Outcomes for Pressure Ulcer Trials (OUTPUTs) project: review and classification of outcomes reported in pressure ulcer prevention research.

In order to overcome inconsistencies in the reporting of outcomes in clinical trials, core outcome sets (COSs) have been developed in many clinical areas and the awareness of this concept is growing steadily. The Outcomes for Pressure Ulcer Trials (OUTPUTs) project aims to improve the quality of evidence from pressure ulcer prevention trials by developing a COS. As an initial step in the COS process we aimed to identify and classify both outcomes and concepts that represent potential outcomes for future trials that have been reported in pressure ulcer prevention research. A review was conducted in 12 major databases covering the literature indexed until 2016. Outcomes and relevant concepts reported in primary studies and/or reviews on pressure ulcer prevention in adult patients were extracted as presented in the articles, and afterwards inductively grouped into outcome domains. The domains were then categorized according to the outcome domain taxonomy recently proposed by the COMET group. In total 332 studies were included and 68 outcome domains were identified, covering multiple aspects of pressure ulcer prevention. Pressure ulcer occurrence was reported in 71% of all included studies, representing the most frequent outcome, followed by costs (22% of all studies) and acceptability of intervention and comfort (18% of all studies). A plethora of different outcomes are applied in pressure ulcer prevention research and substantial variations in definitions and reporting of similar outcomes were observed. A COS for pressure ulcer prevention trials is needed to overcome the noncomparability of outcomes.

Instrumento para la monitorización de la evolución de una úlcera por presión / Pressure ulcers evolution assessment tools

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An instrument to measure healing in pressure ulcers: development and validation of the pressure ulcer scale for healing (PUSH).

BACKGROUND: Currently, there is no instrument that provides an accurate and simple method of monitoring pressure ulcer healing in clinical practice. This article reports the two studies that were conducted to assess the validity of the Pressure Ulcer Scale for Healing (PUSH) as a tool to monitor healing of stage II-IV pressure ulcers. METHODS: Subjects in both studies (N = 103 and N = 269) were elderly (mean Study 1, 75 years, mean Study 2, 80 years), and the majority were women (Study 1, 51%, Study 2, 70%). Study data were extracted from patients' permanent records. RESULTS: Principal components analysis confirmed that the PUSH tool accounted for 58% to 74% of the wound healing variance over a 10-week period in Study 1 and 40% to 57% of the wound healing variance over a 12-week period in Study 2. In addition, multiple regression analysis, used to measure the sensitivity of the model to total healing, showed PUSH accounted for 39% of the variance in 6 weeks and 31% of the variance over 12 weeks (p <.001; Studies 1 and 2, respectively). CONCLUSIONS: Data from these two studies confirmed that the PUSH tool, with the components of length times width, exudate amount, and tissue type, is a valid and sensitive measure of pressure ulcer healing. It is a practical approach that provides clinically valid data regarding pressure ulcer healing. Further testing is needed to confirm these findings.

Outcomes of 4 methods of debridement using a decision analysis methodology.

OBJECTIVE: To compare the clinical efficacy of 4 debridement alternatives in pressure ulcer management. DESIGN: Nonexperimental design combining computer modeling and a decision analysis methodology. Data input into the model were derived from a literature review of the MEDLINE database for the years 1985 to 1995 (indexing terms: pressure ulcer, decubitus, economics, cost-effectiveness, and outcome) and a Delphi consensus process with an independent panel of 9 specialists in geriatric care. SETTING: Long-term care. PATIENTS: Hypothetical elderly female resident with a new full-thickness pressure ulcer (mild odor, minimal draining, no undermining, intact periulcer skin). INTERVENTIONS: The study patient underwent 1 month of therapy with each of 4 debridement methods: autolysis, wet-to-dry dressings, collagenase (Santyl) or fibrinolysin (Elase). MAIN OUTCOME: Specific clinical outcomes (time to clean wound bed, risk of infection) and relative cost-effectiveness of each debridement method were calculated. RESULTS: The likelihood of achieving a clean wound bed at 2 weeks was 70% for collagenase, 57% for fibrinolysin, 50% for autolysis, and 30% for wet-to-dry dressings. The total cost for 1 month of treatment was $610.96 for collagenase, $920.73 for autolysis, $986.38 for fibrinolysin, and $1,008.72 for wet-to-dry dressings. CONCLUSIONS: The study patient was most likely to have a clean wound bed after 2 and 4 weeks of treatment, less likely to need to switch debridement methods, and of equal or less likelihood of experiencing and infection and subsequent hospitalization when her wound was debrided with collagenase. Treatment with collagenase also resulted in the lowest total cost of treatment. Longer term, prospective studies using actual utilization data are needed to refine these estimates of the clinical and cost-effectiveness of each product.

Pressure ulcer research: pressure ulcer treatment. A monograph from the National Pressure Ulcer Advisory Panel.

