Protocol for the cultural adaptation of pulmonary rehabilitation and subsequent testing in a randomised controlled feasibility trial for adults with chronic obstructive pulmonary disease in Sri Lanka.

INTRODUCTION: International guidelines recommend pulmonary rehabilitation (PR) should be offered to adults living with chronic obstructive pulmonary disease (COPD), but PR availability is limited in Sri Lanka. Culturally appropriate PR needs to be designed and implemented in Sri Lanka. The study aims to adapt PR to the Sri Lankan context and determine the feasibility of conducting a future trial of the adapted PR in Sri Lanka. METHODS AND ANALYSIS: Eligible participants will be identified and will be invited to take part in the randomised controlled feasibility trial, which will be conducted in Central Chest Clinic, Colombo, Sri Lanka. A total of 50 participants will be recruited (anticipated from April 2021) to the trial and randomised (1:1) into one of two groups; control group receiving usual care or the intervention group receiving adapted PR. The trial intervention is a Sri Lankan-specific PR programme, which will consist of 12 sessions of exercise and health education, delivered over 6 weeks. Focus groups with adults living with COPD, caregivers and nurses and in-depth interviews with doctors and physiotherapist will be conducted to inform the Sri Lankan specific PR adaptations. After completion of PR, routine measures in both groups will be assessed by a blinded assessor. The primary outcome measure is feasibility, including assessing eligibility, uptake and completion. Qualitative evaluation of the trial using focus groups with participants and in-depth interviews with PR deliverers will be conducted to further determine feasibility and acceptability of PR, as well as the ability to run a larger future trial. ETHICS AND DISSEMINATION: Ethical approval was obtained from the ethics review committee of Faculty of Medical Sciences, University of Sri Jayewardenepura, Sri Lanka and University of Leicester, UK. The results of the trial will be disseminated through patient and public involvement events, local and international conference proceedings, and peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN13367735.

Psychometric Properties of Sinhala Version of Short-Form McGill Pain Questionnaire-2 (SF MPQ-2-Sin) among Patients with Cancer Pain in Sri Lanka.

Introduction: Pain is one of the most common and unpleasant symptoms that distress the well-being of patients with cancer. Considerable evidence supports the validity and reliability of the McGill Pain Questionnaire (MPQ) and its short forms, the SF MPQ and SF MPQ-2-which are the most widely used tools for pain assessment-in terms of patients with cancer. Pain and its characteristics are best assessed using validated and culturally adapted tools developed in participants' mother tongue. Although many pain assessment tools are available worldwide, only a limited number of them have been translated into Sinhala language and validated in Sri Lanka. We aimed to translate SF MPQ-2 into Sinhala language and validate using Sinhala-speaking patients suffering from cancer pains in Sri Lanka. Materials and Methods: Translation has been conducted according to the guidelines laid down by Mapi Research Trust, in five stages, namely, forward translation, backward translation, expert opinion, cognitive debriefing interviews, and proofreading. The questionnaire was administered among 207 patients attending Apeksha Hospital, Sri Lanka, who are suffering from cancer pain. Content validity was tested using expert opinion, and face validity, by interviewing patients with cancer pain. Factor structure was tested through a factor analysis, and reliability, by internal consistency with Cronbach's alpha. Results: A total of 207 participants (112 males and 95 females), aged between 20 and 80 years, were included in the study. Factor analysis identified four factors compatible with studies done in other countries, which explained 53.5% of the variance. The analysis of data indicated Cronbach's alpha of neuropathic, affective, intermittent, and continuous subscales as 0.768, 0.791, 0.824, and 0.789, respectively, which were over the acceptable threshold of 0.70. Confirmatory factor analysis supported the four-factor model. Conclusion: SF MPQ-2-Sinhala version is a statistically proven reliable and valid pain descriptor which can be utilized to evaluate pain suffered by patients with cancer in Sri Lanka whose mother tongue is Sinhala.