Dove Medical Press
Appendix 1: Flowchart of search results.Appendix 2: Quality of selected literature and data analysisDistributions based on study type and cost analysis of the final selected literature are represented in figures A2.1 and A2.2, respectively. Observational studies, both prospective and retrospective dominate the study spectra (figure 2), with various approaches to cost analysis (figure A2.2).Figure A2.1. Number of publications per study type.Figure A2.2. Number of publications per cost analysis.A continuously increasing number of research reports about POCT and its cost effectiveness was observed over the last 20 years. These reports were dominantly originating from studies undertaken in United States, followed by Sub-Saharan Africa region (figure A2.3). The main health concern examined within the studies were related to maternal and child care, followed by cardiovascular diseases (figure A2.4).Figure A2.3. Number of publications per region/country.Figure A2.4. Number of publications per disease type.Studies can also be classified as a function of the country’s income level as grouped by the World Bank. Most of the literature belongs to studies undertaken in high income group countries (figure A2.5). Figure A2.5. Number of publications per country’s income group.Table A3.1. Summary of the selected literature on POCT in maternal and neonatal care based on type of POCT.Author/YearType of study / countryStudy design/ Sample sizeDisease/ Target PopulationHealth OutcomesEconomic OutcomesCommentsUltrasound (POCUS) including US trainingAmoah et al. 201625Pilot studyGhana (Central region)Survey preceding roll out of pilot ANC system: 100 women (aged between 19 and 49, mean = 29.4 ± 6.5 years, had pregnancies within 5 years prior to the study) were interviewed in the preliminary surveyThe pilot project: 323 pregnant women from four rural communities in the Central Region of Ghana were followed within a 11-month project40 gave birth during observationMaternal and child death, obstetric complicationsPregnant women in rural communities in low income countriesPreliminary survey: Women had their births attended by skilled attendants - less likely to have retained placenta (p<0.05);Women attended ANC - less likely to have a miscarriage (p<0.001); Women attended at least four ANC visits - less likely to practice self-medication (p<0.05)Pilot Study:40 gave birth during observation: 62.5 % of pregnant women had their labor attended in clinics or hospitals as against 37.5 % among the cases reported in the pre-survey. 1 case of ectopic and 2 cases of breech pregnancies were detected, and appropriate medical interventions were sought.Promising results were shown by using an application for low-cost mobile phones and portable ultrasound machines, by offering professional monitoring and supervision in rural areas.Allow early detection of specific adversities, which reduces the time between first appearance andprofessional munity initiative, an onlinemanagement system A remote ultrasound imaging approach combining CHWs and portable ultrasound acquisitions.WHO has recommended at least 4 ANC visits and skilled attendants at birth. A comprehensive cost-benefit analysis needs to be carried out.Chan et al. 200124 A pilot studywith cost benefit analysisQueensland, Australia71 patients with a total of 90 tele-ultrasound consultations Fetal anomaly90% of the babies have been delivered, and outcome data have been received on all pregnancies.All significant anomalies and diagnoses have been confirmed.Major indications for referral were: complex fetal problems such as twin complications or multiple fetalanomalies (43%); detailed assessment of high-risk patients (19%); isolated fetal anomalies (17%); evaluation of markers for anomalies (13%); and assessment of growth restriction/ fetal wellbeing in the third trimester (8%).The referring clinicians would have physically referred 24 of the 71 patients to Brisbane in the absence of telemedicine.A crude cost–benefit calculation suggests that the tele-ultrasound service resulted in a net saving of A$6340, enabling almost 4 times the number of consultations to be carried out.Realtime fetal tele-ultrasound consultation service:uses ISDN transmission at 384 kbit/s, allows patients in Townsville to be examined by subspecialists in Brisbane, 1500 km away.Only crude estimates. Neither the initial set-up and equipment costs nor the costs for the clinicians have been included. Benefits in terms of reduced anxiety and social costs to the families involved were not measured.Crispín Milart et al. 201614Observational case-control studyGuatemala (rural)From September 2012 to November 2013, the community facilitators attended a total of 1,509 pregnant women.Control group is composed by 747 pregnant women attended by the community facilitator, which is the common practice in rural Guatemala. Intervention group is composed by 762 pregnant women attended under the innovative Healthy Pregnancy project.Maternal and neonatal mortalityNo maternal deaths reported within the intervention group vs 5 cases in the control group.64% reduction of neonatal mortality. 