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Neoadjuvant therapy or upfront surgery in advanced endometrial cancer: a systematic review protocol

BMJ Open. 2021 Nov 11;11(11):e054004. doi: 10.1136/bmjopen-2021-054004.

ABSTRACT

INTRODUCTION: There is no consensus on the optimal treatment strategy for people with advanced endometrial cancer. Neoadjuvant therapies such as chemotherapy and radiotherapy have been employed to try to reduce the morbidity of surgery, improve its feasibility and/or improve functional performance in people considered unfit for primary surgery. The objective of this review is to assess whether neoadjuvant chemotherapy or radiotherapy improves health outcomes in people with advanced endometrial cancer when compared with upfront surgery.

METHODS AND ANALYSIS: This review will consider both randomised and non-randomised studies that compare health outcomes associated with the neoadjuvant therapy and upfront surgery in advanced endometrial cancer. Potential studies for inclusion will be collated from electronic searches of OVID Medline, Embase, international trial registries and conference abstract lists. Data collection and extraction will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The methodological quality of the studies will be assessed using the Risk of Bias 2 and Risk of Bias in Non-randomised Studies of Interventions tools. If appropriate, we will perform a meta-analysis and provide summary statistics for each outcome.

ETHICS AND DISSEMINATION: Ethics approval was not required for this study. Once complete, we will publish our findings in peer-reviewed publications, via conference presentations and to update relevant practice guidelines.

PMID:34764178 | DOI:10.1136/bmjopen-2021-054004

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Integrating expert knowledge for dementia risk prediction in individuals with mild cognitive impairment (MCI): a study protocol

BMJ Open. 2021 Nov 11;11(11):e051185. doi: 10.1136/bmjopen-2021-051185.

ABSTRACT

INTRODUCTION: To date, there is no broadly accepted dementia risk score for use in individuals with mild cognitive impairment (MCI), partly because there are few large datasets available for model development. When evidence is limited, the knowledge and experience of experts becomes more crucial for risk stratification and providing MCI patients with prognosis. Structured expert elicitation (SEE) includes formal methods to quantify experts’ beliefs and help experts to express their beliefs in a quantitative form, reducing biases in the process. This study proposes to (1) assess experts’ beliefs about important predictors for 3-year dementia risk in persons with MCI through SEE methodology and (2) to integrate expert knowledge and patient data to derive dementia risk scores in persons with MCI using a Bayesian approach.

METHODS AND ANALYSIS: This study will use a combination of SEE methodology, prospectively collected clinical data, and statistical modelling to derive a dementia risk score in persons with MCI . Clinical expert knowledge will be quantified using SEE methodology that involves the selection and training of the experts, administration of questionnaire for eliciting expert knowledge, discussion meetings and results aggregation. Patient data from the Prospective Registry for Persons with Memory Symptoms of the Cognitive Neurosciences Clinic at the University of Calgary; the Alzheimer’s Disease Neuroimaging Initiative; and the National Alzheimer’s Coordinating Center’s Uniform Data Set will be used for model training and validation. Bayesian Cox models will be used to incorporate patient data and elicited data to predict 3-year dementia risk.

DISCUSSION: This study will develop a robust dementia risk score that incorporates clinician expert knowledge with patient data for accurate risk stratification, prognosis and management of dementia.

PMID:34764172 | DOI:10.1136/bmjopen-2021-051185

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Expert consensus on a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation: protocol for an international e-Delphi study

BMJ Open. 2021 Nov 11;11(11):e050219. doi: 10.1136/bmjopen-2021-050219.

ABSTRACT

INTRODUCTION: Spinal and peripheral joint manipulation (SMT) and mobilisation (MOB) are widely used and recommended in the best practice guidelines for managing musculoskeletal conditions. Although adverse events (AEs) have been reported following these interventions, a clear definition and classification system for AEs remains unsettled. With many professionals using SMT and MOB, establishing consensus on a definition and classification system is needed to assist with the assimilation of AEs data across professions and to inform research priorities to optimise safety in clinical practice.

METHODS AND ANALYSIS: This international multidisciplinary electronic Delphi study protocol is informed by a scoping review and in accordance with the ‘Guidance on Conduction and Reporting Delphi Studies’. With oversight from an expert steering committee, the study comprises three rounds using online questionnaires. Experts in manual therapy and patient safety meeting strict eligibility criteria from the following fields will be invited to participate: clinical, medical and legal practice, health records, regulatory bodies, researchers and patients. Round 1 will include open-ended questions on participants’ working definition and/or understanding of AEs following SMT and MOB and their severity classification. In round 2, participants will rate their level of agreement with statements generated from round 1 and our scoping review. In round 3, participants will rerate their agreement with statements achieving consensus in round 2. Statements reaching consensus must meet the a priori criteria, as determined by descriptive analysis. Inferential statistics will be used to evaluate agreement between participants and stability of responses between rounds. Statements achieving consensus in round 3 will provide an expert-derived definition and classification system for AEs following SMT and MOB.

