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  • Kim D
  • Bashrum BS
  • Kotlier JL
  • Mayfield CK
  • Thompson AA
  • et al.
Arthrosc Sports Med Rehabil. 2024 Jan 16;6(1):100851 doi: 10.1016/j.asmr.2023.100851.
POPULATION:

Patients with hip osteoarthritis (15 systematic reviews).

INTERVENTION:

Systematic review to describe the incidence and types of spin bias in systematic reviews of platelet-rich plasma injections for hip osteoarthritis and to determine whether patterns in study characteristics could be identified among studies with identifiable spin.

COMPARISON:

OUTCOME:

All studies contained at least two types of spin (range 2-9), with a median of 2. The most common type of spin was type 14 ("Failure to report a wide confidence interval of estimates"), which was observed in 10 studies. The second most common type of spin was type 13 ("Failure to specify the direction of the effect when it favors the control intervention"), found in 6 studies. Several associations were found between spin types and the study characteristics of AMSTAR 2 rating, Scopus CiteScore, journal impact factor, and PROSPERO preregistration.

PURPOSE:

To describe the incidence and types of spin in systematic reviews of platelet-rich plasma (PRP) injections for hip osteoarthritis (OA) and to determine whether patterns in study characteristics could be identified among studies with identifiable spin.

METHODS:

The PubMed, Scopus, and SPORTDiscus databases were queried. Inclusion criteria were systematic reviews or meta-analyses that included an assessment of intra-articular PRP injections as a stand-alone treatment for hip OA. Two authors independently assessed the presence of spin in the included studies and recorded general study characteristics. The prevalence of the 15 different categories of spin was quantified using descriptive statistics.

RESULTS:

Fifteen studies met inclusion criteria for this study. All studies contained at least two types of spin (range 2-9), with a median of 2. The most common type of spin was type 14 ("Failure to report a wide confidence interval of estimates"), which was observed in 10 studies. The second most common type of spin was type 13 ("Failure to specify the direction of the effect when it favors the control intervention"), found in 6 studies.

CONCLUSIONS:

Spin is highly prevalent in abstracts of systematic reviews of PRP in the treatment of hip OA. Several associations were found between spin types and the study characteristics of AMSTAR 2 rating, Scopus CiteScore, journal impact factor, and PROSPERO preregistration. When present, spin in the abstracts of reviewed studies tended to favor the use of PRP in hip osteoarthritis.

CLINICAL RELEVANCE:

It is important to understand the prevalence of spin in published abstracts, especially in areas of great impact or interest, so authors and readers can have a greater awareness of this potential form of bias.

  • Singh B
  • Lant S
  • Cividini S
  • Cattrall JWS
  • Goodwin LC
  • et al.
PLoS One. 2022 Jun 2;17(6):e0263595 doi: 10.1371/journal.pone.0263595.
BACKGROUND:

Neurological COVID-19 disease has been reported widely, but published studies often lack information on neurological outcomes and prognostic risk factors. We aimed to describe the spectrum of neurological disease in hospitalised COVID-19 patients; characterise clinical outcomes; and investigate factors associated with a poor outcome.

METHODS:

We conducted an individual patient data (IPD) meta-analysis of hospitalised patients with neurological COVID-19 disease, using standard case definitions. We invited authors of studies from the first pandemic wave, plus clinicians in the Global COVID-Neuro Network with unpublished data, to contribute. We analysed features associated with poor outcome (moderate to severe disability or death, 3 to 6 on the modified Rankin Scale) using multivariable models.

RESULTS:

We included 83 studies (31 unpublished) providing IPD for 1979 patients with COVID-19 and acute new-onset neurological disease. Encephalopathy (978 [49%] patients) and cerebrovascular events (506 [26%]) were the most common diagnoses. Respiratory and systemic symptoms preceded neurological features in 93% of patients; one third developed neurological disease after hospital admission. A poor outcome was more common in patients with cerebrovascular events (76% [95% CI 67-82]), than encephalopathy (54% [42-65]). Intensive care use was high (38% [35-41]) overall, and also greater in the cerebrovascular patients. In the cerebrovascular, but not encephalopathic patients, risk factors for poor outcome included breathlessness on admission and elevated D-dimer. Overall, 30-day mortality was 30% [27-32]. The hazard of death was comparatively lower for patients in the WHO European region.

INTERPRETATION:

Neurological COVID-19 disease poses a considerable burden in terms of disease outcomes and use of hospital resources from prolonged intensive care and inpatient admission; preliminary data suggest these may differ according to WHO regions and country income levels. The different risk factors for encephalopathy and stroke suggest different disease mechanisms which may be amenable to intervention, especially in those who develop neurological symptoms after hospital admission.

  • Choi J
  • Chang S
  • Kim E
  • Min SY
Medicine (Baltimore). 2022 Feb 18;101(7):e28802 doi: 10.1097/MD.0000000000028802.
BACKGROUND:

Kawasaki disease (KD) is a major cause of coronary artery lesions (CALs) in children. Approximately 10% to 20% of children treated with intravenous immunoglobulin are intravenous immunoglobulin-resistant. This study evaluated the efficacy and safety of adding herbal medicine to conventional western medicines versus conventional western medicines alone for CALs in children with KD.

