Use the labels in the right column to find what you want. Or you can go thru them one by one, there are only 34,370 posts. Searching is done in the search box in upper left corner. I blog on anything to do with stroke. DO NOT DO ANYTHING SUGGESTED HERE AS I AM NOT MEDICALLY TRAINED, YOUR DOCTOR IS, LISTEN TO THEM. BUT I BET THEY DON'T KNOW HOW TO GET YOU 100% RECOVERED. I DON'T EITHER BUT HAVE PLENTY OF QUESTIONS FOR YOUR DOCTOR TO ANSWER.
Changing stroke rehab and research worldwide now.Time is Brain!trillions and trillions of neuronsthatDIEeach day because there areNOeffective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.
What this blog is for:
My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.
Showing posts with label clinical trial results. Show all posts
Showing posts with label clinical trial results. Show all posts
Stroke survivors don't care about 'cost'. They want to know 100% RECOVERY EFFECTIVENESS! Are you that blitheringly stupid? What are the EXACT RECOVERY RESULTS? This just seems to be get them somewhat mobile so we can kick them out the door!
Of course, this technology has been out there a while and the incompetence shown in how long to bring it in is FUCKINGLY IMPRESSIVE!
Danielle M. Dobney, PhD, MSc, CAT, Gaven Ren, BKin, Samena Rashid-Mohamed , BSc, MHSc,
CHE, Danvir Sandhu , BSc (Candidate), Eimerie Mengulloe , Diploma in Digital
Communications and Media
Affiliations
University of Toronto, Toronto, Canada
University of Western Ontario, London, Canada
University of Waterloo, Waterloo, Canada
Trent University, Peterborough, Canada
Study Context
Ontario Hospital System, Canada
Corresponding Author
Danielle Dobney
Email: ddobney@kickstartcanada.com
Running Title
Budget Impact of Kickstart in Stroke Rehabilitation
Keywords
stroke rehabilitation, budget impact analysis, health economics, exoskeleton, Ontario
Word count
4765 (excluding title page and references)
Abstract:
Background: Stroke places a significant and growing economic burden on the Ontario health
care system, particularly within inpatient rehabilitation. Technologies that accelerate functional
recovery may improve both patient outcomes and system efficiency.
Objective:
To estimate the budget impact of implementing Kickstart technology in Ontario
hospitals.
Methods:
A budget impact model was developed using Ontario-specific attributable stroke
costs, adjusted to 2026 values using healthcare inflation. Hospital scenarios were modeled for
community hospitals and regional stroke centres using published admission volumes. Savings
were estimated based on reductions in inpatient rehabilitation length of stay (1-5 days) and a
per-diem cost range of $800 - $1,200 CAD. A 35% eligibility rate was applied to reflect patients
meeting clinical criteria for device use.
Results:
The projected 2026 attributable cost of stroke was $39,455 CAD per patient, including
$8,492 for inpatient rehabilitation. In community hospitals, annual savings ranged from $44,000
to $330,000, with a moderate estimate of $165,000. In regional centres, savings ranged from
$112,000 to $840,000, with a moderate estimate of $420,000. Device costs were offset after
approximately 5–9 patients.
Conclusion:
Kickstart implementation may yield substantial cost savings by reducing
rehabilitation length of stay while improving system capacity and efficiency. These findings
support further real-world evaluation to validate projected benefits.
You'll have to ask your competent? doctor what the preliminary results are for this trial. I had some sleep apnea but that was not found by the medical staff at the hospital.
Do you prefer your doctor, hospital and board of director's incompetence NOT KNOWING? OR NOT DOING?
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
And you really think your insurance will pay for this? And your hospital has such machines? No objective results given so this doesn't even get you 100% recovered.
The average cost per patient was USD 1.108 for a
treatment course consisting of 3 minute sessions, whereas the price was
USD 1.844 for the 37 minute, standard TMS protocol. The average cost per
remission was USD 3.695 for iTBS and USD 6.146 for standard TMS – which
is a difference of USD 2.451. According to the cost analysis, the
reasons for these significant cost-savings associated with the short 3
minute iTBS stimulation can be attributed to the shorter treatment
sessions and increase in treatment capacity.
Virtual
reality and arm cycling have been reported as effective treatments for
improving upper limb motor recovery in patients with stroke.
