scholarly journals Four points regarding reproducibility and external statistical validity: a comment on Walter et al.

2021 ◽  
Author(s):  
Greg Guerin
Keyword(s):  
External Validity ◽  
Statistical Tests ◽  
Phase 1 ◽  
Trial Data ◽  
Age Group ◽  
Efficacy Trials ◽  
Statistical Validity ◽  
Potential Risks ◽  
Serious Disease ◽  
Gold Standards

Walter et al. (2021) present phase 1–2–3 trial data that show two doses of the BNT162b2 (Pfizer–BioN-Tech) Covid-19 vaccine were safe and effective in children aged 5–11 years. Given that millions of children in this age group are receiving the paediatric Pfizer COVID-19 vaccine, that there are potential risks, and that the balance of benefits over potential risks is more limited in children compared to adults due to low rates of serious disease (ATAGI 2021), gold standards ought to be applied to supporting data in terms of placebo-controlled disease endpoint efficacy trials, safety databases large enough to detect adverse events, and appropriate data sharing to enable reproduction and scrutiny of results. Four points are worthy of attention regarding the reproducibility and external statistical validity of the analysis reported in Walter et al. (2021). ‘External validity’ refers to the extent to which conclusions drawn from the data (and statistical tests thereof) are likely to correspond to, or be generalisable to, the real world (Campbell 1957). ‘Reproducibility’ refers to the ability of independent researchers to draw the same conclusions from the data (Kass et al. 2016).

Determining the prevalence and incidence of SARS-CoV-2 infection in prisons in England: the Rationale, Conceptualization and Design of the COVID in Prisons Study (CiPS) (Preprint)

2021 ◽  
Author(s):  
Emma Plugge ◽  
Danielle Burke ◽  
Maciej Czachorowski ◽  
Kerry Gutridge ◽  
Fiona Maxwell ◽  
...  
Keyword(s):  
Phase 1 ◽  
Recovery Period ◽  
Epidemiological Data ◽  
Study Data ◽  
Mental Wellbeing ◽  
Nasopharyngeal Swab ◽  
Policy And Practice ◽  
Community Factors ◽  
Staff Members ◽  
Serious Disease

BACKGROUND There are over 80,000 people imprisoned in England and Wales in 117 prisons. The management of the COVID-19 pandemic presents particular challenges in this setting where the confined, crowded and poorly ventilated conditions facilitate the rapid spread of infectious diseases. The consequences for imprisoned people are likely to be serious given the high proportion of individuals with risk factors for serious disease and death. OBJECTIVE The COVID-19 in Prison Study (CiPS) aims to examine the epidemiology of SARS-CoV-2 in prisons in England in order to inform public health policy and practice during the pandemic and the recovery period. METHODS CiPS Phase 1 comprises a repeated panel survey of prison residents and staff in a sample of 28 prisons across England, selected to be as representative of the closed prison estate as possible. All residents and all staff in the study prisons are eligible for inclusion. Participants will be tested for SARS-CoV-2 antigens using nasopharyngeal swab twice, six weeks apart. Staff will also be tested for antibodies to SARS-CoV-2. Phase 2 focuses on SARS-CoV-2 infection in prisons with recognised COVID-19 outbreaks. Any prison in England will be eligible to participate if an outbreak is declared. In three outbreak prisons, all participating staff and residents will be tested for SARS-CoV-2 antigens at three timepoints: as soon as possible after the outbreak is declared (day 0), seven days later (day 7) and at day 28. They will be swabbed twice: a nasal swab for lateral flow device testing and a nasopharyngeal swab for PCR testing. Data will also be collected on individual, prison level and community factors. RESULTS Data collection started on 20th July 2020 and will end on 31st May 2021. As of May 2021, we had enrolled 4,192 staff members and 6,496 imprisoned people in the study. Data analysis has started and we expect to publish initial findings in summer/autumn 2021 CONCLUSIONS CiPS presents an important opportunity to gather data in a unique high-risk setting from the whole population - residents and staff alike. It will provide important epidemiological data to develop our understanding of the transmission dynamics of SARS-CoV-2 in prisons and provide preliminary data on the mental wellbeing of staff and residents. However, there are huge logistical challenges compounded by the fact researchers are currently not allowed into prisons and therefore testing teams, trained in antigen testing for SARS-CoV-2 and the use of PPE must be deployed. CLINICALTRIAL Not applicable

The Measurement of Performance in Probabilistic Diagnosis

1978 ◽  
Vol 17 (04) ◽  
pp. 227-237 ◽  
Author(s):  
J. Hilden ◽  
J. D. F. Habbema ◽  
B. Bjerregaard
Keyword(s):  
Acute Abdomen ◽  
External Validity ◽  
Statistical Tests ◽  
Computer Aided Diagnosis ◽  
Discriminatory Power ◽  
Statistical Measures ◽  
Computer Aided ◽  
Size Bias ◽  
Aided Diagnosis ◽  
Probabilistic Diagnosis

