INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY First, save this document to your computer and remember to save your work often. Completed file is due November 15, 2015. Submit this file or questions to Lyn Donze at: ldonze@aawconline.org. 800.237.7285, ext. 242 SECTION 1: PARTICIPANT DEMOGRAPHICS 1. Country in which you practice: 2. State or Province: 3. Professional title (Enter all that apply. 1= PhD 2= MD 3= Physical Therapist 4= Nurse 5= CWOCN 6= Advanced Practice Nurse (APN) 7=DPM 8=Other podiatric specialist 9= Medical social worker, case worker or other patient advocate 10= Vascular specialist 11= Endocrinologist 12= Dietitian 13= Pedorthist 14= Microbiologist 16= Other (write in box at right) 4. Gender: 1=female 2= male 5. Years of wound care experience (Please enter 1,2,3 or 4 for the following):: 1= < 6 years 2= 6 - 10 years 3= 11 - 15 years 4= > 15 yrs. 6. Percent of time you spend in each setting where you manage patients with wounds: Acute care (inpatients) Acute care (outpatients) Long term acute care Extended care facility Skilled nursing facility Office practice Home care Sub-acute care facility Separate wound clinic Group practice organization Medical school Government agency VA Hospital Other setting Please write in box at right 7. Distribution of types of wounds in your practice: Pressure ulcers Venous ulcers Arterial (ischemic) ulcers Diabetic foot ulcers (neuropathic or neuro-ischemic) Mixed etiology ulcers, e.g. venous/arterial Burns or traumatic open wounds healing by second intention Surgical open wounds healing by second intention Dermatological conditions resulting in broken skin Other: Please write in box at right 8. How many wound infection patients do you treat during an average week of practice? © Association for the Advancement of Wound Care 2015 Please Enter Your Answers Below % (Blank if 0) % of each type Page 1 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY SECTION 2. CONTENT VALIDATION INFORMATION AND INSTRUCTIONS Thank you for participating in the International Consolidated Pressure Ulcer Guideline (ICPUG) content validation study to assess clinical relevance of the ICPUG Task Force’s “Guideline of Pressure Ulcer Guidelines”. Our aim is to create evidence-based clinical practice guidelines for diagnosing, preventing and treating venous ulcers. As you read each Pressure Ulcer Guideline recommendation, you will be asked to rate its clinical relevance to best evidence-based wound infection clinical practice based on your knowledge. By participating, your valuable input will help shape pressure ulcer management for years to come! Please do not rate each ICPUG recommendation relative to your current practice because factors beyond your control may prevent you from engaging in what you believe is best clinical practice. Instead please rate each step in the framework of what you believe would be the best evidence-based clinical practice you would like to deliver to patients in your care who are at risk of developing or have developed a pressure ulcer. Please rate each item on a clinical relevance scale of 1 to 4, repeated in red at the top of each page. 1. A rating of 1 means the item is not clinically relevant to pressure ulcer management and should be deleted from the final guideline. 2. A rating of 2 means that the wording or content of the item was confusing and you are unable to assess its relevance without further information. 3. A rating of 3 means that the item is clinically relevant to best practice for pressure ulcer management, but needs minor improvements to make it very relevant and succinct. Please list the improvements needed for that recommendation in the box below it. 4. A rating of 4 means the item is very relevant to best practice for pressure ulcer management. If you add a new recommendation in Section 4. General Comments and Questions after the last Validation Survey recommendation, please include, with the new recommendation, one to three best available references citing its clinical importance in pressure ulcer management. This will help establish its clinical relevance and supporting evidence. In addition to rating clinical relevance, you will be asked to rate the strength of the recommendation based on your own knowledge of how much benefit or harm will result for patients if the recommendation is followed. Please rate each item on strength of recommendation scale of 0 or 1, repeated in red at the top of each page: A rating of 2 means that the benefits of using the recommendation strongly outweigh its costs, risks or harms. A rating of 1 means it is unclear if benefits of using the recommendation outweigh its costs, risks or harms. A rating of 0 means that costs, risks or harms clearly outweigh its benefits in managing pressure ulcers. When finished, please submit the completed survey to Lynn Donze at: ldonze@aawconline.org. Questions? Email ldonze@aawconline.org or call 800.237.7285, ext. 242. © Association for the Advancement of Wound Care 2015 Page 2 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER Part I: Assess, Document and Diagnose Pressure Ulcer Risk Factors A. Perform a structured pressure ulcer risk assessment and document actions taken to address each risk factor identified. 1. For all settings, a trained professional should assess and document patient pressure ulcer risk on admission, then thereafter by health care setting protocol and when any significant change in the individual’s health status occurs. (Comfort, 2008 MA of 9 HCT; Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Magnan & Makelbust, 2008-CO; Makelbust&Magnan, 2009-CCT; Tippet 2009—CO) A a. In all Acute Care settings perform pressure ulcer risk assessment within 24 hours after admission or document why patient did not meet criteria for risk assessment, then reassess every 24 to 48 hours, on change of patient status or transfer to a higher level of care. (Comfort, 2008 MA of 9 HCT; Compton, 2008 2 CO in ICU ; Defloor, 2005 RCT) A b. In Long Term Care: perform within 72 hours of admission and regularly per institutional protocol, e.g. every 1-2 weeks for the first 4 weeks after admission, then quarterly or on change in resident status. (WOCN 2010 Guideline—EO; RNAO, 2008 Guideline—EO; Tippet, 2009—CO) C2 c. In Home Health Care: Perform within 72 hours of admission, reassess on resumption of care, recertification of need, or on change in patient status. (Ayello, Braden 2002—LR (0 CT or CO) C3 d. In Hospice Care: perform within 72 hours of admission, weekly for 4 weeks, then monthly. (Henoch & Gustaffson, 2003—CO; Seaman & Shively, 2000—CO) A 2. Use an age appropriate, structured, valid risk assessment tool with good predictive validity for the patient setting; consider valid tools such as Braden Q, Braden, Norton, or Waterlow scale; or a focused tool such as SCALE for end of life, PERFORMANCE Palliation Scale for pediatrics, NSRAS neonate skin risk assessment scale, Neonatal skin condition score, STARKID skin score for spinal cord injured pediatrics, or the interRAI Pressure Ulcer RISK SCALE BASED ON MSDS minimum data set for LTCF & HHC populations, the OH or K scale for elderly bedridden, SCIPUS for spinal injured adults. ( Bolton,2007—SR of 42 studies; RNAO guideline 2013; NPUAP,EPUAP,PPPIA, 2014) A a. Braden Scale has highest inter-rater reliability and percent of correct predictions, assessing mobility, activity(e.g. bedfast or chair fast individuals), nutrition, friction/shear, moisture, and sensory perception, with pressure ulcer risk rated as Mild (15-18) ,Moderate (13-14) ,High (10-12) or Severe (<9 ). (Kottner et al., 2008—SR (6 CO); Pancorbo-Hidalgo et al,2006 MA; Bolton,2007—SR of 42 studies) A b. Norton scale assesses physical condition, mental condition, activity, mobility and incontinence with total scores corresponding to low (>18), medium (18-14), high (14-10) or very high (<10) pressure ulcer risk. (Pancorbo-Hidalgo et al, 2006-MA; Bolton,2007—SR 42 studies) A c. Braden Q for pediatrics (from 21 days of age to 8 years). Scale assesses mobility, activity, nutrition, friction/shear, moisture, sensory perception and perfusion/oxygenation. Risk Determined from total score: Mild risk (22-25, Moderate risk 17-21, high risk <16). (Curley & Quigley 2003—CO; Quigley & Curley 1996—CO) A d. Waterlow scale assesses age, BMI, skin, gender, recent weight loss, eating, nutrition, continence, mobility, tissue malnutrition, neurological deficit, surgery time, and medications. (Note: One large cohort study (Anthony et al) showed that gender is not a significant PU predictor within Waterlow Scale, Anthony et al., 2003—CO; Bolton,2007—SR 42 studies; Leblebici et al. 2007—CO) A 3. Use clinical judgment in addition to valid risk assessment scales to develop care plans that implement appropriate interventions for patient and skin site risk factors for PU prevention and treatment; refer to appropriate health care specialist for ulcers resulting directly from impaired vasculature or other non-pressure related factors. (WOCN, 2010—EO; NPUAP,EPUAP,PPPIA, 2014—EO) C3 a. . Recognize additional risk factors beyond structured scales, such as bedfast and chair fast individuals, significant environmental, functional capacity, medical and psychosocial factors. Brink et al. 2006-CO; Baharestani 1994—CS; NPUAP,EPUAP,PPPIA, 2014--EO) C1 b. . Extremes of age increase PU risk, especially for those over 62 years of age and neonates. (Fowler & McGuire, 2008— LR; Bergstrom & Braden 1992-CO; Bergstrom et al, 1996—CO ; Quigley & Curley 1996-CO) A c. Any individual with a previous or current PU of any category or stage is at high risk of developing further pressurerelated skin injury e.g. added or enlarged pressure ulcers. (Guihan et al, 2008—CO; NPUAP, EPUAP ,PPPIA, 2014— EO) C1 B. Conduct a nutritional assessment to identify those significantly malnourished who are at increased risk of developing a PU 1. Perform a preliminary nutritional investigation on all patients on admission as indicated by medical status and reassess with significant changes in medical condition. (Guenter et al., 2000—CO; Langer et al 2003—SR 8RCT; Reed et al 2003—CO) A © Association for the Advancement of Wound Care 2015 Page 3 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER a. Document independent eating ability and total nutrient intake (protein, calorie and fluid intake , including oral supplements and enteral or parenteral feeds) as feasible, e.g. 3-day calorie count and intake record. (Guenter et al., 2000—CO; Langer et al 2003—SR 8RCT; Pinchofsky-Devin 1986—CO) A b. Use a valid, reliable anthropometric measurement or body mass index conducted by properly trained staff. (Hengstermann et al. 2007—CO; Lindgren et al. 2005—C; Pinchofsky-Devin et al. 1986—CO; Scott et al. 1999— RCT; Uzun & Tan 2007—CO) A c. Record current and usual weight, height as working baseline to set goals or estimate BMI (kg/m 2) as weight (kg) divided by square of height (m2). Standard adult values: Below 18.5=Underweight; 18.5 - 24.9= Normal; 25 - 29.9= Overweight; 30+= Obese. Refer underweight or overweight individuals to a nutrition professional to develop a weight management plan. (Fujii et al. 2010—CO; Kernozek et al., 2002—CO; Uzun & Tan 2007—CO) A d. Record history of involuntary weight loss (over 5% in 30 days or 10% or more in 180 days) . (Pinchofsky-Devin et al. 1986—CO; NPUAP,EPUAP,PPPIA, 2014—EO) C2 e. Note Medical/Surgical relevant history on past or current conditions influencing intake or absorption of nutrients or fluids. Assess for oral, dental, gastro-intestinal and swallowing abnormalities. (EO)C3 f. Note drug-nutrient interactions such as chemotherapy agents causing nausea, agents to correct hyperkalemia causing diarrhea etc. (Pinchofsky-Devin 1986—CO) C2 g. Assess risk for malnutrition using a valid, reliable scale, such as the Mini-Nutritional Assessment (MNA), Subjective Global Assessment (SGA), Malnutrition universal Screening Tool (“MUST”). (WOCN , 2010—EO; NPUAP,EPUAP,PPPIA, 2014—EO, JSPU, 2014-EO) C3 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. 