RESUMEN
Robotic-assisted surgery is criticized for its high cost. As surgeons get more experienced in robotic surgery, modifications to existing techniques are tried to reduce surgical costs. Vaginal cuff closure using prograsp forceps in lieu of needle holder can be safe and cost-effective in patients undergoing robotic-assisted hysterectomy. The objective of this study is to compare the safety, efficacy, and cost effectiveness of using prograsp forceps in lieu of needle holder for suturing the vaginal cuff after robotic-assisted hysterectomy. This was a single-institution retrospective review of patients who underwent robotic-assisted hysterectomy for benign and malignant conditions from October 2015 to August 2018. Patients were stratified based on whether prograsp forceps or needle holder was used for suturing vaginal cuff. Data obtained included demographic, surgical data, and postoperative outcomes. Mann-Whitney U test and Chi-square test were used to compare qualitative and quantitative data, respectively. 367 patients underwent robotic-assisted hysterectomies during this period. 75 patients belonged to the needle holder cohort; 292 patients had vaginal cuff closure using prograsp forceps. Vault closure time was comparable between the groups (6.4 vs. 6.6 p = 0.33). There were no significant differences in the postoperative vault-related complications between groups. There was no instrument damage in either group. Using prograsp saved 220 USD in instrument-related charges. This study shows that using prograsp in lieu of needle holder for suturing is safe, there is no increase in operative time or complications, and there is a cost advantage.
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Ahorro de Costo/economía , Análisis Costo-Beneficio , Histerectomía/economía , Histerectomía/instrumentación , Agujas/economía , Procedimientos Quirúrgicos Robotizados/economía , Procedimientos Quirúrgicos Robotizados/instrumentación , Instrumentos Quirúrgicos/economía , Técnicas de Sutura/economía , Técnicas de Sutura/instrumentación , Vagina/cirugía , Técnicas de Cierre de Heridas/economía , Técnicas de Cierre de Heridas/instrumentación , Anciano , Femenino , Humanos , Histerectomía/métodos , Persona de Mediana Edad , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/métodos , Seguridad , Resultado del TratamientoRESUMEN
OBJECTIVES: to analyze the mean direct cost and peripheral venous access length outcomes using devices over needle with and without extension. METHODS: quantitative, exploratory-descriptive research. Venous punctures and length of the devices were followed. The mean direct cost was calculated by multiplying the time (timed) spent by nursing professionals by the unit cost of labor, adding to the cost of materials. RESULTS: the total mean direct cost of using devices "with extension" (US$ 9.37) was 2.9 times the cost of using devices "without extension" (US$ 4.50), US$ 7.71 and US$ 2.66, respectively. Totaling 96 hours of stay, the "device over needle with extension" showed a lower occurrence of accidental loss. CONCLUSIONS: the use of the "device over needle with extension", despite its higher mean direct cost, was more effective in favoring adequate length of peripheral venous access.
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Cateterismo Periférico/economía , Cateterismo Periférico/normas , Evaluación de Resultado en la Atención de Salud/normas , Adulto , Anciano , Anciano de 80 o más Años , Cateterismo Periférico/estadística & datos numéricos , Costos y Análisis de Costo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Agujas/economía , Agujas/normas , Agujas/estadística & datos numéricos , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricosRESUMEN
ABSTRACT Objectives: to analyze the mean direct cost and peripheral venous access length outcomes using devices over needle with and without extension. Methods: quantitative, exploratory-descriptive research. Venous punctures and length of the devices were followed. The mean direct cost was calculated by multiplying the time (timed) spent by nursing professionals by the unit cost of labor, adding to the cost of materials. Results: the total mean direct cost of using devices "with extension" (US$ 9.37) was 2.9 times the cost of using devices "without extension" (US$ 4.50), US$ 7.71 and US$ 2.66, respectively. Totaling 96 hours of stay, the "device over needle with extension" showed a lower occurrence of accidental loss. Conclusions: the use of the "device over needle with extension", despite its higher mean direct cost, was more effective in favoring adequate length of peripheral venous access.
