About EffectiveStrokeCare.org
What is effectivestrokecare.org?
effectivestrokecare.org is a fully indexed, searchable, web-enabled database of evidence for stroke care management.
What will I find in effectivestrokecare.org?
effectivestrokecare.org provides you with a systematic, accessible and transparent database of the evidence of effectiveness of interventions in stroke care.
Topic – question - intervention
- Evidence about all aspects of stroke care management is presented in TOPICS. [Read about how topics were identified].
- A TOPIC reflects a problem that a patient with stroke may have (e.g. poor balance), or problem relating to the management of a patient with stroke (e.g. where should the patient be cared for?).
- For each topic, one or more relevant QUESTIONs have been asked; these questions ask about the effectiveness of an intervention. [Read about how the questions were defined].
- For each question, one or more INTERVENTIONs have been identified.
- You can browse the TOPICs – QUESTIONs – INTERVENTIONs as a ‘tree-view’ or flow diagram, or you can use the search facility to go straight to the question and intervention of interest to you.
Evidence statement, critical appraisals and guidelines
- A rigorous literature search has been carried out to find the relevant high quality evidence relating to the QUESTION and INTERVENTION. This produces references to randomised controlled trials and systematic reviews. [Read about searching for the evidence]
- For each intervention, an EVIDENCE STATEMENT is presented, based on the evidence found in the literature search. The evidence statement uses a systematic method to categorise the level of effectiveness of the intervention, and to provide a clear statement of the benefits and harms of the intervention. [Read about the method of summarising the evidence into an evidence statement]
- The evidence statement is based on CRITICAL APPRAISALS of all relevant systematic reviews and randomised controlled trials. [Read about appraising the evidence]
- The evidence statement also provides direct links to national GUIDELINES related to the intervention and question. [Read about how national guidelines are linked to questions and interventions]
- If you click on a QUESTION you will see a list of interventions, each with an evidence ‘category’ (Beneficial, Likely to be beneficial, Trade-off between benefits and harms, Unknown effectiveness, Unlikely to be beneficial, Likely to be ineffective or harmful.) and a clear statement of the evidence found. (Find out more about the evidence categories: www.clinicalevidence.com/ceweb/about/guide.jsp )
- If you click on an INTERVENTION you will see the same evidence category and statement of evidence for that one intervention. In addition you will also see a statement of the benefits and/or harms of the interventions; key comments regarding the available evidence and it’s appraisal; and direct links to the critical appraisals of the individual systematic reviews or randomised controlled trials, and to any relevant guidelines.
How has effectivestrokecare.org compiled this evidence?
Evidence-based practice in stroke care is reliant on the availability and accessibility of robust research evidence. For this research to make an impact it has to be relevant. Rigorous steps have therefore been taken to identify all relevant TOPICS in stroke care. Consultation with professionals working in the field of stroke care, and extensive examination of educational and research literature, established a range of questions covering i) ways of organising stroke care services, and ii) the management of specific clinical topics.
Between 1998 and 2004 STEP undertook a series of consultation exercises with various professional groups. Initially, a Delphi Process was used to determine the ‘Burning Questions’ of stroke health care workers in Scotland (Legg et al. A multidisciplinary research agenda for stroke rehabilitation. B J Therap Rehabil 2000; 7: 319 – 24). Subsequent projects have included work with the National Association of Neurological Occupational Therapists (NANOT) to identify burning questions (funded by NANOT). Consultation is currently ongoing with the Scottish Stroke Nurses Forum (SSNF) (funded by Chest, Heart and Stroke Scotland). The consultation exercises with professional groups provided the core information relating to topics relevant to stroke health care workers. However topics identified in these consultations have been supplemented by hand searching of National Guidelines, library databases, and relevant educational texts. This was done to ensure that the identified topic list was comprehensive and inclusive.
