Interventions for improving modifiable risk factor control in the secondary prevention of stroke

Bernadeta Bridgwood; Kate E Lager; Amit K Mistri; Kamlesh Khunti; Andrew D Wilson; Priya Modi

doi:10.1002/14651858.CD009103.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item from each study

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Figure 4

Funnel plot of comparison: 2 Organisational interventions versus usual care, outcome: 2.1 Mean systolic blood pressure.

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Figure 5

Funnel plot of comparison: 2 Organisational interventions versus usual care, outcome: 2.2 Mean diastolic blood pressure.

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Figure 6

Funnel plot of comparison: 2 Organisational interventions versus usual care, outcome: 2.3 Blood pressure target achievement.

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Analysis 1.1

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 1: Mean systolic blood pressure

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Analysis 1.2

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 2: Mean diastolic blood pressure

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Analysis 1.3

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 3: Blood pressure target achievement

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Analysis 1.4

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 4: Mean total cholesterol

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Analysis 1.5

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 5: Total cholesterol target achievement

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Analysis 1.6

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 6: Mean low density lipoprotein

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Analysis 1.7

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 7: Mean high density lipoprotein

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Analysis 1.8

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 8: Mean triglycerides

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Analysis 1.9

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 9: Mean HbA1c

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Analysis 1.10

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 10: HbA1C target achievement

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Analysis 1.11

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 11: Mean BMI

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Analysis 1.12

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 12: Proporation of participants with secondary stroke

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Analysis 1.13

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 13: Number of secondary TIAs

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Analysis 1.14

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 14: Number of myocardial infarctions

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Analysis 1.15

Comparison 1: Educational or behavioural interventions for patients versus usual care, Outcome 15: Number of cardiovascular deaths

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Analysis 2.1

Comparison 2: Organisational interventions versus usual care, Outcome 1: Mean systolic blood pressure

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Analysis 2.2

Comparison 2: Organisational interventions versus usual care, Outcome 2: Mean diastolic blood pressure

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Analysis 2.3

Comparison 2: Organisational interventions versus usual care, Outcome 3: Blood pressure target achievement

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Analysis 2.4

Comparison 2: Organisational interventions versus usual care, Outcome 4: Mean total cholesterol

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Analysis 2.5

Comparison 2: Organisational interventions versus usual care, Outcome 5: Total cholesterol target achievement

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Analysis 2.6

Comparison 2: Organisational interventions versus usual care, Outcome 6: Mean low density lipoprotein

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Analysis 2.7

Comparison 2: Organisational interventions versus usual care, Outcome 7: Low density lipoprotein target achievement

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Analysis 2.8

Comparison 2: Organisational interventions versus usual care, Outcome 8: Mean high density lipoprotein

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Analysis 2.9

Comparison 2: Organisational interventions versus usual care, Outcome 9: High density lipoprotein target achievement

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Analysis 2.10

Comparison 2: Organisational interventions versus usual care, Outcome 10: Mean triglycerides

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Analysis 2.11

Comparison 2: Organisational interventions versus usual care, Outcome 11: Triglyceride target achievement

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Analysis 2.12

Comparison 2: Organisational interventions versus usual care, Outcome 12: Mean HbA1C

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Analysis 2.13

Comparison 2: Organisational interventions versus usual care, Outcome 13: HbA1C target achievement

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Analysis 2.14

Comparison 2: Organisational interventions versus usual care, Outcome 14: Mean BMI

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Analysis 2.15

Comparison 2: Organisational interventions versus usual care, Outcome 15: BMI target achievement

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Analysis 2.16

Comparison 2: Organisational interventions versus usual care, Outcome 16: Mean Framingham cardiovascular risk score

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Analysis 2.17

Comparison 2: Organisational interventions versus usual care, Outcome 17: Proportion of participants with secondary stroke or TIA

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Analysis 2.18

Comparison 2: Organisational interventions versus usual care, Outcome 18: Number of secondary strokes

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Analysis 2.19

Comparison 2: Organisational interventions versus usual care, Outcome 19: Number of secondary TIAs

