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Clinical question
Should an early mobilization intervention vs. delayed mobilization or standard care be used for people at risk of pressure injuries?
Context
Population:
Intervention:
Comparison:
Main Outcomes:
Setting:
Background:
Conflicts on Interest:
People at risk of pressure injuries
an early mobilization intervention
delayed mobilization or standard care
Critical care settings
Pressure Injury occurrence
Evidence to Decision Framework
(Click on the individual judgements for more information)
Summary of Judgements
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Yes
Moderate
Trivial
Very low
No important uncertainty or variability
Probably favors the intervention
Moderate costs
Very low
Favors the intervention
Probably no impact
Don’t know
Varies
1. Problem:
Is the problem (pressure injuries) a priority?
JUDGEMENT
No
Probably No
Probably Yes
Yes
Varies
Don’t Know
RESEARCH EVIDENCE
The problem of preventing pressure injuries is a significant priority to healthcare in most clinical settings. In a stakeholder survey conducted by the Guideline Governance Group in 2021, the target audiences for the guideline, including individuals with or at risk of PIs, their informal carers and health professionals, all identified that receiving clinical guidance on repositioning in a bed or chair is of the highest priority (median ranking 5/5, where 5 is the highest priority). In an earlier survey conducted by the previous Guideline Governance Group in 2018 (Haesler, Pittman et al. 2022), 76.2% (292/383) of individuals with or at risk of PIs and 69.8% (593/850) of informal carers rated receiving information on repositioning as important or very important. The median (inter quartile range [IQR]) priority ranking for receiving information on support surfaces was 4(1) for individuals with or at risk of PIs and 5 (1) for informal carers (possible score range 1 to 5).
2. Desirable Effects:
How substantial are the desirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
Outcome | With early mobilization | With delayed mobilization / standard care | Difference | Relative effect |
---|---|---|---|---|
PI occurrence (a prevention of PI) | 144/2764 (5.2%) | 191/2788 (6.9%) | 17 fewer PIs per 1,000 (from 27 fewer to 5 fewer) |
RR 0.75 (0.61-0.92) |
(prevention of) intensive care-acquired weakness (Wang, Ren et al. 2020) | Explored, but specific values not reported | Explored, but specific values not reported | Not calcuable | RR 0.49 (0.32-0.74) |
shortened duration of mechanical ventilation (Wang, Ren et al. 2020) | Explored, but specific values not reported | Explored, but specific values not reported | Not calcuable | Reported to favour early mobilization, but statistical analysis not reported |
(prevention of) deep vein thrombosis (Wang, Ren et al. 2020) | Explored, but specific values not reported | Explored, but specific values not reported | Not calcuable | RR 0.16 (0.06-0.47) |
(prevention of) pneumonia (Wang, Ren et al. 2020) | Explored, but specific values not reported | Explored, but specific values not reported | Not calcuable | RR 0.39 (0.16-0.98) |
Outcome 1: PI Occurrence
The meta-analysis included six randomized controlled trials (RCTs – some reported in reviews) (Naito, Kamiya et al. 2020, Wang, Ren et al. 2020, Gazineo, Godino et al. 2021) and six non-randomized comparative studies (Titsworth, Hester et al. 2012, Clark, Lowmann et al. 2013, Dickinson, Tschannen et al. 2013, Klein, Mulkey et al. 2015, Floyd, Craig et al. 2016, Nieto-Garcia, Carpio-Perez et al. 2021) that compared early mobilization to usual care for people in intensive care settings. Some of the studies were only available in Chinese but were summarized in a previous meta-analysis (Wang, Ren et al. 2020). Almost all the studies recruited individuals an intensive care setting. The studies explored a wide range of different early mobilization strategies that included incremental sitting out of bed, walking, wheelchair use and other exercises, some of which were individualized regimens and others that were standardized early mobility plans. Most programs were implemented daily and included different levels of activity through which the individual progressed over time (Nieto-Garcia, Carpio-Perez et al. 2021). Duration of the intervention was hard to determine in most of the studies. The duration of follow-up was hard to determine in most reports, but some of the studies followed people for over three months (Titsworth, Hester et al. 2012, Clark, Lowmann et al. 2013, Dickinson, Tschannen et al. 2013, Klein, Mulkey et al. 2015, Floyd, Craig et al. 2016). The meta-analysis showed that early mobilization was statistically significantly associated with 17 fewer (from 27 fewer to 5 fewer) Category/Stage 1 or greater PIs (RR = 0.75, 95%CI 0.61 to0.82, p=0.005).
Other benefits
A systematic review indicated that early mobilization is associated with other benefits beyond reduction in pressure injuries. These included reduction in intensive care-acquired weakness (RR 0.49, 95% CI 0.32 to 0.74, p = 0.0008), shortened duration of mechanical ventilation (mean difference -2.10, 95% CI -2.4 to -1.73, p < 0.0001), reduced risk of deep vein thrombosis (RR 0.16, 95% CI 0.06 to 0.47, p = 0.0007), and reduced risk of pneumonia (RR 0.39, 95% CI 0.16 to 0.98, p = 0.05) (Wang, Ren et al. 2020).
3. Undesirable Effects:
How substantial are the undesirable anticipated effects?
