Development of the Efteli and Güneş (EFGU) Pressure Ulcer Risk Assessment Scale. A systematic review of risk factors for PU/I development identified that PU/I risk assessment scales should be developed on the basis of multivariable analyses to identify factors that are independently associated with a PU/I.30 In addition, a conceptual framework to establish a theoretical structure is needed to determine factors that are critical to the development of PU/Is.31 Several conceptual frameworks have been proposed in this regard over the past 30 years.23,32 The PU/I risk factor assessment tool developed by the current authors was based on the conceptual framework of Coleman et al,31 where characteristics are classified as key direct, key indirect, and other potential indirect causal risk factors31 (see Figure 1). The risk assessment scale was intended to comprise risk factors with high level of evidence not found in the current risk assessment scales and that could distinguish individuals according to their PU/I risk. A total of 10 draft scale items that have a high level of evidence was chosen from the conceptual framework of Coleman et al31 and evaluated by a panel of 10 specialists with professional expertise in PU/Is. The items were not divided into sections or weighted equally. Each item had a score range of 0 to 3 in accordance with the 3 response categories.
Direct risk factors (ie, immobility, skin/pressure ulcer status, and poor perfusion). Physical inactivity is a primary risk factor in PU/I development. Strong evidence31 indicates that inadequate perfusion and the skin’s status (ie, status factors that may indicate the skin is more vulnerable to PU/I development such as redness, blanching erythema, dryness) reduce patient tolerance of pressure and accelerate PU/I development. These critical factors were incorporated into the new risk assessment scale. PU/I prevention guidelines23,33,34 encourage the individual to make small shifts in body position every hour to relieve the pressure on the bony prominences. Therefore, the current authors assessed the ability of the patient to shift positions using the following scale: 0 = being able to make repositioning shifts of at least 15˚ to 20˚ in approximately 60 seconds once an hour; 1 = making these shifts once in 2 hours; 2 = making these shifts once in 4 hours; and 3 = no ability to shift. Skin status in the areas exposed to pressure, especially on sacrum and great trochanter, were scored as 0 = healthy skin; 1 = thin-sensitive skin, edema, moist-cold skin, dry-cracked skin; and 2 = hyperemia.
Diastolic blood pressure and a skin tolerance test were used to evaluate perfusion status. Low diastolic blood pressure reduces perfusion in peripheral tissues and has been shown in a cohort study35,36 to increase PU risk. The average diastolic blood pressure per day was obtained and scored as 0 = 60 mm Hg or more, and 1 = less than 60 mm Hg. The skin tolerance test showed how much pressure an individual can tolerate without damage and whether the circulation in the region deteriorated.23 In order to evaluate skin tolerance, a finger was pressed over the reddened area for 10 seconds. If the area blanched within 20 seconds of the finger being lifted, the score was 0 (normal response); if it took more than 20 seconds, the score was 1 (late response); if the area stayed red, the score was 2.
Key indirect risk factors (poor sensory perception and response, diabetes, moisture, poor nutrition, and low albumin). These factors indirectly influence PU/I risk and include discomfort/pain sensation, diabetes, and incontinence. As shown in a systematic review,33 the patient’s perception of pain and discomfort in the area under pressure after inadequate perfusion and the change in position in this direction are extremely important to what can be accomplished to prevent PU/Is33; on the new scale, this item was scored as 0 = no discomfort on the sacrum or great trochanter (areas typically exposed to the greatest pressure), 1 = discomfort, and 2 = no sensory perception in the aformentioned areas. Diabetes is thought to be a contributing factor in PU/I development, despite the lack of strong evidence.37 The presence of diabetes was scored as 0 = does not have diabetes and 1 = has diabetes. Moisture accelerates PU/I development by reducing epidermal resistance.23 Extrinsic moisture from perspiration, urine, and feces can macerate the skin surface and was scored as 0 = no incontinence or the presence of a urinary catheter, 1 = urinary incontinence, 2 = fecal incontinence, and 3 = urinary and fecal incontinence.
Other potential indirect risk factors (older age, medication, presence of pitting edema, chronic wound infection, acute illness, and/or raised body temperature). Although scientific evidence is weak or limited regarding these indirect factors, they are thought to influence key direct or indirect risk factors.31 In a systematic review30 of PU/I risk factors, older age emerged as an important predictor of PU/I development. Therefore, age was considered a variable for the new scale and was assigned scores of 0 = 65 years of age or under and 1 = older than 65 years.
