Data-Driven Decision Making for New Drugs

2012 ◽  
pp. 144-162
Author(s):  
George P. Sillup ◽  
Ronald Klimberg ◽  
David P. McSweeney
Keyword(s):  
Decision Making ◽  
Healthcare Delivery ◽  
New Drugs ◽  
Pharmaceutical Marketing ◽  
Patient Records ◽  
Electronic Patient Records ◽  
Real World Data ◽  
Collaborative Process ◽  
Pharmacy Claims ◽  
Student Teams

Two courses, advanced decision-making and pharmaceutical marketing, were combined in a collaborative process to mimic how the pharmaceutical industry determines the potential of new drugs. Integrated student teams worked together to complete semester-long projects and taught each other their respective knowledge areas—marketing and statistics. Real-world data for medical and pharmacy claims payments were “cleaned” and mined by students to analyze usage and cost patterns for anti-hypertensive and anti-hypercholesterolemia drugs currently on the market. Analyses included merging the medical and pharmaceutical data records to derive individual electronic patient records, which were the basis of financial projections for the new drugs. Importantly, the single patient record is congruent with the needs of the stakeholders currently working to reform U.S. healthcare delivery.

Data-Driven Decision Making for New Drugs

2010 ◽  
Vol 1 (2) ◽  
pp. 42-59 ◽  
Author(s):  
George P. Sillup ◽  
Ronald K. Klimberg ◽  
David P. McSweeney
Keyword(s):  
Decision Making ◽  
Healthcare Delivery ◽  
New Drugs ◽  
Data Driven ◽  
Electronic Patient Records ◽  
Single Patient ◽  
Real World Data ◽  
Collaborative Process ◽  
Pharmacy Claims ◽  
Student Teams

Two courses, advanced decision-making and pharmaceutical marketing, were combined in a collaborative process to mimic how the pharmaceutical industry determines the potential of new drugs. Integrated student teams worked together to complete semester-long projects and taught each other their respective knowledge areas—marketing and statistics. Real-world data for medical and pharmacy claims payments were “cleaned” and mined by students to analyze usage and cost patterns for anti-hypertensive and anti-hypercholesterolemia drugs currently on the market. Analyses included merging the medical and pharmaceutical data records to derive individual electronic patient records, which were the basis of financial projections for the new drugs. Importantly, the single patient record is congruent with the needs of the stakeholders currently working to reform U.S. healthcare delivery.

Common-Sense Epidemiology in the Age of Electronic Patient Records (EPR)

2020 ◽  
pp. 343-364
Author(s):  
Shirly Bar-Lev ◽  
Dizza Beimel
Keyword(s):  
Decision Making ◽  
Common Sense ◽  
Clinical Information ◽  
Active Role ◽  
Patient Records ◽  
Electronic Patient Records ◽  
Professional Help ◽  
Course Of Action ◽  
The Relationship ◽  
Practical Recommendations

Encouraging patients to play a more active role in their health care is crucial for healthcare planning and for the design of services. This chapter shifts the scholarly focus from practitioners' decision making to that of laypersons' trying to make sense of the lab results available on their EPRs. The authors developed a methodology to capture the relationship between information formats (graph, numeric, or verbal), laypersons' assessment of the conditions' gravity, and their preferred course of action. Focusing on the effect of “not knowing” on laypersons' preferred courses of action, our findings show that formats that left respondents less able to understand the results—namely, the numeric and verbal formats—produced a lower sense of urgency, and correspondingly, less inclination to actively seek professional help. The chapter takes a step toward deriving practical recommendations as to how personal clinical information should be communicated, to improve laypersons' interpretation of the information's significance.

scholarly journals Adverse Physiological Events under Anaesthesia and Sedation: A Pilot Audit of Electronic Patient Records

2008 ◽  
Vol 36 (2) ◽  
pp. 222-229 ◽  
Author(s):  
C. Grant ◽  
G. Ludbrook ◽  
E. A. Hampson ◽  
R. Semenov ◽  
R. Willis
Keyword(s):  
Adverse Event ◽  
Quality Improvement ◽  
Adverse Events ◽  
Best Practice ◽  
Healthcare Delivery ◽  
Electronic Record ◽  
Physiological Data ◽  
Patient Records ◽  
Electronic Patient Records ◽  
Record Keeping

Review of perioperative activity, including adverse events, throughput and compliance with ‘best practice’, can theoretically be used to optimise healthcare delivery. Computer-based analysis of electronic patient records could provide a practical means to manage quality improvement. This pilot study examined the effectiveness of such a system in practice. All intraoperative patient notes and physiological data were collected over 17 months in a rural hospital using data from an electronic record-keeping system. Algorithms were developed to automatically identify potential adverse events based on physiological measures. Each computer-identified event was reviewed by a panel of three anaesthetists and assessed for validity, severity and probable cause. Two areas were identified to pilot quality improvement activities—sedation for colonoscopies and inhalational anaesthesia with desflurane. Specific ‘inhouse’ guidelines were created for these procedures and feedback on the patterns of adverse events were provided to anaesthetic staff. A total of 138 separate adverse events were identified for all operative cases over 17 months, with an overall adverse event incidence of 3.3%. The adverse event incidence during colonoscopy and laryngospasm/hypoxia during desflurane anaesthesia was 6.3% and 1.3% respectively. This decreased to 2.8% (P <0.005) and 0.13% (P <0.0001) respectively for the nine months following feedback and the introduction of guidelines. Anaesthesia information systems can be an effective quality improvement tool and may enhance existing tools such as incident reporting systems.

