Desktop software to identify patients eligible for recruitment into
a clinical trial: using SARMA to recruit to the ROAD feasibility
trial

Treweek, Shaun; Pearson, Ewan R.; Neville, Ron; Sargeant, Paul; Boswell, Brian; Sullivan, Frank

doi:10.14236/jhi.v18i1.753

Cited by 24 publications

(35 citation statements)

References 12 publications

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“…We proposed to use TT software (formerly known as Scottish Acute Recruitment Multi-Agent), 34 as this had been used previously and was designed and piloted to meet our objectives (see Appendix 1 for more details).…”

Section: Trial Torrent Recruitment Softwarementioning

confidence: 99%

A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study

Francis

Ridd

Thomas-Jones

et al. 2016

Health Technol Assess

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BackgroundSecondary skin infection is common during eczema exacerbations and many children are treated with antibiotics when this is suspected, although there is little high-quality evidence to justify this practice.ObjectiveTo determine the clinical effectiveness of oral and topical antibiotics, in addition to standard treatment with emollients and topical corticosteroids, in children with clinically infected eczema.DesignMulticentre randomised, double-blind, placebo-controlled trial.SettingGeneral practices and dermatology clinics in England, Wales and Scotland.ParticipantsChildren (aged 3 months to < 8 years) with a diagnosis of eczema (according to U.K. Working Party definition) and clinical suspicion of infection.Interventions(1) Oral flucloxacillin and topical placebo; (2) topical fusidic acid (Fucidin®, Leo Laboratories Limited) and oral placebo; and (3) oral and topical placebos, all for 1 week.Main outcome measuresPatient-Orientated Eczema Measure (POEM) at 2 weeks (assessing subjective severity in the week following treatment).ResultsWe randomised 113 children (36 to oral antibiotic, 37 to topical antibiotic and 40 to placebo), which was fewer than our revised target sample size of 282. A total of 103 (92.0%) children had one or more clinical features suggestive of infection and 78 (69.6%) children hadStaphylococcus aureuscultured from a skin swab. Oral and topical antibiotics resulted in a 1.52 [95% confidence interval (CI) –1.35 to 4.40] and 1.49 (95% CI –1.55 to 4.53) increase (worse subjective severity) in POEM score at 2 weeks, relative to placebo and controlling for baseline POEM score. Eczema Area and Severity Index (objective severity) scores were also higher (worse) in the intervention groups, at 0.20 (95% CI –0.12 to 0.52) and 0.42 (95% CI 0.09 to 0.75) for oral and topical antibiotics, respectively, at 2 weeks. Analyses of impact on the family, quality of life, daily symptom scores, and longer-term outcomes were all consistent with the finding of no or limited difference and a trend towards worse outcomes in the intervention groups. Sensitivity analyses, including adjusting for compliance and imputation for missing data, were consistent with the main findings.ConclusionsOur data suggest that oral and topical antibiotics have no effect, or a harmful effect, on subjective eczema severity in children with clinically infected eczema in the community. The CIs around our estimates exclude a meaningful beneficial effect (published minimal clinically important difference for POEM is 3.4). Although most patients in this trial had features suggestive of infection andS. aureuson their skin, participants primarily had mild–moderate eczema and those with signs of more severe infection were often excluded. Clinicians should consider avoiding oral and topical antibiotic use in children with suspected infected eczema in the community who do not have signs of ‘severe infection’. Further research should seek to understand how best to encourage the use of topical steroids and limit use of antibiotics in those with eczema flares without signs of severe infection, as well as developing tools to better phenotype eczema flares, in order to better define a population that may benefit from antibiotic treatment.Trial registrationEuropean Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2011-003591-37 and Current Controlled Trials ISRCTN96705420.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Trial Torrent Recruitment Softwarementioning

confidence: 99%

A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study

Francis

Ridd

Thomas-Jones

et al. 2016

Health Technol Assess

Self Cite

View full text Add to dashboard Cite

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“…It is possible that the physicians judged patients unfit for the trial for reasons beyond the criteria that were considered by the CTRSS or that the patients were unwilling to participate. Séroussi and Bouaud [108], Weng et al [124], and Treweek et al [118] compared the effectiveness of their CTRSS with conventional methods of recruitment by running them in parallel over the whole study period. However, the lack of enrollment numbers for a preceding phase without the CTRSS made it impossible to quantify the effect of the CTRSS.…”

Section: Resultsmentioning

confidence: 99%

Employing Computers for the Recruitment into Clinical Trials: A Comprehensive Systematic Review

