Qualitative Methods and Process Evaluation in Clinical Trials Context: Where to Head to?

Process evaluation of complex interventions: Medical Research Council guidance

Moore, G. F., Audrey, S., Barker, M., Bond, L., Bonell, C., Hardeman, W., Moore, L., O'Cathain, A., Tinati, T., Wight, D., et al. (2015) · BMJ · doi:10.1136/bmj.h1258 · Cited by 6,204 · see citing works

Qualitative Research: Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research

Pope, C., & Mays, N. (1995) · BMJ · doi:10.1136/bmj.311.6996.42 · Cited by 2,336 · see citing works

International Journal of Qualitative Methods

(2008) · The SAGE Encyclopedia of Qualitative Research Methods · doi:10.4135/9781412963909.n230 · Cited by 1,501 · see citing works

Qualitative and Mixed Methods Provide Unique Contributions to Outcomes Research

Curry, L. A., Nembhard, I. M., & Bradley, E. H. (2009) · Circulation · doi:10.1161/circulationaha.107.742775 · Cited by 1,091 · see citing works

Users' Guides to the Medical Literature: XXIII. Qualitative Research in Health Care A. Are the Results of the Study Valid?

Giacomini, M. K., Cook, D. J., & for the Evidence-Based Medicine Working Group (2000) · JAMA · doi:10.1001/jama.284.3.357 · Cited by 931 · see citing works

Triangulation and integration: processes, claims and implications

Moran‐Ellis, J., Alexander, V. D., Cronin, A., Dickinson, M., Fielding, J., Sleney, J., & Thomas, H. (2006) · Qualitative Research · doi:10.1177/1468794106058870 · Cited by 777 · see citing works

A Primer on Effectiveness and Efficacy Trials

Singal, A. G., Higgins, P. D. R., & Waljee, A. K. (2014) · Clinical and Translational Gastroenterology · doi:10.1038/ctg.2013.13 · Cited by 698 · see citing works

Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

Lewin, S., Glenton, C., & Oxman, A. D. (2009) · BMJ · doi:10.1136/bmj.b3496 · Cited by 678 · see citing works

Health Services Research

Williams, J. I., Höher, J., & Lauterbach, K. W. (1998) · Springer eBooks · doi:10.1007/978-1-4612-1888-3_57 · Cited by 411 · see citing works

How will we know "good" qualitative research when we see it? Beginning the dialogue in health services research.

Devers, K. J. (1999) · PubMed Central · Cited by 366 · see citing works

Ethnographic methods for process evaluations of complex health behaviour interventions

Morgan‐Trimmer, S., & Wood, F. (2016) · Trials · doi:10.1186/s13063-016-1340-2 · Cited by 168 · see citing works

Process evaluation: the new miracle ingredient in public health research?

Munro, A., & Bloor, M. (2010) · Qualitative Research · doi:10.1177/1468794110380522 · Cited by 60 · see citing works

Protocol for the process evaluation of a complex intervention designed to increase the use of research in health policy and program organisations (the SPIRIT study)

the CIPHER team, Haynes, A. S., Brennan, S., Carter, S. M., O’Connor, D. A., Schneider, C. H., Turner, T., & Gallego, G. (2014) · Implementation Science · doi:10.1186/s13012-014-0113-0 · Cited by 44 · see citing works

Describing qualitative research undertaken with randomised controlled trials in grant proposals: a documentary analysis

Drabble, S. J., O’Cathain, A., Thomas, K. J., Rudolph, A., & Hewison, J. (2014) · BMC Medical Research Methodology · doi:10.1186/1471-2288-14-24 · Cited by 41 · see citing works

The death of mixed methods?: Research labels and their casualties

Gorard, S. A. C., & Symonds, J. E. (2010) · Cited by 32 · see citing works

What can qualitative studies offer in a world where evidence drives decisions?

