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[ARTICLE] Cell-Based Therapies for Stroke: Are We There Yet? – Full Text

Stroke is the second leading cause of death and physical disability, with a global lifetime incidence rate of 1 in 6. Currently, the only FDA approved treatment for ischemic stroke is the administration of tissue plasminogen activator (tPA). Stem cell clinical trials for stroke have been underway for close to two decades, with data suggesting that cell therapies are safe, feasible, and potentially efficacious. However, clinical trials for stroke account for <1% of all stem cell trials. Nevertheless, the resources devoted to clinical research to identify new treatments for stroke is still significant (53–64 million US$, Phase 1–4). Notably, a quarter of cell therapy clinical trials for stroke have been withdrawn (15.2%) or terminated (6.8%) to date. This review discusses the bottlenecks in delivering a successful cell therapy for stroke, and the cost-to-benefit ratio necessary to justify these expensive trials. Further, this review will critically assess the currently available data from completed stroke trials, the importance of standardization in outcome reporting, and the role of industry-led research in the development of cell therapies for stroke.

Introduction

Background

Stroke has a devastating effect on the society worldwide. In addition to its significant mortality rate of 50% as reported in 5-year survival studies (1), it affects as many as 1 in 6 people in their lifetimes, and is the leading cause of disability worldwide (2). A stroke results in a complex interplay of inflammation and repair with effects on neural, vascular, and connective tissue in and around the affected areas of the brain (3). Therefore, sequelae of stroke such as paralysis, chronic pain, and seizures can persist long term and prevent the patient from fully reintegrating into society. Stroke therefore remains the costliest healthcare burden as a whole (4). In 2012, the total cost of stroke in Australia was estimated to be about $5 billion with direct health care costs attributing to $881 million of the total (5).

Unfortunately, treatment options for stroke are still greatly limited. Intravenous recombinant tissue plasminogen activator (tPA) and endovascular thrombectomy (EVT) are currently the only effective treatments available for acute stroke. However, there is only a brief window of opportunity where they can be successfully applied. EVT is performed until up to 24 h of stroke onset (6), while tPA is applied within 4.5 h of stroke onset. Notably, the recent WAKE-UP (NCT01525290) (7) and EXTEND (NCT01580839) trials have shown that this therapeutic window can be safely extended to 9 h from stroke onset. Furthermore, advancements in acute stroke care and neurorehabilitation have shown to be effective in improving neurological function (8). However, there are no treatments that offer restoration of function and as a result, many patients are left with residual deficits following a stroke. Cell-based therapies have shown promising results in animal models addressing the recovery phase following stroke (9). This is encouraging as currently, there are no approved treatment options addressing the reversal of neurological damages once a stroke has occurred (10).

The majority of data from animal studies and clinical trials demonstrate the therapeutic potential of stem cells in the restoration of central nervous system (CNS) function (1112), applicable to neurodegenerative diseases as well as traumatic brain injury. Transplanted stem cells were reportedly able to differentiate into neurons and glial cells, whilst supporting neural reconstruction and angiogenesis in the ischemic region of the brain (13). Previous work demonstrated the ability of mesenchymal stem cells (MSCs) to differentiate into neurons, astrocytes (14), endothelial cells (1516), and oligodendrocyte lineage cells (17) such as NG2-positive cells (18in vitro, and undergo neuronal or glial differentiation in vivo (19). Bone marrow-derived mesenchymal stem cells (BMSCs) have shown potential to differentiate into endothelial cells in vitro (20). Additionally, both BMSCs and adipose stem cells (ASCs) have been shown to demonstrate neural lineage differentiation potential in vitro (2123). Furthermore, stem cells are able to modulate multiple cell signaling pathways involved in endogenous neurogenesis, angiogenesis, immune modulation and neural plasticity, sometimes in addition to cell replacement (3). The delivery of stem cells from the brain, bone marrow, umbilical cord, and adipose tissue, have been reported to reduce infarct size and improve functional outcomes regardless of tissue source (9). While these were initially exciting reports, they raise the question as to the validity of the findings to date since these preclinical reports are almost uniformly positive. The absence of scientific skepticism and robust debate may in fact have negated progress in this field.

Cell-based therapies have been investigated as a clinical option since the 1990s. The first pilot stroke studies in 2005 investigated the safety of intracranial delivery of stem cells (including porcine neural stem cells) to patients with chronic basal ganglia infarcts or subcortical motor strokes (2425). However, since the publication of these reports, hundreds of preclinical studies have shown that a variety of cell types including those derived from non-neural tissues can enhance structural and functional recovery in stroke. Cell therapy trials, mainly targeted at small cohorts of patients with chronic stroke, completed in the 2000s, showed satisfactory safety profiles and suggestions of efficacy (10). Current treatments such as tPA and EVT only have a narrow therapeutic window, limited efficacy in severe stroke and may be accompanied by severe side effects. Specifically, the side effects of EVT include intracranial hemorrhage, vessel dissection, emboli to new vascular territories, and vasospasm (26). The benefit of tPA for patients with a severe stroke with a large artery occlusion can vary significantly (27). This is mainly due to the failure (<30%) of early recanalisation of the occlusion. Thus, despite the treatment options stroke is still a major cause of mortality and morbidity, and there is need for new and improved therapies.

Stem cells have been postulated to significantly extend the period of intervention and target subacute as well as the chronic phase of stroke. Numerous neurological disorders such as Parkinson’s disease (1228), Alzheimer’s disease (29), age-related macular degeneration (30), traumatic brain injury (31), and malignant gliomas (32) have been investigated for the applicability of stem cell therapy. These studies have partly influenced the investigation of stem cell therapies for stroke. A small fraction of stem cell research has been successfully translated to clinical trials. As detailed in Table 1, most currently active trials use neuronal stem cells (NSCs), MSCs or BMSCs (3537), including conditionally immortalized neural stem-cell line (CTX-DP) CTX0E03 (38), neural stem/progenitor cells (NSCs/NPSCs) (e.g., NCT03296618), umbilical cord blood (CoBis2, NCT03004976), adipose (NCT02813512), or amnion epithelial cells (hAECs, ACTRN 1261800076279) (39).

Table 1. Challenges and bottlenecks of stem cell therapy and clinical trials using stem cells (3334).

