Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.
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SUBMITTER: Kohler M
PROVIDER: S-EPMC4353284 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundClinical trials are one of the most important sources of evidence for guiding evidence-based practice and the design of new trials. However, most of this information is available only in free text - e.g., in journal publications - which is labour intensive to process for systematic reviews, meta-analyses, and other evidence synthesis studies. This paper presents an automatic information extraction system, called ExaCT, that assists users with locating and extracting key trial characteristics (e.g., eligibility criteria, sample size, drug dosage, primary outcomes) from full-text journal articles reporting on randomized controlled trials (RCTs).MethodsExaCT consists of two parts: an information extraction (IE) engine that searches the article for text fragments that best describe the trial characteristics, and a web browser-based user interface that allows human reviewers to assess and modify the suggested selections. The IE engine uses a statistical text classifier to locate those sentences that have the highest probability of describing a trial characteristic. Then, the IE engine's second stage applies simple rules to these sentences to extract text fragments containing the target answer. The same approach is used for all 21 trial characteristics selected for this study.ResultsWe evaluated ExaCT using 50 previously unseen articles describing RCTs. The text classifier (first stage) was able to recover 88% of relevant sentences among its top five candidates (top5 recall) with the topmost candidate being relevant in 80% of cases (top1 precision). Precision and recall of the extraction rules (second stage) were 93% and 91%, respectively. Together, the two stages of the extraction engine were able to provide (partially) correct solutions in 992 out of 1050 test tasks (94%), with a majority of these (696) representing fully correct and complete answers.ConclusionsOur experiments confirmed the applicability and efficacy of ExaCT. Furthermore, they demonstrated that combining a statistical method with 'weak' extraction rules can identify a variety of study characteristics. The system is flexible and can be extended to handle other characteristics and document types (e.g., study protocols).
| S-EPMC2954855 | biostudies-literature
Project description:ObjectiveTo expand an emerging classification for problems with health information technology (HIT) using reports submitted to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.DesignHIT events submitted to MAUDE were retrieved using a standardized search strategy. Using an emerging classification with 32 categories of HIT problems, a subset of relevant events were iteratively analyzed to identify new categories. Two coders then independently classified the remaining events into one or more categories. Free-text descriptions were analyzed to identify the consequences of events.MeasurementsDescriptive statistics by number of reported problems per category and by consequence; inter-rater reliability analysis using the ? statistic for the major categories and consequences.ResultsA search of 899?768 reports from January 2008 to July 2010 yielded 1100 reports about HIT. After removing duplicate and unrelated reports, 678 reports describing 436 events remained. The authors identified four new categories to describe problems with software functionality, system configuration, interface with devices, and network configuration; the authors' classification with 32 categories of HIT problems was expanded by the addition of these four categories. Examination of the 436 events revealed 712 problems, 96% were machine-related, and 4% were problems at the human-computer interface. Almost half (46%) of the events related to hazardous circumstances. Of the 46 events (11%) associated with patient harm, four deaths were linked to HIT problems (0.9% of 436 events).ConclusionsOnly 0.1% of the MAUDE reports searched were related to HIT. Nevertheless, Food and Drug Administration reports did prove to be a useful new source of information about the nature of software problems and their safety implications with potential to inform strategies for safe design and implementation.
| S-EPMC3240763 | biostudies-literature
Project description:BACKGROUND:No study has looked at differences of pooled estimates-such as meta-analyses-of corresponding study documents of the same intervention. In this study, we compared meta-analyses of human papillomavirus (HPV) vaccine trial data from clinical study reports with trial data from corresponding trial register entries and journal publications. METHODS:We obtained clinical study reports from the European Medicines Agency and GlaxoSmithKline, corresponding trial register entries from ClinicalTrials.gov and corresponding journal publications via the Cochrane Collaboration's Central Register of Controlled Trials, Google Scholar and PubMed. Two researchers extracted data. We compared reporting of trial design aspects and 20 prespecified benefit and harm outcomes extracted from each study document type. Risk ratios were calculated with the random effects inverse variance method. RESULTS:We included study documents from 22 randomized clinical trials and 2 follow-up studies with 95,670 healthy participants and non-HPV vaccine comparators (placebo, HPV vaccine adjuvants and hepatitis vaccines). We obtained 24 clinical study reports, 24 corresponding trial register entries and 23 corresponding journal publications; the median number of pages was 1351 (range 357 to 11,456), 32 (range 11 to 167) and 11 (range 7 to 83), respectively. All 24 (100%) clinical study reports, no (0%) trial register entries and 9 (39%) journal publications reported on all six major design-related biases defined by the Cochrane Handbook version 2011. The clinical study reports reported more inclusion criteria (mean 7.0 vs. 5.8 [trial register entries] and 4.0 [journal publications]) and exclusion criteria (mean 17.8 vs. 11.7 and 5.0) but fewer primary outcomes (mean 1.6 vs. 3.5 and 1.2) and secondary outcomes (mean 8.8 vs. 13.0 and 3.2) than the trial register entries. Results were posted for 19 trial register entries (79%). Compared to the clinical study reports, the trial register entries and journal publications contained 3% and 44% of the seven assessed benefit data points (6879 vs. 230 and 3015) and 38% and 31% of the 13 assessed harm data points (167,550 vs. 64,143 and 51,899). No meta-analysis estimate differed significantly when we