Abstract
BackgroundIn studies evaluating methods for diagnosing tuberculosis (TB), follow-up to verify the presence or absence of active TB is crucial and high dropout rates may significantly affect the validity of the results. In a study assessing the diagnostic performance of the QuantiFERON®-TB Gold In-Tube test in TB suspect children in Tanzania, factors influencing patient adherence to attend follow-up examinations and reasons for not attending were examined.MethodsIn 160 children who attended and 102 children who did not attend scheduled 2-month follow-up baseline health characteristics, demographic data and risk factors for not attending follow-up were determined. Qualitative interviews were used to understand patient and caretakers reasons for not returning for scheduled follow-up.ResultsBeing treated for active TB in the DOTS program (OR: 4.14; 95% CI:1.99–8.62;p-value<0.001) and receiving money for the bus fare (OR:129; 95% CI 16->100;P-value<0.001) were positive predictors for attending follow-up at 2 months, and 21/85(25%) of children not attending scheduled follow-up had died. Interviews revealed that limited financial resources, i.e. lack of money for transportation and poor communication, were related to non-adherence.ConclusionPatients lost to follow-up is a potential problem for TB research. Receiving money for transportation to the hospital and communication is crucial for adherence to follow-up conducted at a study facility. Strategies to ensure follow-up should be part of any study protocol.
Highlights
Poor follow-up adherence may lead to increased cost of research projects, underpowered studies, biased results, and in worst case incorrect conclusions because of missing data [1]
Missing data is pervasive in clinical trials and has a major impact on the quality of research
Hollis and Campbell reviewed 249 clinical trials in 1997 and found that 75% of the studies were affected by missing data related to primary outcome variables [2]
Summary
Poor follow-up adherence may lead to increased cost of research projects, underpowered studies, biased results, and in worst case incorrect conclusions because of missing data [1]. Hollis and Campbell reviewed 249 clinical trials in 1997 and found that 75% of the studies were affected by missing data related to primary outcome variables [2]. Several studies from East Africa have reported that patient adherence to follow-up is a significant problem when analysing data [3,4]. Inadequate adherence in research studies may necessitate increasing the sample size in order to evaluate the research hypotheses, which lengthens investigations and requires more staff and money. Clarifying risk factors for poor adherence, in relation to attending scheduled follow-up, will be useful for researchers in general, when planning a clinical trial. In a study assessing the diagnostic performance of the QuantiFERONH-TB Gold In-Tube test in TB suspect children in Tanzania, factors influencing patient adherence to attend follow-up examinations and reasons for not attending were examined
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