Development of a framework for classifying and organising information
It was important to develop an accessible framework that would allow users to easily locate a topic of interest to them. The list of topics was systematically examined, and common themes were identified and grouped. Then using a system of coding and classification, the following broad categories of topics were constructed: -
PATIENTS - Optimising outcomes after stroke
Acute stroke management
Common problems – management
Enabling adjustment to life changes after stroke
Enabling independent living in the community
Secondary prevention - avoiding another stroke
SERVICES - Organisation and delivery of stroke care
CAREGIVERS - Involvement in post-stroke care
Adjusting to the changes that stroke may bring
Communicating with the communication impaired
Developing practical caring skills improving carers' knowledge about stroke
Understanding stroke
Prioritising topics for review in effectivestrokecare.org
The long-term aim is that each identified topic will have completed a review process. However, due to the large number of topics to be considered, a system of prioritisation of topics was required. Topics addressed by Cochrane systematic reviews were prioritised for inclusion in effectivestrokecare.org. Topics addressed by Cochrane protocols (Cochrane reviews in progress) are highlighted in effectivestrokecare.org with a note that we are awaiting the results of the full Cochrane review. Topics without Cochrane Systematic Reviews or protocols were prioritised according to the availability of reviewers with clinical expertise in these areas.
The first stage in the effectivestrokecare.org process is to convert the information needs of the stroke professionals into questions that can potentially be answered by reference to the research literature. We define the clinical question in terms of the specific patient problem. We do this using the PICO model. [Formulating Patient Centered Questions: The PICO Model for Clinical Questions][University of Illinois at Chicago].
The PICO model:
Patient, Population or Problem
| What are the characteristics of the patient or population or problem?
|
Intervention or exposure
| What is the intervention of interest?
|
Comparison of intervention
| What is the alternative to the intervention (e.g. placebo, different drug, different therapy, surgery)?
|
Outcome
| What are the relevant outcomes (e.g. death, morbidity, complications)?
|
What type of question are we asking?
| Diagnosis, Aetiology, Harm, Prevention, Prognosis, Therapy
|
What would be the most appropriate design to answer the question?
| Randomised controlled trial, cohort, case control, before-and-after, single-case, retrospective follow-up, or cross-over studies, economic analyses, qualitative techniques etc.
|
Defining a clinical question using this method is more likely to lead us to clinically relevant evidence.
An example: A topic identified by consultation with health professionals was “gait” and the “best ways to re-educate” patients with impaired gait. Using the PICO model we converted the topic of ‘Gait’ into 3 specific questions:
Types of evidence used to answer effectivestrokecare.org questions
Effectivestrokecare.org is primarily interested in providing answers to questions about interventions for stroke patients and their carers and about the best organisation of stroke services. The most appropriate study designs to answer these questions are the randomised controlled trial (RCT) or systematic reviews of RCTs. The types of evidence used by effectivestrokecare.org are therefore limited to systematic reviews and RCTs.
Effectivestrokecare.org does not address other types of clinical question that may arise including questions about prognosis, diagnosis or aetiology.
Effectivestrokecare.org hand search the Cochrane Database of Systematic Reviews (CDSR) (link to What is the CDSR?), the Database of Abstracts of Reviews of Effectiveness (DARE) (link to What is DARE?) and the Cochrane Stroke Group Specialised Trials Register (link to What is the CSGSTR?) for trial evidence relating to each question defined. CDSR is a database found on the Cochrane Library (link to What is the Cochrane Library?).
What is the Cochrane Database of Systematic Reviews (CDSR)?
The Cochrane Database of Systematic Reviews is a database of high quality systematic reviews of evidence, usually from randomised controlled trials which is updated on a quarterly basis. Advantages of Cochrane Reviews, as compared to other reviews of effectiveness, include:
What is the Database of Abstracts of Reviews of Effectiveness (DARE)?
