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Background: Currently five SARS-CoV-2 vaccines are approved in North America (FDA) and Europe (EMA). Across the world other vaccines have been developed but not approved in high-income countries. Of the approved vaccines, 2 are mRNA vaccines, 2 are viral vectored vaccines, and 1 is a protein subunit vaccine. As immunogenicity markers are increasingly being used by regulatory agencies as surrogate markers for vaccine efficacy to inform authorization decisions, this meta-analysis compared the size of immunogenicity responses response elicited by the different COVID-19 vaccine types (mRNA, protein subunit, inactivated virus, viral vectors) and approved and unapproved COVID-19 vaccines. Method(s): Systematic review of trial registers and databases identified RCTs for SARS-CoV-2 vaccines. Risk of bias analysis was conducted using the Cochrane Risk of Bias tool. High risk of bias studies were excluded from analysis. Meta-analysis of seroconversion rates and geometric antibody titers (GMT) for neutralising (NAb) and anti-spike antibodies was conducted, each compared with a placebo using random effects model Cochrane-Mantel Haenszel Tests. Result(s): All studies assessed immunogenicity of COVID-19 vaccines on healthy non-immunocompromised adults between the age of 18 and 59. Statistically significant difference was identified between the different vaccine types for NAb GMT, anti-spike GMT, NAb seroconversion, and anti-spike seroconversion (P< 0.00001 for all). Conversely, no statistical significant difference was identified between approved and unapproved vaccines for NAb seroconversion (P=0.39), Nab GMT (P=0.36), anti-spike seroconversion (P=0.07), and antispike GMT (P=0.54). mRNA vaccines had the best immunogenicity results for NAb seroconversion, GMT, and anti-spike seroconversion. Viral vector vaccines had the lowest results for NAb seroconversion and GMT, while inactivated viruses had the lowest result for anti-spike seroconversion and mRNA vaccines for anti-spike GMT. High heterogeneity was observed across the different studies. Conclusion(s): This metanalysis of 35 randomised trials in 33,813 participants showed approved and unapproved vaccines to be comparable in postvaccination GMT values and seroconversion for both NAb and anti-spike. However, while comparing COVID-19 vaccines by vaccine types, statistically significant differences are observed. Variations in study designs, populations enrolled, and infection prevalence during trial duration could have influenced results.
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Introduction: The Covid-19 pandemic resulted in the closure of community therapy services in Ireland. The need for the provision of upper limb rehabilitation for stroke survivors remained. A new method of service provision was developed and evaluated. Aim- To deliver an upper limb rehabilitation programme to older adults post stroke through virtual means and to compare the stroke interventions of mirror therapy (MT) and constraint induced movement therapy (CIMT). Method(s): 21 participants recruited. The investigator recorded 36 upper limb rehabilitation sessions (12 MT, 12 CIMT and 12 control) which were sent electronically to participants- 6 week therapy programme. Participants were assessed pre and post intervention using the DASH, OSA-SF, JAMAR Hand Function Test, 9 Hole Peg Test and Dynamometer. Statistical significance for CIMT group in grip strength and minimal fine motor skills improvement. MT showed significance in both fine and gross motor skills, grip and pinch strength and overall participants self-perceptions of function. Result(s): 21 participants completed upper limb rehabilitation programmes in their own homes successfully. The MT group showed greater significance than CIMT when completed through virtual means. Telehealth may be a means of service delivery going forward and MT has proven effective as virtual intervention. Conclusion(s): Further evaluation of this intervention through virtual means is needed. Implications for practice- The incorporation of telehealth into upper limb stroke rehabilitation practice can alleviate waiting lists through allowing multiple patients access to interventions at once and also can provide a stroke service in a timely manner.
