Factors influencing smartwatch use and comfort with health data sharing: a sequential mixed-method study protocol.

INTRODUCTION: Smartwatches have become ubiquitous for tracking health metrics. These data sets hold substantial potential for enhancing healthcare and public health initiatives; it may be used to track chronic health conditions, detect previously undiagnosed health conditions and better understand public health trends. By first understanding the factors influencing one's continuous use of the device, it will be advantageous to assess factors that may influence a person's willingness to share their individual data sets. This study seeks to comprehensively understand the factors influencing the continued use of these devices and people's willingness to share the health data they generate. METHODS AND ANALYSIS: A two-section online survey of smartwatch users over the age of 18 will be conducted (n ≥200). The first section, based on the expectation-confirmation model, will assess factors influencing continued use of smartwatches while the second section will assess willingness to share the health data generated from these devices. Survey data will be analysed descriptively and based on structural equation modelling.Subsequently, six focus groups will be conducted to further understand the issues raised in the survey. Each focus group (n=6) will consist of three smartwatch users: a general practitioner, a public health specialist and an IT specialist. Young smartwatch users (aged 18-44) will be included in three of the focus groups and middle-aged smartwatch users (aged 45-64) will be included in the other three groups. This is to enhance comparison of opinions based on age groups. Data from the focus groups will be analysed using the microinterlocutor approach and an executive summary.After the focus group, participants will complete a brief survey to indicate any changes in their opinions resulting from the discussion. ETHICS AND DISSEMINATION: The results of this study will be disseminated through publication in a peer-reviewed journal, and all associated data will be deposited in a relevant, publicly accessible data repository to ensure transparency and facilitate future research endeavours.This study was approved by the Social Research Ethic Committee (SREC), University College Cork-SREC/SOM/21062023/2.

High risk features in colorectal adenomatous polyps: A multi-institutional study.

High risk features in colorectal adenomatous polyps include size >1 cm and advanced histology: high-grade dysplasia and villous architecture. We investigated whether the diagnostic rates of advanced histology in colorectal adenomatous polyps were similar among institutions across the United States, and if not, could differences be explained by patient age, polyp size, and/or CRC rate. Nine academic institutions contributed data from three pathologists who had signed out at least 100 colorectal adenomatous polyps each from 2018 to 2019 taken from patients undergoing screening colonoscopy. For each case, we recorded patient age and sex, polyp size and location, concurrent CRC, and presence or absence of HGD and villous features. A total of 2700 polyps from 1886 patients (mean age: 61 years) were collected. One hundred twenty-four (5 %) of the 2700 polyps had advanced histology, including 35 (1 %) with HGD and 101 (4 %) with villous features. The diagnostic rate of advanced histology varied by institution from 1.7 % to 9.3 % (median: 4.3 %, standard deviation [SD]: 2.5 %). The rate of HGD ranged from 0 % to 3.3 % (median: 1 %, SD: 1.2 %), while the rate of villous architecture varied from 1 % to 8 % (median: 3.7 %, SD: 2.5 %). In a multivariate analysis, the factor most strongly associated with advanced histology was polyp size >1 cm with an odds ratio (OR) of 31.82 (95 % confidence interval [CI]: 20.52-50.25, p < 0.05). Inter-institutional differences in the rate of polyps >1 cm likely explain some of the diagnostic variance, but pathologic subjectivity may be another contributing factor.

Compliance of Type 2 Diabetes Applications to International Guidelines: Protocol for a Quantitative App Assessment.

