Assessing variability and uncertainty in orthopedic randomized controlled trials.
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ABSTRACT:
SUBMITTER: Raittio L
PROVIDER: S-EPMC8023899 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:This study sought to evaluate whether restrictive blood transfusion strategies are associated with a risk of infection in orthopedic patients by conducting a meta-analysis of randomized controlled trials (RCTs). RCTs with restrictive versus liberal red blood cell (RBC) transfusion strategies were identified by searching Medline, Embase, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews from their inception to December 2014. Eight RCTs with infections as outcomes were included in the final analysis. According to the Jadad scale, all studies were considered to be of high quality. The pooled risk ratio [RR] for the association between transfusion strategy and infection was 0.65 (95% CI, 0.47-0.91; p = 0.012), and the number of patients needed to treat to avoid an infection using a restrictive transfusion strategy was 62. No heterogeneity was observed. The sensitivity analysis indicated unstable results, and no significant publication bias was observed. This meta-analysis of RCTs demonstrates that restrictive transfusion strategies in orthopedic patients result in a significant reduction in infections compared with more liberal strategies.
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Project description:AimsTo compare the characteristics of individuals participating in randomized controlled trials (RCTs) of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods. Design Analyses using data from RCT samples from the National Institute of Drug Abuse Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set-Admissions (TEDS-A). Settings Multiple clinical trial sites and nation-wide usual SUD treatment settings in the United States.ParticipantsA total of 3592 individuals from 10 CTN samples and 1 602 226 individuals selected from TEDS-A between 2001 and 2009. Measurements The propensity scores for enrolling in the RCTs were computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use and the number of prior treatments. Findings The proportion of those with ≥ 12 years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively, at P < 0.001). The pooled difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at P < 0.001.ConclusionsIn the United States, individuals recruited into randomized controlled trials of substance use disorder treatments appear to be very different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings.
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Project description:PurposeThe purpose of this study was to compare outcomes assessed in extant randomized controlled trials (RCTs) to outcomes that stakeholders expect from survivorship care plans (SCPs). To facilitate the transition from active treatment to follow-up care for the 15.5 million US cancer survivors, many organizations require SCP use. However, results of several RCTs of SCPs' effectiveness have been null, possibly because they have evaluated outcomes on which SCPs should be expected to have limited influence. Stakeholders (e.g., survivors, oncologists) may expect outcomes that differ from RCTs' outcomes.MethodsWe identified RCTs' outcomes using a PubMed literature review. We identified outcomes that stakeholders expect from SCPs using semistructured interviews with stakeholders in three healthcare systems in the USA and Canada. Finally, we mapped RCTs' outcomes onto stakeholder-identified outcomes.ResultsRCT outcomes did not fully address outcomes that stakeholders expected from SCPs, and RCTs assessed outcomes that stakeholders did not expect from SCPs. RCTs often assessed outcomes only from survivors' perspectives.ConclusionsRCTs of SCPs' effectiveness have not assessed outcomes that stakeholders expect. To better understand SCPs' effectiveness, future RCTs should assess outcomes of SCP use that are relevant from the perspective of multiple stakeholders.Implications for cancer survivorsSCPs' effectiveness may be optimized when used with an eye toward outcomes that stakeholders expect from SCPs. For survivors, this means using SCPs as a map to guide them with respect to what kind of follow-up care they should seek, when they should seek it, and from whom they should seek it.