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Background In Stem Cell Transplants approximately two thirds of donors are identified and used from unrelated donor registries. In January 2020, we considered the impact that Covid19 infections and restrictions would have on donor availability. We identified that we needed to change our practice to ensure we could continue the SCT procedures which are critical for patients. Methods In January 2020, the Joint United Kingdom Blood Transfusion and Transplantation Service Professional Advisory committee (JPAC) changed the Tissue and cell donor selection guidelines. The risk and restrictions of Covid19 caused significant challenges including logistical issues for product delivery. Donor deferrals at medical assessments increased from 14% to 29% and overall activity in the UK was 75% of usual provision. Best practice was established and agreed with the donor registries. As per NICE guidelines, cryopreservation of all stem cell products was recommended with fresh donations considered according to patient condition. Back up donors were identified where possible. All donors were tested for Covid 19 on day of medical and harvest to ensure effective screening. We carried out 58 stem cell procedures from unrelated donors in 2020 and 56 in 2021. This activity is comparable to previous years. We secured stem cell products from Germany, USA, Korea, Poland, Turkey, Greece, Switzerland, the Netherlands and the UK. We analysed our data to assess if any delays occurred. Ethical approval was not required for this service evaluation. Results SCT activity was maintained throughout Covid19 with only postponement of elective SCT's which was assessed to be in the patient's best interest. Discussion We were able to adapt our practice to the benefit of our patients in unique and challenging circumstances. Conclusion We implemented measures which enabled BMT activity to continue throughout the acute Covid19 period despite challenges with new variants and further restrictions.
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INTRODUCTION: Ventilatory ratio (VR) is a simple bedside index of carbon dioxide removal. VR correlates well with physiologic dead space fraction (VD/VT) and clinical outcomes in patients with acute respiratory distress syndrome (ARDS). We hypothesized that high VR would identify COVID-19 ARDS patients with higher risk for death and organ failure. METHOD(S): We conducted a retrospective cohort study of patients admitted to a single hospital in New York, NY, USA from March-July 2020 who had PCR-confirmed SARS-CoV-2 infection, met the Berlin criteria for ARDS, and required tracheostomy for prolonged invasive mechanical ventilation (MV). MV parameters were collected 2-8 hours after intubation. Based on prior studies, a VR>2 was considered to be abnormally elevated. Comparisons were performed using the Wilcoxon rank-sum test or z-test for difference in proportions with alpha=0.05. The primary outcome was 30- day mortality and the secondary outcome was a composite endpoint of death or organ failure defined as requiring renal replacement or extracorporeal membrane oxygenation (ECMO) during the hospitalization. RESULT(S): Of 139 subjects enrolled, 67 (48.2%) had a VR>2. Low and high VR groups had similar baseline characteristics, including age (mean 58 years, SD +/-15.2), body mass index (30.1+/-6.69 kg/m2), simplified acute physiology score II (35.4+/-12.4), sequential organ failure assessment (SOFA) score (5.7+/-2.5), and a 19-point review of systemic disease history. High VR was not significantly associated with mortality (OR 0.92, p=0.827). However, high VR was associated with increased risk for the composite endpoint (OR 1.96, p=0.049) and independently identified patients with a higher risk of organ failure (OR 2.03, p=0.047). High VR was also associated with longer hospital length-of-stay for subjects who survived to discharge (52 vs. 43, p=0.035), more MV-free days within the 30 days after intubation (3.2 vs. 1.8, p=0.029), and higher SOFA score at 10+/-4 days post-intubation (6.2 vs. 4.8, p=0.024). CONCLUSION(S): Ventilatory ratio identifies COVID-ARDS ventilated patients with increased risk for organ failure requiring advanced intervention, as well as patients who may require prolonged mechanical ventilation and hospitalization.
