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Two weeks ago, the Transportation Security Administration announced that it would began allowing travelers to apply for its PreCheck program, "an expedited screening process" through airport security.

Curiously though, the only airport in the country where travelers could complete the program's required background interview was Indianapolis International Airport. That changed today when TSA opened three enrollment centers in the Washington, DC area. Interestingly, none of them are at DC-area airports. Nor are any of them in DC itself.

Continue reading Sorry Indianapolis, You're No Longer the Sole Location Offering TSA PreCheck Enrollment Background Checks

Sorry Indianapolis, You're No Longer the Sole Location Offering TSA PreCheck Enrollment Background Checks originally appeared on Gadling on Mon, 16 Dec 2013 15:07:00 EST. Please see our terms for use of feeds.

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Honolulu – Injured public employees in Hawaii must complete a return-to-work program before receiving vocational rehabilitation benefits, under a new state law.

; Credit: LA Johnson/NPR

Elissa Nadworny | NPR

Undergraduate college enrollment fell again this spring, down nearly 5% from a year ago. That means 727,000 fewer students, according to new data from the National Student Clearinghouse.

"That's really dramatic," says Doug Shapiro, who leads the clearinghouse's research center. Fall enrollment numbers had indicated things were bad, with a 3.6% undergraduate decline compared with a year earlier, but experts were waiting to see if those students who held off in the fall would enroll in the spring. That didn't appear to happen.

"Despite all kinds of hopes and expectations that things would get better, they've only gotten worse in the spring," Shapiro says. "It's really the end of a truly frightening year for higher education. There will be no easy fixes or quick bounce backs."

Overall enrollment in undergraduate and graduate programs has been trending downward since around 2012, and that was true again this spring, which saw a 3.5% decline — seven times worse than the drop from spring 2019 to spring 2020.

The National Student Clearinghouse attributed that decline entirely to undergraduates across all sectors, including for-profit colleges. Community colleges, which often enroll more low-income students and students of color, remained hardest hit by far, making up more than 65% of the total undergraduate enrollment losses this spring. On average, U.S. community colleges saw an enrollment drop of 9.5%, which translates to 476,000 fewer students.

"The enrollment landscape has completely shifted and changed, as though an earthquake has hit the ground," says Heidi Aldes, dean of enrollment management at Minneapolis Community and Technical College, a community college in Minnesota. She says her college's fall 2020 enrollment was down about 8% from the previous year, and spring 2021 enrollment was down about 11%.

"Less students are getting an education"

Based on her conversations with students, Aldes attributes the enrollment decline to a number of factors, including being online, the "pandemic paralysis" community members felt when COVID-19 first hit, and the financial situations families found themselves in.

"Many folks felt like they couldn't afford to not work and so couldn't afford to go to school and lose that full-time income," Aldes says. "There was so much uncertainty and unpredictability."

A disproportionately high number of students of color withdrew or decided to delay their educational goals, she says, adding to equity gaps that already exist in the Minneapolis area.

"Sure, there is a fiscal impact to the college, but that isn't where my brain goes," Aldes says. "There's a decline, which means there are less students getting an education. That is the tragedy, that less students are getting an education, because we know how important education is to a successful future."

To help increase enrollment, her team is reaching out to the high school classes of 2020 and 2021, and they're contacting students who previously applied or previously enrolled and stopped attending. She says she's hopeful the college's in-person offerings — which now make up nearly 45% of its classes — will entice students to come back, and appeal to those who aren't interested in online courses. So far, enrollment numbers for fall 2021 are up by 1%. "We are climbing back," she says.

A widening divide

Despite overall enrollment declines nationally, graduate program enrollments were up by more than 120,000 students this spring. That means there are more students who already have college degrees earning more credentials, while, at the other end of the spectrum, students at the beginning of their higher ed careers are opting out — a grim picture of a widening gap in America.

"It's kind of the educational equivalent of the rich getting richer," Shapiro says. "Those gaps in education and skills will be baked into our economy, and those families' lives, for years to come."

