Risks to patient safety associated with implementation of electronic applications for medication management in ambulatory care--a systematic review.

BACKGROUND: The objective was to find evidence to substantiate assertions that electronic applications for medication management in ambulatory care (electronic prescribing, clinical decision support (CDSS), electronic health record, and computer generated paper prescriptions), while intended to reduce prescribing errors, can themselves result in errors that might harm patients or increase risks to patient safety. METHODS: Because a scoping search for adverse events in randomized controlled trials (RCTs) yielded few relevant results, we systematically searched nine databases, including MEDLINE, EMBASE, and The Cochrane Database of Systematic Reviews for systematic reviews and studies of a wide variety of designs that reported on implementation of the interventions. Studies that had safety and adverse events as outcomes, monitored for them, reported anecdotally adverse events or other events that might indicate a threat to patient safety were included. RESULTS: We found no systematic reviews that examined adverse events or patient harm caused by organizational interventions. Of the 4056 titles and abstracts screened, 176 full-text articles were assessed for inclusion. Sixty-one studies with appropriate interventions, settings and participants but without patient safety, adverse event outcomes or monitoring for risks were excluded, along with 77 other non-eligible studies. Eighteen randomized controlled trials (RCTs), 5 non-randomized controlled trials (non-R,CTs) and 15 observational studies were included. The most common electronic intervention studied was CDSS and the most frequent clinical area was cardio-vascular, including anti-coagulants. No RCTS or non-R,CTS reported adverse event. Adverse events reported in observational studies occurred less frequently after implementation of CDSS. One RCT and one observational study reported an increase in problematic prescriptions with electronic prescribing CONCLUSIONS: The safety implications of electronic medication management in ambulatory care have not been established with results from studies included in this systematic review. Only a minority of studies that investigated these interventions included threats to patients' safety as outcomes or monitored for adverse events. It is therefore not surprising that we found little evidence to substantiate fears of new risks to patient safety with their implementation. More research is needed to focus on the draw-backs and negative outcomes that implementation of these interventions might introduce.

The effect of how outcomes are framed on decisions about whether to take antihypertensive medication: a randomized trial.

BACKGROUND: We conducted an Internet-based randomized trial comparing three valence framing presentations of the benefits of antihypertensive medication in preventing cardiovascular disease (CVD) for people with newly diagnosed hypertension to determine which framing presentation resulted in choices most consistent with participants' values. METHODS AND FINDINGS: In this second in a series of televised trials in cooperation with the Norwegian Broadcasting Company, adult volunteers rated the relative importance of the consequences of taking antihypertensive medication using visual analogue scales (VAS). Participants viewed information (or no information) to which they were randomized and decided whether or not to take medication. We compared positive framing over 10 years (the number escaping CVD per 1000); negative framing over 10 years (the number that will have CVD) and negative framing per year over 10 years of the effects of antihypertensive medication on the 10-year risk for CVD for a 40 year-old man with newly diagnosed hypertension without other risk factors. Finally, all participants were shown all presentations and detailed patient information about hypertension and were asked to decide again. We calculated a relative importance score (RIS) by subtracting the VAS-scores for the undesirable consequences of antihypertensive medication from the VAS-score for the benefit of CVD risk reduction. We used logistic regression to determine the association between participants' RIS and their choice. 1,528 participants completed the study. The statistically significant differences between the groups in the likelihood of choosing to take antihypertensive medication in relation to different values (RIS) increased as the RIS increased. Positively framed information lead to decisions most consistent with those made by everyone for the second, more fully informed decision. There was a statistically significant decrease in deciding to take antihypertensives on the second decision, both within groups and overall. CONCLUSIONS: For decisions about taking antihypertensive medication for people with a relatively low baseline risk of CVD (70 per 1000 over 10 years), both positive and negative framing resulted in significantly more people deciding to take medication compared to what participants decided after being shown all three of the presentations. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Register ISRCTN 33771631.

The effect of alternative summary statistics for communicating risk reduction on decisions about taking statins: a randomized trial.

BACKGROUND: While different ways of presenting treatment effects can affect health care decisions, little is known about which presentations best help people make decisions consistent with their own values. We compared six summary statistics for communicating coronary heart disease (CHD) risk reduction with statins: relative risk reduction and five absolute summary measures-absolute risk reduction, number needed to treat, event rates, tablets needed to take, and natural frequencies. METHODS AND FINDINGS: We conducted a randomized trial to determine which presentation resulted in choices most consistent with participants' values. We recruited adult volunteers who participated through an interactive Web site. Participants rated the relative importance of outcomes using visual analogue scales (VAS). We then randomized participants to one of the six summary statistics and asked them to choose whether to take statins based on this information. We calculated a relative importance score (RIS) by subtracting the VAS scores for the downsides of taking statins from the VAS score for CHD. We used logistic regression to determine the association between participants' RIS and their choice. 2,978 participants completed the study. Relative risk reduction resulted in a 21% higher probability of choosing to take statins over all values of RIS compared to the absolute summary statistics. This corresponds to a number needed to treat (NNT) of 5; i.e., for every five participants shown the relative risk reduction one additional participant chose to take statins, compared to the other summary statistics. There were no significant differences among the absolute summary statistics in the association between RIS and participants' decisions whether to take statins. Natural frequencies were best understood (86% reported they understood them well or very well), and participants were most satisfied with this information. CONCLUSIONS: Presenting the benefits of taking statins as a relative risk reduction increases the likelihood of people accepting treatment compared to presenting absolute summary statistics, independent of the relative importance they attach to the consequences. Natural frequencies may be the most suitable summary statistic for presenting treatment effects, based on self-reported preference, understanding of and satisfaction with the information, and confidence in the decision. CLINICAL TRIALS REGISTRATION: ISRCTN85194921.