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INTRODUCTION: Mortality and morbidity associated with COVID-19 acute respiratory distress syndrome (ARDS) has been associated with pulmonary vasculopathy, which has been hypothesized to increase pulmonary dead space (VD/ VT). However, VD/VT is rarely measured at the bedside. As a result, multiple proxy estimates have been developed. Our hypothesis was proxy estimates for VD/VT would have differing utilities in prognostication of COVID-19 ARDS. METHOD(S): We conducted a retrospective cohort study of patients admitted to an intensive care unit with SARSCoV- 2 ARDS who required invasive mechanical ventilation. Ventilation parameters were collected 2-8 hours after intubation. The VD/Vt proxies examined were 1) ventilatory ratio (VR), 2) estimation of VD/VT using the Harris-Benedict equation for energy expenditure (VD/VT-HB), 3) direct estimation of VD/VT using Beitler et. al.'s formula (VD/VTDir), and 4) corrected minute ventilation (VECorr). For each proxy, subjects were dichotomized using the median value. Comparisons were performed using the Wilcoxon rank-sum test with alpha=0.05. RESULT(S): For 139 subjects, mean VR was 2.08 (SD+/-0.80), mean VD/VT-HB was 0.614 (+/-0.15), mean VD/VT-Dir was 0.657 (+/-0.08), and mean VECorr was 12.2 (+/-4.6) L/min. All four proxies had strong inter-measure correlation (Pearson's r 0.748-0.881, p< 0.001 for all comparisons). No proxy was predictive of 30-day hospital mortality. High VR and VECorr were associated with increased morbidity using a composite endpoint of death or organ failure (defined as requiring renal dialysis or extracorporeal membrane oxygenation) with both having an odds ratio of 2.20 (95% CI: 1.12-4.33, p=0.022), while VD/VT-HB (p=0.552) and VD/VT-Dir (p=0.554) were not significantly associated. Of all proxies, only VR was significantly associated with increased sequential organ failure assessment (SOFA) score at 10+/-4 days post-intubation (6.2 vs. 4.8, p=0.024) and more ventilatorfree days within the 30 days after intubation (3.2 vs. 1.8, p=0.029). CONCLUSION(S): Ventilatory ratio and corrected minute volume appear to have stronger associations with morbidity in COVID-19 ARDS compared to other VD/VT estimates. Ventilatory ratio is also associated with ventilator-free days and delayed SOFA score.
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INTRODUCTION: Ventilatory ratio (VR) is a bedside index of impaired ventilation that can be used as a surrogate marker for pulmonary dead space fraction (VD/VT). Vasculopathy is hypothesized to increase VD/VT in patients with acute respiratory distress syndrome (ARDS) due to COVID-19. The purpose of this study was to investigate associations between VR and markers of inflammation in critically ill COVID-ARDS patients. METHOD(S): We conducted a retrospective study of patients admitted to an intensive care unit due to SARS-CoV-2 infection. All subjects required invasive mechanical ventilation and met the Berlin criteria for ARDS. Clinical lab values were collected at two timepoints: 2-8 hours after intubation (T1) and 2-24 hours before tracheostomy (T2). VR was split into high (VR>2) and low (VR< 2) groups. Comparisons were performed using student's t, Mann-Whitney, and z tests for difference in proportions with alpha=0.05. RESULT(S): Of the 139 subjects enrolled at T1, 67 (48%) had high VR (>2), with an overall mean VR of 2.08. High VR was significantly associated with leukocyte count (WBC) (13.3 vs. 10.6 x10
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Background. Five SARS-CoV-2 vaccines are approved in North America and/or Europe: Pfizer/BioNTech, Moderna, Janssen, Oxford-AstraZeneca and Novavax. Other vaccines have been developed, including Sinopharm, SinoVac, QazVac, Covaxin, Soberana, Corbevac, Medicago, Clover and Cansino, but are not approved in high income countries. This meta-analysis compared the efficacy of approved and unapproved vaccines in randomised clinical trials (RCTs). Methods. A systematic review of clinical trial registries, PUBMED and EMBASE identified placebo-controlled RCTs of SARS-CoV-2 vaccines prospectively evaluating risks of symptomatic or severe infection with clearly defined endpoints. For each trial, risk of bias was assessed using Cochrane tool 2.0 and the CONSORT checklist. In the pre-defined meta-analysis, relative risks of symptomatic infection and severe disease were compared for each vaccine versus placebo, using Cochrane-Mantel Haenszel Tests (random effects method). Results. There were 21 RCTs assessing efficacy of the COVID-19 vaccines identified. One RCT was excluded for high risk of bias. Ten RCTs in 206,667 participants evaluated 5 approved vaccines;10 RCTs in 158,599 participants evaluated 8 unapproved vaccines. In the meta-analysis, prevention of symptomatic infection was 84% (95% C.I. 68-92%) for approved vaccines versus 72% (95% C.I. 65-77%) for unapproved vaccines, with no significant difference between vaccine types (p=0.13). Prevention of severe SARS-CoV-2 infection was 95% (95% C.I. 78-99%) for approved vaccines versus 84% (95% C.I. 72-91%) for unapproved vaccines (p=0.12). In addition, the risk of serious adverse events was similar between vaccine types (p=0.49). Efficacy of approved and unapproved SARS-CoV-2 vaccines Percentage efficacy of approved and unapproved SARS-CoV-2 vaccines against symptomatic infection (Panel A) and severe disease (Panel B). Vaccines are arranged by approval-status (approved vaccines to the left and unapproved vaccines to the right of discontinuous line) and colour-coded by vaccine type. Error bars represent 95% confidence intervals. RIBSP, Research Institute for Biological Safety Problems;IFV, Instituto Finlay de Vacunas. Conclusion. This meta-analysis of 20 RCTs in 365,266 participants, showed no significant difference in efficacy between the approved and unapproved SARS-CoV-2 vaccines for endpoints of either symptomatic or severe infection. Differences in study design, end-point definitions, variants and prevalence of infection may have influenced the results. Head-to-head RCTs will be required to make definitive conclusions. If efficacy is proved definitively, new patent-free vaccines could lower costs of worldwide SARS-CoV-2 vaccination campaigns significantly.