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Analysis 2.20

Comparison 2: Organisational interventions versus usual care, Outcome 20: Number of secondary TIA or stroke

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Analysis 2.21

Comparison 2: Organisational interventions versus usual care, Outcome 21: Proportion of participants with secondary cardiovascular events

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Analysis 2.22

Comparison 2: Organisational interventions versus usual care, Outcome 22: Number of secondary cardiovascular events

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Analysis 2.23

Comparison 2: Organisational interventions versus usual care, Outcome 23: Number of myocardial infarctions

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Analysis 2.24

Comparison 2: Organisational interventions versus usual care, Outcome 24: Number of vascular deaths

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Summary of findings 1. Educational or behavioural interventions for patients compared to usual care for improving modifiable risk factor control in the secondary prevention of stroke

Outcomes	№ of participants (studies) Follow up	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects^ (95% CI)**
Educational or behavioural interventions for patients compared to usual care for improving modifiable risk factor control in the secondary prevention of stroke
Patient or population: The trials included a total of 33,840 participants with cerebrovascular disease. The mean or median age of participants ranged from 60 years to 74.3 years. Nine studies included participants with diagnoses of ischaemic stroke; six studies included participants with either ischaemic or haemorrhagic stroke; one focused on lacunar strokes; two did not specify stroke subtype; four included participants with TIA only and 19 trials included a broader range of participants with a diagnosis of either stroke or TIA. Settings: Primary or secondary care Intervention: Educational or behavioural interventions for patients Comparison: Usual care
Outcomes	№ of participants (studies) Follow up	Quality of the evidence (GRADE)	Relative effect (95% CI)	Risk with usual care	Risk difference with Educational or behavioural interventions for patients
Mean systolic blood pressure	1398 (11 RCTs)	⊕⊕⊕⊝ MODERATE ¹	‐	The mean systolic blood pressure was 135.59 mmHg	MD 2.81 mmHg lower (7.02 lower to 1.39 higher)
Mean diastolic blood pressure	1398 (11 RCTs)	⊕⊕⊕⊝ MODERATE ¹	‐	The mean diastolic blood pressure was 78.28 mmHg	MD 0.83 mmHg lower (2.8 lower to 1.13 higher)
Blood pressure target achievement	266 (3 RCTs)	⊕⊕⊕⊝ MODERATE ¹	OR 1.34 (0.70 to 2.59)	Study population
				385 per 1000	71 more per 1000 (80 fewer to 234 more)
				Low
				260 per 1000	60 more per 1000 (63 fewer to 216 more)
				High
				430 per 1000	73 more per 1000 (84 fewer to 231 more)
Medication adherence	33,762 (13 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 3}	‐	Most studies measuring medication adherence outcomes found no significant differences between the intervention and control groups on any indicator of adherence
Mean low density lipoprotein	495 (4 RCTs)	⊕⊕⊕⊝ MODERATE ⁴	‐	The mean low density lipoprotein was 2.62 mmol/L	MD 0.13 mmol/L lower (0.28 lower to 0.02 higher)
Mean HbA1c	70 (1 RCT)	⊕⊕⊝⊝ LOW ^{4 5}	‐	The mean HbA1c was 5.98	MD 0.11 lower (0.39 lower to 0.17 higher)
Mean BMI	127 (2 RCTs)	⊕⊕⊕⊝ MODERATE ⁴	‐	The mean BMI was 24.01 kg/m²	MD 0.22 kg/m² higher (0.85 lower to 1.29 higher)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ The methods used in these studies were heterogenous which made these difficult to directly correlate ² Contains at least one study that scores 'high' using the Cochrane risk analysis and thus down graded by one level ³ Results were inconsistent across the studies ⁴ Secondary outcome ⁵ One study provided evidence for this outcome

Summary of findings 1. Educational or behavioural interventions for patients compared to usual care for improving modifiable risk factor control in the secondary prevention of stroke

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Summary of findings 2. Organisational interventions compared to usual care for improving modifiable risk factor control in the secondary prevention of stroke

