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Air-fluidized beds used for treatment of pressure ulcers in the home environment |
ECRI |
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Authors' objectives To determine the effectiveness of air-fluidised beds and group 2 support surfaces, as defined by the Centers for Medicare and Medicaid Services, for the treatment of stage III or IV pressure ulcers in the home and other settings. The authors also addressed broader issues: the stage of ulcer development when air-fluidised beds should be used; the requirements needed for nursing or care-giving in the home setting when using an air-fluidised bed or group 2 support surfaces; and the aspects of wound care that constitute proper treatment of patients using air-fluidised beds or group 2 support surfaces.
Searching PubMed, EMBASE, the Cochrane Library, REHABDATA, National GuidelinesClearinghouse, CINAHL, International Health Technology Assessment, Health Devices International Sourcebase, the ECRI library catalogue, Health Devices Alerts, Healthcare Standards Directory and the U.S. Food and Drug Administration's MDR (Medical Device Reports) and MAUDE (Manufacturer and User Facility Device Experience) databases were searched. The authors also searched over 1,000 journals and supplements maintained in ECRI's collections, as well as non-journal publications and conference proceedings from professional organisations, private agencies and government agencies. Bibliographies and reference lists from peer-reviewed and grey literature were also searched. The search terms and dates were not reported. Only studies published as a full article, in English, after 1985 were eligible for inclusion in the review.
Study selection Study designs of evaluations included in the reviewStudies with a parallel control group and at least 10 patients in each treatment group were eligible for inclusion in the review. Other technology assessments were also eligible for inclusion.
Specific interventions included in the reviewControlled studies of air-fluidised beds or group 2 support surfaces in the home setting were eligible for inclusion in the review.
Owing to the paucity of research in the home setting, the authors relaxed their inclusion criteria and included studies that were not in the home setting.
Participants included in the reviewStudies that included patients with stage III or IV pressure ulcers, which presented results separately from those of patients with stage I and II pressure ulcers, were eligible for inclusion in the review. Due to the lack of studies in patients with stage III or IV ulcers, one study of patients with 'large' ulcers was included.
Outcomes assessed in the reviewThe studies had to report one of the following outcome measures to be eligible for inclusion in the review: the number of wounds completely healed during the study period; the number of wounds that decreased in size during the study period; the number of wounds that became worse or stayed the same during the study period; the mean time to heal; the time to 50% wound healing; the mean area of wound reduction; the number of patients needing hospitalisation, or developing a complication with pressure ulcer care; or the length of stay during the treatment period.
How were decisions on the relevance of primary studies made?The authors did not state how the papers were selected for the review, or how many reviewers performed the selection.
Assessment of study quality The studies were evaluated for quality according to the following criteria: blinding, randomisation, prospective study design, sample size, attrition, concurrent wound care, co-morbidities, pre-study wound size, patient ages, study length and method of measuring wound healing. The authors did not state how the papers were assessed for quality, or how many reviewers performed the quality assessment. Studies of low quality were excluded from the review.
Data extraction The authors did not state how the data were extracted for the review, or how many reviewers performed the data extraction. Data were extracted on the support surfaces evaluated, patient characteristics, characteristics of the pressure ulcers, patient attrition and patient co-morbidities.
Methods of synthesis How were the studies combined?A narrative synthesis of the studies was presented.
How were differences between studies investigated?The authors do not appear to have formally assessed heterogeneity. However, they stated that meta-analytical techniques were inappropriate due to the lack of common control groups, the lack of common outcome measures and the differences in study lengths.
Results of the review Four randomised controlled trials (RCTs; n=288) addressed the main review question. A further 26 studies, 6 sets of clinical guidelines and 2 user manuals that addressed the broader issues within the review were considered. Adverse events reported in the MDR and MAUDE databases were also presented.
One RCT (n=112) of air-fluidised beds versus various conventional therapies was conducted in the home setting. Its findings were confounded by between-group differences in nursing care and other methodological weaknesses.
One RCT (n=72) conducted in a hospital setting found statistically-significant differences in favour of air-fluidised beds over group 2 surfaces for the proportion of patients improved and in the reduction of total ulcer area.
Two RCTs comparing a low-air-loss mattress with a foam mattress overlay and one RCT comparing an alternating air mattress with a foam mattress overlay (all in the hospital or nursing home) found no statistically-significant difference in the promotion of healing of stage III or IV ulcers. There was some indication of healing with group 2 surfaces, but the studies were underpowered to detect small clinical effects.
Authors' conclusions The single (hospital-based) RCT favoured air-fluidised beds over alternating air mattresses. The generalisability to patients with stage III or IV ulcers in the home setting is not known. In addition, since the study was performed over 10 years ago, it does not directly address the effectiveness of group 2 support surfaces as they are now manufactured.
Three RCTs indicated that stage III and IV pressure ulcers progress towards healing on group 2 devices, but differences in the reported outcomes prevent a comparison across the studies.
With regard to the broader issues addressed in the review, the authors concluded that the available evidence was also insufficient to determine which types of patient would benefit from initial conservative treatment or air-fluidised bed therapy.
A number of important considerations for proper patient care while using air-fluidised beds or group 2 support surfaces were identified.
Conclusions could not be drawn about which dressings or debridement procedures may work best with patients on air-fluidised beds or group 2 support surfaces.
CRD commentary The research questions and the inclusion criteria were well defined, although the authors relaxed the inclusion criteria when no relevant studies were identified. Thus, the generalisability of the findings to the population and situations the authors attempted to study may be limited.
A number of sources were searched for published and unpublished literature, but the search terms and dates were not reported and the possibility of publication bias was not assessed. The authors did not state whether language restrictions were applied to their search. Sufficient details of the included studies were presented. The studies were assessed for quality and low-quality studies were excluded from the review, although no specific definition of 'low quality studies' was given and the quality of some of the included studies was poor. The authors did not report details of how the review was conducted (e.g. who assessed the studies for relevance and quality, or abstracted data for the review), therefore, the possibility of bias or error cannot be excluded.
The authors do not appear to have formally assessed heterogeneity, but the narrative synthesis appears to have been appropriate.
Owing to the paucity of good-quality primary studies identified, the authors' limited conclusions should be interpreted with caution.
Implications of the review for practice and research The authors did not state any implications for practice or further research.
Funding Agency for Healthcare Research and Quality, contract number 290- 97-0020.
Bibliographic details ECRI. Air-fluidized beds used for treatment of pressure ulcers in the home environment. Rockville, MD, USA: Agency for Healthcare Research and Quality. Health Care Technology Assessment; 6. 2001 Indexing Status Subject indexing assigned by CRD MeSH Beds; Pressure; Pressure Ulcer /prevention & control AccessionNumber 12003008004 Date bibliographic record published 30/06/2004 Date abstract record published 30/06/2004 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. |
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