37% prevalence of anemia detected. 42 cases (5.5%) with hemoglobin levelsunder 9 g/dL.Diagnosis and treatment of anaemic patients would have been useful for the prevention of 2 death cases due to postpartum haemorrhage.633 results of urine dipsticks were reported; urinary tract infection was diagnosed and treated in 29 cases (4.58%). 1 patient was referred by positive proteinuria and suspected preeclampsia.Non-urgent referral was recommended to 70 pregnancies, the main reported cause being fetal malpresentation.The major reduction observed in maternal and neonatal mortality provides promising prospects for these low-cost diagnostic procedures.Portable ultrasound (important diagnostic tool for fetal malpresentation, twinpregnancy, amniotic fluid pathology and abortions)Blood/urine testsCare package include: screening for anemia, screening for maternal bacteriuria, screening for hypertensive disorders of pregnancy, iron supplementation to prevent maternal anemiaand preparedness for births and emergencies.Intervention and control groups were not randomly assigned.A comprehensive cost-benefit analysis needs to be carried out.Cuneo et al. 20199Prospective study with cost benefit analysisUnited States455 US-based telecardiology performed for 368 pregnant women from November 2015 to December 2018 (Mean±SD maternal age: 29.6±66.2 years, ranged 16–49 years; Mean gestational age: 25.2±4.4 weeks, ranged 13–39 weeks).Fetal Cardiac Anomalies With telecardiology, all foetuses with congenital heart disease (CHD) were correctly risk-stratified for delivery.CHD or arrhythmia was diagnosed in 28 and 15 foetuses respectively, with 1 false-negative result in CHD.No mother had to return for a second telecardiology appointment because of poor echocardiographic image quality.Cost savings per visit for point of care telecardiology were USD$61 at a local site and USD$581 at a distant site, mainly due to savings in travel and accommodation and in cost of lost work (for a mother travelling for an appointment to a local site)The feasibility of this service was found to dependon strong links with the community,obstetric care providers and the obstetric ultrasonographers.Telecardiology improved access to subspecialtycare services for a vulnerable population.Could be a model for expansion to remote and rural communities.Kozuki et al. 201615Prospective observational study with cost analysisNepal (rural)Women who were ≥32 weeks in gestational age were enrolled and received ultrasound examinations from the auxiliary nurse midwives during home visits.804 women enrolledNon-cephalic presentation, multiple gestation, and placenta previaAmong the 745 women with true fetal presentation data, 29 were diagnosed with singleton non-cephalic presentation. 10 resulted in a true non-cephalic birth and 3 in Caesarean section. 2 non-cephalic births were identified. Of the 786 women with twinning data, 5 were diagnosed with twins on ultrasound, and all five were true multiple births. No twin pair went undiagnosed.Over 5 years, 160 perinatal deaths may be avoided with early diagnosis.The total cost of ultrasound machine, gel, and personnel training over five-years would be $10,355, for 15,000 births over five years in a catchment area of 100,000 in population. POCUSultrasound trainingsEstimated cost of $65 per life saved.Ross et al. 201312Retrospective quantitative study - nocontrol groupUganda (rural)Records at Nawanyago clinic were reviewed to obtain the number of antenatal visits and deliveries for 42 months preceding the introduction of ultrasound and 23 months following the implementation of POCUS..General conditions for maternal and neonatal healthSignificant increases were seen in the number of mean monthly deliveries and antenatal visits. The mean number of monthly deliveries at the clinic increased by 17 (13.3–20.6,95% CI) from a pre-ultrasound average of 28.4 to a post-ultrasound monthly average of 45.4. The number of deliveries at a clinic used as control remained flat over this time. The monthly mean number of antenatal visits increased by 97.4 (83.3–111.5, 95% CI) from a baseline monthly average of 133.5 to a post-ultrasound monthly mean of 231.0, with increases seen in all categories of antenatal visits.The availability of a low-cost antenatal ultrasound program may assist progress towards MillenniumDevelopment Goal 5 by encouraging women in a rural environment to come to a health care facility for skilled antenatal care and delivery assistance instead of utilizing more traditional methods.A Low-Cost Ultrasound ProgramA comprehensive cost-benefit analysis needs to be carried out.Vinayak et al. 