Deans' stroke musings

Changing stroke rehab and research worldwide now.Time is Brain!Just think of all the trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 493 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:

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's quite disgusting that this information is not available from every stroke association and doctors group.
My back ground story is here:http://oc1dean.blogspot.com/2010/11/my-background-story_8.html

Sunday, June 17, 2018

10 foods for riding the obligatory brain injury roller-coaster

This is written by a brain injury survivor, NOT our doctors or researchers. Our fucking failures of stroke associations can't even deign to write up something as simple as this as a protocol.  We need exact amounts per weight and sex.

10 foods for riding the obligatory brain injury roller-coaster


10 foods for riding the obligatory brain injury roller-coaster

Follow me :
When people politely ask me how I’m doing, I say “not bad”. I like to think of this as not lying as it’s just a snap shot of my life. Some days are tolerable, and even a special few are bloody brilliant. That’s probably true for the majority of people. But when I have a bad brain day, I feel like my world has collapsed all over again. It’s like I’m stuck on a roller-coaster that gives me relief when it’s on the climb. But I reach the top and it punishes me when I’m in free fall coming down.

I don’t even know how to explain it when I’m in the middle of a bad brain day.

As I do quiet well at expressing what life post brain injury is like, I still find it surprising that I can’t explain myself when I’m in a bad place. Just recently I haven’t been awful, but everyday I find I am spent very quickly. It’s not terrible, just leaves me grumpy, unmotivated, and unable to follow through with plans. This part of my roller-coaster isn’t the big dipper. It’s more like one of those super fast ones that throws you from side to side whilst nipping under a bridge that you think it’s going to smash into. There’s no dramatic highs and lows, but still even a scream can’t escape.

How diet can ease the roller-coaster ride of brain injury.

We all know you are what you eat. I’ll be the first to admit that whilst I would love to say I treat my body like a temple, I don’t. I comfort eat particularly when I’m feeling like a turd. But I’m going about this the wrong way. Any form of injury means your body needs extra nutrition to be able to heal. Brain injury often means you struggle to use nutrients as effectively as you did before, so you need even more of them. So I’m going to be putting extra effort into giving myself some TLC.

Foods at the link. 


Boone Hospital Center awarded for stroke treatment - Columbia, Missouri

Who the fuck cares about caring for patients? Stroke survivors want results, 100% recovery. GET THERE!
https://www.columbiamissourian.com/news/local/boone-hospital-center-awarded-for-stroke-treatment/article_e4c1b1fe-5e9c-11e8-90fb-e7ba70aa6ea5.html
The American Heart Association and American Stroke Association have awarded Boone Hospital Center with their Get With The Guidelines-Stroke Gold Plus Quality Achievement Award. 
The award is the highest level offered by the associations, recognizing hospitals that meet performance standards for 24 months or more. Boone Hospital Center was specifically awarded for the diagnosis and treatment of stroke patients.
“This is another great achievement by Boone Hospital’s stroke team,” Donna Pond, Boone Hospital Center stroke program coordinator, said in a news release. “We have a great team, from our neurologists and neurosurgeons, to our endovascular team, our nurses and rehab staff and everyone else involved. We all take great pride in caring for our patients.”
The hospital also received the associations' Target: Stroke Honor Roll Elite Plus award, which recognizes a hospital's measures to reduce the time between a patient arriving at the hospital and receiving treatment for a stroke.
Boone Hospital Center was named the top mid-Missouri hospital by U.S. News & World Report in 2015, 2016, and 2017, according to the hospital.

