Are We There Yet? Human Factors Knowledge and Health Information Technology - the Challenges of Implementation and Impact.

Objective: To review the developments in human factors (HF) research on the challenges of health information technology (HIT) implementation and impact given the continuing incidence of usability problems and unintended consequences from HIT development and use. Methods: A search of PubMed/Medline and Web of Science® identified HF research published in 2015 and 2016. Electronic health records (EHRs) and patient-centred HIT emerged as significant foci of recent HF research. The authors selected prominent papers highlighting ongoing HF and usability challenges in these areas. This selective rather than systematic review of recent HF research highlights these key challenges and reflects on their implications on the future impact of HF research on HIT. Results: Research provides evidence of continued poor design, implementation, and usability of HIT, as well as technology-induced errors and unintended consequences. The paper highlights support for: (i) strengthening the evidence base on the benefits of HF approaches; (ii) improving knowledge translation in the implementation of HF approaches during HIT design, implementation, and evaluation; (iii) increasing transparency, governance, and enforcement of HF best practices at all stages of the HIT system development life cycle. Discussion and Conclusion: HF and usability approaches are yet to become embedded as integral components of HIT development, implementation, and impact assessment. As HIT becomes ever-more pervasive including with patients as end-users, there is a need to expand our conceptualisation of the problems to be addressed and the suite of tactics and strategies to be used to calibrate our pro-active involvement in its improvement.

Human Factors for More Usable and Safer Health Information Technology: Where Are We Now and Where do We Go from Here?

A wide range of human factors approaches have been developed and adapted to healthcare for detecting and mitigating negative unexpected consequences associated with technology in healthcare (i.e. technology-induced errors). However, greater knowledge and wider dissemination of human factors methods is needed to ensure more usable and safer health information technology (IT) systems. OBJECTIVE: This paper reports on work done by the IMIA Human Factors Working Group and discusses some successful approaches that have been applied in using human factors to mitigate negative unintended consequences of health IT. The paper addresses challenges in bringing human factors approaches into mainstream health IT development. RESULTS: A framework for bringing human factors into the improvement of health IT is described that involves a multi-layered systematic approach to detecting technology-induced errors at all stages of a IT system development life cycle (SDLC). Such an approach has been shown to be needed and can lead to reduced risks associated with the release of health IT systems into live use with mitigation of risks of negative unintended consequences. CONCLUSION: Negative unintended consequences of the introduction of IT into healthcare (i.e. potential for technology-induced errors) continue to be reported. It is concluded that methods and approaches from the human factors and usability engineering literatures need to be more widely applied, both in the vendor community and in local and regional hospital and healthcare settings. This will require greater efforts at dissemination and knowledge translation, as well as greater interaction between the academic and vendor communities.

Immunological responses to chronic heat exposure and food restriction in rats.

Immunological variables were studied in rats chronically exposed to high environmental temperature (35 degrees C). Responses were compared with those of rats at 25 degrees C both fed ad libitum and pair fed to the decreased intake found in heat-exposed rats. Heat-exposed rats showed slower delayed-type hypersensitivity responses to keyhole limpet hemocyanin. They showed lower counts of peripheral blood total T cells (OX19+) as well as helper T cells (W3/25+) and smaller numbers of splenic T cells. The thymus was decreased in size. Increased levels of serum IgG antitetanus toxoid antibodies were found in heat-exposed rats. [3H]-thymidine incorporation into Concanavalin A (ConA)-stimulated splenic lymphocytes was decreased in pair-fed rats but not significantly altered in heat-exposed rats compared with controls. Heat exposure alters some aspects of both cellular and humoral immune function in a manner different from that induced by comparable food restriction without heat exposure.

In vivo and in vitro humoral immunity in surgical patients: antibody response to pneumococcal polysaccharide.

