Definitions for the overall quality of evidence (high, moderate, low, or insufficient evidence to determine net benefits or risks) and the strength of the recommendations (strong, weak) are provided at the end of the “Major Recommendations” field.

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Major Recommendations

Definitions for the overall quality of evidence (high, moderate, low, or insufficient evidence to determine net benefits or risks) and the strength of the recommendations (strong, weak) are provided at the end of the “Major Recommendations” field.

Recommendation 1: American College of Physicians (ACP) recommends that clinicians use protein or amino acid supplementation in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)

Evidence showed that nutritional supplementation with protein or amino acids reduced pressure ulcer wound size, but evidence for the optimal dose or form of protein was insufficient. Protein supplementation was assessed in conjunction with standard therapies, such as dressings or support surfaces. Also, the trials generally included patients with nutritional deficiencies, and the evidence may not be generalizable to all patients with pressure ulcers because they may not benefit from nutritional supplementation. Evidence also did not show any benefit of vitamin C supplementation compared with placebo. Data are insufficient to comment on complete wound healing. The relationship between reduction in wound size or rate of healing and eventual complete healing has not been well-defined.

Recommendation 2: ACP recommends that clinicians use hydrocolloid or foam dressings in patients with pressure ulcers to reduce wound size. (Grade: weak recommendation, low-quality evidence)

Low-quality evidence showed that hydrocolloid dressings are better than gauze dressings for reducing wound size. In addition, moderate-quality evidence showed that hydrocolloid dressings resulted in complete wound healing similar to that of foam dressings (hydrocellular or polyurethane). Evidence was insufficient to determine whether specific dressings resulted in fewer harms than others. Data are insufficient to comment on complete wound healing. The relationship between reduction in wound size or rate of healing and eventual complete healing has not been well-defined.

Recommendation 3: ACP recommends that clinicians use electrical stimulation as adjunctive therapy in patients with pressure ulcers to accelerate wound healing. (Grade: weak recommendation, moderate-quality evidence)

Moderate-quality evidence supports the use of electrical stimulation in addition to standard treatment because it has been shown to accelerate the healing rate of stage 2 to 4 ulcers. Data are insufficient to comment on complete wound healing. The relationship between reduction in wound size or rate of healing and eventual complete healing has not been well-defined. The Figure in the original guideline document summarizes the recommendations and clinical considerations.

Definitions:

Grading of Quality of Evidence

High-Quality Evidence: Evidence is considered high quality when it is obtained from 1 or more well-designed and well-executed randomized, controlled trials (RCTs) that yield consistent and directly applicable results. This also means that further research is very unlikely to change confidence in the estimate of effect.

Moderate-Quality Evidence: Evidence is considered moderate quality when it is obtained from RCTs with important limitations—for example, biased assessment of the treatment effect, large loss to follow-up, lack of blinding, unexplained heterogeneity (even if it is generated from rigorous RCTs), indirect evidence originating from similar (but not identical) populations of interest, and RCTs with a very small number of participants or observed events. In addition, evidence from well-designed controlled trials without randomization, well-designed cohort or case-control analytic studies, and multiple time series with or without intervention are in this category. Moderate-quality evidence also means that further research will probably have an important effect on confidence in the estimate of effect and may change the estimate.

Low-Quality Evidence: Evidence obtained from observational studies would typically be rated as low quality because of the risk for bias. Low-quality evidence means that further research is very likely to have an important effect on confidence in the estimate of effect and will probably change the estimate. However, the quality of evidence may be rated as moderate or even high, depending on circumstances under which evidence is obtained from observational studies. Factors that may contribute to upgrading the quality of evidence include a large magnitude of the observed effect, a dose-response association, or the presence of an observed effect when all plausible confounders would decrease the observed effect.

Insufficient Evidence to Determine Net Benefits or Risks: When the evidence is insufficient to determine for or against routinely providing a service, the recommendation was graded as “insufficient evidence to determine net benefits or risks.” Evidence may be conflicting, of poor quality, or lacking, and hence the balance of benefits and harms cannot be determined. Any estimate of effect that is very uncertain as evidence is either unavailable or does not permit a conclusion.

The American College of Physicians Guideline Grading System*
Quality of Evidence	Strength of Recommendation
	Benefits Clearly Outweigh Risks and Burden or Risks and Burden Clearly Outweigh Benefits	Benefits Finely Balanced with Risks and Burden
Insufficient evidence to determine net benefits or risks
High	Strong	Weak
Moderate	Strong	Weak
Low	Strong	Weak

*Adopted from the classification developed by the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) workgroup.