The effect of alternative graphical displays used to present the benefits of antibiotics for sore throat on decisions about whether to seek treatment: a randomized trial.

BACKGROUND: We conducted an Internet-based randomized trial comparing four graphical displays of the benefits of antibiotics for people with sore throat who must decide whether to go to the doctor to seek treatment. Our objective was to determine which display resulted in choices most consistent with participants' values. METHODS AND FINDINGS: This was the first of a series of televised trials undertaken in cooperation with the Norwegian Broadcasting Company. We recruited adult volunteers in Norway through a nationally televised weekly health program. Participants went to our Web site and rated the relative importance of the consequences of treatment using visual analogue scales (VAS). They viewed the graphical display (or no information) to which they were randomized and were asked to decide whether to go to the doctor for an antibiotic prescription. We compared four presentations: face icons (happy/sad) or a bar graph showing the proportion of people with symptoms on day three with and without treatment, a bar graph of the average duration of symptoms, and a bar graph of proportion with symptoms on both days three and seven. Before completing the study, all participants were shown all the displays and detailed patient information about the treatment of sore throat and were asked to decide again. We calculated a relative importance score (RIS) by subtracting the VAS scores for the undesirable consequences of antibiotics from the VAS score for the benefit of symptom relief. We used logistic regression to determine the association between participants' RIS and their choice. 1,760 participants completed the study. There were statistically significant differences in the likelihood of choosing to go to the doctor in relation to different values (RIS). Of the four presentations, the bar graph of duration of symptoms resulted in decisions that were most consistent with the more fully informed second decision. Most participants also preferred this presentation (38%) and found it easiest to understand (37%). Participants shown the other three presentations were more likely to decide to go to the doctor based on their first decision than everyone based on the second decision. Participants preferred the graph using faces the least (14.4%). CONCLUSIONS: For decisions about going to the doctor to get antibiotics for sore throat, treatment effects presented by a bar graph showing the duration of symptoms helped people make decisions more consistent with their values than treatment effects presented as graphical displays of proportions of people with sore throat following treatment. CLINICAL TRIALS REGISTRATION: ISRCTN58507086.

How should the impact of different presentations of treatment effects on patient choice be evaluated? A pilot randomized trial.

BACKGROUND: Different presentations of treatment effects can affect decisions. However, previous studies have not evaluated which presentations best help people make decisions that are consistent with their own values. We undertook a pilot study to compare different methods for doing this. METHODS AND FINDINGS: We conducted an Internet-based randomized trial comparing summary statistics for communicating the effects of statins on the risk of coronary heart disease (CHD). Participants rated the relative importance of treatment consequences using visual analogue scales (VAS) and category rating scales (CRS) with five response options. We randomized participants to either VAS or CRS first and to one of six summary statistics: relative risk reduction (RRR) and five absolute measures of effect: absolute risk reduction, number needed to treat, event rates, tablets needed to take, and natural frequencies (whole numbers). We used logistic regression to determine the association between participants' elicited values and treatment choices. 770 participants age 18 or over and literate in English completed the study. In all, 13% in the VAS-first group failed to complete their VAS rating, while 9% of the CRS-first group failed to complete their scoring (p = 0.03). Different ways of weighting the elicited values had little impact on the analyses comparing the different presentations. Most (51%) preferred the RRR compared to the other five summary statistics (1% to 25%, p = 0.074). However, decisions in the group presented the RRR deviated substantially from those made in the other five groups. The odds of participants in the RRR group deciding to take statins were 3.1 to 5.8 times that of those in the other groups across a wide range of values (p = 0.0007). Participants with a scientific background, who were more numerate or had more years of education were more likely to decide not to take statins. CONCLUSIONS: Internet-based trials comparing different presentations of treatment effects are feasible, but recruiting participants is a major challenge. Despite a slightly higher response rate for CRS, VAS is preferable to avoid approximation of a continuous variable. Although most participants preferred the RRR, participants shown the RRR were more likely to decide to take statins regardless of their values compared with participants who were shown any of the five other summary statistics. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN85194921.

A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia.

