Saturday, February 25, 2023

Beluga whale: applicationprocess@msche.org for CC-4 MIT OCW-centric wiki World University & School * * MSCHE Accreditation (from Connie Clifton and Diana Bonner) * * * Professor Derek Angus MD, Title: "The RCT is dead. Long live the RCT" (Randomized Clinical Trials) - 2/24/23 Univ of Pitt Philosophy of Science talk * * Are you familiar with Alphabet's Google's Verily's Project Baseline (see PS below) - and even for streaming people in studies' health data (for new rethought approaches to RCTs) ... and also brainstorming-wise streamed into an online #RealisticVirtualEarthFor Medicine learning system - eg #RealisticVirtualEarthForBrainScience - #RealisticVirtualEarthForSurgery ... with machine learning? Regarding Project Baseline, think "Blood, Sweat and Tears" ' physical samples from people in studies translated into data for mapping pathways to health and longevity ... and maybe for far greater than 122 years of age longevity, with new developing approaches to Randomized Clinical Trials


applicationprocess@msche.org for CC-4 MIT OCW-centric wiki World University & School


Dear Diana Bonner at MSCHE, Peter Norvig (a head of Google AI), Sid Mazumdar at HHS, All, 


Greetings, and as a follow up further: 

Just noticed this MSCHE Tweet from Feb 21, 2023 - 

@mscheorg encourages institutions to submit feedback during the comment period for the
@usedgov Updated Third-party Service Provider Guidance. #MSCHEAdvocacy

https://twitter.com/mscheorg/status/1628169970617131009?s=20


And World Univ & Sch just Tweeted in these regards: 

Dear #DianaBonner #PresidentPerfetti @mscheorg #MiddleStatesCommissionOnHigherEducation’s (#MSCHE) With @WorldUnivAndSch's recent #PADepartmentOfEducationAuthorization (#MichelleSimmons), is this #USDEAdvocacyAlert something that #WorldUniversityAndSchool .org should be engaging?

https://twitter.com/WorldUnivAndSch/status/1629164495703625734?s=20


retweeting -

@mscheorg encourages institutions to submit feedback during the comment period for the
@usedgov Updated Third-party Service Provider Guidance. #MSCHEAdvocacy

https://twitter.com/mscheorg/status/1628169970617131009?s=20



Diana Bonner, is this something CC-4 licensed MIT OCW-centric Wiki World Univ & Sch should be engaging in, please, and regarding World Univ & Sch's ongoing search for funding to pay the MSCHE and state of PA department of education's accreditation and licensure fees? 

Thanks, Scott


In a related vein, and regarding WUaS accreditation - 

WUaS just JOINED @GEGPennsylvania ... (Google Educators' Groups)

In developing OCW.MIT.EDU -centric #wiki WorldUniversityAndSchool.org for free online #WUaSdegrees, #WUaSaccrediting & #WUaSlicensing in #PA, Just JOINED @GEGPennsylvania in #PghPA & regarding @GegProgram in all  200 countries in their main #WUaSLanguages & in 50 US states

https://twitter.com/WorldUnivAndSch/status/1622255167901995011?s=20&t=10I7D8lScO1rhCrK32XmwQ

https://twitter.com/scottmacleod/status/1622256483416117252

https://twitter.com/sgkmacleod/status/1622256855681490946

https://twitter.com/TheOpenBand/status/1622256981707837442

https://twitter.com/HarbinBook/status/1622257264399630336

https://twitter.com/WUaSPress/status/1622257756848660480





* * 

MSCHE Accreditation

External
Inbox

Connie Clifton CClifton@msche.org

Feb 24, 2023, 1:42 PM (1 day ago)
to meIdnaDiana

President MacLeod,



President MacLeod,

Thank you for your email regarding MSCHE accreditation. As the Director for Membership, I am happy to discuss any aspect of our process with you. I work with Diana Bonner who has provided me with some context regarding her communications with you. Please do not misconstrue her explanation of our process as a “green light” for WUaS to pursue any type of licensure, authorization, or accreditation process outside of MSCHE. Representing her statements as such is misleading and inaccurate. Additionally, MSCHE is not involved with the fundraising efforts of any institution, nor can we advise on such.