The value of a college degree — and its impact on earning power and recession resilience — has only been reinforced by the pandemic. According to the U.S. Bureau of Labor Statistics, Americans with a college degree were more likely to stay employed during the pandemic, and if they did lose a job, they were more likely to get hired again. Unemployment rates were higher for those without a degree or credential beyond high school.

"Almost all of the income gains and the employment gains for the last decade have gone to people with higher education degrees and credentials," Shapiro says. "Those who are getting squeezed out of college today, especially at community colleges, are just getting further and further away from being able to enjoy some of those benefits."

In the National Student Clearinghouse data, traditional college-aged students, those 18 to 24, were the largest age group missing from undergraduate programs. That includes many students from the high school class of 2020, who graduated at the beginning of the pandemic. Additional research from the Clearinghouse shows a 6.8% decline in college-going rates among the class of 2020 compared to the class of 2019 — that's more than four times the decline between the classes of 2018 and 2019. College-going rates were worse for students at high-poverty high schools, which saw declines of more than 11%.

For the communities and organizations tasked with helping high school graduates transition and succeed in college, the job this year is exponentially harder. Students have always struggled to attend college: "It's not new to us," says Nazy Zargarpour, who leads the Pomona Regional Learning Collaborative, which helps Southern California high school students enroll and graduate from college. "But this year, it's on steroids because of COVID."

Her organization is offering one-on-one outreach to students to help them enroll or re-enroll in college. As part of that effort, Zargarpour and her colleagues conducted research to help them understand why students didn't go on to college during the pandemic.

"Students told us that it's a variety of things, including a lot of just life challenges," she says. "Families being disrupted because of lack of work; families being disrupted because of the challenges of the illness itself; students having to take care of their young siblings; challenges with technology."

The biggest question now: Will those students return to college? Experts say the farther a student gets from their high school graduation, the less likely they are to enroll, because life gets in the way. But Zargarpour is hopeful.

"It will take a little bit of time for us to catch up to normal and better, but my heart can't bear to say all hope is lost for any student ever."

Copyright 2021 NPR. To see more, visit https://www.npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.

U.S. colleges and universities should respond with urgency to the current surge in undergraduate enrollments in computer science courses and degree programs, which is straining resources at many institutions, says a new report from the National Academies of Sciences, Engineering, and Medicine.

Allied Enrollment Centers Ethical Standards Shine with Second BBB Torch Award Nomination

Digital Postcards Drive 87% Engagement for First-Time Users, Reinforcing the Power of Multimedia and Mobile-Friendly Benefits Communication

Learn And Play Montessori® School is now accepting preschool enrollments across all campuses, with special emphasis on the new Hercules and established Sunnyvale locations.

Learn And Play® Montessori School announces fall enrollment opportunities for daycare and preschool programs at the new Sunnyvale campus.

Long Island, New York's X-RobotX unveils a new slate of fall classes set to ignite passion for coding and robotics. Led by top educators, these courses prepare students today for the world of tomorrow.

Salon and Spa Galleria independent beauty pros offered a variety of supplemental coverages.

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Learn And Play® Montessori School is excited to announce the beginning of fall enrollments across campus locations. "Early Bird" parents are encouraged to explore and enroll their children for top-quality education.

Managing new entity and payer enrollment with payers can be a complex, time-consuming process for health care organizations. Whether launching a new practice, merging with another entity or expanding into new markets, the administrative burden of enrolling with insurance payers and Medicare/Medicaid is significant. From navigating payer-specific requirements to meeting tight deadlines, it’s easy for...

The post Why it’s Simpler for Health Care Organizations to Outsource Payer and Entity Enrollment appeared first on Anders CPA.

We talked with Jay DeFruscio, the Chief Operating Officer for the Archdiocese of Philadelphia Schools, about the huge benefit provided by the Educational Improvement Tax Credit Program. Here are three of the postings we shared on Facebook. https://www.facebook.com/share/v/o9mfCwioL8PfuHa8/?mibextid=WC7FNe https://www.facebook.com/share/v/8Hbz7PVfKdKSFrWM/?mibextid=WC7FNe https://www.facebook.com/share/v/d83WFnKC8ZZ4oQAi/?mibextid=WC7FNe    

Denver Public Schools has recommended closing 10 schools in response to declining enrollment.

