Related Articles

Summary

Quality of life (QOL) has become a widely used outcome parameter in the evaluation of treatment modalities in clinical oncology research. By now, many of the practical problems associated with measuring QOL in clinical practice can be overcome by the use of computer-based assessment methods. QOL assessment in oncology is dominated by two measurement systems, the FACT scales and the EORTC QLQ-C30 with its modules. The amount of human resources required to implement routine data collection has been reduced significantly by advanced computer technology allowing data collection in busy clinical practice. Monitoring of QOL can contribute to oncologic care by facilitating detection of physical and psychological problems and tracking the course of disease and treatment over time. Furthermore, the integration of screening for psychosocial problems into QOL monitoring contributes to the identification of patients who are in need of psychooncologic interventions. Computer-based QOL monitoring does not replace the direct physician-patient communication but enables to identify specific impairments and symptoms including psychological problems. Beyond clinical practice, QOL data can be used for research purposes and may help health care planners to determine those patient services that should be maintained or ones that should be developed.

We have implemented a survey tool to collect patient-entered Quality of Life (QoL) and symptomology data for clinician use in an outpatient cancer treatment center. The system is currently implemented using a web infrastructure and delivered to patients in the waiting room via wireless laptops. The software assesses and records patient consent, delivers survey questions and records answers, and summarizes the results for clinical use in the during the patient's visit. Optionally, the data are recorded in a research database. The infrastructure can be expanded to support generalized survey delivery for future clinical and research purposes. (MESH: Internet, Data Collection, Quality of Life, Information Systems, Patient Participation, Data Display)

This report, based on a workshop jointly sponsored the National Institute of Biomedical Imaging and Biomedical Engineering and the Office of the National Coordinator for Health Information Technology, examines the role and value of images as multimedia data in electronic health records (EHRs). The workshop, attended by a wide range of stakeholders, was motivated in part by the absence of image data from discussions of meaningful use of health information technology. Collectively, the workshop presenters and participants argued that images are not ancillary data and should be central to health information systems to facilitate clinical decisions and higher quality, efficiency, and safety of care. They emphasized that the imaging community has already developed standards that form the basis of interoperability. Despite the apparent value of images, workshop participants also identified challenges and barriers to their implementation within EHRs. Weighing the opportunities and challenges, workshop participants provided their perspectives on possible paths forward toward fully multimedia EHRs.

Objective

This 3-year field experiment engaged 60 nurses and 282 patients in the design and evaluation of an innovative home care nursing model, technology enhanced practice (TEP).

Method

Nurses in the TEP conditions augmented usual care with a web-based resource (HeartCareII) that provided patients with self-management information, self-monitoring tools, and messaging services.

Results

Patients exposed to TEP demonstrated better quality of life and self-management of chronic heart disease during the first four weeks and were no more likely than patients in usual care to make unplanned visits to a clinician or the hospital. Both groups demonstrated the same long term symptom management and health status achievements.

Conclusion

This project provides new evidence that it is possible to purposefully create patient-tailored web resources within a hospital portal; that it is hard for nurses to modify their practice routines even with a highly-tailored web resource, and that the benefits of this intervention are more discernable in the early post-discharge stages of care.

Background

Information technology (IT) support for remote collaboration of geographically distributed communities of practice (CoP) in health care must deal with a number of sociotechnical aspects of communication within the community. In the mid-1990s, participants of the Swedish Oral Medicine Network (SOMNet) began discussing patient cases in telephone conferences. The cases were distributed prior to the conferences using PowerPoint and email. For the technical support of online CoP, Semantic Web technologies can potentially fulfill needs of knowledge reuse, data exchange, and reasoning based on ontologies. However, more research is needed on the use of Semantic Web technologies in practice.

Objectives

The objectives of this research were to (1) study the communication of distributed health care professionals in oral medicine; (2) apply Semantic Web technologies to describe community data and oral medicine knowledge; (3) develop an online CoP, Swedish Oral Medicine Web (SOMWeb), centered on user-contributed case descriptions and meetings; and (4) evaluate SOMWeb and study how work practices change with IT support.

Methods

Based on Java, and using the Web Ontology Language and Resource Description Framework for handling community data and oral medicine knowledge, SOMWeb was developed using a user-centered and iterative approach. For studying the work practices and evaluating the system, a mixed-method approach of interviews, observations, and a questionnaire was used.

Results

By May 2008, there were 90 registered users of SOMWeb, 93 cases had been added, and 18 meetings had utilized the system. The introduction of SOMWeb has improved the structure of meetings and their discussions, and a tenfold increase in the number of participants has been observed. Users submit cases to seek advice on diagnosis or treatment, to show an unusual case, or to create discussion. Identified barriers to submitting cases are lack of time, concern about whether the case is interesting enough, and showing gaps in one’s own knowledge. Three levels of member participation are discernable: a core group that contributes most cases and most meeting feedback; an active group that participates often but only sometimes contribute cases and feedback; and a large peripheral group that seldom or never contribute cases or feedback.

