Data management in multi-centre research:examination of Epi Info 2002 in amulti-professional team context

Sarah Hills and Luca Landucci

RISC Project Coordinating CentreDepartment of Internal Medicine, University of Pisa, Pisa, Italy

Introduction

• International multi-centre research (MCR) projects are increasing.

• Data organisation is central to MCR to ensure valid database. Flow of data

between recruiting centres and coordinating centre must run smoothly.

• Equipment and infrastructures for data collection and electronic transfer

vary across Europe, which should be considered when methods of data

collection/transfer are chosen.

• Research staff have different professional backgrounds and may not share

the same training and experience for electronic data entry.

Epi Info 2002

• The Centres for Disease Control (CDC) produce Epi Info 2002, free software

that can be implemented in multi-centre research by health care staff.

• Epi Info is based on Access and Excel, it can be downloaded from the

internet and comes with instruction manual and telephone helpline. It

needs minimal PC requirements for installation. Epi Info can create user-

friendly data entry templates to reproduce case report forms (CRFs).

• We copied eight CRFs onto CD-ROM and distributed to recruiting centres.

• Data are inserted, exported to Excel, then transferred to coordinating centre

by project website or email.

Background to this study

• Funds were limited and new hardware and software were expensive so Epi

Info 2002 was chosen for data management.

• A questionnaire survey of research staff was carried out within the RISC

project to assess Epi Info.

• A literature search gleaned little information on data organisation in MCR

(Blumenstein et al. 1995, Kearney et al. 2000). Few articles mentioned Epi

Info 2002 (187 articles on Medline discussed mainly older versions), none

for Epi Info 2002 in MCR.

• We report our experience over the past two years using Epi Info 2002.

Aims

• to assess training and past experience in local data entry

• to examine the data entry procedure with Epi Info 2002 as used in RISC

Methods

• Questionnaire of past experience and training in computer data entry

together with opinions about Epi Info as used in RISC.

• 23 questionnaires were sent to research staff in 18 of 19 recruiting centres

(one centre not recruiting) in 14 countries.

• Quantitative are presented as n (%), qualitative data were analysed by

content analysis (Cohen and Manion 1994).

Results

England Ireland Scotland3 (14%)

Austria Germany Serbia 3 (14%)

France Greece

Italy Spain Switzerland

9 (43%)

Denmark Finland Sweden 6 (29%)

Figure 1. Geographic location of respondents (n=21)Data are n followed by % of total responses

Table 1. Representation of professions by country group

________________________________________________________Country group Physicians Nurses Technical

(n=12) (n=4) (n=5)________________________________________________________

Austria, Germany, Serbia 3 (100%) 0 (0%) 0 (0%)

Denmark, Finland, Sweden 1 (17%) 2 (33%) 3 (50%)

England, Ireland, Scotland 1 (33%) 2 (66%) 0 (0%)

France, Greece, Italy

Spain, Switzerland 7 (78%) 0 (0%) 2 (22%)________________________________________________________Data are n followed by % of total responses according to country group

(country groups according to Hofstede 2001)

10

50%

7

35%

3

15%

8

53%

5

33%

2

13%

0

10

20

30

40

50

60

70

80

90

100

Bad Satisfactory Good

Percen

tag

e o

f resp

on

den

ts

All respondents (20)

Epi Info users (15)

Figure 2. Overall satisfaction with data collection, one respondent (not using Epi)did not reply. All respondents shown together with Epi Info users (sub-set) whowere slightly more satisfied with data collection.

• Epi Info used less by those with no data entry experience or training, the

most common reason (four of five responses) was that it was too time

consuming compared with paper CRFs.

‘at the investigator meeting I heard from several persons that Epi Infowas very time consuming, that’s why we don’t use it (nurse).

• Time to enter data was the most frequent problem (31% reported more

than 1 hour to enter one subject), which also relates to length of CRFs.

‘questionnaire is time consuming but the rest is fantastic’ (physician)

‘ time consuming especially lifestyle questionnaire. Converting files andzipping them is fairly complex’ (nurse)

‘CRFs are quite complicated and long and transferring data requires timeand efforts, and we do not have personnel helping us on this’ (physician)

• Gradual resolution of problems with Epi Info over time was mentioned by

three respondents:

‘some teething problems to start with both with entry and analysis, whichI overcame with the assistance of the coordinating office’ (nurse)

‘at the beginning there was a lot of problems how to use Epi program, butnow is ok’ (technician)

‘at the beginning it was really time consuming, but with training its gettingof course faster and easier’ (physician)

Conclusions

• Overall we report a positive experience with Epi Info. It is free, possible to

implement by non-specialist staff and has a good support service.

• In RISC it has been used to collect data from 19 recruiting centres.

• Minimal experience needed to install and implement Epi Info, create local

database and transfer data. Few problems found when transmitting data,

main area of dissatisfaction is time to enter data.

Recommendations

• Share experience with free programs such as Epi Info.

• Assess training needs and organise training in non-commercial projects

References

Blumenstein BA, James KE, Lind BK, Mitchell HE (1995) Functions and organisation ofcoordinating centres for multicenter studies. Controlled Clinical Trials 16:4S-29S

Cohen L, Manion L (1994) Research methods in education. Routledge, LondonHofstede G (2001) Comparing values, behaviors, institutions, and organizations across nations.

Sage, Thousand OaksKearney N, Miller M, Sermeus W, Hoy D, Vanhaecht K (2000) Multicentre research and the

WISECARE experience. Journal of Advanced Nursing 32:999-1007

Epi Info website (http://www.cdc.gov/epiinfo/) contains links to publications on Epi Info2002, along with courses, tutorials and access to a user’s message board.

Acknowledgements:

Thanks are due to the research staff of the RISC project who gave their time to respond to thequestionnaire.Study was undertaken as part of the MSc thesis of Sarah Hills (University of Greenwich, UK).The RISC project is funded by the EU 5th Framework (QLG1-CT-2001-01252) and AstraZeneca.