A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

Skivington, Kathryn; Matthews, Lynsay; Simpson, Sharon Anne; Craig, Peter; Baird, Janis; Blazeby, Jane M; Boyd, Kathleen; Craig, Neil; French, David P.; McIntosh, Emma; Petticrew, Mark; Rycroft‐Malone, Jo; White, Martin; Moore, Linda

doi:10.1136/bmj.n2061

Cited by 1,771 publications

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“…If the acceptability of behaviour change interventions is overlooked, their effectiveness may be undermined [12]. Acceptability of health behaviour interventions has generally been conceptualised as the level of tolerance required to undertake health interventions or, more recently, the perceived appropriateness to those delivering or receiving a healthcare intervention based on their cognitive and emotional responses [13].…”

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confidence: 99%

The Acceptability of Physical Activity to Older Adults Living in Lower Socioeconomic Status Areas: A Multi-Perspective Study

Devereux-Fitzgerald

Powell

French

2021

IJERPH

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Older adults in lower socioeconomic status (SES) areas are the least active of all adult groups but are often absent from physical activity research. The present study aimed to elicit perspectives on acceptability of physical activity from older adults and physical activity providers in lower SES areas. Semi-structured interviews were conducted with 19 older adults and eight physical activity trainers/providers in lower SES areas. An inductive, multi-perspective Thematic Analysis was conducted. Eight themes were identified that covered one or both groups’ perceptions of what was important in ensuring acceptability of activity provision. Older adults perceived a lack of value that was reinforced by lack of resources and unequal provision. Acceptability was hindered by centralisation of facilities and lack of understanding of needs by facility management. Facilitating social interaction within physical activities appeared key, thereby meeting multiple needs with fewer resources. In conclusion, to increase acceptability of physical activity for older adults in low SES areas, providers should address the lack of perceived value felt by many older adults. Equitable provision of physical activities addressing multiple needs may allow older adults with limited resources to be physically active without sacrificing other needs. Facilitating creation of social bonds may foster maintenance of physical activities.

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Section: Introductionmentioning

confidence: 99%

The Acceptability of Physical Activity to Older Adults Living in Lower Socioeconomic Status Areas: A Multi-Perspective Study

Devereux-Fitzgerald

Powell

French

2021

IJERPH

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“…In this study informal caregivers were found to generally be very satisfied with the ICBT intervention which indicates its potential for this population. (21). There is also a set of common core elements outlined, relevant for all phases: consideration of the context, refinement of the theory, engagement of stakeholders, identification of uncertainties, refinement of the intervention and consideration of the economic factors.…”

Section: Introductionmentioning

confidence: 99%

“…Various frameworks exist for guiding the development, evaluation, and implementation of the internet interventions. The Medical Research Council (MRC) framework for complex interventions (interventions including several interacting components among other characteristics) ( 19 – 21 ) is a well-known and cited framework. It suggests that the intervention research consists of four phases: identification or development of an intervention, feasibility, evaluation, and implementation ( 21 ).…”

Section: Introductionmentioning

confidence: 99%

“…The Medical Research Council (MRC) framework for complex interventions (interventions including several interacting components among other characteristics) ( 19 – 21 ) is a well-known and cited framework. It suggests that the intervention research consists of four phases: identification or development of an intervention, feasibility, evaluation, and implementation ( 21 ). There is also a set of common core elements outlined, relevant for all phases: consideration of the context, refinement of the theory, engagement of stakeholders, identification of uncertainties, refinement of the intervention and consideration of the economic factors.…”

Section: Introductionmentioning

confidence: 99%

“…Process evaluation has been defined as a process of exploring various aspects within research trials, such as receipt, setting, implementation and meaning of the results involving both, quantitative and qualitative methods ( 22 ). In their most recent update ( 21 ) MRC has reiterated that methods, such as process evaluations, can help researchers to move beyond evaluating the effectiveness of the interventions and answer other relevant questions, such as why the intervention does or does not work or how it could be optimized further.…”

