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Surgical digest

Recruitment and follow up of study participants in surgery research in low resource settings


Jenny Löfgren, MD, PhD

Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

Alphonsus Matovu, MD

Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

Mubende Regional Referral Hospital, Mubende, Uganda

Thomas Ashley, MD

Department of Surgery, Connaught Hospital, Freetown, Sierra Leone

Ann Gånfält, MD

Department of Surgery, Skaraborg Hospital, Skövde, Sweden

Andreas Wladis, MD, PhD5

Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Jessica Beard, MD, MPH

Department of Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA

Hannah Ashley, MD

Upper Eden Medical Practice, Cumbria, UK

Filippa Lindén Bergman, MD

Department of Surgery, Södertälje Hospital, Södertälje, Sweden

Alex J. van Duinen, MD, PhD

Institute of Nursing and Public Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway

Michael Ohene-Yeboah, MD

Department of Surgery, University of Ghana Medical School, Korle Bu, Accra, Ghana

https://doi.org/10.58974/bjss/azbc045

Cut and run

Historically, “global surgery” publications often circulated around short-term missions of surgeons from high-income countries visiting low-income countries. The reports would include a description of the high number of patients operated on during the mission, accompanied with a photo of the team in the operating room and a happy patient in colourful clothing. There would be very little additional information about the outcomes of these procedures, in particular in the longer term, as the teams usually left shortly after carrying out the surgeries. Volume of surgery was the main outcome measure in these reports.

Today we ask more of surgical initiatives. Cut and run is no longer acceptable. With surgery comes complications and managing these is an important part of the job, regardless of the country where the surgery is performed. It is not reasonable to get the luxury of cherry picking doing the surgery and leaving others to manage the entire postoperative period. From the scientific perspective, we already know that it is possible to operate on a large number of patients in two weeks, with very few in-hospital postoperative complications. Many of us have been there, researching the major operating theatre logbook for numbers and types of procedures done, for what indication and by whom, wondering what happened next. The researchers of today as well as funders and policy makers want to know more!

Why follow-up matters

To assess the true effects and quality of surgery, follow-up is necessary. In-hospital mortality and complications are important but do not reflect the entire spectrum of complications that may occur within the postoperative period which is usually considered to be the first 30 days after surgery. For instance, infections usually occur some days after surgery. Long term outcomes including recurrence, disease progression, quality of life and patient satisfaction are possibly even more important outcomes of surgery. All of these require long-term follow-up.

In countries where access to surgery and health care services are limited by many and high barriers, it is very likely that adverse events will go unnoticed by the surgery and research team unless clinical follow up is planned and budgeted for. It cannot be assumed that all is well if we do not hear from patients. It is not certain that we would hear about complications that have occurred if we do not specifically look for these ourselves. Clinical follow up is the only way to assess both safety, effectiveness and long-term outcomes of surgical services provided.

Figure 1.

How to

Experience from the projects carried out by our research team in Uganda, Ghana and Sierra Leone shows that long term follow-up after surgery in these countries is indeed possible.1, 2, 3 We have achieved follow-up rates at 1 year postoperatively of up to 100% and at 5 years of about 80%. This does not mean that it is easy. Below we present some strategies and lessons learnt that we hope can be helpful to others.

Planning and logistics is everything

The actual study activities such as carrying out surgery and collecting data are a small part of a clinical trial. Much more time goes into planning. The obvious are the scientific aspects including methodology, obtaining ethical approval and similar. The latter can be difficult if each project requires ethical clearance from several institutions and countries, where opinions about what is ethically appropriate can vary. Finding funding is also very time-consuming and makes lead times long. Logistics concerning the project implementation require a lot of attention. It includes space, staff, stuff and study participants in the right place, at the right time. Space includes things such as access to a room dedicated for your clinical examinations and some additional space where research assistants can do interviews with study participants one-on-one. It is wise to consider where this space is located. Carrying out recruitment and follow-up in a TB or HIV clinic for instance can be problematic. Staff includes the core research team and additional support staff such as research assistants that may be needed. Stuff includes everything from examination gloves to scissors for suture removal and the actual study tools. An electronic overview-document that is updated in real-time during follow-up facilitates the coordination of the activities. Distances can be long for the team and the study participants, and this has important implications for the planning of everything from recruitment to the surgical procedures and follow-up.

Contact information

In our studies, we collect very detailed contact information about the study participants. It includes their address, head of household, phone numbers and also phone numbers to a next of kin and a village leader if these have been involved in recruitment. The contact information is updated at each follow-up visit. Still, it frequently happens that contact details are not accurate at the time of the next follow-up. In Sierra Leone, a very particular problem is that many people have the exact same names. We have found that young people are more likely to move to another location, compared to older people. People in rural areas are less likely to move than those in urban settings. Women also seem to move around less than men. This is worth considering when deciding from where to recruit study participants.

Jenny Löfgren, MD, PhD on a radio talk show to recruit study participants.

