Reporting quality of published reviews of commercial and publicly available mobile health apps (mHealth app reviews): a scoping review protocol.

INTRODUCTION: Reviews of commercial and publicly available smartphone (mobile) health applications (mHealth app reviews) are being undertaken and published. However, there is variation in the conduct and reporting of mHealth app reviews, with no existing reporting guidelines. Building on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we aim to develop the Consensus for APP Review Reporting Items (CAPPRRI) guidance, to support the conduct and reporting of mHealth app reviews. This scoping review of published mHealth app reviews will explore their alignment, deviation, and modification to the PRISMA 2020 items for systematic reviews and identify a list of possible items to include in CAPPRRI. METHOD AND ANALYSIS: We are following the Joanna Briggs Institute approach and Arksey and O'Malley's five-step process. Patient and public contributors, mHealth app review, digital health research and evidence synthesis experts, healthcare professionals and a specialist librarian gave feedback on the methods. We will search SCOPUS, CINAHL Plus, AMED, EMBASE, Medline, APA PsycINFO and the ACM Digital Library for articles reporting mHealth app reviews and use a two-step screening process to identify eligible articles. Information on whether the authors have reported, or how they have modified the PRISMA 2020 items in their reporting, will be extracted. Data extraction will also include the article characteristics, protocol and registration information, review question frameworks used, information about the search and screening process, how apps have been evaluated and evidence of stakeholder engagement. This will be analysed using a content synthesis approach and presented using descriptive statistics and summaries. This protocol is registered on OSF (https://osf.io/5ahjx). ETHICS AND DISSEMINATION: Ethical approval is not required. The findings will be disseminated through peer-reviewed journal publications (shared on our project website and on the EQUATOR Network website where the CAPPRRI guidance has been registered as under development), conference presentations and blog and social media posts in lay language.

Inpatient-level care at home delivered by virtual wards and hospital at home: a systematic review and meta-analysis of complex interventions and their components.

BACKGROUND: Technology-enabled inpatient-level care at home services, such as virtual wards and hospital at home, are being rapidly implemented. This is the first systematic review to link the components of these service delivery innovations to evidence of effectiveness to explore implications for practice and research. METHODS: For this review (registered here https://osf.io/je39y ), we searched Cochrane-recommended multiple databases up to 30 November 2022 and additional resources for randomised and non-randomised studies that compared technology-enabled inpatient-level care at home with hospital-based inpatient care. We classified interventions into care model groups using three key components: clinical activities, workforce, and technology. We synthesised evidence by these groups quantitatively or narratively for mortality, hospital readmissions, cost-effectiveness and length of stay. RESULTS: We include 69 studies: 38 randomised studies (6413 participants; largely judged as low or unclear risk of bias) and 31 non-randomised studies (31,950 participants; largely judged at serious or critical risk of bias). The 69 studies described 63 interventions which formed eight model groups. Most models, regardless of using low- or high-intensity technology, may have similar or reduced hospital readmission risk compared with hospital-based inpatient care (low-certainty evidence from randomised trials). For mortality, most models had uncertain or unavailable evidence. Two exceptions were low technology-enabled models that involve hospital- and community-based professionals, they may have similar mortality risk compared with hospital-based inpatient care (low- or moderate-certainty evidence from randomised trials). Cost-effectiveness evidence is unavailable for high technology-enabled models, but sparse evidence suggests the low technology-enabled multidisciplinary care delivered by hospital-based teams appears more cost-effective than hospital-based care for those with chronic obstructive pulmonary disease (COPD) exacerbations. CONCLUSIONS: Low-certainty evidence suggests that none of technology-enabled care at home models we explored put people at higher risk of readmission compared with hospital-based care. Where limited evidence on mortality is available, there appears to be no additional risk of mortality due to use of technology-enabled at home models. It is unclear whether inpatient-level care at home using higher levels of technology confers additional benefits. Further research should focus on clearly defined interventions in high-priority populations and include comparative cost-effectiveness evaluation. TRIAL REGISTRATION: https://osf.io/je39y .

Evidence assessing the development, evaluation and implementation of digital health technologies in wound care: A rapid scoping review.

OBJECTIVE: To scope published data on the development, evaluation and implementation of digital health technologies for use in wound care. We focused on digital health technologies that supported one or more of the following functions: system level (such as electronic health records, management systems), wound imaging and measurement, and communication. METHODS: For this rapid scoping review, Ovid MEDLINE and Ovid Embase were searched in January 2021 and relevant experts were consulted. We identified English language publications that reported the development, evaluation, and/or implementation of relevant digital health technologies. Studies were screened and data extracted and coded following the established scoping review methodology. Data were presented narratively, and in tabular formats. RESULTS: We included 156 studies in the review. After reported technologies were categorised based on their predominant function, 51 (32.7%) studies reported on system level technologies; 123 (78.8%) on wound imaging and measurement technologies; and 34 (21.8%) on communication-focused technologies such as video-conferencing technologies, messaging technologies). Of the 156 studies, 37 (23.7%) reported data on development of the technology; 135 (86.5%) reported evaluation activities, mainly for wound imaging and measurement technologies; and 2 (1.3%) reported implementation research. CONCLUSION: There is increasing focus on digital health technologies in wound care. Assessment of digital health technologies aimed at wound care has mainly been for those with a primary function around wound imaging and measurement. Most studies reported evaluation whilst evidence suggests the field may lack transparent reporting of technology development and implementation activities that could aid further decision-making.

The accuracy of pulse oximetry in measuring oxygen saturation by levels of skin pigmentation: a systematic review and meta-analysis.

BACKGROUND: During the COVID-19 pandemic, there have been concerns regarding potential bias in pulse oximetry measurements for people with high levels of skin pigmentation. We systematically reviewed the effects of skin pigmentation on the accuracy of oxygen saturation measurement by pulse oximetry (SpO2) compared with the gold standard SaO2 measured by CO-oximetry. METHODS: We searched Ovid MEDLINE, Ovid Embase, EBSCO CINAHL, ClinicalTrials.gov, and WHO International Clinical Trials Registry Platform (up to December 2021) for studies with SpO2-SaO2 comparisons and measuring the impact of skin pigmentation or ethnicity on pulse oximetry accuracy. We performed meta-analyses for mean bias (the primary outcome in this review) and its standard deviations (SDs) across studies included for each subgroup of skin pigmentation and ethnicity and used these pooled mean biases and SDs to calculate accuracy root-mean-square (Arms) and 95% limits of agreement. The review was registered with the Open Science Framework ( https://osf.io/gm7ty ). RESULTS: We included 32 studies (6505 participants): 15 measured skin pigmentation and 22 referred to ethnicity. Compared with standard SaO2 measurement, pulse oximetry probably overestimates oxygen saturation in people with the high level of skin pigmentation (pooled mean bias 1.11%; 95% confidence interval 0.29 to 1.93%) and people described as Black/African American (1.52%; 0.95 to 2.09%) (moderate- and low-certainty evidence). The bias of pulse oximetry measurements for people with other levels of skin pigmentation or those from other ethnic groups is either more uncertain or suggests no overestimation. Whilst the extent of mean bias is small or negligible for all subgroups evaluated, the associated imprecision is unacceptably large (pooled SDs > 1%). When the extent of measurement bias and precision is considered jointly, pulse oximetry measurements for all the subgroups appear acceptably accurate (with Arms < 4%). CONCLUSIONS: Pulse oximetry may overestimate oxygen saturation in people with high levels of skin pigmentation and people whose ethnicity is reported as Black/African American, compared with SaO2. The extent of overestimation may be small in hospital settings but unknown in community settings. REVIEW PROTOCOL REGISTRATION: https://osf.io/gm7ty.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In January 2021, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane risk of bias tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. Our primary outcomes were SSI, mortality, and wound dehiscence. MAIN RESULTS: In this fourth update, we added 18 new randomised controlled trials (RCTs) and one new economic study, resulting in a total of 62 RCTs (13,340 included participants) and six economic studies. Studies evaluated NPWT in a wide range of surgeries, including orthopaedic, obstetric, vascular and general procedures. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Eleven studies (6384 participants) which reported mortality were pooled. There is low-certainty evidence showing there may be a reduced risk of death after surgery for people treated with NPWT (0.84%) compared with standard dressings (1.17%) but there is uncertainty around this as confidence intervals include risk of benefits and harm; risk ratio (RR) 0.78 (95% CI 0.47 to 1.30; I2 = 0%). Fifty-four studies reported SSI; 44 studies (11,403 participants) were pooled. There is moderate-certainty evidence that NPWT probably results in fewer SSIs (8.7% of participants) than treatment with standard dressings (11.75%) after surgery; RR 0.73 (95% CI 0.63 to 0.85; I2 = 29%). Thirty studies reported wound dehiscence; 23 studies (8724 participants) were pooled. There is moderate-certainty evidence that there is probably little or no difference in dehiscence between people treated with NPWT (6.62%) and those treated with standard dressing (6.97%), although there is imprecision around the estimate that includes risk of benefit and harms; RR 0.97 (95% CI 0.82 to 1.16; I2 = 4%). Evidence was downgraded for imprecision, risk of bias, or a combination of these. Secondary outcomes There is low-certainty evidence for the outcomes of reoperation and seroma; in each case, confidence intervals included both benefit and harm. There may be a reduced risk of reoperation favouring the standard dressing arm, but this was imprecise: RR 1.13 (95% CI 0.91 to 1.41; I2 = 2%; 18 trials; 6272 participants). There may be a reduced risk of seroma for people treated with NPWT but this is imprecise: the RR was 0.82 (95% CI 0.65 to 1.05; I2 = 0%; 15 trials; 5436 participants). For skin blisters, there is low-certainty evidence that people treated with NPWT may be more likely to develop skin blisters compared with those treated with standard dressing (RR 3.55; 95% CI 1.43 to 8.77; I2 = 74%; 11 trials; 5015 participants). The effect of NPWT on haematoma is uncertain (RR 0.79; 95 % CI 0.48 to 1.30; I2 = 0%; 17 trials; 5909 participants; very low-certainty evidence). There is low-certainty evidence of little to no difference in reported pain between groups. Pain was measured in different ways and most studies could not be pooled; this GRADE assessment is based on all fourteen trials reporting pain; the pooled RR for the proportion of participants who experienced pain was 1.52 (95% CI 0.20, 11.31; I2 = 34%; two studies; 632 participants). Cost-effectiveness Six economic studies, based wholly or partially on trials in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in five indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty; coronary artery bypass grafts; and vascular surgery with inguinal incisions. They calculated quality-adjusted life-years or an equivalent, and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the evidence certainty varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People with primary closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSIs  than people treated with standard dressings but there is probably no difference in wound dehiscence (moderate-certainty evidence). There may be a reduced risk of death after surgery for people treated with NPWT compared with standard dressings but there is uncertainty around this as confidence intervals include risk of benefit and harm (low-certainty evidence). People treated with NPWT may experience more instances of skin blistering compared with standard dressing treatment (low-certainty evidence). There are no clear differences in other secondary outcomes where most evidence is low or very low-certainty. Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Beds, overlays and mattresses for preventing and treating pressure ulcers: an overview of Cochrane Reviews and network meta-analysis.

