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1.
Cochrane Database Syst Rev ; 3: CD002303, 2024 03 07.
Article in English | MEDLINE | ID: mdl-38451842

ABSTRACT

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. Most leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or damaged valves. Venous ulcer prevention and treatment typically involves the application of compression bandages/stockings to improve venous return and thus reduce pressure in the legs. Other treatment options involve removing or repairing veins. Most venous ulcers heal with compression therapy, but ulcer recurrence is common. For this reason, clinical guidelines recommend that people continue with compression treatment after their ulcer has healed. This is an update of a Cochrane review first published in 2000 and last updated in 2014. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) for preventing recurrence of venous leg ulcers. SEARCH METHODS: In August 2023, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, three other databases, and two ongoing trials registries. We also scanned the reference lists of included studies and relevant reviews and health technology reports. There were no restrictions on language, date of publication, or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that evaluated compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected studies, assessed risk of bias, and extracted data. Our primary outcome was reulceration (ulcer recurrence anywhere on the treated leg). Our secondary outcomes included duration of reulceration episodes, proportion of follow-up without ulcers, ulceration on the contralateral leg, noncompliance with compression therapy, comfort, and adverse effects. We assessed the certainty of evidence using GRADE methodology. MAIN RESULTS: We included eight studies (1995 participants), which were published between 1995 and 2019. The median study sample size was 249 participants. The studies evaluated different classes of compression (UK class 2 or 3 and European (EU) class 1, 2, or 3). Duration of follow-up ranged from six months to 10 years. We downgraded the certainty of the evidence for risk of bias (lack of blinding), imprecision, and indirectness. EU class 3 compression stockings may reduce reulceration compared with no compression over six months (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.27 to 0.76; 1 study, 153 participants; low-certainty evidence). EU class 1 compression stockings compared with EU class 2 compression stockings may have little or no effect on reulceration over 12 months (RR 1.70, 95% CI 0.67 to 4.32; 1 study, 99 participants; low-certainty evidence). There may be little or no difference in rates of noncompliance over 12 months between people using EU class 1 stockings and people using EU class 2 stockings (RR 1.22, 95% CI 0.40 to 3.75; 1 study, 99 participants; low-certainty evidence). UK class 2 hosiery compared with UK class 3 hosiery may be associated with a higher risk of reulceration over 18 months to 10 years (RR 1.55, 95% CI 1.26 to 1.91; 5 studies, 1314 participants; low-certainty evidence). People who use UK class 2 hosiery may be more compliant with compression treatment than people who use UK class 3 hosiery over 18 months to 10 years (RR for noncompliance 0.69, 95% CI 0.49 to 0.99; 5 studies, 1372 participants; low-certainty evidence). There may be little or no difference between Scholl UK class 2 compression stockings and Medi UK class 2 compression stockings in terms of reulceration (RR 0.77, 95% CI 0.47 to 1.28; 1 study, 166 participants; low-certainty evidence) and noncompliance (RR 0.97, 95% CI 0.84.1 to 12; 1 study, 166 participants; low-certainty evidence) over 18 months. No studies compared different lengths of compression (e.g. below-knee versus above-knee), and no studies measured duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. AUTHORS' CONCLUSIONS: Compression with EU class 3 compression stockings may reduce reulceration compared with no compression over six months. Use of EU class 1 compression stockings compared with EU class 2 compression stockings may result in little or no difference in reulceration and noncompliance over 12 months. UK class 3 compression hosiery may reduce reulceration compared with UK class 2 compression hosiery; however, higher compression may lead to lower compliance. There may be little to no difference between Scholl and Medi UK class 2 compression stockings in terms of reulceration and noncompliance. There was no information on duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. More research is needed to investigate acceptable modes of long-term compression therapy for people at risk of recurrent venous ulceration. Future trials should consider interventions to improve compliance with compression treatment, as higher compression may result in lower rates of reulceration.


Subject(s)
Varicose Ulcer , Humans , Compression Bandages , Stockings, Compression , Ulcer , Varicose Ulcer/prevention & control , Wound Healing
2.
Cochrane Database Syst Rev ; 10: CD009490, 2018 10 11.
Article in English | MEDLINE | ID: mdl-30307602

ABSTRACT

BACKGROUND: Pressure ulcers are treated by reducing pressure on the areas of damaged skin. Special support surfaces (including beds, mattresses and cushions) designed to redistribute pressure, are widely used as treatments. The relative effects of different support surfaces are unclear. This is an update of an existing review. OBJECTIVES: To assess the effects of pressure-relieving support surfaces in the treatment of pressure ulcers. SEARCH METHODS: In September 2017 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 published or unpublished randomised controlled trials (RCTs), that assessed the effects of support surfaces for treating pressure ulcers, in any participant group or setting. DATA COLLECTION AND ANALYSIS: Data extraction, assessment of 'Risk of bias' and GRADE assessments were performed independently by two review authors. Trials with similar participants, comparisons and outcomes were considered for meta-analysis. Where meta-analysis was inappropriate, we reported the results of the trials narratively. Where possible, we planned to report data as either risk ratio or mean difference as appropriate. MAIN RESULTS: For this update we identified one new trial of support surfaces for pressure ulcer treatment, bringing the total to 19 trials involving 3241 participants. Most trials were small, with sample sizes ranging from 20 to 1971, and were generally at high or unclear risk of bias. PRIMARY OUTCOME: healing of existing pressure ulcersLow-tech constant pressure support surfacesIt is uncertain whether profiling beds increase the proportion of pressure ulcer which heal compared with standard hospital beds as the evidence is of very low certainty: (RR 3.96, 95% CI 1.28 to 12.24), downgraded for serious risk of bias, serious imprecision and indirectness (1 study; 70 participants).There is currently no clear difference in ulcer healing between water-filled support surfaces and foam replacement mattresses: (RR 0.93, 95% CI 0.63 to 1.37); low-certainty evidence downgraded for serious risk of bias and serious imprecision (1 study; 120 participants).Further analysis could not be performed for polyester overlays versus gel overlays (1 study; 72 participants), non-powered mattresses versus low-air-loss mattresses (1 study; 20 participants) or standard hospital mattresses with sheepskin overlays versus standard hospital mattresses (1 study; 36 participants).High-tech pressure support surfacesIt is currently unclear whether high-tech pressure support surfaces (such as low-air-loss beds, air suspension beds, and alternating pressure surfaces) improve the healing of pressure ulcers (14 studies; 2923 participants) or which intervention may be more effective. The certainty of the evidence is generally low, downgraded mostly for risk of bias, indirectness and imprecision.Secondary outcomesNo analyses were undertaken with respect to secondary outcomes including participant comfort and surface reliability and acceptability as reporting of these within the included trials was very limited.Overall, the evidence is of low to very low certainty and was primarily downgraded due to risk of bias and imprecision with some indirectness. AUTHORS' CONCLUSIONS: Based on the current evidence, it is unclear whether any particular type of low- or high-tech support surface is more effective at healing pressure ulcers than standard support surfaces.


