On the receiving end: have patient perceptions of the side-effects of cancer chemotherapy changed since the twentieth century?

BACKGROUND: Studies in 1983 and 1993 identified and ranked symptoms experienced by cancer patients receiving chemotherapy. We repeated the studies to obtain updated information on patient perceptions of chemotherapy-associated symptoms. PATIENTS AND METHODS: A cross-sectional interview and patient-reported outcome questionnaires were administered to out-patients receiving chemotherapy. Patients selected from 124 cards to identify and rank the severity of physical and non-physical symptoms they had experienced and attributed to chemotherapy (primary endpoint). The patient's medical oncologist and primary chemotherapy nurse were invited to rank the five symptoms they believed the patient would rank as their most severe. We analysed the association of symptoms and their severity with patient demographics, chemotherapy regimen, and patient-reported outcomes. Results were compared to the earlier studies. RESULTS: Overall, 302 patients completed the interview: median age 58 years (range 17-85); 56% female; main tumour types colorectal 81 (27%), breast 67 (22%), lung 49 (16%); 45% treated with curative intent. Most common symptoms (reported by >50%) were: alopecia, general weakness, effects on family/partner, loss of taste, nausea, fatigue, difficulty sleeping, effects on work/home duties, and having to put life on hold. The most severe symptoms (ranked by >15% in top five) were: concern about effects on family/partner, nausea, fear of the future, fatigue, not knowing what will happen, putting my life on hold, and general weakness. Perceptions of doctors and nurses of patients' symptom severity closely matched patients' rankings. CONCLUSIONS: Compared to earlier studies, there was an increase in non-physical concerns such as effects on family and future, and a decrease in physical symptoms, particularly vomiting, but nausea, fatigue and general weakness remained bothersome. HIGHLIGHTS: • Symptoms related to chemotherapy have changed over time, likely due to less toxic regimens and improvements in supportive care. • Effects on family/partner, fear of the future, not knowing what will happen, and "life on hold" were major issues for patients. • Vomiting has decreased but nausea, fatigue and general weakness remain common symptoms for chemotherapy patients.

Preferences for life expectancy discussions following diagnosis with a life-threatening illness: a discrete choice experiment.

PURPOSE: To explore in a sample of adult cancer patients: (1) the relative influence of initiation source, information format and consultation format on preferred approach to life expectancy disclosure using a discrete choice experiment (DCE); and (2) whether patient age, cancer type and perceived prognosis were associated with preferences within the three attributes. METHODS: A DCE survey of adult solid tumour and haematological cancer patients. Participants chose between three hypothetical scenarios about life expectancy disclosure consisting of three attributes: initiation source (i.e. doctor versus patient-initiated discussion), information content (i.e. estimate presented as best-worst-typical length of life case scenario versus median survival time) and consultation format (i.e. two 20-min versus one 40-min consultation). Respondents selected their most preferred scenario within each question. RESULTS: Three hundred and two patients completed the DCE (78% consent rate). Initiation source was the most influential predictor of patient choice. More preferred a doctor deliver life expectancy information as soon as it is available rather than waiting for the patient to ask (59% vs 41% z = - 7.396, p < 0.01). More patients preferred the two 20-min rather than the one 40-min consultation format (55% vs 45%, z = 4.284, p < 0.01). Information content did not influence choice. Age, cancer type, and patient-perceived prognosis were not associated with preferences. CONCLUSION: Healthcare professionals should assess cancer patients' preferences for engaging in life expectancy discussions as soon as they have this information, and ensure patients have adequate time to consider the information they receive, seek additional information and involve others if they wish.

A randomised controlled trial of an advance care planning intervention for patients with incurable cancer.

