Use Of Infusion Pumps Research Articles

Analysis of the Effect of Ambulatory Chemotherapy (Portable Infusion Pump Use) Video Education on Knowledge, Self-efficacy, and Anxiety of Colorectal Cancer Patients

Objective: To analyze the effect of video education on ambulatory chemotherapy with a portable infusion pump on the knowledge, self-efficacy, and anxiety of colorectal cancer patients. Methods: This study employs a quasi- experimental study as a nonequivalent control group and a non-synchronized design. The 48 participants selected in this study were colorectal cancer patients who received chemotherapy with a portable infusion pump through an ambulatory care unit. Patient education was divided into printed materials and videos, and the patient’s knowledge, self-efficacy, and anxiety were measured. Data were analyzed using independent t-test, paired t-test, and Wilcoxon’s signed rank test. Results: In the video education group, the patient’s knowledge (Z = -4.09, P < 0.001) and self-efficacy (Z = -2.72, P = 0.012) significantly increased after education, and anxiety significantly decreased (Z = 2.24, P = 0.035). However, there was no difference in knowledge (t = 0.09, P = 0.931), self-efficacy (t = 1.22, P = 0.229), and anxiety (t = -1.16, P = 0.250) between the two groups after education. Conclusion: To improve the quality of life of cancer patients, it is necessary to promote self-efficacy and reduce anxiety. The results of this study suggested that more diverse educational methods should be attempted to improve knowledge and self-efficacy and reduce anxiety in colorectal cancer patients.

The Sensor Occlusion SEN0257 on the Infusion Device Analyzer 2 Channel with TFT Display ensures high accuracy in detecting occlusions.

Syringepump and Infuspump function to provide drugs or fluids that are carried out directly and continuously for a certain period of time through a blood vessel. Often encountered problems of blockage or occlusion in the use of infusion pumps and syringe pumps. Occlusion in the infusion device causes the incoming drug fluid to not flow constantly. Occlusion limit set at 20 Psi according to ECRI. To ensure this, proper calibration is required at least once a year. The purpose of this research is to analyze the accuracy of the pressure sensor on the Occlusion measurement on the Infusion Device Analyzer 2 Channel showing TFT. This study has 2 channels so that it can calibrate 2 tools simultaneously. The design of this module uses a Water Pressure Sensor to measure occlusion and a solenoid valve for pressure simulation. When the sensor is depressed, the sensor detects the pressure and is processed by the Arduino. The pressure results are then displayed on a 7-inch TFT LCD in the form of graphs and numbers in real time and stored on the SD card.

Defining the Current Deployment of Neonatal Infusion Pumps in Low- and Lower-Middle-Income Countries: A Rapid Review.

There has been limited review of the reported deployment of infusion pumps in low- and lower-middle-income countries. This paper aims to identify the current distribution of infusion pumps in low- and lower-middle-income countries (LLMICs) used to treat neonates. A rapid review was conducted using material sourced from ProQuest, Pubmed, Web of Science, and IEEE Xplore. Twenty-six search results met the inclusion criteria. Within these, 41 neonatal healthcare facilities were discussed with 17 of the facilities having infusion pumps available, 13 limited access, and 11 none. Infusion pump use remains limited in Sub-Saharan Africa so efforts should be made to deploy specialist neonatal care improvement packages, potentially including infusion pumps designed for LLMICs. The effects of COVID-19, to neonatal care LLMICs, should be accessed to ensure progress has not regressed. These proposals aim to aid in the continued improvement of neonatal care globally and reduce newborn mortalities.

Does the use of infusion pumps increase hemolysis during blood transfusion in patients with thalassemia?

