Scott Wilkes

Epidemiology and management of infertility: a population-based study in UK primary care

BACKGROUND Our current knowledge of the epidemiology of infertility is limited and outdated. Health care provision for infertility in the UK attracts public interest because of restrictions on access to services. OBJECTIVE To describe the incidence, prevalence, referral patterns and outcomes of infertile couples, presenting in general practice in UK. METHODS A population-based retrospective observational outcome study of infertile couples from general practices in Northumberland, Tyne and Wear, UK (population 1 043 513). Outcome data at 1 year were collected on all couples who presented to their GP between the 1st January 2005 and 30th June 2006 with a fertility problem. RESULTS Thirty-four per cent of general practices in the study area contributed data (population 404 263). The incidence of infertility was 0.9 couples per 1000 general population. The average age of women was 31 years, and the average time attempting conception was 18 months. Treatment end points for half of all couples were in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Over half of the couples in the study were not eligible for National Health Service (NHS) fertility treatment on social criteria. At 12 months, 27% of all couples in the study achieved a pregnancy spontaneously and a further 9% with treatment. CONCLUSIONS Infertile women present to their GP later in life compared with 20 years ago, and after a shorter period of infertility. Half of the couples required treatment with IVF or ICSI. Adopting the British Fertility Society recommendation of allowing couples, where one or both partners has a child in a previous relationship, will result in an additional 26% of infertile couples becoming eligible for NHS fertility treatment.

The use of bupropion SR in cigarette smoking cessation.

Cigarette smoking remains the largest preventable cause of premature death in developed countries. Until recently nicotine replacement therapy (NRT) has been the only recognised form of treatment for smoking cessation. Bupropion, the first non-nicotine based drug for smoking cessation was licensed in the United States of America (US) in 1997 and in the United Kingdom (UK) in 2000 for smoking cessation in people aged 18 years and over. Bupropion exerts its effect primarily through the inhibition of dopamine reuptake into neuronal synaptic vesicles. It is also a weak noradrenalin reuptake inhibitor and has no effect on the serotonin system. Bupropion has proven efficacy for smoking cessation in a number of clinical trials, helping approximately one in five smokers to stop smoking. Up to a half of patients taking bupropion experience side effects, mainly insomnia and a dry mouth, which are closely linked to the nicotine withdrawal syndrome. Bupropion is rarely associated with seizures however care must be taken when co-prescribing with drugs that can lower seizure threshold. Also, bupropion is a potent enzyme inhibitor and can raise plasma levels of some drugs including antidepressants, antiarrhythmics and antipsychotics. Bupropion has been shown to be a safe and cost effective smoking cessation agent. Despite this, NRT remains the dominant pharmacotherapy to aid smoking cessation.

Obesity and female fertility: a primary care perspective.

Infertility affects approximately one in six couples during their lifetime. Obesity affects approximately half of the general population and is thus a common problem among the fertile population. Obese women have a higher prevalence of infertility compared with their lean counterparts. The majority of women with an ovulatory disorder contributing to their infertility have polycystic ovary syndrome (PCOS) and a significant proportion of women with PCOS are obese. Ovulation disorders and obesity-associated infertility represent a group of infertile couples that are relatively simple to treat. Maternal morbidity, mortality and fetal anomalies are increased with obesity and the success of assisted reproductive technology (ART) treatments is significantly reduced for obese women. Body mass index (BMI) treatment limits for ART throughout the UK vary. The mainstay for treatment is weight loss, which improves both natural fertility and conception rates with ART. The most cost-effective treatment strategy for obese infertile women is weight reduction with a hypo-caloric diet. Assisted reproduction is preferable in women with a BMI of 30 kg/m2 or less and weight loss strategies should be employed within primary care to achieve that goal prior to referral.

Patient experience of infertility management in primary care: an in-depth interview study

BACKGROUND GPs do not have a full range of diagnostic resources to help manage infertile couples. Little is known about the patient experience of infertility management in primary care. OBJECTIVE To explore the patient experience of infertility management from a primary care perspective. METHODS This was a nested qualitative study with infertile couples in North-East England. In-depth interviews of infertile couples identified in the course of an observational study describing the incidence, prevalence, referral patterns and pregnancy outcomes for infertile couples. A grounded approach was used, with the interviews and analysis proceeding together using the method of constant comparison. Emergent themes and their links gave an overall explanation to the interview data. RESULTS We interviewed 22 patients in 13 interviews. Factors that influenced a couples experience of infertility management were personal and professional relationships, patient autonomy in decision making and access to services. CONCLUSIONS This study provides insights into the experiences of infertile couples seeking assisted reproduction from their GP. A good experience was linked to a strong personal relationship, a patient-centred professional relationship fostering informed decision making by the couple, GPs using diagnostic resources, interpreting restrictive clinical and social criteria and referring appropriately.

