Quality assessment of patient‐reported outcome measures for patients with multiple ear complaints

Clinical Journal of the American Society of Nephrology

Design, setting, participants, and measurements: Using mail and telephone survey modalities, we approached 1372 patients treated with peritoneal dialysis or home hemodialysis for participation. Using results from completed surveys, we evaluated item calibration by assessing item floor and ceiling effects. We tested three sets of composite scores and used factor analysis to assess model fit for each. We evaluated associations of composite scores with global ratings, and separately with patient and dialysis facility characteristics. Finally, we measured test-retest reliability in patients who completed the survey at two separate time points.Results:Overall, 495 eligible patients completed at least one survey (response rate 36%). Of these, 49 completed the survey in Spanish and 61 completed a second survey within 30 days. We did not detect significant floor or ceiling effects except for one item that demonstrated> 90 …

The Cleft Palate Craniofacial Journal

Objectives(1) Assess caregiver-reported development in infants born with cleft lip ± alveolus (CL ± A) and cleft lip and palate (CLP); (2) determine factors associated with increased developmental risk; and (3) determine consistency of developmental risk before and after surgery for cleft lip.DesignProspective, longitudinal assessment of development. Time (T) 1, prior to lip closure; T2, 2 months post lip closure.SettingThree US craniofacial teams and online parent support groups.Participants123 total caregivers (96% mothers); 100 at T1, 92 at T2, and 69 at both T1 and T2.MeasureAges and Stages Questionnaire-3 (ASQ-3): Communication, Gross Motor, Fine Motor, Problem Solving, Personal Social Domains.ResultsAt T1 47%; at T2 42% passed all 5 Domains; 36% of infants pass all 5 Domains at both T1 and T2. Infants with CLP were at greatest risk on Communication [B = 1.449 (CI = .149-20.079), p …

The Cleft Palate Craniofacial Journal

ObjectiveTo evaluate the sensitivity to change of daily ratings of the comfort (COMF) and behavioral/emotional health (BEH) domains of the Infants with Clefts Observation Outcomes Instrument (iCOO) at 3 time points, and to assess the association of post-surgical interventions on iCOO ratings.DesignThe COMF and BEH domains were completed by caregivers before (T0), immediately after (T1), and 2-months after (T2) cleft lip (CL) surgery. Analyses included descriptive statistics, correlations, t-tests, and generalized estimating equations.ParticipantsCaregivers (N  =  140) of infants with CL with/without cleft palate.Main Outcome MeasuresThe COMF and BEH domain scores of the iCOO: Scale (SCALE), a summary of observable signs; and Global Impression (IMPR), a single item measuring caregivers’ overall impression.ResultsDaily COMF and BEH SCALE and IMPR scores changed significantly during T1 (P's …

Disability and Rehabilitation

PurposeFacial weakness and its functional consequences are an often underappreciated clinical feature of facioscapulohumeral muscular dystrophy (FSHD) by healthcare professionals and researchers. This is at least in part due to the fact that there are few adequate clinical outcome measures available.MethodsWe developed the Facial Function Scale, a Rasch-built questionnaire on the functional disabilities relating to facial weakness in FSHD. A preliminary 33-item questionnaire was created based on semi-structured interviews with 16 FSHD patients and completed by 119 patients. For reliability studies, 73 patients completed it again after a two-week interval. Data were subjected to semi-automated Rasch analysis to select the most appropriate item set to fit model expectations.ResultsThis resulted in a 25-item unidimensional, linear-weighted questionnaire with high internal consistency (person separation …

The Cleft Palate Craniofacial Journal

ObjectiveOur goal was to compare data collected from 3- and 7-day Infant with Clefts Observation Outcomes (iCOO) diaries.DesignSecondary data analysis of an observational longitudinal cohort study. Caregivers completed the daily iCOO for 7 days before cleft lip surgery (T0) and for 7 days after cleft lip repair (T1). We compared 3- and 7-day diaries collected at T0 and 3- and 7-day diaries collected at T1.SettingUnited States.ParticipantsPrimary caregivers of infants with cleft lip with and without cleft palate (N  =  131) planning lip repair and enrolled in original iCOO study.Main Outcomes Measure(s)Mean differences and Pearson correlation coefficients.ResultsCorrelation coefficients were high for global impressions (>0.90) and scaled scores (0.80–0.98). Mean differences were small across iCOO domains at T0. T1 comparisons reflected the same pattern.ConclusionsThree-day diary data is comparable to 7 …