If approved by the school board in two weeks, the closures and restructuring will affect 1,844 students and 267 employees.

The number of Black men enrolled at Historically Black Colleges and Universities is the lowest it’s been since 1976.

A group of Vermont high school students backed by a powerful conservative Christian legal organization is accusing the state of religious discrimination.

Penn State remains one of the largest public universities in the United States with 87,995 students enrolled across the University’s campuses in fall 2024, according to the annual enrollment snapshot released today (Nov. 11).

The marketplace’s eighth open enrollment period starts Sunday, Nov. 1, and ends Tuesday, Dec. 15, at www.HealthCare.gov, where consumers can renew existing coverage or sign up for a new plan. Coverage for enrollees who sign up by Dec. 15 and pay their first month’s premium will take effect Jan. 1.

NEW CASTLE (Dec. 23, 2020) – Enrollment on Delaware’s Health Insurance Marketplace increased more than 5% during the open enrollment period that ended Dec. 15. From Nov. 1 through Dec. 15, a total of 25,260 Delawareans signed up for 2021 coverage through the marketplace, an increase of 5.3% over last year’s open enrollment period, when […]

Consumers should be wary of non-marketplace plans that offer limited benefits Insurance Commissioner Trinidad Navarro is joining commissioners across the country in cautioning residents who may be considering purchasing an insurance plan that does not adequately meet their needs or comply with Affordable Care Act (ACA) benefit requirements. The Special Enrollment Period, which started February […]

Free one-on-one counseling and information available to residents; Bureau earns federal grant The Delaware Medicare Assistance Bureau (DMAB), a division of the Delaware Department of Insurance, is encouraging residents to get ready for Medicare Open Enrollment. DMAB, which provides free, one-on-one Medicare counseling, offers a myriad of virtual appointment options for residents, as well as […]

Delawareans can renew existing coverage or sign up for a new plan. Coverage for enrollees who sign up by Dec. 15 and pay their first month’s premium will take effect Jan. 1, 2022.

As the October 15 to December 7 Medicare Open Enrollment quickly approaches, the Delaware Department of Insurance and its Medicare Assistance Bureau (DMAB) are sharing their annual consumer information announcement.

As Medicare Open Enrollment approaches, the Delaware Department of Insurance and its Medicare Assistance Bureau (DMAB) are sharing their annual consumer information update. From October 15 to December 7, consumers can join, switch, or drop a Medicare Prescription Drug Plan (Part D) or Medicare Advantage Plan. DMAB’s free, confidential, unbiased one-on-one assistance can help residents determine if making a coverage change is the right choice. In 2022, the team completed 5,123 counseling sessions, saving beneficiaries a combined $1.5 million.

The Delaware Agricultural Lands Preservation Foundation voted to extend district enrollment until December 31, 2020 to any agricultural landowners who want to preserve their farms. These landowners will have the opportunity to apply for Round 25 in 2021. Farms must be enrolled in a preservation district before the landowner can submit a bid to sell an easement.

The Delaware Department of Agriculture reminds any farmers who have yet to enroll their property as a farmland preservation district that October 31, 2023, is the deadline to be eligible for 2024 preservation funding.

NEW CASTLE (Feb. 3, 2022) – With strong public demand for coverage during the COVID-19 pandemic, enhanced federal subsidies, and Delaware’s reinsurance program keeping the cost of monthly premiums relatively steady, enrollment on Delaware’s Health Insurance Marketplace for 2022 set an all-time high, increasing 26.8% over the open enrollment total for 2021. During Delaware’s ninth […]

The marketplace’s 10th open enrollment period started today, Nov. 1, and ends Jan. 15, 2023, at www.HealthCare.gov, where consumers can renew existing coverage or sign up for a new plan. Coverage for enrollees who sign up by Dec. 15 and pay their first month’s premium will be effective Jan. 1.

With more choice in plans than ever before, enhanced federal subsidies, and Delaware's reinsurance program keeping the cost of monthly premiums relatively steady, enrollment on Delaware's Health Insurance Marketplace for 2023 again set an all-time high, increasing 8% over the open enrollment total for 2022.

