Logistical organisation of research team

Apart from the investigator, a medium-size fieldwork team, including 10 full-time people and some extra part time at specific times in the study, was assembled to complete the tasks set out in this project in both urban and rural study sites. Key personnel included two doctors, two nurses, one data manager and various fieldworkers. The later group comprised individuals that live in the same community of the urban study site who were trained as community health workers in the past and had experience in other research studies.

Once training and piloting was completed in the research office responsibilities were assigned to various members of the team, such as fieldwork enrolment, clinical appointment and data monitoring.

The main investigator of this study monitored and supervised all activities in both sites on a daily basis.

4.1.6.1. Fieldwork enrolment

Briefly, the fieldwork team had the responsibilities to locate in the community through household visits the selected individual from the census, invite them to the study, read consent forms and make an initial clinical appointment and apply questionnaires to participants. Fieldwork personnel would also have the task to revisit up to three times the randomly selected individual. If the selected person was not found after a third visit, he/she was dropped from the study as a not contacted

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person. Based on the design of the study —age and sex matched— a replacement subject from the same age- and sex group was randomly selected.

If at any point a randomly selected individual was found but did not agree to participate in the study, they were considered as contacted but refused to take part in the study —a type of non-responders— and were asked to fill a short rejection form with basic demographic and socioeconomic information (form shown in Appendix D, presented in next chapter). If the non-responder did not agree to complete such information, the team fieldworker had the task to try to fill as much information as possible from observation or through neighbours’ information.

In some circumstances the participant will initially agree to take part on the study and gave their informed consent. This was considered an enrolled participant.

However, for various reasons, mostly time constraints, study fieldworkers were not able to regain contact with the enrolled participant thus affecting the completion of the study. For this, fieldworkers were also asked to revisit the selected person up to three times after the person was considered an enrolled participant. All these definitions are discussed in the next Chapter, in the section related to response rate.

For practical and working reasons for some participants, it was easier for them to attend the research office during the weekend. Mechanisms were put in place to have an effective working team during those weekends and to be able to work with an increased flow of participants. Some of these tasks included use of motorised transport to collect participants and an increased number of fieldworkers in research office to ensure completion of surveys.

4.1.6.2. Laboratory and clinical measurements

The clinical team had the responsibility to complete all clinical measurements and laboratory blood samples following standardised protocols. Guidelines for measurements and definitions used have already been presented (see section 2.3, Data requirements).

At the beginning of the study it was observed that some people feared the amount of blood drawn for laboratory tests. Thus, fieldwork personnel were explained and

trained to provide explanations about blood testing. These included reasons to use different tubes and practical exercises showing the real volume of blood that filled each tube. A practical local explanation was that each tube contains the volume

“equivalent of a tea spoon”. Such information was then transmitted to people in the community, and additional emphasis in explaining reasons for blood testing was placed at the research clinic at the moment of the laboratory tests itself.

A free consultation clinic was arranged to return laboratory results to each participant and provide free interpretation of their tests, including data from blood pressure and BMI. If a subject was identified with abnormal levels of known risk factors, usually high blood pressure, high cholesterol or high glucose levels, they were referred to the local health post. This was done by the investigator and two medically trained personnel who were part of the study. If a participant did not collect his/her laboratory test results at the research clinic, it was then transferred to the fieldworkers to return those tests at each of the participant’s households.

4.1.6.3. Data management

A lesson from early stages of fieldwork was to ensure a continuous monitoring system. This was observed once fieldworkers were set out to visit the community to enrol participants. Some difficulties observed during fieldwork activities included the need to revisit households of selected individuals, the difficulty to locate some participants, and the need to make quick decisions once a subject was classified as a non-responder. A list of randomly selected replacements for non-responders (age and sex matched individuals) were prepared in advance and provided to fieldworkers.

A more challenging issue was to keep track of all households’ visits and revisits.

Initially all household visits were recorded in paper and managed by the fieldworker.

However, this system was difficult to update and risked the loss of information. It was decided that a data monitoring team was necessary to keep all household visits in an electronic dataset. Such tasks were initially delegated to two clinical fieldworkers and later a data management worker joined the study.

The data monitoring team had the responsibility to monitor daily progress in various parts of the research (enrolment, questionnaires, and laboratory) and ensure that data

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was fully recorded. A more strict monitoring system was placed for the supervision of the enrolled individuals to ensure completion of the study (see for example Figure IV-1, page 98).

A standard double-entry method was used for inputting all data collected through questionnaires, a process which was also supervised by the data monitoring team.

Laboratory tests results were also double checked for outliers, comparing the data provided in the electronic spreadsheet against the printed data and the intranet information site.

4.1.6.4. Study execution in rural study site

Once the mechanisms were tested in a number or urban-resident participants, planning for the study in the rural site took place. For the rural site, local Quechua speaking people were hired to take on the same fieldworker’s tasks as their counterparts in Lima. Two members of the team were fluent in Quechua, being themselves migrants or descendents from migrants, and they were part of the team in the rural study site providing training to local fieldworkers. Co-ordinations were made with the local health centre in San Jose de Secce, rural study site, which agreed to provide space for the clinical measurements.

As shown in the table in the following page, most interviews in the rural site were conducted in Quechua, the local language, whereas in the urban site most interviews were carried out in Spanish.

Table IV-1. Language used at interviews

Spanish Quechua Both Total

n % n % n % n Rural 20 10 156 77.6 25 12.4 201

Migrant 575 97.6 2 0.3 12 2 589

Urban 197 99 0 0 2 1 199

Total 792 80.1 158 16 39 3.9 989

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