Selection criteria for large core trials: rationale for the ANGEL-ASPECT study design

Gridhrasi, one among the Nanatmaja Vikara, specific Nidana and Samprapti is not explained in classics so that the general Vata Vyadi Nidhana Samprapthi can be considered. The Chikitsa of Gridhrasi includes Sneha, Sweda, Bastikarma and Agni karma. Generally, Basti is the best line of treatment for Vata dosa. References from Acharya Charaka also explain Basti as one of the treatment modalities. With the support of Niruhadikara in Chakradhatta, we have the reference of Ardhamatrika Basti, which is one among Kashaya Basti, here he explains the practical utility along with many added benefits of Bala, Varna, Vrushatha and Pumsavanathva which gifted by Atreya Maharshi. Ardhamatrika Basti, one among Madhutailika Basti (having an equal quantity of Madhu and Taila), can be clinically explored where neither Parihara Kala nor Purva karma like Sneha, Sweda are necessary. The study design selected for the study was a comprehensive clinical trial. The sample size for the present study was 30 patients suffering from Gridrasi as per the selection criteria. Patients were randomly selected irrespective of sex and were treated with Ardhmatrika Basti as a yoga Basti for eight days. Among 30 patients taken for study, marked improvement in the symptomatology of the disease is obtained. 26.7% of patients got complete Shamana, 36.7% achieved Prayika shamana, 30% reported Amsika shamana, and 6.6% had Kinchit shamana. In the assessment criteria taken in patients, Ruja BT - 2.68 after follow up reduced to 1.8, Spandana BT - 2.38 after follow up reduced to 1.73, Sakthana Utksepa-nigraha BT - 2.82 after follow up reduced to 1.58, Gourava BT - 2.5 after follow up reduced to 1.7, Arochaka BT - 2.22 after follow up reduced to 1.87. This result shows that the present study of Ardhamatrika Basti has given a marked improvement in treating Gridhrasi.

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Abstract 1122‐000012: Study Design and Selection Criteria of a Large Core Thrombectomy Trial —— ANGEL‐ASPECT

Stroke: Vascular and Interventional Neurology ◽

10.1161/svin.01.suppl_1.000012 ◽

2021 ◽

Vol 1 (S1) ◽

Author(s):

Xiaochuan Huo ◽

Zeguang Ren ◽

Gaoting Ma ◽

...

Keyword(s):

Selection Criteria ◽

Controlled Trial ◽

Asian Population ◽

Western World ◽

Inclusion Criteria ◽

Large Core ◽

Infarct Core ◽

Intracranial Atherosclerotic Disease ◽

Multicenter Randomized Controlled Trial ◽

Core Volume

Introduction : The ANGEL‐ASPECT trial (NCT 04551664) is an ongoing, multicenter, randomized controlled trial (RCT) currently being conducted in China. The goal of ANGEL‐ASPECT’s is to include the maximum patients with a true large core for whom EVT is not recommended under current guidelines with level 1 evidence. By enrolling patients with ASPECTS <6, expanding the window to 24h from stroke onset (beyond the windows in DAWN and DEFUSE3), and defining large core volume as >70 cc, ANGEL‐ASPECT maximizes the inclusion of patients with true large cores. What’s more, intracranial atherosclerotic disease (ICAD) is common in the Asian population while most of the previous trials have been performed in the Western world where ICAD is less prevalent. Methods : We reviewed the merits of ANGEL‐ASPECT’s design and suggest that it be included in the discussion of patient selection criteria in large core trials. Results : The primary goal of our trial is to determine whether EVT will benefit or harm AIS patients with LVO and a “large core” infarct. The inclusion criteria for ANGEL‐ASPECT are: 1. If ASPECTS is 3–5 and presentation is within 24 hours of onset, patients are enrolled without obtaining CTP. 2. If ASPECTS is >5 and presentation is beyond 6 hours of onset, only patients with relative cerebral blood flow (rCBF) of < 30% by CTP or apparent diffusion coefficient (ADC) of < 620 on MRI and estimated core volume of 70–100 cc are enrolled. 3. If ASPECTS is <3, only patients with rCBF < 30% or ADC on MRI < 620 and estimated core volume of 70–100 cc are enrolled. Patients are enrolled under a pre‐specified protocol. Each randomized patient is qualified by two core lab members who are available at all hours to calculate ASPECTS and infarct core volume using specialized, RAPID software. Conclusions : We believe that defining core volume using CTP can compensate for the inconsistencies of ASPECTS if we exclude patients with onset within six hours and core volume of 50–70 cc since these patients have already been shown to benefit from EVT in multiple RCTs. We believe that this decision captures more patients with true large core volumes for the trial. The ANGEL‐ASPECT inclusion criteria also eliminate the second group of “good ASPECTS + unfavorable CTP” . The sample size of our trial is calculated based on studies excluding these populations. The power of the trial was maintained for the relatively consistent large core volume patient population.

