Commentary

David Sackett and his co-authors, in their book ‘Evidence-based medicine: How to practice and teach EBM’,[1] have outlined five steps for clinicians to practice evidence- based medicine. These are (1) asking a question to address the need for relevant information in a clinical context, (2) searching for the best available evidence to do the above, (3) doing a critical appraisal of the evidence, (4) applying this to our particular patient and (5) continually examining the efficiency in how we do this with ongoing improvements.[1] Bhatnagar has noted the importance of evidence-based practice in chronic pain, and emphasized that the N-of-1 randomized controlled trials (RCTs) are limited in pain medicine and pointed out the need for pain and palliative care physicians to conduct randomized controlled trials in the various domains of pain, including assessment and management.[2] The need for well-conducted research in palliative care in India has also been addressed elsewhere.[3] Therefore, a randomized controlled study on ‘Safety and efficacy of oral transmucosal fentanyl citrate compared to morphine sulphate immediate release tablet in management of breakthrough cancer pain’ published in this issue, is the right step in the direction of evidence-based medicine in pain and palliative care settings in India.[4]

Breakthrough pain can have significant adverse impact on the quality of life of cancer patients with pain. A Cochrane Collaboration review has looked at the evidence for different opioid preparations for management of breakthrough cancer pain (BTCP).[5] Another review has outlined the use of transmucosal fentanyl in BTCP.[6] The authors of the article in this issue of Indian Journal of Palliative Care have set the rationale for their RCT well, highlighting the fact that this is the first study of its kind in India, addressing the need for managing breakthrough pain of cancer patients, comparing efficacy of oral transmucosal fentanyl citrate (OTFC) over oral morphine immediate release preparations. Readers pursuant of evidence-based medicine can discern the strengths of a well-conducted RCT for e.g. explaining the method of randomization for sequence generation, using objective measures and reporting as per Consolidated Standards of Reporting Trials for RCTs.[7] The study does have some limitations. The trial could use only one available dose strength of OTFC, which meant that appropriate dose titration could not be done, as duly pointed out by the authors themselves.

The authors give us an opportunity to learn about both the conduct of the RCT in our setting, as well as on the reporting. The multicentric nature of the study highlights the importance of collaboration in undertaking research activity in this field.

The clinical implication of this study for managing breakthrough cancer pain in ‘at- home’ patients is important, as stated by the authors. The research implications are myriad, mainly serving as an encouragement to palliative care physicians in our country to undertake rigorous and methodologically sound research studies contributing to high levels of evidence and thus give a boost to the quality of the evidence in practice and in journals in this discipline in our country.

Conducting clinical research in palliative care has met with some barriers related to patients and ethical issues. However, a study by LeBlanc and colleagues[8] has noted that barriers though present and ‘significant’, are not ‘insurmountable’. They have enumerated evidence-based strategies that could help in the recruitment in palliative care trials. We could adapt these steps to our socio-cultural context and devise good quality studies, including RCTs like the present one.

The five steps enumerated above in practicing and teaching evidence-based medicine will continue, paving the way forward for high quality research in pain and palliative care in all the domains i.e. physical, psychological, social, spiritual and existential, which will translate to enhanced quality of care for our patients and their caregivers.