Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Monday, October 23, 2017

Minimal Clinically Important Difference for Safe and Simple Novel Acute Ischemic Stroke Therapies

No clue what this means but they talk about guidelines, NOT protocols so to me this is useless.  Until we get to protocols stroke survivors will never have a path to 100% recovery. Guidelines are fucking worthless and lazy ways to make it look like progress.
http://stroke.ahajournals.org/content/48/11/2946?etoc=
Jessica S. Cranston, Brett D. Kaplan, Jeffrey L. Saver

Abstract

Background and Purpose—Determining the minimal clinically important difference (MCID) is essential for evaluating novel therapies. For acute ischemic stroke, expert surveys have yielded MCIDs that are substantially higher than the MCIDs observed in actual expert behavior in guideline writing and clinical practice, potentially because of anchoring bias.
Methods—We administered a structured, internet-based survey to a cross-section of academic stroke neurologists in the United States. Survey responses assessed demographic and clinical experience, and expert judgment of the MCID of the absolute increase needed in the proportion of patients achieving functional independence at 3 months to consider a novel, safe neuroprotective agent as clinically worthwhile. To mitigate anchoring bias, the survey response framework used a base 1000 rather than base 100 patient framework.
Results—Survey responses were received from 122 of 333 academic stroke neurologists, there were 23% women, 72.8% had ≥6 years of practice experience, and neurovascular disease accounted for more than half of practice time in >70%. Responder–nonresponder and continuum of resistance tests indicated that responders were representative of the full expert population. Among respondents, the median MCID was 1.3% (interquartile range, 0.8% to >2%).
Conclusions—Stroke expert responses to MCID surveys are affected by anchoring and centrality bias. When survey design takes these into account, the expert-derived MCID for a safe acute ischemic stroke treatment is 1.1% to 1.5%, in accord with actual physician behavior in guideline writing and clinical practice. This revised MCID value can guide clinical trial design and grant-funding and regulatory agency decisions.

Introduction

The minimal clinically important difference (MCID) is the smallest change in a treatment outcome that a patient, a care provider, or both would consider worthwhile.1
Establishing the MCID for a disease state is an essential prerequisite for clinical trial sample size calculation and informs funding decisions by the National Institutes of Health and other sponsors and drug or device approval decisions by the Food and Drug Administration and other regulatory agencies. For superiority trials, declarations that a novel treatment is clinically superior to standard therapy require that the improved outcome rate exceeds the MCID. For equivalence and noninferiority trials, declarations that 2 treatments are of equal clinical efficacy require that their outcome rates fall within the MCID. The smaller the MCID, the larger the sample size needed for a randomized trial to ensure that the study is adequately powered to detect or exclude a treatment benefit of clinical relevance.
Approaches to establishing the MCID for a particular disease or symptom fall into 3 categories: distribution-based, anchor-based, and Delphi expert–based approaches. Distribution-based approaches statistically derive an MCID from the distribution of outcome data, such as using one half the SD of an end point. They have the advantage of direct calculation from outcome data sets, but the drawback of not clearly correlating with clinically important change.
Anchor-based approaches compare change in end point scores with an external anchor, most commonly a patient global impression of change. Patient judgments that a change has been meaningful are relatively straightforward to elicit for treatments that are applied to patients with a previously stable disease-related health state. When interventions move patients from one to another long-lasting disease–related health state, patients can draw on their personal experience of both the before and the after states to render assessments comparing the 2. However, patient judgments that a change has been meaningful are challenging to derive for treatments that are applied to patients with an abrupt onset new condition, such as acute ischemic stroke. With acute onset conditions, patients can draw on their personal experience of only 1 stable disease-related health state, their own final outcome, and cannot compare this state to any alternative, personally experienced outcome state.
Given the limitations of the distribution- and anchor-based approaches for acute stroke, the survey methods have been the leading technique for determining what is a minimally important change in stroke outcomes. Surveys are administered to physicians, nurses, and other healthcare providers about the worth of different outcome states. Because healthcare providers have direct observational familiarity with a range of stroke outcomes, they are able to knowledgeably make comparative judgments of the value of alternative disease-related health states. But, for simple and safe therapies for acute ischemic stroke, MCIDs derived from expert judgment (5%–10%)2 have been higher than MCIDs derived from econometric modeling (2%–3%)3 and higher than MCIDs derived from observations of actual physician behavior and medical guidelines (1%–1.5%).47 These elevated expert-derived MICD values have been highlighted in European and American consensus statements on acute ischemic stroke clinical trial design.2,8
Recent studies of both nonexperts and experts have shown that human judgment in a wide variety of settings is prone to cognitive biases—systematic deviations from rationality. Notably, the architecture of questions used to elicit expert opinion may bias the resulting responses.9 Investigations of expert judgment of acute stroke MCID have generally used multiple choice questions, which are subject to anchoring and centrality bias. We sought to determine whether altering the question anchor framework would yield expert-derived MCIDs for acute stroke that better accord with actual expert behavior.

More at link.

No comments:

Post a Comment