Describing the health-related quality of life of Maori adults in Aotearoa me Te Waipounamu (New Zealand).

PURPOSE: In Aotearoa me Te Waipounamu (New Zealand; NZ) there are considerable inequities in health status and outcomes for Maori, the Indigenous peoples of NZ. It is therefore important that the health status and preferences of Maori are specifically considered in healthcare policy and decision making. This paper describes the health-related quality of life of 390 Maori adults who took part in the NZ EQ-5D-5L valuation study. METHODS: Responses on the five dimensions of the EQ-5D-5L were dichotomised into "no problems" and "any problems", summarised and disaggregated by age group. Mean preference weights were reported by age group and overall. Mean utility values (calculated by applying each participant's preference weights to their EQ-5D-5L profile) were summed and respective means and standard deviations reported by age, chronic disease status and disability. RESULTS: The EQ-5D-5L dimensions with the highest proportion of participants reporting any problems were pain/discomfort (61.5%) and anxiety/depression (50%). The most commonly-reported chronic disease was mental illness/distress (24.6%). Anxiety/depression ranked as the most important dimension, with usual activities, the least important. The mean utility value was 0.83 with the lowest value (0.79) found in the 18-24 and 45-54 age groups. For participants with at least one chronic disease the mean utility value was 0.76 compared to 0.91 for those with none. CONCLUSION: To reduce inequities experienced by Maori it is crucial that the health status of Maori and the values Maori place on health-related quality of life are properly understood. This can only be achieved using Maori-specific data.

The Impact of Surveillance Imaging Frequency on the Detection of Distant Disease for Patients with Resected Stage III Melanoma.

BACKGROUND: It is not known whether there is a survival benefit associated with more frequent surveillance imaging in patients with resected American Joint Committee on Cancer stage III melanoma. OBJECTIVE: The aim of this study was to investigate distant disease-free survival (DDFS), melanoma-specific survival (MSS), post distant recurrence MSS (dMSS), and overall survival for patients with resected stage III melanoma undergoing regular computed tomography (CT) or positron emission tomography (PET)/CT surveillance imaging at different intervals. PATIENTS AND METHODS: A closely followed longitudinal cohort of patients with resected stage IIIA-D disease treated at a tertiary referral center underwent 3- to 4-monthly, 6-monthly, or 12-monthly surveillance imaging between 2000 and 2017. Survival outcomes were estimated using the Kaplan-Meier method, and log-rank tests assessed the significance of survival differences between imaging frequency groups. RESULTS: Of 473 patients (IIIA, 19%; IIIB, 31%; IIIC, 49%; IIID, 1%) 30% underwent 3- to 4-monthly imaging, 10% underwent 6-monthly imaging, and 60% underwent 12-monthly imaging. After a median follow-up of 6.2 years, distant recurrence was recorded in 252 patients (53%), with 40% detected by surveillance CT or PET/CT, 43% detected clinically, and 17% with another imaging modality. Median DDFS was 5.1 years (95% confidence interval 3.9-6.6). Among 139 IIIC patients who developed distant disease, the median dMSS was 4.4 months shorter in those who underwent 3- to 4-monthly imaging than those who underwent 12-monthly imaging. CONCLUSION: Selecting patients at higher risk of distant recurrence for more frequent surveillance imaging yields a higher proportion of imaging-detected distant recurrences but is not associated with improved survival. A randomized comparison of low versus high frequency imaging is needed.

The prevalence of chronic kidney disease in Samoans living in Auckland, New Zealand.

AIMS: Pacific peoples have higher rates of chronic kidney disease (CKD) and are five times more likely to commence kidney replacement therapy compared with New Zealand (NZ) Europeans. As the majority live Auckland, this study looked at the prevalence of CKD in two Auckland Pacific Island health providers caring for a large proportion of Pacific peoples, of which almost 50% are Samoan, as well as NZ Europeans. METHODS: De-identified information was requested on individuals who had two or more CKD tests (serum creatinine and urinary albumin creatinine ratios) more than 3 months apart. CKD prevalence across different demographic groups was determined. Logistic regression was used to look at associations of known risk factors and CKD. RESULTS: Data from 25 127 patients was evaluated. Of the total sample, 7451 individuals identified as Samoans. The prevalence of CKD amongst all Samoans in this sample was 17.8% increasing to 36.3% in those Samoans that had been tested for CKD. The prevalence of CKD in this total sample was 13% increasing to 27.5% considering only those who had CKD testing. The odds of Samoans having CKD (adjOR: 1.9 [95%CI 1.7, 2.2]), all other Pacific Island ethnicities identified and NZ Maori (adjOR:1.5 [95%CI 1.3, 1.8]), were increased compared with non-Maori-non-Pacific (likelihood p value <.001). CONCLUSION: We report the high prevalence of CKD (15.9%-33.4%) in Samoans living in New Zealand. This reveals an urgent need for further studies to develop strategies to prevent or reduce the development of kidney failure and premature death.

