This protocol template with example study documents and SOPs was prepared by ACT Consortium Social Scientists Clare Chandler and Joanna Reynolds with examples drawn from Sarah Staedke and her study team in Uganda (), Lindsay Mangham and her study teams in Cameroon () and Nigeria (), and Peter Mangesho and team in Tanzania (). Please refer to the ACT Consortium Guidance document, Qualitative Methods for International Health Intervention Research, for more detail on approaches and methods of qualitative work. Suggested citation: Chandler, C.I.R., and Reynolds, J. (2013) ACT Consortium Guidance: Qualitative Methods Protocol Template with example Tools and SOPs. Available at
Consortium Social Scientist should help to ensure that data collection processes are being conducted in an appropriate and consistent manner. At least one assessment of quality assurance will be conducted during the data collection phase by a moderator who will be external to the field team, preferably a collaborator from a similar study in a neighbouring country. These assessments will use the SOPs as guidance against which to evaluate the practice of the research team in each stage of the research process including recruitment, data collection and data analysis. If any issues or concerns arise as a result of this, the moderator will take action as appropriate. Team roles Give a break-down of all of the key research team staff with brief job descriptions. Eg. Lead field social scientist – managing and overseeing recruitment and data collection in the field; input into data analysis and writing up stages. ACT Consortium research fellow – designing and supervising the research study; responsible for monitoring progress of data collection; leading on data analysis and writing up. Research Assistant 1 – identifying and recruiting participants; assisting with data collection; input into writing up. Research Assistant 2 – identifying and recruiting participants; assisting with organisation of interviews/FGDs; assisting with transcribing and translation. Transcriber/translator – primary responsibility for conducting transcription and translation of all relevant field documents. Data collection Identify which team members will be involved in data collection, doing what roles and under whose supervision. Eg. The lead field social scientist will act as the moderator for FDGs and interviewer in IDIs, and will have overall responsibility for the organisation of data collection, for monitoring the recruitment and data collection processes in line with the quality assurance protocol, and for holding team debriefings and feeding back to other members of the research team. The research assistants will assist in the recruitment process, in arranging suitable times and locations for the FDGs/IDIs and for ensuring participants are able to attend the events. For the FDGs, one research assistant will act as note-taker and the other will act as coordinator, ensuring the organisation and arrangement of facilities at the FDG. Research assistants may take it in turns to act as note-taker and coordinator, as desired. Following the FDGs/IDIs, the lead field social scientist will be responsible
Eg. Dates Study phase Activities Who Beginning of first quarter, 2011 Scoping & Preparation Meet field team Draft SOPs and topic guides Assess locations for data collection Consult with InterACT regarding recruitment and participants LFSS, ACT RF, RA1, RA2, TT LFSS, ACT RF, RA1, RA2, Beginning/mid first quarter, 2011 Training Conduct training with field team prior to data collection Revise and finalise SOPs. Pilot topic guides and revise. ACT RF LFSS, ACT RF, RA1, RA2, Mid/end of first quarter to end of second quarter, 2011 Data Collection Begin recruitment and data collection Transcribe and translate data as it is collected Regular team debriefings and feedback to wider research team Share data with ACT RF On-going coding and analysis of data LFSS, RA1, RA2 TT LFSS, RA1, RA2, TT LFSS ACT RF Mid second quarter to mid third quarter, 2011 Data Analysis Continue coding Develop theoretical constructs and narratives ACT RF ACT RF Mid third quarter to early fourth quarter, 2011 Writing up Write up final report Write up publication(s) ACT RF, LFSS, RA1 ACT RF, LFSS, RA1 Appendices: example tools Appendix A - Example health facility log Appendix B - Example health worker log Appendix C - Example information sheet Appendix D - Example consent form Appendix E - Example IDI topic guide Appendix F - Example contact summary form - IDIs Appendix G - Example team debriefing minutes form - IDIs Appendix H - Example FGD topic guide