RESUMEN Objetivos: analizar el costo directo promedio y los resultados de permanencia del acceso venoso periférico, utilizando dispositivos de aguja con y sin extensión. Métodos: investigación cuantitativa, exploratoria descriptiva. Se siguieron los pinchazos venosos y el tiempo de permanencia de los dispositivos. El costo directo promedio se calculó multiplicando el tiempo (cronometrado) dedicado por los profesionales de enfermería por el costo unitario de la mano de obra, lo que se suma al costo de los materiales. Resultados: el costo directo promedio total de usar dispositivos "extendidos" (US$ 9,37) fue 2,9 veces el costo de usar dispositivos "no extendidos" (US$ 4,50) de materiales, US$ 7.71 y US$ 2.66, respectivamente. Con un total de 96 horas de estadía, el "dispositivo de aguja extendida" mostró una menor ocurrencia de pérdida accidental. Conclusiones: a pesar del costo directo promedio más alto, el uso de un "dispositivo de aguja extendida" fue más efectivo para favorecer un tiempo de acceso venoso periférico adecuado.
RESUMO Objetivos: analisar o custo direto médio e os desfechos de permanência de acesso venoso periférico, utilizando dispositivos sobre agulha com e sem extensão. Métodos: pesquisa quantitativa, exploratório-descritiva. Acompanharam-se as punções venosas e o tempo de permanência dos dispositivos. Calculou-se o custo direto médio multiplicando-se o tempo (cronometrado) despendido por profissionais de enfermagem pelo custo unitário da mão de obra, somando-se ao custo dos materiais. Resultados: o custo direto médio total do uso de dispositivo "com extensão" (US$ 9,37) foi 2,9 vezes do que o custo do uso de dispositivo "sem extensão" (US$ 4,50), destacando-se os custos dos materiais, US$ 7,71 e US$ 2,66, respectivamente. Totalizando 96 horas de permanência, o "dispositivo sobre agulha com extensão" apresentou menor ocorrência de perda acidental. Conclusões: o uso do "dispositivo sobre agulha com extensão", apesar do maior custo direto médio, foi mais eficaz para favorecer o adequado tempo de permanência do acesso venoso periférico.
Asunto(s)
Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cateterismo Periférico/economía , Cateterismo Periférico/normas , Evaluación de Resultado en la Atención de Salud/normas , Cateterismo Periférico/estadística & datos numéricos , Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Costos y Análisis de Costo , Agujas/economía , Agujas/normas , Agujas/estadística & datos numéricosRESUMEN
OBJECTIVE: From 2011 to 2013, the Global Fund (GF) supported needle and syringe programmes in Mexico to prevent transmission of HIV among people who inject drugs. It remains unclear how GF withdrawal affected the costs, quality and coverage of needle and syringe programme provision. DESIGN: Costing study and longitudinal cohort study. SETTING: Tijuana, Mexico. PARTICIPANTS: Personnel from a local needle and syringe programme (n=6) and people who inject drugs (n=734) participating in a longitudinal study. PRIMARY OUTCOME MEASURES: Provision of needle and syringe programme services and cost (per contact and per syringe distributed, in 2017 $USD) during GF support (2012) and after withdrawal (2015/16). An additional outcome included needle and syringe programme utilisation from a concurrent cohort of people who inject drugs during and after GF withdrawal. RESULTS: During the GF period, the needle and syringe programme distributed 55 920 syringes to 932 contacts (60 syringes/contact) across 14 geographical locations. After GF withdrew, the needle and syringe programme distributed 10 700 syringes to 2140 contacts (five syringes/contact) across three geographical locations. During the GF period, the cost per harm reduction contact was approximately 10-fold higher compared with after GF ($44.72 vs $3.81); however, the cost per syringe distributed was nearly equal ($0.75 vs $0.76) due to differences in syringes per contact and reductions in ancillary kit components. The mean log odds of accessing a needle and syringe programme in the post-GF period was significantly lower than during the GF period (p=0.02). CONCLUSIONS: Withdrawal of GF support for needle and syringe programme provision in Mexico was associated with a substantial drop in provision of sterile syringes, geographical coverage and recent clean syringe utilisation among people who inject drugs. Better planning is required to ensure harm reduction programme sustainability is at scale after donor withdrawal.