Intermittent theta burst stimulation (iTBS) can increase ipsilesional
cortical excitability, and has been increasingly used in patients with
stroke. However, few studies examined the augmented effect of iTBS on
neurorehabilitation program. In this study, we investigated the
augmented effect of iTBS on virtual reality-based cycling training (VCT)
for upper limb function in patients with stroke.
Methods
In
this randomized controlled trial, 23 patients with stroke were
recruited. Each patient received either 15 sessions of iTBS or sham
stimulation in addition to VCT on the same day. Outcome measures were
assessed before and after the intervention. Primary outcome measures for
the improvement of upper limb motor function and spasticity were
Fugl-Meyer Assessment-Upper Extremity (FMA-UE) and Modified Ashworth
Scale Upper-Extremity (MAS-UE). Secondary outcome measures for activity
and participation were Action Research Arm Test (ARAT), Nine Hole Peg
Test (NHPT), Box and Block Test (BBT) and Motor Activity Log (MAL), and
Stroke Impact Scale (SIS). Wilcoxon signed-rank tests were performed to
evaluate the effectiveness after the intervention and Mann–Whitney U
tests were conducted to compare the therapeutic effects between two
groups.
Results
At
post-treatment, both groups showed significant improvement in FMA-UE
and ARAT, while only the iTBS + VCT group demonstrated significant
improvement in MAS-UE, BBT, NHPT, MAL and SIS. The Mann–Whitney U tests
revealed that the iTBS + VCT group has presented greater improvement
than the sham group significantly in MAS-UE, MAL-AOU and SIS. However,
there were no significant differences in the changes of the FMA-UE,
ARAT, BBT, NHPT and MAL-QOM between groups.
Conclusions
Intermittent
TBS showed augmented efficacy on VCT for reducing spasticity,
increasing actual use of the affected upper limb, and improving(Both are weasel words signifying nothing objective.)participation in daily life in stroke patients. This study provided an
integrated innovative intervention, which may be a promising therapy to
improve upper limb function recovery in stroke rehabilitation. However,
this study has a small sample size, and thus a further larger-scale
study is warranted to confirm the treatment efficacy.
Trial registration This trial was registered under ClinicalTrials.gov ID No. NCT03350087, retrospectively registered, on November 22, 2017
Background
Stroke
is a leading cause of upper limb (UL) motor impairments. UL impairment
commonly persists after the acute phase, resulting in long-term
disability and decreased health-related life quality [1].
Despite receiving traditional neurorehabilitation programs, 50–60% of
post-stroke patients remained functional motor limitations at variable
degrees [2].
Various interventions and rehabilitation protocols have been developed
in recent decades to enhance motor recovery and improve the quality of
life in post-stroke patients. These rehabilitation programs include
constraint-induced movement therapy, mirror therapy, and virtual reality
(VR). Interventions include non-invasive brain stimulation (NIBS) and
laser therapy.
Holden et al. identified repetition, positive
feedback and patient’s motivation as the three key elements for
post-stroke patients to achieve optimal functional recovery [3].
Therefore, this study combines VR with arm cycling to attain those
elements. With the advancement of technology, VR has been increasingly
utilized to treat neurological disorders. VR provides real-time
somatosensory feedback to enhance motor control and learning [4],
and initiates motivation for patients to endure repeated practice.
Additionally, arm cycling was selected for the current rehabilitation
program because it involves repetitive movement of bilateral upper
limbs. Previous studies have demonstrated that bilateral extremities
training induces interhemispheric facilitation [5], and that a repetitive training program provides additional benefit for functional recovery of upper limbs [6, 7].
Besides, unilateral virtual reality-based cycling training (VCT) was
difficult for patients with hemiplegia. Taken together, this study
applied bilateral VCT program for UL rehabilitation.
Repetitive
transcranial magnetic stimulation (rTMS), a non-invasive brain
stimulation technique, has been increasingly reported as a promising
intervention that safely improves motor performance in the affected UL
of stroke patients. Although the precise underlying mechanism remains
unclear, rTMS is generally considered effective in improving functional
outcome in patients with stroke by modulating motor cortical
excitability and inducing reorganization of neural networks [8].