[…]

 

Continue —>  Frontiers | Cell-Based Therapies for Stroke: Are We There Yet? | Neurology

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[WEB SITE] Telerehab Program Works as Well as Clinic-Based Program for Improved Arm Function Poststroke – JAMA Neurology

It’s probably not news to physical therapists (PTs) when research backs up the idea that patients who experience arm impairments poststroke will tend to make greater functional improvements with larger and longer doses of rehabilitation. Unfortunately, PTs are also familiar with the fact that what’s optimal isn’t necessarily what’s typical, with challenges such as payment systems, logistics, and clinic access making it difficult to achieve the best possible results. That’s where telerehabilitation could make a big difference, say authors of a new study that found an entirely remotely delivered rehab program to be as effective as an equal amount of clinic-based sessions.

The findings lend further support to the ideas behind APTA’s efforts to increase telehealth opportunities for PTs and their patients—a significant component of the association’s current public policy priorities. In addition, APTA provides multiple telehealth resources on a webpage devoted to the topic, and has created the Frontiers in Research, Science, and Technology Council that provides interested members and other stakeholders with an online community to discuss technology’s role in physical therapy.

The study, published in JAMA Neurology (abstract only available for free), involved 124 participants who experienced arm motor deficits poststroke. All participants were enrolled in a rehabilitation therapy program that included 36 70-minute treatment sessions, half of which were supervised, over a 6- to 8-week period. The only major difference: one group’s supervised sessions were face-to-face with a physical therapist (PT) or occupational therapist (OT), while the other group received telerehab from a PT or OT via a computer with video capabilities, accompanied by the use of a gaming system.

Researchers were interested in finding out how patients fared in each approach, using scores from the Fugl Meyer (FM) assessment of motor recovery poststroke as their primary measure. Authors of the study also measured patient adherence with therapy as well as levels of patient motivation related to how well they liked the therapy they were receiving and their degree of dedication to treatment goals.

Using a treatment approach “based on an upper-extremity task-specific training manual and Accelerated Skill Acquisition Program,” researchers set up matched programs that included at least 15 minutes per session of arm exercises from a common set of 88 possible exercises, at least 15 minutes of functional training, and 5 minutes of stroke education. The clinic-based participants received in-person instruction on the exercises and used “standard exercise hardware”; the telerehab patients received instructions via video link and engaged in functional exercise via a videogame interface. Here’s what the researchers found:

  • Both groups improved at about the same rate, with the telerehab participants averaging a 7.86 FM gain, compared with an average gain of 8.36 points for the clinic-based group.
  • Improvements were also about the same for the subgroup of participants who entered rehabilitation more than 90 days poststroke, with these “late” participants averaging a 6.6-point gain for the telerehab group and a 7.4-point increase for the clinic-based group.
  • While both groups reported high levels of dedication to treatment goals, the clinic-based group tended to report better levels of motivation and satisfaction. Adherence was also high for both groups, with a 93.4% adherence rate for the clinic-based group and a rate of 98.3% for the telerehab group.
  • Both groups increased their knowledge of stroke at similar rates.

As for the technical details of the telerehab sessions, the system included a computer linked to the internet, a table, a chair, and 12 “gaming input devices.” Keyboards were not necessary. The supervised sessions began with a 30-minute videoconference between the patient and therapist, and the functional training games used were designed to match the functional task work being done with the clinic-based participants. Unsupervised sessions adhered to the same content but didn’t include contact with the therapist.

“In an era when prescribed doses of poststroke rehabilitation therapy are declining, adversely affecting patient outcomes, these and prior findings suggest that outcomes could be improved for many patients…if larger doses of rehabilitation therapy were prescribed,” authors write. “Our study found that a 6-week course of daily home-based [telerehab] is safe, is rated favorably by patients, is associated with excellent treatment adherence, and produces substantial gains in arm function that were not inferior to dose-matched interventions delivered in the clinic.”

Authors acknowledged that patient satisfaction with telerehab might be improved by increasing the amount of time spent with the therapist—providing that therapist is properly trained. “Current results underscore the importance of maintaining a licensed therapist’s involvement during [telerehab],” they write.

Ultimately, it’s still too early to determine just how generalizable the findings are to other populations and conditions, the researchers say, but all indicators seem to point to the need for increasing the availability of telerehab and its inclusion in health plans.

“The US Bipartisan Budget Act of 2018 expanded telehealth benefits,” authors write. “Eventually, home-based [telerehab] may plan an ascendant role for improving patient outcomes.”

Research-related stories featured in PT in Motion News are intended to highlight a topic of interest only and do not constitute an endorsement by APTA. For synthesized research and evidence-based practice information, visit the association’s PTNow website.

via JAMA Neurology: Telerehab Program Works as Well as Clinic-Based Program for Improved Arm Function Poststroke

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[WEB SITE] Amitriptyline: Uses, side effects, warnings, and interactions

Amitriptyline is an antidepressant drug that doctors prescribe to treat depression. It also has off-label uses for other mental and physical health conditions.

Amitriptyline is a drug in the tricyclic antidepressant (TCA) family.

TCAs were introduced in the late 1950s as a treatment for depression. Since then, other less toxic drugs have become available. Among them are selective serotonin reuptake inhibitors, better known as SSRIs.

Doctors prescribe amitriptyline to people with depression who have not responded to other antidepressants. There are additional uses for amitriptyline that the Food and Drug Administration (FDA) have not approved.

Read on to learn more about the uses, side effects, warnings, and potential interactions of amitriptyline.

What is amitriptyline?

amitriptyline

Amitriptyline is a prescription antidepressant drug.

The structure of amitriptyline allows it to attach to receptors in the brain called alpha-adrenergic, histaminic, and muscarinic receptors. This means that amitriptyline can cause more side effects than some other TCAs.

Some examples of other drugs in the TCA class include:

  • clomipramine
  • desipramine
  • doxepin
  • imipramine
  • nortriptyline
  • protriptyline
  • trimipramine

There are six dosages of amitriptyline: 10 milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.

Amitriptyline was once manufactured under the brand Elavil, but only generic forms of the drug are currently available.

Uses

Doctors prescribe amitriptyline to treat depression in adults.

They may also use the drug in ways that the FDA has not approved, known as off-label uses. For example, a doctor may recommend amitriptyline as an off-label treatment for:

amitriptyline headache

Taking amitriptyline can cause dizziness and drowsiness.

Amitriptyline may also cause blurred vision, urinary retention, a rapid heartbeat, and acute-angle glaucoma when it binds to muscarinic receptors in the body.

When amitriptyline attaches to histaminic receptors, it may cause sedation, confusion, and delirium.

People who have seizures should use amitriptyline with caution because it can lower the seizure threshold.

Serious cardiac side effects can occur when amitriptyline binds to alpha-adrenergic receptors in the heart. Low blood pressure upon standing and heart rate fluctuations and irregularities are some of these effects.