Conclusions

SOMWeb is beneficial for individual clinicians as well as for the SOMNet community. The system provides an opportunity for its members to share both high quality clinical practice knowledge and external evidence related to complex oral medicine cases. The foundation in Semantic Web technologies enables formalization and structuring of case data that can be used for further reasoning and research. Main success factors are the long history of collaboration between different disciplines, the user-centered development approach, the existence of a “champion” within the field, and nontechnical community aspects already being in place.

A web-based research information system was designed to enable our research team to efficiently measure health related quality of life among frail older adults in a variety of health care settings (home care, nursing homes, assisted living, PACE). The structure, process, and outcome data is collected using laptop computers and downloaded to a SQL database. Unique features of this project are the ability to transfer research to practice by instantly sharing individual and aggregate results with the clinicians caring for these elders and directly impacting the quality of their care. Clinicians can also dial in to the database to access standard queries or receive customized reports about the patients in their facilities. This paper will describe the development and implementation of the information system. The conference presentation will include a demonstration and examples of research to practice benefits.

Objectives

There is emerging evidence for a genetic basis of patient-reported quality-of-life (QOL) outcomes that can ultimately be incorporated into clinical research and practice. Objectives are (1) to provide arguments for the timeliness of investigating the genetic basis of QOL given the scientific advances in genetics and patient-reported QOL research; (2) to describe the clinical implications of such investigations; (3) to present a theoretical foundation for investigating the genetic underpinnings of QOL; and (4) to describe a series of papers resulting from the GENEQOL Consortium that was established to move this work forward.

Methods

Discussion of scientific advances based on relevant literature.

Results

In genetics, technological advances allow for increases in speed and efficiency and decreases in costs in exploring the genetic underpinnings of disease processes, drug metabolism, treatment response, and survival. In patient-based research, advances yield empirically based and stringent approaches to measurement that are scientifically robust. Insights into the genetic basis of QOL will ultimately allow early identification of patients susceptible to QOL deficits and to target care. The Wilson and Cleary model for patient-reported outcomes was refined by incorporating the genetic underpinnings of QOL.

Conclusions

This series of papers provides a path for QOL and genetics researchers to work together to move this field forward and to unravel the intricate interplay of the genetic underpinnings of patient-reported QOL outcomes. The ultimate result will be a greater understanding of the process relating disease, patient, and doctor that will have the potential to lead to improved survival, QOL, and health services delivery.

Background

Investigators addressing nursing research are faced increasingly with the need to analyze data that involve variables of mixed types and are characterized by complex nonlinearity and interactions. Tree-based methods, also called recursive partitioning, are gaining popularity in various fields. In addition to efficiency and flexibility in handling multifaceted data, tree-based methods offer ease of interpretation.

Objectives

To introduce tree-based methods, discuss their advantages and pitfalls in application, and describe their potential use in nursing research.

Method

In this paper, (a) an introduction to tree-structured methods is presented, (b) the technique is illustrated via quality of life (QOL) data collected in the Breast Cancer Education Intervention (BCEI) study, and (c) implications for their potential use in nursing research are discussed.

Discussion

As illustrated by the QOL analysis example, tree methods generate interesting and easily understood findings that cannot be uncovered via traditional linear regression analysis. The expanding breadth and complexity of nursing research may entail the use of new tools to improve efficiency and gain new insights. In certain situations, tree-based methods offer an attractive approach that help address such needs.

Objectives

To provide an overview of research and practice related to patient-reported symptom and quality of life assessment integrated into clinical care.

Data sources

Literature retrieved through the PUBMED and CINAHL databases.

Conclusion

Assessing and incorporating patient preferences, engaging the patient in self-report and extending the interaction to the place and time favored by the patient are necessary to bring meaning to the term, patient-centered. There is beginning evidence that these approaches can make a difference, improving care quality.

Implications for nursing practice

Oncology nurses no longer need to be constrained by paper symptom checklists. Patient-reported symptom and quality of life information can be electronically collected and simultaneously made available for home and clinical use through the utilization of Web-based programs.

Background

Over the last 30 years options for collecting self-reported data in health surveys and questionnaires have increased with technological advances. However, mode of data collection such as face-to-face interview or telephone interview can affect how individuals respond to questionnaires. This paper adapts a framework for understanding mode effects on response quality and applies it to a health research context.

