scholarly journals The burden of incontinence in a real-world data environment – insights from a digital patient companion (Preprint)

2019 ◽  
Author(s):  
Alexandra von Au ◽  
Stephanie Wallwiener ◽  
Lina Maria Matthies ◽  
Benjamin Friedrich ◽  
Sabine Keim ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Pelvic Floor ◽  
Real World ◽  
Pelvic Floor Muscle ◽  
Digital Health ◽  
Scientific Data ◽  
Real World Data ◽  
World Data ◽  
First Choice ◽  
The Impact

BACKGROUND Urinary Incontinence (UI) can have a potentially devastating effect on women’s quality of life (QoL) in the physical, social, sexual, and psychological spheres. During pregnancy and after delivery, the strength of the pelvic floor muscle may decrease, resulting in a high rate of UI. Conservative treatment by means of pelvic floor muscle training is the first-choice treatment modality. Nowadays, this can be supported by digital apps. Those apps have the advantage of giving insights into real-world data on UI. OBJECTIVE The aim of the present study was to analyze the impact of UI on QoL using the app pelvina. METHODS We analyzed data from pelvina - a digital health companion pelvic floor course. This course regularly examines incontinence symptoms through “The Questionnaire for Urinary Incontinence Diagnosis” (QUID) and QoL through SF-6D. Subsequently, we analyzed the incidence and degree of incontinence in a real-world environment and determined the influence of different demographic factors. In addition, the impact of UI on the QoL was evaluated in more detail. RESULTS In all, 293 patients with a median age of 36 years and a median of 2 deliveries could be included in this study. Patients were slightly to moderately affected by UI with a QUID of 6 (2 - 11, max: 24). Age and parity were independently associated with the incidence of UI with an adjusted odds ratio (aOR) of 1.06 (95% CI 1.01 – 1.12) and aOR of 1.86 (95% CI 1.12 – 3.08), respectively. The severity of incontinence symptoms strongly correlated with impairment in QoL ( = 0.489, P < 0.001). CONCLUSIONS The use of real-world data, as generated by digital health solutions such as pelvina, gives us, for the first time, the opportunity to gain insight into the reality of patients' lives outside of classical clinical studies. In this paper we can corroborate the known associations between parity and UI known from the literature and the great influence UI has on QoL on a daily basis. This study shows that, in the future, the use of digital apps can make an important contribution to scientific data acquisition and, for example, therapy monitoring.

scholarly journals The burden of incontinence in a real-world data environment—insights from a digital patient companion

2021 ◽  
Author(s):  
Alexandra von Au ◽  
Stephanie Wallwiener ◽  
Lina Maria Matthies ◽  
Benjamin Friedrich ◽  
Sabine Keim ◽  
...  
Keyword(s):  
Pelvic Floor ◽  
Real World ◽  
Digital Health ◽  
Therapy Monitoring ◽  
Great Influence ◽  
Scientific Data ◽  
Real World Data ◽  
World Data ◽  
Number Of Children ◽  
First Choice

Abstract Introduction and hypothesis Urinary incontinence (UI) has a potentially devastating effect on women’s quality of life (QoL). Conservative treatment by means of pelvic floor muscle training is the first-choice treatment modality. Nowadays, this can be supported by digital apps like pelvina©—a digital health companion pelvic floor course. Methods Using pelvina©, UI symptoms and QoL are regularly examined through the questionnaires QUID and SF-6D. Subsequently, we analyzed the incidence and degree of UI and its impact on QoL in 293 users in a real-world environment. Results The 293 patients included in this study had a median age of 36 years and a median of two children. Patients were slightly to moderately affected by UI with a QUID of 6 (2–11, maximum 24). Age and number of children were independently associated with the incidence of UI with an adjusted odds ratio (aOR) of 1.06 (95% CI 1.01–1.12) and aOR of 1.86 (95% CI 1.12–3.08). The severity of UI strongly correlated with impairment of QoL (ρ = 0.866, P < 0.001). Conclusions The use of real-world data generated by digital health solutions offers the opportunity to gain insight into the reality of patients’ lives. In this article, we corroborate the known associations between number of children and UI as well as the great influence UI has on QoL. This study shows that, in the future, the use of digital apps can make an important contribution to scientific data acquisition and, for example, therapy monitoring.

scholarly journals Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?

2021 ◽  
pp. 026988112110085
Author(s):  
Robin L Carhart-Harris ◽  
Anne C Wagner ◽  
Manish Agrawal ◽  
Hannes Kettner ◽  
Jerold F Rosenbaum ◽  
...  
Keyword(s):  
Real World ◽  
Best Practice ◽  
Digital Health ◽  
Real World Data ◽  
Treatment Protocols ◽  
World Data ◽  
Cost Efficient ◽  
Personalised Treatment ◽  
New Research ◽  
Confirmatory Trials

Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.

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

scholarly journals The Use of Disposable Tampons as Visual Biofeedback in Pelvic Floor Muscle Training

2019 ◽  
Vol 16 (12) ◽  
pp. 2143 ◽  
Author(s):  
María Zahara Pintos-Díaz ◽  
Paula Parás-Bravo ◽  
Cristina Alonso-Blanco ◽  
César Fernández-de-las-Peñas ◽  
María Paz-Zulueta ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Pelvic Floor ◽  
Pelvic Floor Muscle Training ◽  
Pelvic Floor Muscle ◽  
Sexual Relations ◽  
Muscle Training ◽  
Visual Biofeedback ◽  
Quality Life ◽  
The Impact

Background: Urinary incontinence represents a complex problem which commonly affects women and influences their physical, mental and social wellbeing. The objective was to determine the effect of pelvic floor muscle training using a tampon as visual biofeedback. Methods: A non-randomized clinical trial involving 60 women >18 years of age, both with, and without, urinary incontinence. All women exercised with a program involving visual biofeedback using disposable tampons at home for three months. The compliance rate was 76.8 ± 24.1 An electromyographic assessment of the pelvic floor was performed and assessments of the impact of the exercise program. Results: 54.5% of women without incontinence and 81.6% of women incontinence reported improvements (p = 0.041). In both groups, there was increased quality life (p > 0.05). The women without incontinence experienced greater improvement in the quality of their sexual relations (Pre 6.8 ± 1.4–Post 7.2 ± 1.0). Conclusions: After the intervention, a high percentage of women showed a statistically significant improvement in their symptoms. The participants reported an increase in quality of life and the women without incontinence reported an improvement in quality of their sexual relations. Our findings suggest that visual BFB for training the PFM may be beneficial for women with or without incontinence.

scholarly journals The impact of pelvic floor muscle training on the myostatin concentration and severity of urinary incontinence in elderly women with stress urinary incontinence – a pilot study

2018 ◽  
Vol Volume 13 ◽  
pp. 1893-1898 ◽  
Author(s):  
Agnieszka Radzimińska ◽  
Magdalena Weber-Rajek ◽  
Agnieszka Strączyńska ◽  
Marta Podhorecka ◽  
Mariusz Kozakiewicz ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Pilot Study ◽  
Stress Urinary Incontinence ◽  
Pelvic Floor ◽  
Elderly Women ◽  
Pelvic Floor Muscle Training ◽  
Pelvic Floor Muscle ◽  
Muscle Training ◽  
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.

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

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