Background
Methods
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Brief decision aids: designed to guide clinical decision making about thrombolysis, and/or engage patients/relatives in decision making by facilitating understanding of the available options and concomitant risks/benefits.
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Risk communication tools: primarily focused on communication of probabilistic information to patients/relatives on risks/benefits of thrombolysis.
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Patient information tools: primarily designed for patients/relatives to facilitate understanding of diagnosis, treatment, and management, but not specifically to engage them in decision making [5].
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Standardised information for clinicians: primarily designed to support clinicians in explaining the risks/benefits of thrombolysis to patients/relatives.
Search strategy
Data extraction and critical analysis
Results
Title | Organization/Authors | Country | Publication date (review date) | Type of Tool (research evidence) | Format / Length |
---|---|---|---|---|---|
HandiStroke: A handheld tool for the emergent evaluation of acute stroke patients | Shapiro et al. | USA | 2003 (NS) | Brief decision aid (NINDS) | Electronic/palm-based |
The stroke-thrombolytic predictive instrument | Kent et al. | USA | 2006 (NS) | Brief decision aid (NINDS 1&2, ATLANTIS A&B, ECASS II) | Electronic/web-based tool |
Patient Information Leaflet: Thrombolysis (treatment with a clot dissolving drug - alteplase) for acute stroke | The University of North Staffordshire NHS Trust | UK | 2007 (NS) | Patient information tool (NICE) | Paper/1 x A4 |
After a stroke starts: What you need to know about clot-busting therapy | Genentech | USA | 2007 (NS) | Patient information tool (NINDS) | Paper/10 x A4 |
tPA for stroke: potential benefit, risk and alternatives | American Academy of Emergency Medicine | USA | 2007 (NS) | Risk communication tool (NINDS, ECASS I/II, ATLANTIS, MAST-I/E, ASK, Cochrane Review and other literature) | Paper/3 x A4 |
Clot-busting treatment for acute stroke: patient information | NHS Lothian | UK | 2007 (NS) | Risk communication tool (Research evidence NS) | Paper/1 x A4 |
Clot-busting treatment for acute stroke: patient information | NHS Lothian | UK | 2008 (NS) | Risk communication tool Research evidence NS | Paper/1 x A4 |
Information for Patients about thrombolysis (clot dissolving drugs) for stroke | Royal United Hospital Bath NHS Trust | UK | 2008 (Sep 2011) | Patient information tool (Research evidence NS) | Paper/2 x A4 |
Tissue Plasminogen Activator (tPA) what you should know | American College of Emergency Physicians, American Academy of Neurology, American Heart Association/American Stroke Association | USA | 2008 (NS) | Patient information tool (FDA) | Paper/1 x A4 |
Thrombolytic Treatment of Acute Ischaemic Stroke | Patient UK | UK | 2008 (Nov 2011) | Patient information tool (MAST-I/E, ASK, NINDS, ECASS I/II, ATLANTIS, STAT, SITS-MOST, NICE) | Web page/6 x A4 |
The Outcome Wheel a potential tool for shared decision-making in ischemic stroke thrombolysis | Cunningham | Canada | 2008 (NS) | Brief decision aid (NINDS) | Electronic/Excel file |
Information to give to patients/relatives before administration of Alteplase | Stroke Northumbria | UK | 2009 (NS) | Standardised Information (Research evidence NS) | Paper/< 1 A4 |
Stroke Thrombolysis (Clot Dissolving Drugs): an information leaflet | Stockport NHS Foundation Trust | UK | 2009 (Mar 2010) | Patient information tool (Research evidence NS) | Paper/3 x A4 |
Information for Patients and families about tPA (Tissue Plasminogen) for Stroke | The Ottawa Hospital | Canada | 2009 (NS) | Patient information tool (Research evidence NS) | Paper/1 x A4 |