201710Prospective cross-sectional study; pilot studyCost analysisKenyaA curriculum (training period was just more than 1 month) was designed to teach 3 midwives without previous training in ultrasound to independently work at a healthcare facility to identify high-risk pregnancies.Consecutive pregnant patients 18–50 y ofage were recruited to have a scan at 1 of the 3 antenatal clinics, and a total of 271 patients were scanned, 220 patients were tracedto delivery.Care of pregnancy in rural areaExcellent correlation between final outcomes of pregnancies and diagnoses on the basis of reports generated by the midwives. Scan results versus actual outcomes revealed 2 discrepancies in the 20 patients identified as high risk.Overall flow turnaround time (from patient presentation to validated report) was reduced from 35 min to 25 min. The unique mobile phone transmission was faultless and there was no degradation of image quality. The cost of the internet bundle (1 GB) per 5 patients was approximately $1.00 Valuable to train midwives in POCUS to use an ultrasound tablet device and transmit images and reports via the internet to radiologists for review.Training of midwives to perform basic obstetric ultrasoundexaminations in rural areaA tablet-sized ultrasound scanner VISIQIdentification of high risk patients through POCUS was valuable in a remote healthcare facility.Biomarkers / lab test based POCTArthurs et al. 201020Retrospective observationalcost analysis studyUnited KingdomAssessment of laboratory workload by retrospective review of hospital clinical information systems, pathology databases, patient admission rate and clinical workload Study period: 3 years, including 12 monthsimmediately before and 24 months immediately after the introductionof the Roche OMNI-S analyzer to the neonatal unit.Neonatesneonatal intensive care unitsAn increase in the number of admissions(15.7%) and total days of neonatal activity (21.8%). A concurrent decrease in the number of laboratory assays (-38.0%) and transfusions performed over the same time (-18.7%). This equates to a 46.4% reduction in lab testing and a 29.6% reduction in transfusions per admission.POCT analyzerthe Roche OMNI-S blood gas analyzerClear cost-effectiveness was demonstrated through POCT implementation.El Helali et al. 201950Observational studyWith effectiveness and costs analysisFrance11,226 deliveries in 2006– 2009, using antenatal culture for polymerase chain reaction (PCR)screening for early onset of Group BStreptococcus (GBS) and 18,835 deliveries in 2010–2015 with intrapartum PCR screening were recorded.NeonatesIntrapartum PCR screening was associated with a significant decrease in the rate of proven and probable early-onset neonatal GBS disease cases (comparedto antenatal culture screening).There was a threefold reduction in the total numbers of days of hospital and antibiotics for early onset GBS disease.With the implementation of intrapartum GBS PCR screening, the yearly cost of delivery and treatment of newborns with GBS infection was decreased from USD$41,875±6,823 to USD$11,945±10,303 (P<0.001). While the intrapartum PCR screening is more expensive (USD$90) compared to antenatal (USD$21) – overall healthcare costs due to early-onset GBS diseasecases/year are reduced.GBS is the most common pathogen resulting sepsis in newborns during the first week of life in developed countriesPoint-of-care intrapartum GBS PCRscreening was also associated with a significant decrease inthe rate of early-onset GBS disease and antibiotic use innewborns.Golden et al. 201019Retrospective observational study with cost benefit analysisUnited StatesPatients undergoing CCduring the first quarter of 2007 (n = 38), with the central laboratory, and patients undergoing CC during the first quarter of 2008 (n = 50), after implementation of a POC blood gas analyzer, were included in the study. Pediatric patientsWith the implementation of intrapartum GBS PCR screnning, the rate of proven early-onset GBS disease cases was reduced from 1.01/1,000 to 0.21/1,000 (P=0.026); the rate of probable early-onset GBS disease cases was reduced from 2.8/1,000 to 0.73/1,000 (P<0.001); the total days of hospital and antibiotic therapy for early-onset GBS disease was reduced by 64% and 60% respectively.The incremental cost of POCT was estimated to be $33 per test, which is very small compared with the overall costs of a CC procedure.POCT analyzer for ABGs during CC(Radiometer ABL80 analyzer)Subjective determinations of improved patient caremay be sufficient to justify the increased costs of POCT.Kovacs et al. 201723Longitudinal comparison studyCost-minimization analysisHungaryCosts of bedside DRI-based screening were compared to those of traditional transport and BIO-based screening.From 2009-2014, 3722 bedside examinations were performed in thePCA covered central region of Hungary.ROP in premature newbornsDRI combined