NEW CASTLE – Delawareans seeking coverage for 2024 will find more choice in insurers and plans than ever before on the Health Insurance Marketplace in the 11th year of open enrollment. The marketplace’s open enrollment period started today, Nov. 1, and ends Jan. 15, 2024. Consumers can renew existing coverage or sign up for a […]

Free one-on-one counseling saved Delawareans $3.8M in 2023 As Medicare Open Enrollment approaches, the Delaware Department of Insurance and its Medicare Assistance Bureau (DMAB) are sharing their annual consumer information update. From October 15 to December 7, consumers can join, switch, or drop a Medicare Prescription Drug Plan (Part D) or Medicare Advantage Plan. DMAB’s […]

The open enrollment period will run through Jan. 15, 2025. Delawareans can renew existing coverage or sign up for a new plan at www.HealthCare.gov. Coverage for enrollees who sign up by Dec. 15 and pay their first month’s premium will be effective Jan. 1.

Even by the already-painfully-embarrassingly-low standards of clinical trial enrollment in general, patient enrollment in cancer clinical trials is slow. Horribly slow. In many cancer trials, randomizing one patient every three or four months isn't bad at all – in fact, it's par for the course. The most
commonly-cited number is that only 3% of cancer patients participate in a trial – and although exact details of how that number is measured are remarkably difficult to pin down, it certainly can't be too far from reality.

Ultimately, the cost of slow enrollment is borne almost entirely by patients; their payment takes the form of fewer new therapies and less evidence to support their treatment decisions.

So when a couple dozen thousand of the world's top oncologists fly into Chicago to meet, you'd figure that improving accrual would be high on everyone’s agenda. You can't run your trial without patients, after all.

But every year, the annual ASCO meeting underdelivers in new ideas for getting more patients into trials. I suppose this a consequence of ASCO's members-only focus: getting the oncologists themselves to address patient accrual is a bit like asking NASCAR drivers to tackle the problems of aerodynamics, engine design, and fuel chemistry.

Nonetheless, every year, a few brave souls do try. Here is a quick rundown of accrual-related abstracts at this year’s meeting, conveniently sorted into 3 logical categories:

1. As Lord Kelvin may or may not have said, “If you cannot measure it, you cannot improve it.”

• Abstract e15572: Inadequate data availability on clinical trial accrual and its effect on progress in cancer research

Probably the most sensible of this year's crop, because rather than trying to make something out of nothing, the authors measure exactly how pervasive the nothing is. Specifically, they attempt to obtain fairly basic patient accrual data for the last three years' worth of clinical trials in kidney cancer. Out of 108 trials identified, they managed to get – via search and direct inquiries with the trial sponsors – basic accrual data for only 43 (40%).

That certainly qualifies as “terrible”, though the authors content themselves with “poor”.

Interestingly, exactly zero of the 32 industry-sponsored trials responded to the authors' initial survey. This fits with my impression that pharma companies continue to think of accrual data as proprietary, though what sort of business advantage it gives them is unclear. Any one company will have only run a small fraction of these studies, greatly limiting their ability to draw anything resembling a valid conclusion.

• Abstract TPS6645: Predictors of accrual success for cooperative group trials: The Cancer and Leukemia Group B (Alliance) experience

CALGB investigators look at 110 trials over the past 10 years to see if they can identify any predictive markers of successful enrollment. Unfortunately, the trials themselves are pretty heterogeneous (accrual periods ranged from 6 months to 8.8 years), so finding a consistent marker for successful trials would seem unlikely.

And, in fact, none of the usual suspects (e.g., startup time, disease prevalence) appears to have been significant. The exception was provision of medication by the study, which was positively associated with successful enrollment.

The major limitation with this study, apart from the variability of trials measured, is in its definition of “successful”, which is simply the total number of planned enrolled patients. Under both of their definitions, a slow-enrolling trial that drags on for years before finally reaching its goal is successful, whereas if that same trial had been stopped early it is counted as unsuccessful. While that sometimes may be the case, it's easy to imagine situations where allowing a slow trial to drag on is a painful waste of resources – especially if results are delayed enough to bring their relevance into question.

