No abstract available.A Program Grant Fellowship from The George Institute for Global Health.http://frontiersin.org/Medicinedm2022Speech-Language Pathology and Audiolog

Andersson, Gerhard

Liu, Hueiming

Manchaiah, Vinaya

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EDITORIALpublished: 11 July 2022doi: 10.3389/fmed.2022.950637Frontiers in Medicine | www.frontiersin.org 1 July 2022 | Volume 9 | Article 950637Edited and reviewed by:Sandor Kerpel-Fronius,Semmelweis University, Hungary*Correspondence:Hueiming Liuhliu@georgeinstitute.org.auSpecialty section:This article was submitted toRegulatory Science,a section of the journalFrontiers in MedicineReceived: 23 May 2022Accepted: 06 June 2022Published: 11 July 2022Citation:Liu H, Andersson G and Manchaiah V(2022) Editorial: The ProcessEvaluation of Clinical Trials.Front. Med. 9:950637.doi: 10.3389/fmed.2022.950637Editorial: The Process Evaluation ofClinical TrialsHueiming Liu 1,2*, Gerhard Andersson 3,4 and Vinaya Manchaiah 5,6,7,8,91Center Health Systems Science, The George Institute for Global Health, The University of New South Wales, Newtown,NSW, Australia, 2 School of Public Health, University of Sydney, Sydney, NSW, Australia, 3Department of Behavioral Sciencesand Learning, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden, 4Division ofPsychiatry, Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden, 5Department ofOtolaryngology–Head and Neck Surgery, University of Colorado School of Medicine, Aurora, CO, United States, 6UCHealthHearing and Balance, University of Colorado Hospital, Aurora, CO, United States, 7 Virtual Hearing Lab, CollaborativeInitiative Between University of Colorado School of Medicine and University of Pretoria, Aurora, CO, United States,8Department of Speech-Language Pathology and Audiology, University of Pretoria, Pretoria, South Africa, 9Department ofSpeech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, IndiaKeywords: clinical trials, process evaluation, qualitative, mixed-methods, randomized controlled trial,implementation science, implementation researchEditorial on the Research TopicThe Process Evaluation of Clinical TrialsBACKGROUND: HISTORY OF PROCESS EVALUATIONSThe history of clinical trials goes back a long way to 500 BC, though some credits Frenchsurgeon Ambrose pare for the first documented clinical trial involving treatment of woundsduring sixteenth century (1). Since then, clinical trials have evolved tremendously and havenow become the foundation of modern medical and healthcare practice, focusing on clinicaloutcomes. However, over the past decades there has been increasing interest in performing“process evaluations” of clinical trials of complex interventions (2). While the outcome evaluationfocuses on whether a new intervention works, a process evaluation supplements our knowledge byproviding an understanding of the causal mechanisms of the intervention, contextual factors, andimplementation factors impacting on the outcomes (3).Process evaluation methodology has evolved through the years (2). Previously, they were usedto assess implementation through the analysis of quantitative process indicators. Subsequently,there was increasing recognition and the need for qualitative research alongside trials to provide adeeper understanding of the disease condition, acceptability of an intervention and implementationissues (4). Process evaluations were deemed particularly relevant during a negative trial result, as towhether there was either implementation or intervention failure, or both. However, there is also agrowing recognition that using qualitative and quantitative data, and theoretical frameworks withinprocess evaluations will help facilitate evidence to practice (5–7). Process evaluations can helpaddress stakeholders’ question of “Is this intervention acceptable, effective, affordable and feasible(for me or) for this population?” (7).Key domains are summarized in UK Medical Research Council (MRC) process evaluationguidance (context, quality of implementation and mechanisms of the intervention), and alsoinclude concepts from established evaluation frameworks that have been used widely including:Reach, Effectiveness, Adoption, Implementation and Maintenance framework (RE-AIM) (8) andLinnan and Steckler (9). Although each is unique, there is some overlap, in their emphasis toenable research translation. The key concepts include: (i) reach and recruitment (i.e., investigatingthe extent to which the intervention as received by the targeted group), (ii) adoption (i.e., relatedto the delivery of the intervention, (iii) acceptability (i.e., extent to which participants find theintervention acceptable), (iv) implementation fidelity (i.e., extent to which intervention is deliveredLiu et al. Editorial: The Process Evaluation of Clinical Trialsas planned), (v) maintenance (i.e., extent to which theintervention can be sustained over time after the clinical trialis over).SPECIAL ISSUE: PROCESS EVALUATIONSOF CLINICAL TRIALSThis special issue builds on the emerging value and methodologyof process evaluations. It includes nine manuscripts focusing on arange of interventions. Therefore, highlighting the transferabilityand value of process evaluations across types of interventions,and also in unpacking context from lower-middle incomecountries to high income countries with established healthsystems. Chu et al. presented the mixed-methods processevaluation of community-based dietary sodium reduction inRural China. In another study, expectations regarding pragmatictrial design of integrative medicine for diabetes and kidneydiseases among patients and physicians was evaluated andreported (Chan et al.). Four studies focused on processevaluation of telehealth interventions. Meijerink et al. presentedprocess evaluation of online support program for hearing aidusers. Beukes et al. and Biliunaite et al. provided processevaluation results of internet-based cognitive behavioral therapyfor tinnitus and informal caregivers, respectively. Indraratnaet al. presented the process evaluation of TeleClinical carefor acute coronary syndrome and heart failure. Two studiesalso included implementation science approach. Riddell et al.evaluated the implementation and scalability of the AccreditedSocial Health Activists (ASHAs) led community-based supportgroups for hypertension in Rural India. In