Dataset Information

An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction.

ABSTRACT:

Background

Transanal irrigation (TAI) has emerged as a key option when more conservative bowel management does not help spinal cord injured (SCI) individuals with neurogenic bowel dysfunction (NBD).

Aim

To investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD.

Design

We present an open, prospective efficacy study on Navina Smart, in individuals with NBD secondary to SCI, studied at three months.

Population

Eighty-nine consecutive consenting established SCI individuals (61 male; mean age 48, range 18-77) naïve to TAI treatment were recruited from ten centres in seven countries. Subjects had confirmed NBD of at least moderate severity (NBD score ?10).

Methods

Subjects were taught how to use the device at baseline assisted by the Navina Smart app, and treatment was tailored during phone calls until optimal TAI regime was achieved. The NBD score was measured at baseline and at three months follow up (mean 98 days). Safety analysis was performed on the complete population while per protocol (PP) analysis was performed on 52 subjects.

Results

PP analysis showed a significant decrease in mean NBD score (17.8 to 10, p<0.00001). In subjects with severe symptoms (defined as NBD score ?14), mean NBD scores decreased (19.4 to 10.9, p<0.0001). The number of subjects with severe symptoms decreased from 41 (79%) subjects at baseline to 16 (31%) at three months follow-up. Device failure accounted for the commonest cause for loss of data. Side effects possibly related to the device developed in 11 subjects (12%). Discontinuation due to failure of therapy to relieve symptoms was reported by 5 subjects (6%).

Conclusion

Navina Smart is effective for individuals with NBD, even those with severe symptoms; long-term data will follow. Whilst there were some device problems (addressed by the later stages of subject recruitment) the treatment was generally safe.

Clinical trial

(ClinicalTrials.gov number NCT02979808).

SUBMITTER: Emmanuel A

PROVIDER: S-EPMC7845961 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction.

Emmanuel Anton A Kurze Ines I Krogh Klaus K Ferreiro Velasco Maria Elena ME Christensen Peter P Del Popolo Giuilio G Bazzocchi Gabriele G Hultling Claes C Perrouin Verbe Brigitte B Bothig Ralf R Glott Thomas T Gonzalez Viejo Miguel Angel MA

PloS one 20210129 1

<h4>Background</h4>Transanal irrigation (TAI) has emerged as a key option when more conservative bowel management does not help spinal cord injured (SCI) individuals with neurogenic bowel dysfunction (NBD).<h4>Aim</h4>To investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD.<h4>Design</h4>We present an open, prospective efficacy study on Navina Smart, in individuals with NBD secondary to SCI, studied at three months.<h4>Population</h4>Eigh ...[more]

PMID: 33513187

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Project description:BackgroundElectronic medical record (EMR) chronic disease measurement can help direct primary care prevention and treatment strategies and plan health services resource management. Incomplete data and poor consistency of coded disease values within EMR problem lists are widespread issues that limit primary and secondary uses of these data. These issues were shared by the McMaster University Sentinel and Information Collaboration (MUSIC), a primary care practice-based research network (PBRN) located in Hamilton, Ontario, Canada.ObjectiveWe sought to develop and evaluate the effectiveness of new EMR interface tools aimed at improving the quantity and the consistency of disease codes recorded within the disease registry across the MUSIC PBRN.MethodsWe used a single-arm prospective trial design with preintervention and postintervention data analysis to assess the effect of the intervention on disease recording volume and quality. The MUSIC network holds data on over 75,080 patients, 37,212 currently rostered. There were 4 MUSIC network clinician champions involved in gap analysis of the disease coding process and in the iterative design of new interface tools. We leveraged terminology standards and factored EMR workflow and usability into a new interface solution that aimed to optimize code selection volume and quality while minimizing physician time burden. The intervention was integrated as part of usual clinical workflow during routine billing activities.ResultsAfter implementation of the new interface (June 25, 2017), we assessed the disease registry codes at 3 and 6 months (intervention period) to compare their volume and quality to preintervention levels (baseline period). A total of 17,496 International Classification of Diseases, 9th Revision (ICD9) code values were recorded in the disease registry during the 11.5-year (2006 to mid-2017) baseline period. A large gain in disease recording occurred in the intervention period (8516/17,496, 48.67% over baseline), resulting in a total of 26,774 codes. The coding rate increased by a factor of 11.2, averaging 1419 codes per month over the baseline average rate of 127 codes per month. The proportion of preferred ICD9 codes increased by 17.03% in the intervention period (11,007/17,496, 62.91% vs 7417/9278, 79.94%; χ21=819.4; P<.001). A total of 45.03% (4178/9278) of disease codes were entered by way of the new screen prompt tools, with significant increases between quarters (Jul-Sep: 2507/6140, 40.83% vs Oct-Dec: 1671/3148, 53.08%; χ21=126.2; P<.001).ConclusionsThe introduction of clinician co-designed, workflow-embedded disease coding tools is a very effective solution to the issues of poor disease coding and quality in EMRs. The substantial effectiveness in a routine care environment demonstrates usability, and the intervention detail described here should be generalizable to any setting. Significant improvements in problem list coding within primary care EMRs can be realized with minimal disruption to routine clinical workflow.

Dataset Information

An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction.

Background

Aim

Design

Population

Methods

Results

Conclusion

Clinical trial

Publications

An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction.

Similar Datasets

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