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Programas de Intercambio de Agujas/economía , Programas de Intercambio de Agujas/estadística & datos numéricos , Agujas/provisión & distribución , Abuso de Sustancias por Vía Intravenosa/epidemiología , Jeringas/provisión & distribución , Costos y Análisis de Costo , Infecciones por VIH/prevención & control , Hepatitis C/prevención & control , Humanos , Estudios Longitudinales , México/epidemiología , Agujas/economía , Jeringas/economíaRESUMEN
BACKGROUND: Hemodialysis requires needle insertions every treatment. Needle injury (mechanical or hemodynamic) may cause complications (aneurysms/stenosis) that compromise dialysis delivery requiring interventions. Metal needles have a sharp slanted "V"-shaped cutting tip; plastic cannulae have a dull round tip and four side holes. Preliminary observations demonstrated a difference in intradialytic blood flow images and mean Doppler velocities at cannulation sites between the two devices. Complications from mechanical and hemodynamic trauma requiring interventions were compared in each group. MATERIALS AND METHODS: In all, 33 patients (13 females and 17 new accesses) were randomized to metal group (n = 17) and plastic group (n = 16). Mechanical trauma was minimized by having five nurses performing ultrasound-guided cannulations. Complications were identified by the clinician and addressed by the interventionalists, both blinded to study participation. Patients were followed for up to 12 months. RESULTS: Baseline characteristics were not significant. Procedures to treat complications along cannulation segments increased from 0.41 to 1.29 per patient (metal group) and decreased from 1.25 to 0.69 per patient (plastic group; p = 0.004). The relative risks of having an intervention (relative risk = 1.5, 95% confidence interval = 0.88-2.67) and having an infiltration during hemodialysis (relative risk = 2.26, 95% confidence interval = 1.03-4.97) were higher for metal needles. Time to first intervention trended in favor of plastic cannula (p = 0.069). Cost of supplies for these interventions was approximately CAD$20,000 lower for the plastic group. CONCLUSION: Decreased burden of illness related to cannulation (less infiltrations during hemodialysis) and Qb were associated with plastic cannulae. Decreased procedure costs were suggested during the study period in the plastic group.
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Cánula , Cateterismo/instrumentación , Metales , Agujas , Plásticos , Diálisis Renal/instrumentación , Anciano , Cánula/efectos adversos , Cánula/economía , Cateterismo/efectos adversos , Cateterismo/economía , Ahorro de Costo , Análisis Costo-Beneficio , Diseño de Equipo , Femenino , Costos de la Atención en Salud , Humanos , Masculino , Metales/economía , Persona de Mediana Edad , Agujas/efectos adversos , Agujas/economía , Proyectos Piloto , Plásticos/economía , Punciones , Diálisis Renal/efectos adversos , Diálisis Renal/economía , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
BACKGROUND: Pen needles are an important component of insulin delivery among patients with diabetes, but are not universally covered in China. We compared clinical and economic characteristics of insulin-dependent patients in China who have some level of pen needle (PN) reimbursement to those with no PN reimbursement. METHODS: A cross-sectional study was conducted among 400 insulin users with Type 1 or Type 2 diabetes treated in outpatient endocrinology units of four large tertiary care hospitals in Nanjing, Chongqing, Beijing and Zhengzhou. Demographics, medical history, healthcare resource