Subject(s)
Bedding and Linens/standards , Beds/standards , Pressure Ulcer/therapy , Equipment Design , Humans , Randomized Controlled Trials as Topic , Surface Properties , Wound Healing
3.
F1000Res ; 6: 1634, 2017.
Article in English | MEDLINE | ID: mdl-28979768

ABSTRACT

Background: Scientific editors (i.e., those who make decisions on the content and policies of a journal) have a central role in the editorial process at biomedical journals. However, very little is known about the training needs of these editors or what competencies are required to perform effectively in this role. Methods: We conducted a survey of perceptions and training needs among scientific editors from major editorial organizations around the world, followed by a modified Delphi process in which we invited the same scientific editors to rate the importance of competency-related statements obtained from a previous scoping review. Results: A total of 148 participants completed the survey of perceptions and training needs. At least 80% of participants agreed on six of the 38 skill and expertise-related statements presented to them as being important or very important to their role as scientific editors. At least 80% agreed on three of the 38 statements as necessary skills they perceived themselves as possessing (well or very well).  The top five items on participants' list of top training needs were training in statistics, research methods, publication ethics, recruiting and dealing with peer reviewers, and indexing of journals. The three rounds of the Delphi were completed by 83, 83, and 73 participants, respectively, which ultimately produced a list of 23 "highly rated" competency-related statements and another 86 "included" items. Conclusion: Both the survey and the modified Delphi process will be critical for understanding knowledge and training gaps among scientific editors when designing curriculum around core competencies in the future.

4.
BMC Med ; 15(1): 167, 2017 09 11.
Article in English | MEDLINE | ID: mdl-28893269

ABSTRACT

BACKGROUND: Scientific editors are responsible for deciding which articles to publish in their journals. However, we have not found documentation of their required knowledge, skills, and characteristics, or the existence of any formal core competencies for this role. METHODS: We describe the development of a minimum set of core competencies for scientific editors of biomedical journals. RESULTS: The 14 key core competencies are divided into three major areas, and each competency has a list of associated elements or descriptions of more specific knowledge, skills, and characteristics that contribute to its fulfillment. CONCLUSIONS: We believe that these core competencies are a baseline of the knowledge, skills, and characteristics needed to perform competently the duties of a scientific editor at a biomedical journal.


Subject(s)
Biomedical Research/methods , Consensus , Editorial Policies , Humans , Periodicals as Topic , Publishing
5.
Cochrane Database Syst Rev ; 7: CD010031, 2017 07 14.
Article in English | MEDLINE | ID: mdl-28707751

ABSTRACT

BACKGROUND: Fungal infection of the toenails, also called onychomycosis, is a common problem that causes damage to the nail's structure and physical appearance. For those severely affected, it can interfere with normal daily activities. Treatment is taken orally or applied topically; however, traditionally topical treatments have low success rates due to the nail's physical properties. Oral treatments also appear to have shorter treatment times and better cure rates. Our review will assist those needing to make an evidence-based choice for treatment. OBJECTIVES: To assess the effects of oral antifungal treatments for toenail onychomycosis. SEARCH METHODS: We searched the following databases up to October 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We sought to identify unpublished and ongoing trials by correspondence with authors and by contacting relevant pharmaceutical companies. SELECTION CRITERIA: RCTs comparing oral antifungal treatment to placebo or another oral antifungal treatment in participants with toenail onychomycosis, confirmed by one or more positive cultures, direct microscopy of fungal elements, or histological examination of the nail. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 48 studies involving 10,200 participants. Half the studies took place in more than one centre and were conducted in outpatient dermatology settings. The participants mainly had subungual fungal infection of the toenails. Study duration ranged from 4 months to 2 years.We assessed one study as being at low risk of bias in all domains and 18 studies as being at high risk of bias in at least one domain. The most common high-risk domain was 'blinding of personnel and participants'.We found high-quality evidence that terbinafine is more effective than placebo for achieving clinical cure (risk ratio (RR) 6.00, 95% confidence interval (CI) 3.96 to 9.08, 8 studies, 1006 participants) and mycological cure (RR 4.53, 95% CI 2.47 to 8.33, 8 studies, 1006 participants). Adverse events amongst terbinafine-treated participants included gastrointestinal symptoms, infections, and headache, but there was probably no significant difference in their risk between the groups (RR 1.13, 95% CI 0.87 to 1.47, 4 studies, 399 participants, moderate-quality evidence).There was high-quality evidence that azoles were more effective than placebo for achieving clinical cure (RR 22.18, 95% CI 12.63 to 38.95, 9 studies, 3440 participants) and mycological cure (RR 5.86, 95% CI 3.23 to 10.62, 9 studies, 3440 participants). There were slightly more adverse events in the azole group (the most common being headache, flu-like symptoms, and nausea), but the difference was probably not significant (RR 1.04, 95% CI 0.97 to 1.12; 9 studies, 3441 participants, moderate-quality evidence).Terbinafine and azoles may lower the recurrence rate when compared, individually, to placebo (RR 0.05, 95% CI 0.01 to 0.38, 1 study, 35 participants; RR 0.55, 95% CI 0.29 to 1.07, 1 study, 26 participants, respectively; both low-quality evidence).There is moderate-quality evidence that terbinafine was probably more effective than azoles for achieving clinical cure (RR 0.82, 95% CI 0.72 to 0.95, 15 studies, 2168 participants) and mycological cure (RR 0.77, 95% CI 0.68 to 0.88, 17 studies, 2544 participants). There was probably no difference in the risk of adverse events (RR 1.00, 95% CI 0.86 to 1.17; 9 studies, 1762 participants, moderate-quality evidence) between the two groups, and there may be no difference in recurrence rate (RR 1.11, 95% CI 0.68 to 1.79, 5 studies, 282 participants, low-quality evidence). Common adverse events in both groups included headache, viral infection, and nausea.Moderate-quality evidence shows that azoles and griseofulvin probably had similar efficacy for achieving clinical cure (RR 0.94, 95% CI 0.45 to 1.96, 5 studies, 222 participants) and mycological cure (RR 0.87, 95% CI 0.50 to 1.51, 5 studies, 222 participants). However, the risk of adverse events was probably higher in the griseofulvin group (RR 2.41, 95% CI 1.56 to 3.73, 2 studies, 143 participants, moderate-quality evidence), with the most common being gastrointestinal disturbance and allergic reaction (in griseofulvin-treated participants) along with nausea and vomiting (in azole-treated participants). Very low-quality evidence means we are uncertain about this comparison's impact on recurrence rate (RR 4.00, 0.26 to 61.76, 1 study, 7 participants).There is low-quality evidence that terbinafine may be more effective than griseofulvin in terms of clinical cure (RR 0.32, 95% CI 0.14 to 0.72, 4 studies, 270 participants) and mycological cure (RR 0.64, 95% CI 0.46 to 0.90, 5 studies, 465 participants), and griseofulvin was associated with a higher risk of adverse events, although this was based on low-quality evidence (RR 2.09, 95% CI 1.15 to 3.82, 2 studies, 100 participants). Common adverse events included headache and stomach problems (in griseofulvin-treated participants) as well as taste loss and nausea (in terbinafine-treated participants). No studies addressed recurrence rate for this comparison.No study addressed quality of life. AUTHORS' CONCLUSIONS: We found high-quality evidence that compared to placebo, terbinafine and azoles are effective treatments for the mycological and clinical cure of onychomycosis, with moderate-quality evidence of excess harm. However, terbinafine probably leads to better cure rates than azoles with the same risk of adverse events (moderate-quality evidence).Azole and griseofulvin were shown to probably have a similar effect on cure, but more adverse events appeared to occur with the latter (moderate-quality evidence). Terbinafine may improve cure and be associated with fewer adverse effects when compared to griseofulvin (low-quality evidence).Only four comparisons assessed recurrence rate: low-quality evidence found that terbinafine or azoles may lower the recurrence rate when compared to placebo, but there may be no difference between them.Only a limited number of studies reported adverse events, and the severity of the events was not taken into account.Overall, the quality of the evidence varied widely from high to very low depending on the outcome and comparison. The main reasons to downgrade evidence were limitations in study design, such as unclear allocation concealment and randomisation as well as lack of blinding.


