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Background: Co-production is a collaborative approach to prepare, plan, conduct, and apply research with those who will use or be impacted by research (knowledge users). Our team of knowledge users and researchers sought to conduct and evaluate co-production of a systematic review on decision coaching. Methods: We conducted a mixed-methods case study within a review to describe team co-production of a systematic review. We used the Collaborative Research Framework to support an integrated knowledge translation approach to guide a team through the steps in co-production of a systematic review. The team agreed to conduct self-study as a study within a review to learn from belonging to a co-production research team. A core group that includes a patient partner developed and conducted the study within a review. Data sources were surveys and documents. The study coordinator administered surveys to determine participant preferred and actual levels of engagement, experiences, and perceptions. We included frequency counts, content, and document analysis. Results: We describe co-production of a systematic review. Of 17 team members, 14 (82%) agreed to study participation and of those 12 (86%) provided data pre- and post-systematic review. Most participants identified as women (n = 9, 75.0%), researchers (n = 7, 58%), trainees (n = 4, 33%), and/or clinicians (n = 2, 17%) with two patient/caregiver partners (17%). The team self-organized study governance with an executive and Steering Committee and agreed on research co-production actions and strategies. Satisfaction for engagement in the 11 systematic review steps ranged from 75 to 92%, with one participant who did not respond to any of the questions (8%) for all. Participants reported positive experiences with team communication processes (n = 12, 100%), collaboration (n = 12, 100%), and negotiation (n = 10–12, 83–100%). Participants perceived the systematic review as co-produced (n = 12, 100%) with collaborative (n = 8, 67%) and engagement activities to characterize co-production (n = 8, 67%). Participants indicated that they would not change the co-production approach (n = 8, 66%). Five participants (42%) reported team logistics challenges and four (33%) were unaware of challenges. Conclusions: Our results indicate that it is feasible to use an integrated knowledge translation approach to conduct a systematic review. We demonstrate the importance of a relational approach to research co-production, and that it is essential to plan and actively support team engagement in the research lifecycle. [ABSTRACT FROM AUTHOR]

Background: Many colorectal cancer (CRC) survivors experience ongoing sequelae from their cancer treatment. Limited evidence exists regarding how CRC survivors and general practitioners (GPs) manage these sequelae in the community. This study aimed to explore the experiences and perspectives of CRC survivors and GPs on current approaches to monitoring and managing sequelae of CRC treatment. Methods: We conducted a mixed-methods study using cross-sectional national surveys and qualitative interviews with CRC survivors and GPs to explore: (1) treatment sequelae experienced by CRC survivors, (2) how these were monitored and managed by general practitioners, and (3) suggestions to improve ongoing management of the treatment sequelae. Survey responses were reported descriptively. Qualitative data were thematically analysed using an interpretive descriptive approach. Results: Seventy participants completed surveys: 51 CRC survivors and 19 GPs, and four interviews were conducted with GPs. CRC survivors experienced a range of treatment sequelae, but often did not discuss these with their GPs (experienced vs discussed: 86% vs 47% for fatigue/lack of energy, 78% vs 27% for psychological/emotional concern, 63% vs 22% for impaired sleep, 69% vs 29% for weight loss/gain, 59% vs 16% for sexual and intimacy concerns). GPs reported inadequate information transfer from cancer services and workload as major barriers to optimal care. Conclusions: System-level changes that facilitate adequate information transfer from cancer services to GPs upon CRC treatment completion, as well as addressing time constraint issues essential for comprehensive monitoring and management of CRC treatment sequelae, could enhance the care of CRC survivors in the community setting. Many colorectal cancer survivors face various post-treatment challenges that impact their daily lives. How these are treated within the primary care setting remains poorly understood. This study found that colorectal cancer survivors commonly experienced various challenges after cancer treatment, such as fatigue, changed bowel habits and psychological difficulties, but often did not discuss them with their general practitioners. Potential ways to better identify and address these common post-treatment challenges for colorectal cancer survivors are needed. [ABSTRACT FROM AUTHOR]