BACKGROUND: This trial was conducted as part of a project that aims to enhance public understanding and use of research in decisions about healthcare by enabling viewers to participate in research and to follow the process, through television reports and on the web. Valerian is an herbal over-the-counter drug that is widely used for insomnia. Systematic reviews have found inconsistent and inconclusive results about its effects. METHODS: Participants were recruited through a weekly nationally televised health program in Norway. Enrolment and data collection were over the Internet. 405 participants who were 18 to 75 years old and had insomnia completed a two week diary-keeping run-in period without treatment and were randomised and mailed valerian or placebo tablets for two weeks. All participants and investigators were blind to treatment until after the analysis was completed. FINDINGS: For the primary outcome of a minimally important improvement in self-reported sleep quality (> or = 0.5 units on a 7 point scale), the difference between the valerian group (29%) and the placebo group (21%) was not statistically significant (difference 7.5%; 95% CI-0.9 to 15.9; p = 0.08). On the global self-assessment question at the end of the treatment period 5.5% (95% CI 0.2 to 10.8) more participants in the valerian group perceived their sleep as better or much better (p = 0.04). There were similar trends favouring the valerian group for night awakenings (difference = 6.0%, 95% CI-0.5 to 12.5) and sleep duration (difference = 7.5%, 95% CI-1.0 to 16.1). There were no serious adverse events and no important or statistically significant differences in minor adverse events. INTERPRETATION: Based on this and previous studies, valerian appears to be safe, but with modest beneficial effects at most on insomnia compared to placebo. The combined use of television and the Internet in randomised trials offers opportunities to answer questions about the effects of health care interventions and to improve public understanding and use of randomised trials. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN72748991.

International questionnaire postal response rate: an experiment comparing no return postage to provision of International Postage Vouchers--"Coupon-Réponse International".

BACKGROUND: Previous studies of methods to increase response rates on international postal surveys did not include providing return postage. We provided International Postage Vouchers--"Coupon-Réponse International" to cover this. The objective of this study was to see if these International Postage Vouchers had an effect on response rates. METHODS: Between-groups, randomized, after-only. RESULTS: There was no difference in response rates between the group that received International Postage Vouchers and the group that did not. (p = 0.23). CONCLUSION: International Postage Vouchers--"Coupon-Réponse International" have no effect on response rates for international postal surveys.

Medical messages in the media--barriers and solutions to improving medical journalism.

CONTEXT: Medical issues are widely reported in the mass media. These reports influence the general public, policy makers and health-care professionals. This information should be valid, but is often criticized for being speculative, inaccurate and misleading. An understanding of the obstacles medical reporters meet in their work can guide strategies for improving the informative value of medical journalism. OBJECTIVE: To investigate constraints on improving the informative value of medical reports in the mass media and elucidate possible strategies for addressing these. DESIGN: We reviewed the literature and organized focus groups, a survey of medical journalists in 37 countries, and semi-structured telephone interviews. RESULTS: We identified nine barriers to improving the informative value of medical journalism: lack of time, space and knowledge; competition for space and audience; difficulties with terminology; problems finding and using sources; problems with editors and commercialism. Lack of time, space and knowledge were the most common obstacles. The importance of different obstacles varied with the type of media and experience. Many health reporters feel that it is difficult to find independent experts willing to assist journalists, and also think that editors need more education in critical appraisal of medical news. Almost all of the respondents agreed that the informative value of their reporting is important. Nearly everyone wanted access to short, reliable and up-to-date background information on various topics available on the Internet. A majority (79%) was interested in participating in a trial to evaluate strategies to overcome identified constraints. CONCLUSIONS: Medical journalists agree that the validity of medical reporting in the mass media is important. A majority acknowledge many constraints. Mutual efforts of health-care professionals and journalists employing a variety of strategies will be needed to address these constraints.

Blind faith? The effects of promoting active sick leave for back pain patients: a cluster-randomized controlled trial.

STUDY DESIGN: A cluster-randomized controlled trial. OBJECTIVE: To evaluate the effects of two strategies to increase the use of active sick leave (ASL) among patients with low back pain (LBP) on improved return to work and quality of life. SUMMARY OF BACKGROUND DATA: Active sick leave is an option provided by the Norwegian National Insurance Administration that enables employees to return to modified duties at the workplace with 100% of normal wages. A proactive implementation strategy increased the use of ASL for LBP patients from 11.5% to 17.7% compared with a passive intervention and a control group ( = 0.006). METHODS: Sixty-five municipalities were randomly assigned to a passive intervention, a proactive intervention, or a control group. The interventions, which were designed to improve the use of ASL, were targeted at patients on sick leave for LBP for more than 16 days (n = 6179), their general practitioners, employers, and local insurance officers. The main outcome measures were the average number of days off work, the proportion of patients returning to work within 1 year, and self-reported quality of life while on sick leave. RESULTS: The median number of days on sick leave was similar in the proactive intervention group (70 days), the passive intervention group (68 days), and the control group (71 days) ( = 0.8). The proportion of patients returning to work before 50 weeks was also similar in the proactive (89%), passive (89.5%), and control groups (89.1%). Response rates for the questionnaires that were sent to patients were low (38%), and no significant differences were observed across the three groups for quality of life or patient satisfaction. CONCLUSIONS: It is not likely that efforts to increase the use of ASL will result in measurable economic benefits or improved health outcomes at the population level. The benefits of ASL for individual patients with LBP are not known.