 As a reminder, to be eligible to apply for MSCHE accreditation, an institution must be able to demonstrate that it meets the following Pre-Applicant Minimum Requirements:


1.      The institution must be legally authorized or licensed, from an appropriate governmental organization or agency to operate as a postsecondary educational institution and must award postsecondary degrees or hold proper legal exemption in accordance with Requirement of Affiliation No.1 and federal regulation 34 CFR §602.28(a).

2.      The institution must be in good standing with no current non-compliance, adverse or the equivalent type of action with the state or other accreditors in accordance with federal regulation 34 CFR §602.28(b).

3.      The institution must be operational, with students actively enrolled in its degree programs.

4.      The institution must have a mission statement and related goals that define its purposes within the context of higher education.

5.      The institution must have a governance and administration structure that allows it to have education as its primary purpose and operate as an academic institution with appropriate autonomy.

6.      The institution must have documented financial resources, funding base, and plans for financial development, including those from any related entities (including without limitation systems, religious sponsorship, and corporate ownership) adequate to support its educational purposes and programs and to ensure financial stability.

7.      The institution must review the Certifications and Disclosures Statement and certify that the information provided throughout the application process is accurate, honest, and truthful.


If, following a review by the Commission staff and peer evaluators, the institution is determined by the Commission to satisfactorily meet the Pre-Applicant Minimum Requirements, it will be allowed to submit an application for Candidate for Accreditation Status.

Moving forward, please direct all of your communications regarding obtaining accreditation to me. Ms. Bonner and I are the only MSCHE staff who work with applicant institutions. Copying other staff members can be confusing and counterproductive. We will be happy to answer any questions you have and assist you with our process.


Kind regards,

Connie Clifton



Connie Clifton, D.E.L.
Director for Membership



Middle States Commission on Higher Education
P: (267) 284-5086
cclifton@msche.org
www.msche.org
Follow us: @mscheorg






Dear Connie, Diana, All, 


Thank you for your email, Connie, and thank you for your call Diana Bonner on Thursday, January 12, 2023 to me, as Head of MIT OCW-centric wiki World University and School (https://scott-macleod.blogspot.com/2023/01/virginia-opossum.html); - as a consequence, Diana, and Connie, I reached out to the state of Pennsylvania's department of education, and WUaS received an email and phone call with 

PA Department of Education Authorization

for licensure on Thu, Jan 26, 2023, from Michelle Simmons in the state of PA's department of education, in Harrisburg, PA, I think, and where the next step for WUaS would be to communicate with a state of PA Higher Education Associate as WUaS applies for licensure with them IN TANDEM with completing a Pre-Application for Accreditation with MSCHE, I think, too -

See -
and

Connie, Diana, PER YOUR GUIDELINES BELOW, and further, how can CC-4 licensed MIT OCW-centric wiki World Univ & Sch offer degrees, if WUaS is not accredited, per MSCHE's guidelines below, and particularly item 3 (working down the list) -  

3.      The institution must be operational, with students actively enrolled in its degree programs.

please? This is only one of a number of ongoing conundrums that WUaS faces in seeking to further develop WUaS accreditation with the Middle States' Commission on Higher Education. But I think WUaS meets all the other guidelines in the items below, too. Thank you for helping all of us on the WUaS Accreditation committee with this question, and related ones. 

Connie, I have removed all other MSCHE representatives and their email addresses from this email, besides the ones you included in this email, per your request

Thank you, 
Scott

WUaS mission statement here - 



--


Scottish Small Piping album #2 - Honey Piobaireachd (2022)


- Scott GK MacLeod  
Founder, President, CEO & Professor
CC-4 licensed MIT OCW-centric. Wiki, 
World University & School (WUaS) 
- PO Box 442, Canyon, CA 94516 
- 210 East End Avenue, Pittsburgh, PA 15221
1) non-profit World University and School - http://worlduniversityandschool.org  
2) for profit general stock company WUaS Corporation in CA - http://worlduniversityandschool.org/AcademicPress.html