We have previously shown that the antibody response to a T cell-dependent protein antigen, tetanus toxoid is reduced in patients having surgery. Because most bacterial antigens are not protein but polysaccharide, we studied in vivo and in vitro antibody responses to a relatively T cell-independent polysaccharide antigen, 23 valent pneumococcal polysaccharide (Pneumovax) (PPS). Subjects were classified by skin testing with five standard antigens as reactive patients (R, positive response to any antigen, N = 5), anergic patients (A, no response, N = 7) or laboratory controls (C, reactive personnel, N = 8). Blood lymphocytes taken before and after immunization with 0.5 ml PPS were cultured in vitro. Quantities of total and anti-PPS IgG, IgM, and IgA in culture supernatants and serum were measured by radioimmunoassay. There was no difference in in vivo anti-PPS production in the three groups (p greater than 0.05 for all comparisons, Wilcoxon rank-sum test). Positive response rates (greater than twofold increase) for all classes of immunoglobulin were also similar in the three groups (X2(2) = 0.36, 0.36, and 0.81 for IgG, IgM, and IgA, p greater than 0.05). In in vitro studies, peak quantities of IgA anti-PPS produced by A were significantly less than C (0.64 X divided by 0.41 versus 2.03 X divided by 0.6, p less than 0.05, Wilcoxon rank-sum test). Synthesis of all other classes of Ig anti-PPS and simultaneous measurement of total Ig (nanograms per culture) produced in vitro were not significantly different among all groups (p greater than 0.05, Wilcoxon rank-sum test). In C, R, and A, peak in vitro isotype-specific anti-PPS production correlated with the magnitude of the in vivo serum response (Spearman rank correlation = 0.53, 0.60, and 0.59 for IgG, IgM, and IgA, p less than 0.05). We conclude that these data show normal in vivo antibody responses to a relatively T cell-independent bacterial polysaccharide antigen in surgical patients and a good correlation of in vivo- to in vitro-specific antibody responses. The data imply that a T cell defect is responsible for reduced humoral immunity to protein antigens. Because most bacterial antigens are not protein but polysaccharides, active immunization of patients with bacterial vaccines may produce effective immunity.

Malnutrition and humoral immunity: short-term acute nutritional deprivation.

The effects of short-term acute nutritional deprivation and refeeding on immune function was investigated in rats. Animals previously sensitized to keyhole-limpet hemocyanin were starved for 72 hours and refed for 7 days. Recall skin testing with keyhole-limpet hemocyanin and immunization with tetanus toxoid (TT) were used to assess delayed-type hypersensitivity (DTH) and humoral immune responses. DTH was maximally depressed late, after refeeding had begun. Anti-TT responses were depressed early during starvation. Neither DTH nor anti-TT responses had returned to normal after a period of refeeding sufficient to restore weight. The data indicate that short-term acute nutritional deprivation may contribute to acquired immunodeficiency in patients undergoing surgery.

Abnormal in vitro immunoglobulin synthesis in surgical patients.

Blood mononuclear cells from surgical patients produce large amounts of IgG in vitro. This synthesis is not increased by stimulation with pokeweed mitogen. To determine if this abnormal pattern of IgG synthesis extended to other immunoglobulin classes, surgical patients were stratified according to delayed-type hypersensitivity responses as reactive or anergic. Healthy personnel were studied as controls. Mononuclear cells were cultured without or with pokeweed mitogen, and IgG, IgM, and IgA were measured in supernatants. Unstimulated IgG and IgA synthesis was increased in surgical patients, especially in those with reduced delayed-type hypersensitivity responses. Synthesis of IgM was normal or low. With mitogen stimulation, IgG synthesis was increased in control and reactive subjects, but not in anergic subjects. For IgM, mitogen stimulation increased synthesis to a less than normal level in all patients. For IgA, synthesis was increased in all groups.

Assessing operative site infection in surgical patients.