2. Assess biochemical laboratory parameters on malnutrition risk individuals on admission, significant change in health status, and regularly if documented nutritional deficiencies or non-healing pressure ulcer. Acceptable adult lab value scale; pre-albumin >15 mg/dL, albumin > 3.5 g/dL, Transferrin > 200mg/dL, Total Lymphocytes > 1800 mm³. (NPUAP,EPUAP,PPPIA, 2014—EO) C3 a. Pre-albumin (Transthyretin); (Chernecky, Berger 2004—LR Fowler et al.2008—LR, RCT; Guenter et al. 2000—CO; Pinchofsky-Devin 1986—CO ) A Adult 10-40mg/dL Value <5=severe malnutrition 21.5/male mean 18.2/female mean Child (2-12 yr) 16-28.1 mg/dL Age 12 mo (mean) 10mg/dL Newborn 10.4-11.4 mg/dL. b. Total protein (Chernecky, Berger 2004—LR; Pinchofsky-Devin 1986—CO) C1 Adult 6-8g/dL Child 4.3-7.6 g/dL Infant 6.2-8.0 g/dL c. Serum albumin (Fowler et al.2008—LR, RCT; Lindgren et al 2005—CO; Pinchofsky-Devin 1986—CO; Reed et al, 2003-CO; Uzun & Tan 2007—CO) A Adult 3.4 -5.0g/dL (Adult: Severe<2.5, Moderate<3-2.5, Mild <3.5-3.0) Pediatric: 1-12 y 3.2-5.1 3-12 mo: 2.8-5.7 1-3 mo: 2.1-4.8 Newborn: 3.2-4.8 mg/dl) d. Hematocrit or hemoglobin (Baranoski, Ayello 2004—LR 1CO; Chernecky, Berger 2004—LR) C1 Adult HCT=35-47% for Female; 37-51% for Male Children: neonate 42-68%, 3 month 29-54%, 1-2 yr 35-44%, 6-10 yr 31-43% e. Transferrin (Chernecky, Berger 2004—LR) C3 Adult 200-400 mg/dL Newborn 130-275 mg/dL © Association for the Advancement of Wound Care 2015 Page 4 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER f. Total lymphocyte count (Baranoski, Ayello 2004—LR 1CO; Chernecky, Berger 2004—LR; Pinchofsky-Devin 1986—CO) A Adult 2500/ µL or mm³, <800=adult severe malnutrition Newborn 1100-1200/µL 2-6 yr 400-530/µL 8-20 yr 350-400/µL 3. Refer those at risk for or with a PU to a qualified dietician or an inter-professional nutritional team for a comprehensive nutritional assessment and development of an individualized nutrition care plan based on assessment and relevant evidencebased guidelines on nutrition and hydration. ( NPUAP,EPUAP,PPPIA, 2014—EO) C3 C. MEDICAL/SURGICAL HISTORY 1. Perform or obtain initial comprehensive systems assessment on individuals with a PU or high-risk for development of PU, if feasible. Document and address unstable or significant intrinsic risk factors and co-morbidities that impede healing or contribute to altered tissue tolerance or integrity, including 1a-n below: (De Laat et al 2007—CO; Fowler et al.2008—LR, RCT; Milne et al, 2009—LR; Chacon et al., 2010; Konishi et al., 2008) A a. Severe chronic or terminal disease; including malignancy. (IHI, 2007—LR 1 CO; Fowler et al.2008—LR, RCT) B b. Endocrine system; Diabetes, including whether blood glucose is in control as shown by HbA1c < 6.5%. (Fowler et al.2008—LR, RCT; Amer. Diab. Assn. 2009—G) C1 (Chacon et al., 2010—CO; Konishi et al 2008—CO) A c. Cardiovascular condition; including cardiovascular accident (CVA) and congestive heart failure ( CHF), leading to altered perfusion, sensation or motor function. (Fowler et al.2008—LR, RCT; De Laat et al 2007—CO; IHI 2007—LR) A d. Renal disease or condition (Chacon et al., 2010—CO; Konishi et al 2008—CO) A e. Pulmonary disease or condition (Chacon et al., 2010—CO; Konishi et al 2008—CO) A f. Peripheral vascular disease or condition: refer as appropriate to assess lower extremity arterial disease as co-morbidity for lower extremity pressure ulcers. Example tests may include: Doppler pulses, capillary refill time, edema grading, or Ankle/Brachial Systolic Blood Pressure > 0.9 to rule out arterial disease in a foot pressure ulcer. (Chacon et al., 2010— CO; Konishi et al 2008—CO; Fowler et al.2008—LR) A g. Gastrointestinal and genitourinary conditions; unmanaged bowel or bladder conditions. (Chacon et al., 2010—CO; Konishi et al 2008—CO) A h. Dehydration or failure to thrive (Fowler et al.2008—LR, RCT; IHI 2007—LR) B i. Neuromuscular conditions: spasticity, peripheral neuropathy, spinal cord injury, multiple sclerosis, Parkinson’s disease, or similar conditions. (Chacon et al., 2010—CO; Konishi et al 2008—CO; Fowler et al.2008—LR:1RCT ,2 CO; IHI 2007— LR) A j. Skeletal Conditions; severe arthritis, skeletal malformation, deviations in alignment, amputation, or musculoskeletal posturing irregularities/abnormalities such as habitual positioning, contractures, rigid or spastic conditions that alter range of motion, repositioning or flexibility. (Fowler et al.2008—LR, RCT; IHI 2007—LR, CS) B k. Increased body temperature (NPUAP,EPUAP,PPPIA, 2014—EO) C3 l. Bacteremia (Bryan et al., 1983—CO; Chow et al. 1977—CO; Lewis et al 1988—CO) A m. Previous pressure ulcer site(s) including treatment or surgical interventions. (Fowler et al.2008—LR, RCT; IHI 2007—LR 1 CO) A 2. Explore and document extrinsic factors that contribute to PU development (RNAO 2010-EO) C3 a. Prior or current use of one or more medical devices such as a brace, cast, nasal cannula, tracheotomy or other intubation device, or respiratory assistive device such as positive air pressure (PAP) or oscillatory ventilation device. (Black et al. 2010—CO; Fujii et al. 2010—CO; Jaryszak et al. 2011—RET; Schindler et al. 2011—RET; Schluer et al. 2012—CO) A b. Smoking, alcohol or other substance abuse issues, including complications from injection sites. (Cackmak et al 2009— CCT; Smith et al., 2008—CO; Suriadi et al, 2007) A c. Medications (e.g. sedation, impediments to healing: steroids, immunosuppressive agents, anti-cancer drugs or antiembolic agents) (Fowler et al.2008—LR, RCT; IHI 2007—LR, CO) A Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. d. Traumatic injury, including falls. (Fowler et al.2008—LR, RCT; De Laat et al., 2007—CO; IHI 2007—LR) A 3. Obtain history of restricted mobility related to care, treatment, procedure: time spent, room temperature, pressure reducing surfaces used, and positioning extremes or limitations , such as those cited below: © Association for the Advancement of Wound Care 2015 Page 5 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER a. Emergency Department e.g. extended stay on hospital stretchers or backboards (Linares et al., 1987—CO) C2 b. Acute Care; including critical care units (Schoonhoven et al, 2006-CO; Langemo et al 2006 LR ; Lyder et al 2001 CO) A c. Long Term Care (Bergstrom & Braden 1992-CO; Bergstrom, Braden, Kemp et al., 1998-CO) A d. Operating Room (Aronovich 2007—LR > 2 CO; Fowler et al., 2008—LR 2 CO; Schoonhoven et al, 2006-C O) A e. Dialysis treatment center chairs (Reed et al 2003—CO) C1 f. Procedural lab; e.g. for catheter-related or radiological procedures (Reed et al 2003—CO) C1 g. Long ambulance or air transfers (Baharestani,1994—CS) C2 D. Psychosocial And Quality Of Life Assessment 1. Assess psychological conditions including those listed in a-g below: a. . Goals and motivation of patient, family and care provider(s) to participate in care. (Brink et al., 2006--CS Letizia et al., 2010—EO) C2 b. . Ability to adhere to pressure ulcer prevention, treatment and health management protocols to maintain good general health status. (Brink et al., 2006—CS; Ratliffe et al., 2005—EO; NPUAP,EPUAP,PPPIA, 2014—EO) C2 c. Cognition and ability to comprehend or retain information. (Langemo et al., 2010—EO) C3 d. Behavioral disorders that may affect capacity to engage in self care. (Langemo et al., 2010—EO) C3 e. Patient-reported sexual goals. (Black et al. 2011—EO) C3 f. Culture, ethnicity can affect risk of developing a PU and increase likelihood of mortality in patients with a PU. Pay special attention to those with more darkly pigmented skin or with little social support. (Bergstrom & Braden 2002—RCO; Redeling et al. 2005—CO; Saladin et al., 2009—CO) A g. Pharmaceutical complications e.g. polypharmacy or drug interactions that increase pressure ulcer risk factors such as cognition, mobility, etc. (Faraga et al. 2007—LR 0 CS; Harris &Fraser 2004—LR CS) C2 2. Assess social support systems and resources. (Saladin et al., 2009—CO) C2 a. Vocational or occupational rehabilitation for chair and bed bound patients. (Frost 1993—LR CS; Vesmarovich et al. 1999—CS) C2 b. Peer counseling. (Baharestani, 1994—CS) C2 c. Family or significant other availability, skills/knowledge, and follow through. (Baharestani, 1994—CS) C2 d. Financial status, insurance coverage/ limitations, access to equipment. (Baharestani, 1994—CS) C2 E. Assess prior and current environment including likely sources of pressure, friction or shear 1. Assess for ineffective lifting, turning, positioning or transferring techniques that may result in pressure, shear or friction ; all positions, all environments. (RNAO—EO) C3 2. Monitor and document adherence to prescribed off-loading regimen,including condition and proper use of equipment or adaptive aids. (NICE—EO; RNAO—EO; WOCN—EO) C3 3. Assess for ill-fitting devices/seating and ineffective equipment/assistive devices; Observe all seating, mattresses, adjunctive devices or braces for fit and accommodation to body size and/or contours,. feel for "bottoming out" or observe for skin irritation/PU development. (RNAO—EO) C3 F. Conduct a physical exam and skin assessment to identify and support care decisions to prevent or manage pressure injury and related complications as early as is feasible and develop a differential diagnosis of PU from other skin injuries. 1. Perform and document visual and tactile head-to-toe skin assessment with attention to bony prominences and any skin surfaces in contact with removable devices within 8 hours of admission if feasible (or first home care visit). Repeat regularly per institutional protocols and prior to individual’s discharge.(e.g. 1a-f). (NPUAP,EPUAP,PPPIA, 2014—EO; RNAO, 2010—EO) C3 a. b. c. d. e. f. Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Supine position: occipital, sacrum, scapula(e) and heels. (NPUAP,EPUAP,PPPIA, 2014—EO) C3 Prone position: face, chest, anterior superior iliac crests, penis, symphysis pubis, patella, anterior tibial regions, toes. (NPUAP,EPUAP,PPPIA, 2014—EO; Romero et al., 2009—CS) C2 Sitting position: ischium, coccyx, elbow, trochanter. (NPUAP,EPUAP,PPPIA, 2014—EO) C3 Side lying position: trochanter, lateral foot, ankle, knee, ear . (NPUAP,EPUAP,PPPIA, 2014—EO) C3 Skeletal deviations: bunion, kyphosis, lordosis, pelvic obliquity. (NPUAP,EPUAP,PPPIA, 2014—EO) C3 Increase the frequency of skin assessments in response to any deterioration in patient or ulcer condition, assess at least once per week for skin near a PU. (NPUAP,EPUAP,PPPIA, 2014—EO) C3 © Association for the Advancement of Wound Care 2015 Page 6 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER 2. Specially trained staff document alterations in skin appearance, texture, temperature, or pain using standardized patient- and age-appropriate scale, then develop an effective care plan to normalize the skin and minimize patient-reported pain. .( BatesJenson 1997—LR 2CO; Lyder et al 2001—CO; 2002—HCT ; Milne et al., 2009—CO ,LR ; Rosen et al.,2006—CO; Schoonhoven et al, 2006-CO) A a. If skin is darkly pigmented be alert for skin changes that appear darker than the patient’s normal pigmentation rather than red toned visual changes and pay special attention to features other than color, such as texture, tenderness, pain, and skin temperature. (Bates-Jenson 1997—LR 2CO; Baumgarten et al. 2004—CO; Gorecki et al. 2011—SR; Judy et al. 2011—CO; Sprigle et al, 2001—CO; VanGilder et al., 2008—CO) A b. Use the finger or transparent disk method to differentiate between blanchable erythema, which may herald inflammation versus non-blanchable erythema which requires treatment as a Category/Stage 1 PU. (Farid et al., 2012—RET; NPUAP,EPUAP,PPPIA, 2014—EO; JSPU, EO; Witkowski & Parish 1982—CS) C2 c. Perform tactile exam of skin to note texture changes; unusual hardness (induration), softness/boggy nature , or rough/bunched surface, or edema. (Bates-Jenson 1997—LR 2CO; NPUAP,EPUAP,PPPIA, 2014—EO) A d. Note sites of limited sensation, which are at increased PU risk (Braden et al 1994—CO; Copeland-Fields et al.1989— CO) A e. Note reddened area with temperature above that of surrounding skin; predicts PU development or that an existing PU is less likely to heal. (Judy et al. 2011—CO; Nakagami et al., 2009—CO; Sae-Sia et al, 2005, 2007—Cos; Sprigle et al, 2001—CO) A 3. Trained health care professional assess wound characteristics 3a-k, establish differential diagnosis, and develop a care plan to meet patient goals and wound needs as early as feasible. (Bates-Jenson 1997—LR 2CO; Gardner et al 2005—CO) A a. Tissue changes at anatomic locations over a bony prominence or at a site exposed to repeated or prolonged pressure, friction or sheer are commonly associated with PU etiology. (Bates-Jenson 1997— Buntinx, 1996—CO; 2CO; Gardner et al 2005—CO) A b. Consistently use reliable, valid methods within and across settings and consistent subject positioning to measure and document PU area ( estimated as ulcer length x width) to