with remote interpretation has similar diagnostic performance to that of BIO.Meanwhile, bedside ROP screening is needed in vulnerable premature infants and avoidance of transportation.From 2009 to 2014, PCA-PERP saved 92,248 km and 3633 staff working hours, with an annual nominal cost-savings ranging from 17,435 to 35,140 Euro. The net present value was 127,847 Euro at the end of 2014, with a payback period of 4.1 years and an internal rate of return of 20.8%.PCA-PERP: DRI with remote interpretation in bedside ROP screeningService provider (PCA) perspectiveMahieu et al 201221Retrospective observational cohort studyCost–benefit analysisBelgiumA study in a NICU compared with two serial cohorts of 2 years each, over a 4-year period (2006–2009)Data from the 1st cohort (no use POCT, during 2006–2007) were compared with those from the 2nd cohort (after the use of the multi-parameter POCT during 2008–2009)Throughout the 4-year study period, 1393 patients were enrolledVery low birth weight infantsiatrogenic blood loss and anemia in NICU patients.Implementation of POCT decreased central laboratory performed testing for bilirubin (?32% per patient) and electrolytes (?36% perpatient). On average, the net blood volume taken per admitted patient for electrolyte testing decreased with 23.7% and 22.2% for bilirubin testing in the second cohort. Fewer very low birth weight infants required blood transfusion (38.9% vs 50%, p<0.05) as the number of transfusion/infantsdecreased by 48% (1.57 vs 2.53, p<0.01).For the entire study population, the cumulative cost for blood transfusion decreased from 35,318€ in the 1st cohort to 29,543€ in the 2nd cohort (?16%) or a saving of 5775€, which is equal to a mean cost reduction of 52.1€ to 41.03€ per neonate (?21%). In the very low birth weight group, the transfusion cost decreased by 7561€ (?24%), from 30,257€ in the first cohort to22,696€ in the second cohort, which represents a mean cost reduction from 44.7€ to 31.7€ per neonate (?29.1%).Multi-parameter Point-of-Care-blood test analyzer:reduces central laboratory testing and need for blood transfusionsThe implementation of POCT was cost-efficient for the Belgian national health insurance, with cost reduction of ?8.3% per neonate.Whitney et al. 201622 Randomized control trialCost-effectiveness analysisUnited StatesA decision analysis model was constructed to calculate cost-savings from the point of view of the payer and the provider.Dehydration, common in children with AGE in PEDPOCT helps evaluate degree of dehydration in children.From the perspective of the payer, POCT resulted in a cost savings of $303.30 per patient compared to traditional serum testing.From the perspective of the provider, POCT resulted in mean savings of $36.32 ($8.29-$64.35) per patient.POC electrolyte testingi-Stat Analyzer, a handheld, cartridge-driven device capableof performing basic electrolyte and blood gas tests in less than 2minutes, with less than 0.1 mL of blood.Hospital perspectiveModels of careGao et al. 201417Prospective cohort study (retrospective baseline data)A cost-consequences analysisNorthern Territory, AustraliaCompare the cost-effectiveness of 2 models of service delivery: MGP and baseline cohortBaseline cohort (retrospectively audited) included all Aboriginal mothers (n=412), and their infants (n=416), from 2 remote communities who gave birth between 2004 and 2006. The MGP cohort (prospective) included all Aboriginalmothers (n=310), and their infants (n=315), from 7 communities who gave birth between 2009 and 2011.Care of pregnancyin Aboriginal mothers and infantsMGP: women had significantly more antenatal care, more ultrasounds, morelikely to be admitted to hospital antenatally, and had more postnatal care in town (2.5 vs 1.6, p<0.001); had significantly reduced average length of stay for infants admitted to SCN. MGP women experienced better outcomes associated with vaginal birth than women in the baseline cohort (p<0.001) but there was no difference with caesarean birth (p=0.757).No significant difference between the two cohorts for major birth outcomes such as mode of birth, preterm birth rate and low birth weight.Costs savings of MGP (mean AUD 703) were found, although these were not statistically significant, compared to the baseline cohort.MGP: significantly reduced birthing costs (? AUD 411, p=0.049) and SCN costs (? AUD 1767, p=0.144) but increased costs of antenatal care (AUD 272, p<0.001), postnatal care in town (AUD 277, p<0.001), infantread mission costs (AUD 476, p=0.05) and travel (AUD 115, p=0.011)For remote dwelling Aboriginal women of all risk who travelled to town for birth, MGP was likely to be cost effective.MGP: characterised by a small group of midwives (3–4) offering continuity of care throughout pregnancy, labour, birth and the early postnatal period.MGP team provided a woman-centred model of care to all remote dwelling