Intention to treat and per protocol analysis in clinical trials

Tripepi, Giovanni; Chesnaye, Nicholas C.; Dekker, Friedo W.; Zoccali, Carmine; Jager, Kitty J.

doi:10.1111/nep.13709

Cited by 142 publications

(112 citation statements)

References 11 publications

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“…“as-treated” analysis). This approach, which is “hypothesis generating” and associated with a post hoc analysis, has been already used in previous studies [ 15 ] and allow to investigate the effects of receiving the assigned treatment, as specified in the protocol, on patients’ outcome [ 16 ]. We excluded patients with missing information on primary outcome.…”

Section: Methodsmentioning

confidence: 99%

Effect of intra-arrest trans-nasal evaporative cooling in out-of-hospital cardiac arrest: a pooled individual participant data analysis

et al. 2021

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Background Randomized trials have shown that trans-nasal evaporative cooling initiated during CPR (i.e. intra-arrest) effectively lower core body temperature in out-of-hospital cardiac arrest patients. However, these trials may have been underpowered to detect significant differences in neurologic outcome, especially in patients with initial shockable rhythm. Methods We conducted a post hoc pooled analysis of individual data from two randomized trials including 851 patients who eventually received the allocated intervention and with available outcome (“as-treated” analysis). Primary outcome was survival with favourable neurological outcome at hospital discharge (Cerebral Performance Category [CPC] of 1–2) according to the initial rhythm (shockable vs. non-shockable). Secondary outcomes included complete neurological recovery (CPC 1) at hospital discharge. Results Among the 325 patients with initial shockable rhythms, favourable neurological outcome was observed in 54/158 (34.2%) patients in the intervention and 40/167 (24.0%) in the control group (RR 1.43 [confidence intervals, CIs 1.01–2.02]). Complete neurological recovery was observed in 40/158 (25.3%) in the intervention and 27/167 (16.2%) in the control group (RR 1.57 [CIs 1.01–2.42]). Among the 526 patients with initial non-shockable rhythms, favourable neurological outcome was in 10/259 (3.8%) in the intervention and 13/267 (4.9%) in the control group (RR 0.88 [CIs 0.52–1.29]; p = 0.67); survival and complete neurological recovery were also similar between groups. No significant benefit was observed for the intervention in the entire population. Conclusions In this pooled analysis of individual data, intra-arrest cooling was associated with a significant increase in favourable neurological outcome in out-of-hospital cardiac arrest patients with initial shockable rhythms. Future studies are needed to confirm the potential benefits of this intervention in this subgroup of patients.

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Section: Methodsmentioning

confidence: 99%

Effect of intra-arrest trans-nasal evaporative cooling in out-of-hospital cardiac arrest: a pooled individual participant data analysis

et al. 2021

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“…The outcome represents the ratio between the geometric means of the intervention period as compared to the control period. The same statistical procedure was applied when analyzing the data according to the per-protocol approach, in order to investigate the effect of the intervention excluding sales data for the healthier snacks from ten days on which the intervention was not executed correctly [49]. Statistical analyses were performed using the statistical software package IBM SPSS Statistics for Windows, version 25.0.…”

Section: Statistical Analysesmentioning

confidence: 99%

Can Healthy Checkout Counters Improve Food Purchases? Two Real-Life Experiments in Dutch Supermarkets

