Constance M. Johnson

A user-centered framework for redesigning health care interfaces

Numerous health care systems are designed without consideration of user-centered design guidelines. Consequently, systems are created ad hoc, users are dissatisfied and often systems are abandoned. This is not only a waste of human resources, but economic resources as well. In order to salvage such systems, we have combined different methods from the area of computer science, cognitive science, psychology, and human-computer interaction to formulate a framework for guiding the redesign process. The paper provides a review of the different methods involved in this process and presents a life cycle of our redesign approach. Following the description of the methods, we present a case study, which shows a successfully applied example of the use of this framework. A comparison between the original and redesigned interfaces showed improvements in system usefulness, information quality, and interface quality.

Antibiotic Treatment of Gastric Lymphoma of Mucosa-Associated Lymphoid Tissue: An Uncontrolled Trial

Gastric low-grade B-cell lymphoma is related to Helicobacter pylori infection according to histopathologic, epidemiologic, and clinical characteristics. Although normal gastric mucosa does not contain organized lymphoid tissue, lymphoid follicles develop with H. pylori infection (1) and with autoimmune diseases, such as the Sjgren syndrome (2). Low-grade B-cell lymphoma has been postulated to arise within this mucosa-associated lymphoid tissue (MALT) and is often called low-grade MALT lymphoma (3, 4). The incidence of gastric low- and high-grade MALT lymphoma is increased in populations with a high prevalence of H. pylori infection, and H. pylori infection has been reported in up to 90% of patients with low-grade MALT lymphoma (4-6). In addition, investigators have shown that growth of this tumor may depend on antigenic stimulation by H. pylori: They demonstrated that the proliferation of lymphoma B cells in cell culture can be stimulated by H. pylori-specific T cells and related cytokines in the presence of H. pylori (7). On the basis of these findings, trials of antibiotic treatment of gastric low-grade MALT lymphoma have been initiated, and the regression of lymphoma after cure of H. pylori infection has been reported in a high proportion of patients with low tumor burden (8-13). Data on patients with significant tumor infiltration are still forthcoming (13, 14). Because MALT lymphoma has only recently been approached as a distinct clinicopathologic entity (15, 16), its natural history and clinical course are not fully defined. Current data suggest that it is often an indolent tumor with long periods of mild activity and confinement to the stomach. Patients often present with nonspecific upper intestinal discomfort, ulcer-associated symptoms, or gastric bleeding. The endoscopic appearance may suggest benign gastritis, and extensive biopsies may be required for diagnosis. Progression to significant tumor mass, dissemination, or transformation to high-grade, aggressive lymphoma occur in an undefined subset of patients, who may present with early satiety or weight loss. Spontaneous remissions are rare (17-20). Because low-grade MALT lymphoma is an uncommon, often indolent form of cancer with few clinical findings and because the risk for progression to high-grade MALT lymphoma is still unknown (15, 16), definitive data on cure require long-term follow-up of large cohorts from standardized clinical trials. This report presents an interim analysis of an ongoing trial designed to determine the long-term response of low-grade gastric MALT lymphoma to antibiotic treatment and to define criteria for treatment and follow-up. Methods Patients Patients with gastric MALT lymphoma restricted to the stomach and perigastric lymph nodes (modified Ann Arbor stage I and II N1) were eligible for the study. The University of Texas, M.D. Anderson Cancer Center (MDACC), Internal Review Board approved the study, and all patients provided written informed consent. The National Cancer Institute and the institutional review boards of participating institutions approved the multi-institutional protocol. To enable a follow-up period of at least 18 months, only patients treated before May 1997 were included in this analysis. Study Design and Treatment The interim data are derived from an ongoing, prospective, uncontrolled treatment trial with third-party patient registry. Patients were studied at four participating centers. Pathologic diagnosis and resolution of MALT lymphoma were confirmed at MDACC, and all but one patient were examined endoscopically at MDACC. Study design included 1) tumor staging with bilateral bone marrow biopsies and aspirates and computed tomography of the abdomen and pelvis done at baseline and yearly; 2) endoscopy at baseline, at weeks 6 to 8, at 3- to 4-month intervals thereafter until resolution of MALT lymphoma was seen on two consecutive endoscopies, at 6-month intervals thereafter for 2 years, and then yearly thereafter; and 3) endoscopic ultrasonography at baseline and at each endoscopy until resolution of masses or infiltration of the muscularis propria, if present (defined as thickness>2 mm or obliteration of wall architecture), and then at 6- to 12-month intervals. The treatment protocol consisted of two of the following three oral antibiotic regimens1] amoxicillin, 750 mg three times daily, and clarithromycin, 500 mg three times daily; 2) tetracycline, 500 