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BACKGROUND: To facilitate deployment of point-of-care testing for severe acute respiratory syndrome coronavirus 2, we evaluated the Access Bio CareStart COVID-19 Antigen test in a high-throughput, drive-through, free community testing site using anterior nasal (AN) swab reverse-transcription polymerase chain reaction (RT-PCR) for clinical testing. METHODS: Consenting symptomatic and asymptomatic children (≤18 years) and adults received dual AN swabs. CareStart testing was performed with temperature/humidity monitoring. All tests had 2 independent reads to assess interoperator agreement. Patients with positive CareStart results were called and instructed to isolate pending RT-PCR results. The paired RT-PCR result was the reference for sensitivity and specificity calculations. RESULTS: Of 1603 participants, 1245 adults and 253 children had paired RT-PCR/CareStart results and complete symptom data. Eighty-three percent of adults and 87% of children were asymptomatic. CareStart sensitivity/specificity were 84.8% (95% confidence interval [CI], 71.1-93.7)/97.2% (95% CI, 92.0-99.4) and 85.7% (95% CI, 42.1-99.6)/89.5% (95% CI, 66.9-98.7) in adults and children, respectively, within 5 days of symptoms. Sensitivity/specificity were 50.0% (95% CI, 41.0-59.0)/99.1% (95% CI, 98.3-99.6) in asymptomatic adults and 51.4% (95% CI, 34.4-68.1)/97.8% (95% CI, 94.5-99.4) in asymptomatic children. Sensitivity in all 234 RT-PCR-positive people was 96.3% with cycle threshold (Ct) ≤25, 79.6% with Ct ≤30, and 61.4% with Ct ≤35. All 21 false-positive CareStart tests had faint but normal bands. Interoperator agreement was 99.5%. Operational challenges included identification of faint test bands and inconsistent swab elution volumes. CONCLUSIONS: CareStart had high sensitivity in people with Ct ≤25 and moderate sensitivity in symptomatic people overall. Specificity was unexpectedly lower in symptomatic versus asymptomatic people. Excellent interoperator agreement was observed, but operational challenges indicate that operator training is warranted.

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Rapid diagnostic tests (RDTs) for SARS-CoV-2 antigens (Ag) that can be performed at point of care (POC) can supplement molecular testing and help mitigate the COVID-19 pandemic. Deployment of an Ag RDT requires an understanding of its operational and performance characteristics under real-world conditions and in relevant subpopulations. We evaluated the Abbott BinaxNOW COVID-19 Ag card in a high-throughput, drive-through, free community testing site in Massachusetts using anterior nasal (AN) swab reverse transcriptase PCR (RT-PCR) for clinical testing. Individuals presenting for molecular testing in two of seven lanes were offered the opportunity to also receive BinaxNOW testing. Dual AN swabs were collected from symptomatic and asymptomatic children (≤18 years of age) and adults. BinaxNOW testing was performed in a testing pod with temperature/humidity monitoring. One individual performed testing and official result reporting for each test, but most tests had a second independent reading to assess interoperator agreement. Positive BinaxNOW results were scored as faint, medium, or strong. Positive BinaxNOW results were reported to patients by phone, and they were instructed to isolate pending RT-PCR results. The paired RT-PCR result was the reference for sensitivity and specificity calculations. Of 2,482 participants, 1,380 adults and 928 children had paired RT-PCR/BinaxNOW results and complete symptom data. In this study, 974/1,380 (71%) adults and 829/928 (89%) children were asymptomatic. BinaxNOW had 96.5% (95% confidence interval [CI], 90.0 to 99.3) sensitivity and 100% (95% CI, 98.6 to 100.0) specificity in adults within 7 days of symptoms and 84.6% (95% CI, 65.1 to 95.6) sensitivity and 100% (95% CI, 94.5 to 100.0) specificity in children within 7 days of symptoms. Sensitivity and specificity in asymptomatic adults were 70.2% (95% CI, 56.6 to 81.6) and 99.6% (95% CI, 98.9 to 99.9), respectively, and in asymptomatic children, they were 65.4% (95% CI, 55.6 to 74.4) and 99.0% (95% CI, 98.0 to 99.6), respectively. By cycle threshold (CT ) value cutoff, sensitivity in all subgroups combined (n = 292 RT-PCR-positive individuals) was 99.3% with CT values of ≤25, 95.8% with CT values of ≤30, and 81.2% with CT values of ≤35. Twelve false-positive BinaxNOW results (out of 2,308 tests) were observed; in all 12, the test bands were faint but otherwise normal and were noted by both readers. One invalid BinaxNOW result was identified. Interoperator agreement (positive versus negative BinaxNOW result) was 100% (n = 2,230/2,230 double reads). Each operator was able to process 20 RDTs per hour. In a separate set of 30 specimens (from individuals with symptoms ≤7 days) run at temperatures below the manufacturer's recommended range (46 to 58.5°F), sensitivity was 66.7% and specificity 95.2%. BinaxNOW had very high specificity in both adults and children and very high sensitivity in newly symptomatic adults. Overall, 95.8% sensitivity was observed with CT values of ≤30. These data support public health recommendations for use of the BinaxNOW test in adults with symptoms for ≤7 days without RT-PCR confirmation. Excellent interoperator agreement indicates that an individual can perform and read the BinaxNOW test alone. A skilled laboratorian can perform and read 20 tests per hour. Careful attention to temperature is critical.