BACKGROUND: Diabetes is among the most common chronic conditions people live with across the world. While it can be managed to a substantial degree, it can result in significant complications. As such, easy access to accurate tools to aid diabetes management is useful in minimizing these complications. Mobile apps are highly accessible and widely used, but there is a gap in the literature examining their compliance with medical guidelines. OBJECTIVE: The aims of this study are to develop the Analysis of Diabetes Apps (ADA) checklist to evaluate apps' compliance to guidelines set by the International Diabetes Federation (IDF) on the treatment and management of type 2 diabetes; to assess type 2 diabetes apps in the Apple App Store and the Android Google Play Store, and their compliance with international guidelines using the ADA framework; and to compare the novel ADA checklist against both the Mobile App Rating Scale (MARS) tool kit and app ratings for each store. METHODS: We will develop a checklist based on the "IDF Clinical Practice Recommendations for Managing Type 2 Diabetes in Primary Care." Type 2 diabetes apps will be scraped from 6 countries' app stores using web scraping tools. These countries include Australia, Brazil, India, Nigeria, the United States, and the United Kingdom, which were selected based on the largest population of English-speaking people in each continent. The apps will be searched on the web-based scraper using the search terms "blood sugar," "diabetes," "glucose level," "insulin," "sugar level," and "type 2 diabetes." Apps will be excluded if they are paid or are not in English. The apps will be assessed using the ADA checklist to evaluate their compliance to the international diabetes guidelines. Once scored, the results will be analyzed with descriptive statistics. The most popular apps will be further analyzed using the MARS tool kit. The ADA checklist scores will then be compared to both the MARS tool kit score and app ratings for each store. RESULTS: The ADA checklist developed based on the IDF guidelines focuses on general information, risk factors, diagnosis, pharmacology, lifestyle modification, glycemic recommendations, and medications. The initial stress testing of the protocol resulted in 173 included apps. This will vary in the final search as the app stores are constantly changing. CONCLUSIONS: The protocol presents the development of a checklist to investigate the compliance of type 2 diabetes apps with international guidelines. The checklist will hopefully form the basis of a scoring system for future research on compliance of mobile apps with international guidelines. High standardization of the ADA checklist will make it a robust tool for people with diabetes and their health care providers alike in assessing type 2 diabetes apps in the future. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48781.

Investigating the characteristics of health-related data collection tools used in randomised controlled trials in low-income and middle-income countries: protocol for a systematic review.

INTRODUCTION: Health-related data collection tools, including digital ones, have become more prevalent across clinical studies in the last number of years. However, using digital data collection tools in low-income and middle-income countries presents unique challenges. In this review, we aim to provide an overview of the data collection tools currently being used in randomised controlled trials (RCTs) conducted in low-resource settings and evaluate the tools based on the characteristics outlined in the modified Mobile Survey Tool framework. These include functionality, reliability, usability, efficiency, maintainability, portability, effectiveness, cost-benefit, satisfaction, freedom from risk and context coverage. This evidence may provide a guide to selecting a suitable data collection tool for researchers planning to conduct research in low-income and middle-income countries for future studies. METHODS AND ANALYSIS: Searches will be conducted in four electronic databases: PubMed, CINAHL, Web of Science and EMBASE. For inclusion, studies must be a RCT, mention a health-related data collection tool and conducted in a low- and middle-income country. Only studies with available full-text and written in English will be included. The search was restricted to studies published between January 2005 and June 2023. This systematic review will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) tool. Two review authors will screen the titles and abstracts of search results independently for inclusion. In the initial screening process, the full-text articles will be retrieved if the abstract contains limited information about the study. Disagreements will be resolved through discussion. If the disagreement cannot be resolved, a third author (JO'D) will adjudicate. The study selection process will be outlined in a PRISMA flow-diagram. Data will be analysed using a narrative synthesis approach. The included studies and their outcomes will be presented in a table. ETHICS AND DISSEMINATION: Formal ethical approval is not required as primary data will not be collected in this study. The findings from this systematic review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42023405738.

Patient-healthcare provider communication and age-related hearing loss: a qualitative study of patients' perspectives.