How to take and dosage

When treating depression with amitriptyline, doctors usually prescribe a starting dosage of 25 mg per day — at bedtime because it can cause drowsiness. For off-label uses, doctors may prescribe dosages of 10–20 mg per day.

Depending on a person’s response to the medication, the doctor may increase the dosage by 25 mg every 3–7 days. The effective dosage of amitriptyline is one that controls symptoms without causing too many side effects.

The maximum daily dosage of amitriptyline is 150–300 mg per day.

When the dosage is correct, people should notice their symptoms improving within 2–4 weeks. The doctor will recommend maintaining an effective dosage for at least 3 months to prevent symptoms from returning.

If a person wants to stop taking amitriptyline, it is important to develop a tapering schedule with a doctor to prevent withdrawal symptoms. Stopping amitriptyline abruptly can cause side effects.

What happens when you stop taking it?

It is important to gradually reduce the dosage of amitriptyline to prevent withdrawal symptoms.

Withdrawal symptoms can include:

  • nausea
  • headache
  • general discomfort

A doctor will recommend a tapering schedule. An individual approach is key because each person may have a different reaction to stopping the drug.

Keeping track of any symptoms and informing the doctor can help them judge whether to speed up or slow down the tapering.

Warnings

Short-term studies have shown that antidepressants can increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Research has not shown that people older than 24 years experience these or similar effects.

Before prescribing amitriptyline to a child, adolescent, or young adult, the doctor should weigh the benefits and risks carefully. During treatment, doctors and caregivers need to monitor people taking amitriptyline for worsening symptoms of depression, suicidal thoughts, and unusual behaviors.

Anyone who has experienced an allergic reaction to amitriptyline should refrain from using this drug.

If a person has a history of cardiac problems, such as arrhythmiaheart failure, or a recent heart attack, a doctor should not prescribe amitriptyline.

Anyone over 50 and anyone with a history of heart trouble will undergo an electrocardiogram before beginning amitriptyline treatment. They will repeat this test during treatment so a doctor can check for new or worsening heart conditions.

Amitriptyline can worsen existing angle-closure glaucoma, urinary retention, and seizures. It is important to discuss any symptoms with a doctor, who can rule out these issues, before beginning treatment.

Doctors should prescribe lower doses of amitriptyline to people with liver or kidney failure.

Suicide prevention

  • If you know someone at immediate risk of self-harm, suicide, or hurting another person:
  • Call 911 or the local emergency number.
  • Stay with the person until professional help arrives.
  • Remove any weapons, medications, or other potentially harmful objects.
  • Listen to the person without judgment.
  • If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide Prevention Lifeline is available 24 hours a day at 1-800-273-8255.

Interactions

When a person takes amitriptyline and certain other drugs, three critical interactions can occur: monoamine oxidase inhibitor (MAOI) interactions, QT prolongation interactions, and serotonin syndrome interactions.

MAOI interactions

amitriptyline overheating fan

A person may experience an increased body temperature when taking amitriptyline.

MAOIs work by blocking the effect of the enzyme monoamine oxidase. This enzyme is responsible for breaking down monoamines in the body.

Monoamines include epinephrine, norepinephrine, dopamine, serotonin, and tyramine. When levels of these chemicals rise in the body, a person may experience:

  • increased heart rate
  • increased body temperature
  • muscle twitching
  • high blood pressure
  • agitation

MAOI drugs include :

  • isocarboxazid
  • phenelzine
  • tranylcypromine
  • selegiline

QT prolongation

The QT interval on an electrocardiogram is an important measure of the electrical conduction of the heart. When this interval lengthens, a person may experience an abnormal heart rhythm, which can lead to arrhythmia.

Amitriptyline can prolong the QT interval. Combining this drug with others that have the same effect puts a person at risk of developing arrhythmia.

Some examples of other drugs that can prolong the QT interval include:

  • astemizole
  • cisapride
  • disopyramide
  • ibutilide
  • indapamide
  • pentamidine
  • pizomide
  • procainamide
  • quinidine
  • sotalol
  • terfenadine

Serotonin syndrome

Serotonin syndrome occurs when there is too much serotonin in the body. This can cause symptoms that can range in severity from mild-to-life-threatening.

Serotonin syndrome symptoms include:

  • dilated pupils
  • flushed skin
  • dry mucous membranes
  • increased bowel sounds
  • excessive sweating
  • increased body temperature
  • a rapid heartbeat
  • muscle rigidity
  • muscle twitching
  • abnormal reflexes agitation
  • anxiety
  • restlessness
  • nausea
  • vomiting
  • tremor
  • disorientation
  • an altered mental status

Amitriptyline increases the amount of serotonin in the brain. When a person also takes other drugs that have this effect, it puts them at risk of developing serotonin syndrome.

Some other drugs that can increase the amount of serotonin in the brain include:

  • isocarboxazid
  • phenelzine
  • procarbazine
  • safinamide
  • selegiline
  • tranylcypromine

Cost

The manufacturer has discontinued the Elavil brand of amitriptyline, so only generic forms are available.

The following list shows the prices for 30 tablets of amitriptyline by dosage.

  • Amitriptyline 10 mg: $4.00
  • Amitriptyline 25 mg: $4.00
  • Amitriptyline 50 mg: $4.00
  • Amitriptyline 75 mg: $4.00
  • Amitriptyline 100 mg: $16.82
  • Amitriptyline 150 mg: $23.50

Summary

Doctors usually prescribe amitriptyline to treat depression. In addition, some off-label uses include treating anxiety, IBS, and chronic pain.

People taking amitriptyline may experience drowsiness, headaches, and dizziness, among other side effects, some of which are more severe.

Anyone taking any antidepressant should remain watchful for worsening of symptoms. Some people have experienced suicidal thoughts and behaviors while taking amitriptyline, and this requires immediate medical attention.

Also, some drugs can interact with amitriptyline. It is crucial that doctors and pharmacists carefully weigh the benefits and risks of adding amitriptyline to a person’s care plan.

 

via Amitriptyline: Uses, side effects, warnings, and interactions

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[Magazine] Brain Injury HOPE Magazine -July 2019

Hope after Brain Injury Magazine

 

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[WEB SITE] Best gripping aid for me? – The Active Hands Company

Best gripping aid for me?

Active Hands now sells a wide range of gripping aids for a wide variety of activities. To help you decide which gripping aid is right for you, please read the guide below.

