PHP153 - KEY STAKEHOLDERS PERCEPTIONS OF HEOR USAGE IN LEBANON

A Taxonomy of Generative Artificial Intelligence in Health Economics and Outcomes Research: An ISPOR Working Group Report.

Reimagining Patient Data Access for Researchers

MSR57 A Scoping Review of the Use of Machine Learning in Health Economics and Outcomes Research: Part 2 - Data from Non-Wearables

Assessing quality of life in progressive conditions like dementia presents unique challenges for Health Economics and Outcomes Research (HEOR). This commentary discusses current practices, highlighted by recent appraisals of lecanemab by NICE, where concerns about proxy-reported data-specifically, the risk of underestimating benefits-were noted as a limitation in the evaluation.While progressive cognitive decline complicates traditional self-reporting methodologies, emerging evidence demonstrates that adaptive strategies and technology-assisted methods can extend reliable self-reporting windows. The analysis identifies four critical challenges: (1) cognitive heterogeneity across dementia subtypes and stages clashing with HEOR's stable preference assumptions; (2) temporal fluctuations undermining single-timepoint assessments; (3) systematic discrepancies between self- and proxy-reported outcomedata, inadequately addressed by current methods; and (4) the conceptual and psychometric limitations of currentgeneric and condition-specific instruments. To address thesechallenges, the author advocates for a paradigm shift, inviting HEOR communityto view diverse expressions of preference as a catalyst for innovation. This involves moving beyond static, binary preference assumptions to embrace dynamic, multimodal methods capturing non-verbal expressions in more advanced dementia. Proposed solutions include proxy calibration, an ecosystem of hybrid and graduated assessment integrating standardized domains with adaptable modules; reforming proxy protocols using Pickard's dual-gap framework to position proxy input as complementary, not substitutive; employing modern psychometrics and adopting relationship-centred engagement and process consent. Crucially, it calls for HEOR to integrate adaptive methods from adjacent fields-such as phenomenological inquiry, sensor technology, and data triangulation. These approaches can enhancethe ability of HEOR to measure, value, and assessquality of life in the context of dementia and other progressive neurodegenerative conditions, ultimately anchoring value in lived experience and ensuring methodological limitations do not become barriers to accessing care and treatments.

Evaluating efficacy and real-world effectiveness for novel therapies targeting rare mutations or patient subpopulations with unmet needs is a growing challenge in health economics and outcomes research (HEOR). In these settings it may be difficult to recruit enough patients to run adequately powered randomized clinical trials, resulting in greater reliance on single-arm trials or basket trial designs. Additionally, evidence networks for performing network meta-analysis may be sparse or disconnected when comparing available treatments in narrower patient populations. These challenges create an increased need for use of appropriate methods for handling small sample sizes, structural modelling assumptions and more nuanced decision rules to arrive at "best-available evidence" on comparative and non-comparative efficacy/effectiveness. We advocate for greater use of Bayesian methods to address these challenges as they can facilitate efficient and transparent borrowing of information across varied data sources under flexible modelling assumptions, probabilistic sensitivity analysis to assess model assumptions, and more nuanced decision-making where limited power reduces the utility of classical frequentist hypothesis testing. We illustrate how Bayesian methods have been recently used to overcome several challenges of rare indications in HEOR, including approaches to borrowing information from external data sources, evaluation of efficacy in basket trials, and incorporating non-randomized studies into network meta-analysis. Lastly, we provide several recommendations for HEOR practitioners on appropriate use of Bayesian methods to address challenges in the rare disease setting.

