Hybrid experimental design: A suitable design to tackle contamination of control groups

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Acuña Mora, Mariela,1990Gothenburg University,Göteborgs universitet,Institutionen för vårdvetenskap och hälsa,Institute of Health and Care Sciences (author)

Hybrid experimental design: A suitable design to tackle contamination of control groups

Article/chapterEnglish2016

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2016

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LIBRIS-ID:oai:gup.ub.gu.se/238199
https://gup.ub.gu.se/publication/238199URI

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Language:English

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SwePubSwePub

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Subject category:ref swepub-contenttype
Subject category:kon swepub-publicationtype

Notes

Background: Randomized controlled trials (RCTs) are considered to be the “gold standard” to assess the effectiveness of interventions. Because nursing interventions are most likely complex, multicomponent interventions, RCTs are often not suitable due to the risk of contamination of the control group. Such contamination can lead to a lower point estimate of the intervention’s effect and to underestimate the difference between both groups. Objective: To describe an innovative study design aiming to verify the contamination in the control group when testing the effectiveness of a person-centered transition program for adolescents with congenital heart disease (ConHD). Design: A hybrid experimental design is developed, in which a longitudinal, observational study is embedded in a RCT, resulting in a 3-arms design. The study will be conducted in 4 ConHD-centers in Sweden. Two centers will perform the RCT, by randomly assigning patients to either the experimental group (60 patients) or the comparison group (60 patients). This latter group may be subject of contamination. Two other centers are “intervention-naïve” and therefore comprise a contamination-free control group (120 patients). The occurrence of contamination will be investigated by comparing the comparison group and control group. Participants and setting: Participants are literate, Swedish-speaking adolescents with ConHD, aged 16 years and their parents. Discussion: This hybrid experimental design will give us the opportunity to investigate potential contamination of the comparison group, by studying differences with the control group from intervention-naïve centers. If this design is successful, it can be employed in the evaluation of complex nursing interventions.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Hälsovetenskap hsv//swe
MEDICAL AND HEALTH SCIENCES Health Sciences hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Hälsovetenskap Omvårdnad hsv//swe
MEDICAL AND HEALTH SCIENCES Health Sciences Nursing hsv//eng
study design
randomized controlled trial
transition to adult care

Added entries (persons, corporate bodies, meetings, titles ...)

Sparud Lundin, Carina,1964Gothenburg University,Göteborgs universitet,Institutionen för vårdvetenskap och hälsa,Institute of Health and Care Sciences(Swepub:gu)xspaca (author)
Bratt, Ewa-Lena,1970Gothenburg University,Göteborgs universitet,Institutionen för vårdvetenskap och hälsa,Institute of Health and Care Sciences(Swepub:gu)xbraew (author)
Moons, Philip,1968 (author)
Göteborgs universitetInstitutionen för vårdvetenskap och hälsa (creator_code:org_t)

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In:Nordic Conference in Nursing Research: Methods and Networks for the Future, June 15-17, Stockholm

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Health Sciences

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