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Table 2 List of major protocol amendments

From: The efficacy of indwelling pleural catheter placement versus placement plus talc sclerosant in patients with malignant pleural effusions managed exclusively as outpatients (IPC-PLUS): study protocol for a randomised controlled trial

SA01 • Clarification of randomisation target of 154 patients
• All references to Short Form 36 Quality of Life (SF-36 QoL) questionnaire removed
• Added an exclusion criterion: patients must have access to phone for investigator trial contact
• Clarified sample collection and analysis
• Clarified procedure pre-randomisation
• Clarified that patients may also be excluded from randomisation for clinical reasons other than X-ray appearances
• Updated summary tables and clarified pre-randomisation day nomenclature
• Stipulated a time window in which patients must have first indwelling pleural catheter (IPC) drainage post-randomisation
• Clarified time window in which patients may have follow-up appointments
• Clarified wording in safety reporting section and highlighted expected minor side effects from talc
• Updated members of the Trial Steering Committee
• New sites added: Preston, Portsmouth and Bristol Royal Infirmary
SA02 • Change of principal investigator at Portsmouth site
SA03 • New sites added: Worcester, North Staffordshire, North Tyneside, Middlesbrough, South Manchester and Blackpool
• Creation of letter and short trial summary for district nurses
• Alteration to primary endpoint; changing minimal fluid volume required for pleurodesis from 20 to 50 mls
• Change to time limit given to patients to consider patient information sheet
• Removed requirement that trial chest X-ray must only be taken as a posterior-anterior image
• Trial flow chart updated, allowed patients to have follow-up appointments at satellite centres
• Allowance for patients to be approached as an inpatient but management must be as an outpatient for trial
• Clarifications to adverse event and serious adverse event reporting procedures
SA04 • New site added: Bath
SA05 • New sites added: London, Mansfield, Stockton-on-Tees and Sheffield
• Clarification of wording of primary endpoint, removal of duplicate secondary endpoint and addition of new secondary endpoint
• Clarification of definition of trapped lung in trial flow chart and protocol
• Addition of new QoL questionnaire (QLQ-C30) for all new trial participants
• Expanded the use of pleural manometry to all centres
• Removed the need for 0.9% saline placebo to be sourced from a particular manufacturer
• Updated wording of how the primary outcome will be analysed
• Updated membership of the Trial Steering Committee
SA06 • New sites added: Northampton, Ayr, Cambridge, Aintree and Hull
• Change of inclusion criteria to require World Health Organisation (WHO) performance of two or better to be eligible, three if score will decrease to two after drainage.
• Allow patients with previous pleurodesis as long as longer than 56 days before trial entry
• Relax follow-up visits by allowing day 42 and 56 to be carried out over the telephone
• Allow carers or relatives to perform chest drains after the day 28 post-randomisation visit
• Extend recruitment period to May 2015
• Relaxation of manometry recordings from every 100 ml to every 100 to 200 ml
• Updated membership of the Trial Steering Committee