BACKGROUND: The prevalence of age-related hearing loss (ARHL) significantly increases in people aged 60 and older. Medical errors are frequently reported because of communication breakdown, especially for patients with ARHL. AIMS: This qualitative study focuses on identifying the communication challenges faced by people aged over 65 with ARHL and potential ameliorative strategies based on the participants' personal experiences. METHODS: Thirteen participants, attending a support service for older adults with hearing loss in the South of Ireland, were recruited using convenience sampling. Semi-structured interviews were conducted with participants. Interviews were audio-recorded and transcribed using NVivo 12 software. Braun and Clarke's thematic analysis methodology was used to identify themes arising from two main study domains: difficulties faced during the most recent healthcare interaction and suggestions for improving overall healthcare communication. RESULTS: Older adults with hearing loss identified general mishearing, lack of awareness and use of medical terminology to be the cause of ineffective communication. Raising awareness of the impact of presbycusis on clinical interaction among healthcare professionals was cited as being of crucial importance. Other helpful strategies include repeat and rephrase, use of written information, providing context, minimizing ambient noise, continuity of care, longer consultation length and good body language. CONCLUSION: Effective clinical communication can be achieved through a clear understanding of the patient's perspective. Healthcare providers should be made aware of the hearing issues and associated communication difficulties posed, within the context of the development of patient-centred strategies to improve patient safety.

Colorectal Carcinoma With Sarcomatoid Components: Report of 15 Cases and Literature Review of an Exceedingly Rare Carcinoma Subtype.

Colorectal carcinoma with sarcomatoid components (which includes so-called carcinosarcomas and sarcomatoid carcinomas) is a rare subtype with 50 reported cases in the literature and overlapping criteria with undifferentiated carcinoma. We collected and described 15 cases from 10 men and 5 women, with a mean age of 66 years. Symptoms included abdominal pain and gastrointestinal bleeding. Most tumors presented in the rectosigmoid region, with a mean size of 8.2 cm. The sarcomatoid component, on average, represented 58% of the tumors and took many forms, including spindled (10 cases), anaplastic (9 cases), and rhabdoid (3 cases); one case showed osteoid matrix. Tumor budding was usually high, and tumor-infiltrating lymphocytes were usually low. The sarcomatoid component was keratin-positive in 10 cases. One case showed loss of mismatch repair protein expression, and 2 cases showed SMARCA4 loss (1 also with SMARCA2 loss). Molecular testing identified mutations in KRAS (n=1), NRAS (n=2), BRAF (n=2), APC (n=1), and TP53 (n=1) in a few cases. Tumors often presented at advanced stage, with 11 cases pT4, 9 cases with nodal metastases, and 7 cases with distant metastases. Follow-up was available for 10 cases (median: 2 months), with 2 alive without disease, 3 alive with disease, and 5 dead. Our findings roughly corresponded with those in previously reported cases. Colorectal carcinoma with sarcomatoid components is rare and aggressive, with a poor prognosis for many patients. We suggest that spindled cells, anaplasia, heterologous elements, and/or a component with definable sarcomatous lineage be used to distinguish colorectal carcinoma with sarcomatoid components from undifferentiated carcinoma.

Postinfantile Giant Cell Hepatitis in Native and Allograft Livers: A Multi-Institutional Clinicopathologic Study of 70 Cases.

Postinfantile giant cell hepatitis (PIGCH) is a rare hepatitis pattern in adults with variable etiologies and clinical outcomes. We conducted a multi-institutional retrospective study to define the clinicopathologic characteristics of patients with PIGCH. A total of 70 PIGCH cases were identified and reviewed for pathological features, including fibrosis, cholestasis, inflammation, steatosis, necrosis, and apoptosis, as well as the distribution of giant cells and the maximum number of giant cells per high-power field. Demographic and clinical data, including age, sex, laboratory results, etiologies, and follow-up results, were recorded. Among the 70 cases, 40% (28/70) were associated with autoimmune liver diseases, followed by 9 (13%) with unknown etiology, 8 (11%) with viral infection, 5 (7%) with medications, 5 with combined etiologies, and 4 (6%) with malignancies (mostly chronic lymphocytic leukemia). Notably, another 16% were de novo PIGCH in liver allografts, most of which occurred after a rejection event. During follow-up, 26 (37%) patients died of the disease and 44 (63%) were alive. Deceased patients were characterized by older age (mean age, 54.9 vs 45.5 years; P = .02), higher alkaline phosphatase level (mean value, 253.3U/L vs 166.3 U/L; P = .03), higher fibrosis stage (stage 3-4 vs stage 0-2, 57.7% vs 29.6%; P = .03), being more likely to have de novo PIGCH after transplantation (23.1% vs 11.4%; P = .04), and being less likely to have primary autoimmune liver disease etiology (26.9% vs 47.7%; P = .04). These results indicate that PIGCH is a rare pattern of liver injury associated with different etiologies and variable clinical outcomes. Autoimmune liver disease with PIGCH is associated with better survival, whereas de novo PIGCH in allografts is associated with poorer survival. Older age, higher alkaline phosphatase level, and advanced fibrosis are adverse prognostic factors.