BACKGROUND: Pressure ulcers (also known as pressure injuries, pressure sores and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Specific kinds of beds, overlays and mattresses are widely used with the aim of preventing and treating pressure ulcers. OBJECTIVES: To summarise evidence from Cochrane Reviews that assess the effects of beds, overlays and mattresses on reducing the incidence of pressure ulcers and on increasing pressure ulcer healing in any setting and population. To assess the relative effects of different types of beds, overlays and mattresses for reducing the incidence of pressure ulcers and increasing pressure ulcer healing in any setting and population. To cumulatively rank the different treatment options of beds, overlays and mattresses in order of their effectiveness in pressure ulcer prevention and treatment. METHODS: In July 2020, we searched the Cochrane Library. Cochrane Reviews reporting the effectiveness of beds, mattresses or overlays for preventing or treating pressure ulcers were eligible for inclusion in this overview. Two review authors independently screened search results and undertook data extraction and risk of bias assessment using the ROBIS tool. We summarised the reported evidence in an overview of reviews. Where possible, we included the randomised controlled trials from each included review in network meta-analyses. We assessed the relative effectiveness of beds, overlays and mattresses for preventing or treating pressure ulcers and their probabilities of being, comparably, the most effective treatment. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We include six Cochrane Reviews in this overview of reviews, all at low or unclear risk of bias. Pressure ulcer prevention: four reviews (of 68 studies with 18,174 participants) report direct evidence for 27 pairwise comparisons between 12 types of support surface on the following outcomes: pressure ulcer incidence, time to pressure ulcer incidence, patient comfort response, adverse event rates, health-related quality of life, and cost-effectiveness. Here we focus on outcomes with some evidence at a minimum of low certainty. (1) Pressure ulcer incidence: our overview includes direct evidence for 27 comparisons that mostly (19/27) have very low-certainty evidence concerning reduction of pressure ulcer risk. We included 40 studies (12,517 participants; 1298 participants with new ulcers) in a network meta-analysis involving 13 types of intervention. Data informing the network are sparse and this, together with the high risk of bias in most studies informing the network, means most network contrasts (64/78) yield evidence of very low certainty. There is low-certainty evidence that, compared with foam surfaces (reference treatment), reactive air surfaces (e.g. static air overlays) (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.29 to 0.75), alternating pressure (active) air surfaces (e.g. alternating pressure air mattresses, large-celled ripple mattresses) (RR 0.63, 95% CI 0.42 to 0.93), and reactive gel surfaces (e.g. gel pads used on operating tables) (RR 0.47, 95% CI 0.22 to 1.01) may reduce pressure ulcer incidence. The ranking of treatments in terms of effectiveness is also of very low certainty for all interventions. It is unclear which treatment is best for preventing ulceration. (2) Time to pressure ulcer incidence: four reviews had direct evidence on this outcome for seven comparisons. We included 10 studies (7211 participants; 699 participants with new ulcers) evaluating six interventions in a network meta-analysis. Again, data from most network contrasts (13/15) are of very low certainty. There is low-certainty evidence that, compared with foam surfaces (reference treatment), reactive air surfaces may reduce the hazard of developing new pressure ulcers (hazard ratio (HR) 0.20, 95% CI 0.04 to 1.05). The ranking of all support surfaces for preventing pressure ulcers in terms of time to healing is uncertain. (3) Cost-effectiveness: this overview includes direct evidence for three comparisons. For preventing pressure ulcers, alternating pressure air surfaces are probably more cost-effective than foam surfaces (moderate-certainty evidence). Pressure ulcer treatment: two reviews (of 12 studies with 972 participants) report direct evidence for five comparisons on: complete pressure ulcer healing, time to complete pressure ulcer healing, patient comfort response, adverse event rates, and cost-effectiveness. Here we focus on outcomes with some evidence at a minimum of low certainty. (1) Complete pressure ulcer healing: our overview includes direct evidence for five comparisons. There is uncertainty about the relative effects of beds, overlays and mattresses on ulcer healing. The corresponding network meta-analysis (with four studies, 397 participants) had only three direct contrasts and a total of six network contrasts. Again, most network contrasts (5/6) have very low-certainty evidence. There was low-certainty evidence that more people with pressure ulcers may heal completely using reactive air surfaces than using foam surfaces (RR 1.32, 95% CI 0.96 to 1.80). We are uncertain which surfaces have the highest probability of being the most effective (all very low-certainty evidence). (2) Time to complete pressure ulcer healing: this overview includes direct evidence for one comparison: people using reactive air surfaces may be more likely to have healed pressure ulcers compared with those using foam surfaces in long-term care settings (HR 2.66, 95% CI 1.34 to 5.17; low-certainty evidence). (3) Cost-effectiveness: this overview includes direct evidence for one comparison: compared with foam surfaces, reactive air surfaces may cost an extra 26 US dollars for every ulcer-free day in the first year of use in long-term care settings (low-certainty evidence). AUTHORS' CONCLUSIONS: Compared with foam surfaces, reactive air surfaces may reduce pressure ulcer risk and may increase complete ulcer healing. Compared with foam surfaces, alternating pressure air surfaces may reduce pressure ulcer risk and are probably more cost-effective in preventing pressure ulcers. Compared with foam surfaces, reactive gel surfaces may reduce pressure ulcer risk, particularly for people in operating rooms and long-term care settings. There are uncertainties for the relative effectiveness of other support surfaces for preventing and treating pressure ulcers, and their efficacy ranking. More high-quality research is required; for example, for the comparison of reactive air surfaces with alternating pressure air surfaces. Future studies should consider time-to-event outcomes and be designed to minimise any risk of bias.

Progress and challenges of network meta-analysis.

In the past years, network meta-analysis (NMA) has been widely used among clinicians, guideline makers, and health technology assessment agencies and has played an important role in clinical decision-making and guideline development. To inform further development of NMAs, we conducted a bibliometric analysis to assess the current status of published NMA methodological studies, summarized the methodological progress of seven types of NMAs, and discussed the current challenges of NMAs.

Compression bandages or stockings versus no compression for treating venous leg ulcers.

BACKGROUND: Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First-line treatment options often include the use of compression bandages or stockings. OBJECTIVES: To assess the effects of using compression bandages or stockings, compared with no compression, on the healing of venous leg ulcers in any setting and population. SEARCH METHODS: In June 2020 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions by language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials that compared any types of compression bandages or stockings with no compression in participants with venous leg ulcers in any setting. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, and risk-of-bias assessment using the Cochrane risk-of-bias tool. We assessed the certainty of the evidence according to GRADE methodology. MAIN RESULTS: We included 14 studies (1391 participants) in the review. Most studies were small (median study sample size: 51 participants). Participants were recruited from acute-care settings, outpatient settings and community settings, and a large proportion (65.9%; 917/1391) of participants had a confirmed history or clinical evidence of chronic venous disease, a confirmed cause of chronic venous insufficiency, or an ankle pressure/brachial pressure ratio of greater than 0.8 or 0.9. The average age of participants ranged from 58.0 to 76.5 years (median: 70.1 years). The average duration of their leg ulcers ranged from 9.0 weeks to 31.6 months (median: 22.0 months), and a large proportion of participants (64.8%; 901/1391) had ulcers with an area between 5 and 20 cm2. Studies had a median follow-up of 12 weeks. Compression bandages or stockings applied included short-stretch bandage, four-layer compression bandage, and Unna's boot (a type of inelastic gauze bandage impregnated with zinc oxide), and comparator groups used included 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where some participants received compression (but it was not the norm). Of the 14 included studies, 10 (71.4%) presented findings which we consider to be at high overall risk of bias. Primary outcomes There is moderate-certainty evidence (downgraded once for risk of bias) (1) that there is probably a shorter time to complete healing of venous leg ulcers in people wearing compression bandages or stockings compared with those not wearing compression (pooled hazard ratio for time-to-complete healing 2.17, 95% confidence interval (CI) 1.52 to 3.10; I2 = 59%; 5 studies, 733 participants); and (2) that people treated using compression bandages or stockings are more likely to experience complete ulcer healing within 12 months compared with people with no compression (10 studies, 1215 participants): risk ratio for complete healing 1.77, 95% CI 1.41 to 2.21; I2 = 65% (8 studies with analysable data, 1120 participants); synthesis without meta-analysis suggests more completely-healed ulcers in compression bandages or stockings than in no compression (2 studies without analysable data, 95 participants). It is uncertain whether there is any difference in rates of adverse events between using compression bandages or stockings and no compression (very low-certainty evidence; 3 studies, 585 participants). Secondary outcomes Moderate-certainty evidence suggests that people using compression bandages or stockings probably have a lower mean pain score than those not using compression (four studies with 859 participants and another study with 69 ulcers): pooled mean difference -1.39, 95% CI -1.79 to -0.98; I2 = 65% (two studies with 426 participants and another study with 69 ulcers having analysable data); synthesis without meta-analysis suggests a reduction in leg ulcer pain in compression bandages or stockings, compared with no compression (two studies without analysable data, 433 participants). Compression bandages or stockings versus no compression may improve disease-specific quality of life, but not all aspects of general health status during the follow-up of 12 weeks to 12 months (four studies with 859 participants; low-certainty evidence). It is uncertain if the use of compression bandages or stockings is more cost-effective than not using them (three studies with 486 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: If using compression bandages or stockings, people with venous leg ulcers probably experience complete wound healing more quickly, and more people have wounds completely healed. The use of compression bandages or stockings probably reduces pain and may improve disease-specific quality of life. There is uncertainty about adverse effects, and cost effectiveness. Future research should focus on comparing alternative bandages and stockings with the primary endpoint of time to complete wound healing alongside adverse events including pain score, and health-related quality of life, and should incorporate cost-effectiveness analysis where possible. Future studies should adhere to international standards of trial conduct and reporting.