Outcomes	№ of participants (studies) Follow up	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects^ (95% CI)**
Organisational interventions compared to usual care for improving modifiable risk factor control in the secondary prevention of stroke
Patient or population: The trials included a total of 33,840 participants with cerebrovascular disease. The mean or median age of participants ranged from 60 years to 74.3 years. Nine studies included participants with diagnoses of ischaemic stroke; six studies included participants with either ischaemic or haemorrhagic stroke; one focused on lacunar strokes; two did not specify stroke subtype; four included participants with TIA only and 19 trials included a broader range of participants with a diagnosis of either stroke or TIA. Settings: Primary or secondary care Intervention: Organisational derived interventions Comparison: Usual care
Outcomes	№ of participants (studies) Follow up	Quality of the evidence (GRADE)	Relative effect (95% CI)	Risk with usual care	Risk difference with Organisational interventions
Mean systolic blood pressure	17,490 (16 RCTs)	⊕⊕⊕⊝ MODERATE²	‐	The mean mean systolic blood pressure was 133.85 mmHg	MD 1.58 mmHg lower (‐4.66 lower to 1.51 higher)
Mean diastolic blood pressure	17,178 (14 RCTs)	⊕⊕⊕⊝ MODERATE²	‐	The mean mean diastolic blood pressure was 75.12 mmHg	MD 0.91 mmHg lower (‐2.75 lower to 0.93 higher)
Blood pressure target achievement	23,631 (13 RCTs)	⊕⊕⊕⊝ MODERATE²	OR 1.44 (1.09 to 1.90)	Study population
				391 per 1000	89 more per 1000 (21 more to 159 more)
				Low
				220 per 1000	69 more per 1000 (15 more to 129 more)
				High
				800 per 1000	52 more per 1000 (13 more to 84 more)
	Sensitivity analysis Repeating analyses excluding unpublished studies: no unpublished results included Repeating analyses excluding studies at high risk of bias (OR 1.44, 95% CI 1.05 to 1.97, P = 0.02) or unclear risk of bias (OR 1.20, 95% CI 1.11 to 1.29, P < 0.05) Repeating analyses excluding very large studies to investigate the extent to which they dominated the results (OR 1.31, 95% CI 1.09 to 1.57, P < 0.05) Repeating analyses using different statistical models (fixed‐effect OR 1.35, 95% CI 1.28 to 1.57, P < 0.05)
Medication adherence	5384 (8 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 3}	‐	Most studies measuring medication adherence outcomes found no significant differences between the intervention and control groups on any indicator of adherence
Mean low density lipoprotein	1008 (5 RCTs)	⊕⊕⊕⊝ MODERATE ⁴	‐	The mean mean low density lipoprotein was 2.60 mmol/L	MD 0.21 mmol/L lower (‐0.31 to ‐0.11)
Mean HbA1C	554 (4 RCTs)	⊕⊕⊝⊝ LOW ^{3 4}	‐	The mean mean HbA1c was 5.71	MD 0.2 lower (‐0.98 to 0.59)
Mean BMI	1089 (5 RCTs)	⊕⊕⊝⊝ LOW ^{3 4}	‐	The mean mean BMI was 27.89 kg/m²	MD 0.47 kg/m² lower (‐1.24 to 0.30)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ One included study did not include an explanation of blinding ² The methods and outcome measures used in these studies were heterogenous which made these difficult to directly correlate ³ One study deemed high risk when assessed using Cochrane risk of bias tool Contains at least one study thus down graded by one level ⁴ The methods used in these studies were heterogenous which made these difficult to directly correlate

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Table 1. Intervention categories

