Trial lay summaries were not fit for purpose.

BACKGROUND AND OBJECTIVES: To establish if trial lay summaries are suitable for lay readers. METHODS: A random sample of 60 randomized controlled trial (RCT) reports (15%) from the National Institute for Health and Care Research (NIHR) Journals Library, UK, were selected from 407 available ones. We extracted the lay summary and determined the readability using the previously validated Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Simplified Measure of Gobbledegook (SMOG), Gunning Fog (GF), Coleman-Liau Index (CLI), and Automated Readability Index (ARI) readability scales. This provided us with a reading age. We also assessed the compatibility of the lay summaries with the Plain English UK Guidelines and the National Adult Literacy Agency Guidelines, Ireland. RESULTS: No lay summary met the recommended reading age for health care information of 11-12 years. None of them were considered "easy" to read, in fact over 85% were considered "difficult" to read. CONCLUSION: The lay summary is a key document for disseminating trial results to a broad population who may not necessarily have the medical or technical jargon to read a trial report. Its importance cannot be overstated. Assessing readability in conjunction with plain language guidelines is relatively easy and therefore an immediate change to practice is feasible. However, since specific skills are required to write lay summaries that meet the required standards, it is important that the need for such expertise is recognized and supported by research funders.

Measurement of pregnancy-related anxiety worldwide: a systematic review.

BACKGROUND: The perinatal period is often characterized by specific fear, worry, and anxiety concerning the pregnancy and its outcomes, referred to as pregnancy-related anxiety. Pregnancy-related anxiety is uniquely associated with negative maternal and child health outcomes during pregnancy, at birth, and early childhood; as such, it is increasingly studied. We examined how pregnancy-related anxiety is measured, where measures were developed and validated, and where pregnancy-related anxiety has been assessed. We will use these factors to identify potential issues in measurement of pregnancy-related anxiety and the geographic gaps in this area of research. METHODS: We searched the Africa-Wide, CINAHL, MEDLINE, PsycARTICLES, PsycINFO; PubMed, Scopus, Web of Science Core Collection, SciELO Citation Index, and ERIC databases for studies published at any point up to 01 August 2020 that assessed pregnancy-related anxiety. Search terms included pregnancy-related anxiety, pregnancy-related worry, prenatal anxiety, anxiety during pregnancy, and pregnancy-specific anxiety, among others. Inclusion criteria included: empirical research, published in English, and the inclusion of any assessment of pregnancy-related anxiety in a sample of pregnant women. This review is registered on PROSPERO (CRD42020189938). RESULTS: The search identified 2904 records; after screening, we retained 352 full-text articles for consideration, ultimately including 269 studies in the review based on the inclusion and exclusion criteria. In total, 39 measures of pregnancy-related anxiety were used in these 269 papers, with 18 used in two or more studies. Less than 20% of the included studies (n = 44) reported research conducted in low- and middle-income country contexts. With one exception, all measures of pregnancy-related anxiety used in more than one study were developed in high-income country contexts. Only 13.8% validated the measures for use with a low- or middle-income country population. CONCLUSIONS: Together, these results suggest that pregnancy-related anxiety is being assessed frequently among pregnant people and in many countries, but often using tools that were developed in a context dissimilar to the participants' context and which have not been validated for the target population. Culturally relevant measures of pregnancy-related anxiety which are developed and validated in low-income countries are urgently needed.