Karen Eden

Assessing the Quality of Decision Support Technologies Using the International Patient Decision Aid Standards instrument (IPDASi)

Objectives To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids). Design Scale development study, involving construct, item and scale development, validation and reliability testing. Setting There has been increasing use of decision support technologies – adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation. Methods Scale development study, involving construct, item and scale development, validation and reliability testing. Participants Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies. Results IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbachs alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbachs alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92). Conclusions This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DSTs components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.

Do Patient Decision Aids Meet Effectiveness Criteria of the International Patient Decision Aid Standards Collaboration? A Systematic Review and Meta-analysis

Objective. To describe the extent to which patient decision aids (PtDAs) meet effectiveness standards of the International Patient Decision Aids Collaboration (IPDAS). Data sources. Five electronic databases (to July 2006) and personal contacts (to December 2006). Results. Among 55 randomized controlled trials, 38 (69%) used at least 1 measure that mapped onto an IPDAS effectiveness criterion. Measures of decision quality were knowledge scores (27 trials), accurate risk perceptions (12 trials), and value congruence with the chosen option (3 trials). PtDAs improved knowledge scores relative to usual care (weighted mean difference [WMD] = 15.2%, 95% confidence interval [CI] = 11.7 to 18.7); detailed PtDAs were somewhat more effective than simpler PtDAs (WMD = 4.6%, 95% CI = 3.0 to 6.2). PtDAs with probabilities improved accurate risk perceptions relative to those without probabilities (relative risk = 1.6, 95% CI = 1.4 to 1.9). Relative to simpler PtDAs, detailed PtDAs improved value congruence with the chosen option. Only 2 of 6 IPDAS decision process criteria were measured: feeling informed (15 trials) and feeling clear about values (13 trials). PtDAs improved these process measures relative to usual care (feeling uninformed WMD = —8.4, 95% CI = —11.9 to —4.8; unclear values WMD = —6.3, 95% CI = —10.0 to —2.7). There was no difference in process measures when detailed and simple PtDAs were compared. Conclusions. PtDAs improve decision quality and the decision processs measures of feeling informed and clear about values; however, the size of the effect varies across studies. Several IPDAS decision process measures have not been used. Future trials need to use a minimum data set of IPDAS evaluation measures. The degree of detail PtDAs require for positive effects on IPDAS criteria should be explored.

Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force.