Discussion

Data collection modes are distinguished by key features (whether the survey is self- or interviewer-administered, whether or not it is conducted by telephone, whether or not it is computerised, whether it is presented visually or aurally). Psychological appraisal of the survey request will initially entail factors such as the cognitive burden upon the respondent as well as more general considerations about participation. Subsequent psychological response processes will further determine how features of the data collection mode impact upon the quality of response provided. Additional antecedent factors which may further interact with the response generation process are also discussed. These include features of the construct being measured such as sensitivity, and of the respondent themselves (e.g. their socio-demographic characteristics). How features of this framework relate to health research is illustrated by example.

Summary

Mode features can affect response quality. Much existing evidence has a broad social sciences research base but is of importance to health research. Approaches to managing mode feature effects are discussed. Greater consideration must be given to how features of different data collection approaches affect response from participants in studies. Study reports should better clarify such features rather than rely upon global descriptions of data collection mode.

Background

Translational medicine requires the integration of knowledge using heterogeneous data from health care to the life sciences. Here, we describe a collaborative effort to produce a prototype Translational Medicine Knowledge Base (TMKB) capable of answering questions relating to clinical practice and pharmaceutical drug discovery.

Results

We developed the Translational Medicine Ontology (TMO) as a unifying ontology to integrate chemical, genomic and proteomic data with disease, treatment, and electronic health records. We demonstrate the use of Semantic Web technologies in the integration of patient and biomedical data, and reveal how such a knowledge base can aid physicians in providing tailored patient care and facilitate the recruitment of patients into active clinical trials. Thus, patients, physicians and researchers may explore the knowledge base to better understand therapeutic options, efficacy, and mechanisms of action.

Conclusions

This work takes an important step in using Semantic Web technologies to facilitate integration of relevant, distributed, external sources and progress towards a computational platform to support personalized medicine.

Availability

TMO can be downloaded from http://code.google.com/p/translationalmedicineontology and TMKB can be accessed at http://tm.semanticscience.org/sparql.

This study examined the usefulness of caregiver ratings of cancer patients' quality of life (QOL), an issue of relevance to both adequate patient care and to the possible use of proxy QOL raters in clinical studies. We compared QOL ratings of 90 cancer patients receiving inpatient chemotherapy with those provided by their significant others (most often the spouse), physicians and nurses. During patients' scheduled appointment for receiving chemotherapy on a clinical ward, all raters completed independently the Dartmouth COOP Functional Health Assessment charts/WONCA, an instrument developed by a cooperative group of primary care physicians to briefly assess a core set of seven QOL domains (physical fitness, feelings, daily and social activities, overall health, pain and quality of life) by single items with five response options. With few exceptions, mean scores of the proxy raters were equivalent or similar to those of the patients. Most patient–proxy correlations varied between 0.40 and 0.60, indicating a moderate level of agreement at the individual level. Of all comparisons made, 41% were in exact agreement and 43% agreed within one response category, leaving 17% more profound patient–proxy discrepancies. Disagreement was not dependent on the type of proxy rater, or on raters' background characteristics, but was influenced by the QOL dimension under consideration and the clinical status of the patient. Better patient–proxy agreement was observed for more concrete questions (daily activities, pain) and for patients with either a very good (ECOG 0) or poor (ECOG 3) performance status. The results indicate that both significant others and health care providers can be useful sources of information about cancer patients' QOL. © 1999 Cancer Research Campaign

Information technology can support the implementation of clinical research findings in practice settings. Technology can address the quality gap in health care by providing automated decision support to clinicians that integrates guideline knowledge with electronic patient data to present real-time, patient-specific recommendations. However, technical success in implementing decision support systems may not translate directly into system use by clinicians. Successful technology integration into clinical work settings requires explicit attention to the organizational context. We describe the application of a “sociotechnical” approach to integration of ATHENA DSS, a decision support system for the treatment of hypertension, into geographically dispersed primary care clinics. We applied an iterative technical design in response to organizational input and obtained ongoing endorsements of the project by the organization's administrative and clinical leadership. Conscious attention to organizational context at the time of development, deployment, and maintenance of the system was associated with extensive clinician use of the system.

Effective public health practice relies on the availability of public health data sources and assessment tools to convey information to investigators, practitioners, policy makers, and the general public. Emerging communication technologies on the Internet can deliver all components of the "who, what, when, and where" quartet more quickly than ever with a potentially higher level of quality and assurance, using new analysis and visualization tools. Open-source software provides the opportunity to build low-cost information systems allowing health departments with modest resources access to modern data analysis and visualization tools. In this paper, we integrate open-source technologies and public health data to create a web information system which is accessible to a wide audience through the Internet. Our web application, "EpiVue," was tested using two public health datasets from the Washington State Cancer Registry and Washington State Center for Health Statistics. A third dataset shows the extensibility and scalability of EpiVue in displaying gender-based longevity statistics over a twenty-year interval for 3,143 United States counties. In addition to providing an integrated visualization framework, EpiVue's highly interactive web environment empowers users by allowing them to upload their own geospatial public health data in either comma-separated text files or MS Excel™ spreadsheet files and visualize the geospatial datasets with Google Maps™.