PURPOSE: Electronic patient-reported outcomes (ePROs) are an evidence-based means of detecting symptoms earlier and improving patient outcomes. However, there are few examples of successful implementation in routine cancer care. We conducted a qualitative study to identify barriers and facilitators to implementing ePRO symptom monitoring in routine cancer care using the Consolidated Framework for Implementation Research (CFIR). METHODS: Participants were adult patients with cancer, their caregivers, or health care professionals involved in ePRO monitoring or processes. Focus groups or individual interviews were conducted using a semistructured approach informed by the CFIR. Data were analyzed deductively using the CFIR. Barriers were matched to theory-informed implementation strategies using the CFIR-Expert Recommendations for Implementing Change (ERIC) matching tool. RESULTS: Thirty participants were interviewed: 22 females (73%), aged 31-70 years (28, 94%), comprising patients (n = 8), caregivers (n = 2), medical oncologists (n = 4), nurses (n = 4), hospital leaders (n = 6), clinic administrators (n = 2), pharmacists (n = 2), and information technology specialists (n = 2). Barriers pertaining to four CFIR domains were identified and several were novel, including the challenge of adapting ePROs for different anticancer treatments. Facilitators pertaining to all CFIR domains were identified, such as leveraging acceptability of remote care post–COVID-19 to drive implementation. Conducting consensus discussions with stakeholders to tailor ePROs to the local setting, identifying/preparing individual and group-level champions, and assessing readiness for change (including leveraging technological advances and increased confidence in using remote monitoring post–COVID-19) were the most frequently recommended implementation strategies. CONCLUSION: The CFIR facilitated identification of known and novel barriers and facilitators to implementing ePRO symptom monitoring in routine cancer care. Implementation strategies summarized in a conceptual framework will be used to codesign an ePRO symptom monitoring system for immunotherapy side effects. [ABSTRACT FROM AUTHOR]

Background: Advances in screening and treatments for colorectal cancer (CRC) have improved survival rates, leading to a large population of CRC survivors. Treatment for CRC can cause long-term side-effects and functioning impairments. General practitioners (GPs) have a role in meeting survivorship care needs of this group of survivors. We explored CRC survivors' experiences of managing the consequences of treatment in the community and their perspective on the GP's role in post-treatment care. Methods: This was a qualitative study using an interpretive descriptive approach. Adult participants no longer actively receiving treatment for CRC were asked about: side-effects post-treatment; experiences of GP-coordinated care; perceived care gaps; and perceived GP role in post-treatment care. Thematic analysis was used for data analysis. Results: A total of 19 interviews were conducted. Participants experienced side-effects that significantly impacted their lives; many they felt ill-prepared for. Disappointment and frustration was expressed with the healthcare system when expectations about preparation for post-treatment effects were not met. The GP was considered vital in survivorship care. Participants' unmet needs led to self-management, self-directed information seeking and sourcing referral options, leaving them feeling like their own care coordinator. Disparities in post-treatment care between metropolitan and rural participants were observed. Conclusion: There is a need for improved discharge preparation and information for GPs, and earlier recognition of concerns following CRC treatment to ensure timely management and access to services in the community, supported by system-level initiatives and appropriate interventions. Colorectal cancer survivors can experience ongoing side-effects and functioning impairments long after completing treatment. This study explored how colorectal cancer survivors manage their consequences of treatment in the community. Colorectal cancer survivors were interviewed about the side-effects they experienced after treatment; their experiences of general practitioner-coordinated care; perceived care gaps; and their perception of the general practitioner role in post-treatment survivorship care. [ABSTRACT FROM AUTHOR]

Introduction: Radiation therapy (RT) can benefit approximately 50% of cancer patients and contribute to 40% of all cancer cures, yet its utilisation in cancer is low globally. Several factors contribute to this including perceived inconvenience related to accessing and utilising RT. To quantitatively assess the latter, a new tool – the Radiation therapy‐related Inconvenience Questionnaire (RIQ) – was developed. This study aimed to pre‐test the RIQ and explore barriers and facilitators to implementing it in routine clinical practice and clinical trials. Methods: Semi‐structured cognitive interviews were conducted with patients undertaking RT, recruited via three hospitals to examine content validity, acceptability, and comprehensibility of the RIQ. Interviews identified inconsistencies, relevance, and clarity of items. Semi‐structured interviews with healthcare professionals involved in the delivery of care to individuals undertaking RT explored barriers and facilitators to routine usage. Thematic analysis was used to identify themes. Results: Patients (N = 15) identified problems in content, instructions, layout, length, and response options; consequently, 25 items were revised and eight removed, resulting in a final 29‐item questionnaire. Clinicians identified staff‐ and patient‐specific barriers to implementing RIQ in clinical practice. Perceived facilitators included the following: (a) workplace factors, (b) mode of administration, and (c) imparting knowledge. Conclusion: This study demonstrated acceptability and comprehensibility of the 29‐item RIQ amongst cancer patients undertaking RT and treating clinicians. The next phase will evaluate the RIQ's measurement properties in a larger clinical study. The barriers and facilitators identified can guide future implementation of RIQ in clinical practice and clinical trials. [ABSTRACT FROM AUTHOR]