Patient preference and adherence

PurposeThis study implemented the individualized Youth Quality of Life Instrument-Research Version (YQOL-R) to estimate the quality of life (QoL) among Chinese adolescents with three different Body Mass Index (BMI) levels. The study aims to explore and provide a reference for developing individualized QoL (IQoL) measurements in China.MethodsThe sample consisted of 822 aged 11–18 from nine schools. The data collection included all participants’ primary characters (age, sex, annual household income, parental education, and recruitment community) and their self-report QoL. Precisely, based on the generic measurement of YQOL-R, we developed IQoL measurements by asking adolescents’ perceived five most important things to them (IQOLimportance) and the aspects they most want to change (IQOLchange) from 19 facets, respectively. The one-way analysis of variance (ANOVA) was applied to …

Journal of Clinical and Translational Science

Background/Objective The goal of the Patient-Centered Outcomes Research Partnership was to prepare health care professionals and researchers to conduct patient-centered outcomes and comparative effectiveness research (CER). Substantial evidence gaps, heterogeneous health care systems, and decision-making challenges in the USA underscore the need for evidence-based strategies. Methods We engaged five community-based health care organizations that serve diverse and underrepresented patient populations from Hawai’i to Minnesota. Each partner nominated two in-house scholars to participate in the 2-year program. The program focused on seven competencies pertinent to patient-centered outcomes and CER. It combined in-person and experiential learning with asynchronous, online education, and created adaptive, pragmatic learning opportunities and a Summer Institute. Metrics included …

ObjectivesGI cancers account for over 25% of global cancer cases. Impact of cancer stage on patient-reported outcomes is poorly understood. This research aimed to understand symptom burden and HRQoL impact by stage for colorectal, esophageal, and pancreatic cancer.MethodsLiterature searches were conducted using an AI-assisted platform to identify relevant articles published in the last five (2017-2022) or ten years (2012-2022) where articles were limited. Conference abstracts were searched for the last two years (2020-2022). Geographic scope was the US, Canada, and Europe.ResultsCompared with early-stage colorectal cancer, patients with advanced stage disease reported significantly poorer physical SF-12 scores in two studies (both p< 0.05). Mental SF-12 scores were significantly poorer in advanced stage disease (p< 0.01) in one study while the second study did not find a meaningful association …

Background The importance of patient-reported outcome measurement in chronic kidney disease (CKD) populations has been established. However, there remains a lack of research that has synthesised data around CKD-specific symptom and health-related quality of life (HRQOL) burden globally, to inform focused measurement of the most relevant patient-important information in a way that minimises patient burden. The aim of this review was to synthesise symptom prevalence/severity and HRQOL data across the following CKD clinical groups globally: (1) stage 1–5 and not on renal replacement therapy (RRT), (2) receiving dialysis, or (3) in receipt of a kidney transplant. Methods and findings MEDLINE, PsycINFO, and CINAHL were searched for English-language cross-sectional/longitudinal studies reporting prevalence and/or severity of symptoms and/or HRQOL in CKD, published between January 2000 and September 2021, including adult patients with CKD, and measuring symptom prevalence/severity and/or HRQOL using a patient-reported outcome measure (PROM). Random effects meta-analyses were used to pool data, stratified by CKD group: not on RRT, receiving dialysis, or in receipt of a kidney transplant. Methodological quality of included studies was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Studies Reporting Prevalence Data, and an exploration of publication bias performed. The search identified 1,529 studies, of which 449, with 199,147 participants from 62 countries, were included in the analysis. Studies used 67 different symptom and HRQOL outcome measures, which provided data on …

