1717. The Impact of Routine Molecular Point-of-care Testing for Gastrointestinal Pathogens in Adults Hospitalized With Suspected Gastroenteritis: Results of a Pragmatic Randomized Controlled Trial (GastroPOC)

Abstract Background Adults hospitalised with diarrhoea are routinely isolated as an infection control measure, but many have non-infectious etiology. Side room facilities are a limited resource in hospitals. Routine laboratory testing takes several days to generate results but rapid molecular platforms can test comprehensively for GI pathogens and generate a result in 1 hour, making them deployable as point-of-care tests (POCT). POCT could reduce unnecessary isolation facility use in addition to other benefits. Methods In this pragmatic, pilot randomised controlled trial, adults hospitalised with suspected gastroenteritis were recruited and randomised 1:1 to receive either POCT (using the FilmArray GI panel) or routine clinical care. Results of POCT were communicated directly to clinical and infection control teams. The primary outcome was duration of time in a side room and secondary outcomes included turnaround time, proportion of patients with a pathogen detected, proportion of patients correctly de-isolated, time to de-isolation, antibiotic use and length of hospital stay. Results 140 patients were recruited. Groups (n = 70) were well matched in terms of baseline characteristics. The median [IQR] turnaround time for results was 1.7 [1.6–2.3] hours in the POCT group and 61 [49–84] hours in the control group, P < 0.0001. Pathogens were detected in 44% of patients in the POCT group and 23% in the control group; P = 0.012. Overall the duration of side room isolation was 1.9 [1.0–2.9] days in the POCT group compared with 2.7 [1.8–5.1] days in the control group; P = 0.001. For those testing negative for pathogens this was 1.3 [0.8–2.5] days in the POCT group versus 2.7 [1.8–5.0] days in the control group, P < 0.0001. 63% of pathogen-negative patients were correctly de-isolated in the POCT group versus 28% in the control group, P = 0.0012. Antibiotic use and length of stay data will be available subsequently. Conclusion POCT using the FilmArray GI panel resulted in a substantially reduced turnaround time for results and an increase in the proportion of patients with pathogens correctly detected. POCT was associated with a reduction in the duration of unnecessary side room use. If these benefits are confirmed in further studies and cost effectiveness is demonstrated, molecular POCT for GI pathogens should replace current diagnostic pathways. Disclosures T. Clark, BioFire LLC: Collaborator, Research support and Speaker honorarium. NIHR: Grant Investigator, Grant recipient.

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120. Impact of a Molecular Point-of-care ‘test and Treat’ Strategy for Influenza in Hospitalised adults: A Multi-centre, Randomised Controlled Trial (FluPOC)

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.430 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S188-S188

Author(s):

Tristan William Clark ◽

Kate Beard ◽

Nathan J Brendish ◽

Ahalya Malachira ◽

Samuel Mills ◽

...

Keyword(s):

Relative Risk ◽

Point Of Care ◽

Controlled Trial ◽

Clinical Care ◽

Group Versus ◽

Control Group ◽

Material Support ◽

Point Of Care Test ◽

Randomised Controlled ◽

Isolation Facility

Abstract Background The diagnosis of Influenza in hospitalised patients is delayed due to long turnaround times of laboratory testing, leading to inappropriate and late antiviral and isolation facility use. Molecular point-of-care test (mPOCT) are highly accurate, easy to use and generate results in under 1 hour but high quality evidence for their clinical impact is lacking. Methods In this multicentre, randomised controlled trial we enrolled adults hospitalised with acute respiratory illness during influenza seasons. Patients were randomised (1:1) to receive mPOCT for influenza or routine clinical care. The primary outcome was the proportion of influenza-infected patients who received antivirals. Secondary outcomes included time to antivirals, isolation facility use, and clinical outcome. This study is registered with ISRCTN, number:17197293, and has completed. Results Between December 2017 and May 2019, 613 patients were enrolled (307 assigned to mPOCT and 306 to routine care) and all were analysed. 100 (33%) of 307 patients in the mPOCT group and 102 (33%) of 306 in the control group had influenza. 100 (100%) of 100 influenza-infected patients were diagnosed in the mPOCT group and 60 (59%) of 102 were diagnosed though routine clinical care (relative risk 1·7, 95%CI 1·7 to 1·7;p< 0·0001). 99 (99%) of 100 influenza-infected patients received antivirals in the mPOCT group versus 63 (62%) 102 in the control group (relative risk 1·6, 95%CI 1·4 to 1·9;p< 0·0001). Median time to antivirals was 1·0 hour in the mPOCT group versus 6·0 hours in the control group (difference of 5·0 hours, 95%CI 0 to 6·0;p=0·004). 70 (70%) of 100 influenza-infected patients in the mPOCT group were nursed in single room accommodation versus 39 (38%) of 102 in the control group (relative risk 1·8, 95%CI 1·4 to 2·4;p< 0·0001). Median hospital recovery scale score (an ordinal 6 point scale used to assess patient outcome) at 7 days was lower in the mPOCT group verses the control group (p=0·045). Figure 1a: Time-to-event curve showing antiviral use over time in influenza-infected patients. Figure 1b: Time-to-event curve showing isolation facility use over time in influenza-infected patients. Conclusion Routine mPOCT for influenza was associated with enhanced influenza detection, improvements in appropriate and timely antiviral and isolation facility use, and more rapid clinical recovery. Disclosures Tristan William. Clark, BM MRCP DTM&H MD, BioFire Diagnostics (Other Financial or Material Support, Equiptment and consumables for the purposes of research)BioMerieux (Other Financial or Material Support, Equipment and consumables for the purposes of research)Qiagen (Other Financial or Material Support, Discounted Equipment and consumables for the purposes of research)