Aims: Patients with chronic health conditions not responding to conventional treatment can access medicinal cannabis (MC) prescriptions from clinicians in Australia. We aimed to assess overall health-related quality of life (HRQL), pain, fatigue, sleep, anxiety, and depression in a large real-world sample of patients accessing prescribed medicinal cannabis. We hypothesized that all patient-reported outcomes (PROs) would improve from baseline to 3-months. Methods: The QUEST Initiative is a large prospective multicenter study of patients with any chronic health condition newly prescribed medicinal cannabis between November 2020 and December 2021. Eligible patients were identified by 120 clinicians at medical centers across six Australian states. Consenting participants completed the EuroQol Group EQ-5D-5L health status questionnaire; European Organization for Research & Treatment of Cancer Quality of Life questionnaire (QLQ-C30); Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms in Fatigue and Sleep Disturbance, and the Depression Anxiety Stress Scale (DASS-21) before starting therapy, at 2-weeks titration, then monthly for 3-months. Results: Of the 2762 consenting participants, 2327 completed baseline and at least one follow-up questionnaire. Ages ranged between 18–97 years (mean 51y; SD = 15.4), 62.8% were female. The most commonly treated conditions were chronic pain (n = 1598/2327; 68.7%), insomnia (n = 534/2327; 22.9%), generalized anxiety (n = 508/2327; 21.5%), and mixed anxiety and depression (n = 259/2327; 11%). Across the whole cohort both EQ-5D-5L utility scores and QLQ-C30 summary scores showed clinically meaningful improvement in HRQL from baseline to mean follow-up with d = 0.54 (95%CI:0.47 to 0.59) and d = 0.64 (95%CI:0.58 to 0.70) respectively; and clinically meaningful improvement in fatigue (d = 0.54; 95%CI:0.48 to 0.59). There was clinically meaningful reduction of pain for those with chronic pain (d = 0.65; 95%CI:0.57 to 0.72); significant improvements for those with moderate to extremely severe anxiety (X2 = 383; df = 4; p<0.001) and depression (X2 = 395; df = 4; p<0.001); and no changes in sleep disturbance. Conclusions: We observed statistically significant, clinically meaningful improvements in overall HRQL and fatigue over the first 3-months in patients with chronic health conditions accessing prescribed medical cannabis. Anxiety, depression, and pain also improved over time, particularly for those with corresponding health conditions. The study continues to follow-up patients until 12-months to determine whether improvements in PROs are maintained long-term. Trail registration: Study registration - Australian New Zealand Clinical Trials Registry: ACTRN12621000063819. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000063819. [ABSTRACT FROM AUTHOR]

Management of low-risk ductal carcinoma in situ (DCIS) is controversial, with clinical trials currently assessing the safety of active monitoring amidst concern about overtreatment. Little is known about general community views regarding DCIS and its management. We aimed to explore women's understanding and views about low-risk DCIS and current and potential future management options. This mixed-method study involved qualitative focus groups and brief quantitative questionnaires. Participants were screening-aged (50–74 years) women, with diverse socioeconomic backgrounds and no personal history of breast cancer/DCIS, recruited from across metropolitan Sydney, Australia. Sessions incorporated an informative presentation interspersed with group discussions which were audio-recorded, transcribed and analysed thematically. Fifty-six women took part in six age-stratified focus groups. Prior awareness of DCIS was limited, however women developed reasonable understanding of DCIS and the relevant issues. Overall, women expressed substantial support for active monitoring being offered as a management approach for low-risk DCIS, and many were interested in participating in a hypothetical clinical trial. Although some women expressed concern that current management may sometimes represent overtreatment, there were mixed views about personally accepting monitoring. Women noted a number of important questions and considerations that would factor into their decision making. Our findings about women's perceptions of active monitoring for DCIS are timely while results of ongoing clinical trials of monitoring are awaited, and may inform clinicians and investigators designing future, similar trials. Exploration of offering well-informed patients the choice of non-surgical management of low-risk DCIS, even outside a clinical trial setting, may be warranted. [ABSTRACT FROM AUTHOR]

