MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial.

OBJECTIVES: To evaluate the feasibility of a randomised trial of a modified, pre-existing, mindfulness meditation smartphone app for women with chronic pelvic pain. DESIGN: Three arm randomised feasibility trial. SETTING: Women were recruited at two gynaecology clinics in the UK. Interventions were delivered via smartphone or computer at a location of participants choosing. PARTICIPANTS: Women were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6 months or more, and had access to a computer or smartphone. 90 women were randomised. INTERVENTIONS: Daily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app. Interventions were delivered over 60 days. PRIMARY AND SECONDARY OUTCOME MEASURES: Outcomes included length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes measured at baseline, two, three and 6 months. RESULTS: The target sample size was recruited in 145 days. Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control). Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up. The 95% CIs for clinical outcomes were consistent with no benefit from the mindfulness meditation app; for example, mean differences in pain acceptance scores at 60 days (higher scores are better) were -2.3 (mindfulness meditation vs usual care, 95% CI: -6.6 to 2.0) and -4.0 (mindfulness meditation vs active control, 95% CI: -8.1 to 0.1). CONCLUSIONS: Despite high recruitment and adequate follow-up rates, demonstrating feasibility, the extremely low adherence suggests a definitive randomised trial of the mindfulness meditation app used in this study is not warranted. Future research should focus on improving patient engagement. TRIAL REGISTRATION NUMBERS: NCT02721108; ISRCTN10925965; Results

Short interpregnancy interval and pregnancy outcomes: How important is the timing of confounding variable ascertainment?

BACKGROUND: Estimation of causal effects of short interpregnancy interval on pregnancy outcomes may be confounded by time-varying factors. These confounders should be ascertained at or before delivery of the first ("index") pregnancy, but are often only measured at the subsequent pregnancy. OBJECTIVES: To quantify bias induced by adjusting for time-varying confounders ascertained at the subsequent (rather than the index) pregnancy in estimated effects of short interpregnancy interval on pregnancy outcomes. METHODS: We analysed linked records for births in British Columbia, Canada, 2004-2014, to women with ≥2 singleton pregnancies (n = 121 151). We used log binomial regression to compare short (<6, 6-11, 12-17 months) to 18-23-month reference intervals for 5 outcomes: perinatal mortality (stillbirth and neonatal death); small for gestational age (SGA) birth and preterm delivery (all, early, spontaneous). We calculated per cent differences between adjusted risk ratios (aRR) from two models with maternal age, low socio-economic status, body mass index, and smoking ascertained in the index pregnancy and the subsequent pregnancy. We considered relative per cent differences <5% minimal, 5%-9% modest, and ≥10% substantial. RESULTS: Adjustment for confounders measured at the subsequent pregnancy introduced modest bias towards the null for perinatal mortality aRRs for <6-month interpregnancy intervals [-9.7%, 95% confidence interval [CI] -15.3, -6.2). SGA aRRs were minimally biased towards the null (-1.1%, 95% CI -2.6, 0.8) for <6-month intervals. While early preterm delivery aRRs were substantially biased towards the null (-10.4%, 95% CI -14.0, -6.6) for <6-month interpregnancy intervals, bias was minimal for <6-month intervals for all preterm deliveries (-0.6%, 95% CI -2.0, 0.8) and spontaneous preterm deliveries (-1.3%, 95% CI -3.1, 0.1). For all outcomes, bias was attenuated and minimal for 6-11-month and 12-17-month interpregnancy intervals. CONCLUSION: These findings suggest that maternally linked pregnancy data may not be needed for appropriate confounder adjustment when studying the effects of short interpregnancy interval on pregnancy outcomes