Cryobiopsy with radial-endobronchial ultrasound (Cryo-Radial) has comparable diagnostic yield with higher safety in comparison to computed tomography-guided transthoracic biopsy for peripheral pulmonary lesions: An exploratory randomised study.

BACKGROUND: Computed tomography-guided transthoracic biopsy (CT-TTB) is the 'gold standard' biopsy for lung nodules. Radial-endobronchial ultrasound (R-EBUS) bronchoscopy is another recommended biopsy but carries a lower diagnostic yield. Addition of cryobiopsy with R-EBUS (Cryo-Radial) has shown promising results. There are no studies comparing CT-TTB with Cryo-Radial biopsy. AIM: The co-primary aims were the diagnostic yeild and safety. The secondary aim: ability to test epidermal growth factor receptor (EGFR). METHODS: A randomised controlled, multicentre exploratory study was conducted at three tertiary hospitals. Patients with nodules >1 cm on CT of the chest were randomised to CT-TTB or Cryo-Radial. With Cryo-Radial, patients had 1-3 cryo-biopsies in addition to at least one R-EBUS biopsy through the 2.6 mm guide sheath. RESULTS: Forty-eight patients were randomised: 22 to CT-TTB and 26 to Cryo-Radial. Sixteen in the CT-TTB and 20 in the Cryo-Radial received the allocated biopsy. The diagnostic yield was CT-TTB 93.8% (15/16) versus Cryo-Radial 85% (17/20) P = 0.61 and the odds ratio was 0.37. For 5/13 (38%), a diagnosis was solely made on cryobiopsy. Eleven (78%) of 14 in CT-TTB versus 7/10 (70%) Cryo-Radial were suitable for EGFR testing P = 0.66, with odds ratio 0.63. Pneumothorax occurrence was 44% (7/16) in CT-TTB versus 4.2% (1/24) in Cryo-Radial. Two (12.5%) of 16 CT-TTB required chest drain insertion. CONCLUSION: Cryo-Radial is comparable in diagnostic yield and ability to perform EGFR testing with a significantly lower risk of pneumothorax, compared with CT-TTB. Cryo-Radial has the additional advantage of mediastinal staging during the same procedure with Linear-EBUS and is a promising first-line tool in the diagnostic method of lung cancer.

Development of a Bronchoscopy-Radiologic Skills and Task Assessment Tool (BRadSTAT): A Tool for Evaluating the Radiological Skills of Bronchoscopists with Different Experience.

BACKGROUND: Competency using radiologic images for bronchoscopic navigation is presumed during subspecialty training, but no assessments objectively measure combined knowledge of radiologic interpretation and ability to maneuver a bronchoscope into peripheral airways. OBJECTIVES: The objectives of this study were (i) to determine whether the Bronchoscopy-Radiology Skills and Tasks Assessment Tool (BRadSTAT) discriminates between bronchoscopists of various levels of experience and (ii) to improve construct validity using study findings. METHODS: BRadSTAT contains 10 questions that assess chest X-ray and CT scan interpretation using multiple images per question and 2 technical skill assessments. After administration to 33 bronchoscopists (5 Beginners, 9 Intermediates, 10 Experienced, and 9 Experts), discriminative power was strengthened using differential weighting on CT-related questions, producing the BRadSTAT-CT score. Cut points for both scores were determined via cross-validation. RESULTS: Mean BRadSTAT scores for Beginner, Intermediate, Experienced, and Expert were 74 (±13 SD), 78 (±14), 86 (±9), and 88 (±8), respectively. Statistically significant differences were noted between Expert and Beginner, Expert and Intermediate, and Experienced and Beginner (all p ≤ 0.05). Mean BRadSTAT-CT scores for Beginner, Intermediate, Experienced, and Expert were 63 (±14), 74 (±15), 82 (±13), and 90 (±9), respectively, all statistically significant (p ≤ 0.03). Cut points for BRadSTAT-CT had lower sensitivity but greater specificity and accuracy than for BRadSTAT. CONCLUSION: BRadSTAT represents the first validated assessment tool measuring knowledge and skills for bronchoscopic access to peripheral airways, which discriminates between bronchoscopists of various experience levels. Refining BRadSTAT produced the BRadSTAT-CT, which had higher discriminative power. Future studies should focus on their usefulness in competency-based bronchoscopy programs.