 

How does your disability affect you? What do you want to grip? Which aid is right for you?
Reduced hand functionPoor finger strength

Tremors or involuntary movement

(This may include people with
Spinal Cord Injury, MS, cerebral palsy,
Guillan-Barré Syndrome, muscular dystrophy,
spina bifia, stroke survivors and other
similar disabilities).

 

Gym Equipment General Purpose gripping aid
D-ring gripping aids
Looped exercise aids
Hook aids
Gym pack/Gym pack deluxe
DIY tools General Purpose gripping aid
Kitchen implements General Purpose gripping aid
Sports equipment; rowing, kayaking etc General Purpose gripping aid
Looped Exercise aids
Hook aids
Gardening tools General Purpose gripping aid
Winter sports equipment such as adaptive skiing Winter Sports aid
Small diameter item: pen, make-up, toothbrush Small Item gripping aid
Adaptive tricycle/children’s walking frame General Purpose Mini aid (for children under 5) or General Purpose gripping aid
Missing fingersMissing parts of hands

This may include people with
dysmelia (conditions from birth), or amputation, illness or injury
later in life.

Gym equipment General Purpose gripping aid
D-ring gripping aids
Looped exercise aids
DIY tools Limb Difference gripping aid
Kitchen implements Limb Difference gripping aid
Sports equipment; rowing, kayaking etc Limb Difference gripping aid
Looped exercise aids
Gardening tools Limb Difference gripping aid

Find the product that best suits you…

Visit Site —> Best gripping aid for me? – The Active Hands Company

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[Abstract + References] An Exoskeleton Design Robotic Assisted Rehabilitation: Wrist & Forearm – Conference paper

Abstract

Robotic systems are being used in physiotherapy for medical purposes. Providing physical training (therapy) is one of the main applications of fields of rehabilitation robotics. Upper-extremity rehabilitation involves shoulder, elbow, wrist and fingers’ actions that stimulate patients’ independence and quality of life. An exoskeleton for human wrist and forearm rehabilitation is designed and manufactured. It has three degrees of freedom which must be fitted to real human wrist and forearm. Anatomical motion range of human limbs is taken into account during design. A six DOF Denso robot is adapted. An exoskeleton driven by a serial robot has not been come across in the literature. It is feasible to apply torques to specific joints of the wrist by this way. Studies are still continuing in the subject.

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Image result for An Exoskeleton Design Robotic Assisted Rehabilitation: Wrist & Forearm

Fig. 1. Wrist and forearm motions [17]

via An Exoskeleton Design Robotic Assisted Rehabilitation: Wrist &amp; Forearm | SpringerLink

 

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[NEWS] Nerve Stimulation Therapy May Help Some People Recover After a Stroke

Electrical stimulation may help people recover after having a common type of stroke.

Experts are investigating a new type of treatment for strokes. Getty Images

Each year, more than 795,000 people in the United States have a stroke.

Of them, nearly 40 percent go on to experience moderate to severe physical and mental complications, estimates the National Stroke Association. Another 25 percent have minor issues in the aftermath of a stroke.

Now stroke patients may have access to a new type of treatment that may help minimize the degree of complications.

The therapy, known as active nerve cell cluster stimulation, uses a small device implanted through the roof of the mouth that sends electrical stimulation to the nerves behind the nose.

When administered within 24 hours after a stroke, the nerve stimulation treatment was found to reduce the degree of disability in stroke patients three months after having the most common type of stroke, according to a new study published in The LancetTrusted Source last month.

The new treatment could be a safe, effective option for many stroke patients who are not eligible to receive traditional clot-busting medications, the researchers said.

“This study opens the avenues to develop treatment options for patients with acute ischemic stroke who are not eligible for standard of care acute stroke therapy to improve functional outcomes and to reduce long-term disabilities,” Dr. Anand Patel, a vascular neurologist at North Shore University Hospital in Manhasset, New York, told Healthline.

Nerve stimulation reduces degree of disability

To measure just how effective the therapy is, researchers from multiple institutions, including UCLA and Northwestern University, studied 1,000 participants who had an acute cortical ischemic stroke. In this type of stroke, blood flow to the brain is obstructed.

The participants were randomly assigned into two groups: one that received the stimulation therapy and another that underwent a placebo therapy.

Throughout the study, the first group received stimulation to the nerve-cell cluster behind the nose four hours per day for five consecutive days.

In a subgroup of 520 participants who’d experienced major deficits and injury to the brain, nearly half of the participants who received the new, experimental nerve therapy experienced favorable outcomes, versus 40 percent of the participants who didn’t receive the stimulation.

Although these findings aren’t statistically significant, the researchers note, when the results are combined with previous research from earlier trials, there’s enough evidence to suggest that the therapy is a safe, effective stroke treatment when given anywhere from 8 to 24 hours after a stroke.

Here’s how the therapy could help stroke patients

During a stroke, there’s an interruption of blood supply to the brain.

The key to treating a stroke and minimizing long-term damage is to quickly and effectively restore blood flow to the brain.

Typically, doctors treat stroke by opening blocked arteries or removing a clot. They do this with either clot-dissolving medications or surgically reopening clotted blood vessels.

However, the medication’s effectiveness drops significantly if it’s given more than three hours after a stroke. The medicine also doesn’t work for all patients, and some aren’t able to take it due to other health issues.

Furthermore, not every medical center has the proper expertise needed to treat patients with clot-retrieval devices.

Stimulating the nerve cells behind the nose may improve stroke outcomes in one of three ways, according to health experts.

“First, stimulation of this nerve bundle actually improved blood flow to the brain starved of oxygen during a stroke. Second, stimulation seems to fortify the blood-brain barrier, thereby [decreasing] the leakiness that causes swelling after a stroke,” said Dr. Jason Tarpley, a stroke neurologist and director of the Stroke and Aneurysm Center at Providence St. Joseph Health Pacific Neuroscience Institute.

“Finally, stimulation enhances plasticity of the brain, in which noninjured parts of the brain can pick up the job of the injured brain areas,” Tarpley added.

In other words, this therapy can quickly feed oxygen to the brain and protect tons of brain cells.

Stroke is one of the leading causes of death in the U.S.

Ischemic stroke is the leading cause of long-term physical and psychological disabilities, according to Patel.

The road to recovery can be a long and difficult one.

Following a stroke, many people will experience a wide range of complications, including slurred speech, double vision, an inability to perform tasks, and trouble maintaining balance, among several others.

Strokes are also responsible for about 140,000 deaths in the United States each year, according to the Centers for Disease Control and Prevention (CDC)Trusted Source.