Attention is focused on one important aspect of good performance in probabilistic diagnosis, the »reliability« (external validity) of probabilistic assertions: a diagnostic alternative claimed to be 90% certain, say, must occur neither more nor less than nine times out of ten on the average. Statistical measures are offered by which departures from such perfect reliability can be estimated, and statistical tests are developed in order to test the hypothesis of perfect reliability. The specific reliability defects looked for include overconfident diagnoses and so-called size bias (common diseases being over diagnosed). Reliability is contrasted with discriminatory power and other performance aspects. The illustrative data derive from a study of computer-aided diagnosis of the acute abdomen.

scholarly journals Perfil epidemiológico do câncer de colo uterino no município de feira de santana, Bahia, Brasil

2009 ◽  
Vol 3 (4) ◽  
pp. 998
Author(s):  
Rita De Cássia Rocha Moreira ◽  
Ludmilla Oliveira Souza ◽  
Manoela De Assis Silva Carvalho ◽  
Scheila Conceição Sacramento Saldanha
Keyword(s):  
Cervical Cancer ◽  
Quantitative Methods ◽  
Statistical Tests ◽  
Descriptive Analysis ◽  
Annual Reports ◽  
Cervix Uteri ◽  
Age Group ◽  
Cin Iii ◽  
Hospital Morbidity ◽  
Epidemiological Profile

Objective: to determine the cervical cancer epidemiological profile in Feira de Santana city, from 2000 to 2004. Methods: documental research, quantitative methods, descriptive, whose data collection were in annual reports issued by the Municipal Secretariat of Health through the Information System in Cancer of the Uterine Cervix (SISCOLO). The collection instrument was a form consolidated. Descriptive analysis was conducted using statistical tests, calculating the incidence, relative frequency and mortality rates by age. The results are presented in tables. Results: regards to Cervical Intra-epithelial Neoplasia I (CIN I) the age group between 20-39 years old had the greatest number of cases, but in relation to CIN II the age group between 20-39 years old not presented cases in 2004. In CIN III there was an increase in the percentage distribution in the age group between 20-39 years old, there was a decrease in women between 40-59 years old and over 60 years old there were cases only occurred in 2002. The hospital morbidity predominated in the age group between 40-59 years. The absolute frequency shows decrease in the number of cases of hospitalization. Deaths by cervical cancer were predominant in the age group over 60 years old. Conclusion: to know cervical cancer epidemiological variables is fundamental because it makes possible to draw actions which contribute to the women’s health promotion. Descriptors: cancer; cervix uteri; prevention; epidemiology.

The impact of docetaxel (D) in an older population of patients with advanced prostate cancer (PC): A simulation study using TAX327 and SEER Medicare data

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16074-e16074
Author(s):  
E. Onukwugha ◽  
C. D. Mullins ◽  
N. Obeidat ◽  
B. Seal ◽  
A. Hussain
Keyword(s):  
Prostate Cancer ◽  
Median Survival ◽  
Survival Benefit ◽  
Statistical Tests ◽  
Trial Data ◽  
Medicare Data ◽  
Kaplan Meier ◽  
Hormone Refractory ◽  
Parametric Survival ◽  
The Impact

e16074 Background: The survival benefit of D in treatment of hormone refractory PC (HRPC) has been established in the TAX327 trial, but it is unclear how this benefit would translate in a heterogeneous population. This study sought to simulate the survival impact of D in a population of older pts with M1 PC on androgen deprivation therapy (ADT). Methods: A combination of TAX327 trial data and SEER-Medicare (SM) data were used. In pts age 69+ and randomized to D (every 3 weeks, D3P) or mitoxantrone (M), trial data showed a survival benefit for D. Accordingly, SM pts age 69+ diagnosed with M1 PC between 1994 and 2002 and receiving only ADT were selected. Graphical plots and statistical tests were used to find best-fitting parametric survival functions for D3P, M, and SM pts. The survival benefit for D was imposed on unadjusted and covariate-adjusted SM survival curves. The simulated benefit was assessed at 12 mos and 24 mos post-diagnosis of M1 PC in SM pts. Results: There were 326 TAX327 trial pts (D3P = 159, M = 167) used in the analysis. Median survival was 15.7 mos (12.6 - 19) in the M arm and 18.9 mos [17 - 21.8] in the D3P arm (p = 0.03). There were 3,515 SM pts, based on inclusion criteria. Median survival benefit of D was 3.2 mos based on Kaplan-Meier estimates and 2.4 mos using parametric curves in the TAX327 69+ group. Following covariate-adjustment in the SM sample, at 12 mos post-diagnosis, the median survival in mos was 61.7 (CI 36.3 - 87) in the ADT group and 62 (CI 37.6 - 87.1) in the simulated ADT+D group (i.e., 0.3 mos simulated benefit of D). A 0.8 mos simulated benefit was found if D was initiated 24 mos post diagnosis (in pts more likely to have HRPC). Conclusions: The survival benefit of docetaxel from the TAX327 trial is attenuated in a heterogeneous SEER-Medicare sample, and the simulated survival benefit is larger among patients who are more likely to have hormone refractory prostate cancer. [Table: see text]