DARE contains summaries and assessments of systematic reviews published in the journal literature on the effectiveness of health care interventions which meet the Cochrane Collaboration's standards/criteria. DARE is provided by the Centre for Reviews & Dissemination, University of York, UK. (E-mail:
crd@york.ac.uk). DARE is available on the Cochrane Library.
What is the Cochrane Stroke Group Specialised Trials Register?
The Cochrane Stroke Group (CSG) based in the Department of Clinical Neurosciences, Western General Hospital, Edinburgh, produces up-to-date systematic reviews of interventions for the prevention of stroke, treatment and rehabilitation of stroke patients and organisation of stroke services.
The CSG maintain a register of all trials in any aspect of stroke care known as the Cochrane Stroke Group Specialised Trials Register. The CSG have a systematic approach to trial identification, which includes regular searches of 20 general and specialist electronic bibliographic databases and an international programme of handsearching and translation. They also contact pharmaceutical companies and researchers in an effort to identify unpublished and ongoing trials. In addition, using the Internet and other sources, they identify and regularly search international clinical trials and research registers. Bibliographic details of the published trial reports from the Cochrane Stroke Group Specialised Trials Register are publicly available in the Cochrane Central Register of Controlled Trials in the Cochrane Library.
The CSG Trials Register is probably the most comprehensive and complete database of trials in stroke care anywhere in the world.
Find out more about the:
The Cochrane Library
Cochrane Collaboration
Cochrane Stroke Group
Having searched for and found the evidence in the form of systematic reviews or randomised controlled trials, the next stage is to critically appraise this evidence. Critical appraisal is a process to determine whether evidence is valid (close to the truth, believable, free from bias) and important (and therefore useful to you as a health care professional). Effectivestrokecare.org use an explicit, systematic process to critically appraise the evidence.
Appraising a systematic review
Systematic reviews are scientific investigations. They are systematic overviews of primary research studies, which address the same or similar research questions. Primary research study designs are critically appraised, data are synthesised and results interpreted.
Systematic review use strategies to limit bias and random error. Strategies used include:
- the use of pre-planned methods
- the development of a clearly formulated question
- a comprehensive search of all potentially relevant articles
- the use of explicit, reproducible criteria in the selection of primary research studies for review.
However, reviews can still have methodological problems. Problems may include:
- failure to present a clearly formulated review question
- failure to identify a primary outcome of interest
- failure to adequately report criteria for selecting studies to be included in the review
- failure to avoid bias in the selection of studies
- failure to adequately report criteria used to assess validity
- failure to apply criteria to assess the validity of selected studies
Methodological problems in systematic reviews like those outlined above can lead to distorted results and false conclusions. It is therefore important that the methodology of a systematic review is critically appraised before any conclusions are drawn from the presented results.
Effectivestrokecare.org critically appraises each systematic review using a standard and explicit process. This process involves asking seven simple questions about the methodology of the systematic review:
- Is the review question clearly formulated? (Condition of interest; participants; interventions; outcomes; comparisons; types of study)
- Is there a primary outcome of interest?
- Have the authors conducted a thorough search for all relevant studies (bibliographic databases; reference lists; personal contact, hand search etc)
- Did the reviewers assess for (and document): method of allocation concealment in the included trials?
- Did the reviewers assess for (and document): blindness of those receiving care? blindness of those providing care?
- Did the reviewers assess for (and document): completeness of follow-up? intention to treat analysis?
- Did the reviewers assess for (and document): blinding of outcome assessor(s)? identification of specification of pre-defined primary outcomes in trials.
Appraising a randomised controlled trial
An RCT is a prospective experimental study. Generally, individuals similar at the beginning of a trial are randomly assigned to two or more treatment groups; one (the experimental group) receiving the intervention that is being tested, and the other (the comparison group or controls) receiving an alternative treatment or placebo. The outcomes of the groups are compared after sufficient follow-up time. The strength of the RCT is that the only difference between the two (or more) groups is the treatment under investigation.
