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Long term extension of a randomised controlled trial of probiotics using electronic health records.

ABSTRACT: Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in children born 2005-2007, with traditional fieldwork follow up to two years. Participants and trial outcomes were identified and analysed after five years using secure, routine, anonymised, person-based electronic health service databanks. At two years, we identified 93% of participants and compared fieldwork with electronic health records, highlighting areas of agreement and disagreement. Retention of children from lower socio-economic groups was improved, reducing volunteer bias. At 5 years we identified a reduced 82% of participants. These data allowed the trial's first robust analysis of asthma endpoints. We found no indication that probiotic supplementation to pregnant mothers and infants protected against asthma or eczema at 5 years. Continued longer-term follow up is technically straightforward.

SUBMITTER: Davies G

PROVIDER: S-EPMC5955897 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Long term extension of a randomised controlled trial of probiotics using electronic health records.

Davies Gareth G Jordan Sue S Brooks Caroline J CJ Thayer Daniel D Storey Melanie M Morgan Gareth G Allen Stephen S Garaiova Iveta I Plummer Sue S Gravenor Mike M

Scientific reports 20180516 1

Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in child ...[more]

PMID: 29769554

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Project description:BackgroundUse of electronic health records (EHR) to provide real-world data for research is established, but using EHR to deliver randomised controlled trials (RCTs) more efficiently is less developed. The Allergy AntiBiotics And Microbial resistAnce (ALABAMA) RCT evaluated a penicillin allergy assessment pathway versus usual clinical care in a UK primary care setting. The aim of this paper is to describe how EHRs were used to facilitate efficient delivery of a large-scale randomised trial of a complex intervention embracing efficient participant identification, supporting minimising GP workload, providing accurate post-intervention EHR updates of allergy status, and facilitating participant follow up and outcome data collection. The generalisability of the EHR approach and health economic implications of EHR in clinical trials will be reported in the main ALABAMA trial cost-effectiveness analysis.MethodsA descriptive account of the adaptation of functionality within SystmOne used to deliver/facilitate multiple trial processes from participant identification to outcome data collection.ResultsAn ALABAMA organisation group within SystmOne was established which allowed sharing of trial functions/materials developed centrally by the research team. The 'ALABAMA unit' within SystmOne was also created and provided a secure efficient environment to access participants' EHR data. Processes of referring consented participants, allocating them to a trial arm, and assigning specific functions to the intervention arm were developed by adapting tools such as templates, reports, and protocols which were already available in SystmOne as well as pathways to facilitate allergy de-labelling processes and data retrieval for trial outcome analysis.ConclusionsALABAMA is one of the first RCTs to utilise SystmOne EHR functionality and data across the RCT delivery, demonstrating feasibility and applicability to other primary care RCTs.Trial registrationClinicalTrials.gov: NCT04108637, registered 05/03/2019. ISRCTN: ISRCTN20579216.

Project description:BackgroundLong-term care (LTC) facilities are an important part of the health care industry, providing care to the fastest-growing group of the population. However, the adoption of electronic health records (EHRs) in LTC facilities lags behind other areas of the health care industry. One of the reasons for the lack of widespread adoption in the United States is that LTC facilities are not eligible for incentives under the Meaningful Use program. Implementation of an EHR system in an LTC facility can potentially enhance the quality of care, provided it is appropriately implemented, used, and maintained. Unfortunately, the lag in adoption of the EHR in LTC creates a paucity of literature on the benefits of EHR implementation in LTC facilities.ObjectiveThe objective of this systematic review was to identify the potential benefits of implementing an EHR system in LTC facilities. The study also aims to identify the common conditions and EHR features that received favorable remarks from providers and the discrepancies that needed improvement to build up momentum across LTC settings in adopting this technology.MethodsThe authors conducted a systematic search of PubMed, Cumulative Index of Nursing and Allied Health (CINAHL), and MEDLINE databases. Papers were analyzed by multiple referees to filter out studies not germane to our research objective. A final sample of 28 papers was selected to be included in the systematic review.ResultsResults of this systematic review conclude that EHRs show significant improvement in the management of documentation in LTC facilities and enhanced quality outcomes. Approximately 43% (12/28) of the papers reported a mixed impact of EHRs on the management of documentation, and 33% (9/28) of papers reported positive quality outcomes using EHRs. Surprisingly, very few papers demonstrated an impact on patient satisfaction, physician satisfaction, the length of stay, and productivity using EHRs.ConclusionsOverall, implementation of EHRs has been found to be effective in the few LTC facilities that have implemented them. Implementation of EHRs in LTC facilities caused improved management of clinical documentation that enabled better decision making.