Köpcke

Prokosch²

2014

J Med Internet Res

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BackgroundMedical progress depends on the evaluation of new diagnostic and therapeutic interventions within clinical trials. Clinical trial recruitment support systems (CTRSS) aim to improve the recruitment process in terms of effectiveness and efficiency.ObjectiveThe goals were to (1) create an overview of all CTRSS reported until the end of 2013, (2) find and describe similarities in design, (3) theorize on the reasons for different approaches, and (4) examine whether projects were able to illustrate the impact of CTRSS.MethodsWe searched PubMed titles, abstracts, and keywords for terms related to CTRSS research. Query results were classified according to clinical context, workflow integration, knowledge and data sources, reasoning algorithm, and outcome.ResultsA total of 101 papers on 79 different systems were found. Most lacked details in one or more categories. There were 3 different CTRSS that dominated: (1) systems for the retrospective identification of trial participants based on existing clinical data, typically through Structured Query Language (SQL) queries on relational databases, (2) systems that monitored the appearance of a key event of an existing health information technology component in which the occurrence of the event caused a comprehensive eligibility test for a patient or was directly communicated to the researcher, and (3) independent systems that required a user to enter patient data into an interface to trigger an eligibility assessment. Although the treating physician was required to act for the patient in older systems, it is now becoming increasingly popular to offer this possibility directly to the patient.ConclusionsMany CTRSS are designed to fit the existing infrastructure of a clinical care provider or the particularities of a trial. We conclude that the success of a CTRSS depends more on its successful workflow integration than on sophisticated reasoning and data processing algorithms. Furthermore, some of the most recent literature suggest that an increase in recruited patients and improvements in recruitment efficiency can be expected, although the former will depend on the error rate of the recruitment process being replaced. Finally, to increase the quality of future CTRSS reports, we propose a checklist of items that should be included.

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“…Strategies such as placing researchers with honorary contracts into practices have been suggested as an alternative method of accessing records [27], methods have also been piloted to use "agents" (software to flag eligible patients) to meet this need [28]. However, all of these methods, including SAPREL rely on the clinicians responsible for patient's health data having trust in the professionalism of the person extracting these data [29].…”

Section: Discussionmentioning

confidence: 99%

Detecting referral and selection bias by the anonymous linkage of practice, hospital and clinic data using Secure and Private Record Linkage (SAPREL): case study from the evaluation of the Improved Access to Psychological Therapy (IAPT) service

Lusignan

Navarro

Chan

et al. 2011

BMC Med Inform Decis Mak

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BackgroundThe evaluation of demonstration sites set up to provide improved access to psychological therapies (IAPT) comprised the study of all people identified as having common mental health problems (CMHP), those referred to the IAPT service, and a sample of attenders studied in-depth. Information technology makes it feasible to link practice, hospital and IAPT clinic data to evaluate the representativeness of these samples. However, researchers do not have permission to browse and link these data without the patients' consent.ObjectiveTo demonstrate the use of a mixed deterministic-probabilistic method of secure and private record linkage (SAPREL) - to describe selection bias in subjects chosen for in-depth evaluation.MethodWe extracted, pseudonymised and used fuzzy logic to link multiple health records without the researcher knowing the patient's identity. The method can be characterised as a three party protocol mainly using deterministic algorithms with dynamic linking strategies; though incorporating some elements of probabilistic linkage. Within the data providers' safe haven we extracted: Demographic data, hospital utilisation and IAPT clinic data; converted post code to index of multiple deprivation (IMD); and identified people with CMHP. We contrasted the age, gender, ethnicity and IMD for the in-depth evaluation sample with people referred to IAPT, use hospital services, and the population as a whole.ResultsThe in IAPT-in-depth group had a mean age of 43.1 years; CI: 41.0 - 45.2 (n = 166); the IAPT-referred 40.2 years; CI: 39.4 - 40.9 (n = 1118); and those with CMHP 43.6 years SEM 0.15. (n = 12210). Whilst around 67% of those with a CMHP were women, compared to 70% of those referred to IAPT, and 75% of those subject to in-depth evaluation (Chi square p < 0.001). The mean IMD score for the in-depth evaluation group was 36.6; CI: 34.2 - 38.9; (n = 166); of those referred to IAPT 38.7; CI: 37.9 - 39.6; (n = 1117); and of people with CMHP 37.6; CI 37.3-37.9; (n = 12143).ConclusionsThe sample studied in-depth were older, more likely female, and less deprived than people with CMHP, and fewer had recorded ethnic minority status. Anonymous linkage using SAPREL provides insight into the representativeness of a study population and possible adjustment for selection bias.

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Desktop software to identify patients eligible for recruitment into a clinical trial: using SARMA to recruit to the ROAD feasibility trial

Cited by 24 publications

References 12 publications

A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study

A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study

Employing Computers for the Recruitment into Clinical Trials: A Comprehensive Systematic Review

Detecting referral and selection bias by the anonymous linkage of practice, hospital and clinic data using Secure and Private Record Linkage (SAPREL): case study from the evaluation of the Improved Access to Psychological Therapy (IAPT) service

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