Severe asthma assessment, management and the organisation of care in Australia and New Zealand: expert forum roundtable meetings.

Severe asthma imposes a significant burden on individuals, families and the healthcare system. Treatment is complex, due to disease heterogeneity, comorbidities and complexity in care pathways. New approaches and treatments improve health outcomes for people with severe asthma. However, emerging multidimensional and targeted treatment strategies require a reorganisation of asthma care. Consensus is required on how reorganisation should occur and what areas require further research. The Centre of Excellence in Severe Asthma convened three forums between 2015 and 2018, hosting experts from Australia, New Zealand and the UK. The forums were complemented by a survey of clinicians involved in the management of people with severe asthma. We sought to: (i) identify areas of consensus among experts; (ii) define activities and resources required for the implementation of findings into practice; and (iii) identify specific priority areas for future research. Discussions identified areas of unmet need including assessment and diagnosis of severe asthma, models of care and treatment pathways, add-on treatment approaches and patient perspectives. We recommend development of education and training activities, clinical resources and standards of care documents, increased stakeholder engagement and public awareness campaigns and improved access to infrastructure and funding. Further, we propose specific future research to inform clinical decision-making and develop novel therapies. A concerted effort is required from all stakeholders (including patients, healthcare professionals and organisations and government) to integrate new evidence-based practices into clinical care and to advance research to resolve questions relevant to improving outcomes for people with severe asthma.

Treatable traits can be identified in a severe asthma registry and predict future exacerbations.

BACKGROUND AND OBJECTIVE: A new taxonomic and management approach, termed treatable traits, has been proposed for airway diseases including severe asthma. This study examined whether treatable traits could be identified using registry data and whether particular treatable traits were associated with future exacerbation risk. METHODS: The Australasian Severe Asthma Web-Based Database (SAWD) enrolled 434 participants with severe asthma and a comparison group of 102 participants with non-severe asthma. Published treatable traits were mapped to registry data fields and their prevalence was described. Participants were characterized at baseline and every 6 months for 24 months. RESULTS: In SAWD, 24 treatable traits were identified in three domains: pulmonary, extrapulmonary and behavioural/risk factors. Patients with severe asthma expressed more pulmonary and extrapulmonary treatable traits than non-severe asthma. Allergic sensitization, upper-airway disease, airflow limitation, eosinophilic inflammation and frequent exacerbations were common in severe asthma. Ten traits predicted exacerbation risk; among the strongest were being prone to exacerbations, depression, inhaler device polypharmacy, vocal cord dysfunction and obstructive sleep apnoea. CONCLUSION: Treatable traits can be assessed using a severe asthma registry. In severe asthma, patients express more treatable traits than non-severe asthma. Traits may be associated with future asthma exacerbation risk demonstrating the clinical utility of assessing treatable traits.

Radial-probe endobronchial ultrasound outcomes in the investigation of peripheral pulmonary lesions: a New Zealand perspective.