JUDGEMENT
Trivial
Small
Moderate
Large
Varies
Don’t Know
RESEARCH EVIDENCE
Outcome | With early mobilization | With delayed mobilization / standard care | Difference | Relative effect |
---|---|---|---|---|
any adverse events (e.g. falls, injuries, self-extubation, cardiac or respiratory events, line disconnections) (Nieto-Garcia, Carpio-Perez et al. 2021) | Explored, but specific values not reported | Explored, but specific values not reported | Not calculable | Reported to favour early mobilization, but statistical analysis not reported |
ICU mortality rates (Wang, Ren et al. 2020) | Explored, but specific statistical results not reported | Explored, but specific statistical results not reported | Not calculable | Reported to favour early mobilization, but statistical analysis not reported |
hospital mortality rates (Wang, Ren et al. 2020) | Explored, but specific statistical results not reported | Explored, but specific statistical results not reported | Not calculable | Reported to favour early mobilization, but statistical analysis not reported |
falls(Nieto-Garcia, Carpio-Perez et al. 2021) | 10/303 (3.3%) |
2/104 (1.9%) |
14 more per 1000 (from 12 fewer to 118 more) |
OR 1.74 (0.38 to 8.08) |
In one systematic review (Nieto-Garcia, Carpio-Perez et al. 2021) four of the included studies that reported on adverse events (e.g. falls, injuries, self-extubation, cardiac or respiratory events, line disconnections) indicated that these were not different for early mobilization programs versus usual care. The second systematic review (Wang, Ren et al. 2020) reported no difference in ICU mortality rates or hospital mortality rates. An additional study also reported no significant difference in fall rates (Naito, Kamiya et al. 2020).
4. Overall certainty of evidence: What is the overall certainty of the evidence of effects?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
Outcome | Relative Importance | Certainty of Evidence |
---|---|---|
PI occurrence | CRITICAL | VERY LOW |
Outcome 1: PI occurrence
In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcome set for PI prevention trials, the main outcome, PI occurrence, was rated as being a critically important (score of 7-9).
The certainty of evidence is very low. The evidence was downgraded one for risk of bias because most of the studies had a high risk of bias in at least one category (Wang, Ren et al. 2020, Nieto-Garcia, Carpio-Perez et al. 2021). Certainty was also downgraded once for indirectness due to the wide variety in the interventions, and once for inconsistency due to heterogeneity.
5. Values:
Is there important uncertainty about or variability in how much people value the main outcomes?
JUDGEMENT
Important uncertainty or variability
Possibly important uncertainty or variability
Probably no important uncertainty or variability
No important uncertainty or variability
RESEARCH EVIDENCE
In a Delphi survey (Lechner, Coleman et al. 2022) that developed a core outcome set for PI prevention trials, the main outcome, PI occurrence, was rated as being a critically important (score of 7-9) by all types of stakeholders (health professionals, people with or at risk of a PI and their informal carers, industry representatives and researchers). Greater than 90% of the 158 participants rated this outcome measure as critically important (Lechner, Coleman et al. 2022).
6. Balance of Effects:
Does the balance between desirable and undesirable effects favour the intervention or the comparison?
JUDGEMENT
Favors the comparison
Probably favors the comparison
Does not favor either the intervention or the comparison
Probably favors the intervention
Favors the intervention
Varies
Don’t know
RESEARCH EVIDENCE
7. Resources Required:
How large are resource requirements (costs) of the intervention?
JUDGEMENT
Large costs
Moderate costs
Negligible costs and savings
Moderate savings
Large savings
Varies
Don’t know
RESEARCH EVIDENCE
It is likely that early mobilization programs would require increased health professional time (Nieto-Garcia, Carpio-Perez et al. 2021) but this was not formally measured in any English-language studies included in the meta-analysis.
The Panel Group noted that this intervention generally requires increased staffing to implement. In some ICU settings a specific team (e.g. a physical therapy team) might be implemented to assist in implementation.
8. Certainty of evidence of required resources:
What is the certainty of evidence of resource requirements (costs) of the intervention?
JUDGEMENT
Very low
Low
Moderate
High
No included studies
RESEARCH EVIDENCE
There was minimal information on resources.
9. Cost Effectiveness: Does the cost-effectiveness of the intervention favour the intervention or the comparison?
JUDGEMENT
Favors the comparison
Probably favors the comparison
Does not favor either the intervention or the comparison
Probably favors the intervention
Favors the intervention
Varies
No included studies
RESEARCH EVIDENCE
One meta-analysis (Wang, Ren et al. 2020) reported that early mobilization was associated with a reduced hospital length of stay (weighted mean difference -3.71, 95% confidence interval [CI] -5.70 to -1.71, p=0.0003). There were no cost-effective studies.
10. Inequity:
What would be the impact of recommending the intervention on health inequity?
JUDGEMENT
Reduced
Probably reduced
Probably no impact
Probably increased
Increased
Varies
Don’t know
RESEARCH EVIDENCE
The Panel Group noted that this intervention is most relevant in ICU settings, and is accessible in most geographic regions.
11. Acceptability:
Is the intervention acceptable to key stakeholders?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
There was no information on how acceptable the implementation of early mobilization program is for stakeholders.
12. Feasibility:
Is the intervention feasible to implement?
JUDGEMENT
No
Probably no
Probably yes
yes
Varies
Don’t know
RESEARCH EVIDENCE
Barriers to implementing an early mobilization program include hemodynamical or pulmonary instability of the individual and a traditional lack of mobility within the ICU setting (Nieto-Garcia, Carpio-Perez et al. 2021). The Panel Group noted that some individuals in ICU at risk of pressure injuries have hemodynamic instability and early mobilization would not be feasible in this clinical context.