According to W. Edwards Deming, American companies require nothing less than a transformation of management style and of governmental relations with industry. In Out of the Crisis, originally published in 1982, Deming offers a theory of management based on his famous 14 Points for Management. Management's failure to plan for the future, he claims, brings about loss of market, which brings about loss of jobs. Management must be judged not only by the quarterly dividend, but by innovative plans to stay in business, protect investment, ensure future dividends, and provide more jobs through improved product and service. In simple, direct language, he explains the principles of management transformation and how to apply them.

Out of the Crisis

This new edition of Ann Bowling's well-known and highly respected text has been thoroughly revised and updated to reflect key methodological developments in health research. It is a comprehensive, easy to read, guide to the range of methods used to study and evaluate health and health services. It describes the concepts and methods used by the main disciplines involved in health research, including: demography, epidemiology, health economics, psychology and sociology.The research methods described cover the assessment of health needs, morbidity and mortality trends and rates, costing health services, sampling for survey research, cross-sectional and longitudinal survey design, experimental methods and techniques of group assignment, questionnaire design, interviewing techniques, coding and analysis of quantitative data, methods and analysis of qualitative observational studies, and types of unstructured interviewing. With new material on topics such as cluster randomization, utility analyses, patients' preferences, and perception of risk, the text is aimed at students and researchers of health and health services. It has also been designed for health professionals and policy makers who have responsibility for applying research findings in practice, and who need to know how to judge the value of that research.

Research Methods in Health. Investigating health and health services

Objectives To update a 2004 systematic review of health care service use and health outcomes related to differences in health literacy level and interventions designed to improve these outcomes for individuals with low health literacy. Disparities in health outcomes and effectiveness of interventions among different sociodemographic groups were also examined. Data sources We searched MEDLINE®, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, PsychINFO, and the Educational Resources Information Center. For health literacy, we searched using a variety of terms, limited to English and studies published from 2003 to May 25, 2010. For numeracy, we searched from 1966 to May 25, 2010. Review methods We used standard Evidence-based Practice Center methods of dual review of abstracts, full-text articles, abstractions, quality ratings, and strength of evidence grading. We resolved disagreements by consensus. We evaluated whether newer literature was available for answering key questions, so we broadened our definition of health literacy to include numeracy and oral (spoken) health literacy. We excluded intervention studies that did not measure health literacy directly and updated our approach to evaluate individual study risk of bias and to grade strength of evidence. Results We included good- and fair-quality studies: 81 studies addressing health outcomes (reported in 95 articles including 86 measuring health literacy and 16 measuring numeracy, of which 7 measure both) and 42 studies (reported in 45 articles) addressing interventions. Differences in health literacy level were consistently associated with increased hospitalizations, greater emergency care use, lower use of mammography, lower receipt of influenza vaccine, poorer ability to demonstrate taking medications appropriately, poorer ability to interpret labels and health messages, and, among seniors, poorer overall health status and higher mortality. Health literacy level potentially mediates disparities between blacks and whites. The strength of evidence of numeracy studies was insufficient to low, limiting conclusions about the influence of numeracy on health care service use or health outcomes. Two studies suggested numeracy may mediate the effect of disparities on health outcomes. We found no evidence concerning oral health literacy and outcomes. Among intervention studies (27 randomized controlled trials [RCTs], 2 cluster RCTs, and 13 quasi-experimental designs), the strength of evidence for specific design features was low or insufficient. However, several specific features seemed to improve comprehension in one or a few studies. The strength of evidence was moderate for the effect of mixed interventions on health care service use; the effect of intensive self-management inventions on behavior; and the effect of disease-management interventions on disease prevalence/severity. The effects of other mixed interventions on other health outcomes, including knowledge, self-efficacy, adherence, and quality of life, and costs were mixed; thus, the strength of evidence was insufficient. Conclusions The field of health literacy has advanced since the 2004 report. Future research priorities include justifying appropriate cutoffs for health literacy levels prior to conducting studies; developing tools that measure additional related skills, particularly oral (spoken) health literacy; and examining mediators and moderators of the effect of health literacy. Priorities in advancing the design features of interventions include testing novel approaches to increase motivation, techniques for delivering information orally or numerically, "work around" interventions such as patient advocates; determining the effective components of already-tested interventions; determining the cost-effectiveness of programs; and determining the effect of policy and practice interventions.

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Health literacy interventions and outcomes: an updated systematic review.

Background
Printed educational materials are widely used passive dissemination strategies to improve the quality of clinical practice and patient outcomes. Traditionally they are presented in paper formats such as monographs, publication in peer-reviewed journals and clinical guidelines.

Objectives
To assess the effect of printed educational materials on the practice of healthcare professionals and patient health outcomes.

To explore the influence of some of the characteristics of the printed educational materials (e.g. source, content, format) on their effect on professional practice and patient outcomes.

Search methods
For this update, search strategies were rewritten and substantially changed from those published in the original review in order to refocus the search from published material to printed material and to expand terminology describing printed materials. Given the significant changes, all databases were searched from start date to June 2011. We searched: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), HealthStar, CINAHL, ERIC, CAB Abstracts, Global Health, and the EPOC Register.