Creating opportunities to improve detection of older adult abuse: a national interRAI study.

Despite being recognized as a major global health issue, older adult abuse (OAA) remains largely undetected and under-reported. Most OAA assessment tools fail to capture true prevalence. Follow up of patients where abuse exposure is not easily determined is a necessity. The interRAI-HC (International Resident Assessment Instrument-Home Care) currently underestimates the extent of abuse. We investigated how to improve detection of OAA using the interRAI-HC. Analysis of 7 years of interRAI-HC data from an Aotearoa New Zealand cohort was completed. We identified that through altering the criteria for suspicion of OAA, capture rates of at-risk individuals could be nearly doubled from 2.6% to 4.8%. We propose that via adapting the interRAI-HC criteria to include the "unable to determine" whether abuse occurred (UDA) category, identification of OAA sufferers could be substantially improved. Improved identification will facilitate enhanced protection of this vulnerable population.

Performance of Long-Term CT and PET/CT Surveillance for Detection of Distant Recurrence in Patients with Resected Stage IIIA-D Melanoma.

BACKGROUND: Follow-up for patients with resected stage IIIA-D melanoma may include computed tomography (CT) or positron emission tomography (PET)/CT imaging to identify distant metastases. The aim of this study was to evaluate the test performance over follow-up time, of structured 6- and 12-monthly follow-up imaging schedules in these patients. METHODS: We conducted a retrospective analysis of consecutive resected stage IIIA-D melanoma patients from Melanoma Institute Australia (2000-2017). Patients were followed until a confirmed diagnosis of distant metastasis, end of follow-up schedule, or death. Test accuracy was evaluated by cross-classifying the results of the test against a composite reference standard of histopathology, cytology, radiologic imaging, and/or clinical follow-up, and then quantified longitudinally using logistic regression models with random effects. RESULTS: In total, 1373 imaging tests were performed among 332 patients. Distant metastases were detected in 110 (33%) patients during a median follow-up of 61 months (interquartile range 38-86), and first detected by imaging in 86 (78%) patients. 152 (68%) patients had at least one false-positive result. Sensitivity of the schedule over 5 years was 79% [95% confidence interval (CI) 70-86%] and specificity was 88% (95% CI 86-90%). There was no evidence of a significant difference in test performance over follow-up time or by American Joint Committee on Cancer (AJCC) substage. The positive predictive value ranged between 33 and 48% over follow-up time, reflecting a ratio of 1:2 false-positives per true-positive finding. CONCLUSIONS: Regular 6- or 12-monthly surveillance imaging using CT or PET/CT has reasonable and consistent sensitivity and specificity over 5-year follow-up for resected stage IIIA-D melanoma patients. These data are useful when discussing the risks and benefits of long-term follow-up.

New Zealand Population Norms for the EQ-5D-5L Constructed From the Personal Value Sets of Participants in a National Survey.

OBJECTIVES: To derive New Zealand (NZ) population norms for the EQ-5D-5L and to examine the association between participants' sociodemographic characteristics and their health-related quality of life. METHODS: Data from the 2018 NZ EQ-5D-5L valuation study (n = 2468) were used. Each participant's 5-digit profile was converted to a single utility value using their personal value set. The profiles, mean utility values, and mean EuroQol visual analog scale (EQ-VAS) scores were summarized by dimension and disaggregated by age group and gender. Multivariable logistic and Tobit regressions were used to investigate the association between participants' sociodemographic characteristics and the EQ-5D-5L dimensions, utility values, and EQ-VAS scores. RESULTS: The mean utility value was 0.847 and the mean EQ-VAS score was 74.8. Of the 3125 possible EQ-5D-5L profiles, 25 profiles represented the current health status of the majority of participants (78%). The odds of having problems with anxiety or depression was greatest for people aged 18 to 24 years and decreased with age. People with a long-term disability or chronic illness had greater odds of problems on all dimensions and lower (poorer) utility values and EQ-VAS scores. Age, ethnicity, employment status, long-term disability, and chronic illness were associated with utility. CONCLUSION: EQ-5D-5L population norms were derived for the NZ population using the personal value sets of 2468 participants. Consistent with other countries' population norms, EQ-5D-5L utility values and EQ-VAS scores were associated with age, employment status, long-term disability, and chronic illness. These norms will support resource allocation decision making and help in understanding the health-related quality of life of the NZ population.