utilization (RU), out-of-pocket costs, insurance and PN reimbursement status were surveyed. Unit costs were assigned to healthcare RU and compared using descriptive statistics and multivariate regression models. RESULTS: A total of 400 patients were analyzed; 142 (35.5%) with some level of PN coverage/reimbursement and 258 (64.5%) without. Patients without PN reimbursement had a higher prevalence of lipohypertrophy (59.3% vs. 40.7%, p = 0.0007), greater median PN reuse (12 vs. 7 times per needle, p < 0.0001), greater 6-month insulin costs (1591 vs. 1328 Renminbi [RMB], p = 0.0025) and total unadjusted 6-month expenditures (6433 vs. 4432 RMB, p < 0.0001), respectively. After controlling for clinical and demographic characteristics, patients without PN reimbursement had 4.6 times greater odds of high costs compared to those with PN reimbursement. CONCLUSIONS: Insulin users without PN reimbursement may pose a greater economic burden to China compared to those with PN reimbursement. Expansion of insurance coverage for insulin PNs can improve the quality of care and potentially help reduce the economic burden in this population.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Cobertura del Seguro/estadística & datos numéricos , Seguro de Salud/estadística & datos numéricos , Agujas/economía , Aceptación de la Atención de Salud/estadística & datos numéricos , China/epidemiología , Estudios Transversales , Diabetes Mellitus Tipo 2/economía , Sistemas de Liberación de Medicamentos/economía , Sistemas de Liberación de Medicamentos/instrumentación , Composición Familiar , Femenino , Gastos en Salud , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/economía , Inyecciones Subcutáneas/economía , Insulina/administración & dosificación , Insulina/economía , Masculino , Persona de Mediana Edad , Agujas/estadística & datos numéricos , Jeringas/economíaRESUMEN
We hypothesized that ultrasound (US) guidance improves outcomes of corticosteroid injection of trochanteric bursitis. 40 patients with greater trochanteric pain syndrome defined by pain to palpation over the trochanteric bursa were randomized to injection with 5 ml of 1% lidocaine and 80 mg of methylprednisolone using (1) conventional anatomic landmark palpation guidance or (2) US guidance. Procedural pain (Visual Analogue Pain Scale), pain at outcome (2 weeks and 6 months), therapeutic duration, time-to-next intervention, and costs were determined. There were no complications in either group. Ultrasonography demonstrated that at least a 2-in (50.8 mm) needle was required to consistently reach the trochanteric bursa. Pain scores were similar at 2 weeks: US: 1.3 ± 1.9 cm; landmark: 2.2 ± 2.5 cm, 95% CI of difference: - 0.7 < 0.9 < 2.5, p = 0.14. At 6 months, US was superior: US: 3.9 ± 2.0 cm; landmark: 5.5 ± 2.6 cm, 95% CI of difference: 0.8 < 1.6 < 2.4, p = 0.036. However, therapeutic duration (US 4.7 ± 1.4 months; landmark 4.1 ± 2.9 months, 95% CI of difference - 2.2 < - 0.6 < 1.0, p = 0.48), and time-to-next intervention (US 8.7 ± 2.9 months; landmark 8.3 ± 3.8 months, 95% CI of difference - 2.8 < - 0.4 < 2.0, p = 0.62) were similar. Costs/patient/year was 43% greater with US (US $297 ± 99, landmark $207 ± 95; p = 0.017). US-guided and anatomic landmark injection of the trochanteric bursa have similar 2-week and 6-month outcomes; however, US guidance is considerably more expensive and less cost-effective. Anatomic landmark-guided injection remains the method of choice, but should be routinely performed using a sufficiently long needle [at least a 2 in (50.8 mm)]. US guidance should be reserved for extreme obesity or injection failure.