BACKGROUND: We modified and evaluated an advance care planning (ACP) intervention, which had been shown to improve compliance with patient's end of life (EoL) wishes, in a different patient population. METHODS: Patients with incurable cancer, and a Family Member (FM), were randomised one-to-one to usual care or usual care plus an ACP intervention, between April 2014 and January 2017. Oncologists and participants were non-blinded. ACP was based on the Respecting Patient Choices model, with an offer to provide individualised ranges for typical, best-case and worst-case scenarios for survival time. Seven facilitators (two oncology nurses, two nurses and three allied health professionals) delivered the intervention within 2 weeks of study enrolment. The primary outcome measure, assessed by interviewing the FM 3 months after patient death, was the FM perception that the patient's wishes were discussed, and met. RESULTS: Six hundred and sixty-five patients from seven Australian metropolitan oncology centres were referred for consideration by their oncologists, 444 (67%) met the study inclusion criteria and were approached by a study researcher. Two hundred and eight patients (47%) and their FM entered the trial as dyads. Fifty-three (46%) dyads in the ACP group and 63 (54%) dyads in the usual-care group had complete primary outcome data (p = 0.16). Seventy-nine patients and 53 FMs attended an ACP discussion. Mean length of discussion was 57 min. FMs from 23 (43%) dyads allocated to ACP and 21 (33%) dyads allocated usual care reported the patient's EoL wishes were discussed and met (difference 10%, 95% CI: -2 to 8, p = 0.27). There were no differences in EoL care received, patient satisfaction with care; FM satisfaction with care or with death; or FM well being. Rates of palliative care referral were high in both groups (97% vs 96%). CONCLUSIONS: A formal ACP intervention did not increase the likelihood that EoL care was consistent with patients' preferences.

Patient autonomy and advance care planning: a qualitative study of oncologist and palliative care physicians' perspectives.

IMPORTANCE: Patients' are encouraged to participate in advance care planning (ACP) in order to enhance their autonomy. However, controversy exists as to what it means to be autonomous and there is limited understanding of how social and structural factors may influence cancer patients' ability to exercise their autonomy. OBJECTIVE: The objective of this study is to explore oncologists' and palliative care physicians' understanding of patient autonomy, how this influences reported enactment of decision-making at the end of life (EOL), and the role of ACP in EOL care. DESIGN AND SETTING: Qualitative semi-structured interviews were conducted with consultant oncologists (n = 11) and palliative medicine doctors (n = 7) working in oncology centres and palliative care units across Australia. RESULTS: We found that doctors generally conceptualized autonomy in terms of freedom from interference but that there was a profound disconnect between this understanding of autonomy and clinical practice in EOL decision-making. The clinicians in our study privileged care, relationships and a 'good death' above patient autonomy, and in practice were reluctant to 'abandon' their patients to total non-interference in decision-making. Patient autonomy in healthcare is bounded, as while patients were generally encouraged to express their preferences for care, medical norms about the quality and 'reasonableness' of care, the availability of services and the patients' family relationships act to enhance or limit patients' capacity to realize their preferences. While for many, this disconnect between theory and practice did not diminish the rhetorical appeal of ACP; for others, this undermined the integrity of ACP, as well as its relevance to care. For some, ACP had little to do with patient autonomy and served numerous other ethical, practical and political functions. CONCLUSION: The ethical assumptions regarding patient autonomy embedded in academic literature and policy documents relating to ACP are disconnected from the realities of clinical care. Medical norms and professional boundaries surrounding 'good deaths' have a greater influence on care than patient preference. ACP programs, therefore, may be rejected by healthcare professionals as irrelevant to care or may have the unintended consequence of limiting patient autonomy when used as a professional tool to encourage a 'right' way to die. A singular focus on bureaucratic ACP programs, which reduce patient autonomy to a 'tick box' exercise, may fail to enhance EOL care in any meaningful way.

"Standard Care" in Cancer Clinical Trials: An Analysis of Care Provided to Women in the Control Arms of Breast Cancer Clinical Trials.

