Intensive and Critical Care Nursing (2010) 26, 125—127

avai lab le at www.sc iencedi rec t .com

journa l homepage: www.e lsev ier .com/ iccn

REVIEW

Practical problems of doing research across differentcultures: Experiences from the RACHEL study

Christina Jones ∗

ICU, Whiston Hospital, Prescot and School of Clinical Science, University of Liverpool, UK

Accepted 28 January 2010

KEYWORDSMulti-cultural

Summary For many nurses the thought of conducting a research study, even one based inone centre, is daunting but coordinating a multi-centred study across different countries with

research different cultures can seem overwhelming. Some of the practical problems of doing researchacross different cultures are predictable and can be planned for, while others may surface asthe study is started and need to be reacted to as they happen. Clear lines of communicationare therefore essential. This article discusses some of the issues and problems that can occurusing examples from a large multi-national nursing study by the RACHEL group.

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Introduction

There is a need for multi-centred studies in critical carenursing to recruit sufficient study numbers in an area wherethe patient population is small. In addition such studies needto be multi-national to ensure that any nursing interventionsstudied work across different cultures. The use of pluralis-tic research methods has been postulated in psychotherapyand psychology (Bernal, 2006). In nursing research there hasbeen a call for more multi-cultural interventional researchstudies to examine health disparities (Jacobson et al., 2004).The barriers to such research, particularly in the field of

nursing, are many, for example, financial, ethical, method-ological and logistical. I will use examples from a recentmulti-centred study I coordinated examining the impact ofICU diaries on the development of post traumatic stress dis-

∗ ICU, Warrington Road, Prescot L35 5DR, Merseyside UK.Tel.: +44 151 430 2382.

E-mail address: christina.jones@sthk.nhs.uk.

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0964-3397/$ — see front matter © 2010 Elsevier Ltd. All rights reserved.doi:10.1016/j.iccn.2010.01.003

served.

rder (Jones et al., 2009) to illustrate some of the problems.he study involved the RACHEL group of 12 ICUs in 6 Euro-ean countries and was a randomised, controlled trial of these of ICU diaries.

thical barriers

he lack of consistency in the factors taken into accounty different ethical committees within a single country cane magnified when running a multi-national study. This canesult in these studies over-running their original plannednd time point as each country in the study will have theirwn system of applying for ethical approval. In the RACHELiary study one out of the three study ICUs in Sweden andne out of two in Portugal were unable to start recruitmentor a number of months due to delayed ethical approval. For

he Portuguese unit as the study coordinator I had to make annplanned site visit to Porto in Portugal to discuss the studyith a representative of the ethics committee to address

he ethic concerns which came out of a misunderstandingf what an ICU diary was; the concerns of the Swedish com-

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ittee was eventually addressed in writing but were muchhe same. This delayed the end point of the whole study byhree months. Where finance is time limited this could resultn the projected study numbers not being achieved. As theACHEL study was run predominantly on good will the mainnancial impact of these problems was the cost of an Easyjetight to Portugal, which was thankfully very reasonable. Thetudy coordinator in Porto very kindly put me up in her ownome to reduce the costs. Such good will is very importanto being able to achieve large multi-centred studies out-ide of the pharmaceutical setting. Site visits should allowome time to socialize with the local researchers as suchriendships strengthen the research process in this setting.

Even within Europe there may be significant differencesn ethical considerations such as informed consent. Someountries in the European Union, such as Portugal, haveigh rates of illiteracy in rural populations, particularlymongst the elderly. Written information sheets and consentorms have to be gone through with another family mem-er present who can read and sufficient time given for theatient to discuss the study with their family. The patientay not be able to sign the consent forms and the familyember may be required to witness that the patient has

rally agreed to be in a study where they are not able torite at all (Mystakidou et al., 2009).

Paternalism can still be an issue in some Southernuropean countries, particularly amongst elderly patientsToscani et al., 2006). This can mean that patients may read-ly give consent to be in studies, without even reading thenformation sheet, thinking that the researcher knows whats best for them. In a multi-cultural study the coordinatorhould ensure that the research staff are aware that thisan happen and that they understand the need to ensurenformed consent, even if that means stopping patients giv-ng consent until they have read the information sheet orad it read to them!