women, from 7 communities who were transferred to Darwin for birthTeam was based in a suburban shopping complex 3km away from the hospital.Department of Health perspective.Archibong et al. 201718Analytical studyUnited StatesTests for the function of the platformPregnancy-related complicationsPreeclampsia and HELLP syndromeProvides potential life-saving advantage with a turnaround time of about 10min (vs over 4 hours for conventional laboratory analytical methods)Haemoglobin concentrations can be measured with an accuracy of ~1mg/dL at lower hemoglobin valuesPrimary cost of the platform is the smart phone.Provides potential life-saving advantage with a cost of circa $1/ unit (assuming with the presence of phone and software).POC mobile phone–based platform (mHealth platform): quickly characterise level of hemolysis by measuring the color of blood plasmaA comprehensive cost-benefit analysis needs to be carried out.Abbreviations: ANC = antenatal care; CHWs = Community health workers; HELLP = hemolysis, elevated liver enzymes, and low platelet count; POC = Point-of-care; POCT = point-of-care testing; MGP = Midwifery Group Practice; SCN = Special Care Nursery; ABGs = arterial blood gases; CC = cardiac catheterization; DRI = digital retinal imaging; PCA-PERP = Peter Cerny Ambulance - Premature Eye Rescue Program; BIO = binocular indirect ophthalmoscopy; ROP = retinopathy of prematurity; NICU = neonatal intensive care unit; AGE = Acute gastroenteritis; PED = pediatric emergency department.Table A3.2. Summary of the selected literature on POCT in cardiovascular disease based on type of POCT.Author/YearType of study / countryStudy design/ Sample sizeDisease/ Target PopulationHealth OutcomesEconomic OutcomesCommentsUltrasound (POCUS) and EchocardiographyFerrada et al. 201431Retospective studyCost analysisUnited StatesEvaluate the utilityof LTTE in nonsurviving patients who presented to the trauma bay with traumatic cardiac arrest.(patients undergoing LTTE vs non-LTTE).From Jan 2012 to Jan 2013, 37 patients did not survive traumatic cardiac arrest while in the trauma bay: 14 in the LTTE group and 23 in the non–LTTE group.Patientswith Traumatic Cardiac ArrestDecreases the rate of nontherapeutic interventionsCompared with the non–LTTE group, the LTTE group spent significantly less time in the trauma bay (13.7 vs 37.9 min), received fewer blood products (7.1% vs 31.2%), and were less likely to undergo nontherapeutic thoracotomy in the emergency department (7.14% vs 39.1%; P < 0.05).The non–LTTE group had a mean of $3040.50 in hospital costs, compared with the mean for the LTTE group of $1871.60 (P = 0.0054).The mean hospital charges for LTTE were $8282.50, which were statistically significantly lower compared with $14,182.30 for the non–LTTE group (P = 0.0135).Limited transthoracic echocardiography (LTTE) is cost efficient in trauma bays.Hothi et al 201429Descriptive studyUnited StatesEvaluation of applications, advantages and limitations of devolved quick-scancardiac ultrasound by H-USS.Cardiac diseasesA quick-scan is rapid (3-5 min) and can quickly identify pericardial effusion, severe LV systolic dysfunction (LVSD), RV dilatation, major heart valve disease and inferior vena cava (IVC) dilatation, allowing immediate potentially lifesaving changes in management. Inferior at assessing LV dimensions, RV function and mitral regurgitation, and cannot assess diastolic function.H-USS devices cost around ?5,000 are portable and ideal for integration with clinical examination, compared to complex devices (?100,000) and more classic portable machines (?30,000–?40,000) (often batterypowered, enabling movement between beds without being turned off). Quick-scan cardiac ultrasound by H-USS.A comprehensive cost-benefit analysis needs to be carried out.Ploutz et al. 201638Prospective studyUganda, Gulu1002 children were enrolled, with956 (11.1 years, 41.8% male) having complete data for review.Conducted between June and August of 2014 in 2 public primary schools to evaluate the performance of a simplified screening approach in the hands ofnon-experts.RHD913 (95.5%) children wereclassified normal, 32 (3.3%) borderline RHD and 11 (1.2%) definite RHD. The simplified approach had asensitivity of 74.4% (58.8% to 86.5%) and a specificity of 78.8% (76.0% to 81.4%) for any RHD (borderline and definite). Sensitivity improved to 90.9% (58.7% to 98.5%) for definite RHD. Identification / measurement of erroneous colour jets was the most common reason for false-positive studies (n=164/194), while missed mitral regurgitation and shorter regurgitant jet lengths with HAND were common reasons for false negative studies (n=10/11).Offer a potential solution to financial and workforce barriers that limit widespread RHD pared with STAND, HAND offers a lower price point and higher degree of portability. Length of encounter was 6.69 min (SD 2.54 min) with 4.97 min (SD 2.28 min) required to acquire theechocardiographic images.Handheld echocardiographyNon-expert-led HAND screeningprograms A comprehensive cost-benefit analysis needs to be carried out.Biomarkers / lab test based POCTApple et al. 200633Observational retrospective studyCost consequence analysisUnited StatesPatients presenting with symptoms suggestive of ACS were enrolled pre-POC (PreCS, n=271) and post- POC (PostCS, n=274).ACS patients in a community hospital cardiology unit, e.g. AMIBoth short stay and intensive care patientsOne-year survival was greater in the <0.1 μg/l patients (PreCS 96.2%, PostCS 97.2%) compared to the ≥0.1 μg/l patients (PreCS 77.7%, PostCS 75.5%); both p<0.001. In the PreCS group there were 6 deaths in the <0.1 μg/l cTnI group (n=195) compared to 12 deaths in the ≥0.1 μg/l cTnI group (n=76). In the PostCS groups, there were 6 deaths in the <0.1 μg/l cTnI group (n=250) compared to 4 deaths in the ≥0.1 μg/l cTnI group (n=24).A decrease in time from blood draw to result for the healthcare provider (PreCS mean 76 min; PostCS mean 19.5 min; p<0.001)A decrease trend in charge per patient admission ($4281 savings) following of POC testing. Total charges per patient admission decreased by 25% PostCS vs. PreCS ($17,163 vs. $12,882); lower charges for: boarding (?21%), other departments (?58%), pharmacy (?28%), labs (?22%), non-cardiac procedures (?28%), cardiac procedures (?14%). Mean LOS decreased from PreCS (2.36 days) to PostCS (2.19 days).cTnI reagents charges to the lab were higher for POC assay, $10.54 vs the central lab assay, $3.83.POC cardiac troponin I (cTnI) testingOverall, POC for cardiac troponin testing showed cost-effectiveness.Blick 200532Prospective studyCost analysisUnited StatesAround 4200 patients with chest pain annually were evaluated in the study Data mining for outcomes was performed on the Meditech computer systemPeer comparison data were acquired from Healthcare Corporation of America and Cardiac Data SolutionsACS and CHFNo reported inapt discharge-to-home events.A reduction in 15 hours ED LOS/wait time for ACS workup of non-ST-segment elevation acute myocardial infarction patients to a consistent ED LOS of no more than 8 hours. Due to rapid (< 2h) POC testing protocol, the time to discharge for ED chest pain patients was reduced from 3.6 to 2.3 hours. Inpatient LOS for CCU CHF patients has been significantly reduced from 5.2 to 3.2 days, a potential savings of over $1000 per day per patient, with an estimated total savings of 440 CCU patient-days in this setting.POCT for cardiac markers, includemyoglobin, CK-MB, and troponin I, for ACS evaluation and BNP for CHF evaluationPOCT for cardiac markers justified by positive health economics parametersFitzgerald et al. 201134Randomized controlled trialCost utility analysisUnited KingdomRATPAC trial -multicenter randomized controlled trial comparing rapid diagnostic assessment with a POC biomarker panel to standard carePatients attending 6 EDswith acute chest pain due to suspected MI (n = 2,243)Standard care, n = 1,118; POC, n = 1,125.Cost-effectiveness was estimated in terms of probability of dominance and incremental costper QALY.Data were collected from 246 patients for the micro-costing study.Chest pain due to suspected MIMean QALYs in POCT were 0.158 (SD ± 0.052) vs 0.161 in standard care (SD ± 0.056; p = 0.250)Greater use of coronary care and cardiac interventions is appropriate and confers patient benefit. However, this benefit is uncertain and difficult to estimate in thislow-risk patient group.Overall, the micro-costing study showed that POC testing added ?53.16 ($82.87) to the costs of ED management.Point-of-care panel assessment was associated with higher ED costs, coronary care costs, andcardiac intervention costs, but lower general inpatient costs.Mean costs per patient were ?1217.14 (SD ± ?3164.93), or $1,987.14 (SD ± $4,939.25), with POC vs ?1005.91 (SD ± ?1907.55), or $1,568.64 (SD ± $2,975.78), with standard care (p = 0.056). Point-of-care panel assessment was not shown to represent a cost-effective use of health care resources.Point-of-care biomarkerassessment for suspected MIBiomarkers included CK-MB, myoglobin and troponinUnited Kingdom National Health Service's perspectiveSpalding et al. 200730 Retrospective studyCost consequence analysisGermanyAnnual treatment costs of all cardiosurgical patients were analyzed before (729 patients) andafter (693 patients) implementation of ‘bedside’ coagulation test Average monthly numbers and costs were compared. Number of resternotomies and early mortality was assessed and compared in both periods.Perioperative coagulation management in cardiac surgeryTotal number of resternotomies decreased from 6.6% to 5.5% without reaching statistical significance (p = 0.384) while early mortality (5.9%; 6.0%) remained stable.After POCT implementation, cumulative RBC expenditure showed 25% decrease while PltCexhibited 50% decrease. FFP expenditure remained unchanged. PCC, FXIII factor concentrates were markedly reduced (-80%). Fibrinogen, however, increased two-fold. Cumulative average monthly costs of all blood products decreased from 66,000€ to 45,000€ (-32%).Coagulation factor average monthly costs decreased from 60,000€ to 30,000€.In contrast, average monthly costs for POCT were 1.580€.Overall, costs decreased from €125,828 to €55,925.