Section: Introductionmentioning

confidence: 99%

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Process Evaluation of Internet-Based Cognitive Behavioral Therapy Intervention for Informal Caregivers

et al. 2021

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Background: Informal caregivers are individuals who provide care for ill, frail, or otherwise dependent family members, siblings, or friends. Due to the caregiving demands, informal caregivers are known to experience negative mental health symptoms, such as stress or anxiety. Interventions based on Internet-based Cognitive Behavioral Therapy (ICBT) principles have been previously found to be effective for different populations and could also be considered as a plausible support option for informal caregivers. However, findings regarding effectiveness alone might not be sufficient for informing about the overall feasibility of the intervention.Objective: The aim of this process evaluation study was to evaluate the feasibility of a previously developed ICBT intervention for informal caregivers in Lithuania. More specifically, we evaluated the suitability of the intervention in relation to its content and delivery mode.Methods: Two studies were conducted. Study 1 consisted of participant evaluations of an 8-week, 8-module long therapist supported ICBT intervention. Evaluations for the Study 1 were retrieved from previously unused data, obtained from pilot testing of the intervention in which 63 informal caregivers took part. The evaluations contained of qualitative data (participant comments), as well as quantitative data (evaluations of each of the sessions). The Study 2 was an online stakeholder focus-group discussion conducted via Zoom. Eight stakeholders took part in the discussion, among whom there were social workers, medical professionals as well as individuals with caregiving experience themselves. Data were analyzed using descriptive statistics, thematic analysis, and data coding.Results: Results of the Study 1 showed that most of the pilot randomized controlled trial participants evaluated content and format of the intervention positively. These results were complemented by the findings in the Study 2, in which stakeholders evaluated the intervention as suitable and promising. In addition, stakeholders made certain suggestions for improving the intervention's usability for the informal caregivers. This included improving the instructions, providing with more guidance, and considering personalization options.Conclusion: The process evaluation helped to evaluate the feasibility of the ICBT intervention for informal caregivers in Lithuania from the two perspectives: users and stakeholders. Our findings suggest that the intervention is suitable for the target population.

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Effects of a Narrative-Based Psychoeducational Intervention to Prepare Patients for Responding to Acute Myocardial Infarction

Yan

et al. 2022

JAMA Netw Open

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ImportanceDespite decades of educational efforts, patients’ prolonged delays in seeking care for symptoms of acute myocardial infarction (AMI) remain the greatest obstacle to successful management of the condition.ObjectiveTo compare the effects of a narrative-based psychoeducational intervention with a didactic educative approach on AMI survivors’ intention to seek care for AMI symptoms and on AMI knowledge.Design, Setting, and ParticipantsA multisite randomized clinical trial recruited community-dwelling patients aged 18 years or older with a history of AMI from 4 hospitals in Hong Kong from January 1, 2018, to January 22, 2021, and followed up participants for 1 year.InterventionsAn 8-week narrative-based psychoeducational intervention aimed to create a vivid cognitive experience of complex decision-making and modeled desirable behavioral changes through nurse-led, interactive video sessions using model patients. The control group received 4 nurse-led sessions comprising education about AMI and care seeking delivered using a didactic approach.Main Outcomes and MeasuresThe primary outcome was the behavioral intention between the 2 groups, reflected by participants’ attitudes and beliefs about care seeking for AMI measured using the Acute Coronary Syndrome Response Index—Chinese version. The secondary outcome was AMI knowledge.ResultsSix hundred and eight participants (mean [SD] age, 67.2 [8.3] years; 469 [77.1%] male) were randomized to either the narrative-based psychoeducation group (n = 304) or the didactic education group (n = 304). The psychoeducational intervention group reported greater positive changes than the control group in their attitudes (β = −1.053 [95% CI, −1.714 to −0.391]; P &lt; .001) and beliefs (β = −0.686 [95% CI, −1.354 to −0.180]; P = .04) toward care seeking at the 3-month follow-up, and the difference was sustained at 12 months for both attitudes (β = −0.797 [95% CI, −1.477 to −0.117]; P = .02) and beliefs (β = −0.692 [95% CI, −1.309 to −0.012]; P = .047). There were no significant differences in AMI knowledge between the 2 study groups at the 3-month and 12-month time points.Conclusions and RelevanceThe results of this randomized clinical trial found that a novel approach of narrative-based psychoeducation was effective in improving patients’ behavioral intention to seek care for AMI symptoms. Longer-term follow-up to evaluate actual care-seeking behavior and clinical outcomes in patients with AMI is warranted to determine the sustained effects of this intervention.Trial RegistrationChiCTR Identifier: ChiCTR-IIC-17010576

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A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

Cited by 1,771 publications

References 73 publications

The Acceptability of Physical Activity to Older Adults Living in Lower Socioeconomic Status Areas: A Multi-Perspective Study

The Acceptability of Physical Activity to Older Adults Living in Lower Socioeconomic Status Areas: A Multi-Perspective Study

Process Evaluation of Internet-Based Cognitive Behavioral Therapy Intervention for Informal Caregivers

Effects of a Narrative-Based Psychoeducational Intervention to Prepare Patients for Responding to Acute Myocardial Infarction

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