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Introduction: Colorectal cancer (CRC) is prevalent in the developed world, with unhealthy lifestyles and diet contributing to rising incidence. Advances in effective screening, diagnosis, and treatments have led to improved survival rates, but CRC survivors suffer poorer long-term gastrointestinal consequences than the general population. However, the current state of clinical practice around provision of health services and treatment options remains unclear. Purpose: We aimed to identify what supportive care interventions are available to manage gastrointestinal (GI) symptoms for CRC survivors. Methods: We searched Cochrane Central Register of Controlled Trials, Embase, MEDLINE, PsycINFO, and CINAHL from 2000 to April 2022 for resources, services, programs, or interventions to address GI symptoms and functional outcomes in CRC. We extracted information about characteristics of supportive care interventions, the study design, and sample characteristics from included studies, and performed a narrative synthesis Results: Of 3807 papers retrieved, seven met the eligibility criteria. Types of interventions for managing or improving GI symptoms included two rehabilitation, one exercise, one educational, one dietary, and one pharmacological. Pelvic floor muscle exercise may help to resolve GI symptoms more quickly in the post-operative recovery phase. Survivors may also benefit from rehabilitation programs through improved self-management strategies, especially administered soon after completing primary treatment. Conclusions/Implications for cancer survivors: Despite a high prevalence and burden of GI symptoms post-treatment, there is limited evidence for supportive care interventions to help manage or alleviate these symptoms. More, large-scale randomized controlled trials are needed to identify effective interventions for managing GI symptoms that occur post-treatment. [ABSTRACT FROM AUTHOR]

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: While there is increasing evidence on the benefits of PROMs in cancer care, the extent of routine collection and use of PROMs in clinical cancer practice across Australia and New Zealand (ANZ) is unknown. This study examined the prevalence and characteristics of PROMs use in routine clinical cancer care in ANZ. Methods: An online survey was designed and disseminated via professional societies and organisations using a snowball sampling approach to clinical and health administration professionals managing cancer care in ANZ. A poster advertising the study was also circulated on professional social media networks via LinkedIn and Twitter inviting health professionals from ANZ to participate if they were using or intending to use PROMs in clinical cancer practice. Responders opted into the survey via the survey link. Results: From 132 survey views, 91(response rate, 69%) respondents from 56 clinical practices across ANZ agreed to participate in the survey, and of these 55 (n = 55/91, 60%) respondents reported collecting PROMs within their clinical practice. The majority of the respondents were from the State of New South Wales in Australia (n = 21/55, 38%), hospital (n = 35/55, 64%), and a public setting (n = 46/55, 83%). PROMs were collected in all cancer types (n = 21/36, 58%), in all stages of the disease (n = 31/36, 86%), in an adult population (n = 33/36, 92%), applied in English (n = 33/36, 92%), and used to facilitate communication with other reasons (27/36, 75%). A geospatial map analysis provided insights into the variation in PROMs uptake between the two countries and in certain jurisdictions within Australia. This study also highlights the limited resources for PROMs implementation, and a lack of systematic priority driven approach. Conclusion: PROM use across Australia and New Zealand seems variable and occurring predominantly in larger metropolitan centres with limited standardisation of approach and implementation. A greater focus on equitable adoption of PROMs in diverse cancer care settings is urgently needed. [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]

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]

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]

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]

Purpose: Colorectal cancer (CRC) survivors experience treatment-effects such as symptoms and functional impairments. There is limited evidence about how these are managed and what services or supports are available in the community. We aimed to identify current practice and available supports for managing consequences of treatment from clinician and CRC survivor perspectives. Methods: This qualitative study, informed by an interpretivist constructionist paradigm, included semi-structured interviews. Clinicians with experience of treating CRC patients and adult CRC survivors were recruited across Australia. Interviews explored experiences about problems experienced after CRC treatment and how these were managed. Data collection and analysis, using thematic analysis, was iterative whereby emergent themes during analysis were incorporated into subsequent interviews. Results: We interviewed 16 clinicians and 18 survivors. Survivors experienced a range of consequences of treatment amendable to support including allied health, information, and self-management. Barriers to support access included clinicians’ worry about patient out-of-pocket expenses, long waitlists, lack of awareness about existing supports, and perception no therapeutic options were available. Healthcare professionals with expertise in CRC were often difficult to identify outside of cancer settings. Survivorship care could be improved with individualised timely information and identification of pathways to access healthcare providers with expertise in managing consequences of CRC treatment within primary care. Conclusions: To improve CRC survivor lives posttreatment, routine assessment of consequences of treatment, individualised care planning involving relevant healthcare professionals, access to supportive care when needed, and improved information provision and engagement of a range of health professionals in follow-up care are needed. [ABSTRACT FROM AUTHOR]