Subject(s)
Antifungal Agents/therapeutic use , Azoles/therapeutic use , Foot Dermatoses/drug therapy , Griseofulvin/therapeutic use , Naphthalenes/therapeutic use , Onychomycosis/drug therapy , Administration, Oral , Adult , Aged , Antifungal Agents/administration & dosage , Antifungal Agents/adverse effects , Azoles/administration & dosage , Azoles/adverse effects , Female , Griseofulvin/administration & dosage , Griseofulvin/adverse effects , Humans , Male , Middle Aged , Naphthalenes/administration & dosage , Naphthalenes/adverse effects , Randomized Controlled Trials as Topic , Recurrence , Secondary Prevention , Terbinafine
6.
BMC Med ; 14: 16, 2016 Feb 02.
Article in English | MEDLINE | ID: mdl-26837937

ABSTRACT

BACKGROUND: Biomedical journals are the main route for disseminating the results of health-related research. Despite this, their editors operate largely without formal training or certification. To our knowledge, no body of literature systematically identifying core competencies for scientific editors of biomedical journals exists. Therefore, we aimed to conduct a scoping review to determine what is known on the competency requirements for scientific editors of biomedical journals. METHODS: We searched the MEDLINE®, Cochrane Library, Embase®, CINAHL, PsycINFO, and ERIC databases (from inception to November 2014) and conducted a grey literature search for research and non-research articles with competency-related statements (i.e. competencies, knowledge, skills, behaviors, and tasks) pertaining to the role of scientific editors of peer-reviewed health-related journals. We also conducted an environmental scan, searched the results of a previous environmental scan, and searched the websites of existing networks, major biomedical journal publishers, and organizations that offer resources for editors. RESULTS: A total of 225 full-text publications were included, 25 of which were research articles. We extracted a total of 1,566 statements possibly related to core competencies for scientific editors of biomedical journals from these publications. We then collated overlapping or duplicate statements which produced a list of 203 unique statements. Finally, we grouped these statements into seven emergent themes: (1) dealing with authors, (2) dealing with peer reviewers, (3) journal publishing, (4) journal promotion, (5) editing, (6) ethics and integrity, and (7) qualities and characteristics of editors. DISCUSSION: To our knowledge, this scoping review is the first attempt to systematically identify possible competencies of editors. Limitations are that (1) we may not have captured all aspects of a biomedical editor's work in our searches, (2) removing redundant and overlapping items may have led to the elimination of some nuances between items, (3) restricting to certain databases, and only French and English publications, may have excluded relevant publications, and (4) some statements may not necessarily be competencies. CONCLUSION: This scoping review is the first step of a program to develop a minimum set of core competencies for scientific editors of biomedical journals which will be followed by a training needs assessment, a Delphi exercise, and a consensus meeting.


Subject(s)
Editorial Policies , Peer Review, Research/standards , Periodicals as Topic/standards , Professional Competence/standards , Biomedical Research/standards , Databases, Factual , Humans , Publishing , Quality Control
7.
Cochrane Database Syst Rev ; (9): CD001735, 2015 Sep 03.
Article in English | MEDLINE | ID: mdl-26333288