ETHICS AND DISSEMINATION: This study was approved by the Canadian Memorial Chiropractic College Research Ethics Board and deemed exempt by Parker University’s Institutional Review Board. Results will be disseminated through scientific, professional and educational reports, publications and presentations.

PMID:34764170 | DOI:10.1136/bmjopen-2021-050219

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Relevance of assessment items in community paramedicine home visit programmes: results of a modified Delphi study

BMJ Open. 2021 Nov 11;11(11):e048504. doi: 10.1136/bmjopen-2020-048504.

ABSTRACT

OBJECTIVE: Guidelines for a structured assessment in community paramedicine home visit programmes have not been established and evidence to inform their creation is lacking. We sought to investigate the relevance of assessment items to the practice of community paramedics according to a pre-established clarity-utility matrix.

DESIGN: We designed a modified-Delphi study consisting of predetermined thresholds for achieving consensus, number of rounds of for scoring items, a defined meeting and discussion process, and a sample of participants that was purposefully representative.

SETTING AND PARTICIPANTS: We established a panel of 26 community paramedics representing 20 municipal paramedic services in Ontario, Canada. The sample represented a majority of paramedic services within the province that were operating a community paramedicine home visit programme.

MEASURES: Drawing from a bank of standardised assessment items grouped according to domains aligned with the International Classification on Functioning, Disability, and Health taxonomy, 64 previously pilot-tested assessment items were scored according to their clarity (being free from ambiguity and easy to understand) and utility (being valued in care planning or case management activities). Assessment items covered a broad range of health, social and environmental domains. To conclude scoring rounds, assessment items that did not achieve consensus for relevance to assessment practices were discussed among participants with opportunities to modify assessment items for subsequent rounds of scoring.

RESULTS: Resulting from the first round of scoring, 54 assessment items were identified as being relevant to assessment practices and 3 assessment items were removed from subsequent rounds. The remaining 7 assessment items were modified, with some parts removed from the final items that achieved consensus in the final rounds of scoring.

CONCLUSION: A broadly representative panel of community paramedics identified consensus for 61 assessment items that could be included in a structured, multidomain, assessment instrument for guiding practice in community paramedicine home visit programmes.

TRAIL REGISTRATION NUMBER: ISRCTN58273216.

PMID:34764166 | DOI:10.1136/bmjopen-2020-048504

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Barn Owl’s Auditory Space Map Activity Matching Conditions for a Population Vector Readout to Drive Adaptive Sound Localizing Behavior

J Neurosci. 2021 Nov 10:JN-RM-1061-21. doi: 10.1523/JNEUROSCI.1061-21.2021. Online ahead of print.

ABSTRACT

Space specific neurons in the owl’s midbrain form a neural map of auditory space, which supports sound orienting behavior. Previous work proposed that a population vector (PV) readout of this map, implementing statistical inference, predicts the owl’s sound localization behavior. This model also predicts the frontal localization bias normally observed and how sound localizing behavior changes when the signal to noise ratio varies, based on the spread of activity across the map. However, the actual distribution of population activity and whether this pattern is consistent with premises of the PV readout model on a trial-by-trial bases remains unknown. To answer these questions, we investigated whether the population response profile across the midbrain map in the barn owl’s optic tectum matches these predictions using in vivo multi-electrode array recordings. We found that response profiles of recorded sub-populations are sufficient for estimating the stimulus ITD using responses from single trials. Furthermore, this decoder matches the expected differences in trial-by-trial variability and frontal bias between stimulus conditions of low and high signal-to-noise ratio. These results support the hypothesis that a PV readout of the midbrain map can mediate statistical inference in sound localizing behavior of barn owls.SIGNIFICANCE STATEMENTWhile the tuning of single neurons in the owl’s midbrain map of auditory space has been considered predictive of this species’ highly specialized sound localizing behavior, response properties across the population remain largely unknown. For the first time, this study analyzed the spread of population responses across the map using multi-electrode recordings and how it changes with signal-to-noise ratio. The observed responses support the hypothesis of a population vector readout’s ability to predict biases in orienting behaviors and mediate uncertainty-dependent behavioral commands. The results are of significance for understanding potential mechanisms for the implementation of optimal behavioral commands across species.

PMID:34764158 | DOI:10.1523/JNEUROSCI.1061-21.2021

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SARS-CoV-2 antibody prevalence in Sierra Leone, March 2021: a cross-sectional, nationally representative, age-stratified serosurvey

BMJ Glob Health. 2021 Nov;6(11):e007271. doi: 10.1136/bmjgh-2021-007271.

