Integrating Qualitative Research in Experimental

Design and Trials

March 7, 2016

Josephine Bamanya: Guelph MSc RPD Student - jbamanya@uoguelph.ca

Outline• Descriptions (Qualitative, experimental design)• Randomized control trials• Research areas using randomized control trials

(RCTs)• Qualitative methods in experimental designs and

trials• Flow chart depicting qualitative research in RCTs• Case examples• Strength and Limitations• Summary• References

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Qualitative research-description

• Its an inductive research methodology• describes an event in its natural complexity • subjectively looks at life as it is lived • an attempt to explain the studied behavior• Gives an in-depth description of phenomena

Abusabha, & Woelfel (2003)

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Experimental design and Trials-description

• Uses randomized control trials (RCTs)• determine causality or correlation i.e.o impact of independent variables on the dependent

variableso demonstrate cause and effect relationshipso comparison between the project/program group

(intervention group) and a control group

4Bamberger, et al (2006)

Randomized control trials (RCTs)

Intervention group

RandomizationControl group

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(no intervention)

Pre-intervention Post-intervention

A1, B1= Pre-intervention data collection pointsA2, B2= Post-intervention data collection posts

Bamberger, et al (2006)

Research areas using randomized control trials (RCTs)

Areas/field of use of RCTs•Trials of new medicines•Training schemes for staff or target groups of people•New modes of treatment delivery•Testing “real world” effects

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Qualitative research in Experiment design and trials

Qualitative research is used:• before and after the intervention• Enrolment, allocation, follow-up and at analysis

phasesSome data collection methods• Participant observations• In-depth interviews• Photo and video elicitation• Participatory action research/workshops• Focus groups discussions

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Flow chart depicting qualitative research in two RCTs groups through the different phases

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Schulz et al, (2010)

RCT phases1)Enrolment2)Allocation3)Follow-up4)Analysis

Qualitative research in the randomized control trial phases

Table 1: Qualitative data that might be generated at each phase.

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Randomized control trial phase

Qualitative research data

1) Enrolment • Recruitment of participants• Genuine informed consent• Allocation of groups (control & intervention)

2) Allocation Reasons why an intervention is not received3) Follow-up Reasons for discontinuation (reflect on the

prisoner’s experiment in Reasons for disappeared /lost participantsReasons for positive or negative progress in implementation

4) Analysis Provides evidence for the impactsThe process of how impacts occur

Case examplesExample 1: Evaluation of the Stepping stones sexual health

program in the Gambia.• Intervention and control villages were randomly chosen• Problems and actions were identified through participatory

action workshops• Focus groups were used after one to follow up intervention

village• Observations used to study change of behavior in both

villages• In-depth interviews used to test understanding of sexually

transmitted diseases & HIV/AIDs and prevention

Green & Thorogood, (2004)10

…..continued case examples

Example 2: Ann Oakleys (1990) evaluation about interventions designed to increase support for new mothers.

• Used in-depth interviews to evaluate: midwives’ social support during pregnancy Intervention outcomes such as satisfaction with care Infant birth weight

11Green & Thorogood, (2004)

Strength of qualitative in experimental and trialsBenefits of qualitative in causal experiments and trials• Generate hypotheses about why a given intervention has a

specific impact,• Describes how the impact occurs, • and in what organizational context it occurs• Improves internal validity• Trials are successful, feasible and viable• Generates genuine informed consent during randomization• Aids selection of participants in control and intervention

groups

12Curry et al, (2009)

Limitation of qualitative in experimental and trials

Limitations• Biaso Presenting results o recommendations• Requires expertise and skills• Timeo Experiments and trials can last for more than a year• Expensiveo Meeting intervention group requirements

13Curry et al, (2009)

SummaryIntegrating qualitative research in experimental design and trials•Pre-intervention•Intervention•Post- intervention•Enrolment, allocation, follow-up and analysisStrength•Generates informed consent for participation•Improves internal validityLimitationsBias in reporting results

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ReferencesAbusabha, R. & Woelfel, M.L. (2003). Qualitative vs. Quantitative Methods:

Two Opposites that Make a Perfect Match. Journal of the American Dietetic Association. 103(5). 566-575.

Bamberger, M. J.; Rugh, J.; & Mabry, L. (2006). RealWorld Evaluation. Working Under Budget, Time, Data, and Political Constraints. Thousand Oaks : Sage Publications, Inc. Condensed summary. Retrieved: http://www.realworldevaluation.org/uploads/Condensed_Summary_Overview_of_RealWorld_Evaluation_2nd_edition.pdf

Curry, A. L.; Nembhard, M. I.; and Bradley, H. E.(2009) Qualitative and Mixed Methods Provide Unique Contributions to Outcomes Research. Circulation. 119:1442-1452.

Green, J.; and Thorogood, N. (2004) Qualitative methods for health research. Thousand Oaks: Sage Publictions, Inc. Chapter 2. Pages 35-40.

Schulz, K. F., Altman, D., and Moher, D. (2010) CONSORT 2010 statement:: Updated guidelines for reporting parallel group randomized trials. The British medical journal. 340:c332. Retrieved from: http://www.bmj.com/content/340/bmj.c332.full 15

Thank you.

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