Since rTMS provides an environment to enhance neuroplasticity instead
of skill acquisition, previous studies indicated combination therapy
with rTMS and rehabilitative training improve motor functions to an
extent that could not be attained by rTMS alone [9, 10].
For this reason, rTMS is often combined with motor behavioral
intervention to enhance motor function. Intermittent theta burst
stimulation (iTBS) is a variant of rTMS that may provide equivalent or
even better efficacy. Therefore, this study explores the augmented
efficacy provided by iTBS on the neurorehabilitation program to improve
UL function.
Theta burst stimulation (TBS) is a novel stimulation
protocol of rTMS that requires a lower stimulation intensity within a
shorter time to achieve therapeutic effect in post-stroke patients [11]. Previous studies have indicated that TBS evoked comparable or even greater motor-evoked potentials (MEPs) [12] with longer-lasting effects than conventional rTMS methods [11].
Di Pino et al. proposed the bimodal balance-recovery model, integrating
the interhemispheric competition and vicariation effect over the intact
hemisphere, and suggested that stimulation protocol should be
individualized according to the structural reserve [13].
The interhemispheric competition model was thought to predict recovery
better in post-stroke patients with high structural reserve, while the
vicariation theory is more relevant in post-stroke patients with low
structural reserve. However, due to variable extent of residual neuronal
networks, iTBS is generally applied to the ipsilesional primary motor
cortex to facilitate cortical excitability, while continuous TBS (cTBS)
is used to suppress the cortical excitability of the contralesional site
based on the interhemispheric competition model [11].
The interhemispheric competition model indicates that cortical
excitability decreases in the affected hemisphere following stroke,
while transcallosal inhibitory signals from the unaffected hemisphere
increase due to cortical hyperexcitability [14].
The increased cortical excitability in the intact hemisphere results in
suppression of the ipsilesional hemisphere, which further leads to poor
motor recovery in post-stroke patients [15].
Ward et al. found that the interhemispheric inhibition decreases with
time, suggesting that cTBS has limited effect in stroke patients during
chronic stage. Additionally, a recent meta-analysis revealed that iTBS
has a better effect than cTBS for UL motor recovery in patients with
stroke [16].
Therefore, iTBS was administered over the primary motor cortex of the
ipsilesional hemisphere to assess its efficacy for improving UL
function.
VCT aims to target the peripheral mechanisms of stroke
recovery, while iTBS aims toward the central mechanisms by modulating
cortical excitability [8]. Virtual reality also targets the central mechanisms by inducing cortical reorganization [17],
which may cause a synergistic effect when combined with iTBS. A
previous study revealed that combining low-frequency rTMS with VR
training could improve UL function and quality of life in patients with
subacute stroke [18].
Therefore, this study added iTBS on VCT to examine whether combining
these two neurotechnologies shows additive effects, and whether central
stimulation augments the effect of peripheral training.
To the
best of our knowledge, this is the first randomized controlled trial to
propose an innovative protocol adding iTBS on VCT, and to investigate
the augmented efficacy of iTBS on VCT for upper limb motor function in
patients with stroke. A 15-day intervention was implemented. Based on
previous researches, iTBS was reported to reduce spasticity [19, 20] and improve motor function [19, 21].
We hypothesized that post-stroke patients completing a 15-day treatment
program with iTBS and VCT have better UL function than the patients
receiving sham stimulation and VCT.
Of course not, that is your doctor's job. Are they good at it? I've listed thousands that your doctor and stroke hospital should have interpreted and created stroke protocols. HAVE THEY DONE A SINGLE ONE?
STAT’s guide to interpreting clinical trial results
$499.00
Interpreting clinical trial results is not for the faint of
heart. Companies spin, short-sellers hawk, and everyone else is left
swimming through the muck. But there is an art to reading, and writing,
scientific results — and you can learn it.
In our latest STAT Report, STAT senior writers Sharon Begley and Adam Feuerstein
provide basic tools to help you read clinical trial results with an
appropriately skeptical (or at least critical) eye. They also examine
specific examples of spin, noting the sections of papers reporting the
results of clinical trials where they appear — and why that matters. If
you’re looking to cut through noise to better understand scientific data
or make sense of company performance and value, this report will give
you the foundation you need to make smarter business decisions. Highlights include:
A definition of spin in clinical trials, supported by real life examples.