Aims: Many large-scale population-based surveys, research studies, and clinical care allow for inclusion of proxy reporting as a strategy to collect outcomes when patients are unavailable or unable to provide reliable self-report. Prior work identified an absence of methodological guidelines regarding proxy reporting in adult populations, including who can serve as a proxy, and considerations for data collection, analysis, and reporting. The primary objective of this work by the ISOQOL Proxy Task Force was to review documents and clinical outcome assessment measures with respect to proxy reporting and to develop, through consensus, considerations for proxy reporting. Methods: We assembled an international group with clinically relevant and/or methodological expertise on proxy use in adult populations. We conducted a targeted review of documentation based on regulatory, non-regulatory, professional society, and individual measure sources. Using a standardized collection form, proxy-related information was extracted from each source including definitions of a proxy, characteristics of a proxy, domains addressable or addressed by a proxy, and observer-reporting. Results: The definition of proxy was inconsistent across 39 sources, except regulatory documents which defined a proxy as a person other than the patient who reports on an outcome as if she/he were the patient. While proxy report was discouraged in regulatory documentation, it was acknowledged there were instances where self-report was impossible. Many documentation sources indicated proxies would be well-justified in certain contexts, but did not indicate who could act as a proxy, when proxies could be used, what domains of patient health they could report on, or how data should be reported. Observer-reported outcomes were typically defined as those based on observed behaviors, however there was not a consistent differentiation between proxy and observer reporting. Based on information extracted from these resources, we developed a checklist of considerations when including proxy-reported measures or using proxies in study design, data collection, analysis, interpretation and reporting of proxy reported data. Conclusion: Our targeted review highlights a lack of clarity in capturing, interpreting and reporting data from proxies in adult populations. We provide a checklist of considerations to assist researchers and clinicians with including proxies in research studies and clinical care. Lastly, our review identified areas where further guidance and future research are necessary. [ABSTRACT FROM AUTHOR]

PURPOSE: Increasing use of immune checkpoint inhibitors (ICIs) in routine cancer care will increase the incidence of immune-related adverse events (irAEs). Systems are needed to support remote monitoring for irAEs. Electronic patient-reported outcome (ePRO) symptom monitoring systems can help monitor and manage symptoms and side effects. We assessed the content and features of ePRO symptom monitoring systems for irAEs, and their feasibility, acceptability, and impact on patient outcomes and health care utilization. METHODS: A systematic literature search was conducted in May 2022 on MEDLINE, Embase, PsycINFO, and Cochrane Central Register of Controlled Trials. Quantitative and qualitative data relevant to the review questions were extracted and synthesized in tables. RESULTS: Seven papers describing five ePRO systems were included. All systems collected PROs between clinic visits. Two of five used validated symptom questionnaires, 3/5 provided prompts to complete questionnaires, 4/5 provided reminders to self-report, and 3/5 provided clinician alerts for severe/worsening side effects. Four of five provided coverage of ≥26/30 irAEs in the ASCO irAE guideline. Feasibility and acceptability were demonstrated with consent rates of 54%-100%, 17%-27% of questionnaires generating alerts, and adherence rates of 74%-75%. One paper showed a reduction in grade 3-4 irAEs, treatment discontinuation, clinic visit duration, and emergency department presentations, while another showed no difference in these outcomes or the rate of steroid use. CONCLUSION: There is preliminary evidence of the feasibility and acceptability of ePRO symptom monitoring for irAEs. However, further studies are needed to confirm the impact on ICI-specific outcomes, such as the frequency of grade 3-4 irAEs and duration of immunosuppression. Suggestions for the content and features of future ePRO systems for irAEs are provided. [ABSTRACT FROM AUTHOR]

