Requirements for the successful set-up of an international, multicentre, multilanguage, noninterventional patient-reported outcomes pain study

BACKGROUND For setting up and implementing an international follow-up survey study in different countries, many prerequisites are necessary: obtaining permission or licenses to use the tools/questionnaires selected, translating the questionnaires according to a standardised translation process, implementing the survey technically, recruiting, training and monitoring the data collecting study sites, obtaining ethics approvals and data protection clearance, developing the study and training materials, and registering the study. OBJECTIVE Within the IMI-PainCare project (Improving the care of patients suffering from acute or chronic pain), we needed to conduct a large noninterventional patient survey – PROMPT NIT-1 – aiming to find out which PROMs (patient-reported outcome measures) work best for postoperative pain assessment. Planning and implementing this international multicentre, multilanguage, follow-up study was complex and time consuming. Consequently, experiences from its successful implementation may help future study coordinators. DESIGN The NIT-1 surveys consisted of several established tools. We planned to include 4000 patients, and to collect data at seven time points: baseline, postoperative days (POD) 1, 3 and 7 and follow-up on postoperative months (POM) 1, 3 and 6. SETTING Eighteen hospitals, mostly primary care, across Europe collected data for our study. First patient in was in August 2019, last patient out in June 2022. PATIENTS Adult patients of both sexes who had undergone one of four defined surgical procedures answered our surveys; total knee arthroplasty (TKA), breast surgery, endometriosis surgery and sternotomy. MAIN OUTCOMES Results from the study related to the primary and secondary outcomes are not part of this publication and will be presented separately. This publication describes only the technical, administrative and coordinating implementation. RESULTS Although the COVID-19 pandemic affected patient inclusion, and some preparations took longer than foreseen, 18 hospitals across Europe included 3303 patients. We were able to attain sufficient case numbers, and follow-up rates were very good. CONCLUSION The setting up and implementation of a large, international, multilanguage data collection is challenging and ambitious but feasible if it is well planned, if sufficient resources (project management and technical/IT expertise, qualified staff, funding, commitment) are available and if the timeframe for preparing the study is generously calculated. TRIAL REGISTRATION clinicaltrials.gov (ID NCT03834922).