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Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol

BMJ Open ◽

10.1136/bmjopen-2019-031674 ◽

2019 ◽

Vol 9 (12) ◽

pp. e031674 ◽

Cited By ~ 2

Author(s):

Kate Beard ◽

Nathan Brendish ◽

Ahalya Malachira ◽

Samuel Mills ◽

Cathleen Chan ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Point Of Care ◽

Controlled Trial ◽

Clinical Care ◽

Respiratory Illness ◽

Acute Respiratory Illness ◽

National Guidelines ◽

South Central ◽

Randomised Controlled ◽

The Impact

BackgroundInfluenza infections often remain undiagnosed in patients admitted to hospital due to lack of routine testing. When tested for, the diagnosis and treatment of influenza are often delayed due to the slow turnaround times of centralised laboratory PCR testing. Newer molecular systems, have comparable accuracy to laboratory PCR testing, and can generate a result in under 1 hour, making them potentially deployable as point-of-care tests (POCTs). High-quality evidence for the impact of routine POCT for influenza on clinical outcomes is, however, currently lacking. This large pragmatic multicentre randomised controlled trial aims to address this evidence gap.Methods and analysisThe FluPOC trial is a pragmatic, multicentre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England. Up to 840 patients will be recruited over up to three influenza seasons, and randomised (1:1) to receive either POCT using the FilmArray respiratory panel, or routine clinical care. Clinical and infection control teams will be informed of the results in real time and where influenza is detected clinical teams will be encouraged to offer neuraminidase inhibitor (NAI) treatment in accordance with national guidelines. Those allocated to standard clinical care will have a swab taken for later analysis to allow assessment of missed diagnoses. The outcomes assessment will be by retrospective case note analysis. The outcome measures include the proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality.Ethics and disseminationPrior to commencing the study, approval was obtained from the South Central Hampshire A Ethics Committee (reference 17/SC/0368, granted 7 September 2017). Results generated from this protocol will be published in peer-reviewed scientific journals and presented at national and international conferences.Trial registration numberISRCTN17197293

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2796. The Impact of Syndromic Molecular Point-of-Care Testing for Respiratory Viruses on Antibiotic Use in Adults Presenting to Hospital with Exacerbation of Airways Disease: Further Analysis From a Randomized Controlled Trial

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.2473 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S988-S988

Author(s):

Tristan William Clark ◽

Samuel Mills ◽

Nathan Brendish

Keyword(s):