scholarly journals Benchmarking of semantic annotation systems

2021 ◽  
Author(s):  
Minal Patel
Keyword(s):  
Statistical Tests ◽  
Semantic Annotation ◽  
Subjective Evaluation ◽  
Evaluation Technique ◽  
Different Types ◽  
Gold Standards

In this research, an effort has been made to evaluate the semantic annotators with a systematic subjective evaluation technique. So far, most of the previous evaluation efforts have involved creation of gold standards and by measuring basic metrics, the performance of semantic annotators has been analysed. But in this work, a subjective evaluation technique has been applied to evaluate some of the publicly available semantic annotation systems. In this method, 60 participants have been involved in the evaluation. A survey has been carried out to collect the response from participants about what they think how well the annotators perform on different types of texts (e.g. long texts, short texts and tweets). Their responses have been analysed using standard statistical tests. Using this approach, it has been concluded that Wikipedia Miner performs better on long texts and Tag Me performs better on short texts and tweets than other systems.

scholarly journals Assessment of visually challenged patients treated in special care clinic in a hospital setting

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 287-291
Author(s):  
Dhanvanth M ◽  
Uma Maheswari T N ◽  
Deepika Rajendran
Keyword(s):  
Oral Hygiene ◽  
Statistical Tests ◽  
Hospital Setting ◽  
Signs And Symptoms ◽  
Special Care ◽  
The Body ◽  
Age Group ◽  
Care Clinic ◽  
Periodontal Status ◽  
Visually Challenged

  The oral cavity is a window or mirror to the overall health of the body, and it reveals the early signs and symptoms of systemic diseases. The aim of the study was to assess the dental considerations for visually challenged patients treated in the Special Care Department in a hospital setting. A total of 20 cases were collected from the special care clinic. The data collected were assembled year wise and compiled in excel sheets with age, gender, periodontal status and oral hygiene status. The incomplete cases were removed. Frequency distribution statistical tests were used to calculate the frequency of age, gender, periodontal status and oral hygiene status of visually challenged patients. The comparison of the frequency of age, in visually challenged patients were common in the age group of 30 to 50 years of age. On comparing gender, males 60% were higher than females 40%. On comparing the frequency of periodontal status, it showed more prevalence of Generalized chronic gingivitis 55%, than Localised periodontitis 30% and generalized chronic periodontitis 15%. On comparing dental procedures done, the highest procedure done was restoration 85%. On comparing oral hygiene status, it showed more patients affected with OHI score 3.4 in the age group <35 years. On comparing oral hygiene status with gender, the males have higher prevalence with OHI score 2.5 compared with female 2.0. The conclusion is that males mostly attended to dental problems among visually challenged patients. The age group between 30 to 50 years were affected. The Oral hygiene status of visually challenged patients on calculating OHI scores results fair, and most of them have generalised chronic gingivitis. The common dental procedure done was restoration 85%, extraction 45%, prophylaxis 70% and prosthesis 15%.

scholarly journals Safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152: a phase 1, double-blind, randomised control trial

2020 ◽  
Author(s):  
Raches Ella ◽  
Krishna Mohan ◽  
Harsh Jogdand ◽  
Sai Prasad ◽  
Siddharth Reddy ◽  
...  
Keyword(s):  
Phase 1 ◽  
Neutralizing Antibody ◽  
Cold Chain ◽  
Wild Type Virus ◽  
Randomised Control Trial ◽  
Enzyme Linked Immunosorbent Assay ◽  
Double Blind ◽  
Efficacy Trials ◽  
National Immunization ◽  
Antibody Titers

