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ObjectiveTo describe recommendations applicable to new diagnostic and screening tests brought to market in the UK as of 01 June 2023; and extract agreements, disagreements and gaps.DesignExtant regulations, recommendations and guidelines for new diagnostic and screening tests applicable to new products placed in the UK market as of 01 June 2023. Non-English and references not applicable to new tests seeking market access in the UK on 01 June 2023 were excluded.Data sourcesPubMed, Web of Science Core Collection and Scopus; grey literature via EuropePMC and Google, government regulations and guidelines, and relevant professional societies. References of relevant included data were scanned for includable articles. Resultant data were thematically analysed and presented as a narrative scoping review.Eligibility for selecting studiesPubMed, Web of Science Core Collection and Scopus were searched from 1/1/2018 for regulations, guidelines or recommendations for in vitro diagnositic tests as applied to the UK on 1/6/23. Relevant papers also had references searched.Results943 items were initially identified with 892 excluded. Reference searching located a further 31 papers and 82 items were analysed. Seven themes were identified: regulation, companion diagnostics and lab developed tests, safety and evidence, test specific recommendations, data, innovation and recommendations for patients/the public. Wide agreement included the need to reduce bureaucracy and duplication; to mitigate to avoid unintended consequences of In Vitro Diagnostic Regulation. Disagreement over whether high-quality evidence should precede regulatory approval, or could be gathered as part of postmarketing surveillance emerged.ConclusionsIndustry, regulators, academics, patients representing a variety of views, should collaborate to work through areas of disagreement.

ObjectiveTo understand the relationship between financial conflicts of interest and recommendations for atrial fibrillation (AF) screening in the UK, via examining (1) if the UK media recommend for or against screening for AF, and (2) the financial conflicts of interests of AF screening commentators.DesignCross-sectional study.Setting/participantsReferences in UK mainstream media, Twitter, the UK’s National Health Service (NHS), patient information websites and major UK heart-related charities regarding screening for AF between1 January 2018 and 31 July 2021.Outcome measuresProportion of references advocating for, against and presenting balanced/neutral views on screening. Proportion of references citing commentators with financial conflicts of interest.Results217 media stories were identified, containing 284 comments about screening for AF. 185/217 (85.3%) of articles were in favour, 9 (4.1%) were against and 23 (10.6%) were balanced. Quotations within were located from 194 commentators; 44 were quoted more than once. 41/44 (93.2%) were in favour of screening. Of these 41, 37 (90.2%) had a direct or indirect financial conflict of interest, including that due to a work role. Two were balanced and one was negative. 2553 tweets using 3 hashtags promoting screening were analysed. 2119 (83%) of the most impactful tweets promoting AF screening were by industry or organisations with industry funding. Of 23 NHS organisations holding information about funding and promoting AF screening online, 22 (96%) had industry funding. 9 (90%) of the top 10 patient information websites promoting AF screening had industry funding. Four main UK patient charities in this sector promoting screening received industry funding.ConclusionsThe vast majority of UK media promotes screening for AF, in contrast to the position of the independent UK National Screening Committee, which recommends against screening. Most commentators, internal NHS organisations and UK charities promoting screening had a direct or indirect financial conflict of interest. Independent information was rare. The reasons for this are unknown. Readers should consider the potential for the impact of financial conflicts on recommendations to screen.

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AbstractIn this paper I examine the relationship between benefits, harms and evidence-based medicine in the context of British primary healthcare. First, I will examine: ‘What is a benefit and what is a harm?’ Second, what should we know about where the balance of risk and benefit appear to lie? Third, what should we do with this knowledge, particularly in the context of the biopsychosocial gaze of primary care? I conclude that even perfect knowledge about benefits and harms requires to be translated in the context of the individual patient: it also requires to be interpreted according to what that persons’ wishes are.Why this matters to meBy reiterating again and again how biases are stacked in favour of recommending treatments and interventions well beyond their rational evidence, my hope is that more honest medicine will result in less but higher value medicine. Stopping doing things that don’t work, or work rarely, or come with an unacceptable burden of side effects or appointments should make room for the pleasure of practicing medicine.Key message(s)• Even perfect knowledge about benefits and harms requires to be translated in the context of the individual patient: it also requires to be interpreted according to what that persons’ wishes are.• In the real, messy frontline world of general practice, we will always have uncertainty about where the balance of risk and benefit might lie.

The article focuses on fitness trackers for heart conditions and mentions the heart condition atrial fibrillation.