The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial.
BACKGROUND
Recruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely collected data to identify potential trial participants. We discuss the strengths and limitations of this approach, assess its potential value, report challenges and ethical issues encountered.


METHODS
Swansea University's Health Information Research Unit's Secure Anonymised Information Linkage (SAIL) database of routinely collected health records was interrogated, using Structured Query Language (SQL). Read codes were used to create an algorithm of inclusion/exclusion criteria with which to identify suitable anonymous participants. Two independent clinicians rated the eligibility of the potential participants' identified. Inter-rater reliability was assessed using the kappa statistic and inter-class correlation.


RESULTS
The study population (N = 37263) comprised all adults registered at five general practices in Swansea UK. Using the algorithm 867 anonymous potential participants were identified. The sensitivity and specificity results > 0.9 suggested a high degree of accuracy from the algorithm. The inter-rater reliability results indicated strong agreement between the confirming raters. The Intra Class Correlation Coefficient (Cronbach's Alpha) > 0.9, suggested excellent agreement and Kappa coefficient > 0.8; almost perfect agreement.


CONCLUSIONS
This proof of concept study showed that routinely collected primary care data can be used to identify potential participants for a pragmatic randomised controlled trial of folate augmentation of antidepressant therapy for the treatment of depression. Further work will be needed to assess generalisability to other conditions and settings and the inclusion of this approach to support Electronic Enhanced Recruitment (EER).
McGregor
Joanna
J
Centre for Health Information Research and Evaluation (CHIRAL), School of Medicine, Grove Building, Swansea University, Singleton Park, Swansea, UK.
Brooks
Caroline
C
Chalasani
Padmaja
P
Chukwuma
Jude
J
Hutchings
Hayley
H
Lyons
Ronan A
RA
Lloyd
Keith
K
D000328:Adult; D000465:Algorithms; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003863:Depression / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D005492:Folic Acid / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008490:Medical Informatics; D016347:Medical Records Systems, Computerized; D015588:Observer Variation; D018579:Patient Selection; D011320:Primary Health Care; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D014803:Vitamin B Complex / Q000627:therapeutic use*; D014852:Wales
D000928:Antidepressive Agents; D014803:Vitamin B Complex; D005492:Folic Acid
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