‘Bedside’ coagulation testSaved costs for blood- and coagulation products noticeably outweighed the expenses of POCT.Adequate differential coagulation management can be cost-effective.Models of careTirimacco et al 200928Prospective studySouth Australia (rural)Analysis of patient outcome via Integrated South Australian (SA) Activity Collection inpatient separations database that collects patient demographics, primary and secondary diagnoses, procedure codes, nature of separation / admission, discharge date. Analysis of effectiveness: previous South East Regional Health Service as the intervention site,compared to other rural sites in SA with noinvolvement in the Network as controls.ACSPreliminary results showed improved patient outcomes in the Network by significantly reducing the 30-day readmission rate for ACS from 10.4% to 4.2% (P = 0.03). A marked trend to reduction of ACS in hospital death rates from 15.8 to 9.8%.Significant potential cost savings for hospitals involved in the Network have been identified: reduced unnecessary patient transfers, improved bed capacity from POCT availability in smaller hospitals, reduced urgent specimen transport and laboratory staff recall costs, a reduction in the 30-day readmission rate for ACS and improved patient clinical outcomes including reduced in-hospital ACS death rate.iCARnet/ Network based on POC pathological testing for troponin. Troponin POCT protocols were integrated with treatment and triage recommendations in clinical pathways for chest pain and ACS managementA comprehensive cost-benefit analysis needs to be carried out.Abbreviations: AMI = acute myocardial infarction; ACS = acute coronary syndrome; POC T= point-of-care testing; LOS =length of stay; CHF = congestive heart failure; ED = emergency department; BNP = B-type natriuretic peptide; CCU = coronary care unit; LTTE = Limited transthoracic echocardiography; MI = myocardial infarction; H-USS = hand-held ultrasound; HAND = Handheld echocardiography; RHD = rheumatic heart disease; STAND = standard portable echocardiography; RBC = red blood cell; FFP = fresh frozen plasma; PltC = Platelet concentrates; iCARnet = Integrated Cardiac Assessment Regional Network.Table A3.3. Summary of the selected literature on POCT in general clinical diagnosisAuthor/YearType of studyStudy design/ Sample sizeDisease/ Target PopulationTypes of POCTHealth OutcomesEconomic OutcomesCommentsBarron et al. 201836Observational prospective studyNicaragua, Sébaco, (rural)A total of 79 POCUS examinations were performed on 59 patients by 2 physicians with extensive POCUS training during a 1-week-long medical mission in Feb 2017.80% were women, withan average age of 40.5 years (range 1.6–87 years).Determine how oftenPOCUS changed medical management. Assess the most commonreasons for POCUS use.General clinical diagnosisPOCUSThe use of US changed management for 35.6% of total patients examined, divided among: changes in diagnosis, pharmacotherapy, new referral, or referral not needed.A wide range of POCUS examinations were performed, with lung, gallbladder, obstetric/gynecologic, and cardiac examinations performed most often.The average time to perform a POCUS examinationwas 6.0 minutes. POCUS was used to add value to patient care, reduce referrals, thus costs of healthcare delivery in RLSsAn increased interest in nonemergency and noncritical care POCUS was seen, with increase of low-cost, accurate, handheld US devices. It is probable that more physicians traveling to RLSs will use POCUS positively affecting patient care.A comprehensive cost-benefit analysis needs to be carried out.Blattner et al. 201039Prospectivecost analysisNew Zealand (remote north).Test indication, pre-test differential diagnosis and planned patient disposition were recorded over 6 months before and after POC test use in November 2008269 POC tests were undertaken for 177 patients.General clinical diagnosisPOCTs in a rural hospitalPOCTs significantly increased diagnostic certainty (2.5 diagnoses pre-test vs 1.3 diagnoses post-test (p<0.001)), and altered disposition for 43% of patients (p<0.001) by reducing transfers to base hospital by 62% and increasing discharges by 480%.SIgnificant treatment change was reported in 75% of cases.Overall financial benefits amounted to $452,360 annually.POCT can improve diagnostic accuracy in a cost-effective manner.Laurence et al 201040Randomisedcontrolled trialCost-effectiveness analysisAustraliaA