BACKGROUND: Radial-probe endobronchial ultrasound (radial-EBUS) is becoming an important investigation for peripheral pulmonary lesions (PPL). A key advantage of radial-EBUS is the favourable risk profile compared with current gold-standard computerised tomography-guided biopsy. AIM: To investigate the diagnostic yield, predictors of positive yield and radial-EBUS safety in a New Zealand institution. We also determined whether molecular analysis was possible on the same tissue samples. METHODS: We performed a retrospective analysis of all patients (n = 68) from Middlemore Hospital, Auckland, undergoing radial-EBUS with guide-sheath for PPL from March 2015 to August 2016. Clinical, radiological and procedural data were collected. Radial-EBUS diagnostic yield was determined for malignant and benign diagnoses, and molecular analysis yield was determined on appropriate malignant samples. Logistic regression was used to determine factors predicting successful radial-EBUS. RESULTS: Overall diagnostic yield of radial-EBUS was 55.9% (95% confidence interval (CI): 44.3-67.9). Malignant diagnostic sensitivity was 60.8% (95% CI: 46.1-74.2) and benign diagnostic sensitivity was 50% (95% CI: 23-77). Lesions close to the hilum (P = 0.039), concentric radial-probe positioning (P = 0.008) and the use of forceps as first instrument (P = 0.0049) significantly predicted successful diagnostic yield. Of the malignant cases 81.0% (95% CI: 58.1-94.6) were sufficient for molecular analysis. Pneumothorax occurred in 4.4% (95% CI: 0.9-12.4), none required chest drain intervention. There were no cases of significant pulmonary haemorrhage. CONCLUSION: Radial-EBUS was shown to be safe with diagnostic yield similar to international reports. Important predictors of success include distance from hilum, probe position and forceps as first instrument. We also demonstrated that molecular analysis is possible in radial-EBUS obtained samples.

Effect of an Indwelling Pleural Catheter vs Talc Pleurodesis on Hospitalization Days in Patients With Malignant Pleural Effusion: The AMPLE Randomized Clinical Trial.

Importance: Indwelling pleural catheter and talc pleurodesis are established treatments for malignant pleural effusions among patients with poor prognosis. Objective: To determine whether indwelling pleural catheters are more effective than talc pleurodesis in reducing total hospitalization days in the remaining lifespan of patients with malignant pleural effusion. Design, Setting, and Participants: This open-label, randomized clinical trial included participants recruited from 9 centers in Australia, New Zealand, Singapore, and Hong Kong between July 2012 and October 2014; they were followed up for 12 months (study end date: October 16, 2015). Patients (n = 146) with symptomatic malignant pleural effusion who had not undergone indwelling pleural catheter or pleurodesis treatment were included. Interventions: Participants were randomized (1:1) to indwelling pleural catheter (n = 74) or talc pleurodesis (n = 72), minimized by malignancy (mesothelioma vs others) and trapped lung (vs not), and stratified by region (Australia vs Asia). Main Outcomes and Measures: The primary end point was the total number of days spent in hospital from procedure to death or to 12 months. Secondary outcomes included further pleural interventions, patient-reported breathlessness, quality-of-life measures, and adverse events. Results: Among the 146 patients who were randomized (median age, 70.5 years; 56.2% male), 2 withdrew before receiving the randomized intervention and were excluded. The indwelling pleural catheter group spent significantly fewer days in hospital than the pleurodesis group (median, 10.0 [interquartile range [IQR], 3-17] vs 12.0 [IQR, 7-21] days; P = .03; Hodges-Lehmann estimate of difference, 2.92 days; 95% CI, 0.43-5.84). The reduction was mainly in effusion-related hospitalization days (median, 1.0 [IQR, 1-3] day with the indwelling pleural catheter vs 4.0 (IQR, 3-6) days with pleurodesis; P < .001; Hodges-Lehmann estimate, 2.06 days; 95% CI, 1.53-2.58). Fewer patients randomized to indwelling pleural catheter required further ipsilateral invasive pleural drainages (4.1% vs 22.5%; difference, 18.4%; 95% CI, 7.7%-29.2%). There were no significant differences in improvements in breathlessness or quality of life offered by indwelling pleural catheter or talc pleurodesis. Adverse events were seen in 22 patients in the indwelling pleural catheter group (30 events) and 13 patients in the pleurodesis group (18 events). Conclusions and Relevance: Among patients with malignant pleural effusion, treatment with an indwelling pleural catheter vs talc pleurodesis resulted in fewer hospitalization days from treatment to death, but the magnitude of the difference is of uncertain clinical importance. These findings may help inform patient choice of management for pleural effusion. Trial Registration: anzctr.org.au Identifier: ACTRN12611000567921.

Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters.

BACKGROUND: Malignant pleural effusion (MPE) is a debilitating condition as it commonly causes disabling breathlessness and impairs quality of life (QoL). Indwelling pleural catheter (IPC) offers an effective alternative for the management of MPE. However, IPC-related infections remain a significant concern and there are currently no long-term strategies for their prevention. The Australasian Malignant PLeural Effusion (AMPLE)-4 trial is a multicentre randomised trial that evaluates the use of topical mupirocin prophylaxis (vs no mupirocin) to reduce catheter-related infections in patients with MPE treated with an IPC. METHODS: A pragmatic, multi-centre, open-labelled, randomised trial. Eligible patients with MPE and an IPC will be randomised 1:1 to either regular topical mupirocin prophylaxis or no mupirocin (standard care). For the interventional arm, topical mupirocin will be applied around the IPC exit-site after each drainage, at least twice weekly. Weekly follow-up via phone calls or in person will be conducted for up to 6 months. The primary outcome is the percentage of patients who develop an IPC-related (pleural, skin, or tract) infection between the time of catheter insertion and end of follow-up period. Secondary outcomes include analyses of infection (types and episodes), hospitalisation days, health economics, adverse events, and survival. Subject to interim analyses, the trial will recruit up to 418 participants. DISCUSSION: Results from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections. ETHICS AND DISSEMINATION: Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023.

A survey of adult respiratory and sleep services in Aotearoa New Zealand: inequities in the provision of adult respiratory and sleep services.

AIMS: The New Zealand "Standards for Adult Respiratory and Sleep Services" were published by the Ministry of Health in 2004. A 2006 survey demonstrated major gaps in the staffing and service provision and significant variation between district health boards (DHBs). We repeated this survey in 2019/20 in order to highlight issues which should be addressed as part of health service reforms. METHODS: Survey of all adult DHB respiratory services assessing staffing and service provision. RESULTS: There is marked regional variation in staffing levels for all specialist clinicians. There are 1.18 FTE/100,000 population respiratory physicians, which is well below Australian and United Kingdom levels. Two hundred thousand people in New Zealand do not have access to a local respiratory physician. For provided services we found a four-fold variation between DHBs for CPAP treatments, six-fold for oxygen services, and eight-fold for pulmonary rehabilitation. CONCLUSION: The place of residence of New Zealanders determines access to respiratory services. There are inequities in access, with little progress made since 2006. Data on health outcomes are required. The restructure of the health service must rectify this situation. The need to end a "postcode lottery" is demonstrated when reviewing current respiratory services in New Zealand.

Bronchoscopy in Patients With Known or Suspected COVID-19: Results From the Global Pandemic SARS-CoV-2 Bronchoscopy Database (GPS-BD).

BACKGROUND: Amid the Coronavirus Disease 2019 (COVID-19) pandemic, the benefits and risks of bronchoscopy remain uncertain. This study was designed to characterize bronchoscopy-related practice patterns, diagnostic yields, and adverse events involving patients with known or suspected COVID-19. METHODS: An online survey tool retrospectively queried bronchoscopists about their experiences with patients with known or suspected COVID-19 between March 20 and August 20, 2020. Collected data comprised the Global Pandemic SARS-CoV-2 Bronchoscopy Database (GPS-BD). All bronchoscopists and patients were anonymous with no direct investigator-to-respondent contact. RESULTS: Bronchoscopy procedures involving 289 patients from 26 countries were analyzed. One-half of patients had known COVID-19. Most (82%) had at least 1 pre-existing comorbidity, 80% had at least 1 organ failure, 51% were critically ill, and 37% were intubated at the time of the procedure. Bronchoscopy was performed with diagnostic intent in 166 (57%) patients, yielding a diagnosis in 86 (52%). and management changes in 80 (48%). Bronchoscopy was performed with therapeutic intent in 71 (25%) patients, mostly for secretion clearance (87%). Complications attributed to bronchoscopy or significant clinical decline within 12 hours of the procedure occurred in 24 (8%) cases, with 1 death. CONCLUSION: Results from this international database provide a widely generalizable characterization of the benefits and risks of bronchoscopy in patients with known or suspected COVID-19. Bronchoscopy in this setting has reasonable clinical benefit, with diagnosis and/or management change resulting from about half of the diagnostic cases. However, it is not without risk, especially in patients with limited physiological reserve.

