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  • 1
    In: JAMA Neurology, American Medical Association (AMA), Vol. 76, No. 8 ( 2019-08-01), p. 969-
    Type of Medium: Online Resource
    ISSN: 2168-6149
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2019
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  • 2
    In: Reproduction and Fertility, Bioscientifica, Vol. 4, No. 2 ( 2023-04-01)
    Abstract: In vitro fertilisation (IVF) add-ons are techniques, medicines, or procedures used in addition to standard IVF with the aim of improving the chance of success. The United Kingdom’s IVF regulator, the Human Fertilisation Embryology Authority (HFEA) developed a traffic light system to categorise add-ons as either green, amber, or red, based on results of randomised controlled trials. We undertook qualitative interviews to explore understanding and views of the HFEA traffic light system among IVF clinicians, embryologists, and IVF patients across Australia and the United Kingdom ( n  = 73). Overall, participants were supportive of the intention of the traffic light system; however, many limitations were raised. It was widely recognised that a simple traffic light system necessarily omits information which may be important to understanding the evidence. In particular, the red category was used in scenarios that patients viewed as having different implications for their decision-making, including ‘no evidence’ and ‘evidesssnce of harm’. Patients were surprised at the absence of any green add-ons and questioned the value of a traffic light system in this context. Many participants considered the website a helpful starting point, but desired more detail, including the contributing studies, results specific to patient demographics (e.g. 〈 35 years and 〉 35 years), and inclusion of more options (e.g. acupuncture). Overall, participants believed the website to be reliable and trustworthy, particularly due to the Government affiliation, and despite some concerns regarding transparency and an overly cautious regulator. The limitations of the traffic light system could be considered in any future updates to the HFEA website and others developing similar decision support tools. Lay summary In vitro fertilisation (IVF) add-ons are medical procedures or technologies that may be used in addition to standard IVF. They are usually used with the aim of increasing the chance of pregnancy and live birth. However, most add-ons have not been studied in high-quality clinical trials so it is uncertain whether they are beneficial. The UK’s IVF regulator developed a traffic light system for add-ons. They label them red, amber, or green, depending on whether there is evidence the add-on increases the chance of having a baby from IVF. We interviewed IVF patients, IVF doctors, and embryologists about the traffic light system. Overall, many people thought it was a reliable and trustworthy resource – however, many problems were identified. People generally thought the system was too simple and didn’t give enough information, it had limited detail about the number and types of studies included, and some important add-ons were missing, such as acupuncture.
    Type of Medium: Online Resource
    ISSN: 2633-8386
    Language: Unknown
    Publisher: Bioscientifica
    Publication Date: 2023
    detail.hit.zdb_id: 3063977-3
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  • 3
    In: BMJ Open, BMJ, Vol. 13, No. 7 ( 2023-07), p. e069146-
    Abstract: In vitro fertilisation (IVF) add-ons are additional procedures offered alongside an IVF cycle with the aim of improving live birth rates. They are controversial because of the paucity of evidence to support their efficacy and safety, alongside the additional financial cost they often pose to patients. Despite this, they are popular. However, there is limited qualitative research regarding their use. The aims of the VALUE Study were to understand the decision-making process surrounding using or recommending add-ons; report sources of information for add-ons; and explore concerns for safety and effectiveness when considering their use. Design ‘VALUE’ is a qualitative semistructured interview study using inductive thematic analysis of anonymised transcriptions. Setting Participants were recruited from a broad geographical spread across the UK and Australia from public and private clinical settings. Participants Patients (n=25) and health professionals (embryologists (n=25) and clinicians (n=24)) were interviewed. A purposive sampling strategy was undertaken. The sampling framework included people having state-subsidised and private cycles, professionals working in public and private sectors, geographical location and professionals of all grades. Results Patients often made decisions about add-ons based on hope, minimising considerations of safety, efficacy or cost, whereas professionals sought the best outcomes for their patients and wanted to avoid them wasting their money. The driving forces behind add-on use differed: for patients, a professional opinion was the most influential reason, whereas for professionals, it was seen as patient driven. For both groups, applying the available evidence to individual circumstances was very challenging, especially in the sphere of IVF medicine, where the stakes are high. Conclusions There is scope to build on the quality of the discourse between patients and professionals. Patients describe valuing their autonomy with add-ons, but for professionals, undertaking informed consent will be critical, no matter where they sit on the spectrum regarding add-ons. Trial registration osf.io/vnyb9.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 4
    In: DIGITAL HEALTH, SAGE Publications, Vol. 1 ( 2015-01), p. 205520761559299-
    Abstract: The purpose of this study was to conduct a proof-of-concept study to evaluate remote recruitment and assessment of individuals (“virtual research visits”) with Parkinson's disease who have pursued direct-to-consumer genetic testing. Methods Participants in 23andMe’s “Parkinson’s Research Community” were contacted by 23andMe. Fifty willing participants living in 23 states underwent a remote, standardized assessment including cognitive and motor tests by a neurologist via video conferencing and then completed a survey. Primary outcomes assessed were (a) proportion of participants who completed the remote assessments; (b) level of agreement (using Cohen’s kappa coefficient) of patient-reported data with that of a neurologist; and (c) interest in future virtual research visits. Results The self-reported diagnosis of Parkinson’s disease was confirmed in all cases ( k = 1.00). The level of agreement for age of symptom onset ( k = 0.97) and family history ( k = 0.85) was very good but worse for falling ( k = 0.59), tremor ( k = 0.56), light-headedness ( k = 0.31), and urine control ( k = 0.15). Thirty-eight (76%) of the 50 participants completed a post-assessment survey, and 87% of respondents said they would be more or much more willing to participate in future clinical trials if they could do research visits remotely. Conclusion Remote clinical assessments of individuals with known genotypes were conducted nationally and rapidly from a single site, confirmed self-reported diagnosis, and were received favorably. Direct-to-consumer genetic testing and virtual research visits together may enable characterization of genotype and phenotype for geographically diverse populations.
    Type of Medium: Online Resource
    ISSN: 2055-2076 , 2055-2076
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
    detail.hit.zdb_id: 2819396-9
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