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INTRODUCTION: Digital breast tomosynthesis (DBT) may improve sensitivity in population screening. However, evidence is currently limited on the performance of DBT in patients at a higher risk of breast cancer. This systematic review compares the clinical effectiveness and cost-effectiveness of DBT, digital mammography (DM), and ultrasound, for breast cancer detection in women with dense breasts and additional risk factors. METHODS: Medline, Embase, and Evidence-Based Medicine Reviews via OvidSP were searched to identify literature from 2010 to August 21, 2023. Selection of studies, data extraction, and quality assessment (using QUADAS-2 and CHEERS) were completed in duplicate. Findings were summarised descriptively and narratively. RESULTS: Twenty-six studies met pre-specified inclusion criteria. In women with breast symptoms or recalled for investigation of screen-detected findings (19 studies), DBT may be more accurate than DM. For example, in symptomatic women, the sensitivity of DBT + DM ranged from 82.8 % to 92.5 % versus 56.8 %-81.3 % for mammography (DM/synthesised images). However, most studies had a high risk of bias due to participant selection. Evidence regarding DBT in women with a personal or family history of breast cancer, for DBT versus ultrasound alone, and cost-effectiveness of DBT was limited. CONCLUSIONS: In women with dense breasts and additional risk factors for breast cancer, evidence is limited about the accuracy of DBT compared to other imaging modalities, particularly in those with personal or family history of breast cancer. Future research in this population should consider head-to-head comparisons of imaging modalities to determine the relative effectiveness of these imaging tests. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42021236470.
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INTRODUCTION: It is now widely recognised that engaging consumers in research activities can enhance the quality, equity and relevance of the research. Much of the commentary about consumer engagement in research focuses on research processes and implementation, rather than dissemination in conference settings. This article offers reflections and learnings from consumers, researchers and conference organisers on the 12th Health Services Research Conference, a biennial conference hosted by the Health Services Research Association of Australia and New Zealand (HSRAANZ). METHOD: We were awarded funds via a competitive application process by Bellberry Limited, a national not-for-profit agency with a focus on improving research quality, to incorporate consumer engagement strategies in conference processes and evaluate their impact. FINDINGS: Strategies included consumer scholarships, a buddy system, designated quiet space and consumer session co-chairs; the reflections explored in this paper were collected in the funded, independent evaluation. Our insights suggest a need for more structured consumer involvement in conference planning and design, as well as the development of specific engagement strategies. CONCLUSION: To move toward active partnership in scientific conference settings, our experience reinforces the need to engage consumers as members in designing and conducting research and in presenting research and planning conference content and processes. PUBLIC CONTRIBUTION: Consumer engagement in research dissemination at conferences is the focus of this viewpoint article. Consumers were involved in the conception of this article and have contributed to authorship at all stages of revisions and edits.
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Participación de la Comunidad , Congresos como Asunto , Humanos , Participación de la Comunidad/métodos , Australia , Investigación sobre Servicios de Salud , Nueva ZelandaRESUMEN
INTRODUCTION: Over 50% of people affected by cancer report unmet support needs. To address unmet information and psychological needs, non-government organisations such as Cancer Councils (Australia) have developed state-based telephone cancer information and support services. Due to competing demands, evidence of the value of these services is needed to ensure that future investment makes the best use of scarce resources. This research aims to determine the costs and broader economic and social value of a telephone support service, to inform future funding and service provision. METHODS AND ANALYSIS: A codesigned, evaluative social return on investment analysis (SROI) will be conducted to estimate and compare the costs and monetised benefits of Cancer Council Victoria's (CCV) telephone support line, 13 11 20, over 1-year and 3-year benefit periods. Nine studies will empirically estimate the parameters to inform the SROI and calculate the ratio (economic and social value to value invested): step 1 mapping outcomes (in-depth analysis of CCV's 13 11 20 recorded call data; focus groups and interviews); step 2 providing evidence of outcomes (comparative survey of people affected by cancer who do and do not call CCV's 13 11 20; general public survey); step 3 valuing the outcomes (financial proxies, value games); step 4 establishing the impact (Delphi); step 5 calculating the net benefit and step 6 service improvement (discrete choice experiment (DCE), 'what if' analysis). Qualitative (focus groups, interviews) and quantitative studies (natural language processing, cross-sectional studies, Delphi) and economic techniques (willingness-to-pay, financial proxies, value games, DCE) will be applied. ETHICS AND DISSEMINATION: Ethics approval for each of the studies will be sought independently as the project progresses. So far, ethics approval has been granted for the first two studies. As each study analysis is completed, results will be disseminated through presentation, conferences, publications and reports to the partner organisations.