Criteria and Process for Initiating and Developing an ISPOR Good Practices Task Force Report

This paper discusses key challenges and opportunities that arise when using linked electronic health records (EHR) in health economics and outcomes research (HEOR), with a particular focus on estimating healthcare costs. These challenges and opportunities are framed in the context of a case study modelling the costs of stable coronary artery disease in England. The challenges and opportunities discussed fall broadly into the categories of (1) handling and organising data of this size and sensitivity; (2) extracting clinical endpoints from datasets that have not been designed and collected with such endpoints in mind; and (3) the principles and practice of costing resource use from routinely collected data. We find that there are a number of new challenges and opportunities that arise when working with EHR compared with more traditional sources of data for HEOR. These call for greater clinician involvement and intelligent use of sensitivity analysis.

Commentary--goodbye M(C)ID! Hello MID, where do you come from?

Challenges in the Development and Reimbursement of Personalized Medicine—Payer and Manufacturer Perspectives and Implications for Health Economics and Outcomes Research: A Report of the ISPOR Personalized Medicine Special Interest Group

A Real-World Evidence Systematic Literature Review of Health-Related Quality of Life, Costs and Economic Evaluations in Newly-Diagnosed Multiple Myeloma Patients

Health-related quality of life (HRQOL) is an important and frequently used patient-reported outcome in health research. However, little qualitative research exists in this field in South Africa. This study was set in Khayelitsha, one of the largest informal settlements in South Africa, where the burden of HIV and tuberculosis (TB) co-infection are amongst the highest in the world and significantly affect HRQOL. To explore the experience of HRQOL among patients living with HIV-associated TB. We conducted sixteen interviews with male (n = 10) and female (n = 6) adult participants (ages 24-56; median age 35) to explore their HRQOL living with HIV-associated TB, related treatment and how this impacted on life domains they considered relevant for HRQOL. We used thematic analysis to analyse data, using both an inductive and deductive analysis using an interpretive phenomenological approach (IPA). Experiences of HRQOL were identified along the predominantly emerging themes of physical, social, and mental aspects of HRQOL. Identified sub-themes included well-being, loss of strength, and self-care for the physical domain; usual activities and stigma for the social domain; concerns and coping for the mental domain. The findings illustrate that HRQOL domains are interconnected through social experience. The social experience of HRQOL was identified as the common denominator connecting all domains, around which HRQOL revolved for these participants. HRQOL is experienced socially. The interpersonal connections patients have with significant others present as key to high HRQOL among patients living with HIV-associated TB. This study adds to the existing literature of HRQOL and examines HRQOL using IPA which may help to inform future interventions to improve HRQOL among HIV/TB patients.

Not-only-a-title

Improving access and quality while reducing expenditures in the United States health system is expected to be a priority for many years. The use of health information technology (HIT), including electronic prescribing (eRx), is an important initiative in efforts aimed at improving safety and outcomes, increasing quality, and decreasing costs. Data from eRx has been used in studies that document reductions in medication errors, adverse drug events, and pharmacy order-processing time. Evaluating programs and initiatives intended to improve health care can be facilitated through the use of HIT and eRx. eRx data can be used to conduct research to answer questions about the outcomes of health care products, services, and new clinical initiatives with the goal of providing guidance for clinicians and policy makers. Given the recent explosive growth of eRx in the United States, the purpose of this manuscript is to assess the value and suggest enhanced uses and applications of eRx to facilitate the role of the practitioner in contributing to health economics and outcomes research.

Although chronic hepatitis C (CHC) is often mild and asymptomatic, it may lead to decompensated hepatic cirrhosis and death. CHC is now the single most important indication for liver transplantation in North America. CHC is also an important cause of morbidity. Recent work is reviewed and shows that the health-related quality of life (HRQOL) of patients with CHC is markedly reduced compared with that of age- and sex-matched controls. For as yet unknown reasons, this reduction is more severe in CHC patients than in those with chronic hepatitis B. Successful therapy of CHC with type 1 interferons (IFNs) leads to substantial improvement - to nearly normal levels - in patients' HRQOL. In addition, IFN or IFN plus ribavirin therapy for CHC is highly cost effective, despite its limited long term efficacy; estimates of the costs to gain one year of quality-adjusted life range from no cost (that is, therapy is cost saving) to US$11,400 (for those most difficult to cure). Thus, despite the limited effectiveness of current therapies for CHC, they are fully justified based on their beneficial effects on patients' HRQOL and their cost effectiveness.