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Speech pathology students are required to demonstrate competency across a range of practice areas. There are, however, limited opportunities for students to access clinical placements in the area of stuttering. Simulation-based learning (SBL) activities have proven to be effective in increasing students' clinical experience in this area. Due to the COVID-19 pandemic, the delivery of in-person SBL programs was not feasible, resulting in a shift to online provision. The aim of this study was to investigate the perceptions of students, clinical educators and simulated patients who participated in an online adult stuttering SBL experience. Ten first-year graduate entry Masters program speech pathology students participated in the study alongside four clinical educators and four simulated patients. The experience involved two online SBL sessions and one online tutorial via videoconferencing from separate locations. Each participant group engaged in focus group interviews exploring their perceptions of the online SBL activity. Thematic network analysis of the focus group interview data was conducted. Overall interpretation of the data from the perspectives of students, clinical educators and simulated patients revealed an overarching global theme that online SBL offers a positive, comfortable and comparable experience to enable students to build client-centred, clinical and telepractice skills. The positive outcomes of this study suggest that together with in-person clinical experiences, online SBL has an important role in the education of speech pathology students. © 2022 Adriana Penman, Monique Waite, Anne E. Hill, Taliesha-Jayne Leslie, Brooke-Mai Whelan & Andrea Whitehead. This Open Access article is distributed under the terms of the Creative Commons Attribution Attribution-Non-Commercial No Derivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited and is unaltered.
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Introduction: Following The mass rollout of COVID-19 vaccination, regional lymphadenopathy presents as a diagnostic dilemma for clinicians. The aim of this study explores The incidence and management of unilateral axillary lymphadenopathy following vaccination at a symptomatic tertiary breast unit. Method(s): This is a retrospective review of a prospectively maintained database of all patients who underwent axillary imaging for symptomatic or incidental axillary lymphadenopathy detected On imaging following COVID-19 vaccination between January 2021-December 2021. Radiological and histological information were obtained from The hospital s NIMIS radiology and PIPE histology system. Additional patient and clinical information was obtained from patient's clinical notes. Result(s): A total of 253 patients underwent axillary ultrasounds during The twelve-month interval. Of these 24 (9.4%) of patients underwent investigation for axillary lymphadenopathy related to recent COVID vaccination. Of these, 21 patients had image consistent reactive nodes while The remaining 3 patients had normal radiological investigation. Only 6 patients underwent ultrasound guided biopsy of these nodes which confirmed reactive notes. Conclusion(s): Patient and clinician educationisrequiredtoraiseawareness in COVID-19 related axillary lymphadenopathy. Standardization in The management including The timing of breast screening and radiological investigation in relation to COVID vaccination is required, in order to minimize over investigation in this patient cohort. Take-home message: COVID-19 vaccine related axillary lymphadenopathy is being seen in tertiary symptomatic breast clinic. Patient and clinician education is necessary to raise awareness of this and contribute to a standardised approach of investigation and management of this phenomenon.