Effects of health literacy, screening, and participant choice on action plans for reducing unhealthy snacking in Australia: A randomised controlled trial.

BACKGROUND: Low health literacy is associated with poorer health outcomes. A key strategy to address health literacy is a universal precautions approach, which recommends using health-literate design for all health interventions, not just those targeting people with low health literacy. This approach has advantages: Health literacy assessment and tailoring are not required. However, action plans may be more effective when tailored by health literacy. This study evaluated the impact of health literacy and action plan type on unhealthy snacking for people who have high BMI or type 2 diabetes (Aim 1) and the most effective method of action plan allocation (Aim 2). METHODS AND FINDINGS: We performed a 2-stage randomised controlled trial in Australia between 14 February and 6 June 2019. In total, 1,769 participants (mean age: 49.8 years [SD = 11.7]; 56.1% female [n = 992]; mean BMI: 32.9 kg/m2 [SD = 8.7]; 29.6% self-reported type 2 diabetes [n = 523]) were randomised to 1 of 3 allocation methods (random, health literacy screening, or participant selection) and 1 of 2 action plans to reduce unhealthy snacking (standard versus literacy-sensitive). Regression analysis evaluated the impact of health literacy (Newest Vital Sign [NVS]), allocation method, and action plan on reduction in self-reported serves of unhealthy snacks (primary outcome) at 4-week follow-up. Secondary outcomes were perceived extent of unhealthy snacking, difficulty using the plans, habit strength, and action control. Analyses controlled for age, level of education, language spoken at home, diabetes status, baseline habit strength, and baseline self-reported serves of unhealthy snacks. Average NVS score was 3.6 out of 6 (SD = 2.0). Participants reported consuming 25.0 serves of snacks on average per week at baseline (SD = 28.0). Regarding Aim 1, 398 participants in the random allocation arm completed follow-up (67.7%). On average, people scoring 1 SD below the mean for health literacy consumed 10.0 fewer serves per week using the literacy-sensitive action plan compared to the standard action plan (95% CI: 0.05 to 19.5; p = 0.039), whereas those scoring 1 SD above the mean consumed 3.0 fewer serves using the standard action plan compared to the literacy-sensitive action plan (95% CI: -6.3 to 12.2; p = 0.529), although this difference did not reach statistical significance. In addition, we observed a non-significant action plan × health literacy (NVS) interaction (b = -3.25; 95% CI: -6.55 to 0.05; p = 0.054). Regarding Aim 2, 1,177 participants across the 3 allocation method arms completed follow-up (66.5%). There was no effect of allocation method on reduction of unhealthy snacking, including no effect of health literacy screening compared to participant selection (b = 1.79; 95% CI: -0.16 to 3.73; p = 0.067). Key limitations include low-moderate retention, use of a single-occasion self-reported primary outcome, and reporting of a number of extreme, yet plausible, snacking scores, which rendered interpretation more challenging. Adverse events were not assessed. CONCLUSIONS: In our study we observed nominal improvements in effectiveness of action plans tailored to health literacy; however, these improvements did not reach statistical significance, and the costs associated with such strategies compared with universal precautions need further investigation. This study highlights the importance of considering differential effects of health literacy on intervention effectiveness. TRIAL REGISTRATION: Australia and New Zealand Clinical Trial Registry ACTRN12618001409268.

Correction to: Estimation of treatment preference effects in clinical trials when some participants are indifferent to treatment choice.

In the original publication of this article [1], the number "- 0.49" in the below sentence in the Results section should be changed to "-3.23", and this typo does not affect the wider conclusions.

Patient attitude and acceptance towards episiotomy during pregnancy before and after information provision: a questionnaire.