The AHCPR guideline on Treatment of Pressure Ulcers was released in December 1994. This guideline was based on the best available scientific evidence published between 1966 and May 1, 1993. Over 45,000 abstracts were reviewed in the literature analysis. Yet only 63.2% of the guideline recommendations were based on research of any type, and only 4.5% of the recommendations were supported by two or more randomized clinical trials. A more recent literature review (covering articles on pressure ulcers listed in the MEDLINE database between May 1, 1993, and December 1, 1996), revealed minimal advances in the scientific body of knowledge on pressure ulcer treatment. Advances have been made in the knowledge of electrical therapy and growth factors, and efforts are under way to enhance tools for monitoring healing. In an era of limited research funding, we need to carefully target our research efforts to maximize the advancement of our knowledge of pressure ulcer treatment. It is the hope of the NPUAP that this monograph will guide the research needed to ensure the most efficient utilization of funds to improve patient outcomes.

Pressure ulcer classification: what do we have? What do we need?

This paper will lay the foundation for subsequent papers by: summarizing the limitations of the current pressure ulcer classification system exploring methods to monitor the dynamic process of pressure ulcer healing establishing common criteria for evaluating various methods of monitoring pressure ulcer healing.

Pressure ulcer scale for healing: derivation and validation of the PUSH tool. The PUSH Task Force.

Measuring progress toward healing is fundamental to the management of pressure ulcers. A method to assess progress of an individual ulcer over time is lacking. Given the limitations of currently available instruments and the need for a precise and practical method of monitoring healing in clinical practice, the National Pressure Ulcer Advisory Panel initiated the development of a new tool for measuring pressure ulcer healing. The key elements in developing an instrument include simplicity of use in clinical settings, validity for measuring whether ulcers are improving or worsening, and sensitivity to changes in the ulcer between observations. A new tool incorporating surface area, exudate amount, and surface appearance is proposed. Content validity, correlation validity, prospective validity, and sensitivity to change can be met by the proposed Pressure Ulcer Scale for Healing instrument.

Clinical practice guidelines: prediction and prevention of pressure ulcers.

Prevention, as well as effective early treatment and intervention, provides an opportunity for both reducing financial costs and improving the quality of life for the patients involved. The Agency for Health Care Policy and Research (AHCPR), therefore, has developed clinical practice guidelines concerning the prevention and treatment of pressure ulcers. The Guidelines target four overall goals: Identify at-risk individuals who need prevention and the specific factors that place them at risk; maintain and improve tissue tolerance to pressure in order to prevent injury; protect against the adverse effects of external mechanical forces (pressure, friction, shear); and reduce the incidence of pressure ulcers through educational programs.

Clinical practice guidelines: prediction and prevention of pressure ulcers.

1. Prevention, as well as effective early treatment and intervention, provides an opportunity for both reducing financial costs and improving the quality of life for the patients involved. 2. The Agency for Health Care Policy and Research (AHCPR), therefore, has developed clinical practice guidelines concerning the prevention and treatment of pressure ulcers. 3. The Guidelines target four overall goals: Identify at-risk individuals who need prevention and the specific factors that place them at risk; maintain and improve tissue tolerance to pressure in order to prevent injury; protect against the adverse effects of external mechanical forces (pressure, friction, shear); and reduce the incidence of pressure ulcers through educational programs.

Decision support and outcomes of nurses' care planning.

One hundred forty-three nurses served as their own controls in planning care for hypothetical patients under three different manipulated conditions of decision support: (A) use of traditional resources; (B) use of a printout of a computerized protocol for care planning (NPC); and (C) use of an NPC protocol and a self study guide. A series of 3 x 5 repeated measures analyses of variance (ANOVAs) were used to evaluate the main effects and interactions of the experimental treatment conditions and the two nurse attribute variables of education and experience (each with five levels). The case problems and conditions were counterbalanced to control for extraneous variables. The repeated measures ANOVA demonstrated significantly higher mean ratings of quality for care planned under both computerized decision support conditions than the traditional condition on all three patient problem situations F(2, 270) = 7.9, p less than .01. Time on task was also significant F(2, 272) = 5.8, p less than .01 with use of the decision support consultants tending to increase time in planning.

Gastric bleeding and benorylate, a new aspirin.

Benorylate (4-acetamidophenyl 2-acetoxybenzoate) is a new esterified aspirin preparation whose antirheumatic properties are reported to be as good as those of aspirin. Gastrointestinal blood loss, measured with (51)Cr-labelled red cells, during benorylate therapy was compared with that during therapy with soluble aspirin in 15 subjects, a simplified crossover procedure being used. Mean blood loss during benorylate therapy was 1.7 ml/day which was significantly less than that during therapy with soluble aspirin (5.1 ml/day; P <0.001). In 12 of the 15 patients blood loss with benorylate was less than 2.5 ml/day. Benorylate appears to be a definite improvement on current formulations of aspirin and should be a useful drug for the treatment of patients with chronic rheumatic disorders.