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A Systematic Assessment of Statements on UK Fertility Centre Websites

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A Systematic Assessment of Statements on UK Fertility Centre Websites BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013940 on 27 November 2016. Downloaded from Claims for fertility interventions: a systematic assessment of statements on UK fertility centre websites. ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2016-013940 Article Type: Research Date Submitted by the Author: 18-Aug-2016 Complete List of Authors: Spencer, Elizabeth; University of Oxford, Primary Care Health Sciences Mahtani, Kamal; University of Oxford, Department of Primary Health Care Sciences Goldacre, bben; University of Oxford, Primary Health Care Heneghan, Carl; Oxford University, Primary Health Care <b>Primary Subject Communication Heading</b>: Secondary Subject Heading: Reproductive medicine fertility, evidence-based medicine, patient information, Reproductive Keywords: medicine < GYNAECOLOGY http://bmjopen.bmj.com/ on October 4, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 32 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013940 on 27 November 2016. Downloaded from 1 2 3 4 Claims for fertility interventions: a systematic assessment of statements on UK 5 6 fertility centre websites. 7 8 9 1 1 1 1 Spencer EA , Mahtani KR , Goldacre B , Heneghan C 10 11 12 13 Corresponding author 14 [email protected] 15 For peer review only 16 17 1 18 Centre for Evidence-Based Medicine, 19 20 Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care 21 Building, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG 22 23 Tel. 01865 289300 24 25 26 27 28 29 30 31 32 33 34 35 http://bmjopen.bmj.com/ 36 37 38 39 40 41 42 43 on October 4, 2021 by guest. Protected copyright. 44 45 46 47 48 49 50 Word count, excluding title page, abstract, references, figures and tables = 2,805 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 32 BMJ Open: first published as 10.1136/bmjopen-2016-013940 on 27 November 2016. Downloaded from 1 2 3 ABSTRACT 4 5 6 7 Background 8 9 10 Fertility services in the UK are offered by over 200 HFEA-registered NHS and private clinics. Whilst IVF 11 12 and ICSI form part of NICE guidance many further interventions are offered. We aimed to record claims 13 of benefit for interventions offered by fertility centres via information on the centres’ websites, and 14 15 record what evidenceFor was cited peer for these claims. review only 16 17 18 19 Methods 20 21 22 We obtained from HFEA a list of all UK centres providing fertility treatments and examined their 23 24 websites. We listed fertility interventions offered in addition to standard IVF and ICSI, and recorded 25 statements about interventions that claimed or implied improvements in fertility in healthy women. We 26 27 recorded which claims were quantified, and the evidence cited in support of the claims. Two reviewers 28 29 extracted data from websites. We accessed websites from 21 December 2015 to 31 March 2016. 30 31 32 Results 33 34 35 http://bmjopen.bmj.com/ 36 We found 233 websites for HFEA-registered fertility treatment centres, of which 152 (65%) were 37 excluded as duplicates or satellite centres, two were andrology clinics and five were unavailable or 38 39 under construction websites. In total, 74 fertility centre websites, incorporating 1,401 web-pages, were 40 41 examined for claims. We found 282 claims of benefit relating to 42 different fertility interventions made 42 by 60 of the 74 centres, (median 3 per website; range 0 to 10). Quantification was given for 79 (28%) of 43 on October 4, 2021 by guest. Protected copyright. 44 the claims. 16 published references were cited 21 times on 13 of the 74 websites. 45 46 47 48 Conclusions 49 50 51 Many fertility centres in the UK offer a range of treatments in addition to standard IVF procedures, and 52 53 for many of these interventions claims of benefit are made. In most cases the claims are not quantified 54 and evidence is not cited to support the claims. There is a need for more information on interventions to 55 56 be made available by fertility centres, to support well informed treatment decisions. 