Diabetes prevalence is increasing globally especially in the Asian subcontinent. It is expected that by the year 2030 there may be close to 400 million people with diabetes. All of the research in the past 25 years has clearly documented the effectiveness of improving glucose control in reducing long-term complications of diabetes, both microvascular and macrovascular. The improvement in glucose control usually requires continuous intensive diabetes management, particularly in insulin-requiring patients, which must include home self-monitoring of blood glucose (SMBG). Despite the convincing evidence, the role of SMBG in diabetes management is still being debated even though its availability in the past 35 years has revolutionised diabetes care, especially at home. The International Diabetes Federation (IDF) recently published guidelines for SMBG use in non-insulin-treated diabetic patients, recommending that SMBG should be used only when patients and/or their clinicians possess the ability, willingness and knowledge to incorporate SMBG and therapy adjustment into their diabetes care plan. The IDF also recommends that structured SMBG be performed with the choice of applying different defined blood glucose testing algorithms to patients' individual diabetes care plans. These defined blood glucose testing algorithms give SMBG a medically meaningful structure to collect high quality glucose information and are called structured SMBG. Former SMBG studies have demonstrated SMBG to be beneficial when patients receive feedback regarding the impact of their behaviours on SMBG results. Other studies which did not link SMBG results to these principal behaviours have shown no SMBG benefit. A new wave of clinical studies performed after the release of the IDF guideline have recently been published and have proved the success of the new application of SMBG. The reasons for this ongoing debate may in part be due to rising healthcare costs globally, lack of convincing data in non-insulin-requiring patients with type 2 diabetes in randomised controlled clinical trials and multiple controversial meta-analyses performed on several studies. Sometimes the decisions are extended to insulin-requiring patients, even those with type 1 diabetes. For example, last year in the state of Washington in the USA, legislators were going to stop reimbursing glucose test strips for children with type 1 diabetes. After much debate with committee members (who were not diabetologists and or endocrinologists) and law makers, not only SMBG but even in some cases continuous glucose monitoring (CGM) is now reimbursed. The issue was simply educating non-understanding but well-meaning people whose main concern is saving money. In the end, no one, even those not familiar with paediatric type 1 diabetes, can disagree about the need for SMBG in this age group. It seems to us that we should instead be spending our time and effort in advancing the field and improving diabetes management for patients through newer technologies like CGM and closed-loop systems. As discussed in the section on CGM (Chapter 2) there is ample data from both non-randomised and randomised clinical trials showing the efficacy in reducing time spent in hypoglycaemia and hyperglycaemia along with improvement in glucose control without introducing any additional medication. We hope that the future will be spent in advancing the care rather than useless meta-analyses or going back in time. It is worthwhile to review existing evidence about SMBG to learn, transfer and apply knowledge about the core requirement for good diabetes management, glucose information. Fendler W, Hogendorf A, Szadkowska A, Młynarski W Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz, Poland Pediatr Endocrinol Diabetes Metab 2011; 17 : 57–63 Background: SMBG is one of the major components of diabetes management. Aims: To evaluate the potential for miscoding of a personal glucometer, to define a target population among paediatric patients with diabetes for a non-coding glucometer and to assess the accuracy of the Contour TS non-coding system. Methods: Potential for miscoding during SMBG was evaluated by means of an anonymous questionnaire, with worst and best case scenarios evaluated depending on the response pattern. Testing of the Contour TS system was performed according