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. 2021 Mar 2;24(1):44–72. doi: 10.5770/cgj.24.434

TABLE 2.

GRADE summary of findings

graphic file with name cgj-24-44t2a.jpg

Outcome Timeframe Study Results and Measurements Absolute Effect Estimates Usual Care Volunteers Certainty of Evidence
Anxietya Longest follow-up Measured by: HADS-A1
Scale: 11–21 Lower better
Based on data from 920 patients in 5 studies
Follow up longest follow-up (average 34.4 wks)
0.36
Mean
0.32
Mean
Moderate
Due to serious risk of biasb
Difference: MD 0.04 lower (CI 95% 0.56 higher to 0.65 lower)

Depressionc Longest follow-up Measured by: HADS-D
Scale: 11–21 Lower better
Based on data from 1382 patients in 11 studies
Follow up longest follow-up (average 24.2 wks)
0.43
Mean
0.16
Mean
Low
Due to serious risk of bias, Due to serious imprecisiond
Difference: MD 0.27 lower (CI 95% 0.03 higher to 0.57 lower)

Emotional Functioninge Longest follow-up Measured by: Mental Component Summary score (SF-36)
Scale: 0–100 High better
Based on data from 1341 patients in 10 studies
Follow up longest follow-up (average 26.6 wks)
1.84
Mean
1.50
Mean
Moderate
Due to serious risk of biasf
Difference: MD −0.34 lower (CI 95% 1.22 lower to 0.54 higher)

Physical Functioningg Longest follow-up Measured by: Physical Component Summary score (SF-36)
Scale: 0–100 High better
Based on data from 1521 patients in 12 studies
Follow up longest follow-up (average 25.1 wks)
0.62
Mean
3.67
Mean
Low
Due to serious risk of bias, Due to serious inconsistency leading to imprecisionh
Difference: MD 3.05 higher (CI 95% 0.87 higher to 5.24 higher)

Quality of lifei Longest follow-up Measured by: EQ-5D total score
Scale: 0–1 High better
Based on data from 1437 patients in 8 studies
Follow up longest follow-up (average 39.2 wks)
−0.02
Mean
0.01
Mean
Low
Due to serious risk of bias, and publication bias (i.e. small study effect)j
Difference: MD 0.00 lower (CI 95% 0.02 lower to 0.01 higher)
Physical Activity Longest follow-up Measured by: MET (energy/kg/mns/wk); MVPA per week; minutes spent on exercise
Scale: - High better
Based on data from 1349 patients in 6 studies (average 10.2 months)
Mean Mean Low
Due to serious risk of bias and indirectnessk
Difference: SMD 0.48 more (CI 95% 0.14 more – 0.83 more)

Frequency of Hospital Admissions Measured by: Narrative report: Admission rate not provided(37) and mean hospital admission rate per 1000 participants(58) 2 studies reported hospitalization frequency. One qualitative report of no significant difference between groups.(37) Another study reported the incidence of hospitalization as (27.9/1000) in the intervention group versus (30.13/1000) control group (p = < .01) (58) Low
Due to serious risk of bias and inconsistencyl

Falls Measured by: Narrative report: Proportion of participants reporting one or more falls in the past 3 months (fallers)(51) and the incidence of falls(54) 2 studies reported falls. One RCT reported the difference between proportion of fallers in the intervention group (14/35) versus (8/19) in the control group (P= 0.11)(51) Another study (cluster RCT) reported the incidence of falls in the intervention population (100/183) versus (158/217) in the control population (p = < .01)(54) Low
Due to serious risk of bias and inconsistencym

Adverse Events Narrative summary (results not pooled) 6 studies reported adverse events, no events or no difference between groups was found(32,34,46,54,57) Low
Due to serious risk of bias and inconsistencyn

HADS = Hospital Anxiety-Depression-Depression; HADS-A = Hospital Anxiety Depression-Anxiety; MET = Metabolic Equivalent Task, Energy used/per Kg/minute/week; MVPA +Time spent in moderate to vigorous physical activity.

a

All Measures converted to HADS-A.

b

Anxiety: Risk of bias: Serious. Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, Incomplete data and/or large loss to follow up; Inconsistency: Serious. Imprecision: Not serious. Wide confidence intervals; decided not to rate down further for imprecision as it is due to inconsistency.; Publication bias: Not serious. Not assessed due to small number of studies.

c

All measures converted to HADS-D.

d

Depression: Risk of bias: Serious. Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, Incomplete data and/or large loss to follow up.; Inconsistency: Serious. Point estimates vary widely, The confidence interval of some of the studies do not overlap with those of most included studies/ the point estimate of some of the included studies.; Imprecision: Not serious. Decided not to rate down for imprecision as it is mostly due to inconsistency.

e

Emotional Function: Risk of bias: Serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, Incomplete data and/or large loss to follow up; Inconsistency: Not serious. Decided not to rate further down as the observed heterogeneity seems to be due to risk of bias; Imprecision: Serious. Wide confidence intervals.

f

All measures converted to PCS score.

g

Physical Function: Risk of bias: Serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, Incomplete data and/or large loss to follow up.

h

All measures converted to EQ-5D total score.

i

Quality of Life: Risk of bias: Serious. Incomplete data and/or large loss to follow up; significant test of interaction for the subgroup of low vs. high risk of bias due to missing participants data.; Publication bias: Serious. Asymmetrical funnel plot with evidence of small study effect.

j

Physical Activity: Risk of bias: Serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, Incomplete data and/or large loss to follow up; Inconsistency: Not serious. Decided not to rate further down as the observed heterogeneity seems to be due to risk of bias; Indirectness: Serious, Publication bias: Not serious. Less than 10 studies.

k

All measures converted to MCS.

l

Hospital admission: Risk of bias: Serious. Inadequate concealment of allocation during randomization process, resulting in potential for selection bias, inadequate/lack of blinding of outcome assessors; Inconsistency: Serious Uncertain effects narrative summary.

m

Falls: Risk of bias: Serious. Inadequate concealment of allocation during randomization process resulting in potential for selection bias; Inconsistency: Serious. Uncertain effects with narrative summary.

n

Averse events: Risk of bias: Serious. Inadequate/lack of blinding of assessors resulting in potential for detection bias, incomplete outcome reporting. Inconsistency: Serious Uncertain effects narrative summary.