI] 8.1% to 30%), 10.5% (95% CrI 2.9% to 23.7%) and 3.2% (95% CrI 0.01% to 19.8%), respectively. The 30-day rate of health resources utilization was 1.7%, with 0.95% of participants seeking the services of a physician. No predictors of the cumulative 30-day incidence of MAEs were identified. DISCUSSION: The incidence of MAEs was highest in the 48 h following colonoscopy and uncommon after two weeks, supporting the Canadian Association of Gastroenterology's recommendation for assessment of late complications at 14 days. Predictors of new onset of MAEs were not identified, but wide CrIs did not rule out possible associations. Although <1% of participants reported consulting a physician for MAEs, this figure may represent a substantial number of visits given the increasing number of colonoscopies performed annually. CONCLUSION: Postcolonoscopy MAEs are common, occur mainly in the first two weeks postcolonoscopy and result in little use of health resources.

Feasibility of a call-in centre to deliver colorectal cancer screening in primary care.

OBJECTIVE: To evaluate the feasibility of a call-in centre to deliver colorectal cancer (CRC) screening in primary care through self-administered fecal occult blood testing (FOBT). DESIGN: Four-month intervention study (September 2010 to January 2011) with randomly selected follow-up interviews. SETTING: The family medicine clinics of 3 hospitals in Montreal, Que. PARTICIPANTS: Letters from doctors invited their patients to contact the call-in centre (N = 761). Eligible patients agreeing to FOBT were sent testing kits that could be returned by mail (N = 100). Randomly selected patients (N = 36) were interviewed to explore the reasons why they did not contact the call-in centre, or why they did or did not adhere to FOBT. MAIN OUTCOME MEASURES: Feasibility was assessed by the proportions of patients who contacted the call-in centre, who were eligible for FOBT, and who adhered to FOBT; and by the time between invitation mail-out and contact with the call-in centre, initial telephone contact and receipt of the signed consent form, and FOBT kit mail-out and receipt of the kit by the laboratory. Hierarchical logistic regression evaluated the effect of patient characteristics on feasibility indicators, adjusting for clustering by physician and centre. RESULTS: Of 761 patients (61.6% female, mean age 61.0 years), 250 (32.9%) contacted the call-in centre, of whom 100 (40.0%) were eligible for and consented to FOBT; 62 (62.0%) of these patients adhered to FOBT. Median (interquartile range) time from invitation mail-out to call-in centre contact was 21 (7 to 29) days, from initial telephone contact to receipt of the signed consent form was 24 (10 to 38) days, and from FOBT kit mail-out to receipt at the laboratory was 23 (18 to 32) days. With the exception of previous cancer diagnosis, patient characteristics were not associated with feasibility indicators. Of the 115 (46.0%) patients determined to be ineligible for FOBT screening, 111 (96.5%) were up to date with or already scheduled for screening. CONCLUSION: Feasibility of the call-in centre was demonstrated. Targeting screening-eligible individuals or coupling a call-in service with another evidence-based CRC screening improvement strategy might further improve uptake of fecal testing.