Point Of Care ◽

Survival Curve ◽

Controlled Trial ◽

Antibiotic Use ◽

Respiratory Viruses ◽

Influenza Viruses ◽

Rank Test ◽

Point Of Care Testing ◽

Early Discontinuation ◽

The Impact

Abstract Background The ResPOC study demonstrated that syndromic molecular point-of-care testing (POCT) for respiratory viruses was associated with earlier discontinuation of unnecessary antibiotics. Subgroup analysis suggests this occurs predominantly in patients with exacerbation of airways disease. Molecular POCT use is becoming widespread but there is a lack of evidence to inform the choice between multiplex syndromic panels vs. uniplex tests for influenza. Methods We evaluated patients with exacerbation of asthma or COPD who were treated with antibiotics. The duration of antibiotics and proportion with early discontinuation were compared between patients testing positive for viruses by POCT (FilmArray Respiratory Panel) those testing negative by POCT and controls. Patients testing positive for viruses by POCT were compared according to virus types detected. Survival curves were generated for duration of antibiotics and compared using the log-rank test. Results There were 118 patient with exacerbation of airways disease in the POCT group who received antibiotics and 111 in the controls. In the POCT group 49/118 (42%) patients tested positive for viruses. Of those testing positive for viruses by POCT 17/49 (35%) had early discontinuation of antibiotics vs. 9/81 (13%) in those testing negative and 7/111 (6%) in controls, P < 0.0001. Survival curve analysis showed a reduced time to antibiotic discontinuation in those testing positive for viruses, P = 0.034. Of those positive for viruses by POCT 20% were positive for influenza, 43% for rhinovirus and 37% for other viruses combined. The proportion with early discontinuation of antibiotics was not different between the virus types, P = 0.53. Conclusion Syndromic molecular POCT for viruses in adults with exacerbation of airways disease leads to early discontinuation in those positive for viruses. As most viruses detected were non-influenza viruses and there was no difference in antibiotic use between virus types, syndromic molecular POCT for respiratory viruses should be favored over uniplex POCT for influenza. Disclosures All authors: No reported disclosures.

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Impact of point-of-care tests in community pharmacies: a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2019-034298 ◽

2020 ◽

Vol 10 (5) ◽

pp. e034298 ◽

Cited By ~ 1

Author(s):

Ali Albasri ◽

Ann Van den Bruel ◽

Gail Hayward ◽

Richard J McManus ◽

James Peter Sheppard ◽

...

Keyword(s):

Systematic Review ◽

Point Of Care ◽

Controlled Trial ◽

Meta Analysis ◽

Clinical Care ◽

Cochrane Central Register ◽

Upper Respiratory Tract ◽

Review Team ◽

Tract Infections ◽

The Impact

ObjectivesTo summarise the literature regarding the use of point-of-care test (POCT) in pharmacies versus control/usual care.Design and settingSystematic review and random-effects meta-analysis in community pharmacy.Data sourcesMEDLINE, Cochrane Central Register of Controlled Trials, Embase, ClinicalTrial.gov and Web of Science databases were searched.Eligibility criteriaArticles were included if they: involved a POCT conducted by a community pharmacist, member of pharmacy staff or local equivalent; measured a clinically relevant outcome for example, clinical parameter monitoring. No clinical condition or language limits were set.Patient and public involvementNo patient involvement.Data extraction and synthesisData were independently extracted by two members of the review team to capture changes in clinical care that resulted from the use of the POCTs. The methodological quality of included studies was assessed, using the Cochrane Risk of Bias tool and Newcastle-Ottawa scale.ResultsThirteen of the 1584 articles found were included in the meta-analyses. Studies covered four therapeutic areas: targeted anti-malarial therapy (n=3 studies), glycated haemoglobin (HbA1c) in diabetes (n=2 studies), lipid control (n=3 studies) and international normalised ratio (INR) control in patients taking warfarin (n=5 studies). POCT in pharmacies reduced the risk of receiving antimalarial treatment when not clinically indicated (risk ratio 0.34, 95% CI 0.31 to 0.37). Lipid and HbA1c control appeared largely unaffected by pharmacy POCTs, and the impact on INR time-in-therapeutic-range was inconclusive.ConclusionsOnly 4 out of 13 included studies used a gold-standard randomised controlled trial (RCT) design, limiting our ability to conclusively determine the clinical utility of POCT conducted in pharmacies. Further RCTs are needed, particularly in areas such as upper respiratory tract infections, which have gathered momentum among service commissioners in recent years.PROSPERO registration numberCRD42017048578.

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Rapid syndromic PCR testing in patients with respiratory tract infections reduces time to results and improves microbial yield

Scientific Reports ◽

10.1038/s41598-021-03741-7 ◽

2022 ◽

Vol 12 (1) ◽

Author(s):

S. Serigstad ◽

D. Markussen ◽

H. M. S. Grewal ◽

M. Ebbesen ◽

Ø. Kommedal ◽

...