Phase 1 Trial of Amnion Cell Therapy for Ischemic Stroke

You'll have to ask your doctor and stroke hospital to followup.  They have never done it in the past, so why would they start now?
https://www.frontiersin.org/articles/10.3389/fneur.2018.00198/full?
  • 1Clinical Trials, Imaging and Informatics (CTI) Division, Stroke & Ageing Research (STARC), Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia
  • 2The Ritchie Centre, Department of Obstetrics and Gynaecology, Hudson Institute of Medical Research, Monash Health and Monash University, Melbourne, VIC, Australia
  • 3Department of Physiology, Anatomy and Microbiology, School of Life Sciences, LaTrobe University, Melbourne, VIC, Australia
Background: There is increasing interest in stem cell therapy as another treatment modality in stroke, particularly for patients who are unable to receive endovascular clot retrieval or thrombolysis therapies, or for whom standard treatment has failed. We have recently shown that human amniotic epithelial cells (hAECs) are effective in reducing infarct volume in different animal models of ischemic stroke, including in non-human primates. hAEC therapy attenuated infarct growth and/or promoted functional recovery, even when administered 1–3 days after the onset of stroke.
Methods: We now propose an open label Phase 1 dose escalation trial to assess the safety of allogeneic hAECs in stroke patients with a view to providing an evidence platform for future Phase 2 efficacy trials. We propose a modified 3 + 3 dose escalation study design with additional components for measuring magnetic resonance signal of efficacy as well as the effect of hAECs on immunosuppression after stroke.
Result: The trial will commence in 2018. The findings will be published in a peer-reviewed journal.
Conclusion: The trial is registered with ANZCTR (ACTRN12618000076279p).

Introduction

Prior to 2015, the standard clinical approach for reducing disability and death in ischemic stroke was Stroke Unit admission, antiplatelet therapy, and treatment with recombinant tissue plasminogen activator (TPA), within 4.5 h from onset in selected patients (1). However, the rate of vessel re-opening when there is a large obstructive clot is low (12%), even with TPA (2). Since 2015, there has been considerable optimism about the place of endovascular clot retrieval (ECR), for large clot removal, as a new and transformative therapy (1). However, even with this extended time window (up to 24 h), the number of eligible patients for ECR is less than 15% (1, 3). Further, a substantial proportion of those patients in the trial who received these treatments was left with moderate to severe disability or died (72% of patients who received TPA and 48% of those who received TPA and ECR) (2). In short, there remain enormous challenges in achieving the effective management of stroke across all patients. There is thus an urgent need to explore alternative therapeutic strategies that may be both suitable for more stroke patients and be more effective in improving outcome after stroke.
One such strategy is to move from the current time-based approach to an imaging tissue-based approach where treatment is based on the presence of salvageable ischemic tissue (3, 4). However, reperfusion therapies shift the peri-infarct zone toward the ischemic core but do not address the local and systemic immune response cascades that separate from the ischemic insult itself, promoting further tissue damage surrounding the infarct (5). The body’s intended effect of post-stroke immunosuppression appears to be the dampening of the “autoaggressive” Th1 immune response within the brain (6), but the unintended consequence is an increased risk of infection such as pneumonia (7), and this phenomenon is associated with high mortality and poor functional outcomes. These infiltrating inflammatory cells are located in the peri-infarct area, which has been referred to as the “inflammatory penumbra,” which denotes an area susceptible to further injury from the inflammatory cascade (5). Recognition of the need to manage the inflammatory response as part of stroke therapy has led to a call for future therapies that also focus on mitigating injurious events in the peri-infarct zone and not just on reperfusion therapy (5). In this regard, stem cell therapy has emerged as one potentially attractive option because of its ability to modulate inflammatory pathways at multiple sites appropriate to the changing pathophysiological state over time (8). By contrast, an example of a unimodal neuroprotectant drug target that would be unsuitable for modulating the inflammatory cascade is matrix metalloproteinase (MMP-9). In the early phase of stroke, MMP-9 damages the blood–brain barrier (BBB) (9) and contributes to vasogenic edema, whereas in later stages, it contributes to remodeling around the peri-infarct areas, and consequently targeting MMP-9 at this time can be harmful (5).

Much more at link. 

Innovation in Systems of Care in Acute Phase of Ischemic Stroke. The Experience of the Catalan Stroke Programme