Targeted Next-Generation Sequencing Improves the Prognostication of Patients with Disseminated Appendiceal Mucinous Neoplasms (Pseudomyxoma Peritonei).

BACKGROUND: Appendiceal mucinous neoplasms (AMNs) with disseminated disease (pseudomyxoma peritonei) are heterogeneous tumors with variable clinicopathologic behavior. Despite the development of prognostic systems, objective biomarkers are needed to stratify patients. With the advent of next-generation sequencing (NGS), it remains unclear if molecular testing can improve the evaluation of disseminated AMN patients. METHODS: Targeted NGS was performed for 183 patients and correlated with clinicopathologic features to include American Joint Committee on Cancer/World Health Organization (AJCC/WHO) histologic grade, peritoneal cancer index (PCI), completeness of cytoreduction (CC) score, and overall survival (OS). RESULTS: Genomic alterations were identified for 179 (98%) disseminated AMNs. Excluding mitogen-activated protein kinase genes and GNAS due to their ubiquitous nature, collective genomic alterations in TP53, SMAD4, CDKN2A, and the mTOR genes were associated with older mean age, higher AJCC/WHO histologic grade, lymphovascular invasion, perineural invasion, regional lymph node metastasis, and lower mean PCI (p < 0.040). Patients harboring TP53, SMAD4, ATM, CDKN2A, and/or mTOR gene alterations were found to have lower OS rates of 55% at 5 years and 14% at 10 years, compared with 88% at 5 years and 88% at 10 years for patients without the aforementioned alterations (p < 0.001). Based on univariate and multivariate analyses, genomic alterations in TP53, SMAD4, ATM, CDKN2A, and/or the mTOR genes in disseminated AMNs were a negative prognostic factor for OS and independent of AJCC/WHO histologic grade, PCI, CC score, and hyperthermic intraperitoneal chemotherapy treatment (p = 0.006). CONCLUSIONS: Targeted NGS improves the prognostic assessment of patients with disseminated AMNs and identifies patients who may require increased surveillance and/or aggressive management.

Framework to assess the quality of mHealth apps: a mixed-method international case study protocol.

INTRODUCTION: Healthcare professionals (HCPs) often recommend their patients to use a specific mHealth app as part of health promotion, disease prevention and patient self-management. There has been a significant growth in the number of HCPs downloading and using mobile health (mHealth) apps. Most mHealth apps that are available in app stores employ a 'star rating' system. This is based on user feedback on an app, but is highly subjective. Thus, the identification of quality mHealth apps which are deemed fit for purpose can be a difficult task for HCPs. Currently, there is no unified, validated standard guidelines for assessment of mHealth apps for patient safety, which can be used by HCPs. The Modified Enlight Suite (MES) is a quality assessment framework designed to provide a means for HCPs to evaluate mHealth apps before they are recommended to patients. MES was adapted from the original Enlight Suite for international use through a Delphi method, followed by preliminary validation process among a population predominantly consisting of medical students. This study aims to evaluate the applicability and validity of the MES, by HCPs, in low, middle and high income country settings. METHODS AND ANALYSIS: MES will be evaluated through a mixed-method study, consisting of qualitative (focus group) and quantitative (survey instruments) research, in three target countries: Malawi (low income), South Africa (middle income) and Ireland (high income). The focus groups will be conducted through Microsoft Teams (Microsoft, Redmond, Washington, USA) and surveys will be conducted online using Qualtrics (Qualtrics International, Seattle, Washington, USA). Participants will be recruited through the help of national representatives in Malawi (Mzuzu University), South Africa (University of Fort Hare) and Ireland (University College Cork) by email invitation. Data analysis for the focus group will be by the means of thematic analysis. Data analysis for the survey will use descriptive statistics and use Cronbach alpha as an indicator of internal consistency of the MES. The construct validity of the mHealth app will be assessed by computing the confirmatory factor analysis using Amos. ETHICS AND DISSEMINATION: The study has received ethical approval from the Social Research Ethics Committee (SREC) SREC/SOM/03092021/1 at University College Cork, Ireland, Malawi Research Ethics Committee (MREC), Malawi MZUNIREC/DOR/21/59 and Inter-Faculty Research Ethics Committee (IFREC) of University of Fort Hare (REC-2 70 710-028-RA). The results of the study will be disseminated through the internet, peer-reviewed journals and conference presentations.

