Re: Hofmann et al. Overdiagnosis, one concept, three perspectives, and a model.

It is with great interest we have read the article "Overdiagnosis: one concept, three perspectives, and a model" by Hofmann and colleagues. We share the authors' ambition of understanding what overdiagnosis is and what it isn't. In our research, we define overdiagnosis on the basis of two interrelated phenomena: overdetection and overdefinition. Overdetection is the labelling of a person with a disease or abnormal condition, that would not have caused the person harm, e.g., symptoms or death, if left undiscovered. Overdefinition is the creation of new diagnoses by overmedicalising ordinary life experiences or expanding existing diagnoses by lowering thresholds or widening diagnostic criteria, without evidence of improved outcomes. These phenomena have different causes and thereby often different drivers. However, they have one important consequence in common: people are turned into patients unnecessarily, i.e., overdiagnosed. On a personal level, overdiagnosis cause various types of harms, including physical, psychological, social and financial harm. On a societal level, overdiagnosis may also cause harm to public health, cause resource waste, and cultural changes with overmedicalisation of normal life events. By definition, none of the aforementioned phenomena lead to any clinical benefit. Therefore, we disagree with Hofmann and colleagues' definition of overdiagnosis as diagnoses that "…on balance, do more harm than good.". We argue that introducing balance and benefits to the definition of overdiagnosis complicates the concept unnecessarily and cause problems operationalising overdiagnosis.

Overdiagnosis in malignant melanoma: a scoping review.

OBJECTIVES: We aimed to systematically identify and scrutinise published empirical evidence about overdiagnosis in malignant melanoma and examine how frequent overdiagnosis of melanoma is and whether this is related to different types of interventions or diagnostic technologies. DESIGN AND SETTING: Empirical studies that discussed overdiagnosis in malignant melanoma were eligible, including qualitative and quantitative studies in any type of population, age group and geographical location. We excluded studies that did not include empirical data, studies that only mentioned 'overdiagnosis' without addressing it further and studies that used the term overdiagnosis for cases of misdiagnosis or false positives.We developed the search strategy in cooperation with an information specialist. We searched five databases on 21 April 2022: MEDLINE, Embase, CINAHL, PsycINFO and Cochrane Library.This scoping review adheres to The JBI methodology and Prefered Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping reviews (PRISMA-ScR). Two reviewers independently screened titles, abstracts and full texts for inclusion and extracted data from the included studies. The data extracted include study characteristics, population details, research question, the context and the study's main results. RESULTS: Our search resulted in 1134 potentially relevant studies. 35 studies were included: 29 register studies, 3 cohort studies, 1 case-control study, 1 survey study and 1 randomised controlled trial. Most register studies examined trends in melanoma incidence and/or mortality and found a significant increase in incidence between 0.39% and 6.6% annually and a little or no increase in mortality. Three cohort studies and one case-control study showed that skin screening was associated with increased detection of melanoma; especially in situ or thin invasive melanoma. Three studies estimated the degree of overdiagnosis which ranged from 29% to 60%. CONCLUSIONS: Epidemiological data suggest a high degree of overdiagnosis in malignant melanoma. Studies that examined the association between skin screening and malignant melanoma all found increased detection of melanomas, mostly thin and in situ melanomas, which raises concern about overdiagnosis.

Social Media Promotion of Health Tests With Potential for Overdiagnosis or Overuse: Protocol for a Content Analysis.

BACKGROUND: In recent years, social media have emerged as important spaces for commercial marketing of health tests, which can be used for the screening and diagnosis of otherwise generally healthy people. However, little is known about how health tests are promoted on social media, whether the information provided is accurate and balanced, and if there is transparency around conflicts of interest. OBJECTIVE: This study aims to understand and quantify how social media is being used to discuss or promote health tests with the potential for overdiagnosis or overuse to generally healthy people. METHODS: Content analysis of social media posts on the anti-Mullerian hormone test, whole-body magnetic resonance imaging scan, multicancer early detection, testosterone test, and gut microbe test from influential international social media accounts on Instagram and TikTok. The 5 tests have been identified as having the following criteria: (1) there are evidence-based concerns about overdiagnosis or overuse, (2) there is evidence or concerns that the results of tests do not lead to improved health outcomes for generally healthy people and may cause harm or waste, and (3) the tests are being promoted on social media to generally healthy people. English language text-only posts, images, infographics, articles, recorded videos including reels, and audio-only posts are included. Posts from accounts with <1000 followers as well as stories, live videos, and non-English posts are excluded. Using keywords related to the test, the top posts were searched and screened until there were 100 eligible posts from each platform for each test (total of 1000 posts). Data from the caption, video, and on-screen text are being summarized and extracted into a Microsoft Excel (Microsoft Corporation) spreadsheet and included in the analysis. The analysis will take a combined inductive approach when generating key themes and a deductive approach using a prespecified framework. Quantitative data will be analyzed in Stata SE (version 18.0; Stata Corp). RESULTS: Data on Instagram and TikTok have been searched and screened. Analysis has now commenced. The findings will be disseminated via publications in peer-reviewed international medical journals and will also be presented at national and international conferences in late 2024 and 2025. CONCLUSIONS: This study will contribute to the limited evidence base on the nature of the relationship between social media and the problems of overdiagnosis and overuse of health care services. This understanding is essential to develop strategies to mitigate potential harm and plan solutions, with the aim of helping to protect members of the public from being marketed low-value tests, becoming patients unnecessarily, and taking resources away from genuine needs within the health system. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56899.