Electronic Patient Records in Medical Practice: A Multidisciplinary Endeavor

1999 ◽  
Vol 38 (04/05) ◽  
pp. 287-288 ◽  
Author(s):  
J. van der Lei ◽  
P. W. Moorman ◽  
M. A. Musen
Keyword(s):  
Medical Practice ◽  
Patient Records ◽  
Electronic Patient Records

Clinical Judgment Revisited

1999 ◽  
Vol 38 (04/05) ◽  
pp. 279-286 ◽  
Author(s):  
L. L. Weed
Keyword(s):  
Decision Making ◽  
Medical Practice ◽  
Clinical Judgment ◽  
Medical Information ◽  
Patient Records ◽  
Practice Of Medicine ◽  
The Way

AbstractIt is widely recognised that accessing and processing medical information in libraries and patient records is a burden beyond the capacities of the physician’s unaided mind in the conditions of medical practice. Physicians are quite capable of tremendous intellectual feats but cannot possibly do it all. The way ahead requires the development of a framework in which the brilliant pieces of understanding are routinely assembled into a working unit of social machinery that is coherent and as error free as possible – a challenge in which we ourselves are among the working parts to be organized and brought under control.Such a framework of intellectual rigor and discipline in the practice of medicine can only be achieved if knowledge is embedded in tools; the system requiring the routine use of those tools in all decision making by both providers and patients.

Postmarketing Surveillance Based on Electronic Patient Records: The IPCI Project

1999 ◽  
Vol 38 (04/05) ◽  
pp. 339-344 ◽  
Author(s):  
J. van der Lei ◽  
B. M. Th. Mosseveld ◽  
M. A. M. van Wijk ◽  
P. D. van der Linden ◽  
M. C. J. M. Sturkenboom ◽  
...  
Keyword(s):  
General Practitioner ◽  
General Practitioners ◽  
Validation Studies ◽  
Resource Planning ◽  
Routine Practice ◽  
Patient Records ◽  
Postmarketing Surveillance ◽  
Electronic Patient Records ◽  
Use Of Data ◽  
Data Requirements

AbstractResearchers claim that data in electronic patient records can be used for a variety of purposes including individual patient care, management, and resource planning for scientific research. Our objective in the project Integrated Primary Care Information (IPCI) was to assess whether the electronic patient records of Dutch general practitioners contain sufficient data to perform studies in the area of postmarketing surveillance studies. We determined the data requirements for postmarketing surveil-lance studies, implemented additional software in the electronic patient records of the general practitioner, developed an organization to monitor the use of data, and performed validation studies to test the quality of the data. Analysis of the data requirements showed that additional software had to be installed to collect data that is not recorded in routine practice. To avoid having to obtain informed consent from each enrolled patient, we developed IPCI as a semianonymous system: both patients and participating general practitioners are anonymous for the researchers. Under specific circumstances, the researcher can contact indirectly (through a trusted third party) the physician that made the data available. Only the treating general practitioner is able to decode the identity of his patients. A Board of Supervisors predominantly consisting of participating general practitioners monitors the use of data. Validation studies show the data can be used for postmarketing surveillance. With additional software to collect data not normally recorded in routine practice, data from electronic patient record of general practitioners can be used for postmarketing surveillance.

scholarly journals Comparison of adherence between fixed and unfixed topical combination glaucoma therapies using Japanese healthcare/pharmacy claims database: a retrospective non-interventional cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chikako Shirai ◽  
Nobushige Matsuoka ◽  
Toru Nakazawa
Keyword(s):  
Cohort Study ◽  
Real World ◽  
Fixed Combination ◽  
Japanese Patients ◽  
Eye Drops ◽  
Combination Therapies ◽  
Real World Data ◽  
Healthcare Database ◽  
Pharmacy Claims ◽  
Persistence Rate