establish if a PU is on a path to healing. (Bates-Jenson 1997—LR 2CO; Gardner et al 2005—C; Sanada et al., 2004; Iizaka et al, 2012—CO ; Zhong et al. 2013--CO) A i. If a PU decreases in area at least 47% in 2 weeks of consistent care, it is likely to heal in 2 months. If a fullthickness (Stage III or IV) PU does not decrease in area at least 39% during 2 weeks, despite optimal patient and PU care, reassess PU causes of tissue damage adjusting the care plan as patient-appropriate to address factors that impair PU healing and resume its path to healing. (Gunes 2009—CO; van Rijswijk, 1993—CO; van Rijswijk & Polansky, 1994—CO) A ii. Avoid relying solely on clinical judgment or on digital photography to support care decisions or document PU progress over time as accuracy varies and inter-rater agreement is lower than that reported for standardized assessments such as the BWAT or DESIGN-R documentation tools. (Davis et al. 2013—CO; George-Saintilus et al. 2009—CS; Sanada et al, 2004, CS; Terris et al. 2011—CS) C1 c. Record exudate; type (e.g. bloody, serous, purulent, foul) and amount (e.g. none, moist, small, moderate or large ) usually based on appearance of dressing. (Gardner et al., 2001-CO; Stotts et al 2001-CO; Iizaka et al, 2012—CO; Zhong et al. 2013—CO) A d. Note wound odor; e.g. none, mild, foul. If odor accompanied by other signs of infection such as increasing pain and exudate, edema, erythema, purulence, or delayed healing refer as appropriate for possible infection. (Gardner et al., 2001-CO; Stotts et al 2001-CO; Iizaka et al, 2012—CO; Zhong et al. 2013—CO) A e. Record undermining- e.g. pocketing under wound edges running lateral with skin ; measure distance from wound edge to back edge of wound pocket. (Bates-Jenson 1997--LR 2CO; Stotts et al 2001--CO) A f. Record sinus tracts or tunneling-e.g. tortuous or linear extensions to tissues or structures beyond the wound base; measure distance from wound base to tunnel base or point of origin in the deeper structures. (Bates-Jenson 1997--LR 2CO; Stotts et al 2001--CO) A g. Document PU depth as partial- or full--thickness or mm of maximum depth tissue injury. As valid, reliable predictors of PU healing, expect about 36% of full-thickness PU or 61% of partial-thickness PU to heal within 12 weeks using standardized, evidence-based, content validated PU care with < 5% gauze primary dressings. (Bates-Jenson 1997—LR: 2 CO; Bolton et al.2004—CO; Izaka et al, 2012—CO; Zhong et al. 2013—CO) A © Association for the Advancement of Wound Care 2015 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Page 7 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER h. Train staff to optimize inter-rater reliability and accuracy if using a standardized staging system, e.g. Stage (Category) of ulcer: Suspected Deep Tissue Injury- purpuric change under the skin or blood blister depth undetermined, INonblanchable skin erythema, II-Partial-thickness skin loss confined to skin layers, III-Full-thickness skin loss extending into subcutaneous tissue level, IV-full thickness tissue loss extending beyond subcutaneous into muscle/bone/tendon structures, Unstageable-devitalized tissue obscuring ulcer surface depth unknown. Staging is only appropriate for PU not for other wound or ulcer etiologies. (Konishi et al 2008—CO; RNAO, 2005—EO; NPUAP EPUAP, PPPIA 2014—EO) C1 i. If PU staging is used to support care decisions, increase inter-observer reliability and diagnostic sensitivity and specificity by including blanchable erythema, area measures and clinical signs infection. (Konishi et al 2008—CO; NPUAP EPUAP, PPPIA 2014—EO) C1 i. Document wound surface tissue types and amounts inclusive of i-iv below and include as a guide for care decisions: ( Stotts et al 2001-CO; Iizaka et al, 2012—CO; Zhong et al. 2013—CO) A i. Epithelium (% reepithealization over granulated stage III/IV or healing stageII) Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. ii. Granulation tissue (% beefy red replacement tissue filling stage III/IV wound depth) j. k. l. iii. Yellow fibrin or slough (% devitalized tissue covering stage III, IV or unstageable) iv. Black, brown or gray necrotic tissue or eschar (% devitalized tissue covering stage III, IV or unstageable) Note ulcer margins; normal vs epibole, , hyperkeratotic/calloused, macerated or other abnormal condition. (BatesJenson 1997--LR 2CO; Stotts et al 2001--CO) A Record peri-wound skin status; normal vs erythema , edema, warmth, denudation, or purpuric changes. (Bahrestani et al. 2007—LR; Gorecki et al. 2011—SR; Gunes 2008—CS; Stotts et al 2001—CO) A Perform localized wound pain assessment using a patient- and age-appropriate validated pain scale; pain may indicate progressing tissue injury and/or infection to be addressed if healing is a relevant goal. (Chang et al., 1998—RCT; Flock, 2003—RCT; Gardner et al., 2001—CO; Heyneman et al., 2008—SR) A m. Repeat wound assessment regularly (per institutional guidelines) normally weekly and on any change in wound condition. (Chacon et al., 2010—CO; Konishi et al 2008—CO) A 4. Evaluate for wound complications; document treatment and duration. (Milne et al, 2009—CO, LR) C1 a. Fistula(e) (Milne et al, 2009—CO, LR) C1 b. c. Abscess(es) (NPUAP,EPUAP,PPPIA, 2014--EO) C3 Osteomyelitis (Evaluate if bone is exposed, bone has rough or soft texture or if wound probes to bone and PU has failed to heal after 2 weeks of optimal care). (NPUAP,EPUAP,PPPIA, 2014--EO) C3 d. Cellulitis/wound infection signs include: erythema, edema, purulent or foul-smelling exudate, increase in ulcer pain and/or exudate, fever, friable/irregular or pale/ irregular granulation tissue) . (NPUAP,EPUAP,PPPIA, 2014--EO) C3 e. Cancer; e.g. Marjolin’s ulcer. (Milne et al, 2009—CO, LR) C3 f. Heterotopic bone formation. (Milne et al, 2009—CO, LR) C3 5. Rule out differential diagnoses (e.g. skin tear, Herpes lesions, incontinence-associated dermatitis, candidiasis, arterial insufficiency ulcer) to improve accuracy of pressure ulcer diagnosis. (Chacon et al., 2010—CO; Konishi et al 2008—CO) A a. When obesity is present use judgment to differentiate diagnosis of intertriginous dermatitis (most frequently under pannus, breasts, groin or perineum) from partial-thickness pressure ulcers G. Use valid diagnostic tests to identify pressure ulcers and assess causes of delayed healing. 1. If limited vascular perfusion is suspected, consider appropriate vascular laboratory consult or a bedside Ankle-to-Brachial Index to assist in differential diagnosis. ABI normal=>.86, Mild arterial disease= 0.75-0.85 Intermittent claudication=. 0.50-0.75 Severe arterial disease= 0.30-0.50,Gangrene=<0.20 (Chernecky C, Berger B; 2004, LR; Rennert et al 2009-LR, CO) C1 2. Obtain quantitative tissue swab or bone/tissue culture in suspected infection, obvious cellulitis or on non-healing wounds if consistent with treatment goal. (Gardner et al 2006, CO; Rennert et al 2009-CO, LR) A 3. Consider biopsy on chronic non-healing ulcers; suspected malignancy if no healing is observed in response to optimal care after 12 weeks. (Whitney et al., 2006—LR (2 CS) C2 4. Obtain bone Imaging using a patient-compatible method, e.g. MRI / CT scan / Nuclear scan/ PET) in suspected osteomyelitis. (Strobel & Stumpe 2007-LR, EO; Rennert et al 2009-LR, CO; Boutin et al 1998-LR, EO) C2 5. Consider ultrasonography in predicting the depth of DTI (deep tissue injury) PU category. (JSPU, 2014-EO) C3 © Association for the Advancement of Wound Care 2015 Page 8 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER 6. Obtain corresponding blood analysis as indicated to establish baseline values, assist in the diagnosis of infection and/or reflect the status of co-morbid conditions affecting wound healing: Complete blood count with differential, metabolic profile, coagulation studies (PT, PTT), lipid profile, HbA1c, hepatic function profile, pre-albumin, thyroid function (TSH), C-reactive protein, (CRP) erythrocyte sedimentation rate (ESR), blood cultures (if bacteremia or osteomyelitis is suspected). (Rennert et al 2009-LR, CO) C2 H. Document and communicate all findings and assessments on approved forms or tools 1. Ensure all assessments and test results are accessible to those providing or consulting on pressure ulcer care. (Milne et al, 2009—CO, LR; Powers 1997—CS) C1 Part II. Prevent pressure ulcer occurrence or recurrence by identifying and removing causes of skin breakdown A. Skin Inspection And Maintenance: Develop and implement a PU prevention plan based on specific individual risk factors or skin changes identified in PU risk assessments regular skin inspections. 1. Perform comprehensive visual and tactile skin inspections during patient care and at assigned intervals as determined by agency protocol and patient risk status and address documented skin changes . (Schonhoven et al, 2006-CO; Bergstrom & Braden 1992—CO; NPAP,EPUAP,PPPIA, 2014—G) A a. Assess skin under and around special garments, protectors and medical devices at least twice daily for those at PU risk assuring that devices are properly secured, positioned and free of loose foreign objects that could induce tissue injury. Educate home caregivers or patients to do this in the home care setting. (Bergstrom & Braden, 1992—CO; Black et al., 2010—CO; NPUAP,EPUAP,PPPIA, 2014—EO) A b. Follow recommended measuring standards for fitting medical devices and select correctly sized devices, paying special attention to pediatric or obese individuals. Use according to manufacturer’s instruction to minimize skin trauma. Properly train health professionals in device selection, fitting and maintenance. (Boesch et al. 2012—POS; RNAO 2005—EO; Skillman et al. 2012—POS; Zaratkiewicz et al. 2010—POS) C2 c. Observe individuals with altered perfusion, risks of fluid shifts or severe edema more frequently as irreversible skin changes can occur under low tissue stress. d. Avoid positioning patient on medical devices such as bedpans for extended periods and assure that all medical devices are size appropriate, secured to prevent dislodgment; and removed as soon as medically feasible. (Zaratkiewicz et al. 2010—POS; NPUAP,EPUAP,PPPIA, 2014—EO) C2 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. 2. Protect skin from environmental irritants or exposure to excess moisture, including areas affected by drainage, incontinence or perspiration. (RNAO, 2005—EO; Lyder et al. 2002—HCT; NPUAP,EPUAP,PPPIA, 2014—EO) C2 a. Manage skin microclimate by selecting patient-appropriate clothing and support surface interfaces that provide lowfriction, heat-dissipating, conforming, absorbent and /or breathable properties. (Caladonato et al. 2012—CCT; RNAO, 2005—EO; Smith et al. 2010,-RCT) B i. Select effective under-pads and/or briefs to wick incontinence away from skin; avoid trapping moisture against skin and use appropriate skin protectants. Give close attention to skin folds in bariatric patients. (RNAO, 2010—EO; NPUAP,EPUAP,PPPIA, 2014—EO) C3 ii. Avoid applying heating devices such as heated bed surfaces, heating pads or hot water bottles directly to PU or skin surfaces at risk for a PU. (NUAP,EPUAP,PPPIA, 2014—EO) C3 iii. When utilizing heating/cooling blankets place on top of an individual; avoid positioning these devices underneath weight bearing zones. (Reger, , et al, 2007—LR 1 CS) C2 Clean and dry skin as soon as possible after each incontinence episode avoiding vigorous rubbing or massaging; consider referral to a continence specialist if appropriate. (Hodgkinson et al. 2007—SR: 1 RCT; Lyder et al. 2002—HCT, RNAO, 2005—EO) B i. Use no-rinse pH-balanced skin cleansers avoiding saline or soap. (Bergstrom et al., 2005—CO: ii. Hodgkinson 2007—SR: 1 RCT; Lyder et al. 2002—HCT) B iii. .Use incontinence skin barriers as needed to protect and maintain skin integrity. . (Lyder et al. 2002—HCT, RNAO, 2005--EO, WOCN, 2010—EO) C2 b. Establish, implement and document an individualized bowel and bladder program for patients with incontinence. To establish a toileting program determine the type of fecal or /urinary incontinence based on symptoms and history; consider onset, duration, aggravating and relieving factors. (RNAO, 2005—EO; NPUAP,EPUAP,PPPIA, 2014—EO) C3 i. Consider pouching system or collection device to contain excessive urine or stool and protect skin from effluent © Association for the Advancement of Wound Care 2015 Page 9 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER ii. Consider indwelling catheter for brief periods if urine contributes to skin breakdown 