Seeing as stroke is such a common and debilitating health issue in the United States, it is crucial to develop new, powerful treatment options to maximize the chances of people returning to their regular lives as soon as possible after a stroke.

The bottom line

Each year, nearly 795,000 people in the United States have a stroke. More than half go on to experience a range of physical and mental complications.

Scientists have found that a new type of therapy, called active nerve cell cluster stimulation, may have what it takes to effectively reduce the degree of disability in some people after a stroke.

 

via Nerve Stimulation Therapy May Help Some People Recover After a Stroke

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[WEB SITE] The Non-Scientist’s Guide to Reading and Understanding a Scientific Paper

It’s not as difficult as you think. Well, maybe it is. But reading scientific articles will help you make more informed decisions, and better understand and participate in the public debate about important scientific issues

Highlights:
More than 2.5 million new English-language scientific papers are published each year in more than 28,000 peer-review journals.
While many are paywalled, there are also prestigious open-access journals where you can read articles for free.
Reading articles will help you make more informed decisions in the areas of life that concern you, and better understand and participate in the public debate about important scientific issues.
Here are the basic steps: focus on the big picture the scientists are addressing; read the Abstract, Introduction, and Discussion, in that order; think critically about the conclusions the scientists make; conduct follow-up research.
For practice, we provide a link to a popular scientific paper on light-emitting e-readers.

We live in a golden age of scientific research. The top five countries in scientific research and development — the U.S., China, Japan, Germany, and South Korea, respectively — spend over $1 trillion on it each year. But where do all the resulting discoveries and eureka! moments go? Eventually they may find their way into textbooks or form the foundation of a life-saving therapeutic, but first most of them they go onto the page, in a scientific article.

According to a report by the International Association of Scientific, Technical and Medical Publishers (available for download here), more than 2.5 million new English-language scientific papers are published each year in more than 28,000 verified journals that use the stringent “peer review” system, whereby multiple scientists who are specialists in the relevant field of study provide a critical and in-depth review of a new paper. The process takes months and is overseen by a journal editor and several reviewers who read the study; only once the editor is convinced the author has addressed notes from peer reviewers in such categories as originality, importance, manner of presentation, and critical flaws, is it accepted into a journal.

The most common form of scientific article is a primary research article, an original report of research which chronicles an experiment in such a way that it can be replicated and the results reproduced by other scientists — core tenets of the scientific method. (Another type is a review article, where several primary research articles are discussed and their findings placed in greater context.)

The internet has made disseminating that sea of scientific information easier than ever, one result of which is a deluge of “A Groundbreaking New Study Finds…” headlines on websites and in magazines. While overly reductive reporting on scientific breakthroughs is not new to the media — the general public has at times felt whipsawed by science and health reporting for decades — the total quantity of scientific research and media sources is only increasing. More often than not, those articles grab the biggest “finding” and speculate on what it might mean a decade into the future, which often falls short of explaining the study in context and helping readers form an educated understanding of what the scientific research actually showed.

So how do you distinguish hyperbole from scientific evidence? By reading the papers yourself.

That’s not easy, even for scientists, who readily admit that reading these papers can be akin to torture. (A recent article in Science, enumerating the steps of reading a paper, included “fear,” “regret,” “bafflement,” “distraction,” and “rage.”) Rather than charging headfirst into several thousand words of science-speak, follow this plan of attack for primary research articles. With a little practice, you can do more than just understand them: you can replace conventional wisdom with knowledge, make more informed decisions in the areas of life that concern you most — health, fitness, and diet, for example — and better understand and participate in the public debate about important scientific issues.

Editor’s Note: To illustrate the process, we’ve chosen a popular scientific paper published in 2015 in Proceedings of the National Academy of Sciences, “Evening use of light-emitting eReaders negatively affects sleep, circadian timing, and next-morning alertness.” You can access the paper for free here.

1. Locate the Article

You’ll likely begin your search one of two ways: either by tracking down a paper cited in a news story (in which case: Google), or by searching for papers on a topic that interests you. The highest profile sources of peer-reviewed articles are Nature, a British journal, and Science, its American competitor. But there are credible journals for every branch and sub-branch of science. The best place to find those is on PubMed.gov, a database holding more than 27 million citations to credible journals.

Note that many scientific papers are not available for free. In a 2015 list of the most influential primary research papers by AltMetric, 42 were open access and 58 were paywalled. Paywalls are a source of frustration for a large swath of the general public (including academia, industry, and media), who argue that open access to research hastens innovation — and indeed that the public has a right to access the research it funds with tax dollars. This friction between publishers and everyone else has given rise to a variety of responses, including open-access journals, the search engine Sci-Hub, and policies from funding sources, like the Bill & Melinda Gates Foundation, that require research to be disseminated to the public free of charge.


Before You Start: The Anatomy of a Primary Research Article
Abstract: A condensed version of the article including the problem scientists were looking into, related work in the field, why this paper is new and novel, the most important findings, the overall conclusion, problems that occurred during the experiments.
Introduction: Scientists cite previous research in the field and explain their hypothesis in broad terms.
Methods and Materials: A precise description of the experiments such that they can be replicated by other scientists.
Results: All the important resulting data from the experiments.
Discussion/Interpretation/Conclusion: How the authors interpret the data.

2. Wrap Your Head Around the Big Picture

Read the Abstract for the bottom line of the study and then dig into the Introduction. While the Abstract can be dense prose, the Introduction is where the authors provide big picture context for the study and explain previous research in the field, often in a narrative style that’s easy to follow. It’s helpful to imagine each scientific paper as a single chapter in a long novel; this section is where you’ll gain an understanding of what chapters came before. It’s also where the authors broadly explain their hypothesis — or, where they’re guessing their own chapter will lead.

You want to come away from the Introduction with an understanding of the central problem the particular field of science is dealing with, as well as a subset of questions (related to the problem) that the authors of the paper plan to address. They will offer a hypothesis about the answer to those questions and suggest a plan of attack — the experiment(s) — for investigating whether it’s true.

In the e-reader article, the central problem is, How significantly are human sleep cycles, and therefore health, affected by technology? The authors explain that the “previous chapters” in this field have discovered that a circadian timing system directly affects when and how we sleep, and that the circadian cycle is directly affected by exposure to light in the early evening and nighttime, which suppresses the release of melatonin, a hormone that tells our bodies to sleep; the resulting lack of melatonin acutely increases alertness. The specific questions posed in the paper are, How does the light of an e-reader’s screen affect the circadian rhythm of test subjects, how does that affect the quality of their sleep and their alertness the next day?

