How to select and understand guidelines for patient-reported outcomes: a scoping review of existing guidance.

BACKGROUND: Over the past few decades, patient-reported outcomes (PROs) have been used to understand patient health conditions better. Therefore, numerous PRO measures (questionnaires) and guidelines or guidance have been developed. However, it is challenging to select target guidance from among the many available guidance and to understand the chosen guidance. This study comprehensively collected the existing PRO guidance for clinical trials or studies and practices to support novice PRO users in academia, industry, clinical practice, and regulatory and reimbursement decision-making. METHODS: For the scoping review, we searched the MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf databases from 2009 to 2023. The eligibility criteria were PRO guidance for clinical trials, clinical practice, or application such as health technology assessment. Those guidance cover aspects such as quality of life (QOL), PRO, health-related QOL, health state utilities, psychometric requirements, implementation methods, analysis and interpretation, or clinical practice applications. After the systematic search, three researchers individually reviewed the collected data, and the reviewed articles and books were scrutinized using the same criteria. RESULTS: We collected the PRO guidance published in articles and books between 2009 and 2023. From the database searches, 1,455 articles and 387 books were identified, of which one book and 33 articles were finally selected. The collected PRO guidance was categorized into the adoption of PRO measures, design and reporting of trials or studies using PROs, implementation of PRO evaluation in clinical trials or studies or clinical practice, analysis and interpretation of PROs, and application of PRO evaluation. Based on this categorization, we suggest the following for novices: When selecting guidance, novices should clarify the "place" and "purpose" where the guidance will be used. Additionally, they should know that the terminology related to PRO and the scope and expectations of PROs vary by "places" and "purposes". CONCLUSIONS: From this scoping review of existing PRO guidance, we provided summaries and caveats to assist novices in selecting guidance that fits their purpose and understanding it.

Accuracy of rating scales for evaluating aphasic patients' psychological aspects and language function: A scoping review protocol.

Aphasia nearly affects half of all poststroke patients. Furthermore, aphasia affects all language functions, well-being, and quality of life of patients. Therefore, rehabilitation of patients with aphasia requires an accurate assessment of language function and psychological aspects. However, assessment scales for language function and psychological aspects of patients with aphasia are said to be inaccurate. In Japan, this sign is more prominent than in English-speaking countries. Therefore, we are putting together a scoping review of research articles published in English and Japanese to date, with the aim of summarizing the accuracy of rating scales for language function and psychological aspects of people with aphasia. The scoping review was intended to be a comprehensive examination of the accuracy of rating scales for people with aphasia. We will search the article databases PubMed, MEDLINE, Embase, PsycINFO, Web of Science, and the Medical Journal Web (Japan). The observational studies that describe the reliability and validity of the rating scales in adult aphasic after stroke will be searched for. There will be no publication date for the articles that will be searched. We believe that this scoping review aims to assess the accuracy of rating scales used to measure different aspects of aphasia, with a focus on research conducted in English-speaking countries and Japan. By conducting this review, we believe to identify any problems with rating scales used in English and Japanese research and improve their accuracy.

A clinical study of attention-deficit/hyperactivity disorder in preschool children--prevalence and differential diagnoses.

OBJECTIVE: We aimed to examine (1) the prevalence and characteristics of ADHD in preschool children, and (2) differential diagnoses among children who display symptoms of inattention and hyperactivity-impulsivity in early childhood. METHODS: The participants were children living in Kanie-cho, in Japan's Aichi Prefecture, who underwent their age 5 exams at the municipal health center between April 2009 and March 2011. We first extracted children who were observed to be inattentive or hyperactive-impulsive during their age 5 exams and considered as possibly having ADHD. We conducted follow-ups with these children using post-examination consultations, visits to preschools, and group rehabilitation. The results of the age 5 exams were combined with behavior observations and interview content obtained during subsequent follow-ups. A child psychiatrist and several clinical psychologists discussed these cases and made a diagnosis in accordance with the DSM-IV-TR. RESULTS: 91 (15.6%) of the 583 children selected were considered as possibly having ADHD; we were able to conduct follow-ups with 83 of the 91 children. Follow-up results showed that 34 children (5.8% of all participants) remained eligible for a diagnosis of ADHD. Diagnoses for the remaining children included: pervasive developmental disorders (six children, or 6.6% of suspected ADHD children), intellectual comprehension problems (four children, or 4.4%), anxiety disorders (seven children, or 7.7%), problems related to abuse or neglect (four children, or 4.4%), a suspended diagnosis for one child (1.1%), and unclear diagnoses for 29 children (31.9%). CONCLUSIONS: ADHD tendencies in preschool children vary with changing situations and development, and the present study provides prevalence estimates that should prove useful in establishing a diagnostic baseline.