Multi-sensory processing in adults: An EEG study of latency and amplitude in the N1 and P2 peaks

Research has shown that processing of modality specific stimuli begins early on in cortical processing, affecting the peaks of event related potentials that occur earlier in EEG waveforms. Processing of combined sensory inputs has been shown to affect the latency and amplitude of later occurring peaks, the N2 and P300, suggesting that sensory stimuli are processed in a combined manner in a later stage of cortical processing. Two of the earlier peaks, the N1 and P2, of auditory and visual event related potentials (ERPs) can be used to study the effects of multiple sensory inputs on the human sensory system. Using EEG to detect and record ERPs during a randomized single sensory and combined sensory detection task, this study examined whether or not a multisensory stimulus would affect the latency and amplitude of the auditory and visual N1 and P2 peaks. While outcomes of the study did not yield significant results for effects on the latency of the N1, there were significant effects for the amplitude of the N1 peak and the latency of the P2 peak; with the most significant results seen in an increase in amplitude of the P2 peak for the combined stimulus condition. Research Question: Are changes in the latency and amplitude of the N1 and P2 auditory and visual ERP peaks seen in multisensory processing, and if so, do these changes imply integration of multiple sensory inputs at earlier cortical stages of sensory processing

Parents' agendas in paediatric clinical trial recruitment are different from researchers' and often remain unvoiced: a qualitative study

Ensuring parents make an informed decision about their child's participation in a clinical trial is a challenge for practitioners as a parent's comprehension of a trial may differ from that intended by the practitioners responsible for recruitment. We explored what issues parents consider important when making a decision about participation in a paediatric clinical trial and their comprehension of these issues to inform future recruitment practice. This qualitative interview and observational study examined recruitment in four placebo-controlled, double-blind randomised clinical trials of medicines for children. Audio-recorded trial recruitment discussions between practitioners and parents (N = 41) were matched with semi-structured interviews with parents (N = 41). When making a decision about trial entry parents considered clinical benefit, child safety, practicalities of participation, research for the common good, access to medication and randomisation. Within these prioritised issues parents had specific misunderstandings, which had the potential to influence their decisions. While parents had many questions and concerns about trial participation which influenced their decision-making, they rarely voiced these during discussions about the trials with practitioners. Those involved in the recruitment of children to clinical trials need to be aware of parents' priorities and the sorts of misunderstandings that can arise with parents. Providing trial information that is tailored to what parents consider important in making a decision about a clinical trial may improve recruitment practice and ultimately benefit evidence-based paediatric medicine. © 2013 Woolfall et al

Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ

OBJECTIVES: Adding, omitting or changing prespecified outcomes can result in bias because it increases the potential for unacknowledged or post hoc revisions of the planned analyses. Journals have adopted initiatives such as requiring the prospective registration of trials and the submission of study protocols to promote the transparency of reporting in clinical trials. The main objective of this feasibility study was to document the frequency and types of outcome discrepancy between prespecified outcomes in the protocol and reported outcomes in trials submitted to The BMJ.METHODS: A review of all 3156 articles submitted to The BMJ between 1 September 2013 and 30 June 2014. Trial registry entries, protocols and trial reports of randomised controlled trials published by The BMJ and a random sample of those rejected were reviewed. Editorial, peer reviewer comments and author responses were also examined to ascertain any reasons for discrepancies.RESULTS: In the study period, The BMJ received 311 trial manuscripts, 21 of which were subsequently published by the journal. In trials published by The BMJ, 27% (89/333) of the prespecified outcomes in the protocol were not reported in the submitted paper and 11% (31/275) of reported outcomes were not prespecified. In the sample of 21 trials rejected by The BMJ, 19% (63/335) of prespecified outcomes went unreported and 14% (45/317) of reported outcomes were not prespecified. None of the reasons provided by published authors were suggestive of outcome reporting bias as the reasons were unrelated to the results.CONCLUSIONS: Mandating the prospective registration of a trial and requesting that a protocol be uploaded when submitting a trial article to a journal has the potential to promote transparency and safeguard the evidence base against outcome reporting biases as a result of outcome discrepancies. Further guidance is needed with regard to documenting reasons for outcome discrepancies.</p

Association rule mining to identify potential under-coding of conditions in the problem list in primary care electronic medical records

