scholarly journals Outcome Measures Used in Arthroplasty Trials: Systematic Review of the 2008 and 2013 Literature

2017 ◽  
Vol 44 (8) ◽  
pp. 1277-1287 ◽  
Author(s):  
Bethan L. Richards ◽  
Peter D.H. Wall ◽  
Andrew P. Sprowson ◽  
Jasvinder A. Singh ◽  
Rachelle Buchbinder

Objective.Previously published literature assessing the reporting of outcome measures used in joint replacement randomized controlled trials (RCT) has revealed disappointing results. It remains unknown whether international initiatives have led to any improvement in the quality of reporting and/or a reduction in the heterogeneity of outcome measures used. Our objective was to systematically assess and compare primary outcome measures and the risk of bias in joint replacement RCT published in 2008 and 2013.Methods.We searched MEDLINE, EMBASE, and CENTRAL for RCT investigating adult patients undergoing joint replacement surgery. Two authors independently identified eligible trials, extracted data, and assessed risk of bias using the Cochrane tool.Results.Seventy RCT (30 in 2008, 40 in 2013) met the eligibility criteria. There was no significant difference in the number of trials judged to be at low overall risk of bias (n = 6, 20%) in 2008 compared with 2013 [6 (15%); chi-square = 0.302, p = 0.75]. Significantly more trials published in 2008 did not specify a primary outcome measure (n = 25, 83%) compared with 18 trials (45%) in 2013 (chi-square = 10.6316, p = 0.001). When specified, there was significant heterogeneity in the measures used to assess primary outcomes.Conclusion.While less than a quarter of trials published in both 2008 and 2013 were judged to be at low overall risk of bias, significantly more trials published in 2013 specified a primary outcome. Although this might represent a temporal trend toward improvement, the overall frequency of primary outcome reporting and the wide heterogeneity in primary outcomes reported remain suboptimal.

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Igho Onakpoya ◽  
Rohini Terry ◽  
Edzard Ernst

The purpose of this paper is to assess the efficacy of green coffee extract (GCE) as a weight loss supplement, using data from human clinical trials. Electronic and nonelectronic searches were conducted to identify relevant articles, with no restrictions in time or language. Two independent reviewers extracted the data and assessed the methodological quality of included studies. Five eligible trials were identified, and three of these were included. All studies were associated with a high risk of bias. The meta-analytic result reveals a significant difference in body weight in GCE compared with placebo (mean difference: kg; 95%CI: , ). The magnitude of the effect is moderate, and there is significant heterogeneity amongst the studies. It is concluded that the results from these trials are promising, but the studies are all of poor methodological quality. More rigorous trials are needed to assess the usefulness of GCE as a weight loss tool.


2016 ◽  
Vol 96 (5) ◽  
pp. 641-649 ◽  
Author(s):  
Julie C. Kendall ◽  
Jan Hartvigsen ◽  
Michael F. Azari ◽  
Simon D. French

Background Nonpharmacological interventions have been shown to have some effectiveness in adults with dizziness; however, the effectiveness of these interventions in older people is unknown. Purpose The aim of this study was to determine the effects of conservative nonpharmacological interventions for dizziness in older people. Data Sources The Cochrane Central Register of Controlled Trials, PubMed, EMBASE, SCOPUS, CINAHL, AMED, Index to Chiropractic Literature, PsycINFO, and MANTIS were searched from inception to May 2014. Study Selection Two investigators independently screened controlled trials with participants who were more than 60 years old and experienced dizziness. Studies of participants with dizziness from a specific diagnosis, such as Ménière disease and benign paroxysmal positional vertigo, were excluded. Outcome measures from the selected studies included self-reported dizziness and postural balance. Data Extraction Two investigators independently extracted data on participants, interventions, comparison group, outcome measures, and results. The risk of bias of the included studies was assessed with Cochrane guidelines. Data Synthesis Seven articles consisting of 7 controlled trials were included. All studies involved some form of exercise, including vestibular rehabilitation exercises, postural balance exercises, and tai chi exercise, as the main intervention. The studies had a high risk of bias because of the lack of adequate randomization and allocation concealment, the lack of reporting on cointerventions, the lack of reporting on reasons for dropouts, and the lack of reporting on participant adherence. Limitations Heterogeneity among the included studies in interventions and outcome measures prohibited a meta-analysis. Only 2 studies reported a significant difference between the intervention group and the comparison group for self-reported dizziness. Conclusions There is insufficient evidence to determine the effectiveness of nonpharmacological treatments for dizziness in older people. Current evidence is hampered by a high risk of bias, and well-designed trials with adequate masking, randomization, and adherence are needed.


