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 2,634 publications

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References 73 publications

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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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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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“…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].…”

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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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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Frequency of Screening and Spontaneous Breathing Trial Techniques

Burns,

Wong,

Rizvi

et al. 2024

JAMA

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ImportanceThe optimal screening frequency and spontaneous breathing trial (SBT) technique to liberate adults from ventilators are unknown.ObjectiveTo compare the effects of screening frequency (once-daily screening vs more frequent screening) and SBT technique (pressure-supported SBT with a pressure support level that was &gt;0-≤8 cm H2O and a positive end-expiratory pressure [PEEP] level that was &gt;0-≤5 cm H2O vs T-piece SBT) on the time to successful extubation.Design, Setting, and ParticipantsRandomized clinical trial with a 2 × 2 factorial design including critically ill adults who were receiving invasive mechanical ventilation for at least 24 hours, who were capable of initiating spontaneous breaths or triggering ventilators, and who were receiving a fractional concentration of inspired oxygen that was 70% or less and a PEEP level of 12 cm H2O or less. Recruitment was between January 2018 and February 2022 at 23 intensive care units in North America; last follow-up occurred October 18, 2022.InterventionsParticipants were enrolled early to enable protocolized screening (more frequent vs once daily) to identify the earliest that patients met criteria to undergo pressure-supported or T-piece SBT lasting 30 to 120 minutes.Main Outcome and MeasuresTime to successful extubation (time when unsupported, spontaneous breathing began and was sustained for ≥48 hours after extubation).ResultsOf 797 patients (198 in the once-daily screening and pressure-supported SBT group, 204 in once-daily screening and T-piece SBT, 195 in more frequent screening and pressure-supported SBT, and 200 in more frequent screening and T-piece SBT), the mean age was 62.4 (SD, 18.4) years and 472 (59.2%) were men. There were no statistically significant differences by screening frequency (hazard ratio [HR], 0.88 [95% CI, 0.76-1.03]; P = .12) or by SBT technique (HR, 1.06 [95% CI, 0.91-1.23]; P = .45). The median time to successful extubation was 2.0 days (95% CI, 1.7-2.7) for once-daily screening and pressure-supported SBT, 3.1 days (95% CI, 2.7-4.8) for once-daily screening and T-piece SBT, 3.9 days (95% CI, 2.9-4.7) for more frequent screening and pressure-supported SBT, and 2.9 days (95% CI, 2.0-3.1) for more frequent screening and T-piece SBT. An unexpected interaction between screening frequency and SBT technique required pairwise contrasts that revealed more frequent screening (vs once-daily screening) and pressure-supported SBT increased the time to successful extubation (HR, 0.70 [95% CI, 0.50-0.96]; P = .02). Once-daily screening and pressure-supported SBT (vs T-piece SBT) did not reduce the time to successful extubation (HR, 1.30 [95% CI, 0.98-1.70]; P = .08).Conclusions and RelevanceAmong critically ill adults who received invasive mechanical ventilation for more than 24 hours, screening frequency (once-daily vs more frequent screening) and SBT technique (pressure-supported vs T-piece SBT) did not change the time to successful extubation. However, an unexpected and statistically significant interaction was identified; protocolized more frequent screening combined with pressure-supported SBTs increased the time to first successful extubation.Trial RegistrationClinicalTrials.gov Identifiers: NCT02399267 and NCT02969226

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

Cited by 2,634 publications

References 73 publications

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

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

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

Frequency of Screening and Spontaneous Breathing Trial Techniques

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