1. Salcido, Richard ''Sal'' MD, EdD

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We have all seen well-worn dirt paths cutting across the green grass, deviating from well-intended straight-line sidewalks, with occasional signs that read, "Stay on the sidewalk." As wound care clinicians know too well, patients don't always walk on the academic or clinical investigator "sidewalks." I share a few "learning moments" from my mentors to underscore the point: "The patients don't read the books" or "Who am I to tell cancer where to go?"-a profound statement for a novice learner to hear! The patient's expected goals and treatment outcomes need to be reflected, especially in the type of patient-oriented clinical research (POR) we publish in our journal.

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Researchers communicate the "how" of the research using the time-honored convention of scientific methodology. The interpretation, reproducibility, and transparency of methods used in POR are important contemporary issues. To be sure, the definitions of "patient orientation" in the literature are not always easy to interpret and likewise difficult to document or support the conclusions of research findings. Given the complexity of patients with chronic wounds, perhaps a patient-outcome orientation taxonomy is appropriate.


Patient centeredness has been defined by the Institute of Medicine (IOM) as "respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions."1 Reuben and Tinetti2 suggest that the IOM definition of patient centeredness1 may not be appropriate or go far enough for the patient with significant chronic disease or multiple comorbidities. For patients with heterogeneous chronic conditions, they suggest a "goal-oriented patient care model."2 Although they give examples of the model in palliative care, it may also apply to chronic wound patients. Most wound trials focus on the closure of the wound as the end point. The goal orientation model suggests that what is important to the patient may also be above and beyond the function domain. In other words, what's important to the patient may not be entirely functionally oriented; it may include other domains, such as adequate pain management for the wound and dressing changes, lifestyle, and psychosocial needs.


To more discretely focus on wound care needs from the patient perspective, Augustin et al3 embarked on the development of a novel patient-centered index titled, Patient Benefit Index-Wound (PBI-W). The authors provided an elegant characterization of the problem encountered in POR: "There is little agreement on the definition of 'therapeutic benefit' in either the literature or jurisprudence. A consensus is, however, that patient-relevant benefit should be self-assessed by the patients."3 To this end, the authors developed a combined tool that incorporated 2 content-validated, patient-centered questionnaires. These included the Patient Needs Questionnaire (pretreatment) and the Patient Benefit Questionnaire (posttreatment). Consequently, they combined the two to develop a weighted PBI-W. They validated the PBI-W through a prospective study that included 172 patients with acute or chronic wounds treated by vacuum-assisted therapy. Validation criteria were change in generic and disease-specific quality of life (QOL)3 as measured by judgment of efficacy by patients and physicians, treatment satisfaction, and patients' willingness to recommend the therapy to others. The criteria for construct validation of the PBI-W included change in generic health-related QOL within the study period, change in disease-specific QOL, patient-reported efficacy of treatment, physician-reported efficacy of treatment, patient-reported treatment satisfaction, and patient-reported willingness to recommend the treatment to others.3


Codesign is an emerging model, borrowed from the service industry. Robert et al4 posit, "Patients can and should take a more direct and ongoing role in identifying, implementing, and evaluating improvements to healthcare services." The authors give examples of patients and staff working as partners to improve services using a unique approach termed "experience-based codesign,"4 an intense 6-stage process that usually takes about a year to complete. The stages include project setup; gathering staff caregiver experiences through 12 to 15 filmed narrative-based interviews; bringing staff, patients, and caregivers together to share their experiences of a service and identify their shared priorities for improvement, prompted by an edited 30-minute "trigger" film of patient narratives; small groups of patients and staff work on the identified priorities; and a celebration and review event. The author documented success using this model in patients with epidermolysis bullosa to codevelop a prototype wound care compression garment.5,6




1. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001. [Context Link]


2. Reuben DB, Tinetti ME. Goal-oriented patient care-an alternative health outcomes paradigm. N Engl J Med 2012; 366: 777-9. [Context Link]


3. Augustin M, Blome C, Zschocke I, et al. Benefit evaluation in the therapy of chronic wounds from the patients' perspective-development and validation of a new method. Wound Repair Regen 2012; 20 (1): 8-14. [Context Link]


4. Robert G, Cornwell J, Locock L, Purushotham A, Sturmey G, Gager M. Patients and staff as codesigners of healthcare services. BMJ 2015; 350: g7714. [Context Link]


5. Grocott P, Blackwell R, Currie C, Pillay E, Robert G. Co-producing novel wound care products for epidermolysis bullosa; an empirical case study of the use of surrogates in the design and prototype development process. Int Wound J 2012; 10: 265-73. [Context Link]


6. Grocott P, Graham T, Blackwell R, et al. Individualising research: the Woundcare for Epidermolysis Bullosa Project. Wounds UK 2013; 9 (3): 23-32. [Context Link]