Introduction The problem list of a patient’s primary care electronic medical record (EMR) generally reflects their important medical conditions. We will use association rule mining to assess between-provider and between-clinic variation in the coding of select conditions in the EMR problem list, in order to identify possible under-coding outliers. Objectives and Approach EMR data from participating clinics in the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) will be used, with a focus on three commonly-occurring conditions (hypertension, diabetes, and depression). Association rule mining will be used to develop association rules between these conditions and other clinical information available in the EMR, such as other diagnoses in the problem list, billing codes, medications, and laboratory results (e.g., a rule of “diabetic medication→diabetes” indicates that patients prescribed a diabetic medication are likely to have diabetes in the problem list). Under-coding outliers at the provider and clinic levels will be identified by comparing rule enforcement. Results Results from this work in progress will be presented at the conference. An estimated 270 clinics, 1340 providers, and 1.8 million patients will be included from the CPCSSN database. Rule ‘confidence’ will be used to identify outliers; the confidence of a rule X→Y is the proportion of individuals with X who also have Y (Pr(Y|X)). For example, we may find that on average 80% of patients prescribed a diabetic medication will also have a diagnosis of diabetes in the problem list (average confidence of 80%), but an outlier clinic may have a confidence of 40%; this low rule confidence may indicate under-coding of diabetes in the problem list. Confounding by patient demographics (e.g., age, sex, urban/rural) will be assessed and adjusted for, if necessary. Conclusion/Implications This work examines a novel method to identify potential under-coding in the EMR problem list. Providers/clinics could use this information to update patients’ problem list or inform quality improvement interventions. Researchers using primary care EMR data need to be aware of potential under-coding and take steps to mitigate the effects

A review of the Cochrane COVID-19 Study Register reveals inconsistency in the choice and measurement of SARS-CoV-2 infection outcomes in prevention trials

Background: Multiple studies are evaluating how to prevent SARS-CoV-2 infection. Interventions are wide ranging and include vaccines, prophylactic drugs, public health safety measures, and behavioural interventions. Heterogeneity in the outcomes measured and reported is leading to research waste and inefficiency, slowing worldwide identification and implementation of effective methods to prevent infection. A core outcome set (COS) for studies of interventions to prevent SARS-CoV-2 infection has recently been developed, identifying infection as a critical outcome to measure. This paper examines how SARS-CoV-2 infection outcomes are measured in registered COVID-19 prevention trials and considers how this can be improved. Methods: We searched the Cochrane COVID-19 Study Register to identify and review SARS-CoV-2 infection outcomes in prevention trials, including the rationale for choice of outcome measurement. We included phase 3 and 4 trials of COVID-19 prevention interventions. Early phase trials and studies relating to the transmission, treatment or management of COVID-19 were excluded. Results: We identified 430 entries in the register, of which 199 unique prevention trials were included across eight settings and 12 intervention types. Fifteen (8%) trials did not include any SARS-CoV-2 infection outcomes. The remaining 184 (92%) studies included a total of 268 SARS-CoV-2 infection outcomes, of which 32 (17%) did not specify how infection would be measured. Testing (i.e. formal diagnostic test) as a standalone method for determining infection was used in 57 (31%) trials, whereas defining infection by symptoms alone was used in 16 (9%) trials. All other trials (n=79, 43%) included multiple infection outcomes, defined in different ways. Discussion: There is considerable variation in how SARS-CoV-2 infection is measured within and across different interventions and settings. Furthermore, few studies report the rationale for outcome selection and measurement. Better transparency and standardisation of SARS-CoV-2 infection measurement is needed for the findings from prevention trials to inform decision-making.</ns3:p

Impact of the Choosing Wisely Canada recommendations on potentially inappropriate antibiotic prescribing in emergency medicine across Alberta, Canada: An interrupted time-series analysis.

