A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set.

BACKGROUND: Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. OBJECTIVE: To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. SEARCH STRATEGY: We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). SELECTION CRITERIA: Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse. DATA COLLECTION AND ANALYSIS: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated. MAIN RESULTS: Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%). CONCLUSIONS: Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness. PROSPERO: CRD42017062456.

A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set.

INTRODUCTION: We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality. METHODS: We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1-5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1-6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables. RESULTS: Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (ß = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (ß = 0.078; P = 0.306), year of publication (ß = 0.149; P = 0.295), study size (ß = 0.008; P = 0.961) and commercial funding (ß = -0.013; P = 0.918). CONCLUSIONS: Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues.

Fractionating nonword repetition: The contributions of short-term memory and oromotor praxis are different.

The ability to reproduce novel words is a sensitive marker of language impairment across a variety of developmental disorders. Nonword repetition tasks are thought to reflect phonological short-term memory skills. Yet, when children hear and then utter a word for the first time, they must transform a novel speech signal into a series of coordinated, precisely timed oral movements. Little is known about how children's oromotor speed, planning and co-ordination abilities might influence their ability to repeat novel nonwords, beyond the influence of higher-level cognitive and linguistic skills. In the present study, we tested 35 typically developing children between the ages of 5-8 years on measures of nonword repetition, digit span, memory for non-verbal sequences, reading fluency, oromotor praxis, and oral diadochokinesis. We found that oromotor praxis uniquely predicted nonword repetition ability in school-age children, and that the variance it accounted for was additional to that of digit span, memory for non-verbal sequences, articulatory rate (measured by oral diadochokinesis) as well as reading fluency. We conclude that the ability to compute and execute novel sensorimotor transformations affects the production of novel words. These results have important implications for understanding motor/language relations in neurodevelopmental disorders.

Williams syndrome: a surprising deficit in oromotor praxis in a population with proficient language production.

Williams Syndrome (WS) is a neurodevelopmental disorder of known genetic origin, characterized by serious delays in language onset yet relatively verbose, intelligible and fluent speech in late childhood and adulthood. How do motor abilities relate to language in this group? We investigated planning and co-ordination of the movement of the speech articulators (oromotor praxis) in 28 fluent-speaking individuals with WS, aged between 12 and 30 years. Results indicate that, despite their fluent language, oromotor praxis was impaired in WS relative to two groups of typically-developing children, matched on either vocabulary or visuospatial ability. These findings suggest that the ability to plan, co-ordinate and execute complex sensorimotor movements contribute to an explanation of the delay in expressive language early in development in this neurodevelopmental disorder. In the discussion, we turn to more general issues of how individual variation in oromotor praxis may account for differences in speech/language production abilities across developmental language disorders.