Deaths and cardiopulmonary events following colorectal cancer screening-A systematic review with meta-analyses.

BACKGROUND: Colorectal cancer screening programmes (CRCSPs) are implemented worldwide despite recent evidence indicating more physical harm occurring during CRCSPs than previously thought. Therefore, we aimed to review the evidence on physical harms associated with endoscopic diagnostic procedures during CRCSPs and, when possible, to quantify the risk of the most serious types of physical harm during CRCSPs, i.e. deaths and cardiopulmonary events (CPEs). METHODS: Systematic review with descriptive statistics and random-effects meta-analyses of studies investigating physical harms following CRCSPs. We conducted a systematic search in the literature and assessed the risk of bias and the certainty of the evidence. RESULTS: We included 134 studies for review, reporting findings from 151 unique populations when accounting for multiple screening interventions per study. Physical harm can be categorized into 17 types of harm. The evidence was very heterogeneous with inadequate measurement and reporting of harms. The risk of bias was serious or critical in 95% of assessments of deaths and CPEs, and the certainty of the evidence was very low in all analyses. The risk of death was assessed for 57 populations with large variation across studies. Meta-analyses indicated that 3 to 23 deaths occur during CRCSPs per 100,000 people screened. Cardiopulmonary events were assessed for 55 populations. Despite our efforts to subcategorize CPEs into 17 distinct subtypes, 41% of CPE assessments were too poorly measured or reported to allow quantification. We found a tendency towards lower estimates of deaths and CPEs in studies with a critical risk of bias. DISCUSSION: Deaths and CPEs during CRCSPs are rare, yet they do occur during CRCSPs. We believe that our findings are conservative due to the heterogeneity and low quality of the evidence. A standardized system for the measurement and reporting of the harms of screening is warranted. TRIAL REGISTRATION: PROSPERO Registration number CRD42017058844.

Long-term psychosocial consequences of false-positive screening mammography: a cohort study with follow-up of 12-14 years in Denmark.

OBJECTIVE: To compare the long-term psychosocial consequences of mammography screening among women with breast cancer, normal results and false-positive results. DESIGN: A matched cohort study with follow-up of 12-14 years. SETTING: Denmark from 2004 to 2019. PARTICIPANTS: 1170 women who participated in the Danish mammography screening programme in 2004-2005. INTERVENTION: Mammography screening for women aged 50-69 years. OUTCOME MEASURES: We assessed the psychosocial consequences with the Consequences Of Screening-Breast Cancer, a condition-specific questionnaire that is psychometrically validated and encompasses 14 psychosocial dimensions. RESULTS: Across all 14 psychosocial outcomes, women with false-positive results averagely reported higher psychosocial consequences compared with women with normal findings. Mean differences were statistically insignificant except for the existential values scale: 0.61 (95% CI (0.15 to 1.06), p=0.009). Additionally, women with false-positive results and women diagnosed with breast cancer were affected in a dose-response manner, where women diagnosed with breast cancer were more affected than women with false-positive results. CONCLUSION: Our study suggests that a false-positive mammogram is associated with increased psychosocial consequences 12-14 years after the screening. This study adds to the harms of mammography screening. The findings should be used to inform decision-making among the invited women and political and governmental decisions about mammography screening programmes.

Fictitious cases as a methodology to discuss sensitive health topics in focus groups.

PURPOSE: It can be challenging to research aspects of people's health behaviour, attitudes, and emotions due to the sensitive nature of these topics. We aimed to develop a novel methodology for discussing sensitive health topics, and explore the effectiveness in focus groups using prostate cancer and screening as an example. METHOD: We developed a fictitious case and employed it as a projective technique in focus groups on prostate cancer and screening. The participants were men and their partners who lived in Denmark. RESULTS: The technique encouraged emotional and cognitive openness in focus group discussions about the risk of prostate cancer, the benefits and harms of screening, and decision-making about screening. It appeared that using the fictitious case allowed the participants to personally distance themselves from the topic, project emotions onto the case, and thereby openly talk about their emotions. CONCLUSION: This article presents a methodological contribution to communication about sensitive topics in focus groups, using prostate cancer screening as an example. Further refinement of the methodology is needed to enable participants to transfer improvements in knowledge to their own decision about screening.