ABSTRACT

BACKGROUND: Pressure ulcers (i.e. bedsores, pressure sores, pressure injuries, decubitus ulcers) are areas of localised damage to the skin and underlying tissue. They are common in the elderly and immobile, and costly in financial and human terms. Pressure-relieving support surfaces (i.e. beds, mattresses, seat cushions etc) are used to help prevent ulcer development. OBJECTIVES: This systematic review seeks to establish:(1) the extent to which pressure-relieving support surfaces reduce the incidence of pressure ulcers compared with standard support surfaces, and,(2) their comparative effectiveness in ulcer prevention. SEARCH METHODS: In April 2015, for this fourth update we searched The Cochrane Wounds Group Specialised Register (searched 15 April 2015) which includes the results of regular searches of MEDLINE, EMBASE and CINAHL and The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 3). SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-randomised trials, published or unpublished, that assessed the effects of any support surface for prevention of pressure ulcers, in any patient group or setting which measured pressure ulcer incidence. Trials reporting only proxy outcomes (e.g. interface pressure) were excluded. Two review authors independently selected trials. DATA COLLECTION AND ANALYSIS: Data were extracted by one review author and checked by another. Where appropriate, estimates from similar trials were pooled for meta-analysis. MAIN RESULTS: For this fourth update six new trials were included, bringing the total of included trials to 59.Foam alternatives to standard hospital foam mattresses reduce the incidence of pressure ulcers in people at risk (RR 0.40 95% CI 0.21 to 0.74). The relative merits of alternating- and constant low-pressure devices are unclear. One high-quality trial suggested that alternating-pressure mattresses may be more cost effective than alternating-pressure overlays in a UK context.Pressure-relieving overlays on the operating table reduce postoperative pressure ulcer incidence, although two trials indicated that foam overlays caused adverse skin changes. Meta-analysis of three trials suggest that Australian standard medical sheepskins prevent pressure ulcers (RR 0.56 95% CI 0.32 to 0.97).  AUTHORS' CONCLUSIONS: People at high risk of developing pressure ulcers should use higher-specification foam mattresses rather than standard hospital foam mattresses. The relative merits of higher-specification constant low-pressure and alternating-pressure support surfaces for preventing pressure ulcers are unclear, but alternating-pressure mattresses may be more cost effective than alternating-pressure overlays in a UK context. Medical grade sheepskins are associated with a decrease in pressure ulcer development. Organisations might consider the use of some forms of pressure relief for high risk patients in the operating theatre.


Subject(s)
Bedding and Linens , Beds , Pressure Ulcer/prevention & control , Beds/standards , Humans , Pressure Ulcer/therapy , Randomized Controlled Trials as Topic
8.
Cochrane Database Syst Rev ; (9): CD002930, 2015 Sep 03.
Article in English | MEDLINE | ID: mdl-26334539

ABSTRACT

BACKGROUND: Pressure ulcers are defined as areas "of localized damage to the skin and underlying tissue caused by pressure, shear, friction and/or the combination of these". Electromagnetic therapy (EMT), in which electrodes produce an electromagnetic field across the wound, may improve healing of chronic wounds such as pressure ulcers. OBJECTIVES: To assess the effects of EMT on the healing of pressure ulcers. SEARCH METHODS: For this update we searched the Cochrane Wounds Group Specialised Register (searched 10 June 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 6); Ovid MEDLINE (2014 to 10 June 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 10 June 2015); Ovid EMBASE (2014 to 10 June 2015); and EBSCO CINAHL (2014 to 6 July 2012). SELECTION CRITERIA: Randomised controlled trials comparing EMT with sham EMT or other (standard) treatment. DATA COLLECTION AND ANALYSIS: For this update two review authors independently scrutinised the results of the search to identify relevant RCTs and obtained full reports of potentially eligible studies. In previous versions of the review we made attempts to obtain missing data by contacting study authors. A second review author checked data extraction and disagreements were resolved after discussion between review authors. MAIN RESULTS: We identified no new trials for this update.Two randomised controlled trials (RCTs), involving 60 participants, at unclear risk of bias were included in the original review. Both trials compared the use of EMT with sham EMT, although one of the trials included a third arm in which only standard therapy was applied. Neither study found a statistically significant difference in complete healing in people treated with EMT compared with those in the control group. In one trial that assessed percentage reduction in wound surface area, the difference between the two groups was reported to be statistically significant in favour of EMT. However, this result should be interpreted with caution as this is a small study and this finding may be due to chance. Additionally, the outcome, percentage reduction in wound area, is less clinically meaningful than complete healing. AUTHORS' CONCLUSIONS: The results provide no strong evidence of benefit in using EMT to treat pressure ulcers. However, the possibility of a beneficial or harmful effect cannot be ruled out because there were only two included trials, both with methodological limitations and small numbers of participants. Further research is recommended.


Subject(s)
Magnetic Field Therapy/methods , Pressure Ulcer/therapy , Female , Humans , Male , Randomized Controlled Trials as Topic , Wound Healing
9.
Cochrane Database Syst Rev ; (7): CD010471, 2015 Jul 14.
Article in English | MEDLINE | ID: mdl-26171906

ABSTRACT

BACKGROUND: Foot ulcers in people with diabetes mellitus are a common and serious global health issue. Dressings form a key part of ulcer treatment, with clinicians and patients having many different types to choose from. A clear and current overview of current evidence is required to facilitate decision-making regarding dressing use. OBJECTIVES: To summarize data from systematic reviews of randomised controlled trial evidence on the effectiveness of dressings for healing foot ulcers in people with diabetes mellitus (DM). METHODS: We searched the following databases for relevant systematic reviews and associated analyses: the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2015, Issue 2); Database of Abstracts of Reviews of Effects (DARE; The Cochrane Library 2015, Issue 1); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 14 April 2015); Ovid EMBASE (1980 to 14 April 2015). We also handsearched the Cochrane Wounds Group list of reviews. Two review authors independently performed study selection, risk of bias assessment and data extraction. Complete wound healing was the primary outcome assessed; secondary outcomes included health-related quality of life, adverse events, resource use and dressing performance. MAIN RESULTS: We found 13 eligible systematic reviews relevant to this overview that contained a total of 17 relevant RCTs. One review reported the results of a network meta-analysis and so presented information on indirect, as well as direct, treatment effects. Collectively the reviews reported findings for 11 different comparisons supported by direct data and 26 comparisons supported by indirect data only. Only four comparisons informed by direct data found evidence of a difference in wound healing between dressing types, but the evidence was assessed as being of low or very low quality (in one case data could not be located and checked). There was also no robust evidence of a difference between dressing types for any secondary outcomes assessed. AUTHORS' CONCLUSIONS: There is currently no robust evidence for differences between wound dressings for any outcome in foot ulcers in people with diabetes (treated in any setting). Practitioners may want to consider the unit cost of dressings, their management properties and patient preference when choosing dressings.