Sedentary behavior (little to no recreational, household, or occupational physical activity) is one of the strongest risk factors for many chronic diseases and conditions, including cardiovascular disease, hypertension, diabetes, obesity, osteoporosis, colon cancer, and depression (1, 2). Only 25% of Americans achieve the level of physical activity recommended in Healthy People 2010 guidelines, that is, 30 minutes of moderate activity on 5 or more days per week or 20 minutes of vigorous activity three or more times per week (3). Twenty-nine percent report getting no regular physical activity. A recent review of observational studies reported that risk for all-cause mortality was 20% to 30% lower among adults who met the Healthy People 2010 recommendations and somewhat lower for adults who exercised moderately or vigorously at least a few times per month or once per week (4). Despite inconclusive evidence that counseling by primary care clinicians improves patient activity levels, in 1996 the U.S. Preventive Services Task Force (USPSTF) recommended counseling to promote regular physical activity for all children and adults based on evidence of the benefits of increased physical activity. Surveys of patients suggest that a minority of clinicians follow this recommendation. In the 1997 Behavioral Risk Factor Surveillance System, 42% of adult respondents reported receiving clinician advice to increase physical activity levels (5, 6). Approximately three fourths of the patients who reported receiving clinician advice also reported increasing physical activity levels, compared with only half of the patients who reported receiving no clinician advice. Two recent systematic reviews came to different conclusions about the efficacy of counseling (7, 8). One review focused on eight studies published between 1988 and 1998 in which primary care clinicians directly advised patients to increase physical activity (8). The authors rated only two of these studies as good quality; in four studies, counseling led to small, short-term increases in self-reported activity levels. The other review summarized 15 studies published between 1979 and 1999 of interventions initiated or conducted in the primary care setting, regardless of whether the primary care clinician played any role (7). This review concluded that counseling was moderately effective but did not use study quality as a criterion for inclusion. Neither review sought evidence about the potential harms associated with increasing physical activity. Since these reviews were published, results of several additional trials of counseling have been made available. In consultation with members of the USPSTF, we performed a new systematic review that focused on controlled trials published since the 1996 USPSTF guidelines and addressed these questions: 1) Do adults counseled by primary care clinicians improve or maintain physical activity behavior? 2) If so, what types of interventions are most effective? From the trials on physical activity counseling, we also assessed the harms associated with increased physical activity. Methods Search Strategy and Study Selection The scope of the two previous systematic reviews (7, 8) differed sharply: One included only studies of counseling by the clinician alone (8), while the other included studies of interventions performed in the primary care setting even when clinicians did not interact with patients in any way (7). In consultation with members of the USPSTF, we took the middle ground of including all controlled clinical trials in which some components of the intervention were performed by the patients primary care clinician (nurse practitioner, nurse, physician, or physician assistant). To describe the clinicians role as well as other components of interventions consistently, we used an abstraction tool developed by the Behavioral Counseling Work Group of the current USPSTF (9). The tool is based on a practical 5-A framework (Assess, Advise, Agree, Assist, and Arrange/Adjust) originally developed to describe the elements of brief provider tobacco-cessation interventions (10). We limited our review to trials that had been published since the last USPSTF review (1994 and later) and that reported behavioral outcomes of an intervention to increase physical activity. We searched the Cochrane Database of Systematic Reviews and Registry of Controlled Trials through March 2002 using the term physical activity and found abstracts for 49 reviews and 966 controlled trials. We searched the MEDLINE and HealthStar database from 1994 to March 2002, using the Medical Subject Headings exercise, physical fitness, counseling, patient education, and health education, and found 549 abstracts. Experts and reference lists of pertinent articles provided an additional 145 references. We excluded two randomized, controlled trials that reported physical activity outcomes but did not mention counseling to increase physical activity (11, 12). We excluded one ongoing trial that has not yet reported results for the physical activity intervention in the treatment groups (13). We excluded four randomized, controlled trials (14-17) in which all components of the intervention were provided by a research staff member or exercise specialist. For example, in one study (15), a research associate recruited patients from waiting rooms or from lists provided by the general practitioners. The patients were mailed an invitation to participate in an intervention conducted by health educators at a fitness center. As a team, we reviewed this study and excluded it because no components of the intervention were performed by a primary care clinician. Data Abstraction and Synthesis A single reviewer abstracted information about setting, patient participants, providers, interventions, adherence, and outcomes. The outcome of primary interest was the proportion of patients who met the Healthy People 2010 goal in the long term, which we defined as at least 6 months after randomization. When this outcome was not available, we recorded mean changes in activity levels. We also recorded short-term results if reported. At least two reviewers summarized the quality of each study using criteria developed by the current USPSTF (18). In applying the USPSTF criteria to trials that used randomization by practice rather than by individual patient, we placed particular importance on the methods used to create comparable groups, such as matching and stratification, and on whether the groups were similar at baseline. We also placed emphasis on whether the interventions were clearly described and whether most patients were retained throughout the study. The internal validity of each trial was rated good, fair, or poor. A rating of good means that the trial met all criteria and was very likely to be valid. A fair rating means that the study was possibly or probably valid, depending on the nature or severity of its flaws. Poor studies have fatal flaws rendering the results invalid; such studies were excluded from further consideration. We summarized the design, quality, and results of each included trial in an evidence table, focusing on the magnitude of change in and duration of physical activity. We examined the consistency of results among studies and the relationship between effects and specific components of the interventions, discussing studies that compared an intervention with usual care separately from those that compared two interventions. Role of the Funding Source This review was funded by the U.S. Agency for Healthcare Research and Quality under a contract to support the work of the USPSTF. Task Force members participated in the initial design of the review and reviewed interim summaries as well as the final manuscript. The funding source had no role in the study design, data collection, or data synthesis; however, representatives of the Agency for Healthcare Research and Quality reviewed interim summaries and copies of the manuscript. Since our report was prepared for the current USPSTF, it was distributed for review to 13 outside experts and representatives of professional societies and federal agencies. Results Seven randomized, controlled trials (19-25) and one nonrandomized, controlled trial (26) met our inclusion criteria (Table). A pilot study for one of the trials (20) was excluded (29). Five other trials (30-34) were excluded because they received a quality rating of poor according to criteria developed by the current USPSTF (18). (See the Appendix Table for a description of the excluded studies.) Table. Summary of Controlled Trials of Counseling for Physical Activity Most of the trials were conducted in typical primary care practices, and all included multiple sites. Clinicians delivered advice themselves but usually did not perform the initial assessment. In some trials, the patients completed a self-report tool on physical activity levels (20, 22, 26) or answered selected questions from larger validated health-assessment tools administered by telephone, in the office waiting area, or in the home (19, 21, 23). Often, a nurse or research assistant conducted a baseline assessment and placed it on the medical chart for review during the clinicians visit (20, 22, 26). The clinician used the assessment information to exclude patients for whom physical activity was contraindicated or to tailor the intervention to each patients needs. In most trials, the clinician advised sedentary or minimally active patients to achieve regular, moderate-intensity physical activity; in some trials, clinicians recommended vigorous activity as an option. Five studies (20, 22, 24-26) targeted physical activity alone, while three (19, 21, 23) also had other behavioral targets (for example, diet change, smoking cessation). In three of the trials, the primary care clinicians condensed advice and counseling on behavior change into a single 3- to 5-minute encounter and, for some patients, a follow-up session wi