Well fuck, then write it up as a protocol and get it distributed and implemented around the world. Oh wait, that should be the responsibility of our fucking failures of stroke associations. Oh well, a few more people die from stroke with no protocols, they would have died eventually anyway.
https://www.frontiersin.org/articles/10.3389/fneur.2018.00427/full?
Rosa M. Vivanco-Hidalgo1*, Sònia Abilleira2, Mercè Salvat-Plana3, Aida Ribera4, Guillem Gallofré3 and Miquel Gallofré3
  • 1Stroke Programme, Catalan Stroke Foundation, Barcelona, Spain
  • 2Stroke Programme, Agency for Health Quality and Assessment of Catalonia, CIBER Epidemiología y Salud Pública, Barcelona, Spain
  • 3Stroke Programme, Barcelona, Spain
  • 4Cardiovascular Epidemiology Unit, Cardiology Department, Hospital Vall d'Hebron, Barcelona, Spain
Stroke, and mainly ischemic stroke, is the second cause of death and disability. To confront the huge burden of this disease, innovative stroke systems of care are mandatory. This requires the development of national stroke plans to offer the best treatment to all patients eligible for reperfusion therapies. Key elements for success include a high level of organization, close cooperation with emergency medical services for prehospital assessment, an understanding of stroke singularity, the development of preassessment tools, a high level of commitment of all stroke teams at Stroke Centres, the availability of a disease-specific registry, and local government involvement to establish stroke care as a priority. In this mini review, we discuss recent evidence concerning different aspects of stroke systems of care and describe the success of the Catalan Stroke Programme as an example of innovation. In Catalonia, reperfusion treatment rates have increased in recent years and currently are among the highest in Europe (17.3% overall, 14.3% for IVT, and 6% for EVT in 2016).

Introduction

Stroke—mainly ischemic stroke—is the second cause of death and disability worldwide (1). The stroke burden has increased across the globe in both men and women of all ages throughout the past two decades (2). However, population awareness of early symptoms, the accuracy of current brain imaging tests, and the development of acute therapies are contributing to reduce this trend (3). However, success will depend mainly on the structure of the healthcare system and it is uncertain whether systems in different countries are prepared to deal with this huge burden. Therefore, innovation in stroke systems of care is mandatory to transform them and prepare them to confront this health challenge.

Innovating in Systems of Acute Stroke Care. Organization and Cooperation to Deliver More Treatment, More Rapidly

The natural history of ischaemic stroke has changed dramatically since the 1990s. The beginning of the Intravenous Thrombolysis (IVT) Era in the late 90s (4) and recent approval of endovascular therapy (EVT) (5), the demonstration of improved stroke outcomes with stroke unit care, and the benefits of implementing organized stroke systems of care have all contributed to reduce mortality and disability in patients with acute ischaemic stroke (AIS) (3, 6).
The proportion of patients treated has increased in recent years in high-income countries, mainly in comprehensive stroke centers (CSCs), where EVT is provided (7). The effectiveness of reperfusion therapies is highly time-dependent: The sooner the patient arrives to the hospital after symptoms onset, the better. Once in hospital, highly organized workflows are of utmost importance to achieve door-to-needle times in IVT and door-to-groin-puncture times in EVT. A set of effective strategies has been successfully implemented in hospitals to reduce these critical time delays, especially pre-notification of arrival by Emergency Medical Services (EMS), direct transfer to the radiology service for brain CT scan or direct alteplase administration in the scanner (8, 9).
The eligibility of patients with AIS for reperfusion therapies is evolving as new evidence is published. Partially dependent patients, otherwise excluded from IVT trials, might benefit from thrombolysis (10) and certain patients with unknown time of stroke onset, precluded from seminal EVT trials, have shown improved outcomes after EVT (11, 12). Therefore, the overall proportion of AIS patients who might benefit from reperfusion therapies is rising and changing inclusion criteria generate uncertainty about how many more are potentially eligible.
The capacity to increase the proportion of patients treated is related to the structure of the system of care. Current evidence shows that patients who require interhospital transfer for EVT achieve reperfusion between 109 and 120 min later than those directly transported to CSCs, and have a lower absolute probability of independent outcome (1315). These data should prompt a rethinking of systems of stroke care at national and regional levels in order to improve the “hub-and-spoke” transfer networks. This form of medical transport optimization organizes traffic routes as a series of 'spokes' that connect outlying points to a central 'hub.' In acute care for stroke, the Hubs are CSCs with great expertise that concentrate a huge volume of procedures and are connected with centers having a lower level of expertise and smaller volume of procedures.

