Author Correction: Placebo use and unblinding in COVID-19 vaccine trials: recommendations of a WHO Expert Working Group

ObjectivesThis document aimed to summarise the key components of exertional heat stroke (EHS) prehospital management.MethodsMembers of the International Olympic Committee Adverse Weather Impact Expert Working Group for the Olympic Games Tokyo 2020 summarised the current best practice regarding the EHS prehospital management.ResultsSports competitions that are scheduled under high environmental heat stress or those that include events with high metabolic demands should implement and adopt policy and procedures for EHS prehospital management. The basic principles of EHS prehospital care are: early recognition, early diagnosis, rapid, on-site cooling and advanced clinical care. In order to achieve these principles, medical organisers must establish an area called the heat deck within or adjacent to the main medical tent that is optimised for EHS diagnosis, treatment and monitoring. Once admitted to the heat deck, the rectal temperature of the athlete with suspected EHS is assessed to confirm an elevated core body temperature. After EHS is diagnosed, the athlete must be cooled on-site until the rectal temperature is below 39°C. While cooling the athlete, medical providers are recommended to conduct a blood analysis to rule out exercise-associated hyponatraemia or hypoglycaemia, provided that this can be safely performed without interrupting cooling. The athlete is transported to advanced care for a full medical evaluation only after the treatment has been provided on-site.ConclusionsA coordination of care among all medical stakeholders at the sports venue, during transport, and at the hospital is warranted to ensure effective management is provided to the EHS athlete.

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Development of a Best Practice Statement on the Use of Ankle-Foot Orthoses Following Stroke in Scotland

Prosthetics and Orthotics International ◽

10.3109/03093646.2010.486392 ◽

2010 ◽

Vol 34 (3) ◽

pp. 245-253 ◽

Cited By ~ 17

Author(s):

Roy Bowers ◽

Karyn Ross

Keyword(s):

Health Service ◽

Working Group ◽

Best Practice ◽

Foot Orthoses ◽

Ankle Foot Orthoses ◽

Expert Working Group ◽

Health Service Quality ◽

The Impact ◽

Successes And Challenges

A National Health Service Quality Improvement Scotland (NHS QIS) scoping exercise in 2007 identified the use of ankle-foot orthoses (AFOs) following stroke as a clinical improvement priority, leading to the development of a best practice statement (BPS) on AFO use after stroke. This paper outlines the development process of the BPS which is available from NHS QIS. The authors were involved as part of a working group that included practitioners from the fields of orthotics, physiotherapy, stroke nursing and bioengineering, staff of NHS QIS and a patient representative. In consultation with an NHS QIS health services researcher, the authors undertook a systematic literature review to evidence where possible the recommendations made in the BPS. Where evidence was unavailable, consensus was reached by the expert working group. As the BPS was designed for the non-specialist and non-orthotic practitioner the authors also developed educational resources which were included within the BPS to aid the understanding of the principles underpinning orthotic design and prescription. The BPS has been widely distributed throughout the health service in Scotland and is available electronically at no cost via the NHS QIS website. As part of an ongoing evaluation of the impact of the BPS on the quality of orthotic provision, NHS QIS has invited feedback regarding successes and challenges to implementation.

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Utility of algorithms for the analysis of integratedSalmonellasurveillance data

Epidemiology and Infection ◽

10.1017/s0950268816000182 ◽

2016 ◽

Vol 144 (10) ◽

pp. 2165-2175 ◽

Cited By ~ 4

Author(s):

L. VRBOVA ◽

D. M. PATRICK ◽

C. STEPHEN ◽

C. ROBERTSON ◽

M. KOEHOORN ◽

...

Keyword(s):

Food Chain ◽

Working Group ◽

Surveillance System ◽

Farm Animals ◽

Seasonal Patterns ◽

Surveillance Programme ◽

The Third ◽

Expert Working Group ◽

Statistical Algorithms

SUMMARYThe objective of this study was to assess the use of statistical algorithms in identifying significant clusters ofSalmonellaspp. across different sectors of the food chain within an integrated surveillance programme. Three years of weeklySalmonellaserotype data from farm animals, meat, and humans were used to create baseline models (first two years) and identify weeks with counts higher than expected using surveillance algorithms in the third (test) year. During the test year, an expert working group identified events of interest reviewing descriptive analyses of same data. The algorithms did not identifySalmonellaevents presenting as gradual increases or seasonal patterns as identified by the working group. However, the algorithms did identify clusters for further investigation, suggesting they could be a valuable complementary tool within an integrated surveillance system.