(m) 412 478 0116 - sgkmacleod@gmail.com 

World Univ & Sch Innovation Research -  scottmacleod.com 




Scott MacLeod <sgkmacleod@worlduniversityandschool.org>

Fri, Feb 24, 2:02 PM (1 day ago)

to Peter, Alden, David, Sioux, Nick, Kenneth, Ann, byronhann1, Susan, Edward, Henry, Hugh, John, Larry, Nancy, Stephon, Lydia, Roland, Dick, Sid, edsmythmd, Terence, Janie, Claudia, Marc, Shawn, Hank, Robert, Info, Joan, Scott, Scott, Meeting, Anne, George, stuart, Robin, Sri, Connie, Idna, Diana


Dear Connie, Diana, All, 

Thank you for your email, Connie, and thank you for your call Diana Bonner on Thursday, January 12, 2023 to me, as Head of MIT OCW-centric wiki World University and School (https://scott-macleod.blogspot.com/2023/01/virginia-opossum.html); - as a consequence, Diana, and Connie, I reached out to the state of Pennsylvania's department of education, and WUaS received an email and phone call with 

PA Department of Education Authorization

for licensure on Thu, Jan 26, 2023, from Michelle Simmons in the state of PA's department of education, in Harrisburg, PA, I think, and where the next step for WUaS would be to communicate with a state of PA Higher Education Associate as WUaS applies for licensure with them IN TANDEM with completing a Pre-Application for Accreditation with MSCHE, I think, too -


See -

https://scott-macleod.blogspot.com/2023/01/weaver-bird-ploceus-recording-of-monday.html

and

https://scott-macleod.blogspot.com/2023/03/green-darner-dragonfly.html


Connie, Diana, PER YOUR GUIDELINES BELOW, and further, how can CC-4 licensed MIT OCW-centric wiki World Univ & Sch offer degrees, if WUaS is not accredited, per MSCHE's guidelines below, and particularly item 3 (working down the list) -  


3.      The institution must be operational, with students actively enrolled in its degree programs.

please? This is only one of a number of ongoing conundrums that WUaS faces in seeking to further develop WUaS accreditation with the Middle States' Commission on Higher Education. But I think WUaS meets all the other guidelines in the items below, too. Thank you for helping all of us on the WUaS Accreditation committee with this question, and related ones. 

Connie, I have removed all other MSCHE representatives and their email addresses from this email, besides the ones you included in this email, per your request. 

Thank you, 

Scott


WUaS mission statement here - 

https://wiki.worlduniversityandschool.org/wiki/World_University_Foundation



--


Scott MacLeod - World University books


Scottish Small Piping album #2 - Honey Piobaireachd (2022)

-- Poetry! Order Book #5 Light, Float, Sit, Watsu ~ Virtually (2021)

Scottish Small Piping album #1 Honey in the Bag ~ Out of the Air tune (2020)

Order Book #4 To the Dance or the Pools? ~ Virtually! How different it is to soak at Harbin Hot Springs, than to realize it in virtual reality (2019)

Order Book #3 Winding Road Rainbow: Harbin, Wandering & the Poetry of Loving Bliss (2018)

Order Book #2 Haiku-ish and Other Loving Hippie Harbin Poetry (2017) 

Order Actual-Virtual Ethnographic Book #1: Naked Harbin Ethnography (2016)



- Scott GK MacLeod  

Founder, President, CEO & Professor

CC-4 licensed MIT OCW-centric. Wiki, 

World University & School (WUaS) 

- PO Box 442, Canyon, CA 94516 

- 210 East End Avenue, Pittsburgh, PA 15221

1) non-profit World University and School - http://worlduniversityandschool.org  

2) for profit general stock company WUaS Corporation in CA - http://worlduniversityandschool.org/AcademicPress.html


(o) 415 480 4577 - sgkmacleod@worlduniversiryandschool.org 

(m) 412 478 0116 - sgkmacleod@gmail.com 


World Univ & Sch Innovation Research -  scottmacleod.com 




 

* * * 


Derek Angus Title: The RCT is dead. Long live the RCT - 2/24/23 Pitt Philosophy of Science talk