Clinical studies conducted in intensive care units are associated with logistical and ethical challenges. Diseases investigated are precipitous and life-threatening, care is highly technological, and patients are often incapacitated and decision-making is provided by surrogates. These investigations increasingly involve collection of genetic data. The manner in which the exigencies of critical illness impact attitudes regarding genetic data collection is unstudied. Given interest in understanding stakeholder preferences as a foundation for the ethical conduct of research, filling this knowledge gap is timely. The conduct of opinion research in the critical care arena is novel. This brief report describes the development of parallel patient/surrogate decision-maker quantitative survey instruments for use in this environment. Future research employing this instrument or a variant of it with diverse populations promises to inform research practices in critical illness gene variation research.

Executive Summary

In February 2010, the Medical Advisory Secretariat (MAS) began work on evidence-based reviews of the literature surrounding three pharmacogenomic tests. This project came about when Cancer Care Ontario (CCO) asked MAS to provide evidence-based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario.

Evidence-based analyses have been prepared for each of these technologies. These have been completed in conjunction with internal and external stakeholders, including a Provincial Expert Panel on Pharmacogenetics (PEPP). Within the PEPP, subgroup committees were developed for each disease area. For each technology, an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative (THETA) and is summarized within the reports.

The following reports can be publicly accessed at the MAS website at: http://www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.html

Gene Expression Profiling for Guiding Adjuvant Chemotherapy Decisions in Women with Early Breast Cancer: An Evidence-Based Analysis

Epidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: an Evidence-Based Analysis

K-RAS testing in Treatment Decisions for Advanced Colorectal Cancer: an Evidence-Based Analysis

Objective

The Medical Advisory Secretariat undertook a systematic review of the evidence on the clinical effectiveness and cost-effectiveness of epidermal growth factor receptor (EGFR) mutation testing compared with no EGFR mutation testing to predict response to tyrosine kinase inhibitors (TKIs), gefitinib (Iressa®) or erlotinib (Tarceva®) in patients with advanced non-small cell lung cancer (NSCLC).

Clinical Need: Target Population and Condition

With an estimated 7,800 new cases and 7,000 deaths last year, lung cancer is the leading cause of cancer deaths in Ontario. Those with unresectable or advanced disease are commonly treated with concurrent chemoradiation or platinum-based combination chemotherapy. Although response rates to cytotoxic chemotherapy for advanced NSCLC are approximately 30 to 40%, all patients eventually develop resistance and have a median survival of only 8 to 10 months. Treatment for refractory or relapsed disease includes single-agent treatment with docetaxel, pemetrexed or EGFR-targeting TKIs (gefitinib, erlotinib). TKIs disrupt EGFR signaling by competing with adenosine triphosphate (ATP) for the binding sites at the tyrosine kinase (TK) domain, thus inhibiting the phosphorylation and activation of EGFRs and the downstream signaling network. Gefitinib and erlotinib have been shown to be either non-inferior or superior to chemotherapy in the first- or second-line setting (gefitinib), or superior to placebo in the second- or third-line setting (erlotinib).

Certain patient characteristics (adenocarcinoma, non-smoking history, Asian ethnicity, female gender) predict for better survival benefit and response to therapy with TKIs. In addition, the current body of evidence shows that somatic mutations in the EGFR gene are the most robust biomarkers for EGFR-targeting therapy selection. Drugs used in this therapy, however, can be costly, up to C$ 2000 to C$ 3000 per month, and they have only approximately a 10% chance of benefiting unselected patients. For these reasons, the predictive value of EGFR mutation testing for TKIs in patients with advanced NSCLC needs to be determined.

The Technology: EGFR mutation testing

The EGFR gene sequencing by polymerase chain reaction (PCR) assays is the most widely used method for EGFR mutation testing. PCR assays can be performed at pathology laboratories across Ontario. According to experts in the province, sequencing is not currently done in Ontario due to lack of adequate measurement sensitivity. A variety of new methods have been introduced to increase the measurement sensitivity of the mutation assay. Some technologies such as single-stranded conformational polymorphism, denaturing high-performance liquid chromatography, and high-resolution melting analysis have the advantage of facilitating rapid mutation screening of large numbers of samples with high measurement sensitivity but require direct sequencing to confirm the identity of the detected mutations. Other techniques have been developed for the simple, but highly sensitive detection of specific EGFR mutations, such as the amplification refractory mutations system (ARMS) and the peptide nucleic acid-locked PCR clamping. Others selectively digest wild-type DNA templates with restriction endonucleases to enrich mutant alleles by PCR. Experts in the province of Ontario have commented that currently PCR fragment analysis for deletion and point mutation conducts in Ontario, with measurement sensitivity of 1% to 5%.

