Validation of a cross-NTD toolkit for assessment and monitoring of NTD-related morbidity and disability

Neglected tropical diseases (NTDs) are a group of 17 diverse infectious diseases with high impact on morbidity and mortality rates in developing countries. Annually, the NTDs cause 534,000 deaths. Although not all NTDs cause death within a short period of time, many NTDs are disabling, disfiguring and stigmatized. There is a lack of data on the morbidity and disabling consequences of NTDs. This hampers advocacy for interventions and funders. Furthermore, the planning, monitoring and evaluation of the interventions are more efficient if more accurate data would be available. Also, appropriate services for the often life-long consequences could be established if this gap would be fulfilled. In August 2015, an agreed cross-NTD toolkit was developed by Van ‘t Noordende and colleagues at the VU-University of Amsterdam in collaboration with NTD NGDO network. The initial validation of the toolkit was done in Fortaleza, Brazil, among people with Chagas disease, leishmaniasis, leprosy and schistosomiasis.

The toolkit is composed of 8 health related quality of life questionnaires. These questionnaires have been developed in a source country with their particular cultural settings and language. However, the cross-NTD toolkit needs to be applicable in various countries with different cultures and languages in order generate universal comparative data. Therefore, the questionnaires should be equivalent in both the target culture and the source culture. Colombia is one of the Spanish speaking countries in Latin America and is still endemic for multiple NTDs. Therefore; the aim of the present study is to validate several tools of the cross-NTD toolkit in the cultural settings of Cartagena and Cucuta, Colombia.

This study validated the following tools of the cross-NTD toolkit: Clinical Profile, Self-Reporting Questionnaire, WHO Quality Of Life-BREF & WHO Quality Of Life-DIS. The tools are validated among people affected with leprosy and leishmaniasis. The design of the study is a crosssectional case study and a qualitative method approach. The validated tools are quantitative questionnaires. However, this study focused on the experiences that the participants have with accomplishing the questionnaires. During meta-cognitive interviews and group discussions following the administration of the questionnaires, the participants were asked about their thoughts on the relevance and the understanding of the tools. The recordings of the qualitative data collection were transcribed, translated and analyzed using open coding and content analysis. Subsequently, the concept equivalence, item equivalence, semantic equivalence and operational equivalence were approached resulting in the measurement of the validity of the instruments.

The validation was done among 55 participants affected by leprosy or leishmaniasis, 35 and 20 participants respectively. The SRQ was easily understood by the participants, although the subjects addressed were more sensitive and emotionally affecting. The Clinical Profile has shown to have several semantic difficulties. This questionnaire needed rephrasing as well as examples. Terms used were sometimes unclear or too medical for the general population. The WHOQOL-BREF also needed rephrasing and examples. The results show the SRQ in its current state is valid for the population of Colombia and can be included in the toolkit without any additional changes. The Clinical Profile and WHOQOL-BREF are relatively less well understood. However, with some additional changes these tools are also valid to fit the cross-NTD toolkit. The WHOQOL-DIS is not well understood. This questionnaire need changes before if can be included as a valid tool in the toolkit for the use in Colombia. The findings of the SRQ are supported by several studies conducted in Colombia and it has been shown to be valid in other groups of the society. The Clinical Profile has been developed in 2015 and used in the pilot study in Brazil. However, in Brazil this tool was relatively easy understood. The difficulties in Colombia can probably ascribed to semantic equivalence. In Brazil were more problems with the WHOQOL-BREF compared to Colombia. However, several changes need to be made in order to meet the semantic equivalence. The WHOQOL-DIS has only been administered to participants who answered in the Clinical Profile to have disabilities or limitations, and have only been administered to 15 participants. Although the results show the tool was significantly less well understood by the participants, this tool should be retested among participants in Colombia. Interestingly, in Brazil this tool was relatively easy understood. The participants have experienced the total administration time for all tools as acceptable.