3. Employ non-friction tepid bathing standards. (Lyder et al. 2002—HCT) C2 a. Hydrate dry skin with patient-appropriate moisturizing agents or skin lubricants. (Lyder et al. 2002—HCT; RNAO, 2005—E O) C2 b. Avoid dimethyl sulfoxide topical application as there is no consistent evidence that massaging at risk skin sites with said agent can prevent PU development and some evidence it may do harm. (Houwing et al. 2008—RCT; NPUAP,EPUAP,PPPIA, 2014—EO) C1 4. Use prophylactic dressings according to package instructions to reduce pressure intensity, friction and shear on skin at medical device contact points, if appropriate. (Lyder et al. 2002—HCT; Weng et al. 2008 RCT; NPUAP,EPUAP,PPPIA, 2014—EO) B a. Select appropriate dressing type, size, softness, transparency, adherence and conformability for the patient and anatomic site ,if there is clinical evidence of dressing’s capacity to reduce pressure, friction or shear on sites at PU risk and the intervention is the most appropriate and cost effective. ( Gunlemez et al., 2010—RCT; Lyder et al., 2002—HCT; Ohura et al. 2005—LAB; Torra I Bou et al., 2009-RCT; Weng et al. 2008—RCT) A i. Transparent film or hydrocolloid dressings. (Flam & Raab 1991—CCT; Huang et al. 2009—CCT; Lyder et al., 2002—HCT; Milne et al.1999—CCT; Weng et al. 2008—RCT) B ii. Soft silicone gel sheeting, or foam dressings with or without silicone. (Gunlemez et al. 2010—RCT; Kuo et al. 2013—CO; Torra I Bou et al., 2009—RCT; Forni et al. 2011—CCT) A 5. Avoid vigorous massage over bony prominences. (Ek et al, 1985—HCT; Dyson 1978—HCT) C2 6. Apply safe, patient- and site-appropriate electrical muscle stimulation to spinal-cord-injured patients at risk of developing a PU or with delayed PU healing. ( Janssen et al 2010—RCT; Smitt et al 2012—CCT; NPUAP,EPUAP,PPPIA, 2014—EO) C1 B. Implement and document a structured plan of hydration and nutrition addressing patient-specific risk factors consistent with patient’s condition, goals and wishes. 1. Maintain adequate nutrition and glycemic control per dietary specialist recommendations, if feasible. (Reed et al. 2003—CCT; Stratford et al., 2005—MA 5 RCT; Theilla et al 2007—RCT) A 2. Restore adequate nutrition by implementing a restorative dining program to improve oral intake and optimize independent eating... a. Provide foods with high nutritive value in portions and consistency of patient tolerance. (Sratford et al, 2005—MA 5 RCT; Desneves, et al, 2005—RCT) A a. Provide nutrition supplements with or between meals if needed. (NPUAP,EPUAP, PPPIA, 2014—G; Stratford et al., 2005—MA1 RCT; Theilla et al, 2007—RCT) A b. Provide adaptive utensils, cups or plates as indicated to aid independent feeding. 3. Enteral nutrition only if medically needed to maintain adequate nutrition and consistent with patient and family wishes. (NPUAP,EPUAP, PPPIA, 2014—G; Stratford et al., 2005—MA1 RCT; Theilla et al, 2007—RCT) A a. Risks of percutaneous endoscopic gastrostomy tube feeding may exceed benefits . (NPUAP,EPUAP, PPPIA, 2014—G; Teno et al. 2012–CO) C2 4. Parenteral nutrition only if consistent with patient and family wishes, medically needed to maintain adequate nutrition and enteral nutrition is not an option. (Compton, 2008 2 CO in ICU) C1 5.Provide and encourage adequate intake of hydrating fluids with repositioning schedule as consistent with patient’s condition, capabilities and goals. (RNAO, 2005—EO; NPUAP,EPUAP, PPPIA, 2014—EO) C3 Offer additional fluids as medically appropriate to those experiencing dehydrating conditions such as fever, diaphoresis, diarrhea, vomiting or heavily draining wounds. Monitor signs and symptoms of dehydration such as low skin turgor or urine output, or high serum sodium or osmolarity. (RNAO, 2005—EO; NPUAP,EPUAP, PPPIA, 2014—EO) C3 C. Engage those at PU risk in Rehabilitative And Restorative Programs 1. Document and address immobility and/or inactivity in bed- or chair-bound patients using a patient-appropriate program to restore or improve mobility, activity, and strength. (Allman,1987-RCT; Allman et al.,1995-CO; Berlowitz & Wilking, 1989-CO; Rennert et al, 2009-LR, CO) C1 a. Begin progressive mobility program as soon as the individual’s condition allows. (RNAO, 2005—EO; NPUAP,EPUAP, PPPIA, 2014—EO) C3 b. Consider using passive range of motion to treat or prevent contractures. NPUAP,EPUAP, PPPIA, 2014—EO) C3 2. Manage muscle spasms appropriately. (Whitney et al. 2007—EO) C3 3. Refer to professional trained in restorative rehabilitation for functional assessment and restorative exercise program recommendations. NPUAP,EPUAP, PPPIA, 2014—EO) C3 © Association for the Advancement of Wound Care 2015 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Page 10 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER D. As consistent with patient goals, apply repositioning standards of care with prescribed frequency and duration to relieve or redistribute pressure and reduce skin exposure to pressure, shear or friction for all those with existing pressure ulcers or with pressure ulcer risk factors in Part I.A-G 1. Reposition vulnerable individuals to reduce pressure/shear, avoiding areas of localized pain, erythema or edema. Consider individual status or condition to determine patient repositioning frequency and parameters, rather than a ritualistic schedule. NPUAP,EPUAP, PPPIA 2014—EO) C3 2. Turn or reposition as patient appropriate when in bed; at least every 2 – 3 hours when lying on a standard mattress or every 4 hours when on a pressure redistributing surface such as a high-specification foam or air flotation mattress. (Defloor De Bacquer et al 2005—RCT; Vanderwee et al. 2005—RCT) A Avoid folding and stretching of soft tissues during and after repositioning. (NPUAP,EPUAP,PPPIA, 2014—EO) C3 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Use a 30o laterally inclined position to avoid positioning directly on trochanter ,or 90oside-lying, or supine or semi-recumbent position. (Defloor. 2000—HC; Kallman et al. 2013—HCT; NPUAP,EPUAP,PPPIA 2014—EO) C1 3. Maintain head of bed at or below 30 degrees or at the lowest degree of elevation as consistent with medical condition. ( Bergstrom et al., 1992—EO; Chung et al., 2012—HCT; RNAO, 2010—EO) C3 4. Use lift sheets, split-leg slings or other appropriate mechanical devices to turn and transfer dependent patients; avoid dragging the patient over surfaces. .( Gucer et al., 2013—Survey; NPUAP,EPUAP,PPPIA, 2014—EO) C3 a. When using mechanical handling devices remove slings/sleeves or other handling equipment from under patient after maneuvering is complete, according to device instructions. (NICE/NCCNSC, 2003—EO; NPUAP, EPUAP, PPPIA 2014— EO) C3 5. Provide patient-appropriate devices such as overhead trapeze, grab bars, walker, transfer board, including those specially adapted for obese patients, to reduce friction and shear and support mobility and independence. NPUAP,EPUAP,PPPIA, 2014— EO) C3 6. Apply pillows, towels, dressings, padding ,cushions or other positioning devices as appropriate to prevent contact between bony prominences (i.e., between knees, ankles, feet etc), between skin folds of obese individuals, under/between contact areas of severe contractures, or between medical devices and the skin. (RNAO, 2005—EO) C3 7. Relieve pressure under heels when supine or reclined with legs elevated by using specially structured mattresses with evidence based heel zone or effective heel suspension devices, such as boots or foam cushions according to manufacturers’ instructions; assure that heels, calf and Achilles tendon are free of intense pressure subsequent to contact with non-conforming surfaces in beds, chairs, wheelchairs or limb devices. Applies to all settings, including home, operating/recovery rooms, or critical care. (Cadue et al. 2008—RCT; Donnelly et al. 2011—RCT; Reddy et al., 2006—LR: 2 RCT; Zernike 1994—RCT) A a. Avoid use of fluid-filled gloves or bags, synthetic pads or cutout rings to displace heel pressure as they are less effective than standardized heel suspension devices that conform to the lower limb heel to knee, equalizing pressure load across a larger area. (Bales 2012—CCT; NPUAP, EPUAP, PPPIA, 2014—EO) C2 b. When using heel elevation, flex knees 5-10o to enhance popliteal vein circulation. (Huber et al. 2008—CS) C2 c. Remove fitted heel suspension devices during regular skin assessment to detect PU. (NPUAP,EPUAP,PPPIA, 2014— EO) C3 d. Implementing localized pressure management devices (e.g. heel boots, wedges,etc.) creates potential for increased pressure over surrounding areas of the skin by the device; employ Caregiver training and education to ensure correct use of the device. (RNAO, 2010—EO) C3 8. For seated individuals capable of changing body position encourage repositioning every 15 minutes.; if unable, reposition by caregiver every hour when in chair. (RNAO, 2005—EO; NPUAP, EPUAP, PPPIA, 2014—EO) C3 a. Limit sitting duration if unable to reposition without assistance; avoid sitting intervals of more than 4 hours for at-risk individuals. (Defloor et al., 2005—RCT Whitney et al., 2006—G) C1 b. Complete bed rest is not recommended for the prevention and healing of pressure ulcers. Determine the rationale for bed rest and focus on getting the client up into an appropriate wheelchair for part of the day, as appropriate. (RNAO, 2010EO) C3 9. Utilize small frequent position changes to redistribute pressure on bony areas , when feasible, and if skin assessment or patient comfort is not improving, reconsider the frequency and method of repositioning or consider an alternative support surface. (RNAO, 2005—EO; NPUAP, EPUAP, PPPIA, 2014—EO) C3 E. Implement and document patient-appropriate off-loading regimens and surfaces used on beds, , wheel chairs, bedside chairs, stretchers, or procedural tables in all settings. © Association for the Advancement of Wound Care 2015 Page 11 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER 1. Avoid doughnut-shaped pressure redistribution devices (except on plantar surface of the foot). (RNAO, 2005—EO; NPUAP, EPUAP, PPPIA, 2014—EO; Whitney et al., 2006—EO) C3 2. Use natural medical grade sheepskin to prevent pressure ulcers more than standard nursing care or a standard hospital mattress, but avoid use of synthetic sheepskin for pressure reduction without added heel and elbow protection. (Jolley et al. 2004—RCT; McGowan et al. 2000—RCT; Reddy et al, 2006—LR: 1 RCT, 1CCT (to avoid synthetic sheepskin alone.) A Relevance rating (Content Valdity Index) Strength of Recommendation Rating Please Type Your Rating Below 3. Avoid standard (spring-style) mattresses as pressure redistributing equipment. (Reddy 2006 LR; 8 RCT or CCT) A 4. All individuals vulnerable to pressure ulcers, including those in critical or palliative care require a patient-acceptable support surface such as; “high specification foam, reactive foam” , static air mattress, low air loss or alternating pressure in a replacement mattress or overlay and regular repositioning at a minimum. (Comfort, 2008—MA of 9 HCT; Defloor et al., 2005—RCT; McInnes et al., 2011—MA; Nicosia et al. 2007 MA; Reddy 2006 LR; 5 RCT; Tippet 2009-CO(static air mattress) A a. Use holistic assessment to determine supportive devices; risk level, general health status, comfort, skin status, lifestyle and abilities, critical care needs and acceptability by patient/caregiver. (Konishi et al., 2008—CO ; NICE/NCCNSC 2003—EO; NPUAP, EPUAP, PPPIA, 2014—EO) C2 b. High specification foam mattress should have the following minimum characteristics: high resilience, 35 kg/m 2 density; a support factor ratio of 1.75 to 2.4 calculated as force to indent the surface (IFD) 65%/ IFD 25%; depth at least 150 mm; minimum moisture vapor transmission rate (MVTR) of the mattress cover 300 g/m 2/24 h , ideally waterproof to prevent contamination of the foam, with a low friction coefficient, fire retardant properties and cleanable according to facility protocol and manufacturers’ guidelines. (NPUAP, EPUAP, PPPIA, 2014—EO; Standards Australia, 1993—EO) C3 c. If frequent manual repositioning is not possible, pressure ulcer history, elevated risk score, complex clinical condition, or when a less effective device has failed to prevent a pressure ulcer, use a low air loss bed with microclimate management, alternating pressure mattress or overlay support surface which changes load distribution properties with or without applied load, high-density air flotation, high specification foam or similar pressure redistribution replacement mattress. (Black et al. 2012—RCT; Maksous et al., 2009—RCT; McInnis et al., 2011—SR 3 RCT; Vanderwee et al, 2008 LR 2 RCTs; Nixon et al. 2006 RCT) A d. Avoid use of alternating pressure support surfaces with air cells of diameter less than 10 cm as they are less effective in preventing PU than larger air cells. .