The Cleft Palate Craniofacial Journal

BackgroundCaregiver and observer-reported measures are frequently used as outcomes for research on infants and young children who are unable to report on their own health. Our team developed the Infant with Clefts Observation Outcomes Instrument (iCOO) for infants with cleft lip with or without cleft palate. This exploratory study compared test-retest and interrater reliabilities to inform whether differences in caregiver perspective might affect the iCOO.MethodsThis study is a secondary analysis comparing caregiver interrater agreement to test-retest reliability. Twenty-five pairs of caregivers completed the iCOO before surgery, 1 week later for test-retest reliability, 2 days after surgery, and 2 months after surgery. Reliability was assessed using intraclass correlations (ICCs) and t-tests were used to compare ratings between caregivers.ResultsInfants had cleft lip (28%) or cleft lip and palate (72%). Primary …

Annals of Oncology

BackgroundA multi-cancer early detection (MCED) test using methylation patterns in plasma cell-free DNA to detect a cancer signal and predict site of origin was evaluated in the prospective PATHFINDER study. Because MCED testing has the potential to cause anxiety and distress, participant-reported outcomes were assessed.MethodsAdults≥ 50 y with or without additional cancer risk factors (a cancer diagnosis> 3 years prior, smoking history, genetic predisposition) underwent the MCED blood test to screen for cancer. When a cancer signal was detected, the diagnostic workup was directed by the physician. Participants completed the Patient Reported Outcomes Measurement Information System (PROMIS) anxiety short form (higher scores= increased anxiety) pre-MCED test, post return of MCED test results (RoR), diagnostic resolution, and at end of study (EOS; 12 months). An adapted Multidimensional Impact …

Latino youth are disproportionately impacted by obesity, prediabetes and type 2 diabetes (T2D). Pediatric obesity is characterized by abnormal increases in pro-inflammatory markers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and monocyte chemoattractant protein-1 (MCP-1) and reductions in anti-inflammatory markers, high molecular weight adiponectin (HMW Adpn) and interleukin-10 (IL-10). Interleukin-1 receptor antagonist (IL-1ra) is an anti-inflammatory that is positively associated with obesity. IL-6, TNF-α, MCP-1 and IL-1ra have been associated with reduced insulin sensitivity and β-cell dysfunction, two central pathophysiologic mediators of glucose intolerance, while HMW Adpn and IL-10 have been associated with increased insulin sensitivity and β-cell function. The United States Diabetes Prevention Program (DPP) supported lifestyle intervention as the cornerstone approach for …

JAMA network open

ImportanceLatino youths are disproportionately impacted by prediabetes and type 2 diabetes (T2D). Lifestyle intervention is the first-line approach for preventing or delaying T2D among adults with prediabetes.ObjectiveTo assess the efficacy of a diabetes prevention program among Latino youths aged 12 to 16 years with prediabetes.Design, Setting, and ParticipantsThis 2-group parallel randomized clinical trial with 2:1 randomization assessed a lifestyle intervention against usual care among Latino youths with prediabetes and obesity with 6- and 12-month follow-up. The study was conducted at YMCA facilities in Phoenix, Arizona from May 2016 to March 2020.InterventionParticipants were randomized to lifestyle intervention (INT) or usual care control (UCC). The 6-month INT included 1 d/wk of nutrition and health education and 3 d/wk of physical activity. UCC included 2 visits with a pediatric endocrinologist and …

Value in Health

ObjectivesCaregiver and other observer-reported measures are frequently used as outcomes for clinical trials with infants and young children who are unable to report on their own health. Our team has developed a novel measure, the Infant with Clefts Observation Outcomes Instrument (iCOO), to assess health outcomes in infants with cleft lip and/or palate (CL/P). Previous studies have assessed health outcomes for older children with CL/P; however, the iCOO is the first measure for assessing outcomes in young children with CL/P. This study is a secondary analysis of the original measure development and compared caregiver interrater agreement with test-retest reliability.MethodsTwenty-five pairs of primary and secondary caregivers completed the iCOO at baseline, one week later (before cleft lip surgery) for test-retest reliability, and at two days and two months post-surgery. Test-retest reliability and interrater …

