Research Publications and Outputs

The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial

2020-01-01T00:00:00Z

The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial Tarnow-Mordi, William Odita; Abdel-Latif, Mohamed E; Martin, Andrew; Pammi, Mohan; Robledo, Kristy; Manzoni, Paolo; Osborn, David; Lui, Kei; Keech, Anthony; Hague, Wendy; Ghadge, Alpana; Travadi, Javeed; Brown, Rebecca; Darlow, Brian A; Liley, Helen; Pritchard, Margo; Kochar, Anu; Isaacs, David; Gordon, Adrienne; Askie, Lisa; Cruz, Melinda; Schindler, Tim; Dixon, Kelly; Deshpande, Girish; Tracy, Mark; Schofield, Deborah; Austin, Nicola; Sinn, John; Simes, R John Background Very low birthweight or preterm infants are at increased risk of adverse outcomes including sepsis, necrotising enterocolitis, and death. We assessed whether supplementing the enteral diet of very low-birthweight infants with lactoferrin, an antimicrobial protein, reduces all-cause mortality or major morbidity. Methods We did a multicentre, double-blind, pragmatic, randomised superiority trial in 14 Australian and two New Zealand neonatal intensive care units. Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using minimising web-based randomisation to receive once daily 200 mg/kg pasteurized bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks’ postmenstrual age (or for 2 weeks, if longer), or until discharge from the study hospital if that occurred first. Designated nurses preparing the daily feeds were not masked to group assignment, but other nurses, doctors, parents, caregivers, and investigators were unaware. The primary outcome was survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks’ post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population. Safety analyses were by treatment received. We also did a prespecified, PRISMA-compliant meta-analysis, which included this study and other relevant randomized controlled trials, to estimate more precisely the effects of lactoferrin supplementation on late-onset sepsis, necrotizing enterocolitis, and survival. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000247976. Findings Between June 27, 2014, and Sept 1, 2017, we recruited 1542 infants; 771 were assigned to the intervention group and 771 to the control group. One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis. In-hospital death or major morbidity occurred in 162 (21%) of 770 infants in the intervention group and in 170 (22%) of 771 infants in the control group (relative risk [RR] 0·95, 95% CI 0·79–1·14; p=0·60). Three suspected unexpected serious adverse reactions occurred; two in the lactoferrin group, namely unexplained late jaundice and inspissated milk syndrome, but were not attributed to the intervention and one in the control group had fatal inspissated milk syndrome. Our meta-analysis identified 13 trials completed before Feb 18, 2020, including this Article, in 5609 preterm infants. Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71–0·88; p<0·0001; I²=58%), but not necrotising enterocolitis or all-cause mortality. Interpretation Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late onset sepsis, as found in our meta-analysis of over 5000 infants. Future collaborative studies should use products with demonstrated biological activity, be large enough to detect moderate and clinically important effects reliably, and assess greater doses of lactoferrin in infants at increased risk, such as those not exclusively receiving breastmilk or infants of extremely low birthweight.

SHaPED (Sydney Health Partners Emergency Department) dataset

2025-03-25T00:00:00Z

SHaPED (Sydney Health Partners Emergency Department) dataset Machado, Gustavo This dataset includes data for 4,625 encounters (from 18 years old) of low back pain to emergency departments, from two local health districts in Sydney and Western New South Wales, Australia. Data includes demographics, emergency department presentation data, medication use and imaging referrals. Patient reported outcome data is available for a sub-sample of 416 participants (pain, function, and satisfaction with care). The file type is .XLS

A Phase II study to evaluate the safety and potential palliative benefit of intraperitoneal bevacizumab in patients with symptomatic ascites due to advanced chemotherapy resistant gynaecological cancers: REZOLVE dataset

2024-07-16T00:00:00Z

A Phase II study to evaluate the safety and potential palliative benefit of intraperitoneal bevacizumab in patients with symptomatic ascites due to advanced chemotherapy resistant gynaecological cancers: REZOLVE dataset Sjoquist, Katrin This dataset includes 24 female participants (38 - 86 years old) receiving intraperitoneal bevacizumab recruited into the REZOLVE study from six hospitals in New South Wales, Queensland and Victoria, Australia. Baseline data includes demographics, ECOG performance status, prior systemic treatment, doses of the intervention administered, clinical chemistry, quality of life, adverse events and overall survival. Follow-up data was collected within three months after the first intraperitoneal administration of bevacizumab and includes adverse events and quality of life. The file type is .XLS.

Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: the PARTNER project dataset

2024-06-18T00:00:00Z

Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: the PARTNER project dataset Hunter, David This dataset includes 38 general practices and 217 patient participants ( ≥45 years old, 60% female) participating in a cluster randomised controlled trial to test a new model of telehealth service delivery for knee osteoarthritis (the PARTNER study). Participants were recruited via general practices in NSW and Victoria, Australia. The dataset includes baseline descriptive and demographic data for the general practices. For participants, baseline data includes participant reported demographics, medical history, body weight and BMI, knee pain and symptoms, quality of life, mood, sleep impairment, fatigue, physical activity, willingness for knee replacement surgery, fear of movement, pain coping, and self-efficacy. Follow-up data were collected at 6 and 12 months (primary outcome), and also included satisfaction with treatment, satisfaction with knee symptoms, global rating of change and adverse events. The tile type is .xls.

Short, medium, and long deferral of umbilical cord clamping compared with umbilical cord milking and immediate clamping at preterm birth: a systematic review and network meta-analysis with individual participant data

2023-01-01T00:00:00Z

Short, medium, and long deferral of umbilical cord clamping compared with umbilical cord milking and immediate clamping at preterm birth: a systematic review and network meta-analysis with individual participant data Seidler, Lene; Libesman, Sol; Hunter, Kylie; Barba, Angie; Aberoumand, Mason; Williams, Jonathan; Shrestha, Nipun; Aagerup, Jannik; Sotiropoulos, James; Montgomery, Alan; Gyte, Gillian; Duley, Lelia; Askie, Lisa Background Deferred (also known as delayed) cord clamping can improve survival of infants born preterm (before 37 weeks of gestation), but the optimal duration of deferral remains unclear. We conducted a systematic review and individual participant data network meta-analysis with the aim of comparing the effectiveness of umbilical cord clamping strategies with different timings of clamping or with cord milking for preterm infants. Methods We searched medical databases and trial registries from inception until Feb 24, 2022 (updated June 6, 2023) for randomised controlled trials comparing cord clamping strategies for preterm infants. Individual participant data were harmonised and assessed for risk of bias and quality. Interventions were grouped into immediate clamping, short deferral (≥15 s to <45 s), medium deferral (≥45 s to <120 s), long deferral (≥120 s), and intact cord milking. The primary outcome was death before hospital discharge. We calculated one-stage, intention-to-treat Bayesian random-effects individual participant data network meta-analysis. This study was registered with PROSPERO, CRD42019136640. Findings We included individual participant data from 47 trials with 6094 participants. Of all interventions, long deferral reduced death before discharge the most (compared with immediate clamping; odds ratio 0·31 [95% credibility interval] 0·11–0·80; moderate certainty). The risk of bias was low for 10 (33%) of 30 trials, 14 (47%) had some concerns, and 6 (20%) were rated as having a high risk of bias. Heterogeneity was low, with no indication of inconsistency. Interpretation This study found that long deferral of clamping leads to reduced odds of death before discharge in preterm infants. In infants assessed as requiring immediate resuscitation, this finding might only be generalisable if there are provisions for such care with the cord intact. These results are based on thoroughly cleaned and checked individual participant data and can inform future guidelines and practice. Funding Australian National Health and Medical Research Council.

Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis

2023-01-01T00:00:00Z

Deferred cord clamping, cord milking, and immediate cord clamping at preterm birth: a systematic review and individual participant data meta-analysis Seidler, Lene; Aberoumand, Mason; Hunter, Kylie; Barba, Angie; Libesman, Sol; Williams, Jonathan; Shrestha, Nipun; Aagerup, Jannik; Sotiropoulos, James; Montgomery, Alan; Gyte, Gillian; Duley, Lelia; Askie, Lisa Background Umbilical cord clamping strategies at preterm birth have the potential to affect important health outcomes. The aim of this study was to compare the effectiveness of deferred cord clamping, umbilical cord milking, and immediate cord clamping in reducing neonatal mortality and morbidity at preterm birth. Methods We conducted a systematic review and individual participant data meta-analysis. We searched medical databases and trial registries (from database inception until Feb 24, 2022; updated June 6, 2023) for randomised controlled trials comparing deferred (also known as delayed) cord clamping, cord milking, and immediate cord clamping for preterm births (<37 weeks' gestation). Quasi-randomised or cluster-randomised trials were excluded. Authors of eligible studies were invited to join the iCOMP collaboration and share individual participant data. All data were checked, harmonised, re-coded, and assessed for risk of bias following prespecified criteria. The primary outcome was death before hospital discharge. We performed intention-to-treat one-stage individual participant data meta-analyses accounting for heterogeneity to examine treatment effects overall and in prespecified subgroup analyses. Certainty of evidence was assessed with Grading of Recommendations Assessment, Development, and Evaluation. This study is registered with PROSPERO, CRD42019136640. Findings We identified 2369 records, of which 48 randomised trials provided individual participant data and were eligible for our primary analysis. We included individual participant data on 6367 infants (3303 [55%] male, 2667 [45%] female, two intersex, and 395 missing data). Deferred cord clamping, compared with immediate cord clamping, reduced death before discharge (odds ratio [OR] 0·68 [95% CI 0·51–0·91], high-certainty evidence, 20 studies, n=3260, 232 deaths). For umbilical cord milking compared with immediate cord clamping, no clear evidence was found of a difference in death before discharge (OR 0·73 [0·44–1·20], low certainty, 18 studies, n=1561, 74 deaths). Similarly, for umbilical cord milking compared with deferred cord clamping, no clear evidence was found of a difference in death before discharge (0·95 [0·59–1·53], low certainty, 12 studies, n=1303, 93 deaths). We found no evidence of subgroup differences for the primary outcome, including by gestational age, type of delivery, multiple birth, study year, and perinatal mortality. Interpretation This study provides high-certainty evidence that deferred cord clamping, compared with immediate cord clamping, reduces death before discharge in preterm infants. This effect appears to be consistent across several participant-level and trial-level subgroups. These results will inform international treatment recommendations. Funding Australian National Health and Medical Research Council.