( Bliss et al., 1966—CCT; Manzano et al., 2013—HCT) C1 e. Trained assessors with specific knowledge and expertise on effective weight redistribution principles and support surface function/structure should review equipment for all individuals at PU risk including the characteristics and functionality of pressure redistribution mattresses, seating cushions, and supportive aids. Consider potential for instability or shear, clinical effectiveness/outcomes, comfort, safety, patient abilities, and accommodation to changes in general status. (Konishi et al., 2008—CO; Magnan&Makelbust 2009—HCT; Makelbust&Magnan 2009—CCT) B 5. Use pressure redistribution devices intra-operatively for individuals assessed to be at risk for pressure ulcer development, lengthy operative procedures, or procedures requiring positions of intense loading on particular body regions. (Bots & Apotheker, 2004—HCT ; Reddy 2006 LR; 2 RCT) A 6. Consider heel/foot /elbow area off-loading devices, such as medical sheep skin to augment support surfaces. (Reddy 2006 LR; 4 RCT) A 7. Position all chair-bound patients with attention to postural alignment and balance; including arm- support, distribution of weight, foot support, seat width/depth proportionate to size, lumbar/back/head support as needed. Educate personnel on assessing patient’s skin regularly, selecting proper chair support surface and seating system/chair type. (Bergstrom et al, 1994—CO; NPUAP,,EPUAP, PPPIA, 2014—EO; Milne et al, 2009—CO, LR) C1 8. Utilize a pressure redistributing cushion in all wheelchairs and extended sitting chairs/recliners for individuals at risk of PU or with an existing PU. NPUAP,,EPUAP, PPPIA, 2014—EO a. For wheelchair-bound individuals with severe mobility/positioning deficits provide an individually prescribed wheelchair with seat-tilt and pressure redistribution surface. (RNAO, 2005—EO) C3 b. Prescribe wheelchairs and seating systems according to individualized needs based on anthropometric, ergonomic and functional principles. (RNAO, 2005—EO) C3 c. Measure the effects of posture and deformity on interface pressure distribution if feasible. Use clinical judgment and objective data in determining the compatibility of individuals shape/posture with seating system. (RNAO, 2005—EO) C3 d. Use power weight shifting wheelchair system for individuals who are unable to independently perform effective weight shift . (RNAO, 2005—EO) C3 © Association for the Advancement of Wound Care 2015 Page 12 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER 9. Inspect & maintain functionality of a wheelchair support surface at regularly scheduled intervals, including 3-4” high density foam, static air cushions or other therapeutic cushion designed for pressure redistribution. (Defloor and Grykdonck 2000-RCT; Brienza and Karg, 2005—EO) C1 F. An inter- or multi-disciplinary team collaborate to develop a plan to achieve patient-oriented goals such as healing, pain management, and comfort; include the patient and family members in making decisions as appropriate 1. Implement a patient-centered plan of care including patient-appropriate pharmacologic and non-pharmacologic interventions based on intrinsic and extrinsic PU risk factors, risk score data, and clinical judgment from interdisciplinary team collaboration. (Bogie & Ho 2007-LR; Konishi et al., 2008-CO; Milne et al., 2009-LR 1 CO; Tippet, 2009—CO) C2 a. Formulate a position statement on the benefits of team care with references, such as the AAWC Statement on Benefits of Team Care. (Milne et al., 2009—LR 1 CO) C2 2. Consult wound care specialist and individuals trained in off-loading principles and equipment for determination most effective care regimens for PU prevention and treatment. (Allman et al, 1987—RCTB; Brienza et al., 2010—RCT; Cullum et al., 2004 LR >2 RCT; Makelbust & Magnan 2009—CCT) A 3. Consult a dietitian in cases of malnutrition or suspected malnutrition in patients at risk for pressure ulcers. (Langer et al 2003— SR 8 RCT; Reed et al 2003—CO; van Rijswijk & Polansky1994—CO) A 4. Determine need for referral to continence care specialist. (RNAO, 2005—EO) C3 5. Consult Occupational or Physical Therapy or other seating specialist for chair-bound or wheelchair-bound individuals at risk of or with existing PU. Utilize OT, PT and individuals trained in restorative rehab in developing patient-centered care plans and seating selection. (NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005—EO) C3 G. Educate patient, caregiver, family and healthcare providers by developing and implementing organized, structured and comprehensive training programs on prevention and treatment of pressure ulcers. 1. Teach patients, families, caregivers and significant others effective strategies for prevention and treatment of pressure ulcers; Include training on principles 1.a-h below. (Rosen et al., 2006 CO; Milne et al, 2009—CO, LR; Rennert et al 2009-LR 1 CO) C2 Principles of pressure ulcer development, prevention and healing. (Horn et al. 2010—HCT; Milne et al, 2009—CO, LR) C2 a. Individualized interventions to reduce pressure, shear or friction. (Horn et al. 2010—HCT; Milne et al, 2009—CO, LR) C2 b. Skin inspection methods; how to recognize signs of skin breakdown or delayed wound healing and when to request professional help for skin/wound conditions. (Horn et al. 2010—HCT; Milne et al, 2009—LR CO; NPUAP, EPUAP, PPPIA, 2014—EO) C2 c. Use and maintenance of pressure redistribution devices. (Cheney 1993—CO; Horn et al. 2010—HCT; Milne et al, 2009—LR CO) C2 d. Available resources for assistance and advice. (Milne et al, 2009—LR CO) C2 e. Signs and symptoms of infection or other wound complications. (Milne et al, 2009—LR CO) C2 f. Nutrition and hydration interventions that promote healthy skin. (Milne et al, 2009—LR CO) C2 g. Written and verbal instruction and negative impact of smoking, alcohol & drug abuse on pressure ulcer prevention & treatment. (Rosen et al., 2006 CO; Milne et al, 2009—CO, LR; Rennert et al 2009-LR 1 CO) C2 2. Develop organized, structured and comprehensive healthcare personnel training programs on items 2.a-I. ((Horn et al. 2010— HCT; Magnan and Makelbust 2008—HCT; Makelbust and Magnan 2009—CCT; Milne et al, 2009—LR CO) B Risk assessment factors and patient assessment tool. (Magnan and Makelbust 2008—HCT; Makelbust and Magnan 2009— CCT) B a. Pressure ulcer pathophysiology and prevention strategies. (Magnan and Makelbust 2008—HCT; Makelbust and Magnan 2009—CCT) B b. Skin and wound assessment parameters. (Magnan and Makelbust 2008—HCT; Makelbust and Magnan 2009— CCT) B c. Roles and responsibilities related to assessment and prevention. (Magnan and Makelbust 2008—HCT; Makelbust and Magnan 2009—CCT) B d. Development and implementation of individualized plan of care. (Magnan and Makelbust 2008—HCT; Makelbust and Magnan 2009—CCT) B e. Selection, use and maintenance of pressure redistribution devices to divert pressure from sites at risk of developing a PU as well as existing Pus. (Magnan and Makelbust 2008—HCT; Makelbust and Magnan 2009—CCT) B f. Patient education and information giving techniques. (Milne et al, 2009—LR CO) C2 g. Accurate documentation of pertinent data. Horn et al. 2010—HCT; Milne et al, 2009—LR CO) C2 © Association for the Advancement of Wound Care 2015 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Page 13 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER Demonstration of positioning and transferring techniques. Horn et al. 2010—HCT; Milne et al, 2009—LR CO) C2 PART III. PRESSURE ULCER TREATMENT STRATEGIES A. Implement/continue PU assessment and prevention measures to prevent new pressure ulcers and optimize existing PU healing 1. At each encounter, or at least once per week, if patient-appropriate, assess skin status and PU progress;, analyze preventive and treatment programs to ensure outcomes align with individual needs, goals and capabilities. (Magnan and Makelbust 2008— HCT; Makelbust and Magnan 2009—CCT; Milne et al, 2009—LR CO) B 2. Set/revise treatment goals consistent with patient’s goals, values and lifestyle, assuring that all systemic, topical or pressure redistribution interventions have evidence of efficacy in achieving goals, safety, and prevention of complications. (NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005—EO) C3 B. Remove or alleviate the primary pressure ulcer cause through selection of bed and seating pressure redistribution support surfaces that meet individual body contours, size, clinical needs and personal goals. 1. Use a pressure redistribution product with verified capacity to redistribute pressure, reduce sheer, and control the microclimate for individuals with all stages of PU. ( NICE/NCCNSC 2003—EO; NPUAP, EPUAP, PPPIA, 2014—EO) C3 a. Consider a non-powered support surface for individuals who can be positioned without weight bearing on an ulcer and without bottoming out on the support surface. There is insufficient evidence for differences in PU outcomes using different types of support surfaces. (Cheney, 1993—CO; Cheneworth, 1994 CCT; Cullum et al 2004—LR; NPUAP, EPUAP, PPPIA, 2014—EO) B b. Consider a powered support surface if individual is at high risk for an added PU’s, is failing to heal a PU and cannot be positioned without pressure on an ulcer, when a non-powered support surface bottoms out, or if new PU develops. (Ferrell 1993—RCT; Cullum et al 2004, LR 11 RCT; Rosenthal et al., 2003—RCT) A Use support surfaces with verified functionality such as algorithm sensing technology support systems, low air loss, or air fluidized beds in the treatment of multiple region pressure ulcers or unstageable deep tissue injuries , severely compromised skin conditions, for temperature and moisture control in the presence of large stage III or IV ulcers, or for surgical graft sites. . (Allman et al., 1987—RCT; Cullum et al. 2004—LR 11RCT; Ferrell et al 1993—RCT; Economides 1995—RCT; Rosenthal et al., 2003— RCT) A 2. As feasible, avoid positioning directly on pressure ulcer or suspected deep tissue injury when on bed, wheel chair, bedside chair, or any other surface. If this is not feasible, provide patient-appropriate pressure redistributing surfaces. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 a. When supine use positioning aids to relieve direct pressure on ulcers or vulnerable skin by elevating the skin or ulcer away from the support surface through placement of a positioning aid above/below the area of concern; continue repositioning protocols regardless of support surfaces in use. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 b. Avoid positioning the chair- or wheelchair-seated individual directly on an ischial or coccygeal pressure ulcer in a fully erect posture; consider reclining or tilt in space seating options. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 c. Limit sitting intervals to 1 hour or less if an individual with a pressure ulcer is capable of performing weight shifts every 15 minutes; use power weight-shifting wheelchair system for individuals who are unable to independently perform effective weight shift. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. d. Reposition chair-bound individuals regularly according to evidence-based protocols and patient outcomes, regardless of support surface; if not possible or if PU worsens, decrease sitting intervals and/or consult a seating specialist. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 C. Debride pressure ulcers to remove foreign matter or necrotic tissue. 