mg four times daily, and clarithromycin, 500 mg three times daily; or 3) tetracycline, 500 mg four times daily, and metronidazole, 500 mg three times dailyadministered sequentially for 21 days at baseline and at 8 weeks along with a proton-pump inhibitor (lansoprazole, 30 mg twice daily [n=29], or omeprazole, 20 mg twice daily [n=5]), and bismuth subsalicylate, two tablets four times daily. Patients who were allergic to penicillin received the tetracycline-based regimens. Tumor Staging Tumors were staged endoscopically to separate superficial gastritis from significant ulcers and infiltration and from mass lesions. A modified Ann Arbor staging system that incorporated changes proposed by Blackledge, Musshoff, and Rohatiner and their coworkers was used initially (21-23). The TNM (tumor, node, metastasis) classification of the American Joint Committee on Cancer and Union Internationale Contre le Cancer (24, 25), which corresponds to the modified Ann Arbor staging, was subsequently adapted and applied (Table 1). The extent of tumor (T) infiltration through the stomach wall and to adjacent organs corresponds to T staging of gastric cancer. Modified Ann Arbor stage I corresponds to stage I T1-4 N0 M0. Modified Ann Arbor stage II1 (22) (involvement of perigastric lymph nodes) corresponds to stage II T1-4 N1 M0. Modified Ann Arbor stage II2 (22) (involvement of distant lymph nodes caudal to the diaphragm, including para-aortic and retroperitoneal lymph nodes) corresponds to stage II T1-4 N2 M0. Ann Arbor stage III (lymph node involvement on both sides of the diaphragm) is designated by stage III T1-4 N3 M0. Ann Arbor stage IV (organ metastasis or involvement of a second extranodal site) is designated by stage IV T1-4 N0-3 M1. Table 1. Staging of Gastric Lymphoma of Mucosa-Associated Lymphoid Tissue Criteria for Response Response to treatment was evaluated at 3- to 4-month intervals beginning with the fifth month after treatment. Treatment was considered to have failed if patients did not meet criteria for improvement; these patients were removed from the study. In stage I T2, I T3, and II N1 tumors, improvement was defined as regression to a lower stage, 30% reduction in abnormal wall thickness, or 30% reduction in the size of the tumor mass (product of the greatest diameters). These patients remained in the study if sequential improvement was evident at each 3-month interval. Patients with persistent mucosal disease (stage I T1) documented by histopathology were formally reviewed at 12-month intervals; a consensus on withdrawal from or continuation in the study was based on clinical considerations, current knowledge, and patient preference. Initially, patients with persistent stage I T1 disease were withdrawn from the study at 12 months (n=2). Subsequently, patients with persistent stage I T1 disease were observed for more than 36 months if improvement was documented at 12-month intervals. Criteria for improvement in stage I T1 disease included reduction in the number of affected gastric sites or affected biopsy specimens or improved histologic score (8), endoscopic appearance of progressive atrophy and scarring, or resolution of abnormal wall thickness on endoscopic ultrasonography. Complete remission was defined as the absence of histopathologic evidence of lymphoma and an endoscopic appearance of gastritis or better. Partial remission was defined as a reduction in endoscopic stage in stage I T2 disease or at least 50% reduction in the size of the mass lesions in stage I T3 or II T3 N1 disease. In stage I T1 disease, partial remission was defined as at least 75% reduction in the number of gastric sites or biopsy specimens showing lymphoma. Treatment was considered to have failed in patients who met criteria for failure or who were withdrawn from the study before complete remission occurred. Endoscopy and Biopsies The gastric mapping protocol included 2 or more maximum-capacity biopsies from each of 7 to 12 areas of the gastric map (26) and at least 6 biopsies from 2 or more of the most abnormal areas. The more extensive mapping was done at baseline and at clinically relevant time points. Studies, done at defined intervals, included routine histopathology, H. pylori testing by Genta stain, rapid urease test (CLO-test, Delta West, Bentley, Australia) or serology, Southern blot or polymerase chain reaction (PCR) for immunoglobulin gene rearrangement analysis, and immunoglobulin light-chain immunocytochemistry. Diagnostic Criteria Low-grade B-cell MALT lymphoma was diagnosed by established histologic criteria [15, 27], including 1) a dense diffuse infiltrate of marginal-zone centrocyte-like B cells with round to slightly irregular nuclear contours, often with abundant pale cytoplasm; 2) presence of lymphoepithelial lesions, characterized by infiltration and disruption of gastric glands or crypts by groups of neoplastic lymphoid cells; and 3) absence of any areas where large cells predominate. Minor criteria supporting but not essential for diagnosis included presence of immunoglobulin light-chain restriction; presence of residual secondary follicle centers with or without intact mantles; and presence of follicular colonization, defined as replacement of follicle centers by neoplastic lymphoid cells. Immunophenotypic expression of pan-B-cell antigens, such as CD20, and lack of expression of CD5 or CD10 supported the diagnosis. Patients with foci of large-cell transformation were excluded from the study. Southern Blot and Polymerase Chain Reaction High-molec