Journal of Cystic Fibrosis

Background The purpose of these analyses was to determine whether overall costs were reduced in cystic fibrosis (CF) patients experiencing pulmonary exacerbation (PEx) who received shorter versus longer durations of treatment. Methods Among people with CF experiencing PEx, we calculated 30-day inpatient, outpatient, emergency room, and medication costs and summed these to derive total costs in 2020 USD. Using the Kaplan-Meier sample average (KMSA) method, we calculated adjusted costs and differences in costs within two pairs of randomized groups: early robust responders (ERR) randomized to receive treatment for 10 days (ERR-10 days) or 14 days (ERR-14 days), and non-early robust responders (NERR) randomized to receive treatment for 14 days (NERR-14 days) or 21 days (NERR-21 days). Results Patients in the shorter treatment duration groups had shorter lengths of stay per …

294Background: TRANSCEND NHL 001 (TRANSCEND; NCT02631044) evaluated efficacy and safety of the CAR T cell therapy lisocabtagene maraleucel (liso-cel) as third-line or later treatment in patients with R/R LBCL. Prior research demonstrated improvements in HRQOL with liso-cel; however, evidence of HRQOL in the context of CAR T cell‒specific adverse events was not evaluated. In TRANSCEND, the incidence of all-grade cytokine release syndrome (CRS) and neurological events (NE) was 42% and 30%, respectively. This analysis examined longitudinal HRQOL in the presence of CRS and NEs among clinical responders. Methods: Patients in TRANSCEND who responded to liso-cel treatment (n = 137) were stratified into 3 groups: no CRS or NEs, either CRS or NEs but not both, and both CRS and NEs. HRQOL was evaluated with the European Organisation for Research and Treatment of Cancer core …

International Journal of Environmental Research and Public Health

Background: This study was to culturally adapt a lifestyle intervention for employees’ obesity control and prevention using a participatory process, and evaluate the effectiveness of the project at worksites. Methods: A group randomized experimental study included four worksites (two intervention, two control) in the Yangtze River Delta in China was conducted. A total of 388 participants (216 in the intervention worksites and 172 in the control worksites) were finally recruited from 955 employees at the four worksites (464 in the intervention worksites and 491 in the control worksites). The final evaluation was completed by two hundred and seventy-eight employees (159 in the intervention worksites and 119 in the control worksites, respectively). Data of demographic information, weight, BMI, waist circumference, hip circumference and weight-related behaviors including diary behaviors and physical activities were collected before and after a 12-month intervention and analyzed using descriptive statistics, t-test, chi-square test, linear mixed regression and logistic mixed regression. Results: Although the intervention worksites had a reduction in body mass index (23.21 to 22.95, p < 0.01), hip circumference (95.97 to 95.28, p = 0.03) and waist-to-height ratio (0.49 to 0.48, p = 0.01), the differential changes compared to those of the control group were not statistically significant. The frequency of sweet beverages (−1.81, 95%CI: −0.52, −3.11), frequency of vegetable intake (5.66, 95%CI: 1.59, 9.74), daily servings of vegetables (0.53, 95%CI: 0.24, 0.82), frequency of fruit intake (3.68, 95%CI: 1.25, 6.12), daily servings of fruit (0.26, 95%CI: 0.44, 0.92), daily …

Background and ObjectivesTo evaluate reporting of minimal important difference (MID) estimates using anchor-based methods for patient-reported outcome measures (PROMs), and the association with reporting deficiencies on their credibility.MethodsSystematic survey of primary studies empirically estimating MIDs. We searched Medline, EMBASE, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database until October 2018. We evaluated study reporting, focusing on participants’ demographics, intervention(s), characteristics of PROMs and anchors, and MID estimation method(s). We assessed the impact of reporting issues on credibility of MID estimates.ResultsIn 585 studies reporting on 5,324 MID estimates for 526 distinct PROMs, authors frequently failed to adequately report key characteristics of PROMs and MIDs, including minimum and maximum values of PROM scale …