compared pooled risk ratio estimates of corresponding study document data as ratios of relative risk. CONCLUSION:There were no significant differences in the meta-analysis estimates of the assessed outcomes from corresponding study documents. The clinical study reports were the superior study documents in terms of the quantity and the quality of the data they contained and should be used as primary data sources in systematic reviews. SYSTEMATIC REVIEW REGISTRATION:The protocol for our comparison is registered on PROSPERO as an addendum to our systematic review of the benefits and harms of the HPV vaccines: https://www.crd.york.ac.uk/PROSPEROFILES/56093_PROTOCOL_20180320.pdf: CRD42017056093. Our systematic review protocol was registered on PROSPERO on January 2017: https://www.crd.york.ac.uk/PROSPEROFILES/56093_PROTOCOL_20170030.pdf. Two protocol amendments were registered on PROSPERO on November 2017: https://www.crd.york.ac.uk/PROSPEROFILES/56093_PROTOCOL_20171116.pdf. Our index of the HPV vaccine studies was published in Systematic Reviews on January 2018: https://doi.org/10.1186/s13643-018-0675-z. A description of the challenges obtaining the data was published on September 2018: https://doi.org/10.1136/bmj.k3694.
| S-EPMC7047365 | biostudies-literature
Project description:BackgroundThe contribution of usability flaws to patient safety issues is acknowledged but not well-investigated. Free-text descriptions of incident reports may provide useful data to identify the connection between health information technology (HIT) usability flaws and patient safety.ObjectivesThis article examines the feasibility of using incident reports about HIT to learn about the usability flaws that affect patient safety. We posed three questions: (1) To what extent can we gain knowledge about usability issues from incident reports? (2) What types of usability flaws, related usage problems, and negative outcomes are reported in incidents reports? (3) What are the reported usability issues that give rise to patient safety issues?MethodsA sample of 359 reports from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database was examined. Descriptions of usability flaws, usage problems, and negative outcomes were extracted and categorized. A supplementary analysis was performed on the incidents which contained the full chain going from a usability flaw up to a patient safety issue to identify the usability issues that gave rise to patient safety incidents.ResultsA total of 249 reports were included. We found that incident reports can provide knowledge about usability flaws, usage problems, and negative outcomes. Thirty-six incidents report how usability flaws affected patient safety (ranging from incidents without consequence, to death) involving electronic patient scales, imaging systems, and HIT for medication management. The most significant class of involved usability flaws is related to the reliability, the understandability, and the availability of the clinical information.ConclusionIncidents reports involving HIT are an exploitable source of information to learn about usability flaws and their effects on patient safety. Results can be used to convince all stakeholders involved in the HIT system lifecycle that usability should be considered seriously to prevent patient safety incidents.
| S-EPMC6561760 | biostudies-literature
Project description:Introduction: Generic entry is a well-known driver of competition and cost containment. Objectives: We aim to measure the market exclusivity of originator drugs and to determine what influences the entry of generics in South Korea. Methods: A list of originator drugs approved by the authority from 2000 to 2013 and their corresponding generics were paired. An event history model was applied for a statistical estimation for the duration until generic entry and to identify abbreviating or prolonging factors on the duration. Results: A total of 2,061 pairs of originator and generics were identified. The market exclusivity for the originator drugs, including NDAs and non-NDAs, has not notably changed. However, competition among non-NDAs was less common than we expected. We found delayed time to entry of generics in the long run, particularly for non-NDAs in injection forms and biologics, and this finding is partially associated with market attractiveness. Conclusion: The authority should address the delayed availability of certain types of generic drugs. The government could provide information on off-patent pharmaceuticals with no generic competition, designate their corresponding submissions as prioritized in the review process, and provide additional market exclusivity when entering the market via a long period of exclusivity.
| S-EPMC8056004 | biostudies-literature
Project description:Rationale and objectivesAssess the impact of implementing a structured report template and a computer-aided diagnosis (CAD) tool on the quality of prostate multiparametric magnetic resonance imaging (mp-MRI) reports.Materials and methodsInstitutional Review Board approval was obtained for this Health Insurance Portability and Accountability Act-compliant study performed at an academic medical center. The study cohort included all prostate mp-MRI reports (n = 385) finalized 6 months before and after implementation of a structured report template and a CAD tool (collectively the information technology [IT] tools) integrated into the picture archiving and communication system workstation. Primary outcome measure was quality of prostate mp-MRI reports. An expert panel of our institution's subspecialty-trained abdominal radiologists defined prostate mp-MRI report quality as optimal, satisfactory, or unsatisfactory based on documentation of nine variables. Reports were reviewed to extract the predefined quality variables and determine whether the IT tools were used to create each report. Chi-square and Student's t tests were used to compare report quality before and after implementation of IT tools.ResultsThe overall proportion of optimal or satisfactory reports increased from 29.8% (47/158) to 53.3% (121/227) (P < .001) after implementing the IT tools. Although the proportion of optimal or satisfactory reports increased among reports generated using at least one of the IT tools (47/158 = [29.8%] vs. 105/161 = [65.2%]; P < .001), there was no change in quality among reports generated without use of the IT tools (47/158 = [29.8%] vs. 16/66 = [24.2%]; P = .404).ConclusionsThe use of a structured template and CAD tool improved the quality of prostate mp-MRI reports compared to free-text report format and subjective measurement of contrast enhancement kinetic curve.