BackgroundPatients with thalassemia need regular blood transfusions to maintain normal growth and suppression of ineffective erythropoiesis. Packed red blood cell (RBC) units can be delivered by infusion pumps (IPs); however, IPs may cause mechanical stress-induced RBC lysis. This study aimed to investigate the biomarkers of hemolysis related to transfusion techniques in patients with thalassemia. Material and methodsEighty-one thalassemia patients compared to those 42 healthy controls in terms of hemolysis markers (hemoglobin, plasma free hemoglobin (Hb), haptoglobin, potassium (K), lactate dehydrogenase (LDH)) before transfusion. Considering the age and peripheral venous diameter of the patient, the physician decided on the caliber of vascular access device (22 G or 24 G) for transfusion and the method to be used (gravitational method [GM] or IP). Hemolysis markers were repeated after transfusion in thalassemia patients. ResultsPacked RBC units were transfused to 24 (30 %) patients by IP and 57 (70 %) patients by GM. Plasma free Hb was significantly increased from 4.76 ± 7.92 mg/dL to 9.01 ± 7.66 mg/dL following transfusion (p < 0.001). There was no significant difference between IP and GM in terms of plasma free Hb increase. Post-transfusion plasma free Hb, LDH, and K levels significantly increased in patients who were transfused with 24 G catheters compared to those transfused with 22 G. ConclusionAn elevation in LDH levels was detected after transfusion with volumetric IPs; however, plasma free Hb or K levels were not affected by the transfusion method. Studies are needed to determine the factors associated with hemolysis after transfusion.

Outcome of Oxytocin on Haemodynamic Change During Caesarean Section under Spinal Anaesthesia

Background: Oxytocin is generally used in obstetric exercise as a uterotonic drug for induction and augmentation of labor and stays the drug of desire for facilitating uterine contractions all through vaginal and operative delivery. It is now spreading up to far-flung areas. The infusion method of oxytocin is protected in the caesarean area beneath spinal anaesthesia. Objective: This is to evaluate the hemodynamic modifications precipitated by oxytocin given as an I/V bolus or infusion to limit uterine bleeding in cesarean section. Methods: This prospective, interventional learning was once carried out at the Department of Anaesthesiology, Abdul Malek Ukil Medical College &amp; Hospital, Noakhali, Bangladesh, from January to December 2020. A whole range of fifty sufferers ASA grade I had been selected. Thirty affected people in every group. In crew A, the parturient acquired oxytocin 5IU of I/V in bolus, and in team B, infusion of oxytocin 5IU diluted with 5ml everyday saline given I/V over two min by way of the use of infusion pump. Systolic and diastolic BP, MAP, coronary heart rate, uterine bleeding have been recorded every 1 min. The learning about duration used to be started out simply earlier than oxytocin is given, and it used to be persisted for an additional 10 min. Results: In our study, every group had n=25. All outcomes are expressed as mean± standard deviation. The studied groups became statistically matched for age, gestational age, weight, coronary heart rate, systolic and diastolic blood pressure, suggesting arterial pressure. The implied distinction of all hemodynamic parameters at 2 to 5 minutes of oxytocin administration has been statistically significant (p&lt;0.05). Conclusion: Oxytocin remains the first-line uterotonic after vaginal and caesarean delivery. The hemodynamic changes were more marked in the I/V bolus of oxytocin than infusion technique. Recent research elucidates the therapeutic range of oxytocin during caesarean delivery and receptor desensitization. A slower injection of oxytocin can effectively minimize cardiovascular side effects and equally effectively reduce blood loss without compromising the therapeutic benefits. Evidence-based protocols for preventing and treating uterine atony during cesarean delivery are recommended.

Effect of Ambulatory Chemotherapy (Portable Infusion Pump Use) Video Education on Knowledge, Self-efficacy and Anxiety of Colorectal Cancer Patients

Effect of Ambulatory Chemotherapy (Portable Infusion Pump Use) Video Education on Knowledge, Self-efficacy and Anxiety of Colorectal Cancer Patients

Taking Serious Games Forward in Curriculum and Assessment: Starting Infusions Right Every Time.

Technology-driven educational modalities are increasingly utilized today in a variety of forms. Different combinations of the spectrum of simulation-based learning, the use of virtual reality, augmented reality, mixed reality, and serious gaming continue to gain traction on various educational platforms. In this paper, we share the formation of our project team to plan and execute a serious game on starting infusions and the use of infusion pump for nursing and health-care staff. The incorporation of element of assessment is also discussed.The various phases we went through included: Learning needs assessment and conceptualizationAssembly of project teamTransfer of medical conceptsStoryboard and content productionLearners' experiential mappingTesting of the prototypeBeta testing and release of the final product The collaborative work and coordination between the subject-matter experts together with the technical production team is critical. Issues such as assessment and debriefing in serious gaming were also addressed, not forgetting the need to ensure that, above all, learning must take place.

