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Background: Routinely collected hospital data provide increasing opportunities to assess the performance of health care systems. Several factors may, however, influence performance measures and their interpretation between countries., Objective: We compared the occurrence of in-hospital venous thromboembolism (VTE) in patients undergoing hip replacement across 5 countries and explored factors that could explain differences across these countries., Methods: We performed cross-sectional studies independently in 5 countries: Canada; France; New Zealand; the state of California; and Switzerland. We first calculated the proportion of hospital inpatients with at least one deep vein thrombosis (DVT) or pulmonary embolism by using numerator codes from the corresponding Patient Safety Indicator. We then compared estimates from each country against a reference value (benchmark) that displayed the baseline risk of VTE in such patients. Finally, we explored length of stay, number of secondary diagnoses coded, and systematic use of ultrasound to detect DVT as potential factors that could explain between-country differences., Results: The rates of VTE were 0.16% in Canada, 1.41% in France, 0.84% in New Zealand, 0.66% in California, and 0.37% in Switzerland, while the benchmark was 0.58% (95% confidence interval, 0.35-0.81). Factors that could partially explain differences in VTE rates between countries were hospital length of stay, number of secondary diagnoses coded, and proportion of patients who received lower limb ultrasound to screen for DVT systematically before hospital discharge. An exploration of the French data showed that the systematic use of ultrasound may be associated with over detection of DVT but not pulmonary embolism., Conclusions: In-hospital VTE rates after arthroplasty vary widely across countries, and a combination of clinical, data-related, and health system factors explain some of the variations in VTE rates across countries.

Objectives: Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials., Design: Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003., Setting: Randomized clinical trials involving patients in an acute or nonacute care setting., Subjects and Interventions: We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators., Measurements and Main Results: Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size., Conclusions: Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.

Objective: To investigate the prevalence of discontinuation and nonpublication of surgical versus medical randomized controlled trials (RCTs) and to explore risk factors for discontinuation and nonpublication of surgical RCTs., Background: Trial discontinuation has significant scientific, ethical, and economic implications. To date, the prevalence of discontinuation of surgical RCTs is unknown., Methods: All RCT protocols approved between 2000 and 2003 by 6 ethics committees in Canada, Germany, and Switzerland were screened. Baseline characteristics were collected and, if published, full reports retrieved. Risk factors for early discontinuation for slow recruitment and nonpublication were explored using multivariable logistic regression analyses., Results: In total, 863 RCT protocols involving adult patients were identified, 127 in surgery (15%) and 736 in medicine (85%). Surgical trials were discontinued for any reason more often than medical trials [43% vs 27%, risk difference 16% (95% confidence interval [CI]: 5%-26%); P = 0.001] and more often discontinued for slow recruitment [18% vs 11%, risk difference 8% (95% CI: 0.1%-16%); P = 0.020]. The percentage of trials not published as full journal article was similar in surgical and medical trials (44% vs 40%, risk difference 4% (95% CI: -5% to 14%); P = 0.373). Discontinuation of surgical trials was a strong risk factor for nonpublication (odds ratio = 4.18, 95% CI: 1.45-12.06; P = 0.008)., Conclusions: Discontinuation and nonpublication rates were substantial in surgical RCTs and trial discontinuation was strongly associated with nonpublication. These findings need to be taken into account when interpreting surgical literature. Surgical trialists should consider feasibility studies before embarking on full-scale trials.

Objective: To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications., Design: Cohort of protocols of randomised controlled trial and subsequent full journal publications., Setting: Six research ethics committees in Switzerland, Germany, and Canada., Data Sources: 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications., Results: Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis., Conclusions: Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials., (© The DISCO study group 2014.)

Importance: The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear., Objectives: To determine the prevalence, characteristics, and publication history of discontinued RCTs and to investigate factors associated with RCT discontinuation due to poor recruitment and with nonpublication., Design and Setting: Retrospective cohort of RCTs based on archived protocols approved by 6 research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics and planned recruitment from included protocols. Last follow-up of RCTs was April 27, 2013., Main Outcomes and Measures: Completion status, reported reasons for discontinuation, and publication status of RCTs as determined by correspondence with the research ethics committees, literature searches, and investigator surveys., Results: After a median follow-up of 11.6 years (range, 8.8-12.6 years), 253 of 1017 included RCTs were discontinued (24.9% [95% CI, 22.3%-27.6%]). Only 96 of 253 discontinuations (37.9% [95% CI, 32.0%-44.3%]) were reported to ethics committees. The most frequent reason for discontinuation was poor recruitment (101/1017; 9.9% [95% CI, 8.2%-12.0%]). In multivariable analysis, industry sponsorship vs investigator sponsorship (8.4% vs 26.5%; odds ratio [OR], 0.25 [95% CI, 0.15-0.43]; P < .001) and a larger planned sample size in increments of 100 (-0.7%; OR, 0.96 [95% CI, 0.92-1.00]; P = .04) were associated with lower rates of discontinuation due to poor recruitment. Discontinued trials were more likely to remain unpublished than completed trials (55.1% vs 33.6%; OR, 3.19 [95% CI, 2.29-4.43]; P < .001)., Conclusions and Relevance: In this sample of trials based on RCT protocols from 6 research ethics committees, discontinuation was common, with poor recruitment being the most frequently reported reason. Greater efforts are needed to ensure the reporting of trial discontinuation to research ethics committees and the publication of results of discontinued trials.