American Journal of Ophthalmology

PURPOSETo develop a patient-reported outcome measure for capturing visual and ocular symptoms before and after implantation of intraocular lenses (IOLs) for treatment of cataracts.DESIGNQuestionnaire development and validation study.METHODSThe Questionnaire for Visual Disturbances (QUVID) was developed based on a literature and instrument review; 13 clinician interviews among ophthalmologists in the United States and Europe; and 67 hybrid qualitative patient interviews among adult patients in the United States and Australia before and/or after monofocal, traditional multifocal, or trifocal IOL implantation. Assessment of the QUVID's psychometric properties was conducted via a noninterventional cross-sectional study of previously treated cataract patients in the United States, Canada, and Australia (n = 150), and assessment of ability to detect meaningful change via 2 pivotal US clinical trials among …

Clinical otolaryngology

2 METHODSProcedures employing transnasal endoscopic high-definition distal chip-digitally recorded laryngoscopy were performed in the operating room and an otolaryngology office-setting. Procedures involved laser ablation and biopsy of laryngeal lesions. Approval from Institutional Review Board was obtained for retrospective analysis of procedures involving the use of laser fibres in channelled flexible laryngoscopy. Clinical practice guidelines were followed according to the AGREE Reporting Checklist. 6 Written informed consent was obtained from all patients included in the study, including those used in the video demonstration. Repair costs and shipping costs for flexible channelled laryngoscopes between 1 January 2016 and 31 December 2022 were obtained through consultation with nursing and department billing.

Clinical otolaryngology

2 METHODSProcedures employing transnasal endoscopic high-definition distal chip-digitally recorded laryngoscopy were performed in the operating room and an otolaryngology office-setting. Procedures involved laser ablation and biopsy of laryngeal lesions. Approval from Institutional Review Board was obtained for retrospective analysis of procedures involving the use of laser fibres in channelled flexible laryngoscopy. Clinical practice guidelines were followed according to the AGREE Reporting Checklist. 6 Written informed consent was obtained from all patients included in the study, including those used in the video demonstration. Repair costs and shipping costs for flexible channelled laryngoscopes between 1 January 2016 and 31 December 2022 were obtained through consultation with nursing and department billing.

Clinical Otolaryngology

Introduction There is an increased demand for well‐validated PROMs in otology. This study will systematically assess the methodological quality of all published patient‐reported outcome measures (PROMS) for patients with multiple ear complaints and to identify the best suitable PROM for use by clinicians treating patients with multiple ear complaints. Methods An extensive systematic mapping review of all otology questionnaires was performed to identify questionnaires measuring multiple ear complaints. The ‘Consensus‐based standards for the selection of health measurement Instruments’ (COSMIN) checklists were used to evaluate the quality of the questionnaire by two researchers. The worst item score per aspect of the methodological assessment counted. Results Twelve multiple‐complaint questionnaires were included in the study for quality assessment. Ten questionnaires were disease‐specific …

Clinical Otolaryngology

Objective To investigate the clinical characteristics associated with measured gustatory dysfunction in patients with chemosensory (smell and taste) discomfort. Study design Retrospective study. Design Hospital‐based cohort. Setting The clinical characteristics associated with the measured diagnosis of gustatory dysfunction were statistically analysed. Participants Patients who underwent all the psychophysical olfactory and chemical gustatory function tests (YSK olfactory function test and chemical gustometry exam) and the subjective questionnaires between October 2021 and February 2023. Main outcome measures YSK olfactory function test and chemical gustometry results, subjective questionnaire score about chemosensory (smell and taste) functions. The Medical records of patients who visited the smell and taste centre in a tertiary. Results A total of 219 patients were enrolled; 180 were diagnosed as …

Clinical Otolaryngology

2 MATERIALS AND METHODSApproval was obtained from: South Central—Hampshire B Research Ethics Committee (ref number 18/SC/0378); Health Research Authority (IRAS ID: 239892); Newcastle Upon Tyne Hospitals NHS Foundation Trust (R&D number: 8841). This study is reported according to the consolidated criteria for reporting qualitative research.