Project description:ImportanceShort-term studies suggest antidepressants are associated with modest weight gain but little is known about longer-term effects and differences between individual medications in general clinical populations.ObjectiveTo estimate weight gain associated with specific antidepressants over the 12 months following initial prescription in a large and diverse clinical population.Design, setting, and participantsWe identified 22,610 adult patients who began receiving a medication of interest with available weight data in a large New England health care system, including 2 academic medical centers and affiliated outpatient primary and specialty care clinics. We used electronic health records to extract prescribing data and recorded weights for any patient with an index antidepressant prescription including amitriptyline hydrochloride, bupropion hydrochloride, citalopram hydrobromide, duloxetine hydrochloride, escitalopram oxalate, fluoxetine hydrochloride, mirtazapine, nortriptyline hydrochloride, paroxetine hydrochloride, venlafaxine hydrochloride, and sertraline hydrochloride. As measures of assay sensitivity, additional index prescriptions examined included the antiasthma medication albuterol sulfate and the antiobesity medications orlistat, phentermine hydrochloride, and sibutramine hydrochloride. Mixed-effects models were used to estimate rate of weight change over 12 months in comparison with the reference antidepressant, citalopram.Main outcome and measureClinician-recorded weight at 3-month intervals up to 12 months.ResultsCompared with citalopram, in models adjusted for sociodemographic and clinical features, significantly decreased rate of weight gain was observed among individuals treated with bupropion (β [SE]: -0.063 [0.027]; P = .02), amitriptyline (β [SE]: -0.081 [0.025]; P = .001), and nortriptyline (β [SE]: -0.147 [0.034]; P < .001). As anticipated, differences were less pronounced among individuals discontinuing treatment prior to 12 months.Conclusions and relevanceAntidepressants differ modestly in their propensity to contribute to weight gain. Short-term investigations may be insufficient to characterize and differentiate this risk.

Project description:Despite the benefits associated with longer buprenorphine treatment duration (i.e., >180 days) (BTD) for opioid use disorder (OUD), retention remains poor. Research on the impact of co-occurring psychiatric issues on BTD has yielded mixed results. It is also unknown whether the genetic risk in the form of polygenic scores (PGS) for OUD and other comorbid conditions, including problematic alcohol use (PAU) are associated with BTD. We tested the association between somatic and psychiatric comorbidities and long BTD and determined whether PGS for OUD-related conditions was associated with BTD. The study included 6686 individuals with a buprenorphine prescription that lasted for less than 6 months (short-BTD) and 1282 individuals with a buprenorphine prescription that lasted for at least 6 months (long-BTD). Recorded diagnosis of substance addiction and disorders (Odds Ratio (95% CI) = 22.14 (21.88-22.41), P = 2.8 × 10-116), tobacco use disorder (OR (95% CI) = 23.4 (23.13-23.68), P = 4.5 × 10-111), and bipolar disorder (OR(95% CI) = 9.70 (9.48-9.92), P = 1.3 × 10-91), among others, were associated with longer BTD. The PGS of OUD and several OUD co-morbid conditions were associated with any buprenorphine prescription. A higher PGS for OUD (OR per SD increase in PGS (95%CI) = 1.43(1.16-1.77), P = 0.0009), loneliness (OR(95% CI) = 1.39(1.13-1.72), P = 0.002), problematic alcohol use (OR(95%CI) = 1.47(1.19-1.83), P = 0.0004), and externalizing disorders (OR(95%CI) = 1.52(1.23 to 1.89), P = 0.0001) was significantly associated with long-BTD. Associations between BTD and the PGS of depression, chronic pain, nicotine dependence, cannabis use disorder, and bipolar disorder did not survive correction for multiple testing. Longer BTD is associated with diagnoses of psychiatric and somatic conditions in the EHR, as is the genetic score for OUD, loneliness, problematic alcohol use, and externalizing disorders.

Dataset Information

Long term extension of a randomised controlled trial of probiotics using electronic health records.

Publications

Long term extension of a randomised controlled trial of probiotics using electronic health records.

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