Thorne, S. E. (2017) · Asia-Pacific Journal of Oncology Nursing · doi:10.4103/apjon.apjon_51_17 · Cited by 18 · see citing works

The Role of Qualitative Research in Clinical Trial Development: The EASE Back Study

Bartlam, B., Waterfield, J., Bishop, A., Holden, M. A., Barlas, P., ISMAIL, K. M. K., Kettle, C., & Foster, N. E. (2016) · Journal of Mixed Methods Research · doi:10.1177/1558689816656740 · Cited by 16 · see citing works

Parent perceptions of participation in a parent-mediated communication-focussed intervention with their young child with autism spectrum disorder

Leadbitter, K., Macdonald, W., Taylor, C., & Buckle, K. L. (2020) · Autism · doi:10.1177/1362361320936394 · Cited by 71 · see citing works

Skill Acquisition Methods Fostering Physical Literacy in Early-Physical Education (SAMPLE-PE): Rationale and Study Protocol for a Cluster Randomized Controlled Trial in 5–6-Year-Old Children From Deprived Areas of North West England

Rudd, J., Crotti, M., Fitton-Davies, K., O’Callaghan, L., Bardid, F., Utesch, T., Roberts, S., Boddy, L., Cronin, C. J., Knowles, Z., et al. (2020) · Frontiers in Psychology · doi:10.3389/fpsyg.2020.01228 · Cited by 68 · see citing works

Designing process evaluations using case study to explore the context of complex interventions evaluated in trials

Grant, A. M., Bugge, C., & Wells, M. (2020) · Trials · doi:10.1186/s13063-020-04880-4 · Cited by 54 · see citing works

Use of mixed methods research in intervention studies to increase young people’s interest in STEM: A systematic methodological review

Fàbregues, S., Sáinz, M., Romano, M. J., Escalante‐Barrios, E. L., Younas, A., & Pérez, B. S. L. (2023) · Frontiers in Psychology · doi:10.3389/fpsyg.2022.956300 · Cited by 45 · see citing works

A qualitative evaluation of a mental health literacy intervention for parents delivered through community sport clubs

Hurley, D., Swann, C., Allen, M. S., & Vella, S. A. (2019) · Psychology of sport and exercise · doi:10.1016/j.psychsport.2019.101635 · Cited by 31 · see citing works

Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation

Allan, S., McLeod, H. J., Bradstreet, S., Beedie, S. A., Moir, B., Gleeson, J., Farhall, J., Morton, E. E., & Gumley, A. I. (2019) · JMIR Research Protocols · doi:10.2196/15634 · Cited by 16 · see citing works

Qualitative Research in Clinical Epidemiology

Thompson, S., & Schick‐Makaroff, K. (2021) · Methods in molecular biology · doi:10.1007/978-1-0716-1138-8_20 · Cited by 17 · see citing works

Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial

Allan, S., McLeod, H. J., Bradstreet, S., Bell, I. H., Whitehill, H., Wilson-Kay, A., Clark, A., Matrunola, C., Morton, E. E., Farhall, J., et al. (2021) · JMIR Human Factors · doi:10.2196/24055 · Cited by 16 · see citing works

How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme

Powell, A. E., Hoare, S. E., Modi, R. N., Williams, K. M., Dymond, A., Chapman, C., Griffin, S. J., Mant, J., & Burt, J. (2022) · Trials · doi:10.1186/s13063-022-06308-7 · Cited by 17 · see citing works

What do we want to get out of this? a critical interpretive synthesis of the value of process evaluations, with a practical planning framework

French, C. M., Dowrick, A., Fudge, N., Pinnock, H., & Taylor, S. J. (2022) · BMC Medical Research Methodology · doi:10.1186/s12874-022-01767-7 · Cited by 15 · see citing works

Qualitative assessment of healthy volunteer experience receiving subcutaneous infusions of high-dose benzathine penicillin G (SCIP) provides insights into design of late phase clinical studies