Background: Body image is a subjective concept encompassing a person's views and emotions about their body. Head and neck cancer (HNC) diagnosis and treatment affects several psychosocial concepts including body image. Large numbers of HNC patients are diagnosed each year in India but there are no suitable measures in regional languages to assess their body image. This study assessed the psychometric properties of the Body Image Scale (BIS), a measure suitable for clinical and research use in HNC populations, translated into Tamil, Telugu and Hindi and compared body image distress between language groups. Methods: Translated versions of BIS were completed by HNC patients recruited from three cancer centers across India one time only. Psychometric evaluation was conducted including factor analysis using principal component analysis and internal consistency reliability using Cronbach's alpha. Patients completed the EORTC Quality of Life Questionnaire (QLQ) C-30 and EORTC QLQ HN-35 measures to enable exploration of convergent and discriminant validity. ANOVA was used to calculate difference in mean values for body image. Results: Our sample included 621 HNC patients (Tamil = 205, Telugu = 216, Hindi = 200). Factor analysis revealed a one-factor solution and Cronbach's alpha coefficients ranged between 0.891 and 0.969 indicating good reliability. Hypothesized correlations between similar and different constructs were as expected, supporting construct validity. On the BIS, we found a statistically significant difference (F = 11.0954, P < 0.05) between means of Tamil, Telugu, and Hindi groups, with higher body image scores in Telugu (M = 12.86; SD = 7.65) and Hindi groups (M = 12.52; SD = 7.36) indicating more symptoms/body image distress, when compared to Tamil population (M = 9.28; SD = 10.04). Conclusion: The reliability and validity of the three translated Indian versions of the BIS were maintained, providing a method for assessing body image of HNC population worldwide speaking Tamil, Telugu, and Hindi across the illness trajectory. [ABSTRACT FROM AUTHOR]

Ductal carcinoma in situ (DCIS) is a highly prevalent pre-cancerous condition. Multiple factors affect patient outcomes, and over-treatment of DCIS is an international concern. This study aimed to examine information provision and sufficiency of existing resources to meet the needs of women with DCIS. Healthcare professionals (HCPs) on the Breast Cancer Network Australia (BCNA) national database were surveyed. Quantitative data was analysed with descriptive statistics and Chi-squared tests. In total, 132 HCPs participated. Most (55%) indicated that breast care nurses were primarily responsible for providing DCIS-related information. Cancer Australia's DCIS booklet (61.5%) was most commonly used. Most respondents were aware of the My journey kit but only half gave it to their patients. Of those that used it, 36.4% described it as suboptimal, but the best currently available. A new DCIS-specific resource is needed to ensure provision of relevant information to facilitate shared treatment decision-making. [ABSTRACT FROM AUTHOR]

Venous leg ulcers (VLUs) are a common chronic often undertreated condition, which affects individual's health‐related quality of life (HRQoL). Numerous patient‐reported outcome measures (PROMs) have been validated to capture HRQoL in patients with VLUs. However, available instruments contain many items, are hard to use in clinical practice, and present with weak responsiveness. This study aims to determine clinical utility of an existing VLU‐QoL instrument and to develop a comprehensive PROs assessment framework to guide clinical practice treatment in people with VLUs in Australia. Semi‐structured qualitative interviews were conducted with VLU patients (N = 13) and their managing clinicians (N = 6) in Victoria, Australia. Interview topics covered content and face validity, appropriateness, and acceptability of the VLU‐QoL instrument to determine suitable and appropriate for use in clinical practice. Clinicians and patients agreed that a VLU‐QoL instrument was needed in clinical practice. Both clinicians and patients agreed it would be appropriate to answer PROMs questions prior to consultation with clinicians every 3–6 months. However, patients considered that some of the questions are ambiguous and too technical. Patients reported that it would be useful to include additional items relating to daily wound care, compression bandaging, and dressings. Clinicians reported that the VLU‐QoL instrument was too long and required restructuring to facilitate utility in practice. A conceptual framework for HRQoL in VLUs included traditional HRQoL components and VLU‐specific issues. Overall, the VLU‐QoL was well accepted, although changes to make it more concise, comprehensive, and to clearly reflect consumers' perspectives were lacking. The proposed conceptual framework will inform the development of a new PROM for use by clinicians and patients in clinical settings. [ABSTRACT FROM AUTHOR]

