The development and use of a structured instrument for assessing the quality of complex interventions

Article type
Authors
Corry M1, Corry SB2, Neenan K1, Smith V1
1University of Dublin, TCD
2University of York
Abstract
Background: the quality of the complex interventions (including their design and delivery), tested in research studies, impacts on the outcomes and has implications for conclusions that can be drawn from individual studies and review findings.

Objectives: to provide an overview of the development and application of criteria used to assess the quality of interventions reported in studies included in a Cochrane Review on telephone interventions for informal caregivers of adults with diagnosed illnesses.

Intervention Quality Assessment Method: in addition to noting and recording reported quality descriptions or rating by the study authors, a quality-assessment instrument based on Section 5 of the data extraction form was devised and piloted. Section 5 of the data extraction form was designed to extract data on different aspects of intervention design, such as the framework used to develop the intervention, the stated aim/goal of the intervention, the match between intervention and stated goal, intensity of the intervention in terms of frequency of delivery/receipt (weekly, bi-weekly, two weekly, monthly) and duration (in months), fidelity to the intervention in terms of the extent to which it was delivered in a consistent manner, and in accordance with the intervention trial protocol. We evaluated the extent to which contamination was minimised and monitored, the selection and standardisation of training the interventionists, standardisation and monitoring the delivery and receipt of the intervention, and the ability of participants to use the skills. We devised a scoring system was devised which enabled the review authors to categorise the interventions as low, medium or high quality based on the extent to which it was developed and delivered in accordance with best practice guidelines. We piloted the quality-assessment instrument on one study prior to use in the review.

Two pairs of review authors independently evaluated the intervention against the criteria in the quality of the intervention assessment form. Disagreements were resolved by discussion to reach consensus.

Results: the use of the intervention quality assessment instrument enabled the review authors to factor the quality of the interventions when discussing the quality of evidence and the review’s overall conclusion. Of the interventions evaluated in 20 included studies, two only were rated as high, 16 as medium, and two as low quality.

Conclusions: using the quality of intervention tool in our review emphasised the value and need for reporting the development and delivery aspects of complex interventions in healthcare (CREDICI) when reporting on caregiver telephone interventions, which should be included in reporting guidelines.

Patient or healthcare consumer involvement: a caregiver representative provided comments at the protocol and review stage.