Background: BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a TLR 7/8 agonist molecule adsorbed to alum (Algel-IMDG). Methods We conducted a double-blind randomized controlled phase 1 clinical trial to evaluate the safety and immunogenicity of BBV152. A total of 375 participants were randomized equally to receive three vaccine formulations (n=100 each) prepared with 3 μg with Algel-IMDG, 6 μg with Algel-IMDG, and 6 μg with Algel, and an Algel only control arm (n=75). Vaccines were administered on a two-dose intramuscular accelerated schedule on day 0 (baseline) and day 14. The primary outcomes were reactogenicity and safety. The secondary outcomes were immunogenicity based on the anti-IgG S1 response (detected with an enzyme-linked immunosorbent assay [ELISA] and wild-type virus neutralization [microneutralization and plaque reduction neutralization assays]). Cell-mediated responses were also evaluated. Results: Reactogenicity was absent in the majority of participants, with mild events. The majority of adverse events were mild and were resolved. One serious adverse event was reported, which was found to be unrelated to vaccination. All three vaccine formulations resulted in robust immune responses comparable to a panel of convalescent serum. No significant differences were observed between the 3-μg and 6-μg Algel-IMDG groups. Neutralizing responses to homologous and heterologous SARS-CoV-2 strains were detected in all vaccinated individuals. Cell-mediated responses were biased to a Th-1 phenotype. Conclusions BBV152 induced binding and neutralising antibody responses and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. Vaccine-induced neutralizing antibody titers were reported with two divergent SARS-CoV-2 strains. BBV152 is stored between 2°C and 8°C, which is compatible with all national immunization program cold chain requirements. Both Algel-IMDG formulations were selected for the phase 2 immunogenicity trials. Further efficacy trials are underway.

scholarly journals Using geographic information systems to map older people’s emergency department attendance for future health planning

2019 ◽  
pp. emermed-2018-207952 ◽  
Author(s):  
Eoin O'Mahony ◽  
Éidín Ní Shé ◽  
Jade Bailey ◽  
Hasheem Mannan ◽  
Eilish McAuliffe ◽  
...  
Keyword(s):  
Information Systems ◽  
Geographic Information Systems ◽  
Statistical Tests ◽  
Health Planning ◽  
Geographic Information ◽  
University Teaching ◽  
Age Group ◽  
Future Health ◽  
Large Hospital ◽  
Age Cohort

ObjectivesThis study aimed to assess the pattern of use of EDs, factors contributing to the visits, geographical distribution and outcomes in people aged 65 years or older to a large hospital in Dublin.MethodsA retrospective analysis of 2 years of data from an urban university teaching hospital ED in the southern part of Dublin was reviewed for the period 2014–2015 (n=103 022) to capture the records of attenders. All ED presentations by individuals 65 years and older were extracted for analysis. Address-matched records were analysed using QGIS, a geographic information systems (GIS) analysis and visualisation tool to determine straight-line distances travelled to the ED by age.ResultsOf the 49 538 non-duplicate presentations in the main database, 49.9% of the total are women and 49.1% are men. A subset comprised of 40 801 had address-matched records. When mapped, the data showed a distinct clustering of addresses around the hospital site but this clustering shows different patterns based on age cohort. Average distances travelled to ED are shorter for people 65 and older compared with younger patients. Average distances travelled for those aged 65–74 was 21 km (n=4177 presentations); for the age group 75–84, 18 km (n=2518 presentations) and 13 km for those aged 85 and older (n=2104 presentations). This is validated by statistical tests on the clustered data. Self-referral rates of about 60% were recorded for each age group, although this varied slightly, not significantly, with age.ConclusionsHealth planning at a regional level should account for the significant number of older patients attending EDs. The use of GIS for health planning in particular can assist hospitals to improve their understanding of the origin of the cohort of older ED patients.

scholarly journals The effects of releasing early results from ongoing clinical trials

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Steffen Ventz ◽  
Sergio Bacallado ◽  
Rifaquat Rahman ◽  
Sara Tolaney ◽  
Jonathan D. Schoenfeld ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Trial Data ◽  
Simulation Models ◽  
Trial Data ◽  
Operating Characteristics ◽  
Trial Duration ◽  
The Public ◽  
Early Results ◽  
Statistical Validity ◽  
Experimental Treatments

AbstractMost trials do not release interim summaries on efficacy and toxicity of the experimental treatments being tested, with this information only released to the public after the trial has ended. While early release of clinical trial data to physicians and patients can inform enrollment decision making, it may also affect key operating characteristics of the trial, statistical validity and trial duration. We investigate the public release of early efficacy and toxicity results, during ongoing clinical studies, to better inform patients about their enrollment options. We use simulation models of phase II glioblastoma (GBM) clinical trials in which early efficacy and toxicity estimates are periodically released accordingly to a pre-specified protocol. Patients can use the reported interim efficacy and toxicity information, with the support of physicians, to decide which trial to enroll in. We describe potential effects on various operating characteristics, including the study duration, selection bias and power.

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