Acute Stroke Thrombolysis | University Hospitals Bristol NHS Foundation Trust | UK | 2009 (NS) | Patient information tool (Research evidence NS) | Paper/4 x A5 |
Thrombolysis Treatment after Stroke | Chest, Heart and Stroke Scotland | UK | 2009 (NS) | Patient information tool (Research evidence NS) | Paper/16 x A5 |
Hypothetical representation of 16 patients treated with Activase (t-PA) vs 16 patients treated with placebo is based on NINDS results at 3 months | Genentech | USA | 2009 (NS) | Risk communication tool (NINDS 2) | Web page/3 x A4 |
Alteplase: a treatment for stroke: Information for patients | Knapp et al. | UK | 2010 (NS) | Patient information tool (NINDS, ECASS, SITS-MOST) | Paper/4 x A5 |
Assessment and improvement of figures to visually convey benefit and risk of stroke thrombolysis | Gadhia et al. | USA | 2010 (NS) | Risk communication tool (NINDS) | Paper/1 xA4 |
Patient and carer information leaflet: thrombolysis in stroke | NHS Wales | UK | 2010 (expires 2013) | Patient information tool (NICE/SITS-MOST) | Paper/4 x A4 |
t-PA information sheet | Saint Alphonsus Health System Outreach Program | USA | 2010 (NS) | Patient information tool (FDA) | Paper/1 x A4 |
Patient Information Sheet for Thrombolysis | NHS Fife | UK | 2010 (NS) | Patient information tool (Research evidence NS) | Paper/1 x A4 |
Stroke Thrombolysis Information for Patients and Relatives | Gloucestershire Hospitals NHS Foundation Trust | UK | 2011 (NS) | Patient information tool (Research evidence NS) | Web page/2 x A4 |
Stroke Thrombolysis - Information Sheet | South Tyneside NHS Foundation Trust | UK | 2011 (NS) | Patient information tool (Research evidence NS) | Paper/2 x A4 |
Patient Information Sheet | Massachusetts General Hospital Stroke Service | USA | Unknown (NS) | Patient information tool (FDA) | Paper/1 x A4 |
Information about tPA | Thunder Bay Regional Health Sciences Centre | Canada | Unknown (NS) | Patient information tool (Research evidence NS) | Web page/1 x A4 |
Acute stroke outcomes included in tools
Patient information tool (n = 17) | Risk communication tool (n = 5) | Brief decision aid (n = 3) | Standardised information (n = 1) | Overall (n = 26) | |
---|---|---|---|---|---|
Good outcome*
| 17 (100) | 5 (100) | |
| 2 (67) | 1 (100) | 25 (96) |
Poor outcome**
| 2 (12) | 5 (100) | |
| 0 (0) | 1 (100) | 8 (31) |
Poor outcome/death***
| 4 (24) | 1 (20) | |
| 2 (67) | 0 (0) | 7 (27) |
Death | 5 (29) | 4 (80) | 0 (0) | 1 (100) | 10 (39) |
Intra-cranial hemorrhage (ICH) | 17 (100) | 5 (100) | |
| 2 (67) | 1 (100) | 25 (96) |
Outcome following ICH | 16 (94) | 3 (60) | |
| 0 (0) | 1 (100) | 20 (77) |
Methods used to convey probabilistic information
Textual | Numerical | Graphical | |||||
---|---|---|---|---|---|---|---|
Verbal descriptors | Percentages | Number needed to treat/harm | Frequencies | Pie chart | Bar graph | Pictogram/graph | |
Patient Information Tool | 16 (94) | 11 (65) | 5 (29) | 13 (77) | 0 (0) | 2 (12) | 1 (6) |
Risk Communication Tool | 3 (60) | 4 (80) | 0 (0) | 5 (100)*
| 1 (20) | 0 (0) | 4 (80) |
Brief Decision Aid | 0 (0) | 3 (100) | 0 (0) | 0 (0) | 1 (33) | 0 (0) | 0 (0) |
Standardised Information | 1 (100) | 0 (0) | 0 (0) | 1 (100) | 0 (0) | 0 (0) | 0 (0) |
Overall | 20 (77) | 18 (69) | 5 (19) | 19 (73) | 2 (8) | 2 (8) | 5 (19) |
Readability and information content of patient information tools
Start with a clear statement of aims? | N | % | |
---|---|---|---|
Describes its purpose (e.g. to aid decision-making) | 9 | 53 | |
Describes what it covers (to help the reader judge whether it’s worth carrying on) | 8 | 47 | |
Describes who it is for (i.e. which patient groups) | 15 | 88 | |
Provide unbiased and detailed information about options?