Background: Patient-reported experience measures (PREMs) assess quality-of-care from patients' perspectives. PREMs can be used to enhance patient-centered care and facilitate patient engagement in care. With increasing quality improvement studies in clinical practice, the use of PREMs has surged. As a result, knowledge about stakeholder experiences of using PREMs to assess quality of care across diverse clinical settings is needed to inform PREM implementation efforts. To address this, this review examines the qualitative literature on patient and healthcare provider experiences of using PREMs in clinical practice. Methods: Medline, Embase and PsycInfo were systematically searched from inception to May 2021. Additional searching of reference lists for all included articles and relevant review articles were performed. Retrieved articles were screened for eligibility by one reviewer and 25% cross-checked by a second reviewer across all stages of the review. Full texts meeting eligibility criteria were appraised against the COREQ checklist for quality assessment and thematic analysis was used to analyze textual data extracted from the results. Results: Electronic searches identified 2683 records, of which 20 studies met eligibility criteria. Extracted data were synthesized into six themes: facilitators to PREM implementation; barriers to PREM implementation; healthcare providers' perspectives towards using PREMs; patients' perspectives towards using PREMs; advantages of using PREMs in clinical practice; limitations and practical considerations to reduce resistance of PREM usage. The primary factors facilitating and impeding the use of PREMs include organizational-, staff- and patient-related factors. Conclusion: Results can be used to guide the usage and implementation of PREMs in clinical settings by addressing the identified barriers and building on the perceived benefits to encourage adoption of PREMs. Results around facilitators to PREM implementation and practical considerations could also promote appropriate use of PREMs by healthcare providers, helping to improve practice and the quality of care based on patient feedback. [ABSTRACT FROM AUTHOR]

Purpose: Chemotherapy-induced peripheral neuropathy (CIPN) is a common toxicity of cancer treatment, with potential to significantly impact cancer survivors' long-term quality of life. Patient reported outcome measures (PROMs) are increasingly utilised to evaluate CIPN. However, guidance remains lacking on how to identify fit for purpose PROMs with considerations necessarily differing when used in various research and in-clinic contexts. This study aimed to evaluate evidence about CIPN PROMs measurement properties and propose considerations to optimize CIPN PROM selection for each purpose. Methods: A systematic review was conducted to identify literature assessing measurement properties of CIPN PROMs. These were evaluated against Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) criteria and International Society for Quality of Life minimum standards. Risk of Bias (RoB) was assessed using the COSMIN RoB checklist. Results: Thirty-nine papers evaluating measurement properties of 13 PROMs were included. The European Organization for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy Questionnaire (QLQ-CIPN20) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) were the most commonly investigated PROMs and had the most measurement properties meeting established criteria. Conclusion: The use of the QLQ-CIPN20 and FACT/GOG-Ntx to assess CIPN in research settings has the most supporting evidence. However other considerations including study aims, endpoints and target population also factor into PROM selection and need to be considered more often when determining the most suitable outcome measure. Evidence of CIPN PROMs use in clinical practice is limited and their adoption to individual-patient level management requires more evaluation. [ABSTRACT FROM AUTHOR]