Subject(s)
Bandages , Diabetic Foot/therapy , Review Literature as Topic , Humans , Randomized Controlled Trials as Topic
10.
Cochrane Database Syst Rev ; (2): CD007948, 2015 Feb 12.
Article in English | MEDLINE | ID: mdl-25674776

ABSTRACT

BACKGROUND: Blood for transfusion may become contaminated at any point between collection and transfusion and may result in bacteraemia (the presence of bacteria in the blood), severe illness or even death for the blood recipient. Donor arm skin is one potential source of blood contamination, so it is usual to cleanse the skin with an antiseptic before blood donation. One-step and two-step alcohol based antiseptic regimens are both commonly advocated but there is uncertainty as to which is most effective. OBJECTIVES: To assess the effects of cleansing the skin of blood donors with alcohol in a one-step compared with alcohol in a two-step procedure to prevent contamination of collected blood or bacteraemia in the recipient. SEARCH METHODS: In December 2014, for this third update, we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library; Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. SELECTION CRITERIA: All randomised trials (RCTs) comparing alcohol based donor skin cleansing in a one-step versus a two-step process that includes alcohol and any other antiseptic for pre-venepuncture skin cleansing were considered. Quasi randomised trials were to have been considered in the absence of RCTs. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. MAIN RESULTS: No studies (RCTs or quasi RCTs) met the inclusion criteria. AUTHORS' CONCLUSIONS: We did not identify any eligible studies for inclusion in this review. It is therefore unclear whether a two-step, alcohol followed by antiseptic skin cleansing process prior to blood donation confers any reduction in the risk of blood contamination or bacteraemia in blood recipients, or conversely whether a one-step process increases risk above that associated with a two-step process.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Bacteremia/prevention & control , Blood Donors , Disinfection/methods , Ethanol/administration & dosage , Skin/microbiology , Blood Transfusion , Humans
11.
Cochrane Database Syst Rev ; (9): CD002303, 2014 Sep 09.
Article in English | MEDLINE | ID: mdl-25203307

ABSTRACT

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. The majority of leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or weakness of the valves in the veins of the leg. Prevention and treatment of venous ulcers is aimed at reducing the pressure either by removing/repairing the veins, or by applying compression bandages/stockings to reduce the pressure in the veins.The majority of venous ulcers heal with compression bandages, however ulcers frequently recur. Clinical guidelines therefore recommend that people continue to wear compression, usually in the form of hosiery (tights, stockings, socks) after their ulcer heals, to prevent recurrence. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) in preventing the recurrence of venous ulcers. If compression does prevent ulceration compared with no compression, then to identify whether there is evidence to recommend particular levels of compression (high, medium or low, for example), types of compression, or brands of compression to prevent ulcer recurrence after healing. SEARCH METHODS: For this second update we searched The Cochrane Wounds Group Specialised Register (searched 4 September 2014) which includes the results of regular searches of MEDLINE, EMBASE and CINAHL; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 8). SELECTION CRITERIA: Randomised controlled trials (RCTs)evaluating compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: Two review authors undertook data extraction and risk of bias assessment independently. MAIN RESULTS: Four trials (979 participants) were eligible for inclusion in this review. One trial in patients with recently healed venous ulcers (n = 153) compared recurrence rates with and without compression and found that compression significantly reduced ulcer recurrence at six months (Risk ratio (RR) 0.46, 95% CI 0.27 to 0.76).Two trials compared high-compression hosiery (equivalent to UK class 3) with moderate-compression hosiery (equivalent to UK class 2). The first study (n=300) found no significant reduction in recurrence at five years follow up with high-compression hosiery compared with moderate-compression (RR 0.82, 95% CI 0.61 to 1.12). The second study (n = 338) assessed ulcer recurrence at three years follow up and found that high-compression hosiery reduced recurrence compared with moderate-compression (RR 0.57, 95% CI 0.39 to 0.81). Statistically significant heterogeneity precluded meta-analysis of the results from these studies. Patient-reported compliance rates were reported in both trials;,there was significantly higher compliance with medium-compression than with high-compression hosiery in one and no significant difference in the second.A fourth trial (166 patients) found no statistically significant difference in recurrence between two types of medium (UK class 2) compression hosiery (Medi versus Scholl: RR 0.74, 95% CI 0.45 to 1.2).No trials of compression bandages for preventing ulcer recurrence were identified. AUTHORS' CONCLUSIONS: There is evidence from one trial that compression hosiery reduces rates of reulceration of venous ulcers compared with no compression. Results from one trial suggest that recurrence is lower in high-compression hosiery than in medium-compression hosiery at three years whilst another trial found no difference at 5 years. Rates of patient intolerance of compression hosiery were high. There is insufficient evidence to aid selection of different types, brands, or lengths of compression hosiery.


Subject(s)
Stockings, Compression , Varicose Ulcer/prevention & control , Adult , Compression Bandages , Humans , Randomized Controlled Trials as Topic , Risk , Secondary Prevention , Time Factors
12.
Trials ; 15: 19, 2014 Jan 14.
Article in English | MEDLINE | ID: mdl-24422753

ABSTRACT

BACKGROUND: Critical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality. METHODS: A systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed. RESULTS: A total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered. CONCLUSIONS: This overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must be made to follow international standards for conducting and reporting RCTs. There is currently minimal evidence of an influence of industry funding on methodological quality although analyses had limited power and funding source was not reported for a quarter of studies.


Subject(s)
Health Care Sector , Randomized Controlled Trials as Topic , Research Design , Research Support as Topic , Wounds and Injuries/therapy , Bias , Chronic Disease , Conflict of Interest , Health Care Sector/economics , Health Care Sector/standards , Humans , Quality of Health Care , Randomized Controlled Trials as Topic/economics , Randomized Controlled Trials as Topic/standards , Research Design/standards , Research Support as Topic/standards , Treatment Outcome , Wound Healing , Wounds and Injuries/diagnosis , Wounds and Injuries/economics
13.
Cochrane Database Syst Rev ; (5): CD006477, 2013 May 31.
Article in English | MEDLINE | ID: mdl-23728661