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Frequency of Hypocalcemia with Exchange Transfusion in Neonatal Jaundice

10.53350/pjmhs211581849 ◽

2021 ◽

Vol 15 (8) ◽

pp. 1849-1851

Author(s):

Ambreen Ali ◽

Ashfaq Ahmad Shah Bukhari ◽

Shameela Majeed ◽

Saira Gul ◽

Nomana Khalil ◽

...

Keyword(s):

Serum Level ◽

Study Design ◽

Selection Criteria ◽

Exchange Transfusion ◽

Neonatal Jaundice ◽

Serum Bilirubin ◽

Cross Sectional Study ◽

Total Serum ◽

Sectional Study ◽

Cross Sectional

Aim: To determine the frequency of hypocalcemia with exchange transfusion in neonatal jaundice. Study design: Descriptive cross-sectional study Place and duration of study: Departments of Pediatrics and Pathology, Naseer Teaching Hospital Peshawar from 1stJanuary 2018 to 31st December 2018. Methodology: One hundred and sixty twopatients of jaundiced neonates having total serum bilirubin >20mg/dl, both gender and patients having age up to 14 days were included. Patients fulfilling the selection criteria had undergone exchange transfusion. Hypocalcaemia was evaluated and considered positive if calcium serum level is <8 mg/dl or <2 mmol/L. Results: 50% of neonates were between 1-5 days, 45% of neonates were between 5-10 days, and 3% of neonates were in age 10-14 days. One hundred and ten (68%) of neonates were males and 52 (32%) of neonates were females. 30% neonates had hypocalcemia while 70% were without hypocalcemia. Conclusion: The incidence of hypocalcemia was found to be 30% with exchange transfusion in neonatal jaundice. Keywords: Hypocalcemia, Exchange transfusion, Neonatal jaundice

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Easy to Believe in, But Difficult to Carry Out—Norwegian Midwives' Experiences of Promoting Normal Birth in an Obstetric-Led Maternity Unit

International Journal of Childbirth ◽

10.1891/2156-5287.8.3.167 ◽

2018 ◽

Vol 8 (3) ◽

pp. 167-176 ◽

Cited By ~ 2

Author(s):

Elisabeth Hemnes Aanensen ◽

Karin Skjoldal ◽

Eva Sommerseth ◽

Bente Dahl

Keyword(s):

Qualitative Research ◽

Research Design ◽

Study Design ◽

Selection Criteria ◽

Personal Attributes ◽

Maternity Unit ◽

Convenience Sample ◽

Normal Birth ◽

Qualitative Research Design ◽

Descriptive Approach

PURPOSETo explore and describe midwives' experiences of promoting normal birth in medicalized obstetric-led birth units in Norway.STUDY DESIGNA qualitative research design with an explorative/descriptive approach. A convenience sample of 10 midwives was recruited from 2 obstetric-led birth units.MAJOR FINDINGSThree main themes were identified. First, personal attributes and attitudes were perceived to influence the birthing process. Second, lack of time and impatient staff negatively affected the woman's chances of giving birth normally. Third, increasing focus on procedures, selection criteria, and technology threatened the use of midwifery skills and prevented midwives from promoting normal births.MAIN CONCLUSIONPromoting normal birth is influenced by midwives' disposition and attitudes. It is therefore disturbing that midwives experience a loss of their autonomy and responsibility for normal births in obstetric-led wards.