3. Skip Ahead to the Conclusion

The Methods and Results sections come next, but skip ahead to the Discussion, alternatively called the Conclusion or Interpretations, which will summarize the findings — at least what the authors think they have showed — in a digestible way. This section includes how the authors interpret the data from their experiment and what it means for their original hypothesis. At the very end they will speak to how their findings change our understanding of the bigger picture, those surrounding chapters in the novel that makes up the scientific field’s entire progress. Keep in mind that scientific articles have limitations, often acknowledged in the paper, which require further research.

The scientists behind the e-reader study address both the larger problem and their unique questions in their Conclusion. “These results indicate that reading an LE (light emitting) eBook in the hours before bedtime likely has unintended biological consequences that may adversely impact performance, health, and safety,” they write. Specifically, based on their data they suggest that beyond just disrupting single instances of sleep, the light from e-readers may lead to a pattern of sleep deficiency by delaying the circadian timing system, which in turn reduces the REM sleep that would otherwise happen closer to waking.

And they describe a harrowing big picture given these findings: teenagers are spending upwards of 7.5 hours a day consuming media on readers, phones and computers, much of which happens in the evening and nighttime. The authors are especially concerned because studies of night shift workers have found a relationship between chronic suppressed nocturnal melatonin release and colorectal, breast and prostate cancer.

4. Understand the Results

The Results section and its attending figures and tables present the data without interpretation from the paper’s authors. As a result, this section will usually be the most difficult for the non-scientist.

A few statistics terms will help you navigate the data: “significant” and “non-significant.” This basic statistics terminology is used by scientists to describe events that could be the result of random chance (“non-significant”) versus data that could represent meaningful discoveries (“significant”). If you’re not familiar with statistics, consider reading a primer like this one from Harvard Business Review. Be aware that the Results section (and Methods) is sometimes challenging even for other scientists who are reading outside their field of expertise.

Pay attention to the figures and charts, which pack a lot of clear information into visuals. Read the captions closely, since they tend to explain the results with simple, clear language. And circle back to simplest questions: What is being measured? Given what you read in the Introduction and Discussion, what do the data illustrate?

The e-reader study includes several results from its experiment that support the interpretation in the Discussion section, all fairly easily understood using the figures and captions. For example, that after five consecutive days of reading using electronic light, the e-reader group’s melatonin onset levels were significantly suppressed in the evening when compared to the group reading traditional books. Those using the e-reader also took an average 10 minutes longer to fall asleep than those in reading books. And those using e-readers had significantly less REM sleep on average.


Assessing the Subject: Cells, Model Organisms, and Humans
A small but important detail: What are an experiment’s test subjects? There’s a big difference between the implications of results found studying model organisms (non-human species) or in human cells ex vivo (outside the body) versus results discovered in clinical studies (humans) — one that articles in the news usually don’t usually mention in the first few paragraphs.
While research cells and animals is vital for advancing our understanding in various fields of science and can produce groundbreaking results, these results don’t always carry over to humans. Scientists can reliably extend the life of mice by 30 percent, but that doesn't mean it can be done in humans.

5. Understand the Experiments

“Materials and Methods” is where the authors describe their experiment in enough detail that they can be replicated by other scientists. This is vital for the entire field of science, which is built on reproducible data. It also makes this section challenging and perhaps less important to understand for non-scientists. However, you’ll be rewarded for working toward a general understanding of the Methods section since plenty of experiments are poorly-designed, particular in the areas of randomization, blinding, and sample size. If you are curious about how the experiment was carried out, expect to spend time here looking up challenging terminology.

6. Recognize This Is Just the Beginning

In the final moments of the Conclusion and you may find a call to action: Scientists often recommend what they believe should be done next. “Because technology use in the hours before bedtime is most prevalent in children and adolescents,” the authors of the e-reader study write, “physiological studies on the impact of such light exposure on both learning and development are needed.” If you’re interested in learning more you can turn to the References section for further reading, or even contact one of the authors with questions. After all, a lot of scientific research is funded with public money, and the science community is surprisingly accessible. Odds are the author will be happy to discuss a topic that’s likely his or her lifelong passion.

 

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[Editorial] Five good reasons to be disappointed with randomized trials: Journal of Manual & Manipulative Therapy – Full Text

Background

Randomized controlled trials (RCTs) are recognized to exhibit very high levels of evidence, representing a coveted position near the top of the evidence-based pyramid [1Murad MHAsi NAlsawas M, et al. New evidence pyramid. BMJ Evidence Based Med. 2016;21(4). [Google Scholar]]. Both authors of this editorial have been part of small to large-scale RCTs and support the need for this form of research design. Yet, few things annoy us more than the deification that clinicians and selected researchers have given to randomize controlled trials. Yes, RCTs are useful in testing the efficacy and effectiveness of interventions between groups; essentially, identifying which treatment intervention is superior between two or more unique groups [2Fritz JMCleland J.Effectiveness versus efficacy: more than a debate over language. J Orthop Sports Phys Ther. 2003;33:163165.[Crossref][PubMed][Web of Science ®][Google Scholar]]. Moreover, RCTs are necessary to reduce bias and confounding and are perceived to yield causal inferences [3Deaton ACartwright NUnderstanding and misunderstanding randomized controlled trials. Soc Sci Med. 2018;210:221.[Crossref][PubMed][Web of Science ®][Google Scholar]]. However (and we can’t emphasize this enough), it is our impression that few understand the noteworthy limitations of RCTs, and even fewer are able to extrapolate how these limitations influence clinical practice. Our experiences with these misunderstandings have prompted us to outline some (trust us, there are more) of the limitations of RCTs, specifically those that might influence clinical practice in an orthopedic setting.

