results were interesting. Remember, the special care group were warned that they would experience pain and were encouraged to ask for as much medication as they wanted. You might think that this would have made them super‐vigilant and sensitive about their pain and, along with the invitation to dip into the analgesic jar as often as they wanted, their medication use might be high. The researchers were able to calculate the use of pain killers for each patient, and then to compare the two groups. The results showed that the special care group used half as much analgesic as the control group. (See Figure 3.2.) The independent observer noted that the special care group patients ‘appeared to be more comfortable and in better physical and emotional condition than the control group”. The surgeons discharged patients in the special care group on average 2.7 days earlier than those in the control group.
FIGURE 3.2 Postoperative treatment with narcotics (Means for each day + Standard error of the mean).
Don't you just love this study? It was a relatively inexpensive one to conduct. And its findings were clear. The study design was a dream (Figure 3.3).
1 They identified a problem− post‐operative pain in surgical patients.
2 They developed an intervention based upon current theory and knowledge – the psychology of fear and stress. They took from that the fact that if we know in advance that something stressful or unpleasant is about to happen, then we are better able to prepare ourselves to deal with it. And, if we have a sense of control, we are more likely to be able to cope with it.
3 Their interventions were based upon theory ‐ aspects of the of the psychology of fear and stress (Janis, 1958). These were: (i) anticipation – warning the patients in advance that they would experience pain; and (ii) giving them a sense of control – ‘you can do this to help avoid the pain’ and ‘you can ask for as much pain‐killing medication as you want’. They worked!
4 They engaged an appropriate methodology – a twin‐arm, double‐blind, experimental approach, and chose a consecutive series of patients to participate in it.
5 They carried out the study and analysed their results.
6 They published their results for all the world to see!
FIGURE 3.3 Egbert et al.'s research design.
Let me tell you something about this study and its findings. I have taught about it since 1974. I have lectured about it to medical and nursing students, to psychology students, to sociology students, to healthcare administrators, undergraduates and postgraduates, and to members of the public. All but one of these groups either said something like, ‘Oh, that's interesting’. (yawn), or ‘We already know that’ (not!). The one group who sat up and started taking notes were … Guess who? …Yes – the healthcare administrators! I could almost see them doing the calculations, Half our analgesics budget, that's about £xxx,000! And 2.7 hospital bed days in a surgical ward – that about £5000–6000 per patient! Meanwhile, those who should have been thinking, ‘How can I use this study to improve my patients' care?’ (medical and nursing students) were yawning or dismissing it! Sometimes, it's a hard job being a teacher!
This study could be called an RCT. But the researchers described it as an experiment. So, I have included it in this chapter as a fine example of what can be achieved when experimental design is applied in a real‐life situation. In the next chapter I shall discuss RCTs.
To Sum Up
You can see clearly that these real‐life experiments we have looked at above are quantitative – they all use numerical data! They are clearly hypothetico‐deductive – they had a clear purpose and set of expectations in mind before they began. They are in the interventional domain – they introduced an experimental variable which was not there at the start; from Snow removing the handle of the water pump to Egbert et al. providing additional information to surgical patients. They are prospective – they all had a start point where they made their initial measurements, they had their interventions, and they had an end point when they made their final measurements. And they were all conducted outside of the lab!
You can see that Snow’s ‘experiment’ was a single‐arm one – He believed that if he removed the pump handle, then people would not be able to drink contaminated water. He did it and the cases reduced.
The Paddington Station and the Brighton Tunnel experiments were good examples of testing behaviour in public places. Their ‘interventions’ – an actor in different roles in Paddington, and different music, in Brighton, evoked different behaviours which were filmed, noted, and measured.
Egbert used the everyday practice of preparing patients for operations as an opportunity to add an intervention – special briefing – and then to note and measure the impact of this in comparison with no special briefing.
McKinley, in Boston, used actors as the ‘interventions’ and by noting physician’s responses to different actors was able to determine how actors from different ethnic/racial backgrounds were treated in different ways.
Research is the art of the possible!
References
1 Chapelle F. (2005). Wellsprings. Rutgers University Press: New Brunswick. New Jersey, p. 82.
2 Easteal M, Bannister S, Francesco JK, et al. (2015). Urban sound planning in Brighton and Hove. Conference paper presented at Forum Acusticum, 7–12 September, Krakow.
3 Egbert LD, Battit GE, Welch CE, et al. (1964). Reduction of postoperative pain by encouragement and instruction of patients: a study of doctor‐patient rapport. New England Journal of Medicine 20(16): 825–827.
4 Janis IL. (1958). Psychological Stress: Psychoanalytic and Behavioural Studies of Surgical Patients. Wiley: New York.
5 John S. (1849). On the Mode of Communication of Cholera. John Churchill: London.
6 John BM, Lisa DM, and Rebecca JP. (2012). Do doctors contribute to the social patterning of disease? The case of race/ethnic disparities in diabetes mellitus. Medical Care Research 69(2): 176–193.
7 Reece RD and Siegal HA. (1991). Studying People: A Primer in the Ethics of Social Research. Mercer University Press: Georgia.
8 Sissons M. (1971). The psychology of social class in Money, Wealth and Class. Open University Press: Milton Keynes.
CHAPTER 4 Experimental Quantitative Approaches: Non‐randomised Clinical Trials
Introduction
Clinical trials of new forms of tests or treatment begin with Phase I trials then Phase II Trials. (Phase III trials or Randomised Control Trials (RCTs) are covered in the next chapter.)
These early trials to test new forms of assessing or treating patients are:
Still in the quantitative domain – we measure and quantify