The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) dataset

2024-02-23T00:00:00Z

The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) dataset John, Simes This dataset includes 9,014 participants receiving either pravastatin, 40 mg/day or placebo, with a total cholesterol level at baseline of 4.0 to 7.0 mmol/L (155 to 270 mg/dl) and with a history of acute myocardial infarction or hospitalization for unstable angina pectoris. Baseline data will include demographics, qualifying event (myocardial infarction or unstable angina), coronary heart disease risk factors (smoking status, history of hypertension, diabetes mellitus and obesity), history of other vascular diseases, revascularization, medication use and lipid concentrations (total cholesterol, LDL-c, HDL-c and triglycerides). Clinical outcomes will include overall survival and cause of death over a 6-year and 16-year follow-up period.

Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease (CLARITY) dataset

2024-02-23T00:00:00Z

Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease (CLARITY) dataset Jardine, Meg This dataset includes up to 787 participants receiving an oral angiotensin receptor blocker (no placebo per standard of care in Australia, and telmisartan in India) recruited from seventeen hospitals in India and Australia. Baseline data includes demographics (age, sex, ethnicity, height, and weight), pregnancy status, smoking status, and co-morbidities. Primary follow-up data was collected daily from days 1 to 28 during treatment period and will include clinical outcome (Clinical Health Score), temperature, respiratory measures (oxygen saturation, use of supplemental oxygen), hypotension (vasopressor requirement), incidence of acute kidney injury, and hyperkalaemia (serum potassium concentration of >6.0 mmol/L).

Patterns of care and outcomes for a clinical cohort of patients with lung cancer (2016-2021): Report on the Embedding Research (and Evidence) in Cancer Healthcare – EnRICH Program

2023-10-19T00:00:00Z

Patterns of care and outcomes for a clinical cohort of patients with lung cancer (2016-2021): Report on the Embedding Research (and Evidence) in Cancer Healthcare – EnRICH Program Brown, Bernadette (Bea); Boyer, Michael; Young, Jane; Chin, Venessa; Brown, Christopher; Eggins, Renee; Simes, Robert John Despite advances in diagnosis and treatment, lung cancer continues to be the leading cause of cancer-related death in Australia. Survival outcomes remain disappointing with less than a quarter of patients (22%) alive five years after diagnosis. Strategies to improve lung cancer care have focused on more rapid diagnosis and treatment from initial symptom presentation; a greater use of combined modalities of therapy; novel approaches using molecular-based diagnostics, targeted therapies, and immunotherapies; as well as a greater use of supportive and palliative care. The Embedding Research (and Evidence) in Cancer Healthcare (EnRICH) Program has explored patterns of care and clinical outcomes in a cohort of 2000 real-world patients presenting to six major specialist cancer centres in NSW with a first diagnosis between September 2016 and October 2021. This report provides valuable information on the natural history of patients following their initial diagnosis and maps out the use of evidence-based care, as well as identifying important factors defining overall prognosis. The report identifies that tumour stage at diagnosis remains one of the most important prognostic factors for both non-small cell (NSCLC) and small cell (SCLC) lung cancer. In NSCLC, stage, age, sex, performance status, co-morbid illness, neutrophil to lymphocyte ratio, haemoglobin levels, non-English speaking background, and mutation status are each independent factors predicting survival outcomes. Stage, performance status, and neutrophil to lymphocyte ratio are also predictive of survival in SCLC lung cancer. Overall, patients at major specialist cancer centres in NSW have done relatively well compared with other Australian cohorts such as those included in the Victorian Lung Cancer Registry and the Queensland Lung Cancer Quality Index, but it is important to note that the EnRICH cohort only includes those seen at least once at a major specialist cancer centre and does not represent all patients with lung cancer in these regions – a topic being further investigated in a subsequent report. Several quality indicators of cancer care are being captured and fed back to NSW practitioners and health administrators to inform practice and service development. While these indicators are comparable with other regions, there remain areas for improvement - a focus of ongoing work. Reassuringly, quality of care and outcomes for patients in the EnRICH cohort were not adversely affected by health service disruptions during the COVID-19 pandemic. Through this effort we hope to better document current outcomes of patients with lung cancer and the care they receive with the aim of improving current evidence-based care and accelerating the uptake of new emerging evidence.

VESPRO: Statistical Report

2023-06-29T00:00:00Z

VESPRO: Statistical Report Gibbs, Emma; Brown, Chris; Gebski, Val An individual patient data prospective meta-analysis (IPD_PMA) of selective internal radiation therapy (SIRT) versus sorafenib for advanced, locally advanced or recurrent hepatocellular carcinoma (HCC) of the SARAH and SIRveNIB trials

Benefits Of Oxygen Saturation Targeting Study (BOOST-II) dataset

2023-06-27T00:00:00Z

Benefits Of Oxygen Saturation Targeting Study (BOOST-II) dataset Tarnow-Mordi, William This dataset includes 1135 participants receiving either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range in 15 centres in Australia. Baseline data will include demographics, antenatal glucocorticoid treatment, method of delivery and temperature at admission to the neonatal unit. Clinical outcomes will include survival or disability status, language or cognitive score (based on the Bayley III Developmental Assessment) as well as health status including cerebral palsy with GMFCS ≥2, severe visual loss and severe hearing loss (based on the Health Status Assessment or Short Health Status Questionnaire) at corrected age of 2 years.

Performance of long-term CT and PET/CT surveillance for detection of distant recurrence in patients with resected stage IIIA-D melanoma

2021-01-01T00:00:00Z

Performance of long-term CT and PET/CT surveillance for detection of distant recurrence in patients with resected stage IIIA-D melanoma Turner, Robin M; Dieng, Mbathio; Khanna, Nikita; Nguyen, Mai; Zeng, Jiaxu; Nijhuis, Amanda AG; Nieweg, Omgo E; Einstein, Andrew J.; Emmett, Louise; Lord, Sally J; Menzies, Alexander M; Thompson, John F.; Saw, Robyn PM; Morton, Rachael L 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.

Symptom monitoring With Feedback trial (SWIFT) dataset

2023-05-19T00:00:00Z

Symptom monitoring With Feedback trial (SWIFT) dataset Morton, Rachael This dataset contains the Patient Reported Outcome Measures (PROMs) of the SWIFT participants, a cohort of 2422 satellite dialysis patients clustered into 143 centres across Australia. The PROMs data are the EQ-5D-5L qualitry of life survey, IPOS-Renal survey and SONg-HD fatigue survey. In addition to the PROMs data, health data from the ANZDATA Registry including health utilisation for hospitalisations, survival data and dialysis modality are in the dataset.

Dialysis initiation, modality choice, access, and prescription: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference

2019-01-01T00:00:00Z

Dialysis initiation, modality choice, access, and prescription: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference Chan, Christopher T.; Blankestijn, Peter J.; Dember, Laura M.; Gallieni, Maurizio; Harris, David C.H; Lok, Charmaine E.; Mehrotra, Rajnish; Stevens, Paul E.; Wang, Angela Yee-Moon; Cheung, Michael; Wheeler, David C.; Winkelmayer, Wolfgang C.; Pollock, Carol A. Globally, the number of patients undergoing maintenance dialysis is increasing, yet throughout the world there is significant variability in the practice of initiating dialysis. Factors such as availability of resources, reasons for starting dialysis, timing of dialysis initiation, patient education and preparedness, dialysis modality and access, as well as varied "country-specific" factors significantly affect patient experiences and outcomes. As the burden of end-stage kidney disease (ESKD) has increased globally, there has also been a growing recognition of the importance of patient involvement in determining the goals of care and decisions regarding treatment. In January 2018, KDIGO (Kidney Disease: Improving Global Outcomes) convened a Controversies Conference focused on dialysis initiation, including modality choice, access, and prescription. Here we present a summary of the conference discussions, including identified knowledge gaps, areas of controversy, and priorities for research. A major novel theme represented during the conference was the need to move away from a "one-size-fits-all" approach to dialysis and provide more individualized care that incorporates patient goals and preferences while still maintaining best practices for quality and safety. Identifying and including patient-centered goals that can be validated as quality indicators in the context of diverse health care systems to achieve equity of outcomes will require alignment of goals and incentives between patients, providers, regulators, and payers that will vary across health care jurisdictions.

Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow-up? A protocol for the MEL-SELF randomised controlled trial

2021-01-01T00:00:00Z

Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow-up? A protocol for the MEL-SELF randomised controlled trial Ackermann, Deonna M.; Smit, Amelia K.; Janada, Monika; van Kemenade, Cathelijne H.; Dieng, Mbathio; Morton, Rachael L.; Turner, Robin M.; Cust, Anne E.; Irwig, Les; Hersch, Jolyn K.; Guitera, Pascale; Soyer, H. Peter; Mar, Victoria; Saw, Robyn P.M.; Low, Donald; Low, Cynthia; Drabarek, Dorothy; Espinoza, David; Emery, Jon; Murchie, Peter; Thompson, John F.; Scolyer, Richard A.; Azzi, Anthony; Lilleyman, Alister; Bell, Katy J.L. Background Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma. Methods Stage 0/I/II melanoma patients (n = 600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n = 300) or control (usual care, n = 300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n = 150) or non-polarised (n = 150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician’s usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician’s usual practice. The primary outcome, measured at 12 months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised). Discussion The findings from this study may inform guidance on evidence-based follow-up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered on 18 February 2021.

The Fenofibrate And Microvascular Events in Type 1 diabetes Eye (FAME 1 EYE) dataset

2023-05-03T00:00:00Z

The Fenofibrate And Microvascular Events in Type 1 diabetes Eye (FAME 1 EYE) dataset Jenkins, Alicia; Keech, Anthony The estimated sample size is 450. Demographics, clinical characteristics and outcomes measures will be available from patients with type 1 diabetes. All timepoints points (baseline, 6-week, 3-month, 6-month, 1-year, 2-year, 3-year assessments) will be included in the dataset.

