Deriving a preference-based measure for cancer using the EORTC QLQ-C30 : a confirmatory versus exploratory approach

Background: To derive preference-based measures from various condition-specific descriptive health-related quality of life (HRQOL) measures. A general 2-stage method is evolved: 1) an item from each domain of the HRQOL measure is selected to form a health state classification system (HSCS); 2) a sample of health states is valued and an algorithm derived for estimating the utility of all possible health states. The aim of this analysis was to determine whether confirmatory or exploratory factor analysis (CFA, EFA) should be used to derive a cancer-specific utility measure from the EORTC QLQ-C30. Methods: Data were collected with the QLQ-C30v3 from 356 patients receiving palliative radiotherapy for recurrent or metastatic cancer (various primary sites). The dimensional structure of the QLQ-C30 was tested with EFA and CFA, the latter based on a conceptual model (the established domain structure of the QLQ-C30: physical, role, emotional, social and cognitive functioning, plus several symptoms) and clinical considerations (views of both patients and clinicians about issues relevant to HRQOL in cancer). The dimensions determined by each method were then subjected to item response theory, including Rasch analysis. Results: CFA results generally supported the proposed conceptual model, with residual correlations requiring only minor adjustments (namely, introduction of two cross-loadings) to improve model fit (increment χ2(2) = 77.78, p 75% observation at lowest score), 6 exhibited misfit to the Rasch model (fit residual > 2.5), none exhibited disordered item response thresholds, 4 exhibited DIF by gender or cancer site. Upon inspection of the remaining items, three were considered relatively less clinically important than the remaining nine. Conclusions: CFA appears more appropriate than EFA, given the well-established structure of the QLQ-C30 and its clinical relevance. Further, the confirmatory approach produced more interpretable results than the exploratory approach. Other aspects of the general method remain largely the same. The revised method will be applied to a large number of data sets as part of the international and interdisciplinary project to develop a multi-attribute utility instrument for cancer (MAUCa)

Staff perspectives on the feasibility of a clinical pathway for anxiety and depression in cancer care, and mid-implementation adaptations.

BACKGROUND: Clinical pathways (CPs) are intended to standardise and improve care but do not always produce positive outcomes, possibly because they were not adapted to suit the specific context in which they were enacted. This qualitative study aimed to explore staff perspectives of implementation of a CP for routine screening, assessment, referral and management of anxiety and depression (the ADAPT CP) for patients with cancer, focussing on perceived feasibility of the CP and negotiated adaptations made during the implementation phase. METHODS: The ADAPT CP was implemented in 12 urban and regional oncology services in Australia. Services were randomised to receive core versus enhanced implementation strategies. Core sites received support until implementation commencement and could access progress reports. Enhanced sites received proactive, ongoing support during the 12-month implementation. Purposively selected staff were interviewed prior to implementation (n = 88) and 6 months later, half-way through the implementation period (n = 89). Monthly meetings with lead multi-disciplinary teams at the eight enhanced sites were recorded. Data were thematically analysed. RESULTS: Six overarching themes were identified: ADAPT is of high value; timing for introducing the CP and screening is difficult; online screening is challenging; a burden too much; no-one to refer patients to; and micro-logistics are key. While early screening was deemed desirable, diverse barriers meant this was complex, with adaptations made to time and screening location. Online screening prompted by email, seen as time-saving and efficient, also proved unsuccessful in some services, with adaptations made to in-clinic or phone screening, or repeated email reminders. Staff negative attitudes to ADAPT, time constraints, and perceived poor fit of ADAPT to work roles and flows, all impacted implementation, with key tasks often devolving to a few key individuals. Nevertheless, services remained committed to the ADAPT CP, and worked hard to create, review and adapt strategies to address challenges to optimise success. CONCLUSIONS: This study demonstrates the interactive nature of health service change, with staff actively engaging with, forming views on, and problem-solving adaptations of the ADAPT CP to overcome barriers. Obtaining staff feedback is critical to ensure health service change is sustainable, meaningful and achieves its promise of improving patient outcomes. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347

Acceptability and appropriateness of a clinical pathway for managing anxiety and depression in cancer patients: a mixed methods study of staff perspectives.