User-Centered Design: Developing the RELI Delivery System - a Low-Cost, Non-Electric, Pneumatic Infusion Pump.

PurposeInfusion pumps are the preferred method for intravenous delivery of drugs and fluids, and an essential tool in health facilities. Their high cost, complexity and reliance on electricity pose serious challenges to wide-spread use, availability and access in low- and middle-income countries. PATH developed the RELI Delivery System (RELI), a low cost, non-electric infusion pump to address these challenges. Input collected from fifty-nine newborn and maternal care providers and from seven national level decision makers in Uganda was used to guide product development, further informing product design requirements, and optimal design features to best serve their needs.MethodsA formative evaluation following a mixed methods approach including focus group discussions (FGDs), stakeholder interviews, and observations was used to collect data from end users.ResultsStakeholders provided critical input on the RELI prototype design features, safety criteria, and contexts of use of infusion pumps, as well as recommendations for design refinements. Infusion systems are greatly needed but not readily available and their use is limited to well-resourced higher level facilities, even though the need is high in non-tertiary care hospital where patient volume is high, resources are scarce, power is inconsistent, and facilities are understaffed and overcrowded. Users expressed a need for an affordable and simple device with an intuitive user interface, clear instructions for use, and basic safety features.ConclusionThe study provided important guidance for further design refinements based on input from respondents and confirmed the need for robust, affordable, infusion pumps that meet the requirements for use in low-resource settings.

Assessment of Awareness Among Parents of Children with Thalassemia Major in Bangladesh: A Hospital Based Study

<i>Introduction</i>: Thalassemia is the world’s most common hereditary disease and is a paradigm of monogenic genetic disease. Many children in Bangladesh are carrier of thalassemia which is a major threat for the upcoming generation. The aim of this study was to determine the awareness among parents of children with thalassemia major. <i>Methodology & Materials</i>: This descriptive cross-sectional study was conducted in the Department of Pediatrics, Chittagong Medical College Hospital, Bangladesh during July 2010 to December 2010. A total of 131 parents of diagnosed cases of thalassemia major children attended for blood transfusion in the Pediatric Ward of Chittagong Medical College Hospital and Thalassemia Centre, Jamal Khan, Chittagong, Bangladesh were enrolled in this study. The collected data were analyzed by the SPSS 23.0 windows version and the association between the categorical variables was assessed through Chi-Squared test where p<0.05 considered as significant. <i>Result</i>: A total of 131 parents of children with thalassemia major were included in this study. The socio-demographic characteristics of the majority parents were low. The educational qualification of the majority father was up to secondary level (29.77%) and the maximum mother’s educational qualification was up to primary level (31.30%). Most of the parents fully immunized their children according to EPI schedule (73.28%) but majority of them not received Hepatitis B vaccine (74.05%). A large number of parents had no knowledge about consanguinity of marriage (68.70%), 92 (70.23%) parents had no knowledge about mode of inheritance of the disease, 100 (76.34%) parents had no knowledge about premarital screening, 74.81% had no other affected children in their family, 42 (32.06%) parents collected blood from professional blood donors, 47 (35.88%) parents screened the blood of their children regularly and had knowledge about screening of blood before transfusion for HBV, HCV, HIV, malaria and syphilis were being 19 (14.50%), 12 (9.16%), 7 (5.34%), 6 (4.58%) and 4 (3.05%). Parents’ knowledge regarding iron overload, iron chelation, oral iron chelation, parenteral iron chelation and use of infusion pump also were being 48 (36.64%), 42 (32.06%), 27 (20.61%), 09 (6.87%), 06 (4.58%) and 29 (22.14%). All the above factors were statistically significant (p<0.05). <i>Conclusion</i>: The awareness and knowledge among parents of children with thalassemia major were insufficient. They have inadequate knowledge regarding the disease, safe blood transfusion and treatments of associated complications. Awareness programs should be taken to improve knowledge among the parents of the children with thalassemia.