Introduction: Failure to incorporate key patient-reported outcome (PRO) content in trial protocols affects the quality and interpretability of the collected data, contributing to research waste. Our group developed evidence-based training specifically addressing PRO components of protocols. We aimed to assess whether 2-day educational workshops improved the PRO completeness of protocols against consensus-based minimum standards provided in the SPIRIT-PRO Extension in 2018. Method: Annual workshops were conducted 2011–2017. Participants were investigators/trialists from cancer clinical trials groups. Although developed before 2018, workshops covered 15/16 SPIRIT-PRO items. Participant feedback immediately post-workshop and, retrospectively, in November 2017 was summarised descriptively. Protocols were evaluated against SPIRIT-PRO by two independent raters for workshop protocols (developed post-workshop by participants) and control protocols (contemporaneous non-workshop protocols). SPIRIT-PRO items were assessed for completeness (0 = not addressed, 10 = fully addressed). Mann–Whitney U tests assessed whether workshop protocols scored higher than controls by item and overall. Results: Participants (n = 107) evaluated the workshop positively. In 2017, 16/41 survey responders (39%) reported never applying in practice; barriers included role restrictions (14/41, 34%) and lack of time (5/41, 12%). SPIRIT-PRO overall scores did not differ between workshop (n = 13, median = 3.81/10, interquartile range = 3.24) and control protocols (n = 9, 3.51/10 (2.14)), (p = 0.35). Workshop protocols scored higher than controls on two items: 'specify PRO concepts/domains' (p = 0.05); 'methods for handling missing data' (p = 0.044). Conclusion: Although participants were highly satisfied with these workshops, the completeness of PRO protocol content generally did not improve. Additional knowledge translation efforts are needed to assist protocol writers address SPIRIT-PRO guidance and avoid research waste that may eventuate from sub-optimal PRO protocol content. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcome measures (PROMs) are increasingly used in clinical settings to inform individual patient care. In-depth understanding of end-users' experiences may help identify factors that promote or hinder their use in clinical decision-making. We aimed to examine stakeholder perceptions of the utility of using PROMs in clinical practice based on real-life experience. Methods: Systematic review searching Medline, Embase and PsychINFO from inception to May 2021. Qualitative studies examining patients' and/or clinicians' experiences of using PROMs in clinical settings were included. Study screening and data extraction were performed by two independent reviewers. Qualitative data from included studies was analysed thematically. Results: Of 2388 abstracts retrieved, 52 articles reporting 50 studies met eligibility. Five key benefits were identified: (1) promotes active patient involvement (enables goal setting and discussion of sensitive topics); (2) enhances the focus of consultations (prioritizes patient needs); (3) improves quality of care (enables tailored, holistic care and prompts action); (4) enables standardized monitoring of patient outcomes; and (5) enhances the patient–clinician relationship (provides reassurance). Perceived limitations included the capacity of PROMs to shift the focus of consultations; inaccurately estimate problems; raise unrealistic expectations for care; inhibit patient–clinician interaction; lack clinically meaningful information; and not be suitable for all patients. Conclusion: Both patients and clinicians reported benefits of using PROMs across diverse health conditions and clinical settings, but also highlighted several limitations. These limitations shed some light on why PROM use may not always improve patient outcomes and provide considerations for the design and implementation of future PROM initiatives. [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]

Aims: Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. Methods: We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. Results: The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. Discussion: Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. Systematic review registration: PROSPERO No. CRD42018103179 [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]

Background: Head and neck cancers (HNC) and their treatments cause dysfunction and distress. Ongoing psychological assessment using disease-specific patient-reported measures may optimize clinical decision-making, facilitate interventions to reduce psychosocial burden. As most such measures are developed in English, non-English speaking patients are disadvantaged. This study translated HNC-specific measures (Body Image Scale, Patient Concerns Inventory, Zung's Self-Rating Anxiety and Depression Scales and Patient Health Questionnaire-9) into three Indian languages (Hindi, Tamil and Telugu) and linguistically validated them. Methods: Translation followed established guidelines on translation and linguistic validation of measures. Process involved two independent forward translations, reconciliation, two independent backward translations by bilingual experts, and cognitive debriefing interviews with nine healthcare professionals (HCPs) and 29 HNC patients. Translated versions were compared with the original versions for semantic, cultural and conceptual equivalence. Results: Overall, 17 Hindi items, 19 Tamil items and 13 Telugu items were identified to have semantic, cultural and/or conceptual issues. These were resolved to achieve equivalence with the original measures. Interviews with HCPs indicated that equivalent terms for words such as anxiety, panicky, sexuality, and self-conscious might be difficult to understand. Interviews with patients indicated all items were understandable, easy, sensitive, unambiguous and relevant. Hence, no further revisions were made. Conclusions: The translated Hindi, Tamil and Telugu versions of the Body image scale, Patient concerns inventory, Zung's self-rating anxiety and depression scales and Patient health questionnaire-9 measures are conceptually and linguistically validated and equivalent with the original English versions. Psychometric validation of these measures with relevant patient populations is needed. [ABSTRACT FROM AUTHOR]

Purpose: To ensure clarity in communication in the field of quality of life research, and meaningful use of 'quality of life' as a research outcome, requires two things: awareness that there is a range of conceptualisations and definitions of 'quality of life', and for any particular study, consistency between the way the term is defined and operationalised in that setting. We aimed to identify how frequently research articles described (HR)QOL as a construct of interest, how frequently they referred to "patient-reported outcome (measures)", which patient-reported outcome measures were used, and how (HR)QOL was defined. Methods: We reviewed all Quality of Life Research articles published in 2017 and recorded whether they described health-related quality of life or quality of life as constructs of interest, and/or mentioned the term(s) patient-reported outcome (measures). We recorded definitions of (HR)QOL stated and questionnaires used. We classified articles according to constructs assessed and instruments used, and examined whether articles citing the same definition used the same questionnaires. Results: We reviewed 300 articles; 65% stated that (HR)QOL was a construct of interest, 27% mentioned patient-reported outcome (measures), and 20% mentioned neither. Fifty-one articles provided definitions of (HR)QOL, citing 66 sources, with 11 definitions cited more than once. PROMIS, SF, EQ-5D, and EORTC instruments were the most commonly used. The only definition and questionnaire consistently used together were the WHO definitions/instruments. Conclusion: These results demonstrate considerable heterogeneity in the definition and operationalisation of (HR)QOL, between and within studies. This limits meaningful interpretation of (HR)QOL scores and complicates literature searches. Investigators should define constructs and select instruments aligned with their definitions. [ABSTRACT FROM AUTHOR]