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Exercise Prescription in Patients with Different Combinations of Cardiovascular Disease Risk Factors: A Consensus Statement from the EXPERT Working Group

Sports Medicine ◽

10.1007/s40279-018-0930-4 ◽

2018 ◽

Vol 48 (8) ◽

pp. 1781-1797 ◽

Cited By ~ 36

Author(s):

Dominique Hansen ◽

Josef Niebauer ◽

Veronique Cornelissen ◽

Olga Barna ◽

Daniel Neunhäuserer ◽

...

Keyword(s):

Risk Factors ◽

Cardiovascular Disease ◽

Working Group ◽

Consensus Statement ◽

Exercise Prescription ◽

Disease Risk ◽

Cardiovascular Disease Risk ◽

Cardiovascular Disease Risk Factors ◽

Expert Working Group

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M42. INDEPENDENT REVIEW & MONITORING IMPROVES QUALITY OF PANSS DATA IN GLOBAL CLINICAL TRIALS

Schizophrenia Bulletin ◽

10.1093/schbul/sbaa030.354 ◽

2020 ◽

Vol 46 (Supplement_1) ◽

pp. S150-S150

Author(s):

Barbara Echevarria ◽

Cong Liu ◽

Selam Negash ◽

Mark Opler ◽

Patricio Molero ◽

...

Keyword(s):

Clinical Trials ◽

Data Quality ◽

Working Group ◽

Double Blind Study ◽

Open Label ◽

Rater Training ◽

Double Blind ◽

Open Label Extension ◽

Expert Working Group ◽

Independent Review

Abstract Background The Positive and Negative Syndrome Scale (PANSS) (1) is the most widely used endpoint for measuring change in schizophrenia clinical trials. A set of flags have been developed by ISCTM expert working group to identify potential scoring errors in PANSS assessments (2). Measures have been taken by sponsors (pharmaceutical industry) with the goal of increasing scoring reliability and data quality, such as the use of Independent Review (IRev). We evaluated changes in data quality when site raters stop being recorded and monitored via IRev by comparing two studies with the same cohort of raters, one with independent review and one without. Methods Data from PANSS assessments in two global multisite schizophrenia clinical trials were analyzed. We selected data from raters participating in both studies (which run concurrently for a significant period of time). Raters were rigorously trained on administration and scoring conventions and certified prior to the study through demonstration of adequate interrater reliability. In addition to these steps, raters in study A were required to audio record all PANSS assessments with a selected subset of visits being subject to IRev. PANSS assessments in study B were neither recorded nor monitored via IRev. Data quality after study completion was examined by calculating the frequency of anomalous data patterns identified as “high” (very probable or definite error) by the ISCTM Working Group in both studies. Additionally, we examined the percentage of assessments with lower than expected PANSS interview duration as captured via an eCOA platform. Results There were 9441 eCOA PANSS assessments in study A and 6178 in study B included in this analysis. The proportions of flags that represented highly probable/definite error differed significantly between the studies (9% vs 18% for Study A and B, respectively, p<.01). The most significant differences in ISCTM flags were related to overly consistent scoring patterns (27 or more items scored identically to the prior visit) occurring with higher frequency in study B. Additionally, study B also had a significantly higher frequency of assessments flagged for low interview duration (< 15 minutes) (1% vs 4% for Study A and B, respectively, p<.01). Discussion Initial rater training is necessary but not sufficient to ensure adequate data quality in schizophrenia trials. Implementation of additional in-study oversight through Independent Review or similar methods reduces the probability of data error in PANSS assessments, including the appearance of improbable rating patterns and decreased time spent interviewing study subjects. One potential limitation is that study A is a double-blind study whereas study B is an open label extension of study A.

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