ОПРЕДЕЛЕНИЕ КОНЦЕНТРАЦИИ РОПИВАКАИНА В ВЕНОЗНОЙ КРОВИ ПРИ ПРОВЕДЕНИИ ДЛИТЕЛЬНОЙ АНАЛЬГЕЗИИ ПОСЛЕОПЕРАЦИОННОЙ РАНЫ

Aim. Determinations of concentrations of total ropivacaine in venous blood with use of the selected scheme of prolonged analgesia of the postoperative wound after cesarean operation. Materials and Methods. The study involved 47 female patients after cesarean operation in whom during suturing of the laparotomy wound a multiperforated catheter was installed under aponeurosis of the abdominal muscles for a prolonged postoperative analgesia. With use of infu-sion pump, 0.2% ropivacaine solution was introduced at constant speed 4 ml/h with the total amount 200.0 ml. Blood was taken by puncture of the peripheral vein in control points in 30 min, 24 hours and 48 hours after the start of injection of the solution. The quantitative determination of the concentration of the total ropivacaine of venous blood plasma (free and bound with plasma proteins) was conducted using gas chromatograph with mass-selective detector. Results. The highest concentrations of the total ropivacaine of venous blood were recorded in 48 hours Me (Q1; Q3)=0.053 (0.043; 0.071) which was significantly lower than minimal potentially toxic concentrations. Also not a single case of appearance of clinical signs of systemic toxicity of local anesthetics was recorded. No statistically reliable correlation was found between body mass, height, body mass index and concentration of total ropivacaine in blood. Conclusion. The given study permitted to confirm safety of the selected scheme of introduction of the solution of local anesthetic, since no potentially toxic concentrations of the total ropivacaine were reached in venous blood in a single patient included into the study.

Segurança do paciente na usabilidade de bombas de infusão na terapia intensiva: revisão integrativa

Objetivou-se analisar o impacto na segurança do paciente diante da usabilidade de bombas de infusão pela equipe de enfermagem na terapia intensiva. Trata-se de uma revisão integrative da literatura nas bases: Medical Literature Analysis and Retrieval System Online, Latin American and Caribbean Center in Health Sciences Information, Web of Science Core Collection e Base de Dados em Enfermagem. Os descritores usados na estratégia de pesquisa foram: "Patient Safety", "Equipment and Supplies Utilization", "Critical Care" e "Nursing Care". Foram selecionados 21 estudos. A partir da análise de conteúdo, emergiram três categorias: Usabilidade de bombas de infusão na Terapia Intensiva, Ocorrência de eventos adversos na utilização das bombas de infusão e O impacto da usabilidade de alarmes na segurança do paciente. Conclui-se que a destreza na usabilidade de alarmes demonstrou-se benéfica por corroborar com maior atenção da equipe e evitar a ocorrência da fadiga e dessensibilização destes alarmes.

System-Level Patient Safety Practices That Aim to Reduce Medication Errors Associated With Infusion Pumps: An Evidence Review.

ObjectivesIn this literature review, we discuss 2 system-level, nurse-targeted patient safety practices (PSPs) that aim to reduce medication errors associated with infusion pumps, including smart pumps. One practice focuses on implementing structured process changes and redesigning workflows to improve efficiencies with pump use. The other focuses on investing in initial and ongoing staff training on the correct use, maintenance, and monitoring of infusion pumps.MethodsTwo databases were searched for “infusion pumps” and related synonyms, along with relevant terms for each PSP. Articles were excluded if outcomes were not directly relevant to the PSP addressed in this review, the article was out of scope, or study design was insufficiently described.ResultsLimited research was found on best practices for reducing errors and improving infusion pump use through workflow and process changes, as well as education and training. Four studies reported medication administration errors, procedural errors, or deviations from hospital policy as clinical outcomes of workflow or process changes. Mixed results were found examining process outcomes related to pump handling. Education on the correct use of smart pumps was found to decrease medication errors and adverse drug events, and 2 studies found an increase in nurses’ adherence to using the medication safety software library as a result of education.ConclusionsStandardization of process and integration of technology and workflows were found as facilitators. Type and content of education provided were identified as facilitators, whereas time and energy constraints on nurse educators can be barriers to implementing large hospital-wide education programs.

