[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Activity-based funding (ABF) of hospitals is a policy intervention intended to re-shape incentives across health systems through the use of diagnosis-related groups. Many countries are adopting or actively promoting ABF. We assessed the effect of ABF on key measures potentially affecting patients and health care systems: mortality (acute and post-acute care); readmission rates; discharge rate to post-acute care following hospitalization; severity of illness; volume of care. METHODS: We undertook a systematic review and meta-analysis of the worldwide evidence produced since 1980. We included all studies reporting original quantitative data comparing the impact of ABF versus alternative funding systems in acute care settings, regardless of language. We searched 9 electronic databases (OVID MEDLINE, EMBASE, OVID Healthstar, CINAHL, Cochrane CENTRAL, Health Technology Assessment, NHS Economic Evaluation Database, Cochrane Database of Systematic Reviews, and Business Source), hand-searched reference lists, and consulted with experts. Paired reviewers independently screened for eligibility, abstracted data, and assessed study credibility according to a pre-defined scoring system, resolving conflicts by discussion or adjudication. RESULTS: Of 16,565 unique citations, 50 US studies and 15 studies from 9 other countries proved eligible (i.e. Australia, Austria, England, Germany, Israel, Italy, Scotland, Sweden, Switzerland). We found consistent and robust differences between ABF and no-ABF in discharge to post-acute care, showing a 24% increase with ABF (pooled relative risk = 1.24, 95% CI 1.18-1.31). Results also suggested a possible increase in readmission with ABF, and an apparent increase in severity of illness, perhaps reflecting differences in diagnostic coding. Although we found no consistent, systematic differences in mortality rates and volume of care, results varied widely across studies, some suggesting appreciable benefits from ABF, and others suggesting deleterious consequences. CONCLUSIONS: Transitioning to ABF is associated with important policy- and clinically-relevant changes. Evidence suggests substantial increases in admissions to post-acute care following hospitalization, with implications for system capacity and equitable access to care. High variability in results of other outcomes leaves the impact in particular settings uncertain, and may not allow a jurisdiction to predict if ABF would be harmless. Decision-makers considering ABF should plan for likely increases in post-acute care admissions, and be aware of the large uncertainty around impacts on other critical outcomes.
[Show abstract][Hide abstract] ABSTRACT: INTRODUCTION:
Symptomatic hip osteoarthritis (OA) is a disabling condition with up to a 25% cumulative lifetime risk. Total hip arthroplasty (THA) is effective in relieving patients' symptoms and improving function. It is, however, associated with substantial risk of complications, pain and major functional limitation before patients can return to full function. In contrast, hip arthroscopy (HA) is less invasive and can postpone THA. However, there is no evidence regarding the delay in the need for THA that patients would find acceptable to undergoing HA. Knowing patients' values and preferences (VP) on this expected delay is critical when making recommendations regarding the advisability of HA. Furthermore, little is known on the optimal amount of information regarding interventions and outcomes needed to present in order to optimally elicit patients' VP.
METHODS AND ANALYSIS:
We will perform a multinational, structured interview-based survey of preference in delay time for THA among patients with non-advanced OA who failed to respond to conservative therapy. We will combine these interviews with a randomised trial addressing the optimal amount of information regarding the interventions and outcomes required to elicit preferences. Eligible patients will be randomly assigned (1 : 1) to either a short or a long format of health scenarios of THA and HA. We will determine each patient's VP using a trade-off and anticipated regret exercises. Our primary outcomes for the combined surveys will be: (1) the minimal delay time in the need for THA surgery that patients would find acceptable to undertaking HA, (2) patients' satisfaction with the amount of information provided in the health scenarios used to elicit their VPs.
ETHICS AND DISSEMINATION:
The protocol has been approved by the Hamilton Integrated Research Ethics Board (HIREB13-506). We will disseminate our study findings through peer-reviewed publications and conference presentations, and make them available to guideline makers issuing recommendations addressing HA and THA.