Background: Head and neck cancers (HNC) are one of the most traumatic forms of cancer because they affect essential aspects of life such as speech, swallowing, eating and disfigurement. HNCs are common in India, with over 100,000 cases being registered each year. HNC and treatment are both associated with considerable anxiety and depression. With increasing multinational research, no suitable measures in Indian languages are available to assess anxiety and depression in Indian HNC patients. This study evaluated the psychometric properties of cross-culturally adapted versions of Zung's self-rating Anxiety Scale (SAS) and the Patient health questionnaire – 9 (PHQ-9) in Tamil, Telugu and Hindi speaking Indian HNC populations. Methods: HNC patients were recruited from three tertiary cancer centres in India. Patients completed the cross-culturally adapted versions of SAS and PHQ-9. We assessed targeting, scaling assumptions, construct validity (exploratory and confirmatory factor analyses), convergent validity, and internal consistency reliability. Results: The study sample included 205 Tamil, 216 Telugu and 200 Hindi speaking HNC patients. Exploratory and confirmatory factor analyses indicated a two-factor solution for PHQ-9 and four-factor solution for SAS in all three languages. Cronbach's alpha coefficients ranged between 0.717 and 0.890 for PHQ-9 and between 0.803 and 0.868 for SAS, indicating good reliability. Correlations between hypothesized scales were as expected providing evidence towards convergent validity. Conclusions: This first psychometric evaluation of the measurement properties of Tamil, Telugu and Hindi versions of the SAS and PHQ-9 in large, Indian HNC populations supported their use as severity and outcome measures across the disease and treatment continuum. [ABSTRACT FROM AUTHOR]

Use of patient-reported measures (PRMs) in healthcare is increasing internationally. In New South Wales (NSW) Australia the implementation of a system-wide PRMs program is underway. This program is an enabler for value based healthcare. We report an evaluation (2015/16) of this program's first year. We evaluated the program using mixed methods. People living with chronic conditions from 18 sites across NSW completed PROMIS10 at all sites; DASS21 and CAT administered at selected sites depending on patient cohorts. PRM completion rates and mean scores were calculated. Stakeholder interviews were analysed using thematic analysis. PRM completion rates were high at baseline (69%) but suboptimal at follow-up time-points. Mean scores indicated people with back pain had worse physical health and stress compared to those with other conditions. People with alcohol or drug problems had worse mental health, disease symptoms, depression and anxiety compared to other conditions. Stakeholders reported collection of PRMs could improve health outcomes for patients, enhance service delivery, and reduce avoidable hospital admissions. Routine collection and use of PRMs can be implemented across NSW care settings. Several challenges need to be overcome to realise the full benefits of the PRM program and to improve follow-up completion rates. [ABSTRACT FROM AUTHOR]

Objective: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can occur life-long. In this context, patient-reported outcomes (PROs) are important considerations to patients and managing clinicians. We undertook a systematic review to synthesise PRO results relevant to NMIBC treatment to explore trajectories overtime and differences between treatment options. Methods: We searched databases AMED, MEDLINE, EMbase, PsycINFO, Web of Knowledge and Scopus (inception to 5th December 2019), reference lists and contacted key authors to identify studies that reported PROs after NMIBC treatment. Two reviewers independently applied inclusion and quality criteria and extracted findings. Results for PROs were synthesised for treatment groups across three time periods: acute/during induction therapy; during maintenance therapy; and long-term follow-up (> 1 year). Results: Of 3193 papers screened, 29 were eligible. These provided evidence about induction treatment effects, but few reported maintenance or long-term evidence, and evidence about differences between NMIBC treatment options was lacking. A range of symptoms (pain in bladder area, urinary frequency and urgency, pain or burning during urination) were commonly experienced during and soon after treatment for NMIBC. Less common symptoms included fatigue, disrupted sleep and gastrointestinal problems. Conclusions: Treatments for NMIBC can cause symptoms and functional impairment during the acute treatment phase and reduce quality of life. Clinicians should be aware of these impairments to prepare patients for short-term sequelae and enable those with treatment options to exercise preferences in choosing among them. However, gaps in current evidence limit our understanding of PRO trajectories from diagnosis through to long-term survivorship and treatment effects. [ABSTRACT FROM AUTHOR]