Understanding the Singularity of Stroke to Improve Care

Management of AIS has taken lessons from acute myocardial infarction management; however, unlike heart attack, in most cases acute stroke leaves patients unable to speak and to alert EMS by themselves. Population campaigns are crucial to raise awareness about stroke symptoms and how to detect them. In addition, EMS technicians must be specifically trained to detect stroke, activate the stroke code and pre-notify arrival to the nearest hospital with proper treatment capabilities.
The possibility of diagnostic testing in the ambulance to inform hospital treatment is another huge difference between heart attack and stroke. The recent development of CT-equipped mobile stroke units is considered an important advancement. This approach is safe and feasible, has increased IVT rates, and achieved significantly shorter time-to-treatment compared to conventional care in the areas tested, mainly in Germany (16). However, a recent study found no significant difference between the proportion of patients with a modified Rankin Scale score of 1 or less who received this type of care compared with conventional care (17). Therefore, due to its high cost without clear long-term benefit, we can conclude that an efficient technology for prehospital diagnosis of stroke that can be easily implemented is lacking.

Organizing to Achieve Better Results. Organization and Cooperation at Different Levels of Care

Once the stroke code is activated, where do we transfer the patient? Given the beneficial results of bridging therapy (IVT plus EVT) in patients with large vessel occlusion (LVO) (5), it seems clear that the demand for neurointervention in coming years will grow in line with increasing numbers of EVT-capable centers. Nonetheless, it is difficult to justify the establishment of EVT-capable centers in remote areas with low population density.
Therefore, a crucial question is how to define the best transfer network for AIS patients located in remote and distant areas. The drip-and-ship model, which takes the patient to the nearest stroke center, prioritizes the initial diagnostic workup and IVT. In this model, the identification of an LVO patient is followed by interhospital transfer to a CSC. Another model is direct transfer to a CSC, thus bypassing the Primary Stroke Centre (PSC), known as the mothership model. A recent study in Canada used conditional probability modeling to find an answer, testing different transportation options to identify the better modeled outcome in specific regions. The authors concluded that a drip-and-ship model is appropriate if the treatment in a PSC is delivered in less than 30 min and the patient is then transferred to a capable CSC (18). In Catalonia, the ongoing RACECAT trial (Direct Transfer to an Endovascular Centre Compared to Transfer to the Closest Stroke Centre in Acute Stroke Patients with Suspected Large Vessel Occlusion; NCT02795962) is expected to provide answers to important questions of logistics and increase the efficient delivery of treatments and the number of acute stroke patients that have access to them.
There is still room for network innovation. In remote areas with no access to stroke experts, a possible and feasible solution is TeleStroke Centres (TSC). Using videoconferencing and image-sharing technology, stroke specialists from a CSC can examine patients at remote hospitals to help with diagnosis and recommend a plan of care.
Results from a third model, called trip-and-treat, have been recently published. This urban interhospital service delivery model consists of a shared mobile interventional stroke team that travels to PSCs in New York City to provide on-site interventional capability. The authors concluded that, in their area of reference, the trip-and-treat model had shorter time-to-treatment for EVT, compared with drip-and-ship, offering a valid alternative to current interhospital stroke transfers in urban environments (19).

Prehospital Assessment

Theoretically, the benefits of a primary transfer to a CSC would only apply to patients with LVO and may unnecessarily delay treatment in all others. Therefore, the predictive power of initial screening tools to identify patients with suspected LVO becomes of paramount importance. Various scoring systems have been developed to detect potential candidates to EVT. These scales must meet key criteria: rapid and simple to use, applicable to an unselected population with a suspected stroke, high interrater reliability, and high accuracy to avoid underdiagnosis (low false-negative rate; i.e., 1-sensitivity) and overdiagnosis that could overload the CSC (low false positive rate, i.e., 1-specificity). Finally, the scale must be validated and proven to improve patient outcomes (20). A recent observational study compared 13 validated prehospital scales and concluded that published cutoff scores to predict LVO in clinical settings were associated with high accuracy but also yielded a high false-negative rate (21).
Among them, one that showed high accuracy and a comparatively lower false-negative rate was the RACE scale. This scale is a simplification of the NIHSS scale, using only those items with a higher ability to predict the presence of LVO. The RACE scale evaluates 5 items: facial palsy, brachial paresis, crural paresis, oculocephalic deviation and aphasia/agnosia. Scores range from 0 to 9. A score > 4 allows the suspicion of a LVO with a sensitivity of 85% and specificity of 69% (22). The RACE scale was designed and validated in Catalonia with a prospective study that included 357 patients in 2011–2013. Therefore, in optimizing stroke systems of care, the prehospital assessment is a key factor to take into account.