total of 4968 patients were recruited: 3010 (intervention group) and 1958 (control group).All patients were followed up for 18 months by 53 general practices in urban, rural and remote locations across three states in Australia.Assess the incremental cost effectivenessof a clinical strategy based on performing POCT in GP compared to current practice of testing through a pathology laboratory.General clinical diagnosisPoint of care testing in ageneral practice settingAll POCT resulted in an increasein the number of tests per person-year.Higher number of GP visits per person-year for the intervention group (19.2 visits) compared to the control group (13.6 visits)Total direct costs per patient to the health care sector for POCT was less for ACR (-$34) than pathology lab testing, but greater for INR, HbA1c and lipids, although none of these was statistically significant.There was no statistically significant difference in overall costs between point of care and lab, irrespective of tests.For all tests, the intervention group had significantlylower patient costs for travel and time seeking healthcare.Australian society overall's perspectiveNnakenyi et al. 201752Descriptive studyNigeriaA descriptive study of 61 POCT sites at 5 tertiary hospitals across NigeriaGeneral clinical diagnosisA wide range of POCT devices tested59% of sites used POCT because of rapid result with all tests. They included: glucose meters, Urinalysis dipstick, HIV rapid test, hematocrit reader, urine pregnancy test, HbA1c, malaria rapid test, cholesterol/ lipid profile, coagulometer, blood gas analyzer, bilirubin meter, cardiac marker reader, urea/ creatinine, HBsAg rapid kit, Hepatitis C virus rapid kit, syphilis rapid test and Urine drug abuse test.POCT costs below $2 in 54% of the sites. Results are produced in less than 5 minutes and require blood specimens ranging from a drop to 3 mL, whereas urine-based tests need 5 to 20 mL.Several POCT devices can be efficiently implemented in remote areas.Reynolds et al. 201835Prospective descriptive cross-sectional studyTanzania,Dar es SalaamData on POCUS studies during a period of 10 months was collected on consecutive patients during periods when research assistants were available.Data was collected for 986 studies performed on 784 patients. Median patient age was 32 years; 56% were male.General clinical diagnosisPOCUSUse of POCUS changed either diagnostic impression or disposition plan in 29% of all cases. Rates of change in diagnostic impression or disposition plan increased to 45% in patients for whom more than one POCUS study type was performedN/AUse of POCUS for health benefits is justified in general clinical settings. Cost-benefit analysis needs to be carried out.Rominger et al 201837Descriptive studyMexico, state of Chiapas584 ultrasound studies were documented over 12-month period.General clinical diagnosisPOCUS 12-month longitudinal ultrasound educational curriculumMost common investigations: transabdominal obstetric examination (45.5%), abdomen/pelvis (26.6%), musculoskeletal (5.7%), skin and soft tissue (5.7%). POCUS changed the clinical diagnosis in 34% of patients and likely prevented delays in care and expedited referral and hospitalization where needed.The longitudinal study was an efficient way to teach ultrasound in resource limited settings. If offers local physicians with a tool to guide clinical diagnoses and improve patient management.A comprehensive cost-benefit analysis needs to be carried out.Spaeth et al. 20182Retrospective study with cost effectiveness analysisAustralia, Northern Territory (NT)A decision analytic simulation model used to assess whether POCT leads to cost savings compared to usual care in three separate acute medical conditions.3 common acute conditions (chest pain, chronic renal failure due to missed dialysis session(s), and acute diarrheaPOCT included tests for cardiac troponin I, electrolytes, blood gases, urea, creatinine, glucose, ionized calcium, INR.POCT prevented 60 unnecessary medical evacuations from a total of 200 patient casesmeeting the selection criteria (48/147 for chest pain, 10/28 for missed dialysis, and 2/25 for acute diarrhea).Test results were available in less than 10 minutes.The associated cost savings for chest pain, missed dialysis, and acute diarrhea were AUD $4,674, $8,034, and $786 per patient translating to NT-wide savings of AUD $13.72 million, $6.45 million, and $1.57 million per annum (AUD $21.75 million in total), respectively.Health sector (Medicare) cost's perspective.Abbreviations: POCUS = point of care ultrasound; US = ultrasound; STMM = Short-Term Medical Mission; RLSs = resource-limited settings; GP = general practice; POCT = point-of-care testing; INR = internationalised normalised ratio; HbA1c = glycated hemoglobin; ACR = albumin creatinine ratio; ................
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