Previous reviews explored weight loss-induced metabolic changes in overweight and obese adults with type 2 diabetes (T2D) but did not report on the impact on patient-reported outcomes (PROs). This systematic review investigated the effect of weight loss interventions on weight loss and PROs in overweight and obese adults with T2D. We searched three electronic databases from inception to March 2018 for randomised controlled trials (RCTs) of weight loss interventions in overweight and obese (according to BMI) adults aged ≥ 18 years reporting changes in PROs from baseline to at least one follow-up assessment during or post-intervention. One reviewer screened abstracts, performed data extraction, and conducted the narrative synthesis, with 25% cross-checking by a second reviewer. We extracted data relating to sample characteristics, intervention and comparison conditions, weight loss, and change in PROs. We identified 540 papers of which 23 met eligibility reporting on 19 RCTs. Four types of interventions (diet, surgery, pharmacological, and multi-component lifestyle interventions) significantly reduced weight. Weight loss was consistently associated with improvements in sexual and physical function across all intervention types, with diet and multi-component lifestyle interventions producing more substantial improvements than surgical or pharmacological interventions. Findings for other PROs, such as HRQOL and depressive symptoms, were inconsistent across studies and intervention types. The four weight loss interventions can be prescribed to engender weight loss in overweight and obese adults with T2D, with multi-component lifestyle interventions generating substantial improvements in physical and sexual function, perhaps due to the potency of exercise in improving PROs. [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: Colorectal cancer (CRC) is prevalent in the developed world. Favourable survival rates highlight the need to better understand CRC survivors' experiences of long-term impacts of treatment, which can in turn inform decision making. This systematic review aimed to identify and synthesise CRC survivors' experiences of long-term impacts on health-related quality of life. Methods: We searched Medline, Embase and PsychINFO from inception to January 2019. Qualitative studies describing CRC survivors' experiences at least 1-year post-treatment were included. Study eligibility, quality assessment (COREQ guidelines), and data synthesis was performed independently by two reviewers and discussed with the study team. Results: Of 1363 papers retrieved, 20 reporting 15 studies met eligibility. Thematic synthesis produced 12 themes: symptoms, physical, social, psychological and sexual functioning, impact on relationships, informal care needs provided by family/friend, supportive care needs provided by healthcare professional, health care experiences, health behaviour, financial toxicity and occupational experiences. Stoma problems (e.g. leakage, skin irritation) were common in ostomates. Survivors with no/reversed stoma experienced unexpected, long-term altered and unpredictable bowel functioning. Survivors often regulated timing, amount and foods consumed to manage bowel functioning. Less common symptoms included fatigue, impaired sleep and anal pain. Stoma problems and altered bowel functioning impaired survivors' physical, social, sexual and psychological functioning. Cognitive functioning and heredity issues were not reported in any paper. Conclusion: CRC survivors experience ongoing symptoms and functioning impairments more than 1-year post-treatment completion. Many survivors find their own ways to manage symptoms rather than seek professional help. Follow-up care for CRC survivors should integrate screening for long-term effects and provide targeted supportive care. [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]

Introduction: The prognostic value of patient-reported outcomes (PROs) has been determined in some cancers, but a focussed review in colorectal cancer (CRC) has not yet been conducted. We systematically reviewed PRO predictors of CRC patient survival.Methods: We searched four electronic databases (from inception to May 2018), reference lists and professional organisations to identify studies reporting pre-treatment PRO predictors of overall survival (OS) or progression-free survival (PFS) in CRC identified through univariate or multivariate models. Two reviewers independently applied inclusion criteria and extracted data on study characteristics, median and 1-year survival rates, PROs assessed and model results.Results: In 25 of 27 studies (n = 12,544), at least one PRO was significantly associated with survival. Physical functioning, fatigue, pain and appetite loss predicted OS more often than other PROs in metastatic disease (19/27 studies). One study explored PRO predictors in early-stage CRC, finding emotional well-being and mood predicted OS. In mixed-stage samples (7/27 studies), physical functioning predicted OS more often than other PROs. Few studies modelled PFS, for which few PROs had predictive value.Conclusions: Physical and psychological functioning, pain, fatigue and appetite loss had prognostic significance above and beyond clinical predictors in CRC. Routine monitoring of these PROs may allow earlier detection and amelioration of problems, which may improve quality of life and perhaps extend survival. More research is needed to determine prognostic value of PROs in early-stage CRC, and prognostic significance of changes in PRO scores. [ABSTRACT FROM AUTHOR]