Background: For trials to validly evaluate new treatments, comparison against the best existing alternative treatment is essential. We reviewed the care provided to women in control arms of breast cancer clinical trials to estimate the proportion consistent with the standard of care as defined in clinical guidelines. Methods: We analyzed phase III randomized controlled breast cancer trials comparing drug treatments with "standard care," enrolling between 2004 and 2014, and registered on ClinicalTrials.gov Our primary outcome was the proportion of trials in which treatment in the control arm was consistent with concurrent NCCN Guidelines. A secondary analysis assessed trials recruiting outside the United States that provided control group therapy not consistent with NCCN Guidelines, comparing them with the German Gynecological Oncology Group (AGO) guidelines. We assessed associations between the primary outcome and a priori selected trial characteristics. Results: This study included 210 trials that recruited 229,182 women worldwide; 29% of trials (60/210) did not provide control group treatment that was consistent with NCCN Guidelines. For trials not recruiting in the United States, results were similar; in 21% of trials, control arm treatment was inconsistent with both AGO and NCCN Guidelines. Factors significantly associated with offering control arm treatment that were inconsistent with guidelines were time period (later trials were less likely to be consistent), breast cancer stage and type (trials in early-stage breast cancer and estrogen receptor-negative disease were less likely consistent), and recruitment in ≥4 countries and recruitment outside the United States. Conclusions: To ensure that clinical trials achieve their goal of obtaining the best information to guide patient treatment, the question of how investigators chose and describe "standard care" for control arm participants warrants further investigation.

Adapting an Australian question prompt list in oncology to a Norwegian setting-a combined method approach.

PURPOSE: A question prompt list (QPL) is an inexpensive communication aid that has been proved effective in encouraging patients to ask questions during medical consultations. The aim of this project was to develop a QPL for Norwegian cancer patients. METHODS: A multimethod approach was chosen combining literature review, focus groups, and a survey in the process of culturally adjusting an Australian QPL for the Norwegian setting. Participants were recruited from the University Hospital of North Norway. They were asked to review and comment on iterative drafts of the QPL. RESULTS: Eighteen patients, mean age 54, participated in the focus groups, and 31 patients, mean age 55, participated in the survey. Focus groups suggested that topics related to accompanying relatives, children as next of kin, and rehabilitation were important and should be added to the original QPL. The survey revealed that most questions from the original QPL were considered both useful and understandable. Although half of the patients found some questions about prognosis unpleasant, the vast majority considered the same questions useful. Questions regarding clinical studies, multidisciplinary teams, and public versus private hospitals had lower ratings of usefulness. CONCLUSION: QPLs require some adjustment to the local cultural context, and a mixed method approach may provide a useful model for future cultural adaptation of QPLs. The present QPL has been adjusted to the needs of oncology patients in the Norwegian health care setting.

Advance Care Planning: is quality end of life care really that simple?

The routine implementation of Advance Care Planning (ACP) is now a prominent feature of policy directed at improving end of life care in Australia. However, while complex ACP interventions may modestly reduce medical care at the end of life and enable more people to die at home or outside of acute hospital settings, existing legal, organisational, cultural and conceptual barriers limit the implementation and utility of ACP. We suggest that meaningful improvements in end of life care will not result from the institutionalisation of ACP but from more significant changes to the design and delivery of care.

Perceptions of cancer of unknown primary site: a national survey of Australian medical oncologists.

BACKGROUND: Despite being the sixth most common cause of cancer death in Australia, cancer of unknown primary (CUP) site remains poorly understood. AIMS: To describe practices relating to the diagnosis, investigation, classification, communication and management of CUP among medical oncologists. METHODS: We invited all members of the Medical Oncology Group of Australia to participate in a national, anonymous online survey about CUP. The survey collected data regarding diagnosis acceptance, diagnostic tests, treatment protocols and communication practices around the diagnosis of CUP. RESULTS: Three hundred and two oncologists were invited and 86 (28%) completed the survey. Eighty (93%) respondents were directly involved in the assessment of patients with CUP. Eighty-five (99%) respondents were prepared to make a diagnosis of CUP if, after appropriate diagnostic tests, the primary location could not be ascertained. Eighty-three percent would assign a primary site to obtain Pharmaceutical Benefits Schedule funding of medical therapy. Sixty-two percent did not have a specific treatment protocol designed for CUP. The majority of oncologists used serum tumour markers and computed tomography scans in the initial work-up, while 43% indicated they would use a positron emission tomography scan in the majority of cases. The majority would arrange mammography in female patients. Thematic analysis of responses to open-ended questions about how CUP is described identified little consistency in the language being used. CONCLUSION: The approach to diagnosis, investigation and management of CUP by medical oncologists in Australia is variable. Many preferred to estimate the primary site and treat accordingly. Pharmaceutical Benefits Schedule restrictions may encourage the practice of 'best guessing'.