Research Questions

In patients with locally-advanced or metastatic NSCLC, what is the clinical effectiveness of EGFR mutation testing for prediction of response to treatment with TKIs (gefitinib, erlotinib) in terms of progression-free survival (PFS), objective response rates (ORR), overall survival (OS), and quality of life (QoL)?

What is the impact of EGFR mutation testing on overall clinical decision-making for patients with advanced or metastatic NSCLC?

What is the cost-effectiveness of EGFR mutation testing in selecting patients with advanced NSCLC for treatment with gefitinib or erlotinib in the first-line setting?

What is the budget impact of EGFR mutation testing in selecting patients with advanced NSCLC for treatment with gefitinib or erlotinib in the second- or third-line setting?

Methods

A literature search was performed on March 9, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, Wiley Cochrane, CINAHL, Centre for Reviews and Dissemination/International Agency for Health Technology Assessment for studies published from January 1, 2004 until February 28, 2010 using the following terms:

Non-Small-Cell Lung Carcinoma

Epidermal Growth Factor Receptor

An automatic literature update program also extracted all papers published from February 2010 until August 2010. Abstracts were reviewed by a single reviewer and for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, and then a group of epidemiologists, until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.

The inclusion criteria were as follows:

Population: patients with locally advanced or metastatic NSCLC (stage IIIB or IV)

Procedure: EGFR mutation testing before treatment with gefitinib or erlotinib

Language: publication in English

Published health technology assessments, guidelines, and peer-reviewed literature (abstracts, full text, conference abstract)

Outcomes: progression-free survival (PFS), Objective response rate (ORR), overall survival (OS), quality of life (QoL).

The exclusion criteria were as follows:

Studies lacking outcomes specific to those of interest

Studies focused on erlotinib maintenance therapy

Studies focused on gefitinib or erlotinib use in combination with cytotoxic agents or any other drug

Grey literature, where relevant, was also reviewed.

Outcomes of Interest

PFS

ORR determined by means of the Response Evaluation Criteria in Solid Tumours (RECIST)

OS

QoL

Quality of Evidence

The quality of the Phase II trials and observational studies was based on the method of subject recruitment and sampling, possibility of selection bias, and generalizability to the source population. The overall quality of evidence was assessed as high, moderate, low or very low according to the GRADE Working Group criteria.

Summary of Findings

Since the last published health technology assessment by Blue Cross Blue Shield Association in 2007 there have been a number of phase III trials which provide evidence of predictive value of EGFR mutation testing in patients who were treated with gefitinib compared to chemotherapy in the first- or second-line setting. The Iressa Pan Asian Study (IPASS) trial showed the superiority of gefitinib in terms of PFS in patients with EGFR mutations versus patients with wild-type EGFR (Hazard ratio [HR], 0.48, 95%CI; 0.36-0.64 versus HR, 2.85; 95%CI, 2.05-3.98). Moreover, there was a statistically significant increased ORR in patients who received gefitinib and had EGFR mutations compared to patients with wild-type EGFR (71% versus 1%). The First-SIGNAL trial in patients with similar clinical characteristics as IPASS as well as the NEJ002 and WJTOG3405 trials that included only patients with EGFR mutations, provide confirmation that gefitinib is superior to chemotherapy in terms of improved PFS or higher ORR in patients with EGFR mutations. The INTEREST trial further indicated that patients with EGFR mutations had prolonged PFS and higher ORR when treated with gefitinib compared with docetaxel.

In contrast, there is still a paucity of strong evidence regarding the predictive value of EGFR mutation testing for response to erlotinib in the second- or third-line setting. The BR.21 trial randomized 731 patients with NSCLC who were refractory or intolerant to prior first- or second-line chemotherapy to receive erlotinib or placebo. While the HR of 0.61 (95%CI, 0.51-0.74) favored erlotinib in the overall population, this was not a significant in the subsequent retrospective subgroup analysis. A retrospective evaluation of 116 of the BR.21 tumor samples demonstrated that patients with EGFR mutations had significantly higher ORRs when treated with erlotinib compared with placebo (27% versus 7%; P=0.03). However, erlotinib did not confer a significant survival benefit compared with placebo in patients with EGFR mutations (HR, 0.55; 95%CI, 0.25-1.19) versus wild-type (HR, 0.74; 95%CI, 0.52-1.05). The interaction between EGFR mutation status and erlotinib use was not significant (P=0.47). The lack of significance could be attributable to a type II error since there was a low sample size that was available for subgroup analysis.