[Show abstract][Hide abstract] ABSTRACT: Background:Bridging the gap between clinical research and everyday healthcare practice requires effective communication strategies. To address current shortcomings in conveying practice recommendations and supporting evidence, we are creating and testing presentation formats for clinical practice guidelines (CPGs). Methods:We carried out multiple cycles of brainstorming and sketching, developing a prototype. Physicians participating in the user testing viewed CPG formats linked to clinical scenarios and engaged in semi-structured interviews applying a think-aloud method for exploring important aspects of user experience. Results:We developed a multilayered presentation format that allows clinicians to successively view more in depth information. Starting with the recommendations clinicians can on demand access a rationale and a key information section containing statements on quality of the evidence, balance between desirable and undesirable consequences, values and preferences, and resource considerations. We collected feedback from 27 stakeholders and performed user testing with 47 practicing physicians from six countries. Advisory group feedback and user testing of the first version revealed problems with conceptual understanding of underlying CPG methodology, as well as difficulties with the complexity of the layout and content. Extensive revisions made before the second round of user testing resulted in most participants expressing overall satisfaction with the final presentation format. Conclusion:We have developed an electronic multilayered CPG format that enhances the usability of CPGs for front-line clinicians. We have implemented the format in electronic guideline tools which guideline organizations can now use when authoring and publishing their guidelines.
[Show abstract][Hide abstract] ABSTRACT: The purpose of this study was to determine if the SPRINT definition of a "critical-sized defect" (fracture gap at least 1 cm in length and involving over 50 % of the cortical diameter) was accurate, to discern which factors predict reoperation in patients with these defects, and to compare the patient-based outcomes of these patients to patients without a critical defect.
[Show abstract][Hide abstract] ABSTRACT: Although multivessel coronary artery disease has been associated with poor health outcomes in patients with acute ST-segment elevation myocardial infarction (STEMI), the optimal approach to revascularization remains uncertain. The objective of this review was to determine the benefits and harms of culprit vessel only vs immediate complete percutaneous coronary intervention (PCI) in patients with acute STEMI. We searched MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) for randomized controlled trials (RCTs). Teams of 2 reviewers, independently and in duplicate, screened titles and abstracts, completed full-text reviews, and abstracted data. We calculated pooled risk ratios (RRs) and associated 95% confidence intervals (CIs) using random-effect models for nonfatal myocardial infarction (MI), revascularization, cardiovascular mortality, all-cause mortality, and adverse events, and used the GRADE approach to rate confidence in estimates of effect. Of 341 patients randomized to complete revascularization and followed to study conclusion, 31 experienced revascularization, as did 80 of 324 randomized to culprit vessel only revascularization (RR: 0.35, 95% CI: 0.24-0.53). Ten patients in the complete revascularization group and 28 patients in the culprit vessel only revascularization group experienced nonfatal MI (RR: 0.35, 95% CI: 0.17-0.72). All-cause mortality and cardiac deaths did not differ between groups (RR: 0.69, 95% CI: 0.40-1.21 for all-cause mortality; RR: 0.48, 95% CI: 0.22-1.04 for cardiac deaths). Pooled data from 3 RCTs suggest that immediate complete revascularization probably reduces revascularization in patients with acute STEMI; although results suggest possible benefits on MI and death, confidence in estimates is low.
[Show abstract][Hide abstract] ABSTRACT: Although previous evidence suggests advantages of nifedipine over terbutaline as tocolytic agents, in some jurisdictions, terbutaline is approved for use and nifedipine is not. In women in preterm labour, we compared the impact of terbutaline versus nifedipine on inhibition of uterine contractions, preterm birth, neonatal sepsis, intracranial haemorrhage or necrotizing enterocolitis, death or admission to a neonatal intensive care unit and maternal adverse reactions. We randomized 32 women to nifedipine and 34 to terbutaline. We found no difference between groups in tocolysis or preterm birth. No serious maternal adverse effects or serious neonatal adverse outcomes occurred in either group. Less serious maternal adverse effects less common with terbutaline included flushing (2.94% versus 43.7%) and headache (5.9% versus 31.2%). The administration of terbutaline increased tremor (76.4% versus 0%), nausea (58.8% versus 9.4%) and dizziness (29.4% versus 6.25%). The total number of side effects, and the proportion of women experiencing one or more side effects, proved greater with terbutaline.In this study, terbutaline and nifedipine performed similarly in their tocolytic effects. Each drug has specific side effects, though overall, nifedipine was associated with fewer adverse effects.This article is protected by copyright. All rights reserved.