Clinical Otolaryngology

2 METHODS2.1 DesignThis was a single-centre retrospective cohort study of patients undergoing radiotherapy for HNC who required inpatient admission to initiate reactive NGT feeding.2.2 SettingThis cohort study was carried out in the Northern Centre for Cancer Care, Newcastle Upon Tyne, which is a tertiary oncology centre in the United Kingdom.

Clinical Otolaryngology

Objective The present study aimed to investigate the in vivo activity of nasal irrigation (NI) with saline, NI with povidone–iodine (PVP–I) 1%, NI with a mix of hypertonic alkaline and PVP–I 1% against Severe acute respiratory syndrome‐coronavirus‐2 (SARS‐CoV‐2). Design This study was a prospective randomised clinical trial. Setting A multicenter study involving tertiary care centres. Participants The study included adult outpatients whose qualitative SARS‐CoV‐2 RT‐PCR tests in nasopharyngeal swabs were positive. One hundred twenty patients were divided into four equal groups. Standard COVID‐19 treatment was given to Group 1, NI containing saline was added to patients' treatment in Group 2, NI containing 1% PVP–I solution was added to patients' treatment in Group 3, and NI containing 1% PVP–I solution and the hypertonic alkaline solution was added to patients' treatment in Group 4. Main …

Clinical Otolaryngology

Objective There is a paucity of research examining patient experiences of cochlear implants. We sought to use natural language processing methods to explore patient experiences and concerns in the online cochlear implant (CI) community. Materials and Methods Cross‐sectional study of posts on the online Reddit r/CochlearImplants forum from 1 March 2015 to 11 November 2021. Natural language processing using the BERTopic automated topic modelling technique was employed to cluster posts into semantically similar topics. Topic categorisation was manually validated by two independent reviewers and Cohen's kappa calculated to determine inter‐rater reliability between machine vs human and human vs human categorisation. Results We retrieved 987 posts from 588 unique Reddit users on the r/CochlearImplants forum. Posts were initially categorised by BERTopic into 16 different Topics, which were …

Clinical Otolaryngology

Background Quality of life (QoL) assessment forms an integral part of modern cancer care and research. The aim of this study is to determine patients' preferences and willingness to complete commonly used head‐and‐neck cancer (HNC) QoL questionnaires (QLQs) in routine follow‐up clinics. Methods This is a randomised control trial of 583 subjects from 17 centres during follow‐up after treatment for oral, oropharyngeal or laryngeal cancer. Subjects completed three structured validated questionnaires: EORTC QLQ‐HN35; FACT‐HN and UW‐QOL, and an unstructured patient‐generated list. The order of questionnaire presentation was randomised, and subjects were stratified by disease site and stage. Patients self‐rated the questionnaires they found most helpful to communicate their health concerns to their clinicians. Results Of the 558 respondents, 82% (457) found QLQs useful to communicate their …

Clinical Otolaryngology

Objectives To assess the correlation between inflammatory markers (IM) and hearing loss (HL) in a large cohort of apparently healthy individuals. Design A cross sectional study. Setting Tel‐Aviv Medical Center (a tertiary referral center) Inflammatory Survey Participants Individuals who attended the Tel‐Aviv Medical Center Inflammatory Survey (TAMCIS) for a routine annual health check. Results Out of 2,500 individuals included in the final study cohort, 1,170 (47.3%) had some hearing impairment. Those with a hearing loss in 1 or both ears had significantly higher levels of neutrophils, lymphocytes, neutrophil‐to‐lymphocyte ratio, monocyte‐to‐lymphocyte ratio, and red blood cell counts. There was a difference between low‐ and high‐ frequencies losses associated with the inflammatory status. Conclusions IM levels were associated with the presence of a HL, supporting a link between inflammatory changes …

Clinical Otolaryngology

Background Quality of life (QoL) assessment forms an integral part of modern cancer care and research. The aim of this study is to determine patients' preferences and willingness to complete commonly used head‐and‐neck cancer (HNC) QoL questionnaires (QLQs) in routine follow‐up clinics. Methods This is a randomised control trial of 583 subjects from 17 centres during follow‐up after treatment for oral, oropharyngeal or laryngeal cancer. Subjects completed three structured validated questionnaires: EORTC QLQ‐HN35; FACT‐HN and UW‐QOL, and an unstructured patient‐generated list. The order of questionnaire presentation was randomised, and subjects were stratified by disease site and stage. Patients self‐rated the questionnaires they found most helpful to communicate their health concerns to their clinicians. Results Of the 558 respondents, 82% (457) found QLQs useful to communicate their …