The Stroke Code System of Catalonia as an Example

Catalonia has a population of 7.5 M and an organized and highly territorialized stroke system of care administered by the Stroke Programme, an organization created in 2004 by the Catalan Health Department. In 2006, the Stroke Programme implemented the Stroke Code System in 2006 to cover all the territory (23) (Figure 1). Current criteria for Stroke Code activation are clinical suspicion of acute stroke, less than 8 h from symptom onset (or unknown), and previous functional independence (Rankin 0–2) with no age limit (24, 25). Upon Stroke Code activation, the EMS coordinates patient transport to the nearest Stroke Centre (SC) according to predefined pathways. After initial recognition of stroke symptoms, the destination SC is pre-alerted by the EMS. The Stroke Code can be activated directly from EMS upon identification of a stroke patient in the field (60% of all Stroke Code activations) or at the Emergency Department of any hospital when patients arrive at the hospital by their own means. In recent years, our network of acute hospitals that are active in the stroke code system has grown to include 26 centers: (1) Twelve TSCs with capacity to deliver IVT via tele-consultation with a vascular neurologist who covers all tele-consultations from the 7 TSCs in the outer metropolitan area of Barcelona; the remaining 5 TSCs are located in the Catalan provinces and are usually covered by the neurologist on call at the nearest provincial PSC, with the central on-call service acting as a backup. (2) Eight PSCs with capacity to deliver IVT and admit patients to a certified Stroke Unit. (3) Six EVT-capable centers or CSCs, all of them located in the inner metropolitan area of Barcelona.

What's Next In Patient Engagement?