| S-EPMC4589255 | biostudies-literature
Project description:Mini-Abstract ChatGPT is an artificial intelligence (AI) technology that has begun to transform academics through its ability to create human-like text. This has raised ethical concerns about its assistance in writing scientific literature. Our aim is to highlight the benefits and risks that this technology may pose to the surgical field.
| S-EPMC10513298 | biostudies-literature
Project description:This paper uses newly available data from Web of Science on publications matched to researchers in Survey of Doctorate Recipients to compare the quality of scientific publication data collected by surveys versus algorithmic approaches. We illustrate the different types of measurement errors in self-reported and machine-generated data by estimating how publication measures from the two approaches are related to career outcomes (e.g., salaries and faculty rankings). We find that the potential biases in the self-reports are smaller relative to the algorithmic data. Moreover, the errors in the two approaches are quite intuitive: the measurement errors in algorithmic data are mainly due to the accuracy of matching, which primarily depends on the frequency of names and the data that was available to make matches, while the noise in self reports increases over the career as researchers' publication records become more complex, harder to recall, and less immediately relevant for career progress. At a methodological level, we show how the approaches can be evaluated using accepted statistical methods without gold standard data. We also provide guidance on how to use the new linked data.
| S-EPMC8480886 | biostudies-literature
Project description:BackgroundHealth information technology (HIT) certification and meaningful use are interventions encouraging the adoption of electronic health records (EHRs) in the USA. However, these initiatives also constitute a significant intervention which will change the structure of the EHR market.ObjectiveTo describe quantitatively recent changes to both the demand and supply sides of the EHR market.Materials and methodsA cohort of 3447 of hospitals from the HIMSS Analytics Database (2006-10) was created. Using hospital referral regions to define the local market, we determined the percentage of hospitals using paper records, the number of vendors, and local EHR vendor competition using the Herfindahl-Hirschman Index. Changes over time were assessed using a series of regression equations and geographic information systems analyses.ResultsOverall, there was movement away from paper records, upward trends in the number of EHR vendors, and greater competition. However, changes differed according to hospital size and region of the country. Changes were greatest for small hospitals, whereas competition and the number of vendors did not change dramatically for large hospitals.DiscussionThe EHR market is changing most dramatically for those least equipped to handle broad technological transformation, which underscores the need for continued targeted support. Furthermore, wide variations across the nation indicate a continued role for states in the support of EHR utilization.ConclusionThe structure of the EHR market is undergoing substantial changes as desired by the proponents and architects of HIT certification and meaningful use. However, these transformations are not uniform for all hospitals or all the country.
| S-EPMC3638173 | biostudies-literature
Project description:BackgroundAs production of rapid reviews (RRs) increases in healthcare, knowing how to efficiently convey RR evidence to various end-users is important given they are often intended to directly inform decision-making. Little is known about how often RRs are produced in the published or unpublished domains, and what and how information is structured.ObjectivesTo compare and contrast report format and content features of journal-published (JP) and non-journal published (NJP) RRs.MethodsJP RRs were identified from key databases, and NJP RRs were identified from a grey literature search of 148 RR producing organizations and were sampled proportionate to cluster size by organization and product type to match the JP RR group. We extracted and formally compared 'how' (i.e., visual arrangement) and 'what' information was presented.ResultsWe identified 103 RRs (52 JP and 51 NJP) from 2016. A higher percentage of certain features were observed in JP RRs compared to NJP RRs (e.g., reporting authors; use of a traditional journal article structure; section headers including abstract, methods, discussion, conclusions, acknowledgments, conflict of interests, and author contributions; and use of figures (e.g., Study Flow Diagram) in the main document). For NJP RRs, a higher percentage of features were observed (e.g., use non-traditional report structures; bannering of executive summary sections and appendices; use of typographic cues; and including outcome tables). NJP RRs were more than double in length versus JP RRs. Including key messages was uncommon in both groups.ConclusionsThis comparative study highlights differences between JP and NJP RRs. Both groups may benefit from better use of plain language, and more clear and concise design. Alternative innovative formats and end-user preferences for content and layout should be studied further with thought given to other considerations to ensure better packaging of RR results to facilitate uptake into policy and practice.Study registrationThe full protocol is available at: https://osf.io/29xvk/.
| S-EPMC7449464 | biostudies-literature