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.