Modification and Validation of an mHealth App Quality Assessment Methodology for International Use: Cross-sectional and eDelphi Studies.

BACKGROUND: Over 325,000 mobile health (mHealth) apps are available to download across various app stores. However, quality assurance in this field of medicine remains relatively undefined. Globally, around 84% of the population have access to mobile broadband networks. Given the potential for mHealth app use in health promotion and disease prevention, their role in patient care worldwide is ever apparent. Quality assurance regulations both nationally and internationally will take time to develop. Frameworks such as the Mobile App Rating Scale and Enlight Suite have demonstrated potential for use in the interim. However, these frameworks require adaptation to be suitable for international use. OBJECTIVE: This study aims to modify the Enlight Suite, a comprehensive app quality assessment methodology, to improve its applicability internationally and to assess the preliminary validity and reliability of this modified tool in practice. METHODS: A two-round Delphi study involving 7 international mHealth experts with varied backgrounds in health, technology, and clinical psychology was conducted to modify the Enlight Suite for international use and to improve its content validity. The Modified Enlight Suite (MES) was then used by 800 health care professionals and health care students in Ireland to assess a COVID-19 tracker app in an online survey. The reliability of the MES was assessed using Cronbach alpha, while the construct validity was evaluated using confirmatory factor analysis. RESULTS: The final version of the MES has 7 sections with 32 evaluating items. Of these items, 5 were novel and based on consensus for inclusion by Delphi panel members. The MES has satisfactory reliability with a Cronbach alpha score of .925. The subscales also demonstrated acceptable internal consistency. Similarly, the confirmatory factor analysis demonstrated a positive and significant factor loading for all 32 items in the MES with a modestly acceptable model fit, thus indicating the construct validity of the MES. CONCLUSIONS: The Enlight Suite was modified to improve its international relevance to app quality assessment by introducing new items relating to cultural appropriateness, accessibility, and readability of mHealth app content. This study indicates both the reliability and validity of the MES for assessing the quality of mHealth apps in a high-income country, with further studies being planned to extrapolate these findings to low- and middle-income countries.

Tumor Size Differences Between Preoperative Endoscopic Ultrasound and Postoperative Pathology for Neoadjuvant-Treated Pancreatic Ductal Adenocarcinoma Predict Patient Outcome.

BACKGROUND & AIMS: The assessment of therapeutic response after neoadjuvant treatment and pancreatectomy for pancreatic ductal adenocarcinoma (PDAC) has been an ongoing challenge. Several limitations have been encountered when employing current grading systems for residual tumor. Considering endoscopic ultrasound (EUS) represents a sensitive imaging technique for PDAC, differences in tumor size between preoperative EUS and postoperative pathology after neoadjuvant therapy were hypothesized to represent an improved marker of treatment response. METHODS: For 340 treatment-naïve and 365 neoadjuvant-treated PDACs, EUS and pathologic findings were analyzed and correlated with patient overall survival (OS). A separate group of 200 neoadjuvant-treated PDACs served as a validation cohort for further analysis. RESULTS: Among treatment-naïve PDACs, there was a moderate concordance between EUS imaging and postoperative pathology for tumor size (r = 0.726, P < .001) and AJCC 8th edition T-stage (r = 0.586, P < .001). In the setting of neoadjuvant therapy, a decrease in T-stage correlated with improved 3-year OS rates (50% vs 31%, P < .001). Through recursive partitioning, a cutoff of ≥47% tumor size reduction was also found to be associated with improved OS (67% vs 32%, P < .001). Improved OS using a ≥47% threshold was validated using a separate cohort of neoadjuvant-treated PDACs (72% vs 36%, P < .001). By multivariate analysis, a reduction in tumor size by ≥47% was an independent prognostic factor for improved OS (P = .007). CONCLUSIONS: The difference in tumor size between preoperative EUS imaging and postoperative pathology among neoadjuvant-treated PDAC patients is an important prognostic indicator and may guide subsequent chemotherapeutic management.