BACKGROUND: Clinical pathways (CPs) can improve health outcomes, but to be sustainable, must be deemed acceptable and appropriate by staff. A CP for screening and management of anxiety and depression in cancer patients (the ADAPT CP) was implemented in 12 Australian oncology services for 12 months, within a cluster randomised controlled trial of core versus enhanced implementation strategies. This paper compares staff-perceived acceptability and appropriateness of the ADAPT CP across study arms. METHODS: Multi-disciplinary lead teams at each service tailored, planned, championed and implemented the CP. Staff at participating services, purposively selected for diversity, completed a survey and participated in an interview prior to implementation (T0), and at midpoint (6 months: T1) and end (12 months: T2) of implementation. Interviews were recorded, transcribed and thematically analysed. RESULTS: Seven metropolitan and 5 regional services participated. Questionnaires were completed by 106, 58 and 57 staff at T0, T1 and T2 respectively. Eighty-eight staff consented to be interviewed at T0, with 89 and 76 at T1 and T2 (response rates 70%, 66% and 57%, respectively). Acceptability/appropriateness, on the quantitative measure, was high at T0 (mean of 31/35) and remained at that level throughout the study, with no differences between staff from core versus enhanced services. Perceived burden was relatively low (mean of 11/20) with no change over time. Lowest scores and greatest variability pertained to perceived impact on workload, time and cost. Four major themes were identified: 1) Mental health is an important issue which ADAPT addresses; 2) ADAPT helps staff deliver best care, and reduces staff stress; 3) ADAPT is fit for purpose, for both cancer care services and patients; 4) ADAPT: a catalyst for change. Opposing viewpoints are outlined. CONCLUSIONS: This study demonstrated high staff-perceived acceptability and appropriateness of the ADAPT CP with regards to its focus, evidence-base, utility to staff and patients, and ability to create change. However, concerns remained regarding burden on staff and time commitment. Strategies from a policy and managerial level will likely be required to overcome the latter issues. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347. https://www.anzctr.org.au/

Comparison of implementation strategies to influence adherence to the clinical pathway for screening, assessment and management of anxiety and depression in adult cancer patients (ADAPT CP): Study protocol of a cluster randomised controlled trial

© 2018 The Author(s). Background: Health service change is difficult to achieve. One strategy to facilitate such change is the clinical pathway, a guide for clinicians containing a defined set of evidence-based interventions for a specific condition. However, optimal strategies for implementing clinical pathways are not well understood. Building on a strong evidence-base, the Psycho-Oncology Co-operative Research Group (PoCoG) in Australia developed an evidence and consensus-based clinical pathway for screening, assessing and managing cancer-related anxiety and depression (ADAPT CP) and web-based resources to support it - staff training, patient education, cognitive-behavioural therapy and a management system (ADAPT Portal). The ADAPT Portal manages patient screening and prompts staff to follow the recommendations of the ADAPT CP. This study compares the clinical and cost effectiveness of two implementation strategies (varying in resource intensiveness), designed to encourage adherence to the ADAPT CP over a 12-month period. Methods: This cluster randomised controlled trial will recruit 12 cancer service sites, stratified by size (large versus small), and randomised at site level to a standard (Core) versus supported (Enhanced) implementation strategy. After a 3-month period of site engagement, staff training and site tailoring of the ADAPT CP and Portal, each site will "Go-live", implementing the ADAPT CP for 12 months. During the implementation phase, all eligible patients will be introduced to the ADAPT CP as routine care. Patient participants will be registered on the ADAPT Portal to complete screening for anxiety and depression. Staff will be responsible for responding to prompts to follow the ADAPT CP. The primary outcome will be adherence to the ADAPT CP. Secondary outcomes include staff attitudes to and experiences of following the ADAPT CP, using the ADAPT Portal and being exposed to ADAPT implementation strategies, collected using quantitative and qualitative methods. Data will be collected at T0 (baseline, after site engagement), T1 (6 months post Go-live) and T2 (12 months post Go-live). Discussion: This will be the first cluster randomised trial to establish optimal levels of implementation effort and associated costs to achieve successful uptake of a clinical pathway within cancer care. Trial registration: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN1261700041134

