scholarly journals 211Real-World Data Assessment Plan for a Heat-Not-Burn Tobacco Product: Proof of Concept

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Angela van der Plas ◽  
Matthew Hankins ◽  
Annie Heremans
Keyword(s):  
Hospital Admissions ◽  
Population Level ◽  
Chronic Obstructive ◽  
Proof Of Concept ◽  
Ecological Studies ◽  
Multiple Sources ◽  
Real World Data ◽  
Japanese Market ◽  
World Data ◽  
The Impact

Abstract Focus of Presentation Real-world data (RWD) is readily available in Japan through multiple sources. Considering the crucial need to substantiate the beneficial effects of switching from cigarette smoking to heat-not-burn (HNB) products, both at the individual and population levels, the use of RWD seems a viable option. For instance, ecological studies using RWD have assessed the impact of population-level interventions such as smoking bans and their effects on smoking-related diseases and their endpoints As a proof of concept, ecological analyses were performed to assess the rates of chronic obstructive pulmonary disease (COPD) exacerbations and acute Ischemic Heart Disease (IHD) hospitalizations before and after the introduction of and HNB product in the Japanese market. Findings Hospital admissions associated with ICD codes for COPD and IHD from 2008 to 2019—5 years before and 4 years after the introduction of the target HNB product in the Japanese market—were retrieved from the MDV database. Referrals were below those predicted from pre-launch trends. Conclusions The use of RWD in assessment of HNB products is viable for ecological studies with the well-known caveats. Their use in exposure-specific studies will become feasible once the systematic collection of exposure to tobacco products and use history is guaranteed. This will greatly increase the range and robustness of the evidence base. Key messages The use of RWD is a practical way of assessing the impact of HNB products in the population as a whole.

PD-0776 A Bayesian approach to evaluate the impact of change in IGRT protocol using real world data

2021 ◽  
Vol 161 ◽  
pp. S608
Author(s):  
I. Fornacon-Wood ◽  
H. Mistry ◽  
C. Johnson-Hart ◽  
J.P.B. O’Connor ◽  
C. Faivre-Finn ◽  
...  
Keyword(s):  
Bayesian Approach ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
The Impact

VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies

2017 ◽  
Vol 33 (S1) ◽  
pp. 149-150
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klunger ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Relative Effectiveness ◽  
Internal Validity ◽  
Health Technology ◽  
Real World Data ◽  
World Data ◽  
The Impact

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.

scholarly journals Reduction in hospitalisations for acute gastroenteritis-associated childhood seizures since introduction of rotavirus vaccination: a time-series and change-point analysis of hospital admissions in England

2019 ◽  
Vol 73 (11) ◽  
pp. 1020-1025 ◽  
Author(s):  
Daniel James Hungerford ◽  
Neil French ◽  
Miren Iturriza-Gómara ◽  
Jonathan M Read ◽  
Nigel A Cunliffe ◽  
...  
Keyword(s):  
Time Series ◽  
Acute Gastroenteritis ◽  
Change Point ◽  
Hospital Admissions ◽  
Population Level ◽  
Febrile Seizures ◽  
Change Point Analysis ◽  
Rotavirus Vaccination ◽  
Point Analysis ◽  
The Impact

