The range of bicycle helmet performance at real world impact locations

2021 ◽  
pp. 175433712110577
Author(s):  
Ann R Harlos ◽  
Steven Rowson
Keyword(s):  
Real World ◽  
Test Line ◽  
Linear Acceleration ◽  
The United States ◽  
Consumer Product Safety Commission ◽  
Bicycle Helmets ◽  
Impact Location ◽  
Increased Risk ◽  
Post Hoc ◽  
The Impact

In the United States, all bicycle helmets must comply with the standard created by the Consumer Product Safety Commission (CPSC). In this standard, bike helmets are only required to by tested above an established test line. Unregulated helmet performance below the test line could pose an increased risk of head injury to riders. This study quantified the impact locations of damaged bike helmets from real-world accidents and tested the most commonly impacted locations under CPSC bike helmet testing protocol. Ninety-five real-world impact locations were quantified. The most common impact locations were side-middle (31.6%), rear boss-rim (13.7%), front boss-rim (9.5%), front boss-middle (9.5%), and rear boss-middle (9.5%). The side-middle, rear boss-rim, and front boss (front boss-middle and front boss-rim regions combined) were used for testing. Two of the most commonly impacted regions were below the test line (front boss-rim and rear boss-rim). Twelve purchased helmet models were tested under CPSC protocol at each location for a total of 36 impacts. An ANOVA test showed that impact location had a strong influence on the variance of peak linear acceleration (PLA) ( p = 0.002). A Tukey HSD post hoc test determined that PLA at the side-middle (214.9 ± 20.8 g) and front boss (228.0 ± 39.6 g) locations were significantly higher than the PLA at the rear boss-rim (191.5 ± 24.2 g) location. The highest recorded PLA (318.8 g) was at the front boss-rim region. This was the only test that exceeded the 300 g threshold. This study presented a method for quantifying real-world impact locations of damaged bike helmets. Higher variance in helmet performance was found at the regions on or below the test line than at the region above the test line.

scholarly journals Football concussion case series using biomechanical and video analysis

Neurology ◽  
2018 ◽  
Vol 91 (23 Supplement 1) ◽  
pp. S2.2-S2
Author(s):  
Mirellie Kelley ◽  
Jillian Urban ◽  
Derek Jones ◽  
Alexander Powers ◽  
Christopher T. Whitlow ◽  
...  
Keyword(s):  
Video Analysis ◽  
Case Series ◽  
Linear Acceleration ◽  
The United States ◽  
Head Impact ◽  
Rotational Acceleration ◽  
Impact Location ◽  
Injury Mechanisms ◽  
The Mean ◽  
Impact Data

Approximately 1.1–1.9 million sport-related concussions among athletes ≤18 years of age occur annually in the United States, but there is limited understanding of the biomechanics and injury mechanisms associated with concussions among lower level football athletes. Therefore, the objective of this study was to combine biomechanical head impact data with video analysis to characterize youth and HS football concussion injury mechanisms. Head impact data were collected from athletes participating on 22 youth and 6 HS football teams between 2012 and 2017. Video was recorded, and head impact data were collected during all practices and games by instrumenting players with the Head Impact Telemetry (HIT) System. For each clinically diagnosed concussion, a video abstraction form was completed, which included questions concerning the context in which the injury occurred. Linear acceleration, rotational acceleration, and impact location were used to characterize the concussive event and each injured athlete's head impact exposure on the day of the concussion. A total of 9 (5 HS and 4 youth) concussions with biomechanics and video of the event were included in this study. The mean [range] linear and rotational acceleration of the concussive impacts were 62.9 [29.3–118.4] g and 3,056.7 [1,046.8–6,954.6] rad/s2, respectively. Concussive impacts were the highest magnitude impacts for 6 players and in the top quartile of impacts for 3 players on the day of injury. Concussions occurred in both practices (N = 4) and games (N = 5). The most common injury contact surface was helmet-to-helmet (N = 5), followed by helmet-to-ground (N = 3) and helmet-to-body (N = 1). All injuries occurred during player-to-player contact scenarios, including tackling (N = 4), blocking (N = 4), and collision with other players (N = 1). The biomechanics and injury mechanisms of concussions varied among athletes in our study; however, concussive impacts were among the highest severity for each player and all concussions occurred as a result of player-to-player contact.

