Table 2.
List of major protocol amendments
| 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 |