Design and Development of a Low cost, Smart Infusion Pump to deliver Medications for patients Using LabVIEW Interface with Arduino

An infusion pump is a medical device that delivers fluids such as nutrients into a patient’s body in controlled amount. They are widely used in clinical settings such as hospitals, nursing homes etc. There are many types of infusion pumps including large volume, patient-controlled analgesia and insulin pumps. Some are designed mainly for stationary use at a patient’s bedside, because infusion pumps are frequently used to administer critical fluids, including high-risk medications, pump failures and can have significant implications for patient’s safety. From 2005 to 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths. Some of the problems include software problems, alarm errors, inadequate design, broken components, battery failures, spark, and shock. In order to overcome these problems, our team came up with an idea to rectify. Our project is very compact in size when compared to the ordinary syringe pump. It can be lifted with single hand since it is weightless and the components used in our project are reliable, cost efficient and user friendly.

Risk of Medication Errors With Infusion Pumps

The risk of medication errors with infusion pumps is well established, yet a better understanding is needed of the scenarios and factors associated with the errors. Our study explored the frequency of medication errors with infusion pumps, based on events reported to the Pennsylvania Patient Safety Reporting System (PA-PSRS) during calendar year 2018. Our study identified a total of 1,004 events involving a medication error and use of an infusion pump, which occurred at 132 different hospitals in Pennsylvania. Fortunately, a majority of medication errors did not cause patient harm or death; however, we did find that 22% of events involved a high-alert medication. Our study shows that the frequency of events varies widely across the stages of medication process and types of medication error. In a subset of our data, we manually reviewed a free-text narrative field in each event report to better understand the nature of errors. For example, we found that a majority of wrong rate errors led to medication being infused at a faster rate than intended, and user programming was the most common contributing factor. Overall, results from our study can help providers identify areas to target for risk mitigation related to medication errors and the use of infusion pumps.

Cost-effectiveness of infusion pumps to reduce errors in a Pediatric ICU.

To analyze cost-effectiveness and to calculate incremental cost-effectiveness ratio of the use of infusion pumps with drug library to reduce errors in intravenous drug administration in pediatric and neonatal patients in Intensive Care Units. Mathematical modeling for economic analysis of the decision tree type. The base case was composed of reference and alternative settings. The target population was neonates and pediatric patients hospitalized in Pediatric and Neonatal Intensive Care Units, comprising a cohort of 15,034 patients. The cost estimate was based on the bottom-up and top-down approaches. The decision tree, after RollBack, showed that the infusion pump with drug library may be the best strategy to avoid errors in intravenous drugs administration. The analysis revealed that the conventional pump, although it has the lowest cost, also has lower effectiveness.

A Hazard Analysis of Class I Recalls of Infusion Pumps.

BackgroundThe adverse event report of medical devices is one of the postmarket surveillance tools used by regulators to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. However, with the development of the related technologies and market, the number of adverse events has also been on the rise, which in turn results in the need to develop efficient tools that help to analyze adverse events monitoring data and to identify risk signals.ObjectiveThis study aimed to establish a hazard classification framework of medical devices and to apply it over practical adverse event data on infusion pumps. Subsequently, it aimed to analyze the risks of infusion pumps and to provide a reference for the risk management of this type of device.MethodsThe authors define a general hierarchical classification of medical device hazards. This classification is combined with the Trace Intersecting Theory to form a human-machine-environment interaction model. Such a model was applied to the dataset of 2001 to 2017 class I infusion pump recalls extracted from the Food and Drug Administration (FDA) website. This dataset does not include cases involving illegal factors.ResultsThe proposed model was used for conducting hazard analysis on 70 cases of class I infusion pump recalls by the FDA. According to the analytical results, an important source of product technical risk was that the infusion pumps did not infuse accurate dosage (ie, over- or underdelivery of fluid). In addition, energy hazard and product component failure were identified as the major hazard form associated with infusion pump use and as the main direct cause for adverse events in the studied cases, respectively.ConclusionsThe proposed human-machine-environment interaction model, when applied to adverse event data, can help to identify the hazard forms and direct causes of adverse events associated with medical device use.