to the national committee for clinical laboratory standards guidelines. Results: The estimated frequency of individuals prone to non-coding ranged from 68.21% [95% confidence interval (CI) 60.70%–75.72%] to 7.95% (95% CI 3.86%–12.31%) for the worse and best case scenarios, respectively. Factors associated with increased likelihood of non-coding were a smaller number of tests per day, a greater number of individuals involved in testing and self-testing by the patient. The Contour TS device showed intra- and inter-assay accuracy of –95%, a linear association with laboratory measurements (R2 = 0.99, p < 0.0001) and small bias of –1.12% (95% CI –3.27% to 1.02%). Clarke error grid analysis showed 4% of values within the benign error zone (B) with the other measurements yielding an acceptably accurate result (zone A). Conclusions: The Contour TS system showed sufficient accuracy to be safely used in the monitoring of paediatric patients with diabetes. Patients from families with a high throughput of test-strips or multiple individuals involved in SMBG using the same meter are candidates for clinical use of such devices due to an increased risk of calibration errors. Comment: This study further highlights the role of making SMBG simpler and easier so that patients can monitor the glucose more effectively. The current study used the Contour TS system which does not require coding by the patient and thus removes the barrier of mis-coding of SMBG. We personally think that all meters going forward must be non-coding meters. Nerhus K 1 , Rustad P 2 , Sandberg S 1,3 1 Norwegian Centre for Quality Improvement of Primary Care Laboratories, Department of Public Health and Primary Health Care, University of Bergen, Bergen, Norway, 2 Norwegian Clinical Chemistry EQA-Program, Fürst Medical Laboratory, Oslo, Norway, 3 Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway Diabetes Technol Ther 2011; 13: 883–92 Background: Analytical quality of SMBG can be affected by environmental conditions. Aims: To determine the influence of a shift in the ambient temperature immediately before measurement and taking measurements in the lower and upper part of the operating temperature range. Methods: Different SMBG systems (n = 9) available on the Norwegian market were tested with heparinised venous blood (4.8 and 19.0 mmol/l). To test the effect of a shift in ambient temperature, the glucometer and strips were equilibrated for 1 h at 5 °C or 30 °C before the meter and strips were moved to room temperature, and measurements were performed after 0, 5, 10, 15 and 30 min. To test the lower and upper temperature range, measurements were performed at 10 °C and at 39 °C after 1 h for temperature equilibration of the glucometer and strips. All the measurements were compared with measurements performed simultaneously on a meter and strips kept the whole time at room temperature. Results: Six of nine SMBG systems overestimated and/or underestimated results by more than 5% after moving meters and strips from 5 °C or 30 °C to room temperature immediately before the measurements. Two systems underestimated the results at 10 °C. One system overestimated and another underestimated the results by more than 5% at 39 °C. Conclusions: A rapid shift in the ambient temperature affects analytical performance. Therefore patients need to wait at least 15 min for temperature equilibration of affected meters and strips before measuring blood glucose. Comment: This study highlights the importance of ambient temperature on analytical performance of SMBG. The study shows that rapid shift in ambient temperature may affect the accuracy and bias in SMBG measurement and highlights the need for 15 min temperature equilibration. In addition to what has been highlighted in the study, future studies also need to assess the accuracy of existing meters (especially the one using glucose oxidase) at higher altitudes (10,000 feet or higher). It is known that many of these meters do not perform well at high altitudes. McAndrew LM 1,2 , Horowitz CR 3 , Lancaster KJ 4 , Quigley KS 2,5,6 , Pogach LM 1,2 , Mora PA 7 , Leventhal H 8 1 War Related Illness and Injury Study Center and REAP Center for Healthcare Knowledge Management, Department of Veterans Affairs, New Jersey Health Care System, East Orange, NJ, USA, 2 University of Medicine and Dentistry