Dear Derek, (Colin and Ken), 

Thank you for your great Pitt Philosophy talk yesterday - https://www.centerphilsci.pitt.edu/event/als-d-angus/. Are you familiar with Alphabet's Google's Verily's Project Baseline (see PS below) - and even for streaming people in studies' health data (for new rethought approaches to RCTs) ... and also brainstorming-wise streamed into an online #RealisticVirtualEarthFor Medicine learning system - eg #RealisticVirtualEarthForBrainScience - #RealisticVirtualEarthForSurgery ... https://twitter.com/hashtag/RealisticVirtualEarthForSurgery?src=hashtag_click - (https://scott-macleod.blogspot.com/search/label/virtual%20earth) - with machine learning? Regarding Project Baseline, think "Blood, Sweat and Tears" ' physical samples from people in studies translated into data for mapping pathways to health and longevity ... and maybe for far greater than 122 years of age longevity, with new developing approaches to Randomized Clinical Trials. 

Derek, could you as the inaugural innovation chancellor for health care innovation at the Univ of Pitt open the ways for Univ Pitts Med Ctr and its Med Sch working with Google and Alphabet in these regards? 

Looking forward to meeting you more directly sometime, since I was sitting toward the back with tie dye bandana mask and hat on (and see Tweet below in some of these regards too). Do you visit Scotland often? (I've lived in Edinburgh for 2 full years, in high school at Fettes College, and at the University of Edinburgh, in the school of Scottish and Celtic Studies (researching nascent virtual St. Kilda / Hirta).

Thank you again, abolitionally, best regards, 
Scott




200 planned online MIT OCW-centric wiki  WUaS Medical Schools with 200 online teaching hospitals -




- Scott GK MacLeod  
Founder, President, CEO & Professor
CC-4 licensed MIT OCW-centric. Wiki, 
World University & School (WUaS) 
- PO Box 442, Canyon, CA 94516 
- 210 East End Avenue, Pittsburgh, PA 15221
1) non-profit World University and School - http://worlduniversityandschool.org  
2) for profit general stock company WUaS Corporation in CA - http://worlduniversityandschool.org/AcademicPress.html

(m) 412 478 0116 - sgkmacleod@gmail.com 

World Univ & Sch Innovation Research -  scottmacleod.com 




PS
more about Project Baseline - 

What is Project Baseline?
Project Baseline is an initiative to make it easy and engaging for people to contribute to the map of human health and participate in clinical research. Together with researchers, clinicians, engineers, designers, advocates, and volunteers like you, we're collaborating to design the next generation of healthcare tools and services.

Project Baseline was founded by Verily, a subsidiary of Alphabet focused on life sciences and healthcare. We partner with organizations like Duke University School of Medicine, Stanford Medicine, and our sister company Google to make clinical research opportunities more accessible. Learn more about our team. Our Project Baseline efforts began in 2017 with the Project Baseline Health Study.

What is clinical research?
Clinical research is the scientific process to answer research questions related to health and disease through clinical studies. A clinical study involves human volunteers (also called participants) and is intended to advance medical knowledge and practice. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. A clinical trial involves testing interventions such as medical products, medications, or procedures, whereas an observational study observes participants over a given time period. More information on clinical studies is available here.

Because medicines must be rigorously tested  and participants closely monitored, it usually takes about 10 years for a new treatment to get approved. Finding enough participants -- from all backgrounds -- remains one of the greatest research challenges.

Randomized - In many studies, participants are randomly sorted into different groups. This allows researchers to observe the effects of a new treatment against a control group, which does not receive the treatment.

Double blind - In double blind studies, participants and investigators don't know who is receiving an experimental treatment. This helps reduce bias due to placebo effect (a phenomenon where people experience benefit from belief that they are receiving a treatment, which can't be attributed to the properties of the treatment itself).

Investigational - An investigational treatment has not yet received approval from the FDA.

Intervention - A health 'intervention' refers to any activity undertaken with the goal of improving human health. This includes interventions that aim to prevent disease, cure or reduce the severity of a disease, or restore function.


Clinical research consists of five main phases, each progressively larger as the investigational treatment or intervention moves through approvals.

Preclinical development: initial testing and safety data are gathered before human studies, usually in laboratory animals.