1. Debride eschar or devitalized tissue if area well-perfused PU areas and appropriate to individual’s condition and goals of care; refer hypoperfused wounds for vascular assessment prior to surgical or non-surgical debridement . (Burgos et al., 2000—RCT; Jones & Fennie, 2007 CO; Rennert et al., 2009—CO) C1 2. Choose a safe, effective debridement method from options a-f below as appropriate to setting, ulcer status, individual condition and goals of care. (Alvarez et al., 2002—RCT; Burgos et al., 2000—RCT; Jones & Fennie, 2007 CO) A a. Autolytic debridement through use of moisture retentive dressings is as effective as or more effective than enzymatic debridement with collagenase. (Barr et al. 1995—CCT; Burgos et al., 2000—RCT; Jones & Fennie, 2007 CO; Konig et al 2005—RCT; Sayag 1988--HCT) A © Association for the Advancement of Wound Care 2015 Page 14 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER b. Enzymatic debridement efficacy and safety vary with different enzymes. Collagenase efficacy has been shown to be similar to some enzymes and autolytic debridement but less effective than papain-urea though healing results were similar; the use of enzymes may be enhanced if combined with surgical or autolytic debridement using moisture-retentive dressings. (Alvarez et al., 2002—RCT; Burgos et al., 2000—RCT; Muller et al. 2001—RCT; Pullen et al. 2002 –RCT; Ramundo & Gray 2008—SR 5RCT; Waycaster et al. 2013—RCT) A c. Mechanical debridement, e.g. using high flow irrigation, hydrosurgery or ultrasound. (Fujioka et al., 2008—CS;NPUAP, EPUAP, PPPIA, 2014—EO; Whitney et al., 2006—EO) C2 i. i. Hydrotherapy or whirlpool (1 RCT showed Whirlpool is not effective and poses a risk for ulcer contamination. ) Do not immerse those with compromised vascular , respiratory or immune systems. . (Moore & Cowman, 2008—SR 1 RCT: no effect of whirlpool; NPUAP, EPUAP, PPPIA, 2014—EO) C3 ii. ii. Debridement using wet-to-dry gauze is considered substandard practice as it delays healing, increases wound pain and is cost-intensive due to frequent dressing changes. (Jones & Fennie, 2007—CO; NICE 2005—LR 2RCT;Singh et al., 2004—MA 4 RCT) A Perform surgical or conservative sharp debridement on sites with adequate vascular perfusion if there is need to achieve rapid removal of necrotic tissue; ensure properly trained health professionals that are qualified per institutional protocols, use sterile technique and instruments,and if debriding large amounts of necrotic tissue use the operating room if feasible. ( Chow et al., 1977—CO; Golinko et al., 2009—CO; Gordon 1996—Survey & LR; Ramundo & Gray 2008—SR 0 RCT; Rennert et al 2009-LR CO) C1 i. As needed, perform histopathology to confirm adequate removal of hyperkeratotic or fibrotic tissue. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 ii. Surgical debridement is the first method of choice when urgent need; advancing cellulitis or sepsis, Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. and increased pain, exudates, or odor. (Chow et al., 1977—CO; Golinko et al., 2009—CO; Blluestein, Javaheri, 2008—EO; Whitney et al., 2006—EO) C2 Iii. If feasible and consistent with patient goals, needs and condition, refer those with full-thickness PU that are undermined, tunneling or have sinus tracts or extensive necrotic tissue for surgical evaluation. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 iv. Use appropriate precautions to avoid complications;r refrain from surgical debridement on those with systemic infections, bleeding disorders, compromised immune or vascular systems, anticoagulant therapy, stable heel eschar with compromised vascular circulation at the ulcer site, gravely ill or critically unstable individuals. (Bluestien & Javaheri, 2008—EO; Langemo et al., 2010—EO; NPUAP, EPUAP, PPPIA, 2014—EO; Whitney et al., 2006--EO) C3 d. Use biological or larval debridement by maggots if patient-appropriate and feasible, avoiding use on exposed blood vessels, tendons or acute infections. (Gray 2008—LR 1 CO, 1 HCT; Sherman 2002—RCT ) B e. Consider “maintenance” debridement with safe topical antimicrobial use for PU experiencing unexplained healing delay despite optimal care, while recognizing that insufficient evidence supports a choice of any method of debridement compared to another for this use. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 f. Assure timely, effective patient-appropriate pain management related to surgical, enzymatic, larval or mechanical debridement. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 D. Cleanse wounds as needed to assess the wound surface, remove foreign matter, and reduce surface microbial count. 1.Cleanse PU at each dressing change, using low pressure (4-15 pounds/square inch) cleansing methods that optimize removal of debris and minimize trauma to the wound. Avoid scrubbing the ulcer or inflicting trauma. (Bergstrom et al., 2006—CO; Burke et al., 1998—RCT; Rodeheaver & Ratliff, 2007—LR 0 RCT) C1 a. Consider using pulsatile lavage at 4-15 psi to cleanse pressure ulcers. (Ho et al. 2012—RCT; NPUAP, EPUAP, PPPIA, 2014—EO; Rodeheaver & Ratliff 2007—LR) C1 2. Use safe, effective ulcer cleansing solutions such as potable tap water or saline to cleanse chronic wounds or wound cleansers with anionic surfactants for heavy exudate or adherent material. (Fernandez et al. 2012--SR 7 RCT) A 3. Avoid whirlpool hydrotherapy for wound cleansing. (1 RCT showed Whirlpool is not effective and poses a risk for ulcer contamination. ) Do not immerse those with compromised vascular , respiratory or immune systems. (Moore & Cowman, 2008— SR 1 RCT: no effect of whirlpool; NPUAP, EPUAP, PPPIA, 2014—EO) C3 4. Cleanse pressure ulcer- sinus tracts, tunneling or undermining with caution; ensure cleansing solution can be drained from wound beds that cannot be visualized. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 5. Avoid antiseptic or cytotoxic agents in clean uncompromised wounds. (Bergstrom et al.1994—G 1 RCT,1 HCT; Bluestein, Javaheri 2008—LR; Rodeheaver & Ratliff 2007—LR) B © Association for the Advancement of Wound Care 2015 Page 15 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER 6. Wound cleansing is usually adequate to prevent infection. However, if the wound is clearly infected or if there is excessive exudate or pus , the wound may be disinfected using antiseptics prior to cleansing. (JSPU, 2014-EO) C3 7. Warm wound irrigant to body temperature for comfort and wound environment tolerance. (Fernandez et al., 2012—SR 1 RCT; Rodeheaver & Ratliff 2007—LR) C1 8. Use a volume of irrigant appropriate for wound size, depth and condition (usually 100 to 150 ml otherwise determine quantities sufficient to remove debris and reduce microbial count on the wound surface ). (Rodeheaver & Ratliff 2007—LR) C3 9. Cleanse the skin around the ulcer with a pH balanced skin cleanser and water. . (Konya et al. 2005(b)—RCT; Lyder et al., 2002—HCT; Rodeheaver & Ratliff 2007—LR) B E. Prevent PU contamination and manage bacterial colonization and infection by using aseptic technique and safe, effective antimicrobial interventions for wounds at risk of infection, such as those on individuals with compromised immune, nutritional, metabolic or tissue perfusion status. (See also sections on cleansing and debridement) 1. Implement appropriate local policies and universal precautions for wound management, continence management, hand washing, protective equipment, dressing and irrigation solution containment and disposal. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 a. Clean technique in home care and long-term care. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 b. Sterile technique in acute care. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 c. Isolation precautions as indicated. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 2. Use systemic antibiotics specific to sensitivity report for bacteremia, sepsis, advancing cellulitis, fasciitis osteomyelitis, or systemic inflammatory response syndrome (SIRS). (Bergstrom et al, 1994—G 2 RCT; Chow et al., 1977—HCT; NPUAP, EPUAP, PPPIA, 2014—EO; Rennert et al 2009-LR CO) A 3. Treat distant infections such as urinary tract, pneumonia, cranial sinus or cardiac valves in patients with or at risk of developing a pressure ulcer. (Whitney et al., 2006—G 2 CCT, 1 CO) C2 4. Evaluate ulcer for signs and symptoms of clinical infection at each dressing change (increased local pain, odor, heat, drainage, erythema or edema or unexplained delayed healing). If ulcer infection is suspected based on clinical signs of infection and/or if wound regresses or plateaus despite appropriate PU preventive and treatment measures, determine type and level of microorganisms by validated quantitative swab cultures as described in 4.a. to inform care decisions. (Gardner et al 2006, CO; NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C2 a. Irrigate wound with normal saline before obtaining swab culture, identify a 1 cm2 viable area within the wound, then swab only this area by rotating the end of a sterile alginate-tipped applicator for 5 seconds with enough pressure to express tissue fluid, place swab into a collection device using sterile technique., Avoid swabbing pus, eschar/slough/surface exudate/edges. Avoid environmental contamination of the swab during the culture process. (Gardner et al 2006, CO; NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C2 b. Consider a diagnosis of PU infection if the wound culture contains >10 5 colony-forming units/g of tissue and/or beta hemolytic streptococci are present. (Gardner et al 2006, CO; NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C2 c. Consider using tissue biopsy and microscopy to determine the presence of biofilm, though benefits remain to be determined. (Gardner et al 2006, CO; NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C2 5. If osteomyelitis is suspected obtain tissue and/or bone biopsy for diagnosis if appropriate to patient’s condition and consistent with patient goals. (Lewis et al., 1988—CO; Rennert et al 2009—LR CO) A a. For osteomyelitis, perform conservative bone debridement and excise ulcer necrotic tissue. (Lewis et al., 1988—CO; Rennert et al 2009—LR CO) A b. Remove underlying bony prominence and fibrotic bursa cavities if indicated. (Rennert et al 2009—LR CO) C1 6. If infection is suspected, use only non-toxic concentrations of topical antimicrobial cleansing solutions, gels, ointments, creams, and aqueous preparations effective against gram-negative, gram-positive and anaerobic organisms. (Bluestein, Javaheri 2008— LR; NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C3 a. Initiate on clean ulcers (those absent of devitalized tissue) with delayed healing despite 2-4 weeks of optimal care, while rigorously continuing all other appropriate PU prevention and treatment interventions. (NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C3 b. Re-evaluate use after 2 weeks & discontinue topical antimicrobial treatments as infection abates. (NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C3 7. Use safe, effective, patient-appropriate antimicrobial dressings on wounds with delayed healing despite 2-4 weeks of optimal care, after ruling out patient allergies. (NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C3 © Association for the Advancement of Wound Care 2015 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Page 16 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER a. Use medical-grade honey dressings to reduce wound microbial burden and improve healing of PU. (Biglari et al. 2012—CS; Gunes et al. 2007—RCT; Weheida et al. 1991—RCT) A b. Use dressings releasing ionic silver or silver sulfadiazine for clinically infected or heavily colonized PU or those at high risk of infection, while taking all appropriate actions to prevent and manage wound infection, Discontinue use once wound infection is controlled. (Coutts & Sibbald, 2005—CS; NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005—EO; Munter et al., 2006—RCT) C1 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. c. Dressings releasing povidone iodine or cadexomer iodine. (Moberg et al. 1983—RCT; NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005—EO) C1 d. Gauze or other dressings containing topical antimicrobial agents. (RNAO, 2005—EO) C3 e. Gentian violet foam dressings. (RNAO, 2005—EO) C3 F. Select wound dressings that address wound and patient needs; use ulcer dressing(s) according to manufacturers’ instructions. Remove dressings gently if adherent to skin or wound surfaces to reduce likelihood of injury. 1. Use a dressing that reduces dressing change frequency, protects the ulcer and surrounding skin from contamination, friction, shear, trauma and irritation ,manages exudate to eliminate risk of ulcer desiccation or maceration, and provides thermal stability. (Bots & Apotheker 2004—RCT; Kerstein et al., 2001—MA; Meaume et al. 2003—RCT; Payne et al. 2009—RCT; Smitten et al, 2005—CO; Fernandez et al. 2012—LR1 RCT) A 2. Closely monitor wound dressing materials when applying or changing dressings; assure that no dressing fragment/layer/pieces remain as foreign bodies in the wound base/undermining/tunnel areas; avoid excess dressing or packing which can add to pressure between skin folds, between skin and support surfaces, and in tunneled or undermined areas causing delayed healing. Avoid using multiple small pieces of foam, gauze or other non-absorbable material in cavity ulcers. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 3. Select the most appropriate dressing with evidence of efficacy in healing PU consistent with principles of PU care, patient needs, individual ulcer status, cost, availability and caregiver ability. (Heyneman et al., 2008—SR >2 RCT; Kerstein et al 2001— MA; Payne et al. 2009—RCT) A a. Manage excess ulcer drainage using an alginate or other absorbent primary dressing covered with a secondary moisture-retentive dressing with matching indicated wear time. (Barr et al. 1995—CCT; Bolton et al., 2004—CO; Payne et al. 2009—RCT; Smitten et al, 2005—CO) B b. Select either an absorbent or hydrating primary wound filler to fill wound cavity dead space beneath secondary surface dressings, as indicated by wound condition and exudate amount . (Bolton et al., 2004; NPUAP, EPUAP, PPPIA, 2014— EO) C1 i. Use alginate or Hydrofiber® primary dressings, with or without silver, either alone or with other dressings to absorb exudate, prolong secondary moisture retentive dressing wear, or control minor bleeding. ii. Use hydrating ulcer fillers, including hydrogels, honey, or hydrocolloid paste to manage excess wound cavity dryness. (Dobrzanski 1990—RCT; Gunes et al, 2007—RCT; Heyneman et al. 2008—SR; Matzen et al. 1991—RCT; Thomas et al., 2005—RCT) A c. Avoid use of transparent film dressings as the primary dressing over moderate to heavy exuding PU as they manage very little fluid. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 d. Maintain a balanced moist ulcer environment using moisture-retentive dressings to optimize healing. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 e. .Moisture retentive hydrocolloid or transparent film dressings support moist healing and autolytic debridement in low to moderate exuding wounds. (Bouza et al 2005—SR >2 RCT; Cullum & Petherick 2008—SRDeLaat 2005—SR >2RCT; Hollisaz et al 2004—RCT; Singh et al., 2004—MA 4 RCT) A f. Hydrocolloid dressings used either alone, or over absorbent primary dressings to prolong dressing wear, heal PU more cost effectively than gauze or collagen matrix. (Belmin et al., 2002 RCT; Bouza et al 2005 SR >2 RCT; Cullum & Petherick 2008—SR > 2 RCT; DeLaat 2005—LR; Graumlich et al., 2003—RCT Heyneman et al., 2008—SR Kerstein et al 2001—MA >2 RCT) A g. Hydrate dry ulcers with an amorphous or sheet hydrogel to support autolytic debridement, wound comfort and moist wound healing (avoid use in case of a stable heel eschar where debridement is contraindicated). (Bolton et al., 2004— CO; Heyneman et al., 2008—SR 2 RCT; Matzen et al. 1991—RCT ) A h. . Foam dressings are more absorbent and easier to remove than a hydrocolloid dressing with similar healing and dressing wear time. Foams decrease costs of care and extend wear time compared to gauze dressings. (Bale et al., 1997—RCT; Heyneman et al., 2008—SR; Payne et al. 2009—RCT; Sopata et al., 2002—RCT) A © Association for the Advancement of Wound Care 2015 Page 17 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER i. Border-adherent silicone foam dressings are easier to remove, with less tissue damage than self-adherent polymer foam dressings, but have similar levels of leakage, inflammation and odor. ( Meaume et al, 2003—RCT) C1 j. In the presence of foul drainage consider dressings that reduce wound odor. (NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005—EO; Munter et al., 2006—RCT) C1 k. Use composite dressings with randomized controlled evidence of efficacy for healing PU. (Kordestani et al 2008—RCT; Meaume et al. 2005—RCT; Gunes et al. 2007—RCT) A l. In patients with altered immune responsesconsider moisture-retentive dressings with evidence of efficacy in reducing likelihood of infection or bacterial burden, such as medical grade honey, hydrocolloid, ,antimicrobial impregnated foam, or ionic silver-releasing dressings. (Hutchinson et al. 1990—MA; Gunes et al. 2007—RCT; Munter et al. 2006—RCT; Trial et al. 2010—RCT; Weheida et al. 1991—RCT) A 4. Avoid gauze use as a primary dressing when possible as it is less cost effective in healing pressure ulcers and is associated with increased infection rates and pain. (de Laat et al. 2005—LR 3 RCT; Hutchinson & McGuckin 1990—MA 9 RCT; Maume et al 2003—RCT; Kerstein et al. 2001—MA 3 RCT) A a. If no other form of moisture-retentive primary dressing is available, loosely fill deep PU with moistened gauze every 4 hours to provide moist wound healing. This is preferable to wet-to-dry or dry gauze, though less cost effective. (Colwell et al. 1993—RCT; NPUAP, EPUAP, PPPIA, 2014--EO) C1 b. Use a semiocclusive secondary dressing to reduce evaporation through primary dressings when the tissue-dressing interface layer is moist. (NPUAP, EPUAP, PPPIA, 2014--EO) C3 c. Use loosely woven gauze to pack highly exuding ulcers or tightly woven gauze for minimally exuding ulcers; change the dressing frequently enough to manage exudate and prevent ulcer dessication. (NPUAP, EPUAP, PPPIA, 2014--EO) C3 d. Use one continuous gauze strip, roll, or sheet to fill deep ulcers to avoid retaining dressing pieces in the wound as a foreign body. If wound dynamics require more than 1 dressing to fill the cavity mark the dressing topper with the number of dressing sheets used during dressing application. (NPUAP, EPUAP, PPPIA, 2014--EO) C3 5. Manage exuberant granulation tissue that may impede healing. (PVA, 2000—EO; RNAO, 2005—EO) C3 6. Monitor all dressing sites daily; schedule change frequency based on ulcer and patient status, amount of exudates, dressing condition or leakage, and dressing manufacturer’s recommendations. Observe wound status each dressing change, assuring that the PU is progressing toward healing; revise dressings according to ulcer outcomes and patient goals. (NPUAP, EPUAP, PPPIA, 2014—EO; PVA, 2000—EO) C3 G. Monitor and manage pressure ulcer-related pain, using subject- and age-appropriate pain scales such as visual analogue scales or FACES. 1. Use a moisture-retentive pressure ulcer dressings that require less frequent changes, maintain a moist ulcer environment, and reduce patient-reported pain. (Maume et al 2003—RCT; Kerstein et al., 2001—MA 3 RCT; Queen et al., 2005) A 2. Use topical analgesics or local anesthetics when appropriate; e.g. coordinate with care delivery, painful procedures, or to alleviate ulcer-related pain . (de Laat et al. 2005—LR 2RCT; Evans et al., 2005—LR RCT; Tippett 2015—CO) A 3. Use systemic pain medications to manage chronic pain only when appropriate in doses consistent with the World Health Organization Pain Dosing Ladder. (NPUAP, EPUAP, PPPIA, 2014—EO; Reddy et al. 2003, LR EO) C3 4. Correct patient posture as able to minimize pain using repositioning and pressure redistribution principles described in section III.B. . (NPUAP, EPUAP, PPPIA, 2014—EO; Reddy et al. 2003, LR EO) C3 5. Use support surfaces that minimize pain. (NPUAP, EPUAP, PPPIA, 2014—EO; Reddy et al. 2003, LR EO) C3 6. Refer patient to a pain specialist or for psycho-social interventions as needed, (NPUAP, EPUAP, PPPIA, 2014—EO; Reddy et al. 2003, LR EO) C3 7. Use non-pharmacologic pain management meditation or diversion techniques, including patient-directed “time out” during procedures, if appropriate. (NPUAP, EPUAP, PPPIA, 2014—EO; Reddy et al. 2003, LR EO) C3 8. Refer patient for massage if needed to manage muscle cramping or lymphatic conditions, but avoid massage over reddened bony prominences. (RNAO, 2005—G 2 CS) C2 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. H. Implement evidence-based nutritional Interventions adjusted to individualized needs and wishes, medical history and comprehensive nutritional assessment results for all patients at risk for or with a pressure ulcer 1. Ensure adequate patient-appropriate nutrient and fluid intake revised as needed to maximize potential for preventing pressure ulcer development or healing existing wounds, Adjust intake to meet patient needs and goals in consultation with a medical professional and managed by a qualified dietitian as feasible. a. Calories (30-40 kcal/kg/day) (Cereda et al., 2009—RCT; Langer et al., 2003—SR (1 RCT; et al. 2011 (p 83NPUAP) A © Association for the Advancement of Wound Care 2015 Page 18 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER b. Provide adequate protein for positive nitrogen balance for those at risk for or with a pressure ulcer (1.25-1.5 g protein/kg/day), after assessing renal function to assure that this is patient-appropriate. da et al., 2009—RCT; Langer et al 2003—SR 1 RCT; Lee et al, 2006—RCT; Reddy et al, 2009—SR 1 RCT) A (Note: 1.25 per NPUAP Guidelines) c. Micronutrients If vitamin or mineral deficiencies are confirmed or suspected, provide appropriate supplements in combination with a balanced diet rich in vitamins and minerals as feasible, including supplemental: i. Zinc (Cereda et al., 2009—RCT; Desneves et al, 2005—RCT) A ii. Vitamin C (Cereda et al., 2009—RCT; Desneves et al, 2005—RCT) A iii . Vitamin A (NPUAP, EPUAP, PPPIA, 2014—EO) C3 iv. Vitamin E (NPUAP, EPUAP, PPPIA, 2014—EO) C3 v Amino acids, such as arginine (Cereda et al., 2009—RCT; Desneves et al, 2005—RCT) A d. Hydration program 30-35 cc/kg of body weight or as medically indicated (NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005--EO) C3 2. If underweight or losing weight, enhance intake to place the individual into positive nitrogen balance, e.g. by offering fortified foods and/or high calorie, high protein oral supplements between meals if needed to sustain adequate nutritional status. (Cereda et al., 2009—RCT; Langer et al 2003—SR 1 RCT; Pinchofsky-Devin 1986—CO; Stratton et al 2005—SR 4 RCTs; NPUAP, EPUAP, PPPIA, 2014—EO) A a. Anabolic agents: such as Oxandralone (Spungin 2001—CS) C2 b. Appetite stimulants: such as Megistered Acetate (NPUAP, EPUAP, PPPIA, 2014—EO) C3 3 Evaluate effectiveness of nutritional interventions regularly (Pinchofsky-Devin 1986—CO; van Rijswijk & Polansky 1994—CO) C2 I. Apply adjunctive interventions for chronic pressure ulcer management if ulcer is unresponsive to best available evidence-based therapy after 4 weeks 1. Electrical stimulation (Feedar et al, 1991—RCT; Gardner et al, 1999—MA 4 –RCT; Mulder, 1991—RCT; Wood et al, 1993—RCT) A 2. Hyperbaric oxygen therapy has insufficient evidence of efficacy for use on PU. .( Kranke P et al, 2004—LR:-no studies supported PU effect) A—supporting no effect on PU a. Adjunctive topical hyperbaric oxygen to enhance antibiotic effect if osteomyelitis or ischemic conditions are present has insufficient evidence to inform clinical PU care decisions. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 3. Negative Pressure Wound Therapy (NPWT) 75 to 125 mmHg—has insufficient evidence to inform PU care decisions about its use as an adjuvant to recognized PU care Those considering NPWT use as an early adjuvant to full-thickness PU treatment to reduce PU edema or volume or to manage excess fluid should practice safe use based on acute wound research (a-e). . (Baharestani et al., 2008—CO; Gregor et al., 2008 SR—2 RCT; Ubbink et al., 2008—SR. No significant effect reported on any RCT) a. NPWT is not recommended on dry, inadequately debrided or malignant wounds or where vital organs or major blood vessels are exposed or in individuals with coagulopathy or clinical infection. (NPUAP, EPUAP, PPPIA, 2014—RCT, CCT) B b. Use safe, clean technique for applying and removing NPWT dressings, Assure removal of all tissue interface layers and record the number of dressings placed in the PU to avoid retained interface dressings. Arrange all dressing, drainage collection and tubing components to avoid added pressure over bony prominences. (NPUAP, EPUAP, PPPIA, 2014— RCT, CCT) B c. Minimize patient pain by using a non-adherent primary dressing and using lower levels of 75-80 mmHg NPWT. Avoid petrolatum or emulsion dressings that may interfere with wound fluid transfer. (NPUAP, EPUAP, PPPIA, 2014—RCT, CCT) B d. Educate patient, family and community caregivers and provide emergency contacts for appropriate immediate action if the seal loosens, alarms ring, blood or tissue is seen in the tubing or erythema develops. (NPUAP, EPUAP, PPPIA, 2014—RCT, CCT) B 4. Therapeutic; contact or non-contact ultrasound has -- insufficient PU RCTs supporting healing or debridement decisions. (Baba-Akbari et al, 2006 LR; 3 RCT, Ramundo & Gray 2008—SR) A 5. UV Light/ or multi-wavelength phototherapy. (Taly AB et al, 2004 RCT: only effect (p=0.047) was on 8 stage III/IV subset) C1 6. Pulsed electromagnetic field therapy has not been consistently associated with improved PU healing. (Salzberg et al, 1995— RCT; Olyaee Manesh et al, 2006 LR; 2 RCT, no statistically significant findings) A © Association for the Advancement of Wound Care 2015 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. Page 19 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. 