Rationale and Objective: The information assessment method (IAM) permits health professionals to systematically document the relevance, cognitive impact, use and health outcomes of information objects delivered by or retrieved from electronic knowledge resources. The companion review paper (Part 1) critically examined the literature, and proposed a 'Push-Pull-Acquisition-Cognition-Application' evaluation framework, which is operationalized by IAM. The purpose of the present paper (Part 2) is to examine the content validity of the IAM cognitive checklist when linked to email alerts., Methods: A qualitative component of a mixed methods study was conducted with 46 doctors reading and rating research-based synopses sent on email. The unit of analysis was a doctor's explanation of a rating of one item regarding one synopsis. Interviews with participants provided 253 units that were analysed to assess concordance with item definitions., Results and Conclusion: The content relevance of seven items was supported. For three items, revisions were needed. Interviews suggested one new item. This study has yielded a 2008 version of IAM., (© 2010 Blackwell Publishing Ltd.)

Canadian healthcare is changing. Over the course of the past decade, the Health Care in Canada Survey (HCIC) has annually measured the reactions of the public and professional stakeholders to many of these change forces. In HCIC 2008, for the first time, the public's perception of their health status and all stakeholders' views of the burden and effective management of chronic diseases were sought. Overall, Canadians perceive themselves as healthy, with 84% of adults reporting good-to-excellent health. However, good health decreased with age as the occurrence of chronic illness rose, from 12% in the age group 18-24 to 65% for the population =65 years. More than 70% of all stakeholders were strongly or somewhat supportive of the implementation of coordinated care, or disease management programs, to improve the care of patients with chronic illnesses. Concordant support was also expressed for key disease management components, including coordinated interventions to improve home, community and self-care; increased wellness promotion; and increased use of clinical measurements and feedback to all stakeholders. However, there were also important areas of non-concordance. For example, the public and doctors consistently expressed less support than other stakeholders for the value of team care, including the use of non-physician professionals to provide patient care; increased patient involvement in decision-making; and the use of electronic health records to facilitate communication. The actual participation in disease management programs averaged 34% for professionals and 25% for the public. We conclude that chronic diseases are common, age-related and burdensome in Canada. Disease management or coordinated intervention often delivered by teams is also relatively common, despite its less-than-universal acceptance by all stakeholders. Further insights are needed, particularly into the variable perceptions of the value and efficacy of team-delivered healthcare and its important components.

Objectives: Implementation of the International Statistical Classification of Disease and Related Health Problems, 10th Revision (ICD-10) coding system presents challenges for using administrative data. Recognizing this, we conducted a multistep process to develop ICD-10 coding algorithms to define Charlson and Elixhauser comorbidities in administrative data and assess the performance of the resulting algorithms., Methods: ICD-10 coding algorithms were developed by "translation" of the ICD-9-CM codes constituting Deyo's (for Charlson comorbidities) and Elixhauser's coding algorithms and by physicians' assessment of the face-validity of selected ICD-10 codes. The process of carefully developing ICD-10 algorithms also produced modified and enhanced ICD-9-CM coding algorithms for the Charlson and Elixhauser comorbidities. We then used data on in-patients aged 18 years and older in ICD-9-CM and ICD-10 administrative hospital discharge data from a Canadian health region to assess the comorbidity frequencies and mortality prediction achieved by the original ICD-9-CM algorithms, the enhanced ICD-9-CM algorithms, and the new ICD-10 coding algorithms., Results: Among 56,585 patients in the ICD-9-CM data and 58,805 patients in the ICD-10 data, frequencies of the 17 Charlson comorbidities and the 30 Elixhauser comorbidities remained generally similar across algorithms. The new ICD-10 and enhanced ICD-9-CM coding algorithms either matched or outperformed the original Deyo and Elixhauser ICD-9-CM coding algorithms in predicting in-hospital mortality. The C-statistic was 0.842 for Deyo's ICD-9-CM coding algorithm, 0.860 for the ICD-10 coding algorithm, and 0.859 for the enhanced ICD-9-CM coding algorithm, 0.868 for the original Elixhauser ICD-9-CM coding algorithm, 0.870 for the ICD-10 coding algorithm and 0.878 for the enhanced ICD-9-CM coding algorithm., Conclusions: These newly developed ICD-10 and ICD-9-CM comorbidity coding algorithms produce similar estimates of comorbidity prevalence in administrative data, and may outperform existing ICD-9-CM coding algorithms.

Quality of health care has been a subject of attention for many years in the USA and in Europe. Since the introduction of the new federal law on insurance in 1996 it has evolved to a progressively more important issue within the Swiss health care system. In this review, some theoretical concepts of quality of health care, variations, and surveillance systems are explored. Examples of quality of health care surveillance systems that have been developed successfully in the USA, in Canada, in Australia, and in Europe are discussed. They all demonstrate the interest in creating a large range of quality indicators in the surveillance system and in evaluating hospital performance using a benchmark approach. Currently, the measurement of quality with appropriate indicators is a subject of intense debate between the Swiss Hospitals Association (H+) and the Swiss Health Insurance Consortium (Santésuisse). Examples of existing surveillance systems in Switzerland are the Outcome Verein in Zurich and the quality of care program of the Canton of Valais. The FoQual association has also contributed to the debate by reviewing six indicators, which could be used nationally for a healthcare surveillance system. In this debate it is important to stress that ideal quality indicators intended for use as measures of quality in Swiss hospitals need to be both appropriate and valid. Only indicators that fulfil these conditions should be integrated in a Swiss health care surveillance system. Priority needs to be given to quality indicators and methods with the highest level of evidence and with a solid scientific basis.