Study Site

The study was carried out in Amber woreda (district), part of East Gojjam Zone in Amhara regional state, where the prevalence of podoconiosis in the adult population is 3.4% [20]. The woreda is located 280 km North West of Addis Ababa and 20 km south east of Debre Markos, the zonal capital. According to the 2007 Census, Aneded woreda is made up of 19 kebeles (smallest administrative unit) and has a total population of 91,224, with 89,446 living in rural kebeles [21]. It has 4 Health Centres and 20 Health Post (HPs). Each HP is staffed with two trained Health Extension Workers (HEWs), female civil servants implementing the health extension package at kebele level under the direct supervision of Health Centers and the Woreda Health Office[22].

According to the Ethiopian Demographic & Health Survey 2011, 62% of women and 37% of men in Amhara Region cannot read at all[23].

Study design

In-Depth Interviews (IDIs) and Focus Group Discussions (FGDs) were the main methods of data collection. Items in the semi-structured interview and focus group guides used were adapted from rapid ethical assessment instruments previously used in Ethiopia and the Gambia [9, 13]. Slightly differing interview schedules were used for each category of respondent. Items in the guides were presented in the same order as anticipated in the trial, i.e. approaching patients, provision of information, decision making, constraints and randomisation. In addition, the interview guide for researchers and experts included items about how comprehension of information given about the study should be assessed and application of international ethical guidelines in the local context. The study was approved by the Research Governance and Ethics Committee of Brighton & Sussex Medical School and the Institutional Review Board of the College of Health Sciences, Addis Ababa University. Introductory letters were presented to regional, zonal and woreda level health authorities.

Participants

These included researchers from Debre Markos University who had conducted studies in the area, podoconiosis prevention and treatment service providers from International Orthodox Christian Charities (IOCC), woreda level health and agricultural experts, development agents and health professionals, kebele, community, iddir (a form of social insurance group) and religious leaders. Community participants were identified by Health Extension Workers (HEWs) and a group of ten participants took part in each FGD from three kebeles based on their distances from the woreda capital: remote and less remote. Accordingly, Wonga Nifasam, Yewobi and Mislawash kebeles were included. A total of 14 IDIs and 8 FGDs were planned. Separate FGDs for people with podoconiosis and non podoconiosis-affected community members of both sexes were conducted.

Data collection

The REA was conducted from July to August 2013. Data were collected by a public health expert and a social anthropologist (both Ethiopians). Individual participants were informed about the objectives of the study and oral consent obtained. Once permission to participate was secured, interviews were recorded using digital recorders. The interviews were conducted in offices and community settings. After the first few interviews, data collection activities were halted until previously collected data were analyzed. This was to identify themes that emerged and modify interview guides accordingly. Interviews and FGDs were conducted in the local language (Amharic), and on average lasted one to one-and-a-half hours, respectively. Core questions for IDIs and FGDs are given in Table 1.

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Table 1. Core questions for in-depth interviews and focus group discussions.

https://doi.org/10.1371/journal.pntd.0004531.t001

Data analysis

Data analysis was started alongside collection. First, data were transcribed and translated into English. This was followed by categorizing and organizing data thematically in accordance with the objectives of the study. Final data analysis was made using a thematic approach based on themes identified a priori and those that emerged during the analysis.

Approaching patients

The way researchers approach communities and individual participants to provide information about a study plays a vital role in obtaining informed consent. The approaches described here could be seen as being at two levels: first approaching the community as a whole followed by individual participants. Some suggested kebele leaders and law enforcement as key to approaching the community and individual participants

“The kebele leader will guide you…he knows all the patients. The local police department know where all the patients live, and the two can work together…they’ll call patients to a meeting and everyone will attend, since they respect and obey the orders of the kebele leader” (P5, Non-patient, Male).

“Without the kebele’s assistance, it will be like walking in darkness…you can’t go without the kebele helping you!” (P6, Non-patient, Male).

Regarding the order of approach, community members suggested that kebele officials should be approached first. These would then arrange a meeting with the community either in a kebele compound or in a church on a specific religious day, and information about the study could be provided.

“For example, you can use St. Michael’s day when everyone will be attending the Church (P7, Patient, Male).

