Abstract
Background:
Surgical reconstruction (SR) to close severe pressure ulceration (SPU) has not been evaluated.
Aim and objectives:
We aimed to investigate the feasibility of research to evaluate SR for SPUs by:
1.Systematically reviewing evidence about: the effectiveness of SR for SPUs; the impact of pressure ulceration on health-related quality-of-life (HRQoL; review2).
2.Surveying primary and secondary care healthcare professionals about surgical referrals of patients with SPUs and SPU management including SR.
3.Describing patients with incident pressure ulcers (PUs) and with SPUs having SR.
4.Comparing outcomes in patients with SPUs having/not having SR.
5.Seeking consensus about treatments and management strategies for SPUs.
Design:
Systematic reviews; surveys; binary choice experiment (BCE); retrospective cohort studies using routine data; consensus meeting.
Participants:
General practitioners; nurses; and surgeons managing PUs; people with incident PUs and hospitalised with SPUs.
Intervention:
SR.
Comparator:
No SR.
Outcomes:
SR, time to next admission with SPU, time to next admission, hospital stay, all-cause mortality, SR after discharge.
Results:
Review1 included three studies comparing different SR techniques. None reported wound-free time. Recurrence occurred in ≈20%. Review2 included three RCTs measuring HRQoL, but none observed benefits of interventions evaluated.
Among primary care survey respondents, 54% did not know SR can treat SPUs; >50% had never referred a patient to a surgeon. Among nurses, 72% had considered SR for a SPU; 54% believed SR should be more available. Among surgeons, 39% had never offered SR and 52% offered SR to <50%; 68% believed SR should be more available.
Routine data recorded 367,884 admissions with SPU diagnoses in England over 7.5 years; SRs were performed in at least 404 and at most 1018 admissions. 20 English hospitals performed >70% of the SRs. Comparing SR (n=325) versus no SR (n=1474) patients, time to next admission with SPU was longer in patients having SR (hazard ratio=0.79, 95%CI 0.61, 1.03, p=0.07).
Estimated PU incidence in primary care was ≈5/10,000 but the true incidence was believed to be ≈7 times higher. Episodes of PU care could not be identified.
There was consensus about a referral pathway for SPU patients wanting SR, including both community-led and surgically-led multidisciplinary team meetings, and about the influence of several patient and SPU characteristics on suitability for SR.
Limitations:
Surveys only considered factors one-by-one. Analyses of the HES cohort depended on coding accuracy. For the comparison of SR and no SR, the no NSR group had to be admitted. Routine data do not record wound healing outcomes. Primary care data underestimated PU incidence; PU care episodes could not be identified. The consensus meeting did not include surgeons. The COVID-19 pandemic caused delays, made team members unavailable and restricted face-to-face meetings.
Conclusions:
There is insufficient evidence to determine the effectiveness of SR on HRQoL or wound healing for SPUs. Too few procedures are carried out to enable a RCT to be feasible.
Future work:
We identified three areas: qualitative research on the acceptability of SR; a core outcome set for interventions to treat PUs; economic modelling of SR cost-effectiveness.
Study registrations:
PROSPERO: 2019 CRD42019156436, 2019 CRD42019156450; ISRCTN13292620
Surgical reconstruction (SR) to close severe pressure ulceration (SPU) has not been evaluated.
Aim and objectives:
We aimed to investigate the feasibility of research to evaluate SR for SPUs by:
1.Systematically reviewing evidence about: the effectiveness of SR for SPUs; the impact of pressure ulceration on health-related quality-of-life (HRQoL; review2).
2.Surveying primary and secondary care healthcare professionals about surgical referrals of patients with SPUs and SPU management including SR.
3.Describing patients with incident pressure ulcers (PUs) and with SPUs having SR.
4.Comparing outcomes in patients with SPUs having/not having SR.
5.Seeking consensus about treatments and management strategies for SPUs.
Design:
Systematic reviews; surveys; binary choice experiment (BCE); retrospective cohort studies using routine data; consensus meeting.
Participants:
General practitioners; nurses; and surgeons managing PUs; people with incident PUs and hospitalised with SPUs.
Intervention:
SR.
Comparator:
No SR.
Outcomes:
SR, time to next admission with SPU, time to next admission, hospital stay, all-cause mortality, SR after discharge.
Results:
Review1 included three studies comparing different SR techniques. None reported wound-free time. Recurrence occurred in ≈20%. Review2 included three RCTs measuring HRQoL, but none observed benefits of interventions evaluated.
Among primary care survey respondents, 54% did not know SR can treat SPUs; >50% had never referred a patient to a surgeon. Among nurses, 72% had considered SR for a SPU; 54% believed SR should be more available. Among surgeons, 39% had never offered SR and 52% offered SR to <50%; 68% believed SR should be more available.
Routine data recorded 367,884 admissions with SPU diagnoses in England over 7.5 years; SRs were performed in at least 404 and at most 1018 admissions. 20 English hospitals performed >70% of the SRs. Comparing SR (n=325) versus no SR (n=1474) patients, time to next admission with SPU was longer in patients having SR (hazard ratio=0.79, 95%CI 0.61, 1.03, p=0.07).
Estimated PU incidence in primary care was ≈5/10,000 but the true incidence was believed to be ≈7 times higher. Episodes of PU care could not be identified.
There was consensus about a referral pathway for SPU patients wanting SR, including both community-led and surgically-led multidisciplinary team meetings, and about the influence of several patient and SPU characteristics on suitability for SR.
Limitations:
Surveys only considered factors one-by-one. Analyses of the HES cohort depended on coding accuracy. For the comparison of SR and no SR, the no NSR group had to be admitted. Routine data do not record wound healing outcomes. Primary care data underestimated PU incidence; PU care episodes could not be identified. The consensus meeting did not include surgeons. The COVID-19 pandemic caused delays, made team members unavailable and restricted face-to-face meetings.
Conclusions:
There is insufficient evidence to determine the effectiveness of SR on HRQoL or wound healing for SPUs. Too few procedures are carried out to enable a RCT to be feasible.
Future work:
We identified three areas: qualitative research on the acceptability of SR; a core outcome set for interventions to treat PUs; economic modelling of SR cost-effectiveness.
Study registrations:
PROSPERO: 2019 CRD42019156436, 2019 CRD42019156450; ISRCTN13292620
| Original language | English |
|---|---|
| Journal | Health Technology Assessment |
| Publication status | Accepted/In press - 29 Oct 2024 |