of New Jersey, Newark, NJ, USA, 3 Department of Health Evidence and Policy, Mount Sinai School of Medicine,New York, NY, USA, 4 Department of Nutrition, Food Studies and Public Health, New York University, New York, NY, USA, 5 Department of Veterans Affairs, Edith Nourse Rogers Memorial VA Hospital, Bedford, MA, USA, 6 Department of Psychology, Northeastern University, Boston, MA, USA, 7 Psychology Department, University of Texas at Arlington, Arlington, TX, USA, and 8 Institute for Health, Health Care Policy and Research, Rutgers University, New Brunswick, NJ, USA J Diabetes 2011; 3 : 147–52; Comment in J Diabetes 2011; 3 : 93–4 Background: It is unknown whether SMBG can motivate adherence to dietary recommendations. Aims: To evaluate if patients who used more SMBG would also report lower fat and greater fruit and vegetable consumption. Methods: This was a cross-sectional study of primarily minority individuals living with diabetes in East Harlem, New York (n = 401). Fat intake and fruit and vegetable consumption were measured with the Block Fruit/Vegetable/Fiber and Fat Screeners. Results: Greater frequency of SMBG was associated with lower fat intake [r(s) = –0.15; p < 0.01], but not fruit and vegetable consumption. The effects of SMBG were not moderated by insulin use. A significant interaction was found between frequency of SMBG and changing one's diet in response to SMBG on total fat intake. Conclusions: The frequency of SMBG was associated with lower fat intake. The data suggest that participants who use SMBG to guide their diet do not have to monitor multiple times a day to benefit. Comment: This study further highlights the importance of SMBG in daily lifestyle changes. Subjects with higher frequency of SMBG consumed less fat, in part related to overall education and seeing the impact from making dietary changes on SMBG levels. Kuo CY 1,2 , Hsu CT 3 , Ho CS 3 , Su TE 3 , Wu MH 4 , Wang CJ 2,5 1 Department of Clinical Laboratory, Tai-An Hospital, Taichung, Taiwan, 2 Institute of Biochemistry and Biotechnology, Chung Shan Medical University, Taichung, Taiwan, 3 Department of Core Technical Research, Bionime Corporation, Taichung, Taiwan, 4 Department of Laboratory Medicine, Min-Sheng General Hospital, Taoyuan, Taiwan, 5 Department of Medical Research, Chung Shan Medical University Hospital, Taichung, Taiwan Diabetes Technol Ther 2011; 13 : 596–600 Background: SMBG systems should at least meet the minimal requirement of the World Health Organization's ISO 15197:2003. For tight glycaemic control, a tighter accuracy requirement is needed. Methods: Seven SMBG systems were evaluated for accuracy and precision: Bionime Rightest™ GM550 (Bionime Corp., Dali City, Taiwan), Accu-Chek® Performa (Roche Diagnostics, Indianapolis, IN, USA), OneTouch® Ultra®2 (LifeScan Inc., Milpitas, CA, USA), MediSense® Optium™ Xceed (Abbott Diabetes Care Inc., Alameda, CA, USA), Medisafe (TERUMO Corp., Tokyo, Japan), Fora® TD4227 (Taidac Technology Corp., Wugu Township, Taiwan) and Ascensia Contour® (Bayer HealthCare LLC, Mishawaka, IN, USA). The 107 participants were 23–91 years old. The analytical results of seven SMBG systems were compared with those of plasma analysed with the hexokinase method (Olympus AU640, Olympus America Inc., Center Valley, PA, USA). Results: The imprecision of the seven blood glucose meters ranged from 1.1% to 4.7%. Three of the seven blood glucose meters (42.9%) fulfilled the minimum accuracy criterion of ISO 15197:2003. The mean absolute relative error value for each blood glucose meter was calculated and ranged from 6.5% to 12.0%. Conclusions: More than 40% of evaluated SMBG systems meet the minimal accuracy criterion requirement of ISO 15197:2003. However, considering a tighter criterion for accuracy of ±15%, only the Bionime Rightest GM550 meets this requirement. Manufacturers have to try to improve accuracy and precision and to ensure the good quality of blood glucose meters and test strips. Comment: This study further highlights the need for more accurate SMBG systems. Their data concluded that more than 40% of the evaluated SMBG systems meet the minimum ISO criteria. Since patients use blood glucose information for adjusting their insulin dose and/or treating hypoglycaemia, the accuracy of the glucose meters has to be consistent and improved. Hortensius J 