Ethical approval for this study was obtained from the University of Nottingham Medical School Ethics Committee (SNMP 11042012) (Appendix 10) and the National Health Sciences Research Committee of Malawi (Appendix 11). The study was registered by Current Controlled Trials ISRCTN72861423 in October 2012. The protocol for this study has been published (Nkhoma et al., 2013) appendix 15.
Carrying out research among participants with a chronic illness like HIV/AIDS raises a number of ethical issues. People living with HIV/AIDS and their family carers experience physical, social, psychological and spiritual problems. They are therefore considered a vulnerable group of people and require special attention in relation to research (Addington-Hall et al., 2007). The following ethical issues were carefully considered when designing and implementing the study.
‚ The principle of beneficence which stipulates that the researcher should come up with strategies to minimising harm, but maximise benefits (Polit
165 and Beck, 2008). There was no physical harm in this study because the trial did not involve invasive procedures in technical sense, so the risk of harm was low; however possibly there was psychological harm, because the participants had to contribute their time to be involved in the study. In addition participants in the control group had to wait for two months before they received the intervention. However since the study evaluated the effectiveness of the education intervention, I needed a control group in order to come up with conclusive results and evidence. In line with this (Polit, 2006, Medical Research Council, 2005) argues that considering risk versus benefit ratio the study is ethical because the outcomes of the study are expected to inform policy and practice in the management of HIV/AIDS pain in patients’ homes.
‚ Participant’s right to decide whether or not to take part in the trial was respected. There were no rewards for participants who decided to take part in the study. Participants were given information sheets about the study.
These were available in both English and Tumbuka, the local language in Malawi. The language used was simple and clear (Cormack, 2000). The information sheets explained details about the study aims and objectives.
Participants who took part in the study were given an informed consent, they were fully informed that they have the right to withdraw from the trial at any time without giving reasons and that this was not going to affect their routine care. Data were privately, confidentially stored in a password protected personal and or university computer. Data was not shared with any person apart from my supervisors; each participant was assigned an identification number which was used to collect baseline and follow-up assessments.
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‚ The question of equipoise was also taken into consideration. This refers to genuine uncertainty that treatment in one arm of the trial is superior over treatment from the other arm of the trial (Djulbegovic, 2007, Mann and Djulbegovic, 2003). It was not known whether the pain education intervention was effective among this population and it was not part of routine care. Therefore, no patients or carers were denied a treatment through random allocation that they would normally get under the current service arrangements. To avoid disappointment for those not randomised to the pain education intervention, the intervention was also delivered to those randomised to usual care on completion of the trial. Equipoise did exist in this study because previous studies reviewed have not produced evidence that pain education interventions are effective in the population of HIV/AIDS and their family carers (Millard et al., 2013). It would have been unethical and unnecessary to conduct this study if I was certain that pain education interventions are effective in HIV/AIDS (Djulbegovic et al., 2000).
In order to ensure that participants were not burdened greatly due to taking part in the study, the intervention was kept simple and short, the questionnaires were short.
6.17 Chapter summary
This thesis is based on a randomised controlled trial evaluating the effects of a pain education intervention (consisting of a face-to-face verbal
discussion, an information leaflet and follow-up phone call reminder at two-weeks) on pain severity and pain management among HIV/AIDS patients
167 and their family carers. The intervention was specifically designed to improve pain severity and pain management among HIV/AIDS and family carers. The study design included developing a leaflet on pain management titled “All about your pain” through consultations with patients, family carers, and healthcare workers involved in care provision to HIV/AIDS patients, and piloting the tools and the intervention. The design of the intervention was guided by the bio-psychosocial model and the adult learning theory was used to deliver the intervention. Due to the design of this study, it is difficult to know how an education intervention leads to pain improvement among patients and carers. However when
patient/carer dyads experienced pain or perceived pain they were taught how to rate the pain, classify the pain, use self-management interventions and how to seek medical care.
Adult HIV/AIDS patients and their family carers were randomised to either usual care/wait list control group or 30 minutes face-to-face verbal
instructions and discussion on pain management, augmented by a leaflet and a phone call reminder after two weeks group. The primary outcome was average pain severity measured by a sub-scale of the BPI. Secondary outcomes for the patient were pain interference with daily activities of living measured by the sub-scale of BPI, patient pain knowledge measured by a sub-scale of the patient pain questionnaire, patient quality of life measured by a sub-scale of the APCA African POS. Secondary outcomes for the carers were pain knowledge measured by a sub-scale of the family pain questionnaire, quality of life measured by a sub-scale of the APCA African POS and carers motivation measured by Picot Caregiver Rewards Scale.
168 Baseline measurers were conducted two to four weeks after introducing the study to potential participants while follow-up measurers were conducted eight weeks after randomisation. The next chapter presents the results of the trial.
169 CHAPTER SEVEN: TRIAL RESULTS
7.1 Introduction
This chapter reports the results of the pain education intervention trial. The recruitment and flow of participants, the baseline characteristics of the study participants in the two arms of the trial are described. I describe the uptake and adherence of the participants to the intervention. The follow-up assessments at eight weeks after randomisation and delivery of the intervention are reported. In this chapter I report the differences observed in primary and secondary outcomes between the two arms of the trial.