Pleural effusion in patients with pulmonary embolism.

BACKGROUND AND OBJECTIVE: It has been suggested that pulmonary embolism (PE) is an under-recognized cause of pleural effusion. This study aimed to (i) establish the incidence and clinical relevance of pleural effusion in patients with pulmonary emboli; and (ii) determine if there is a relationship between development of pleural effusions and the location of emboli and number of pulmonary arteries involved. METHODS: A retrospective analysis of all CT pulmonary angiograms (CTPA) performed over 12 months on adult patients with clinically suspected PE in a hospital which used CTPA as first-line imaging investigation for PE. RESULTS: Of 285 CTPA, 60 patients (21%) had evidence of pulmonary emboli (38 had both central and peripheral clots and 22 peripheral emboli only). Emboli were bilateral in 39 cases and unilateral in 21 cases. Pleural effusion was present in almost one half (n = 29, 48%) of the patients with pulmonary emboli. Patients with pulmonary emboli were more likely to have a pleural effusion (OR 2.2 (95% CI: 1.1-4.7), P < 0.05) than patients without PE; however, the effusions were generally very small. Most (86%) of the effusions were present on the same side as the emboli. The location of emboli and number of arteries involved did not predict the presence of pleural effusions. CONCLUSIONS: Pleural effusion is common in patients with pulmonary emboli demonstrated on CTPA. These effusions are small and seldom alter clinical management. Clinicians should therefore have a high threshold of suspicion in attributing large or contralateral pleural effusions to embolic diseases without excluding alternative diagnoses.

Novel hybrid cryo-radial method: an emerging alternative to CT-guided biopsy in suspected lung cancer. A prospective case series and description of technique.

In diagnosing peripheral pulmonary lesions (PPL), radial endobronchial ultrasound (R-EBUS) is emerging as a safer method in comparison to CT-guided biopsy. Despite the better safety profile, the yield of R-EBUS remains lower (73%) than CT-guided biopsy (90%) due to the smaller size of samples. We adopted a hybrid method by adding cryobiopsy via the R-EBUS Guide Sheath (GS) to produce larger, non-crushed samples to improve diagnostic capability and enhance molecular testing. We report six prospective patients who underwent this procedure in our institution. R-EBUS samples were obtained via conventional sampling methods (needle aspiration, forceps biopsy, and cytology brush), followed by a cryobiopsy. An endobronchial blocker was placed near the planned area of biopsy in advance and inflated post-biopsy to minimize the risk of bleeding in all patients. A chest X-ray was performed 1 h post-procedure. All the PPLs were visualized with R-EBUS. The mean diameter of cryobiopsy samples was twice the size of forceps biopsy samples. In four patients, cryobiopsy samples were superior in size and the number of malignant cells per high power filed and was the preferred sample selected for mutation analysis and molecular testing. There was no pneumothorax or significant bleeding to report. Cryobiopsy samples were consistently larger and were the preferred samples for molecular testing, with an increase in the diagnostic yield and reduction in the need for repeat procedures, without hindering the marked safety profile of R-EBUS. Using an endobronchial blocker improves the safety of this procedure.

Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial.

