Clinical question

Should a sensor system that measures frequency of movement versus no system be used to inform repositioning of individuals at risk of pressure injuries?

Context

Population:

Intervention:

Comparison:

Main Outcomes:

Setting:

Background:

Conflicts on Interest:

People at risk of pressure injuries

Sensor system that measures the individual’s movement to inform if repositioning is required

No sensor system

any clinical settings

Pressure Injury occurrence

None

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

Large

Trivial

Very low

No important uncertainty or variability

Probably favors the intervention

Moderate costs

No included studies

Varies

Probably increased

Probably yes

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 movement sensor No movement sensor Difference Relative effect
Reduction in PI occurrence 6/857 (0.7%) 87/1268 (6.9%) 58 fewer PIs per 1,000
(from 67 fewer to 5 more)
RR 0.15
(0.02-1.08)

Outcome 1: PI Occurrence

The meta-analysis included three studies (one randomized controlled trial [RCT](Pickham, Berte et al. 2018) and two non-randomized comparative studies(Yap, Kennerly et al. 2019, Maguire, Hastings et al. 2021)) that compared a using a movement sensor** to not using a movement sensor to determine if a person at risk of pressure injuries requires repositioning. The studies were conducted in either intensive care unit (ICUs) or aged care settings, with sensors being used for mean durations of between 18 days and seven months. In the largest study,(Pickham, Berte et al. 2018) more than 60% of the participants had a Braden Scale score of above 19, suggesting the participants were mostly not at risk of PIs. In all the studies, repositioning frequencies programmed in the movement sensor were either two hourly, or between one and four hourly based on an assessment of the individual’s risk. The comparator group received repositioning based on the same regimen used in programming sensors. The meta-analysis showed that 58 fewer people per 1,000 (between 67 fewer and 5 more) might experience a PI when a movement sensor is used (RR 0.15, 95% CI 0.02 to 1.08, p = 0.06).

** All studies explored the same patient monitoring sensor, as detailed in the data extraction tables. In all the studies, the movement sensor was programmed with a repositioning frequency based on which a visual cue was provided to health professionals to indicate if the person was due to be repositioned. If the sensor detected sufficient repositioning had occurred, the duration before the visual cue was displayed to staff was extended accordingly.

3. Undesirable Effects:
How substantial are the undesirable anticipated effects?

JUDGEMENT

  • Trivial

  • Small

  • Moderate

  • Large

  • Varies

  • Don’t Know

RESEARCH EVIDENCE

Three studies that explored various outcomes from implementing a sensor device in ICU and aged care settings did not report any significant adverse events associated with using the sensor device.(Pickham, Berte et al. 2018, Yap, Kennerly et al. 2019, Maguire, Hastings et al. 2021)

The expert Panel Group noted that reliance on sensors to determine whether an individual requires repositioning might increase the risk of a PI occurring at certain areas that the device does not monitor, particularly the heels. However, there was no increase in heel PI occurrence reported in the available research.

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 outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical importance (score of 7-9).

The evidence was downgraded for risk of bias because all studies had moderate or high risk of bias in at least one domain, and all had an overall moderate risk of bias. The evidence was downgraded for indirectness because in the largest study more than 60% of participants were at no or low risk of PIs. The evidence was downgraded for inconsistency and for imprecision due to wide confidence intervals crossing the threshold between recommending and not recommending treatment, and with substantial variation in point estimates.

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 outcomes et for PI prevention trials, the outcome of PI occurrence was rated as being of critical 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

Based on small desirable effects and trivial undesirable effects the balance of effects probably favors using a sensor system.

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

Using a sensor device requires investment in patient monitoring devices, visual display and staff training. The costs were not reported in any of the research, but are likely to represent a non-negligible investment. One study noted that use of the sensor device may not be economically feasible in long term care activities; however, costs were not reported.(Maguire, Hastings et al. 2021)

One of the studies noted that staff time spent repositioning was generally lower with using a sensor to inform when repositioning was required, as individualized repositioning required less frequent repositioning events, allowing staff to prioritize their time for other care activities. However, a formal measure of staff time investment was not reported.(Maguire, Hastings et al. 2021)

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

Full evaluation of the costs has not been conducted.

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

Using a decision analytic model to simulate expected costs and outcomes, the patient wearable sensor was found to be cost-saving. Modelling assumed better clinical outcomes (77% reduction in HAPIs) compared to standard care and an expected cost savings of $6,621 per patient over a one-year period. The modelling is based on use of the sensor in acute care settings in the US. (Nherera, Larson et al. 2021)

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

A sensor device system to inform repositioning protocols has low availability in many geographic and clinical settings.

11. Acceptability:
Is the intervention acceptable to key stakeholders?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

In the RCT, adherence to repositioning regimens was significantly higher when a sensor device was in use (67% versus 54% compliance, p<0.001).(Pickham, Berte et al. 2018) In one study, (Yap, Kennerly et al. 2019) the impact of the sensor device on the professional care team was formally measured using the Nursing Culture Assessment Tool, which evaluated expectations, behavior, communication, teamwork, satisfaction and commitment. There was no significant impact of the sensor device on these measures. However, clinical staff reported positive experiences using the device in focus group discussions.(Yap, Kennerly et al. 2019)

In another study,(Maguire, Hastings et al. 2021) the sensor device was reported to be well-received by staff because it assisted in work prioritization and teamwork, but no formal measures of these outcomes was reported. The staff adherence rate to repositioning protocols using the sensor to inform clinical decision ranged from 66% to 90%, depending on the repositioning timetable programmed into the sensor.(Maguire, Hastings et al. 2021)

In one of the studies, nursing home residents appeared to accept the intervention, illustrated by refusal rate of less than 10% across the 7 month study time frame.(Maguire, Hastings et al. 2021)

12. Feasibility:
Is the intervention feasible to implement?

JUDGEMENT

  • No

  • Probably no

  • Probably yes

  • yes

  • Varies

  • Don’t know

RESEARCH EVIDENCE

One study(Yap, Kennerly et al. 2019) noted challenges using the sensor device in an aged care setting. These included having sufficient monitors visible to care staff, sensors becoming detached fand/or being removed by the resident/patient (a particular issue with individuals with cognitive impairment), and the availability of devices to assist with adequate repositioning to enable the device to detect a significant change in position.(Yap, Kennerly et al. 2019) In a second study the sensor device was applied to the trunk rather than the sternum in an attempt to address some of these technical issues.(Pickham, Berte et al. 2018)

One study noted that the use of the sensor device requires individuals to wear an adhesive sensor continuously, which may not be feasible in long term care and community care settings. For these reasons, the researchers in this study limited the participants to those at highest risk of PIs and those newly admitted to the facility.(Maguire, Hastings et al. 2021)

The expert Panel Group noted that access to sensor devices are highly limited in most care settings.