Four key questions to ask when evaluating
clinical trial results, and an overview of additional tools you need to
read results more critically
Analysis of the red flags you should look for in clinical trial design, execution, and reporting of results.
How it works
Add this report to your cart, and then complete the checkout
process. Once you have, you'll receive an email with the link to
download the full report file. This report is digital-only, so you will
not receive a printout.
If we had a great stroke association with a fully functioning database of all stroke trials and their results we would know immediately when results should be available. Then the president of that great stroke association could do their job and get the results published. THIS IS WHY WE NEED SURVIVORS IN CHARGE. Existing stroke leadership is a complete fucking failure, see here for why I say that; 13 stroke problems with no cure
For 20 years, the U.S. government has urged companies, universities,
and other institutions that conduct clinical trials to record their
results in a federal database, so doctors and patients can see whether
new treatments are safe and effective. Few trial sponsors have
consistently done so, even after a 2007 law made posting mandatory for
many trials registered in the database. In 2017, the National Institutes
of Health (NIH) and the Food and Drug Administration (FDA) tried again,
enacting a long-awaited “final rule” to clarify the law’s expectations
and penalties for failing to disclose trial results. The rule took full
effect 2 years ago, on 18 January 2018, giving trial sponsors ample time
to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.
Science examined more than 4700 trials whose results should
have been posted on the NIH website ClinicalTrials.gov under the 2017
rule. Reporting rates by most large pharmaceutical companies and some
universities have improved sharply, but performance by many other trial
sponsors—including, ironically, NIH itself—was lackluster. Those
sponsors, typically either the institution conducting a trial or its
funder, must deposit results and other data within 1 year of completing a
trial. But of 184 sponsor organizations with at least five trials due
as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline.
As of that date, those habitual violators had failed to report any
results for 67% of their trials and averaged 268 days late for those and
all trials that missed their deadlines. They included such eminent
institutions as the Harvard University–affiliated Boston Children’s
Hospital, the University of Minnesota, and Baylor College of
Medicine—all among the top 50 recipients of NIH grants in 2019.
The violations cover trials in virtually all fields of medicine, and
the missing or late results offer potentially vital information for the
most desperate patients. For example, in one long-overdue trial,
researchers compared the efficacy of different chemotherapy regimens in
200 patients with advanced lymphoma; another—nearly 2 years late—tests
immunotherapy against conventional chemotherapy in about 600 people with
late-stage lung cancer.
Other leading NIH grantees did only slightly better in Science’s analysis based on data collected from the TrialsTracker website
of the University of Oxford, which automatically mines information from
ClinicalTrials.gov. The University of Texas MD Anderson Cancer Center
and the Mayo Clinic both failed to report results on time, or at all, in
about two-thirds of their trials. Yale University failed to do so in
84% of its trials. NIH’s own institutes also had a bad record. They are
directly responsible for reporting results when they sponsor studies
done by agency staff or some grantees, and the top four NIH institute
sponsors, taken together, reported results late or not at all in more
than six of every 10 trials Science looked at.
Contacted for comment, none of the institutions disputed the findings of this investigation. In all 4768 trials Science
checked, sponsors violated the reporting law more than 55% of the time.
And in hundreds of cases where the sponsors got credit for reporting
trial results, they have yet to be publicly posted because of quality
lapses flagged by ClinicalTrials.gov staff (see sidebar).
Although the 2017 rule, and officials’ statements at the time,
promised aggressive enforcement and stiff penalties, neither NIH nor FDA
has cracked down. FDA now says it won’t brandish its big
stick—penalties of up to $12,103 a day for failing to report a trial’s
results—until after the agency issues further “guidance” on how it will
exercise that power. It has not set a date. NIH said at a 2016 briefing
on the final rule that it would cut off grants to those who ignore the
trial reporting requirements, as authorized in the 2007 law, but so far
has not done so.
Missed deadlines
Among more than 4700 clinical trials examined by Science, less than 45% had their results reported early or on time to ClinicalTrials.gov.