Alternative reactive support surfaces (non-foam and non-air-filled) for preventing pressure ulcers.

BACKGROUND: Pressure ulcers (also known as injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive surfaces that are not made of foam or air cells can be used for preventing pressure ulcers. OBJECTIVES: To assess the effects of non-foam and non-air-filled reactive beds, mattresses or overlays compared with any other support surface on the incidence of pressure ulcers in any population in any setting. SEARCH METHODS: In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials that allocated participants of any age to non-foam or non-air-filled reactive beds, overlays or mattresses. Comparators were any beds, overlays or mattresses used. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a non-foam or non-air-filled surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses. MAIN RESULTS: We included 20 studies (4653 participants) in this review. Most studies were small (median study sample size: 198 participants). The average participant age ranged from 37.2 to 85.4 years (median: 72.5 years). Participants were recruited from a wide range of care settings but were mainly from acute care settings. Almost all studies were conducted in Europe and America. Of the 20 studies, 11 (2826 participants) included surfaces that were not well described and therefore could not be fully classified. We synthesised data for the following 12 comparisons: (1) reactive water surfaces versus alternating pressure (active) air surfaces (three studies with 414 participants), (2) reactive water surfaces versus foam surfaces (one study with 117 participants), (3) reactive water surfaces versus reactive air surfaces (one study with 37 participants), (4) reactive water surfaces versus reactive fibre surfaces (one study with 87 participants), (5) reactive fibre surfaces versus alternating pressure (active) air surfaces (four studies with 384 participants), (6) reactive fibre surfaces versus foam surfaces (two studies with 228 participants), (7) reactive gel surfaces on operating tables followed by foam surfaces on ward beds versus alternating pressure (active) air surfaces on operating tables and subsequently on ward beds (two studies with 415 participants), (8) reactive gel surfaces versus reactive air surfaces (one study with 74 participants), (9) reactive gel surfaces versus foam surfaces (one study with 135 participants), (10) reactive gel surfaces versus reactive gel surfaces (one study with 113 participants), (11) reactive foam and gel surfaces versus reactive gel surfaces (one study with 166 participants) and (12) reactive foam and gel surfaces versus foam surfaces (one study with 91 participants). Of the 20 studies, 16 (80%) presented findings which were considered to be at high overall risk of bias. PRIMARY OUTCOME: Pressure ulcer incidence We did not find analysable data for two comparisons: reactive water surfaces versus foam surfaces, and reactive water surfaces versus reactive fibre surfaces. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (14/205 (6.8%)) may increase the proportion of people developing a new pressure ulcer compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds (3/210 (1.4%) (risk ratio 4.53, 95% confidence interval 1.31 to 15.65; 2 studies, 415 participants; I2 = 0%; low-certainty evidence). For all other comparisons, it is uncertain whether there is a difference in the proportion of participants developing new pressure ulcers as all data were of very low certainty. Included studies did not report time to pressure ulcer incidence for any comparison in this review. Secondary outcomes Support-surface-associated patient comfort: the included studies provide data on this outcome for one comparison. It is uncertain if there is a difference in patient comfort between alternating pressure (active) air surfaces and reactive fibre surfaces (one study with 187 participants; very low-certainty evidence). All reported adverse events: there is evidence on this outcome for one comparison. It is uncertain if there is a difference in adverse events between reactive gel surfaces followed by foam surfaces and alternating pressure (active) air surfaces applied on both operating tables and hospital beds (one study with 198 participants; very low-certainty evidence). We did not find any health-related quality of life or cost-effectiveness evidence for any comparison in this review. AUTHORS' CONCLUSIONS: Current evidence is generally uncertain about the differences between non-foam and non-air-filled reactive surfaces and other surfaces in terms of pressure ulcer incidence, patient comfort, adverse effects, health-related quality of life and cost-effectiveness. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds may increase the risk of having new pressure ulcers compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision-makers. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and adjudicators of the photographs being blinded to group allocation. Further review using network meta-analysis will add to the findings reported here.

ANTECEDENTES: Las úlceras por presión (también conocidas como úlceras y escaras de decúbito) son lesiones localizadas en la piel o en los tejidos blandos subyacentes, o en ambos, causadas por la presión, el cizallamiento o la fricción no aliviados. Las superficies estáticas que no son de espuma o celdas de aire se pueden utilizar para prevenir las úlceras por presión. OBJETIVOS: Evaluar los efectos de las camas, los colchones o los sobrecolchones estáticos sin espuma y sin aire en comparación con cualquier otra superficie especial para el manejo de la presión (SEMP) o sobre la incidencia de las úlceras por presión en cualquier población y en cualquier contexto. MÉTODOS DE BÚSQUEDA: En noviembre de 2019 se hicieron búsquedas en el Registro especializado del Grupo Cochrane de Heridas (Cochrane Wounds), en el Registro Cochrane central de ensayos controlados (Cochrane Central Register of Controlled Trials, CENTRAL); Ovid MEDLINE (incluido In­Process & Other Non­Indexed Citations); Ovid Embase y EBSCO CINAHL Plus. También se buscaron estudios en curso y no publicados en los registros de ensayos clínicos, y se examinaron las listas de referencias de los estudios incluidos pertinentes, así como de las revisiones, los metanálisis y los informes de tecnología sanitaria para identificar estudios adicionales. No hubo restricciones en cuanto al idioma, la fecha de publicación ni el contexto de los estudios. CRITERIOS DE SELECCIÓN: Se incluyeron los ensayos controlados aleatorizados que asignaron a participantes de cualquier edad a camas, colchones o sobrecolchones estáticos sin espuma y sin aire. Los comparadores fueron todas las camas, sobrecolchones o colchones utilizados. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Al menos dos autores de la revisión evaluaron de forma independiente los ensayos según criterios de inclusión predeterminados. Se realizó la extracción de los datos, la evaluación del riesgo de sesgo mediante la herramienta Cochrane "Risk of bias" y la evaluación de la certeza de la evidencia según el método Grading of Recommendations, Assessment, Development and Evaluations. Si se comparaba una superficie sin espuma o sin aire con superficies que no estaban claramente especificadas, se registraba y describía el estudio incluido, pero no se tenía en cuenta en ningún análisis de datos. RESULTADOS PRINCIPALES: En esta revisión se incluyeron 20 estudios (4653 participantes). La mayoría de los estudios eran pequeños (mediana del tamaño muestral de los estudios: 198 participantes). La edad promedio de los participantes varió entre 37,2 y 85,4 años (mediana: 72,5 años). Los participantes se reclutaron en una amplia variedad de ámbitos asistenciales, pero principalmente en ámbitos de cuidados intensivos y de agudos. Casi todos los estudios se realizaron en Europa y América. De los 20 estudios, 11 (2826 participantes) incluían superficies que no estaban bien descritas y, por lo tanto, no se podían clasificar completamente. Se resumieron los datos de las 12 comparaciones siguientes: (1) superficies de agua estáticas versus superficies de aire de presión alternante (activas) (tres estudios con 414 participantes), (2) superficies de agua estáticas versus superficies de espuma (un estudio con 117 participantes), (3) superficies de agua estáticas versus superficies de aire estáticas (un estudio con 37 participantes), (4) superficies de agua estáticas versus superficies de fibras estáticas (un estudio con 87 participantes), (5) superficies de fibras estáticas versus superficies de aire de presión alternante (activas) (cuatro estudios con 384 participantes), (6) superficies de fibras estáticas versus superficies de espuma (dos estudios con 228 participantes), (7) superficies de gel estáticas en las mesas de operaciones, seguidas de superficies de espuma en las camas de las salas, versus superficies de aire de presión alternante (activas) en las mesas de operaciones y posteriormente en las camas de las salas (dos estudios con 415 participantes), (8) superficies de gel estáticas versus superficies de aire estáticas (un estudio con 74 participantes) (9) superficies de gel estáticas versus superficies de espuma (un estudio con 135 participantes), (10) superficies de gel estáticas versus superficies de gel estáticas (un estudio con 113 participantes), (11) superficies de espuma y gel estáticas versus superficies de gel estáticas (un estudio con 166 participantes) y (12) superficies de espuma y gel estáticas versus superficies de espuma (un estudio con 91 participantes). De los 20 estudios, 16 (80%) presentaron resultados que se consideraron con alto riesgo general de sesgo. Desenlace principal: incidencia de las úlceras por presión No se encontraron datos analizables para dos comparaciones: superficies de agua estáticas versus superficies de espuma, ni superficies de agua estáticas versus superficies de fibras estáticas. Las superficies de gel estáticas utilizadas en las mesas de operaciones seguidas de las superficies de espuma aplicadas en las camas de hospital (14/205 [6,8%]) podrían aumentar la proporción de personas que presentan una nueva úlcera por presión en comparación con las superficies de aire de presión alternante (activas) aplicadas en las mesas de operaciones y en las camas de hospital (3/210 [1,4%]) (razón de riesgos 4,53; intervalo de confianza del 95%: 1,31 a 15,65; dos estudios, 415 participantes; I2 = 0%; evidencia de certeza baja). Para todas las demás comparaciones, no hay certeza de que haya una diferencia en la proporción de participantes que presentan nuevas úlceras por presión, ya que todos los datos eran de certeza muy baja. Los estudios incluidos no informaron el tiempo hasta la incidencia de las úlceras por presión para ninguna comparación en esta revisión. Desenlaces secundarios Comodidad del paciente asociada con la SEMP: los estudios incluidos proporcionan datos sobre este desenlace para una comparación. No está claro si existe una diferencia en la comodidad del paciente entre las superficies de aire de presión alternante (activas) y las superficies de fibras estáticas (un estudio con 187 participantes; evidencia de certeza muy baja). Todos los eventos adversos informados: hay evidencia sobre este desenlace para una comparación. No se sabe si existe una diferencia en los eventos adversos entre las superficies de gel estáticas seguidas de superficies de espuma y las superficies de aire de presión alternante (activas) aplicadas tanto en las mesas de operaciones como en las camas de hospital (un estudio con 198 participantes; evidencia de certeza muy baja). No se encontró evidencia acerca de la calidad de vida relacionada con la salud ni de la coste­efectividad para ninguna comparación en esta revisión. CONCLUSIONES DE LOS AUTORES: Por lo general no se desconoce la evidencia actual sobre las diferencias entre las superficies estáticas sin espuma y sin aire y otras superficies en términos de la incidencia de las úlceras por presión, la comodidad del paciente, los efectos adversos, la calidad de vida relacionada con la salud y la coste­efectividad. Las superficies de gel estáticas utilizadas en las mesas de operaciones, seguidas de las superficies de espuma aplicadas en las camas de hospital, podrían aumentar el riesgo de aparición de nuevas úlceras por presión en comparación con las superficies de aire de presión alternante (activas) aplicadas en las mesas de operaciones y en las camas de hospital. Los estudios de investigación futuros en este campo deberían considerar la evaluación de las SEMP más importantes desde la perspectiva de aquellos que toman decisiones. En los estudios futuros se deben considerar los desenlaces de tiempo hasta el evento, la evaluación cuidadosa de los eventos adversos y la evaluación de la coste­efectividad a nivel de ensayo. Los ensayos deben estar diseñados para minimizar el riesgo de sesgo de detección; por ejemplo, con el uso de fotografía digital y el cegamiento de los adjudicatarios de las fotografías a la asignación a los grupos. Una revisión posterior mediante metanálisis en red ampliará los resultados aquí proporcionados.