BACKGROUND: Indwelling pleural catheters are an established management option for malignant pleural effusion and have advantages over talc slurry pleurodesis. The optimal regimen of drainage after indwelling pleural catheter insertion is debated and ranges from aggressive (daily) drainage to drainage only when symptomatic. METHODS: AMPLE-2 was an open-label randomised trial involving 11 centres in Australia, New Zealand, Hong Kong, and Malaysia. Patients with symptomatic malignant pleural effusions were randomly assigned (1:1) to the aggressive (daily) or symptom-guided drainage groups for 60 days and minimised by cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group [ECOG] score 0-1 vs ≥2), presence of trapped lung, and prior pleurodesis. Patients were followed up for 6 months. The primary outcome was mean daily breathlessness score, measured by use of a 100 mm visual analogue scale during the first 60 days. Secondary outcomes included rates of spontaneous pleurodesis and self-reported quality-of-life measures. Results were analysed by an intention-to-treat approach. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000963527. FINDINGS: Between July 20, 2015, and Jan 26, 2017, 87 patients were recruited and randomly assigned to the aggressive (n=43) or symptom-guided (n=44) drainage groups. The mean daily breathlessness scores did not differ significantly between the aggressive and symptom-guided drainage groups (geometric means 13·1 mm [95% CI 9·8-17·4] vs 17·3 mm [13·0-22·0]; ratio of geometric means 1·32 [95% CI 0·88-1·97]; p=0·18). More patients in the aggressive group developed spontaneous pleurodesis than in the symptom-guided group in the first 60 days (16 [37·2%] of 43 vs five [11·4%] of 44, p=0·0049) and at 6 months (19 [44·2%] vs seven [15·9%], p=0·004; hazard ratio 3·287 [95% CI 1·396-7·740]; p=0·0065). Patient-reported quality-of-life measures, assessed with EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L), were better in the aggressive group than in the symptom-guided group (estimated means 0·713 [95% CI 0·647-0·779] vs 0·601 [0·536-0·667]). The estimated difference in means was 0·112 (95% CI 0·0198-0·204; p=0·0174). Pain scores, total days spent in hospital, and mortality did not differ significantly between groups. Serious adverse events occurred in 11 (25·6%) of 43 patients in the aggressive drainage group and in 12 (27·3%) of 44 patients in the symptom-guided drainage group, including 11 episodes of pleural infection in nine patients (five in the aggressive group and six in the symptom-guided drainage group). INTERPRETATION: We found no differences between the aggressive (daily) and the symptom-guided drainage regimens for indwelling pleural catheters in providing breathlessness control. These data indicate that daily indwelling pleural catheter drainage is more effective in promoting spontaneous pleurodesis and might improve quality of life. FUNDING: Cancer Council of Western Australia and the Sir Charles Gairdner Research Advisory Group.

Right ventricular dysfunction and pulmonary hypertension following sub-massive pulmonary embolism.

BACKGROUND AND OBJECTIVES: Persistent right ventricular dysfunction (RVD) and pulmonary hypertension (PHT) are important outcomes following sub-massive pulmonary embolism (PE). The aims were to determine the rates and factors associated with RVD and/or PHT on echocardiography (ECHO) and the rate of 30-day and 1-year all-cause mortality following sub-massive PE. Patients who received thrombolysis and non-thrombolysis were also compared. METHODS: Consecutive patients with sub-massive PE over a five year period with at least 1-year follow-up were retrospectively identified. Regression analysis was performed to identify predictors of outcomes. RESULTS: Eighty-seven patients met inclusion criteria. Sixty-one (70%) had admission ECHOs with a follow-up ECHO in 42 (48.3%) at a mean of 7.6 months (SD 5.2). Fifty-one had RVD (58.6%) and 35 (40.2%) had PHT on admission. The rates of persistent RVD and raised right ventricular systolic pressure in this study population were 12% and 17%, respectively. Thrombolysis was associated with a trend towards improvement of PHT (53.3% PHT on admission to 0% PHT on follow-up in the thrombolysis group, P = 0.29). The rate of 30-day and 1-year all-cause mortality were 12.6% and 21.8%, respectively. Thirty-day all-cause mortality was independently predicted by the presence of right heart strain on computed tomography pulmonary angiography [OR 3.7 (P = 0.045)], echocardiographic evidence of RVD [OR 3.9 (P = 0.041)] and age. CONCLUSION: The majority of patients with RVD and PHT at the time of sub-massive PE improve on follow-up; however, there is a subset who remain abnormal. Future studies are needed to identify modifiable risk factors for these complications.