This is most easily achieved by site visits to all the studyentres.

ethodological issues

onsistency in applying the research protocol across studyentres in international research can be aided by trainingll research staff, using a flow diagram for data collec-ion and having clear inclusion and exclusion criteria. The

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Table 1 Master file with patient details and dates to complete fo

Patient name Study IDNO 1 week post ICUICU Memory Tool

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ULAR scleroderma trials and research group have improvedhe quality of the international studies by running regularteach the teachers’ courses to standardize research endoints such as skin scoring (Tyndall et al., 2008). Ideally thetudy coordinator during their site visits should go throughhe study protocol and the research questionnaires with allesearch staff to ensure everyone fully understand who isligible for the study, important time points and how todminister the tools. A simple flow diagram and master fileable where all the patients recruited at a particular unitre recorded (see Table 1) clearly showing the time pointsf the study with what should happen when makes it easieror novice researchers and helps ensure complete datasets.he protocol, any questionnaires (see Endacott, 2010 previ-us edition), consent forms, patient information and masterle tables need to be translated into the relevant languagesnd back translated to ensure face validity. English is oftensed as the universal language in multi-national studies andhile English-speaking nurses are very much more common

n the Scandinavian countries, this may be a problem inountries such as Spain and Italy. As site visits and e-mailommunication are often in English a nominated Englishpeaker for each study site makes communication muchasier.

In some countries the population density is so low thatatients may have to travel unacceptable distances to com-lete follow-up questionnaires. Postal questionnaires mayave a poor return rate, particularly when assessing psy-hological problems such as post traumatic stress disorder,here the patients who have the most problems are thoseost likely not to return the questionnaires. An alternativeay be telephone interviews with letters to prearrange con-

enient call times. In the RACHEL ICU diary study (Jones etl., 2009) one of the Norwegian study centres had difficultyringing some of their patients back for follow-up at 1 and 3onths and giving the intervention patients their diaries atmonth because of travel difficulties, particularly in winter.he follow-up questionnaires were completed with theseatients over the telephone and the intervention patientsere told over the phone that they would receive their diary

hrough the post with a time when the researcher would

hone and go through the diary with them using a photocopy.hey were asked not to read the diary themselves until theurse had gone through it with them. With the increase innternet availability across the world teleconsultation coulde another follow-up option in the future.

llow-up questionnaires.

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Multi-cultural research: Experiences from the RACHEL study

Logistical issues

Obtaining as complete a dataset as possible can be problem-atic even with a single centre study and becomes much moreof a challenge when other research centres are involved. Asimple excel based database with clear header explanationsof each field makes data entry easier for novice researchers.Data files can be sent into the primary study centre attachedto an e-mail with appropriate security precautions, includinganonymous patient data without names and dates of birthand password encryption using software such as WinZip. Allthis should be discussed with the study centres during theoriginal site visit.

Culturally there are perceived differences in the empow-erment of nurses across different countries and their abilityto take a lead in research studies (Malloy et al., 2009). Inthe RACHEL diary study there were three Southern Euro-pean study centres in Italy and Portugal. In the Italian unitalthough diaries are normally seen as a nursing interven-tion it was the doctors who took a lead for the study andthe nurses did not engage with the process, in Portugalthe doctors led the research team but the nurses werefully involved. In the Northern European study centres theresearch teams were either entirely nursing or nurse led withmedical support. So for nursing research studies to run effec-tively in some countries, even within the European Union,there may need to be considerable support from medicalcolleagues.

Randomised control trials (RCTs) traditionally have notbeen a preferred research method for nursing studies. How-ever, to compare the impact of nursing interventions onfactors such as patient comfort or recovery RCTs are the goldstandard. For multi-centred randomised controlled inter-vention studies all the study centres need a robust process torandomise patients to either intervention or control groupsto reduce possible bias (Attia, 2005). One of the best waysis for the coordinating centre to generate all the ran-domisation. A unique computer-generated permuted-blockrandomisation scheme should be created for each study cen-tre, blocks of 6 patients are frequently used so that thetwo study groups are more likely to end up with similarnumbers of individuals in them (Beller et al., 2002). Each

block of six has 3 intervention and controls and the orderis randomly permuted (rearranged) so that all possible per-mutations are created (see Fig. 1). A block is then chosenat random and treatments allocated according to that blockand then another chosen at random etc. Each study site can

Figure 1 Blocking for blocks of 6.

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hen be supplied by the coordinating centre with consec-tively numbered, sealed opaque randomisation envelopesith a tri-folded piece of paper inside with the treatmentssignment.

Study group meetings, involving at least the individualoordinators from each centre, are important as differentays of approaching specific issues related to the study cane discussed and adopted. Such meeting costs are oftenot available through research funding unless you are lucknough to get funding from the European Union throughchemes such as Framework 7. European meetings suchs the Annual Congress for the European Society of Inten-ive Care Medicine are a good venue for such meetingss individuals may have funding available for travel andccommodation outside of the study funding. A lunchtimer evening meeting, with self-financed dinner, can then berganised.

onclusions

hile there is a considerable amount of work involved inoordinating and running multi-national research studieshe rewards are worth it. Not only do you end up with aell-powered study, but you may also acquire long last-

ng friendships across different cultures which broaden yournowledge of nursing, research and of life.

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