150631.6%
Not reported
113223.7%
(GRAPHIC) N. DESAI/SCIENCE; (DATA) CLINICALTRIALS.GOV, VIA TRIALSTRACKER
Many scientists who conduct clinical trials, and their sponsors
or funders, have downplayed concerns about late or missing results in
ClinicalTrials.gov. Researchers, doctors, and patients can instead learn
about trial outcomes from peer-reviewed publications, they say. But
thousands of trials are never published, particularly when they find
treatments ineffective, history has shown. ClinicalTrials.gov also uses a
common format, allowing relatively easy comparisons of results across
trials that journal articles rarely make possible. Doctors, researchers,
and potential trial participants rely on the site, to judge from its
215 million monthly page views.
Deborah Zarin, a physician at Brigham and Women’s Hospital and
Harvard who headed ClinicalTrials.gov between 2005 and 2018, says the Science findings
show failures of the research culture, FDA, and NIH. “If this was a
priority for the leadership of NIH, then they could ensure that
high-quality, timely reporting happened all of the time,” says Zarin, an
NIH-paid research consultant for the database. “You can set up
processes so trial reporting is an expectation. You can’t pass ‘go’ and
collect $200 until this is done.”
Zarin, who works in a program to advance clinical research, adds that
the problem persists because “reporting to ClinicalTrials.gov is
frequently seen by sponsors, funders, and trialists as an annoying
administrative and perhaps legal burden, not a scientific imperative.
Human nature being what it is, people follow the requirements when
forced to do so.”
NIH and FDA officials do not seem inclined to apply that pressure.
Lyric Jorgenson, NIH deputy director for science policy, says her agency
has been “trying to change the culture of how clinical trial results
are reported and disseminated; not so much on the ‘aha, we caught you,’
as much as getting people to understand the value, and making it as easy
as possible to share and disseminate results.” To that end, she says,
ClinicalTrials.gov staff have educated researchers about the website and
improved its usability.
As for FDA, Patrick McNeilly, an official at the agency who handles
trial enforcement matters, recently told an industry conference session
on ClinicalTrials.gov that “FDA has limited resources, and we encourage
voluntary compliance.” He said the agency also reviews reporting of
information on ClinicalTrials.gov as part of inspections of trial sites,
or when it receives complaints.
McNeilly declined an interview request, but at the conference he
discounted violations of ClinicalTrials.gov reporting requirements found
by journalists and watchdog groups. “We’re not going to blanketly
accept an entire list of trials that people say are noncompliant,” he
said. Such determinations require “nonpublic information” submitted to
the agency by trial sponsors. In response to Science’s
findings, a spokesperson said an absence of posted results on
ClinicalTrials.gov did not mean a trial sponsor has broken the 2007 law.
Yet that law and the 2017 final rule detail only a few exemptions
that would allow trial sponsors to withhold results on the basis of
nonpublic information. The very few registered trials that qualify for
those exemptions are not flagged as violators by TrialsTracker or in Science’s analysis. Congress approved the creation of ClinicalTrials.gov
in 1997, after allegations that patients were harmed because companies
withheld evidence showing their medicines were ineffective or hazardous.
A widely cited case involved the GlaxoSmithKline antidepressant Paxil
(paroxetine). According to legal filings and a report in The BMJ,
the firm held secret data showing that in clinical trials the drug was
ineffective and caused suicidal thoughts in teenagers, yet encouraged
doctors to prescribe it for young people.
Registration was only required initially for trials of
treatments for serious or life-threatening diseases. But the 2007 law,
the Food and Drug Administration Amendments Act, required sponsors to
register a much broader range of trials within 21 days of enrolling the
first patient, and to post summary results, adverse events, and other
data to ClinicalTrials.gov within 1 year of collecting the last patient
data. Although many trials, such as industry-sponsored early-stage
evaluations of drug safety, are exempt from reporting, about 326,000
have been registered, and results have been posted for more than 40,000.
Yet until 2015, even the most active investigators at clinical
research institutions treated the law more as a suggestion—not
surprising given that the government enforced no penalties and did not
publicly identify violators. A report on the news website STAT by
this author and Talia Bronshtein first drew significant attention to
specific trial sponsors—companies, government agencies, universities,
and individuals—that routinely ignored reporting requirements. It
sparked immediate improvement, according to NIH. (Those same authors
documented some of that improvement in a 2018 STATarticle.)
