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BackgroundA randomised controlled trial (RCT) in general practice, recruiting incident patients with (sub)acute sciatica, was discontinued because of insufficient recruitment.AimTo describe factors that influenced the recruitment process and ultimately led to discontinuation of this trial, and to enable others to learn from this experience.Design & settingA pragmatic RCT was designed to compare two pain medication prescription strategies for treatment of (sub)acute sciatica in general practice. After 1 year of patient recruitment, the trial was prematurely terminated.MethodTo analyse the underperforming recruitment, patient information systems of 20 general practices were screened twice a month to search for eligible patients and identify reasons for non-eligibility. Secondly, after study termination, an open question was distributed to the participating GPs for their views on the recruitment process.ResultsA total of 116 GPs from 37 general practices collaborated in the trial. Only eight of 234 patients were included after 12 months. The 22 GPs who offered their opinion on the main reasons for unsuccessful recruitment considered that these were the low incidence rate and strict eligibility criteria, a strong patient and/or GP preference, and time constraints.ConclusionFor this RCT, multiple factors were related to recruitment problems but it remains unknown which determinants prevailed. As the research question is unanswered but remains relevant, it is recommended that GPs’ daily practice is taken into account when designing an RCT, a pilot study should be performed for feasibility of recruitment, and GP assistants should be involved at an early stage.
Three clinical prediction models were developed for nonrecovery in older adults seeking care for back pain; the model predicting persistent disability performed best (optimism-adjusted R 2 46%, area under the curve 0.85).
Back pain is a prevalent health problem. Research often focuses on adults. Evidence on the long-term course of back pain in older patients is limited. A prospective cohort study (BACE) was conducted in a primary care setting in the Netherlands. We aim to investigate the 5-year course and medical consumption of older adults (>55 years) presenting with back pain in general practice. Methods: Patients aged >55 years, consulting their general practitioner with a new back pain episode, were included between 2009 to 2011. Follow-up questionnaires included, for example, pain severity, disability, quality of life, recovery, and medical consumption. Results: A total of 675 patients (mean age ؎ SD, 66.4 ؎ 7.6 years) participated, showing a mean (؎ SD) back pain reduction from 5.2 (؎ 2.7) to 3.6 (؎ 2.8) (numeric rating scale, 0 to 10) at 3 months follow-up; disability decreased from 9.8 (؎ 5.8) to 7.8 (؎ 6.2) (Roland-Morris Disability Questionnaire, 0 to 24). After 6 months, this remained practically constant over time. Medical consumption was highest in the first months; medication was used by 72% at baseline and approximately onethird (25% to 39%) during follow-up. At 5-year follow-up (response rate 58%; n ؍ 392), 43% had recovered; a majority reported persistent or recurrent back pain. Conclusion: Clinically relevant improvements in back pain intensity and disability were seen in the first 3 to 6 months of follow-up. A majority of patients does not become pain free within 3 months; this does not improve over 5 years. However, most patients stop consulting health care professionals during follow-up. Current medical strategies may not be sufficient in older back pain patients, where back pain becomes a recurrent or chronic condition in the majority of patients.
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