1 , Slingerland RJ 2 , Kleefstra N 1,3,4 , Logtenberg SJ 1 , Groenier KH 5 , Houweling ST 3,6 , Bilo HJ 1,4 1 Diabetes Centre, Isala Clinics, Zwolle, The Netherlands, 2 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 3 Medical Research Group, Langerhans, The Netherlands, 4 Department of Internal Medicine, University Medical Center, Groningen, The Netherlands, 5 Department of General Practice, University of Groningen, Groningen, The Netherlands, and 6 General Practice Sleeuwijk, Sleeuwijk, The Netherlands Diabetes Care 2011; 34 : 556–60 Background: There is no agreement regarding the use of the first or second drop of blood for glucose monitoring. Aims: To investigate whether capillary glucose concentrations, as measured in the first and second drops of blood, differed ≥10% compared with a control glucose concentration in different situations. Methods: Capillary glucose concentrations were measured in two consecutive drops of blood in 123 patients with diabetes in the following circumstances: without washing hands, after exposing the hands to fruit, after washing the fruit-exposed hands, and during application of different amounts of external pressure around the finger. The results were compared with control measurements. Results: Not washing hands led to a difference of ≥10% in glucose concentration in the first and in the second drops of blood in 11% and 4% of the participants, respectively. In fruit exposed fingers, these differences were found in 88% and 11% of the participants, respectively. Different external pressures led to ≥10% differences in glucose concentrations in 5%–13% of the participants. Conclusions: Washing hands with soap and water, drying them, and using the first drop of blood for SMBG is recommended. If washing hands is not possible, it is acceptable to use the second drop of blood after wiping away the first drop. External pressure may lead to unreliable readings. Comment: Over the years we have probably under-emphasised the importance of technique with SMBG. One has to wonder how much iatrogenic hypoglycaemia has occurred due to unintended exposure to glucose on the hands, and how often CGM devices are due to technique with SMBG use. 1,2 , 3 , 4 , 5 , 6 , 7 , 8 , 8 , 8 1 University of CA, USA, 2 Diabetes CA, USA, 3 University of CA, USA, 4 University Health System, USA, 5 America Diabetes USA, 6 Health IN, USA, 7 USA, and 8 Diagnostics, Indianapolis, IN, USA Diabetes Care 2011; 34 : To assess the effectiveness of structured blood glucose testing in controlled patients with type 2 diabetes without insulin Methods: A study patients with type 2 diabetes (n = and glycaemic control from 34 care in the were randomised to an control with care or a structured testing with care and at least use of structured SMBG. patients and were to use a to glucose consecutive The was measured at Results: The analysis = = showed greater in mean in the compared with the = p = analysis = = showed even greater mean in the compared with the p < more patients a at the first compared with patients, of the p < and patients significant < 0.0001) in Conclusions: use of structured SMBG glycaemic control and more changes in patients with type 2 diabetes without Comment: It is with an healthcare using a structured glucose testing can improve glucose control in non-insulin-treated Potential are of this can be in a with the more time in a care to be , 5 , 6 , 1,4 1 Department of and Laboratory Medicine, University of 2 Department of and University of 3 Department of Pediatrics, University of 4 Laboratory 5 Corporation, MA, USA, and 6 Department of Health University of J Diabetes Technol 4 : Aims: To analytical error in and glucose meters by in and Methods: The of and were tested and in with each glucose meter and with a plasma glucose method at glucose was by consecutive analysis (n = at glucose levels. analysis was used to the bias associated with the and in Results: Three meters demonstrated bias that was glucose bias on the and the of bias was on small significant on meters. of and of increased the bias and was by of total analytical the glucose meter devices of total analytical error in glucose measurement ranged from to the Conclusions: The of glucose meters to significant analytical is the analytical Comment: with to for SMBG and the research is it does not that many people