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Análisis Costo-Beneficio , Neoplasias , Humanos , Neoplasias/terapia , Neoplasias/economía , Australia , Teléfono , Proyectos de Investigación , Apoyo SocialRESUMEN
INTRODUCTION: As cancer incidence continues to rise, challenges remain in how to communicate accurate, timely information to people with cancer, their families and healthcare professionals. One option is to provide support and comprehensive, tailored information via a telephone cancer information and support service (CISS). This systematic review aims to summarise the service characteristics of telephone CISS and identify what aspects of services are important from callers' perspectives. METHODS AND ANALYSIS: A comprehensive literature search will be conducted for articles published from database inception to 30 March 2023 (OVID MEDLINE, EMBASE, CINAHL, PsycINFO and SocINDEX). Published, peer-reviewed, articles reporting qualitative research on the service characteristics of telephone CISS important to callers in any language will be included. One researcher will complete the searches, two researchers will independently screen results for eligible studies and a third researcher will resolve any disagreement. A narrative and thematic synthesis of studies will be provided. Study characteristics will be independently extracted by one researcher and checked by a second. Included studies' methodological quality will be evaluated independently by two researchers using the 2022 Critical Appraisal Skills Programme Qualitative Studies Checklist. Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research tool will assess the confidence of the review findings. ETHICS AND DISSEMINATION: Ethics approval is not required for this research as it is a planned systematic review of published literature. Findings will be presented at leading cancer, health economic and supportive care conferences, published in a peer-reviewed journal, and disseminated via websites and social media. PROSPERO REGISTRATION NUMBER: CRD42023413897.
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Personal de Salud , Neoplasias , Humanos , Neoplasias/terapia , Investigación Cualitativa , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , TeléfonoRESUMEN
INTRODUCTION: Globally, incidence, prevalence and mortality rates of skin cancers are escalating. Earlier detection by well-trained primary care providers in techniques such as dermoscopy could reduce unnecessary referrals and improve longer term outcomes. A review of reviews is planned to compare and contrast the conduct, quality, findings and conclusions of multiple systematic and scoping reviews addressing the effectiveness of training primary care providers in dermoscopy, which will provide a critique and synthesis of the current body of review evidence. METHODS AND ANALYSIS: Four databases (Cochrane, CINAHL, EMBASE and MEDLINE Complete) will be comprehensively searched from database inception to identify published, peer-reviewed English-language articles describing scoping and systematic reviews of the effectiveness of training primary care providers in the use of dermoscopy to detect skin cancers. Two researchers will independently conduct the searches and screen the results for potentially eligible studies using 'Research Screener' (a semi-automated machine learning tool). Backwards and forwards citation tracing will be conducted to supplement the search. A narrative summary of included reviews will be conducted. Study characteristics, for example, population; type of educational programme, including content, delivery method, duration and assessment; and outcomes for dermoscopy will be extracted into a standardised table. Data extraction will be checked by the second reviewer. Methodological quality will be evaluated by two reviewers independently using the Critical Appraisal Tool for Health Promotion and Prevention Reviews. Results of the assessments will be considered by the two reviewers and any discrepancies will be resolved by team consensus. ETHICS AND DISSEMINATION: Ethics approval is not required to conduct the planned systematic review of peer-reviewed, published articles because the research does not involve human participants. Findings will be published in a peer-reviewed journal, presented at leading public health, cancer and primary care conferences, and disseminated via website postings and social media channels. PROSPERO REGISTRATION NUMBER: CRD42023396276.