Once the community is informed about the intended study, researchers can proceed to approach individual patients for consent. Participants indicated that individuals should be approached for consent at their homes in one of two ways. The first would be to identify and train locally known individuals and send them to patients’ houses. Secondly, researchers could go to patients’ houses accompanied by a local guide.

“We take them [people coming from other places] to peoples’ houses in the community, greet them and explain the purpose of our visit, they’ll listen and give their responses, we then continue to next household” (P7, Non-patient, Female).

A range of views was expressed on researchers going house-to-house unaccompanied. Focus group participants explained that patients would not refuse to meet anyone offering help to treat their illness:

“It is for their own benefit, so they don’t need a lot of explanation, they’ll accept an invitation to participate” (P3, Non-patient, Female).

However, most preferred the assistance of the Health Extension Workers (HEWs) in reaching individual patients.

“The responsibility should only be given to HEWs, as they go house-to-house to deliver the various health service packages. Thus, Health Extension Workers know where there’re pregnant women, if children were absent from school and also houses of podoconiosis patients” (Podoconiosis expert 1).

Provision and comprehension of information

In this section, the responses included are mainly those of researchers and podoconiosis experts because focus group participants rarely discussed the kind of information that should be provided.

International ethical guidelines require that information about potential risks, inconvenience or restrictions should be balanced against any possible benefits. It is very interesting and rather worrying to note, however, that the expert participants in this REA repeatedly suggested de-emphasizing information on risks or possible negative consequences that participation in the study may have on individuals.

“We stress the purpose of the study and its importance in improving patients’ conditions…patients should not feel too much about risks” (Podoconiosis expert 1).

“When informed about risks, although some may rarely occur, people focus more on risks instead of the benefits…your study has minimal risks associated with participation, except maybe the discomfort of being identified as a podo patient” (Podoconiosis expert 3).

This invited a follow up question about applicability of other aspects of international ethical guidelines locally. Participants believed one size would not fit all and that international guidelines needed to be contextualized.

“The main problem is adopting guidelines prepared by western standards if we provide levels of information suitable for literate people to those who’re illiterate; it will become boring and unclear for most community members” (Podoconiosis expert 3).

Similarly, although international ethical guidelines require provision of relevant information such as contact details of researchers and their institutional affiliation, to assist participants with information needs and to answer queries, reflecting on previous experience, a researcher said:

“I don’t think the majority in our community will phone requesting additional information…we have never given contact information to individual participants [laughing]…that information exists only on paper [study document/proposal]…if and when they ask, mostly we show them the introductory letter from the woreda” (Researcher 2).

Different views were offered regarding whether information should be provided in groups or individually -

“It is preferable to provide information as a group, for example, for people gathered in a kebele compound…once information about the study is presented, inviting a discussion will help to get people’s opinions. The majority are illiterate so using flyers would be difficult” (Expert 1).

“We approached individuals on a house-to-house visit…explained the purpose of the study, asked willingness to take part, and where agreed, asked for signature, as indication of agreement. Then Health Extension Workers collected the data” (Researcher 1).

When it comes to who should provide information, some thought that anyone could provide information, while others thought the person providing information should thoroughly understand the cultural milieu of the area -

“Someone who is from that community understands the culture and is trusted by the people” (Researcher 2).

In relation to checking comprehension of information, the simplest way would be asking potential participants to recount the most important aspects of information provided -

“To check the extent of understanding, ask a few questions focusing on important elements of the study, repeating questions if necessary” (Researcher 1).

A few FGD participants maintained there was no need for information, and that requesting willingness to participate suffices, because in the end it is for their own benefit:

“First of all no one will refuse to participate, since they’re all ill” (P3, Patient, Female).

“We all want to be healthy and thus no one will refuse” (P4, Patient, Female).

Finally, when it comes to signing the written consent form, participants stressed the importance of understanding the study. Experts who had experience conducting research in the area said:

“I’ve seen people agreeing orally, but refusing to sign the consent form. This is because they fear the purpose is to confiscate their lands…you’ve to clearly explain the purpose and meaning of signing the form…if they trust you, they’ll sign” (Podoconiosis expert 1).

“People in our communities are very fearful of signing anything. If asked to sign something, they always think it is linked with some form of legal issues, something that will later result in a legal obligation and responsibility. But, can be achieved through discussion, especially if community leaders are involved in discussions and made to understand the purpose clearly” (Podoconiosis expert 2).