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Anestésicos Locales/administración & dosificación , Anestésicos Locales/economía , Bolsa Sinovial/efectos de los fármacos , Bursitis/tratamiento farmacológico , Bursitis/economía , Costos de los Medicamentos , Glucocorticoides/administración & dosificación , Glucocorticoides/economía , Lidocaína/administración & dosificación , Lidocaína/economía , Metilprednisolona/administración & dosificación , Metilprednisolona/economía , Ultrasonografía Intervencional/economía , Adulto , Anciano , Puntos Anatómicos de Referencia , Anestésicos Locales/efectos adversos , Bolsa Sinovial/diagnóstico por imagen , Bolsa Sinovial/fisiopatología , Bursitis/diagnóstico por imagen , Bursitis/fisiopatología , Análisis Costo-Beneficio , Diseño de Equipo , Femenino , Fémur , Glucocorticoides/efectos adversos , Humanos , Inyecciones Intralesiones , Lidocaína/efectos adversos , Masculino , Metilprednisolona/efectos adversos , Persona de Mediana Edad , Agujas/economía , Dimensión del Dolor , Palpación/economía , Datos Preliminares , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Intervencional/efectos adversos , Estados UnidosAsunto(s)
Huesos/cirugía , Procedimientos Ortopédicos/métodos , Técnicas de Sutura , Enfermedades Óseas/rehabilitación , Enfermedades Óseas/cirugía , Humanos , Agujas/economía , Tempo Operativo , Procedimientos Ortopédicos/economía , Procedimientos Ortopédicos/instrumentación , Suturas , Factores de TiempoRESUMEN
OBJECTIVE: Currently available measles vaccines are administered by subcutaneous injections and require reconstitution with a diluent and a cold chain, which is resource intensive and challenging to maintain. To overcome these challenges and potentially increase vaccination coverage, microneedle patches are being developed to deliver the measles vaccine. This study compares the cost-effectiveness of using microneedle patches with traditional vaccine delivery by syringe-and-needle (subcutaneous vaccination) in children's measles vaccination programs. METHODS: We built a simple spreadsheet model to compute the vaccination costs for using microneedle patch and syringe-and-needle technologies. We assumed that microneedle vaccines will be, compared with current vaccines, more heat stable and require less expensive cool chains when used in the field. We used historical data on the incidence of measles among communities with low measles vaccination rates. RESULTS: The cost of microneedle vaccination was estimated at US$0.95 (range US$0.71-US$1.18) for the first dose, compared with US$1.65 (range US$1.24-US$2.06) for the first dose delivered by subcutaneous vaccination. At 95 % vaccination coverage, microneedle patch vaccination was estimated to cost US$1.66 per measles case averted (range US$1.24-US$2.07) compared with an estimated cost of US$2.64 per case averted (range US$1.98-US$3.30) using subcutaneous vaccination. CONCLUSIONS: Use of microneedle patches may reduce costs; however, the cost-effectiveness of patches would depend on the vaccine recipients' acceptability and vaccine effectiveness of the patches relative to the existing conventional vaccine-delivery method. This study emphasizes the need to continue research and development of this vaccine-delivery method that could boost measles elimination efforts through improved access to vaccines and increased vaccination coverage.
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Vacuna Antisarampión/administración & dosificación , Vacuna Antisarampión/economía , Microinyecciones/economía , Agujas/economía , Parche Transdérmico/economía , Preescolar , Análisis Costo-Beneficio , Humanos , Inyecciones SubcutáneasRESUMEN
AIM: A formal Needle and Syringe Program (NSP) is not provided in Australian prisons. Injecting equipment circulates in prisons as part of an informal and illegal economy. This paper examined how this economy generates blood-borne virus (BBV) risk and risk mitigation opportunities for inmates. METHOD: The HITS-p cohort recruited New South Wales inmates who had reported ever injecting drugs and who had a negative HCV serological test within 12 months prior to enrolment. For this study, qualitative interviews were conducted with 30 participants enrolled in HITS-p. Participants included 10 women and were incarcerated in 12 prisons. RESULTS: A needle/syringe was nominated as being typically priced in the 'inside' prison economy at $100-$150, with a range of $50-$350. Purchase or hire of equipment was paid for in cash (including transactions that occurred outside prison) and in exchange for drugs and other commodities. A range of other resources was required to enable successful needle/syringe economies, especially relationships with visitors and other prisoners, and violence to ensure payment of debts. Strategies to mitigate BBV risk included retaining one needle/syringe for personal use while hiring out others, keeping drug use (and ownership of equipment) "quiet", stealing used equipment from the prison health clinic, and manufacture of syringes from other items available in the prison. CONCLUSIONS: The provision of prison NSP would disrupt the inside economies built around contraband needles/syringes, as well as minimise BBV risk. However, any model of prison NSP should be interrogated for any unanticipated markets that could be generated as a result of its regulatory practices.