INTRODUCTION AND HYPOTHESIS: Evidence regarding how women feel about episiotomies is not recorded in the literature. As the most common surgical procedure, there is a need to understand how women feel about episiotomy. METHODS: The primary outcome was to identify the percentage of women who would accept an episiotomy if required. A literature review was compiled to provide nulliparous women in their third trimester with evidence-based information about episiotomies and perineal tears. Questions eliciting demographics, pre-information level of anxiety and acceptance of episiotomy were asked. After reading the information sheets, anxiety and knowledge were assessed again. Changes in anxiety levels from pre- to post-information were investigated using paired samples t tests. Because anxiety was measured on a scale, we assessed potential departures from normality by using the Wilcoxon signed-rank test. Questions also assessed the value women placed on this form of education. RESULTS: There were 105 responses, with 88% accepting episiotomy, 2% declining and 10% seeking more information to decide. Eighty-one percent of women agreed that the information provided helped them to understand more about childbirth and 62% agreed that they felt more comfortable with the birthing process after reading the material. There was a reduction in anxiety levels regarding episiotomies after reading information (p = 0.002) and perineal tears (p = 0.02). CONCLUSIONS: Most women will accept an episiotomy if required. Antenatal education about episiotomies is important to women and helps them feel more comfortable with the birthing process. Written information increases acceptance and reduces anxiety levels regarding episiotomies.

False-Positive Results and Incidental Findings with Annual CT or PET/CT Surveillance in Asymptomatic Patients with Resected Stage III Melanoma.

OBJECTIVE: The aim of this study was to quantify false-positive and incidental findings from annual surveillance imaging in asymptomatic, American Joint Committee on Cancer stage III melanoma patients. METHODS: This was a cohort study of patients treated at Melanoma Institute Australia (2000-2015) with baseline computed tomography (CT) or positron emission tomography (PET)/CT imaging and at least two annual surveillance scans. False-positives were defined as findings suspicious for melanoma recurrence that were not melanoma, confirmed by histopathology, subsequent imaging, or clinical follow-up, while incidental findings were defined as non-melanoma-related findings requiring further action. Outcomes of incidental findings were classified as 'benign' if they resolved spontaneously or were not seriously harmful; 'malignant' if a second malignancy was identified; or 'other' if potentially harmful. RESULTS: Among 154 patients, 1022 scans were performed (154 baseline staging, 868 surveillance) during a median follow-up of 85 months (interquartile range 56-112); 57 patients (37%) developed a recurrence. For baseline and surveillance imaging, 124 false-positive results and incidental findings were identified in 81 patients (53%). The frequency of these findings was 5-14% per year, and an additional 181 tests, procedures, and referrals were initiated to investigate these findings. The diagnosis was benign in 109 findings of 124 findings (88%). Fifteen patients with a benign finding underwent an unnecessary invasive procedure. Surveillance imaging identified distant metastases in 20 patients (13%). CONCLUSION: False-positive results and incidental findings occur in at least half of all patients undergoing annual surveillance imaging, and the additional healthcare use is substantial. These findings persist over time. Clinicians need to be aware of these risks and discuss them with patients, alongside the expected benefits of surveillance imaging.

Optimising the two-stage randomised trial design when some participants are indifferent in their treatment preferences.

Outcomes in a clinical trial can be affected by any underlying preferences that its participants have for the treatments under comparison and by whether they actually receive their preferred treatment. These effects cannot be evaluated in standard trial designs but are estimable in the alternative two-stage randomised trial design, in which some patients can choose their treatment, while the rest are randomly assigned. We have previously shown that, when all two-stage trial participants have a preferred treatment, the preference effects can be evaluated, in addition to the usual direct effect of treatment. We also determined criteria by which to optimise how many participants should be given a choice of treatment vs being randomised. More recently, we extended our methodology to allow for participants who are unable or unwilling to express a treatment preference if they are assigned to the choice group. In this paper, we show how to optimise the two-stage design when some participants are undecided about their treatment. We demonstrate that the undecided group should be regarded as distinct in the analysis, to obtain valid estimates of the preference effects. We derive the optimal proportion of participants who should be offered a choice of treatment, which in many cases will be close to 50%. More generally, the optima depend on the preference rates for treatments and the proportion of undecided participants, and the parameters of primary interest. We discuss some advantages and disadvantages of the two-stage trial design in this situation and describe a practical example.