Enkel, S. L., Kado, J. H., Hla, T. K., Salman, S., Bennett, J., Anderson, A., Carapetis, J. R., & Manning, L. A. (2023) · PLoS ONE · doi:10.1371/journal.pone.0285037 · Cited by 11 · see citing works

Compliance with the Very Integrated Program (VIP) for Smoking Cessation, Nutrition, Physical Activity and Comorbidity Education Among Patients in Treatment for Alcohol and Drug Addiction

Hovhannisyan, K., Günther, M., Raffing, R., Wikström, M., Adami, J., & Tønnesen, H. (2019) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph16132285 · Cited by 10 · see citing works

Feasibility of the PalliSupport care pathway: results from a mixed-method study in acutely hospitalized older patients at the end of life

Flierman, I., van Rijn, M., de Meij, M. A., Poels, M., Niezink, D. M., Willems, D. L., & Buurman, B. M. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-00676-0 · Cited by 8 · see citing works

Using qualitative process evaluation in the development of a complex intervention to advance person-centred practice by pharmacists: The Medicines and Alcohol Consultation (MAC)

Madden, M., Morris, S. L., Stewart, D., Atkin, K. M., Gough, B., Mills, T., & McCambridge, J. (2021) · SSM - Qualitative Research in Health · doi:10.1016/j.ssmqr.2021.100012 · Cited by 8 · see citing works

Pilot study of a ketogenic diet in bipolar disorder: a process evaluation

Rigby, B. P., Needham, N., Grossi, H., Kamenská, I., Campbell, I. H., Meadowcroft, B., Creasy, F., Fisher, C., Bahuguna, P., Norrie, J. D., et al. (2025) · BMC Psychiatry · doi:10.1186/s12888-025-06479-y · Cited by 7 · see citing works

Experiences of Using a Digital Text Messaging Intervention to Support Oral Medication Adherence for People Living With Type 2 Diabetes: Qualitative Process Evaluation

Newhouse, N., Bartlett, Y. K., Simao, S. C., Miles, L. M., Cholerton, R., Kenning, C., Locock, L., Williams, V., French, D., Rea, R. D., et al. (2025) · Journal of Medical Internet Research · doi:10.2196/70203 · Cited by 7 · see citing works

Aged care staff perceptions of an online training program for responsive behaviours of residents with dementia

Almutairi, H., Stafford, A. C., Etherton‐Beer, C., Flicker, L. A., & Saunders, R. (2021) · Australian Journal on Ageing · doi:10.1111/ajag.13015 · Cited by 7 · see citing works

‘Nobody will put baby in the corner!’: A qualitative evaluation of a physical activity intervention to improve mental health

Peddie, N., Westbury, T., & Snowden, A. W. (2020) · Health & Social Care in the Community · doi:10.1111/hsc.13017 · Cited by 6 · see citing works

Exploring the experiences and perceptions of patients awaiting rotator cuff repair surgery: An integrated qualitative study within the POWER pilot and feasibility trial

Moffatt, M., Wade, J., Foster, N. E., & Littlewood, C. (2023) · Musculoskeletal Science and Practice · doi:10.1016/j.msksp.2023.102893 · Cited by 6 · see citing works

Gender differences in the context of interventions for improving health literacy in migrants: a qualitative evidence synthesis

Aldin, A., Baumeister, A., Chakraverty, D., Monsef, I., Noyes, J., Kalbe, E., Woopen, C., & Skoetz, N. (2024) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013302.pub2 · Cited by 5 · see citing works

Examining clinician choice to follow-up (or not) on automated notifications of medication non-adherence by clinical decision support systems

Thorpe, D., Strobel, J. E., & Bidargaddi, N. P. (2023) · BMC Medical Informatics and Decision Making · doi:10.1186/s12911-022-02091-2 · Cited by 5 · see citing works

Implementation Monitoring of a Promotora-Led, Home-Based Obesity Prevention Pilot Study With Latino Preschool Children and Their Mothers