A series of phase II studies have examined the clinical effectiveness of erlotinib in patients known to have EGFR mutations. Evidence from these studies has consistently shown that erlotinib yields a very high ORR (typically 70% vs. 4%) and a prolonged PFS (9 months vs. 2 months) in patients with EGFR mutations compared with patients with wild-type EGFR. Although having a prolonged PFS and higher respond in EGFR mutated patients might be due to a better prognostic profile regardless of the treatment received. In the absence of a comparative treatment or placebo control group, it is difficult to determine if the observed differences in survival benefit in patients with EGFR mutation is attributed to prognostic or predictive value of EGFR mutation status.

Conclusions

Based on moderate quality of evidence, patients with locally advanced or metastatic NSCLC with adenocarcinoma histology being treated with gefitinib in the first-line setting are highly likely to benefit from gefitinib if they have EGFR mutations compared to those with wild-type EGFR. This advantage is reflected in improved PFS, ORR and QoL in patients with EGFR mutation who are being treated with gefitinib relative to patients treated with chemotherapy.

Based on low quality of evidence, in patients with locally advanced or metastatic NSCLC who are being treated with erlotinib, the identification of EGFR mutation status selects those who are most likely to benefit from erlotinib relative to patients treated with placebo in the second or third-line setting.

Background

Internet portal technologies that provide access to portions of electronic health records have the potential to revolutionize patients’ involvement in their care. However, relatively few descriptions of the demographic characteristics of portal enrollees or of the effects of portal technology on quality outcomes exist. This study examined data from patients who attended one of seven Duke Medicine clinics and who were offered the option of enrolling in and using the Duke Medicine HealthView portal (HVP). The HVP allows patients to manage details of their appointment scheduling and provides automated email appointment reminders in addition to the telephone and mail reminders that all patients receive.

Objective

Our objective was to test whether portal enrollment with an email reminder functionality is significantly related to decreases in rates of appointment “no-shows,” which are known to impair clinic operational efficiency.

Methods

Appointment activity during a 1-year period was examined for all patients attending one of seven Duke Medicine clinics. Patients were categorized as portal enrollees or as nonusers either by their status at time of appointment or at the end of the 1-year period. Demographic characteristics and no-show rates among these groups were compared. A binomial logistic regression model was constructed to measure the adjusted impact of HVP enrollment on no-show rates, given confounding factors. To demonstrate the effect of HVP use over time, monthly no-show rates were calculated for patient appointment keeping and contrasted between preportal and postportal deployment periods.

Results

Across seven clinics, 58,942 patients, 15.7% (9239/58,942) of whom were portal enrollees, scheduled 198,199 appointments with an overall no-show rate of 9.9% (19,668/198,199). We found that HVP enrollees were significantly more likely to be female, white, and privately insured compared with nonusers. Bivariate no-show rate differences between portal enrollment groups varied widely according to patient- and appointment-level attributes. Large reductions in no-show rates were seen among historically disadvantaged groups: Medicaid holders (OR = 2.04 for nonuser/enrollee, 5.6% difference, P < .001), uninsured patients (OR = 2.60, 12.8% difference, P < .001), and black patients (OR = 2.13, 8.0% difference, P < .001). After fitting a binomial logistic regression model for the outcome of appointment arrival, the adjusted odds of arrival increased 39.0% for portal enrollees relative to nonusers (OR = 1.39, 95% CI 1.22 - 1.57, P < .001). Analysis of monthly no-show rates over 2 years demonstrated that patients who registered for portal access and received three reminders of upcoming appointments (email, phone, and mail) had a 2.0% no-show rate reduction (P < .001), whereas patients who did not enroll and only received traditional phone and mail reminders saw no such reduction (P < .09).

Conclusions

Monthly no-show rates across all seven Duke Medicine clinics were significantly reduced among patients who registered for portal use, suggesting that in combination with an email reminder feature, this technology may have an important and beneficial effect on clinic operations.

The Internet is now a major channel for publishing medical research data and documents, including clinical practice guidelines. It is now possible to capture guidelines in a computer interpretable form opening up the capability of using the internet (and intra/extranets etc.) to deliver patient-specific advice and other services. A development lifecycle and technology for publishing and delivering services at the point of care ("publets") are described. As with all new technologies, however, these new methods entail risks as well as opportunities. The paper closes with a discussion of quality requirements and an argument that publets should include a safety case as an integral part of their content.