Community perceptions

The studies are often carried out within the specific context of different communities. Most communities have clearly defined hierarchies with different types of leaders. They may be politically elected or otherwise selected to be leaders in their communities. Other leaders may be those in churches or mosques. People in the communities look up to and trust these leaders. If the leaders are informed and approve of an intervention or research project, it can help both recruitment and follow-up. It is particularly relevant for studies including surgical interventions as patients can be very hesitant due to reasons such as fear of surgery.

The leaders can be extremely instrumental when trying to relocate study participants several years after surgery. They know their community members very well and would know if they have moved, study or work at a different location. This mainly applies to rural communities where the turnover of people is a lot less than in urban settings. It is worth considering compensation for the leaders, as these people often end up investing a lot of time helping you out.

Recruitment can be done using a variety of methods such as radio announcements, local leadership and the partner health care units. Knowing the society well, you will know which radio stations to use and how to approach the leaders so that they inform their communities about your project. The research assistants frequently serve as a bridge between the team leader and the local community. Word of mouth is also a powerful tool that is useful after having carried out a successful project or part of a project where people and community have clearly benefitted from your services.

Set up a great team

Recruitment and follow-up is a team effort. The team needs to possess the skills required to attract study participants and motivate them to stay in the project even after they have received the surgical intervention. Essential competencies include speaking the local language, knowing the community, finding your way around and constantly being able to problem solve. It also includes an ability to stick to a tight budget and to adhere to important scientific and ethical principles. It further includes technical skills on how to examine patients and correctly diagnose the condition under study.

The dream team comes about when everyone has a defined role and does everything in their power to reach a common goal and make the project successful. We have been blessed with team members who constantly walk the extra mile for the study participants and the projects. This includes behaving in a way that study participants develop trust in the research team, to the extent that they can call any us to consult if there is a problem or question.

As always with people, there can be conflicts and not everyone is reliable. Sooner or later, it will happen. It can be extremely disappointing and discouraging to find out that a research assistant is cheating and forging data, stealing from you or the other team members, or behaving in a way that puts the team and project in a bad light. Working slowly in order to get more paid days also happens. Corruption can impact the team and project in numerous ways. All these things are very hard to know beforehand and the best way is to keep your eyes open and take action when needed. In the light of such difficulties, it becomes even more important to treasure, reward and take care of the team members who do their work diligently and who are devoted to your project.

Last but not least, have fun and celebrate achievements!

The team in the field
 
The ideal team for field work – recruitment or follow-up, is a team that can take on all necessary roles. It is good to keep the team fairly small. If travelling with the team is necessary, it is preferable if everyone can fit in the same car.
 
Team leader – PhD student or lead researcher
 
MD – a colleague to discuss with, when in doubt, or to assure reliability of assessments
 
Research assistants – 1 to 3, of which one may get additional leadership roles to facilitate decision-making and one may help with translation if the study participants speak another language than the team leader and the MD partner. This is not an issue exclusive to international researchers. In many countries, languages that are very different are spoken and frequently also national researchers do not speak the same language as the study participants.

Take care of the study participants

The well-being of the patient must come first, before the success of the project. Most study participants appreciate the extra attention that they get within the framework of a study that includes follow-up. They are happy when you confirm that their wound has healed well and that there is no hernia. If there is a complication it is important to deal with it, take responsibility and follow the study participant until the problem has been resolved. We usually offer advice for other conditions too when we are asked. We provide meals for the study participants during the hospital stay. Study participants with recurrent hernias have been offered repair at no cost.

Compensation

There are important ethical implications of research with surgical interventions offered to people in low resource settings. Many of the study participants in our studies have been subsistence farmers who have difficulties meeting the expenses of a hernia repair under normal circumstances. We have been compensating the study participants with a flat rate for time spent at the hospital and transportation costs to the hospital for the follow-up. The rate has been determined by the ethics review boards of the respective countries. Without the transport refund, many would not have been able to come for follow-up.

Information

We have used a few different strategies. In some studies, we have offered health education and study information to potential study participants and interested community members before face-to-face information, as part of the informed consent process. Group information makes the information process more efficient. It is also a good way to facilitate discussion. The information that goes along with the informed consent is delivered both orally and in writing in selected languages, as well as in English. At discharge from the hospital, the patients receive oral and written information about what to expect during the postoperative period, warning signs for complications, contact details to the study team as well as date and place for the follow-up.

Never give up

It gets tiring at times. Feelings of hopelessness and fear of failure are close acquaintances of every researcher. A growth mindset and ability to adapt to changing conditions and new information is a key to success. A set of plans from a to z is necessary. The immense reward that a successful project entails is worth all the struggle.

Disclosure

This text was written based on experiences from work in Uganda, Ghana and Sierra Leone. These are low- and lower middle-income countries in West and East Africa, south of the Sahara. We believe that many of the insights outlined in this text are generic to a number of countries. At the same time, we want to stress that there are important differences between countries, and that each research team needs to be aware of and adapt the recruitment and follow-up strategies accordingly.

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