Foam surfaces for preventing pressure ulcers.

BACKGROUND: Pressure ulcers (also known as pressure injuries) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Foam surfaces (beds, mattresses or overlays) are widely used with the aim of preventing pressure ulcers. OBJECTIVES: To assess the effects of foam beds, mattresses or overlays compared with any support surface on the incidence of pressure ulcers in any population in any setting. SEARCH METHODS: In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials that allocated participants of any age to foam beds, mattresses or overlays. Comparators were any beds, mattresses or overlays. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a foam surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses. MAIN RESULTS: We included 29 studies (9566 participants) in the review. Most studies were small (median study sample size: 101 participants). The average age of participants ranged from 47.0 to 85.3 years (median: 76.0 years). Participants were mainly from acute care settings. We analysed data for seven comparisons in the review: foam surfaces compared with: (1) alternating pressure air surfaces, (2) reactive air surfaces, (3) reactive fibre surfaces, (4) reactive gel surfaces, (5) reactive foam and gel surfaces, (6) reactive water surfaces, and (7) another type of foam surface. Of the 29 included studies, 17 (58.6%) presented findings which were considered at high overall risk of bias. PRIMARY OUTCOME: pressure ulcer incidence Low-certainty evidence suggests that foam surfaces may increase the risk of developing new pressure ulcers compared with (1) alternating pressure (active) air surfaces (risk ratio (RR) 1.59, 95% confidence interval (CI) 0.86 to 2.95; I2 = 63%; 4 studies, 2247 participants), and (2) reactive air surfaces (RR 2.40, 95% CI 1.04 to 5.54; I2 = 25%; 4 studies, 229 participants). We are uncertain regarding the difference in pressure ulcer incidence in people treated with foam surfaces and the following surfaces: (1) reactive fibre surfaces (1 study, 68 participants); (2) reactive gel surfaces (1 study, 135 participants); (3) reactive gel and foam surfaces (1 study, 91 participants); and (4) another type of foam surface (6 studies, 733 participants). These had very low-certainty evidence. Included studies have data on time to pressure ulcer development for two comparisons. When time to ulcer development is considered using hazard ratios, the difference in the risk of having new pressure ulcers, over 90 days' follow-up, between foam surfaces and alternating pressure air surfaces is uncertain (2 studies, 2105 participants; very low-certainty evidence). Two further studies comparing different types of foam surfaces also reported time-to-event data, suggesting that viscoelastic foam surfaces with a density of 40 to 60 kg/m3 may decrease the risk of having new pressure ulcers over 11.5 days' follow-up compared with foam surfaces with a density of 33 kg/m3 (1 study, 62 participants); and solid foam surfaces may decrease the risk of having new pressure ulcers over one month's follow-up compared with convoluted foam surfaces (1 study, 84 participants). Both had low-certainty evidence. There was no analysable data for the comparison of foam surfaces with reactive water surfaces (one study with 117 participants). Secondary outcomes Support-surface-associated patient comfort: the review contains data for three comparisons for this outcome. It is uncertain if there is a difference in patient comfort measure between foam surfaces and alternating pressure air surfaces (1 study, 76 participants; very low-certainty evidence); foam surfaces and reactive air surfaces (1 study, 72 participants; very low-certainty evidence); and different types of foam surfaces (4 studies, 669 participants; very low-certainty evidence). All reported adverse events: the review contains data for two comparisons for this outcome. We are uncertain about differences in adverse effects between foam surfaces and alternating pressure (active) air surfaces (3 studies, 2181 participants; very low-certainty evidence), and between foam surfaces and reactive air surfaces (1 study, 72 participants; very low-certainty evidence). Health-related quality of life: only one study reported data on this outcome. It is uncertain if there is a difference (low-certainty evidence) between foam surfaces and alternating pressure (active) air surfaces in health-related quality of life measured with two different questionnaires, the EQ-5D-5L (267 participants) and the PU-QoL-UI (233 participants). Cost-effectiveness: one study reported trial-based cost-effectiveness evaluations. Alternating pressure (active) air surfaces are probably more cost-effective than foam surfaces in preventing pressure ulcer incidence (2029 participants; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Current evidence suggests uncertainty about the differences in pressure ulcer incidence, patient comfort, adverse events and health-related quality of life between using foam surfaces and other surfaces (reactive fibre surfaces, reactive gel surfaces, reactive foam and gel surfaces, or reactive water surfaces). Foam surfaces may increase pressure ulcer incidence compared with alternating pressure (active) air surfaces and reactive air surfaces. Alternating pressure (active) air surfaces are probably more cost-effective than foam surfaces in preventing new pressure ulcers. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision-makers. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and by blinding adjudicators of the photographs to group allocation. Further review using network meta-analysis will add to the findings reported here.

ANTECEDENTES: Las úlceras por presión (también conocidas como úlceras de decúbito) son lesiones localizadas en la piel o en los tejidos blandos subyacentes, o en ambos, y causadas por la presión, el cizallamiento o la fricción no aliviados. Las superficies de espuma (camas, colchones o sobrecolchones) se utilizan ampliamente con el objetivo de prevenir las úlceras por presión. OBJETIVOS: Evaluar los efectos de las camas, los colchones o los sobrecolchones de espuma en comparación con cualquier superficie especial de manejo de presión (SEMP) sobre la incidencia de las úlceras por presión en cualquier población y en cualquier ámbito. MÉTODOS DE BÚSQUEDA: En noviembre de 2019 se realizaron búsquedas en el Registro especializado del Grupo Cochrane de Heridas (Cochrane Wounds); en el Registro Cochrane central de ensayos controlados (Cochrane Central Register of Controlled Trials; CENTRAL); en Ovid MEDLINE (incluido In­Process & Other Non­Indexed Citations); en Ovid Embase y en EBSCO CINAHL Plus. También se buscaron estudios en curso y no publicados en los registros de ensayos clínicos, y se examinaron las listas de referencias de los estudios incluidos pertinentes, así como de las revisiones, los metanálisis y los informes de tecnología sanitaria para identificar estudios adicionales. No hubo restricciones en cuanto al idioma, la fecha de publicación ni el contexto de los estudios. CRITERIOS DE SELECCIÓN: Se incluyeron los ensayos controlados aleatorizados que asignaron a participantes de cualquier edad a camas, colchones o sobrecolchones de espuma. Los comparadores fueron cualquier cama, colchón o sobrecolchón. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Al menos dos autores de la revisión evaluaron de forma independiente los ensayos según los criterios de inclusión predeterminados. Se realizó la extracción de los datos, la evaluación del "riesgo de sesgo" mediante la herramienta Cochrane "Risk of bias" y la evaluación de la certeza de la evidencia según el método Grading of Recommendations, Assessment, Development and Evaluations. Si se comparaba una superficie de espuma con superficies que no estaban claramente especificadas, se registraba y describía el estudio incluido, pero no se tenía en cuenta en ningún análisis de datos. RESULTADOS PRINCIPALES: En la revisión se incluyeron 29 estudios (9566 participantes). La mayoría de los estudios eran pequeños (mediana del tamaño muestral de los estudios: 101 participantes). El promedio de edad de los participantes varió entre 47,0 y 85,3 años (mediana: 76,0 años). Los participantes procedían principalmente de ámbitos de cuidados intensivos y de agudos. En la revisión se analizaron los datos de siete comparaciones: superficies de espuma comparadas con: (1) superficies de aire de presión alternante, (2) superficies de aire estáticas, (3) superficies de fibra estáticas, (4) superficies de gel estáticas, (5) superficies de espuma y gel estáticas, (6) superficies de agua estáticas y (7) otro tipo de superficie de espuma. De los 29 estudios incluidos, 17 (58,6%) presentaron resultados que se consideraron con alto riesgo general de sesgo. Desenlace principal: incidencia de úlceras por presión Evidencia de certeza baja indica que las superficies de espuma podrían aumentar el riesgo de desarrollar nuevas úlceras por presión en comparación con (1) las superficies de aire de presión alternante (activas) (razón de riesgos [RR] 1,59; intervalo de confianza [IC] del 95%: 0,86 a 2,95; I2 = 63%; cuatro estudios, 2247 participantes) y (2) las superficies de aire estáticas (RR 2,40; IC del 95%: 1,04 a 5,54; I2 = 25%; cuatro estudios, 229 participantes). No hay certeza acerca de la diferencia en la incidencia de las úlceras por presión en las personas tratadas con superficies de espuma y las siguientes superficies: (1) superficies de fibras estáticas (un estudio, 68 participantes); (2) superficies de gel estáticas (un estudio, 135 participantes); (3) superficies estáticas de gel y espuma (un estudio, 91 participantes); y (4) otro tipo de superficies de espuma (seis estudios, 733 participantes). Al respecto se cuenta con evidencia de certeza muy baja. Los estudios incluidos cuentan con datos sobre el tiempo hasta la aparición de úlceras por presión para dos comparaciones. Cuando se considera el tiempo hasta la aparición de la úlcera con el uso de los cocientes de riesgos instantáneos, no está clara la diferencia en el riesgo de tener nuevas úlceras por presión, durante 90 días de seguimiento, entre las superficies de espuma y las de aire de presión alternante (dos estudios, 2105 participantes; evidencia de certeza muy baja). Otros dos estudios que compararon diferentes tipos de superficies de espuma también proporcionaron datos sobre el tiempo hasta el evento, e indicaron que las superficies de espuma viscoelástica con una densidad de 40 a 60 kg/m3 podrían disminuir el riesgo de presentar nuevas úlceras por presión durante 11,5 días de seguimiento en comparación con las superficies de espuma con una densidad de 33 kg/m3 (un estudio, 62 participantes) y las superficies de espuma sólida podrían disminuir el riesgo de presentar nuevas úlceras por presión durante un mes de seguimiento en comparación con las superficies de espuma alveolar (un estudio, 84 participantes). Ambos con evidencia de certeza baja. No hubo datos que se pudieran analizar para la comparación de las superficies de espuma con las de agua estáticas (un estudio con 117 participantes). Desenlaces secundarios Comodidad del paciente asociada con la SEMP: la revisión contiene datos de tres comparaciones para este desenlace. No se sabe si existe una diferencia en la medida de comodidad del paciente entre las superficies de espuma y las superficies de aire de presión alternante (un estudio, 76 participantes; evidencia de certeza muy baja); las superficies de espuma y las superficies de aire estáticas (un estudio, 72 participantes; evidencia de certeza muy baja); y los diferentes tipos de superficies de espuma (cuatro estudios, 669 participantes; evidencia de certeza muy baja). Todos los eventos adversos informados: la revisión contiene datos de dos comparaciones para este desenlace. No están claras las diferencias en los efectos adversos entre las superficies de espuma y las superficies de aire de presión alternante (activas) (tres estudios, 2181 participantes; evidencia de certeza muy baja), ni entre las superficies de espuma y las superficies de aire estáticas (un estudio, 72 participantes; evidencia de certeza muy baja). Calidad de vida relacionada con la salud: sólo un estudio proporcionó datos sobre este desenlace. No se sabe si existe una diferencia (evidencia de certeza baja) entre las superficies de espuma y las superficies de aire de presión alternante (activas) en la calidad de vida relacionada con la salud medida con dos cuestionarios diferentes, el EQ­5D­5L (267 participantes) y el PU­QoL­UI (233 participantes). Coste­efectividad: un estudio proporcionó evaluaciones de coste­efectividad a nivel de ensayo. Las superficies de aire de presión alternante (activas) son probablemente más coste­efectivas que las superficies de espuma en la prevención de la incidencia de las úlceras por presión (2029 participantes; evidencia de certeza moderada). CONCLUSIONES DE LOS AUTORES: La evidencia actual indica que no hay certeza acerca de las diferencias en la incidencia de las úlceras por presión, la comodidad del paciente, los eventos adversos ni la calidad de vida relacionada con la salud entre el uso de superficies de espuma y otras SEMP (superficies de fibras estáticas, superficies de gel estáticas, superficies de espuma y gel estáticas o superficies de agua estáticas). Las superficies de espuma podrían aumentar la incidencia de las úlceras por presión en comparación con las superficies de aire de presión alternante (activas) y las superficies de aire estáticas. Las superficies de aire de presión alternante (activas) son probablemente más coste­efectivas que las superficies de espuma para prevenir nuevas úlceras por presión. Los estudios de investigación futuros en este campo deberían considerar la evaluación de las SEMP más importantes desde la perspectiva de los responsables de la toma de decisiones. En los estudios futuros se deben considerar los desenlaces de tiempo hasta el evento, la evaluación cuidadosa de los eventos adversos y la evaluación de la coste­efectividad a nivel de ensayo. Los ensayos deben estar diseñados para minimizar el riesgo de sesgo de detección; por ejemplo, con el uso de fotografía digital y el cegamiento de los adjudicatarios de las fotografías a la asignación a los grupos. Una revisión posterior mediante metanálisis en red ampliará los resultados aquí proporcionados.