A role for surgery in primary pancreatic B-cell lymphoma: a case report

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Quality of life in patients with breast cancer before and after diagnosis: an eighteen months follow-up study

<p>Abstract</p> <p>Background</p> <p>Measuring quality of life in breast cancer patients is of importance in assessing treatment outcomes. This study examined the impact of breast cancer diagnosis and its treatment on quality of life of women with breast cancer.</p> <p>Methods</p> <p>This was a prospective study of quality of life in breast cancer patients. Quality of life was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its breast cancer supplementary measure (QLQ-BR23) at three points in time: baseline (pre diagnosis), three months after initial treatment and one year after completion of treatment (in all 18 months follow-up). At baseline the questionnaires were administered to all suspected identified patients while both patients and the interviewer were blind to the final diagnosis. Socio-demographic and clinical data included: age, education, marital status, disease stage and initial treatment. Repeated measure analysis was performed to compare quality of life differences over the time.</p> <p>Results</p> <p>In all, 167 patients diagnosed with breast cancer. The mean age of breast cancer patients was 47.2 (SD = 13.5) years and the vast majority (82.6%) underwent mastectomy. At eighteen months follow-up data for 99 patients were available for analysis. The results showed there were significant differences in patients' functioning and global quality of life at three points in time (P < 0.001). Although there were deteriorations in patients' scores for body image and sexual functioning, there were significant improvements for breast symptoms, systematic therapy side effects and patients' future perspective (P < 0.05).</p> <p>Conclusion</p> <p>The findings suggest that overall breast cancer patients perceived benefit from their cancer treatment in long-term. However, patients reported problems with global quality of life, pain, arm symptoms and body image even after 18 months following their treatments. In addition, most of the functional scores did not improve.</p

Microsatellite alteration and immunohistochemical expression profile of chromosome 9p21 in patients with sporadic renal cell carcinoma following surgical resection.

BACKGROUND: Long-term prognostic significance of loss of heterozygosity on chromosome 9p21 for localized renal cell carcinoma following surgery remains unreported. The study assessed the frequency of deletions of different loci of chromosome 9p along with immunohistochemical profile of proteins in surgically resected renal cancer tissue and correlated this with long-term outcomes. METHODS: DNA was extracted from renal tumours and corresponding normal kidney tissues in prospectively collected samples of 108 patients who underwent surgical resection for clinically localized disease between January 2001 and December 2005, providing a minimum of 9 years follow-up for each participant. After checking quality of DNA, amplified by PCR, loss of heterozygosity (LOH) on chromosome 9p was assessed using 6 microsatellite markers in 77 clear cell carcinoma. Only 5 of the markers showed LOH (D9S1814, D9S916, D9S974, D9S942, and D9S171). Protein expression of p15(INK4b), p16(INK4a), p14(ARF), CAIX, and adipose related protein (ADFP) were demonstrated by immunostaining in normal and cancer tissues. Loss of heterozygosity for microsatellite analysis was correlated with tumour characteristics, recurrence free, cancer specific, and overall survival, including significance of immunohistochemical profile of protein expressions. RESULTS: The main deletion was found at loci telomeric to CDKN2A region at D9S916. There was a significant correlation between frequency of LOH stage (p = 0.005) and metastases (p = 0.006) suggesting a higher LOH for advanced and aggressive renal cell carcinoma. Most commonly observed LOH in the 3 markers: D9S916, D9S974, and D9S942 were associated with poor survival, and were statistically significant on multivariate analysis. Immunohistochemical expression of p14, p15, and p16 proteins were either low or absent in cancer tissue compared to normal. CONCLUSIONS: Loss of heterozygosity of p921 chromosome is associated with aggressive tumours, and predicts cancer specific or recurrence free survival on long-term follow-up. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12885-016-2514-8) contains supplementary material, which is available to authorized users