Rehabilitation outcomes for people with lung cancer (UNITE): protocol for the development of a core outcome set.

INTRODUCTION: With treatment-related improvements in survival, rehabilitation is essential to improve function and health-related quality of life and manage the high symptom burden associated with lung cancer. Despite this, significant heterogeneity exists in the outcomes and instruments used to evaluate lung cancer rehabilitation programme impact. This study aims to develop a core set of clinically relevant lung cancer rehabilitation outcomes for use in clinical practice. METHODS AND ANALYSIS: An international Delphi consensus study involving consumer, healthcare professional and researcher stakeholders to determine which outcomes to include and how to measure these. Stage 1 (preliminary): mixed methods to develop the potential list of outcomes (1) overview of systematic reviews of lung cancer exercise interventions and (2) focus groups and individual interviews with people with lung cancer. Stage 2: outcomes were grouped according to the International Classification of Functioning, Disability and Health domains. Stage 3: to determine priority outcomes for core outcome set (COS) inclusion participants will rate each outcome's importance (one-nine-point Likert scale) over two-three survey rounds. Stage 4: following review by the steering committee, a consensus meeting will be held if agreement on the COS has not been reached.Stage 5: recommendations will be made regarding a single instrument for measuring each COS outcome by reviewing existing resources where consensus has already been reached. Where resources do not exist the quality and feasibility of potential measurement instruments will be appraised, and the Delphi consensus survey and meeting process outlined in stages 3-4 will be repeated.This protocol adheres to the COS-Standardised Protocol statement and will be conducted and reported according to the COS-Standards for Development recommendations and the COS-Standards for Reporting. ETHICS AND DISSEMINATION: Ethics approval (20/9/22, University of Melbourne ID 2022-24839-32231-3). Dissemination in peer-reviewed journals and conference presentations.

Web-Based Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care): Multicenter Pragmatic Nonrandomized Trial.

BACKGROUND: Despite the acceptability and efficacy of e-patient-reported outcome (ePRO) systems, implementation in routine clinical care remains challenging. OBJECTIVE: This pragmatic trial implemented the PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care) web-based system into existing clinical workflows and evaluated its effectiveness among a diverse population of patients with cancer. METHODS: Adult patients with solid tumors receiving active treatment or follow-up care in four cancer centers were enrolled. The PROMPT-Care intervention supported patient management through (1) monthly off-site electronic PRO physical symptom and psychosocial well-being assessments, (2) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and (3) tailored online patient self-management resources. Propensity score matching was used to match controls with intervention patients in a 4:1 ratio for patient age, sex, and treatment status. The primary outcome was a reduction in emergency department presentations. Secondary outcomes were time spent on chemotherapy and the number of allied health service referrals. RESULTS: From April 2016 to October 2018, 328 patients from four public hospitals received the intervention. Matched controls (n=1312) comprised the general population of patients with cancer, seen at the participating hospitals during the study period. Emergency department visits were significantly reduced by 33% (P=.02) among patients receiving the intervention compared with patients in the matched controls. No significant associations were found in allied health referrals or time to end of chemotherapy. At baseline, the most common patient reported outcomes (above-threshold) were fatigue (39%), tiredness (38.4%), worry (32.9%), general wellbeing (32.9%), and sleep (24.1%), aligning with the most frequently accessed self-management domain pages of physical well-being (36%) and emotional well-being (23%). The majority of clinical feedback reports were reviewed by nursing staff (729/893, 82%), largely in response to the automated clinical alerts (n=877). CONCLUSIONS: Algorithm-supported web-based systems utilizing patient reported outcomes in clinical practice reduced emergency department presentations among a diverse population of patients with cancer. This study also highlighted the importance of (1) automated triggers for reviewing above-threshold results in patient reports, rather than passive manual review of patient records; (2) the instrumental role nurses play in managing alerts; and (3) providing patients with resources to support guided self-management, where appropriate. Together, these factors will inform the integration of web-based PRO systems into future models of routine cancer care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616000615482; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370633. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12885-018-4729-3.

Estimating the cost of radiotherapy for 5-year local control and overall survival benefit.