Clinical Otolaryngology

Objective To evaluate the effect of Neurotec® herbal capsule (100 mg twice a day for 3 months) on the tinnitus symptoms in comparison with the placebo. Design A double‐blind randomised clinical trial. Setting Otolaryngology clinic of Baqiyatallah Hospital. Participants Patients suffering from subjective tinnitus. Main Outcome Measures Pure tone audiometry was measured at .5, 1, 2, 4 and 6 kHz frequencies before and after the third month of intervention. In addition, Tinnitus Handicap Inventory (THI) questionnaire as well as visual analogue scale (VAS) for tinnitus loudness, daily annoyance, daily life or sleep disturbance, daily perception and mood alteration were evaluated. Results Finally, 103 (69 males and 34 females) patients with a mean age of 51.33 ± 13.91 years were analysed. In contrast with control group, patients in intervention group showed a remarkable decrease in THI score after 3 …

Clinical Otolaryngology

Objective To determine primary and secondary post‐tonsillectomy haemorrhage (PTH) rates and identify predictive factors in a cohort of consecutive adult and paediatric BiZact™ tonsillectomy cases. Setting Retrospective cohort study. Patients from Flinders Medical Centre, Noarlunga Hospital and private otolaryngology practices who underwent BiZact™ tonsillectomy from 2017 to 2020. Data collected: patient age, indication for tonsillectomy, surgeon experience, time and severity of PTH, including return to theatre. Each secondary PTH was graded using the Stammberger classification. Logistic regression was utilised to identify predictors of secondary PTH. Results One thousand seven hundred and seventeen patient medical records were assessed (658 adults and 1059 children). The primary PTH rate was 0.1%, and secondary PTH rate was 5.9%. The majority of secondary PTH cases were Stammberger …

Clinical Otolaryngology

Objectives To characterise the real‐world burden of chronic rhinosinusitis with nasal polyps (CRSwNP) in the UK, stratified by number of surgeries. Design Retrospective cohort study. Setting UK Clinical Practice Research Datalink Aurum database with Hospital Episodes Statistics linkage (2007–2019). Participants Adults ≥18 years of age with a first NP diagnosis (index) and 365 days of baseline and ≥180 days of follow‐up data. Follow‐up continued until disenrollment, death or end of data collection. Main Outcome Measures Primary: primary care physician prescribed CRSwNP‐related treatments, and all‐cause healthcare resource utilisation (HCRU) in 90 days post‐index, stratified by surgeries during follow‐up. Secondary: rate of surgery and CRSwNP point prevalence. Baseline patient demographics, clinical characteristics and comorbidities were also assessed. Results Of the 33 107 patients …

Clinical Otolaryngology

Objective To evaluate the effect of Neurotec® herbal capsule (100 mg twice a day for 3 months) on the tinnitus symptoms in comparison with the placebo. Design A double‐blind randomised clinical trial. Setting Otolaryngology clinic of Baqiyatallah Hospital. Participants Patients suffering from subjective tinnitus. Main Outcome Measures Pure tone audiometry was measured at .5, 1, 2, 4 and 6 kHz frequencies before and after the third month of intervention. In addition, Tinnitus Handicap Inventory (THI) questionnaire as well as visual analogue scale (VAS) for tinnitus loudness, daily annoyance, daily life or sleep disturbance, daily perception and mood alteration were evaluated. Results Finally, 103 (69 males and 34 females) patients with a mean age of 51.33 ± 13.91 years were analysed. In contrast with control group, patients in intervention group showed a remarkable decrease in THI score after 3 …