2021 ◽  
Author(s):  
◽  
Rebecca Jane Jarden

<p>Background: Enteral nutrition is one method of delivering nutrition to intubated patients. There are several issues that prevent optimal delivery of the prescribed enteral nutrition goal rates. The measurement of the patient's gastric residual volume (GRV) may demonstrate tolerability, or intolerability, of enteral nutrition. Identifying a safe GRV, at which to accept and continue enteral nutrition delivery, is essential to ensure the delivery of enteral nutrition adequately achieves the nutritional requirements of patients, and to mitigate the risks associated with the delivery of enteral nutrition. Objectives: This systematic review sought to answer the research question: what is the maximum GRV to accept in order to continue the delivery of enteral nutrition in the Intensive Care Unit (ICU) adult patient? This is specifically related to the primary outcome measures indicative of accepting a specified GRV that is too high or too low. Accepting a GRV that is too high would put the patient at risk of vomiting, regurgitation, aspiration of gastric contents and potentially aspiration pneumonia. Conversely, accepting a GRV that is too low would put the patient at risk of not achieving caloric needs, potentially placing the patient at risk of malnutrition and increased morbidity. Search methods: Databases searched included: CCTR, CLCMR, CLTA, CLEED, OVID MEDLINE (R) (Ovid SP), EMBASE, CINAHL Plus with Full Text (EBSCO host via helicon), AMED, Ovid Nursing Full Text plus, CDSR, ACP Journal Club, DARE, Proquest via helicon (advanced search), Pubmed via helicon (limits "all adult", "humans", "abstract", "title"), all EBM reviews, and the reference lists of articles. Selection criteria: The types of studies eligible for inclusion were published randomised controlled trials, case controlled studies, cohort studies and observational studies. Interventions considered were a comparison of two or more GRV measures. The participants eligible were adult ICU or critical care patients receiving enteral nutrition. The primary outcome measures for study inclusion were caloric requirement met, and specified potential adverse events including vomiting, regurgitation, or aspiration. Data collection and analysis: Data was extracted using a data extraction tool created by the researcher. Risk of bias was assessed by the author using two risk of bias assessment tools. Main results: Three studies met the inclusion criteria for the systematic review (McClave et al., 2005; Metheny, Schallom, Oliver, & Clouse, 2008; Pinilla, Samphire, Arnold, Liu, & Thiessen, 2001). Each of these studies contained methodological risks of bias and limitations related to their study designs. McClave et al.'s study was a prospective study (n = 40), Metheny et al.'s study was a prospective descriptive study (n = 206), and Pinilla et al.'s study was a randomised controlled trial (n = 80). No one study, or a combination of studies, provided conclusive evidence to support the use of one particular GRV over another. Author's conclusion: No recommendation for a definitive GRV was made in this systematic review due to the lack of strong evidentiary support for one GRV over another. There remain opportunities for enhancing practice through developing a consistent, multidisciplinary approach to managing GRVs. There are future research opportunities related to improving the management of GRVs in the enterally fed ICU patient, and achieving optimal volumes of nutrition delivered.</p>


2020 ◽  
pp. 088506662094018
Author(s):  
Nasreen Hassoun-Kheir ◽  
Oryan Henig ◽  
Tomer Avni ◽  
Leonard Leibovici ◽  
Mical Paul