Even worse, though, is that a trial’s enrollment goal is itself a prediction. The trial steering committee determines how many sites, and what resources, will be needed to hit the number needed for analysis. So in the end, this study is attempting to identify predictors of successful predictions, and there is no reason to believe that the initial enrollment predictions were made with any consistent methodology.

2. If you don't know, maybe ask somebody?

• Abstract 8592: Strategies to overcome barriers to accrual (BtA) to NCI-sponsored clinical trials: A project of the NCI-Myeloma Steering Committee Accrual Working Group (NCI-MYSC AWG)
  
• Abstract 1596: Rapid online feedback to improve clinical trial accrual: CODEL anaplastic glioma (AG) (NCCTG/Alliance N0577) as a model

With these two abstracts we celebrate and continue the time-honored tradition of alchemy, whereby we transmute base opinion into golden data. The magic number appears to be 100: if you've got 3 digits' worth of doctors telling you how they feel, that must be worth something.

In the first abstract, a working group is formed to identify and vote on the major barriers to accrual in oncology trials. Then – and this is where the magic happens – that same group is asked to identify and vote on possible ways to overcome those barriers.

In the second, a diverse assortment of community oncologists were given an online survey to provide feedback on the design of a phase 3 trial in light of recent new data. The abstract doesn't specify who was initially sent the survey, so we cannot tell response rate, or compare survey responders to the general population (I'll take a wild guess and go with “massive response bias”).

Market research is sometimes useful. But what cancer clinical trial do not need right now are more surveys are working groups. The “strategies” listed in the first abstract are part of the same cluster of ideas that have been on the table for years now, with no appreciable increase in trial accrual.

3. The obligatory “What the What?” abstract

• Abstract 6564: Minority accrual on a prospective study targeting a diverse U.S. breast cancer population: An analysis of Wake Forest CCOP research base protocol 97609

The force with which my head hit my desk after reading this abstract made me concerned that it had left permanent scarring.

If this had been re-titled “Poor Measurement of Accrual Factors Leads to Inaccurate Accrual Reporting”, would it still have been accepted for this year’s meeting? That's certainly a more accurate title.

Let’s review: a trial intends to enroll both white and minority patients. Whites enroll much faster, leading to a period where only minority patients are recruited. Then, according to the authors, “an almost 4-fold increase in minority accrual raises question of accrual disparity.” So, sites will only recruit minority patients when they have no choice?

But wait: the number of sites wasn't the same during the two periods, and start-up times were staggered. Adjusting for actual site time, the average minority accrual rate was 0.60 patients/site/month in the first part and 0.56 in the second. So the apparent 4-fold increase was entirely an artifact of bad math.

This would be horribly embarrassing were it not for the fact that bad math seems to be endemic in clinical trial enrollment. Failing to adjust for start-up time and number of sites is so routine that not doing it is grounds for a presentation.

The bottom line

What we need now is to rigorously (and prospectively) compare and measure accrual interventions. We have lots of candidate ideas, and there is no need for more retrospective studies, working groups, or opinion polls to speculate on which ones will work best.  Where possible, accrual interventions should themselves be randomized to minimize confounding variables which prevent accurate assessment. Data needs to be uniformly and completely collected. In other words, the standards that we already use for clinical trials need to be applied to the enrollment measures we use to engage patients to participate in those trials.

This is not an optional consideration. It is an ethical obligation we have to cancer patients: we need to assure that we are doing all we can to maximize the rate at which we generate new evidence and test new therapies.

[Image credit: Logarithmic turtle accrual rates courtesy of Flikr user joleson.]

[Fair Warning: I have generally tried to keep this blog separate from my corporate existence, but am making an exception for two quick posts about the upcoming DIA 2013 Annual Meeting.]

Improving Enrollment in Pediatric Clinical Trials

Logistically, ethically, and emotionally, involving children in medical research is greatly different from the same research in adults. Some of the toughest clinical trials I've worked on, across a number of therapeutic areas, have been pediatric ones. They challenge you to come up with different approaches to introducing and explaining clinical research – approaches that have to work for doctors, kids, and parents simultaneously.

On Thursday June 27, Don Sickler, one of my team members, will be chairing a session titled “Parents as Partners: Engaging Caregivers for Pediatric Trials”. It should be a good session.