Impact of Educational Attainment on Health Outcomes in Moderate to Severe CKD

2016-01-01T00:00:00Z

Impact of Educational Attainment on Health Outcomes in Moderate to Severe CKD Morton, Rachael L.; Schlackow, Iryna; Staplin, Natalie; Gray, Alastair; Cass, Alan; Haynes, Richard; Emberson, Jonathan; Herrington, William; Landray, Martin J.; Baigent, Colin; Mihaylova, Borislava Background The inverse association between educational attainment and mortality is well established, but its relevance to vascular events and renal progression in a population with chronic kidney disease (CKD) is less clear. This study aims to determine the association between highest educational attainment and risk of vascular events, cause-specific mortality, and CKD progression. Study Design Prospective epidemiologic analysis among participants in the Study of Heart and Renal Protection (SHARP), a randomized controlled trial. Setting & Participants 9,270 adults with moderate to severe CKD (6,245 not receiving dialysis at baseline) and no history of myocardial infarction or coronary revascularization recruited in Europe, North America, Asia, Australia, and New Zealand. Predictor Highest educational attainment measured at study entry using 6 levels that ranged from “no formal education” to “tertiary education.” Outcomes Any vascular event (any fatal or nonfatal cardiac, cerebrovascular, or peripheral vascular event), cause-specific mortality, and CKD progression during 4.9 years’ median follow-up. Results There was a significant trend (P < 0.001) toward increased vascular risk with decreasing levels of education. Participants with no formal education were at a 46% higher risk of vascular events (relative risk [RR], 1.46; 95% CI, 1.14-1.86) compared with participants with tertiary education. The trend for mortality across education levels was also significant (P < 0.001): all-cause mortality was twice as high among those with no formal education compared with tertiary-educated individuals (RR, 2.05; 95% CI, 1.62-2.58), and significant increases were seen for both vascular (RR, 1.84; 95% CI, 1.21-2.81) and nonvascular (RR, 2.15; 95% CI, 1.60-2.89) deaths. Lifestyle factors and prior disease explain most of the excess mortality risk. Among 6,245 participants not receiving dialysis at baseline, education level was not significantly associated with progression to end-stage renal disease or doubling of creatinine level (P for trend = 0.4). Limitations No data for employment or health insurance coverage. Conclusions Lower educational attainment is associated with increased risk of adverse health outcomes in individuals with CKD.

Advance Care Planning With Patients Who Have End-Stage Kidney Disease: A Systematic Realist Review

2018-01-01T00:00:00Z

Advance Care Planning With Patients Who Have End-Stage Kidney Disease: A Systematic Realist Review O'Halloran, Peter; Noble, Helen; Norwood, Kelly; Maxwell, Peter; Shields, Joanne; Fogarty, Damian; Murtagh, Fliss; Morton, Rachael; Brazil, Kevin Abstract Context Patients with end-stage kidney disease have a high mortality rate and disease burden. Despite this, many do not speak with health care professionals about end-of-life issues. Advance care planning is recommended in this context but is complex and challenging. We carried out a realist review to identify factors affecting its implementation. Objectives The objectives of this study are 1) to identify implementation theories; 2) to identify factors that help or hinder implementation; and 3) to develop theory on how the intervention may work. Methods We carried out a systematic realist review, searching seven electronic databases: Medline, Embase, CINAHL, PsycINFO, Cochrane Library, Google Scholar, and ScienceDirect. Results Sixty-two papers were included in the review. Conclusion We identified two intervention stages—1) training for health care professionals that addresses concerns, optimizes skills, and clarifies processes and 2) use of documentation and processes that are simple, individually tailored, culturally appropriate, and involve surrogates. These processes work as patients develop trust in professionals, participate in discussions, and clarify values and beliefs about their condition. This leads to greater congruence between patients and surrogates; increased quality of communication between patients and professionals; and increased completion of advance directives. Advance care planning is hindered by lack of training; administrative complexities; pressures of routine care; patients overestimating life expectancy; and when patients, family, and/or clinical staff are reluctant to initiate discussions. It is more likely to succeed where organizations treat it as core business; when the process is culturally appropriate and takes account of patient perceptions; and when patients are willing to consider death and dying with suitably trained staff.

GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and rationale

2017-01-01T00:00:00Z

GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and rationale Welch, Vivian A.; Akl, Elie A.; Guyatt, Gordon; Pottie, Kevin; Eslava-Schmalbach, Javier; Ansari, Mohammed T.; Beer, Hans de; Briel, Matthias; Dans, Tony; Dans, Inday; Hultcrantz, Monica; Jull, Janet; Katikireddi, Srinivasa Vittal; Meerpohl, Joerg; Morton, Rachael; Mosdol, Annhild; Petkovic, Jennifer; Schunemann, Holger J.; Sharaf, Ravi N.; Singh, Jasvinder A.; Stanev, Roger; Tonia, Thomy; Tristan, Mario; Vitols, Sigurd; Watine, Joseph; Tugwell, Peter Objectives This article introduces the rationale and methods for explicitly considering health equity in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for development of clinical, public health, and health system guidelines. Study Design and Setting We searched for guideline methodology articles, conceptual articles about health equity, and examples of guidelines that considered health equity explicitly. We held three meetings with GRADE Working Group members and invited comments from the GRADE Working Group listserve. Results We developed three articles on incorporating equity considerations into the overall approach to guideline development, rating certainty, and assembling the evidence base and evidence to decision and/or recommendation. Conclusion Clinical and public health guidelines have a role to play in promoting health equity by explicitly considering equity in the process of guideline development.

Estimating loss in capability wellbeing in the first year of the COVID‑19 pandemic: a cross‑sectional study of the general adult population in the UK, Australia and the Netherlands

2022-01-01T00:00:00Z

Estimating loss in capability wellbeing in the first year of the COVID‑19 pandemic: a cross‑sectional study of the general adult population in the UK, Australia and the Netherlands Mitchell, Paul Mark; Morton, Rachael L.; Hiligsmann, Mickaël; Husbands, Samantha; Coast, Joanna Objectives To estimate capability wellbeing lost from the general adult populations in the UK, Australia and the Netherlands in the first year of the COVID-19 pandemic and the associated social restrictions, including lockdowns. Design Cross-sectional with recalled timepoints. Setting Online panels in the UK, Australia and the Netherlands conducted in February 2021 (data collected 26 January–2 March 2021). Participants Representative general adult (≥ 18 years old) population samples in the UK (n = 1,017), Australia (n = 1,011) and the Netherlands (n = 1,017) Main outcome measure Participants completed the ICECAP-A capability wellbeing measure in February 2021, and for two recalled timepoints during the initial lockdowns in April 2020 and in February 2020 (prior to COVID-19 restrictions in all three countries). ICECAP-A scores on a 0–1 no capability–full capability scale were calculated for each timepoint. Societal willingness to pay estimates for a year of full capability (YFC) was used to place a monetary value associated with change in capability per person and per country. Paired t tests were used to compare changes in ICECAP-A and YFC from pre- to post-COVID-19-related restrictions in each country. Results Mean (standard deviation) loss of capability wellbeing during the initial lockdown was 0.100 (0.17) in the UK, 0.074 (0.17) in Australia and 0.049 (0.12) in the Netherlands. In February 2021, losses compared to pre-lockdown were 0.043 (0.14) in the UK, 0.022 (0.13) in Australia and 0.006 (0.11) in the Netherlands. In monetary terms, these losses were equivalent to £14.8 billion, AUD$8.6 billion and €2.1 billion lost per month in April 2020 and £6.4 billion, A$2.6 billion and €260 million per month in February 2021 for the UK, Australia and the Netherlands, respectively. Conclusions There were substantial losses in capability wellbeing in the first year of the COVID-19 pandemic. Future research is required to understand the specific impact of particular COVID-19 restrictions on people’s capabilities.

Barriers and facilitators to nurse-led advance care planning and palliative care practice change in primary healthcare: a qualitative study

2022-01-01T00:00:00Z

Barriers and facilitators to nurse-led advance care planning and palliative care practice change in primary healthcare: a qualitative study Nagarajan, Srivalli V.; Lewis, Virginia; Halcomb, Elizabeth; Rhee, Joel; Morton, Rachael L.; Mitchell, Geoffrey K.; Tieman, Jennifer; Phillips, Jane L.; Detering, Karen; Gavin, Jennifer; Clayton, Josephine M. Primary care settings are ideal for initiating advance care planning (ACP) conversations and assessing palliative and supportive care needs. However, time constraints and a lack of confidence to sensitively and efficiently initiate such discussions are noted barriers. The Advance Project implemented a national multicomponent training package to support Australian general practice nurses (GPNs) to work with GPs to initiate ACP and palliative care conversations in their practice. This paper reports on semistructured interviews conducted with 20 GPNs to explore barriers and facilitators to implementing the Advance Project model. Participants identified a range of factors that affected implementation, including lack of time, limited support from colleagues, lack of knowledge about systems and funding processes in general practice and a need for better alignment of the Advance Project resources and practices with general practice information management platforms. Barriers related to professional roles, particularly the lack of clarity and/or limitations in the scope of practice of GPNs, highlighted the importance of defining and supporting the roles that different primary health practice staff could play to support implementation of the model. The findings underline the need for complementary training in the Advance Project model for GPs and practice managers to enable a team-based approach to implementation.

T2DM probiotic intervention clinical data

2023-03-30T00:00:00Z

T2DM probiotic intervention clinical data Palacios, Talia This pilot study, single site, randomised, double blind, placebo-controlled clinical trial conducted in Sydney, Australia, assessed the efficacy of a multi-strain probiotic on glycaemic, inflammatory, and permeability markers in adults with prediabetes and early T2DM and to assess whether the probiotic can enhance metformin’s effect on glycaemia . Participants (60 adults, males and females) were allocated to either the multi-strain probiotic or placebo for 12 weeks. Follow-up data was collected at 6 and 12 weeks and includes demographic and clinical data variables (weight, height, fasting plasma glucose, fasting plasma insulin, blood pressure, lipid profile, zonulin levels and inflammatory markers (as described in the data dictionary). The file type is .XLS.

Physician-patient communication of costs and financial burden of cancer and its treatment: a systematic review of clinical guidelines

2021-01-01T00:00:00Z

Physician-patient communication of costs and financial burden of cancer and its treatment: a systematic review of clinical guidelines Agarwal, Anupriya; Livingstone, Ann; Karikios, Deme J.; Stockler, Martin R.; Beale, Philip J.; Morton, Rachael L. 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.

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

2022-01-01T00:00:00Z

The Impact of Surveillance Imaging Frequency on the Detection of Distant Disease for Patients with Resected Stage III Melanoma Dieng, Mbathio; Lord, Sarah J.; Turner, Robin M.; Nieweg, Omgo; Menzies, Alexander M.; Saw, Robyn P.M.; Einstein, Andrew J.; Emmett, Louise; Thompson, John F.; Lo, Serigne N.; Morton, Rachael L. 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.