Beds, overlays and mattresses for treating pressure ulcers.

BACKGROUND: Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Beds, overlays or mattresses are widely used with the aim of treating pressure ulcers. OBJECTIVES: To assess the effects of beds, overlays and mattresses on pressure ulcer healing in people with pressure ulcers of any stage, in any setting. SEARCH METHODS: In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials that allocated participants of any age to pressure-redistributing beds, overlays or mattresses. Comparators were any beds, overlays or mattresses that were applied for treating pressure ulcers. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. MAIN RESULTS: We included 13 studies (972 participants) in the review. Most studies were small (median study sample size: 72 participants). The average age of participants ranged from 64.0 to 86.5 years (median: 82.7 years) and all studies recruited people with existing pressure ulcers (the baseline ulcer area size ranging from 4.2 to 18.6 cm2,median 6.6 cm2). Participants were recruited from acute care settings (six studies) and community and long-term care settings (seven studies). Of the 13 studies, three (224 participants) involved surfaces that were not well described and therefore could not be classified. Additionally, six (46.2%) of the 13 studies presented findings which were considered at high overall risk of bias. We synthesised data for four comparisons in the review: alternating pressure (active) air surfaces versus foam surfaces; reactive air surfaces versus foam surfaces; reactive water surfaces versus foam surfaces, and a comparison between two types of alternating pressure (active) air surfaces. We summarise key findings for these four comparisons below. (1) Alternating pressure (active) air surfaces versus foam surfaces: we are uncertain if there is a difference between alternating pressure (active) air surfaces and foam surfaces in the proportion of participants whose pressure ulcers completely healed (two studies with 132 participants; the reported risk ratio (RR) in one study was 0.97, 95% confidence interval (CI) 0.26 to 3.58). There is also uncertainty for the outcomes of patient comfort (one study with 83 participants) and adverse events (one study with 49 participants). These outcomes have very low-certainty evidence. Included studies did not report time to complete ulcer healing, health-related quality of life, or cost effectiveness. (2) Reactive air surfaces versus foam surfaces: it is uncertain if there is a difference in the proportion of participants with completely healed pressure ulcers between reactive air surfaces and foam surfaces (RR 1.32, 95% CI 0.96 to 1.80; I2 = 0%; 2 studies, 156 participants; low-certainty evidence). When time to complete pressure ulcer healing is considered using a hazard ratio, data from one small study (84 participants) suggests a greater hazard for complete ulcer healing on reactive air surfaces (hazard ratio 2.66, 95% CI 1.34 to 5.17; low-certainty evidence). These results are sensitive to the choice of outcome measure so should be interpreted as uncertain. We are also uncertain whether there is any difference between these surfaces in patient comfort responses (1 study, 72 participants; very low-certainty evidence) and in adverse events (2 studies, 156 participants; low-certainty evidence). There is low-certainty evidence that reactive air surfaces may cost an extra 26 US dollars for every ulcer-free day in the first year of use (1 study, 87 participants). Included studies did not report health-related quality of life. (3) Reactive water surfaces versus foam surfaces: it is uncertain if there is a difference between reactive water surfaces and foam surfaces in the proportion of participants with healed pressure ulcers (RR 1.07, 95% CI 0.70 to 1.63; 1 study, 101 participants) and in adverse events (1 study, 120 participants). All these have very low-certainty evidence. Included studies did not report time to complete ulcer healing, patient comfort, health-related quality of life, or cost effectiveness. (4) Comparison between two types of alternating pressure (active) air surfaces: it is uncertain if there is a difference between Nimbus and Pegasus alternating pressure (active) air surfaces in the proportion of participants with healed pressure ulcers, in patient comfort responses and in adverse events: each of these outcomes had four studies (256 participants) but very low-certainty evidence. Included studies did not report time to complete ulcer healing, health-related quality of life, or cost effectiveness. AUTHORS' CONCLUSIONS: We are uncertain about the relative effects of most different pressure-redistributing surfaces for pressure ulcer healing (types directly compared are alternating pressure air surfaces versus foam surfaces, reactive air surfaces versus foam surfaces, reactive water surfaces versus foam surfaces, and Nimbus versus Pegasus alternating pressure (active) air surfaces). There is also uncertainty regarding the effects of these different surfaces on the outcomes of comfort and adverse events. However, people using reactive air surfaces may be more likely to have pressure ulcers completely healed than those using foam surfaces over 37.5 days' follow-up, and reactive air surfaces may cost more for each ulcer-free day than foam surfaces. Future research in this area could consider the evaluation of alternating pressure air surfaces versus foam surfaces as a high priority. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Further review using network meta-analysis will add to the findings reported here.

Alternating pressure (active) air surfaces for preventing pressure ulcers.

BACKGROUND: Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Alternating pressure (active) air surfaces are widely used with the aim of preventing pressure ulcers. OBJECTIVES: To assess the effects of alternating pressure (active) air surfaces (beds, mattresses or overlays) compared with any support surface on the incidence of pressure ulcers in any population in any setting. SEARCH METHODS: In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials that allocated participants of any age to alternating pressure (active) air beds, overlays or mattresses. Comparators were any beds, overlays or mattresses. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. MAIN RESULTS: We included 32 studies (9058 participants) in the review. Most studies were small (median study sample size: 83 participants). The average age of participants ranged from 37.2 to 87.0 years (median: 69.1 years). Participants were largely from acute care settings (including accident and emergency departments). We synthesised data for six comparisons in the review: alternating pressure (active) air surfaces versus: foam surfaces, reactive air surfaces, reactive water surfaces, reactive fibre surfaces, reactive gel surfaces used in the operating room followed by foam surfaces used on the ward bed, and another type of alternating pressure air surface. Of the 32 included studies, 25 (78.1%) presented findings which were considered at high overall risk of bias. PRIMARY OUTCOME: pressure ulcer incidence Alternating pressure (active) air surfaces may reduce the proportion of participants developing a new pressure ulcer compared with foam surfaces (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.34 to 1.17; I2 = 63%; 4 studies, 2247 participants; low-certainty evidence). Alternating pressure (active) air surfaces applied on both operating tables and hospital beds may reduce the proportion of people developing a new pressure ulcer compared with reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (RR 0.22, 95% CI 0.06 to 0.76; I2 = 0%; 2 studies, 415 participants; low-certainty evidence). It is uncertain whether there is a difference in the proportion of people developing new pressure ulcers between alternating pressure (active) air surfaces and the following surfaces, as all these comparisons have very low-certainty evidence: (1) reactive water surfaces; (2) reactive fibre surfaces; and (3) reactive air surfaces. The comparisons between different types of alternating pressure air surfaces are presented narratively. Overall, all comparisons suggest little to no difference between these surfaces in pressure ulcer incidence (7 studies, 2833 participants; low-certainty evidence). Included studies have data on time to pressure ulcer incidence for three comparisons. When time to pressure ulcer development is considered using a hazard ratio (HR), it is uncertain whether there is a difference in the risk of developing new pressure ulcers, over 90 days' follow-up, between alternating pressure (active) air surfaces and foam surfaces (HR 0.41, 95% CI 0.10 to 1.64; I2 = 86%; 2 studies, 2105 participants; very low-certainty evidence). For the comparison with reactive air surfaces, there is low-certainty evidence that people treated with alternating pressure (active) air surfaces may have a higher risk of developing an incident pressure ulcer than those treated with reactive air surfaces over 14 days' follow-up (HR 2.25, 95% CI 1.05 to 4.83; 1 study, 308 participants). Neither of the two studies with time to ulcer incidence data suggested a difference in the risk of developing an incident pressure ulcer over 60 days' follow-up between different types of alternating pressure air surfaces. Secondary outcomes The included studies have data on (1) support-surface-associated patient comfort for comparisons involving foam surfaces, reactive air surfaces, reactive fibre surfaces and alternating pressure (active) air surfaces; (2) adverse events for comparisons involving foam surfaces, reactive gel surfaces and alternating pressure (active) air surfaces; and (3) health-related quality of life outcomes for the comparison involving foam surfaces. However, all these outcomes and comparisons have low or very low-certainty evidence and it is uncertain whether there are any differences in these outcomes. Included studies have data on cost effectiveness for two comparisons. Moderate-certainty evidence suggests that alternating pressure (active) air surfaces are probably more cost-effective than foam surfaces (1 study, 2029 participants) and that alternating pressure (active) air mattresses are probably more cost-effective than overlay versions of this technology for people in acute care settings (1 study, 1971 participants). AUTHORS' CONCLUSIONS: Current evidence is uncertain about the difference in pressure ulcer incidence between using alternating pressure (active) air surfaces and other surfaces (reactive water surfaces, reactive fibre surfaces and reactive air surfaces). Alternating pressure (active) air surfaces may reduce pressure ulcer risk compared with foam surfaces and reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds. People using alternating pressure (active) air surfaces may be more likely to develop new pressure ulcers over 14 days' follow-up than those treated with reactive air surfaces in the nursing home setting; but as the result is sensitive to the choice of outcome measure it should be interpreted cautiously. Alternating pressure (active) air surfaces are probably more cost-effective than reactive foam surfaces in preventing new pressure ulcers. Future studies should include time-to-event outcomes and assessment of adverse events and trial-level cost-effectiveness. Further review using network meta-analysis will add to the findings reported here.