Joining Don are 2 people I've had the pleasure of working with in the past. Both of them combine strong knowledge of clinical research with a massive amount of positive energy and enthusiasm (no doubt a big part of what makes them successful).

However, they also differ in one key aspect: what they work on. One of them – Tristen Moors from Hyperion Therapeutics - works on an ultra-rare condition, Urea Cycle Disorder, a disease affecting only a few hundred children every year. On the other hand, Dr. Ann Edmunds is an ENT working in a thriving private practice. I met her because she was consistently the top enroller in a number of trials relating to tympanostomy tube insertion. Surgery to place “t-tubes” is one of the most common and routine outpatients surgeries there is, with an estimated half million kids getting tubes each year.

Each presents a special challenge: for rare conditions, how do you even find enough patients? For routine procedures, how do you convince parents to complicate their (and their children’s) lives by signing up for a multi-visit, multi-procedure trial?

Ann and Tristen have spent a lot of time tackling these issues, and should have some great advice to give.

For more information on the session, here’s Don’s posting on our news blog.

Are we looking at our enrollment data in the right way?

Session Details:

June 25, 1:45PM - 3:15PM

• Session Number: 241
• Room Number: 205B

1. Enrollment Analytics: Moving Beyond the Funnel
Paul Ivsin
VP, Consulting Director
CAHG Clinical Trials

2. Use of Analytics for Operational Planning
Diana Chung, MSc
Associate Director, Clinical Operations
Gilead
3. Using Enrollment Data to Communicate Effectively with Sites
Gretchen Goller, MA
Senior Director, Patient Access and Retention Services
PRA

There has been considerable noise coming out of the UK lately about successes in clinical trial enrollment.

First, a couple months ago came the rather dramatic announcement that clinical trial participation in the UK had "tripled over the last 6 years". That announcement, by the chief executive of the

Sweet creature of bombast: is Sir John writing press releases for the NIHR?

National Institute of Health Research's Clinical Research Network, was quickly and uncritically picked up by the media.

That immediately caught my attention. In large, global trials, most pharmaceutical companies I've worked with can do a reasonable job of predicting accrual levels in a given country. I like to think that if participation rates in any given country had jumped that heavily, I’d have heard something.

(To give an example: looking at a quite-typical study I worked on a few years ago: UK sites were overall slightly below the global average. The highest-enrolling countries were about 2.5 times as fast. So, a 3-fold increase in accruals would have catapulted the UK from below average to the fastest-enrolling country in the world.)

Further inquiry, however, failed to turn up any evidence that the reported tripling actually corresponded to more human beings enrolled in clinical trials. Instead, there is some reason to believe that all we witnessed was increased reporting of trial participation numbers.

Now we have a new source of wonder, and a new giant multiplier coming out of the UK. As the Director of the NIHR's Mental Health Research Network, Til Wykes, put it in her blog coverage of her own paper:

Our research on the largest database of UK mental health studies shows that involving just one or two patients in the study team means studies are 4 times more likely to recruit successfully.

Again, amazing! And not just a tripling – a quadrupling!

Understand: I spend a lot of my time trying to convince study teams to take a more patient-focused approach to clinical trial design and execution. I desperately want to believe this study, and I would love having hard evidence to bring to my clients.

At first glance, the data set seems robust. From the King's College press release:

Published in the British Journal of Psychiatry, the researchers analysed 374 studies registered with the Mental Health Research Network (MHRN).

Studies which included collaboration with service users in designing or running the trial were 1.63 times more likely to recruit to target than studies which only consulted service users.  Studies which involved more partnerships - a higher level of Patient and Public Involvement (PPI) - were 4.12 times more likely to recruit to target.

But here the first crack appears. It's clear from the paper that the analysis of recruitment success was not based on 374 studies, but rather a much smaller subset of 124 studies. That's not mentioned in either of the above-linked articles.

And at this point, we have to stop, set aside our enthusiasm, and read the full paper. And at this point, critical doubts begin to spring up, pretty much everywhere.

