Andrea Nelson

Development and validation of a new patient-reported outcome measure for patients with pressure ulcers: the PU-QOL instrument.

BackgroundPatient-reported outcome (PRO) data are integral to patient care, policy decision making and healthcare delivery. PRO assessment in pressure ulcers is in its infancy, with few studies including PROs as study outcomes. Further, there are no pressure ulcer PRO instruments available.MethodsWe used gold-standard methods to develop and evaluate a new PRO instrument for people with pressure ulcers (the PU-QOL instrument). Firstly a conceptual framework was developed forming the basis of PU-QOL scales. Next an exhaustive item pool was used to produce a draft instrument that was pretested using mixed methods (cognitive interviews and Rasch Measurement Theory). Finally, we undertook psychometric evaluation in two parts. This first part was item reduction, using PU-QOL data from 227 patients. The second part was reliability and validity evaluation of the item-reduced version using both Traditional and Rasch methods, on PU-QOL data from 229 patients.ResultsThe final PU-QOL contains 10 scales for measuring symptoms, physical functioning, psychological well-being and social participation specific to pressure ulcers. It is intended for administration and patients rate the amount of “bother” attributed during the past week on a 3-point response scale. Scale scores are generated by summing items, with lower scores indicating better outcome. The PU-QOL instrument was found to be acceptable, reliable (Cronbach’s alpha values ranging 0.89 - 0.97) and valid (hypothesised correlations between PU-QOL and SF-12 scores (r >0.30) and PU-QOL scales and sociodemographic variables (r <0.30) were consistent with predictions).ConclusionsThe PU-QOL instrument provides a standardised method for assessing PROs, reflecting the domains in a pressure ulcer-specific conceptual framework. It is intended for evaluating patient orientated differences between interventions and in particular the impact from the perspective of patients.

Why do patients develop severe pressure ulcers? a retrospective case study.

Objectives This study focuses on the ways in which the organisational context can influence the development of severe pressure ulcers. Severe pressure ulcers are important indicators of failures in the organisation and delivery of treatment and care. We have a good understanding of patients’ risk factors, but a poor understanding of the role played by the organisational context in their development. Setting The study was undertaken in six sites in Yorkshire, England. The settings were sampled in order to maximise diversity, and included patients’ own homes, acute hospital medical and surgical wards, a community hospital and a nursing home during a period of respite care. Participants Data were collected about eight individuals who developed severe pressure ulcers, using a retrospective case study design. The data sources included interviews with individuals with severe pressure ulcers, and with staff who had treated and cared for them, and clinical notes. Results 4 accounts indicated that specific actions by clinicians contributed to the development of severe pressure ulcers. Seven of the 8 accounts indicated that they developed in organisational contexts where (1) clinicians failed to listen and respond to the patients’ or carers’ observations about their risks or the quality of their treatment and care, (2) clinicians failed to recognise and respond to clear signs that a patient had a pressure ulcer or was at risk of developing one and (3) services were not effectively coordinated. Conclusions Patient accounts could only be partially explained in terms of specific events or sequences of events. The findings support the conclusion that there was general acceptance of suboptimal clinical practices in 7 of the 8 contexts where patients developed severe pressure ulcers.

Experiences of Healthcare Provision for Foot Ulceration Occurring in People with Rheumatoid Arthritis

BACKGROUND Participants with rheumatoid arthritis (RA) report that foot ulceration has an impact on their health-related quality of life (HRQL) across physical, social and psychological domains. What is not known is how experiences of healthcare provision influence HRQL. The present study set out to map the patent journey while integrating the impact on HRQL. METHODS A purposive sample of RA patients with open foot ulceration was recruited from podiatry clinics in West Yorkshire (UK) between May 2008 and June 2009. Patients with diabetes were excluded (the impact of foot ulceration in this group is well established). In-depth interviews were taped and transcribed. A framework approach to data management was used to facilitate a case- and theme-based analysis. RESULTS Twenty-three RA patients (18 female, five male; aged 45-88 years) participated. Two themes and five sub-themes were identified. The patient journey theme comprised the following sub-themes: access to care; knowledge acquisition; care pathways and continuity of care. Patient-professional relationships comprised the sub-themes: therapeutic patient-professional relationships and task-orientated care. The journey took a highly variable course that was influenced by patient-specific factors (past experience of ulceration; symptomology; knowledge and self-efficacy); service-specific factors (access to care and care pathways) and professional-specific factors (knowing and trusting someone; holism). CONCLUSIONS The present study highlights the need for clearer care pathways for patients affected by foot ulceration improved patient education and better coordination of care.