scholarly journals Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Daniel C. Beachler ◽  
Cynthia de Luise ◽  
Aziza Jamal-Allial ◽  
Ruihua Yin ◽  
Devon H. Taylor ◽  
...  
Keyword(s):  
Breast Cancer ◽  
United States ◽  
Pulmonary Embolism ◽  
Cohort Study ◽  
Real World ◽  
The United States ◽  
Elevated Risk ◽  
Breast Cancer Patients ◽  
Increased Risk ◽  
Serious Infections

Abstract Background There is limited real-world safety information on palbociclib for treatment of advanced stage HR+/HER2- breast cancer. Methods We conducted a cohort study of breast cancer patients initiating palbociclib and fulvestrant from February 2015 to September 2017 using the HealthCore Integrated Research Database (HIRD), a longitudinal claims database of commercial health plan members in the United States. The historical comparator cohort comprised patients initiating fulvestrant monotherapy from January 2011 to January 2015. Propensity score matching and Cox regression were used to estimate hazard ratios for various safety events. For acute liver injury (ALI), additional analyses and medical record validation were conducted. Results There were 2445 patients who initiated palbociclib including 566 new users of palbociclib-fulvestrant, and 2316 historical new users of fulvestrant monotherapy. Compared to these historical new users of fulvestrant monotherapy, new users of palbociclib-fulvestrant had a greater than 2-fold elevated risk for neutropenia, leukopenia, thrombocytopenia, stomatitis and mucositis, and ALI. Incidence of anemia and QT prolongation were more weakly associated, and incidences of serious infections and pulmonary embolism were similar between groups after propensity score matching. After adjustment for additional ALI risk factors, the elevated risk of ALI in new users of palbociclib-fulvestrant persisted (e.g. primary ALI algorithm hazard ratio (HR) = 3.0, 95% confidence interval (CI) = 1.1–8.4). Conclusions This real-world study found increased risks of several adverse events identified in clinical trials, including neutropenia, leukopenia, and thrombocytopenia, but no increased risk of serious infections or pulmonary embolism when comparing new users of palbociclib-fulvestrant to fulvestrant monotherapy. We observed an increased risk of ALI, extending clinical trial findings of significant imbalances in grade 3/4 elevations of alanine aminotransferase (ALT).

scholarly journals Real-world evidence on sodium-glucose cotransporter-2 inhibitor use and risk of Fournier’s gangrene

2020 ◽  
Vol 8 (1) ◽  
pp. e000985 ◽  
Author(s):  
Jeff Yufeng Yang ◽  
Tiansheng Wang ◽  
Virginia Pate ◽  
John B Buse ◽  
Til Stürmer
Keyword(s):  
Real World ◽  
Fournier’S Gangrene ◽  
Sensitivity Analyses ◽  
Standardized Mortality Ratio ◽  
Fournier's Gangrene ◽  
Diagnosis Codes ◽  
Sodium Glucose Cotransporter ◽  
Real World Evidence ◽  
Increased Risk ◽  
The Impact

BackgroundSodium-glucose cotransporter-2 inhibitors (SGLT2i) have been associated with increased occurrence of Fournier’s gangrene (FG), a rare but serious form of necrotizing fasciitis, leading to a warning from the Food and Drug Administration. Real-world evidence on FG is needed to validate this warning.MethodsWe used data from IBM MarketScan (2013–2017) to compare the incidence of FG among adult patients who initiated either SGLT2i, a dipeptidyl peptidase-4 inhibitor (DPP4i), or any non-SGLT2i antihyperglycemic medication. FG was defined using inpatient International Classification of Diseases, Ninth Edition and Tenth Edition diagnosis codes 608.83 and N49.3, respectively, combined with procedure codes for debridement, surgery, or systemic antibiotics. We estimated crude incidence rates (IRs) using Poisson regression, and crude and adjusted HRs (aHR) and 95% CIs using standardized mortality ratio-weighted Cox proportional hazards models. Sensitivity analyses examined the impact of alternative outcome definitions.ResultsWe identified 211 671 initiators of SGLT2i (n=93 197) and DPP4i (n=118 474), and 305 329 initiators of SGLT2i (n=32 868) and non-SGLT2i (n=272 461). Crude FG IR ranged from 3.2 to 3.8 cases per 100 000 person-years during a median follow-up of 0.51–0.58 years. Compared with DPP4i, SGLT2i initiation was not associated with increased risk of FG for any outcome definition, with aHR estimates ranging from 0.25 (0.04–1.74) to 1.14 (0.86–1.51). In the non-SGLT2i comparison, we observed an increased risk of FG for SGLT2i initiators when using FG diagnosis codes alone, using all diagnosis settings (aHR 1.80; 0.53–6.11) and inpatient diagnoses only (aHR 4.58; 0.99–21.21).ConclusionsNo evidence of increased risk of FG associated with SGLT2i was observed compared with DPP4i, arguably the most relevant clinical comparison. However, uncertainty remains based on potentially higher risk in the broader comparison with all non-SGLT2i antihyperglycemic agents and the rarity of FG.Trial registration numberEUPAS Register Number 30018.