This just proves once again what Amy Farber has to say.
For the past five years Farber has been battling not only her own disease but also the wall of resistance erected by those who believe that a patient can make about as much of a meaningful contribution to the process of scientific discovery as a laboratory rat.
But rats are pretty smart compared to our stroke medical 'professionals'.   If stroke patients were engaged in a stroke strategy we would be a lot farther in solving all the problems in stroke.  We wouldn't be chickenshits but would tackle stroke BHAGs(Big Hairy Audacious Goals) of 100% recovery for all survivors!
https://www.clinicalleader.com/doc/what-s-next-in-patient-engagement-0001
By Barbara Lopez Kunz, global chief executive, DIA
What’s Next
Patients have an irrefutable role in shaping the care they need. We have come a long way since the days when the idea of involving patients in healthcare product development was controversial, if not unheard of. In recent years, the healthcare ecosystem, and the role patients play in it, has evolved in a promising direction, leading to a much deeper understanding of the impact the patient voice can and should have in healthcare.
Across the entire ecosystem, from industry and academia to regulators and health technology assessments (HTAs), the goal to include patients is now on everyone’s agenda. And patient partnerships have flourished as a direct result of the confidence and sense of autonomy patients have gained. Patients, who are experiencing the illness first-hand, have become an invaluable resource, capable of clarifying their priorities and needs long before we embark on discovery and R&D. But how can we derive the most value from this development?
Current Efforts
Numerous initiatives by DIA, the Clinical Trial Transformation Initiative (CTTI), and many other organizations, such as Faster Cures, the European Patients Forum (EPF), and the Patient Centered Outcomes Research Institute (PCORI), to name just a few, are providing us with important insights into patient engagement. They are giving us a sense of the type of metrics, operating models, as well as skills and experiences that are best suited to be effective. For example:
  • Over the years, DIA has led and supported several initiatives to provide frameworks for impactful and ethical patient engagement, including CTTI, EUPATI, a PCORI-sponsored patient-engagement workshop, and most recently, the DIA-Tufts Center for the Study of Drug Development (CSDD) patient-engagement research project.
  • PARADIGM (Patients Active in Research and Dialogues for an Improved Generation of Medicines), a public-private partnership co-led by the EPF and the European Federation of Pharmaceutical Industries and Associations (EFPIA), is developing processes and tools for three key decision-making points: research priority setting, design of clinical trials, and early dialogue.
  • CTTI has put forward recommendations and best practices to support effective patient engagement throughout all stages of the healthcare product development process.
  • Faster Cures launched its Patients Count program that gives more extensive opportunities for the perspective of patients to shape how new therapies are discovered, developed, and delivered.
  • PCORI’s activities center on building a patient-centered outcomes research community (PCOR), engaging the PCOR community in research, and disseminating PCOR research findings.
In all of these instances we have successfully come together and found common ground. But this is no time to rest on our laurels. We can and must learn from these experiences to tackle areas where we’ve only made modest, if any, progress in providing patients with the active role they deserve.
Patient-Centered Benefit-Risk Assessment
Despite the overall positive development over the past many years and the great advancements we’ve made in patient engagement since the early days, there is still plenty of room for improvement. One area where opinions and interests are still diverging and where we need to come together to focus our efforts is patient-centric benefit-risk assessment.
In benefit-risk assessment, benefits are weighed against the risk of harm when using a specific product as treatment. The benefits, risks, and uncertainties must be appropriately balanced from the patient’s point of view to truly meet the needs of those the product is intended for. But patients may weigh these treatment attributes quite differently compared to physicians, regulators, or sponsors. They may even differ as a group when trading off benefits and risks, or when using the same treatment for different conditions. And, when faced with a life-threatening illness, the patient may be willing to tolerate severe risk and uncertainty for the possibility of a life-saving benefit. In fact, the U.S.-wide Right-to-Try Act (signed into law on May 30, 2018) provides terminally ill patients access to experimental therapies that have passed basic safety testing in Phase 1 trials but are not yet fully approved.
Because patients benefit from effective treatments while also bearing the potential risks, their perspectives and judgements must be at the heart of benefit-risk assessment.
Finding Common Ground: Mission Impossible?
Although industry, regulators, and patient groups are increasingly seeing the value of assessing and incorporating patient preferences in benefit-risk assessment and are exploring ways to do so, there is still no clear consensus on the nature and extent of patient involvement:
  • Regulators: Benefit-risk assessment is a keystone in the U.S. FDA’s regulatory review. But the European Medicines Agency (EMA) also acted to better incorporate patients’ values and preferences in regulatory decision making by revising its framework for interacting with patients and consumers. While being receptive to reviewing and using patient preference data, regulators are inherently cautious, though. In their view, the wide adoption of patient-centered value measures will hinge on scientifically validated methods that can reliably quantify patient preferences. Furthermore (and in contrast to clinical trials), any regulatory decision must consider the benefits and risks of a treatment at the population level rather than at the level of a specific group or individual. For example, a common concern is how well patient preference measures capture the diversity of the population at risk.
  • Patients: Some patients feel that they have no active role in the healthcare product development process. They may also be unaware of the impact they could have, or they may lack the motivation, skill, and confidence to contribute to the process. Once involved, a patient’s evaluation of the benefit and risk of a treatment will be very much influenced by their goals for health improvement and how they perceive the treatment affects their quality of life. This assessment, on the other hand, may depend on a variety of individually different factors, including what is and is not considered a tolerable side effect and risk or a sufficient health improvement, the level of uncertainty about benefits and/or risks, the severity and stage of the disease, and the available emotional and physical support to manage the disease and treatment.
    • Medical Product Sponsors: The goal of sponsors, and the pharmaceutical industry in particular, is to get safe and effective products out to patients quickly and to continuously evaluate the experience of their use in the real world. In industry, the approach to patient engagement is quite fragmented, and some still count patient engagement in the nonessential activities in medical product development. The perceived time and effort of patient involvement is one potential barrier, as is the scarcity of validated methods, the current lack of guidance from regulatory authorities, and the uncertainty whether patient data will be accepted for regulatory decision making. The incentive to involve patients in pre-market benefit-risk assessment may therefore vary widely and be very low among some.
Current Patient Roles In Benefit-Risk Assessment
Despite the issues, patient-centered benefit-risk assessment is emerging as the next key aspiration. Stakeholders are realizing that patient perspectives can indeed make us less uncertain about decisions made during product development, regulatory review, and post-market surveillance.
Various organizations have come together to drive research and policy activities that can provide tangible guidance on how to approach patient-centricity in benefit-risk assessment and to systematically incorporate data on patient perspectives into product approval applications. For example:
  • With its Benefit-Risk Bootcamp, Faster Cures tackled the science of eliciting patient preferences, providing a common understanding of methods used to assess patient preferences for benefit expectations and risk tolerance.
  • DIA and PCORI addressed the challenge of how and when to best engage patient partners and published their results in Therapeutic Innovation & Regulatory Science. The goal was to raise awareness among all stakeholders of the importance of patients’ perspectives in benefit-risk assessment, to share existing approaches, identify challenges, and recommend next steps for bridging gaps.
  • With its Patient-Centered Benefit-Risk Project, the Medical Device Innovation Consortium (MDIC) and its partners provided a framework for incorporating information on patient preferences into benefit-risk assessments, a catalog of methods that can be used to assess patient preferences, and an agenda for further research.
  • The goal of the Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (or IMI PREFER) project has been to assess when and how patient preferences on benefits and risks should be incorporated into decisions on medicinal products.
  • The FDA launched initiatives at CDER and CDRH to incorporate patient perspectives in decision making and to communicate assessments of benefits and risks consistently across divisions in each center. The FDA has also made several commitments in PDUFA VI for continued implementation of structured benefit-risk assessment during FY 2018–2022 (see “Benefit-Risk Assessment in Drug Regulatory Decision-Making”).
Becoming Partners
For patients to be truly integrated into the healthcare product development process and life cycle management, it will require consensus and conscious commitment from all stakeholders to work together to develop shared solutions and map a common path forward. It’s imperative to advance the dialogue, particularly among those who might address the issue from different perspectives. Only then are we able to overcome current barriers.
Some first initiatives have shown that this is possible, despite the cultural changes that need to take place among patients, sponsors, and regulators alike. At DIA we realize that, because each approach will be unique, we need to share our knowledge and experiences to make consistent progress in understanding how patients, regulators, and research sponsors can best work together to improve the medical development process — a topic that will be explored extensively at the upcoming DIA Global Annual Meeting in Boston in June.
We are committed to working with all stakeholders to find scientifically valid metrics to reliably assess patient preferences, establish frameworks for incorporating that information into product development, and examine how patient experience data can be incorporated into structured benefit-risk assessment frameworks in regulatory decision-making.
It won’t be easy, but with the right amount of commitment and passion, I’m confident we will make great strides toward benefit-risk assessment in healthcare product development that is truly patient-centric.
About The Author:
Barbara Lopez Kunz, M.S., is global chief executive of DIA. She is leading the transformation of DIA through developing and implementing a strategy that focuses on engaging the global healthcare community in DIA’s neutral platform, to drive thought leadership and innovation in the development of therapeutics to improve the health of people worldwide.