Vaginal birth after cesarean: New insights on maternal and neonatal outcomes

OBJECTIVE: To systematically review the evidence about maternal and neonatal outcomes relating to vaginal birth after cesarean (VBAC). DATA SOURCES: Relevant studies were identified from multiple searches of MEDLINE, DARE, and the Cochrane databases (1980 to September 2009) and from recent systematic reviews, reference lists, reviews, editorials, Web sites, and experts. METHODS OF STUDY SELECTION: Inclusion criteria limited studies to the English-language and human studies conducted in the United States and developed countries specifically evaluating birth after previous cesarean delivery. Studies focusing on high-risk maternal or neonatal conditions, including breech vaginal delivery, or fewer than 10 patients were excluded. Poor-quality studies were not included in analyses. TABULATION, INTEGRATION, AND RESULTS: We identified 3,134 citations and reviewed 963 articles for inclusion; 203 articles met the inclusion criteria and were quality rated. Overall rates of maternal harms were low for both trial of labor and elective repeat cesarean delivery. Although rare in both elective repeat cesarean delivery and trial of labor, maternal mortality was significantly increased for elective repeat cesarean delivery at 0.013% compared with 0.004% for trial of labor. The rates of maternal hysterectomy, hemorrhage, and transfusions did not differ significantly between trial of labor and elective repeat cesarean delivery. The rate of uterine rupture for all women with prior cesarean was 0.30%, and the risk was significantly increased for trial of labor (0.47% compared with 0.03% for elective repeat cesarean delivery). Perinatal mortality was also significantly increased for trial of labor (0.13% compared with 0.05% for elective repeat cesarean delivery). CONCLUSION: Overall the best evidence suggests that VBAC is a reasonable choice for the majority of women. Adverse outcomes were rare for both elective repeat cesarean delivery and trial of labor. Definitive studies are lacking to identify patients who are at greatest risk for adverse outcomes.