7. Laser therapy has insufficient evidence of healing efficacy to inform PU decisions, though related heating artifacts increased healing in mice. (Baba-Akbari et al. 2006—MA with insufficient evidence; Lanzafame et al., 2004—AM) A 8. Platelet-derived growth factor, the only growth factor commercially available for wound management, is not indicated for PU use. Supporting RCTs showed more rapid healing than gauze with placebo. Gauze primary dressings are recognized as substandard practice. No PU RCT comparisons to Level A evidence-based dressings were found. FDA has informed healthcare professionals that a Boxed Warning was added to prescribing information for Regranex® that describes an increased risk of death from cancer in patients treated with three or more tubes of Regranex® compared with those patients who did not use the product. FDA recommends that Regranex® be used only when the benefits can be expected to outweigh the risks. (Mustoe et al. 1994— RCT; Rees et al, 1999—RCT; Robson et al. 1992—RCT) A 9. Topical phenytoin has insufficient evidence of efficacy for PU healing. (Rhodes et a. 2001 RCT more healed with phenytoin (P) than hydrocolloid dressing (HCD) Subbana et al., 2007 RCT: No effect Hollisaz et al: RCT more healed with HCD than P similar to gauze) C1 10. Topical estrogen has insufficient evidence to inform PU management decisions. (EO) C3 11. Consider using polarized or monochromatic Infrared light or light-emitting diodes (LED) as an adjunct to standard therapy to increase PU healing rates if traditional therapies fail. (Dehlin et al. 2007—RCT; Durovic et al. 2008—RCT; Schubert 2001—RCT) A a. Ultraviolet C light stimulation has insufficient evidence supporting healing efficacy or reducing bacterial burden to inform PU care decisions. (NPUAP, EPUAP, PPPIA, 2014—EO; Nussbaum et al. 2013—No significant effect 5 RCT; Thai et al. 2005—CS : 7 PU) A 12. Skin equivalents such as allograft , bioengineered skin, or biologic dressings have insufficient evidence to inform decisions about PU management. (NPUAP, EPUAP, PPPIA, 2014—EO; RNAO, 2005—EO) C3 13. Vibration therapy lacks sufficient evidence of efficacy to inform decisions about Stage I PU care. (Arashi et al. 2010—RCT; NPUAP, EPUAP, PPPIA, 2014—EO) C1 J. Use patient-appropriate surgical interventions only if needed to eliminate extensive undermining, tunneling, sinus tracts or pressure points or address urgent infection symptoms, carefully considering risks of PU recurrence, patient goals, surgical risks and benefits and end-of-life preferences. 1. Use direct closure only if required, as it seldom helps unless the source of pressure is eliminated and the PU is small. (Whitney et al., 2006— EO; Brown et al., 2007—LR EO) C3 2. Pre-operatively, evaluate and address factors that may impair surgical wound healing in myocutaneous, free, fasciocutaneous, or cutaneous flaps. (Brown et al., 2007—LR 2 CS; NPUAP, EPUAP, PPPIA, 2014—EO; Whitney et al., 2006— EO) C2 a. Resect infected bone prior to or during surgical closure if appropriate and consistent with patient goals. (Ichioka et al 2007—CS; Lemaire et al 2008—CO; Wong & Ip 2006—CCT; Rennert et al 2009-LR, CO; Yamamoto et al 1997—CCT) B b. Reduce ulcer bacterial burden to <105 colony forming units per g of sample before surgical closure. (Brown et al., 2007— LR 2 CS; Murphy et al., 1986—AM; Whitney et al., 2006— EO) B c. Manage factors that may impair healing; acute osteomyelitis metabolic instability ,malnutrition, immunosuppressive drug doses,diarrhea, infection, spasms, and contractures. (Ichioka et al 2007—CS; Lemaire et al 2008—CO; Wong & Ip 2006—CCT; Rennert et al 2009-LR, CO; Yamamoto et al 1997—CCT) B. 3. Be aware that skin grafts may exhibit “poor take” over exposed bone. (Brown et al., 2007—LR 2 CS; Whitney et al., 2006— EO) C2 4. Carefully weigh the benefits and risks of anesthesia, loss of functionality, wound infection and other complications of surgery; take all perioperative precautions to optimize outcomes desired by the patient. (Brown et al., 2007—LR 2 CS; Whitney et al., 2006— EO) C2. 5.Intra-operatively assure that patient and surgical site receive optimal care and surgical technique to minimize blood loss, prevent further tissue injury or functional loss, conserve healthy tissue and optimize surgical site viability and repair. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 a. During sedation and operative procedures use appropriate effective support surfaces and pressure redistribution principles and transfer techniques described under Section II PU Prevention. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 © Association for the Advancement of Wound Care 2015 Page 20 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER 6. Optimize post-operative healing and recovery by redistributing pressure with optimal support surfaces, such as an high specification foam, air fluidized bed or low air loss beds with tissue interfaces that minimize sheer and optimize the microclimate, recognizing that individuals are at high PU risk after PU surgery, , (Isik et al. 1997—RCT; Milne et al., 2009—LR CO; NPUAP, EPUAP, PPPIA, 2014—CO, RCT) B a. Trained professionals assess skin daily, document and address all PU risk factors and redistribute, pressure regularly, avoiding friction and sheer and providing quality nutrition/hydration and other PU prevention and treatment in Section II and III. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 b. Document, report and address patient and wound surgical complications: such as wound dehiscence, flap ischemia or failure, infection, abscess, hematoma/seroma, medication reactions, patient-reported procedure-related pain using a patient-appropriate validated, reliable scale. (Gorecki et al. 2011—SR RCT; Isik et al. 1997—RCT) A c. Regularly monitor wound drainage systems and assure removal of fluid from dead space. (NPUAP, EPUAP, PPPIA, 2014—EO) C3 d. Implement a collaborative inter-disciplinary post-operative management protocol including patient and family caregiver education, rehabilitation and social support continuing after hospital discharge from the hospital to avoid re-injury and recurrence,. (Kierney et al. 1998—CS; Schryvers et al. 2000—CO; Yarkin et al. 2009—HCT) C1 e. . Prevent hazards of immobility and increase mobility to sitting over 4-8 weeks, Carefully consider effects of bed elevation, repositioning and support surfaces on all post-operative sites, (NPUAP, EPUAP, PPPIA, 2014—EO) C3 K. Document patient and wound response to treatment program and inform caregiver(s) of progress or lack of progress. 1. Measure ulcer and document overall progress weekly, or sooner if there is a significant change in ulcer status, on an approved data collection form; with wound photograph if feasible. Use validated tools such as the BWAT® (Bates-Jensen Wound Assessment Tool©) DESIGN-R Tool or PUSH© (Pressure Ulcer Scale for Healing) . (Bolton et al., 2004—CO ; Gunes 2009—CO; IIzaka et al. 2012—CO; Zhong et al 2013—CO) C2 2. If no significant reduction in wound area after 2-4 weeks of a treatment regimen, report this lack of response to patient and caregiver, re-evaluate diagnosis and/or care plan. . (vanRijswijk 1993—CO; vanRijswijk & Polansky 1994—CO; Kurd et al. 2009— 2RCT (Level A for chronic wounds: venous or diabetic foot ulcers only. This principle remains to be tested for PU.) C2 3. If complications, non-adherence to protocol, or nutritional concerns arise, revise plan of care or goals of treatment to address patient issues. . (vanRijswijk 1993—CO; vanRijswijk & Polansky 1994—CO; Kurd et al. 2009—2RCT (Level A for chronic wounds: venous or diabetic foot ulcers only. This principle remains to be tested for PU.) C2 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. 4. Interventions and outcomes should be monitored and documented using prevalence and incidence studies, surveys and focused audits (RNAO, 2010-EO) C3 SECTION III. PRESSURE ULCER STRATEGIES; OTHER CONSIDERATIONS L. Palliative wound care if consistent with patient and family wishes. 1. Assess skin regularly for PU and for signs of deep tissue injury or “terminal ulcers” in gravely ill individuals. Validity of “terminal ulcer” is not clear. (Langemo et al 2006—LR; Langemo et al 2010—LR RCT) B 2. Establish individualized goals of care as determined by patient and family wishes and communicate to interdisciplinary team. (Alvarez et al 2007, LR; Langemo et al 2010—LR; Letizia et al., 2010—LR) C2 Stabilize and manage the pressure ulcer and surrounding skin to extent possible while optimizing patient comfort. (Langemo et al 2010—LR RC, CCT; Letizia et al., 2010—LR; McDonald & Lesage, 2006—LR ) B. Provide pressure redistribution mattress and chair cushion sufficient to address wound condition and PU risk status with the goal of preventing new tissue injury or worsening of existing PU. (Langemo et al 2010—LR RC, CCT; Letizia et al., 2010—LR; McDonald & Lesage, 2006—LR ) B Manage PU pain with an effective analgesic (e.g. topical lidocaine or. diamorphine hydrogel, balancing risk of side effects) and by using patient—appropriate ulcer dressings. (Flock 2003—RCT; Langemo et al 2010—LR ; Letizia et al., 2010—LR; McDonald & Lesage, 2006 LR; Tippett 2015—CO) B Minimize or eliminate wound odor by choosing dressings that manage exudate, devitalized tissue and /or bioburden effectively. Langemo et al 2010—LR; Letizia et al., 2010—LR; McDonald & Lesage, 2006 LR; Paul & Peiper 2008—LR 2 RCT) A Minimize dressing change frequency consistent with wound condition and exudate volume ; consider foam or hydrocolloid dressings for extending wear time if wound-appropriate. (Langemo et al 2010—LR RCT, CCT; Letizia et al., 2010—LR; McDonald & Lesage, 2006—LR ) B Assess PU regularly, if feasible, using reliable, valid scales including a patient-appropriate visual analogue or other valid, reliable measure (e.g. MPQ or FACES) of patient-reported PU pain . (Gorecki et al. 2011—SR RCT; Gunes 2008—CS; Langemo et al 2010—LR RCT, CCT; Letizia et al., 2010—LR; McDonald & Lesage, 2006—LR ) A © Association for the Advancement of Wound Care 2015 Page 21 of 22 INTERNATIONAL CONSOLIDATED PRESSURE ULCER GUIDELINE VALIDATION SURVEY Relevance Rating Scale for Content Validation Strength of Recommendation Scale 1 = Not relevant. 2 = Benefits clearly outweigh costs, risks, harms 2 = Confusing/unable to assess relevance without more information 1 = Unclear if benefits outweigh costs, risks, harm 3 = Relevant but needs minor improvements: 0 = Costs, risks, harms clearly outweigh benefits 4 = Very Relevant and succinct Please add item comments/concerns on last page, Section 4. General Comments/Questions Please Type Your Rating Below IF THE GOAL OF THE ICPUG IS TO FACILITATE EVIDENCE-BASED PRESSURE ULCER MANAGEMENT, THEN HOW RELEVANT IS IT TO PERFORM EACH OF THE FOLLOWING FUNCTIONS AND HOW STRONGLY DOES IT BENEFIT THE PATIENT OR ULCER Maintain individual dignity and provide psychosocial support to reduce isolation. (Langemo et al 2010—LR RCT, CCT; Letizia et al., 2010—LR; McDonald & Lesage, 2006—LR ) B Section 4: General Comments and Questions Thank you very much for your time and thoughtful review! Please add comments or questions not addressed in the survey section (Section 3) of the International Consolidated Pressure Ulcer Validation Survey you have just completed. If adding a new item, please provide 1 to 3 published reference citations supporting each item added. © Association for the Advancement of Wound Care 2015 Relevance rating (Content Valdity Index) Strength of Recommendation Rating Section 3. Survey of Content Validation for Relevance and Strength of Recommendation. If related to a recommendation above, please write its number below e.g. for Part I .H.1 for “Ensure all formal assessments are accessible to those providing or consulting on pressure ulcer care .” Page 22 of 22