The introduction of the randomized controlled trial (RCT) is normally attributed to Sir Austin Bradford-Hill.1 Since then it has become the ‘gold standard’ for much investigation in the clinical sciences. The key feature of the RCT is prospective, random allocation of patients to a treatment group and a control group. To demonstrate that an intervention works, the treatment and control groups need to be equal in all respects, apart from the intervention itself, so that any difference in outcome can be attributed to the intervention. Anything else which affects the outcome is known as a confounder. If sample sizes are large enough, random allocation will distribute all confounders equally between the groups, thereby cancelling out any differential effect they may have on outcome. The investigator can therefore infer that any differences in outcome are due to the intervention. Furthermore, in classic RCTs patients, clinicians and data collectors should be blind to whether each patient belongs to the intervention or control group, so that expectations do not bias the results of the trial. The experimental intervention and its alternative need to be clearly defined (and distinguishable), and it must be possible to measure an outcome which is (potentially) relevant to the intervention. The trialists need to enrol a sufficiently large sample to be sure that differences between the intervention and control groups can be detected. If the study is too small it may fail to detect a difference, not because the intervention has no effect, but because the study has insufficient statistical power (a so-called type II error). In practice, RCTs normally identify strict eligibility criteria so that it is clear what patient population the new treatment is being tested on. A distinction is made between explanatory trials and pragmatic trials.2 An explanatory trial seeks to determine whether a treatment is efficacious – that is, whether it works under ideal conditions. Such trials normally investigate a single causal factor, very often a drug. Pragmatic trials investigate effectiveness – whether it works in real world practice conditions – and often investigate more than one variable at a time. For example, while an explanatory trial might compare a new drug with a placebo in a professorial unit, a pragmatic trial might compare the new drug with best current practice in general practice. Trials of palliative care services are almost entirely pragmatic trials and these should be distinguished from trials of drugs in palliative medicine, which usually are not. Below we draw on examples from palliative care pragmatic trials.

Why are trials in palliative care so difficult

Aim To present a novice researcher's use of a reflective research diary in the quantitive measure of a mixed methods study and to recommend resulting changes to practice. Background Reflexivity is often regarded as a useful tool for ensuring the standard of qualitative research. Reflexivity provides transparent information about the positionality and personal values of the researcher that could affect data collection and analysis; this research process is deemed to be best practice. A reflective research diary also allows researchers to record observations about the research process. However, such diaries are rarely used in quantitative research and are even contraindicated. Data sources A reflective research diary maintained while conducting a retrospective audit of 150 hospice casenotes. Review methods A reflective research diary was written at the end of every research session to keep a detailed history of the research process and to critically reflect on the researcher's thoughts, feelings and observations on the day's work. Discussion This paper raises questions about whether reflexivity is appropriate in quantitative research, whether it has the capacity to add something of value or whether it endangers the robustness of the method. The authors consider the place of grounded theory's commitment to reflexivity in this mixed-methods study and discuss whether reflexivity offers any benefits to researcher development. Conclusion Use of reflexivity had a positive impact on the progress of the quantitative measure of this study: it enabled work to be reviewed efficiently and served to inform future research practice. Reflexivity stimulated the acquisition of researcher skills and contributed positively to the development of confidence in the novice researcher. Implications for research/practice Reflexivity in quantitative research practice can be an effective, ongoing means of critically reviewing work, process and researcher development. Reflexivity is recommended to other quantitative researchers.

Use of reflexivity in a mixed-methods study.

Cancer and tourism

Young people, holiday-taking and cancer - an exploratory analysis.

Objective: This study explores men with advanced prostate cancers’ own practices for promoting and maintaining emotional well-being using Interpretative Phenomenological Analysis.Design: Five men with advanced prostate cancer participated in face-to-face, semi-structured, in-depth interviews.Results: Within rich narratives of lost and regained well-being, two super-ordinate themes emerged – ‘living with an imminent and uncertain death’ and ‘holding on to life.’ Well-being was threatened by reduced sense of the future, isolation and uncertainty. Yet, the men pursued well-being by managing their emotions, striving for the future whilst enjoying life in the present, taking care of their families and renegotiating purpose. Running through participant’s accounts was a preference for taking action and problem-solving. Sense of purpose, social connectedness, and life engagement were revealed as concepts central to improving well-being, indicating areas which practitioners could explore with men to help them re-e...

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R. Glynn Owens

Papers

Qualitative Research in the Field of Death and Dying