Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005

OBJECTIVE: To investigate the distribution, design characteristics, and dissemination of clinical trials by funding organisation and medical specialty. DESIGN: Cross sectional descriptive analysis. DATA SOURCES: Trial protocol information from clinicaltrials.gov, metadata of journal articles in which trial results were published (PubMed), and quality metrics of associated journals from SCImago Journal and Country Rank database. SELECTION CRITERIA: All 45 620 clinical trials evaluating small molecule therapeutics, biological drugs, adjuvants, and vaccines, completed after January 2006 and before July 2015, including randomised controlled trials and non-randomised studies across all clinical phases. RESULTS: Industry was more likely than non-profit funders to fund large international randomised controlled trials, although methodological differences have been decreasing with time. Among 27 835 completed efficacy trials (phase II-IV), 15 084 (54.2%) had disclosed their findings publicly. Industry was more likely than non-profit trial funders to disseminate trial results (59.3% (10 444/17 627) v 45.3% (4555/10 066)), and large drug companies had higher disclosure rates than small ones (66.7% (7681/11 508) v 45.2% (2763/6119)). Trials funded by the National Institutes of Health (NIH) were disseminated more often than those of other non-profit institutions (60.0% (1451/2417) v 40.6% (3104/7649)). Results of studies funded by large drug companies and NIH were more likely to appear on clinicaltrials.gov than were those from non-profit funders, which were published mainly as journal articles. Trials reporting the use of randomisation were more likely than non-randomised studies to be published in a journal article (6895/19 711 (34.9%) v 1408/7748 (18.2%)), and journal publication rates varied across disease areas, ranging from 42% for autoimmune diseases to 20% for oncology. CONCLUSIONS: Trial design and dissemination of results vary substantially depending on the type and size of funding institution as well as the disease area under study

Patient recruitment, feasibility evaluations and use of electronic health records in clinical trials - A Nordic approach

Clinical trials constitute an important cornerstone for the development of new drugs. Patient recruitment is one of the main challenges in clinical trials. Pharmaceutical companies apply feasibility evaluations to identify potential countries, investigators and study sites for their trials and to evaluate their potential for successful patient recruitment. Electronic health records (EHR) maintained by health care providers are regarded as one potential tool for improving patient identification and recruitment for clinical trials. This study investigated patient recruitment and trial feasibility evaluations in the Nordic countries and the role and usability of EHR data in those processes. The pharmaceutical industry’s view was investigated by conducting semi-structured qualitative interviews of 21 respondents from Finland, Sweden, Norway and Denmark. Additionally, the usability of one commercial EHR research platform for identifying patients from Turku University Hospital’s EHR system was tested in comparison with a manual search. The success or failure of patient recruitment was influenced by many sponsorrelated, investigator/site-related, patient-related, collaboration-related and start-uprelated factors. Most trials had recruited their patients by reviewing the hospitals’ EHR data, but its use was much less frequent already during the feasibility evaluation phase. Feasibility evaluation was found to be a complex and time-consuming process for estimating the number of potential trial patients. The sponsors did not use HER tools for such evaluations, mainly because of legislative barriers. Although the HER data search tools have limitations in accuracy, they were seen to have great potential for identifying trial participants from the hospital EHR, for example by reducing the manual work. The comprehensive data in the EHR systems in the Nordic countries offer a possibility for more accurate identification of trial participants in the feasibility evaluations and may thus contribute to the success of recruitment. The data protection legislation and its interpretation should be harmonized for the use of EHR data. Continuous improvements in the EHR systems’ technical accuracy and data quality will be needed to enhance the successful use of EHR data in future clinical trials.Potilasrekrytointi, toteutettavuuden arviointi ja elektronisten potilastietojärjestelmien hyödyntäminen kliinisissä tutkimuksissa – Pohjoismainen näkökulma Kliiniset lääketutkimukset ovat uusien lääkkeiden kehityksen kulmakivi. Tutkimuspotilaiden rekrytointi on merkittävä haaste näissä tutkimuksissa. Lääkeyritykset tekevät toteutettavuusarviointeja tunnistaakseen potentiaalisia tutkimukseen osallistuvia maita, tutkijoita ja tutkimuskeskuksia ja arvioidakseen niiden mahdollisuuksia onnistua potilaiden rekrytoinnissa. Terveydenhuolto-organisaatioiden ylläpitämät elektroniset potilastietojärjestelmät (EHR) ovat tässä eräs mahdollinen työkalu. Tässä tutkimuksessa tutkittiin potilaiden rekrytointia ja tutkimusten toteutettavuusarviointeja Pohjoismaissa ja EHR:n roolia ja käytettävyyttä näissä prosesseissa. Näitä tekijöitä tekijöitä tutkittiin lääketeollisuuden näkökulmasta laadullisilla teemahaastatteluilla (21 haastateltavaa Suomesta, Ruotsista, Norjasta ja Tanskasta). Yhden kaupallisesti saatavilla olevan EHR-hakutyökalun tarkkuutta halutun potilasjoukon löytämisessä verrattiin perinteiseen, manuaaliseen hakuun Turun yliopistollisen sairaalan potilastietojärjestelmästä. Potilaiden rekrytoinnin onnistumiseen tai epäonnistumiseen vaikutti moni toimeksiantajaan, tutkijaan/tutkimuskeskukseen, potilaaseen ja tutkimuksen aloitustoimenpiteisiin liittyvä tekijä sekä näiden tahojen yhteistyö. Valtaosassa tutkimuksista tutkittavat rekrytoitiin keskuksen omista potilaista EHR:a hyödyntäen, mutta EHR:n käyttö potilasmäärän arvioinnissa ennen tutkimuksen alkua oli vähäistä. Toteutettavuusarvioinneissa tehdyt potilasmäärien arviot nähtiin monimutkaisina ja aikaa vievinä prosesseina. Toimeksiantajat eivät käyttäneet EHRtyökaluja lainkaan, pääasiassa tietosuojalainsäädäntöön liittyvistä syistä. Vaikka EHR-hakutyökalujen tarkkuudella on rajoitteensa, niitä voidaan hyödyntää esimerkiksi vähentämään manuaalista työtä potilaiden identifioinnissa. Terveydenhuollon kattavat EHR-järjestelmät tarjoavat Pohjoismaissa hyvän mahdollisuuden tutkimuspotilaiden tarkempaan identifiointiin, joka omalta osaltaan vaikuttaa rekrytoinnin onnistumismahdollisuuksiin. Tietosuojalainsäädäntöä ja sen tulkintoja on harmonisoitava EHR:n käytön hyödyntämiseksi. EHR-hakujen teknistä tarkkuutta ja tiedon laatua on edelleen parannettava sen menestyksekkään käytön lisäämiseksi tulevaisuuden kliinisissä tutkimuksissa

