Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry. A broad spectrum of studies use real-world data (RWD) to produce RWE, ranging from randomized trials with outcomes assessed using RWD to fully observational studies. Yet, many proposals for generating RWE lack sufficient detail, and many analyses of RWD suffer from implausible assumptions, other methodological flaws, or inappropriate interpretations. The Causal Roadmap is an explicit, itemized, iterative process that guides investigators to prespecify study design and analysis plans; it addresses a wide range of guidance within a single framework. By supporting the transparent evaluation of causal assumptions and facilitating objective comparisons of design and analysis choices based on prespecified criteria, the Roadmap can help investigators to evaluate the quality of evidence that a given study is likely to produce, specify a study to generate high-quality RWE, and communicate effectively with regulatory agencies and other stakeholders. This paper aims to disseminate and extend the Causal Roadmap framework for use by clinical and translational researchers; three companion papers demonstrate applications of the Causal Roadmap for specific use cases.

The putative host galaxy of FRB 20171020A was first identified as ESO 601-G036 in 2018, but as no repeat bursts have been detected, direct confirmation of the host remains elusive. In light of recent developments in the field, we re-examine this host and determine a new association confidence level of 98%. At 37 Mpc, this makes ESO 601-G036 the third closest FRB host galaxy to be identified to date and the closest to host an apparently non-repeating FRB (with an estimated repetition rate limit of $<$$0.011$ bursts per day above $10^{39}$ erg). Due to its close distance, we are able to perform detailed multi-wavelength analysis on the ESO 601-G036 system. Follow-up observations confirm ESO 601-G036 to be a typical star-forming galaxy with H i and stellar masses of $\log_{10}\!(M_{\rm{H\,{\small I}}} / M_\odot) \sim 9.2$ and $\log_{10}\!(M_\star / M_\odot) = 8.64^{+0.03}_{-0.15}$, and a star formation rate of $\text{SFR} = 0.09 \pm 0.01\,{\rm M}_\odot\,\text{yr}^{-1}$. We detect, for the first time, a diffuse gaseous tail ($\log_{10}\!(M_{\rm{H\,{\small I}}} / M_\odot) \sim 8.3$) extending to the south-west that suggests recent interactions, likely with the confirmed nearby companion ESO 601-G037. ESO 601-G037 is a stellar shred located to the south of ESO 601-G036 that has an arc-like morphology, is about an order of magnitude less massive, and has a lower gas metallicity that is indicative of a younger stellar population. The properties of the ESO 601-G036 system indicate an ongoing minor merger event, which is affecting the overall gaseous component of the system and the stars within ESO 601-G037. Such activity is consistent with current FRB progenitor models involving magnetars and the signs of recent interactions in other nearby FRB host galaxies.

The Variables and Slow Transients Survey (VAST) on the Australian Square Kilometre Array Pathfinder (ASKAP) is designed to detect highly variable and transient radio sources on timescales from 5 s to $\sim\!5$ yr. In this paper, we present the survey description, observation strategy and initial results from the VAST Phase I Pilot Survey. This pilot survey consists of $\sim\!162$ h of observations conducted at a central frequency of 888 MHz between 2019 August and 2020 August, with a typical rms sensitivity of $0.24\ \mathrm{mJy\ beam}^{-1}$ and angular resolution of $12-20$ arcseconds. There are 113 fields, each of which was observed for 12 min integration time, with between 5 and 13 repeats, with cadences between 1 day and 8 months. The total area of the pilot survey footprint is 5 131 square degrees, covering six distinct regions of the sky. An initial search of two of these regions, totalling 1 646 square degrees, revealed 28 highly variable and/or transient sources. Seven of these are known pulsars, including the millisecond pulsar J2039–5617. Another seven are stars, four of which have no previously reported radio detection (SCR J0533–4257, LEHPM 2-783, UCAC3 89–412162 and 2MASS J22414436–6119311). Of the remaining 14 sources, two are active galactic nuclei, six are associated with galaxies and the other six have no multi-wavelength counterparts and are yet to be identified.

Objectives: The aim of this study was to evaluate the impact of computer-assisted “drill-and-strategy” cognitive remediation (CR) for community-dwelling individuals with schizophrenia on cognition, everyday self-efficacy, and independent living skills. Methods: Fifty-six people with schizophrenia or schizoaffective disorder were randomized into CR or computer game (CG) playing (control), and offered twenty 1-hr individual sessions in a group setting over 10 weeks. Measures of cognition, psychopathology, self-efficacy, quality of life, and independent living skills were conducted at baseline, end-group and 3 months following intervention completion. Results: Forty-three participants completed at least 10 sessions and the end-group assessment. Linear mixed-effect analyses among completers demonstrated a significant interaction effect for global cognition favoring CR (p=.028). CR-related cognitive improvement was sustained at 3-months follow-up. At end-group, 17 (77%) CR completers showed a reliable improvement in at least one cognitive domain. A significant time effect was evident for self-efficacy (p=.028) with both groups improving over time, but no significant interaction effect was observed. No significant effects were found for other study outcomes, including the functional measure. Conclusions: Computer-assisted drill-and-strategy CR in schizophrenia improved cognitive test performance, while participation in both CR and CG playing promoted enhancements in everyday self-efficacy. Changes in independent living skills did not appear to result from CR, however. Adjunctive psychosocial rehabilitation is likely necessary for improvements in real-world community functioning to be achieved. (JINS, 2018, 24, 549–562)