Movement Sonification in Stroke Rehabilitation

Sonification has been written about for 5 years. It is about time for our fucking failures of stroke associations to step up to the plate and write a stroke protocol on this. I can guarantee this won't occur.
https://www.frontiersin.org/articles/10.3389/fneur.2018.00389/full?
  • 1Institute of Sports Science, Leibniz University Hannover, Hannover, Germany
  • 2Schön Klinik Bad Aibling, Bad Aibling, Germany
  • 3German Center for Vertigo and Balance Disorders, Ludwig-Maximilians University of Munich, Munich, Germany
  • 4Department of Sport and Health Sciences, Technical University Munich, Human Movement Science, Munich, Germany
  • 5Institute of Microelectronic Systems, Leibniz University Hannover, Hannover, Germany
Stroke often affects arm functions and thus impairs patients' daily activities. Recently, several studies have shown that additional movement acoustics can enhance motor perception and motor control(But with no protocols written and distributed they were useless, just like this one will be useless). Therefore, a new method has been developed that allows providing auditory feedback about arm movement trajectories in real-time for motor rehabilitation after stroke. The present article describes the study protocol for a randomized, controlled, examiner, and patient blinded superiority trial (German Clinical Trials Register, www.drks.de, DRKS00011419), in which the method will be applied to 13 subacute stroke patients with hemiparesis during 12 sessions of 30 min each as additional feedback during the regular movement therapy. As primary outcome, a significant pre-post-change in the Box and Block Test is expected that exceeds the performance increase of 13 patients who will be provided with sham-acoustics. Possible limitations of the method as well as the study design are discussed.