Clinical Algorithm(s)

None provided

Scope

Disease/Condition(s)

Pressure ulcers

Guideline Category

Treatment

Clinical Specialty

Family Practice

Geriatrics

Internal Medicine

Nursing

Intended Users

Advanced Practice Nurses

Dietitians

Hospitals

Nurses

Physical Therapists

Physician Assistants

Physicians

Guideline Objective(s)

To present the evidence and provide clinical recommendations based on the comparative effectiveness of treatments for pressure ulcers

Target Population

Patients with pressure ulcers

Interventions and Practices Considered

Protein or amino acid supplementation

Use of hydrocolloid or foam dressings to reduce wound size

Electrical stimulation (adjunctive therapy)

Major Outcomes Considered

Complete wound healing and wound size (surface area, volume, and depth) reduction

Additional outcomes include:

Pain

Prevention of sepsis

Prevention of osteomyelitis

Recurrence rate

Harms of treatment (including but not limited to pain, dermatologic complications, bleeding, and infection)

Methodology

Methods Used to Collect/Select the Evidence

Hand-searches of Published Literature (Primary Sources)

Hand-searches of Published Literature (Secondary Sources)

Searches of Electronic Databases

Searches of Unpublished Data

Description of Methods Used to Collect/Select the Evidence

Note from the National Guideline Clearinghouse (NGC): A systematic evidence review was prepared by the Oregon Evidence-based Practice Center (EPC) (see the “Availability of Companion Documents” field).

The investigators searched MEDLINE, EMBASE, CINAHL, EBM Reviews, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, and the Health Technology Assessment database through February 2014 for studies in English. The primary outcomes of interest for this guideline include complete wound healing and wound size (surface area, volume, and depth) reduction. Additional outcomes include pain, prevention of sepsis, prevention of osteomyelitis, recurrence rate, and harms of treatment (including but not limited to pain, dermatologic complications, bleeding, and infection). Although most studies reported statistical significance of various outcomes, the guideline panel assessed clinically significant changes when evaluating the evidence.

Further details about the methods and inclusion and exclusion criteria applied in the evidence review are available in the full Agency for Healthcare Research and Quality (AHRQ) report and the Supplement (see the “Availability of Companion Documents” field).

Number of Source Documents

One hundred seventy-four studies (182 articles) were included in the synthesis:

Support surfaces: 24 (26 articles)

Nutrition: 16 (16 articles)

Local wound applications: 89 (92 articles)

Surgery: 6 (6 articles)

Adjunctive therapies: 39 (42 articles)

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Grading of Quality of Evidence

High-Quality Evidence: Evidence is considered high quality when it is obtained from 1 or more well-designed and well-executed randomized, controlled trials (RCTs) that yield consistent and directly applicable results. This also means that further research is very unlikely to change confidence in the estimate of effect.

Moderate-Quality Evidence: Evidence is considered moderate quality when it is obtained from RCTs with important limitations—for example, biased assessment of the treatment effect, large loss to follow-up, lack of blinding, unexplained heterogeneity (even if it is generated from rigorous RCTs), indirect evidence originating from similar (but not identical) populations of interest, and RCTs with a very small number of participants or observed events. In addition, evidence from well-designed controlled trials without randomization, well-designed cohort or case-control analytic studies, and multiple time series with or without intervention are in this category. Moderate-quality evidence also means that further research will probably have an important effect on confidence in the estimate of effect and may change the estimate.

Low-Quality Evidence: Evidence obtained from observational studies would typically be rated as low quality because of the risk for bias. Low-quality evidence means that further research is very likely to have an important effect on confidence in the estimate of effect and will probably change the estimate. However, the quality of evidence may be rated as moderate or even high, depending on circumstances under which evidence is obtained from observational studies. Factors that may contribute to upgrading the quality of evidence include a large magnitude of the observed effect, a dose-response association, or the presence of an observed effect when all plausible confounders would decrease the observed effect.

Insufficient Evidence to Determine Net Benefits or Risks: When the evidence is insufficient to determine for or against routinely providing a service, the recommendation was graded as “insufficient evidence to determine net benefits or risks.” Evidence may be conflicting, of poor quality, or lacking, and hence the balance of benefits and harms cannot be determined. Any estimate of effect that is very uncertain as evidence is either unavailable or does not permit a conclusion.

Methods Used to Analyze the Evidence

Meta-Analysis

Review of Published Meta-Analyses

Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

Note from the National Guideline Clearinghouse (NGC): A systematic evidence review was prepared by the Oregon Evidence-based Practice Center (EPC) (see the “Availability of Companion Documents” field).