Identifying the ‘Active Ingredients’ of an Effective Psychological Intervention to Reduce Fear of Cancer Recurrence: A Process Evaluation

2021-01-01T00:00:00Z

Identifying the ‘Active Ingredients’ of an Effective Psychological Intervention to Reduce Fear of Cancer Recurrence: A Process Evaluation Kan, Janice M.; Dieng, Mbathio; Butow, Phyllis N.; Mireskandari, Shab; Tesson, Stephanie; Menzies, Scott W.; Costa, Daniel S.J.; Morton, Rachael L.; Mann, Graham J.; Cust, Anne E.; Kasparian, Nadine A. Purpose: Psychological interventions targeting fear of cancer recurrence (FCR) are effective in reducing fear and distress. Process evaluations are an important, yet scarce adjunct to published intervention trials, despite their utility in guiding the interpretation of study outcomes and optimizing intervention design for broader implementation. Accordingly, this paper reports the findings of a process evaluation conducted alongside a randomized controlled trial of a psychological intervention for melanoma patients. Methods: Men and women with a history of Stage 0–II melanoma at high-risk of developing new primary disease were recruited via High Risk Melanoma Clinics across Sydney, Australia and randomly allocated to receive the psychological intervention (n = 80) or usual care (n = 84). Intervention participants received a tailored psycho-educational resource and three individual psychotherapeutic sessions delivered via telehealth. Qualitative and quantitative data on intervention context, processes, and delivery (reach, dose, and fidelity), and mechanisms of impact (participant responses, moderators of outcome) were collected from a range of sources, including participant surveys, psychotherapeutic session audio-recordings, and clinical records. Results: Almost all participants reported using the psycho-educational resource (97%), received all intended psychotherapy sessions (96%), and reported high satisfaction with both intervention components. Over 80% of participants would recommend the intervention to others, and a small proportion (4%) found discussion of melanoma-related experiences confronting. Perceived benefits included enhanced doctor-patient communication, talking more openly with family members about melanoma, and improved coping. Of potential moderators, only higher FCR severity at baseline (pre-intervention) was associated with greater reductions in FCR severity (primary outcome) at 6-month follow-up (primary endpoint). Conclusions: Findings support the acceptability and feasibility of a psychological intervention to reduce FCR amongst individuals at high risk of developing another melanoma. Implementation into routine melanoma care is an imperative next step, with FCR screening recommended to identify those most likely to derive the greatest psychological benefit.

Impact of personal genomic risk information on melanoma prevention behaviors and psychological outcomes: a randomized controlled trial

2021-01-01T00:00:00Z

Impact of personal genomic risk information on melanoma prevention behaviors and psychological outcomes: a randomized controlled trial Smit, Amelia K.; Allen, Martin; Beswick, Brooke; Butow, Physllis; Dawkins, Hugh; Dobbinson, Suzanne J.; Dunlop, Kate L.; Espinoza, David; Fenton, Georgina; Kanetsky, Peter A.; Keogh, Louise; Kimlin, Michael G.; Kirk, Judy; Law, Matthew H.; Lo, Serigne; Low, Cynthia; Mann, Graham J.; Reyes-Marcelino, Gillian; Morton, Rachael L.; Newson, Ainsley J.; Savard, Jacqueline; Trevena, Lyndal; Wordsworth, Sarah; Cust, Anne E. Purpose We evaluated the impact of personal melanoma genomic risk information on sun-related behaviors and psychological outcomes. Methods In this parallel group, open, randomized controlled trial, 1,025 Australians of European ancestry without melanoma and aged 18–69 years were recruited via the Medicare database (3% consent). Participants were randomized to the intervention (n = 513; saliva sample for genetic testing, personalized melanoma risk booklet based on a 40-variant polygenic risk score, telephone-based genetic counseling, educational booklet) or control (n = 512; educational booklet). Wrist-worn ultraviolet (UV) radiation dosimeters (10-day wear) and questionnaires were administered at baseline, 1 month postintervention, and 12 months postbaseline. Results At 12 months, 948 (92%) participants completed dosimetry and 973 (95%) the questionnaire. For the primary outcome, there was no effect of the genomic risk intervention on objectively measured UV exposure at 12 months, irrespective of traditional risk factors. For secondary outcomes at 12 months, the intervention reduced sunburns (risk ratio: 0.72, 95% confidence interval: 0.54–0.96), and increased skin examinations among women. Melanoma-related worry was reduced. There was no overall impact on general psychological distress. Conclusion Personalized genomic risk information did not influence sun exposure patterns but did improve some skin cancer prevention and early detection behaviors, suggesting it may be useful for precision prevention. There was no evidence of psychological harm.

Adjuvant immunotherapy recommendations for stage III melanoma: physician and nurse interviews

2021-01-01T00:00:00Z

Adjuvant immunotherapy recommendations for stage III melanoma: physician and nurse interviews Livingstone, Ann; Dempsey, Kathy; Stockler, Martin R.; Howard, Kirsten; Long, Georgina V.; Carlino, Matteo S.; Menzies, Alexander M.; Morton, Rachael L. 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.

Exploring the Integration of Environmental Impacts in the Cost Analysis of the Pilot MEL‑SELF Trial of Patient‑Led Melanoma Surveillance

2022-01-01T00:00:00Z

Exploring the Integration of Environmental Impacts in the Cost Analysis of the Pilot MEL‑SELF Trial of Patient‑Led Melanoma Surveillance Williams, Jake T.W.; Bell, Katy J.L.; Morton, Rachael L.; Dieng, Mbathio Aims Human health is intrinsically linked with planetary health. But planetary resources are currently being degraded and this poses an existential threat to human health and the sustainability of our healthcare systems. The aims of this study were to (1) describe an approach to integrate environmental impacts in a cost analysis; and (2) demonstrate this approach by estimating select environmental impacts alongside traditional health system and other costs using the example of the pilot MEL-SELF randomised controlled trial of patient-led melanoma surveillance. Methods Economic costs were calculated alongside a randomised trial using standard cost analysis methodology from a societal perspective. Environmental impacts were calculated using a type of carbon footprinting methodology called process-based life cycle analysis. This method considers three scopes of carbon emissions: Scope 1, which occur directly from the intervention; Scope 2, which occur indirectly from the intervention’s energy use; and Scope 3, which occur indirectly because of the value chain of the intervention. In this study we only included emissions from patient transport to attend their melanoma clinic over the study period of 6 months. Results The environmental impact per participant across allocated groups for patient transport to their melanoma clinic was estimated to be 10 kg carbon dioxide equivalent. Economic costs across the allocated groups indicated substantial health system costs, out-of-pocket costs, and productivity losses associated with melanoma surveillance. The largest cost contributor was health system costs, and the most expensive category of health system cost was hospital admission. Conclusion Calculating environmental impacts is worthwhile and feasible within a cost analysis framework. Further work is needed to address outstanding conceptual and practical issues so that a comprehensive assessment of environmental impacts can be considered alongside economic costs in health technology assessments.

Approaches to prioritising research for clinical trial networks: a scoping review

2022-01-01T00:00:00Z

Approaches to prioritising research for clinical trial networks: a scoping review Morton, Rachael L.; Tuffaha, Haitham; Blaya-Novakova, Vendula; Spencer, Jenean; Hawley, Carmel M.; Peyton, Phil; Higgins, Alisa; Marsh, Julie; Taylor, William J.; Huckson, Sue; Sillett, Amy; Schneemann, Kieran; Balagurunanthan, Anitha; Cumpston, Miranda; Scuffham, Paul A.; Glasziou, Paul; Simes, Robert J. Background Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critically appraise approaches to research prioritisation applicable to clinical trials, to inform best practice guidelines for clinical trial networks and funders. Methods A scoping review of English-language published literature and research organisation websites (January 2000 to January 2020) was undertaken to identify primary studies, approaches and criteria for research prioritisation. Data were extracted and tabulated, and a narrative synthesis was employed. Results Seventy-eight primary studies and 18 websites were included. The majority of research prioritisation occurred in oncology and neurology disciplines. The main reasons for prioritisation were to address a knowledge gap (51 of 78 studies [65%]) and to define patient-important topics (28 studies, [35%]). In addition, research organisations prioritised in order to support their institution’s mission, invest strategically, and identify best return on investment. Fifty-seven of 78 (73%) studies used interpretative prioritisation approaches (including Delphi surveys, James Lind Alliance and consensus workshops); six studies used quantitative approaches (8%) such as prospective payback or value of information (VOI) analyses; and 14 studies used blended approaches (18%) such as nominal group technique and Child Health Nutritional Research Initiative. Main criteria for prioritisation included relevance, appropriateness, significance, feasibility and cost-effectiveness. Conclusion Current research prioritisation approaches for groups conducting and funding clinical trials are largely interpretative. There is an opportunity to improve the transparency of prioritisation through the inclusion of quantitative approaches.

Incorporating carbon into health care: adding carbon emissions to health technology assessments

2022-01-01T00:00:00Z

Incorporating carbon into health care: adding carbon emissions to health technology assessments McAlister, Scott; Morton, Rachael L.; Barratt, Alexandra Summary At the UN Climate Change Conference 26 in Glasgow, 50 countries committed to low-carbon health services, with 14 countries further committing to net-zero carbon health services by 2050. Reaching this target will require decision makers to include carbon emissions when evaluating new and existing health technologies (tests and treatments). There is currently, however, a scarcity of data on the carbon footprint of health-care interventions, nor any means for decision makers to include and consider carbon emission health-care assessments. We therefore investigated how to integrate carbon emissions calculated by environmental life cycle assessment (LCA) into health technology assessments (HTA). HTAs are extensively used in developing clinical and policy guidelines by individual public or private payers, and by government organisations. In the first section we explain the methodological differences between environmentally extended input-output and process-based LCA. The second section outlines ways in which carbon emissions calculated by LCA could be integrated with HTAs, recognising that HTAs are done in several ways by different jurisdictions. International effort and processes will be needed to ensure that robust and comprehensive carbon footprints of commonly used health-care products are freely available. The technical and implementation challenges of incorporating carbon emissions into HTAs are considerable, but not unsurmountable. Our aim is to lay foundations for meeting these challenges.

Cost Efectiveness of Ambulatory Blood Pressure Monitoring Compared with Home or Clinic Blood Pressure Monitoring for Diagnosing Hypertension in Australia

2022-01-01T00:00:00Z

Cost Efectiveness of Ambulatory Blood Pressure Monitoring Compared with Home or Clinic Blood Pressure Monitoring for Diagnosing Hypertension in Australia Shah, Karan K.; Willson, Melina; Agresta, Blaise; Morton, Rachael L. Objectives The aim of this study was to evaluate the cost effectiveness of ambulatory blood pressure monitoring (ABPM) compared with home blood pressure monitoring (HBPM) and clinic blood pressure monitoring (CBPM) in diagnosing hypertension in Australia. Methods A cohort-based Markov model was built from the Payer’s perspective (Australian government) comparing lifetime costs and effectiveness of ABPM, HBPM and CBPM in people aged ≥ 35 years with suspected hypertension who have a CBPM between ≥ 140/90 mmHg and ≤ 180/110 mmHg using a sphygmomanometer and have not yet commenced antihypertensive treatment. The main outcome measures were incremental cost-effectiveness ratio (ICER) assessing cost per quality-adjusted life-year (QALY) and life-years (LYs) gained by ABPM versus HBPM and CBPM. Cost was measured in Australian dollars (A$). Results Over a lifetime model, ABPM had lower total costs (A$8,491) compared with HBPM (A$9,648) and CBPM (A$10,206) per person. ABPM was associated with a small but significant improvement in the quality and quantity of life for people with suspected hypertension with 12.872 QALYs and 17.449 LYs compared with 12.857 QALYs and 17.433 LYs with HBPM, and 12.850 QALYs and 17.425 LYs with CBPM. In the base-case analysis, ABPM dominated HBPM and CBPM. In scenario analyses, at 100% specificity of HBPM, ABPM no longer remained cost effective at a A$50,000/QALY threshold. However, in probabilistic sensitivity analysis, over 10,000 iterations, ABPM remained dominant. Conclusion ABPM was the dominant strategy for confirming the diagnosis of hypertension among Australian adults aged ≥ 35 years old with suspected hypertension. The findings of this study are important for reimbursement decision makers to support policy change and for clinicians to make practice changes consistent with ABPM recommendations in primary care.