Ross, S. E. T., Smith-Tapia, I., Saunders, R. P., Documet, P. I., & Pate, R. R. (2020) · International Quarterly of Community Health Education · doi:10.1177/0272684x20970375 · Cited by 5 · see citing works

Conducting qualitative research on acute mental health inpatient wards: Lessons from the field

Johnston, I., Morley, H., Gilworth, G., Raphael, J., Wilson, P. M., Edge, D., & Berry, K. (2025) · PLoS ONE · doi:10.1371/journal.pone.0319609 · Cited by 4 · see citing works

Nurses' and physicians' perspectives on implementation barriers and facilitators in a transfer program for parents of adolescents with chronic illness

Thomsen, E. L., Koppelhus, J. C., Boisen, K. A., Hanghøj, S., Hansson, H., & Esbensen, B. A. (2024) · Journal of Advanced Nursing · doi:10.1111/jan.16026 · Cited by 4 · see citing works

Quantitative and Qualitative Strategies to Strengthen Internal Validity in Randomized Trials

Sidani, S., & O’Rourke, H. M. (2020) · Canadian Journal of Nursing Research · doi:10.1177/0844562120974197 · Cited by 4 · see citing works

Your Teeth, You Are in Control: A Process Evaluation of the Implementation of a Cognitive Behavioural Therapy Intervention for Reducing Child Dental Anxiety

Kettle, J., Porritt, J. M., Baker, S. R., RODD, H. D., Cross, E., & Marshman, Z. (2025) · Community Dentistry And Oral Epidemiology · doi:10.1111/cdoe.13025 · Cited by 4 · see citing works

Treatment guided by fractional exhaled nitric oxide in addition to standard care in 6- to 15-year-olds with asthma: the RAACENO RCT

Turner, S., Cotton, S. C., Wood, J., Bell, V., Raja, E. A., SCOTT, N. W., Morgan, H. M., Lawrie, L., Emele, C. D., Kennedy, C., et al. (2022) · Efficacy and Mechanism Evaluation · doi:10.3310/awoi5587 · Cited by 3 · see citing works

Integrated Care Model Salut+Social Assessment by Professionals, Informal Caregivers and Chronic or Social Dependent Patients: A Qualitative Study

Gavaldà-Espelta, E., Fortuño, M. L., Martín, C. A., Pozo, M., ferrate, M. F., Tomàs-Navarro, B., Curto-Romeu, C., Lucas-Noll, J., Baucells-Lluis, J., Gonçalves, A. Q., et al. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph192315467 · Cited by 3 · see citing works

Participant experiences of the Knee Care for Arthritis through Pharmacy Service (KneeCAPS): A personalised hīkoi (journey) through care

Darlow, B. J. S., Brown, M., Vincent, L., Keenan, R., Simmonds, S., Briggs, A. M., Hudson, B., Clark, J., Frew, G., Pask, A., et al. (2026) · Osteoarthritis and Cartilage Open · doi:10.1016/j.ocarto.2026.100759 · Cited by 2 · see citing works

Exploring the Black Box of an mHealth Intervention (LIFE4YOUth): A Qualitative Process and Outcome Evaluation of End-User Engagement

Seiterö, A., Thomas, K., Löf, M., & Müssener, U. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph192114022 · Cited by 2 · see citing works

Experiences of learners with visual impairments in Botswana primary schools

Mukhopadhyay, S., Moswela, E., & Habulezi, J. (2021) · International Journal of Inclusive Education · doi:10.1080/13603116.2021.1965802 · Cited by 3 · see citing works

Implementing an intervention to enhance care delivery and consistency for people with hip fracture and cognitive impairment in acute hospital wards: a mixed methods process evaluation of a randomised controlled feasibility trial (PERFECTED)

Backhouse, T., Fox, C., Hammond, S. P., Poland, F. M., McDermott-Thompson, V., Penhale, B., & Cross, J. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-064482 · Cited by 1 · see citing works