scholarly journals Emicizumab-Kxwh for Previously Untreated Patients with Haemophilia: The Conversation Begins

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2409-2409
Author(s):  
Tiffany Lin Lucas ◽  
Shveta Gupta ◽  
Joanna A. Davis ◽  
Fernando F. Corrales-Medina
Keyword(s):  
Board Of Directors ◽  
Real World ◽  
Research Funding ◽  
Hemophilia A ◽  
The United States ◽  
Haemophilia A ◽  
Advisory Committees ◽  
Inhibitor Development ◽  
Increased Risk ◽  
Prophylaxis Therapy

Introduction: With the Federal Drug and Administration approval of the use of emicizumab from birth to adulthood, clinicians will now grapple with when to choose and offer emicizumab for routine prophylaxis, especially in previously untreated patients (PUPs). Given the overall limited real-world reported data and experience using emicizumab in PUPs, we created and administered a survey to medical providers in the United States who care for paediatric patients with haemophilia to investigate real-world practice strategies and treatment selection for PUPs. Methods: After review and endorsement by the Haemostasis and Thrombosis Research Society (HTRS), the survey was electronically distributed by e-mail to all providers included in the HTRS core member list. The survey was also sent to those providers included in a list of Haemophilia Treatment Centre (HTC) physicians (with duplicate emails reconciled). Providers needed to self-identify as ones that treat pediatric patients to be included. The survey was developed as a tiered survey with questions presented to each recipient based on their prior responses. Results: Seventy-seven completed surveys were included and analysed. All participants were active providers at a comprehensive HTC and the majority (93.4%) were practicing at an academically affiliated site. In terms of characteristics of those that answered the survey, forty-eight percent of responders reported that 1-20% of their patients had expressed interest in emicizumab. 46% of participants (34/74) reported that they would personally consider emicizumab as their prophylaxis recommendation for the majority (>50%) of their hemophilia A patients without inhibitors. 57% (44/76) reported that 1-10% of their non-inhibitor hemophilia A patients were already prescribed emicizumab prophylaxis. Each participant was then asked about his or her consideration of emicizumab as prophylaxis therapy for a 2 month old PUP. Just over the majority were unsure or said no to this consideration (51.3%) and their concerns were lack of information on safety and efficacy in this young age group and increased risk for inhibitor development. If the 2 month old PUP had a high risk of inhibitor, the majority of providers who initially were hesitant to start emicizumab prophylaxis would remain so. Of note, those providers went on to be asked if the patient had gone on to complete 50 exposure days without inhibitor development, they would then become more likely to initiate emicizumab prophylaxis therapy. Use of concurrent factor replacement was posed to all participants and there were varied responses. Discussion: Overall, our results reflect a widespread practice variation and a not yet well-standardized or defined approach for the use of emicizumab in PUPs with haemophilia A. In this survey, patient preference and individual bleeding risk were the top reasons for which a provider would consider using switching to emicizumab prophylaxis in both severe and mild/moderate haemophilia A patients. This pattern of practice reflects the current era of individualized medicine. Overall, our findings reinforce the need for more studies to investigate the outcomes of a combined treatment approach with FVIII concentrates and emicizumab focusing in the potential benefit of this approach in decreasing the risk for inhibitor development PUPs. Clinicians also feel the need for further data to help clarifying the safety of emicizumab in this population. Figure Disclosures Gupta: Novartis: Honoraria, Speakers Bureau; CSL Behring: Research Funding; Novo Nordisk: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Octapharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda-Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Davis:Sanofi: Membership on an entity's Board of Directors or advisory committees; Kedrion: Membership on an entity's Board of Directors or advisory committees; Novo Nordisk: Membership on an entity's Board of Directors or advisory committees; CSL Behring: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda Shire: Consultancy; Spark Therapeutics: Consultancy. Corrales-Medina:Kedrion: Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda-Shire: Membership on an entity's Board of Directors or advisory committees, Research Funding; Octapharma: Membership on an entity's Board of Directors or advisory committees.