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Dermoscopía , Neoplasias Cutáneas , Humanos , Detección Precoz del Cáncer , Revisiones Sistemáticas como Asunto , Neoplasias Cutáneas/diagnóstico por imagen , Proyectos de Investigación , Atención Primaria de Salud , Literatura de Revisión como AsuntoRESUMEN
OBJECTIVES: This study aimed to quantify adult preferences for adjuvant immunotherapy for resected melanoma and the influence of varying levels of key attributes and baseline characteristics. METHODS: A D-efficient design generated 12 choice tasks for two alternative treatments, adjuvant immunotherapy or no adjuvant immunotherapy. Recruitment to the online discrete choice experiment (DCE) occurred via survey dissemination by eight Australian melanoma consumer and professional groups, targeting adults with resected stage III melanoma, considering or having received adjuvant immunotherapy. The DCE included six attributes with two to three levels each, including 3-year risk of recurrence, mild, permanent and fatal adverse events (AEs), drug regimen and annual out-of-pocket costs. A mixed multinomial logit model was used to estimate preferences and calculate marginal rates of substitution and marginal willingness to pay (mWTP). RESULTS: The DCE was completed by 116 respondents, who chose adjuvant immunotherapy over no adjuvant immunotherapy in 70% of choice tasks. Respondents preferred adjuvant immunotherapy when associated with reduced: probabilities of recurrence, permanent and fatal AEs, and out-of-pocket costs. mWTP for an absolute reduction of 1% in 3-year risk of recurrence was less for respondents with lower rather than higher incomes, AU$794 (US$527) and AU$2190 (US$1454) per year. Respondents accepted an additional 4% chance of a permanent AE to reduce their absolute risk of 3-year recurrence by 1%. Respondents were willing to accept an extra 2% chance of 3-year recurrence to lower their chance of a fatal AE by 1%. CONCLUSIONS: Almost three-quarters of respondents chose adjuvant immunotherapy over no adjuvant immunotherapy, preferring treatment that improved efficacy and safety. Findings may inform decisions about access to adjuvant immunotherapy following surgery for melanoma.
Melanoma is the deadliest type of skin cancer. Treatment for melanoma involves surgery to remove it and can be followed by extra (adjuvant) immunotherapy, a type of drug that uses the body's immune system to fight any leftover melanoma. Immunotherapy can help a person live longer (benefits) but has downsides or side-effects (risks) that may need a person to take daily medication for life. We surveyed people with melanoma to learn what was important to them and which immunotherapy treatment risks were acceptable in order to gain benefits (trade-offs). People preferred treatment that lowered the chance of the melanoma returning and lowered the chance of dying from a treatment side-effect. People accepted an extra 4% (4 per 100) chance of a life-long treatment side-effect to lower the chance of their melanoma returning by 1% (1 per 100). This information will help doctors, nurses and governments to consider what treatment options are available to people with melanoma and their families.
