Nurse Education in Practice (2007) 7, 1–3

Nurse

www.elsevierhealth.com/journals/nepr

Educationin Practice

GUEST EDITORIAL

The realities of a nurse led RandomisedControl Trial (RCT)

Introduction

Evidence based practice is fast consolidating its po-sition as a fundamental building block of healthcare delivery. However some disciplines, notablynursing, appear to be encountering difficulties indeveloping an evidence base that is specificallyand exclusively their own. There are a number ofreasons for this, some elements of nursing caredo not necessarily lend themselves to techniquesthat would result in upper hierarchy evidence;some aspects of nursing care, although within thedomain of nursing, have their origins and evidencein the more ‘scientific’ disciplines, such as medi-cine and, finally, the research training of themajority of nurses does not adequately preparethem for experimental enquiry of this nature. Inthe 21st century it is imperative that nursing con-tributes to developing upper hierarchy evidenceusing the appropriate and advanced empirical tech-niques. This means that there is a clear require-ment for more nurse designed and nurse ledrandomised controlled trials.

This discussion paper will reflect upon the les-sons learned from designing, managing and com-pleting such a trial. It will provide an overview ofthe pitfalls and signpost the highlights of the expe-rience and may also be of use to those nurse educa-tors who may be in the position of supporting orsupervising practitioner research.

Background

The opportunity to carry out the RCT resulted froma successful application for an award from the local

1471-5953/$ - see front matter �c 2006 Elsevier Ltd. All rights resedoi:10.1016/j.nepr.2006.12.001

Research and Development department. One of theconditions of the award was that it was completedand results published in a peer review journal within18 months. This was, with hindsight, an unachiev-able target and added a lot of pressure.

We designed and obtained funding for a prospec-tive pragmatic double-blind comparison of 0.125%and 0.0625% bupivacaine, via a continuous epiduralinfusion, for the management of pain in patientsundergoing major abdominal surgery (Duncanet al., 2005). We recruited a multi-disciplinary re-search team that included physiotherapists, phar-macists, doctors and nurses. The majority of theteam were from professions allied to medicineand the entire project was planned, managed andsupervised by two nurses, one a clinician, the otherin an academic role. We recruited over one hun-dred patients over a twelve month period. Thestudy provided interesting and robust results, chal-lenging the assumptions about the efficacy of epi-dural analgesia.

Reflections

Although the project itself progressed smoothlyafter a very rocky start, we detected a number ofextraneous components which appeared to be mak-ing an impact upon the study overall. These in-cluded such discrete elements as the ‘maverick’medic; medical colleagues who never recruited pa-tients to the study; the ‘unhelpful’ nurse who al-ways forgot to complete Visual Analogue Scores,or did not start the next trial infusion; other col-leagues who did not feel that nurses who undertookpractical research in the clinical area were ‘real’nurses and therefore made efforts to frustrate data

rved.

2 Guest editorial

collection; and historical dominators; individualscharged with research in the clinical area who pre-ferred scientific research to remain the province ofthe doctors and elected individuals to key commit-tees accordingly. Fortunately, this negativity wasmore than counterbalanced by the many multi-dis-ciplinary colleagues who were key to the success ofthe research.

We might well have floundered at the start with-out the support and guidance of the Director ofPharmacy. He came to us offering advice, not crit-icism. He had the authority and skill to guide usaround the practical problems of running a dou-ble-blind randomized controlled trial. We facedproblems and barriers that are not standard textin a ‘how to conduct pragmatic controlled trials’and he was able to tell us what the book doesnot. The directorate manager was also extremelysupportive when the drug bill exceeded our estima-tions. This demonstrated to us that help is avail-able in unexpected places and, often, outside ofyour own discipline.

Research support

We used the research award to fund a researchassistant post. The nurse we appointed did nothave a research background and we feel with hind-sight that this was an error. This is not to say thatthe person we did appoint was not effective, shewas brilliant, but she had to undergo a very steeplearning curve that was hard on her and slowedthe study down somewhat. She came from a the-atre environment and her existing good relation-ships with people made her highly effective whenpersuading anaesthetists and theatre staff to co-operate with setting up the epidural infusions. Wewere very dependant on the co-operation ofapproximately twenty anaesthetists, theatrerecovery staff, and all trained staff on six differentclinical areas including critical care – cooperationwhich had been promised with enthusiasm in theplanning stages. Yet when the study started therewere problems, a research presence was neededseven days a week. It was extremely trying copingwith some individuals, who had not only had nointerest in the research, but who extended thatlack of interest into active frustration of the pro-ject. This was difficult for our research assistantto address since she had no experience of dealingwith these scenarios. A further disadvantage ofappointing a clinician rather than a researcher tothe support post was that designing the SPSS data-base, loading data, and data analysis was left tothe primary researchers.

Patient perceptions

Patients picked up on the fact that nurses were un-sure about changing the study bag infusions. Thephrase ‘drugs trial’ caused problems, and a the pa-tient perception was that we were experimentingwith new drugs. The reality is we were only com-paring two concentrations of epidural infusiondrugs that have been available for many years.