At a 2016 press briefing, NIH and FDA rolled out the final rule,
aimed at boosting even greater compliance with the 2007 law. It took
effect in January 2017, with first deadlines for results, and ostensibly
enforcement, 1 year later. Then–FDA Commissioner Robert Califf said it
would thereafter “be pretty hard to hide that you are doing a clinical
trial or hide the result.” FDA, he vowed, was finally prepared, if
necessary, to enforce the daily $10,000 penalty for noncompliance
allowed under the law. (Adjusted for inflation, that figure recently
rose above $12,000.)
“I don’t think anybody wants to be on the wall of shame,” NIH
Director Francis Collins said at the press event, promising that NIH
would publicly flag reporting violations on ClinicalTrials.gov itself.
“We are serious about this,” Collins said, threatening for the first
time to enforce provisions of the 2007 law that allow NIH to rescind
funding to grantees who violate the statute. “It’s hard to herd cats,
but you can … take their food away,” he said. “This is about maintaining
the trust that we have with participants in clinical trials. … If we
fail to live up to that expectation, then that is an ethical failure.”
Three years later, TrialsTracker conservatively estimates that FDA
could have collected more than $6 billion in ClinicalTrials.gov
penalties so far. The agency has yet to demand a single dollar. And
despite more than 2600 trials for which results are overdue or were
filed late, NIH has yet to withhold a single grant as a result or post a
single violation notice on ClinicalTrials.gov. No “wall of shame”
exists.
“Public-facing websites run by the government should be accurate.
That’s not asking much,” Senator Chuck Grassley (R–IA), who advocated
for the 2007 law, wrote in an email after reviewing a summary of the Science findings.
“It’s a question of basic management and agency competence. The
government has a duty to police its work product, especially because the
public trusts .gov websites will be accurate and reliable.”
To physician Ben Goldacre, who directs the Oxford program behind TrialsTracker, “The lack of urgency is really troubling.”
Reporting problems
Science analyzed
ClinicalTrials.gov records of all clinical trials with results legally
required to be reported between 18 January 2018 and 25 September 2019.
The chart, covering trial sponsors with 15 or more results due in that
window or reported early, shows that some results deposited were not
posted due to quality lapses. It also highlights that pharma’s record
has been markedly better than that of academia and the federal
government.Academic/nonprofit
Federal government
Industry
Avg.days late
Totaltrials
Reported on time or early
Reported late
Not reported
Quality problems
Massachusetts General Hospital
Mayo Clinic
Memorial Sloan Kettering Cancer Center
University of North Carolina, Chapel Hill
University of California, San Francisco
Duke University
University of Pennsylvania
Emory University
UT Health Science Center, Houston
Wash. Univ. School of Medicine in St. Louis
University of Chicago
Stanford University
Johns Hopkins University
University of Washington
Wake Forest University Health Sciences
University of Virginia
Sidney Kimmel Comp. Cancer Center
University of Michigan
New York State Psychiatric Institute
Columbia University
Yale University
Dana-Farber Cancer Institute
Icahn School of Medicine at Mount Sinai
Indiana University
University of Colorado, Denver
Medical University of South Carolina
Montefiore Medical Center
Northwestern University
University of Alabama, Birmingham
University of Wisconsin, Madison
National Cancer Institute
Natl. Inst. of Allergy and Infectious Diseases
VA Office of Research and Development
Natl. Heart, Lung, and Blood Institute
Novartis Pharmaceuticals
Gilead Sciences
Pfizer
GlaxoSmithKline
Hoffmann-La Roche
AstraZeneca
Eli Lilly and Company
Allergan
Amgen
Bristol-Myers Squibb
Merck & Co.
Sanofi
Alcon
AbbVie
Celgene
Novo Nordisk
Boehringer Ingelheim
Johnson & Johnson Vision Care
Bayer
Janssen Research & Development
Teva Pharmaceutical Industries
MD Anderson Cancer Center
(GRAPHIC) N. DESAI/SCIENCE; (DATA) CLINICALTRIALS.GOV, VIA TRIALSTRACKER
In a recent article in The BMJ, Goldacre
and colleagues highlighted a long-running MD Anderson trial as an
example of what’s at stake when clinical research results go AWOL.