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BACKGROUND: There are two main methods of accessing arterio-venous fistulas (AVFs); the 'buttonhole' and the 'rope-ladder' cannulation technique. Several small studies have hypothesized that the buttonhole technique is associated with increased rates of fistula-associated infection. This study addresses this hypothesis. METHODS: A retrospective review of all patients attending a large outpatient haemodialysis clinic was performed. Data were collected on the method of cannulation, infection rates, implicated microorganisms, complications of infection and time on haemodialysis. RESULTS: A total of 127 patients had received haemodialysis via an AVF: 53 via the rope-ladder technique and 74 via the buttonhole technique. Nine episodes of clinically significant bacteraemia were recorded in the buttonhole group. This equated to a rate of 0.073 bacteraemia events per 1000 AVF days. There were no episodes of bacteraemia in the rope-ladder group. Eight infections were due to methicillin-sensitive Staphylococcus aureus (MSSA); one was due to Staphylococcus epidermidis. Three patients with MSSA bacteraemia subsequently developed infective endocarditis. Five patients who developed bacteraemia events had been undergoing home haemodialysis. CONCLUSIONS: This study highlights the infectious complications associated with buttonhole cannulation techniques. All organisms isolated in our cohort were known skin colonizers. The reason for the increased rates of infection is unclear. Given this high rate of often life-threatening infection, we recommend regular audit of infection rates. We currently do not recommend this technique to our patients receiving haemodialysis.

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BACKGROUND: The Cochrane review of hallux valgus surgery has disputed the scientific validity of hallux valgus research. Scoring systems and surrogate measures such as x-ray angles are commonly reported at just one year post operatively but these are of dubious relevance to the patient. In this study we extended the follow up to a minimum of 8 years and sought to address patient specific concerns with hallux valgus surgery. The long term follow up also allowed a comprehensive review of the complications associated with the combined rotation scarf and Akin osteotomies. METHODS: Between 1996 and 1999, 101 patients underwent rotation scarf and Akin osteotomies for the treatment of hallux valgus. All patients were contacted and asked to participate in this study. 50 female participants were available allowing review of 73 procedures. The average follow up was over 9 years and the average age at the time of surgery was 57. The participants were physically examined and interviewed. RESULTS: Post-operatively, in 86% of the participants there were no footwear restrictions. Stiffness of the first metatarsophalangeal joint was reported in 8% (6 feet); 10% were unhappy with the cosmetic appearance of their feet, 3 feet had hallux varus, and 2 feet had recurrent hallux valgus. There were no foot-related activity restrictions in 92% of the group. Metatarsalgia occurred in 4% (3 feet). 96% were better than before surgery and 88% were completely satisfied with their post-operative result. Hallux varus was the greatest single cause of dissatisfaction. The most common adverse event in the study was internal fixation irritation. Hallux valgus surgery is not without risk and these findings could be useful in the informed consent process. CONCLUSIONS: When combined the rotation scarf and Akin osteotomies are an effective treatment for hallux valgus that achieves good long-term correction with a low incidence of recurrence, footwear restriction or metatarsalgia. The nature of the osteotomies allows early return to normal shoes and activity without the need for postoperative immobilisation in a plaster cast.