Improving hospital-based end of life care processes and outcomes: a systematic review of research output, quality and effectiveness.

BACKGROUND: As in other areas of health delivery, there is a need to ensure that end-of-life care is guided by patient centred research. A systematic review was undertaken to examine the quantity and quality of data-based research aimed at improving the (a) processes and (b) outcomes associated with delivering end-of-life care in hospital settings. METHODS: Medline, EMBASE and Cochrane databases were searched between 1995 and 2015 for data-based papers. Eligible papers were classified as descriptive, measurement or intervention studies. Intervention studies were categorised according to whether the primary aim was to improve: (a) end of life processes (i.e. end-of-life documentation and discussions, referrals); or (b) end-of-life outcomes (i.e. perceived quality of life, health status, health care use, costs). Intervention studies were assessed against the Effective Practice and Organisation of Care methodological criteria for research design, and their effectiveness examined. RESULTS: A total of 416 papers met eligibility criteria. The number increased by 13% each year (p < 0.001). Most studies were descriptive (n = 351, 85%), with fewer measurement (n = 17) and intervention studies (n = 48; 10%). Only 18 intervention studies (4%) met EPOC design criteria. Most reported benefits for end-of-life processes including end-of-life discussions and documentation (9/11). Impact on end-of-life outcomes was mixed, with some benefit for psychosocial distress, satisfaction and concordance in care (3/7). CONCLUSION: More methodologically robust studies are needed to evaluate the impact of interventions on end-of-life processes, including whether changes in processes translate to improved end-of-life outcomes. Interventions which target both the patient and substitute decision maker in an effort to achieve these changes would be beneficial.

Atypical Ewing sarcoma breakpoint region 1 fluorescence in-situ hybridization signal patterns in bone and soft tissue tumours: diagnostic experience with 135 cases.

AIMS: Recurrent Ewing sarcoma breakpoint region 1 (EWSR1) gene rearrangements characterize a select group of bone and soft tissue tumours. In our routine diagnostic practice with fluorescence in-situ hybridization (FISH), we have occasionally observed EWSR1 gene rearrangements in tumours not associated classically with EWSR1 translocations. This study aimed to review our institutional experience of this phenomenon and also to highlight the occurrence of unusual EWSR1 FISH signals (i.e. 5' centromeric region or 3' telomeric region signals) that do not fulfil the published diagnostic criteria for rearrangements. METHODS AND RESULTS: Using an EWSR1 break-apart probe, we performed FISH assays on formalin-fixed paraffin-embedded tissue sections from 135 bone and soft tissue specimens as part of their routine diagnostic work-up. EWSR1 gene rearrangements were identified in 51% of cases, 56% of which also showed an abnormal FISH signal pattern (in addition to classically rearranged signals). However, atypical FISH signals were present in 45% of the non-rearranged cases. In addition, we observed tumours unrelated to those described classically as EWSR1-associated that were technically EWSR1-rearranged in 6% of cases. Borderline levels of rearrangement (affecting 10-30% of lesional cells) were present in an additional 17% of these cases. CONCLUSIONS: While our study confirmed that FISH is a sensitive and specific tool in the diagnosis of EWSR1-associated tumours, atypical FISH signals and classical rearrangement in entities other than EWSR1-associated tumours can occur. Therefore, it is essential that the FISH result not be used as an isolated test, but must be evaluated in the context of clinical features, imaging, pathological and immunohistochemical findings.

A qualitative analysis of responses to a question prompt list and prognosis and end-of-life care discussion prompts delivered in a communication support program.

