Addressing harms of screening – A review of outcomes in Cochrane reviews and suggestions for next steps

Abstract

Objective: To investigate if Cochrane reviews that assess screening interventions address their major harms. Study design and setting: A systematic search for Cochrane reviews that assess screening interventions was performed. Two authors independently screened abstracts, assessed full-texts, and extracted data from included reviews. For each review, two authors judged whether each predefined harm was relevant. When the harm was judged as of questionable relevance, the review was excluded from the denominator in our calculations. Results: Forty-seven reviews were included. Overdiagnosis was addressed in 6 of 39 (15%), overtreatment in 7 of 43 (16%), and psychosocial consequences in 30 of 47 (64%) of reviews where this was judged relevant. When data on harms were included, they were generally not treated with the same methodological rigor as the benefits, with no assessment of the risk of bias or certainty of the evidence. About half of the Abstracts, Plain Language Summaries, and Summary of Findings tables did not include any harms. Conclusion: The underreporting of harms of screening in Cochrane reviews likely reflects primary research and is problematic. We call for broad collaboration to develop reporting guidelines and core outcome sets for studies of screening interventions.

Screening for mental disorders in police custody settings

“…False-positive results can lead to unnecessary interventions such as surgery for benign conditions or limitations on activity due to false-positive cardiac screening. In a recent systematic search of Cochrane reviews of screening interventions, Johansson et al (2021) found that only one-third of reviews reported on false-positive or false-negative outcomes. As outlined in the Special Circumstances section above, routinely used screening in police custody is inaccurate.…”

How can secondary dementia prevention trials of Alzheimer's disease be clinically meaningful?

“…Screening for the secondary prevention of any condition requires a robust understanding of the potential harms from overdiagnosis, overtreatment, false positive and false negative diagnoses, and complications from treatment. 70 AD biomarker screening via plasma, CSF, and PET techniques is invasive and potentially costly, and a diagnosis of preclinical AD may have ethical, social, and legal ramifications. 7,71 For aducanumab, the first DMT to obtain FDA accelerated approval, patients are required to undergo (and clinicians need to oversee) monthly intravenous infusions and regular magnetic resonance imaging (MRI) scans to detect potential amyloid related imaging abnormalities (ARIA), 72 which affected 43% of high-dose 10 mg/kg aducanumab recipients in Phase 3 trials, one in four of which were symptomatic 73 and linked to cognitive worsening and even death.…”

“…Screening for the secondary prevention of any condition requires a robust understanding of the potential harms from overdiagnosis, overtreatment, false positive and false negative diagnoses, and complications from treatment 70 . AD biomarker screening via plasma, CSF, and PET techniques is invasive and potentially costly, and a diagnosis of preclinical AD may have ethical, social, and legal ramifications 7,71 .…”

Surveillance of Individuals at High Risk of Developing Pancreatic Cancer

“…In the last decade, awareness of the importance of secondary prevention of cancer through surveillance protocols has greatly diffused. Although cancer surveillance has clear benefits, it is important to balance the benefits with potential harms, which are typically under-reported 1 . Pancreatic cancer surveillance is not an exception.…”