Protocol of the Australasian Malignant Pleural Effusion-2 (AMPLE-2) trial: a multicentre randomised study of aggressive versus symptom-guided drainage via indwelling pleural catheters.

INTRODUCTION: Malignant pleural effusions (MPEs) can complicate most cancers, causing dyspnoea and impairing quality of life (QoL). Indwelling pleural catheters (IPCs) are a novel management approach allowing ambulatory fluid drainage and are increasingly used as an alternative to pleurodesis. IPC drainage approaches vary greatly between centres. Some advocate aggressive (usually daily) removal of fluid to provide best symptom control and chance of spontaneous pleurodesis. Daily drainages however demand considerably more resources and may increase risks of complications. Others believe that MPE care is palliative and drainage should be performed only when patients become symptomatic (often weekly to monthly). Identifying the best drainage approach will optimise patient care and healthcare resource utilisation. METHODS AND ANALYSIS: A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5% significance, 90% power) assuming a common between-group SD of 18.9 mm and a 10% lost to follow-up rate. ETHICS AND DISSEMINATION: The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER: ACTRN12615000963527; Pre-results.

Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis.

INTRODUCTION: Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients' remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. METHODS AND ANALYSIS: The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. ETHICS AND DISSEMINATION: The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The trial results will be published in peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBERS: Australia New Zealand Clinical Trials Registry-ACTRN12611000567921; National Institutes of Health-NCT02045121.

Diagnosing malignant pleural effusions: how do we compare?

INTRODUCTION: Accurate and prompt diagnosis of malignant pleural effusion (MPE) is important as patients with suspected MPE often wait for many days before the diagnosis is secure. AIMS: (1) To evaluate the diagnostic yield of pleural fluid cytology for patients admitted to Middlemore Hospital (MMH) in Auckland, New Zealand with MPE between 31 May 2010-1 June 2011. (2) To document the waiting time for cytology results to be made available and whether this contributed to length of stay. (3) To evaluate whether the volume of pleural fluid analysed contributed to diagnostic yield. METHODS: A retrospective audit of pleural fluid cytology results on 36 consecutive patients admitted to MMH with a pleural effusion which was subsequently proven to be due to malignancy. Data was obtained from hospital medical records and Web Eclair databases. RESULTS: 54.8% (17/31) of patients had positive pleural fluid cytology. Initial pleural fluid cytology was positive in 16 (51.6%). Only 4/15 patients with negative pleural fluid cytology had a repeat aspiration (1 was positive). Median cytology turnaround time was 6.72 days, range 2.23-43.06 days. Average length of stay (ALOS) was 7.78 days, range 1.11-20.8 days. Cytology turnaround times seem shorter for inpatients and when a diagnosis of cancer is unknown but the ALOS is longer if patients have negative initial cytology and when a diagnosis of cancer is uncertain. Samples >50mL appear to have a higher diagnostic yield compared to samples less than and equal to 50mL but this was not statistically significant (77.8% to 41.2%, p=0.08). CONCLUSION: Diagnostic yield from pleural fluid cytology at our hospital is comparable with other documented studies. ALOS appears to be influenced by a negative initial pleural fluid cytology and the uncertainty of diagnosis of cancer, not cytology turnaround time. The results suggest a more efficient diagnostic and treatment algorithm could be considered with emphasis on Day Stay investigation and treatment.