Properly executed, the RCT provides the strongest evidence of the clinical effects of preventive and therapeutic procedures in the clinical setting. However, RCTs can be subject to a number of methodological problems:
- failure to prevent foreknowledge of treatment assignment (inadequate allocation concealment)
- failure to keep trial participant’s treatment status secret from the participant and those providing treatment (blinding)
- failure to adequately report losses to follow-up (attrition bias)
- failure to conceal participant’s treatment status from the outcome assessor (blinding).
Methodological problems in RCTs can lead to distorted results and false conclusions. It is therefore important that the methodology of a randomised controlled trial is critically appraised before any conclusions are drawn from the presented results.
Effectivestrokecare.org critically appraises each RCT using a standard and explicit process. This process involves asking eight simple questions about the methodology of the RCT:
- Does the study address an appropriate and clearly focused question (condition of interest, patient group, intervention, outcomes)?
- Was an appropriate method of allocation concealment used?
- Were all participants who entered the trial properly accounted for at the end?
- Were they analysed in the groups to which they were assigned?
- Were those providing care blinded?
- Were those receiving care blinded?
- Were the groups the same at the start of the trial?
- Apart from the treatment under investigation, were the groups treated equally?
Having critically appraised all the systematic reviews or randomised controlled trials related to a topic, question or intervention, effectivestrokecare.org summarises the evidence using an Evidence Statement. The evidence statement includes:
Summary statement
A summary statement provides the results of the evidence-based practice investigation into the effectiveness of the intervention under examination for the problem/patient population of interest and includes a brief statement on the type of research evidence that this information is based on.
Benefits and harms
More detailed information is presented in terms of ‘benefits’ and potential ‘harms’ of the intervention to patients. This information is accompanied by comments on the volume of evidence and the external validity or generalisability/ applicability of results.
Categorisation of evidence
The level of evidence available to determine the effectiveness of each intervention addressing a particular problem is categorised using the following system: -
Beneficial
| Interventions whose effectiveness has been demonstrated by clear evidence from randomised controlled trial(s) with an expectation of harms that is small compared with the benefits. |
Likely to be beneficial
| Interventions for which effectiveness is less well established than those listed under ‘beneficial’. |
Trade-off between benefits and harms
| Interventions for which clinicians and patients should weigh up the beneficial and harmful effects according to individual circumstances and priorities. |
Unknown effectiveness
| Interventions where there are currently insufficient data or data of inadequate quality. |
Unlikely to be beneficial
| Interventions for which lack of effectiveness is less well established than those listed under ‘likely to be ineffective or harmful’. |
Likely to be ineffective or harmful
| Interventions whose lack of effectiveness or harmfulness has been demonstrated by clear evidence. |
The method of summarising and categorising the evidence used by effectivestrokecare.org has been derived (with permission) from Clinical Evidence (http://www.clinicalevidence.com/).
Unknown effectiveness
Many of the interventions used to treat specific problems have been graded as ‘unknown effectiveness’. If you see this in relation to an intervention that you are currently providing, or would like to provide, it’s worth remembering that lack of evidence of effectiveness is not evidence of lack of effect…we just do not have enough evidence from the right type of primary research studies (i.e. randomised controlled trials) at this moment in time to support or refute the use of that particular intervention for that specific problem.
Effectivestrokecare.org has handsearched National Guidelines and has identified guidelines that relate to specific questions and interventions. Hyperlinks to take you directly from effectivestrokecare.org to the relevant guideline are available within the standard evidence statement.
Why effectivestrokecare.org is not a guideline
The evidence statements in effectivestrokecare.org are not clinical guidelines.
Effectivestrokecare.org contains standard statements, based on our assessment of the best available evidence, about whether a particular intervention is likely to beneficial or not. The clinician still needs to apply this information to the context of their particular patient and healthcare system.