Study	Educational/behavioural interventions for patients	Educational/behavioural interventions for service providers	Organisational interventions						Predominant intervention category
Study	Educational/behavioural interventions for patients		Revision of professional roles	Collaboration between multidisciplinary teams	Integrated care services	Knowledge management systems	Quality management	Financial incentives	Predominant intervention category
Allen 2002	X	X		X	X				Organisational
Allen 2009	X	X		X	X				Organisational
Boter 2004	X				X				Organisational
Brotons 2011	X	X			X				Organisational
Damush 2015	X				X				Organisational
Dregan 2014		X			X				Organisational
Ellis 2005	X				X				Organisational
Evans 2010	X		X		X				Organisational
Flemming 2013	X	X	X	X	X				Organisational
Hanley 2015	X			X	X				Organisational
Hedegaard 2014	X			X	X				Organisational
Hornnes 2011	X				X				Organisational
Nailed Stroke 2010	X		X	X	X				Organisational
Johnston 2010		X					X		Organisational
Jönsson 2014	X		X	X	X				Organisational
Joubert 2009	X	X		X	X	X			Organisational
Kerry 2013	X					X			Organisational
Lowrie 2010		X					X		Organisational
Mant 2016					X		X		Organisational
Markle‐Reid 2011		X		X	X	X			Organisational
McAlister 2014	X	X	X	X	X				Organisational
McManus 2014	X			X	X				Organisational
Pergola 2014							X		Organisational
Ranta 2015					X	X			Organisational
Wang 2005	X				X				Organisational
Welin 2010	X				X				Organisational
Adie 2010	X								Educational/behavioural intervention for patients
MIST 2014	X								Educational/behavioural intervention for patients
Boysen 2009	X								Educational/behavioural intervention for patients
Chanruengvanich 2006	X								Educational/behavioural intervention for patients
Chiu 2008	X								Educational/behavioural intervention for patients
Eames 2013	X								Educational/behavioural intervention for patients
Kim 2013	X								Educational/behavioural intervention for patients
Kono 2013	X								Educational/behavioural intervention for patients
Kronish 2014	X								Educational/behavioural intervention for patients
Lowe 2007	X								Educational/behavioural intervention for patients
Maasland 2007	X								Educational/behavioural intervention for patients
MacKenzie 2013	X	X							Educational/behavioural intervention for patients
O'Carroll 2011	X								Educational/behavioural intervention for patients
Peng 2014	X								Educational/behavioural intervention for patients
Slark 2013	X								Educational/behavioural intervention for patients
Wan 2016	X			X					Educational/behavioural intervention for patients

Table 1. Intervention categories

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Comparison 1. Educational or behavioural interventions for patients versus usual care

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Mean systolic blood pressure Show forest plot	11	1398	Mean Difference (IV, Random, 95% CI)	‐2.81 [‐7.02, 1.39]

1.2 Mean diastolic blood pressure Show forest plot	11	1398	Mean Difference (IV, Random, 95% CI)	‐0.83 [‐2.80, 1.13]

1.3 Blood pressure target achievement Show forest plot	3	266	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.39, 1.44]

1.4 Mean total cholesterol Show forest plot	7	721	Mean Difference (IV, Random, 95% CI)	0.10 [‐0.28, 0.47]

1.5 Total cholesterol target achievement Show forest plot	1	56	Odds Ratio (M‐H, Random, 95% CI)	1.78 [0.60, 5.30]

1.6 Mean low density lipoprotein Show forest plot	4	495	Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.28, 0.02]

1.7 Mean high density lipoprotein Show forest plot	3	452	Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.11, 0.05]

1.8 Mean triglycerides Show forest plot	3	182	Mean Difference (IV, Random, 95% CI)	‐0.01 [‐0.31, 0.30]

1.9 Mean HbA1c Show forest plot	1	70	Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.39, 0.17]

1.10 HbA1C target achievement Show forest plot	1	67	Odds Ratio (M‐H, Random, 95% CI)	1.53 [0.57, 4.08]

1.11 Mean BMI Show forest plot	2	127	Mean Difference (IV, Random, 95% CI)	0.22 [‐0.85, 1.29]

1.12 Proporation of participants with secondary stroke Show forest plot	4	4333	Odds Ratio (M‐H, Random, 95% CI)	0.82 [0.37, 1.84]

1.13 Number of secondary TIAs Show forest plot	2	4207	Odds Ratio (M‐H, Random, 95% CI)	1.09 [0.52, 2.30]

1.14 Number of myocardial infarctions Show forest plot	3	4277	Odds Ratio (M‐H, Random, 95% CI)	0.53 [0.17, 1.65]

1.15 Number of cardiovascular deaths Show forest plot	1	386	Odds Ratio (M‐H, Random, 95% CI)	1.34 [0.30, 6.07]

Comparison 1. Educational or behavioural interventions for patients versus usual care