Decision making

Participants suggested that consent to participate depends on the type of research. For example, for short projects and those involving interviews and surveys, obtaining consent may not be that difficult. However, for long term studies such as the trial in question, which demand considerable investment of time from participants, the decision may require permission of other family members, especially if the potential participant happens to be the family breadwinner. Others thought there was no general formula for reaching decisions -

“It varies according to the situation…parents decide on behalf of children. Heads of households both men and women, decide for themselves” (Podoconiosis expert 3).

Several others said that the decision to participate rested with individual patients:

“It is the patients themselves who make that decision” (Community leader).

“They shoulder the disease burden and its social consequences…patients decide for themselves” (Researcher 2).

Others thought that the authority to make a decision differed for men and women. Men could decide for themselves while women needed to consult and get their spouse’s approval before consenting

“What we commonly see is, women don’t decide without first consulting with and obtaining their husband’s permission” (Podoconiosis expert 2).

However, female participants asserted that both men and women decide after discussing with family members. Where women are household heads, (through divorce or widowhood), they decide without consulting others -

“We decide after discussing with family members and considering their advice…but sometimes we can decide ourselves” (P2, Non-patient, Female).

“Since we ask men for advice, they do the same before they decide” (P6, Non-patient, Female).

“I discuss with my neighbours, I don’t decide alone” (P3, Patient, Female).

“I decide on my own, I don’t have anyone to discuss with” (P5, Patient, Female).

Some suggested that in the context of rural Ethiopia, any important decision had to involve significant other people; family members, relatives, neighbours, community elders and religious leaders -

“It is hard to get consent without any influence from others…in this area [Amhara region]; community leaders have a big influence” (Podoconiosis expert 3).

“In rural areas, individuals don’t live distinct from others…individuals’ decisions will be affected by others and vice versa. Therefore, for long term studies, it’s appropriate to obtain the family’s permission too” (Researcher 1).

Constraints to participation

Although focus group participants all agreed there were no clear reasons hindering patients from participating in the trial, in-depth interviewees argued reasons that might deter individuals and explained ways to deal with them -

“I think people will be willing to participate, but my concern is our community has expectations, such as monetary rewards and sometimes for time they spent, when asked, especially by people from other areas to participate in some activity” (Health Professional).

Participants also said false rumours about the study’s purpose may create misconceptions which will impact on decisions to participate. Fertile ground for rumours may be created by botched community sensitisation, and misleading information reaching communities before the study team had a chance to discuss directly with individuals. In order to prevent misconceptions, garnering the support of community, religious and political leaders, ensuring clear understanding of the nature of the study at all levels and proceeding to enter the community in as short a time interval as possible after district level sensitisation are all important -

“Rural communities are small, close-knit villages, and word about any outside visitors will spread very quickly…personal beliefs such as ‘visitors are talking to people with swollen legs and their families, it looks like they’re going to give them aid’ will start to fly around” (Podoconiosis expert 1).

“First, authorities at different levels need to clearly understand the purpose of the study, risks and benefits followed immediately by entry into the community to break any rumours that may arise in the intervening period” (Podoconiosis Expert 3).

“People with no connection with the study may be the ones that start false information…if non-affected people know the purpose of the study; they can stop rumours when they arise (Woreda Health Office expert).

Explaining randomisation and delayed intervention

The main object of this REA was to furnish information on how best to design the consent process for a randomised controlled trial of podoconiosis treatment, so conveying the concept of randomisation was expected to be very important. In the following paragraphs, understanding of randomisation and local analogies used to help explain randomisation is presented. This is followed by suggestions on how to keep participants in the delayed treatment group motivated to continue participating in the trial even when not receiving treatment.

Several local analogies exist that could be used to explain randomisation. The following social organisations were mentioned -

“Everything from ‘Iqqub’, ‘Mahiber’ and ‘Senbete’ work based on the concept of chance…it is important to show people that everyone has been registered before the lottery is drawn; simply tell people, we’ll draw similar to iqqub and those who win will be treated immediately and the rest will wait for a year…they’ll understand” (Podoconiosis expert 1, and Health Professional).