| |||
Describes the health condition | 8 | 47 | |
Describes the natural course without treatment | 7 | 41 | |
Lists the treatment/management/lifestyle options | 9 | 53 | |
Describes benefits of options | 17 | 100 | |
Describes risks of options (harms/side-effects/disadvantages) | 17 | 100 | |
Describes uncertainty around the current evidence (i.e. what is not known) | 1 | 6 | |
Describes procedures (i.e., treatments, targets, monitoring, behaviour change, etc.) | 15 | 88 | |
Contain accurate information?
| |||
Clearly states the evidence sources used in compiling the information | 8 | 47 | |
Information quoted is in line with the most up-to-date clinical evidence | 8 | 47 | |
Where mentioned, prevalence estimates give an accurate impression of how common/rare the condition is | 1 | 6 | |
Personal opinion and/or advertising are clearly distinguished from evidence-based information | 5 | 29 | |
Help patients to make appropriate decisions
| |||
Acknowledges (explicitly or implicitly) that the patient has decisions to make | 8 | 47 | |
Helps patients to imagine what it is like to live with the condition and/or treatment effects | 4 | 24 | |
Asks patients to consider factors (e.g. priorities, motivations, treatment outcomes) affecting possible courses of action | 2 | 12 | |
Suggests ways and/or provides tools to help patients make decisions | 1 | 6 | |
Disclose conflicts of interest?
| |||
Includes authors’ / developers’ credentials or qualifications | 9 | 53 | |
Reports source of funding for development and distribution | 6 | 35 | |
Have a clear structure and layout?
| |||
Is consistent in design and layout throughout | 17 | 100 | |
Includes aids to finding information (e.g. contents, index, site map, or search facility) | 5 | 29 | |
Important points are emphasised through the use of summaries and/or bullet points | 10 | 59 | |
Illustrates information with diagrams and/or pictures | 7 | 41 | |
Where diagrams appear, they are labelled and relate to the subject matter | 5 | 29 | |
Sections are clearly separated | 14 | 82 | |
Help the reader judge its reliability
| |||
Reports date of publication | 10 | 59 | |
Includes sources of further information | 7 | 41 | |
Information content total: median (IQR), min/max
|
13 (6.5), 5/23
| ||
Readability (Fog Index): median (IQR), min/max
|
10.0 (2.9), 7.5/15.9
|
Presentation of outcome probabilities and development process
IPDASi (Probabilities) items [12] | Development process items | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 n (%) | 2 n (%) | 3 n (%) | 4 n (%) | 5 n (%) | 6 n (%) | 7 n (%) | 8 n (%) | Median (IQR) probabilities total | 1 n (%) | 2 n (%) | 3 n (%) | 4 n (%) | 5 n (%) | 6 n (%) | |
RCT | 5 (100) | 5 (100) | 5 (100) | 2 (40) | 2 (40) | 1 (20) | 4 (80) | 5 (100) | 5 (3) | 3 (60) | 1 (20) | 0 (0) | 1 (20) | 1 (20) | 0 (0) |
PIT | 17 (100) | 17 (100) | 13 (77) | 6 (36) | 2 (12) | 1 (6) | 6 (36) | 3 (18) | 4 (1.5) | 8 (47) | 1 (6) | 0 (0) | 2 (12) | 3 (18) | 0 (0) |
BDA | 2 (67) | 2 (67) | 0 (0) | 2 (67) | 2 (67) | 1 (33) | 1 (33) | 0 (0) | 4 (0) | 3 (100) | 1 (33) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
SI | 1 (100) | 1 (100) | 1 (100) | 0 (0) | 1 (100) | 0 (0) | 0 (0) | 0 (0) | 4 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Overall | 25 (96) | 25 (96) | 19 (73) | 10 (39) | 7 (27) | 3 (12) | 11 (42) | 8 (31) | 4 (2) | 14 (54) | 3 (12) | 0 (0) | 3 (12) | 4 (15) | 0 (0) |