Objectives: To assess the effects and safety of β-blockers in hospitalized patients with burns. Methods: A systematic review and meta-analysis of the literature. A broad search was conducted to identify all randomized controlled trials (RCTs) comparing β-blockers to control in hospitalized patients with burns. The primary outcome was 3-month all-cause mortality. Secondary outcomes were clinical patient-relevant end points. We subgrouped results by children/adults and burn severity. Risk of bias was assessed using the individual domain approach. Results: Four RCTs reported in 11 publications were included. Primary outcome of mortality was assessed in children (2 trials, n = 424) and adults (2 trials, n = 148) with severe burns. No significant difference was found between propranolol and control for mortality (risk ratio [RR] = 0.82, 95% CI = 0.48-1.39, 4 trials with broad confidence intervals in adults and children), sepsis (RR = 0.81, 95% CI = 0.46-1.43, 2 trials), and survivors’ length of stay (absolute mean difference = 2.53, 95% CI = −2.58–7.63, 3 trials). There was no significant difference in bradycardia (RR = 1.33, 95% CI = 0.77-2.3, 2 trials), hypotension (RR = 1.26, 95% CI = 0.73-2.17, 3 trials), or cardiac arrhythmia (RR: 2.97, 95% CI: 0.12-71.87, 1 trial). The evidence was graded as very low certainty, due to trial’s internal risk of bias, imprecision, and possible selective reporting. Conclusions: No sufficient evidence was found to support or refute an advantage for β-blocker use in children or adults after burns. Additional studies are needed to create a consensus and formulate practice guidelines on the optimal β-blocker to use, indications for initiation, and duration of treatment.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
David Rosenbaum-Halevi ◽  
Sujan T Reddy ◽  
Alyssa D Trevino ◽  
Muhammad Bilal Tariq ◽  
Mahan Shahrivari ◽  
...  

Introduction: Telemedicine (TM) is increasingly implemented in community hospitals acute ischemic stroke (AIS). The efficiency of TM to facilitate thrombectomy (IAT) is unknown. We addressed this question by studying our spoke hospitals which are staffed by both in-person (IP) consultation (Day: 8am-5pm) and TM (Night: 5pm-8am) to analyze differences between TM and IP and comparing to our university hub which has IP staffing day and night. Methods: We performed a retrospective analysis from 3/2016 to 3/2019 of all IAT cases directly admitted to 4 IAT capable centers (1 hub + 3 spokes) in our system. Demographic, clinical, and time metrics were analyzed. Primary outcome was door to groin (DTG) time. Continuous variables were analyzed with Wilcoxon rank sum test, and categorical variables with chi-square or Fischer’s exact test. Results: Table 1 summarizes the cohort. Eval to tPA (ETPA) time was faster at spokes vs hub (p < 0.0001), with no significant difference in DTG between spoke and hub (p= 0.444). At spokes, while DTPA times were no different between IP and TM at spokes, IP achieved faster DTG times (p<0.0001) (Fig.1A). DTG was equal during day vs. night at the hub. At the spokes, day (IP) DTG times were faster than night (TM) at some but not all spokes (Fig.1B). TPA administration did not delay DTG at either the hub or the spokes (Fig. 1C). At spokes, TM-TPA cases were associated with faster DTG than TM-noTPA (Fig. 1D). Conclusions: While no difference is noted between TM and IP in rapid TPA treatment, our data show delayed DTG at spokes during the TM day and night service. While DTG in TM was prolonged, differences in spoke metrics imply that availability of staff and resources play a significant role. Further analysis is needed to identify factors that prolong DTG at a site-specific level.


PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254196
Author(s):  
Ian A. Harris ◽  
Kara Cashman ◽  
Michelle Lorimer ◽  
Yi Peng ◽  
Ilana Ackerman ◽  
...  

Background Patient-reported outcome measures (PROMs) are commonly used to evaluate surgical outcome in patients undergoing joint replacement surgery, however routine collection from the target population is often incomplete. Representative samples are required to allow inference from the sample to the population. Although higher capture rates are desired, the extent to which this improves the representativeness of the sample is not known. We aimed to measure the representativeness of data collected using an electronic PROMs capture system with or without telephone call follow up, and any differences in PROMS reporting between electronic and telephone call follow up. Methods Data from a pilot PROMs program within a large national joint replacement registry were examined. Telephone call follow up was used for people that failed to respond electronically. Data were collected pre-operatively and at 6 months post-operatively. Responding groups (either electronic only or electronic plus telephone call follow up) were compared to non-responders based on patient characteristics (joint replaced, bilaterality, age, sex, American Society of Anesthesiologist (ASA) score and Body Mass Index (BMI)) using chi squared test or ANOVA, and PROMs for the two responder groups were compared using generalised linear models adjusted for age and sex. The analysis was restricted to those undergoing primary elective hip, knee or shoulder replacement for osteoarthritis. Results Pre-operatively, 73.2% of patients responded electronically and telephone follow-up of non-responders increased this to 91.4%. Pre-operatively, patients responding electronically, compared to all others, were on average younger, more likely to be female, and healthier (lower ASA score). Similar differences were found when telephone follow up was included in the responding group. There were little (if any) differences in the post-operative comparisons, where electronic responders were on average one year younger and were more likely to have a lower ASA score compared to those not responding electronically, but there was no significant difference in sex or BMI. PROMs were similar between those reporting electronically and those reporting by telephone. Conclusion Patients undergoing total joint replacement who provide direct electronic PROMs data are younger, healthier and more likely to be female than non-responders, but these differences are small, particularly for post-operative data collection. The addition of telephone call follow up to electronic contact does not provide a more representative sample. Electronic-only follow up of patients undergoing joint replacement provides a satisfactory representation of the population invited to participate.