Reactive air surfaces for preventing pressure ulcers.

BACKGROUND: Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive air surfaces (beds, mattresses or overlays) can be used for preventing pressure ulcers. OBJECTIVES: To assess the effects of reactive air beds, mattresses or overlays compared with any support surface on the incidence of pressure ulcers in any population in any setting. SEARCH METHODS: In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials that allocated participants of any age to reactive air beds, overlays or mattresses. Comparators were any beds, overlays or mattresses that were applied for preventing pressure ulcers. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a reactive air surface was compared with surfaces that were not clearly specified, then we recorded and described the concerned study but did not included it in further data analyses. MAIN RESULTS: We included 17 studies (2604 participants) in this review. Most studies were small (median study sample size: 83 participants). The average participant age ranged from 56 to 87 years (median: 72 years). Participants were recruited from a wide range of care settings with the majority being acute care settings. Almost all studies were conducted in the regions of Europe and America. Of the 17 included studies, two (223 participants) compared reactive air surfaces with surfaces that were not well described and therefore could not be classified. We analysed data for five comparisons: reactive air surfaces compared with (1) alternating pressure (active) air surfaces (seven studies with 1728 participants), (2) foam surfaces (four studies with 229 participants), (3) reactive water surfaces (one study with 37 participants), (4) reactive gel surfaces (one study with 66 participants), and (5) another type of reactive air surface (two studies with 223 participants). Of the 17 studies, seven (41.2%) presented findings which were considered at high overall risk of bias. PRIMARY OUTCOME: Pressure ulcer incidence Reactive air surfaces may reduce the proportion of participants developing a new pressure ulcer compared with foam surfaces (risk ratio (RR) 0.42; 95% confidence interval (CI) 0.18 to 0.96; I2 = 25%; 4 studies, 229 participants; low-certainty evidence). It is uncertain if there is a difference in the proportions of participants developing a new pressure ulcer on reactive air surfaces compared with: alternating pressure (active) air surfaces (6 studies, 1648 participants); reactive water surfaces (1 study, 37 participants); reactive gel surfaces (1 study, 66 participants), or another type of reactive air surface (2 studies, 223 participants). Evidence for all these comparisons is of very low certainty. Included studies have data on time to pressure ulcer incidence for two comparisons. When time to pressure ulcer incidence is considered using a hazard ratio (HR), low-certainty evidence suggests that in the nursing home setting, people on reactive air surfaces may be less likely to develop a new pressure ulcer over 14 days' of follow-up than people on alternating pressure (active) air surfaces (HR 0.44; 95% CI 0.21 to 0.96; 1 study, 308 participants). It is uncertain if there is a difference in the hazard of developing new pressure ulcers between two types of reactive air surfaces (1 study, 123 participants; very low-certainty evidence). Secondary outcomes Support-surface-associated patient comfort: the included studies have data on this outcome for three comparisons. We could not pool any data as comfort outcome measures differed between included studies; therefore a narrative summary is provided. It is uncertain if there is a difference in patient comfort responses between reactive air surfaces and foam surfaces over the top of an alternating pressure (active) air surfaces (1 study, 72 participants), and between those using reactive air surfaces and those using alternating pressure (active) air surfaces (4 studies, 1364 participants). Evidence for these two comparisons is of very low certainty. It is also uncertain if there is a difference in patient comfort responses between two types of reactive air surfaces (1 study, 84 participants; low-certainty evidence). All reported adverse events: there were data on this outcome for one comparison: it is uncertain if there is a difference in adverse events between reactive air surfaces and foam surfaces (1 study, 72 participants; very low-certainty evidence). The included studies have no data for health-related quality of life and cost-effectiveness for all five comparisons. AUTHORS' CONCLUSIONS: Current evidence is uncertain regarding any differences in the relative effects of reactive air surfaces on ulcer incidence and patient comfort, when compared with reactive water surfaces, reactive gel surfaces, or another type of reactive air surface. Using reactive air surfaces may reduce the risk of developing new pressure ulcers compared with using foam surfaces. Also, using reactive air surfaces may reduce the risk of developing new pressure ulcers within 14 days compared with alternating pressure (active) air surfaces in people in a nursing home setting. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision-makers. Time-to-event outcomes, careful assessment of adverse events and trial-level cost-effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and adjudicators of the photographs being blinded to group allocation. Further review using network meta-analysis will add to the findings reported here.

ANTECEDENTES: Las úlceras por presión (también conocidas como escaras o úlceras de decúbito) son lesiones localizadas en la piel o en los tejidos blandos subyacentes, o en ambos, causadas por la presión, el roce o la fricción no aliviados. Las superficies de aire estáticas (camas, colchones o sobrecolchones) se pueden utilizar para prevenir las úlceras por presión. OBJETIVOS: Evaluar los efectos de las camas, los colchones o los sobrecolchones de aire estáticos en comparación con cualquier superficie especial para el manejo de la presión (SEMP) sobre la incidencia de las úlceras por presión en cualquier población y en cualquier ámbito. MÉTODOS DE BÚSQUEDA: En noviembre de 2019 se hicieron búsquedas en el Registro especializado del Grupo Cochrane de Heridas (Cochrane Wounds), en el Registro Cochrane central de ensayos controlados (CENTRAL); Ovid MEDLINE (incluido In­Process & Other Non­Indexed Citations); Ovid Embase y EBSCO CINAHL Plus. También se buscaron estudios en curso y no publicados en los registros de ensayos clínicos, y se examinaron las listas de referencias de los estudios incluidos pertinentes, así como de las revisiones, los metanálisis y los informes de tecnología sanitaria para identificar estudios adicionales. No hubo restricciones en cuanto al idioma, la fecha de publicación ni el contexto de los estudios. CRITERIOS DE SELECCIÓN: Se incluyeron los ensayos controlados aleatorizados que asignaron a participantes de cualquier edad a camas, colchones o sobrecolchones de aire estáticos. Los comparadores fueron cualquier cama, colchón o sobrecolchón utilizados para prevenir las úlceras por presión. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Al menos dos autores de la revisión evaluaron de forma independiente los ensayos según criterios de inclusión predeterminados. Se realizó la extracción de los datos, la evaluación del riesgo de sesgo mediante la herramienta Cochrane "Risk of bias" y la evaluación de la certeza de la evidencia según el método Grading of Recommendations, Assessment, Development and Evaluations. Si se comparaba una superficie de aire estática con superficies que no estaban claramente especificadas, se registraba y describía el estudio en cuestión pero no se incluía en análisis de datos adicionales. RESULTADOS PRINCIPALES: En esta revisión se incluyeron 17 estudios (2604 participantes). La mayoría de los estudios eran pequeños (mediana del tamaño muestral de los estudios: 83 participantes). La media de edad de los participantes varió entre 56 y 87 años (mediana: 72 años). Los participantes fueron reclutados en una amplia variedad de ámbitos asistenciales, siendo la mayoría de ellos ámbitos de cuidados intensivos y de agudos. Casi todos los estudios se realizaron en las regiones de Europa y América. De los 17 estudios incluidos, dos (223 participantes) compararon superficies de aire estáticas con superficies que no estaban bien descritas y, por tanto, no pudieron clasificarse. Se analizaron los datos de cinco comparaciones: superficies de aire estáticas comparadas con (1) superficies de aire de presión alternante (activas) (siete estudios con 1728 participantes), (2) superficies de espuma (cuatro estudios con 229 participantes), (3) superficies de agua estáticas (un estudio con 37 participantes), (4) superficies de gel estáticas (un estudio con 66 participantes) y (5) otro tipo de superficies de aire estáticas (dos estudios con 223 participantes). De los 17 estudios incluidos, siete (41,2%) presentaron resultados que se consideraron con alto riesgo general de sesgo. Desenlace principal: incidencia de úlceras por presión Las superficies de aire estáticas podrían reducir la proporción de participantes que desarrollan nuevas úlceras por presión en comparación con las superficies de espuma (razón de riesgos [RR] 0,42; intervalo de confianza [IC] del 95%: 0,18 a 0,96; I2 = 25%; cuatro estudios, 229 participantes; evidencia de certeza baja). No se sabe si existe una diferencia en las proporciones de participantes que desarrollan una nueva úlcera por presión en superficies de aire estáticas en comparación con: superficies de aire de presión alternante (activas) (seis estudios, 1648 participantes); superficies de agua estáticas (un estudio, 37 participantes); superficies de gel estáticas (un estudio, 66 participantes) u otro tipo de superficies de aire estáticas (dos estudios, 223 participantes). La evidencia para todas estas comparaciones es de certeza muy baja. Los estudios incluidos cuentan con datos sobre el tiempo hasta la incidencia de úlceras por presión para dos comparaciones. Cuando el tiempo hasta la incidencia de la úlcera por presión se considera con el cociente de riesgos instantáneos (CRI), la evidencia de certeza baja indica que en el ámbito de las residencia de ancianos, las personas sobre superficies de aire estáticas podrían tener menos probabilidades de presentar una nueva úlcera por presión a lo largo de 14 días de seguimiento que las personas sobre superficies de aire de presión alternante (activas) (CRI 0,44; IC del 95%: 0,21 a 0,96; un estudio, 308 participantes). No se sabe si hay una diferencia en el riesgo de presentar nuevas úlceras por presión entre dos tipos de superficies de aire estáticas (un estudio, 123 participantes; evidencia de certeza muy baja). Desenlaces secundarios Comodidad del paciente asociada con la SEMP: los estudios incluidos contienen datos de tres comparaciones para este desenlace. No fue posible agrupar los datos puesto que las medidas de desenlace de comodidad difirieron entre los estudios incluidos; por lo tanto, se proporciona un resumen narrativo. No se sabe si existe una diferencia en las respuestas de comodidad del paciente entre las superficies de espuma y las superficies de aire estáticas sobre superficies de aire de presión alternante (activas) (un estudio, 72 participantes) ni entre aquellos que utilizaron superficies de aire estáticas y los que utilizaron superficies de aire de presión alternante (activas) (cuatro estudios, 1364 participantes). La evidencia para estas dos comparaciones es de certeza muy baja. Tampoco se sabe si hay una diferencia en las respuestas de comodidad de los pacientes entre dos tipos de superficies de aire estáticas (un estudio, 84 participantes; evidencia de certeza baja). Todos los eventos adversos notificados: hubo datos sobre este desenlace para una comparación: no se sabe si existe una diferencia en los eventos adversos entre las superficies de aire estáticas y las superficies de espuma (un estudio, 72 participantes; evidencia de certeza muy baja). Los estudios incluidos no tienen datos sobre la calidad de vida relacionada con la salud y la coste­efectividad para ninguna de las cinco comparaciones. CONCLUSIONES DE LOS AUTORES: La evidencia actual es incierta en cuanto a las diferencias en los efectos relativos de las superficies de aire estáticas sobre la incidencia de úlceras y la comodidad del paciente, cuando se compararon con las superficies de agua estáticas, las superficies de gel estáticas u otro tipo de superficies de aire estáticas. El uso de superficies de aire estáticas podría reducir el riesgo de aparición de nuevas úlceras por presión en comparación con el uso de superficies de espuma. Además, el uso de superficies de aire estáticas podría reducir el riesgo de aparición de nuevas úlceras por presión en los 14 días siguientes en comparación las superficies de aire de presión alternante (activas) en personas en una residencia de ancianos. Los estudios de investigación futuros en este campo deberían considerar la evaluación de las SEMP más importantes desde la perspectiva de aquellos que toman decisiones. En los estudios futuros se deben considerar los desenlaces de tiempo hasta el evento, la evaluación cuidadosa de los eventos adversos y la evaluación de la coste­efectividad a nivel de ensayo. Los ensayos deben estar diseñados para minimizar el riesgo de sesgo de detección; por ejemplo, con el uso de fotografía digital y el cegamiento de los adjudicatarios de las fotografías a la asignación a los grupos. Una revisión posterior mediante metanálisis en red ampliará los resultados aquí proporcionados.