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Programas de Intercambio de Agujas , Agujas , Prisioneros , Prisiones , Conducta de Reducción del Riesgo , Jeringas , Virosis/epidemiología , Virosis/transmisión , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Agujas/economía , Nueva Gales del Sur/epidemiología , Encuestas y Cuestionarios , Jeringas/economía , Virosis/virología , Adulto JovenAsunto(s)
Técnicas Cosméticas/instrumentación , Agujas , Tempo Operativo , Procedimientos de Cirugía Plástica/instrumentación , Rejuvenecimiento , Vulva/cirugía , Adulto , Técnicas Cosméticas/economía , Análisis Costo-Beneficio , Estética , Femenino , Costos de la Atención en Salud , Humanos , Persona de Mediana Edad , Agujas/economía , Procedimientos de Cirugía Plástica/economía , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE To estimate the cost-effectiveness of safety-engineered devices (SEDs) relative to non-SEDs for winged steel needles, intravenous catheter stylets, suture needles, and insulin pen needles. DESIGN Decision analysis modeling. PARTICIPANTS Hypothetical cohort of healthcare workers who utilized needle devices. METHODS We developed a decision-analytic model to estimate and compare the life-cycle costs and benefits for SED and non-SED needle devices. For this cost-effectiveness analysis, we quantified the total direct medical cost per needlestick injury, number of needlestick injuries avoided, and incremental cost-effectiveness ratio. Sensitivity analyses were performed to examine the robustness of the base-case analysis. RESULTS In the base-case analysis, we calculated the incremental cost-effectiveness ratios of SED winged steel needles, intravenous catheter stylets, suture needles, and insulin pen needles to be $2,633, $13,943, $1,792, and $1,269 per needlestick injury avoided, respectively. Sensitivity analyses showed that the calculated incremental cost-effectiveness ratio values for using SEDs did not fall below zero even after adjusting the values of each parameter. CONCLUSION The use of SED needle devices would not produce cost savings for hospitals. Government intervention may be needed to systematically protect healthcare workers in Japan from the risk of bloodborne pathogen infections. Infect Control Hosp Epidemiol 2016;37:1012-1021.
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Accidentes de Trabajo/prevención & control , Agujas/clasificación , Agujas/economía , Lesiones por Pinchazo de Aguja/prevención & control , Flebotomía/instrumentación , Equipos de Seguridad/economía , Patógenos Transmitidos por la Sangre , Análisis Costo-Beneficio , Diseño de Equipo , Humanos , Japón , Personal de Hospital , Administración de la Seguridad/economía , Sensibilidad y EspecificidadRESUMEN
Millions of people die of infectious diseases each year, mostly in developing countries, which could largely be prevented by the use of vaccines. While immunization rates have risen since the introduction of the Expanded Program on Immunization (EPI), there remain major challenges to more effective vaccination in developing countries. As a possible solution, microneedle patches containing an array of micron-sized needles on an adhesive backing have been developed to be used for vaccine delivery to the skin. These microneedle patches can be easily and painlessly applied by pressing against the skin and, in some designs, do not leave behind sharps waste. The patches are single-dose, do not require reconstitution, are easy to administer, have reduced size to simplify storage, transportation and waste disposal, and offer the possibility of improved vaccine immunogenicity, dose sparing and thermostability. This review summarizes vaccination challenges in developing countries and discusses advantages that microneedle patches offer for vaccination to address these challenges. We conclude that microneedle patches offer a powerful new technology that can enable more effective vaccination in developing countries.