Detection of proximal colorectal cancers through analysis of faecal DNA

Detection of mutations in faecal DNA represents a promising, non-invasive approach for detecting colorectal cancers in average-risk populations. One of the first practical applications of this technology involves the examination of microsatellite markers in sporadic cancers with mismatch-repair deficiencies. Since such cancers nearly always occur in the proximal colon, this test might be useful as an adjunct to sigmoidoscopy, which detects only distal colorectal lesions. We report here the first in-depth analysis of faecal DNA from patients with proximal cancers to determine the feasibility, sensitivity, and specificity of this approach. Using a sensitive method for microsatellite mutation detection, we found that 18 of 46 cancers had microsatellite alterations and that identical mutations could be identified in the faecal DNA of 17 of these 18 cases.

Safety Issues Related to the Electronic Medical Record (EMR): Synthesis of the Literature from the Last Decade, 2000-2009

EXECUTIVE SUMMARY Healthcare is a complex industry burdened by numerous and complicated clinical and administrative transactions that require many behavioral changes by patients, clinicians, and provider organizations. While healthcare information technology (HIT) is intended to relieve some of the burden by reducing errors, several aspects of systems such as the electronic medical record (EMR) may actually increase the incidence of certain types of errors or produce new safety risks that result in harm. Healthcare leaders must appreciate the complexity surrounding EMRs and understand the safety issues in order to mandate sound EMR design, development, implementation, and use. This article seeks to inform executives, clinicians, and technology professionals what has been learned through published research on the safety of HIT systems during the last decade, focusing on computerized physician order entry (CPOE), clinical decision support systems (CDSS), and bar‐coded medication administration (BCMA).

Mobile health messages help sustain recent weight loss.

BACKGROUND Using regulatory focus theory, an intervention of daily weight loss-sustaining messages was developed and tested for acceptability, feasibility, and efficacy on helping people sustain weight loss. METHODS Participants (n = 120) were randomized to a promotion, prevention, or an attention-control text message group after completion of a weight loss program. Participants completed baseline assessments, and reported their weight at 1 and 3 months postbaseline. RESULTS Participants found the message content and intervention acceptable and valuable. A minimum of one message per day delivered at approximately 8:00 am was deemed the optimal delivery time and frequency. The sustained weight loss rate at month 3 for the control, promotion, and prevention groups was 90%, 95%, and 100%, respectively. Medium-to-large effects were observed for the promotion and prevention groups at month 1 and for prevention at month 3 relative to controls. The mean weight loss for promotion and prevention was 15 pounds, compared with 10 in the controls at month 3. CONCLUSION A clinically significant decrease in mean weight, higher rate of sustained weight loss, and medium-to-large effects on sustained weight loss occurred in the promotion and prevention interventions. Tools such as this text message-based intervention that are constructed and guided by evidence-based content and theoretical constructs show promise in helping people sustain healthy behaviors that can lead to improved health outcomes.

Health Information Seeking and Social Media Use on the Internet among People with Diabetes

Patients who are active and involved in their self-management and care are more likely to manage chronic conditions effectively (6, 26). With a 5-fold increase in the incidence of chronic illness over the past 20 years, access to information can provide patients the tools and support to self-manage their chronic illness. New media technologies can serve as tools to engage and involve patients in their health care. Due to the increasing ubiquity of the Internet and the availability of health information, patients are more easily able to seek and find information about their health.. Thus, the Internet can serve as a mechanism of empowerment (4, 5). This is especially important for people with diabetes mellitus where intensive self-management is critical.

Development of a Theoretically Driven mHealth Text Messaging Application for Sustaining Recent Weight Loss

Background Mobile phone short message service (SMS) text messaging, has the potential to serve as an intervention medium to promote sustainability of weight loss that can be easily and affordably used by clinicians and consumers. Objective To develop theoretically driven weight loss sustaining text messages and pilot an mHealth SMS text messaging intervention to promote sustaining recent weight loss in order to understand optimal frequency and timing of message delivery, and for feasibility and usability testing. Results from the pilot study were used to design and construct a patient privacy compliant automated SMS application to deliver weight loss sustaining messages. Methods We first conducted a pilot study in which participants (N=16) received a daily SMS text message for one month following a structured weight loss program. Messages were developed from diet and exercise guidelines. Following the intervention, interviews were conducted and self-reported weight was collected via SMS text messaging. Results All participants (N=16) were capable of sending and receiving SMS text messages. During the phone interview at 1 month post-baseline and at 3 months post-baseline, 13/14 (93%) of participants who completed the study reported their weight via SMS. At 3 months post-baseline, 79% (11/14) participants sustained or continued to lose weight. Participants (13/14, 93%) were favorable toward the messages and the majority (10/14, 71%) felt they were useful in helping them sustain weight loss. All 14 participants who completed the interview thought SMS was a favorable communication medium and was useful to receive short relevant messages promptly and directly. All participants read the messages when they knew they arrived and most (11/14, 79%) read the messages at the time of delivery. All participants felt that at least one daily message is needed to sustain weight loss behaviors and that they should be delivered in the morning. Results were then used to develop the SMS text messaging application. Conclusions Study results demonstrated the feasibility of developing weight loss SMS text messages, and the development of an mHealth SMS text messaging application. SMS text messaging was perceived as an appropriate and accepted tool to deliver health promotion content.