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The impact of selection criteria and study design on reported survival outcomes in extracorporeal oxygenation cardiopulmonary resuscitation (ECPR): a systematic review and meta-analysis

Scandinavian Journal of Trauma Resuscitation and Emergency Medicine ◽

10.1186/s13049-021-00956-5 ◽

2021 ◽

Vol 29 (1) ◽

Author(s):

Sameer Karve ◽

Dominique Lahood ◽

Arne Diehl ◽

Aidan Burrell ◽

David H. Tian ◽

...

Keyword(s):

Systematic Review ◽

Study Design ◽

Prospective Studies ◽

Selection Criteria ◽

Meta Analysis ◽

Inclusion Criteria ◽

Newcastle Ottawa Scale ◽

Study Designs ◽

Based Medicine ◽

The Impact

Abstract Background The use of extracorporeal membrane oxygenation (ECMO) during cardiac arrest (ECPR) has increased exponentially. However, reported outcomes vary considerably due to differing study designs and selection criteria. This review assessed the impact of pre-defined selection criteria on ECPR survival. Methods Systematic review applying PRISMA guidelines. We searched Medline, Embase, and Evidence-Based Medicine Reviews for RCTs and observational studies published from January 2000 to June 2021. Adult patients (> 12 years) receiving ECPR were included. Two investigators reviewed and extracted data on study design, number and type of inclusion criteria. Study quality was assessed using the Newcastle–Ottawa Scale (NOS). Outcomes included overall and neurologically favourable survival. Meta-analysis and meta-regression were performed. Results 67 studies were included: 14 prospective and 53 retrospective. No RCTs were identified at time of search. The number of inclusion criteria to select ECPR patients (p = 0.292) and study design (p = 0.962) was not associated with higher favourable neurological survival. However, amongst prospective studies, increased number of inclusion criteria was associated with improved outcomes in both OHCA and IHCA cohorts. (β = 0.12, p = 0.026) and arrest to ECMO flow time was predictive of survival. (β = -0.023, p < 0.001). Conclusions Prospective studies showed number of selection criteria and, in particular, arrest to ECMO time were associated with significant improved survival. Well-designed prospective studies assessing the relative importance of criteria as well as larger efficacy studies are required to ensure appropriate application of what is a costly intervention.

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Selection criteria for large core trials: dogma or data?

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2021-017498 ◽

2021 ◽

pp. neurintsurg-2021-017498

Author(s):

Amrou Sarraj ◽

Bruce Campbell ◽

Marc Ribo ◽

Muhammad Shazam Hussain ◽

Michael Chen ◽

...

Keyword(s):

Selection Criteria ◽

Large Core

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Reweighting selection criteria in dental school admission

Journal of Dental Education ◽

10.1002/j.0022-0337.1979.43.3.tb01242.x ◽

1979 ◽

Vol 43 (3) ◽

pp. 145-146

Author(s):

G Kress

Keyword(s):

Selection Criteria ◽

Dental School

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Current Trends in the Training and Utilization of Paraprofessionals in Speech and Language Programs

Language Speech and Hearing Services in Schools ◽

10.1044/0161-1461.2202.51 ◽

1991 ◽

Vol 22 (2) ◽

pp. 51-59 ◽

Cited By ~ 6

Author(s):

Kathy L. Coufal ◽

Allen L. Steckelberg ◽

Stanley F. Vasa

Keyword(s):

Selection Criteria ◽

Job Descriptions ◽

Paraprofessional Training ◽

Language Programs ◽

Program Administrators ◽

Current Trends ◽

Training And Supervision ◽

Communicative Disorders ◽

Supervision Practices ◽

A Current

Administrators of programs for children with communicative disorders in 11 midwestern states were surveyed to assess trends in the training and utilization of paraprofessionals. Topics included: (a) current trends in employment, (b) paraprofessional training, (c) use of ASHA and state guidelines, and (d) district policies for supervision. Selection criteria, use of job descriptions, training programs, and supervision practices and policies were examined. Results indicate that paraprofessionals are used but that standards for training and supervision are not consistently applied across all programs. Program administrators report minimal training for supervising professionals.

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