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Melanoma , Neoplasias Cutáneas , Adulto , Humanos , Australia , Melanoma/cirugía , Melanoma/tratamiento farmacológico , Neoplasias Cutáneas/cirugía , Inmunoterapia/efectos adversos , Conducta de Elección , Prioridad del Paciente , Melanoma Cutáneo MalignoRESUMEN
OBJECTIVE: The use of extracorporeal cardiopulmonary resuscitation (ECPR) for out-of-hospital cardiac arrests (OHCA) has increased dramatically over the past decade. ECPR is resource intensive and costly, presenting challenges for policymakers. We sought to review the cost-effectiveness of ECPR compared with conventional cardiopulmonary resuscitation (CCPR) in OHCA. METHODS: We searched Medline, Embase, Tufts CEA registry and NHS EED databases from database inception to 2021 or 2015 for NHS EED. Cochrane Covidence was used to screen and assess studies. Data on costs, effects and cost-effectiveness of included studies were extracted by two independent reviewers. Costs were converted to USD using purchasing power parities (OECD, 2022).1 The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist (Husereau et al., 2022)2 was used for reporting quality and completeness of cost-effectiveness studies; the review was registered on PROSPERO, and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: Four studies met the inclusion criteria; three cost-effectiveness studies reported an incremental cost-effectiveness ratio (ICER) for OHCA compared with conventional care, and one reported the mean operating cost of ECPR. ECPR was more costly, accrued more life years (LY) and quality-adjusted life years (QALYs) than CCPR and was more cost-effective when compared with CCPR and other standard therapies. Overall study quality was rated as moderate. CONCLUSION: Few studies have examined the cost-effectiveness of ECPR for OHCA. Of those, ECPR for OHCA was cost-effective. Further studies are required to validate findings and assess the cost-effectiveness of establishing a new ECPR service or alternate ECPR delivery models.
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Reanimación Cardiopulmonar , Oxigenación por Membrana Extracorpórea , Paro Cardíaco Extrahospitalario , Adulto , Análisis Costo-Beneficio , Humanos , Paro Cardíaco Extrahospitalario/terapia , Años de Vida Ajustados por Calidad de Vida , Estudios RetrospectivosRESUMEN
BACKGROUND: Optimising the care of individuals with cancer without imposing significant financial burden related to their anticancer treatment is becoming increasingly difficult. The American Society of Clinical Oncology (ASCO) has recommended clinicians discuss costs of cancer care with patients to enhance shared decision-making. We sought information to guide oncologists' discussions with patients about these costs. METHODS: We searched Medline, EMBASE and clinical practice guideline databases from January 2009 to 1 June 2019 for recommendations about discussing the costs of care and financial burden. Guideline quality was assessed with the AGREE-II instrument. RESULTS: Twenty-seven guidelines met our eligibility criteria, including 16 from ASCO (59%). 21 of 27 (78%) guidelines included recommendations about discussion or consideration of treatment costs when prescribing, with information about actual costs in four (15%). Recognition of the risk of financial burden or financial toxicity was described in 81% (22/27) of guidelines. However, only nine guidelines (33%) included information about managing the financial burden. CONCLUSIONS: Current clinical practice guidelines have little information to guide physician-patient discussions about costs of anticancer treatment and management of financial burden. This limits patients' ability to control costs of treatment, and for the healthcare team to reduce the incidence and severity of financial burden. Current guidelines recommend clinician awareness of price variability and high costs of treatment. Clinicians are recommended to explore cost concerns and address financial worries, especially in high risk groups. Future guidelines should include advice on facilitating cost transparency discussions, with provision of cost information and resources.