Background: A cancer diagnosis is potentially life-threatening, likely causing distress and uncertainty, which may be psychologically debilitating. Depression and anxiety are commonly underdiagnosed and undertreated in cancer patients. Head and neck cancer (HNC) patients face particular challenges that may contribute to distress. This review aims to: i) identify patient reported outcome measures (PROMs) designed to assess anxiety and depression in HNC; and ii) determine their suitability for use in research and clinical practice to screen patients. Methods: We searched five electronic databases between July 2007 to July 2019 for studies assessing anxiety and depression in HNC patients. Searches were limited to this period to account for advances in cancer treatment. Records were screened for eligibility by one reviewer and 10% cross-checked by a second across all stages of the review. In addition to the electronic searches, PROM databases were searched for additional measures of anxiety and depression. All retrieved PROMs were mapped against Diagnostic and Statistical Manual-5 criteria for anxiety and depression to assess content coverage. Then, their psychometric properties appraised against the COSMIN checklist. Results: Electronic searches identified 98 records, from which five anxiety and eight depression measures were retrieved. PROM database searches retrieved an additional four anxiety and four depression measures; a total of nine anxiety and 12 depression measures were appraised. Content coverage of anxiety measures ranged from 50% to 75% and depression measures from 42% to 100%. Demonstration of psychometric properties against COSMIN criteria ranged from 57% to 71% for anxiety measures (three PROMs > 70%) and from 29% to 86% for depression measures (nine PROMs > 70%). Three anxiety and seven depression measures had established clinical cut-offs in cancer populations. Conclusions: The Patient Health Questionnaire-9, Zung Self-rating Depression and Zung Self-rating Anxiety Scales demonstrated good content coverage along with excellent psychometric properties, and thus were considered the most suitable PROMs to assess psychological distress in HNC populations. It is important to have PROMs assessing psychological distress that capture a comprehensive set of subjective symptoms. The identified PROMs will help researchers and health professionals in clinical-decision making, thereby potentially improving quality of life in HNC patients. [ABSTRACT FROM AUTHOR]

Objective: Morbidity from head and neck cancers (HNCs) and their treatment are significant, given their proximity to anatomical sites impacting facial appearance and function. Assessing the needs of HNC patients throughout their cancer journey is critical to informing quality care and improving quality of life. We aimed to identify available unmet needs measures in the HNC setting and appraise their content and psychometric properties.Methods: We conducted a systematic search of five electronic databases (July 2007-July 2019) to identify studies of unmet needs in patients with HNC. In addition, three web-based patient-reported outcome measures (PROMs) databases were searched for unmet needs measures. Citations were screened for eligibility and identified measures reviewed for content coverage and psychometric properties. From identified measures and literature, a conceptual framework with 12 clinically relevant aspects of unmet needs was developed and used to assess the conceptual coverage of available unmet needs measures.Results: Literature search identified 273 records of which 28 studies assessing unmet needs in HNC cancer met eligibility criteria. Seven unmet needs measures were identified from retrieved studies and seven additional measures from PROM databases. Thus, 14 measures in total were reviewed. Content mapping revealed that three measures demonstrated excellent content validity (greater than 80% conceptual coverage): Patient Concerns Inventory (PCI), Needs Assessment for Advanced Cancer Patients (NA-ACP), and James Supportive Care Screening (JSCS).Conclusion: We recommend PCI be used to measure unmet needs in the HNC setting considering the importance of content validity over quantitative psychometric properties. [ABSTRACT FROM AUTHOR]

Flare in knee and hip osteoarthritis (OA) is more than just an exacerbation of pain. Unstructured, semistructured, and focus group interviews followed by Delphi surveys with patients and health professionals (HP) generated candidate domains of an OA flare. Content analysis of interviews with 29 patients and 16 HP extracted 180 statements, which were grouped into 9 clusters. Delphi consensus with 50 patients (Australia, Canada, and France) and 116 HP (17 countries on 4 continents) identified 5 flare domains: pain, swelling, stiffness, psychological aspects, and effect of symptoms. Elements for a preliminary definition of an OA flare are proposed. Registered at clinicaltrials.gov NCT02892058. [ABSTRACT FROM AUTHOR]

Patient‐reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision‐making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient‐reported outcome measures, we compared a generic and disease‐specific measures' ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument—prevention version (PU‐QOL‐P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30‐day posttreatment. Known‐group validity and responsiveness‐to‐change analyses were conducted. The analysis sample consisted of 617 patients that completed both measures at baseline. Known‐group validity revealed that some PU‐QOL‐P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU‐QOL‐P is more sensitive to differences between PU and non‐PU populations. Responsiveness analysis revealed that the PU‐QOL‐P was more responsive in detecting disease severity than the SF12. The PU‐QOL‐P provides a standardized method for assessing PU‐specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required. [ABSTRACT FROM AUTHOR]