Keyword(s):

Respiratory Tract ◽

Influenza A ◽

Controlled Trial ◽

Antibiotic Use ◽

Turnaround Time ◽

Community Acquired Pneumonia ◽

Diagnostic Methods ◽

Randomised Controlled ◽

Tract Infections ◽

The Impact

AbstractLack of rapid and comprehensive microbiological diagnosis in patients with community acquired pneumonia (CAP) hampers appropriate antimicrobial therapy. This study evaluates the real-world performance of the BioFire FilmArray Pneumonia panel plus (FAP plus) and explores the feasibility of evaluation in a randomised controlled trial. Patients presenting to hospital with suspected CAP were recruited in a prospective feasibility study. An induced sputum or an endotracheal aspirate was obtained from all participants. The FAP plus turnaround time (TAT) and microbiological yield were compared with standard diagnostic methods (SDs). 96/104 (92%) enrolled patients had a respiratory tract infection (RTI); 72 CAP and 24 other RTIs. Median TAT was shorter for the FAP plus, compared with in-house PCR (2.6 vs 24.1 h, p < 0.001) and sputum cultures (2.6 vs 57.5 h, p < 0.001). The total microbiological yield by the FAP plus was higher compared to SDs (91% (162/179) vs 55% (99/179), p < 0.0001). Haemophilus influenzae, Streptococcus pneumoniae and influenza A virus were the most frequent pathogens. In conclusion, molecular panel testing in adults with CAP was associated with a significant reduction in time to actionable results and increased microbiological yield. The impact on antibiotic use and patient outcome should be assessed in randomised controlled trials.

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Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

Journal of Evidence-Based Psychotherapies ◽

10.24193/jebp.2020.2.14 ◽

2020 ◽

Vol 20 (2) ◽

pp. 101-120

Author(s):

Ayça Aktaç Gürbüz ◽

Orçun YORULMAZ ◽

Gülşah DURNA

Keyword(s):

Obsessive Compulsive Disorder ◽

Intervention Program ◽

Controlled Trial ◽

Community Sample ◽

Case Vignette ◽

Control Group ◽

Obsessive Compulsive ◽

Compulsive Disorder ◽

Significant Difference ◽

The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

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Impact of an Amaranth-Sorghum Grains Product on Nutrient Intake of Children Aged 6-23 Months in Kiandutu Slums, Thika, Kenya

10.37512/700 ◽

2020 ◽

Keyword(s):

Nutrition Education ◽

Nutrient Intake ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Composite Flour ◽

Monthly Basis ◽

Sorghum Flour ◽

Baseline Characteristics ◽

The Impact

Poor quality complementary foods contribute to undernutrition in children aged 6-23 months. Therefore, there is need to explore foods that will provide adequate nutrients for this age group. This study aimed at determining the impact of a sorghum-amaranth composite flour porridge on nutrient intake of children aged 6-23 months. A randomized controlled trial was conducted at Kiandutu slum, Thika, Kenya. Children in the control group (CG), received a maize-sorghum flour while those in the treatment group (TG) received an amaranth-sorghum flour. The sample size per study group was 73 mother-child pairs. The children in the TG received Kcal 1000 worth of porridge/day while those in the CG received Kcal 266.8/day. Mothers of children in both groups were given nutrition education at baseline, and monthly, for six months. Food intake data was taken at baseline, then monthly for six months. Descriptive statistics were used to describe nutrient intake. Chi square and Mann Whitney U test were was used to compare the baseline characteristics of the two groups and their nutrient intake, respectively. At baseline characteristics of the two groups were similar. On a monthly basis, nutrient intake in the TG was significantly higher for a majority of the nutrients than in the CG. The product can contribute to preventing under-nutrition in children aged 6-23 months.

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Regression of cardiac amyloid deposits with novel therapeutics: reaching new frontiers in cardiac ATTR amyloidosis

European Heart Journal ◽

10.1093/ehjci/ehaa946.2117 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

L Chacko ◽

A Martinez-Naharro ◽

T Kotecha ◽

R Martone ◽

D Hutt ◽

...

Keyword(s):