Background

The assessment of Quality of Life (QoL) is a Medical goal; it is used in clinical research, medical practice, health-related economic studies and in planning health management measures and strategies. The objective of this project is to develop an informational platform to achieve a patient self-assessment with standardized QoL measuring instruments, through friendly software, easy for the user to adapt, which should aid the study of QoL, by promoting the creation of databases and accelerating its statistical treatment and yet generating subsequent useful results in graphical format for the physician analyzes in an appointment immediately after the answers collection.

Methods

First, a software platform was designed and developed in an action-research process with patients, physicians and nurses. The computerized patient self-assessment with standardized QoL measuring instruments was compared with traditional one, to verify if its use did not influence the patient's answers. For that, the Wilcoxon and t-Student tests were applied. After, we adopted and adapted the mathematic Rash model to make possible the use of QoL measure in the routine appointments.

Results

The results show that the computerized patient self-assessment does not influence the patient's answers and can be used as a suitable tool in the routine appointment, because indicates problems which are more difficult to identify in a traditional appointment, improving thus the physician's decisions.

Conclusions

The possibility of representing graphically useful results that physician needs to analyze in the appointment, immediately after the answer collection, in an useful time, makes this QoL assessment platform a diagnosis instrument ready to be used routinely in clinical practice.

Utilizing advanced information technology, Intensive Care Unit (ICU) remote monitoring allows highly trained specialists to oversee a large number of patients at multiple sites on a continuous basis. In the current research, we conducted a time-motion study of registered nurses’ work in an ICU remote monitoring facility. Data were collected on seven nurses through 40 hours of observation. The results showed that nurses’ essential tasks were centered on three themes: monitoring patients, maintaining patients’ health records, and managing technology use. In monitoring patients, nurses spent 52% of the time assimilating information embedded in a clinical information system and 15% on monitoring live vitals. System-generated alerts frequently interrupted nurses in their task performance and redirected them to manage suddenly appearing events. These findings provide insight into nurses’ workflow in a new, technology-driven critical care setting and have important implications for system design, work engineering, and personnel selection and training.

Objective

The US Agency for Healthcare Research and Quality funded an evidence report to address seven questions on multiple aspects of the effectiveness of medication management information technology (MMIT) and its components (prescribing, order communication, dispensing, administering, and monitoring).

Materials and Methods

Medline and 11 other databases without language or date limitations to mid-2010. Randomized controlled trials (RCTs) assessing integrated MMIT were selected by two independent reviewers. Reviewers assessed study quality and extracted data. Senior staff checked accuracy.

Results

Most of the 87 RCTs focused on clinical decision support and computerized provider order entry systems, were performed in hospitals and clinics, included primarily physicians and sometimes nurses but not other health professionals, and studied process changes related to prescribing and monitoring medication. Processes of care improved for prescribing and monitoring mostly in hospital settings, but the few studies measuring clinical outcomes showed small or no improvements. Studies were performed most frequently in the USA (n=63), Europe (n=16), and Canada (n=6).

Discussion

Many studies had limited description of systems, installations, institutions, and targets of the intervention. Problems with methods and analyses were also found. Few studies addressed order communication, dispensing, or administering, non-physician prescribers or pharmacists and their MMIT tools, or patients and caregivers. Other study methods are also needed to completely understand the effects of MMIT.

Conclusions

Almost half of MMIT interventions improved the process of care, but few studies measured clinical outcomes. This large body of literature, although instructive, is not uniformly distributed across settings, people, medication phases, or outcomes.

The context for nursing informatics research has changed significantly since the National Institute of Nursing Research-funded Nursing Informatics Research Agenda was published in 1993 and the Delphi study of nursing informatics research priorities reported a decade ago. The authors focus on three specific aspects of context - genomic health care, shifting research paradigms, and social (Web 2.0) technologies - that must be considered in formulating a nursing informatics research agenda. These influences are illustrated using the significant issue of healthcare associated infections (HAI). A nursing informatics research agenda for 2008–18 must expand users of interest to include interdisciplinary researchers; build upon the knowledge gained in nursing concept representation to address genomic and environmental data; guide the reengineering of nursing practice; harness new technologies to empower patients and their caregivers for collaborative knowledge development; develop user-configurable software approaches that support complex data visualization, analysis, and predictive modeling; facilitate the development of middle-range nursing informatics theories; and encourage innovative evaluation methodologies that attend to human-computer interface factors and organizational context.

Objective

Although industrial sectors involving semiconductors; memory and storage technologies; display, optical, and photonic technologies; energy; biotechnology; and health care produce the most products that contain nanomaterials, nanotechnology is also used as an environmental technology to protect the environment through pollution prevention, treatment, and cleanup. In this review, we focus on environmental cleanup and provide a background and overview of current practice; research findings; societal issues; potential environment, health, and safety implications; and future directions for nanoremediation. We do not present an exhaustive review of chemistry/engineering methods of the technology but rather an introduction and summary of the applications of nanotechnology in remediation. We also discuss nanoscale zerovalent iron in detail.