IntroductionThe incidence of severe childhood diarrhoea has fallen substantially following the introduction of rotavirus vaccine in the UK in July 2013. Since children with rotavirus infection may experience febrile and afebrile seizures, we evaluated the impact of rotavirus vaccination on seizure hospitalisations in children in England.MethodsUsing data from Hospital Episode Statistics, we employed interrupted time-series analyses to assess changes in monthly hospital admissions for seizures among children aged <5 years from July 2000 to June 2017. Outcome measures comprised all seizures and febrile seizures, with and without a co-diagnosis of acute gastroenteritis (AGE). Models were adjusted for pneumococcal conjugate vaccine (PCV) introduction. Change-point analysis was used to independently identify step-changes in the time-series.ResultsAmong hospitalised children aged <5 years, the incidence of any seizures and febrile seizures with AGE decreased post-vaccine introduction by 23% (95% CI: 11% to 33%) and 31% (95% CI: 19% to 41%), respectively. For febrile seizures with AGE, a single change-point was identified in July 2013 (95% CI: June 2013 to December 2013). Reductions in seizure incidence were higher during the rotavirus season (49%, 95% CI: 37% to 58%) compared with out-of-season (13%, 95% CI: −4 to 28%) and showed no relation to PCV introduction. There were small reductions in any seizures with any co-diagnosis (4%, 95% CI: 0% to 8%) and in febrile seizures with any co-diagnosis (10%, 95% CI: 2% to 16%).ConclusionRotavirus vaccination has reduced hospitalisations for seizures associated with AGE in England, providing additional evidence of population-level impact of rotavirus vaccination on seizure incidence in high-income countries.

scholarly journals Differences in hospital admissions practices following self-harm and their influence on population-level comparisons of self-harm rates in South London: an observational study

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032906
Author(s):  
C Polling ◽  
Ioannis Bakolis ◽  
Matthew Hotopf ◽  
Stephani L. Hatch
Keyword(s):  
Hospital Admissions ◽  
Population Level ◽  
City Centre ◽  
Spatial Patterning ◽  
Patient Demographics ◽  
Admission Data ◽  
Self Harm ◽  
Hospital Practices ◽  
The Impact ◽  
The City

ObjectivesTo compare the proportions of emergency department (ED) attendances following self-harm that result in admission between hospitals, examine whether differences are explained by severity of harm and examine the impact on spatial variation in self-harm rates of using ED attendance data versus admissions data.SettingA dataset of ED attendances and admissions with self-harm to four hospitals in South East London, 2009–2016 was created using linked electronic patient record data and administrative Hospital Episode Statistics.DesignProportions admitted following ED attendance and length of stay were compared. Variation and spatial patterning of age and sex standardised, spatially smoothed, self-harm rates by small area using attendance and admission data were compared and the association with distance travelled to hospital tested.ResultsThere were 20 750 ED attendances with self-harm, 7614 (37%) resulted in admission. Proportion admitted varied substantially between hospitals with a risk ratio of 2.45 (95% CI 2.30 to 2.61) comparing most and least likely to admit. This was not altered by adjustment for patient demographics, deprivation and type of self-harm. Hospitals which admitted more had a higher proportion of admissions lasting less than 24 hours (54% of all admissions at highest admitting hospital vs 35% at lowest). A previously demonstrated pattern of lower rates of self-harm admission closer to the city centre was reduced when ED attendance rates were used to represent self-harm. This was not altered when distance travelled to hospital was adjusted for.ConclusionsHospitals vary substantially in likelihood of admission after ED presentation with self-harm and this is likely due to the differences in hospital practices rather than in the patient population or severity of self-harm seen. Public health policy that directs resources based on self-harm admissions data could exacerbate existing health inequalities in inner-city areas where these data may underestimate rates relative to other areas.

550 Real World Treatment Trends for Patients TBSA ≤ 20%: Evaluating Important Shifts in Care and Budget Impact of ASCS Adoption

2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S115-S115
Author(s):  
James H Holmes ◽  
Stacey Kowal ◽  
Cheryl P Ferrufino
Keyword(s):  
Survey Data ◽  
Resource Use ◽  
Real World ◽  
Budget Impact ◽  
Patient Characteristics ◽  
Real World Data ◽  
Treatment Pathways ◽  
World Data ◽  
Burn Care ◽  
The Impact