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Comparison 2. Organisational interventions versus usual care

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Mean systolic blood pressure Show forest plot	16	17490	Mean Difference (IV, Random, 95% CI)	‐1.58 [‐4.66, 1.51]

2.2 Mean diastolic blood pressure Show forest plot	14	17178	Mean Difference (IV, Random, 95% CI)	‐0.91 [‐2.75, 0.93]

2.3 Blood pressure target achievement Show forest plot	13	23631	Odds Ratio (M‐H, Random, 95% CI)	0.70 [0.53, 0.92]

2.4 Mean total cholesterol Show forest plot	7	11955	Mean Difference (IV, Random, 95% CI)	‐0.00 [‐0.04, 0.03]

2.5 Total cholesterol target achievement Show forest plot	6	12539	Odds Ratio (M‐H, Random, 95% CI)	0.78 [0.53, 1.17]

2.6 Mean low density lipoprotein Show forest plot	5	1154	Mean Difference (IV, Random, 95% CI)	‐0.19 [‐0.30, ‐0.09]

2.7 Low density lipoprotein target achievement Show forest plot	5	1790	Odds Ratio (M‐H, Random, 95% CI)	0.73 [0.47, 1.13]

2.8 Mean high density lipoprotein Show forest plot	4	522	Mean Difference (IV, Random, 95% CI)	‐0.02 [‐0.09, 0.04]

2.9 High density lipoprotein target achievement Show forest plot	1	36	Odds Ratio (M‐H, Random, 95% CI)	0.79 [0.20, 3.07]

2.10 Mean triglycerides Show forest plot	3	485	Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.21, 0.04]

2.11 Triglyceride target achievement Show forest plot	1	36	Odds Ratio (M‐H, Random, 95% CI)	4.00 [0.85, 18.84]

2.12 Mean HbA1C Show forest plot	4	554	Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.98, 0.59]

2.13 HbA1C target achievement Show forest plot	3	553	Odds Ratio (M‐H, Random, 95% CI)	0.25 [0.02, 3.33]

2.14 Mean BMI Show forest plot	5	1089	Mean Difference (IV, Random, 95% CI)	‐0.47 [‐1.24, 0.30]

2.15 BMI target achievement Show forest plot	2	234	Odds Ratio (M‐H, Random, 95% CI)	0.58 [0.31, 1.08]

2.16 Mean Framingham cardiovascular risk score Show forest plot	1	36	Mean Difference (IV, Random, 95% CI)	‐6.50 [‐10.22, ‐2.78]

2.17 Proportion of participants with secondary stroke or TIA Show forest plot	4	791	Odds Ratio (M‐H, Random, 95% CI)	0.66 [0.23, 1.86]

2.18 Number of secondary strokes Show forest plot	4	789	Odds Ratio (M‐H, Random, 95% CI)	1.00 [0.54, 1.87]

2.19 Number of secondary TIAs Show forest plot	1	102	Odds Ratio (M‐H, Random, 95% CI)	3.80 [1.57, 9.24]

2.20 Number of secondary TIA or stroke Show forest plot	1	291	Odds Ratio (M‐H, Random, 95% CI)	0.26 [0.08, 0.85]

2.21 Proportion of participants with secondary cardiovascular events Show forest plot	1	324	Odds Ratio (M‐H, Random, 95% CI)	1.48 [0.79, 2.77]

2.22 Number of secondary cardiovascular events Show forest plot	2	381	Odds Ratio (M‐H, Random, 95% CI)	0.73 [0.25, 2.15]

2.23 Number of myocardial infarctions Show forest plot	1	314	Odds Ratio (M‐H, Random, 95% CI)	1.00 [0.14, 7.19]

2.24 Number of vascular deaths Show forest plot	2	605	Odds Ratio (M‐H, Random, 95% CI)	0.38 [0.15, 0.97]

Comparison 2. Organisational interventions versus usual care

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