Abstract Background Adherence to chronic therapies is crucial to prevent the progression of disease, such as glaucoma. However, only a limited number of studies have investigated them using real-world data in Japan. This study aimed to evaluate Japanese patients’ adherence to fixed- and unfixed-combination eye drops as a second-line therapy for glaucoma in real-world practice. Methods This retrospective, non-interventional cohort study utilized a commercially available Japanese healthcare database (MinaCare database). Medical/pharmacy claims data were collected from 2011 to 2016. The primary endpoint was adherence to medications, assessed by proportion of days covered (PDC) with medication during a 12-month post-index period. Meanwhile, the secondary endpoints included the persistence rate. Results A total of 738 patients were included in this study: 309 and 329 in the fixed- and unfixed-combination cohorts, respectively. Prostaglandin analog (PG)/β-blocker (BB) was most commonly claimed in 241/309 (78.0%) patients in the fixed-combination cohort. In the unfixed-combination cohort, PG and BB were claimed in 130/329 (39.5%) patients, whereas PG and α2-agonist were claimed in 87/329 (26.4%) patients. Patients were more adherent to the fixed-combination than the unfixed-combinations (mean PDCs [SD], 79.1% [32.1] vs. 62.2% [38.0]; P < 0.0001). The proportion of patients with good adherence (PDC ≥ 80%) was also higher in the fixed-combination cohort (69.6%) than in the unfixed-combination cohort (48.6%) (P < 0.0001). During the 12-month post-index period, the persistence rate was higher in the fixed-combination cohort than in the unfixed-combination cohort (47.6% [95% confidence intervals (CI): 41.9–53.0] vs. 24.9% [95% CI: 20.4–29.7], P < 0.0001). Conclusions Japanese patients with glaucoma preferred the fixed-combination therapies over the unfixed-combination therapies. Hence, fixed-combination therapies would contribute to the improvement of adherence.

scholarly journals Electronic patient record and its effects on social aspects of interprofessional collaboration and clinical workflows in hospitals (eCoCo): a mixed methods study protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marina Beckmann ◽  
Kerstin Dittmer ◽  
Julia Jaschke ◽  
Ute Karbach ◽  
Juliane Köberlein-Neu ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Services ◽  
Healthcare Professionals ◽  
Social Research ◽  
Interprofessional Collaboration ◽  
Participant Observation ◽  
Patient Records ◽  
Electronic Patient Records ◽  
Daily Work ◽  
Network Analyses

Abstract Background The need for and usage of electronic patient records within hospitals has steadily increased over the last decade for economic reasons as well as the proceeding digitalization. While there are numerous benefits from this system, the potential risks of using electronic patient records for hospitals, patients and healthcare professionals must also be discussed. There is a lack in research, particularly regarding effects on healthcare professionals and their daily work in health services. The study eCoCo aims to gain insight into changes in interprofessional collaboration and clinical workflows resulting from introducing electronic patient records. Methods eCoCo is a multi-center case study integrating mixed methods from qualitative and quantitative social research. The case studies include three hospitals that undergo the process of introducing electronic patient records. Data are collected before and after the introduction of electronic patient records using participant observation, interviews, focus groups, time measurement, patient and employee questionnaires and a questionnaire to measure the level of digitalization. Furthermore, documents (patient records) as well as structural and administrative data are gathered. To analyze the interprofessional collaboration qualitative network analyses, reconstructive-hermeneutic analyses and document analyses are conducted. The workflow analyses, patient and employee assessment analyses and classification within the clinical adoption meta-model are conducted to provide insights into clinical workflows. Discussion This study will be the first to investigate the effects of introducing electronic patient records on interprofessional collaboration and clinical workflows from the perspective of healthcare professionals. Thereby, it will consider patients’ safety, legal and ethical concerns and quality of care. The results will help to understand the organization and thereby improve the performance of health services working with electronic patient records. Trial registration The study was registered at the German clinical trials register (DRKS00023343, Pre-Results) on November 17, 2020.

Mycoplasma genitalium: test positivity in syndromic presentations and clinicians’ adherence with treatment guidelines at Sydney Sexual Health Centre

2021 ◽  
pp. 095646242110225
Author(s):  
Calvin Cheung ◽  
Christopher Bourne ◽  
Rick Varma
Keyword(s):  
Decision Making ◽  
Antimicrobial Resistance ◽  
Sexual Health ◽  
Treatment Guidelines ◽  
Health Centre ◽  
Diagnostic Testing ◽  
Mycoplasma Genitalium ◽  
Macrolide Resistance ◽  
Adherence To Treatment ◽  
Real World Data

Mycoplasma genitalium ( M.genitalium) is associated with urethritis, cervicitis, pelvic inflammatory disease, proctitis and epididymitis. Its treatment is complicated by antimicrobial resistance. To assess clinicians’ adherence to M.genitalium diagnostic testing recommendations for syndromic presentations, as well as resistance-guided management of M.genitalium at Sydney Sexual Health Centre, we reviewed patients presenting between August and December 2018. 349/372 (94%) syndromic presentations were tested for M.genitalium with 16% M.genitalium test positivity and 81% macrolide resistance. 16/27 (59%) macrolide-sensitive infections and 65/77 (84%) macrolide-resistant infections received resistance-guided treatment. Tests of cure (TOCs) were unnecessarily ordered for 82% macrolide-sensitive cases, while 88% macrolide-resistant cases were correctly ordered TOCs. Co-existing STIs at the time of macrolide-sensitive ( p = 0.30) or macrolide-resistant M.genitalium ( p = 0.94) diagnosis did not significantly affect adherence to treatment guidelines. This study confirms the expected prevalence of M.genitalium and macrolide resistance in syndromic presentations while our real-world data highlight the decision-making challenges involved with managing M.genitalium, offering insights for further research.

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