Pragmatic randomised controlled trial to evaluate guidelines for the management of infertility across the primary care-secondary care

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Abstract
Objective: To investigate the effect of clinical guidelines on the management of infertility across the primary care-secondary care interface. Design: Cluster randomised controlled trial. Setting: General practices and NHS hospitals accepting referrals for infertility in the Greater Glasgow Health Board area. Participants: All 221 general practices in Glasgow; 214 completed the trial. Intervention: General practices in the intervention arm received clinical guidelines developed locally. Control practices received them one year later. Dissemination of the guidelines included educational meetings. Main outcome measures: The time from presentation to referral, investigations completed in general practice, the number and content of visits as a hospital outpatient, the time to reach a management plan, and costs for referrals from the two groups. Results: Data on 689 referrals were collected. No significant difference was found in referral rates for infertility. Fewer than 1% of couples were referred inappropriately early. Referrals from intervention practices were significantly more likely to have all relevant investigations carried out (odds ratio 1.32, 95% confidence interval 1.00 to 1.75, P=0.025). 70% of measurements of serum progesterone concentrations during the midluteal phase and 34% of semen analyses were repeated at least once in hospital, despite having been recorded as normal when checked in general practice. No difference was found in the proportion of referrals in which a management plan was reached within one year or in the mean duration between first appointment and date of management plan. NHS costs were not significantly affected. Conclusions: Dissemination of infertility guidelines by commonly used methods results in a modest increase in referrals having recommended investigations completed in general practice, but there are no detectable differences in outcome for patients or reduction in costs. Clinicians in secondary care tended to fail to respond to changes in referral practice by doctors. Guidelines that aim to improve the referral process need to be disseminated and implemented so as to lead to changes in both primary care and secondary care. What is already known on this topic What is already known on this topic Most previous research into clinical guidelines has focused on their development and implementation Evidence is lacking about the outcomes and costs associated with the use of clinical guidelines What this study adds What this study adds Clinical guidelines that may alter the balance of care between general practice and hospital settings require more intensive implementation than guidelines aimed at either setting on its own The cost effectiveness of clinical guidelines should not be assumed