Data sources

We searched the Web of Science for research studies and accessed recent publicly available reports from the U.S. Environmental Protection Agency and other agencies and organizations that addressed the applications and implications associated with nanoremediation techniques. We also conducted personal interviews with practitioners about specific site remediations.

Data synthesis

We aggregated information from 45 sites, a representative portion of the total projects under way, to show nanomaterials used, types of pollutants addressed, and organizations responsible for each site.

Conclusions

Nanoremediation has the potential not only to reduce the overall costs of cleaning up large-scale contaminated sites but also to reduce cleanup time, eliminate the need for treatment and disposal of contaminated soil, and reduce some contaminant concentrations to near zero—all in situ. Proper evaluation of nanoremediation, particularly full-scale ecosystem-wide studies, needs to be conducted to prevent any potential adverse environmental impacts.

The largest cost center and revenue generator in most hospitals, the operating room is subject to demands for increased cost accountability and quality assurance. Information technology tools can be incorporated into the operating room and have the potential to positively affect practices there through addressing nursing, administrative/financial and medical needs. Microcomputer-based operating room systems now on the market can provide functions from scheduling and case costing to medical records and market analysis. Of 21 functions identified, 10 can be characterized as mandatory and the remaining as optional. Individual systems offer varied configurations, providing from 0 to 21 functions. These enhanced capabilities for data collection, monitoring and analysis enable health care professionals to provide both better and more cost-effective care for surgical patients.

Background

Few quality of life (QOL) assessment tools are available for children with specific chronic conditions, and none have been designed specifically for children with hearing loss (HL). A validated hearing-related QOL questionnaire could help clinicians determine whether an intervention is beneficial and whether one intervention is better than another.

Purpose

To examine QOL in children with HL and assess the validity, reliability, and factor structure of a new measure, the Hearing Environments and Reflection on Quality of Life (HEAR-QL) questionnaire.

Research Design

A descriptive and correlational study of a convenience sample of children.

Study Sample

Participants included 35 children with unilateral HL, 45 with bilateral HL, and 35 siblings with normal hearing.

Data Collection and Analysis

Children 7-12 years old were recruited by mail from a tertiary-care pediatric otolaryngology practice and the local county's Special School District. With parent consent, children completed the validated Pediatric Quality of Life Inventory™ (PedsQL™) 4.0 and a 35-item HEAR-QL questionnaire. The factor structure of the HEAR-QL was determined through principal components analysis (PCA), and mean scores were computed for each subscale and the total HEAR-QL. Three weeks following return of the initial questionnaires, a second HEAR-QL questionnaire was sent to participants to assess test-retest reliability. Both PedsQL and HEAR-QL scores were compared between children with and without HL, between children with unilateral and bilateral HL, and between children who used and did not use a hearing device using analysis of variance. Sensitivity and specificity were calculated for both the HEAR-QL and PedsQL. A multivariable, hierarchical linear regression analysis was conducted with independent variables associated with HEAR-QL in unadjusted tests.

Results

Using exploratory PCA, the 35-item HEAR-QL was reduced to 26 items (Cronbach's α=0.97; sensitivity 91% and specificity 92% at cut-off score of 93.5) loading on 3 factors: difficulty hearing in certain environments/situations (Environments α=0.97), impact of HL on social/sports activities (Activities α=0.92), and impact of HL on child's feelings (Feelings α=0.88). Sensitivity 78.8% and specificity 30.9% at a cut-off score of 69.6 on the PedsQL ((at-risk for impaired QOL) were lower than for the HEAR-QL. Participants with HL reported significantly lower mean total HEAR-QL scores (71 [SD 18] versus 98 [SD 5]; p < 0.001), but not mean total PedsQL scores (77 [SD 14] versus 83 [SD 15]; p = 0.47), than participants with normal hearing. Among children with bilateral HL, children who used a hearing device reported lower mean total HEAR-QL scores (p = 0.01), but not mean total PedsQL scores (p = 0.55), than children who did not use a hearing device. The intraclass correlation (ICC) for test-retest reliability for the 26-item HEAR-QL total score was .83. Hearing status and use of a device were independently associated with the HEAR-QL, and the variables in the model accounted for 46% of the HEAR-QL total score variance.

Conclusion

The HEAR-QL appears to be a valid, reliable, and sensitive questionnaire for children with HL. The HEAR-QL was better able than the PedsQL to distinguish between children with and without HL and can help evaluate interventions for children with HL.