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Control de Enfermedades Transmisibles/métodos , Países en Desarrollo , Microinyecciones/métodos , Agujas , Parche Transdérmico , Vacunación/métodos , Animales , Control de Enfermedades Transmisibles/economía , Control de Enfermedades Transmisibles/normas , Enfermedades Transmisibles/economía , Enfermedades Transmisibles/epidemiología , Enfermedades Transmisibles/terapia , Países en Desarrollo/economía , Humanos , Inyecciones Intradérmicas , Microinyecciones/economía , Microinyecciones/normas , Agujas/economía , Agujas/normas , Parche Transdérmico/economía , Parche Transdérmico/normas , Vacunación/economía , Vacunación/normasRESUMEN
With interest in microneedles as a novel drug transdermal delivery system increasing rapidly since the late 1990s (Margetts and Sawyer Contin Educ Anaesthesia Crit Care Pain. 7(5):171-76, 2007), a diverse range of microneedle systems have been fabricated with varying designs and dimensions. However, there are still very few commercially available microneedle products. One major issue regarding microneedle manufacture on an industrial scale is the lack of specific quality standards for this novel dosage form in the context of Good Manufacturing Practice (GMP). A range of mechanical characterisation tests and microneedle insertion analysis techniques are used by researchers working on microneedle systems to assess the safety and performance profiles of their various designs. The lack of standardised tests and equipment used to demonstrate microneedle mechanical properties and insertion capability makes it difficult to directly compare the in use performance of candidate systems. This review highlights the mechanical tests and insertion analytical techniques used by various groups to characterise microneedles. This in turn exposes the urgent need for consistency across the range of microneedle systems in order to promote innovation and the successful commercialisation of microneedle products.
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Microinyecciones/instrumentación , Agujas/normas , Transferencia de Tecnología , Tecnología Farmacéutica/normas , Humanos , Inyecciones Intradérmicas , Microinyecciones/economía , Agujas/economía , Tecnología Farmacéutica/economía , Tecnología Farmacéutica/métodosRESUMEN
OBJECTIVE: The aim of this study was to evaluate the cost-effectiveness of insulin degludec (IDeg) vs insulin glargine (IGlar) as part of a basal-bolus treatment regimen in adults with T1DM, using a short-term economic model. METHODS: Data from two phase III clinical studies were used to populate a simple and transparent short-term model. The costs and effects of treatment with IDeg vs IGlar were calculated over a 12-month period. The analysis was conducted from the perspective of the UK National Health Service. Sensitivity analyses were conducted to assess the degree of uncertainty surrounding the results. The main outcome measure, the incremental cost-effectiveness ratio (ICER), was the cost per quality-adjusted life-year (QALY). RESULTS: IDeg is a cost-effective treatment option vs IGlar in patients with T1DM on a basal-bolus regimen. The base case ICER was estimated at £16,895/QALY, which is below commonly accepted thresholds for cost-effectiveness in the UK. Sensitivity analyses demonstrated that the ICER was stable to variations in the majority of input parameters. The parameters that exerted the most influence on the ICER were hypoglycemia event rates, daily insulin dose, and disutility associated with non-severe nocturnal hypoglycemic events. However, even under extreme assumptions in the majority of analyses the ICERs remained below the commonly accepted threshold of £20,000-£30,000 per QALY gained. CONCLUSIONS: This short-term modeling approach accommodates the treat-to-target trial design required by regulatory bodies, and focuses on the impact of important aspects of insulin therapy such as hypoglycemia and dosing. For patients with T1DM who are treated with a basal-bolus insulin regimen, IDeg is a cost-effective treatment option compared with IGlar. IDeg may be particularly cost-effective for sub-groups of patients, such as those suffering from recurrent nocturnal hypoglycemia and those with impaired awareness of hypoglycemia.