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Introduction: Supporting educators has been identified as vital for the efficacy and sustainability of online teaching. The teaching of clinical skills online presents additional challenges given the vast shift from traditional pedagogies. However, the support needs of health professional educators to teach clinical skills online are unknown. The aim of this study was to explore educator experiences of teaching clinical skills online and investigate their workplace support needs. Methods: A qualitative approach using focus groups was used to investigate educator experiences at three universities in Australia, Chile and South Africa. Data were subject to thematic analysis, and a thematic network tool was used to triangulate international experiences. Results: Seven focus groups were undertaken, with a total of 32 participants. Four global themes were identified following analysis: 1) the educator experience, 2) changes to pedagogy, 3) challenges to teaching online and 4) support for educators. Conclusions: This study has highlighted the professional challenges that teaching clinical skills online creates for health professional educators and the uncertainty regarding expectations and outcomes. Enhancing university support for educators to prepare and provide clinical skills teaching online is suggested to mitigate these challenges. Recommendations are made for universities and educators to consider in the pursuit of effective and sustainable teaching of clinical skills online.
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Background: Durable clinical benefit has been achieved with nivolumab (NIVO) + ipilimumab (IPI), including an overall survival (OS) of 49% and a melanoma-specific survival (MSS) of 56%, with median MSS not reached (NR) at 6.5-y minimum follow-up. Here we report sustained efficacy outcomes at 7.5 y. Methods: Patients (pts) with previously untreated, unresectable stage III/IV melanoma were randomly assigned 1:1:1 and stratified by PD-L1 status, BRAF mutation status, and metastasis stage to receive NIVO 1 mg/kg + IPI 3 mg/kg for 4 doses Q3W, followed by NIVO 3 mg/kg Q2W (n = 314);NIVO 3 mg/kg Q2W + placebo (n = 316);or IPI 3 mg/kg Q3W for 4 doses + placebo (n = 315) until progression or unacceptable toxicity. Co-primary endpoints were progression-free survival (PFS) and OS with NIVO + IPI or NIVO alone versus IPI. Results: With a minimum follow-up of 7.5 y, median OS remained stable at 72.1 mo (NIVO + IPI), 36.9 mo (NIVO), and 19.9 mo (IPI);median MSS was NR, 49.4 mo, and 21.9 mo, respectively (Table). While the objective response rate remained stable at 58% (NIVO + IPI), 45% (NIVO), and 19% (IPI), median duration of response had now been reached for NIVO at 90.8 mo and remains NR and 19.2 mo for NIVO + IPI and IPI, respectively. Subsequent systemic therapy was received by 36%, 49%, and 66% of NIVO + IPI-, NIVO-, and IPI-treated patients, respectively, and median time to that therapy was NR (95% CI, 45.9-NR), 24.7 mo (16.0-38.7), and 8.0 mo (6.5-8.7). Of patients alive at 7.5 y, 106/138 (77%, NIVO + IPI), 80/115 (70%, NIVO), and 27/60 (45%, IPI) were off treatment and had never received subsequent systemic therapy. No change to the safety summary was observed with additional follow-up;updated health-related quality of life data will be reported. Of the 10 new deaths since the 6.5-y follow-up (ie, 5 NIVO + IPI;3 NIVO;2 IPI), none were treatment-related;4 were due to melanoma progression;1 was due to an unknown cause;and 5 were due to other causes, but not associated with a COVID diagnosis. Conclusions: The 7.5-y follow-up continues to demonstrate the durability of responses with NIVO + IPI and an ongoing survival plateau. A substantial difference in median OS and MSS between patients treated with NIVO + IPI or NIVO was observed in descriptive analyses.
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This paper is a set of reflections from researchers in the Center for Sustainable Communities, University of Canberra, drawing out emerging lessons from the process of re-configuring research methods during COVID-19. The pandemic has presented new spaces of negotiation, struggle, and interdependence within research projects and research teams. It has left researchers often uncertain about how to do their work effectively. At the same time, it has opened up opportunities to re-think how researchers undertake the work of research. In this paper we reflect on several current research programs that have had to undergo rapid design shifts to adjust to new conditions under COVID-19. The rapid shift has afforded some surprisingly positive outcomes and raised important questions for the future. In our reflections we look at the impact of COVID-19 at different stages of designing research with partners, establishing new relationships with partners and distant field sites, and data collection and analysis. We draw on Participatory Action Research (PAR) methodological ideas and highlight ways in which we have adapted and experimented with PAR methods during the pandemic. We reflect on the aspects of PAR that have assisted us to continue in our work, in particular, how PAR foregrounds diverse ways of knowing, being and doing, and prioritizes local aspirations, concerns and world views to drive the research agenda and the processes of social or economic change that accompany it. PAR also helps us to reflect on methods for building relationships of mutual trust, having genuine and authentic collaborations, and open conversations. We reflect on the potential lessons for PAR and community engaged research more generally. Amidst the challenges, our experience reveals new pathways for research practice to rebalance power relationships and support local place-conscious capacity for action.