ABSTRACT

INTRODUCTION: As of 26 March 2021, the Africa Centres for Disease Control and Prevention had reported 4 159 055 cases of COVID-19 and 111 357 deaths among the 55 African Union member states; however, no country has published a nationally representative serosurvey as of October 2021. Such data are vital for understanding the pandemic’s progression on the continent, evaluating containment measures, and policy planning.

METHODS: We conducted a cross-sectional, nationally representative, age-stratified serosurvey in Sierra Leone in March 2021 by randomly selecting 120 Enumeration Areas throughout the country and 10 randomly selected households in each of these. One to two persons per selected household were interviewed to collect information on sociodemographics, symptoms suggestive of COVID-19, exposure history to laboratory-confirmed COVID-19 cases, and history of COVID-19 illness. Capillary blood was collected by fingerstick, and blood samples were tested using the Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette. Total seroprevalence was estimated after applying sampling weights.

RESULTS: The overall weighted seroprevalence was 2.6% (95% CI 1.9% to 3.4%). This was 43 times higher than the reported number of cases. Rural seropositivity was 1.8% (95% CI 1.0% to 2.5%), and urban seropositivity was 4.2% (95% CI 2.6% to 5.7%).

DISCUSSION: Overall seroprevalence was low compared with countries in Europe and the Americas (suggesting relatively successful containment in Sierra Leone). This has ramifications for the country’s third wave (which started in June 2021), during which the average number of daily reported cases was 87 by the end of the month:this could potentially be on the order of 3700 actual infections per day, calling for stronger containment measures in a country with only 0.2% of people fully vaccinated. It may also reflect significant under-reporting of incidence and mortality across the continent.

PMID:34764148 | DOI:10.1136/bmjgh-2021-007271

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Potential impact of 5 years of ivermectin mass drug administration on malaria outcomes in high burden countries

BMJ Glob Health. 2021 Nov;6(11):e006424. doi: 10.1136/bmjgh-2021-006424.

ABSTRACT

INTRODUCTION: The global progress against malaria has slowed significantly since 2017. As the current malaria control tools seem insufficient to get the trend back on track, several clinical trials are investigating ivermectin mass drug administration (iMDA) as a potential additional vector control tool; however, the health impacts and cost-effectiveness of this new strategy remain unclear.

METHODS: We developed an analytical tool based on a full factorial experimental design to assess the potential impact of iMDA in nine high burden sub-Saharan African countries. The simulated iMDA regimen was assumed to be delivered monthly to the targeted population for 3 months each year from 2023 to 2027. A broad set of parameters of ivermectin efficacy, uptake levels and global intervention scenarios were used to predict averted malaria cases and deaths. We then explored the potential averted treatment costs, expected implementation costs and cost-effectiveness ratios under different scenarios.

RESULTS: In the scenario where coverage of malaria interventions was maintained at 2018 levels, we found that iMDA in these nine countries has the potential to reverse the predicted growth of malaria burden by averting 20-50 million cases and 36 000-90 000 deaths with an assumed efficacy of 20%. If iMDA has an efficacy of 40%, we predict between 40-99 million cases and 73 000-179 000 deaths will be averted with an estimated net cost per case averted between US$2 and US$7, and net cost per death averted between US$1460 and US$4374.

CONCLUSION: This study measures the potential of iMDA to reverse the increasing number of malaria cases for several sub-Saharan African countries. With additional efficacy information from ongoing clinical trials and country-level modifications, our analytical tool can help determine the appropriate uptake strategies of iMDA by calculating potential marginal gains and costs under different scenarios.

PMID:34764146 | DOI:10.1136/bmjgh-2021-006424

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Quantifying T2-FLAIR Mismatch Using Geographically Weighted Regression and Predicting Molecular Status in Lower-Grade Gliomas

AJNR Am J Neuroradiol. 2021 Nov 11. doi: 10.3174/ajnr.A7341. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: The T2-FLAIR mismatch sign is a validated imaging sign of isocitrate dehydrogenase-mutant 1p/19q noncodeleted gliomas. It is identified by radiologists through visual inspection of preoperative MR imaging scans and has been shown to identify isocitrate dehydrogenase-mutant 1p/19q noncodeleted gliomas with a high positive predictive value. We have developed an approach to quantify the T2-FLAIR mismatch signature and use it to predict the molecular status of lower-grade gliomas.

MATERIALS AND METHODS: We used multiparametric MR imaging scans and segmentation labels of 108 preoperative lower-grade glioma tumors from The Cancer Imaging Archive. Clinical information and T2-FLAIR mismatch sign labels were obtained from supplementary material of relevant publications. We adopted an objective analytic approach to estimate this sign through a geographically weighted regression and used the residuals for each case to construct a probability density function (serving as a residual signature). These functions were then analyzed using an appropriate statistical framework.