Developing an Australian Melanoma Clinical Outcomes Registry (MelCOR): a protocol paper

2022-01-01T00:00:00Z

Developing an Australian Melanoma Clinical Outcomes Registry (MelCOR): a protocol paper Jobson, Dale; Roffey, Benjamin; Best, Renee; Button-Sloan, Alison; Cossio, Danica; Evans, Sue; Shang, Catherine; Moore, Julie; Arnold, Christopher; Mann, Graham; Shackleton, Mark; Soyer, H Peter; Morton, Rachael L; Zalcberg, John; Mar, Victoria Introduction Australia has the highest incidence of melanoma in the world with variable care provided by a diverse range of clinicians. Clinical quality registries aim to identify these variations in care and provide anonymised, benchmarked feedback to clinicians and institutions to improve patient outcomes. The Australian Melanoma Clinical Outcomes Registry (MelCOR) aims to collect population-wide, clinical-level data for the early management of cutaneous melanoma and provide anonymised feedback to healthcare providers. Methods and analysis A modified Delphi process will be undertaken to identify key clinical quality indicators for inclusion in the MelCOR pilot. MelCOR will prospectively collect data relevant to these quality indicators, initially for all people over the age of 18 years living in Victoria and Queensland with a melanoma diagnosis confirmed by histopathology, via a two-stage recruitment and consent process. In stage 1, existing State-based cancer registries contact the treating clinician and provide an opportunity for them to opt themselves or their patients out of direct contact with MelCOR. After stage 1, re-identifiable clinical data are provided to the MelCOR under a waiver of consent. In stage 2, the State-based cancer registry will approach the patient directly and invite them to opt in to MelCOR and share identifiable data. If a patient elects to opt in, MelCOR will be able to contact patients directly to collect patient-reported outcome measures. Aggregated data will be used to provide benchmarked, comparative feedback to participating institutions/clinicians. Ethics and dissemination Following the successful collection of pilot data, the feasibility of an Australia-wide roll out will be evaluated. Key quality indicator data will be the core of the MelCOR dataset, with additional data points added later. Annual reports will be issued, first to the relevant stakeholders followed by the public. MelCOR is approved by the Alfred Ethics Committee (58280/127/20).

Discussion of costs and financial burden in clinical practice: A survey of medical oncologists in Australia

2022-01-01T00:00:00Z

Discussion of costs and financial burden in clinical practice: A survey of medical oncologists in Australia Agarwal, Anupriya; Karikios, Deme J.; Stockler, Martin R.; Morton, Rachael L. Background A diagnosis of cancer is associated with significant physical, psychological and financial burden. Including costs of cancer is an important component of shared decision making. Doctors bear a responsibility towards educating patients about the financial aspects of care. Multiple organisations have advocated for price transparency and implementing Informed Financial Consent in the clinic. However, few studies have evaluated the perspectives of oncologists on the current state of this discussion. Aims The aim of this study is to determine the views and perspectives of medical oncologists regarding communication of costs and financial burden in patients with cancer. Methods We conducted a prospective cross-sectional online survey via REDCap. The survey was distributed to medical oncologists and advanced trainees currently registered with Medical Oncology Group of Australia (MOGA). Data was collected using the online survey comprising socio-demographic characteristics, discussion of costs and financial burden, and facilitators and barriers to these discussions. Results 547 members of MOGA were invited to participate in the study, and 106 of 547 MOGA members (19%) completed the survey. Most oncologists (66%) felt that it was their responsibility to discuss costs of care, however a majority of oncologists (59.3%) reported discussing costs with less than half of their patients. Only 25% of oncologists discussed financial concerns with more than half of their patients, and most oncologists were unfamiliar with cancer-related financial burden. Most Oncologists with greater clinical experience and those working in private practice were more likely to discuss costs with a majority of their patients. Conclusions Certain characteristics of medical oncologists and their practices were associated with reported prevalence of discussing costs of care and financial burden with their patients. In the context of rising costs of cancer care, interventions targeting modifiable factors such as raising oncologist awareness of costs of care and financial burden, screening for financial toxicity and availability of costs information in an easily accessible manner, may help increase the frequency of patient-doctor discussions about costs of care, contributing to informed decision-making and higher-quality cancer care.

Trimming the fat: is there a health economic case for the use of new lipid-lowering drugs in chronic kidney disease? A scoping review

2021-01-01T00:00:00Z

Trimming the fat: is there a health economic case for the use of new lipid-lowering drugs in chronic kidney disease? A scoping review Gallagher, Alexandra; Agresta, Blaise; Smyth, Brendan; Jardine, Meg; Ferro, Charles; Morton, Rachael L. Objective: To estimate the cost-effectiveness of three surveillance imaging strategies using whole-body positron emission tomography (PET) with computed tomography (CT) (PET/CT) in a follow-up program for adults with resected stage III melanoma. Methods: An analytic decision model was constructed to estimate the costs and benefits of PET/CT surveillance imaging performed 3-monthly, 6-monthly, or 12-monthly compared with no surveillance imaging. Results: At 5 years, 3-monthly PET/CT surveillance imaging incurred a total cost of AUD 88,387 per patient, versus AUD 77,998 for 6-monthly, AUD 52,560 for 12-monthly imaging, and AUD 51,149 for no surveillance imaging. When compared with no surveillance imaging, 12-monthly PET/CT imaging was associated with a 4% increase in correctly diagnosed and treated distant disease; a 0.5% increase with 6-monthly imaging and 1% increase with 3-monthly imaging. The incremental cost-effectiveness ratio (ICER) of 12-monthly PET/CT surveillance imaging was AUD 34,362 for each additional distant recurrence correctly diagnosed and treated, compared with no surveillance imaging. For the outcome of cost per diagnostic error avoided, the no surveillance imaging strategy was the least costly and most effective. Conclusion: With the ICER for this strategy less than AUD 50,000 per unit of health benefit, the 12-monthly surveillance imaging strategy is considered good value for money.

Cost-Effectiveness of PET/CT Surveillance Schedules to Detect Distant Recurrence of Resected Stage III Melanoma

2022-01-01T00:00:00Z

Cost-Effectiveness of PET/CT Surveillance Schedules to Detect Distant Recurrence of Resected Stage III Melanoma Dieng, Mbathio; Turner, Robin M.; Lord, Sarah J.; Einstein, Andrew J.; Menzies, Alexander M.; Saw, Robyn P.M. Saw; Nieweg, Omgo E.; Thompson, John F.; Morton, Rachael L. Objective: To estimate the cost-effectiveness of three surveillance imaging strategies using whole-body positron emission tomography (PET) with computed tomography (CT) (PET/CT) in a follow-up program for adults with resected stage III melanoma. Methods: An analytic decision model was constructed to estimate the costs and benefits of PET/CT surveillance imaging performed 3-monthly, 6-monthly, or 12-monthly compared with no surveillance imaging. Results: At 5 years, 3-monthly PET/CT surveillance imaging incurred a total cost of AUD 88,387 per patient, versus AUD 77,998 for 6-monthly, AUD 52,560 for 12-monthly imaging, and AUD 51,149 for no surveillance imaging. When compared with no surveillance imaging, 12-monthly PET/CT imaging was associated with a 4% increase in correctly diagnosed and treated distant disease; a 0.5% increase with 6-monthly imaging and 1% increase with 3-monthly imaging. The incremental cost-effectiveness ratio (ICER) of 12-monthly PET/CT surveillance imaging was AUD 34,362 for each additional distant recurrence correctly diagnosed and treated, compared with no surveillance imaging. For the outcome of cost per diagnostic error avoided, the no surveillance imaging strategy was the least costly and most effective. Conclusion: With the ICER for this strategy less than AUD 50,000 per unit of health benefit, the 12-monthly surveillance imaging strategy is considered good value for money.

Cost Analysis of Adjuvant Whole‑Brain Radiotherapy Treatment Versus No Whole‑Brain Radiotherapy After Stereotactic Radiosurgery and/or Surgery Among Adults with One to Three Melanoma Brain Metastases: Results from a Randomized Trial

2022-01-01T00:00:00Z

Cost Analysis of Adjuvant Whole‑Brain Radiotherapy Treatment Versus No Whole‑Brain Radiotherapy After Stereotactic Radiosurgery and/or Surgery Among Adults with One to Three Melanoma Brain Metastases: Results from a Randomized Trial Tran, Anh Dam; Hong, Angela M.; Nguyen, Mai T. H.; Fogarty, Gerald; Steel, Victoria; Paton, Elizabeth; Morton, Rachael L. Purpose We aimed to compare Australian health system costs at 12 months for adjuvant whole-brain radiotherapy (WBRT) treatment after stereotactic radiosurgery (SRS) and/or surgery versus observation among adults with one to three melanoma brain metastases. We hypothesized that treatment with adjuvant WBRT and subsequent healthcare would be more expensive than SRS/surgery alone. Methods The analysis was conducted alongside a multicentre, randomized phase III trial. A bespoke cost questionnaire was used to measure healthcare use, including hospitalizations, specialist and primary care visits, imaging, and medicines over 12 months. Mean per-patient costs were calculated based on the quantity of resources used and unit costs, reported in Australian dollars ($AU), year 2018 values. Skewness of cost data was determined using normality tests and censor-adjusted costs reported using the Kaplan–Meier sample average method. The analysis of diference in mean costs at each 2-month time point and at 12 months was performed and checked using Kruskal–Wallis, generalized linear models with gamma distribution and log link, modifed Park test, ordinary least squares, and non-parametric bootstrapping. Results In total, 89 patients with similar characteristics at baseline were included in the cost analysis (n = 43 WBRT; n = 46 observation). Hospitalization cost was the main cost, ranging from 63 to 89% of total healthcare costs. The unadjusted 12-monthly cost for WBRT was $AU71,138 ± standard deviation 41,475 and for observation $AU69,848 ± 33,233; p = 0.7426. The censor-adjusted 12-monthly cost for WBRT was $AU90,277 ± 36,274 and $AU82,080 ± 34,411 for observation. There was no signifcant diference in 2-monthly costs between groups (p > 0.30 for all models). Conclusions Most costs were related to inpatient hospitalizations associated with disease recurrence. Adding WBRT after local SRS/surgery for patients with one to three melanoma brain metastases did not signifcantly increase health system costs during the frst 12 months. Trial Registration ACTRN12607000512426, prospectively registered 14 September 2007