Limitations

Reason One: Right Question-Wrong Design: A common response we hear is the belittling of a given study finding because it didn’t involve an RCT. It is imperative to understand that RCTs are a form of research design and this design is not appropriate for all forms of research needs. For example, diagnostic accuracy studies are best analyzed using a case-based, case-control design. Rare diseases are best studied using case-control designs. If one is looking at predictive analytics then a prospective cohort design is the design of choice [2Fritz JMCleland J.Effectiveness versus efficacy: more than a debate over language. J Orthop Sports Phys Ther. 2003;33:163165.[Crossref][PubMed][Web of Science ®][Google Scholar]]. Looking for patterns and effects across different data sources?; a systematic review or a meta-analysis is the design of choice. And although an influential paper from 2004 called for better reporting of harms in RCTs [4CONSORT Group, Ioannidis JPEvans SJGøtzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781788.[Crossref][PubMed][Web of Science ®][Google Scholar],5Chan AWTetzlaff JMAltman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Inter Med. 2013;158(3):200207.[Crossref][PubMed][Web of Science ®][Google Scholar]], an RCT is not the most appropriate study design to truly understand the prevalence of these adverse events [6Zorzela LGolder SLiu Y, et al. Quality of reporting in systematic reviews of adverse events: systematic review. BMJ. 2014;348:f7668.[Crossref][PubMed][Web of Science ®][Google Scholar]]. An observational case-cohort design will better reflect the population, prevalence and downstream influence of harms associated with dedicated care processes [7Checkoway HPearce NKriebel DSelecting appropriate study designs to address specific research questions in occupational epidemiology. Occup Environ Med. 2007;64(9):633638.[Crossref][PubMed][Web of Science ®][Google Scholar]].

Reason Two: The Marginal Patient: Perhaps the most well-known limitation of an RCT is external validity. External validity is the degree to which the conclusions in your study would hold for other persons in other places and at other times. In RCTs, there are unavoidable disparities between the study conditions and populations in comparison to the conditions and populations in which the finding will be inferred [8Pearl JChallenging the hegemony of randomized controlled trials: a commentary on Deaton and Cartwright. Soc Sci Med. 2018;210:6062.[Crossref][PubMed][Web of Science ®][Google Scholar]]. A common assumption is that the findings would be transferable to all patient populations, treatment environments, and cultures. This ‘It-works-somewhere’[9Mulder RSingh ABHamilton A, et al. The limitations of using randomised controlled trials as a basis for developing treatment guidelines. Evid Based Ment Health. 2018;21(1):46.[Crossref][PubMed][Web of Science ®][Google Scholar]] concept is defined as: projected realism.

In an effort to ‘control’ for confounding variables and increase study power, a homogenous sample of diagnostically uniform patients are included that may not represent the actual demographics and complexity in the clinic. These less simple patients are termed ‘the marginal patients’ because the average patient may or may not respond to a given treatment [10McClellan MMcNeil BJNewhouse JPDoes more intensive treatment of acute myocardial-infarction in the elderly reduce mortality – analysis using instrumental variables. JAMA. 1994;272(11):859866.[Crossref][PubMed][Web of Science ®][Google Scholar]12Harris KMRemler DKWho is the marginal patient? Understanding instrumental variables estimates of treatment effects. Health Services Res. 1998;33(5):13371360.[PubMed][Web of Science ®][Google Scholar]]. Unfortunately, many of the requirements needed in an RCT to improve internal validity (and control for confounding bias) result in an artificial-like setting that does not closely match a real-world environment [13Gelman ALoken EThe statistical crisis in science. Am Scientist. 2004;102:460465.[Crossref][Google Scholar]]. Despite the notable juxtaposition between external and internal validity, many RCTs and observational designs involving similar interventions and participants find similar results [14Ioannidis JPARandomized controlled trials: often flawed, mostly useless, clearly indispensable: a commentary on Deaton and Cartwright. Soc Sci Med. 2018;210:5356.[Crossref][PubMed][Web of Science ®][Google Scholar]]. Because RCTs are often exceptionally expensive, authors have recommended different designs, alternative data sources, and unique methodological approaches to identify similar findings (at a reduced cost) [15Frieden TREvidence for Health Decision Making – Beyond Randomized, Controlled Trials. N Engl J Med. 2017;377(5):465475.[Crossref][PubMed][Web of Science ®][Google Scholar]].

Reason Three: Mixed Treatment Effect- Just because one group reports better outcomes than another group in an RCT, it does not mean that the intervention in the group with better outcomes works for all individuals in that group or future groups [13Gelman ALoken EThe statistical crisis in science. Am Scientist. 2004;102:460465.[Crossref][Google Scholar]]. Yes, if one finds differences between two groups, the intervention that is associated with an improved outcome may indeed have higher efficacy (for the group tested). Nevertheless, as most studies demonstrate, some individuals in both groups improve whereas some individuals in both groups do not. An RCT only functions to show whether more people improved in one group versus the other, or ‘who’ (which group) benefits. Why someone improved is not a property of a RCT.

To determine ‘why’ someone improves requires a causal mediation design. Causal mediation analysis identifies potential pathways that could explain whythe outcomes were more effective with that intervention [16Rudolph KEGoin DEPaksarian D, et al. Causal mediation analysis with observational data: considerations and illustration examining mechanisms linking neighborhood poverty to adolescent substance use. Am J Epidemiol 2018. [Epub ahead of print].[PubMed][Google Scholar]]. Causal mediation analysis allows an understanding of the roles of intermediate variables that lie in the causal path between the treatment and outcome variables, and allows the clinician to focus on both the mediating and primary (intervention) variables with targeted applications. Additionally, not all patients may be appropriate to a given mix of interventions with similar conditions. Thus, determining an effective treatment mix may provide more clinically useful information as opposed to a single treatment approach that demonstrates an effective average treatment effect [17Bernstein JNot the last word: choosing wisely. Clin Orthop Relat Res. 2015;473(10):30913097.[Crossref][PubMed][Web of Science ®][Google Scholar]19Birkmeyer JDReames BNMcCulloch P, et al. Understanding of regional variation in the use of surgery. Lancet. 2013;382(9898):11211129.[Crossref][PubMed][Web of Science ®][Google Scholar]]. Sadly, although causal mediation designs are often secondary analyses within an RCT, an RCT in isolation does not provide that information.

Reason Four: Treatment Fidelity: Intervention fidelity refers to the reliability and validity of the clinical interventions that are used in the randomized trial [20Cook CEGeorge SZKeefe FDifferent interventions, same outcomes? Here are four good reasons. Br J Sports Med. 2018;52(15):951952.[Crossref][PubMed][Web of Science ®][Google Scholar]]. In other words, fidelity reflects the applicability of the interventions for the condition of interest, whether the interventions are appropriately performed (application, dosage, and intensity) and whether the interventions adequately represent how the intervention is performed in clinical practice. Interestingly, past studies have found that intervention fidelity is consistently either poorly performed, poorly reported or both [21Toomey ECurrie-Murphy LMatthews J, et al. Implementation fidelity of physiotherapist-delivered group education and exercise interventions to promote self-management in people with osteoarthritis and chronic low back pain: a rapid review part II. Man Ther. 2015;20:287294.[Crossref][PubMed][Google Scholar]]. Unfortunately, because of the costs associated with RCTs, fidelity is commonly sacrificed. Even pragmatic randomized trials (trials designed to test the effectiveness of the intervention in a broad routine clinical practice) are guilty of limited fidelity in the application of behavioral or exercise-based interventions [20Cook CEGeorge SZKeefe FDifferent interventions, same outcomes? Here are four good reasons. Br J Sports Med. 2018;52(15):951952.[Crossref][PubMed][Web of Science ®][Google Scholar]].