We evaluated the contribution of altered host defense to the risk of developing an operative site infection. In part 1 of this study, we measured the following variables in 404 preoperative patients: cutaneous delayed-type hypersensitivity, age, serum albumin level, contamination status at the time of surgery, and the duration of surgery. Patients were examined daily postoperatively for the presence of an operative site infection (culture-positive drainage or infected tissue; overall rate, 17.3%). The above variables, plus previously defined risk factors, were examined by logistic regression analysis using the development of an operative site infection as the dependent variable. An equation to calculate the probability of developing a postoperative wound infection was thus derived. In part 2 of the study, a separate, matched group of 404 preoperative patients was used to test the validity of this predictive equation. A good fit of the model was obtained, with 70.3 wound infections predicted and 67 obtained (chi 2 = 0.8; not significant, ie, no difference between expected and observed wound infections at all probability deciles). We conclude that there are three determinants of an operative site infection, host defense (delayed-type hypersensitivity), acute and chronic physiologic derangement (albumin and age) and bacterial contamination risk at surgery (contamination status and duration of surgery).

The effect of the immunomodulator RU 41,740 (biostim) on the specific and nonspecific immunosuppression induced by thermal injury or protein deprivation.

We studied the effect of RU 41,740 (biostim), a primary macrophage stimulator, in the following two immunosuppressive conditions in rats: (1) a 30% full-thickness burn that leads to significant decreases in cell-mediated (delayed-type hypersensitivity [DTH]), humoral (anti-tetanus toxoid antibody production), and nonspecific immunity (Staphylococcus aureus 502a skin abscess) and (2) protein malnutrition using a 2% protein diet for eight weeks. Biostim administered by gastric intubation at dosages of 10 and 50 mg/kg of body weight for five days following thermal trauma did not prevent the DTH suppression induced by the thermal injury, but resulted in a significant dose-related increase in the amount of anti-tetanus toxoid antibody produced. In the malnourished rats given biostim at dosages of 10 and 50 mg/kg of body weight for seven days, there was a significant dose-related increase in the DTH response in the presence of continued protein depletion in these animals, with a modest but significant reduction in the S aureus 502a skin abscess at three days. Antibody production was not affected with this model. Biostim partially overcomes the suppression in humoral immunity following thermal injury, but not cell-mediated or nonspecific immunity. On the other hand, biostim augments both the cell-mediated and nonspecific immune suppression induced by prolonged protein deprivation but does not affect humoral immunity.

Humoral immunity in surgical patients with and without trauma.

We measured antitetanus toxoid antibody responses after blunt (n = 24) and penetrating (n = 7) trauma and compared them with responses in patients without trauma (n = 55). Patients were defined as anergic or reactive on the basis of delayed type hypersensitivity response. The response to tetanus toxoid vaccination on admission of patients surviving trauma for over 2 weeks was defined as the ratio of day 14 to day 0 serum IgG antitetanus toxoid levels. Antitetanus toxoid responses were normal after both blunt and penetrating trauma. When stratified according to delayed type hypersensitivity responses, patients with trauma showed better antibody responses than patients without trauma. Major infection rates were similar between trauma groups (three of 24 with blunt trauma vs two of seven with penetrating trauma) and independent of delayed type hypersensitivity (two of 20 reactive patients vs three of 11 anergic patients), in contrast to patients without trauma (one of 19 reactive patients vs 15 of 36 anergic patients). We conclude that decreased delayed type hypersensitivity after moderate trauma is temporary, and that this transient immunodeficiency is not as strongly associated with reduced antibody responses and increased risk of infection as anergy in surgical patients without trauma.

Stomal ulcer after gastric bypass.