ABSTRACT

BACKGROUND: Venous leg ulcers are a major health burden: annually, in the UK alone, they contribute an estimated cost to the NHS of GBP 400 million. Flavonoids are a diverse group of naturally-occurring venotonic compounds that address certain microcirculatory parameters involved in venous leg ulcer pathophysiology. OBJECTIVES: To evaluate the clinical effects of flavonoids on the healing of venous leg ulcers. SEARCH METHODS: In February 2013 we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 1); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. No date or language restrictions were applied. We checked reference lists of included trials, and contacted pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials (RCTs) that investigated the efficacy of any flavonoid-containing compound on venous leg ulcer healing in adults. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for the review and disagreements were referred to a third author. All rejected articles were double-checked by a third author. Assessment of risk of bias and data extraction were performed independently by two authors, discrepancies were resolved by referring to the third author. MAIN RESULTS: Of the nine studies (1075 participants): five investigated Micronised Purified Flavonoid Fraction (MPFF), and four investigated hydroxyethylrutosides (HR).Meta-analysis involving 723 participants from five trials - four of which were characterised by poor reporting - showed more venous leg ulcers were healed in the MPFF groups than in the control groups (RR 1.36; 95% CI 1.07 to 1.74). However, the most rigorously conducted trial, which was at low risk of bias, did not show any additional benefit of MPFF (RR 0.94; 95% CI 0.73 to 1.22). Since this trial was unpublished, the possibility of publication bias in trials involving flavonoids must be acknowledged. Overall, the quality of reporting of trials on HR was also poor. Pooling three trials, all at unclear risk of bias, involving 279 participants showed a statistically significant effect in favour of HR with respect to number of ulcers healed (RR 1.70; 95% CI 1.24 to 2.34). AUTHORS' CONCLUSIONS: Although the overall estimate of the number of healed ulcers appeared to show a significant effect in favour of flavonoids (both MPFF and HR), this result needs to be interpreted cautiously, as most of these trials were poorly reported, and so had an unclear risk of bias for randomisation, allocation concealment, blinding and methods for addressing incomplete outcome data. There was also a possibility of publication bias.


Subject(s)
Flavonoids/therapeutic use , Varicose Ulcer/drug therapy , Adult , Humans , Hydroxyethylrutoside/therapeutic use , Randomized Controlled Trials as Topic
14.
Cochrane Database Syst Rev ; (1): CD007948, 2013 Jan 31.
Article in English | MEDLINE | ID: mdl-23440821

ABSTRACT

BACKGROUND: Blood for transfusion may become contaminated at any point between collection and transfusion and may result in bacteraemia (the presence of bacteria in the blood), severe illness or even death for the blood recipient. Donor arm skin is one potential source of blood contamination, so it is usual to cleanse the skin with an antiseptic before blood donation. One-step and two-step alcohol based antiseptic regimens are both commonly advocated but there is uncertainty as to which is most effective. OBJECTIVES: To assess the effects of cleansing the skin of blood donors with alcohol in a one-step compared with alcohol in a two-step procedure to prevent contamination of collected blood or bacteraemia in the recipient. SEARCH METHODS: For this second update we searched the Cochrane Wounds Group Specialised Register (searched 20 November 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) The Cochrane Library 2012, Issue 11; Ovid MEDLINE (20011 to November Week 2 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations November 20, 2012); Ovid EMBASE ( 20011 to 2012 Week 46); and EBSCO CINAHL ( 2008 to 15 November 2012). SELECTION CRITERIA: All randomised trials (RCTs) comparing alcohol based donor skin cleansing in a one-step versus a two-step process that includes alcohol and any other antiseptic for pre-venepuncture skin cleansing were considered. Quasi randomised trials were to have been considered in the absence of RCTs. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. MAIN RESULTS: No studies (RCTs or quasi RCTs) met the inclusion criteria. AUTHORS' CONCLUSIONS: We did not identify any eligible studies for inclusion in this review. It is therefore unclear whether a two-step, alcohol followed by antiseptic skin cleansing process prior to blood donation confers any reduction in the risk of blood contamination or bacteraemia in blood recipients, or conversely whether a one-step process increases risk above that associated with a two-step process.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Bacteremia/prevention & control , Blood Donors , Disinfection/methods , Ethanol/administration & dosage , Skin/microbiology , Blood Transfusion , Humans
15.
Int J Nurs Stud ; 50(3): 419-30, 2013 Mar.
Article in English | MEDLINE | ID: mdl-22698733

ABSTRACT

OBJECTIVES: To examine the effects on healing of pressure relieving support surfaces in the treatment of pressure injury. DESIGN: Systematic review. DATA SOURCES: Cochrane Wound Group Specialised Register, The Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL. The reference sections of included trials were searched for further trials. REVIEW METHODS: Randomised controlled trials, published or unpublished, assessing the effect of support surfaces in treating all pressure injuries were sought. All included studies had to have reported objective measures of pressure injury healing. Where possible, findings from individual trials were calculated using risk ratio estimates or mean difference with 95% confidence intervals. RESULTS: Eighteen eligible trials involving 1309 participants were identified. There was no statistically significant effect on pressure injury size with low air loss devices compared with foam alternatives. One small trial at high risk of bias found that sheepskin positioned under the legs significantly reduced redness and a very small subgroup analysis favoured a profiling bed when compared with a standard bed in terms of the healing of grade 1 pressure injuries. CONCLUSIONS: Overall, there was an absence of good evidence to support the superiority of any pressure relieving device in the treatment of pressure injuries. This review highlights that the current evidence base requires improving by undertaking robust trials to ascertain which support surfaces are most effective for the treatment of pressure injuries.


Subject(s)
Evidence-Based Medicine , Pressure Ulcer , Wounds and Injuries , Humans , Randomized Controlled Trials as Topic , Wounds and Injuries/etiology , Pressure Ulcer/therapy
16.
Cochrane Database Syst Rev ; 10: CD003584, 2012 Oct 17.
Article in English | MEDLINE | ID: mdl-23076898

