The “trial within cohort design” was a pragmatic model for low-resourced settings

Heine, Martin; Derman, Wayne; Hanekom, Susan

doi:10.1016/j.jclinepi.2022.03.010

Cited by 3 publications

(5 citation statements)

References 27 publications

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“…A pragmatic cohort design incorporating a benchmarking comparison derived from previously published RCT results was used [ 19 , 20 , 27 ]. Demographic information and outcome measures were collected at the beginning (Time 1) and end (Time 2) of the Being a Parent parenting course, acceptability data were collected at Time 2.…”

Section: Methodsmentioning

confidence: 99%

Impact of a peer-led, community-based parenting programme delivered at a national scale: an uncontrolled cohort design with benchmarking

Day

Harwood²,

Kendall

et al. 2022

BMC Public Health

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Background Childhood behavioural problems are the most common mental health disorder worldwide and represent a major public health concern, particularly in socially disadvantaged communities. Treatment barriers mean that up to 70% of children do not receive recommended parenting interventions. Innovative approaches, including evidence-based peer-led models, such as Empowering Parents Empowering Communities’ (EPEC) Being a Parent (BAP) programme, have the potential to reduce childhood difficulties and improve parenting if replicable and successfully delivered at scale. Method This real-world quasi-experimental study, with embedded RCT benchmarking, examined the population reach, attendance, acceptability and outcomes of 128 BAP groups (n = 930 parents) delivered by 15 newly established sites participating in a UK EPEC scaling programme. Results Scaling programme (SP) sites successfully reached parents living in areas of greater social deprivation (n = 476, 75.3%), experiencing significant disadvantage (45.0% left school by 16; 39.9% lived in rental accommodation; 36.9% lone parents). The only benchmarked demographic difference was ethnicity, reflecting the greater proportion of White British parents living in scaling site areas (SP 67.9%; RCT 22.4%). Benchmark comparisons showed scaling sites’ parent group leaders achieved similar levels of satisfaction. Scaling site parent participants reported substantial levels of improvement in child concerns (ES 0.6), parenting (ES 0.9), parenting goals (ES 1.2) and parent wellbeing (ES 0.6) that were of similar magnitude to RCT benchmarked results. Though large, parents reported lower levels of parenting knowledge and confidence acquisition compared with the RCT benchmark. Conclusion Despite common methodological limitations associated with real-world scaling evaluations, findings suggest that this peer-led, community-based, parenting approach may be capable of successful replication at scale and may have considerable potential to improve child and parenting difficulties, particularly for socially disadvantaged populations.

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Section: Methodsmentioning

confidence: 99%

Impact of a peer-led, community-based parenting programme delivered at a national scale: an uncontrolled cohort design with benchmarking

Day

Harwood²,

Kendall

et al. 2022

BMC Public Health

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“…Patients offered the program could make an informed decision to participate (similar to decision making within routine clinical practice). (17)…”

Section: Methodsmentioning

confidence: 99%

“…The second data source comprised our own experiences in conducting a feasibility randomized clinical trial of a patient-centred rehabilitation program for patients with non-communicable disease (n=74) living in a South African low-resource setting. (16)(17)(18) For this primary research, ethical approval was obtained from the Stellenbosch University Health…”

Section: Primary Research (Source 2)mentioning

confidence: 99%

Towards a framework for the scale-up of rehabilitation for patients with non-communicable disease in low-resource settings

Heine

Derman

Hanekom

2022

Preprint

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Objective To explore and synthesize critical factors for the scale-up of comprehensive rehabilitation care for people with non-communicable disease in low-resourced settings. Methods A core set of 81 articles were selected from two published scoping reviews. Using the principles of thematic analysis, the core set was analysed for factors that may directly or indirectly affect the feasibility or scale-up of rehabilitation. Categories and themes were formulated via an iterative team approach using the core set (n=81). Subsequently, we triangulated the thematic analysis against our findings from a feasibility study conducted in a low-resourced, urban, setting in South Africa. Next, a validation article set (n=63) was identified by updating the searches for the respective published reviews, and a purposeful sample of articles drawn from the validation set (n=13; 20%) was used to validate the factors identified in the primary analysis based on the principles of data saturation. Findings A total of 40 different themes (i.e., critical factors) were derived from 169 categories. Subsequently the identified factors could be packaged into nine system elements principal for the scale-up of rehabilitation for people with NCDs in terms of increasing population coverage, increasing comprehensiveness, and integration within existing health structures. Conclusion A multitude of factors which affect the feasibility and scale-up of rehabilitation for NCDs in low resource settings were identified. These factors are multi-dimensional and multi-directional. Researchers and policy makers should consider these factors and their interconnectedness when planning to address the rehabilitation needs through implementation and scale-up initiatives

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“…147 (2022): 111-121. [1] M. Heine, W. Derman, S. Hanekom, Towards a framework for the scale-up of rehabilitation for patients with non-communicable disease in low-resource settings, medRxiv 2022.08.03.22278360. [2] B.…”

Section: Specifications Tablementioning

confidence: 99%

“…Patients were recruited from a community-based, public-sector, primary care facility within the Cape Flats region of Cape Town, South Africa. The adapted flowchart, published elsewhere [1] , outlines the flow of participants through the study, adapted for the “trial within cohort” design adopted [1 , 6 , 7] , and in line with CONSORT recommendations [8] . Data on study uptake, exclusion rate, inclusion rate, intervention uptake, retention at follow-up, and adherence to intervention components can be drawn from this flowchart.…”

Section: Data Descriptionmentioning

confidence: 99%

Data on the clinical, functional, and patient-reported outcomes of patient-centred rehabilitation for patients with non-communicable disease living in low-resourced settings

et al. 2022

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The “trial within cohort design” was a pragmatic model for low-resourced settings

Cited by 3 publications

References 27 publications

Impact of a peer-led, community-based parenting programme delivered at a national scale: an uncontrolled cohort design with benchmarking

Impact of a peer-led, community-based parenting programme delivered at a national scale: an uncontrolled cohort design with benchmarking

Towards a framework for the scale-up of rehabilitation for patients with non-communicable disease in low-resource settings

Data on the clinical, functional, and patient-reported outcomes of patient-centred rehabilitation for patients with non-communicable disease living in low-resourced settings

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