2021 ◽  
pp. bmjmilitary-2021-001913
Author(s):  
Beverly P Bergman ◽  
D F Mackay ◽  
J P Pell

IntroductionPhysical activity is an important component of military training. Although injuries and musculoskeletal disorders are the most common cause of medical retirement from the Armed Forces, the long-term risk of lower limb osteoarthritis in veterans is unknown. We used data on hip and knee replacement in Scottish military veterans as a proxy measure.MethodsRetrospective cohort study of 78 000 veterans born between 1945 and 1995 and a comparison group of 253 000 non-veterans, matched for age, sex and area of residence, followed up for up to 37 years, using survival analysis to examine the risk of hip and knee replacement.ResultsVeterans were significantly less likely to undergo hip replacement than non-veterans, Cox proportional HR 0.87, 95% CI 0.80 to 0.95, p<0.001. There was no significant difference between veterans and non-veterans in respect of knee replacement, HR 1.02, 95% CI 0.94 to 1.11, p=0.643, and there was no difference in the ages at which veterans and non-veterans underwent joint replacement. People who had served for longest in the military had similar risk to those with the shortest service.ConclusionsBased on the likelihood of undergoing joint replacement surgery in later life, we found no evidence of a positive association between military service and an increased risk of lower limb osteoarthritis.


2018 ◽  
Vol 46 (5) ◽  
pp. 1106-1113 ◽  
Author(s):  
Martin Kroslak ◽  
George A.C. Murrell

Background: A number of surgical techniques for managing tennis elbow have been described. One of the most frequently performed involves excising the affected portion of the extensor carpi radialis brevis (ECRB). The results of this technique, as well as most other described surgical techniques for this condition, have been reported as excellent, yet none have been compared with placebo surgery. Hypothesis: The surgical excision of the degenerative portion of the ECRB offers no additional benefit over and above placebo surgery for the management of chronic tennis elbow. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: This study investigated surgical excision of the macroscopically degenerated portion of the ECRB (surgery; n = 13) as compared with skin incision and exposure of the ECRB alone (sham; n = 13) to treat patients who had tennis elbow for >6 months and had failed at least 2 nonsurgical modalities. The primary outcome measure was defined as patient-rated frequency of elbow pain with activity at 6 months after surgery. Secondary outcome measures included patient-rated pain and functional outcomes, range of motion, epicondyle tenderness, and strength at 6 months and 2.5 years. All outcome measures up to and including the 6-month follow-up were measured in person; the longer-term questionnaire was conducted in person or over the phone. Results: The 2 groups, surgery and sham, were similar for age, sex, hand dominance, and duration of symptoms. Both procedures improved patient-rated pain frequency and severity, elbow stiffness, difficulty with picking up objects, difficulty with twisting motions, and overall elbow rating >6 months and at 2.5 years ( P < .01). Both procedures also improved epicondyle tenderness, pronation-supination range, grip strength, and modified Orthopaedic Research Institute–Tennis Elbow Testing System at 6 months ( P < .05). No significant difference was observed between the groups in any parameter at any stage. No side effects or complications were reported. The study was stopped before the calculated number of patients were enrolled (40 per group); yet, a post hoc futility analysis was conducted that showed, based on the magnitude of the differences between the groups, >6500 patients would need to be recruited per group to see a significant difference between the groups at 26 weeks in the primary outcome (patient-rated frequency of elbow pain with activity). Conclusion: With the number of available participants, this study failed to show additional benefit of the surgical excision of the degenerative portion of the ECRB over placebo surgery for the management of chronic tennis elbow.