Rapid mapping of the spatial and temporal intensity of influenza.

Surveillance of influenza epidemics is a priority for risk assessment and pandemic preparedness, yet representation of their spatiotemporal intensity remains limited. Using the epidemic of influenza type A in 2016 in Australia, we demonstrated a simple but statistically sound adaptive method of mapping epidemic evolution over space and time. Weekly counts of persons with laboratory confirmed influenza type A infections in Australia in 2016 were analysed by official national statistical region. Weekly standardised epidemic intensity was represented by a standard score (z-score) calculated using the standard deviation of below-median counts in the previous 52 weeks. A geographic information system (GIS) was used to present the epidemic progression. There were 79,628 notifications of influenza A infections included. Of these, 79,218 (99.5%) were allocated to a geographical area. The GIS maps indicated areas of elevated epidemic intensity across Australia by week and area that were consistent with the observed start, peak and decline of the epidemic when compared with counts aggregated at the state and territory level. This simple, adaptable approach could improve local level epidemic intelligence in a variety of settings and for other diseases. It may also facilitate increased understanding of geographic epidemic dynamics.

A low literacy targeted talking book about radiation therapy for cancer: development and acceptability.

PURPOSE: To develop a low literacy talking book (written book with accompanying audio-recording) about radiation therapy and explore its acceptability with patients and caregivers. METHOD: The talking book was developed iteratively using low literacy design principles and a multidisciplinary committee comprising consumers and experts in radiation oncology, nursing, behavioural sciences, and linguistics. It contained illustrations, photos, and information on: treatment planning, daily treatment, side effects, psychosocial health, and a glossary of medical terms. Semi-structured interviews were conducted with patients who self-reported low functional health literacy and caregivers to explore their views on the resource. Thematic analysis using a framework approach informed the analysis. RESULTS: Participants were very satisfied with the content, illustrations, and language in the resource. Most were unfamiliar with the term 'talking book', but liked the option of different media (text and audio). The resource was seen as facilitating communication with the cancer care team by prompting question-asking and equipping patients and their families with knowledge to communicate confidently. CONCLUSIONS: The low literacy talking book was well accepted by patients and their caregivers. The next step is to examine the effect of the resource on patients' knowledge, anxiety, concerns, and communication with the cancer care team.

What information is communicated by radiation therapists to patients during education sessions on the first day of treatment?

This study examined the content covered by radiation therapists (RTs) during education sessions; the frequency and types of questions asked by patients; and the relationship between patient characteristics and the number of questions asked. Fifty-eight education sessions were audio-recorded and transcribed verbatim. A coding scheme was developed to examine the frequency of topics covered. It comprised 16 topics under four themes: (a) treatment schedule, (b) procedural information, (c) treatment-related side effects and (d) who will be involved in treatment provision. All education sessions covered information about the treatment plan (n = 58, 100%), and the majority described procedural information about what happens in the treatment room (n = 56, 97%). Least information was given about who will be providing treatment. On average, patients asked a mean of 6 questions (SD = 4.95; range = 0-28). Most frequently asked questions concerned the general treatment (logistics, schedule), accounting for 67% of all questions asked. The least common types of questions were related to the impact of treatment (6%). There were no statistically significant differences in the total number of questions and patient demographics. Patients are provided with most, but not all, of the recommended information. Tailoring of information by RTs was enabled in response to questions asked.

Use of shared care and routine tests in follow-up after treatment for localised cutaneous melanoma.

BACKGROUND: Patients may decide to undertake shared care with a general practitioner (GP) during follow-up after treatment for localised melanoma. Routine imaging tests for surveillance may be commonly used despite no evidence of clinical utility. This study describes the frequency of shared care and routine tests during follow-up after treatment for localised melanoma. METHODS: We randomly sampled 351 people with localised melanoma [American Joint Cancer Committee (AJCC) substages 0 - II] who had not had recurrent or new primary melanoma diagnosed from a total of 902 people diagnosed and treated for localised melanoma at a specialist centre in 2014. We interviewed participants by telephone about their experience of follow-up in the past year, and documented the proportion of patients who were undertaking shared care follow-up with a GP. We also recorded the frequency and type of investigations during follow-up. We calculated weighted estimates that are representative of the full inception cohort. RESULTS: Of the 351 people who were invited to participate, 230 (66%) people consented to the telephone interview. The majority undertook shared care follow-up with a GP (61%). People who choose to have shared care follow-up with a GP are more likely to be male (p = 0.006), have lower AJCC stage (p for trend = 0.02), reside in more remote areas (p for trend< 0.001), and are less likely to have completed secondary school (p < 0.001). Few people saw a non-doctor health practitioner as part of their follow-up (9%). Many people report undergoing tests for melanoma, much of which may be routine tests for surveillance (37%). CONCLUSIONS: The majority of people treated for a first primary localised melanoma at a specialist centre, without recurrent or new melanoma, choose to undertake shared care follow-up with a GP. Many appear to have routine diagnostic imaging as part of their melanoma surveillance.