another study, Ouyanget al. provided the process evaluation of implementation trialon intracerebral hemorrhage. Finally, Wu et al. presented thecomprehensive process evaluation of the pediatric drug clinicaltrials through a literature review.The process evaluations in this collection are also conductedacross different phases of the research cycle, from studydesign (Chu et al.), pilot/feasibility phase (Biliunaite et al.;Indraratna et al.), evaluation of the clinical trial (Chuet al.; Meijerink et al.; Beukes et al.; Riddell et al.; Ouyanget al.) including long term sustainability (Riddell et al.;Wu et al.). Therefore, highlighting the value of processevaluation findings to inform intervention design and optimizeimplementation. Moreover, while the use of theoreticalframeworks is helpful in eliciting contextual determinantsacross individual, organizational and system, and policylevels, often the breadth and scope of them in literature canbe daunting (3). Careful consideration of what theories arerelevant would be helpful (10). For instance, in this specialissue, for interventions that are related to individual behavioralchange, health belief model used by Chu et al. or otherssuch as behavior change wheel, or cognitive theories may behelpful. Normalization process theory that has a strong focuson understanding organizational behavior, was also used byOuyang et al. the implementation study in stroke units forintracerebral hemorrhage.WHERE TO FROM HERE?Indeed, as we reflect on the emerging value and methodologyof process evaluations, it is worth noting its contributions toimplementation science, as researchers endeavor to meet end-users’ needs, understand what happened on the ground, andhow to overcome implementation barriers. As we continueto invest in clinical trials to inform evidence-based medicineand policy, we recommend that we embed process evaluationsthroughout the research cycle, to examine for whom, how andwhy the clinical trial had its outcomes. This will require buildingcapacity in mixed-methods, implementation science, stakeholderengagement/co-design of implementation strategies, which willrequire allocation of sufficient resourcing, budgeting, time andmost importantly training those who are involved in performingclinical trials on process evaluation and implementation scienceelements. And in doing so, regardless of a positive or negativetrial result, we will learn to improve our research andintervention design to meet local context and enable long termsustainability and scale up of effective interventions.AUTHOR CONTRIBUTIONSHL drafted the initial manuscript, with significant input fromVM. All authors have reviewed the manuscript versions andapproved its submission.FUNDINGHL is supported by a ProgramGrant Fellowship fromTheGeorgeInstitute for Global Health.ACKNOWLEDGMENTSWe thank all the authors of the manuscripts in this specialResearch Topic for their interest and support of this collection.Special thanks to the editors, and reviewers of these manuscriptsthat cover a diverse content area.REFERENCES1. Bhatt A. Evolution of clinical research: a history before and beyond JamesLind. Perspect Clin Res. (2010) 1:6–10.2. Moore GF, Audrey S, Barker M, Bond L, Bonell C, HardemanW, et al. Processevaluation of complex interventions: Medical Research Council guidance.BMJ. (2015) 350:h1258. doi: 10.1136/bmj.h12583. Liu H, Mohammed A, Shanthosh J, News M, Laba TL,Hackett ML, et al. Process evaluations of primary careinterventions addressing chronic disease: a systematic review.BMJ Open. (2019) 9:e025127. doi: 10.1136/bmjopen-2018-0251274. Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongsiderandomised controlled trials of complex healthcare interventions:Frontiers in Medicine | www.frontiersin.org 2 July 2022 | Volume 9 | Article 950637Liu et al. Editorial: The Process Evaluation of Clinical Trialsmethodological study. BMJ. (2009) 339:b3496. doi: 10.1136/bmj.b34965. Curry LA, Nembhard IM, Bradley EH. Qualitative and mixedmethods provide unique contributions to outcomes research.Circulation. (2009) 119:1442–52. doi: 10.1161/CIRCULATIONAHA.107.7427756. McIlvennan CK, Morris MA, Guetterman TC, Matlock DD,Curry L. Qualitative methodology in cardiovascular outcomesresearch: a contemporary look. Circ Cardiovasc Qual Outcomes.(2019) 12:e005828. doi: 10.1161/CIRCOUTCOMES.119.0058287. Skivington K, Matthews L, Simpson SA, Craig P, Baird J,Blazeby JM, et al. A new framework for developing andevaluating complex interventions: update of Medical ResearchCouncil guidance. BMJ. (2021) 374:n2061. doi: 10.1136/bmj.n20618. Glasgow RE, Vogt TM, Boles SM. Evaluating the public healthimpact of health promotion interventions: the RE-AIM framework.Am J Public Health. (1999) 89:1322–7. doi: 10.2105/AJPH.89.9.13229. Linnan L, Steckler A. Process Evaluation for Public Health Interventions andResearch. San Francisco, CA: Jossey-Bass (2002).10. Nilsen P. Making sense of implementation theories, models andframeworks. Implement Sci. (2015) 10:53. doi: 10.1186/s13012-015-0242-0Conflict of Interest: The authors declare that the research was conducted in theabsence of any commercial or financial relationships that could be construed as apotential conflict of interest.Publisher’s Note: All claims expressed in this article are solely those of the authorsand do not necessarily represent those of their affiliated organizations, or those ofthe publisher, the editors and the reviewers. Any product that may be evaluated inthis article, or claim that may be made by its manufacturer, is not guaranteed orendorsed by the publisher.Copyright © 2022 Liu, Andersson and Manchaiah. This is an open-access articledistributed under the terms of the Creative Commons Attribution License (CC BY).The use, distribution or reproduction in other forums is permitted, provided theoriginal author(s) and the copyright owner(s) are credited and that the originalpublication in this journal is cited, in accordance with accepted academic practice.No use, distribution or reproduction is permitted which does not comply with theseterms.Frontiers in Medicine | www.frontiersin.org 3 July 2022 | Volume 9 | Article 950637

Editorial : The process evaluation of clinical trials

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Editorial : The process evaluation of clinical trials

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