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Respuestas clínicas Cochrane

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Study flow diagram ‐ 2011 update
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Figure 1

Study flow diagram ‐ 2011 update

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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 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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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 1 Life skills: 1. No important change in specific skills.
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Analysis 1.1

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 1 Life skills: 1. No important change in specific skills.

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Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 2 Life skills: 2. Average score (Various scales, endpoint, high score = better).
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Analysis 1.2

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 2 Life skills: 2. Average score (Various scales, endpoint, high score = better).

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Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 3 Leaving the study early.
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Analysis 1.3

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 3 Leaving the study early.

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Study

Intervention

Mean

SD

N

Patterson 2003

Life skill

7.20

4.90

16

Patterson 2003

Standard care

7.90

5.00

16

Figuras y tablas -
Analysis 1.4

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 4 Mental state: 1b. Average endpoint score ‐ at 24 weeks (HAM‐D, skewed data).

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Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 5 Mental state: 1a. Average endpoint scores (various scales, high score = worse).
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Analysis 1.5

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 5 Mental state: 1a. Average endpoint scores (various scales, high score = worse).

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Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 6 Mental state: 2a. Average change scores ‐ depression (various scales, high score = poor).
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Analysis 1.6

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 6 Mental state: 2a. Average change scores ‐ depression (various scales, high score = poor).

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Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 7 Mental state: 2b. Average change scores ‐ future outlook (high score = better).
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Analysis 1.7

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 7 Mental state: 2b. Average change scores ‐ future outlook (high score = better).

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Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 8 General functioning: Average endpoint score ‐ at 6 weeks (SSPI, high score = worse).
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Analysis 1.8

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 8 General functioning: Average endpoint score ‐ at 6 weeks (SSPI, high score = worse).

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Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 9 Quality of life: Average endpoint score ‐ at 24 weeks (QWB, high score = better).
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Analysis 1.9

Comparison 1 LIFE SKILLS PROGRAMME versus STANDARD CARE, Outcome 9 Quality of life: Average endpoint score ‐ at 24 weeks (QWB, high score = better).

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Comparison 2 LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL, Outcome 1 Life skills: 1. Average endpoint score ‐ at 24 weeks (various measures, high score = better).
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Analysis 2.1

Comparison 2 LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL, Outcome 1 Life skills: 1. Average endpoint score ‐ at 24 weeks (various measures, high score = better).

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Study

Intervention

Mean

SD

N

Patterson 2006

Life skills

12.70

9.96

82

Patterson 2006

Attention control

14.60

9.58

76

Figuras y tablas -
Analysis 2.2

Comparison 2 LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL, Outcome 2 Life skills: 2. Average endpoint score ‐ medication management ability ‐ at 24 weeks (MMAA, high score = worse, skewed data).

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Comparison 2 LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL, Outcome 3 Mental state: 1. Average endpoint score ‐ at 24 weeks (PANSS total, high score = worse).
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Analysis 2.3

Comparison 2 LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL, Outcome 3 Mental state: 1. Average endpoint score ‐ at 24 weeks (PANSS total, high score = worse).

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Study

Intervention

Mean

SD

N

Patterson 2006

Life skills

10.20

8.14

82

Patterson 2006

Attention control

9.70

7.84

76

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Analysis 2.4

Comparison 2 LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL, Outcome 4 Mental state: 2. Average endpoint score ‐ depression ‐ at 24 weeks (Ham‐D, high score = worse).

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Comparison 2 LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL, Outcome 5 Quality of life: Average endpoint score ‐ at 24 weeks (QWB, high score = better).
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Analysis 2.5

Comparison 2 LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL, Outcome 5 Quality of life: Average endpoint score ‐ at 24 weeks (QWB, high score = better).

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Table 1. Suggested design of study

Methods

Allocation: randomised, fully explicit description of methods of randomisation and allocation concealment.
Blinding: single, tested.
Duration: follow‐up at least 52 weeks.

Participants

Diagnosis: those referred to life skills programme ‐ diagnoses clearly described.
N = 300.*
Age: adults.
Sex: both.

Interventions

1. Life skills programme ‐ available to people in local trial centres. Clearly described by centre. N = 150.

2. Standard care without the life skills programme. N = 150.

Outcomes

General: discontinuation, relapse, general impression of clinician (CGI), career/other, compliance with treatment., healthy days.

Service use: time in hospital.
Quality of life. general impression of quality of life.
Family burden: satisfaction with care.
Social functioning: return to everyday living for 80% of time, employment, specific functional outcomes.
Adverse events: any adverse event recorded.
Economic outcomes.

Notes

* Powered to be able to identify a difference of ˜ 20% between groups for primary outcome with adequate degree of certainty.