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemiantes/economía , Insulina de Acción Prolongada/economía , Automonitorización de la Glucosa Sanguínea , Ensayos Clínicos Fase III como Asunto , Análisis Costo-Beneficio , Hemoglobina Glucada , Humanos , Hipoglucemiantes/uso terapéutico , Insulina Glargina , Insulina de Acción Prolongada/uso terapéutico , Modelos Econométricos , Programas Nacionales de Salud , Agujas/economía , Años de Vida Ajustados por Calidad de Vida , Reino UnidoAsunto(s)
Terapia por Acupuntura/economía , Terapia por Acupuntura/instrumentación , Medicina General/economía , Medicina General/legislación & jurisprudencia , Programas Nacionales de Salud/economía , Programas Nacionales de Salud/legislación & jurisprudencia , Agujas/economía , Alemania , Humanos , Mecanismo de Reembolso/economía , Mecanismo de Reembolso/legislación & jurisprudenciaRESUMEN
Intraosseous infusion is an old knowledge, abandoned in the 1950s in favor of the peripheral vein, and it was essentially described in pediatrics and military medicine. Since 2005, this way is experiencing a resurgence of interest in emergency medicine particularly in adults after the failure's installation of a peripheral vein in order not to waste the time of care and administration of treatment. New devices that allow intraosseous infusion are currently used in humans. We propose to review the different kind of catheters used, to know the main technical characteristics, indications, contraindications and potential complications. We propose a comparison with the peripheral vein and a comparison between the different catheters.
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Infusiones Intraóseas , Adulto , Huesos/irrigación sanguínea , Catéteres/economía , Contraindicaciones , Urgencias Médicas , Diseño de Equipo , Fracturas Óseas , Humanos , Soluciones Hipertónicas , Infusiones Intraóseas/efectos adversos , Infusiones Intraóseas/economía , Infusiones Intraóseas/instrumentación , Infusiones Intraóseas/métodos , Infusiones Intraóseas/tendencias , Agujas/economía , Especificidad de Órganos , Osteítis , Instrumentos Quirúrgicos/economíaRESUMEN
BACKGROUND: Despite an increasing number of procedures being performed, there is no consensus on an optimal approach to EUS-guided FNA (EUS-FNA) or interventions. OBJECTIVE: Validate an algorithmic approach to EUS-FNA/interventions with the objective of improving technical outcomes and resource use. DESIGN: Prospective study. SETTING: Tertiary-care referral center. PATIENTS: Consecutive patients undergoing EUS-FNA and/or interventions. INTERVENTION: Phase I was a retrospective analysis of EUS-FNA/interventions performed in 548 patients. The 19-gauge needle was used for interventions, and the 22- or 25-gauge needle was used interchangeably for performing FNAs. At phase I, the technical failure rate was 11.5%. Based on these observations, an algorithm was proposed by which all transduodenal FNAs were performed by using a 25-gauge needle and other FNAs with a 22-gauge needle. All transduodenal interventions were performed with a Flexible 19-gauge needle and others with a standard 19-gauge needle. This algorithm was tested prospectively in phase II on 500 patients. MAIN OUTCOME MEASUREMENTS: Compare technical failure, diagnostic adequacy, procedural complications, and average needle costs between both phases. RESULTS: The technical failure rate was significantly less in phase II compared with that of phase I (1.6% vs 11.5%; P < .001) for both FNA (1.8% vs 10.9%; P < .001) and therapeutic interventions (0% vs 16.4%; P = .001). Although there was no difference in diagnostic adequacy (97.1% vs 98.4%; P = .191) or complications (0.4% vs 0.2%; P = 1.0) between phases I and II, the average cost per case was significantly less in phase II ($199.59 vs $188.30; P = .008). LIMITATIONS: Single-center study. CONCLUSION: An algorithmic approach to EUS-FNA/interventions yielded better technical outcomes and cost savings without compromising diagnostic adequacy.