RESULTS: We observed statistically significant (P value = .05) differences between the averages of residual signatures for an isocitrate dehydrogenase-mutant 1p/19q noncodeleted class of tumors versus other categories. Our classifier predicts these cases with area under the curve of 0.98 and high specificity and sensitivity. It also predicts the T2-FLAIR mismatch sign within these cases with an under the curve of 0.93.

CONCLUSIONS: On the basis of this retrospective study, we show that geographically weighted regression-based residual signatures are highly informative of the T2-FLAIR mismatch sign and can identify isocitrate dehydrogenase-mutation and 1p/19q codeletion status with high predictive power. The utility of the proposed quantification of the T2-FLAIR mismatch sign can be potentially validated through a prospective multi-institutional study.

PMID:34764084 | DOI:10.3174/ajnr.A7341

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Surgeon effects on cataract refractive outcomes are minimal compared with patient comorbidity and gender: an analysis of 490 987 cases

Br J Ophthalmol. 2021 Nov 11:bjophthalmol-2021-320231. doi: 10.1136/bjophthalmol-2021-320231. Online ahead of print.

ABSTRACT

AIM: To investigate effect of patient age, gender, comorbidities and surgeon on refractive outcomes following cataract surgery.

METHODS: Study population: patients on UK national ophthalmic cataract database on cataract operations undertaken between 1 April 2010 and 31 August 2018. Variables examined included gender, age, diabetic retinopathy, glaucoma, high myopia, inherited retinal disease, optic nerve disease, uveitis, pseudoexfoliation, vitreous opacities, retinal pathology, cataract type, previous surgery and posterior capsular rupture. A multivariate normal cross-classified model was fitted to the refractive outcome using Markov Chain Monte Carlo (MCMC) methods with diffuse priors to approximate maximum likelihood estimation. A MCMC chain was generated with a burn-in of 5000 iterations and a monitoring chain of 50 000 iterations.

RESULTS: 490 987 cataract operations were performed on 351 864 patients by 2567 surgeons. Myopic and astigmatic errors were associated with posterior capsule rupture (-0.38/+0.04×72), glaucoma (-0.10/+0.05×95), previous vitrectomy (-0.049/+0.03×66) and high myopia (-0.07/+0.03×57). Hyperopic and astigmatic errors were associated with diabetic retinopathy (+0.08/+0.03×104), pseudoexfoliation (+0.07/+0.01×158), male gender (+0.12/+0.05×91) and age (-0.01/+0.06×97 per increasing decade). Inherited retinal disease, optic nerve disease, previous trabeculectomy, uveitis, brunescent/white cataract had no significant impact on the error of the refractive outcome. The effect of patient gender and comorbidity was additive. Surgeons only accounted for 4% of the unexplained variance in refractive outcome.

CONCLUSION: Patient comorbidities and gender account for small but statistically significant differences in refractive outcome, which are additive. Surgeon effects are very small.

PMID:34764082 | DOI:10.1136/bjophthalmol-2021-320231

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Transcultural adaptation and validity of a pictogram to assess communication needs in adults with artificial airway in intensive care

Enferm Intensiva (Engl Ed). 2021 Nov 8:S2529-9840(21)00063-X. doi: 10.1016/j.enfie.2021.01.002. Online ahead of print.

ABSTRACT

OBJECTIVE: To perform the cross-cultural adaptation and validity of a pictogram to assess communication needs in adults with artificial airway in ICU in Cartagena, Colombia.

METHOD: Scale validation study, population comprising all the patients who were hospitalized in six ICU of Cartagena-Colombia. The sample was made up of 181 adult patients with artificial airway, the adaptation to Spanish was determined (translation, backtranslation, expert review, pre-final version, pilot test, final version), facial validity by expert agreement, content validity with the Lawshe index modified by Tristan (cut-off point 0.58), exploratory factor analysis (AFE) with the Bartlett’s test of sphericity and Cattell’s graph; internal consistency measured through the Cronbach alpha statistic.

RESULTS: Patients between the ages of 19 and 88 years participated (mean = 54 ± 17), 91.71% expressed frequent needs for accompaniment, knowing date and time; 61% of the experts agreed with the cross-culturally adapted items, the overall Content Validity Index (CVI) was 0.86 with agreement in understanding eleven items. The AFE suggested retaining 13 items and 3 factors (perception/cognition, elimination and exchange, comfort), which explain the construct. The internal alpha Cronbach consistency was 0.64.

CONCLUSIONS: The pictographic material, Spanish version, was shown to be a multidimensional instrument composed of 18 items grouped in 3 factors. Therefore, it is recommended it be applied to the patient with artificial airway and to establish communication as a preliminary point of care in nursing.

PMID:34764072 | DOI:10.1016/j.enfie.2021.01.002