the This has impact on as new guidelines for greater of are the impact on SMBG accuracy be particularly by the device should be a 1 , 1 , 2 , 3 1 Health and 2 Health, and 3 of and Department of Internal Medicine, : Aims: To evaluate the of SMBG in patients with type 2 diabetes with in Methods: In a study a of diabetes was used to from a published study of SMBG in patients with type 2 diabetes, with and with no of a time was from the of a healthcare and clinical were at Results: or times daily SMBG was associated with in which led to increased and and of diabetes complications compared with no SMBG in type 2 diabetes patients on costs increased by and in patients SMBG or times daily compared with those not using SMBG. were well at and per year respectively. Conclusions: SMBG is to be by standards in patients on in the Comment: This analysis is on a showing of and The concern of is that this analysis is not a randomised controlled and at best the data are about the efficacy of this population using this analysis is probably on controversial 1,2 , 3 , S 3 , 1 Health Research, University School of Medicine, Indianapolis, IN, USA, 2 Institute for Health Care, Indianapolis, IN, USA, 3 of University School of Medicine, Indianapolis, IN, USA, and 4 Diabetes and Center, University School of Medicine, Indianapolis, IN, USA Diabetes 2011; : To assess the and of a glucose monitoring system for with type 1 diabetes and their Methods: Patients with type 1 diabetes who been for at least 1 year in the used the system for 6 3 to and with the glucose monitoring as well as how use of the system affect quality of and diabetes management. Results: about the a number of significant that affected use of the all that the in monitoring testing was The use of the did not the quality of their of with their their of diabetes, or their glycaemic control within the time of the Conclusions: This that glucose monitoring can be used in an population to and in self-monitoring Comment: for both SMBG and CGM is clearly the future for with type 1 diabetes. The will be to how to best use this to improve in this To the is new to how best to use more studies will be to this P 1 , 2 , ST 3 , 2 , 2 , 4 , Bilo 5 , Bilo HJ 1 Department of Internal Medicine, Hospital, The Netherlands, 2 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 3 Department of Isala Clinics, Zwolle, The Netherlands, 4 Centre for The Netherlands, 5 Department of Internal Medicine, Isala Clinics, Zwolle, The Netherlands, and 6 Department of Internal Medicine, University Medical Centre, Groningen, The Netherlands One 5 : Background: Patients with diabetes part in and thus blood glucose meters are studies bias in blood glucose measurements using different at high To evaluate if glucose are more by the lower pressure at than glucose Methods: measurements at of nine glucose glucose were compared with glucose measurement on a at and with a laboratory glucose blood of different glucose were were at a bias from glucose and from glucose mmol/l). Results: significant difference was between measurements at and for glucose or glucose as a Two glucose did not meet performance criteria. Conclusions: high all tested glucose did not influence of All for two glucose performed within criteria. are glucose concentration at high high one glucose best precision and Comment: testing for SMBG meters may be In glucose test strips should be at high altitudes. not in this it should be that patients do not this into when or 1 , J 2 , 2 , 1 , 3 , 4 , J 3 , 5 , J 6 , 7 , 7 , 8 1 Department of Health University of Health Center, USA, 2 and Health Department of Medical and University of USA, 3 Department of and Health University of USA, 4 Diabetes Care Center, Medical USA, 5 Department of University of USA, 6 Medicine Technology Center USA, 7 Department of Medicine, University of USA, and 8 Health Research USA J Aims: To assess the and of using as part of an existing system for between patients with diabetes and a care Methods: In glucose meter and two to feedback on glycaemic control were Results: glucose meter with and data feedback were the system to an and feedback system for value in the system as an to the and Conclusions: diabetes management systems may one to improve the quality of diabetes Comment: best to in a care for type 2 diabetes is still It is that there