Data Extraction and Quality Assessment

From the included studies, details of the patient population, study design, analysis, follow-up, and results were extracted by a team member and reviewed for accuracy and completeness by an investigator. For comparability across studies, when possible, ulcer stage or grade was translated to the corresponding stage as defined by the National Pressure Ulcer Advisory Panel (see Appendix Table 1 in the systematic review). The investigators rated the quality (risk of bias) of the individual studies and strength of the body of evidence, and results were reviewed by at least 1 other investigator for accuracy, with disagreements being settled by consensus. The American College of Physicians (ACP) staff used an approach adapted from the Agency for Healthcare Research and Quality (AHRQ) Methods Guide for Effectiveness and Comparative Effectiveness Reviews for determining the strength of evidence as “high,” “moderate,” “low,” or “insufficient” on the basis of the design, quantity, size, and quality (risk of bias) of studies, consistency across studies, precision of estimates and directness of evidence.

Data Synthesis and Analysis

Data were synthesized qualitatively with attention to characteristics, such as ulcer grade and location, patient characteristics and settings, and risk of bias of individual studies. ACP staff conducted meta-analyses in selected instances for comparisons examining the outcome of complete wound healing where the number, quality, and homogeneity of studies permitted.

The investigators chose to limit meta-analysis to the outcome of complete wound healing because this was the principal health outcome of interest and because of the wide variability in the measurement of other outcomes, including reduction in wound size. When a meta-analysis was conducted, ACP staff used relative risk as the effect measure. They assessed the presence of statistical heterogeneity among the studies using standard chi-square tests and the magnitude of heterogeneity using the I² statistic. ACP staff used random-effects models to account for variation among studies and fixed-effects Mantel–Haenszel models when variation among studies was estimated to be zero. Sensitivity analysis was conducted to assess the effect of quality on combined estimates, and meta-regression was conducted to assess the association of effect measure with study duration. All quantitative analyses were done using STATA, version 11.0 (StataCorp, College Station, Texas).

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Note from the National Guideline Clearinghouse (NGC): A systematic evidence review was prepared by the Oregon Evidence-based Practice Center (EPC) (see the “Availability of Companion Documents” field).

This guideline is based on a systematic evidence review, an update of the literature (see the Supplement), and an evidence report sponsored by the Agency for Healthcare Research and Quality (AHRQ) (see the “Availability of Companion Documents” field) that addressed the following key questions:

In adults with pressure ulcers, what is the comparative effectiveness of treatment strategies for improved health outcomes, including but not limited to complete wound healing, healing time, reduced wound surface area, pain, and prevention of serious complications of infection? Does the comparative effectiveness of treatment strategies differ on the basis of features (anatomical site or severity) of the pressure ulcers, patient characteristics, and health care settings?

What are the harms of treatments for pressure ulcers? Do the harms differ on the basis of features (anatomical site or severity) of the pressure ulcers, patient characteristics, and health care settings?

This guideline rates the evidence and recommendations by using the American College of Physicians’ (ACP’s) guideline grading system (see the “Rating Scheme for the Strength of the Evidence” and “Rating Scheme for the Strength of the Recommendations” fields). Details of the guideline development process can be found in the summary of methods paper (see the “Availability of Companion Documents” field).

Rating Scheme for the Strength of the Recommendations

The American College of Physicians Guideline Grading System*
Quality of Evidence	Strength of Recommendation
	Benefits Clearly Outweigh Risks and Burden or Risks and Burden Clearly Outweigh Benefits	Benefits Finely Balanced with Risks and Burden
Insufficient evidence to determine net benefits or risks
High	Strong	Weak
Moderate	Strong	Weak
Low	Strong	Weak

*Adopted from the classification developed by the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) workgroup.

Cost Analysis

The guideline developers reviewed published cost analyses.

Method of Guideline Validation

Internal Peer Review

Description of Method of Guideline Validation

This guideline was approved by the American College of Physicians (ACP) Board of Regents on July 26, 2014.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the “Major Recommendations” field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Most studies reported on only 1 outcome each (such as reduction of pressure ulcer size, improved wound healing, or rate of wound healing). Complete wound healing was reported in few studies; intermediate outcomes, such as reduction of wound size and rate of wound healing, were used to assess efficacy of the interventions. Some improvements were seen only in patients with large ulcers (>7 cm). See the section “Benefits and Comparative Effectiveness of Pressure Ulcer Treatment Strategies” in the original guideline document for more information.

See also Table 1 in the original guideline document for descriptions and advantages of the various treatment strategies.

Potential Harms

Skin irritation, inflammation, tissue damage and maceration were the most commonly reported harms for various dressings and topical therapies.

The most common adverse effect reported with electrical stimulation was skin irritation. Frail elderly patients had more adverse events associated with electrical stimulation than younger patients.

The most commonly reported harm from surgery was dehiscence. Dehiscence was more common if bone was removed during the surgery, and patients with ischial ulcers had higher complication rates than those with sacral or