scholarly journals OR30-01 Real-World Minimed™ 670G System Use and Glycemic Outcomes of Pediatric and Adult Individuals Living with Type 1 Diabetes (T1D) in the United States

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Robert Alan Vigersky ◽  
Michael Stone ◽  
Pratik Agrawal ◽  
Alex Zhong ◽  
Kevin Velado ◽  
...  
Keyword(s):  
Glycemic Control ◽  
Real World ◽  
Adult Population ◽  
Age Groups ◽  
The United States ◽  
System Use ◽  
System Data ◽  
The Mean ◽  
The Impact ◽  
The U.S

Abstract Introduction: The MiniMed™ 670G system was FDA-approved in 2016 for adults and adolescents ≥14yrs, and in 2018 for children ages 7-13yrs with T1D. Since then, use of the system has grown to over 180,000 people in the U.S. The glycemic control benefits of real-world MiniMed™ 670G system Auto Mode use in the U.S. were assessed. Methods: System data (aggregated five-minute instances of sensor glucose [SG]) uploaded from March 2017 to July 2019 by individuals (N=118,737) with T1D and ≥7yrs of age who enabled Auto Mode were analyzed to determine the mean % of overall time spent <54mg/dL/<70mg/dL (TBR); between 70-180mg/dL (TIR); and >180mg/dL/>250mg/dL (TAR). The impact of Auto Mode was further assessed in a sub-group of individuals (N=51,254) with, at least, 7 days of SG data for both Auto Mode turned ON and turned OFF. The % of TIR, TBR and TAR, and the associated glucose management indicator (GMI) were evaluated for the overall OFF (2,524,570 days) and ON (6,308,806 days) periods, and across different age groups. Results: System data TIR was 71.3%; TBR was 0.4% and 1.9%, respectively; and TAR was 26.8% and 6.2%, respectively. User-wise data of Auto Mode OFF versus ON showed a mean of 70.3% of the time spent in Auto Mode, that TIR increased from 60.9% to 69.9%; and that both TBR and TAR decreased. For those 7-13yrs (N=1,417), TIR increased from 48.7% to 61.5%; TBR increased from 0.5% to 0.6% and from 2.0% to 2.2%, respectively; and TAR decreased from 49.3% to 36.3% and from 20.5% to 13.0%, respectively. For those 14-21yrs (N=4,194), TIR increased from 51.0% to 61.5%; TBR decreased from 0.7% to 0.6% and from 2.3% to 2.0%, respectively; and TAR decreased from 46.7% to 36.5% and from 18.5% to 12.5%, respectively. For those ≥22yrs (N=45,643), TIR increased from 62.2% to 70.9%; TBR decreased from 0.7% to 0.5% and from 2.6% to 1.9%, respectively; and TAR decreased from 35.2% to 27.3% and from 9.9% to 6.3%, respectively. The mean GMI decreased by 0.23% (overall), 0.48% (7-13yrs), 0.35% (14-21yrs), and 0.22% (≥22yrs), respectively, with Auto Mode ON versus OFF. Discussion: In over 6 million days of real-world MiniMed™ 670G system Auto Mode use in the U.S., TIR of a large pediatric and adult population with T1D improved by 9% compared to when Auto Mode was OFF, which was comparable to or exceeded the TIR observed in the smaller pivotal trials. These results further support outcomes of the pivotal trials and increased glycemic control with system use.

scholarly journals Relationship between hypoglycaemia, cardiovascular outcomes, and empagliflozin treatment in the EMPA-REG OUTCOME® trial

2019 ◽  
Vol 41 (2) ◽  
pp. 209-217 ◽  
Author(s):  
David Fitchett ◽  
Silvio E Inzucchi ◽  
Christoph Wanner ◽  
Michaela Mattheus ◽  
Jyothis T George ◽  
...  
Keyword(s):  
Cox Regression ◽  
Severe Hypoglycaemia ◽  
Glycated Haemoglobin ◽  
Protective Effects ◽  
Increased Risk ◽  
Symptomatic Hypoglycaemia ◽  
Post Hoc ◽  
The Impact ◽  
Time Varying Covariates

