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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. 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). 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. 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.

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.

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

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. 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. 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. 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.

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. 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. 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. We recommend the DAS-24 and BIS as having adequate coverage of HNC-related issues, and suitable for use in future research.

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.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.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.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.

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. 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. 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. 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.

Background Ductal carcinoma in situ (DCIS) is an in-situ (pre-cancerous) breast malignancy whereby malignant cells are contained within the basement membrane of the breast ducts. Increasing awareness that some low-risk forms of DCIS might remain indolent for many years has led to concern about overtreatment, with at least 3 clinical trials underway internationally assessing the safety of active monitoring for low-risk DCIS. This study aimed to understand healthcare professionals’ (HCPs) views on the management options for patients with DCIS. Methods Qualitative study using semi-structured interviews with HCPs involved in the diagnosis and management of DCIS in Australia and New Zealand. Interviews were audio-recorded, transcribed and analysed thematically using Framework Analysis method. Results Twenty-six HCPs including 10 breast surgeons, 3 breast physicians, 6 radiation oncologists, and 7 breast care nurses participated. There was a strong overall consensus that DCIS requires active treatment. HCPs generally felt uncomfortable recommending active monitoring as a management option for low-risk DCIS as they viewed this as outside current standard care. Overall, HCPs felt that active monitoring was an unproven strategy in need of an evidence base; however, many acknowledged that active monitoring for low-risk DCIS could be appropriate for patients with significant co-morbidities or limited life expectancy. They believed that most patients would opt for surgery wherever possible. Conclusions This study highlights the important need for robust randomised controlled trial data about active monitoring for women with low-risk DCIS, to provide HCPs with confidence in their management recommendations and decision-making., Highlights • First study to explore HCPs’ in-depth views on active monitoring for low-risk DCIS. • HCPs generally feel uncomfortable recommending active monitoring for low-risk DCIS. • Active monitoring may be considered for patients with significant co-morbidities or limited life expectancy. • Need for robust randomised controlled trial data on active monitoring for DCIS.

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.

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.

Purpose Due to increasing numbers of colorectal and anal cancer survivors, more individuals are living with long-term symptoms after treatment. A systematic review was undertaken to assess the extent to which practice guidelines for colorectal and anal cancer provide recommendations for managing long-term symptoms and functioning impairments. Methods Four electronic databases and websites of 30 international cancer societies were searched for clinical practice guidelines, consensus statements, or best practice recommendations for colorectal or anal cancer. Quality of included guidelines was evaluated with the Appraisal of Guidelines for Research & Evaluation II tool. Results were narratively summarized. Results We included 51 guidelines or consensus statements. Recommendations for managing long-term symptoms or functioning impairments were reported in 13 guidelines (25.4%). All 13 recommend a healthy lifestyle, diet, body weight, and physical activity. The ASCO Colorectal Cancer Survivorship Care Guideline is the most comprehensive, including interventions targeting sexual and bowel function to pain and cognitive issues, and also highlights limited evidence for informing management strategies. Other guidelines recommend treating incontinence, chronic diarrhea, and distress, and stress the need for greater awareness for sexual dysfunction, survivorship clinics, and referrals to specific supportive care interventions. Conclusions Few clinical practice guidelines include recommendations for managing long-term symptoms and functioning impairments. It is unclear if this is due to limited evidence or absence of management strategies and interventions. Clear recommendations for managing long-term symptoms and functioning to help health professionals in supporting colorectal and anal cancer survivors are needed.

To explore quality-of-life (QOL) issues considered important when deciding on treatment for ductal carcinoma in situ (DCIS). 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 2 tests. 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. 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.

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. 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. 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%). 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.

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.

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. Refereed/Peer-reviewed

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.

Objective Non-muscle invasive bladder cancer (NMIBC) is a chronic condition requiring ongoing treatment and endoscopic examinations that are frequent and can be life-long. To ensure the comprehensive assessment of the benefits and harms of treatments for NMIBC, the impact on important and relevant patient-reported outcomes (PROs) should be determined. We systematically reviewed the NMIBC PRO literature to determine the suitability of available PRO measures (PROMs) for use in evaluating patient outcomes in NMIBC research. Methods We searched six electronic databases, reference lists, and key authors. Two reviewers independently applied inclusion and quality criteria and extracted findings. PROM domains, item content, and content coverage and relevance were determined for identified PROMs. Content validity was assessed against an empirically derived NMIBC-specific conceptual framework that includes 11 PRO domains and 19 sub-domains. Results Seventeen studies assessed PROs related to NMIBC and treatment impact. From these studies, 11 PROMs were identified, including three generic, three cancer-specific, and five symptom-specific. None of the PROMs cover all PRO domains important in NMIBC as assessed against our conceptual framework. The EORTC QLQ-C30 plus the NMIBC24 module was best aligned to the conceptual model, but failed to represent six outcomes important to NMIBC patients. Conclusions Currently, some outcomes important in NMIBC are inadequately covered by generic and cancer-specific measures despite similar conceptual models. This review identified gaps in the literature regarding assessment of symptoms and other PROs considered important by NMIBC patients. Careful consideration of PROM item content is required when selecting outcome measures for use in future NMIBC clinical trials to ensure that appropriate measures are used to assess outcomes that matter to patients.