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 32 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013940 on 27 November 2016. Downloaded from 1 2 3 Strengths and limitation of this study 4 5 6 • We accessed all HFEA registered fertility centre websites available in the UK that provide IVF and 7 8 treatment information 9 10 • Two reviewers assessed the websites assessed all of the extracted claims and resolved issues by 11 12 discussion 13 • Different reviewers may disagree in categorising some statements as claims, but it is unlikely 14 15 that the patternFor of findings peer would change review substantially. only 16 17 • Web pages are subject to change over time, and a different set of reviewers might locate further 18 19 intervention claims that we missed. 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 http://bmjopen.bmj.com/ 36 37 38 39 40 41 42 43 on October 4, 2021 by guest. Protected copyright. 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 32 BMJ Open: first published as 10.1136/bmjopen-2016-013940 on 27 November 2016. Downloaded from 1 2 3 4 5 BACKGROUND 6 7 8 9 Approximately 1 in 7 UK couples have problems conceiving, [1] and increasing age is one factor that 10 contributes to this. Approximately 98% of women, aged between 19 to 26 years, and having regular 11 12 intercourse, will conceive naturally within two years. However, this figure drops to 90% for women aged 13 14 between 35 to 39 years. [2] Other factors that can affect fertility include ovulatory, tubal, uterine or 15 For peer review only 16 peritoneal disorders as well as male related factors. However, in approximately 25% of couples, there is 17 no identified cause of the infertility. [1] 18 19 20 21 Current UK NICE guidelines advocate that women with unexplained infertility, who have not conceived 22 after two years of regular sexual intercourse, be offered NHS treatment. This may be through medical, 23 24 surgical or assisted conception techniques. For women under 40 years of age, the latter includes 3 full 25 26 cycles of in vitro fertilisation (IVF), with or without intra-cytoplasmic sperm injection (ICSI). [3] 27 28 29 In general, fertility treatments include an array of interventions that seek to aid conception, or treat 30 31 infertility, or subfertility, with the specific aim of increasing the live birth rate or the pregnancy rate 32 33 (sometimes called “clinical pregnancy rate”) as well as conception or survival of cultured embryos or 34 blastocysts. Treatments often involve ovulation stimulation and monitoring, in vitro fertilisation itself 35 http://bmjopen.bmj.com/ 36 (sometimes via intracytoplasmic injection ICSI) and replacement of resulting embryos or blastocysts into 37 38 the uterus. 39 40 41 In addition to these standard treatments, a range of additional investigations and treatments may be 42 43 offered at UK fertility treatment centres. All centres, whether they provide private, NHS or both types of on October 4, 2021 by guest. Protected copyright. 44 45 services, are registered with the Human Fertilisation and Embryology Authority (HFEA), the independent 46 regulator that oversees fertility treatment and research in the UK. [4] However, despite this regulation it 47 48 has been suggested that some of these interventions - offered beyond routine IVF - may not best serve 49 50 patients, as they are not based on evidence of effectiveness, are costly, and some clinics might be using 51 52 IVF techniques that have not been stringently tested. [5] Furthermore, the HFEA recommends that some 53 treatments, such as reproductive immunology, are only used in the context of clinical trials.[6] 54 55 Given the concerns over the evidence base underpinning fertility treatments as well as the implications 56 57 for couples undergoing these treatments, and the resources needed to fund them, we set out to 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 32 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013940 on 27 November 2016. Downloaded from 1 2 3 systematically identify and document claims made by UK fertility centres on the effectiveness of 4 5 treatments offered on their websites as the first information source for individuals. We went on to 6 7 identify the evidence that the centres use to support their claims. Finally, using this information, we 8 9 have conducted a follow up study examining the credibility of the claim statements when compared 10 with the published evidence of effectiveness. 11 12 13 14 METHODS 15 For peer review only 16 17 Identification of fertility claims 18 19 We obtained a list of all UK centres providing fertility treatments from the HFEA website [4]. No centres 20 were excluded. Where it was clear that a primary fertility centre had satellite centres offering 21 22 treatments, we restricted our searching for claims to their main website. We examined the websites for 23 24 each of these centres and for each intervention additional to IVF that was offered.
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