Computerized Aid Improves Safety Decision Process for Survivors of Intimate Partner Violence

A computerized safety decision aid was developed and tested with Spanish or English-speaking abused women in shelters or domestic violence (DV) support groups (n = 90). The decision aid provides feedback about risk for lethal violence, options for safety, assistance with setting priorities for safety, and a safety plan personalized to the user. Women reported that the decision aid was useful and provided much-needed privacy for making safety decisions. The majority (69%) reported severe to extreme danger in their relationship as scored by Danger Assessment (DA); only 60% reported having made a safety plan. After using the safety decision aid, the women felt more supported in their decision (p = .012) and had less total decisional conflict (p = .014). The study demonstrated that a computerized safety decision aid improved the safety planning process, as demonstrated by reduced decisional conflict after only one use in a sample of abused women.

New Insights on Vaginal Birth After Cesarean: Can It Be Predicted?

OBJECTIVE: To evaluate existing vaginal birth after cesarean (VBAC) screening tools and to identify additional factors that may predict VBAC or failed trial of labor. DATA SOURCES: Relevant studies were identified through MEDLINE, Database of Abstracts of Reviews of Effectiveness, and the Cochrane databases (1980-September 2009), and from recent systematic reviews, reference lists, reviews, editorials, web sites, and experts. METHODS OF STUDY SELECTION: Inclusion criteria limited studies to those of humans, written in English, studies conducted in the United States and developed countries, and those rated good or fair quality by the U.S. Preventive Services Task Force criteria. Studies of individual predictors were combined using a random effects model when the estimated odds ratios were comparable across included studies. TABULATION, INTEGRATION, AND RESULTS: We identified 3,134 citations and reviewed 963 papers, of which 203 met inclusion criteria and were quality-rated. Twenty-eight provided evidence on predictors of VBAC and 16 presented information on scored models for predicting VBAC (or failed trial of labor). Six of the 11 scored models for predicting VBAC (or failed trial of labor) were validated by separated dataset, cross-validation, or both. Whereas accuracy remained high across all models for predicting VBAC, with predictive values ranging from 88% to 95%, accuracy for predicting failed trial of labor was low, ranging from 33% to 58%. Individual predictors including Hispanic ethnicity, African-American race, advanced maternal age, no previous vaginal birth history, birth weight heavier than 4 kg, and use of either augmentation or induction were all associated with reduced likelihood of VBAC. CONCLUSION: Current scored models provide reasonable predictability for VBAC, but none provides consistent ability to identify women at risk for failed trial of labor. A scoring model is needed that incorporates known antepartum factors and can be adjusted for current obstetric factors and labor patterns if induction or augmentation is needed. This would allow women and clinicians to better determine individuals most likely to require repeat cesarean delivery.

Coaching and guidance with patient decision aids: A review of theoretical and empirical evidence

BackgroundCoaching and guidance are structured approaches that can be used within or alongside patient decision aids (PtDAs) to facilitate the process of decision making. Coaching is provided by an individual, and guidance is embedded within the decision support materials. The purpose of this paper is to: a) present updated definitions of the concepts “coaching” and “guidance”; b) present an updated summary of current theoretical and empirical insights into the roles played by coaching/guidance in the context of PtDAs; and c) highlight emerging issues and research opportunities in this aspect of PtDA design.MethodsWe identified literature published since 2003 on shared decision making theoretical frameworks inclusive of coaching or guidance. We also conducted a sub-analysis of randomized controlled trials included in the 2011 Cochrane Collaboration Review of PtDAs with search results updated to December 2010. The sub-analysis was conducted on the characteristics of coaching and/or guidance included in any trial of PtDAs and trials that allowed the impact of coaching and/or guidance with PtDA to be compared to another intervention or usual care.ResultsTheoretical evidence continues to justify the use of coaching and/or guidance to better support patients in the process of thinking about a decision and in communicating their values/preferences with others. In 98 randomized controlled trials of PtDAs, 11 trials (11.2%) included coaching and 63 trials (64.3%) provided guidance. Compared to usual care, coaching provided alongside a PtDA improved knowledge and decreased mean costs. The impact on some other outcomes (e.g., participation in decision making, satisfaction, option chosen) was more variable, with some trials showing positive effects and other trials reporting no differences. For values-choice agreement, decisional conflict, adherence, and anxiety there were no differences between groups. None of these outcomes were worse when patients were exposed to decision coaching alongside a PtDA. No trials evaluated the effect of guidance provided within PtDAs.ConclusionsTheoretical evidence continues to justify the use of coaching and/or guidance to better support patients to participate in decision making. However, there are few randomized controlled trials that have compared the effectiveness of coaching used alongside PtDAs to PtDAs without coaching, and no trials have compared the PtDAs with guidance to those without guidance.