Identification and Evaluation of Methodologies to Assess the Quality of Mobile Health Apps in High-, Low-, and Middle-Income Countries: Rapid Review.

BACKGROUND: In recent years, there has been rapid growth in the availability and use of mobile health (mHealth) apps around the world. A consensus regarding an accepted standard to assess the quality of such apps has yet to be reached. A factor that exacerbates the challenge of mHealth app quality assessment is variations in the interpretation of quality and its subdimensions. Consequently, it has become increasingly difficult for health care professionals worldwide to distinguish apps of high quality from those of lower quality. This exposes both patients and health care professionals to unnecessary risks. Despite progress, limited understanding of the contributions of researchers in low- and middle-income countries (LMICs) exists on this topic. Furthermore, the applicability of quality assessment methodologies in LMIC settings remains relatively unexplored. OBJECTIVE: This rapid review aims to identify current methodologies in the literature to assess the quality of mHealth apps, understand what aspects of quality these methodologies address, determine what input has been made by authors from LMICs, and examine the applicability of such methodologies in LMICs. METHODS: This review was registered with PROSPERO (International Prospective Register of Systematic Reviews). A search of PubMed, EMBASE, Web of Science, and Scopus was performed for papers related to mHealth app quality assessment methodologies, which were published in English between 2005 and 2020. By taking a rapid review approach, a thematic and descriptive analysis of the papers was performed. RESULTS: Electronic database searches identified 841 papers. After the screening process, 52 papers remained for inclusion. Of the 52 papers, 5 (10%) proposed novel methodologies that could be used to evaluate mHealth apps of diverse medical areas of interest, 8 (15%) proposed methodologies that could be used to assess apps concerned with a specific medical focus, and 39 (75%) used methodologies developed by other published authors to evaluate the quality of various groups of mHealth apps. The authors in 6% (3/52) of papers were solely affiliated to institutes in LMICs. A further 15% (8/52) of papers had at least one coauthor affiliated to an institute in an LMIC. CONCLUSIONS: Quality assessment of mHealth apps is complex in nature and at times subjective. Despite growing research on this topic, to date, an all-encompassing appropriate means for evaluating the quality of mHealth apps does not exist. There has been engagement with authors affiliated to institutes across LMICs; however, limited consideration of current generic methodologies for application in LMIC settings has been identified. TRIAL REGISTRATION: PROSPERO CRD42020205149; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=205149.

Hearing Impairment and the Amelioration of Avoidable Medical Error: A Cross-Sectional Survey.

