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Clinical Question
Can a constipation action plan improve outcomes in children with functional constipation?
Bottom line
In this study, a constipation action plan was comparable with usual care in achieving the resolution of constipation in children with functional constipation. 2b
Reference
Study design: Randomized controlled trial (nonblinded)
Funding: Self-funded or unfunded
Setting: Outpatient (specialty)
Synopsis
As part of a real-world quality improvement project, this team of gastroenterologists recruited previously toilet-trained children at least 4 years old who had functional constipation. To entice parents to enroll their children, the researchers offered the free use of a defecation posture modification device (ie, a Squatty Potty). They randomized participants to receive usual care (n = 73) or usual care plus a constipation action plan (available for free download at https://wrnmmc.libguides.com/pediatrics/USAP; n = 57). The action plan, available in English and Spanish, is quite similar to asthma management plans and includes, among other things: tailored instructions; red, yellow, and green zone symptoms; and maintenance and rescue medication doses. After 4 months, the proportion of children whose constipation resolved was similar in the usual care group and in the action plan group (79% vs 82%, respectively). In other words, both were highly effective! Although none of the children had pediatric pediatric Bristol Stool Form Scale scores of 3 or 4 (formed, but not hard or dry) at baseline, 59% of children treated with usual care achieved this threshold by the end of the study compared with 77% of those receiving the action plan (number needed to treat = 6; 95% CI 3 - 50). Since this was an unmasked study and participants were randomized at the individual level and not the clinic level, it is possible that patients in the control group could have received the action plan. This would dilute the effect on the intervention group. A cluster randomized trial conducted in multiple clinics would be a stronger design.
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
Impact assessment
Excellent