Examining the value of electronic health records on labor and delivery

OBJECTIVE The objective of the study was to evaluate the impact of an electronic health record (EHR) on documentation completeness and patient care in a labor and delivery unit. STUDY DESIGN We conducted a pre- and postintervention study to compare documentation quality and workflow before and after EHR implementation. Documentation was compared using chi(2) and Fishers exact tests. Objective observers measured workflow activities across all shifts before and after EHR implementation and activities were compared using Kruskal-Wallis tests and analysis of covariance. RESULTS Paper admission records were significantly more likely to miss key clinical information such as chief complaints (contractions, membrane status, bleeding, fetal movement, 10-64% vs 2-5%; P < .0001) and prenatal laboratory results and history (Varicella, group B Streptococcus, human immunodeficiency virus, 26-66% vs 1-16%, P < .0001). Both direct patient care and computer activities increased after EHR implementation (2 vs 12 and 12 vs 17 activities/shift, respectively, P < .0001). CONCLUSION The introduction of an obstetric EHR improved documentation completeness without reducing direct patient care.

Outcomes From Health Information Exchange: Systematic Review and Future Research Needs

Background Health information exchange (HIE), the electronic sharing of clinical information across the boundaries of health care organizations, has been promoted to improve the efficiency, cost-effectiveness, quality, and safety of health care delivery. Objective To systematically review the available research on HIE outcomes and analyze future research needs. Methods Data sources included citations from selected databases from January 1990 to February 2015. We included English-language studies of HIE in clinical or public health settings in any country. Data were extracted using dual review with adjudication of disagreements. Results We identified 34 studies on outcomes of HIE. No studies reported on clinical outcomes (eg, mortality and morbidity) or identified harms. Low-quality evidence generally finds that HIE reduces duplicative laboratory and radiology testing, emergency department costs, hospital admissions (less so for readmissions), and improves public health reporting, ambulatory quality of care, and disability claims processing. Most clinicians attributed positive changes in care coordination, communication, and knowledge about patients to HIE. Conclusions Although the evidence supports benefits of HIE in reducing the use of specific resources and improving the quality of care, the full impact of HIE on clinical outcomes and potential harms are inadequately studied. Future studies must address comprehensive questions, use more rigorous designs, and employ a standard for describing types of HIE. Trial Registration PROSPERO Registry No CRD42014013285; http://www.crd.york.ac.uk/PROSPERO/ display_record.asp?ID=CRD42014013285 (Archived by WebCite at http://www.webcitation.org/6dZhqDM8t).

Delivery after prior cesarean: maternal morbidity and mortality.

Nearly 1 in 3 pregnant women in the United States undergo cesarean. This trend is contrary to the national goal of decreasing cesarean delivery in low-risk women. The decline in vaginal birth after cesarean (VBAC) contributes to the continual increase in cesarean deliveries. Prior cesarean delivery is the most common indication for cesarean and accounts for more than one-third of all cesareans. The appropriate use and safety of cesarean and VBAC are of concern not only at the individual patient and clinician level but they also have far-reaching public health and policy implications at the national level.