Selection criteria
We included randomised controlled trials (RCTs), quasi-randomised trials, controlled before and after studies (CBAs) and interrupted time series (ITS) analyses that evaluated the impact of printed educational materials (PEMs) on healthcare professionals' practice or patient outcomes, or both. We included three types of comparisons: (1) PEM versus no intervention, (2) PEM versus single intervention, (3) multifaceted intervention where PEM is included versus multifaceted intervention without PEM. There was no language restriction. Any objective measure of professional practice (e.g. number of tests ordered, prescriptions for a particular drug), or patient health outcomes (e.g. blood pressure) were included.

Data collection and analysis
Two review authors undertook data extraction independently, and any disagreement was resolved by discussion among the review authors. For analyses, the included studies were grouped according to study design, type of outcome (professional practice or patient outcome, continuous or dichotomous) and type of comparison. For controlled trials, we reported the median effect size for each outcome within each study, the median effect size across outcomes for each study and the median of these effect sizes across studies. Where the data were available, we re-analysed the ITS studies and reported median differences in slope and in level for each outcome, across outcomes for each study, and then across studies. We categorised each PEM according to potential effects modifiers related to the source of the PEMs, the channel used for their delivery, their content, and their format.

Main results
The review includes 45 studies: 14 RCTs and 31 ITS studies. Almost all the included studies (44/45) compared the effectiveness of PEM to no intervention. One single study compared paper-based PEM to the same document delivered on CD-ROM. Based on seven RCTs and 54 outcomes, the median absolute risk difference in categorical practice outcomes was 0.02 when PEMs were compared to no intervention (range from 0 to +0.11). Based on three RCTs and eight outcomes, the median improvement in standardised mean difference for continuous profession practice outcomes was 0.13 when PEMs were compared to no intervention (range from -0.16 to +0.36). Only two RCTs and two ITS studies reported patient outcomes. In addition, we re-analysed 54 outcomes from 25 ITS studies, using time series regression and observed statistically significant improvement in level or in slope in 27 outcomes. From the ITS studies, we calculated improvements in professional practice outcomes across studies after PEM dissemination (standardised median change in level = 1.69). From the data gathered, we could not comment on which PEM characteristic influenced their effectiveness.

Authors' conclusions
The results of this review suggest that when used alone and compared to no intervention, PEMs may have a small beneficial effect on professional practice outcomes. There is insufficient information to reliably estimate the effect of PEMs on patient outcomes, and clinical significance of the observed effect sizes is not known. The effectiveness of PEMs compared to other interventions, or of PEMs as part of a multifaceted intervention, is uncertain.

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Printed educational materials: effects on professional practice and healthcare outcomes

of “Roadmap for Provision of Safer Healthcare Information Systems: Preventing eIatrogenesis” Joan S. Ash, Ph.D., M.L.S., M.B.A.; Charles M. Kilo, M.D., M.P.H.; Michael Shapiro, M.A., M.S.; Joseph Wasserman, B.A.; Carmit McMullen, Ph.D.; William Hersh, M.D. BACKGROUND AND METHODS e-Iatrogenesis, defined as “patient harm caused at least in part by the application of health information technology” (Weiner et al., 2007), is of increasing concern as more and more hospitals are implementing health information systems (HIS). This report assesses how HIS can be designed, developed, implemented, monitored, and maintained to maximize safety. We specifically focus on hospital electronic health records (EHRs), clinical decision support (CDS), and computerized provider order entry (CPOE) systems. This white paper is intended to provide background for an Institute of Medicine (IOM) report on how the use of health information technology affects the safety of patient care by answering the following IOM-posed questions: • What are the risks of health care information systems that arise from workflow and related issues? • How have organizations acted to implement health care information systems safely? • What are the impacts of customization on safety? • What is the industry approach to managing change and customization? A recent literature review by Harrington et al. (2011) has summarized the EHR safety literature, so we first reviewed all papers cited in their report. Of their 43 references, we identified 37 that were relevant to the scope of this article. We analyzed the bibliographies of these selected papers and performed a reverse bibliography search on the articles deemed most relevant and published since 2000. In total, we identified over 100 sources relevant to the scope of this report. We then targeted topics for which published evidence was lacking and conducted several interviews with experts to help fill the knowledge gaps. 1 Full commissioned paper can be found in this project’s Public Access File. C-2 HEALTH IT AND PATIENT SAFETY PREPUBLICATION COPY: UNCORRECTED PROOFS RESULTS What Are the Risks of Health Information Systems That Arise from Workflow and Related Issues? We found seven publications (Chuo and Hicks, 2008; Joint Commission on Accreditation of Healthcare Organizations, 2008; Magrabi et al., 2010; Myers et al., 2011; Santell et al., 2009; Walsh et al., 2006; Zhan et al., 2006) presenting results of assessments of e-iatrogenic risk. All are studies of large databases of reported errors and they consistently indicate low levels of HISrelated risk, under 1 percent of all errors. All point to the need for human diligence when using HIS. Specifically, they indicate that HIS-related errors are due to inadequate staffing levels, lack of user experience, mislabeled bar-codes on medications, human distraction, inaccurate data entry, system downtime, and missing data. How Have Organizations Acted to Implement Health Information Systems Safely? Prior to implementation, health care organizations can mitigate risk. There is a large literature base devoted to the risks inherent in commercial EHR systems, and also warnings about their impact on workflow. Many publications offer guidance to hospitals about assessing workflow, selecting systems for purchase, conducting simulation tests, training, and other mechanisms for ensuring safe HIS implementation. Numerous publications exist to guide the implementation process itself, but there are also several pointing to the risks of rapid implementation without appropriate preparation. Finally, after implementation, continuous monitoring and improvement can mitigate safety risks. What Are the Impacts of Customization on Safety? The literature indicates that customization of the EHR to fit local situations seems to be necessary for many reasons, but there is scant research on how much customization or what form of customization is needed to optimize EHR use and what the risks are from either too much or too little customization. The content of CDS likewise needs adaptation, especially to avoid alert fatigue. Any customization must be done with care so that system upgrades can be accommodated. What Is the Industry Approach to Managing Change and Customization? The current industry approach is fragmented; a report sponsored by the Agency for Healthcare Research and Quality describes a wide variety of vendor practices related to usability of systems (McDonnell et al., 2010). Because purchasers must usually customize systems to fit local workflows and regulations, HIS safety depends on a combination of industry and local diligence.