Clinical Otolaryngology

Objective To assess whether narrow band imaging (NBI) detects fields of cancerisation around suspicious lesions in the upper aerodigestive tract, which were undetected by white light imaging (WLI). Methods In 96 patients with laryngeal and pharyngeal lesions suspicious for malignancy, 206 biopsies were taken during laryngoscopy: 96 biopsies of suspicious lesions detected by both WLI and NBI (WLI+/NBI+), 60 biopsies adjacent mucosa only suspicious with NBI (WLI‐/NBI+), and 46 biopsies of NBI and WLI unsuspicious mucosa (WLI‐/NBI‐) as negative controls. Optical diagnosis according to the Ni‐classification was compared with histopathology. Results Signs of (pre)malignancy were found in 88% of WLI+/NBI+ biopsies, 32% of WLI‐/NBI+ biopsies and 0% in WLI‐/NBI‐ (p < .001). In 58% of the WLI‐/NBI+ mucosa any form of dysplasia or carcinoma was detected. Conclusion The use of additional NBI …

Clinical Otolaryngology

Objectives The strenuous demands of head and neck cancer surgery (HNS) place patients at increased risk of myocardial injury. Troponin positivity (TP) post‐operatively is a predictor of increased complications and mortality. The present study is the first to investigate the effects of TP on potential delays in adjuvant treatment and disease‐specific survival. Design, Setting, Participants and Main outcome measures All patients undergoing HNS from 2014 to 2016 had troponins measured at a single academic centre. Relevant patient data was extracted on retrospective chart review. The main outcome measures were the impact of TP on timing of adjuvant treatment and disease‐specific survival. Results Of 166 patients, 26 (15.6%) developed TP post‐operatively. There was no significant difference between cohorts for baseline characteristics except for age. Overall and disease‐specific survival for TP patients were …

Clinical Otolaryngology

Objective Little is known about the efficacy of using artificial intelligence (AI) to identify laryngeal carcinoma from images of vocal lesions taken in different hospitals with multiple laryngoscope systems. This multicentre study aimed to establish an AI system and provide a reliable auxiliary tool to screen for laryngeal carcinoma. Study design Multicentre case–control study. Setting Six tertiary care centres. Participants Laryngoscopy images were collected from 2179 patients with vocal fold lesions. Outcome measures An automatic detection system of laryngeal carcinoma was established and used to distinguish malignant and benign vocal lesions in 2179 laryngoscopy images acquired from 6 hospitals with 5 types of laryngoscopy systems. Pathological examination was the gold standard for identifying malignant and benign vocal lesions. Results Out of 89 cases in the malignant group, the classifier was able to …

Clinical Otolaryngology

Objective There is a paucity of research examining patient experiences of cochlear implants. We sought to use natural language processing methods to explore patient experiences and concerns in the online cochlear implant (CI) community. Materials and Methods Cross‐sectional study of posts on the online Reddit r/CochlearImplants forum from 1 March 2015 to 11 November 2021. Natural language processing using the BERTopic automated topic modelling technique was employed to cluster posts into semantically similar topics. Topic categorisation was manually validated by two independent reviewers and Cohen's kappa calculated to determine inter‐rater reliability between machine vs human and human vs human categorisation. Results We retrieved 987 posts from 588 unique Reddit users on the r/CochlearImplants forum. Posts were initially categorised by BERTopic into 16 different Topics, which were …

Clinical Otolaryngology

Objectives To evaluate the impact of the COVID‐19 lockdown measures on HNC, by comparing the stage at presentation and treatment of HNC before and after the most severe COVID‐19 restrictions. Design A retrospective cohort study. Setting A regional cancer network serving a patient population of 2.4 million. Participants Newly diagnosed patients with HNC between June and October 2019 (pre‐pandemic) and June and October 2021 (post‐pandemic). Main outcome measures Symptom duration before diagnosis, stage at diagnosis, patient performance status (PS) and intent of treatment delivered (palliative vs. curative). Results Five hundred forty‐five patients were evaluated—250 in the 2019 and 295 in the 2021 cohort. There were no significant differences in symptom duration between the cohorts (p = .359) or patient PS (p = .821). There were no increased odds of presenting with a late (Stage III or …