[‘Iqqub’ is an Amharic term used to describe a traditional saving system where people form groups and pay an agreed amount of money at an agreed interval into a common pool. Each member of the group, selected randomly, will receive one large sum of money, and this continues until everyone has received the sum they’ve contributed in the end. ‘Mahiber’ and ‘Senbete’ are terms referring to a voluntary and mutual religious gathering of a group of people in a church or at home to celebrate a common religious (saint’s) holiday while feeding the poor, on a rotational basis.]

A health professional with considerable experience working in the woreda provided two examples of explaining randomisation through agricultural analogies used previously by agricultural experts assessing poultry farming and the use of modern fertilisers in the community:

“Most people were suspicious of modern fertilizers, but after a comparison of the use of compost with modern fertilizer was made, farmers witnessed the difference in the year’s crop both yielded and began to use modern fertilizers. A similar example could be the chicken farms…there was a problem of which breed to use; foreign or hybrid chickens, then experts demonstrated the difference in the number of eggs laid and convinced farmers” (Woreda Health Office expert 1).

Several other analogies for randomisation were given in patient and non-patient focus groups. “Kircha” is an Amharic term to describe the traditional system for sharing the meat of slaughtered animals (usually a cow or an ox) and “Worefa” a description of waiting in line or of a waiting list:

“Yes, we know and use lottery method for ‘kircha’…but, we haven’t seen this in meetings” (P All, Non-patient, Female).

“Lottery is lottery and ‘worefa’ is ‘worefa’, they’ll understand it (P1, Non-patient, Male).

“Most of the things we do, we do them by ‘worefa’ even we wait in line to be blessed by the priest’s cross…even you put firewood one after the other, not all at once (P4, Non-patient, Male).

“When we take out the herd for grazing, we cast lots to decide who will tend to the cattle first, second and so on” (P6, Non-patient, Male).

Participants suggested several ways to explain delayed treatment

“Explain you are testing the effectiveness of the treatment, if after 12 months’ of observation the treatment needs modification, we will modify it and the delayed group will get the improved treatment…they will understand, most have lived with the disease for a long time so waiting for another year will not be intolerable” (Woreda Health Office expert 2).

“Assure them that they will get treated in a year and that probably they will get a better, improved treatment, next year” (Researcher).

“These people have lived with podoconiosis for long and do not mind waiting for another year. It is also important to inform them that although this is a small scale intervention, the findings will be expanded to a large number of patients in other parts of the country” (Podoconiosis expert 2).

“You should have coffee ceremonies with patients to discuss and inform them the number of patients assigned in this group who are also waiting. Also explain that the result will be of benefit not only for them, but for a lot of other patients in other places” (Woreda Health Office expert 1).

Participants in the FGDs said:

“My sister is a podoconiosis patient and this is how I’ll explain it to her…it’s based on chance, if her chance allows, she’ll get treated now otherwise she’ll wait for some time and get treated” (P6, Non-patient, Male).

“Everyone will participate and no one will feel unhappy to wait…it’s like walking on a narrow road where people travel in a row; one in front and another following, in the end both will reach their destinations…the second group will get treated later and won’t mind waiting”(P6, Non- patient, Male).

“Yes, we’ll wait, it is based on chance and lottery is not biased, does not favour anyone” (P2, Patient, Female).

“Tell them in a way everyone can understand…for example, when the government builds roads, they can’t build all the roads at the same time, it takes time…similarly, in this research, those who get the chance will get treated first and others have to wait” (P3, Patient, Male).

Several views were put forward regarding encouraging continued participation of the delayed treatment group. These ranged from explaining the waiting list scenario at the IOCC treatment and prevention project, mentioning the average waiting time, to regular meetings with the control group, to discussing over coffee to explain the wider benefits. Several respondents felt it was important to guarantee treatment for the control group after a year. However, others seemed to suggest since all are ill and desperate, none would complain, or drop out.

“You need to be able to provide an incentive for the group that has to wait for a year. I don’t think they will wait for a year without getting treated” (Researcher 1).

“More focus should be given to those in the delayed treatment group, as they may be expected to complain. First, explain that a year is a short period to wait; some have waited for 7 to 10 years to get treatment. Then explain that random selection will be used to assign people into one of the groups, they’ll understand and be contented no one was favoured” (Podoconiosis expert 1).

In sum, although there seemed to be a range of approaches, most participants appeared confident that participants would stay in the study given these explanations.