Abstract Aims Hypoglycaemia, in patients with Type 2 diabetes (T2D) is associated with an increased risk for cardiovascular (CV) events. In EMPA-REG OUTCOME, the sodium-glucose co-transporter-2 inhibitor empagliflozin reduced the risk of CV death by 38% and heart failure hospitalization (HHF) by 35%, while decreasing glycated haemoglobin (HbA1c) without increasing hypoglycaemia. We investigated CV outcomes in patients with hypoglycaemia during the trial and the impact of hypoglycaemia on the treatment effect of empagliflozin. Methods and results About 7020 patients with T2D (HbA1c 7–10%) were treated with empagliflozin 10 or 25 mg, or placebo and followed for median 3.1 years. The relationship between on-trial hypoglycaemia and CV outcomes, and effects of empagliflozin on outcomes by incident hypoglycaemia [HYPO-broad: symptomatic hypoglycaemia with plasma glucose (PG) ≤70 mg/dL, any hypoglycaemia with PG <54 mg/dL, or severe hypoglycaemia, and HYPO-strict: hypoglycaemia with PG <54 mg/dL, or severe hypoglycaemia] was investigated using adjusted Cox regression models with time-varying covariates for hypoglycaemia and interaction with treatment. HYPO-broad occurred in 28% in each group and HYPO-strict in 19%. In the placebo group, hypoglycaemia was associated with an increased risk of HHF for both HYPO-broad [hazard ratio (HR, 95% confidence interval, CI) 1.91 (1.25–2.93)] and HYPO-strict [1.72 (1.06–2.78)]. HYPO-broad (but not HYPO-strict) was associated with an increased risk of myocardial infarction (MI) [HR 1.56 (1.06–2.29)]. Empagliflozin improved CV outcomes, regardless of occurrence of hypoglycaemia (P-for interactions >0.05). Conclusion In this post hoc exploratory analysis, hypoglycaemia was associated with an increased risk of HHF and MI. Hypoglycaemia risk was not increased with empagliflozin and incident hypoglycaemia did not attenuate its cardio-protective effects.

scholarly journals Game-Related Impacts in High School Boys’ Lacrosse

2019 ◽  
Vol 7 (4) ◽  
pp. 232596711983558 ◽  
Author(s):  
Shane V. Caswell ◽  
Patricia Kelshaw ◽  
Andrew E. Lincoln ◽  
Lisa Hepburn ◽  
Reginald Dunn ◽  
...  
Keyword(s):  
High School ◽  
Rotational Velocity ◽  
Linear Acceleration ◽  
The United States ◽  
Head Impact ◽  
Level Of Evidence ◽  
Cross Sectional ◽  
Head Impacts ◽  
Direct Head ◽  
The Impact

Background: The rate of concussions in boys’ lacrosse is reported to be the third highest among high school sports in the United States, but no studies have described game-related impacts among boys’ lacrosse players. Purpose: To characterize verified game-related impacts, both overall and those directly to the head, in boys’ varsity high school lacrosse. Study Design: Cross-sectional study; Level of evidence, 3. Methods: A total of 77 male participants (mean age, 16.6 ± 1.2 years; mean height, 1.77 ± 0.05 m; mean weight, 73.4 ± 12.2 kg) were instrumented with sensors and were videotaped during 39 games. All verified game-related impacts ≥20 g were summarized in terms of frequency, peak linear acceleration (PLA), and peak rotational velocity (PRV). Descriptive statistics and impact rates per player-game (PG) with corresponding 95% CIs were calculated. Results: Overall, 1100 verified game-related impacts were recorded (PLA: median, 33.5 g [interquartile range (IQR), 25.7-51.2]; PRV: median, 1135.5 deg/s [IQR, 790.0-1613.8]) during 795 PGs. The rate for all verified game-related impacts was 1.38 impacts per PG (95% CI, 1.30-1.47). Of these, 680 (61.8%) impacts (PLA: median, 35.9 g [IQR, 26.7-55.5]; PRV: 1170.5 deg/s [IQR, 803.2-1672.8]) were directly to the head (impact rate, 0.86 impacts/PG [95% CI, 0.79-0.92]). Overall, midfielders (n = 514; 46.7%) sustained the most impacts, followed by attackers (n = 332; 30.2%), defenders (n = 233; 21.2%), and goalies (n = 21; 1.9%). The most common mechanisms for overall impacts and direct head impacts were contact with player (overall: n = 706 [64.2%]; head: n = 397 [58.4%]) and stick (overall: n = 303 [27.5%]; head: n = 239 [35.1%]), followed by ground (overall: n = 73 [6.6%]; head: n = 26 [3.8%]) and ball (overall: n = 15 [1.4%]; head: n = 15 [2.2%]). Direct head impacts were associated with a helmet-to-helmet collision 31.2% of the time, and they were frequently (53.7%) sustained by the players delivering the impact. Nearly half (48.8%) of players delivering contact used their helmets to initiate contact that resulted in a helmet-to-helmet impact. Players receiving a head impact from player contact were most often unprepared (75.9%) for the collision. Conclusion: The helmet is commonly used to initiate contact in boys’ high school lacrosse, often targeting defenseless opponents. Interventions to reduce head impacts should address rules and coaching messages to discourage intentional use of the helmet and encourage protection of defenseless opponents.