BACKGROUND: Stomal ulcer is a serious complication of gastrogastric fistula following Roux-en-Y gastric bypass for obesity. STUDY DESIGN: A 1-8 year continuous followup of 499 patients with gastric bypass in continuity (GB) and isolated gastric bypass (IGB) documented the incidence of fistula formation, development of stomal ulcer, stimulation of acid production within the gastric pouch, and response to treatment. RESULTS: In 123 GB patients, staple line disruption occurred in 36 (29%) and stomal ulcer occurred in 20 (16%). Gastrogastric fistula with stomal ulcer was significantly lower in 376 patients who underwent IGB, (ie, 11 patients [3%]). Significantly larger amounts of acid, a lower pH, and a greater time with a pH less than 2 were found in the gastric pouches of patients who developed stomal ulcer after Roux-en-Y gastric bypass. All patients had a perforated staple line. Successful closure of the staple line significantly decreased acid production and pH in the gastric pouch when tested before and after remedial operation with healing of stomal ulcers. CONCLUSIONS: Stomal ulcer after gastric bypass is the result of acid production in the bypassed stomach in the presence of a gastrogastric fistula. Separation of the gastric pouch from the main stomach decreases the incidence of fistula formation and stomal ulcer but does not eliminate it. Interposition of a well vascularized organ, the jejunum between the pouch and main stomach, is an attractive solution for patients who require remedial operations on the stomach and possibly for primary operations as well.

Long- or short-limb gastric bypass?

The aim of this study was to determine whether longer limb length improved results of gastric bypass in patients who were morbidly obese (body mass index <50 kg/m(2)) or superobese (body mass index >50 kg/m(2). A total of 242 patients were followed for a mean of 5.5 years. The standard operation was a Roux-en-Y gastric bypass with a 40 cm Roux limb and a 10 cm afferent limb. The long-limb operation had a 100 cm Roux limb and a 100 cm afferent limb. Morbidly obese patients did not benefit from a long-limb bypass. The final body mass index was 28.6 +/- 4.7 kg/m(2) in the short-limb group and 28.5 +/- 3.8 kg/m(2) in the long-limb group. The superobese patients did benefit from a long-limb bypass. Final body mass index was 35.8 +/- 6.7 kg/m(2) in the short-limb patients and 32.7 +/- 5.1 in the long-limb patients (P = 0.049). A subgroup of 20 patients, all of whom had a body mass index greater than 60 kg/m(2), benefited the most from long-limb bypass. No macronutritional side effects unique to the long-limb bypass were encountered.

The evaluation of expert diagnostic systems. How to assess outcomes and quality parameters?

Improvement of the quality in health care and the assessment of health outcomes of medical technologies have attracted an increasing attention in the implementation phases. In this paper 10 recent evaluation studies are reviewed to investigate to what extent they reflect the structure, process, and outcome of the conceptual framework. It is found that all the evaluation studies focus on structure measures. But if computer programs to support medical decision making are to be considered in the planning process of the health care system, the evaluation studies must strive to evaluate process and outcomes measures as well. A proposal for a framework for this kind of exploratory and evaluative research is outlined.

Globalization and the cultural impact on distance education.

With the delivery of distance (or flexible) learning in today's society, the changing roles of both the teacher and the learner need to be seriously considered. This is particularly relevant with the use of new technologies to deliver courses in locations with entirely different cultural and academic traditions. International education of this kind currently faces difficulties in facilitating cross-cultural learning. While problems of limited communications technologies, lack of teacher training, inadequate competence of university administration and general cultural differences may be known, global changes call for the development of new pedagogies with new communication technologies in ways, which are sensitive to issues of cultural diversity.

Strategic planning of the master programme in health informatics at Aalborg University: targeting and updating the programme, to meet explicit customer needs.

Education is essentially giving people new skills and qualifications to fulfil certain tasks. In planning and managing educational programmes it is crucial to know what skills and what qualifications are needed to carry out the tasks in question, not to mention the importance of knowing what tasks are relevant to carry out. The programme in health informatics at Aalborg University produces health informatics professionals. The students are developing skills in solving informatics problems in health care organisations. The programme has been running for 3 years now and to maintain the perception of the aim for the programme a number of activities have been launched. In the following, the programme will be presented, the activities to obtain information on how to keep the programme targeted and updated will be described and the changes that are going to be introduced will be outlined.