A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control

To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof‐of‐concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score‐matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi‐layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow‐up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan–Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ2 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non‐healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison.

CODIFI (Concordance in Diabetic Foot Ulcer Infection): a cross-sectional study of wound swab versus tissue sampling in infected diabetic foot ulcers in England

Objective To determine the extent of agreement and patterns of disagreement between wound swab and tissue samples in patients with an infected diabetic foot ulcer (DFU). Design Multicentre, prospective, cross-sectional study. Setting Primary and secondary care foot ulcer/diabetic outpatient clinics and hospital wards across England. Participants Inclusion criteria: consenting patients aged ≥18 years; diabetes mellitus; suspected infected DFU. Exclusion criteria: clinically inappropriate to take either sample. Interventions Wound swab obtained using Levine’s technique; tissue samples collected using a sterile dermal curette or scalpel. Outcome measures Coprimary: reported presence, and number, of pathogens per sample; prevalence of resistance to antimicrobials among likely pathogens. Secondary: recommended change in antibiotic therapy based on blinded clinical review; adverse events; sampling costs. Results 400 consenting patients (79% male) from 25 centres. Most prevalent reported pathogens were Staphylococcus aureus (43.8%), Streptococcus (16.7%) and other aerobic Gram-positive cocci (70.6%). At least one potential pathogen was reported from 70.1% of wound swab and 86.1% of tissue samples. Pathogen results differed between sampling methods in 58% of patients, with more pathogens and fewer contaminants reported from tissue specimens. The majority of pathogens were reported significantly more frequently in tissue than wound swab samples (P<0.01), with equal disagreement for S. aureus and Pseudomonas aeruginosa. Blinded clinicians more often recommended a change in antibiotic regimen based on tissue compared with wound swab results (increase of 8.9%, 95% CI 2.65% to 15.3%). Ulcer pain and bleeding occurred more often after tissue collection versus wound swabs (pain: 9.3%, 1.3%; bleeding: 6.8%, 1.5%, respectively). Conclusion Reports of tissue samples more frequently identified pathogens, and less frequently identified non-pathogens compared with wound swab samples. Blinded clinicians more often recommended changes in antibiotic therapy based on tissue compared with wound swab specimens. Further research is needed to determine the effect of the additional information provided by tissue samples. Trial registration number ISRCTN52608451.

CODIFI (Concordance in Diabetic Foot Infection): Agreement in reported presence of likely pathogens in swabs and tissue samples from infected diabetic foot ulcers

Aim Wound infection is common in diabetic foot ulcers with potentially life changing sequelae. Targeted treatment of infective organisms requires accurate identification of pathogens to enable refinement of antibiotic protocols to improve outcomes and reduce antibiotic resistance. Wound sampling is routinely conducted using swabs although some guidelines recommend use of tissue samples. To date there is a lack of robust evidence to inform clinical practice regarding sampling technique. This study aimed to evaluate the extent to which results from wound swab and tissue samples taken from the same patient agree with each other; one might report pathogens more than the other, they might both report the same pathogens consistently, or they might disagree with a more complex pattern of disagreement. Here we report agreement and disagreement between the techniques based upon reported presence of likely pathogens.

What is a randomised controlled trial

Randomised controlled trials (RCTs) answer questions about the effectiveness of different care options: ‘what effect does using treatment A or treatment B have on outcomes?’ RCTs are important to nursing as they are the best study design for answering the question ‘should I do this or that?’; nurses ask effectiveness questions frequently. Researchers refer to one treatment being tested as the ‘intervention’ (I) and another treatment (eg, one that would otherwise be used) as the ‘comparator’ (or control) (C). Examples of these effectiveness questions (as well as their interventions and comparators ) include: 1. ‘Should families of children with eczema install a home water softener?’ (I, water softener; C, …

Larval therapy for leg ulcers Study authors respond to points in editorial

In the editorial accompanying our three papers on leg ulcers, Grey and colleagues make several points that deserve reply.1 2 3 4 They do not like our selection of time to healing as the primary outcome in the larval therapy study, but debridement is practised precisely because it is thought to aid healing. They claim that debridement “is more valuable to clinicians,” but is …