Treatment Group ◽

Cardiac Amyloidosis ◽

T1 Mapping ◽

Group Versus ◽

Control Group ◽

Cardiac Amyloid ◽

Attr Amyloidosis ◽

Amyloid Load ◽

The Impact

Abstract Background Cardiac involvement is the main driver of outcome in ATTR amyloidosis. Advances in therapeutics hold potential in transforming the course of the disease but the impact on cardiac amyloid load is unknown. The aim of this study was to evaluate the impact of patisiran, a new double stranded RNA based gene silencing therapy and a stabilizer, diflunisal, on cardiac amyloid load as measured by CMR and T1 mapping, in patients with ATTR amyloidosis. Methods and results Thirty-two patients with hereditary cardiac amyloidosis were studied. Sixteen patients received treatment with patisiran, and sixteen control subjects did not receive any disease modifying treatment. Patients were assessed with echocardiogram, CMR, NT-proBNP and six-minute walk time measurements at baseline and at 1 year (Mean interval 11.45±3.08 months in treatment group, mean interval 12.82±5.06 months in the control group). CMR analysis comprised LV volumes, T1 mapping to measure the extracellular volume (ECV) occupied by amyloid, T2 mapping and late gadolinium enhancement imaging. At 1-year follow-up, there was a substantial reduction in cardiac amyloid burden, in keeping with cardiac amyloid regression in 45% of patients on treatment. Overall the treatment group showed a reduction in ECV at 1 year follow up compared to an increase in ECV at 1 year in the control group (−1.37%, 95% CI: −3.43 to 0.68% versus 5.02%, 95% CI: 2.86% to 7.18% respectively, p<0.001). The treatment group also showed an improvement in change in 6MWT at 1 year follow up compared to 6MWT at 1 year in the control group (−8.12 meters, 95% CI: −50.8 to 34.6 meters in the treatment group versus −132.27 meters, 95% CI: −216 to −48.6 meters in the control group, p=0.002). The treatment group showed a reduction in BNP at 1 year follow up compared to an increase in the control group (−567.87, 95% CI: −1288.90 to 153.15 in the treatment group versus 2004, 95% CI: 12.82 to 3995.45 in the control group, p<0.001). There was no significant difference from baseline and 1-year data between the control and treatment groups for the difference in echocardiographic parameters, native T1, T2. There was a significant reduction in the percentage of injected dose by 99Tc-DPD scintigraphy in treated patients at 1 year compared to baseline. Conclusions These findings provide the first compelling evidence of substantial cardiac amyloid regression in ATTR amyloidosis, as well as the potential for CMR to be used to track response in treated patients with ATTR cardiac amyloidosis. Combination therapy with transthyretin knock down and stabilizing agents may well be synergistic given enhanced stoichiometry of stabilizers in the face of much reduced plasma transthyretin concentration. Funding Acknowledgement Type of funding source: None

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Implementation of C-reactive protein point of care testing to improve antibiotic targeting in respiratory illness in Vietnamese primary care (ICAT): a study protocol for a cluster randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-040977 ◽

2020 ◽

Vol 10 (12) ◽

pp. e040977

Author(s):

Nga Thi Thuy Do ◽

Rachel Claire Greer ◽

Yoel Lubell ◽

Sabine Dittrich ◽

Maida Vandendorpe ◽

...

Keyword(s):

Primary Care ◽

Antibiotic Prescription ◽

Point Of Care ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Antibiotic Use ◽

Routine Care ◽

C Reactive Protein ◽

Reactive Protein ◽

Randomised Controlled

IntroductionC-reactive protein (CRP), a biomarker of infection, has been used widely in high-income settings to guide antibiotic treatment in patients presenting with respiratory illnesses in primary care. Recent trials in low- and middle-income countries showed that CRP testing could safely reduce antibiotic use in patients with non-severe acute respiratory infections (ARIs) and fever in primary care. The studies, however, were conducted in a research-oriented context, with research staff closely monitoring healthcare behaviour thus potentially influencing healthcare workers’ prescribing practices. For policy-makers to consider wide-scale roll-out, a pragmatic implementation study of the impact of CRP point of care (POC) testing in routine care is needed.Methods and analysisA pragmatic, cluster-randomised controlled trial, with two study arms, consisting of 24 commune health centres (CHC) in the intervention arm (provision of CRP tests with additional healthcare worker guidance) and 24 facilities acting as controls (routine care). Comparison between the treatment arms will be through logistic regression, with the treatment assignment as a fixed effect, and the CHC as a random effect. With 48 clusters, an average of 10 consultations per facility per week will result in approximately 520 over 1 year, and 24 960 in total (12 480 per arm). We will be able to detect a reduction of 12% to 23% or more in immediate antibiotic prescription as a result of the CRP POC intervention. The primary endpoint is the proportion of patient consultations for ARI resulting in immediate antibiotic prescription. Secondary endpoints include the proportion of all patients receiving an antibiotic prescription regardless of ARI diagnosis, frequency of re-consultation, subsequent antibiotic use when antibiotics are not prescribed, referral and hospitalisation.Ethics and disseminationThe study protocol was approved by the Oxford University Tropical Research Ethics Committee (OxTREC, Reference: 53–18), and the ethical committee of the National Hospital for Tropical Diseases in Vietnam (Reference:07/HDDD-NDTW/2019). Results from this study will be disseminated via meetings with stakeholders, conferences and publications in peer-reviewed journals. Authorship and reporting of this work will follow international guidelines.Trial registration detailsNCT03855215; Pre-results.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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