will be different of that will for different patient the use of the as a means of that device like the of in diabetes management. the now seems to be how to is a It may be that will be the only for many the of time this population 1 , 2 1 Centre for Policy Research, of Health Health Policy and Research, University of and 2 Institute for Medicine, and Health University Medical Centre 2011; : Background: the of and in Patients with 2 Diabetes a in the risk of in patients with type 2 diabetes who performed SMBG. Aims: To evaluate if these are by a that time Methods: The bias in the study was and demonstrated that it is to the effect of SMBG on Results: In the study, patients were as exposed to SMBG for their whole time if performed SMBG for at least 1 year during the study the time between and the after 1 year of self-monitoring was performed is for patients with SMBG. Patients to at least 1 year to be as exposed to this and were from The total of in the SMBG is at least of at risk After of as the relative risk from to Conclusions: The effect of SMBG on in the study is by time Comment: The study is one of the trials in the of SMBG. Study is probably a major for between the studies. Kleefstra N 1,2 , Hortensius J 1 , Logtenberg SJ 1 , 3 , Groenier K 4 , Houweling ST 2,5 , 6 , 2 , Bilo HJ 1 Diabetes Centre, Isala Clinics, Zwolle, The Netherlands, 2 Medical Research Langerhans, Zwolle, The Netherlands, 3 Department of Clinical Chemistry, Isala Clinics, Zwolle, The Netherlands, 4 Department of General Practice, University of Groningen, Groningen, The Netherlands, 5 General Practice Sleeuwijk, Sleeuwijk, The Netherlands, 6 Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands J : Background: It is not if SMBG glycaemic control in patients with type 2 diabetes. To investigate the effects of SMBG in patients with type 2 diabetes who were in glycaemic Methods: Patients years with an of using one to two blood glucose were in the Patients (n = were to receive SMBG to care or to with care for 1 A glucose value and glucose values were measured The efficacy was quality of and were using the Health the the Diabetes and the Results: in between was (95% CI to p = There were no significant changes between on the type or for the which was lower in the difference (95% CI to Conclusions: type 2 diabetes patients some of their the use of SMBG in these patients is and its use should be Comment: This is another SMBG study in non-insulin-treated type 2 the of not patients what to do with the information is one has to wonder if this at some to have some of the it is to that the in care is to more education and time than is in many of these studies. A 1 , 1 , 1 , S 2 , S 3 , A 1 , A 1 , 1 , 4 , 3 , 3 , 1 1 Department of and School of Medicine, 2 Department of School of Medicine, 3 Department of Biochemistry, School of Medicine, and 4 Department of School of Medicine, Diabetes Technol Ther : Background: glucose meters may not be accurate to Aims: of the accuracy and the capillary and venous of different Xceed (Abbott Diabetes Care, Alameda, CA, USA), Contour TS (Bayer Diabetes Care, (Roche Milpitas, CA, and Inc., in an Methods: The insulin hypoglycaemia test was performed for of mean age was measured from venous blood and capillary before and after of insulin were analysed in the laboratory by the hexokinase In tests for method and precision were also performed by the venous Results: All to hypoglycaemia to some was in error zone and was in the error zone Xceed and Contour TS and were than the other two according to error grid analysis or International for criteria. The in tests were consistent with the clinical The capillary and venous of and were than the other Not all are accurate in blood glucose levels. The patients and the should be of these of the and give more to the hypoglycaemia than the values with the These results that there is a need for the of accuracy standards of at blood glucose levels. Comment: We have the that meters are from especially at levels. patients can state a time when an The are not only for the of hypoglycaemia but also as we forward with CGM about how this about this the with the for use of the meters our clinical with patient error us that accuracy a for glucose meters at levels. has research from Inc., Corporation, Inc., and is a for Diagnostics, Diabetes Care and