Research needs and priorities in health informatics.

A Delphi study was accomplished on the topic "what is needed to implement the information society within healthcare? and which research topics should be given higher priority than other topics to achieve the desired evolution?", involving 29 international experts. The study comprised of four phases, (I) a brainstorming phase based on a open question; (II) an evaluation phase for mutual commenting; (III) a feedback phase allowing corrections/extensions; and (IV) a phase collecting the ratings of individual issues within a questionnaire synthesised from the previous phases. A total of 110 research items and 58 supplementary barriers were raised, divided into 14 topics grouped according to homogeneity. The emphasised research topics are business process re-engineering, the electronic patient record and connected inter-operating systems, (support for) evidence-based medicine and clinical guidelines, and education. Issues inherent to the healthcare domain often are the kernel of the research recommended. Similarly, methods and 'people'-issues are strongly emphasised among the research issues in general and among those for which the experts' joint opinion was rated as statistically significant. In contrast, only a minority of the research issues emphasised was related to technical issues.

Technological changes in the healthcare sector. A method to assess change readiness.

This paper describes the theory, method and recent results of a study developing methods for assessment of change readiness. The empirical focus is on development and implementation of clinical IT systems in the Danish healthcare sector. To assess change readiness, a questionnaire has been developed. The questionnaire has been tested in a hospital department as a part of a pre analysis related to development and implementation of an IT quality assurance system. The study shows a general positive attitude to the IT system and the organisational changes, related to the implementation and use of the system. It also supplies the project organisation with specific information, useful to the project organisation to continue the essential dialogue with the healthcare professionals during the change process. Furthermore it provides a useful tool for planning the ongoing developing processes. Several other healthcare organisations are at the moment entering the study.

Problem oriented project work in a distance education program in health informatics.

At Aalborg University, an important part of the distance education program within Health Informatics is problem oriented project work. Traditionally, distance education has been characterized by one-way communication and self study whereas the problem oriented project study form is based on cooperation and dialogue. In this paper, we describe the way in which we have implemented the problem oriented study form in a program within Health Informatics which is based on distance learning. First, we describe the program with regard to student, structure, aim, and activities. Second, we introduce the problem oriented project study form and present the basic principles behind this approach. Third, we explain important concepts and distinctions within the area of distance education. Finally, we describe the way in which we try to put the ideals of the problem oriented project work into practice. The use of a computer conferencing system is essential but in our experience, it is not in itself sufficient to provide the necessary support for the student project work.

Research needs and priorities in health informatics--early results of a Delphi study.

A four-phased Delphi study has been performed on the topic of "research needs and priorities to implement the Information Society within Healthcare". This contribution presents the outcome of the first three phases. The biggest surprises are that 'Telemedicine' is relatively lower ranked than expected, and that 'Business Process Re-engineering' is the highest ranking topic, as judged from the number of issues and barriers raised by the expert panel.

Keeping education in health informatics on the right track.

The programme in health informatics at Aalborg University has been running for three years and is about to be revised and extended to a full masters programme. In this paper the programme is presented and the systematic activities to obtain the basis for the revision are described.

The Danish EPR Observatory. Assessing organisational impact from EPR implementation.

The EPR Observatory has studied 13 local Danish electronic patient record (EPR) projects through 2 years. The focus has been on expectations and experiences in relation to organisational changes. The main conclusions are that the healthcare professionals, working with the development, implementation and/or use of EPR, are in a very important and difficult process settling up with old traditions and cultures tied to the healthcare professions. Especially the healthcare professionals, working with EPR, shows interest and readiness to participate in new ways of collaboration and to work with highly structured data in structured frameworks. EPR is at this point of time only diffused in few relatively small and isolated healthcare organisations, and the preliminary assessment in the study only outlines the perspectives for what will happen on a wider scale when EPR systems get more diffused.