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

Abstract

BackgroundGPs 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. AimTo 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 studyA pragmatic cluster randomised controlled trial. SettingSeventy-one of 173 general practices in north-east England agreed to participate. MethodA 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. ResultsAn 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. ConclusionProviding GPs with open access to HSG had no effect on the time taken to reach a diagnosis and management plan for couples with infertility.

How usual is usual care in pragmatic intervention studies in primary care? An overview of recent trials

“…Other expressions were also used, such as 'routine care', 15,29,35,63 'usual practice', 41 'normal care', 34 'standard care', 49,78 'care as usual', 55 'usual policy', 60 'usual service', 76 and 'usual management'. 84 Other authors did not use a specific expression.…”

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

“…Both the pilot survey and the cluster-randomized controlled trial demonstrated a shorter time for couples to reach a diagnosis and management plan for those that had open access HSG performed (Wilkes et al 2006;Wilkes et al 2009a). This was reflected in the opinion of the interviewees.…”

“…In this paper, the results of four studies evaluating open access HSG in the initial management of infertility in general practice were mapped to the NPM constructs (Wilkes, 2007). A brief outline of each study is presented, and the studies themselves are described elsewhere (Wilkes et al, 2006;2007;2009a;2009b Practices allocated to the intervention group had access to HSG for those infertile women who fulfilled pre-defined eligibility criteria. The primary outcome measure was the interval between presentation to the GP and the couple receiving a diagnosis and management plan.…”

“…(Female patient; interviewee F10) (Wilkes et al, 2009b) (Wilkes et al, 2009b) In the cluster-randomized trial, 9% of infertile couples had open access HSG performed and reached the primary outcome sooner than those that did not (Wilkes et al, 2009a). The uptake of open access HSG could have risen to a maximum of 25% if all eligible couples were put forward for the investigation (Wilkes et al, 2006).…”

Direct access to diagnostic services

“…3,4 The OATS trial, reported in this issue of the BJGP, evaluates hysterosalpingography for the investigation of primary infertility. 5,6 Previous research suggests that the principle benefit for patients of direct access to diagnostic services is reduced waiting time from presentation to testing and hence treatment. Both the DAMASK and OATS trials echo these findings in showing markedly shorter waiting times for those patients whose GPs used direct access.…”