Appendix B. Example Health Worker Log Health facility code HCW Study ID Position Date visited 1st (dd/mm/ yy) 1st Reason Date of rescheduled visit (dd/mm/ yy) Date visited 2nd (dd/mm/ yy) 2nd Reason Date of rescheduled visit (dd/mm/ yy) Date visited 3rd (dd/mm/ yy) 3rd Reason Enrolled Date complete (dd/mm/yy) Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No
Probes: What problems could you foresee and what ways do you think these might be solved? (e.g. timing – who should conduct the test and what should happen whilst waiting for the result?) Knowledge Are you aware of guideline changes for antimalarial prescribing and malaria diagnosis? Prompt: Where did you receive this information? Do you trust the source of information and why/why not? What has been your experience of training in malaria diagnoses before you started working and during your career? Prompt: What do you think about what you have been taught at different stages? How does it relate to what you know now? Supervision / Physical environment What is your experience with supervision at this health facility? Prompt: Does anyone supervise how diagnoses are made at this health facility? What usually happens with routine supervision from the district: how frequent, who is supervisor, relationship with supervisor, what they ask, do they give any feedback? What is your experience with the way logistics of supplies work at the health facility? Prompt: What roles do different people play, is there an established system for: supply procurement, storage, monitoring? How do you think RDTs might fit with your current systems of logistics and supervision? Prompt: Can you suggest any ways that RDTs could be integrated with your work without creating extra work for you and your colleagues? Social environment In your opinion, what do patients (adults and children) expect from consultations when they attend here with fever? Prompt: Expectations for drugs, clinical or test-based diagnoses? Can you give examples of your own experiences of patient preferences? Do you think you would find it easier to change your practice (types of drugs or diagnostic methods) if patients had different demands? Prompt: How do you think patient demands or expectations might be changed? What strategies might be effective? What do you perceive are the expectations of your peers for the pattern of diagnoses and prescriptions from here? Prompt: What are their perceptions of the risk of malaria, risk of misdiagnosing malaria and other diseases? Do you agree with the opinions of your peers? How is your relationship with colleagues at this health facility- does this create any support/barriers
if you wanted to change your diagnostic/treatment practice? Do you perceive there to be any rule-enforcers in your practice? Prompt: If something goes wrong (wrong diagnosis, treatment, dosage), who holds health workers responsible here? Is it patients, community leaders or supervisors? Promoting RDTs What suggestions can you give for how to promote the use of RDTs for malaria diagnosis amongst prescribers like you and amongst community members? Prompt: Prescribers? Community? In some places where RDTs have been introduced, and the provider has been trained and understands a lot about when to use the RDT and what prescriptions to give based on the results, the provider sometimes still gives antimalarial drugs when the results of the RDT are negative. Can you comment why this might happen and how we can help to enable providers to follow the guidelines? Closing Is there anything else you think is important in diagnosing malaria that we have not talked about? Summarise Thank participant Provide extra information and contacts to participants Appendix F. Example IDI Contact Summary Form Contact summary form for each in-depth interview IDI NO: |__|__|__|__| Facilitator Initials: |__|__|__| Participant sub-group type (circle): male/female Participant title (circle): DHMT leader/ supervisor Audio file #: |__|__|__|__| Site number: |__|__| Date: |__|__|/|__|__|/|__|__| Today’s date: |__|__|/|__|__|/|__|__| How would you describe the atmosphere and context of the interview?
Appendix I. Example FGD Enrolment Form FGD IDNO: |__|__|__|__| Facilitator Initials: |__|__|__| Note-taker Initials: |__|__|__| Participant sub-group: (circle): Fathers/ Mothers/ community leaders Audio file: |__|__|__| Community number: |__|__| Date |__|__|/|__|__|/|__|__| ID First name Age Community Number Children <5 Last time child took an antimalarial Last time visited a HF Which HF? 1 2 3 4 5 6 7 8 9