ABSTRACT

BACKGROUND: About 15% of the world population have fungal infections of the feet (tinea pedis or athlete's foot). There are many clinical presentations of tinea pedis, and most commonly, tinea pedis is seen between the toes (interdigital) and on the soles, heels, and sides of the foot (plantar). Plantar tinea pedis is known as moccasin foot. Once acquired, the infection can spread to other sites including the nails, which can be a source of re-infection. Oral therapy is usually used for chronic conditions or when topical treatment has failed. OBJECTIVES: To assess the effects of oral treatments for fungal infections of the skin of the foot (tinea pedis). SEARCH METHODS: For this update we searched the following databases to July 2012: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), and CINAHL (from 1981). We checked the bibliographies of retrieved trials for further references to relevant trials, and we searched online trials registers. SELECTION CRITERIA: Randomised controlled trials of oral treatments in participants who have a clinically diagnosed tinea pedis, confirmed by microscopy and growth of dermatophytes (fungi) in culture. DATA COLLECTION AND ANALYSIS: Two review authors independently undertook study selection, 'Risk of bias' assessment, and data extraction. MAIN RESULTS: We included 15 trials, involving 1438 participants. The 2 trials (71 participants) comparing terbinafine and griseofulvin produced a pooled risk ratio (RR) of 2.26 (95% confidence interval (CI) 1.49 to 3.44) in favour of terbinafine's ability to cure infection. No significant difference was detected between terbinafine and itraconazole, fluconazole and itraconazole, fluconazole and ketoconazole, or between griseofulvin and ketoconazole, although the trials were generally small. Two trials showed that terbinafine and itraconazole were effective compared with placebo: terbinafine (31 participants, RR 24.54, 95% CI 1.57 to 384.32) and itraconazole (72 participants, RR 6.67, 95% CI 2.17 to 20.48). All drugs reported adverse effects, with gastrointestinal effects most commonly reported. Ten of the trials were published over 15 years ago, and this is reflected by the poor reporting of information from which to make a clear 'Risk of bias' assessment. Only one trial was at low risk of bias overall. The majority of the remaining trials were judged as 'unclear' risk of bias because of the lack of clear statements with respect to methods of generating the randomisation sequence and allocation concealment. More trials achieved blinding of participants and personnel than blinding of the outcome assessors, which was again poorly reported. AUTHORS' CONCLUSIONS: The evidence suggests that terbinafine is more effective than griseofulvin, and terbinafine and itraconazole are more effective than no treatment. In order to produce more reliable data, a rigorous evaluation of different drug therapies needs to be undertaken with larger sample sizes to ensure they are large enough to show any real difference when two treatments are being compared. It is also important to continue to follow up and collect data, preferably for six months after the end of the intervention period, to establish whether or not the infection recurred.


Subject(s)
Antifungal Agents/administration & dosage , Tinea Pedis/drug therapy , Administration, Oral , Antifungal Agents/adverse effects , Chronic Disease , Humans , Randomized Controlled Trials as Topic
17.
Cochrane Database Syst Rev ; (8): CD002303, 2012 Aug 15.
Article in English | MEDLINE | ID: mdl-22895929

ABSTRACT

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. The majority of leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or weakness of the valves in the veins of the leg. Prevention and treatment of venous ulcers is aimed at reducing the pressure either by removing/repairing the veins, or by applying compression bandages/stockings to reduce the pressure in the veins.The majority of venous ulcers heal with compression bandages, however ulcers frequently recur. Clinical guidelines therefore recommend that people continue to wear compression, usually in the form of hosiery (tights, stockings, socks) after their ulcer heals, to prevent recurrence. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) in preventing the recurrence of venous ulcers. If compression does prevent ulceration compared with no compression, then to identify whether there is evidence to recommend particular levels of compression (high, medium or low, for example), types of compression, or brands of compression to prevent ulcer recurrence after healing. SEARCH METHODS: For this update we searched The Cochrane Wounds Group Specialised Register (searched 1 March 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 2); Ovid MEDLINE (1950 to February Week 4 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, February 29, 2012); Ovid EMBASE (1980 to 2012 Week 08); and EBSCO CINAHL (1982 to 1 March 2012). SELECTION CRITERIA: Randomised controlled trials evaluating compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: Two review authors undertook data extraction and risk of bias assessment independently. MAIN RESULTS: Four trials (979 participants) were eligible for inclusion in this review. One trial in patients with recently healed venous ulcers (n = 153) compared recurrence rates with and without compression and found that compression significantly reduced ulcer recurrence at six months (Risk ratio (RR) 0.46, 95% CI 0.27 to 0.76).Two trials compared high-compression hosiery (equivalent to UK class 3) with moderate-compression hosiery (equivalent to UK class 2). The first study (n=300) found no significant reduction in recurrence at five years follow up with high-compression hosiery compared with moderate-compression (RR 0.82, 95% CI 0.61 to 1.12). The second study (n = 338) assessed ulcer recurrence at three years follow up and found that high-compression hosiery reduced recurrence compared with moderate-compression (RR 0.57, 95% CI 0.39 to 0.81). Statistically significant heterogeneity precluded meta-analysis of the results from these studies. Patient-reported compliance rates were reported in both trials;,there was significantly higher compliance with medium-compression than with high-compression hosiery in one and no significant difference in the second.A fourth trial (166 patients) found no statistically significant difference in recurrence between two types of medium (UK class 2) compression hosiery (Medi versus Scholl: RR 0.74, 95% CI 0.45 to 1.2).No trials of compression bandages for preventing ulcer recurrence were identified. AUTHORS' CONCLUSIONS: There is evidence from one trial that compression hosiery reduces rates of reulceration of venous ulcers compared with no compression. Results from one trial suggest that recurrence is lower in high-compression hosiery than in medium-compression hosiery at three years whilst another trial found no difference at 5 years. Rates of patient intolerance of compression hosiery were high. There is insufficient evidence to aid selection of different types, brands, or lengths of compression hosiery.


Subject(s)
Stockings, Compression , Varicose Ulcer/prevention & control , Adult , Compression Bandages , Humans , Randomized Controlled Trials as Topic , Risk , Secondary Prevention
18.
Int J Nurs Stud ; 49(3): 345-59, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22104042

ABSTRACT

OBJECTIVES: To undertake a systematic review of the effectiveness of pressure redistributing support surfaces in the prevention of pressure ulcers. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Cochrane Wound Group Specialised Register, The Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid EMBASE and EBSCO CINAHL. The reference sections of included trials were searched for further trials. REVIEW METHODS: Randomised controlled trials and quasi-randomised trials, published or unpublished, which assessed the effects of support surfaces in preventing pressure ulcers (of any grade), in any patient group, in any setting compared to any other support surface, were sought. Two reviewers extracted and summarised details of eligible trials using a standardised form and assessed the methodological quality of each trial using the Cochrane risk of bias tool. RESULTS: Fifty-three eligible trials were identified with a total of 16,285 study participants. Overall the risk of bias in the included trials was high. Pooled analysis showed that: (i) foam alternatives to the standard hospital foam mattress reduce the incidence of pressure ulcers in people at risk (RR 0.40, 95% CI 0.21-0.74) and Australian standard medical sheepskins prevent pressure ulcers compared to standard care (RR 0.48, 95% CI 0.31-0.74). Pressure-redistributing overlays on the operating table compared to standard care reduce postoperative pressure ulcer incidence (RR 0.53, 95% CI 0.33-0.85). CONCLUSIONS: While there is good evidence that higher specification foam mattresses, sheepskins, and that some overlays in the operative setting are effective in preventing pressure ulcers, there is insufficient evidence to draw conclusions on the value of seat cushions, limb protectors and various constant low pressure devices. The relative merits of higher-tech constant low pressure and alternating pressure for prevention are unclear. More robust trials are required to address these research gaps.