OBJECTIVES: Hearing loss contributes to suboptimal medical treatment. We investigated the nature and magnitude of potential health-care harm of hearing loss alone on a patient's understanding of medical consultations, investigations, and treatments of health conditions unrelated to their hearing loss. METHODS: A cross-sectional, questionnaire-based design of a convenience sample of students with hearing loss, registered with the institutional disability support service in 8 Irish and 15 UK third-level institutions. Content analysis of open-ended item responses identified and coded emergent themes. Closed-ended questionnaire items recorded demographic and clinically relevant characteristics. RESULTS: Ninety-five responses were received and analyzed. Fifty-six (58.9%) indicated "yes" to mishearing a physician/nurse in a hospital. Approximately 60.7% identified this in relation to consultation content; 33.9% mishearing; and 21.4% misinterpreting what was said, including diagnosis, guidelines and advice, and matters relating to medications. Approximately 22.3% indicated physician/nurse-patient communication failures; 19.6% identified failure to initiate/maintain eye contact, turning away from the patient, speaking while wearing surgical masks, excluding the possibility of lip reading. Approximately 7.1% identified speaking in too low a volume or too fast. Concerning common words misheard or misinterpreted, 23.2% identified phonological similarity such as similar sounding words and numbers, 7.4% discrimination of unvoiced consonants. Similar findings emerged in GP clinics. CONCLUSIONS: Most hearing-impaired students experienced difficulty in understanding health-care professionals in a hospital and general practice setting. This underscores the importance for health-care providers to identify hearing-impaired patients and to augment communication using visual aids, a quite environment and optimizing lip reading communication.

Validation of phlebotomy performance metrics developed as part of a proficiency-based progression initiative to mitigate wrong blood in tube.

AIMS: The purpose of this study was to (1) characterise the procedure of phlebotomy, deconstruct it into its constituent parts and develop a performance metric for the purpose of training healthcare professionals in a large teaching hospital and to (2) evaluate the construct validity of the phlebotomy metric and establish a proficiency benchmark. METHOD: By engaging with a multidisciplinary team with a wide range of experience of preanalytical errors in phlebotomy and observing video recordings of the procedure performed in the actual working environment, we defined a performance metric. This was brought to a modified Delphi meeting, where consensus was reached by an expert panel. To demonstrate construct validity, we used the metric to objectively assess the performance of novices and expert practitioners. RESULTS: A phlebotomy metric consisting of 11 phases and 77 steps was developed. The mean inter-rater reliability was 0.91 (min 0.83, max 0.95). The expert group completed more steps of the procedure (72 vs 69), made fewer errors (19 vs 13, p=0.014) and fewer critical errors (1 Vs 4, p=0.002) than the novice group. CONCLUSIONS: The metrics demonstrated construct validity and the proficiency benchmark was established with a minimum observation of 69 steps, with no critical errors and no more than 13 errors in total.

Impact of hearing loss on clinical interactions between older adults and health professionals: a systematic review.

PURPOSE: Age-related hearing loss increases significantly in people aged 60 years and older. An ageing population with impaired hearing presents an additional burden to the multiple comorbidities found among older patients, who are high users of medical services. We sought to quantify the extent to which hearing loss is cited and/or accounted for in studies of older adult interactions with health professionals. METHOD: We conducted a systematic review focusing on clinical communication with older adults, based on a literature search within two databases, PubMed and SCOPUS. Thematic analysis was used to classify studies based on type of health communication. RESULTS: The following health communication categories were identified: quality of clinical communication; enhancement of patient-centred care; information exchange between patient and health professionals; informed consent and shared decision-making. The health profession category 'Physician'/'Doctor' contributed most of the articles (N = 81), and the remaining articles (N = 28) belonged to the other health professions. Twenty-eight papers of 109 (25.7%) mentioned hearing loss; 18 only referred to hearing loss within the context of the text, five referred to hearing loss as an exclusion criterion, three were associational findings, and only two studies included an intervention. CONCLUSIONS: Despite the high prevalence of age-related hearing loss, we demonstrate that across the health professions, very few studies on health professional-older patient communication have incorporated hearing loss as a variable in their study design or analyses. Additionally, there is a lack of research focusing specifically on interventions designed to mitigate the effects of hearing loss on clinical communication.

Age-related hearing loss and provider-patient communication across primary and secondary care settings: a cross-sectional study.