The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry‑based cluster randomised controlled trial in haemodialysis

2022-01-01T00:00:00Z

The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry‑based cluster randomised controlled trial in haemodialysis Greenham, Lavern; Bennett, Paul N.; Dansie, Kathryn; Viecelli, Andrea K.; Jesudason, Shilpanjali; Mister, Rebecca; Smyth, Brendan; Westall, Portia; Herzog, Samuel; Brown, Chris; Handke, William; Palmer, Suetonia C.; Caskey, Fergus J.; Couchoud, Cecile; Simes, John; McDonald, Stephen P.; Morton, Rachael L. Background Kidney failure prevalence is increasing worldwide. Haemodialysis, peritoneal dialysis or kidney transplantation are undertaken to extend life with kidney failure. People receiving haemodialysis commonly experience fatigue, pain, nausea, cramping, itching, sleeping difficulties, anxiety and depression. This symptom burden contributes to poor health-related quality of life (QOL) and is a major reason for treatment withdrawal and death. The Symptom monitoring WIth Feedback Trial (SWIFT) will test the hypothesis that regular symptom monitoring with feedback to people receiving haemodialysis and their treating clinical team can improve QOL. Methods We are conducting an Australia and New Zealand Dialysis and Transplant (ANZDATA) registry-based cluster randomised controlled trial to determine the clinical- and cost-effectiveness at 12 months, of 3-monthly symptom monitoring using the Integrated Palliative Outcome Scale-Renal (IPOS-Renal) survey with clinician feedback, compared with usual care among adults treated with haemodialysis. Participants complete symptom scoring using a tablet, which are provided to participants and to clinicians. The trial aims to recruit 143 satellite haemodialysis centres, (up to 2400 participants). The primary outcome is change in health-related QOL, as measured by EuroQol 5-Dimension, 5-Level (EQ-5D-5L) instrument. Secondary outcomes include overall survival, symptom severity (including haemodialysis-associated fatigue), healthcare utilisation and cost-effectiveness. Discussion SWIFT is the first registry-based trial in the Australian haemodialysis population to investigate whether regular symptom monitoring with feedback to participants and clinicians improves QOL. SWIFT is embedded in the ANZDATA Registry facilitating pragmatic recruitment from public and private dialysis clinics, throughout Australia. SWIFT will inform future collection, storage and reporting of patient-reported outcome measures (PROMs) within a clinical quality registry. As the first trial to rigorously estimate the efficacy and cost-effectiveness of routine PROMs collection and reporting in haemodialysis units, SWIFT will provide invaluable information to health services, clinicians and researchers working to improve the lives of those with kidney failure.

PRehabIlitatiOn with pReoperatIve exercise and educaTion for patients undergoing major abdominal cancer surgerY: protocol for a multicentre randomised controlled TRIAL (PRIORITY TRIAL)

2022-01-01T00:00:00Z

PRehabIlitatiOn with pReoperatIve exercise and educaTion for patients undergoing major abdominal cancer surgerY: protocol for a multicentre randomised controlled TRIAL (PRIORITY TRIAL) Steffens, Daniel; Young, Jane; Riedel, Bernhard; Morton, Rachael; Denehy, Linda; Heriot, Alexander; Koh, Cherry; Li, Qiang; Bauman, Adrian; Sandroussi, Charbel; Ismail, Hilmy; Dieng, Mbathio; Ansari, Nabila; O'Shannassy, Sarah; McKeown, Sam; Cunningham, Derek; Sheehan, Kym; Iori, Gino; Bartyn, Jenna; Solomon, Michael Background Radical surgery is the mainstream treatment for patients presenting with advanced primary or recurrent gastrointestinal cancers; however, the rate of postoperative complications is exceptionally high. The current evidence suggests that improving patients’ fitness during the preoperative period may enhance postoperative recovery. Thus, the primary aim of this study is to establish the effectiveness of prehabilitation with a progressive, individualised, preoperative exercise and education program compared to usual care alone in reducing the proportion of patients with postoperative in-hospital complications. The secondary aims are to investigate the effectiveness of the preoperative intervention on reducing the length of intensive care unit and hospital stay, improving quality of life and morbidity, and reducing costs. Methods This is a multi-centre, assessor-blinded, pragmatic, comparative, randomised controlled trial. A total of 172 patients undergoing pelvic exenteration, cytoreductive surgery, oesophagectomy, hepatectomy, gastrectomy or pancreatectomy will be recruited. Participants will be randomly allocated to prehabilitation with a preoperative exercise and education program (intervention group), delivered over 4 to 8 weeks before surgery by community physiotherapists/exercise physiologists, or usual care alone (control group). The intervention will comprise 12 to 24 individualised, progressive exercise sessions (including aerobic/anaerobic, resistance, and respiratory exercises), recommendations of home exercises (16 to 32 sessions), and daily incidental physical activity advice. Outcome measures will be collected at baseline, the week prior to surgery, during the hospital stay, and on the day of discharge from hospital, and 1 month and 1 months postoperatively. The primary outcome will be the development of in-hospital complications. Secondary outcomes include the length of intensive care unit and hospital stay, quality of life, postoperative morbidity and costs. Discussion The successful completion of this trial will provide robust and high-quality evidence on the efficacy of a preoperative community- and home-based exercise and education intervention on important postoperative outcomes of patients undergoing major gastrointestinal cancer surgery.

Experiences of Patient-Led Surveillance, Including Patient-Performed Teledermoscopy, in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study

2022-01-01T00:00:00Z

Experiences of Patient-Led Surveillance, Including Patient-Performed Teledermoscopy, in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study Drabarek, Dorothy; Habgood, Emily; Janda, Monika; Hersch, Jolyn; Ackermann, Deonna; Low, Don; Low, Cynthia; Morton, Rachael L; Dieng, Mbathio; Cust, Anne E; Morgan, Adelaide; Smith, Elloise; Bell, Katy L J Background: Current clinician-led melanoma surveillance models require frequent routinely scheduled clinic visits, with associated travel, cost, and time burden for patients. Patient-led surveillance is a new model of follow-up care that could reduce health care use such as clinic visits and medical procedures and their associated costs, increase access to care, and promote early diagnosis of a subsequent new melanoma after treatment of a primary melanoma. Understanding patient experiences may allow improvements in implementation. Objective: This study aims to explore patients’ experiences and perceptions of patient-led surveillance during the 6 months of participation in the MEL-SELF pilot randomized controlled trial. Patient-led surveillance comprised regular skin self-examination, use of a mobile dermatoscope to image lesions of concern, and a smartphone app to track and send images to a teledermatologist for review, in addition to usual care. Methods: Semistructured interviews were conducted with patients previously treated for melanoma localized to the skin in New South Wales, Australia, who were randomized to the patient-led surveillance (intervention group) in the trial. Thematic analysis was used to analyze the data with reference to the technology acceptance model. Results: We interviewed 20 patients (n=8, 40% women and n=12, 60% men; median age 62 years). Patients who were more adherent experienced benefits such as increased awareness of their skin and improved skin self-examination practice, early detection of melanomas, and opportunities to be proactive in managing their clinical follow-up. Most participants experienced difficulty in obtaining clear images and technical problems with the app. These barriers were overcome or persevered by participants with previous experience with digital technology and with effective help from a skin check partner (such as a spouse, sibling, or friend). Having too many or too few moles decreased perceived usefulness. Conclusions: Patients with melanoma are receptive to and experience benefits from patient-led surveillance using teledermoscopy. Increased provision of training and technical support to patients and their skin check partners may help to realize the full potential benefits of this new model of melanoma surveillance.

The role of kidney registries in expediting large-scale collection of patient-reported outcome measures for people with chronic kidney disease

2021-01-01T00:00:00Z

The role of kidney registries in expediting large-scale collection of patient-reported outcome measures for people with chronic kidney disease van der Veer, Sabine N.; Couchoud, Cecile; Morton, Rachael L. In this issue of Clinical Kidney Journal, Van der Willik et al. report findings from a pilot study where they introduced collection of patient-reported outcome measures (PROMs) into routine kidney care in Dutch dialysis centres. It is comparable to a registry-led PROMs initiative in Sweden, published in Clinical Kidney Journal in 2020. Both studies reported low average PROMs response rates with substantial between-centre variation, and both identified suboptimal patient and staff engagement as a key barrier to implementing PROMs in routine care for people with chronic kidney disease (CKD). This suggests that national kidney registries could be well placed to facilitate large-scale collection of PROMs data, but that they may require additional guidance on how to do this successfully. In this editorial, we discuss the current state-of-play of PROMs collection by kidney registries and provide an overview of what is (un)known about the feasibility and effectiveness of PROMs in CKD and other conditions. We anticipate that the fast-growing evidence base on whether, and how, PROMs can be of value in CKD settings will expedite registry-based PROMs collection, which will ultimately lead to more valuable and person-centred services and to enhanced health and well-being of people with CKD.

eTRIO trial: study protocol of a randomised controlled trial of online education modules to facilitate effective family caregiver involvement in oncology

2021-01-01T00:00:00Z

eTRIO trial: study protocol of a randomised controlled trial of online education modules to facilitate effective family caregiver involvement in oncology Juraskova, Ilona; Laidsaar-Powell, R; Keast, Rachael; Schofield, Penelope; Costa, Daniel SJ; Kay, Judy; Turner, Sandra; Koczwara, Bogda; Saunders, Christobel; Jefford, Michael; Yates, Pasty; Boyle, Frances; White, Kate; Miller, Annie; Morton, Rachael L; Butt, Zoe; Butow, Phyllis Objective Informal family caregivers play a crucial role in cancer care. Effective caregiver involvement in cancer care can improve both patient and caregiver outcomes. Despite this, interventions improving the caregiver involvement are sparse. This protocol describes a randomised controlled trial evaluating the combined effectiveness of novel online caregiver communication education modules for: (1) oncology clinicians (eTRIO) and (2) patients with cancer and caregivers (eTRIO-pc). Methods and analysis Thirty medical/radiation/surgical oncology or haematology doctors and nurses will be randomly allocated to either intervention (eTRIO) or control (an Australian State Government Health website on caregivers) education conditions. Following completion of education, each clinician will recruit nine patient–caregiver pairs, who will be allocated to the same condition as their recruiting clinician. Eligibility includes any new adult patient diagnosed with any type/stage cancer attending consultations with a caregiver. Approximately 270 patient–caregiver pairs will be recruited. The primary outcome is caregiver self-efficacy in triadic (clinician–patient–caregiver) communication. Patient and clinician self-efficacy in triadic communication are secondary outcomes. Additional secondary outcomes for clinicians include preferences for caregiver involvement, perceived module usability/acceptability, analysis of module use, satisfaction with the module, knowledge of strategies and feedback interviews. Secondary outcomes for caregivers and patients include preferences for caregiver involvement, satisfaction with clinician communication, distress, quality of life, healthcare expenditure, perceived module usability/acceptability and analysis of module use. A subset of patients and caregivers will complete feedback interviews. Secondary outcomes for caregivers include preparedness for caregiving, patient–caregiver communication and caring experience. Assessments will be conducted at baseline, and 1 week, 12 weeks and 26 weeks post-intervention. Ethics and dissemination Ethical approval has been received by the Sydney Local Health District Human Research Ethics Committee (REGIS project ID number: 2019/PID09787), with site-specific approval from each recruitment site. Protocol V.7 (dated 1 September 2020) is currently approved and reported in this manuscript. Findings will be disseminated via presentations and peer-reviewed publications. Engagement with clinicians, media, government, consumers and peak cancer groups will facilitate widespread dissemination and long-term availability of the educational modules.

Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial

2021-01-01T00:00:00Z

Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial Ho, Emma K.; Ferreira, Manuela L.; Bauman, Adrian; Hodges, Paul W.; Maher, Christopher G.; Simic, Milena; Morton, Rachael L.; Lonsdale, Chris; Li, Qiang; Baysari, Melissa T.; Amorim, Anita B.; Ceprnja, Dragana; Clavisi, Ornella; Halliday, Mark; Jennings, Matthew; Kongsted, Alice; Maka, Katherine; Reid, Kate; Reynolds, Tahlia; Ferrerira, Paulo H. Background Although many people with chronic low back pain (LBP) improve following conservative treatment, one in five will experience worsening symptoms after discharge from treatment and seek health care again. The current LBP clinical care pathway in many health services lacks a well-integrated, systematic approach to support patients to remain physically active and self-manage their symptoms following discharge from treatment. Health coaching can support people to improve physical activity levels and may potentially reduce health care utilisation for LBP. The primary aim of this study is to evaluate the effect of introducing a coordinated support system (linking hospital outpatient physiotherapy services to a public health coaching service) at discharge from LBP treatment, on the future use of hospital, medical, and health services for LBP, compared with usual care provided at discharge. Methods Three hundred and seventy-four adults with chronic non-specific LBP will be recruited from the outpatient physiotherapy departments of public hospitals in New South Wales, Australia. Participants will be individually randomised to a support system (n = 187) or usual care group (n = 187). All participants will receive usual care provided at discharge from treatment. Participants allocated to the support system will also receive up to 10 telephone-based health coaching sessions, delivered by the Get Healthy Service®, over a 6-month period. Health coaches will monitor and support participants to improve physical activity levels and achieve personal health-related goals. The primary outcome is the total number of encounters with hospital, medical, and health services for LBP, at 12 months from baseline. A within-trial economic evaluation will quantify the incremental costs and benefits of the support system from a health system perspective, to support reimbursement decision making. Discussion This study will establish the effect of a coordinated support system, introduced at discharge from treatment, on the future use of hospital, medical, and health services for LBP and various health outcomes. Conclusion Innovative community-driven solutions to support people with chronic LBP after discharge from treatment are urgently needed. Study findings will help inform health care policy and clinical practice in Australia.

Health utilities for non‐melanoma skin cancers and precancerous lesions: A systematic review

2021-01-01T00:00:00Z

Health utilities for non‐melanoma skin cancers and precancerous lesions: A systematic review So, C.; Cust, A. E.; Gordon, L. G.; Morton, R. L.; Canfell, K.; Ngo, P.; Dieng, M.; McLoughlin, K.; Watts, C. Background Non-melanoma skin cancers (NMSCs) are common and consume many healthcare resources. A health utility is a single preference-based value for assessing health-related quality of life, which can be used in economic evaluations. There are scarce data on health utilities for NMSCs. Objectives Using a systematic review approach, we synthesized the current data on NMSC-related health utilities. Methods A systematic review of studies of NMSC-related health utilities was conducted in Medline, Embase, and Cochrane databases. Data were extracted based on the protocol and a quality assessment was performed for each study. Results The protocol resulted in 16 studies, involving 121 621 participants. Mean utility values across the studies ranged from 0.56 to 1 for undifferentiated NMSC, 0.84 to 1 for actinic keratosis, 0.45 to 1 for squamous cell carcinoma, and 0.67 to 1 for basal cell carcinoma. There was considerable variability in utilities by type of cancer, stage of diagnosis, time to treatment, treatment modality, and quality of life instrument or method. Utility values were predominantly based on the EuroQol 5-dimension instrument and ranged from 0.45 to 0.96, while other measurement methods produced values ranging from 0.67 to 1. Lower utility values were observed for advanced cancers and for the time period during and immediately after treatment, after which values gradually returned to pre-treatment levels. Conclusions Most utility values clustered around relatively high values of 0.8 to 1, suggesting small decrements in quality of life associated with most NMSCs and their precursors. Variability in utilities indicates that careful characterization is required for measures to be used in economic evaluations.

A meta-review demonstrates improved reporting quality of qualitative reviews following the publication of COREQ- and ENTREQ-checklists, regardless of modest uptake

2021-01-01T00:00:00Z

A meta-review demonstrates improved reporting quality of qualitative reviews following the publication of COREQ- and ENTREQ-checklists, regardless of modest uptake de Jong, Y.; van der Willik, E. M.; Voorend, C. G. N.; Morton, Rachael L.; Dekker, F. W.; Meuleman, Y.; van Diepen, M. Background Reviews of qualitative studies allow for deeper understanding of concepts and findings beyond the single qualitative studies. Concerns on study reporting quality led to the publication of the COREQ-guidelines for qualitative studies in 2007, followed by the ENTREQ-guidelines for qualitative reviews in 2012. The aim of this meta-review is to: 1) investigate the uptake of the COREQ- and ENTREQ- checklists in qualitative reviews; and 2) compare the quality of reporting of the primary qualitative studies included within these reviews prior- and post COREQ-publication. Methods Reviews were searched on 02-Sept-2020 and categorized as (1) COREQ- or (2) ENTREQ-using, (3) using both, or (4) non-COREQ/ENTREQ. Proportions of usage were calculated over time. COREQ-scores of the primary studies included in these reviews were compared prior- and post COREQ-publication using T-test with Bonferroni correction. Results 1.695 qualitative reviews were included (222 COREQ, 369 ENTREQ, 62 both COREQ/ENTREQ and 1.042 non-COREQ/ENTREQ), spanning 12 years (2007–2019) demonstrating an exponential publication rate. The uptake of the ENTREQ in reviews is higher than the COREQ (respectively 28% and 17%), and increases over time. COREQ-scores could be extracted from 139 reviews (including 2.775 appraisals). Reporting quality improved following the COREQ-publication with 13 of the 32 signalling questions showing improvement; the average total score increased from 15.15 to 17.74 (p-value < 0.001). Conclusion The number of qualitative reviews increased exponentially, but the uptake of the COREQ and ENTREQ was modest overall. Primary qualitative studies show a positive trend in reporting quality, which may have been facilitated by the publication of the COREQ.

Person centred care provision and care planning in chronic kidney disease: which outcomes matter? A systematic review and thematic synthesis of qualitative studies

2021-01-01T00:00:00Z

Person centred care provision and care planning in chronic kidney disease: which outcomes matter? A systematic review and thematic synthesis of qualitative studies de Jong, Ype; van der Willik, Esmee M.; Milders, Jet; Meuleman, Yvette; Morton, Rachael L.; Dekker, Friedo W.; van Diepen, Merel Rationale & Objective Explore priorities related to outcomes and barriers of adults with chronic kidney disease (CKD) regarding person centred care and care planning. Study design Systematic review of qualitative studies. Search Strategy & Sources In July 2018 six bibliographic databases, and reference lists of included articles were searched for qualitative studies that included adults with CKD stages 1–5, not on dialysis or conservative management, without a previous kidney transplantation. Analytical Approach Three independent reviewers extracted and inductively coded data using thematic synthesis. Reporting quality was assessed using the COREQ and the review reported according to PRISMA and ENTREQ statements. Results Forty-six studies involving 1493 participants were eligible. The period after diagnosis of CKD is characterized by feelings of uncertainty, social isolation, financial burden, resentment and fear of the unknown. Patients show interest in ways to return to normality and remain in control of their health in order to avoid further deterioration of kidney function. However, necessary information is often unavailable or incomprehensible. Although patients and healthcare professionals share the predominant interest of whether or not dialysis or transplantation is necessary, patients value many more outcomes that are often unrecognized by their healthcare professionals. We identified 4 themes with 6 subthemes that summarize these findings: ‘pursuing normality and control’ (‘pursuing normality’; ‘a search for knowledge’); ‘prioritizing outcomes’ (‘reaching kidney failure’; ‘experienced health’; ‘social life’; ‘work and economic productivity’); ‘predicting the future’; and ‘realising what matters’. Reporting quality was moderate for most included studies. Limitations Exclusion of non-English articles. Conclusions The realisation that patients’ priorities do not match those of the healthcare professionals, in combination with the prognostic ambiguity, confirms fatalistic perceptions of not being in control when living with CKD. These insights may contribute to greater understanding of patients’ perspectives and a more person-centred approach in healthcare prioritization and care planning within CKD care.