Huitink

Poelman

Seidell

et al. 2020

IJERPH

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Most snacks displayed at supermarket checkouts do not contribute to a healthy diet. We investigated the effects of introducing healthier snack alternatives at checkouts in supermarkets on purchasing behavior. In Study 1, we investigated the effect of completely substituting less healthy with healthier snacks (one supermarket). In Study 2, we investigated the effect of placing and discounting healthier snacks while the less healthy snacks remain in place (two supermarkets). In both studies, the number of purchased snacks (per 1000 customers) was used as the outcome variable. Results for Study 1 showed that the absolute number of purchased checkout snacks was 2.4 times lower (95% confidence interval (CI): 1.9–2.7) when healthier snacks instead of less healthy snacks were placed at the supermarket checkouts. Results for Study 2 showed that when additional healthier snacks were placed near the checkouts, the absolute number of healthier purchased snacks increased by a factor of 2.1 (95% CI: 1.3–3.3). When additional healthier snacks were placed near the checkouts and discounted, the absolute number of healthier purchased snacks increased by a factor of 2.7 (95% CI: 2.0–3.6), although this was not statistically significant higher than placement only (ratio: 1.1, 95% CI: 0.7–1.9). Purchases of less healthy snacks did not decline, and even slightly increased, during the intervention period (ratio: 1.3, 95% CI: 1.1–1.5). If supermarkets want to promote healthier snack purchases, additional healthier products can be positioned near the checkouts. However, this does not discourages the purchase of less healthy snacks. Therefore, to discourage unhealthy snack purchases at supermarket checkouts, a total substitution of less healthy snacks with healthier alternatives is most effective.

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“…It is important to note that the intention-to-treat analysis might suggest that an intervention does not affect, while in reality the intervention can be effective in participants who fully adhered to the study protocol (Tripepi et al, 2020). While the intention-to-treat analysis maintains comparability of participants in the different groups generated from the original random treatment allocation, in the per-protocol analysis it is not possible to distinguish whether the intervention effect is due solely to adherence or due to the characteristics of compliant participants (Tripepi et al, 2020). Then, the treatmenton-the-treated analysis includes the per-protocol population, which is defined as a subset of the intention-to-treat population who completed the study without any major protocol violations (Gupta, 2011).…”

Section: Discussionmentioning

confidence: 99%

“…Then, the treatmenton-the-treated analysis includes the per-protocol population, which is defined as a subset of the intention-to-treat population who completed the study without any major protocol violations (Gupta, 2011). In this case, it is recommended a complementary method can be used to investigate the effect of the intervention on those participants who completed the trial (Tripepi et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

A Personalized Remote Video-Feedback Universal Parenting Program: A Randomized Controlled Trial

Linhares

Altafim

Gaspardo

et al. 2021

Psychosocial Intervention

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The randomized controlled trial examined the efficacy of a personalized remote video feedback parenting program to improve parenting and child behavior outcomes. Ninety-two mothers of 2-6-year-old children were randomly allocated into the intervention group (n = 50) and waiting-list control group (n = 42). The Strengthening Bonds preventive program was performed to improve positive parenting. The mothers participated in one in-person group session. During six weeks, the mothers received, via smartphone, remote personalized video feedback about their mother-child interactions in a play situation. Parenting was the primary outcome, and child behavior was the secondary one. Pre-and post-intervention assessments were performed. The generalized estimating equation analysis showed no significant results in the intentionto-treat (ITT). In the treatment-on-the-treated (TOT), there were statistically significant effects of the intervention decreasing mothers' coercive parenting practices and child behavior problems. The structural equation model analysis showed that the intervention-induced reductions in children's behavior problems were mediated by improvements in coercive practices. There was a direct effect of the intervention to improve the parental sense of competence. Despite the null findings in the ITT analysis, the TOT analysis showed promising results to strengthen positive parenting behaviors and beliefs and reduce child behavior problems.

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Intention to treat and per protocol analysis in clinical trials

Cited by 142 publications

References 11 publications

Effect of intra-arrest trans-nasal evaporative cooling in out-of-hospital cardiac arrest: a pooled individual participant data analysis

Effect of intra-arrest trans-nasal evaporative cooling in out-of-hospital cardiac arrest: a pooled individual participant data analysis

Can Healthy Checkout Counters Improve Food Purchases? Two Real-Life Experiments in Dutch Supermarkets

A Personalized Remote Video-Feedback Universal Parenting Program: A Randomized Controlled Trial

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