Who Benefits from Aggressive Rapid Response System Treatments Near the End of Life? A Retrospective Cohort Study.

BACKGROUND: Many patients near the end of life are subject to rapid response system (RRS) calls. A study was conducted in a large Sydney teaching hospital to identify a cutoff point that defines nonbeneficial treatment for older hospital patients receiving an RRS call, describe interventions administered, and measure the cost of hospitalization. METHODS: This was a retrospective cohort of 733 adult inpatients with data for the period three months before and after their last placed RRS call. Subgroup analysis of patients aged ≥ 80 years was conducted. Log-rank, chi-square, and t-tests were used to compare survival, and logistic regression was used to examine predictors of death. RESULTS: Overall, 65 (8.9%) patients had a preexisting not-for-resuscitation (NFR) or not-for-RRS order; none of those patients survived to three months. By contrast, patients without an NFR or not-for-RRS order had three-month survival probability of 71% (log-rank χ2 145.63; p < 0.001). Compared with survivors, RRS recipients who died were more likely to be older, to be admitted to a medical ward, and to have a larger mean number of admissions before the RRS. The average cost of hospitalization for the very old transferred to the ICU was higher than for those not requiring treatment in the ICU (US$33,990 vs. US$14,774; p = 0.045). CONCLUSION: Identifiable risk factors clearly associated with poor clinical outcomes and death can be used as a guide to administer less aggressive treatments, including reconsideration of ICU transfers, adherence to NFR orders, and transition to end-of-life management instead of calls to the RRS team.

Meta-analysis of pre-operative magnetic resonance imaging (MRI) and surgical treatment for breast cancer.

BACKGROUND: Although there is no consensus on whether pre-operative MRI in women with breast cancer (BC) benefits surgical treatment, MRI continues to be used pre-operatively in practice. This meta-analysis examines the association between pre-operative MRI and surgical outcomes in BC. METHODS: A systematic review was performed to identify studies reporting quantitative data on pre-operative MRI and surgical outcomes (without restriction by type of surgery received or type of BC) and using a controlled design. Random-effects logistic regression calculated the pooled odds ratio (OR) for each surgical outcome (MRI vs. no-MRI groups), and estimated ORs stratified by study-level age. Subgroup analysis was performed for invasive lobular cancer (ILC). RESULTS: Nineteen studies met eligibility criteria: 3 RCTs and 16 comparative studies that included newly diagnosed BC of any type except for three studies restricted to ILC. Primary analysis (85,975 subjects) showed that pre-operative MRI was associated with increased odds of receiving mastectomy [OR 1.39 (1.23, 1.57); p < 0.001]; similar findings were shown in analyses stratified by study-level median age. Secondary analyses did not find statistical evidence of an effect of MRI on the rates of re-excision, re-operation, or positive margins; however, MRI was significantly associated with increased odds of receiving contralateral prophylactic mastectomy [OR 1.91 (1.25, 2.91); p = 0.003]. Subgroup analysis for ILC did not find any association between MRI and the odds of receiving mastectomy [OR 1.00 (0.75, 1.33); p = 0.988] or the odds of re-excision [OR 0.65 (0.35, 1.24); p = 0.192]. CONCLUSIONS: Pre-operative MRI is associated with increased odds of receiving ipsilateral mastectomy and contralateral prophylactic mastectomy as surgical treatment in newly diagnosed BC patients.

Fear of new or recurrent melanoma after treatment for localised melanoma.