The total score on the EFGU scale ranged from 0 to 15, with higher scores indicating a higher risk of PU/I development (see Table 1). The total score was obtained by calculating the highest scores for each scale item.
Assessing the EFGU scale.
Design and setting. A prospective, methodological study was conducted between September 1, 2015, and November 1, 2016, in the of Neurology, Internal Medicine, Neurosurgery, Orthopedics, and Traumatology ICUs of Ege University Hospital, Izmir, Turkey.
Participants. The sample comprised patients newly hospitalized in the units where the study was conducted. The inclusion criteria stipulated participants must be patients older than 18 years, without PU/Is on admission, bedbound, who did not take inotropic and vasopressor medications (which affect peripheral vascular resistance), and were expected to stay in the hospital for a minimum of 6 days (see Figure 2). Previous studies on the subject have been used to determine the sample size.1,38 The sample volume was determined at α = 0.05 and power 90% using the standardized effect sizes determined by Cohen.39 The sample size should be at least 5 to 10 times greater than the number of items in the scale to achieve meaningful and reliable results in the scale development process.40,41 The scale consisted of 8 items; 207 persons participated in this study. The sample size was 25 times greater than the number of items.
Instruments. Data were collected using a 3-part instrument that comprised 1) patient demographic data, 2) the EFGU Pressure Ulcer Risk Assessment Scale, and 3) ulcer staging information according to the NPUAP23 Pressure Ulcer Classification System. The patient demographic data form included 7 questions regarding age, gender, hospital unit, diagnoses, follow-up time (in days), diabetes status, the state of consciousness as determined and recorded by the physician, and PU/I presence. Demographic data were collected within the first 24 hours of admission.
Data collection. Data were collected from medical records by a single investigator using a paper and pencil tool. Patients were evaluated during the first 24 hours of admission to the hospital and once a week after until a PU/I developed or the patient was discharged from the unit (maximum stay 12 weeks). All variables were assessed every day during hospital stay. Because patients’ diastolic blood pressure was measured manually 3 times a day, the average was taken and recorded (48; EAKA, Bad Tölz, Bavaria, Germany). Preventive measures for PU/I development, such as positioning, skin care, and nutrition, were provided to all patients.
Data analysis. Data were analyzed by an expert in biostatistics using the Statistical Package for Social Science, version 16.0 (SPSS Inc, Chicago, IL). Means and percentages were calculated, and Student’s t test, chi-squared, and validity and reliability analyses were applied.
Reliability was calculated using Cronbach’s alpha reliability coefficient (>0.80), inter-item correlation (>0.30 and <0.70), and corrected item-total correlation (>0.30) to evaluate the internal consistency of the EFGU Pressure Ulcer Risk Assessment Scale.41,42 Intraclass correlation (ICC) was used to assess interrater agreement. The interrater agreement was examined by Cohen Kappa statistics analysis.43 In this study, interrater reliability was assessed before data collection. Two (2) nurses in the ICU were trained and informed about the aim of the study and received instructions on how to use the EFGU Scale. After completing the training program, the nurses were asked to complete the EFGU Scale for patients newly admitted to the unit. The assessments were made at the same time and each patient was assessed independently by both nurses. The scale was applied to 30 patients to evaluate the interrater agreement of the EFGU Pressure Ulcer Risk Assessment Scale.
Construct validity was determined using explanatory factor analysis. The principal components analysis and varimax rotation method were used to examine the factor structure. An eigenvalue 1 or greater was used as a criterion in factor selection.37,42 The sensitivity, specificity, and positive and negative predictive values were used to determine the predictive validity of the scale. The Kaiser-Meyer-Olkin coefficient and the Bartlett test were used to determine whether the scale is suitable for explanatory factor analysis. The diagnostic index (DI) and Youden index values were calculated at the end of the receiver operating characteristics (ROC) analysis for determining the cutoff value.40,41The theoretical framework of the EFGU is presented in Figure 3.
Ethical consideration. Approval to perform the study was obtained from the ethics committee of Ege University Faculty of Nursing, and the Ege University Medical Faculty Hospital Neurology, Internal Medicine, Neurosurgery, and Orthopedics and Traumatology departments. Additionally, written informed consent was obtained from the patients and their relatives who agreed to participate in the study. Patient confidentially was maintained by separating the personal data page from the instrument. Only the researcher had access to these data. Patients were informed of the precautions that would be taken to protect the confidentiality of the data and who would or might have access. The research data were stored securely by using a USB drive. Patient anonymity was maintained using a code name.