Purpose: Head and neck cancer (HNC) is a relatively common cancer which causes a significant health burden, impacting individuals physically and psychologically. HNC treatment may result in facial disfigurement, eating and communication difficulties, and body image disturbances. We aimed to (1) identify HNC-specific patient-reported outcome measures (PROMs) used to assess body image, (2) evaluate their conceptual coverage, (3) appraise their development process and psychometric properties, and (4) determine appropriate body image PROM(s) for use in the HNC setting.Methods: Online databases were searched (July 2007-July 2017) for studies that assessed body image in patients with HNC. Studies were screened for eligibility. In addition, we searched three PROM databases for relevant PROMs. From available body image frameworks, we compiled a conceptual schema consisting of 18 clinically relevant body image issues important in the HNC setting, against which PROMs were assessed. Selected measures were appraised for psychometric characteristics, content, and readability.Results: A total of 245 records were retrieved. 18 studies with PROMs met our inclusion criteria, reporting eight PROMs. The PROM databases searched yielded 62 measures. After screening, eleven measures were short-listed and appraised. The Derriford Appearance Scale (DAS)-59, DAS-24, and body image scale (BIS) cover > 55% of issues within the body image conceptual schema; were developed based on literature, patient interviews, and clinician opinions; and have evidence of internal consistency (Cronbach alpha > 0.7), validity, and responsiveness.Conclusions: We recommend the DAS-24 and BIS as having adequate coverage of HNC-related issues, and suitable for use in future research. [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]

Aims: A proxy is someone other than a patient who reports a patient's outcomes as if they are the patient. Due to known discordance with patient reports, proxies are often not recommended in clinical trials; however, proxies may be needed in certain research contexts. We aimed to identify and describe trials registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) with proxy-reported endpoints.Methods: ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with proxy-reported endpoints. Primary and secondary endpoints for each trial retrieved by the search were individually coded (proxy-reported: yes/no), and trials with confirmed proxy-reported endpoints were included in the analysis.Results: Of 13,666 registered trials, 469 (3.4%) included a proxy-reported endpoint (867 individual proxy-reported endpoints in total: 62% family member proxy, 22% health professional). Proxy endpoint inclusion did not significantly increase over time (r = 0.18, p = 0.59). Mental health (11.5%), stroke (10.3%) and neurological (8.3%) trials had the highest proportion of trials using proxies. Of the 469 trials, 123 (26.2%) studies involved paediatric patients.Discussion: Proxy-reported endpoints are included in a small but notable number of studies, which may indicate other types of outcomes are used for patients unable to self-report, or that these patients are under-researched. [ABSTRACT FROM AUTHOR]

Purpose: Patient decision-aids (PtDAs) help patients make informed treatment decisions incorporating their values. Health-related quality of life (HRQOL) is sometimes an outcome of PtDA effectiveness trials, but its suitability for this purpose is unclear. We sought to provide insights into this question by critically appraising how randomized controlled trials (RCTs) evaluating PtDA effectiveness measure and report HRQOL.Methods: We conducted a sub-analysis of RCTs included in the 2017 Cochrane review of PtDAs. Trials assessing HRQOL at baseline and post-PtDA, and comparing PtDA with comparison groups were included. Two reviewers independently extracted data and assessed study quality. Analysis was descriptive.Results: Of 105 RCTs, 11 were eligible for inclusion. Patients randomized to PtDAs did not report better HRQOL than those randomized to usual care. While all 11 RCTs adequately described baseline sample characteristics and reported HRQOL results for study groups, few stated a priori HRQOL expectations or hypotheses (36%); made a link between HRQOL and the decision (18%); provided a rationale or justification for HRQOL assessment (18%); provided reason for choice of HRQOL assessment time-points (9%); or adjusted p-values for multiple HRQOL domains and time-points (0%).Discussion: PtDAs did not conclusively impact HRQOL. If this holds generally, then HRQOL is an uninformative endpoint for PtDA effectiveness trials. When planning trials of PtDAs, investigators considering HRQOL endpoints should consider whether and why their PtDA is likely to affect HRQOL in their context, and if so, which specific aspect(s) of HRQOL and at which time-point(s), and ensure HRQOL is assessed accordingly. [ABSTRACT FROM AUTHOR]

Aims: It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics.Methods: ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were individually coded using an established framework to identify trials with PROs for the analysis.Results: Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increased between 2006 and 2016 (r = 0.74, p = 0.009). Among the 6168 trials, there were 17,961 individual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences (9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followed by physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%).Discussion: Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our review identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of PRO findings in clinical care. [ABSTRACT FROM AUTHOR]

