Which design to evaluate complex interventions? Toward a methodological framework through a systematic review

Minary, Lætitia; Trompette, Justine; Kivits, Joëlle; Cambon, Linda; Tarquinio, Cyril; Alla, François

doi:10.1186/s12874-019-0736-6

Cited by 104 publications

(104 citation statements)

References 43 publications

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“…Further, there was no true control group, as it is was unethical to provide 'nothing' to women. In future studies, it is important to consider the most appropriate designs for testing complex interventions like iCAN [80], and to consider the potential influence of baseline measures on outcomes. The incorporation of process-oriented data from women in this trial via exit surveys, along with the subgroup analysis, resulted in important insights that would not be possible if the focus had been on measuring primary and secondary outcomes alone.…”

Section: Limitationsmentioning

confidence: 99%

Longitudinal impacts of an online safety and health intervention for women experiencing intimate partner violence: randomized controlled trial

et al. 2020

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Background: Responding to intimate partner violence (IPV) and its consequences is made complex by women's diverse needs, priorities and contexts. Tailored online IPV interventions that account for differences among women have potential to reduce barriers to support and improve key outcomes. Methods: Double blind randomized controlled trial of 462 Canadian adult women who experienced recent IPV randomly were assigned to receive either a tailored, interactive online safety and health intervention (iCAN Plan 4 Safety) or a static, non-tailored version of this tool. Primary (depressive symptoms, PTSD symptoms) and secondary (helpfulness of safety actions, confidence in safety planning, mastery, social support, experiences of coercive control, and decisional conflict) outcomes were measured at baseline and 3, 6, and 12 months later via online surveys. Generalized Estimating Equations were used to test for differences in outcomes by study arm. Differential effects of the tailored intervention for 4 strata of women were examined using effect sizes. Exit survey process evaluation data were analyzed using descriptive statistics, t-tests and conventional content analysis. Results: Women in both tailored and non-tailored groups improved over time on primary outcomes of depression (p < .001) and PTSD (p < .001) and on all secondary outcomes. Changes over time did not differ by study arm. Women in both groups reported high levels of benefit, safety and accessibility of the online interventions, with low risk of harm, although those completing the tailored intervention were more positive about fit and helpfulness. Importantly, the tailored intervention had greater positive effects for 4 groups of women, those: with children under 18 living at home; reporting more severe violence; living in medium-sized and large urban centers; and not living with a partner. Conclusion: This trial extends evidence about the effectiveness of online safety and health interventions for women experiencing IPV to Canadian women and provides a contextualized understanding about intervention processes and effects useful for future refinement and scale up. The differential effects of the tailored intervention found for specific subgroups support the importance of attending to diverse contexts and needs. iCAN is a promising intervention that can complement resources available to Canadian women experiencing IPV. Trial registration: Clinicaltrials.gov ID NCT02258841 (Prospectively Registered on Oct 2, 2014).

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Section: Limitationsmentioning

confidence: 99%

Longitudinal impacts of an online safety and health intervention for women experiencing intimate partner violence: randomized controlled trial

et al. 2020

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“…Furthermore, study designs not adapted to the complexity of interventions are not appropriate for evaluation. Thus, alternative study designs like pragmatic RCTs, realist RCTS or natural experiments integrating process evaluations should be considered [43].…”

Section: Discussionmentioning

confidence: 99%

“…Since complex interventions are frequently not evaluated by means of conventional methodological approaches (e.g. randomised controlled trials [43]), we opened our inclusion criteria for all studies implementing an intervention and testing it with quantitative methods.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

A systematic review of interventions to improve acute hospital care for people with dementia

Karrer

Schnelli

Zeller

et al. 2020

Preprint

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Background: People with dementia are confronted with negative consequences due to hospital stays. When developing new interventions to improve care for people with dementia in acute care hospitals (by intervention we understand organisational strategies, programmes, and/or treatments and actions performed by healthcare professionals), it is crucial to have a comprehensive overview of previous interventions tested in this field and to know the outcomes.Methods: We conducted a systematic review to provide an overview of interventions targeting the care situation of patients with dementia in acute care hospitals. We included trials with interventional study designs and systematic reviews without restrictions regarding the outcomes. We searched five electronic databases, conducted a hand search of journals and performed forward and backward citation tracking of included studies. For risk of bias assessment, we used the Cochrane Collaboration’s tool for assessing risk of bias in randomised trials, ROBANS (for non-randomised controlled trials) and AMSTAR (for systematic reviews). We provide tabular and narrative summaries of the findings. Results: Twenty studies met the inclusion criteria. The findings indicated a broad range of interventions and outcomes. We categorised the interventions into eight intervention types: educational programmes, special non-pharmacological interventions, delirium management programmes, inpatient rehabilitation interventions, family-/person-centred programmes, use of specially trained nurses, volunteer programmes and special care units. Staff outcomes were investigated in most of the studies, followed by patient outcomes. Outcomes concerning relatives were reported in four studies. Educational programmes were the most commonly reported intervention type and resulted in improved staff outcomes. Family-/person-centred care programmes, use of specially trained nurses and delirium management programmes were effective in improving patient-related outcomes, e.g. delirium severity and functional performance. Rehabilitation interventions after hip fractures and special care units for people with dementia hardly showed any significant effects. Conclusions: Although the included interventional studies reported improved outcomes concerning patients, relatives and staff, the evidence is insufficient to declare which interventions are effective in improving care for people with dementia in acute care hospitals. Future research should focus on relevant patient and family caregiver outcomes. Thereby, it is necessary to consider the complexity of the interventions. Interventions addressing relatives, interprofessional collaboration and the entire practice culture are needed. Trial registration: PROSPERO: CRD42018111032.

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“…We performed a review [21] of peer-reviewed scientific articles evaluating complex interventions in the field of health. The quantitative part of this review has already been published [15]. This article presents the qualitative part of this review.…”

Section: Methodsmentioning

confidence: 99%

“…Here we focus on evaluation. We recently published a review of the principal methods used to evaluate complex interventions [15]. We found that several methods are used successively or together at various stages of evaluation.…”

Section: Introductionmentioning

confidence: 99%

Dimensions of the Complexity of Health Interventions: What Are We Talking about? A Review

Trompette

Kivits

Minary

et al. 2020

IJERPH

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Many recommendations and innovative approaches are available for the development and evaluation of complex health interventions. We investigated the dimensions of complexity described in health research and how these descriptions may affect the adopted research methodology (e.g., the choice of designs and methods). We used a mixed method approach to review the scientific literature evaluating complex interventions in the health field. Of 438 articles identified, 179 were subjected to descriptive analysis and 48 to content analysis. The three principal dimensions of complexity were: stakeholder characteristics, intervention multimodality and context. Recognition of such dimensions influenced the methodological choices made during evaluation of the interventions with their use of designs and methods, which aimed to address the complexity. We analysed not only how researchers view complexity but also the effects of such views on researcher practices. Our results highlight the need for clarification of what complexity means and to consider complexity when deciding how to evaluate research interventions.

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Which design to evaluate complex interventions? Toward a methodological framework through a systematic review

Cited by 104 publications

References 43 publications

Longitudinal impacts of an online safety and health intervention for women experiencing intimate partner violence: randomized controlled trial

Longitudinal impacts of an online safety and health intervention for women experiencing intimate partner violence: randomized controlled trial

A systematic review of interventions to improve acute hospital care for people with dementia

Dimensions of the Complexity of Health Interventions: What Are We Talking about? A Review

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