OBJECTIVE: Discussing end-of-life (EOL) care is challenging when death is not imminent, contributing to poor decision-making and EOL quality-of-life. A communication support program (CSP) targeting these issues may facilitate discussions. We aimed to qualitatively explore responses to a nurse-led CSP, incorporating a question prompt list (QPL-booklet of questions patients/caregivers can ask clinicians), promoting life expectancy and EOL-care discussions. METHODS: Participants met a nurse-facilitator to explore an EOL-focussed QPL. Prognosis and advance care planning (ACP) QPL content was highlighted. Thirty-one transcribed meetings were analysed using thematic text analysis before reaching data saturation. RESULTS: Thirty-one advanced cancer patients (life expectancy <12 months) and 11 family caregivers were recruited from six medical oncology clinics in Sydney, Australia. Intent to use the QPL related to information needs, involvement in care and readiness to discuss EOL issues. Many participants did not want life expectancy estimates, citing unreliable estimates, unknown treatment outcomes, or coping by not looking ahead. Most displayed interest in ACP, often motivated by a loved one's EOL experiences, clear treatment preferences, concerns about caregivers or recognition that ACP is valuable regardless of life expectancy. Timing emerged as a reason not to discuss EOL issues; many maintaining it was too early. CONCLUSION: Patients and caregivers appear ambivalent about acknowledging approaching death by discussing life expectancy but value ACP. Given heterogeneity in responses, individualised approaches are required to guide EOL discussion conduct and content. Further exploration of the role of prognostic discussion in ACP is warranted.

A question prompt list for patients with advanced cancer in the final year of life: development and cross-cultural evaluation.

BACKGROUND: Clinicians and patients find prognosis and end-of-life care discussions challenging. Misunderstanding one's prognosis can contribute to poor decision-making and end-of-life quality of life. A question prompt list (booklet of questions patients can ask clinicians) targeting these issues may help overcome communication barriers. None exists for end-of-life discussions outside the palliative care setting. AIM: To develop/pilot a question prompt list facilitating discussion/planning of end-of-life care for oncology patients with advanced cancer from Australia and the United States and to explore acceptability, perceived benefits/challenges of using the question prompt list, suggestions for improvements and the necessity of country-specific adaptations. DESIGN: An expert panel developed a question prompt list targeting prognosis and end-of-life issues. Australian/US semi-structured interviews and one focus group elicited feedback about the question prompt list. Transcribed data were analysed using qualitative methods. SETTING/PARTICIPANTS: Thirty-four patients with advanced cancer (15 Australian/19 US) and 13 health professionals treating such patients (7 Australian/6 US) from two Australian and one US cancer centre participated. RESULTS: Most endorsed the entire question prompt list, though a minority queried the utility/appropriateness of some questions. Analysis identified four global themes: (1) reinforcement of known benefits of question prompt lists, (2) appraisal of content and suggestions for further developments, (3) perceived benefits and challenges in using the question prompt list and (4) contrasts in Australian/US feedback. These contrasts necessitated distinct Australian/US final versions of the question prompt list. CONCLUSIONS: Participants endorsed the question prompt list as acceptable and useful. Feedback resulted in two distinct versions of the question prompt list, accommodating differences between Australian and US approaches to end-of-life discussions, highlighting the appropriateness of tailoring communication aides to individual populations.

Evaluation of a novel individualised communication-skills training intervention to improve doctors' confidence and skills in end-of-life communication.

BACKGROUND: We developed a novel individualised training program regarding end-of-life communication, designed to be time effective for busy junior-doctors working in hospital settings. AIM: We aimed to pilot this brief individualised training program with junior-doctors to explore its acceptability, feasibility and effect on the doctors' confidence, communication skills, attitudes towards psychosocial care and burnout. DESIGN: The content of the training intervention was informed by a systematic literature review and evidence-based clinical practice guidelines regarding end-of-life communication. The intervention was based on sound educational principles and involved three one-hour teaching sessions over a three-week period, including two individual sessions with an expert facilitator and simulated patient/caregiver. In addition, participants received written and audiovisual take-home learning materials. PARTICIPANTS were videotaped consulting with a simulated patient/caregiver pre/post training to assess the impact of the course on their communication behaviours. PARTICIPANTS completed de-identified questionnaires pre/post training, including self-assessed confidence, attitudes to psychosocial care, and the Maslach Burnout inventory. PARTICIPANTS: PARTICIPANTS included 22 junior-doctors from a large teaching hospital in Sydney, Australia. RESULTS: All participants reported that the training was useful, had been helpful for their communication with patients and that they would recommend the training to others. Significant improvements were found in participants' communication skills (in seven out of 21 specific and all three global communication behaviours assessed, range P=0.02 to <0.001), confidence in communicating about relevant topics (P<0.001), attitudes towards psychosocial care (P=0.03) and sense of personal accomplishment (P=0.043). There were no overall differences in participants' burnout levels. CONCLUSION: This intervention shows promise and warrants further formal evaluation.