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Comunicación , Costo de Enfermedad , Neoplasias/economía , Oncólogos , Relaciones Médico-Paciente , Guías de Práctica Clínica como Asunto/normas , Estrés Financiero/diagnóstico , Estrés Financiero/terapia , Costos de la Atención en Salud , Humanos , Neoplasias/terapia , Sociedades MédicasRESUMEN
BACKGROUND: Adjuvant immunotherapy is revolutionising care for patients with resected stage III and IV melanoma. However, immunotherapy may be associated with toxicity, making treatment decisions complicated. This study aimed to identify factors physicians and nurses considered regarding adjuvant immunotherapy for melanoma. METHODS: In-depth interviews were conducted with physicians (medical oncologists, surgeons and dermatologists) and nurses managing patients with resected stage III melanoma at three Australian tertiary melanoma centres between July 2019 and March 2020. Factors considered regarding adjuvant immunotherapy were explored. Recruitment continued until data saturation and thematic analysis was undertaken. RESULTS: Twenty-five physicians and nurses, aged 28-68 years, 60% females, including eleven (44%) medical oncologists, eight (32%) surgeons, five (20%) nurses, and one (4%) dermatologist were interviewed. Over half the sample managed five or more new resected stage III patients per month who could be eligible for adjuvant immunotherapy. Three themes about adjuvant immunotherapy recommendations emerged: [1] clinical and patient factors, [2] treatment information provision, and [3] individual physician/nurse factors. Melanoma sub-stage and an individual patient's therapy risk/benefit profile were primary considerations. Secondary factors included uncertainty about adjuvant immunotherapy's effectiveness and their views about treatment burden patients might consider acceptable. CONCLUSIONS: Patients' disease sub-stage and their treatment risk versus benefit drove the melanoma health care professionals' adjuvant immunotherapy endorsement. Findings clarify clinician preferences and values, aiding clinical communication with patients and facilitating clinical decision-making about management options for resected stage III melanoma.
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Inmunoterapia , Melanoma/terapia , Neoplasias Cutáneas/patología , Neoplasias Cutáneas/terapia , Adulto , Factores de Edad , Actitud del Personal de Salud , Australia , Instituciones Oncológicas , Toma de Decisiones Clínicas , Consultores , Dermatólogos , Femenino , Humanos , Masculino , Melanoma/patología , Persona de Mediana Edad , Enfermeras y Enfermeros , Oncólogos , Medición de Riesgo , Cirujanos , Melanoma Cutáneo MalignoRESUMEN
BACKGROUND: Adjuvant immunotherapy is a new treatment paradigm for adults with resected stage 3 melanoma. However, therapy can lead to long-term adverse health impacts, making immunotherapy decisions difficult. This study aimed to explore patients and their partners' views when considering whether to commence adjuvant immunotherapy. METHODS: Focus groups and in-depth interviews were conducted among adults with resected stage 3 melanoma and their partners between August 2019 and April 2020. Factors important to adjuvant immunotherapy decision making were explored. Recruitment continued until data saturation, with thematic analysis performed. RESULTS: Thirty-six participants were recruited across two cohorts, including 24 patients (mean age 65 years, 71% male), and 12 partners (mean age 69 years, 75% female). Twenty-two patients (92%) received adjuvant immunotherapy, two (8%) declined. Five patients (21%) ceased treatment early because of toxicity. Five themes about adjuvant immunotherapy were common to all participants: (1) life and death; (2) perceived risks and benefits; (3) seeking information; (4) healthcare team relationship; and (5) immunotherapy treatment considerations. Prolonging life was the primary consideration, with secondary concerns about treatment burden, timing, costs and efficacy. CONCLUSIONS: This information can be used by clinicians to support melanoma treatment decision making.
Melanoma is a type of skin cancer that can be deadly. Treatment for melanoma involves surgery to remove it and can be followed by extra (adjuvant) immunotherapy, a type of drug that uses the body's immune system to fight any leftover melanoma. Immunotherapy can help a person live longer but has downsides or side effects that may need a person to take daily medication for life. We spoke to patients with melanoma and their partners to learn what was important to them when deciding to have immunotherapy. Living longer was most important, followed by concerns about treatment difficulties and costs. This information will help doctors and nurses discuss treatment options for melanoma with patients and their families.