Exploring individuals’ perspectives on participating in a feasibility trial assessing a combined program of education plus exercise versus general advice for ankle osteoarthritis

Costa, N., Vicenzino, B., Vuvan, V., Collins, N. J., Smith, M. M. F., Southern, Z., Duffy, T., Downie, A., Hunter, D. J., & Smith, M. D. (2025) · Musculoskeletal Science and Practice · doi:10.1016/j.msksp.2025.103391 · Cited by 1 · see citing works

Framework for measuring the efficiency and efficacy of sale of distressed mortgaged properties using imports of statistical tests deployed in clinical studies

Ataguba, J. O., & Ugonabo, C. U. (2023) · SN Business & Economics · doi:10.1007/s43546-023-00513-5 · Cited by 1 · see citing works

Supporting older adults with cancer and their support person through geriatric assessment and remote exercise and education: The SOAR study protocol

Jebanesan, N., Alibhai, S. M. H., Mina, D. S., Jones, J. S., Legacy, N., Freeman, L., Smith, A., Cobbing, S., Vadali, N., Lo, S. K., et al. (2025) · Journal of Geriatric Oncology · doi:10.1016/j.jgo.2025.102194 · Cited by 2 · see citing works

Trial staff views on barriers recruitment in a digital intervention for psychosis and how to work around them: A qualitative study within a trialPreprint

Allan, S., Mcloed, H., Bradstreet, S., Morton, E. E., Bell, I. H., Wilson-Kay, A., Whitehill, H., Clark, A., Matrunola, C., Farhall, J., et al. (2020) · doi:10.21203/rs.3.rs-20235/v1 · Cited by 1 · see citing works

Blinding outcome assessors in randomised controlled trials of psychological interventions: how is it done? A narrative review

O’Keeffe, S. (2026) · Trials · doi:10.1186/s13063-026-09698-0

The development, implementation, and evaluation of a mental health literacy intervention for parents in community sport clubs

Hurley, D. (2019) · Research Online (University of Wollongong)

Outcome Evaluation

Sidani, S., & Braden, C. J. (2021) · Wiley eBooks · doi:10.1002/9781119610113.ch14

Process Evaluation

(2021) · Wiley eBooks · doi:10.1002/9781119610113.ch13

PT. Jaso Malindo Perspective of Fiqh Muamalah and Law No.13 of 2003 (Case Study of PT Jaso Malindo Department of Solok-Padang)

Rahmad, J., Hannah, I., & Joanna, C. (2023) · Journal Islamic Economic Minangkabau · doi:10.55849/jiem.v1i1.63

Provisions Regarding Low Heritage In The Compilation Of Islamic Law (Study In Nagari Koto Gadang, Koto Besar District Dharmasraya District)

Putri, D. E., Jaewon, C., & Simone, S. (2023) · Journal Islamic Economic Minangkabau · doi:10.55849/jiem.v1i1.70

Provisions Regarding Low Heritage In The Compilation Of Islamic Law (Study In Nagari Koto Gadang, Koto Besar District Dharmasraya District)

Putri, D. E., Jaewon, C., & Simone, S. (2023) · Sharia Oikonomia Law Journal · doi:10.55849/solj.v1i1.70

PT. Jaso Malindo Perspective of Fiqh Muamalah and Law No.13 of 2003 (Case Study of PT Jaso Malindo Department of Solok-Padang)

Rahmad, J., Hannah, I., & Joanna, C. (2023) · Sharia Oikonomia Law Journal · doi:10.55849/solj.v1i1.63

Efficiency of distressed property sales in Lagos city, Nigeria

Ataguba, J. O., & Ugonabo, C. U. (2023) · Lapai Journal of Economics · doi:10.4314/lje.v7i1.3

Analysis of the Application of the Principles of Business Ethics in Islam

Jonathan, B., Joshua, W., & Niva, M. (2023) · Sharia Oikonomia Law Journal · doi:10.55849/solj.v1i4.665

