1. A multi-site cluster randomised controlled trial comparing the severity of constipation symptoms experienced by palliative care patients receiving usual care compared to those diagnosed and managed according to the underlying pathophysiology. “Management of constipation in palliative care ” Respect Stewardship Healing Hospitality

2. Authors and study staff Brief overview of the study What is working well? What is not working well? Future directions Some preliminary results or why persist with this? What would I do differently next time? Contents

3. Authors and study staff Brief overview of the study What is working well? What is not working well? Future directions Some preliminary results or why persist with this? What would I do differently next time?

4. Authors and Study staff AuthorsStudy Staff Katherine ClarkNaomi Byfieldt David CurrowBelinda Fazekas Nicholas TalleyNatalie Cutri Phillip Dinning Lawrence Lam Meera Agar Patricia Davidson Jane Phillips Tania Shelby-James

5. Authors and study staff Brief overview of the study What is working well? What is not working well? Future directions Some preliminary results or why persist with this What would I do differently next time?

6. A cluster randomised controlled trial of an algorithmic approach to the diagnosis and management of constipation in palliative care versus standard current clinical care. Intervention Units: 7 day assessment period to sub-categorise participants (diagnostic testing) and collect pre-intervention data. Once Assessment period complete, participants will commence the two-week intervention period. Laxative medications will be changed based on the sub-category allocation, participants will be provided with exercises, toileting routine and positioning. All participants will complete an intervention diary. Usual Practice Units: 14 day study period with participants taking their usual laxative medication and recording bowel habits in a daily diary. At the end of the 14 day period, all participants are offered the opportunity to participate in the ‘sub-study’ in which the diagnostic tests are performed and the results provided to their GP.

7. Primary outcome: Change in constipation symptoms as measured by the PAC-SYM at 14 day Secondary outcomes: Change in constipation QoL Frequency with which BO Satisfaction Number and types of extra laxatives Relationship between SAS “bowels” item and PAC-SYM Outcomes ?

8. Authors and study staff Brief overview of the study What is working well? What is not working well? Future directions Some preliminary results or why persist with this What would I do differently next time?

9. Constipation has a whole new persona! The usual practice sites are managing well mainly due to the that it is really a matter of completing questionnaires; The results of the investigations suggest that different physical problems really do underlie constipation. What is working well?

10. Authors and study staff Brief overview of the study What is working well? What is not working well? Future directions Some preliminary results or why persist with this? What would I do differently next time?

11. Recruitment to the intervention arm is very slow, much slower then expected; Some of the participants find the questionnaires burdensome. What is not working well?

12. Authors and study staff Brief overview of the study What is working well? What is not working well? Future directions Some preliminary results or why persist with this? What would I do differently next time?

13. Expanded recruitment sites: Liverpool Westmead Nepean Lower Mid-North Coast Altered emphasis: This study is really about the fact that up to 60% of people admitted to palliative care units are prescribed laxatives with more than ½ taking more than two simultaneously; Future directions

14. Authors and study staff Brief overview of the study What is working well? What is not working well? Future directions Some preliminary results or why persist with this? What would I do differently next time ?

15. The results of the investigations suggest that there are physical changes underlying constipation symptoms, either slow transit or impaired pelvic floor function or most commonly, both. The symptom burden carried by these patients is complex with the majority of people describing abdominal symptoms or difficulties actually passing a bowel action or most commonly both. Although preliminary, there seems to be a correlation between the burden of physical symptoms and self-reported QoL. Why persist with this?

16. Authors and study staff Brief overview of the study What is working well? What is not working well? Future directions Some preliminary results or why persist with this? What would I do differently next time?

17. Different emphasis Greater consumer participation to explore the best approach to describing the study assessments Less patient questions (which is interesting as we are using approaches very well accepted in gastroenterology!) What would I do differently next time?