Figuras y tablas -
Table 1. Suggested design of study
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Summary of findings for the main comparison. Life skills programme compared to standard care for chronic mental illnesses

Life skills programme compared to standard care for chronic mental illnesses

Patient or population: patients with chronic mental illnesses
Settings: day hospital
Intervention: Life skills programme
Comparison: standard care

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

standard care

Life skills programme

Life skills: No important change in household activity skills
Royal Edinburgh Occupational Therapy Assessment Form
Follow‐up: mean 12 weeks

250 per 1000

60 per 1000
(2 to 1000)

RR 0.24
(0.01 to 4.72)

10
(1 study)

⊕⊝⊝⊝
very low1,2,3

Life skills: No important change kitchen skills
Royal Edinburgh Occupational Therapy Assessment Form
Follow‐up: mean 12 weeks

See comment

See comment

Not estimable

10
(1 study)

⊕⊝⊝⊝
very low1,2,3

Life skills: No important change laundry skills
Royal Edinburgh Occupational Therapy Assessment Form
Follow‐up: mean 12 weeks

500 per 1000

70 per 1000
(5 to 1000)

RR 0.14
(0.01 to 2.38)

10
(1 study)

⊕⊝⊝⊝
very low1,2,3

Life skills: No important change self‐care skills
Royal Edinburgh Occupational Therapy Assessment Form
Follow‐up: mean 12 weeks

500 per 1000

500 per 1000
(140 to 1000)

RR 1
(0.28 to 3.54)

10
(1 study)

⊕⊝⊝⊝
very low1,2,3

Leaving the study early
Follow‐up: 6 to 16 weeks

29 per 1000

34 per 1000
(12 to 97)

RR 1.16
(0.4 to 3.36)

345
(5 studies)

⊕⊝⊝⊝
very low2,4,5

Mental state: endpoint score
PANSS positive syndrome. Scale from: 7 to 48.
Follow‐up: mean 24 weeks

The mean mental state: endpoint score in the control groups was
23.9

The mean Mental state: endpoint score in the intervention groups was
0 higher
(3.12 lower to 3.12 higher)

32
(1 study)

⊕⊝⊝⊝
very low3,6,7

Quality of life: Endpoint score
Quality of Well‐Being Scale index. Scale from: 0 to 10.
Follow‐up: mean 24 weeks

The mean quality of life: endpoint score in the control groups was
‐0.49

The mean Quality of life: endpoint score in the intervention groups was
0.02 lower
(0.07 lower to 0.03 higher)

32
(1 study)

⊕⊝⊝⊝
very low3,6,7

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 The one RCT that provided data for this outcome had unclear sequence generation and allocation concealment. It was not blinded. It was not free of selective reporting and it was unclear if it was free of other biases.
2 The 95% confidence intervals are very wide and include both significant benefit and harm of the intervention.
3 Only one study reported on this outcome.
4 Of the five RCTs that provided data for this outcome, only two had adequate sequence generation and it was unclear in all whether there was adequate allocation concealment. One study was single blinded and the remaining were not stated to be blinded. Three the trials dealt with missing data adequately and none of the trials reported all expected outcomes. It was unclear whether any of the trials were free from selective reporting.
5 Five studies reported this outcome, but we excluded many similar studies published in China because of lack of adequate randomisation. It is less likely that small, negative studies have been published.
6 The one RCT that provided data for this outcome had unclear sequence generation and allocation concealment. It was not free from selective reporting and did not address incomplete data. It was unclear of it was free from other biases.
7 The 95% confidence intervals include both significant benefit and harm of the intervention.

Figuras y tablas -
Summary of findings for the main comparison. Life skills programme compared to standard care for chronic mental illnesses
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Summary of findings 2. Life skills programme compared to attention‐control for chronic mental illnesses

Life skills programme compared to attention‐control for chronic mental illnesses

Patient or population: patients with chronic mental illnesses
Settings: board and care facility in community
Intervention: Life skills programme
Comparison: attention‐control

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

attention‐control

Life skills programme

Life skills: Endpoint score
UCSD Performance‐based Skills Assessment ‐ UPSA
Follow‐up: mean 24 weeks

The mean life skills: endpoint score in the control groups was
‐68.2

The mean Life skills: Endpoint score in the intervention groups was
2.5 lower
(8.94 lower to 3.94 higher)

158
(1 study)

⊕⊝⊝⊝
very low1,2,3

Mental state: Endpoint score
PANSS. Scale from: 16 to 96.
Follow‐up: mean 24 weeks

The mean mental state: endpoint score in the control groups was
59.1

The mean Mental state: Endpoint score in the intervention groups was
2.7 higher
(4.78 lower to 10.18 higher)

158
(1 study)

⊕⊝⊝⊝
very low1,2,3

Quality of life: Endpoint score
Quality of Well‐Being Scale. Scale from: 0 to 100.
Follow‐up: mean 24 weeks

The mean quality of life: endpoint score in the control groups was
‐55.9

The mean Quality of life: Endpoint score in the intervention groups was
0.9 higher
(3.12 lower to 4.92 higher)

158
(1 study)

⊕⊝⊝⊝
very low1,2,3

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 The one RCT that provided data for this outcome had unclear sequence generation and allocation concealment. It was not free from selective reporting and it was unclear whether it was free from other biases.
2 The 95% confidence intervals are wide and include both significant benefit and harm of the intervention.
3 Only one study reported on this outcome.