Bacteria and bioburden and healing in complex wounds: A prognostic systematic review.

The wound microbiome may play an important role in the wound healing process. We conducted the first systematic prognosis review investigating whether aspects of the wound microbiome are independent prognostic factors for the healing of complex wounds. We searched Medline, Embase, CINAHL and the Cochrane Library to February 2019. We included longitudinal studies which assessed the independent association of aspects of wound microbiome with healing of complex wounds while controlling for confounding factors. Two reviewers extracted data and assessed risk of bias and certainty of evidence using the GRADE approach. We synthesised studies narratively due to the clinical and methodological heterogeneity of included studies and sparse data. We identified 28 cohorts from 21 studies with a total of 38,604 participants, including people with diabetes and foot ulcers, open surgical wounds, venous leg ulcers and pressure ulcers. Risk of bias varied from low (2 cohorts) to high (17 cohorts); the great majority of participants were in cohorts at high risk of bias. Most evidence related to the association of baseline clinical wound infection with healing. Clinical infection at baseline may be associated with less likelihood of wound healing in foot ulcers in diabetes (HR from cohort with moderate risk of bias 0.53, 95% CI 0.33 to 0.83) or slower healing in open surgical wounds (HR 0.65, 95% CI 0.51 to 0.83); evidence in other wounds is more limited. Most other associations assessed showed no clear relationship with wound healing; evidence was limited and often sparse; and we documented gaps in the evidence. There is low certainty evidence that a diagnosis of wound infection may be prognostic of poorer healing in foot ulcers in diabetes, and some moderate certainty evidence for this in open surgical wounds. Low certainty evidence means that more research could change these findings.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In June 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. MAIN RESULTS: In this third update, we added 15 new randomised controlled trials (RCTs) and three new economic studies, resulting in a total of 44 RCTs (7447 included participants) and five economic studies. Studies evaluated NPWT in the context of a wide range of surgeries including orthopaedic, obstetric, vascular and general procedures. Economic studies assessed NPWT in orthopaedic, obstetric and general surgical settings. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Four studies (2107 participants) reported mortality. There is low-certainty evidence (downgraded twice for imprecision) showing no clear difference in the risk of death after surgery for people treated with NPWT (2.3%) compared with standard dressings (2.7%) (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.50 to 1.47; I2 = 0%). Thirty-nine studies reported SSI; 31 of these (6204 participants), were included in meta-analysis. There is moderate-certainty evidence (downgraded once for risk of bias) that NPWT probably results in fewer SSI (8.8% of participants) than treatment with standard dressings (13.0% of participants) after surgery; RR 0.66 (95% CI 0.55 to 0.80 ; I2 = 23%). Eighteen studies reported dehiscence; 14 of these (3809 participants) were included in meta-analysis. There is low-certainty evidence (downgraded once for risk of bias and once for imprecision) showing no clear difference in the risk of dehiscence after surgery for NPWT (5.3% of participants) compared with standard dressings (6.2% of participants) (RR 0.88, 95% CI 0.69 to 1.13; I2 = 0%). Secondary outcomes There is low-certainty evidence showing no clear difference between NPWT and standard treatment for the outcomes of reoperation and incidence of seroma. For reoperation, the RR was 1.04 (95% CI 0.78 to 1.41; I2 = 13%; 12 trials; 3523 participants); for seroma, the RR was 0.72 (95% CI 0.50 to 1.05; I2 = 0%; seven trials; 729 participants). The effect of NPWT on occurrence of haematoma or skin blisters is uncertain (very low-certainty evidence); for haematoma, the RR was 0.67 (95% CI 0.28 to 1.59; I2 = 0%; nine trials; 1202 participants) and for blisters the RR was 2.64 (95% CI 0.65 to 10.68; I2 = 69%; seven trials; 796 participants). The overall effect of NPWT on pain is uncertain (very low-certainty evidence from seven trials (2218 participants) which reported disparate measures of pain); but moderate-certainty evidence suggests there is probably little difference between the groups in pain after three or six months following surgery for lower limb fracture (one trial, 1549 participants). There is also moderate-certainty evidence for women undergoing caesarean sections (one trial, 876 participants) and people having surgery for lower limb fractures (one trial, 1549 participants) that there is probably little difference in quality of life scores at 30 days or 3 or 6 months, respectively. Cost-effectiveness Five economic studies, based wholly or partially on trials included in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in four indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty and coronary artery bypass graft surgery. They calculated quality-adjusted life-years for treatment groups and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the grade of the evidence varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People experiencing primary wound closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSI than people treated with standard dressings (moderate-certainty evidence). There is no clear difference in number of deaths or wound dehiscence between people treated with NPWT and standard dressings (low-certainty evidence). There are also no clear differences in secondary outcomes where all evidence was low or very low-certainty. In caesarean section in obese women and surgery for lower limb fracture, there is probably little difference in quality of life scores (moderate-certainty evidence). Most evidence on pain is very low-certainty, but there is probably no difference in pain between NPWT and standard dressings after surgery for lower limb fracture (moderate-certainty evidence). Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In June 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. MAIN RESULTS: In this third update, we added 15 new randomised controlled trials (RCTs) and three new economic studies, resulting in a total of 44 RCTs (7447 included participants) and five economic studies. Studies evaluated NPWT in the context of a wide range of surgeries including orthopaedic, obstetric, vascular and general procedures. Economic studies assessed NPWT in orthopaedic, obstetric and general surgical settings. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Four studies (2107 participants) reported mortality. There is low-certainty evidence (downgraded twice for imprecision) showing no clear difference in the risk of death after surgery for people treated with NPWT (2.3%) compared with standard dressings (2.7%) (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.50 to 1.47; I2 = 0%). Thirty-nine studies reported SSI; 31 of these (6204 participants), were included in meta-analysis. There is moderate-certainty evidence (downgraded once for risk of bias) that NPWT probably results in fewer SSI (8.8% of participants) than treatment with standard dressings (13.0% of participants) after surgery; RR 0.66 (95% CI 0.55 to 0.80 ; I2 = 23%). Eighteen studies reported dehiscence; 14 of these (3809 participants) were included in meta-analysis. There is low-certainty evidence (downgraded once for risk of bias and once for imprecision) showing no clear difference in the risk of dehiscence after surgery for NPWT (5.3% of participants) compared with standard dressings (6.2% of participants) (RR 0.88, 95% CI 0.69 to 1.13; I2 = 0%). Secondary outcomes There is low-certainty evidence showing no clear difference between NPWT and standard treatment for the outcomes of reoperation and incidence of seroma. For reoperation, the RR was 1.04 (95% CI 0.78 to 1.41; I2 = 13%; 12 trials; 3523 participants); for seroma, the RR was 0.72 (95% CI 0.50 to 1.05; I2 = 0%; seven trials; 729 participants). The effect of NPWT on occurrence of haematoma or skin blisters is uncertain (very low-certainty evidence); for haematoma, the RR was 0.67 (95% CI 0.28 to 1.59; I2 = 0%; nine trials; 1202 participants) and for blisters the RR was 2.64 (95% CI 0.65 to 10.68; I2 = 69%; seven trials; 796 participants). The overall effect of NPWT on pain is uncertain (very low-certainty evidence from seven trials (2218 participants) which reported disparate measures of pain); but moderate-certainty evidence suggests there is probably little difference between the groups in pain after three or six months following surgery for lower limb fracture (one trial, 1549 participants). There is also moderate-certainty evidence for women undergoing caesarean sections (one trial, 876 participants) and people having surgery for lower limb fractures (one trial, 1549 participants) that there is probably little difference in quality of life scores at 30 days or 3 or 6 months, respectively. Cost-effectiveness Five economic studies, based wholly or partially on trials included in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in four indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty and coronary artery bypass graft surgery. They calculated quality-adjusted life-years for treatment groups and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the grade of the evidence varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People experiencing primary wound closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSI than people treated with standard dressings (moderate-certainty evidence). There is no clear difference in number of deaths or wound dehiscence between people treated with NPWT and standard dressings (low-certainty evidence). There are also no clear differences in secondary outcomes where all evidence was low or very low-certainty. In caesarean section in obese women and surgery for lower limb fracture, there is probably little difference in quality of life scores (moderate-certainty evidence). Most evidence on pain is very low-certainty, but there is probably no difference in pain between NPWT and standard dressings after surgery for lower limb fracture (moderate-certainty evidence). Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Prediction models for diagnosis and prognosis of covid-19: systematic review and critical appraisal