Phase 0: exploratory studies that take place with just a few participants and are designed to demonstrate proof of concept.

Phase I: focused on safety and finding either the optimal dosage of a therapy, or identifying the right patient population.

Phase II: focused on safety and efficacy (how well a therapy or intervention works).

Phase III: compare a new therapy or intervention to existing standard-of-care, in a large population

Phase IV: post-approval by the FDA, researchers continue to study how the drug performs in the real world.

https://www.projectbaseline.com/faq-general/




PPS

Tweets - 


1
Thnx #DerekCAngusMD for your great #PittPhilosophyTalk 2/24/23 "The RCT is dead. Long live the RCT" - https://www.centerphilsci.pitt.edu/event/als-d-angus/ Collaboration with #VerilyProjectBaseline - https://www.projectbaseline.com/faq-general/ in #RealisticVirtualEarthForMedicine w 7.9 billion #AvatarBotElectronicMedicalRecords?











2

#DerekCAngusMD ThxFOR #PittPhilosophyTalk 2/24/23 https://www.centerphilsci.pitt.edu/event/als-d-angus/ Re your #GoogleFlu slide re #GoogleCoronaVirus #GoogleChimney too & #RandomizedClinicalTrials Is https://www.projectbaseline.com/faq-general/ w 7.9 bill. #AvatarBotElectronicMedicalRecords https://wiki.worlduniversityandschool.org/wiki/Clinical_Trials_at_WUaS_(for_all_languages) new #RCTmodel?









3
wearing my #tiedye #GoogleCoronaVirus mask thru your #PittPhilosophyTalk 2/24/23 #DerekCAngusMD Thx! I pulled it up over my eyes as QA began & I left re #RCTdoubleblind Q fr @dreleanorknox re #WUaSabolition of #IllegalSexIndustry in  #AcademicPhilosophy to protect #PhilStudents!










(Here's the tie dye bandana on head on the wee hill above the Unitarian Universalist church of Kensington, near Berzerkeley, CA, in the middle of the corona virus pandemic)



2 and 3 RETWEETING  ... 

Thnx #DerekCAngusMD for your great #PittPhilosophyTalk 2/24/23 "The RCT is dead. Long live the RCT" - https://www.centerphilsci.pitt.edu/event/als-d-angus/ Collaboration with #VerilyProjectBaseline - https://www.projectbaseline.com/faq-general/ in #RealisticVirtualEarthForMedicine w 7.9 billion #AvatarBotElectronicMedicalRecords?









4
Thx #DerekCAngusMD 'inaugural associate vice chancellor for health care innovation' for great #PittPhilosophyTalk 2/24/23 https://www.centerphilsci.pitt.edu/event/als-d-angus Collab. w OCW.MIT.EDU -centric genetic wiki @WorldUnivAndSch's 200 online #WUaSMedSchs #RealisticVirtualEarthForSurgery?






 










PPPS
my notes - 

Archie Cochrane

1972
the birth of Evidence -based medicine


The good news ... 

38,000 RCTs poste din 2022
All FDA drug and device approvals
$50 billion enterprise


We now conduct RCTs very well 
Methodologic conduct


But, ... 

Problems with with EHR?

Problems with separating science and practice 
 

1

2
Too broad

3





1911
Everything in the universe occurs but once, there is no absolute sameness of repetition
Karl Pearson 1911



slide

The RCT sleight of hand



Consider individuals in PROWESS ... 

XIGRIS DRUG




Slide 

actual job

Accurate estimate for the INDIVIDUAL TREATMENT EFFECT 



PHYSICIAN JUDGEMENT 

CATE TO THE ATE ......... >>> ITE


ICD-10

69,000 diseases and conditions 



Problems with separating science and practice 


slide

practice fails to make optimal use of current knowledge



Slide 

No incentive to collaborate




Slide

What do we need?

Google Flu gets it wrong 





Slide


Point-of-care (POC) Clinical Trails


EHR 'clinical moment' alerts trial machinery 




Slide

Adaptive Platform Trials


Randomized controlled trials

Master
Protocols 

Adaptive platform trials

Adaptive trials

VENN diagram

Woodcock and Lavange NEJM 2017 

Nature Drug Discovery 2019 



SLIDE

Remap design




SEMAP - CAP

Enrolled about 13,000 patients




SLIDE

Ok, but ... 