First and foremost: I don’t know any nice way to say this, but the "4 times more likely" line is, quite clearly, a fiction. What is reported in the paper is a 4.12 odds ratio between "low involvement" studies and "high involvement" studies (more on those terms in just a bit).  Odds ratios are often used in reporting differences between groups, but they are unequivocally not the same as "times more likely than".

This is not a technical statistical quibble. The authors unfortunately don’t provide the actual success rates for different kinds of studies, but here is a quick example that, given other data they present, is probably reasonably close:

• A Studies: 16 successful out of 20 
• Probability of success: 80% 
• Odds of success: 4 to 1
• B Studies: 40 successful out of 80
• Probability of success: 50%
• Odds of success: 1 to 1

From the above, it’s reasonable to conclude that A studies are 60% more likely to be successful than B studies (the A studies are 1.6 times as likely to succeed). However, the odds ratio is 4.0, similar to the difference in the paper. It makes no sense to say that A studies are 4 times more likely to succeed than B studies.

This is elementary stuff. I’m confident that everyone involved in the conduct and analysis of the MHRN paper knows this already. So why would Dr Wykes write this? I don’t know; it's baffling. Maybe someone with more knowledge of the politics of British medicine can enlighten me.

If a pharmaceutical company had promoted a drug with this math, the warning letters and fines would be flying in the door fast. And rightly so. But if a government leader says it, it just gets recycled verbatim.

The other part of Dr Wykes's statement is almost equally confusing. She claims that the enrollment benefit occurs when "involving just one or two patients in the study team". However, involving one or two patients would seem to correspond to either the lowest ("patient consultation") or the middle level of reported patient involvement (“researcher initiated collaboration”). In fact, the "high involvement" categories that are supposed to be associated with enrollment success are studies that were either fully designed by patients, or were initiated by patients and researchers equally. So, if there is truly a causal relationship at work here, improving enrollment would not be merely a function of adding a patient or two to the conversation.

There are a number of other frustrating aspects of this study as well. It doesn't actually measure patient involvement in any specific research program, but uses just 3 broad categories (that the researchers specified at the beginning of each study). It uses an arbitrary and undocumented 17-point scale to measure "study complexity", which collapses and quite likely underweights many critical factors into a single number. The enrollment analysis excluded 11 studies because they weren't adequate for a factor that was later deemed non-significant. And probably the most frustrating facet of the paper is that the authors share absolutely no descriptive data about the studies involved in the enrollment analysis. It would be completely impossible to attempt to replicate its methods or verify its analysis. Do the authors believe that "Public Involvement" is only good when it’s not focused on their own work?

However, my feelings about the study and paper are an insignificant fraction of the frustration I feel about the public portrayal of the data by people who should clearly know better. After all, limited evidence is still evidence, and every study can add something to our knowledge. But the public misrepresentation of the evidence by leaders in the area can only do us harm: it has the potential to actively distort research priorities and funding.

Why This Matters

We all seem to agree that research is too slow. Low clinical trial enrollment wastes time, money, and the health of patients who need better treatment options.

However, what's also clear is that we lack reliable evidence on what activities enable us to accelerate the pace of enrollment without sacrificing quality. If we are serious about improving clinical trial accrual, we owe it to our patients to demand robust evidence for what works and what doesn’t. Relying on weak evidence that we've already solved the problem ("we've tripled enrollment!") or have a method to magically solve it ("PPI quadrupled enrollment!") will cause us to divert significant time, energy, and human health into areas that are politically favored but less than certain to produce benefit. And the overhyping those results by research leadership compounds that problem substantially. NIHR leadership should reconsider its approach to public discussion of its research, and practice what it preaches: critical assessment of the data.
Ennis L, & Wykes T (2013). Impact of patient involvement in mental health research: longitudinal study. The British journal of psychiatry : the journal of mental science PMID: 24029538

1. Misstated an odds ratio of 4 as “4 times more likely to”
2. Overstated the recruitment success findings as being based on a sample 3 times larger than it actually was
3. Re-interpreted, without reservation, a statistical association as a causal relationship
4. Misstated the difference between the patient involvement categories as being a matter of merely “involving just one or two patients in the study team”

And you did these consistently and repeatedly – in Dr Wykes's blog post, in the KCL press release, and in the NIHR-written Guardian article.

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