Open Access Tubal aSsessment for the initial management of infertility in general practice (the OATS trial): a pragmatic cluster randomised controlled trial.

BACKGROUND GPs investigate approximately half of all infertile couples with semen analysis and endocrine blood tests. For assessment of tubal status, hysterosalpingography (HSG) is recommended as a first-line investigation for women not known to have comorbidities. AIM To test whether providing GPs with open access to HSG results in infertile couples progressing to a diagnosis and management plan sooner than with usual management. DESIGN OF STUDY A pragmatic cluster randomised controlled trial. SETTING Seventy-one of 173 general practices in north-east England agreed to participate. METHOD A total of 670 infertile couples presented to 33 intervention practices and 25 control practices over a 2-year period. Practices allocated to the intervention group had access to HSG for those infertile women who fulfilled predefined eligibility criteria. The primary outcome measure was the interval between presentation to the GP and the couple receiving a diagnosis and management plan. RESULTS An annual incidence of 0.8 couples per 1000 total population equated to each GP seeing an average of one or two infertile couples each year. Open access HSG was used for 9% of all infertile women who presented to the intervention practices during the study period. The time to reach a diagnosis and management plan for all infertile couples presenting was not affected by the availability of open access HSG (Cox regression hazard ratio = 0.9, 95% confidence interval [CI] = 0.7 to 1.1). For couples who reached a diagnosis and management plan, there was a non-significant difference in time to primary outcome for intervention versus control practices (32.5 weeks versus 30.5 weeks, mean difference 2.2 weeks, 95% CI = 1.6 to 6.1 weeks, P = 0.1). The intracluster correlation coefficient was 0.03 across all practices. CONCLUSION Providing GPs with open access to HSG had no effect on the time taken to reach a diagnosis and management plan for couples with infertility.

A randomized controlled trial in non-responders from Newcastle upon Tyne invited to return a self-sample for Human Papillomavirus testing versus repeat invitation for cervical screening.

Background Non-attenders for cervical screening are at increased risk of cervical cancer. Studies offering self-sampling for high-risk Human Papillomavirus (HrHPV) testing have shown greater uptake than sending another invitation for cytology. Objectives To explore whether uptake would increase in a less diverse, more stable population than the previous English study, which demonstrated a lower response rate than other studies. The primary objective was whether non-attenders were more likely to respond to a postal invitation, including kit, to collect a self-sample compared with a further invitation for cytology screening. The secondary objective was whether women with an abnormal result would attend for follow-up. Methods 6000 non-attenders for screening in this pragmatic, randomized (1:1) controlled trial in Newcastle-upon-Tyne were sent an HPV self-sample kit (intervention) or a further invitation for cytology screening (comparator). Results 411(13%) responded to the intervention, returning a self-sample (247(8%)) or attending for cytology (164(5%)), compared with 183(6%) attending for cytology, relative risk 2.25 (95% CI 1.90–2.65) (comparator arm). Of those testing hrHPV positive (32(13%)), 19(59%) subsequently attended cytology screening. Of those in the intervention group who attended for cytology screening without returning an hrHPV self-sample (n = 164), 5% (n = 8) were referred for colposcopy - all attended. In the comparator group eight of the nine referred for colposcopy attended. Conclusion Persistent non-responders to invitations for cervical screening are significantly more likely to respond to a postal invitation to return a self-collected sample for HPV testing than a further invitation for cytology screening. However, just over half followed up on this positive HPV result.

Patient and professional views of open access hysterosalpingography for the initial management of infertility in primary care.

BACKGROUND Hysterosalpingography (HSG) is recommended as a first-line investigation for tubal assessment of infertile women. This investigation is not routinely available to GPs. AIM To explore the perceptions and attitudes of patients and health professionals to open access HSG for the initial management of infertile couples in general practice. DESIGN OF STUDY A nested qualitative study using in-depth interviews with GPs, fertility specialists, and infertile couples. SETTING Northumberland, Newcastle upon Tyne, North Tyneside, South Tyneside, and Gateshead. METHOD Participants were 39 interviewees: 12 GPs, five fertility specialists, and 13 infertile couples (nine interviewed with their partner). RESULTS Four themes emerged: personal factors; will it benefit patients, GPs, and fertility specialists?; professional factors; does it fit the role of a GP?; local context; do the skills exist in general practice?; and wider context; will it benefit the NHS? GPs who had used open access HSG, felt it was appropriate for general practice and would continue to use the service. All GPs, fertility specialists, and infertile couples who had experienced open access HSG wished the service to remain in place. The main barriers to its uptake were: infrequency with which infertility presents; lack of clarity on perceived responsibilities; difficulty keeping up to date, including assimilating guidelines; low clinical priority; and lack of support in authoritative guidance. CONCLUSION Providing GPs with open access to HSG would allow a full initial assessment of the infertile couple and refer women with blocked tubes directly to tertiary care. While there is general support for the provision of such a facility, the majority of GPs perceive its use as being by a limited number of GPs who have a special interest in infertility. The study findings can inform future development of infertility services at the interface between primary and secondary/tertiary care.

