Evidence for overdiagnosis in noncancer conditions was assessed: a metaepidemiological study using the 'Fair Umpire' framework.

OBJECTIVES: To evaluate the strength of the evidence for, and the extent of, overdiagnosis in noncancer conditions. STUDY DESIGN AND SETTING: We systematically searched for studies investigating overdiagnosis in noncancer conditions. Using the 'Fair Umpire' framework to assess the evidence that cases diagnosed by one diagnostic strategy but not by another may be overdiagnosed, two reviewers independently identified whether a Fair Umpire-a disease-specific clinical outcome, a test result or risk factor that can determine whether an additional case does or does not have disease-was present. Disease-specific clinical outcomes provide the strongest evidence for overdiagnosis, follow-up or concurrent tests provide weaker evidence, and risk factors provide only weak evidence. Studies without a Fair Umpire provide the weakest evidence of overdiagnosis. RESULTS: Of 132 studies, 47 (36%) did not include a Fair Umpire to adjudicate additional diagnoses. When present, the most common Umpire was a single test or risk factor (32% of studies), with disease-specific clinical outcome Umpires used in only 21% of studies. Estimates of overdiagnosis included 43-45% of screen-detected acute abdominal aneurysms, 54% of cases of acute kidney injury, and 77% of cases of oligohydramnios in pregnancy. CONCLUSION: Much of the current evidence for overdiagnosis in noncancer conditions is weak. Application of the framework can guide development of robust studies to detect and estimate overdiagnosis in noncancer conditions, ultimately informing evidence-based policies to reduce it.

Increased diagnosis of attention-deficit hyperactivity disorder despite stable hyperactive/inattentive behaviours: evidence from two birth cohorts of Australian children.

BACKGROUND: Globally, ADHD diagnoses have increased substantially and there is concern that this trend does not necessarily reflect improved detection of cases but that overdiagnosis may be occurring. We directly compared ADHD diagnoses with ADHD-related behaviours and looked for changes across time among Australian children in a large, population-based prospective cohort study. METHODS: We conducted a secondary analysis of the Longitudinal Study of Australian Children, including 4,699 children born 1999/2000 (cohort 1) and 4,425 children born 2003/2004 (cohort 2), followed from 4 to 13 years of age. We compared pre-diagnosis parent-reported hyperactive/inattentive behaviour scores between newly diagnosed (incident cases) and undiagnosed children and fitted Cox's proportional hazards regression models to examine the relationship between birth cohorts 1 and 2 and the risk of incident ADHD diagnosis. RESULTS: Cumulative incident ADHD diagnoses increased from 4.6% in cohort 1 (born in 1999/2000) to 5.6% in cohort 2 (born in 2003/2004), while hyperactive/inattentive behaviour scores remained steady. Among ADHD diagnosed children, 26.5% (88/334) recorded pre-diagnosis behaviours in the normal range, 27.6% (n = 92) had borderline scores and 45.8% (n = 153) scored within the clinical range. Children born in 2003/2004 were more likely to be diagnosed with ADHD compared with those born in 1999/2000 (aHR = 1.33, 95% CI = 1.06-1.67, p = .012), regardless of their ADHD behaviour score (p = .972). CONCLUSIONS: Diagnostic increases were not driven by rises in hyperactive/inattentive behaviours. A quarter of all children with an ADHD diagnosis recorded pre-diagnosis behaviours within the normal range. The increased likelihood of being diagnosed with ADHD for children from the later birth cohort was observed for children across the full range of ADHD-related behaviours.

Association of Attention-Deficit/Hyperactivity Disorder Diagnosis With Adolescent Quality of Life.