Combination versus sequential single agent chemotherapy for metastatic breast cancer.

BACKGROUND: Combination chemotherapy can cause greater tumour cell kill if the drug dose is not compromised, while sequential single agent chemotherapy may allow for greater dose intensity and treatment time, potentially meaning greater benefit from each single agent. In addition, sequentially using single agents might cause less toxicity and impairment of quality of life, but it is not known whether this might compromise survival time. OBJECTIVES: To assess the effect of combination chemotherapy compared to the same drugs given sequentially in women with metastatic breast cancer. SEARCH METHODS: We searched the Cochrane Breast Cancer Group Specialised Register, using the search terms "advanced breast cancer" and "chemotherapy", MEDLINE and EMBASE on 31 October 2013. The World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov were also searched (22 March 2012). SELECTION CRITERIA: Randomised controlled trials of combination chemotherapy compared to the same drugs used sequentially in women with metastatic breast cancer in the first-, second- or third-line setting. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from published trials. Hazard ratios (HR) were derived from time-to-event outcomes where possible, and a fixed-effect model was used for meta-analysis. Response rates were analysed as dichotomous variables (risk ratios (RR)), and toxicity and quality of life data were extracted where available. MAIN RESULTS: Twelve trials reporting on nine treatment comparisons (2317 patients randomised) were identified. The majority of trials (10 trials) had an unclear or high risk of bias. Time-to-event data were collected for nine trials for overall survival and eight trials for progression-free survival. All 12 trials reported results for tumour response. In the 12 trials there were 1023 deaths in 2317 women randomised. There was no difference in overall survival, with an overall HR of 1.04 (95% confidence interval (CI) 0.93 to 1.16; P = 0.45), and no significant heterogeneity. This result was consistent in the four subgroups analysed (risk of bias, line of chemotherapy, type of schema of chemotherapy, and relative dose intensity). In particular, there was no difference in survival according to the type of schema of chemotherapy, that is whether chemotherapy was given on disease progression or after a set number of cycles. In the eight trials that reported progression-free survival, 678 women progressed out of the 886 women randomised. The combination arm had a higher risk of progression than the sequential arm (HR 1.16; 95% CI 1.03 to 1.31; P = 0.01) with no significant heterogeneity. This result was consistent in all subgroups. Overall tumour response rates were higher in the combination arm (RR 1.13; 95% CI 1.03 to 1.24; P = 0.008) but there was significant heterogeneity for this outcome across the trials. In the seven trials that reported treatment-related deaths, there was no significant difference between the two arms, although the CIs were very wide due to the small number of events (RR 1.53; 95% CI 0.71 to 3.29; P = 0.28). The risk of febrile neutropenia was higher in the combination arm (RR 1.32; 95% CI 1.06 to 1.65; P = 0.01). There was no statistically significant difference in the risk of neutropenia, nausea and vomiting, or treatment-related deaths. Overall quality of life showed no difference between the two groups, but only three trials reported this outcome. AUTHORS' CONCLUSIONS: Sequential single agent chemotherapy has a positive effect on progression-free survival, whereas combination chemotherapy has a higher response rate and a higher risk of febrile neutropenia in metastatic breast cancer. There is no difference in overall survival time between these treatment strategies, both overall and in the subgroups analysed. In particular, there was no difference in survival according to the schema of chemotherapy (giving chemotherapy on disease progression or after a set number of cycles) or according to the line of chemotherapy (first-line versus second- or third-line). Generally this review supports the recommendations by international guidelines to use sequential monotherapy unless there is rapid disease progression.