Sex differences in mortality among binational cohort of people with chronic kidney disease: population based data linkage study

2021-01-01T00:00:00Z

Sex differences in mortality among binational cohort of people with chronic kidney disease: population based data linkage study De La Mata, Nicole L.; Rosales, Brenda; MacLeod, Grace; Kelly, Patrick J.; Masson, Philip; Morton, Rachael L.; Wyburn, Kate; Webster, Angela C. Objective To evaluate sex differences in mortality among people with kidney failure compared with the general population. Design Population based cohort study using data linkage. Setting The Australian and New Zealand Dialysis and Transplant Registry (ANZDATA), which includes all patients receiving kidney replacement therapy in Australia (1980-2019) and New Zealand (1988-2019). Data were linked to national death registers to determine deaths and their causes, with additional details obtained from ANZDATA. Participants Of 82 844 people with kidney failure, 33 329 were female (40%) and 49 555 were male (60%); 49 376 deaths (20 099 in female patients; 29 277 in male patients) were recorded over a total of 536 602 person years of follow-up. Main outcome measures Relative measures of survival, including standardised mortality ratios, relative survival, and years of life lost, using general population data to account for background mortality (adjusting for country, age, sex, and year). Estimates were stratified by dialysis modality (haemodialysis or peritoneal dialysis) and for the subpopulation of kidney transplant recipients. Results Few differences in outcomes were found between male and female patients with kidney failure. However, compared with the general population, female patients with kidney failure had greater excess all cause deaths than male patients (female patients: standardised mortality ratio 11.3, 95% confidence interval 11.2 to 11.5, expected deaths 1781, observed deaths 20 099; male patients: 6.9, 6.8 to 6.9, expected deaths 4272, observed deaths 29 277). The greatest difference was observed among younger patients and those who died from cardiovascular disease. Relative survival was also consistently lower in female patients, with adjusted excess mortality 11% higher (95% confidence interval 8% to 13%). Average years of life lost was 3.6 years (95% confidence interval 3.6 to 3.7) greater in female patients with kidney failure compared with male patients across all ages. No major differences were found in mortality by sex for haemodialysis or peritoneal dialysis. Kidney transplantation reduced but did not entirely remove the sex difference in excess mortality, with similar relative survival (P=0.83) and years of life lost difference reduced to 2.3 years (95% confidence interval 2.2 to 2.3) between female and male patients. Conclusions Compared with the general population, female patients had greater excess deaths, worse relative survival, and more years of life lost than male patients, however kidney transplantation reduced these differences. Future research should investigate whether systematic differences exist in access to care and possible strategies to mitigate excess mortality among female patients.

Identifying challenges to implementation of clinical practice guidelines for sentinel lymph node biopsy in patients with melanoma in Australia: protocol paper for a mixed methods study

2020-01-01T00:00:00Z

Identifying challenges to implementation of clinical practice guidelines for sentinel lymph node biopsy in patients with melanoma in Australia: protocol paper for a mixed methods study Rapport, Frances; Smith, Andrea L.; Cust, Anne E.; Mann, Graham J.; Watts, Caroline G.; Gyorki, David E.; Henderson, Michael; Hong, Angela M.; Kelly, John W.; Long, Georgina V.; Mar, Victoria J.; Morton, Rachael L.; Saw, Robyn P.M.; Scolyer, Richard A.; Spillane, Andrew J.; Thompson, John F.; Braithwaite, Jeffrey Introduction Sentinel lymph node biopsy (SLNB) is a diagnostic procedure developed in the 1990s. It is currently used to stage patients with primary cutaneous melanoma, provide prognostic information and guide management. The Australian Clinical Practice Guidelines state that SLNB should be considered for patients with cutaneous melanoma >1 mm in thickness (or >0.8 mm with high-risk pathology features). Until recently, sentinel lymph node (SLN) status was used to identify patients who might benefit from a completion lymph node dissection, a procedure that is no longer routinely recommended. SLN status is now also being used to identify patients who might benefit from systemic adjuvant therapies such as anti-programmed cell death 1 (PD1) checkpoint inhibitor immunotherapy or BRAF-directed molecular targeted therapy, treatments that have significantly improved relapse-free survival for patients with resected stage III melanoma and improved overall survival of patients with unresectable stage III and stage IV melanoma. Australian and international data indicate that approximately half of eligible patients receive an SLNB. Methods and analysis This mixed-methods study seeks to understand the structural, contextual and cultural factors affecting implementation of the SLNB guidelines. Data collection will include: (1) cross-sectional questionnaires and semistructured interviews with general practitioners and dermatologists; (2) semistructured interviews with other healthcare professionals involved in the diagnosis and early definitive care of melanoma patients and key stakeholders including researchers, representatives of professional colleges, training organisations and consumer melanoma groups; and (3) documentary analysis of documents from government, health services and non-government organisations. Descriptive analyses and multivariable regression models will be used to examine factors related to SLNB practices and attitudes. Qualitative data will be analysed using thematic analysis. Ethics and dissemination Ethics approval has been granted by the University of Sydney. Results will be disseminated through publications and presentations to clinicians, patients, policymakers and researchers and will inform the development of strategies for implementing SLNB guidelines in Australia.

Quality of life among caregivers of people with end-stage kidney disease managed with dialysis or comprehensive conservative care

2020-01-01T00:00:00Z

Quality of life among caregivers of people with end-stage kidney disease managed with dialysis or comprehensive conservative care Shah, Karan K.; Murtagh, Fliss E.M.; McGeechan, Kevin; Crail, Susan M.; Burns, Aine; Morton, Rachael L. Background: To measure health-related and care-related quality of life among informal caregivers of older people with end-stage kidney disease (ESKD), and to determine the association between caregiver quality of life and care recipient’s treatment type. Methods: A prospective cross-sectional study was conducted. Three renal units in the UK and Australia were included. Informal caregivers of people aged ≥75 years with ESKD managed with dialysis or comprehensive conservative non-dialytic care (estimated glomerular filtration (eGFR) ≤10 mL/min/1.73m2 ) participated. Healthrelated quality of life (HRQoL) was assessed using Short-Form six dimensions (SF-6D, 0–1 scale) and care-related quality of life was assessed using the Carer Experience Scale (CES, 0–100 scale). Linear regression assessed associations between care-recipient treatment type, caregiver characteristics and the SF-6D utility index and CES scores. Results: Of 63 caregivers, 49 (78%) were from Australia, 26 (41%) cared for an older person managed with dialysis, and 37 (59%) cared for an older person managed with comprehensive conservative care. Overall, 73% were females, and the median age of the entire cohort was 76 years [IQR 68–81]. When adjusted for caregiver sociodemographic characteristics, caregivers reported significantly worse carer experience (CES score 15.73, 95% CI 5.78 to 25.68) for those managing an older person on dialysis compared with conservative care. However, no significant difference observed for carer HRQoL (SF-6D utility index − 0.08, 95% CI − 0.18 to 0.01) for those managing an older person on dialysis compared with conservative care. Conclusions: Our data suggest informal caregivers of older people on dialysis have significantly worse care-related quality of life (and therefore greater need for support) than those managed with comprehensive conservative care. It is important to consider the impact on caregivers’ quality of life when considering treatment choices for their care recipients.

When to replicate systematic reviews of interventions: consensus checklist

2020-01-01T00:00:00Z

When to replicate systematic reviews of interventions: consensus checklist Tugwell, Peter; Welch, Vivian Andrea; Karunananthan, Sathya; Maxwell, Lara J.; Akl, Elie A.; Avey, Marc T.; Bhutta, Zulfiqar A.; Brouwers, Melissa C.; Clark, Jocalyn P.; Cook, Sophie; Cuervo, Luis Gabriel; Curran, Janet Agnes; Ghogomu, Elizabeth Tanjong; Graham, Ian G.; Grimshaw, Jeremy M.; Hutton, Brian; Loannidis, John P.A.; Jordan, Zoe; Jull, Janet Elizabeth; Kristjansson, Elizabeth; Langlois, Etienne V.; Little, Julian; Lyddiatt, Anne; Martin, Janet E.; Marušić, Ana; Mbuagbaw, Lawrence; Moher, David; Morton, Rachael L.; Nasser, Mona; Page, Matthew J.; Pardo Pardo, Jordi; Jennifer, Petkovic; Petticrew, Mark; Pigott, Terri; Pottie, Kevin; Rada, Gabriel; Rader, Tamara; Riddle, Alison; Rothstein, Hannah; Schüneman, Holger; Shamseer, Larissa; Shea, Beverley J.; Simeon, Rosiane; Siontis, Konstantinos C.; Smith, Maureen; Soares-Weiser, Karla; Thavorn, Kednapa; Thavorn, David Tovey; Vachon, Brigitte; Valentine, Jeffery; Villemaire, Rebecca; Walker, Peter; Weeks, Laura; Wells, George; Wilson, David B.; White, Howard For systematic reviews of interventions, replication is defined as the reproduction of findings of previous systematic reviews looking at the same effectiveness question either by: purposefully repeating the same methods to verify one or more empirical findings; or purposefully extending or narrowing the systematic review to a broader or more focused question (eg, across broader or more focused populations, intervention types, settings, outcomes, or study designs) Although systematic reviews are often used as the basis for informing policy and practice decisions, little evidence has been published so far on whether replication of systematic reviews is worthwhile Replication of existing systematic reviews cannot be done for all topics; any unnecessary or poorly conducted replication contributes to research waste The decision to replicate a systematic review should be based on the priority of the research question; the likelihood that a replication will resolve uncertainties, controversies, or the need for additional evidence; the magnitude of the benefit or harm of implementing findings of a replication; and the opportunity cost of the replication Systematic review authors, commissioners, funders, and other users (including clinicians, patients, and representatives from policy making organisations) can use the guidance and checklist proposed here to assess the need for a replication

Cost-effectiveness analysis of PET/CT surveillance imaging to detect systemic recurrence in resected stage III melanoma: study protocol

2020-01-01T00:00:00Z

Cost-effectiveness analysis of PET/CT surveillance imaging to detect systemic recurrence in resected stage III melanoma: study protocol Dieng, Mbathio; Khanna, Nikita; Nguyen, Mai Thi Hoang; Turner, Robin; Lord, Sarah J.; Menzies, Alexander M.; Allen, Jay; Saw, Robyn; Nieweg, Omgo E.; Thompson, John; Morton, Rachael L. Introduction In the new era of effective systemic therapies for advanced melanoma, early detection of lower volume recurrent disease using surveillance imaging can improve survival. However, intensive imaging follow-up strategies are likely to increase costs to health systems and may pose risks to patients. The objective of this study is to estimate from the Australian health system perspective the cost-effectiveness of four follow-up strategies in resected stage III melanoma over a 5-year period following surgical treatment with curative intent. Methods and analysis A decision-analytic model will be built to estimate the costs and benefits of (1) 12 monthly, (2) 6 monthly, (3) 3–4 monthly positron emission tomography/CT imaging for 5 years, compared with (4) no imaging follow-up. The model will be populated with probabilities of disease recurrence, test performance measures using data from >1000 consecutive resected stage III melanoma patients from Melanoma Institute Australia diagnosed between 2000 and 2017. Healthcare resource use, including surveillance imaging, doctor’s visits, subsequent tests and procedures to investigate suspicious findings, will be quantified from detailed patient records and valued using Australian reference pricing. Economic outcomes include cost per new distant melanoma recurrence detected and cost per diagnostic error avoided, for no imaging compared with the other strategies. Deterministic sensitivity analyses will examine the robustness of model results. Ethics and dissemination This study was approved by the Sydney Local Health District, Sydney Local Health District Ethics Review Committee (RPAH Zone), AU/1/830638 and the Australian Institute of Health and Welfare (EO2019-1-454). The results of this study will be published in peer-reviewed medical and health economics journals and will inform melanoma management guidelines.