Importance: Appropriate diagnosis of attention-deficit/hyperactivity disorder (ADHD) can improve some short-term outcomes in children and adolescents, but little is known about the association of a diagnosis with their quality of life (QOL). Objective: To compare QOL in adolescents with and without an ADHD diagnosis. Design, Setting, and Participants: This cohort study followed an emulated target trial design using prospective, observational data from the Longitudinal Study of Australian Children, a representative, population-based prospective cohort study with biennial data collection from 2006 to 2018 with 8 years of follow-up (ages 6-7 to 14-15 years). Propensity score matching was used to ensure children with and without ADHD diagnosis were well matched on a wide range of variables, including hyperactive/inattentive (H/I) behaviors. Eligible children were born in 1999 to 2000 or 2003 to 2004 and did not have a previous ADHD diagnosis. All incident ADHD cases were matched with controls. Data were analyzed from July 2021 to January 2022. Exposures: Incident parent-reported ADHD diagnosis at age 6 to 7, 8 to 9, 10 to 11, 12 to 13, or 14 to 15. Main Outcomes and Measures: Quality of life at age 14 to 15 was measured with Child Health Utility 9D (CHU9D) and 8 other prespecified, self-reported measures mapped to the World Health Organization's QOL domains. Pooled regression models were fitted for each outcome, with 95% CIs and P values calculated using bootstrapping to account for matching and repeat observations. Results: Of 8643 eligible children, a total of 393 adolescents had an ADHD diagnosis (284 [72.2%] boys; mean [SD] age, 10.03 [0.30] years; mean [SD] H/I Strengths and Difficulties Questionnaire score, 5.05 [2.29]) and were age-, sex-, and H/I score-matched with 393 adolescents without ADHD diagnosis at time zero. Compared with adolescents without diagnosis, those with an ADHD diagnosis reported similar QOL on CHU9D (mean difference, -0.03; 95% CI, -0.07 to 0.01; P = .10), general health (mean difference, 0.11; 95% CI, -0.04 to 0.27; P = .15), happiness (mean difference, -0.18; 95% CI, -0.37 to 0.00; P = .05), and peer trust (mean difference, 0.65; 95% CI, 0.00 to 1.30; P = .05). Diagnosed adolescents had worse psychological sense of school membership (mean difference, -2.58; 95% CI, -1.13 to -4.06; P < .001), academic self-concept (mean difference, -0.14; 95% CI, -0.02 to -0.26; P = .02), and self-efficacy (mean difference, -0.20; 95% CI, -0.05 to -0.33; P = .007); displayed more negative social behaviors (mean difference, 1.56; 95% CI, 0.55 to 2.66; P = .002); and were more likely to harm themselves (odds ratio, 2.53; 95% CI, 1.49 to 4.37; P < .001) than adolescents without diagnosis. Conclusions and Relevance: In this cohort study, ADHD diagnosis was not associated with any self-reported improvements in adolescents' QOL compared with adolescents with similar levels of H/I behaviors but no ADHD diagnosis. ADHD diagnosis was associated with worse scores in some outcomes, including significantly increased risk of self-harm. A large, randomized clinical trial with long-term follow-up is needed.

A novel methodological framework was described for detecting and quantifying overdiagnosis.

OBJECTIVES: Methods to quantify overdiagnosis of screen detected cancer have been developed, but methods for quantifying overdiagnosis of noncancer conditions (whether symptomatic or asymptomatic) have been lacking. We aimed to develop a methodological framework for quantifying overdiagnosis that may be used for asymptomatic or symptomatic conditions and used gestational diabetes mellitus as an example of how it may be applied. STUDY DESIGN AND SETTING: We identify two earlier definitions for overdiagnosis, a narrower prognosis-based definition and a wider utility-based definition. Building on the central importance of the concepts of prognostic information and clinical utility of a diagnosis, we consider the following questions: within a target population, do people found to have a disease using one diagnostic strategy but found not to have the disease using another diagnostic strategy (so called 'additional diagnoses'), have an increased risk of adverse clinical outcomes without treatment (prognosis evidence), and/or a decreased risk of adverse outcomes with treatment (utility evidence)? RESULTS: Using Causal Directed Acyclic Graphs and fair umpires, we illuminate the relationships between diagnostics strategies and the frequency of overdiagnosis. We then use the example of gestational diabetes mellitus to demonstrate how the Fair Umpire framework may be applied to estimate overdiagnosis. CONCLUSION: Our framework may be used to quantify overdiagnosis in noncancer conditions (and in cancer conditions) and to guide further studies on this topic.

Overdiagnosis of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Systematic Scoping Review.

Importance: Reported increases in attention-deficit/hyperactivity disorder (ADHD) diagnoses are accompanied by growing debate about the underlying factors. Although overdiagnosis is often suggested, no comprehensive evaluation of evidence for or against overdiagnosis has ever been undertaken and is urgently needed to enable evidence-based, patient-centered diagnosis and treatment of ADHD in contemporary health services. Objective: To systematically identify, appraise, and synthesize the evidence on overdiagnosis of ADHD in children and adolescents using a published 5-question framework for detecting overdiagnosis in noncancer conditions. Evidence Review: This systematic scoping review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Extension for Scoping Reviews and Joanna Briggs Methodology, including the PRISMA-ScR Checklist. MEDLINE, Embase, PsychINFO, and the Cochrane Library databases were searched for studies published in English between January 1, 1979, and August 21, 2020. Studies of children and adolescents (aged ≤18 years) with ADHD that focused on overdiagnosis plus studies that could be mapped to 1 or more framework question were included. Two researchers independently reviewed all abstracts and full-text articles, and all included studies were assessed for quality. Findings: Of the 12 267 potentially relevant studies retrieved, 334 (2.7%) were included. Of the 334 studies, 61 (18.3%) were secondary and 273 (81.7%) were primary research articles. Substantial evidence of a reservoir of ADHD was found in 104 studies, providing a potential for diagnoses to increase (question 1). Evidence that actual ADHD diagnosis had increased was found in 45 studies (question 2). Twenty-five studies showed that these additional cases may be on the milder end of the ADHD spectrum (question 3), and 83 studies showed that pharmacological treatment of ADHD was increasing (question 4). A total of 151 studies reported on outcomes of diagnosis and pharmacological treatment (question 5). However, only 5 studies evaluated the critical issue of benefits and harms among the additional, milder cases. These studies supported a hypothesis of diminishing returns in which the harms may outweigh the benefits for youths with milder symptoms. Conclusions and Relevance: This review found evidence of ADHD overdiagnosis and overtreatment in children and adolescents. Evidence gaps remain and future research is needed, in particular research on the long-term benefits and harms of diagnosing and treating ADHD in youths with milder symptoms; therefore, practitioners should be mindful of these knowledge gaps, especially when identifying these individuals and to ensure safe and equitable practice and policy.