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BACKGROUND: Osteoarthrosis of the second metatarsocuneiform joint presents as pain, stiffness and osteophytic thickening of the midfoot. This study sought to determine the effectiveness and outcome of surgical fusion of osteoarthritic second metatarsocuneiform (MC) joint. The association between the condition and second metatarsal length was also explored. MATERIALS AND METHODS: A series of 23 patients (22 female) of average age 58 years (SD 4.9) underwent second MCJ fusion and were reviewed at an average of 42 months (SD 19.5) postoperatively. The second MC joint fusion involved resection of the joint surfaces and internal fixation with a 3-hole 2.7-mm plate. A variety of graft materials were utilized. RESULTS: The AOFAS midfoot rating scale score rose from a preoperative mean of 47 (SD 13) to a mean 90.5 (SD 12.5) postoperatively, p < 0.0001. Seventeen patients (74%) were completely satisfied. Four patients (17%) were satisfied with reservations. Two patients (9%) were dissatisfied. Twenty-one patients (91%) considered that they were better than before the operation and two patients were no better. Nonunion occurred in three patients and internal fixation was removed in four patients. One patient went onto develop osteoarthrosis in the third MC joint. We could not establish a causal relationship between osteoathrosis of the second MC joint and second metatarsal length. CONCLUSION: Fusion of the second MCJ is a moderately effective treatment for osteoarthrosis of the joint. In this series of patients, 74% were pain-free and nonunion was the most serious complication encountered, no patient was made worse by surgery.

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BACKGROUND: Valgus deviation of the second toe can be associated with metatarsophalangeal joint pain, footwear fitting problems, and cosmetic concerns. It also reduces the buttress effect of the second toe on the hallux and may allow progression of hallux valgus. The traditional operative approaches for digital arthrodesis or lesser metatarsal osteotomy have unpredictable results. METHODS: This study reviewed the effect of a closing wedge osteotomy on the proximal phalanx in 26 women with an average age of 59 years (SD 10) who had a valgus second toe. The patients had weightbearing radiographs preoperatively and at an average 28 months postoperatively. Clinical examination assessed for floating toe, range of metatarsophalangeal joint motion, and patient satisfaction. RESULTS: Before surgery the average second toe valgus angle measured 28 degrees and at final review this had reduced to 14 degrees (p < 0.001). Postoperatively, the average range of dorsiflexion of the digit was 42 degrees (SD 20). The average plantarflexion was 16 degrees (SD 10). Floating of the digit was noted in five patients and recurrence of the deformity in four patients. Nineteen patients (73%) were completely satisfied with the outcome of their surgery, seven were satisfied with reservations, and no patient was dissatisfied. Twenty five patients (96%) considered their second toe to be better than before the operation. CONCLUSIONS: Closing wedge osteotomy of the second toe is technically simple, reasonably safe, and relatively effective for valgus deformity of the second toe. Recurrence of the second toe valgus usually was associated with recurrence of hallux valgus.

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BACKGROUND: The main bony procedures used in the treatment of second hammertoe are excisional arthroplasty and arthrodesis of the proximal interphalangeal (PIP) joint. While a number of studies have reported the outcomes after PIP joint arthrodesis, there are few reports of the outcome of excisional arthroplasty of the PIP joint for the correction of second hammertoes. The purpose of this study was to evaluate the long-term outcome of PIP joint excisional arthroplasty. METHODS: Seventy-five patients (100 toes) who had excisional arthroplasty of the PIP joint for the correction of second hammertoe were reviewed at an average followup of 44 months. All patients were seen in clinic and were physically examined to assess the alignment and function of each digit. The radiographs were evaluated preoperatively. The AOFAS clinical rating scale was used preoperatively and at final followup. Patients were asked to rate their satisfaction on a scale of 0 to 10 and were asked if they would be happy to have the surgery under similar circumstances again. RESULTS: The mean preoperative AOFAS clinical rating scale was 46. At final followup this increased to 94, showing an average improvement of 48 points (p < 0.0001). The mean satisfaction on a scale of 0 to 10 (with 0 equaling complete dissatisfaction and 10 complete satisfaction) was 9.3 (SD 1.3). One patient would not have been happy to undergo outpatient surgery again, because of a change in her social circumstances. CONCLUSION: In a group of 75 patients who had PIP joint arthroplasty for the correction of second hammertoe, high levels of satisfaction were achieved. No serious complications were encountered, and revision surgery was required in just two cases. Floating toe was the most common complication encountered, and although this did decrease the level of patient satisfaction in seven patients it was not a cause of footwear irritation or pain in any patient.

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Seventeen patients (20 feet) underwent Weil osteotomies of the second and third metatarsals for the treatment of central metatarsalgia and were reviewed at an average of 18 months postoperatively. Fourteen patients were completely satisfied with the results of their surgery (85%), one patient was satisfied, one patient satisfied with reservations and one patient was dissatisfied. The American Orthopaedic Foot and Ankle Society clinical rating scale improved by an average of 44 points. One patient had complete recurrence of symptoms, eight out of the 40 toes involved in surgery were floating, four toes were stiff, there were three cases of infection, and transfer metatarsalgia affected the fourth metatarsal in one case. The Weil osteotomy is an effective and safe procedure for the treatment of central metatarsalgia.

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