Health IT and Patient Safety: Building Safer Systems for Better Care

Serious lapses in patient care result from failure to follow-up test results. To systematically review evidence quantifying the extent of failure to follow-up test results and the impact for ambulatory patients. Medline, CINAHL, Embase, Inspec and the Cochrane Database were searched for English-language literature from 1995 to 2010. Studies which provided documented quantitative evidence of the number of tests not followed up for patients attending ambulatory settings including: outpatient clinics, academic medical or community health centres, or primary care practices. Four reviewers independently screened 768 articles. Nineteen studies met the inclusion criteria and reported wide variation in the extent of tests not followed-up: 6.8% (79/1163) to 62% (125/202) for laboratory tests; 1.0% (4/395) to 35.7% (45/126) for radiology. The impact on patient outcomes included missed cancer diagnoses. Test management practices varied between settings with many individuals involved in the process. There were few guidelines regarding responsibility for patient notification and follow-up. Quantitative evidence of the effectiveness of electronic test management systems was limited although there was a general trend towards improved test follow-up when electronic systems were used. Most studies used medical record reviews; hence evidence of follow-up action relied upon documentation in the medical record. All studies were conducted in the US so care should be taken in generalising findings to other countries. Failure to follow-up test results is an important safety concern which requires urgent attention. Solutions should be multifaceted and include: policies relating to responsibility, timing and process of notification; integrated information and communication technologies facilitating communication; and consideration of the multidisciplinary nature of the process and the role of the patient. It is essential that evaluations of interventions are undertaken and solutions integrated into the work and context of ambulatory care delivery.

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Failure to follow-up test results for ambulatory patients: a systematic review

Background Failure to follow-up test results is a critical safety issue. The objective was to systematically review evidence quantifying the extent of failure to follow-up test results and the impact on patient outcomes.

Methods The authors searched Medline, CINAHL, Embase, Inspec and the Cochrane Database from 1990 to March 2010 for English-language articles which quantified the proportion of diagnostic tests not followed up for hospital patients. Four reviewers independently reviewed titles, abstracts and articles for inclusion.

Results Twelve studies met the inclusion criteria and demonstrated a wide variation in the extent of the problem and the impact on patient outcomes. A lack of follow-up of test results for inpatients ranged from 20.04% to 61.6% and for patients treated in the emergency department ranged from 1.0% to 75% when calculated as a proportion of tests. Two areas where problems were particularly evident were: critical test results and results for patients moving across healthcare settings. Systems used to manage follow-up of test results were varied and included paper-based, electronic and hybrid paper-and-electronic systems. Evidence of the effectiveness of electronic test management systems was limited.

Conclusions Failure to follow up test results for hospital patients is a substantial problem. Evidence of the negative impacts for patients when important results are not actioned, matched with advances in the functionality of clinical information systems, presents a convincing case for the need to explore solutions. These should include interventions such as on-line endorsement of results.

https://qualitysafety.bmj.com/content/qhc/20/2/194.full.pdf

The safety implications of missed test results for hospitalised patients: a systematic review

Accuracy of medication documentation in hospital discharge summaries: A retrospective analysis of medication transcription errors in manual and electronic discharge summaries

Joanne Callen

Papers

Failure to follow-up test results for ambulatory patients: a systematic review

The safety implications of missed test results for hospitalised patients: a systematic review

Accuracy of medication documentation in hospital discharge summaries: A retrospective analysis of medication transcription errors in manual and electronic discharge summaries

Evaluation of electronic discharge summaries: a comparison of documentation in electronic and handwritten discharge summaries.

Contextual implementation model: a framework for assisting clinical information system implementations.