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Melanoma , Neoplasias Cutáneas , Anciano , Femenino , Humanos , Inmunoterapia/efectos adversos , Masculino , Melanoma/terapia , Neoplasias Cutáneas/terapiaRESUMEN
BACKGROUND: Immunotherapy improves overall survival for patients with metatstatic melanoma and improves recurrence-free survival in the adjuvant setting, but is costly and has adverse effects. Little is known about the preferences of patients and clinicians regarding immunotherapy. This study aimed to identify factors important to patients and clinicians when deciding about immunotherapy for stages 2-4 melanoma. METHODS: This study searched the Medline, EMBASE, ECONLIT, PsychINFO, and COCHRANE Systematic Reviews databases from inception to June 2018 for immunotherapy choice and preference studies. Findings were tabulated and summarized, and study reporting was assessed against recommended checklists. RESULTS: This investigation identified eight studies assessing preferences for melanoma treatment; four studies regarding nivolumab, pembrolizumab, or ipilimumab; and four studies regarding interferon conducted in the United States, Germany, and Australia. The following 10 factors were important to decision-making: overall survival, recurrence-free survival, treatment side effects, dosing regimen, patient or payer cost, patient age, clinician or family/friend treatment recommendation, quality of life, and psychosocial effects. Overall survival was the most important factor for all respondents. The patients judged severe toxicities to be tolerable for small survival gains. The description of information about treatment harms and benefits was limited in most studies. CONCLUSIONS: Overall survival was of primary importance to patients and clinicians considering immunotherapy. Impaired quality of life due to adverse effects appeared to be a second-order consideration. Future research is required to determine preferences for contemporary combination therapies, extended treatment durations, and avoidance of chronic side effects. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42018095899.
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Antineoplásicos Inmunológicos/uso terapéutico , Toma de Decisiones , Inmunoterapia/mortalidad , Melanoma/tratamiento farmacológico , Prioridad del Paciente/psicología , Calidad de Vida , Análisis Costo-Beneficio , Humanos , Melanoma/inmunología , Melanoma/patología , Pronóstico , Tasa de SupervivenciaRESUMEN
BACKGROUND: The objective of the present study was to perform a systematic review and meta-analysis of randomized controlled trials looking at the effect of distal clavicle resection in patients undergoing rotator cuff repair (RCR). METHODS: A systematic literature search was undertaken to identify randomized controlled trials looking at RCR +/- distal clavicle resection. Primary clinical outcome measures included in the meta-analysis were American Shoulder Elbow Society (ASES) score, pain on visual analogue scale and range of motion in forward elevation. RESULTS: The systematic review identified three studies with a total of 203 participants. Those who underwent distal clavicle resection in conjunction with RCR had worse pain and acromioclavicular joint tenderness at 3-month follow-up. This difference, however, was not observed at the 24-month follow-up. The mean difference (95% confidence interval) for the ASES score was 0.45 (-3.67 to 4.58) and pain on visual analogue scale was - 0.27 (-0.70 to 0.16). CONCLUSIONS: Routine distal clavicle resection in the setting of rotator cuff repair does not result in improved outcomes for patients with no difference being observed at 24 months post surgery. The results of our systematic review and meta-analysis do not support routine distal clavicle resection when performing RCR.
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BACKGROUND: In patients with recurrent glioblastoma, the benefit of bevacizumab beyond progression remains uncertain. We prospectively evaluated continuing or ceasing bevacizumab in patients who progressed while on bevacizumab. METHODS: CABARET, a phase II study, initially randomized patients to bevacizumab with or without carboplatin (Part 1). At progression, eligible patients underwent a second randomization to continue or cease bevacizumab (Part 2). They could also receive additional chemotherapy regimens (carboplatin, temozolomide, or etoposide) or supportive care. RESULTS: Of 120 patients treated in Part 1, 48 (80% of the anticipated 60-patient sample size) continued to Part 2. Despite randomization, there were some imbalances in patient characteristics. The best response was stable disease in 7 (30%) patients who continued bevacizumab and 2 (8%) patients who stopped receiving bevacizumab. There were no radiological responses. Median progression-free survival was 1.8 vs 2.0 months (bevacizumab vs no bevacizumab; hazard ratio [HR], 1.08; 95% CI, .59-1.96; P = .81). Median overall survival was 3.4 vs 3.0 months (HR, .84; 95% CI, .47-1.50; P = .56 and HR .70; 95% CI .38-1.29; P = .25 after adjustment for baseline factors). Quality-of-life scores did not significantly differ between arms. While the maximum daily steroid dose was lower in the continuation arm, the difference was not statistically significant. CONCLUSIONS: Patients who continued bevacizumab beyond disease progression did not have clear survival improvements, although the study was not powered to detect other than very large differences. While these data provide the only randomized evidence related to continuing bevacizumab beyond progression in recurrent glioblastoma, the small sample size precludes definitive conclusions and suggests this remains an open question.