OBJECTIVE: To review and appraise the validity and usefulness of published and preprint reports of prediction models for diagnosing coronavirus disease 2019 (covid-19) in patients with suspected infection, for prognosis of patients with covid-19, and for detecting people in the general population at increased risk of covid-19 infection or being admitted to hospital with the disease. DESIGN: Living systematic review and critical appraisal by the COVID-PRECISE (Precise Risk Estimation to optimise covid-19 Care for Infected or Suspected patients in diverse sEttings) group. DATA SOURCES: PubMed and Embase through Ovid, up to 1 July 2020, supplemented with arXiv, medRxiv, and bioRxiv up to 5 May 2020. STUDY SELECTION: Studies that developed or validated a multivariable covid-19 related prediction model. DATA EXTRACTION: At least two authors independently extracted data using the CHARMS (critical appraisal and data extraction for systematic reviews of prediction modelling studies) checklist; risk of bias was assessed using PROBAST (prediction model risk of bias assessment tool). RESULTS: 37 421 titles were screened, and 169 studies describing 232 prediction models were included. The review identified seven models for identifying people at risk in the general population; 118 diagnostic models for detecting covid-19 (75 were based on medical imaging, 10 to diagnose disease severity); and 107 prognostic models for predicting mortality risk, progression to severe disease, intensive care unit admission, ventilation, intubation, or length of hospital stay. The most frequent types of predictors included in the covid-19 prediction models are vital signs, age, comorbidities, and image features. Flu-like symptoms are frequently predictive in diagnostic models, while sex, C reactive protein, and lymphocyte counts are frequent prognostic factors. Reported C index estimates from the strongest form of validation available per model ranged from 0.71 to 0.99 in prediction models for the general population, from 0.65 to more than 0.99 in diagnostic models, and from 0.54 to 0.99 in prognostic models. All models were rated at high or unclear risk of bias, mostly because of non-representative selection of control patients, exclusion of patients who had not experienced the event of interest by the end of the study, high risk of model overfitting, and unclear reporting. Many models did not include a description of the target population (n=27, 12%) or care setting (n=75, 32%), and only 11 (5%) were externally validated by a calibration plot. The Jehi diagnostic model and the 4C mortality score were identified as promising models. CONCLUSION: Prediction models for covid-19 are quickly entering the academic literature to support medical decision making at a time when they are urgently needed. This review indicates that almost all pubished prediction models are poorly reported, and at high risk of bias such that their reported predictive performance is probably optimistic. However, we have identified two (one diagnostic and one prognostic) promising models that should soon be validated in multiple cohorts, preferably through collaborative efforts and data sharing to also allow an investigation of the stability and heterogeneity in their performance across populations and settings. Details on all reviewed models are publicly available at https://www.covprecise.org/. Methodological guidance as provided in this paper should be followed because unreliable predictions could cause more harm than benefit in guiding clinical decisions. Finally, prediction model authors should adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guideline. SYSTEMATIC REVIEW REGISTRATION: Protocol https://osf.io/ehc47/, registration https://osf.io/wy245. READERS' NOTE: This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication. This version is update 3 of the original article published on 7 April 2020 (BMJ 2020;369:m1328). Previous updates can be found as data supplements (https://www.bmj.com/content/369/bmj.m1328/related#datasupp). When citing this paper please consider adding the update number and date of access for clarity.

Evaluating the development and validation of empirically-derived prognostic models for pressure ulcer risk assessment: A systematic review.

BACKGROUND: Researchers advocate developing empirically-derived prognostic models to predict pressure ulcer risk. However, there remains a scarcity of evidence about the performance and clinical value of these models. OBJECTIVES: To identify and describe empirically-derived models for predicting pressure ulcer risk; to assess the predictive performance of these models; and to evaluate their clinical impact in reducing pressure ulcer incidence. METHODS: We performed a comprehensive database search up to February 2017 and searched other resources to identify longitudinal studies that developed and/or validated prognostic models for predicting pressure ulcer risk and studies evaluating the clinical effects of such models. There were no language or publication date restrictions. Two reviewers independently conducted study selection. Using a pre-prepared data extraction form, one reviewer collected data on the characteristics and performance of the included models and assessed study risk of bias. A second reviewer checked all the data. Using narrative synthesis, we summarised the characteristics of the included studies and models. Using meta-analysis, we combined performance (discrimination and calibration) measurement statistics for relevant models. RESULTS: We included 24 studies with 28 data sources in the review and identified 22 models that were developed using these data. Of the 22 models, only seven had further external validations (one model was validated twice). In development, a third of models used univariate analysis alone to identify statistically significant predictors for subsequent multivariable analysis; and nine of the 16 developed models were formed using stepwise selection processes in multivariable analysis. Missing data were often incompletely reported, and continuous predictors were correctly handled in only two models (e.g., using restricted cubic spline). Sample sizes of the model development studies were small with 13 models involving fewer than 10 events per variable. The risk of bias associated with the development of all 22 models and eight validations was judged as high or unclear. The predictive performance was reported as: c-statistic point estimates ranging from 0.65 to 0.89, and total Observed:Expected risk ratios between 0.94 and 1.00. Compared with heuristic tools, relevant included models had better discrimination and calibration. No eligible study was identified that evaluated the clinical impact of any included model. CONCLUSIONS: Whilst many prognostic models for predicting ulcer risk have been developed few have been validated. The methods used for model development are generally flawed which reduces the potential for using these models in practice. Future research should address these weaknesses.

Cognitive behavioural therapy plus standard care versus standard care for people with schizophrenia.

BACKGROUND: Cognitive behavioural therapy (CBT) is a psychosocial treatment that aims to re-mediate distressing emotional experiences or dysfunctional behaviour by changing the way in which a person interprets and evaluates the experience or cognates on its consequence and meaning. This approach helps to link the person's feelings and patterns of thinking which underpin distress. CBT is now recommended by the National Institute for Health and Care Excellence (NICE) as an add-on treatment for people with a diagnosis of schizophrenia. This review is also part of a family of Cochrane CBT reviews for people with schizophrenia. OBJECTIVES: To assess the effects of cognitive behavioural therapy added to standard care compared with standard care alone for people with schizophrenia. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register (up to March 6, 2017). This register is compiled by systematic searches of major resources (including AMED, BIOSIS CINAHL, Embase, MEDLINE, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings, with no language, date, document type, or publication status limitations for inclusion of records into the register. SELECTION CRITERIA: We selected all randomised controlled clinical trials (RCTs) involving people diagnosed with schizophrenia or related disorders, which compared adding CBT to standard care with standard care given alone. Outcomes of interest included relapse, rehospitalisation, mental state, adverse events, social functioning, quality of life, and satisfaction with treatment.We included studies fulfilling the predefined inclusion criteria and reporting useable data. DATA COLLECTION AND ANALYSIS: We complied with the Cochrane recommended standard of conduct for data screening and collection. Where possible, we calculated relative risk (RR) and its 95% confidence interval (CI) for binary data and mean difference (MD) and its 95% confidence interval for continuous data. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE. MAIN RESULTS: This review now includes 60 trials with 5,992 participants, all comparing CBT added to standard care with standard care alone. Results for the main outcomes of interest (all long term) showed no clear difference between CBT and standard care for relapse (RR 0.78, 95% CI 0.61 to 1.00; participants = 1538; studies = 13, low-quality evidence). Two trials reported global state improvement. More participants in the CBT groups showed clinically important improvement in global state (RR 0.57, 95% CI 0.39 to 0.84; participants = 82; studies = 2 , very low-quality evidence). Five trials reported mental state improvement. No differences in mental state improvement were observed (RR 0.81, 95% CI 0.65 to 1.02; participants = 501; studies = 5, very low-quality evidence). In terms of safety, adding CBT to standard care may reduce the risk of having an adverse event (RR 0.44, 95% CI 0.27 to 0.72; participants = 146; studies = 2, very low-quality evidence) but appears to have no effect on long-term social functioning (MD 0.56, 95% CI -2.64 to 3.76; participants = 295; studies = 2, very low-quality evidence, nor on long-term quality of life (MD -3.60, 95% CI -11.32 to 4.12; participants = 71; study = 1, very low-quality evidence). It also has no effect on long-term satisfaction with treatment (measured as 'leaving the study early') (RR 0.93, 95% CI 0.77 to 1.12; participants = 1945; studies = 19, moderate-quality evidence). AUTHORS' CONCLUSIONS: Relative to standard care alone, adding CBT to standard care appears to have no effect on long-term risk of relapse. A very small proportion of the available evidence indicated CBT plus standard care may improve long term global state and may reduce the risk of adverse events. Whether adding CBT to standard care leads to clinically important improvement in patients' long-term mental state, quality of life, and social function remains unclear. Satisfaction with care (measured as number of people leaving the study early) was no higher for participants receiving CBT compared to participants receiving standard care. It should be noted that although much research has been carried out in this area, the quality of evidence available is poor - mostly low or very low quality and we still cannot make firm conclusions until more high quality data are available.