Intention-to-treat and per-protocol analysis

Shah, Pankaj B.

doi:10.1503/cmaj.111-2033

Cited by 77 publications

(60 citation statements)

References 1 publication

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This involves all participants once randomly allocated to avoid any bias. By contrast, using per‐protocol analysis, which compares only those members of treatment groups who complete their treatment, leads to bias . We report all planned outcomes in relation to both analyses to accurately interpret the effect of our intervention.…”

Section: Discussionmentioning

confidence: 99%

Retracted: Cervical mucus removal prior to intrauterine insemination: a randomized trial

Maher

Sayyed

Elkhouly

2017

BJOG

View full text Add to dashboard Cite

Objective To detect if removing the cervical mucus before performing intrauterine insemination (IUI) could improve pregnancy outcomes in patients with unexplained infertility.Design Prospective randomized study.Setting An Egyptian University Hospital.Population Seven hundred and fourteen couples with unexplained infertility who underwent intrauterine insemination (IUI) with or without cervical mucus removal.Methods Using computer-generated numbers, patients were randomly allocated to cervical-mucus-removal (removed from both internal and external os) or non-mucus-removal groups. Only participants were blinded as to group assignment.Main outcome measures The clinical pregnancy rate.Results Of 714 IUI patients between November 2014 and March 2017, 361 were in the mucus removal group, and 353 in the nonmucus-removal group. Difficult catheterization was encountered in 17 cases out of 666 (2.6%) 12 in the cervical-mucus-removal group and five in the non-mucus-removal group). A total of 666 IUI cycles were completed while 48 were either cancelled or lost in their follow-up. The clinical pregnancy rate was significantly higher in the mucus-removal group [31.0% (n = 112)] than in the non-mucus-removal group [21.8% (n = 77); P = 0.005]. Ovarian hyperstimulation developed in 33 (4.6%) cases: 18 cervical mucus-removal and 15 non-mucus-removal. All except one were mild and managed with outpatient care.Conclusions Cervical mucus removal before IUI could improve pregnancy outcomes in women with unexplained infertility.

show abstract

Section: Discussionmentioning

confidence: 99%

Retracted: Cervical mucus removal prior to intrauterine insemination: a randomized trial

Maher

Sayyed

Elkhouly

2017

BJOG

View full text Add to dashboard Cite

show abstract

“…This entailed a comparison of the intervention groups encompassing only those participants who completed the intervention as originally allocated. Taken on its own, this analysis leads to bias (Shah, ); therefore, for the purposes of our study, we restricted analyses to only those participants who adhered to the inclusion criteria, who participated in the FCS to which they were randomly assigned, and who did not deviate from the protocol (see Fisher et al., ).…”

Section: Methodsmentioning

confidence: 99%

Improving Experience in Personal Social Systems through Family Constellation Seminars: Results of a Randomized Controlled Trial

et al. 2013

View full text Add to dashboard Cite

This study examined the efficacy of family constellation seminars (FCSs) on individuals' experience in their personal social systems, especially the experience of belonging, autonomy, accord, and confidence. We conducted a single-blind, stratified and balanced, randomized controlled trial. Participants were 208 adults (M = 48 years, SD = 10, 79% women) who were randomly allocated either to the intervention group (3-day FCSs; 64 active participants, 40 observing participants) or to the wait-list group (64 active participants, 40 observing participants). Change was measured short-term (2-week and 4-month follow-up) using the Experience In Social Systems Questionnaire, personal domain (EXIS.pers). EXIS.pers is a new outcome measure being applied for the first time in evaluation research. In addition, we used interpersonal scales derived from established measures (Outcome Questionnaire, OQ-45; Tool for the Evaluation of the Psychotherapeutic Progress, FEP). The average person in the intervention group showed improved experience in personal social systems, as compared with approximately 73% of the wait-list group after 2 weeks (total score: Cohen's d = .61, p = .000) and 69% of the wait-list group after 4 months (total score: d = .53, p = .000). The results were confirmed in per-protocol analyses (n = 191) by the results of the EXIS.pers dimensions (Belonging, Autonomy, Accord, and Confidence) and the interpersonal scales derived from the OQ-45 and FEP. No adverse events were reported. This RCT provides first evidence that FCSs tend to positively influence participants' experience in their social systems.

show abstract

“…Contemplating the number of patients reported in the different analyses, none has the initial number of randomized patients and only those patients who completed the study protocol have been included in the analysis. These observations combined with the understandably high patient drop-out rate, and exhaustive data imputation are suggestive that the study may be categorized as per protocol analysis averse to its initial design as an intent-to-treat analysis (15).…”

Section: Commentarymentioning

confidence: 99%

The modest outcome of clinical trials with bone marrow cells for myocardial repair: is the autologous source of cells the prime culprit?

2016

View full text Add to dashboard Cite

Intention-to-treat and per-protocol analysis

Cited by 77 publications

References 1 publication

Retracted: Cervical mucus removal prior to intrauterine insemination: a randomized trial

Retracted: Cervical mucus removal prior to intrauterine insemination: a randomized trial

Improving Experience in Personal Social Systems through Family Constellation Seminars: Results of a Randomized Controlled Trial

The modest outcome of clinical trials with bone marrow cells for myocardial repair: is the autologous source of cells the prime culprit?

Contact Info

Product

Resources

About