Clinical features and management of 205 adults with type 1 diabetes mellitus

Few studies have evaluated the details of insulin therapy for type 1 diabetes mellitus (T1D) in Chile. To describe clinical features and treatment details of adults with T1D and its association with metabolic control. Review of medical records of patients with T1D treated in a clinical network. Demographic and clinical features, types and doses of insulin and glycated hemoglobin levels were registered. The use flash glucose monitors (FGM) and insulin pumps (CSII) were also recorded. 205 records were reviewed, with T1d lasting 12 ± 10 years. Twenty six percent had hypothyroidism, 1% had celiac disease, 12% had hypertension, 20% had dyslipidemia; 13% had diabetic retinopathy, 2% had diabetic nephropathy, 8% had neuropathy and 2% cardiovascular diseases. Mean body mass index was 25 kg/ m2 and mean glycated hemoglobin was 8%. Eighty-two percent used multiple daily injections, 18% used CSII and 24% used FGM. As basal insulin, 35% used slow acting analogs and 65% used ultra-slow analogs. As rapid acting insulin, 69 patients used Lispro, 79 Aspart and 50 Glulisin. Bolus doses were calculated using only capillary glucose in 22%, while 78% also considered carbohydrate consumption. Variables significantly associated to better control were the use of carbohydrates for dosing rapid insulin (A1c 7,85% vs 8,59%, p = 0,008), use of CSII (A1c 7,36% vs 8,16%, p = 0,008), and basal dose < 0,4 U/kg (A1c 7,81% vs 8,58%, p = 0,003). There were no differences regarding insulin type or use of FGM. The use of formulas considering carbohydrates for dosing rapid insulin, use of infusion pumps and physiological doses of basal insulin are significantly associated with a better metabolic control in adults with T1d.

Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities.

Subcutaneous delivery of biotherapeutics has become a valuable alternative to intravenous administration across many disease areas. Although the pharmacokinetic profiles of subcutaneous and intravenous formulations differ, subcutaneous administration has proven effective, safe, well-tolerated, generally preferred by patients and healthcare providers and to result in reduced drug delivery-related healthcare costs and resource use. The aim of this article is to discuss the differences between subcutaneous and intravenous dosing from both health-economic and scientific perspectives. The article covers different indications, treatment settings, administration volumes, and injection devices. We focus on biotherapeutics in rheumatoid arthritis (RA), immunoglobulin-replacement therapy in primary immunodeficiency (PI), beta interferons in multiple sclerosis (MS), and monoclonal antibodies (mAbs) in oncology. While most subcutaneous biotherapeutics in RA, PI, and MS are self-administered at home, mAbs for oncology are still only approved for administration in a healthcare setting. Beside concerns around the safety of biotherapeutics in oncology, a key challenge for self-administration in this area is that doses and dosing volumes can be comparatively large; however, this difficulty has recently been overcome to some extent by the development of high-concentration solutions, the use of infusion pumps, and the coadministration of the dispersion enhancer hyaluronidase. Furthermore, given the increasing number of biotherapeutics being considered for combination therapy and the high dosing complexity associated with these, especially when administered intravenously, subcutaneous delivery of fixed-dose combinations might be an alternative that will diminish these burdens on healthcare systems.

Use of infusion pump for intrauterine transfusion: An effective hands-free transfusion circuit.

Use of infusion pump for intrauterine transfusion: An effective hands-free transfusion circuit.

Wireless Smart Infusion Pumps: A Descriptive Analysis of the Continuous Quality Improvement Data

Errors associated with the use of infusion pumps can cause serious harm or death in hospitalized patients and increased costs to the health care system. Our study reviewed the continuous quality improvement (CQI) data collected from a wireless smart infusion pump device implemented at one of the largest Canadian teaching hospitals. We reviewed the CQI summary data usage between February and December 2016 to assess dose error reduction software (DERS) compliance with the infusion pump’s master drug library and measure the frequency of monthly soft and hard limit events by clinical care area (CCA). In addition, we identified drugs that were most prone to alerts. The CQI data indicated that DERS compliance with the infusion pump ranged from 85.6 to 99.7% depending on the CCAs. The total number of soft limit double-confirmations was 35,174, and dexamethasone, oxytocin, and PACLitaxel had the highest frequency of double-confirmations. The total number of hard limits attempted observed was 13,188, and vancomycin, IV fluids, and potassium phosphate were more prone to hard limit alerts compared with other drugs during the study period. The study findings provided information on patterns of use and risk reduction opportunities to inform the hospital’s goal to enhance the delivery of quality care and patient safety. A CQI data analysis that incorporates open communication and detailed coordination in numerous departments across the hospital would help to increase the effectiveness of the new technology among the patient population.