Objective: Testicular cancer (TC) affects young men and may cause psychological distress despite a good prognosis. This systematic review evaluated the prevalence, severity, and correlates of anxiety, depression, fear of cancer recurrence (FCR), and distress in TC survivors.Methods: A systematic search of literature published 1977 to 2017 was conducted to find quantitative studies including TC survivor-reported outcomes relevant to review objectives. The quality of included articles was assessed, and a narrative synthesis conducted.Results: Of 6717 articles identified, 66 (39 good, 20 fair, and 7 poor quality) reporting results from 36 studies were included. Testicular cancer survivors' mean anxiety levels were higher than in the general population, while mean depression and distress were no different. Clinically significant anxiety (≈1 in 5) and to a lesser extent distress (≈1 in 7), but not depression, were more prevalent in TC survivors than the general population. Approximately 1 in 3 TC survivors experienced elevated FCR. Poorer psychological outcomes were more common among TC survivors who were single, unemployed/low socio-economic status, suffering from co-morbidities, experiencing worse symptoms/side effects, and using passive coping strategies.Conclusions: Many TC survivors do not experience significant psychological morbidity, but anxiety and FCR are prevalent. Inadequate coping resources (eg, low socio-economic status and social support) and strategies (eg, avoidance) and greater symptoms/side effects were associated with poorer outcomes. Theoretically driven prospective studies would aid understanding of how outcomes change over time and how to screen for risk. Age and gender appropriate interventions that prevent and manage issues specific to TC survivors are also needed. [ABSTRACT FROM AUTHOR]

Purpose: Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring repeated treatment and endoscopic examinations that can be life-long. In this context, health-related quality of life (HRQOL) is important to patients and managing clinicians, and integral to treatment recommendations for NMIBC. The aim of this study was to develop a conceptual framework of patient-reported NMIBC symptoms, treatment side effects, and HRQOL impacts from three sources: (1) literature, (2) patients and (3) treating clinicians.Methods: First, we undertook a scoping literature review for studies reporting patient-reported outcomes associated with NMIBC. Outcomes were extracted and grouped conceptually. Then, we conducted semi-structured interviews with patients with NMIBC and treating clinicians. Patients were asked about symptoms and HRQOL impacts experienced from their NMIBC and treatments. Clinicians were asked about commonly reported outcomes, and outcomes they felt were important to assess clinically. Interviews were audio recorded, transcribed and content analysed.Results: A total of 125 symptom- and functioning-related expressions from 18 studies, 26 patients and 20 clinicians were coded into three themes and 18 sub-themes. Patients commonly reported blood in urine and frequent urination. Clinicians considered BCG sepsis and flu-like symptoms important outcomes to assess during treatment for NMIBC.Conclusion: Our empirically derived conceptual framework identifies patient-reported outcomes that are important to people with NMIBC, provides the basis for the development of a new NMIBC-specific symptom index, and guides the design of a comprehensive PRO assessment plan for clinical practice in NMIBC and future clinical trials of treatments for NMIBC. [ABSTRACT FROM AUTHOR]

Purpose: To explore quality-of-life (QOL) issues considered important when deciding on treatment for ductal carcinoma in situ (DCIS). Methods: Breast Cancer Network of Australia members diagnosed with DCIS in the past 5 years (self-identified) participated in an online survey (Sep-Nov 2015). From a list of 74 QOL issues, participants selected all issues they experienced during DCIS diagnosis, treatment or recovery, then the issues they felt important to making a DCIS treatment decision, and completed the Health Literacy Questionnaire (HLQ). Associations between QOL issues and self-reported treatment received were assessed with χ tests. Results: The primary analysis included 38 participants treated with breast-conserving surgery ( n = 15), mastectomy ( n = 23), and/or radiotherapy ( n = 14). Fatigue-related symptoms (82%) and 'fear of progression' (50%) were the most frequently-experienced issues. When deciding on DCIS treatment, the most important consideration was 'fear of progression' (50%). A higher proportion of mastectomy (compared to non-mastectomy) patients considered 'difficultly looking at yourself naked' ( p = 0.03). Radiotherapy (compared to non-radiotherapy) patients were more likely to consider 'feeling unwell' important ( p = 0.006). Results were similar in a sensitivity analysis involving all 101 respondents (i.e., including 63 respondents who reported receiving chemotherapy, endocrine therapy, and/or Herceptin, suggesting that they may have been treated for invasive breast cancer). Health literacy was high across all nine HLQ scales. Conclusion: Fear of progression is a key consideration in DCIS treatment decision making for women with high health literacy. QOL treatment considerations differed by treatments received. Women diagnosed with DCIS may benefit from evidence about QOL to inform treatment decision making. [ABSTRACT FROM AUTHOR]