Abstract Introduction Treatment pathways in burn care are typically determined based on burn center (BC) and patient characteristics, although decisions may be influenced by anecdotal experience, personal preference, and hospital policies/purchasing decisions. Health economic (HE) evaluations can support improved decision-making, identifying the most cost-effective interventions for tailored care. A novel burn care model (BEACON) was developed with burn surgeons over several years and validated through numerous publications, including an assessment of the HE impacts of autologous skin cell suspension (ASCS) use for definitive burn closure. To ensure that BEACON accurately represents the current state of care, it is vital to update data that underpins model projections. This study collected real world data on practice patterns and patient outcomes for the most commonly seen burns (TBSA ≤ 20%) to update the current understanding of standard of care (SOC) costs and outcomes and to refine estimates on the impact of ASCS use in TBSA ≤ 20% patients. Methods Data was collected from a 10% sample of BCs, including: BC and patient characteristics, resource use, inpatient costs, and length of stay (LOS). NBR based inputs in BEACON were updated to reflect survey data for patients with TBSA ≤ 20%, with the ability to view data as a national aggregate sample and across BC characteristics. BEACON estimates patient and BC costs and outcomes across a spectrum of patient profiles (age, gender, inhalation injury, comorbidity status, burn depth, TBSA) and combines information on each patient profile to understand annual budget impact. Key outcomes were compared across the survey sample and published NBR trends. Using the updated BEACON, the BC budget impact of ASCS in burns TBSA ≤ 20% was assessed. Results The survey was collected from 16+ BCs, focusing on inpatient encounters in 2018. LOS was lower than NBR estimates, with some centers reporting LOS per %TBSA far below 1 d/%TBSA. Using the detailed bottom-up estimation of cost from BEACON with survey data, trends suggest total hospital costs for SOC are lower than published NBR charges given shorter LOS and updated cost and resource use assumption. Conclusions Compared to NBR 8.0, contemporary data suggests that fewer small TBSA burns are being treated in the inpatient setting; those treated have a LOS below NBR estimates. When using real world data, the impact of ASCS use in burns TBSA ≤ 20% was still calculated to be cost saving to a BC overall, given reductions in LOS and number of definitive closure procedures. Incorporating ASCS into appropriate TBSA ≤ 20% procedures can still result in a positive financial impact for BCs. Applicability of Research to Practice

scholarly journals Changes in tobacco-related morbidity and mortality in French women: worrying trends

2019 ◽  
Vol 30 (2) ◽  
pp. 380-385 ◽  
Author(s):  
Valérie Olié ◽  
Anne Pasquereau ◽  
Frank A G Assogba ◽  
Pierre Arwidson ◽  
Viet Nguyen-Thanh ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Lung Cancer ◽  
Hospital Admissions ◽  
Population Attributable Fraction ◽  
Morbidity And Mortality ◽  
National Database ◽  
Attributable Mortality ◽  
Chronic Obstructive ◽  
Strong Impact ◽  
The Impact

Abstract Background The high prevalence of smoking among French women since the 1970s has been reflected over the past decade by a strong impact on the health of women. This paper describes age and gender differences in France of the impact of smoking on morbidity and mortality trends since the 2000s. Methods Smoking prevalence trends were based on estimates from national surveys from 1974 to 2017. Lung cancer incidence were estimated from 2002–12 cancer registry data. Morbidity data for chronic obstructive pulmonary disease (COPD) exacerbation and myocardial infarction were assessed through hospital admissions data, 2002–15. For each disease, number of deaths between 2000 and 2014 came from the national database on medical causes of death. The tobacco-attributable mortality (all causes) was obtained using a population-attributable fraction methodology. Results The incidence of lung cancer and COPD increased by 72% and 100%, respectively, among women between 2002 and 2015. For myocardial infarction before the age of 65, the incidence increased by 50% between 2002 and 2015 in women vs. 16% in men and the highest increase was observed in women of 45–64-year-olds. Mortality from lung cancer and COPD increased by 71% and 3%, respectively, among women. The estimated number of women who died as a result of smoking has more than doubled between 2000 and 2014 (7% vs. 3% of all deaths). Conclusions The increase in the prevalence of smoking among women has a major impact on the morbidity and mortality of tobacco-related diseases in women and will continue to increase for a number of years.

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