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Project description:Coastal urban infrastructure and water management programs are vulnerable to the impacts of long-term hydroclimatic changes and to the flooding and physical destruction of disruptive hurricanes and storm surge. Water resilience or, inversely, vulnerability depends on design specifications of the storm and inundation, against which water infrastructure and environmental assets are planned and operated. These design attributes are commonly derived from statistical modeling of historical measurements. Here we argue for the need to carefully examine the approach and associated design vulnerability in coastal areas because of the future hydroclimatic changes and large variability at local coastal watersheds. This study first shows significant spatiotemporal variations of design storm in the Chesapeake Bay of the eastern U.S. Atlantic coast, where the low-frequency high-intensity precipitations vary differently to the tropical cyclones and local orographic effects. Average and gust wind speed exhibited much greater spatial but far less temporal variability than the precipitation. It is noteworthy that these local variabilities are not fully described by the regional gridded precipitation used in CMIP5 climate downscaling and by NOAA's regional design guide Atlas-14. Up to 46.4% error in the gridded precipitation for the calibration period 1950-1999 is further exacerbated in the future design values by the ensemble of 132 CMIP5 projections. The total model projection error (δM) up to -61.8% primarily comes from the precipitation regionalization (δ1), climate downscaling (δ2), and a fraction from empirical data modeling (δE). Thus, a post-bias correction technique is necessary. The bias-corrected design wind speed for 10-yr to 30-yr storms has small changes <20% by the year 2100, but contains large spatial variations even for stations of close proximity. Bias-corrected design precipitations are characteristic of large spatial variability and a notable increase of 2-5 year precipitation in the future along western shores of the Lower and Middle Chesapeake Bay. All these accounts point to the potential vulnerability of water infrastructure and water program in coastal areas, when the hydrological design basis using regional values fails to account for significant spatiotemporal precipitation variations in local coastal watersheds.
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Project description:BackgroundDeliberate hypotension has been shown to reduce the intraoperative bleeding and the need for allogeneic blood transfusion, and improve the surgical field, but there is still controversy on its clinical safety. This systematic review was designed to assess the safety and benefits of deliberate hypotension for orthopedic surgery.MethodsThe review met the requirements of the PRISMA guidelines. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, ISI Web of Science, ScienceDirect, and four Chinese databases (China National Knowledge Infrastructure, Wanfang, vip citation database, and updated version of China Biology Medicine disc from January 1, 2000 to January 1, 2019) were searched. All parallel randomized controlled trials comparing the effects of using deliberate hypotension with not using deliberate hypotension on clinical outcomes of patients undergoing orthopedic surgery were selected. The primary outcome was overall mortality. The secondary outcomes were the intraoperative blood loss, blood transfusion volume, and serious adverse postoperative events.ResultsA total of 30 studies with 36 comparisons (1454 participants) were included in meta-analysis. Two studies with 120 participants reported overall mortality and the result was zero (low-quality evidence). The use of deliberate hypotension reduced the intraoperative blood loss (mean difference, -?376.7; 95% CI -?428.1 to -?325.3; I2 = 94%; 29 studies, 36 comparisons, and 1398 participants; low-quality evidence) and blood transfusion volume (mean difference, -?242.5; 95% CI -?302.5 to -?182.6; I2 = 95%; 13 studies, 14 comparisons, and 544 participants; low-quality evidence). Six studies with 286 participants reported the occurrence of serious adverse postoperative events and the result was zero (low-quality evidence). Subgroup analyses according to age groups, controlled mean artery pressure levels, types of orthopedic surgeries, different combinations of other blood conservative method, and hypotensive methods mostly did not explain heterogeneity; significant differences were identified in almost all subgroups.ConclusionsBased on the available evidence, it is still unclear whether or not deliberate hypotension is a safe technique for orthopedic surgery due to limited studies with very small sample size, though it may decrease the intraoperative blood loss and blood transfusion volume irrespective of age groups, controlled mean artery pressure levels, types of surgeries, hypotensive methods, or different combinations of other blood conservation strategies.Trial registrationPROSPERO CRD42016045480.
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Project description:This systematic review evaluated the reporting quality of COVID-19 vaccine randomized controlled trials (RCTs). Relevant RCTs published between July 20, 2020 and June 11, 2021 were identified in the PubMed database by two independent reviewers. Study quality was evaluated with the 2010 AND 2001 Consolidated Standards of Reporting Trials (CONSORT) adherence scores. A total of 22 RCTs were included. The median CONSORT adherence score according to the 2010 criteria was 21 (range, 12-25), thus indicating that 75% of the items in more than half of the RCTs had clear reports. Univariate analysis showed that CONSORT adherence scores were not predicted by category; analysis of variance also showed no significant difference between groups. Our results indicated that the overall quality of COVID-19 vaccine RCTs was very good. Current evidence indicates that a variety of COVID-19 vaccines are effective. No RCTs have reported serious adverse effects such as mortality.