Consequences of health condition labelling: protocol for a systematic scoping review.

INTRODUCTION: When health conditions are labelled it is often to classify and communicate a set of symptoms. While diagnostic labelling can provide explanation for an individual's symptoms, it can also impact how individuals and others view those symptoms. Despite existing research regarding the effects of labelling health conditions, a synthesis of these effects has not occurred. We will conduct a systematic scoping review to synthesise the reported consequences and impact of being given a label for a health condition from an individual, societal and health practitioner perspective and explore in what context labelling of health conditions is considered important. METHODS AND ANALYSIS: The review will adhere to the Joanna Briggs Methodology for Scoping Reviews. Searches will be conducted in five electronic databases (PubMed, Embase, PsycINFO, Cochrane, CINAHL). Reference lists of included studies will be screened and forward and backward citation searching of included articles will be conducted. We will include reviews and original studies which describe the consequences for individuals labelled with a non-cancer health condition. We will exclude hypothetical research designs and studies focused on the consequences of labelling cancer conditions, intellectual disabilities and/or social attributes. We will conduct thematic analyses for qualitative data and descriptive or meta-analyses for quantitative data where appropriate. ETHICS AND DISSEMINATION: Ethical approval is not required for a scoping review. Results will be disseminated via publication in a peer-reviewed journal, conference presentations and lay-person summaries on various online platforms. Findings from this systematic scoping review will identify gaps in current understanding of how, when, why and for whom a diagnostic label is important and inform future research.

Evaluating two decision aids for Australian men supporting informed decisions about prostate cancer screening: A randomised controlled trial.

BACKGROUND: Australian clinicians are advised to 'offer evidence-based decisional support to men considering whether or not to have a PSA test'. This randomised trial compared the performance and acceptability of two new decision aids (DAs) to aid men in making informed choices about PSA screening. METHODS: ~3000 Australian men 45-60 years with varying educational attainment were recruited via an online panel and randomised to view one of two online decision aids (one full length, one abbreviated) and completed a questionnaire. The primary outcome was informed choice about PSA screening. FINDINGS: Significantly more men in the long DA group (38%) made an informed choice than men who received the shorter DA (33%) (95% CI 1.1% to 8.2%; p = 0.008). On knowledge, the long DA group scored, on average, 0.45 points higher than the short DA group (95% CI 0.14 to 0.76; p = 0.004) and 5% more of the participants achieved an adequate knowledge score (95% CI 1.9% to 8.8%; p = 0.002). Men allocated the long DA were less likely to intend to have a PSA test in the future (53%) than men in the short DA group (59%). Both DAs rated highly on acceptability. CONCLUSIONS: Both DAs were useful and acceptable to men regardless of education level and both supported informed decision making. The long version resulted in higher knowledge, and a higher proportion of men able to make an informed choice, but the differences were small. Long DAs may be useful for men whose informational needs are not satisfied by a short DA.

Evidence of potential overdiagnosis and overtreatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents: protocol for a scoping review.

INTRODUCTION: Worldwide, attention deficit hyperactivity disorder (ADHD) diagnosis rates in children and adolescents have been increasing consistently over the past decades, fuelling a debate about the underlying reasons for this trend. While many hypothesise that a substantial number of these additional cases are overdiagnosed, to date there has been no comprehensive evaluation of evidence for or against this hypothesis. Thus, with this scoping review we aim to synthesise published evidence on the topic in order to investigate whether existing literature is consistent with the occurrence of overdiagnosis and/or overtreatment of ADHD in children and adolescents. METHODS AND ANALYSIS: The proposed scoping review will be conducted in the context of a framework of five questions, developed specifically to identify areas in medicine with the potential for overdiagnosis and overtreatment. The review will adhere to the Joanna Briggs Methodology for Scoping Reviews. We will search Medline, Embase, PsycINFO and the Cochrane Library electronic databases for primary studies published in English from 1979 onwards. We will also conduct forward and backward citation searches of included articles. Data from studies that meet our predefined exclusion and inclusion criteria will be charted into a standardised extraction template with results mapped to our predetermined five-question framework in the form of a table and summarised in narrative form. ETHICS AND DISSEMINATION: The proposed study is a scoping review of the existing literature and as such does not require ethics approval. We intend to disseminate the results from the scoping review through publication in a peer-reviewed journal and through conference presentations. Further, we will use the findings from our scoping review to inform future research to fill key evidence gaps identified by this review.