Introduction

Background

Stroke is the second most common cause of death among the neurological disorders. The great majority of patients who survive a stroke have to rely on health care support afterwards (1). Sensory and motor impairments can lead to dramatic limitations of everyday motor skills and temporary or permanent disability. Most often arm functions are impaired and hamper patients during activities of daily living (2). Hemiparesis, for example, affects spatial and temporal arm motor control and results in disturbed movement trajectories, lower movement amplitudes and enhanced movement times (3). Therefore, one important goal of motor rehabilitation is the improvement of arm functions. Some therapies like the Arm Ability Training (4) or the Constraint Induced Movement Therapy (5) predominantly focus on the improvement of the motor components of the arm movement system. However, Bastian points out that efficacy of stroke rehabilitation might be improved by methods that combine perceptual- and motor oriented approaches (6). A recent study with healthy participants showed a higher efficacy of a sensorimotor compared to a purely motor orientated approach, accordingly, although both approaches address the same adaptation mechanisms (7). An example for a perception-oriented approach for stroke rehabilitation is Ramachandran's mirror visual feedback method. It seems to reestablish congruency between motor commands and visual feedback in patients that watch a mirror image of the unimpaired arm during bilateral movements. Some of these patients report not only to see the impaired arm, but also to feel it moving. A probable explanation is that mirror visual feedback revives temporarily inactive motor neurons and/or ipsilateral corticospinal pathways (8).
As alternative to vision-oriented approaches, a specific feature of recently developed methods is the implementation of auditory signals and sounds to generate additional perceptual information about movement quantities and qualities (9, 10). In particular, music has been shown to be an efficient add-on in stroke therapy: Schneider et al. (11) showed that a music based arm therapy can outperform highly established approaches like the constraint induced movement therapy. Chen et al. (12) reported from a proof of concept case study on five stroke patients that rhythmic auditory cueing enhanced movement speed. Furthermore, two-state continuous musical feedback increased elbow extension as well as shoulder flexion and reduced compensatory trunk movements. Growing evidence suggests that music-supported therapy is superior to conventional physiotherapy without music, probably because it acts on multiple levels and addresses motor, cognitive, and emotional mechanisms (13).
Furthermore, some studies indicate beneficial effects of continuous auditory feedback for movement rehabilitation after stroke. For example, Maulucci and Eckhouse (14) reported that stroke patients relearned functional movement paths faster when they were provided with auditory feedback about spatial deviations from reach paths performed by healthy persons. Secoli et al. (15) found that auditory feedback improved performance in a movement tracking task performed during robot-assisted arm training in patients with chronic left hemiparesis. However, other results were equivocal: According to Robertson et al. (16), feedback about hand orientation during reaching seems to be beneficial for patients with right hemisphere lesions, but detrimental for patients with left hemisphere lesions. Based on a systematic literature review, Molier and colleagues see a possible benefit of performance feedback and augmented auditory feedback, although the determinants for their efficacy remain largely unknown (17).
Since stroke often impairs somatosensation (18, 19), recovery of arm functions might benefit from methods that support proprioception, particularly. Hereto, Sihvonen et al. (13) argue that music-supported therapy might be effective, again, because patients generate an internal expectation about when the next note is going to be heard and thereby improve their movement timing. However, by considering proprioception as integrated percept of multiple sensory streams from multiple receptors which is experienced as motion and position sense, further methods might address specific proprioceptive mechanisms and thereby support the relearning of functional movement patterns after stroke. The method of movement sonification might have this potential. Movement sonification represents a concept for mapping movement parameters to sound in order to create novel perceptual streams congruent to the time course of kinematic or dynamic movement parameters (20). This method differs conceptually from providing feedback on performance errors, because it allows to design artificial perceptual streams structurally equivalent to perceptual streams from other modalities. It has been shown that the amendment of visual motion information by movement acoustics amplifies the activity of multimodal integration areas in the brains of observers and furthermore, activates the basal-ganglia-fronto-cortical motor loop (21, 22). Accordingly, movement sonification has been shown to support learning (23, 24) and adaptation (25) of fine motor skills, (re)learning of arm joint coordination patterns (26) and acquisition of gross motor skills (27, 28) in healthy persons. In deafferented patients, it can substitute proprioception (29). Studies on immediate effects of movement sonification on movement pattern recognition, movement synchronization and own-other discrimination (3033) indicate that movement sonification unfolds its potentials on perception and action by linking to internal movement representations.
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