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Project description:BackgroundBlinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments.Methods and findingsWe undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1) established blinding of patients or health care providers, (2) maintained the blinding of patients or health care providers, and (3) obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58%) describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage), or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or photography), or adjudication of clinical events.ConclusionsThis review classifies blinding methods and provides a detailed description of methods that could help trialists overcome some barriers to blinding in clinical trials and readers interpret the quality of pharmacologic trials.
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Project description:Hemodynamic optimization during surgery is of major importance to decrease postoperative morbidity and length of hospital stay. However, conventional cardiac output monitoring is rarely used at the bedside. Recently, the plethysmographic variability index (PVI) was described as a simplified alternative, using plug-and-play noninvasive technology, but its clinical utility remains to be established.The hemodynamic optimization using the PVI (OPVI) trial is a multicenter randomized controlled two-arm trial, randomizing 440 patients at intermediate risk of postoperative complications after orthopedic surgery. Hemodynamic optimization was conducted using either the PVI (PVI group) or conventional mean arterial pressure (control group). The anesthesiologist performed the randomization the day before surgery using an interactive web response system, available 24 hours a day, 7 days a week. The randomization sequence was generated using permutated blocks and stratified by center and type of surgery (knee or hip arthoplasty). Patients and surgeons, but not anesthesiology staff, were blinded to the allocation group. The primary outcome measure is the length of hospital stay following surgery. The attending surgeon, who was blinded to group assessment, determined hospital discharge. Secondary outcome measures are theoretical length of hospital stay, determined using a dedicated discharge-from-hospital checklist, postoperative arterial lactate level in the recovery room, postoperative troponin level, presence of serious postoperative cardiac complications, and postoperative acute kidney insufficiency.The OPVI trial is the first multicenter randomized controlled study to investigate whether perioperative hemodynamic optimization using PVI during orthopedic surgery could decrease the length of hospital stay and postoperative morbidity.ClinicalTrials.gov NCT02207296 .
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Project description:BackgroundTelemedicine can help mitigate important health care challenges, such as demographic changes and the current COVID-19 pandemic, in high-income countries such as Germany. It gives physicians and patients the opportunity to interact via video consultations, regardless of their location, thus offering cost and time savings for both sides.ObjectiveWe aimed to investigate whether telemedicine can be implemented efficiently in the follow-up care for patients in orthopedic and trauma surgery, with respect to patient satisfaction, physician satisfaction, and quality of care.MethodsWe conducted a prospective randomized controlled trial in a German university hospital and enrolled 60 patients with different knee and shoulder conditions. For follow-up appointments, patients received either an in-person consultation in the clinic (control group) or a video consultation with their physician (telemedicine group). Patients' and physicians' subsequent evaluations of these follow-up appointments were collected and assessed using separate questionnaires.ResultsOn the basis of data from 52 consultations after 8 withdrawals, it was found that patients were slightly more satisfied with video consultations (mean 1.58, SD 0.643) than with in-clinic consultations (mean 1.64, SD 0.569), although the difference was not statistically significant (P=.69). After excluding video consultations marred by technical problems, no significant difference was found in physician satisfaction between the groups (mean 1.47, SD 0.516 vs mean 1.32, SD 0.557; P=.31). Further analysis indicated that telemedicine can be applied to broader groups of patients and that patients who have prior experience with telemedicine are more willing to use telemedicine for follow-up care.ConclusionsTelemedicine can be an alternative and efficient form of follow-up care for patients in orthopedic and trauma surgery in Germany, and it has no significant disadvantages compared with in-person consultations in the clinic.Trial registrationGerman Clinical Trials Register DRKS00023445; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023445.
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