scholarly journals Early Morning Food Intake as a Risk Factor for Metabolic Dysregulation

Nutrients ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 756
Author(s):  
Ellen R. Stothard ◽  
Hannah K. Ritchie ◽  
Brian R. Birks ◽  
Robert H. Eckel ◽  
Janine Higgins ◽  
...  
Keyword(s):  
Food Intake ◽  
Caloric Intake ◽  
The United States ◽  
Early Morning ◽  
Shift Workers ◽  
Wake Time ◽  
Metabolic Dysregulation ◽  
Obesity And Diabetes ◽  
Increased Risk ◽  
The Impact

Increased risk of obesity and diabetes in shift workers may be related to food intake at adverse circadian times. Early morning shiftwork represents the largest proportion of shift workers in the United States, yet little is known about the impact of food intake in the early morning on metabolism. Eighteen participants (9 female) completed a counterbalanced 16 day design with two conditions separated by ~1 week: 8 h sleep opportunity at habitual time and simulated early morning shiftwork with 6.5 h sleep opportunity starting ~1 h earlier than habitual time. After wake time, resting energy expenditure (REE) was measured and blood was sampled for melatonin and fasting glucose and insulin. Following breakfast, post-prandial blood samples were collected every 40 min for 2 h and the thermic effect of food (TEF) was assessed for 3.25 h. Total sleep time was decreased by ~85 min (p < 0.0001), melatonin levels were higher (p < 0.0001) and post-prandial glucose levels were higher (p < 0.05) after one day of simulated early morning shiftwork compared with habitual wake time. REE was lower after simulated early morning shiftwork; however, TEF after breakfast was similar to habitual wake time. Insufficient sleep and caloric intake during a circadian phase of high melatonin levels may contribute to metabolic dysregulation in early morning shift workers.

scholarly journals Extended Screening Costs Associated With Selecting Donors for Fecal Microbiota Transplantation for Treatment of Metabolic Syndrome-Associated Diseases

2017 ◽  
Vol 4 (4) ◽  
Author(s):  
Laura J Craven ◽  
Seema Nair Parvathy ◽  
Justin Tat-Ko ◽  
Jeremy P Burton ◽  
Michael S Silverman
Keyword(s):  
Metabolic Syndrome ◽  
Fecal Microbiota Transplantation ◽  
The United States ◽  
Fecal Microbiota ◽  
Screening Programs ◽  
Central Processing ◽  
Donor Screening ◽  
Increased Risk ◽  
The Cost ◽  
The Impact

Abstract Background Knowledge of the impact of the gut microbiome on conditions other than Clostridium difficile infection has been rapidly increasing, and the potential usefulness of fecal microbiota transplantation (FMT) in these indications is being explored. The need to exclude donors with an increased risk of these diseases has left uncertainties regarding the cost and feasibility of donor screening. The aim of this study was to compare our experience to other donor-screening programs and report the costs associated with establishing a donor-screening program, for the treatment of metabolic syndrome-related conditions. Methods Forty-six potential donors (PDs) had their medical histories and physical examinations undertaken by a physician. Blood, stool, and urine were screened for 31 viral, bacterial, fungal, and protozoan agents in addition to biochemical characteristics. The price of advertising, doctor’s visits and diagnostic tests were calculated to determine the cost of finding a donor. Results Of the PDs screened, 5 of 46 passed the history, examination, blood, stool, and urine tests. The most common reasons for exclusion included a body mass index &gt;25 or the detection of Blastocystis hominis, Dientamoeba fragilis, or Helicobacter pylori. Four of five eligible donors had subsequent travel or illness that contraindicated donation, so only 1 of 46 PDs was suitable. The total cost for finding a single suitable donor was $15190 US dollars. This screening was performed in Canada, and costs in the United States would be substantially higher. Conclusions New potential therapeutic uses for FMT have created a demand for stricter exclusion criteria for donors. This study illustrates that screening many individuals to find a donor and the subsequent associated costs may make central processing and shipment a more reasonable alternative.

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