Multicolor in vitro translation

In vitro translation is a widely used tool for both analytical and preparative purposes. For analytical purposes, small amounts of proteins are synthesized and visualized by detection of labeled amino acids incorporated during translation. The original strategy of incorporating radioactively labeled amino acids, such as [35S]methionine or [14C]leucine, has been superseded by the addition of antigenic tags or the incorporation of biotin-labeled or BODIPY-FL–labeled amino acids. Such nonradioactive tags are easier to visualize after translation and do not pose a radiation hazard. Among the nonradioactive tags, BODIPY-FL–lysine offers the advantage that proteins that have incorporated this amino acid can be directly visualized after gel electrophoresis. We show here that multiple fluorophores introduced into proteins can considerably extend their usefulness, particularly for the comparison of in vitro–translated proteins from related sources. This technology can be applied in various situations, including the simplified detection of rare truncating mutations in clinical samples from cancer patients.

Feasibility and Preliminary Effects of a Virtual Environment for Adults With Type 2 Diabetes: Pilot Study

Background Innovative interventions that empower patients in diabetes self-management (DSM) are needed to provide accessible, sustainable, cost-effective patient education and support that surpass current noninteractive interventions. Skills acquired in digital virtual environments (VEs) affect behaviors in the physical world. Some VEs are programmed as real-time three-dimensional representations of various settings via the Internet. For this research, a theoretically grounded VE that facilitates DSM was developed and pilot tested. It offered weekly synchronous DSM education classes, group meetings, and social networking in a community in which participants practiced real world skills such as grocery shopping, exercising, and dining out, allowing for interactive knowledge application. The VE was available 24/7 on the Internet, minimizing access barriers. Objective The objective of this study was to evaluate the feasibility and efficacy of participation in a VE for DSM education and support. Methods This study utilized a single group, pre-mid-post measure design. At 0, 3, and 6 months, we assessed participants’ perceived VE usability and usefulness, self-efficacy, diabetes self-management behaviors, perceived social support, and diabetes knowledge using validated survey measures; and we recorded metabolic indicators (HbA1c, BP, BMI). Process data were continuously collected in the VE (log-ins, voice recordings, locations visited, objects interacted with, and movement). Data analysis included descriptive statistics, t tests to evaluate changes in mediators and outcomes over time, and depiction of utilization and movement data. Results We enrolled 20 participants (13/20, 65% white, 7/20, 35% black), with an age range of 39-72 years (mean age, 54 years) and diabetes duration from 3 months to 25 years. At baseline, 95% (18/19) and 79% (15/19) of participants rated usefulness and ease of use as high on validated surveys with no significant changes at 3 or 6 months. Participants logged into the site a mean of 2.5 hours/week over the course of 6 months. High DSM class attendance was reflected by the largest percentage of time spent in the classroom (48.6%). Self-efficacy, social support, and foot care showed significant improvement (P<.05). There were improvement trends in clinical outcomes that were clinically meaningful but did not reach statistical significance given the small sample size. Conclusions Because relatively little is known about usability, acceptability, and efficacy of health interventions in VEs, this study constitutes an important, innovative first step in exploring the potential of VEs for facilitating DSM. The preliminary data suggest that VEs provide a feasible and useful platform for patients and educators that affects self-management and related mediators. Flexible access to both synchronous and asynchronous diabetes education, skill building activities, and support from a home computer remove barriers to attending clinic-based meetings. This program has potential for improving DSM in an easily disseminated alternative model.

Molecular approaches for colorectal cancer screening

Molecular genetic approaches for colorectal cancer screening using stool samples have the potential to be very specific, sensitive and cost effective. K-ras oncogene mutation, observed in about 50% of the colorectal tumours, serves as an ideal target for such an approach. Several studies have shown that K-ras gene mutations present in the tumours can be detected from the stool of patients with colorectal cancer. The challenge for clinical application, however, is to develop a simple method for robust PCR amplification and a reliable assay for K-ras gene mutation detection in the stool samples.