OBJECTIVE: To estimate the amount of fear of new or recurrent melanoma among people treated for localised melanoma in an Australian specialist centre. METHODS: We randomly selected 400 potential participants from all those treated for localised melanoma at the Melanoma Institute Australia during 2014 (n = 902). They were asked to complete an adapted version of the Fear of Cancer Recurrence Inventory (FCRI). We calculated summary statistics for demographics, clinical variables and total FCRI and subscale scores. RESULTS: Two hundred fifteen people (54%) completed the FCRI questionnaire. The overall mean severity subscale score was 15.0 (95% CI 14.0-16.1). A high proportion of participants had scores above a proposed threshold to screen for clinical fear of cancer recurrence (77% and 63% of participants with and without new or recurrent melanoma had severity subscale scores ≥13). Most participants also had scores above a threshold found to have high specificity for clinical fear of cancer recurrence (65% and 48% of participants with and without new or recurrent melanoma had severity subscale scores ≥16). The severity subscale appeared to discriminate well between groups with differing levels of risk of new or recurrent melanoma. CONCLUSIONS: There is a substantial amount of fear of new or recurrent melanoma among this population, despite most having a very good prognosis.

Elevated Liver Enzymes and Mortality in Older Individuals: A Prospective Cohort Study.

AIM OF THE STUDY: The aim of the study was to determine the excess risk of all-cause and cardiovascular mortality in older people with elevated liver enzymes [alanine transaminase (ALT) and gamma glutamyltransferase (GGT)]. METHODS: We utilized data from a large, prospective, population based study of 2061 people aged 50 to 99 years with linkage to a National Death Registry. Participants were categorized as having elevated liver enzymes using standard thresholds (for males, GGT>51 and ALT>40 IU/L, and GGT>33 and ALT>31 IU/L for females). Adjusted Cox proportional hazards models assessed the association of elevated liver enzymes and mortality with long duration follow-up. RESULTS: Over a median follow-up of 10 years (20,145 person years), 701 people died, including 203 (34%) from cardiovascular disease. Cox regression models adjusted for sex, age, smoking, and alcohol intake indicated that people with elevated liver enzymes had an increased risk of all-cause mortality that was modified by age (test for interaction P=0.01). Age-stratified analyses demonstrated no increased risk at younger ages [age 59 y and below; hazard ratio (HR): 0.46; 95% confidence interval, 0.06-3.49], but increased risk with age; age 60 to 69, HR: 1.05 (0.53-2.07), age 70 to 79 years, HR: 1.54 (0.81 to 2.93), and age 80 years and above, HR: 3.53 (1.55 to 8.04). Similarly, the risk of cardiovascular mortality with elevated liver enzymes was also modified by, and increased with age (test for interaction P=0.02); age 70 to 79, HR: 3.15 (1.37 to 7.23), age 80 years and above, HR: 6.86 (2.44 to 19.30). CONCLUSIONS: In community-dwelling elderly persons, an elevation in both ALT and GGT are associated with an excess risk of all-cause and cardiovascular mortality which increases with age.

Estimation of treatment preference effects in clinical trials when some participants are indifferent to treatment choice.

BACKGROUND: In the two-stage randomised trial design, a randomly sampled subset of study participants are permitted to choose their own treatment, while the remaining participants are randomised to treatment in the usual way. Appropriate analysis of the data from both arms of the study allows investigators to estimate the impact on study outcomes of treatment preferences that patients may have, in addition to evaluating the usual direct effect of treatment. In earlier work, we showed how to optimise this design by making a suitable choice of the proportion of participants who should be assigned to the choice arm of the trial. However, we ignored the possibility of some participants being indifferent to the treatments under study. In this paper, we extend our earlier work to consider the analysis of two-stage randomised trials when some participants have no treatment preference, even if they are assigned to the choice arm and allowed to choose. METHODS: We compare alternative characterisations of the response profiles of the indifferent or undecided participants, and derive estimates of the treatment and preference effects on study outcomes. We also present corresponding test statistics for these parameters. The methods are illustrated with data from a clinical trial contrasting medical and surgical interventions. RESULTS: Expressions are obtained to estimate and test the impact of treatment choices on study outcomes, as well as the impact of the actual treatment received. Contrasts are defined between patients with stated treatment preferences and those with no preference. Alternative assumptions concerning the outcomes of undecided participants are described, and an approach leading to unbiased estimation and testing is identified. CONCLUSIONS: Use of the two-stage design can provide important insights into determinants of study outcomes that are not identifiable with other designs. The design can remain attractive even in the presence of participants with no stated treatment preference.