Background: Nonmuscle invasive bladder cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumor resections, and intravesical treatments that can occur every 3 months for life. In this clinical context, patient-reported outcomes (PROs) are a critical concern for patients and their managing clinicians. PROs have enormous potential to be integral to treatment assessment and recommendations for NMIBC; however, current PRO measures are inadequate for NMIBC because they lack key NMIBC-specific symptoms and side effects associated with contemporary treatments. Objective: The overarching aim of this study was to develop and evaluate a patient-reported symptom index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients; reliable, valid, and responsive to differences between contemporary treatments for NMIBC; and fit for purpose as an endpoint in clinical trials. Methods: The NMIBC-SI will be evaluated in 2 field tests across a total of 3 years. Field test 1 is a cross-sectional study design involving 225 adult NMIBC patients recruited while undergoing active treatment or those who completed final treatment within the past week. Data collected include patient demographics, clinical features of the tumor, risk category, treatment type, comorbidity, and PROs. Field test 2 is a prospective longitudinal study involving 225 newly diagnosed NMIBC-SI patients. Clinical data and patient-completed questionnaires will be collected at 4 time points during treatment: before tumor resection, 1 week after resection, end-of-induction intravesical therapy, and 1-year follow-up. Standard psychometric tests will be performed to assess the reliability, validity, responsiveness, and clinical utility of the NMIBC-SI. Results: Participant recruitment to field test 1 commenced in February 2017. Recruitment for field test 2 is planned to commence in January 2018. Final results are expected to be published in 2019. The NMIBC-SI will be freely available for use via registration. Conclusions: This study protocol contains detailed methods that will be used across multiple international sites. Phase 2 in the development of the NMIBC-SI will enable a comprehensive evaluation of its reliability, validity, and responsiveness to ensure that the NMIBC-SI is fit for purpose in clinical research and provides an evidence base for the ongoing improvement of future therapies for NMIBC. Trial Registration: ClinicalTrials.gov NCT03091764; http://clinicaltrials.gov/ct2/showNCT03091764 (Archived by WebCite at http://www.webcitation.org/6umBhQeNX) [JMIR Res Protoc 2017;6(11):e216]

Objective Decision-making in ductal carcinoma in situ (DCIS) is complex due to the heterogeneity of the disease. This study aimed to understand women’s experience of making treatment decisions for DCIS, their information and support needs, and factors that influenced decisions. Methods We searched six electronic databases, conference proceedings, and key authors. Two reviewers independently applied inclusion and quality criteria, and extracted findings. Thematic analysis was used to combine and summarise findings. Results We identified six themes and 28 subthemes from 18 studies. Women with DCIS have knowledge deficits about DCIS, experience anxiety related to information given at diagnosis and the complexity of decision-making, and have misconceptions regarding risks and outcomes of treatment. Women’s decisions are influenced by their understanding of risk, the clinical features of their DCIS, and the benefits and harms of treatment options. Women are dissatisfied with the decisional support available. Conclusions Informed and shared decision-making in this complex decision setting requires clear communication of information specific to DCIS and individual’s, as well as decision support for patients and clinicians. Practice implications This approach would educate patients and clinicians, and assist clinicians in supporting patients to an evidence-based treatment plan that aligns with individual values and pReferences

Ductal carcinoma in situ (DCIS) is a pre-invasive breast cancer with excellent prognosis but with potential adverse impacts of diagnosis and treatment on quality of life and other patient-reported outcomes (PROs). We undertook a systematic review to synthesise current evidence about PROs following diagnosis and treatment for DCIS. We searched five electronic databases (from database inception to November 2015), cross-referenced and contacted experts to identify studies that reported PROs after DCIS treatment. Two reviewers independently applied inclusion and quality criteria, and extracted findings. Of 2130 papers screened, 23 were eligible, reporting 17 studies. Short- and long-term PRO evidence about differences between DCIS treatment options was lacking. Evidence pooled across treatments indicated core aspects of quality of life (physical, role, social, emotional function, pain, fatigue) and psychological distress (anxiety, depression) were impacted significantly initially, with most aspects returning to population norms by 6-12 months, and all by 2 years post-operatively. Fears of recurrence and dying from breast cancer were exaggerated, occurred early and persisted for many years. Sexuality and body image impacts were generally low and resolved within 1-3 months after surgery. A minority of women experienced considerable impact, including depression and sexual issues associated with body image problems. Well-powered PRO studies are required to track recovery trajectories and long-term impacts of the range of contemporary and emerging local and systemic treatments for DCIS. PRO data would enable care providers to prepare patients for short-term sequelae and enable patients who have treatment options to exercise preferences in choosing among them.