Closed-World Semantics for Query Answering in Temporal Description Logics

Ontology-mediated query answering is a popular paradigm for enriching answers to user queries with background knowledge. For querying the absence of information, however, there exist only few ontology-based approaches. Moreover, these proposals conflate the closed-domain and closed-world assumption, and therefore are not suited to deal with the anonymous objects that are common in ontological reasoning. Many real-world applications, like processing electronic health records (EHRs), also contain a temporal dimension, and require efficient reasoning algorithms. Moreover, since medical data is not recorded on a regular basis, reasoners must deal with sparse data with potentially large temporal gaps. Our contribution consists of three main parts: Firstly, we introduce a new closed-world semantics for answering conjunctive queries with negation over ontologies formulated in the description logic ELH⊥, which is based on the minimal universal model. We propose a rewriting strategy for dealing with negated query atoms, which shows that query answering is possible in polynomial time in data complexity. Secondly, we introduce a new temporal variant of ELH⊥ that features a convexity operator. We extend this minimal-world semantics for answering metric temporal conjunctive queries with negation over the logic and obtain similar rewritability and complexity results. Thirdly, apart from the theoretical results, we evaluate minimal-world semantics in practice by selecting patients, based their EHRs, that match given criteria

Small Construction Business Owners’ Strategies to Reduce Voluntary Employee Turnover.

Voluntary employee turnover has caused considerable damage to small construction businesses, significantly affecting productivity, profitability, and sustainability. Small construction business owners who lack strategies to reduce voluntary employee turnover may lose experience and valuable knowledge among their employees, negatively impacting the team’s ability to perform. Grounded in the job embeddedness theory, the purpose of this qualitative multiple case study was to explore strategies small construction business owners use to reduce voluntary employee turnover. Participants were four successful small construction business owners in Virginia who successfully implemented strategies that reduced voluntary employee turnover by 75% over 5 years. Data were collected from company documents and semistructured interviews and analyzed using Yin’s five-phase analysis technique. The three themes that emerged were effective human resource management, favorable working conditions, and employee engagement. A key recommendation for small construction business owners is to incorporate a competitive enumeration strategy. The implications for positive social change include the potential to encourage employees to participate in volunteering in local communities’ infrastructure development

Employee Engagement Strategies Call Center Managers Use to Increase Productivity and Profitability

AbstractDecreased employee productivity can result in reduced organizational profitability. Call center leaders are concerned with decreased productivity as it cost call center leaders millions of dollars each year in profit loss. Grounded in leader-member exchange theory, the purpose of this basic qualitative study was to learn the employee engagement strategies nine call center managers in five different industries used to improve productivity in call centers. Data were collected using semi-structured interviews and review of company documents that included process improvement guides and publicly posted annual reports. The three themes that emerged from the thematic analysis were developing relationships, effective communication, and performance management. A key recommendation for call center leaders implementing employee engagement strategies to promote healthy exchange relationships. The implication for positive change is engaged employees could increase their support in community activities such as literacy programs, green initiatives, and tutoring programs