Started in 1999, the trial tested a specialized hormone therapy in
patients who had surgery for prostate cancer and faced a high risk of
recurrence. The treatment might reduce that risk significantly, but
other trials suggested it had serious side effects, including reduced
bone density, sexual dysfunction, and greater risk of diabetes and
cardiovascular events. When Science collected the
ClinicalTrials.gov data, the MD Anderson trial’s results were overdue by
1 year and 8 months without explanation, and no journal appears to have
published them. Doctors and prostate cancer patients weighing the most
appropriate treatment have been left in the dark.
Stephen Hahn, who served as chief medical officer at MD Anderson
until last month, when he became the new FDA commissioner, was
unavailable for comment. An MD Anderson spokesperson said the center
“believes in transparency,” and is making “every effort to comply” with
trial reporting rules, but did not respond to a question on the missing
cancer trial data.
Mayo, Yale, the University of Minnesota, Baylor, and Boston
Children’s, which have similarly poor reporting records, all said via
email that they, too, were committed to fulfilling ClinicalTrials.gov
requirements. Mayo said it deployed dedicated staff to assist
researchers. Yale noted it had registered hundreds of trials exempt from
reporting requirements and added a layer of review to help ensure
compliance. The University of Minnesota recently created a monitoring
system and has made rapid progress on reporting, according to a
spokesperson. Baylor said it planned to centralize trial monitoring, as
“a top priority.” Boston Children’s said it was “committed to achieving
100% compliance.” It submitted data for one long-overdue study after
being contacted by Science, but four others remain in apparent violation as of the end of 2019.
The slow, apparently forgiving regulatory approach favored by NIH and
FDA will never force such organizations into full compliance, some
advocates of clinical trial transparency say. “In an era when every
restaurant is obliged to publish on its front door the hygiene rating in
their kitchen, we’re seriously not saying whether a trial that costs
millions of dollars has broken the law and its obligation to … patient
participants by failing to report its results?” Goldacre asks. “That
seems like extraordinary special treatment for clinical trialists.”
Select institutions have made serious efforts to comply. Twenty big
pharma companies met all reporting requirements under the 2017 rule and
some major academic centers improved sharply compared with data
collected in 2017 (as detailed in the second STAT investigation).
Memorial Sloan Kettering Cancer Center, Duke University, and Johns
Hopkins University—poor performers in 2017—complied with the law in
nearly all their registered trials covered by the new rule. Johns
Hopkins added staff to track and assist on reporting and to identify
“problem records.” And it enlisted university executives to crack down
on recalcitrant investigators, according to Anthony Keyes, a clinical
research manager there.
But such good performance shouldn’t be an exception, Harvard's Zarin
says. “Further public accountability of the trialists, but also our
government organizations, has to happen. One possibility is that FDA and
NIH will be shamed into enforcing the law. Another possibility is that
sponsors will be shamed into doing a better job. A third possibility is
that ClinicalTrials.gov will never fully achieve its vital aspirations.” This story was supported by the Science Fund for Investigative Reporting.
You'll have to ask your doctor how many hours of use will get you recovered enough not to need the suit anymore. If no time frame is specified then they haven't done enough testing. Not available for individual purchase, so you have to hope you get enough time in the suit while in clinical rehab.
Ekso Bionics, the California company that makes some of the most
advanced exoskeletons out there, is releasing its latest
neurorehabilitation suit, the EksoNR.
Designed primarily to help people recovering from a stroke, the
device recreates the natural movement of the legs and helps patients
re-learn how to walk, sit, and do all the things they used to do.
The EksoNR is based on the EksoGT device,
the most popular rehab robotic exoskeleton on the market. The new model
features an optimized gait that is more natural and better matches
individual patients, comes with a new touchscreen interface for
clinicians, and a host of analytics tools to monitor performance and
tune therapy in real time.
The EksoNR has already received regulatory approval in the U.S. and
Europe and is now available for purchase by rehab centers on both sides
of the pond.
Here’s a couple videos Ekso Bionics released introducing the new EksoNR exoskeleton:
You'll have to ask your doctor what the results were and what protocols were used to try to get more than 10% of patients 100% recovered. It ended at the end of October so if your doctor doesn't know about this, once again incompetence reigns supreme.