Subject(s)
Beds , Pressure Ulcer/prevention & control , Humans
19.
Cochrane Database Syst Rev ; (12): CD009490, 2011 Dec 07.
Article in English | MEDLINE | ID: mdl-22161450

ABSTRACT

BACKGROUND: Pressure ulcers are treated by reducing pressure on the areas of damaged skin. Special support surfaces (including beds, mattresses and cushions) designed to redistribute pressure, are widely used as treatments. The relative effects of different support surfaces are unclear. OBJECTIVES: To assess the effects of pressure-relieving support surfaces in the treatment of pressure ulcers. SEARCH METHODS: We searched: The Cochrane Wounds Group Specialised Register (searched 15 July 2011); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 3); Ovid MEDLINE (2007 to July Week 1 2011); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, July 14, 2011); Ovid EMBASE (2007 to 2011 Week 27); EBSCO CINAHL (2007 to 14 July 2011). The reference sections of included studies were also searched. SELECTION CRITERIA: We included published or unpublished randomised controlled trials (RCTs), that assessed the effects of support surfaces for treating pressure ulcers, in any patient group or setting, that reported an objective measure of wound healing. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of risk of bias were performed independently by two review authors. Trials with similar patients, comparisons and outcomes were considered for pooled analysis. Where pooling was inappropriate the results of the trials were reported narratively. Where possible, the risk ratio or mean difference was calculated for the results of individual studies. MAIN RESULTS: We identified 18 trials of support surfaces for pressure ulcer treatment, involving 1309 participants with samples sizes that ranged from 14 to 160. Of three trials comparing air-fluidized devices with conventional therapy, two reported significant reductions in pressure ulcer size associated with air-fluidized devices. Due to lack of reported variance data we could not replicate the analyses. In relation to three of the trials that reported significant reductions in pressure ulcer size favouring low air loss devices compared with foam alternatives, we found no significant differences. A small trial found that sheepskin placed under the legs significantly reduced redness and similarly a small subgroup analysis favoured a profiling bed compared with a standard bed in terms of the healing of existing grade 1 pressure ulcers. Poor reporting, clinical heterogeneity, lack of variance data and methodological limitations in the eligible trials meant that no pooled comparisons were undertaken. AUTHORS' CONCLUSIONS: There is no conclusive evidence about the superiority of any support surface for the treatment of existing pressure ulcers. Methodological issues included variations in outcomes measured, sample sizes and comparison groups. Many studies had small sample sizes and often there was inadequate description of the intervention, standard care and co-interventions. Individual study results were often inadequately reported, with failure to report variance data common, thus hindering the calculation of mean differences. Some studies did not report P values when reporting on differences in outcomes. In addition, the age of some trials (some being 20 years old), means that other technologies may have superseded those investigated.Further and rigorous studies are required to address these concerns and to improve the evidence base before firm conclusions can be drawn about the most effective support surfaces to treat pressure ulcers.


Subject(s)
Bedding and Linens/standards , Beds/standards , Pressure Ulcer/therapy , Equipment Design , Humans , Randomized Controlled Trials as Topic , Surface Properties , Wound Healing
20.
Cochrane Database Syst Rev ; (4): CD001735, 2011 Apr 13.
Article in English | MEDLINE | ID: mdl-21491384

ABSTRACT

BACKGROUND: Pressure ulcers (i.e. bedsores, pressure sores, decubitus ulcers) are areas of localised damage to the skin and underlying tissue. They are common in the elderly and immobile, and costly in financial and human terms. Pressure-relieving support surfaces (i.e. beds, mattresses, seat cushions etc) are used to help prevent ulcer development. OBJECTIVES: This systematic review seeks to establish: (1) the extent to which pressure-relieving support surfaces reduce the incidence of pressure ulcers compared with standard support surfaces, and, (2) their comparative effectiveness in ulcer prevention. SEARCH STRATEGY: For this third update we searched: the Cochrane Wounds Group Specialised Register (searched 8 December 2010), The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 4); Ovid MEDLINE (1950 to November Week 3 2010); Ovid MEDLINE (In-Process & Other Non-Indexed Citations December 07, 2010); Ovid EMBASE (1980 to 2010 Week 48); EBSCO CINAHL (1982 to 3 December 2010), and the reference sections of included studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-randomised studies, published or unpublished, that assessed the effects of any support surface for prevention of pressure ulcers, in any patient group or setting which measured pressure ulcer incidence.Studies reporting only proxy outcomes (e.g. interface pressure) were excluded. Two review authors independently selected studies. DATA COLLECTION AND ANALYSIS: Data were extracted by one author and checked by another. Where appropriate, estimates from similar studies were pooled for meta-analysis. MAIN RESULTS: One new trial was included, bringing the total of included studies to 53.Foam alternatives to standard hospital foam mattresses reduce the incidence of pressure ulcers in people at risk (RR 0.40 95% CI 0.21 to 0.74). The relative merits of alternating- and constant low-pressure devices are unclear. One high-quality trial suggested that alternating-pressure mattresses may be more cost effective than alternating-pressure overlays in a UK context.Pressure-relieving overlays on the operating table reduce postoperative pressure ulcer incidence, although two studies indicated that foam overlays caused adverse skin changes. Meta-analysis of three trials indicated that Australian standard medical sheepskins prevent pressure ulcers (RR 0.56 95% CI 0.32 to 0.97).  AUTHORS' CONCLUSIONS: People at high risk of developing pressure ulcers should use higher-specification foam mattresses rather than standard hospital foam mattresses. The relative merits of higher-specification constant low-pressure and alternating-pressure support surfaces for preventing pressure ulcers are unclear, but alternating-pressure mattresses may be more cost effective than alternating-pressure overlays in a UK context. Medical grade sheepskins are associated with a decrease in pressure ulcer development. Organisations might consider the use of some forms of pressure relief for high risk patients in the operating theatre.


Subject(s)
Beds , Pressure Ulcer/prevention & control , Beds/standards , Humans , Pressure Ulcer/therapy , Randomized Controlled Trials as Topic
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