BACKGROUND: The prevalence of age-related hearing loss (ARHL) increases with age. Older adults are amongst the most dependent users of healthcare and most vulnerable to medical error. This study examined health professionals' strategies, as well as level of formal training completed, for communication with older adults with ARHL, and their views on the contribution of ARHL to suboptimal quality of patient care. METHODS: A 17-item questionnaire was distributed to a sample of Irish primary care physicians, as well as hospital-based clinicians providing inpatient palliative care and geriatric services. RESULTS: A total of 172 primary care physicians and 100 secondary care providers completed the questionnaire. A total of 154 (90%) primary and 97 (97%) secondary care providers agreed that ARHL had a negative impact on quality of care. Across both settings, 10% of respondents reported that communication issues contributed to multiple medication error events each year. Although only 3.5% of secondary care providers and 13% of primary care physicians attended formal training on communication with hearing-impaired patients, 66.5% of respondents were confident in their capacity to communicate with these patients. Primary care physicians reported that they either never used assistive hearing technology (44%) or were unfamiliar with this technology (49%). CONCLUSIONS: Primary and secondary care health providers reported that ARHL reduces patient care quality and may initiate errors leading to patient harm. Formal training addressing the communication needs of ARHL patients appears to be underdeveloped, and there is a limited familiarity with assistive hearing technology. This is both an error in health professional training and healthcare services.

Lifting Agent Granuloma: Histologic Findings Following Use of ORISE Gel for Endoscopic Resections in the Gastrointestinal Tract

OBJECTIVES: Histologic findings after endoscopic resection using submucosal lifting agents Eleview and ORISE gel are described. METHODS: Four cases were identified based on the histologic presence of ORISE gel. Cases were selected to illustrate the histologic appearance of the lifting agent immediately after injection (day 0) and after an interval of approximately 2 months. RESULTS: Immediately after injection, the gel had an appearance similar to acellular mucin on H&E stain and showed mucicarmine positivity but was negative for periodic acid-Schiff stain and Alcian blue. At 2 months, the appearance changed drastically and was characterized by a hard, homogenous eosinophilic quality and elicited a robust foreign body-type giant cell reaction; we have proposed the name lifting agent granuloma for this histologic appearance. The aged material may be mistaken for amyloid or a pulse (legume) granuloma; however, the material was negative on Congo red stain and had a different clinical history and distribution in the tissue from those of a pulse granuloma. CONCLUSIONS: It is important to take note of the histologic appearance of these new submucosal lifting agents over a varying time interval, as outlined here, so that they are readily recognized and not mistaken for other entities.

Loss of SATB2 Expression Is a Biomarker of Inflammatory Bowel Disease-associated Colorectal Dysplasia and Adenocarcinoma.

SATB2 is a sensitive immunohistochemistry marker of colorectal carcinoma and non-neoplastic colorectal epithelium that is complementary to CDX2. However, its expression is affected by molecular alterations. Inflammatory bowel disease-associated neoplasia demonstrates molecular alterations that are different from those in sporadic colorectal neoplasia. Given these differences, we examined SATB2 expression in 73 cases of inflammatory bowel disease-associated neoplasia including 37 dysplasia cases and 36 carcinomas and compared the expression patterns with 50 cases of nondysplastic colorectal mucosa in patients with active inflammatory bowel disease, 40 sporadic colonic polyps (20 conventional adenomas and 20 sessile serrated lesions/polyps), and 343 sporadic colorectal adenocarcinomas to assess SATB2 immunohistochemistry as a biomarker of inflammatory bowel disease-associated neoplasia. Loss of SATB2 expression was only identified in colorectal dysplasia arising in inflammatory bowel disease (15/37, 41%) and was not seen in nondysplastic colorectal mucosa with active inflammatory bowel disease or sporadic colonic polyps (P<0.001). Loss of SATB2 expression was identified in both endoscopically visible dysplasia (11/28, 39%) and invisible (4/9, 44%) dysplasia. Loss of SATB2 expression was identified in 67% (24/36) of inflammatory bowel disease-associated carcinomas and was significantly more frequent compared with sporadic colorectal carcinomas (47/343, 14%, P<0.001). There was no difference in positive CDX2 expression between inflammatory bowel disease-associated colorectal carcinoma and sporadic colorectal carcinoma (89% vs. 85%, P=1.0). In conclusion, loss of SATB2 expression is common in inflammatory bowel disease-associated colorectal dysplasia and adenocarcinoma and may be a helpful ancillary biomarker when evaluating for inflammatory bowel disease-associated dysplasia.