Background and study aims One third of
patients have long term disability after stoke but specialist stroke
rehabilitation usually lasts no more than a few months. Patients who
have on going rehabilitation needs once specialist stroke rehabilitation
finishes may be referred to a range of other health care professionals
or services, but most do not offer specialist stroke rehabilitation. One
of the reasons that specialist stroke rehabilitation is not provided
over a longer period is because it is not yet known if it is beneficial.
This research project is a clinical trial to determine whether a new
extended stroke rehabilitation service is beneficial to patients and
carers.
Who can participate? Adults aged over 18 with a new
stroke who are being discharged from hospital after their stroke under
the care of an Early Supported Discharge team. Carers of stroke patients
may also participate. A carer is the main family member or friend, who
will provide support after discharge. He/she may not necessarily live
with the patient.
What does the study involve? Stroke
patients and carers who agree to participate in the trial will be
randomly allocated to either receive a new extended stroke
rehabilitation service or to continue with usual NHS care when routine
specialist stroke rehabilitation (Early Supported Discharge) ends. The
new extended stroke rehabilitation service will involve on going
contact, usually by telephone, with a senior Early Supported Discharge
(ESD) stroke therapist or nurse for 18 months after ESD finishes. The
therapist/nurse will contact patients and carers at 1, 3, 6, 12 and 18
months after discharge from ESD to review their progress and
rehabilitation needs. Rehabilitation goals will be agreed and the
therapist/nurse will give advice on how to progress towards the goals.
The advice may be verbal advice, for example, exercises to practice at
home. Or, if required, referral for an additional period of therapy from
a service which is available locally may be arranged. Usual NHS care
following specialist stroke rehabilitation may involve referral to a
range of rehabilitation services in accordance with local clinical
practice. The effectiveness of the new extended rehabilitation service
will be evaluated by comparing the health (e.g functional abilities and
quality of life) of patients and carers who received the new service
with those who received usual NHS care.
What are the possible benefits and risks of participating? We
do not know if providing a specialist stroke rehabilitation service
over a longer period of time is beneficial. However, we do know that
rehabilitation treatments early after stroke improve health and
recovery. We believe that rehabilitation over a longer period of time
may be beneficial, but this is not yet proven.
Where is the study run from? The
study is being run from Newcastle University, Newcastle upon Tyne, UK.
Patients and carers from twelve or more NHS stroke services will be
invited to take part.
When is the study starting and how long is it expected to run for? Recruitment
to the study will start on 01 January 2013 and end on 31 May 2015.
Study follow up will end on 31 January 2017. The total duration of the
study is 5 years.
Who is funding the study? UK National Institute for Health Research - Health Technology Assessment Programme.
Who is the main contact? Dr Lisa Shaw Lisa.Shaw@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lisa Shaw
ORCID ID
Contact details
Stroke Research Group Institute for Ageing and Health 3-4 Claremont Terrace Newcastle Upon Tyne NE2 4AE United Kingdom
+44 (0)191 222 6779 lisa.shaw@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12789
Study information
Scientific title
A trial to Evaluate an eXTended RehAbilitation service for Stroke patients (EXTRAS)
Acronym
EXTRAS
Study hypothesis
To determine the clinical and cost effectiveness of an extended stroke rehabilitation service.
Ethics approval
Newcastle and North Tyneside Research Ethics Committee, 25/06/2012, ref: 12/NE/0217
Study design
Randomised interventional phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke Rehabilitation
Intervention
Study intervention: An extended stroke rehabilitation
service provided for 18 months following completion of routine
specialist stroke rehabilitation (Early Supported Discharge). The
extended stroke rehabilitation service will provide on-going contact
with a senior ESD team member who will lead and coordinate further
rehabilitation.
Study control: Usual care post Early Supported
Discharge. Usual care may involve referral of patients to a range of
rehabilitation services upon completion of ESD in accordance with local
clinical practice.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Nottingham Extended Activities of Daily Living Scale at 24 months post randomisation.
Secondary outcome measures
For patients: health status (Oxford Handicap Scale),
quality of life (Euroqol EQ-5D), mood (Hospital Anxiety and Depression
Scale), experience of services and resource use (adaptation of the
Client Service Receipt Inventory) at 12 and 24 months.
For
carers: quality of life (Euroqol EQ-5D), carer stress (Caregiver Strain
Index) and experience of services at 12 and 24 months.