Figuras y tablas -
Summary of findings 2. Life skills programme compared to attention‐control for chronic mental illnesses
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Comparison 1. LIFE SKILLS PROGRAMME versus STANDARD CARE

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Life skills: 1. No important change in specific skills Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 household activity skills

1

10

Risk Ratio (M‐H, Random, 95% CI)

0.24 [0.01, 4.72]

1.2 kitchen skills

1

10

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.3 laundry skills

1

10

Risk Ratio (M‐H, Random, 95% CI)

0.14 [0.01, 2.38]

1.4 self‐care skills

1

10

Risk Ratio (M‐H, Random, 95% CI)

1.0 [0.28, 3.54]

2 Life skills: 2. Average score (Various scales, endpoint, high score = better) Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 NOSIE ‐ at 12‐16 weeks

2

205

Mean Difference (IV, Random, 95% CI)

16.77 [10.56, 22.99]

2.2 UPSA ‐ at 24 weeks

1

32

Mean Difference (IV, Random, 95% CI)

‐1.10 [‐7.82, 5.62]

3 Leaving the study early Show forest plot

5

345

Risk Ratio (M‐H, Random, 95% CI)

1.16 [0.40, 3.36]

4 Mental state: 1b. Average endpoint score ‐ at 24 weeks (HAM‐D, skewed data) Show forest plot

Other data

No numeric data

5 Mental state: 1a. Average endpoint scores (various scales, high score = worse) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 general pathology ‐ at 24 weeks (PANSS general psychopathology)

1

32

Mean Difference (IV, Random, 95% CI)

0.0 [‐3.12, 3.12]

5.2 positive syndrome ‐ at 24 weeks (PANSS positive)

1

32

Mean Difference (IV, Random, 95% CI)

‐0.80 [‐4.38, 2.78]

5.3 negative symptoms ‐ 12‐24 weeks (PANSS negative)

1

32

Mean Difference (IV, Random, 95% CI)

1.90 [‐1.75, 5.55]

5.4 negative symptoms ‐ 12‐24 weeks (SANS)

1

120

Mean Difference (IV, Random, 95% CI)

‐15.82 [‐23.01, ‐8.63]

6 Mental state: 2a. Average change scores ‐ depression (various scales, high score = poor) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

6.1 POMS (depression subscales)

1

25

Mean Difference (IV, Random, 95% CI)

‐5.99 [‐15.96, 3.98]

6.2 Zung

1

25

Mean Difference (IV, Random, 95% CI)

‐7.17 [‐18.65, 4.31]

7 Mental state: 2b. Average change scores ‐ future outlook (high score = better) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

7.1 FOI

1

25

Mean Difference (IV, Random, 95% CI)

‐10.36 [‐34.91, 14.19]

8 General functioning: Average endpoint score ‐ at 6 weeks (SSPI, high score = worse) Show forest plot

1

80

Mean Difference (IV, Fixed, 95% CI)

‐4.33 [‐5.23, ‐3.43]

9 Quality of life: Average endpoint score ‐ at 24 weeks (QWB, high score = better) Show forest plot

1

32

Mean Difference (IV, Random, 95% CI)

‐0.02 [‐0.07, 0.03]
Figuras y tablas -
Comparison 1. LIFE SKILLS PROGRAMME versus STANDARD CARE
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Comparison 2. LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Life skills: 1. Average endpoint score ‐ at 24 weeks (various measures, high score = better) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 everyday functioning (UPSA)

1

158

Mean Difference (IV, Random, 95% CI)

‐2.5 [‐8.94, 3.94]

1.2 social skill performance (SSPA)

1

158

Mean Difference (IV, Random, 95% CI)

‐0.90 [‐3.39, 1.59]

2 Life skills: 2. Average endpoint score ‐ medication management ability ‐ at 24 weeks (MMAA, high score = worse, skewed data) Show forest plot

Other data

No numeric data

3 Mental state: 1. Average endpoint score ‐ at 24 weeks (PANSS total, high score = worse) Show forest plot

1

158

Mean Difference (IV, Random, 95% CI)

2.70 [‐4.78, 10.18]

4 Mental state: 2. Average endpoint score ‐ depression ‐ at 24 weeks (Ham‐D, high score = worse) Show forest plot

Other data

No numeric data

5 Quality of life: Average endpoint score ‐ at 24 weeks (QWB, high score = better) Show forest plot

1

158

Mean Difference (IV, Random, 95% CI)

0.90 [‐3.12, 4.92]
Figuras y tablas -
Comparison 2. LIFE SKILLS PROGRAMME vs ATTENTION‐CONTROL
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