Peer review and editing of effectivestrokecare.org
The content of effectivestrokecare.org is quality-assured by (i) the rigorous and systematic processes that we use to compile and edit the evidence and (ii) peer review.
The systematic processes for appraising and summarising the evidence presented in effectivestrokecare.org are detailed in the section ‘How has effectivestrokecare.org compiled this evidence’.
All evidence statements are subject to an internal review process. Additionally, a significant proportion of these have been subject to external peer review by experts in the field. Thirdly we have a distinguished editorial board drawn representing a wide range of expertise in stroke care and research.
Limitations of effectivestrokecare.org
TOPICS – QUESTIONS – INTERVENTIONS
The topics, questions and interventions have been developed and structured by the STEP team using a variety of different strategies: focus groups and questionnaire studies; stroke literature and guidelines; and expert opinion. Whilst every effort has been made to make the structure of this evidence simple, logical and comprehensive, there can at times be ambiguity in the language used within the field of stroke care. It is therefore possible that users of effectivestrokecare.org may experience difficulties finding the topic/question of interest to them, or that an intervention of interest has not been covered. Please contact us if you experience any such difficulties.
Searching
STEP relies on the Cochrane Stroke Group Specialised Trials Register. The Cochrane Stroke Group kindly provides us with regular updates of their comprehensive and systematic searching of electronic databases, and programme of handsearching. Whilst we believe that it would be difficult for anyone to carry out more thorough and systematic searching, there remains the possibility that not all trials are identified. Read more about the
Cochrane Stroke Group and their
Controlled Trials Register.
STEP has to attribute each review or trial to a topic (or topics). In the first instance this attribution is based on title and brief details produced by the Cochrane Stroke Group. This process is therefore open to error. When STEP works on and completes a topic, all attributed trials are appraised: at this stage. Any errors should be identified, and corrections to the attribution of reviews or trials to topics are carried out.
EVIDENCE STATEMENTS – CRITICAL APPRAISALS
Critically appraised topics (CATs ) are each produced by one person (who is trained and experienced in critical appraisal). Whilst every effort has been made to ensure that each CAT follows a very structured and systematic process, and that all stages of this process are explicit, the introduction of bias and error through personal interpretation of evidence is impossible to avoid entirely. The advisory team does view and comment on the CATs; this should reduce, but not entirely avoid, bias and error within CATs.
A more acceptable and robust method to avoid the introduction of bias and error would be to use two independent reviewers for each CAT. Unfortunately time and resources have, to date, prevented this.
Quality of evidence
The highest quality of evidence regarding the effectiveness of an intervention should come from a Cochrane Systematic Review. The methods of a Cochrane Systematic Review involve the use of two or more independent reviewers and a panel of experts to provide comments on the methodology and content. Read more about the methods of Cochrane Systematic Reviews (link).
The CATs produced for effectivestrokecare.org do not have the robust methodology of a Cochrane Systematic Review. CATs are designed to enable the answers to clinical questions to be reached quickly. In the absence of a Cochrane Systematic Review, a CAT should provide a structured and explicit summary of the available evidence.
In an ideal world, Cochrane Systematic Reviews would be completed for every question and intervention. Until such time as we reach this Utopia CATs, used cautiously and appropriately, can provide evidence to help inform your practice.
What if there’s no evidence?
Within effectivestrokecare.org you will find several evidence statements which state that “we found no systematic reviews or clinical trials addressing this intervention”.
Knowledge of where there is and where there is not high quality evidence is an advantage. We believe that the clear identification of topics and interventions that have not been adequately researched is a strength of effectivestrokecare.org and not a limitation.
Knowledge of the gaps in clinical trial evidence provides two clear advantages:
- It shows researchers where further evidence is required and can be used to set the research agenda.
- It empowers clinicians to justify their choice of treatments using less robust evidence – for example single case studies, expert opinion and personal experience.
An absence, or lack, of evidence is not evidence of no effect. An intervention may be effective, despite the lack of high quality evidence.