Identifying and prioritising gaps in colorectal cancer trials research in Australia.

OBJECTIVES: To identify gaps in colorectal cancer clinical trials research in Australia and to suggest and prioritise trials to fill those gaps. DESIGN, SETTING AND PARTICIPANTS: Retrospective review of colorectal cancer trial activity from 1 January 2005 to 1 July 2011 in Australia and internationally, followed by a consensus meeting of consumers, health care professionals, researchers and funding agencies. MAIN OUTCOME MEASURES: Proportion of Phase III and randomised clinical trials in the areas of prevention, screening, surgery, adjuvant therapy, advanced disease and behavioural interventions, and priority areas of research identified by participants at the consensus meeting. RESULTS: The registry search identified 76 colorectal cancer clinical trials (all phases) registered in Australia from 1 January 2005 to 1 July 2011, of which 51 were Phase III or randomised, and 323 Phase III and randomised trials registered worldwide. In Australia, most trials were in advanced colorectal cancer (32), screening (10), and behavioural interventions (9). Worldwide, most Phase III or randomised trials were in advanced disease (94, 29.1%), surgery (64, 19.8%), behavioural interventions (38, 11.8%), and screening (30, 9.3%). At the consensus meeting, all participant groups emphasised the need for research in secondary prevention, screening, individualised treatments and follow-up care after treatment for colorectal cancer. CONCLUSIONS: There is a mismatch between the high proportion of registered trials in advanced colorectal cancer and the areas of priority identified. The development of specific trials in these priority areas depends on the availability of funding and the existence of plausible interventions likely to improve patient outcomes.

Physician endorsement alone may not enhance question-asking by advanced cancer patients during consultations about palliative care.

PURPOSE: This study aimed to explore the effect of physician endorsement of question-asking on advanced cancer patients' question-asking behaviour during consultations about palliative care and to explore other potential predictors of patient question-asking. METHODS: Data were obtained from 80 control group patients from a randomised controlled trial of standard palliative care (PC) consultation (control group) versus provision of a question prompt list (QPL) before the consultation. Consecutive eligible patients with advanced cancer referred to 15 PC physicians from nine Australian PC centres participated. Baseline measures were obtained from patients; consultations were audiotaped, transcribed and analysed by blinded coders; and physicians estimated the patients' survival. RESULTS: Endorsement of question-asking by the physician was not related to the number of patient questions. Patients with the highest anxiety levels asked 3.5 times as many questions as those with least anxiety (incidence rate ratio (IRR) = 3.54, 95% confidence interval (CI) 1.90-6.59, P = 0.001). After allowing for the effect of anxiety, patients with an estimated survival of >12 weeks asked 76% more questions (IRR = 1.76, 95% CI 1.03-3.00, P = 0.04), whereas age, sex, educational background, occupation, information and involvement preferences and presence of a caregiver were not related to patient question-asking behaviour. CONCLUSION: Physician endorsement of question-asking alone does not appear to increase questions by advanced cancer patients during consultations about PC. Additional resources such as QPLs may be needed to facilitate patient question-asking.

Conflicts of interest: a review of institutional policy in Australian medical schools.

OBJECTIVE: To examine the adequacy of policies at Australian medical schools for managing potential conflicts of interest with the pharmaceutical industry. DESIGN, SETTING AND PARTICIPANTS: National survey of 20 Australian medical schools to assess their policies regarding disclosure and management of conflict of interest, undertaken in October 2009, using the American Medical Student Association's PharmFree Scorecard. MAIN OUTCOME MEASURES: Policy scores and grades for Australian medical schools. RESULTS: Compared with United States medical schools, Australian medical schools performed better in only the curriculum domain and had a lower mean score overall (44% v 58%; P < 0.001). CONCLUSION: Our results indicate a need for improved self-regulation of conflicts of interest in Australian medical schools.