BACKGROUND AND PURPOSE: Escalating health care costs have led to greater efforts directed at measuring the cost and benefits of medical treatments. The aim of this study was to estimate the costs of 5-year local control and overall survival benefits of radiotherapy for the cancer population in Australia. MATERIALS AND METHODS: The local control and overall survival benefits of radiotherapy at 5-years and optimal number of fractions per course have been estimated for 26 tumour sites for which radiotherapy is indicated. For this study, a hybrid approach that merges features from activity based costing (ABC) and relative value units costing (RVU) were used to provide cost estimates. ABC methodology was used to allocate costs to all radiotherapy activities associated with each patient's treatment course, while the RVUs represent the cost of each radiotherapy activity relative to the average cost of all activities and were used to achieve a weighted cost allocation. A patient's journey for the financial year was constructed by consolidating all the radiotherapy activities and their associated costs, and the average cost per activity (fraction) was determined. The cost of radiotherapy per 5-year overall survival and local control was then estimated. RESULTS: The estimated population 5-year local control and overall survival benefits of radiotherapy for all cancer were 23% and 6%, respectively. The optimal number of fractions per treatment course if guidelines were followed was 19.4 fractions. The average cost per fraction for all cancer was AU$276. The estimated cost of radiotherapy was AU$23,585 per 5-year local control and AU$86,480 per 5-year overall survival (equivalent to 5 life years) for all cancer. CONCLUSION: The cost of AU$86,480 per 5-year overall survival would translate to AU$17,296 1-year overall survival. Therefore, the cost of radiotherapy is inexpensive if delivered optimally. Policy implications from this study include knowledge about cost to deliver radiotherapy to allow one to quantify the expected benefit at a population level.

Study protocol for a controlled trial of an eHealth system utilising patient reported outcome measures for personalised treatment and care: PROMPT-Care 2.0.

BACKGROUND: Routine assessment and clinical utilisation of patient-reported outcome (PRO) measures can lead to improved patient outcomes. The PROMPT-Care eHealth system facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions, patient self-management, and shared care. Pilot testing demonstrated acceptability and feasibility of PROMPT-Care Version 1.0. This study aims to implement PROMPT-Care Version 2.0 and determine its efficacy in reducing emergency department (ED) presentations, and improving chemotherapy delivery and health service referrals, compared to usual care. METHODS: Groups eligible to participate in the intervention arm of this controlled trial are patients receiving cancer care (including follow-up). PROMPT-Care patients will complete monthly assessments (distress, symptoms, unmet needs) until voluntary withdrawal or death. In Version 1.0, the care team accessed patients' clinical feedback reports in 'real time' to guide their care, and patients received links to support their self-management, tailored to their PRO responses. Version 2.0 was extended to include: i) an additional alert system notifying the care team of ongoing unresolved clinical issues, ii) patient self-management resources, and iii) an auto-populated Treatment Summary and Survivorship Care Plan (SCP). The control population will be patients extracted from hospital databases of the general cancer patient population who were seen at the participating cancer therapy centres during the study period, with a ratio of 1:4 of intervention to control patients. A minimum sample size of 1760 (352 intervention and 1408 control) patients will detect a 14% reduction in the number of ED presentations (primary outcome) in the PROMPT-Care group compared with the control group. Intervention patients will provide feedback on system usability and value of the self-management materials; oncology staff will provide feedback on usefulness of PROMPT-Care reports, response to clinical alerts, impact on routine care, and usefulness of the SCPs; and GPs will provide feedback on the usefulness of the SCPs and attitudes towards shared-care models of survivorship care planning. DISCUSSION: This study will inform the PROMPT-Care system's impact on healthcare utilisation and utility as an alternative model for ongoing supportive care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12616000615482 ) on 12th May 2016 ( www.anzctr.org.au ).

Variations in breast cancer histology and treatment patterns between the major ethnic groups of South West Sydney.

Studies in the United States and United Kingdom have demonstrated ethnic variations in breast cancer receptor status, histology, and treatment access. This study aimed to investigate whether ethnicity variation similarly exists in Australia. Patients diagnosed with breast cancer between 2006 and 2011 across all public hospitals in the South Western Sydney Local Health District were identified and patient data collected retrospectively. Logistic regression analysis was used to measure the association between various biologic and treatment parameters and ethnicity. Ethnicity was found to have an influence on age of diagnosis, histology, treatment utilization, and recurrence in breast cancer patients.

Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers.

AIM: Clinical trials play a critical role in advancing cancer care, but international research shows that few cancer patients, particularly culturally and linguistically diverse (CALD) patients, participate in trials. This limits generalizability of trial results and increases health disparities. This study aimed to establish rates and correlates of trial participation among CALD patients in South Western Sydney Local Health District (SWSLHD), a highly culturally diverse area. METHODS: Data from all cancer patients diagnosed and/or treated in SWSLHD from January 2006 to July 2016 were analyzed retrospectively. The primary outcome was trial enrolment among patients born in non-English speaking countries (CALD) versus English speaking countries (non-CALD). Multivariable logistic regression evaluated CALD status as a predictor of trial participation. Moderators of trial participation by the different CALD groups, namely those whose preferred language was English (CALD-PLE) or was not English (CALD-PLNE), were examined by testing interactions between CALD status and other demographic and clinical variables. RESULTS: A total of 19 453 patients were analyzed (54.9% non-CALD, 16.5% CALD-PLE, 18.5% CALD-PLNE). Overall, 7.4% of patients were enrolled in a trial. Trial participation was significantly lower in CALD patients than non-CALD patients (5.7% vs 8.4%; odds ratio [OR] = 0.80; 95% confidence interval [CI], 0.69-0.91; P = 0.001). CALD-PLNE patients were less likely to participate in trials than non-CALD (OR = 0.45; 95% CI, 0.36-0.56; P < 0.0001) and CALD-PLE patients (OR = 0.53; 95% CI, 0.67-0.41; P < 0.0001). CONCLUSIONS: Limited English proficiency seems particularly unfavorable to trial participation. Development and evaluation of strategies to overcome language barriers (e.g. simplified and translated multimedia participant information materials) is needed.

Assessing guideline adherence and patient outcomes in cervical cancer.

AIM: To investigate adherence to clinical practice guidelines (CPGs) in cervical cancer and the correlation with clinical outcomes. METHODS: A retrospective analysis was conducted using patient information from a population-based cancer registry (2005-2011, n = 208). Compliance to 10 widely accepted CPGs was assessed. Univariate and multivariate analyses were performed to assess sociodemographic factors associated with CPG adherence. Multivariate Cox regression was performed to assess the relationship between CPG adherence and 5-year survival. RESULTS: Adherence to individual CPGs ranged from 47% to 100%. Compliance to all applicable CPGs was seen in 54% (n = 72) of patients, 62% of stage I and II patients and 22% of stage III and IV patients. Poorest adherence was seen with those with locally advanced disease receiving chemoradiotherapy. Patients who lived within 5 km of the treatment facility were more likely to be compliant. No difference was found for either age, country of birth or socioeconomic status group. Five-year survival was greater for stage I and II patients who received guideline adherent care (93.7% vs 69.7%, P = 0.002), and they had a significant lower risk of death on multivariate analysis (HR = 0.22, P = 0.015). There was no significant difference for those with stage III or IV disease. CONCLUSIONS: In this study, CPG adherence is variable between treatment modalities and only half complied to all applicable CPGs. There was better adherence in those with early-stage disease and this was associated with improved patient outcomes. CPG adherence may be a useful surrogate for quality of care.

Development and Feasibility Testing of PROMPT-Care, an eHealth System for Collection and Use of Patient-Reported Outcome Measures for Personalized Treatment and Care: A Study Protocol.

BACKGROUND: Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients' responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes. OBJECTIVE: This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. METHODS: The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews. RESULTS: Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff at 2 hospitals in New South Wales, Australia. Data will be collected to determine the accuracy and completeness of data transfer procedures, extent of missing data from participants' assessments, acceptability of the eHealth system and usefulness of the self-management resources (via patient evaluation surveys and interviews), and acceptability and perceived usefulness of real-time PRO reporting (via oncology staff interviews) at the completion of the pilot phase. CONCLUSIONS: This research investigates implementation of evidence into real world clinical practice through development of an efficient and user-friendly eHealth system. This study of feasibility and acceptability of the newly developed eHealth system will inform the next stage of larger scale testing and future implementation of the system as part of routine care. CLINICALTRIAL: Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0).