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Background: The WHO recommends enhanced adherence counseling (EAC) before regimen switch for HIV-positive, antiretroviral therapy (ART)-treated individuals with non-suppressed viral loads (VL). However, there is a paucity of data, especially within a clinical trial setting, on the determinants of viral suppression (VS) following EAC among those failing ART. We thus evaluated predictors of VS among adults failing ART who had undergone EAC in the VISEND clinical trial. Methods: Our trial is a randomized 144 week open label non-inferiority study with adults failing (VL≧ 1000 copies/mL) ART of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) plus efavirenz (EFV) or nevirapine (NVP), switched to 1) TDF,3TC,DTG or 2) tenofovir alafenamide (TAF), emtricitabine (FTC),DTG or 3) lopinavir/ritonavir (LPV/r) or atazanavir/r (ATV/r), zidovudine (ZDV),3TC. Viral loads and other biomarkers were collected at weeks 12, 24, 48, 72, 96 and 144. Adults with VL≧ 1000 copies/mL at each of these time points underwent EAC involving 3 sessions over a period of 3 months according to existing guidelines. We calculated proportions of individuals who achieved VS post EAC and analyzed factors (demographic and clinical) independently associated with VS post EAC. Using multivariable log regression models, associations were analyzed as crude risk ratios (CRR) and adjusted risk ratios (ARR). Results: The overall VS rates following EAC among individuals with virologic failure was 66%;broken down as follows: TAF,FTC,DTG (78%), TDF,3TC,DTG (71%), ZDV,3TC,ATV/r (62%), and ZDV,3TC,LPV/r (53%). Compared to adults with no formal education, those having primary (ARR 1.55 [1.32-1.81], P<0.001) or secondary level education (ARR 1.93 [1.65-2.27], P<0.001) were more likely to achieve VS. Those less likely to suppress post EAC were individuals on ART for > 5 years (ARR 0.75 [0.75-0.75], P<0.001), VL > 10,000 copies/mL at time of failure (0.48 [0.48-0.48], P<0.001), presence of comorbidities (ARR 0.77 [0.66-0.90], P=0.001) and those taking concomitant medications (ARR 0.67 [0.58-0.79], P<0.001). Having suffered from COVID-19 infection had no association with VS post EAC (ARR 0.59 [0.22-1.58], P=0.30). Consistent results are in Table 1. Conclusion: In the VISEND trial, EAC led to VS rates near the WHO target of 70% with disparities in outcomes according to gender, education, and other factors. There is a need to routinely incorporate EAC into clinical trials and practice before regimen switch in order to maximize outcomes.
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Background: Successful continuation of research involving blood sample collection during the covid-19 pandemic is particularly challenging due to restrictions on visits to clinic and limited research staff capacity. C-peptide measurement from capillary (finger-prick) samples has been robustly validated. Aim: To increase the rate of return and viability of home finger-prick samples in a prospective multicentre study by combining a more patient-centred approach with improved sampling method. Methods: Original procedure for home sampling involved data collection by telephone followed by independent participant collection of finger-prick samples onto a blood spot card. Following poor rate of return and of successful sample collection, an adapted protocol & novel sampling method were introduced. The improved approach involved the pre-booking of an appointment for both data and sample collection, so that the researcher could support sample collection, and used a blood spot stick (Mitra® VAMS® absorptive device) to enable more user-friendly sampling. We assessed rate of sample return and viability for participants first remote capillary sample collection. Results: 282 participants were followed up using the original method, 173/282 (61%(95% confidence interval 55-67%) samples returned and 112/173 (65%(57-72%) were viable. 115 participants have been followed up using the improved approach, 97 (84%(76-90%) samples returned and 93 (96%(90-99%) were viable for analysis. Summary: A more patient-focused approach with improved method of sample collection was associated with dramatically increased sample rate of return and viability. This novel approach may aid other projects where samples have the stability for home collection.