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PURPOSE: In brain tumours, brain metastases or advanced cancer; treatment with corticosteroids, side effects can add to symptoms. These are best assessed by patients, complementing clinical assessment. We assessed the feasibility and validity of the Dexamethasone Symptom Questionnaire-Chronic (DSQ-Chronic), patient and caregiver versions. METHODS: A longitudinal cohort study was conducted, collecting clinician-rated toxicity, performance status, dexamethasone dose and DSQ-Chronic (patient and caregiver versions) at baseline, then 2, 4 and 8 weeks later. Patients had a primary malignant brain tumour, brain metastases, or advanced cancer; Karnofsky Performance Status ≥40 and predicted survival ≥8 weeks. Analysis included questionnaire completion rates, frequency and severity of dexamethasone-attributable side effects, agreement between patient and caregiver ratings, comparison with clinician-rated toxicity and correlation with performance status. RESULTS: Sixty-six patients were recruited (mean age 60 years), with their caregivers. Completion of questionnaires was over 90% for the dyad at baseline but dropped over time, with caregiver completion rates higher at all timepoints. Agreement between patients and proxies was fair to moderate, and while proxies systematically overestimated symptom severity on DSQ-chronic total scores, the bias was less than 10 points. Patient and clinician agreement was higher for more objective symptoms. CONCLUSION: The DSQ-Chronic is feasible when the patient is relatively well. As capacity to complete the DSQ-Chronic diminishes, caregivers can be proxy-raters. Clinicians capture corticosteroid toxicities, which may not be obvious to the patient. The DSQ-Chronic, patient and caregiver versions, are useful tools to be used with clinician assessment.
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Cuidadores , Dexametasona/efectos adversos , Glucocorticoides/efectos adversos , Autoinforme , Encuestas y Cuestionarios , Adulto , Anciano , Anciano de 80 o más Años , Sesgo , Neoplasias Encefálicas/tratamiento farmacológico , Estudios de Cohortes , Dexametasona/uso terapéutico , Femenino , Glioma/tratamiento farmacológico , Glucocorticoides/uso terapéutico , Humanos , Hipertensión Intracraneal/tratamiento farmacológico , Estado de Ejecución de Karnofsky , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Apoderado , Resultado del TratamientoRESUMEN
BACKGROUND: The optimal use of bevacizumab in recurrent glioblastoma (GBM), including the choice of monotherapy or combination therapy, remains uncertain. The purpose of this study was to compare combination therapy with bevacizumab monotherapy. METHODS: This was a 2-part randomized phase 2 study. Eligibility criteria included recurrent GBM after radiotherapy and temozolomide, no other chemotherapy for GBM, and Eastern Cooperative Oncology Group performance status 0-2. The primary objective (Part 1) was to determine the effect of bevacizumab plus carboplatin versus bevacizumab monotherapy on progression-free survival (PFS) using modified Response Assessment in Neuro-Oncology criteria. Bevacizumab was given every 2 weeks, 10 mg/kg; and carboplatin every 4 weeks, (AUC 5). On progression, patients able to continue were randomized to continue or cease bevacizumab (Part 2). Secondary endpoints included objective radiological response rate (ORR), quality of life, toxicity, and overall survival (OS). RESULTS: One hundred twenty-two patients (median age, 55y) were enrolled to Part 1 from 18 Australian sites. Median follow-up was 32 months, and median on-treatment time was 3.3 months. Median PFS was 3.5 months for each arm (hazard ratio [HR]: 0.92, 95% CI: 0.64-1.33, P = .66). ORR was 14% (combination) versus 6% (monotherapy) (P = .18). Median OS was 6.9 (combination) versus 7.5 months (monotherapy) (HR: 1.18, 95% CI: 0.82-1.69, P = .38). The incidence of bevacizumab-related adverse events was similar to prior literature, with no new toxicity signals. Toxicities were higher in the combination arm. Part 2 data (n = 48) will be reported separately. CONCLUSIONS: Adding carboplatin resulted in more toxicity without additional clinical benefit. Clinical outcomes in patients with recurrent GBM treated with bevacizumab were inferior to those in previously reported studies. CLINICAL TRIALS REGISTRATION NR: ACTRN12610000915055.