Discussion Xerostomia is a very frequent and distressing symptom in PC patients with significant physical, social and psychological consequences which compromise the quality of life of
patients. Managing dry mouth with treatment supported by the best possible evidence will improve the functional status of patients, and improve quality of life (QOL) for patients and carers. The research question is one of the most important ones in PC. Trial findings will provide evidence to service providers, policy makers and #Proton pump inhibitor keyword# consumers to develop policies and practice around the use of pilocarpine for dry mouth in PC patients. It is important to assess n-of-1 trial methodology in a range of medications and symptoms and in an array of PC situations. Using n-of-1 trials will help to accelerate the rate of accumulation Inhibitors,research,lifescience,medical of high-grade evidence to support clinical therapies used in PC. The method will augment the evidence base for PC clinical therapies, contribute to lessening the uncertainty that surrounds many therapies in advanced cancer, and minimize side effects from treatments without proven benefit.
This trial thus forms an important and significant part of the world’s first systematic Inhibitors,research,lifescience,medical evaluation of n-of-1 trials in PC. Moreover, if n-of-1 trial methodology proves to be robust, it will be suitable for many other areas of clinical PC as an alternative method of gathering evidence of similar strength to RCTs, but requiring far fewer subjects to be recruited. N-of-1 trials will accelerate development of the PC evidence base to improve care offered to this very disadvantaged and frail group Inhibitors,research,lifescience,medical and make a significant contribution to quality of life for people with terminal illness and their carers. Abbreviations AR: Adverse (drug) reaction; AE: Adverse event; AKPS: Australian karnofsky
performance scale; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; CRF: Case report form; DAP: Data analysis Inhibitors,research,lifescience,medical plan; DSMC: Data safety monitoring committee; EORTC-QLQC15-PAL: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group shortened the QLQ-C30 specifically for use in Adenylyl cyclase palliative care to a 15-item version entitled the EORTC QLQ-C15-PAL; GCP: Good clinical practice; ICC: Intra-class correlation; IRB: Institutional review board; MPH: Methylphenidate; NCI: National cancer institute; n-of-1: Single patient trials; NRS: Numerical rating scale; OHIP: Oral health impact profile; PaCCSC: Palliative care clinical studies collaborative; PC: Palliative care; QOL: Quality of life; RCT: Randomised controlled trial; SAE: Serious adverse event; SAR: Serious adverse (drug) reaction; SPT: Single patient trials; SUSAR: Suspected unexpected serious adverse reaction; TABS: Tablets; UQ: The University of Queensland; VAS: Visual analogue scale; WHO: World Health Organisation; XI: Xerostomia inventory; XQ: Xerostomia questionnaire.
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