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A method to visualize a complete sensitivity analysis for loss to follow-up in clinical trials.

ABSTRACT: Loss to follow-up occurs in randomized controlled trials. Missing data methods, including multiple imputation (MI), can be used but often rely upon untestable assumptions. Sensitivity analysis can quantify violations of these assumptions. Since an adequate sensitivity analysis requires evaluation of multiple scenarios, presenting this information in an easily interpretable manner is challenging. We propose to graphically represent a thorough sensitivity analysis displaying all possible outcomes for loss to follow-up in randomized controlled trial data relating a completely observed binary exposure to a binary outcome. We describe plausible results under different missingness mechanisms using data from the EAGeR Trial (n = 1228) on low-dose aspirin versus placebo on pregnancy and live birth, in which 140 participants had early withdrawal. For the effect of aspirin on live birth, sensitivity analysis risk ratios (RR) for all potential outcome scenarios ranged from 0.88 to 1.34, applicable to any possible missingness mechanism. MI produced RR = 1.10; 95% confidence interval: (0.98, 1.22). RRs from individual imputations ranged from 1.04 to 1.16, the range of results that could have been observed if data were missing at random. Under this mechanism, the conclusions about the efficacy of low-dose aspirin could have been sensitive to the missing outcome data. Rather than limiting sensitivity analysis for loss to follow-up to a few scenarios that can be presented tabularly, results of a complete sensitivity analysis can be presented in a single plot, which should be implemented in all studies with missing outcome data to convey certainty or uncertainty, confidence or caution.

SUBMITTER: Schisterman EF

PROVIDER: S-EPMC7300145 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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A method to visualize a complete sensitivity analysis for loss to follow-up in clinical trials.

Schisterman Enrique F EF DeVilbiss Elizabeth A EA Perkins Neil J NJ

Contemporary clinical trials communications 20200609

Loss to follow-up occurs in randomized controlled trials. Missing data methods, including multiple imputation (MI), can be used but often rely upon untestable assumptions. Sensitivity analysis can quantify violations of these assumptions. Since an adequate sensitivity analysis requires evaluation of multiple scenarios, presenting this information in an easily interpretable manner is challenging. We propose to graphically represent a thorough sensitivity analysis displaying all possible outcomes ...[more]

PMID: 32577583

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Project description:IntroductionVaginismus is mostly unknown among clinicians and women. Vaginismus causes women to have fear, anxiety, and pain with penetration attempts.AimTo present a large cohort of patients based on prior published studies approved by an institutional review board and the Food and Drug Administration using a comprehensive multimodal vaginismus treatment program to treat the physical and psychologic manifestations of women with vaginismus and to record successes, failures, and untoward effects of this treatment approach.MethodsAssessment of vaginismus included a comprehensive pretreatment questionnaire, the Female Sexual Function Index (FSFI), and consultation. All patients signed a detailed informed consent. Treatment consisted of a multimodal approach including intravaginal injections of onabotulinumtoxinA (Botox) and bupivacaine, progressive dilation under conscious sedation, indwelling dilator, follow-up and support with office visits, phone calls, e-mails, dilation logs, and FSFI reports.Main outcome measuresLogs noting dilation progression, pain and anxiety scores, time to achieve intercourse, setbacks, and untoward effects. Post-treatment FSFI scores were compared with preprocedure scores.ResultsOne hundred seventy-one patients (71%) reported having pain-free intercourse at a mean of 5.1 weeks (median = 2.5). Six patients (2.5%) were unable to achieve intercourse within a 1-year period after treatment and 64 patients (26.6%) were lost to follow-up. The change in the overall FSFI score measured at baseline, 3 months, 6 months, and 1 year was statistically significant at the 0.05 level. Three patients developed mild temporary stress incontinence, two patients developed a short period of temporary blurred vision, and one patient developed temporary excessive vaginal dryness. All adverse events resolved by approximately 4 months. One patient required retreatment followed by successful coitus.ConclusionA multimodal program that treated the physical and psychologic aspects of vaginismus enabled women to achieve pain-free intercourse as noted by patient communications and serial female sexual function studies. Further studies are indicated to better understand the individual components of this multimodal treatment program. Pacik PT, Geletta S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med 2017;5:e114-e123.

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A method to visualize a complete sensitivity analysis for loss to follow-up in clinical trials.

Publications

A method to visualize a complete sensitivity analysis for loss to follow-up in clinical trials.

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