Contraceptive needs of women following bariatric surgery

With one in four adults classified as obese in the UK,1 bariatric surgery is becoming an increasingly common weight loss intervention. The number of procedures has increased from fewer than 1000 procedures performed in 2000 to almost 10 000 in 2010.1 Compared to diet, exercise and pharmacotherapy, bariatric surgery offers sustained, long-term weight loss2 and improvement in obesity-related conditions. Following surgery, published data suggest that patients can expect up to a 72% chance of remission of type 2 diabetes,3 46% resolution of hypertension4 and 75% improvement in sleep apnoea.5 Weight loss through bariatric surgery has also been shown to improve menstrual cycle disorders and theoretically to improve fertility.6 ,7 The National Institute for Health and Care Excellence (NICE) guideline on management of adult obesity recommends bariatric surgery when other weight loss interventions have failed.8 National Health Service criteria for surgery are determined by a body mass index (BMI) (in kg/m2), greater than 40, or 35 with significant disease that could be improved with weight loss, such as type 2 diabetes or hypertension. For severely obese patients with a BMI >50, bariatric surgery may be considered as a first-line option.8 The UK National Bariatric Surgery Registry (NBRS) shows that 80% of bariatric procedures were performed in women, with the majority being in the reproductive age group.1 Compared to women with a normal BMI, obese women may be up to three times more likely to experience infertility.7 Generally, women who undergo bariatric surgical procedures experience improved fertility and maternal outcomes compared to obese cohorts.6 ,7 There is a paucity of literature investigating the effects of the different bariatric procedures on contraceptive efficacy, and whether specific methods should be recommended. Current recommendations advise against pregnancy following bariatric surgery for …

Process evaluation of infertility management in primary care: has open access HSG been normalized?

Aim: To map the results of four empirical quantitative and qualitative studies to the Normalization Process Model (NPM) to explain why open access hysterosalpingography (HSG) for the initial management of infertile couples has or has not normalized in primary care. Background: The NPM is an applied theoretical model to help under- stand the factors that lead to the routine embedding of a complex intervention in everyday practice. Open access HSG has recently become available for the initial assessment of infertility in primary care. Methods: The results of two qualitative studies (a focus group study and an in-depth interview study with patients and pro- fessionals) and two quantitative studies (a pilot survey and a pragmatic cluster- randomized controlled trial) evaluating open access HSG are interpreted by mapping the results to the NPM. Findings: Application of the model shows that open access HSG would confer an advantage to all agencies if they could be sure that the expertise was present and supported within primary care. Conclusions: Open access HSG was adopted but not normalized into everyday practice. Despite demonstration of modest workability, it has been counteracted by limited integration. Further evaluation of integration within contexts is required.

The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial

BackgroundThe role of tonsillectomy in the management of adult tonsillitis remains uncertain and UK regional variation in tonsillectomy rates persists. Patients, doctors and health policy makers wish to know the costs and benefits of tonsillectomy against conservative management and whether therapy can be better targeted to maximise benefits and minimise risks of surgery, hence maximising cost-effective use of resources. NATTINA incorporates the first attempt to map current NHS referral criteria against other metrics of tonsil disease severity.Methods/designA UK multi-centre, randomised, controlled trial for adults with recurrent tonsillitis to compare the clinical and cost-effectiveness of tonsillectomy versus conservative management.An initial feasibility study comprises qualitative interviews to investigate the practicality of the protocol, including willingness to randomise and be randomised. Approximately 20 otolaryngology staff, 10 GPs and 15 ENT patients will be recruited over 5 months in all 9 proposed main trial participating sites.A 6-month internal pilot will then recruit 72 patients across 6 of the 9 sites. Participants will be adults with recurrent acute tonsillitis referred by a GP to secondary care. Randomisation between tonsillectomy and conservative management will be according to a blocked allocation method in a 1:1 ratio stratified by centre and baseline disease severity.If the pilot is successful, the main trial will recruit a further 528 patients over 18 months in all 9 participating sites. All participants will be followed up for a total of 24 months, throughout which both primary and secondary outcome data will be collected. The primary outcome is the number of sore throat days experienced over the 24-month follow-up. The pilot and main trials include an embedded qualitative process evaluation.DiscussionNATTINA is designed to evaluate the relative effectiveness and efficiency of tonsillectomy versus conservative management in patients with recurrent sore throat who are eligible for surgery. Most adult tonsil disease and surgery has an impact on economically active age groups, with individual and societal costs through loss of earnings and productivity. Avoidance of unnecessary operations and prioritisation of those individuals likely to gain most from tonsillectomy would reduce costs to the NHS and society.Trial registrationISRCTN55284102, Date of Registration: 4 August 2014