Could you put a whole trial on the EHR ?


slide (bullets) -

EHR data quality

Institutional commitment

Ethics

Statistics and design

Reporting and dissemination of results

Funding 

Oversight and regulatory approval 

ROB CALIFF 

Integration with other clinical research programs



(CONSORT FLOW CHARTS ?????? )


Slide

Next Steps 

Moving to REMAPs and adaptive platform trials in other diseases


Testing things other than drugs and devices

Revisiting ethical approval and human subjects protection 

Trial design improvements

Addressing superstructure and institutional incentives



Slide

NEJM




Slide

Advances in REMAP Design

Multi-level randomization for complex health Issues
   Allegheny County Vaccine Uptake - REMAP - VAX


Prospective estimation of heterogeneity of treatment effect (multiple cATEs) 

cATEs ??????? 


Optimize randomization rules to minimize the altruism penalty 



Slide

Conclusion

The organization of healthcare in 2 parts (science and practice)


The RCT is elegant ... 




Slide

The goal of a 'true' Learning Health System ... 

To fuse the practice .. 





PPPPS



Title: The RCT is dead.  Long live the RCT.

Abstract:

First introduced in the 1940s, the randomized clinical trial, or RCT, revolutionized medicine. Today, all new therapies must show efficacy in an RCT to gain regulatory approval, fueling a clinical trials industry of over $50 billion per year. Although deemed essential, RCTs have considerable statistical, logistical, and ethical challenges. There are some solutions, but few have been adopted. Consequently, RCT design and execution remains largely unchanged in decades, and increasingly anachronistic. I will discuss some of the challenges with RCTs, review some solutions ushered in by necessity during COVID, and consider some next steps. Some key themes I will discuss include frequentist versus Bayesian inference, heterogeneity of treatment effect, use of adaptive platform designs, the implications of digitized health records, and whether and how clinical care should be fused with knowledge generation under conditions of uncertainty.

This talk will also be available live streamed on You Tube at https://www.youtube.com/channel/UCrRp47ZMXD7NXO3a9Gyh2sg.'



The RCT is dead. 
Long live the RCT!


Derek C. Angus, MD, MPH
Suite 600, Scaife Hall
3550 Terrace Street
Pittsburgh, PA 15261
angusdc@upmc.edu
412-647-6965


ALS: Derek Angus
Title: The RCT is dead.  Long live the RCT.
https://pre.ccm.pitt.edu/?q=content/angus-derek
angusdc@upmc.edu
412-647-6965

February 24 @ 3:30 pm - 5:30 pm EST
1008 Cathedral of Learning
4200 Fifth Ave
Pittsburgh, PA 15260 United States

DETAILS

Date:
February 24
Time:
3:30 pm - 5:30 pm EST


https://www.centerphilsci.pitt.edu/event/als-d-angus/


This talk will also be available live streamed on You Tube at https://www.youtube.com/channel/UCrRp47ZMXD7NXO3a9Gyh2sg.




--


Scottish Small Piping album #2 - Honey Piobaireachd (2022)


- Scott GK MacLeod  
Founder, President, CEO & Professor
CC-4 licensed MIT OCW-centric. Wiki, 
World University & School (WUaS) 
- PO Box 442, Canyon, CA 94516 
- 210 East End Avenue, Pittsburgh, PA 15221
1) non-profit World University and School - http://worlduniversityandschool.org  
2) for profit general stock company WUaS Corporation in CA - http://worlduniversityandschool.org/AcademicPress.html

(m) 412 478 0116 - sgkmacleod@gmail.com 

World Univ & Sch Innovation Research -  scottmacleod.com 





























https://en.wikipedia.org/wiki/Beluga_whale 

https://commons.wikimedia.org/wiki/Category:Delphinapterus_leucas

https://en.wikipedia.org/wiki/Monodontidae


Faroe islands endangered species



Atlantic Halibut Fishes


Balearic Shearwater Birds


Basking Shark Fishes


Beluga Mammals


...




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