title: Exploring the role of pain as an early predictor of category 2 pressure ulcers: a prospective cohort study.
abstract: To explore pressure area related pain as a predictor of category ≥2 pressure ulcer (PU) development.
  
  
  
  Multicentre prospective cohort study.
  
  
  
  UK hospital and community settings.
  
  
  
  Consenting acutely ill patients aged ≥18 years, defined as high risk (Braden bedfast/chairfast AND completely immobile/very limited mobility; pressure area related pain or; category 1 PU).
  
  
  
  Patients too unwell, unable to report pain, 2 or more category ≥2 PUs.
  
  
  
  Twice weekly for 30 days.
  
  
  
  Development and time to development of one or more category ≥2 PUs.
  
  
  
  Of 3819 screened, 1266 were eligible, 634 patients were recruited, 32 lost to follow-up, providing a 602 analysis population. 152 (25.2%) developed one or more category ≥2 PUs. 464 (77.1%) patients reported pressure area related pain on a healthy, altered or category 1 skin site of whom 130 (28.0%) developed a category ≥2 PU compared with 22 (15.9%) of those without pain. Full stepwise variable selection was used throughout the analyses. (1) Multivariable logistic regression model to assess 9 a priori factors: presence of category 1 PU (OR=3.25, 95% CI (2.17 to 4.86), p<0.0001), alterations to intact skin (OR=1.98, 95% CI (1.30 to 3.00), p=0.0014), pressure area related pain (OR=1.56, 95% CI (0.93 to 2.63), p=0.0931). (2) Multivariable logistic regression model to account for overdispersion: presence of category 1 PU (OR=3.20, 95% CI (2.11 to 4.85), p<0.0001), alterations to intact skin (OR=1.90, 95% CI (1.24 to 2.91), p=0.0032), pressure area related pain (OR=1.85, 95% CI (1.07 to 3.20), p=0.0271), pre-existing category 2 PU (OR=2.09, 95% CI (1.35 to 3.23), p=0.0009), presence of chronic wound (OR=1.66, 95% CI (1.06 to 2.62), p=0.0277), Braden activity (p=0.0476). (3) Accelerated failure time model: presence of category 1 PU (AF=2.32, 95% CI (1.73 to 3.12), p<0.0001), pressure area related pain (AF=2.28, 95% CI (1.59 to 3.27), p<0.0001). (4) 2-level random-intercept logistic regression model: skin status which comprised 2 levels (versus healthy skin); alterations to intact skin (OR=4.65, 95% CI (3.01 to 7.18), p<0.0001), presence of category 1 PU (OR=17.30, 95% CI (11.09 to 27.00), p<0.0001) and pressure area related pain (OR=2.25, 95% CI (1.53 to 3.29), p<0.0001).
  
  
  
  This is the first study to assess pain as a predictor of category ≥2 PU development. In all 4 models, pain emerged as a risk factor associated with an increased probability of category ≥2 PU development.
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Isabelle L
authors.initials: IL
authors.lastname: Smith
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Brown
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.|Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McGinnis
authors.affiliation: Division of Nursing, Midwifery & Social Work, & Central Manchester University Hospitals NHS Foundation Trust (CMFT), Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Briggs
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Susanne
authors.initials: S
authors.lastname: Coleman
authors.affiliation: School of Health & Population Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Carol
authors.initials: C
authors.lastname: Dealey
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Delia
authors.initials: D
authors.lastname: Muir
authors.affiliation: School of Healthcare, University of Leeds, Leeds, UK.
authors.forename: E Andrea
authors.initials: EA
authors.lastname: Nelson
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Stevenson
authors.affiliation: Department of Tissue Viability, Leeds Community Healthcare NHS Trust, Leeds, UK.
authors.forename: Nikki
authors.initials: N
authors.lastname: Stubbs
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.|Mid Yorkshire Hospital NHS Trust, Wakefield, UK.
authors.forename: Lyn
authors.initials: L
authors.lastname: Wilson
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Julia M
authors.initials: JM
authors.lastname: Brown
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Nixon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010146:Pain / Q000175:diagnosis* / Q000209:etiology; D011312:Pressure; D003668:Pressure Ulcer / Q000145:classification / Q000150:complications / Q000175:diagnosis*; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D012867:Skin / Q000473:pathology*
keywords: Cohort; Multi-level; Observational; Pain; Pressure Ulcers; Risk factors