Reason Five: Unmeasured Bias: The post-randomization experience is the period that immediately follows individuals’ consent and randomization to one of the treatment groups [22Choudhry NKRandomized, Controlled Trials in Health Insurance Systems. N Engl J Med. 2017;377(10):957964.[Crossref][PubMed][Web of Science ®][Google Scholar]]. Randomization is used to reduce errors, differences in groups, and confounding properties that are unforeseen. The post-randomization experience (‘what happens after the randomization’) can also be a period in which bias may play a notable role. Outside of fidelity and some of the aforementioned items, there are five major considerations involving the post-randomization experience. The Hawthorn effect is a change in behavior of the research subjects, administrators, and clinicians in experimental or observational studies [23Sedgwick PGreenwood NUnderstanding the Hawthorne effect. BMJ. 2015;351:h4672.[Crossref][PubMed][Google Scholar]]. Patients hold certain beliefs and expectations regarding a treatment that have been shown to influence the outcomes [24Harris JPedroza AJones GLPredictors of pain and function in patients with symptomatic, atraumatic full-thickness rotator cuff tears: a time-zero analysis of a prospective patient cohort enrolled in a structured physical therapy program. Am J Sports Med. 2012;40(2):359366.[Crossref][PubMed][Web of Science ®][Google Scholar]]. If the allocated treatment group does not match the patients’ beliefs and expectations then the treatment effect is likely subdued. Personal equipoise exists when a clinician has no good basis for a choice between two or more care options or when one is truly uncertain about the overall benefit or harm offered by the treatment to his/her patient [25Cook CSheets CClinical equipoise and personal equipoise: two necessary ingredients for reducing bias in manual therapy trials. J Man Manip Ther. 2011;19(1):5557.[Taylor & Francis Online][Google Scholar]]. Mode of administration bias exists when the method of outcomes collection (how outcomes were collected from the research participant) is tainted between clinician and research subject [26Cook CMode of administration bias. J Man Manip Ther. 2010;18(2):6163.[Taylor & Francis Online][Google Scholar]]. Lastly, contamination bias occurs when the members of one group in a trial receive the treatment or are exposed to the intervention that is provided to the other group.

To reinforce the influence of the Hawthorne effect and personal equipoise, we provide the following examples. First, provider, health services patterns, and comparison of profession are study foci that are particularly pre-disposed to the Hawthorn effect. Although the studies involve randomizing to control biases, clinician behaviors are likely to change since they know they are being evaluated in a formal study. For example, if you are the prescribing physician in a trial that is examining the negative effects of opioids, you are likely going to prescribe fewer opioids. Personal equipoise toward a particular intervention will unconsciously cause an improve outcome for the treatment of preference. For example, in randomized trials where clinicians preferred a particular treatment approach (despite being randomized between two groups), the preference influenced outcomes in a way that supported their preference [27Cook CLearman KShowalter C, et al. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013;18(3):191198.[Crossref][PubMed][Web of Science ®][Google Scholar],28Bishop MDBialosky JEPenza CW, et al. The influence of clinical equipoise and patient preferences on outcomes of conservative manual interventions for spinal pain: an experimental study. J Pain Res. 2017;10:965972.[Crossref][PubMed][Web of Science ®][Google Scholar]].

Summary

Randomized controlled trials are useful in testing the efficacy and effectiveness of interventions between groups [2Fritz JMCleland J.Effectiveness versus efficacy: more than a debate over language. J Orthop Sports Phys Ther. 2003;33:163165.[Crossref][PubMed][Web of Science ®][Google Scholar]]. Understanding their limitations is essential before extrapolation to clinical practice. Other research designs are needed to understand the diagnosis, validity of outcomes, and other important research issues. Participants enrolled in RCTs may or may not adequately represent the full population in which the study is designed to represent. Randomized controlled trials evaluate the effects of treatment at population levels and do not explain why the outcomes were more effective with that intervention [9Mulder RSingh ABHamilton A, et al. The limitations of using randomised controlled trials as a basis for developing treatment guidelines. Evid Based Ment Health. 2018;21(1):46.[Crossref][PubMed][Web of Science ®][Google Scholar]]. The care provided may or may not reflect what is appropriately provided in clinical practice. And lastly, a biased post-randomization experience is not protected by the initial randomization. Careful controls are necessary at this phase of the trial as well.

Disclosure statement

No potential conflict of interest was reported by the authors.

References

via Five good reasons to be disappointed with randomized trials: Journal of Manual & Manipulative Therapy: Vol 27, No 2

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[Abstract] Towards strengthening rehabilitation in health systems: Methods used to develop a WHO Package of Rehabilitation Interventions

Abstract

Achieving universal health coverage (UHC) is a World Health Organization (WHO) strategic priority. UHC means “all people receive quality health services that meet their needs without being exposed to financial hardship in paying for the services”. Rehabilitation is among the services included in UHC. As part of the WHO Rehabilitation 2030 call for action, WHO is developing its Package of Rehabilitation Interventions (PRI) to support ministries of health in planning, budgeting and integrating rehabilitation interventions into health systems. The aim of this paper is to introduce and describe the PRI and its methodology.

An advisory board composed of members from different WHO departments is overseeing the project, which is led by the WHO Rehabilitation Programme in collaboration with Cochrane Rehabilitation.

The development of the PRI is conducted in six steps: (1) Selection of health conditions (for which rehabilitation interventions will be included in the PRI) based on prevalences, related levels of disability and expert opinion; (2) identification of rehabilitation interventions and related evidence for the selected health conditions from clinical practice guidelines and Cochrane Reviews; (3) expert agreement on the inclusion of rehabilitation interventions in the PRI; (4) description of resources required for the provision of selected interventions; (5) peer review process, and (6) production of an open source web-based tool. Rehabilitation experts and consumers from all world regions will collaborate in the different steps.

In developing the PRI, WHO is taking an important step towards strengthening rehabilitation in health systems and thus, enabling more people to benefit from rehabilitation.

via Towards strengthening rehabilitation in health systems: Methods used to develop a WHO Package of Rehabilitation Interventions – Archives of Physical Medicine and Rehabilitation

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