The Influence of Business Ethics in Entrepreneurship in the Era of Covid-19 Pandemic

Akbar, D. M., Kathryn, M., & Barra, L. (2023) · Sharia Oikonomia Law Journal · doi:10.55849/solj.v1i4.656 · Cited by 4 · see citing works

Use large language models (LLMs) tools for supporting qualitative research: A phenomenological study of Chinese clinical researchers’ experiences and perceptions (Preprint)Preprint

Zuo, Y., Jin, Y., Hu, X., Yang, K., Bai, Z., He, J., & Zhang, J. S. (2024) · doi:10.2196/preprints.64392

Factors Influencing the Outcome, Mechanism, and Implementation of Motivational Interviewing After Hip Fracture: A Qualitative Analysis

Rimayanti, M. U., Shields, N., O’Halloran, P., & Taylor, N. F. (2024) · Journal of Geriatric Physical Therapy · doi:10.1519/jpt.0000000000000435

A qualitative process evaluation of Active Support in the Dutch context: An investigation of implementation and contextual factors

van Herwaarden, A., Peters-Scheffer, N. C., Totsika, V., & Didden, R. (2025) · Journal of Intellectual & Developmental Disability · doi:10.3109/13668250.2025.2503101

“It’s just crucial to deal with emotions as well as the pain” A qualitative acceptability study of an online emotion regulation skills-focused intervention for people with chronic pain

Norman‐Nott, N., Rizzo, R. R. N., Hesam‐Shariati, N., Schroeder, J., Suh, J., McAuley, J. H., Quidé, Y., & Gustin, S. M. (2025) · International Journal of Clinical and Health Psychology · doi:10.1016/j.ijchp.2025.100638

Additional file 1 of What do we want to get out of this? a critical interpretive synthesis of the value of process evaluations, with a practical planning framework

French, C. M., Dowrick, A., Fudge, N., Pinnock, H., & Taylor, S. J. (2022) · Figshare · doi:10.6084/m9.figshare.21628620

Additional file 1 of Examining clinician choice to follow-up (or not) on automated notifications of medication non-adherence by clinical decision support systems

Thorpe, D., Strobel, J. E., & Bidargaddi, N. P. (2024) · Figshare · doi:10.6084/m9.figshare.26565051

Process Evaluation of Teams: A Revised Framework for Use in Extension

Norze, J., Connolly, C., & Stearns, S. (2026) · American Journal of Evaluation · doi:10.1177/10982140251411595

Telerehabilitation for early-stage Parkinson's disease: A randomized controlled feasibility trial of individualised real-time physiotherapy delivered via a videoconference platform

Skelly, R., Lindop, F., Gordon, A. L., Chadborn, N., Malik, M., McFarlane, K., Brown, L. S., Beckhelling, J., Skeggs, A. L., Smith, L., et al. (2026) · Journal of Parkinson s Disease · doi:10.1177/1877718x261418551

Research Approaches in Health Promotion and Illness Prevention

Liamputtong, P., & Zaid, F. A. (2025) · Springer eBooks · doi:10.1007/978-981-97-0821-5_126-1

Research Approaches in Health Promotion and Illness Prevention

Liamputtong, P., & Zaid, F. A. (2026) · Springer eBooks · doi:10.1007/978-981-92-1288-0_126

Qualitative methods in evaluation

Padgett, D. K. (2009) · Cited by 7 · see citing works

Qualitative process evaluation

Langhorne, P., Wu, O., Rodgers, H., Ashburn, A., & Bernhardt, J. A. (2017)

Evaluation of therapeutic processes in clinical interventions: a view of qualitative methodological approaches

Denis, J., Guillemette, F., & Hendrick, S. (2018) · ORBi UMONS

Qualitative and Quantitative Methods in Evaluation

Cook, T. D., & Reichardt, C. S. (1979) · Cited by 36 · see citing works

Qualitative research and evaluation methods

Patton, M. Q. (1980) · Cited by 35,637 · see citing works