Questioning 'Informed Choice' in Medical Screening: The Role of Neoliberal Rhetoric, Culture, and Social Context.

Participation in medical screening programs is presented as a voluntary decision that should be based on an informed choice. An informed choice is often emphasized to rely on three assumptions: (1) the decision-maker has available information about the benefits and harms, (2) the decision-maker can understand and interpret this information, and (3) the decision-maker can relate this information to personal values and preferences. In this article, we empirically challenge the concept of informed choice in the context of medical screening. We use document analysis to analyze and build upon findings and interpretations from previously published articles on participation in screening. We find that citizens do not receive neutral or balanced information about benefits and harms, yet are exposed to manipulative framing effects. The citizens have high expectations about the benefits of screening, and therefore experience cognitive strains when informed about the harm. We demonstrate that decisions about screening participation are informed by neoliberal arguments of personal responsibility and cultural healthism, and thus cannot be regarded as decisions based on individual values and preferences independently of context. We argue that the concept of informed choice serves as a power technology for people to govern themselves and can be considered an implicit verification of biopower.

Methodological Quality of PROMs in Psychosocial Consequences of Colorectal Cancer Screening: A Systematic Review.

Objective: This systematic review aimed to assess the adequacy of measurement properties in Patient-Reported Outcome Measures (PROMs) used to quantify psychosocial consequences of colorectal cancer screening among adults at average risk. Methods: We searched four databases for eligible studies: MEDLINE, CINAHL, PsycINFO, and Embase. Our approach was inclusive and encompassed all empirical studies that quantified aspects of psychosocial consequences of colorectal cancer screening. We assessed the adequacy of PROM development and measurement properties for content validity using The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist. Results: We included 33 studies that all together used 30 different outcome measures. Two PROMs (6.7%) were developed in a colorectal cancer screening context. COSMIN rating for PROM development was inadequate for 29 out of 30 PROMs (97%). PROMs lacked proper cognitive interviews and pilot studies and therefore had no proven content validity. According to the COSMIN checklist, 27 out of 30 PROMs (90%) had inadequate measurement properties for content validity. Discussion: The majority of included PROMs had inadequate development and measurement properties. These findings shed light on the trustworthiness of the included studies' findings and call for reevaluation of existing evidence on the psychosocial consequences of colorectal cancer screening. To provide trustworthy evidence about the psychosocial consequences of colorectal cancer screening, editors could require that studies provide evidence of the methodological quality of the PROM. Alternatively, authors should transparently disclose their studies' methodological limitations in measuring psychosocial consequences of screening validly.

The long-term psychosocial consequences of screen-detected ductal carcinoma in situ and invasive breast cancer.

OBJECTIVE: Ductal carcinoma in situ (DCIS) is a risk factor for invasive breast cancer (IBC). The prognosis of DCIS is considerably better than for IBC, yet women do not distinguish between the threat. We aimed to compare the psychosocial consequences of screen-detected DCIS and IBC, and to examine this comparison over time. METHODS: We surveyed a Danish mammography-screening cohort from 2004 to 2018. We assessed outcomes at six-time points: baseline, 1, 6, 18, 36 months, and 14 years after the screening. We measured psychosocial consequences with the Consequences Of Screening - Breast Cancer (COS-BC): a condition-specific questionnaire that is psychometrically validated and encompasses 14 psychosocial dimensions. We used weighted linear models with generalized estimating equations to compare responses between groups. We used a 1% level of significance. RESULTS: 170 out of 1309 women were diagnosed with breast cancer (13.0%). 23 were diagnosed with DCIS (13.5%) and 147 with IBC (86.5%). From baseline to six months after diagnosis, there were no significant differences between women with DCIS and IBC. However, mean scores indicated that IBC generally was more affected than DCIS. After six months, we observed that women with DCIS and IBC might be affected differently in the long term; mean scores and mean differences showed that IBC were more affected on some scales, while DCIS were on others. CONCLUSION: Overall, the DCIS and IBC experienced similar levels of psychosocial consequences. Women might benefit from renaming DCIS to exclude cancer nomenclature.

The risk of bleeding and perforation from sigmoidoscopy or colonoscopy in colorectal cancer screening: A systematic review and meta-analyses.

INTRODUCTION: Physical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening. DESIGN: Systematic review with descriptive statistics and random-effects meta-analyses. METHODS: We systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses. RESULTS: We included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy. DISCUSSION: Harm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies. TRIAL REGISTRATION: PROSPERO registration number: CRD42017058844.