Patient recruitment

Recruiting patients to the trial became, for all ofus, a patient support session, in much the sameway that it had for Webb in 1986. We found thatwe had a much greater role than explaining thestudy and it was sometime difficult to separatethe clinician role from the research one. Some pa-tients wanted to sign up to please us, perhaps be-cause we had spent time listening and sorting outtheir concerns. This gave us concerns regardingthe nature of their consent and we did, reluctantly,exclude some patients on the grounds that we couldnot adequately demonstrate informed consent.

We were not able to recruit many emergency pa-tients as we were not often present at admissionand the urgent time scales associated with thesepatient precluded adequate time for them to real-istically consider our request to join the study. Wewere aware of the very stressful preoperative con-ditions and we all backed away from taking the pa-tient’s precious time to explain a study.

We also interviewed seventy patients one monthafter their discharge home. Thus demonstratingthat it is possible to design a study which also cap-tures the patient’s perspective of their care. How-ever, our primary aim was more imperative - tochallenge the medical belief that epidural analgesiadid not have serious side effects. Nurses have muchinformation about the patient’s postoperativeexperience to offer our medical colleagues thattheymay be totally unaware of, and are often grate-ful to hear about. Nurse specialist have the opportu-nity of seeing and reporting so many aspects of careand putting it all together in a study such as this.

Credibility

Despite all the evidence to the contrary, the Chairof the Research and Development committee neveracknowledged the nurses as the designers and driv-ing force behind the study. All correspondence fromthe Chair was sent to the anaesthetist who we hadinvited onto the team. The anaesthetist was namedas the academic sponsor – the presumption was

Guest editorial 3

made that he was the experienced researcher,which was far from the case. If it is seen to exist,this historical perception of medics as researchersand nurses as helper is one that requires addressingearly on in any project. Nonetheless, we believe afactor in the support of the trial by the MDT, partic-ularly by surgeons and anaesthetists, is the credibil-ity and motivation of the researchers. Professionalbackground stops being an issue when there is pro-fessional respect between the disciplines.

The nurse researcher is not a passive participantin RCTs. The individual, from any discipline, is thedriving force, problem solver, and motivator.There are so many reasons to give up rather thancarry on. One important lesson that we did learnis that any research project should also be viewedas potential education opportunity for team mem-bers. Answer the following: would you go into workon days off, holidays, apologise endlessly as thenext problem arose, listen to the teasing, occa-sional genuine resentment, and publish your resultswithout registering for a higher degree?

Conclusion

Many clinical interventions, in secondary care, in-volve several professions. Isolationism will notserve us well in the future if we are to build thenurse led RCT portfolio. It should be acknowledgedthat nurses can and do design, manage and publishdouble blind, randomised controlled trials. Whilstthey are not always well received, or published inthe nursing journals, there are several multi-disci-plinary journals which will provide a platform forsuch ‘scientific’ multidisciplinary studies. A goalshould be to publish the research where the resultsmost influence those delivering patient care. Forexample, we wanted to reach the audience thatinitiate postoperative epidurals, particularly aswe found an unacceptably high incidence of apotentially serious complication of the technique.In our case we chose an international multi-disciplinary acute pain journal. The sense ofsatisfaction when practice is changed, andcolleagues from all professions, influenced by ourstudy, suggest ideas for future research, is high.

The learning curve that this experience providedhas lead us to develop a number of basic rules,namely:

� Research nearly always takes longer than youthink so plan for ‘‘slippage’’.� Make sure the nursing voice is heard right at thestart of the work, especially if nurses are thedrivers of the project.� An experienced research assistant can take a lotof work from the shoulders of the primaryresearcher.� Seek help from key players in other disciplines.� Talk to people who have done this sort of studybefore, they can tell you things that the booksleave out.� Expect to spend a great deal of time recruitingand consenting your participants and bewareof those who chose to participate simply toplease.� Look out for the mavericks – they’ll sabotageyour work.

We believe that these rules are crucial to thesuccessful management of multi-disciplinary nurselead trials. We would welcome the opportunity todebate these with colleagues in order to create aconsensus statement.

References

Duncan, F., Culpitt, J., Haigh, C., Vernon, P., Marshall, J.,Neild, A., 2005. A prospective pragmatic double-blindedcomparison of 0.125% and 0.0625% bupivacaine for themanagement of pain after operation in patientsundergoing major abdominal surgery. Acute Pain 7,85–93.

Webb, C., 1986. Professional and lay support for hysterectomypatients. Journal of Advanced Nursing 27 (3), 575–591.

Fiona DuncanVictoria Hospital,

Blackpool,Lancashire, UK

E-mail address: fmduncan@orange.net.

Carol HaighSalford Centre for Nursing,

Midwifery and Collaborative Research,University of Salford,

Salford, UKE-mail address: c.a.haigh@salford.ac.uk.