Objectives In Alberta, Canada, we quantified the rate of potentially inappropriate oral antibiotic prescribing in emergency departments for viral infections or conditions not likely requiring antibiotics from 2010-2020 and assessed the impact of two Choosing Wisely Canada (CWC) campaigns (2015/2016 and 2018) discouraging inappropriate antibiotic prescribing in emergency medicine. Approach We linked emergency department adult and pediatric records from the National Ambulatory Care Reporting System and medication dispensations from community-based pharmacies in the Pharmaceutical Information Network. From January 2010 to February 2020, we identified emergency department visits for 5 conditions that were potentially inappropriately treated using antibiotics per CWC recommendations (bronchitis, asthma, bronchiolitis, pharyngitis, and acute otitis media). We used an interrupted time series design to detect changes in antibiotic prescribing by fitting Autoregressive Integrated Moving Average (ARIMA) models to account for secular trends and seasonality, allowing for change in slopes to measure the effect of each CWC intervention. Results Antibiotics were commonly prescribed in emergency departments for bronchitis (proportion of visits with antibiotics: 57%) and asthma (22%) in adults; bronchiolitis in children (43%); pharyngitis (39%) and acute otitis media (54%) in adults and children. Based on visual inspection, the proportion of emergency department visits for each condition where antibiotics were dispensed remained relatively consistent. The ARIMA models demonstrated mixed impacts on potentially inappropriate antibiotic prescribing associated with two interruptions: the 2015/2016 CWC recommendations and subsequent 2018 CWC Using Antibiotics Wisely campaign. Following each interruption, antibiotic prescribing was slightly reduced for bronchitis (-1.0%/year,p=0.03; -4.4%/year,p=0.004, respectively) and bronchiolitis (not significant) (-0.7%/year,p=0.57; -2.5%/year,p=0.34), but unchanged for asthma (-0.6%/year,p=0.30; 0.7%/year,p=0.74) and pharyngitis (0.0%/year,p=0.95; -0.2%/year,p=0.93), and slightly increased for acute otitis media (not significant) (1.4%/year,p=0.07; 5.9%/year,p=0.052). Conclusion Rates of potentially inappropriate antibiotic prescribing remained constant over the past 10 years in Alberta. Campaigns to rethink antibiotic use in emergency medicine may have resulted in small decreases in antibiotic use; however, further initiatives building upon existing campaigns are required to substantially reduce rates of inappropriate antibiotic prescribing

Human papillomavirus (HPV) vaccination and oropharyngeal HPV in ethnically diverse, sexually active adolescents: community-based cross-sectional study.

OBJECTIVES: Oropharyngeal squamous cell carcinoma is the most common human papillomavirus (HPV)-associated cancer in the UK, but little is known about the prevalence of oropharyngeal HPV in sexually active teenagers. We investigated reported HPV vaccination coverage (in females) and prevalence of oropharyngeal HPV in sexually active students attending six technical colleges in London, UK. METHODS: In 2017, we obtained mouthwash samples and questionnaires from male and female students taking part in the 'Test n Treat' chlamydia screening trial. Samples were subjected to HPV genotyping. RESULTS: Of 232 participants approached, 202 (87%) provided a mouthwash sample and questionnaire. Participants' median age was 17 years and 47% were male. Most (73%) were from black and minority ethnic groups, 64% gave a history of oral sex, 52% reported having a new sexual partner in the past 6 months, 33% smoked cigarettes, 5.9% had concurrent genitourinary Chlamydia trachomatis infection and 1.5% Neisseria gonorrhoeae and 5.0% were gay or bisexual. Only 47% (50/107) of females reported being vaccinated against HPV 16/18, of whom 74% had received ≥2 injections. HPV genotyping showed three mouthwash samples (1.5%, 95% CI 0.3% to 4.3%) were positive for possible high-risk human papillomavirus (HR-HPV), one (0.5%, 0.0% to 2.7%) for low-risk HPV 6/11, but none (0.0%, 0.0% to 1.8%) for HR-HPV. Four samples (2.0%, 0.5% to 5.0%) were positive for HPV16 using a HPV16 type-specific quantitative PCR, but these were at a very low copy number and considered essentially negative. CONCLUSIONS: Despite the high prevalence of oral sex and genitourinary chlamydia and low prevalence of HPV vaccination, the prevalence of oropharyngeal HR-HPV in these adolescents was negligible

UK publicly-funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns

AbstractObjectivesEvaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers.Study Design and SettingWeb-based survey of Directors of 45 UK Clinical Research Collaboration (UKCRC)–registered CTUs.ResultsTwenty-three (51%) CTUs responded: Five (22%) of these had an established data sharing policy and eight (35%) specifically requested consent to use patient data beyond the scope of the original trial. Fifteen (65%) CTUs had received requests for data, and seven (30%) had made external requests for data in the previous 12 months. CTUs supported the need for increased data sharing activities although concerns were raised about patient identification, misuse of data, and financial burden. Custodianship of clinical trial data and requirements for a CTU to align its policy to their parent institutes were also raised. No CTUs supported the use of an open access model for data sharing.ConclusionThere is support within the publicly funded UKCRC-registered CTUs for data sharing, but many perceived barriers remain. CTUs are currently using a variety of approaches and procedures for sharing data. This survey has informed further work, including development of guidance for publicly funded CTUs, to promote good practice and facilitate data sharing