Background: Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual's functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers. Methods/Design: PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 'high-risk' patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee. Discussion: The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for demonstrating either superiority, inferiority of mattresses or futility of the trial. The trial optimises the potential for producing robust clinical evidence on the effectiveness of two commonly used mattresses in clinical practice earlier than in a conventional design. [ABSTRACT FROM AUTHOR]

Cancer is now the biggest cause of mortality worldwide. Although the debilitating physical symptoms of cancer have long been known, the psychological and social impacts of cancer have become the subject of examination only relatively recently. The psychological outcomes that have been examined are primarily negative emotional variables, e.g., anxiety, but emerging research has focused on positive emotional variables, e.g., post-traumatic growth, or cognitive outcomes. In this article, we provide a synthesis of reviews that have addressed the psychosocial impact of cancer. The framework for this synthesis is provided by a conceptualisation in which the presence of cancer impacts on psychosocial outcomes either directly or via mediating variables, including physical symptoms and treatment, and that this effect may be moderated by several variables, some characteristic of the person with cancer (demographic or personality-related variables) and some characteristic of their environment (social support and medical variables). We also briefly examine the impact of cancer on the broader family unit following cancer diagnosis, treatment, survivorship and bereavement. We conclude that the heterogeneity of the cancer experience highlights the need for theoretically driven research and consistency in measurement approaches to determine mechanisms by which cancer exerts influence on psychosocial outcomes. This would allow development and delivery of targeted psychological interventions and a clearer delineation of the roles of the various parties, including clinical psychologists, family members and policymakers. [ABSTRACT FROM AUTHOR]

Purpose: Technological advances in recent decades have led to the availability of new modes to administer patient-reported outcomes (PROs). To aid selecting optimal modes of administration (MOA), we undertook a systematic review to determine whether differences in bias (both size and direction) exist among modes.Methods: We searched five electronic databases from 2004 (date of last comprehensive review on this topic) to April 2014, cross-referenced and searched reference lists. Studies that compared two or more MOA for a health-related PRO measure in adult samples were included. Two reviewers independently applied inclusion and quality criteria and extracted findings. Meta-analyses and meta-regressions were conducted using random-effects models.Results: Of 5100 papers screened, 222 were considered potentially relevant and 56 met eligibility criteria. No evidence of bias was found for: (1) paper versus electronic self-complete; and (2) self-complete versus assisted MOA. Heterogeneity for paper versus electronic comparison was explained by type of construct (i.e. physical vs. psychological). Heterogeneity for self-completion versus assisted modes was in part explained by setting (clinic vs. home); the largest bias was introduced when assisted completion occurred in the clinic and follow-up was by self-completion (either electronic or paper) in the home.Conclusions: Self-complete paper and electronic MOA can be used interchangeably for research in clinic and home settings. Self-completion and assisted completion produce equivalent scores overall, although heterogeneity may be induced by setting. These results support the use of mixed MOAs within a research study, which may be a useful strategy for reducing missing PRO data. [ABSTRACT FROM AUTHOR]

Background When developing new measuring instruments or deciding upon one for research, consideration of the 'best' method of administration for the target population should be made. Current evidence is inconsistent in differentiating superiority of any one method in terms of quantity and quality of response. We trialed a novel mixed methods approach in early scale development to determine the best administration method for a new patient-reported outcome instrument for people with pressure ulcers (the PU-QOL). Methods Cognitive interviews were undertaken with 35 people with pressure ulcers to determine appropriateness of a self-completed version of the PU-QOL instrument. Quantitative analysis, including Rasch analysis, was carried out on PU-QOL data from 70 patients with pressure ulcers, randomised to self-completed or interview-administered groups, to examine data quality and differential item functioning (DIF). Results Cognitive interviews identified issues with PU-QOL self-completion. Quantitative analysis supported these findings with a large proportion of self-completed PU-QOLs returned with missing data. DIF analysis indicated administration methods did not impact the way patients from community care settings responded, supporting the equivalence of both administration versions. Conclusions Obtaining the best possible health outcomes data requires use of appropriate methods to ensure high quality data with minimal bias. Mixed methods, with the inclusion of Rasch, provided valuable evidence to support selection of the 'best' administration method for people with PUs during early PRO instrument development. We consider our approach to be generic and widely applicable to other elderly or chronically ill populations or suitable for use in limited samples where recruitment to large field tests is often difficult. [ABSTRACT FROM AUTHOR]