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Encefálicas/tratamiento farmacológico , Glioblastoma/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Bevacizumab/administración & dosificación , Bevacizumab/efectos adversos , Neoplasias Encefálicas/mortalidad , Carboplatino/administración & dosificación , Carboplatino/efectos adversos , Supervivencia sin Enfermedad , Femenino , Glioblastoma/mortalidad , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Modelos de Riesgos ProporcionalesRESUMEN
AIMS: To provide data on the patterns of care in neuro-oncology practices at Australian cancer centres over the previous 12-month period. METHODS: A 5-page questionnaire was sent to Cooperative Trials Group for Neuro-Oncology members at 28 Australia cancer centres. The questions included access to neuro-oncology services; treatment protocols and patterns of supportive care. RESULTS: Provision of neuro-oncology services was consistent in metropolitan cancer centres. Treatment protocols are virtually identical for patients with an initial diagnosis of glioblastoma multiforme (GBM), with the main variation being for older or less fit patients. Most patients (70%) received chemotherapy at recurrence, most commonly modified schedule temozolomide, with half of the cancer centers offering bevacizumab. For anaplastic astrocytoma (AA), most clinicians offer radiotherapy alone but 30% would use radiotherapy with concurrent and adjuvant temozolomide. Half of clinicians continued to use prophylactic anticonvulsants; 25% do not prescribe prophylactic antibiotics during chemoradiotherapy and half would continue anti-coagulation therapy indefinitely for thromboembolism. CONCLUSION: This is the first Australia-wide patterns of study of care in the management of gliomas. There is general consensus on the use of radiotherapy with concurrent and adjuvant temozolomide and the use of chemotherapy for recurrent GBM. The choice of chemotherapy at recurrence is not standard and the provision of bevacizumab is inconsistent. This survey highlights variation in the treatment of the elderly GBM and patients with AA as well as in areas of supportive care, in particular, the ongoing use of prophylactic anticonvulsants despite guidelines.
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Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/terapia , Glioblastoma/diagnóstico , Glioblastoma/terapia , Oncología Médica/métodos , Oncología Médica/estadística & datos numéricos , Australia , Recolección de Datos , Humanos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Encuestas y CuestionariosRESUMEN
Marginal communities, such as culturally and linguistically diverse (CALD) patients, have significantly lower rates of recruitment, accrual, and retention in cancer clinical trials. A combination of language and cultural barriers means that trial participation from CALD communities remains at suboptimal levels, which in turn favors research findings that are biased towards therapeutic effects or toxicities within the context of non-CALD populations. Here we outline some key challenges and implications for CALD patient participation in glioma research in countries such as Australia, where English is the language of governance and health services implementation. We highlight multistakeholder interventions to improve both investigator recruitment and participation of CALD communities in future glioma research, particularly in this era when global migration has come of age. Enhancing research participation of CALD communities ensures not only wider understanding of genetic heterogeneity to improve glioma outcomes but also equity in access to care.