[Show abstract][Hide abstract] ABSTRACT: Background: The safety of biological agents used to treat psoriasis remains uncertain. Objective: The authors determined the frequency and severity of adverse effects associated with use of biologic agents for psoriasis through patient-registered lawsuits to the government of Sao Paulo, Brazil. Methods: Sources of information included legal records, dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients who used biologic drugs during 2004 - 2011, inquiring about medication-related adverse drug reactions (ADRs) and serious adverse events (SAEs). Results: Of the 218 patients identified, 15 proved ineligible or refused participation. 203 patients were interviewed, with 111 (54.7%) taking infliximab, 43 (21.2%) efalizumab, 35 (17.2%) etanercept and 14 (6.9%) adalimumab. Of 84 (41.4%) patients who experienced one or more ADR related to biological agents, 57 (67.9%) experienced one or more SAE. The only risk factor associated with ADRs was comorbidity odds ratio = 6.54 (95% confident interval [CI] 3.20 - 13.32), p < 0.0001. Conclusion: Biologic agents were associated with high rates of ADRs and SAEs. The data suggests that for patients taking a biologic agent to treat psoriasis and who have one or more comorbidities, warnings of possible adverse events and enhanced surveillance are warranted.
Expert Opinion on Drug Safety 07/2014; · 2.74 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Fluid resuscitation is the cornerstone of sepsis treatment. However, whether balanced or unbalanced crystalloids or natural or synthetic colloids confer a survival advantage is unclear.
Annals of internal medicine 07/2014; · 13.98 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE:
To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications.
Cohort of protocols of randomised controlled trial and subsequent full journal publications.
Six research ethics committees in Switzerland, Germany, and Canada.
894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications.
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.
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.
BMJ: British medical journal 07/2014; · 16.30 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Clinical decisions should be based on the totality of the best evidence and not the results of individual studies. When clinicians apply the results of a systematic review or meta-analysis to patient care, they should start by evaluating the credibility of the methods of the systematic review, ie, the extent to which these methods have likely protected against misleading results. Credibility depends on whether the review addressed a sensible clinical question; included an exhaustive literature search; demonstrated reproducibility of the selection and assessment of studies; and presented results in a useful manner. For reviews that are sufficiently credible, clinicians must decide on the degree of confidence in the estimates that the evidence warrants (quality of evidence). Confidence depends on the risk of bias in the body of evidence; the precision and consistency of the results; whether the results directly apply to the patient of interest; and the likelihood of reporting bias. Shared decision making requires understanding of the estimates of magnitude of beneficial and harmful effects, and confidence in those estimates.
JAMA The Journal of the American Medical Association 07/2014; 312(2):171-9. · 29.98 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The American College of Chest Physicians Antithrombotic Guidelines ninth iteration placed restrictions on panelists with recommendations on which they disclosed a primary conflict of interest (COI). We aimed to describe panelists' financial and intellectual COI and evaluate to what extent, beyond assessing financial COI, assessing intellectual COI affected COI management.
[Show abstract][Hide abstract] ABSTRACT: Low back pain (LBP) is a common complaint among workers receiving Workers' Compensation wage replacement benefits. We used the administrative data from the Ontario Workplace Safety and Insurance Board (WSIB) to explore the association between baseline characteristics and commonly reimbursed therapies and time to claim closure among workers disabled due to LBP.
EPICOH 2014-Challenges for Occupational Epidemiology in the 21-st Century, Chicago, USA; 06/2014