2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0034
Author(s):  
Christopher Hadley ◽  
Mikayla McGrath ◽  
John P. Prodoehl ◽  
Steven B. Cohen ◽  
William D. Emper ◽  
...  

Objectives: Knee arthroscopy results in significant improvements in functional outcomes, pain and quality of life for patients suffering from meniscal tears. Traditionally, patients have undergone formal physical therapy (PT) after knee arthroscopy to regain function. Prior studies have demonstrated that patients who undergo internet-based PT after total knee arthroplasty performed as well as patients receiving traditional PT, but this has not been studied in the knee arthroscopy population. The goal of this study is to compare traditional outpatient physical therapy to internet-based physical therapy in patients undergoing knee arthroscopy for partial meniscectomy. Methods: Patients undergoing knee arthroscopy from October 2017 to September 2018 for partial meniscectomy were enrolled. Patients were randomized to either an outpatient or internet-based physical therapy program. Participants in the outpatient physical therapy were prescribed PT for 2 sessions per week for 4-6 weeks while participants in the online physical therapy group were instructed to login daily to track progress and complete their exercises a minimum of 3 times per week. Additionally, participants completed 4 questionnaires: VR-12 mental and physical health, International Knee Documentation Committee (IKDC), Modified Cincinnati Rating System (MCRS) and Lysholm pre-operatively, 1 week, 6 weeks and 6 months after surgery. The primary outcome of knee function was measured via the IKDC. Results: Of the 97 patients who met the inclusion criteria, 51 (52.6%) were in the internet-based physical therapy group and 46 (47.4%) were in the outpatient PT group. There were 57 males (58.8%) and 40 females (41.2%). Participants in the online physical therapy group logged into the platform an average of 2.74 times pre-operatively and 14.99 times post-operatively. Additionally, patients viewed their PT exercise videos, on average, 5.58 times pre-operatively and 36.71 times post-operatively. At final follow-up, there was no significant difference in the primary outcome with an average IKDC score for the online physical therapy (71.83) compared to outpatient PT group (74.23) [p = 0.699]. Additionally, there was no significant difference noted in the three secondary outcome measures between the internet-based physical therapy group and the outpatient PT group at final follow-up (Table 1). Furthermore, no significant difference was noted between the two patient cohorts pre-operatively and 1 week and 6 weeks after surgery in all four outcome measures (Table 1). Conclusion: The results of our study indicate that patients using internet-based PT had similar functional outcomes as patients using traditional outpatient PT following knee arthroscopy for partial meniscectomy. [Table: see text]


2019 ◽  
Vol 9 (7) ◽  
pp. 735-742
Author(s):  
Hui Qing Lee ◽  
Chien Yew Kow ◽  
Jay Shen Ng ◽  
Patrick Chan ◽  
Lu Ton ◽  
...  

Study Design: Ambispective observational cohort study. Objectives: Synthetic graft usage avoids morbidity associated with harvest and reduces operative time. This study aims to evaluate outcomes of anterior cervical stabilization surgery using a synthetic cage in comparison with iliac crest bone graft (ICBG) following cervical spine trauma. Methods: An ambispective review was conducted on patients from the Alfred Trauma Registry. Consecutive patients treated at a level 1 trauma center, aged 18 years and older who were treated with standalone anterior cervical stabilization following spine trauma (2011-2016) were included in the study. Primary outcome measures were patient overall satisfaction, Neck Disability Index (NDI), neck pain 10-point visual analogue scale (VAS-neck) and arm pain 10-point visual analogue scale (VAS-arm). Secondary outcome measures were radiographic evidence of fusion and rate of revision surgery. All patients had follow-up for at least 1 year. Results: Between 2011 and 2016, 114 traumatic disc levels in 104 patients were treated. ICBG was used in 32% and polyetheretherketone (PEEK) cage in 68% of the patients. Both groups had similar demographic metrics. There was no significant difference in primary outcome measures between the graft types: (1) patient satisfaction ( P = .15), (2) NDI ( P = .11), (3) VAS-neck ( P = .13), and (4) VAS-arm ( P = .20). Radiology based fusion assessment 6 months postsurgery did not show statistical significance ( P = .10). The rates of revision surgery were similar. Conclusions: This study showed no significant difference in patient-reported outcome measures when comparing the usage of PEEK cage and ICBG in anterior stand alone cervical spine stabilization. Level 1 evidence studies are required to further investigate this finding.


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