METHODS:

This study searched 9 electronic databases until August 31, 2021. The inclusion criteria were the randomized controlled trials (RCTs) that assessed the CALs in children with KD and compared integrative treatment with conventional western treatments. Two authors searched independently for RCTs, including eligible articles that fulfilled the inclusion criteria, extracted data, and assessed the methodological quality using the Cochrane risk of bias tool. Meta-analysis was conducted using Cochrane Collaboration's Review Manager 5.4 software. The effect size was presented as the risk ratio (RR), and the fixed-effect models were used to pool the results.

RESULTS:

The finally selected 12 studies included a total of 1030 KD patients. According to a meta-analysis, the integrative treatment showed better results than the conventional treatment in the CAL prevalence rate (RR = 2.00; 95% confidence interval [CI], 1.49-2.71; P < .00001), CAL recovery rate (RR = 1.27; 95% CI, 1.05-1.54; P = .02), and total effective rate (RR = 1.17; 95% CI, 1.11-1.23; P < .00001). Only 2 studies referred to the safety of the treatment. The asymmetrical funnel plot of the CAL prevalence rate indicated the possibility of potential publication bias.

CONCLUSIONS:

This review found the integrative treatment to be more effective in reducing the CAL prevalence rate and increasing the CAL recovery rate and total effective rate in KD patients than conventional western treatment. However, additional well-designed RCTs will be needed further to compensate restrictions of insufficient trials on safety, methodological quality, and publication bias.

  • Chang MJ
  • Shin JY
  • Yoon C
  • Kim TW
  • Chang CB
  • et al.
J Bone Joint Surg Am. 2022 Jan 19;104(2):154-159 doi: 10.2106/JBJS.20.02174.
BACKGROUND:

Tranexamic acid (TXA) is typically discontinued on the day of total knee arthroplasty (TKA). However, bleeding may persist for several days. We sought to determine whether sequential administration of intravenous (IV) and oral TXA could reduce hemoglobin (Hb) drop more than IV TXA alone. We also wanted to determine whether the use of additional oral TXA increased the rate of complications of deep vein thrombosis (DVT) or symptomatic pulmonary embolism (PE).

METHODS:

This prospective, randomized controlled trial included 141 patients. We compared the Hb drop, estimated blood loss (EBL), and transfusion rate of patients receiving IV TXA alone (group IV, n = 48) to those of patients who received IV TXA followed by oral TXA for 2 days (group 2D, n = 46) or 5 days (group 5D, n = 47). IV TXA was administered 10 minutes prior to the tourniquet release and 3 hours after the first IV TXA administration. Computed tomography (CT) was performed on postoperative day 6 to identify radiographic evidence of DVT. We also assessed the prevalence of symptomatic DVT and PE.

RESULTS:

There were no differences in maximal Hb drop, Hb drops measured at each time point, EBL, or transfusion rate among the 3 groups. The mean maximal Hb drop was 3.5 g/dL in group IV, 3.2 g/dL in group 2D, and 3.4 g/dL in group 5D. The mean EBL was 999.9 mL in group IV, 886.4 mL in group 2D, and 972.5 mL in group 5D. One patient in each group required a transfusion. There were no differences in the prevalence of radiographic evidence of DVT or symptomatic DVT. Symptomatic DVT occurred in 3 patients in group IV and 2 patients in group 5D. One patient in group IV developed a symptomatic PE.

CONCLUSIONS:

Although there was no increase in the complication rate, the sequential administration of oral TXA for up to 5 days after IV TXA did not decrease Hb drop. Therefore, our findings suggest that sequential use of oral and IV TXA is not recommended.

LEVEL OF EVIDENCE:

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  • Kim DH
  • Lee J
  • Kim SW
  • Hwang SH
Clin Exp Otorhinolaryngol. 2021 May;14(2):200-209 doi: 10.21053/ceo.2020.00584.
OBJECTIVES:

A systematic review of the literature was conducted to evaluate hypotensive agents in terms of their adverse effects and associations with perioperative morbidity in patients undergoing nasal surgery.

METHODS:

Two authors independently searched databases (Medline, Scopus, and Cochrane databases) up to February 2020 for randomized controlled trials comparing the perioperative administration of a hypotensive agent with a placebo or other agent. The outcomes of interest for this analysis were intraoperative morbidity, operative time, intraoperative bleeding, hypotension, postoperative nausea/vomiting, and postoperative pain. Both a standard pairwise meta-analysis and network meta-analysis were conducted.

RESULTS:

Our analysis was based on 37 trials. Treatment networks consisting of six interventions (placebo, clonidine, dexmedetomidine, beta-blockers, opioids, and nitroglycerine) were defined for the network meta-analysis. Dexmedetomidine resulted in the greatest differences in intraoperative bleeding (-0.971; 95% confidence interval [CI], -1.161 to -0.781), intraoperative fentanyl administration (-3.683; 95% CI, -4.848 to -2.518), and postoperative pain (-2.065; 95% CI, -3.170 to -0.960) compared with placebo. The greatest difference in operative time compared with placebo was achieved with clonidine (-0.699; 95% CI, -0.977 to -0.421). All other agents also had beneficial effects on the measured outcomes. Dexmedetomidine was less likely than other agents to cause adverse effects.

CONCLUSION:

This study demonstrated the superiority of the systemic use of dexmedetomidine as a perioperative hypotensive agent compared with the other five tested agents. However, the other agents were also superior to placebo in improving operative time, intraoperative bleeding, and postoperative pain.

  • Kim DH
  • Kim S
  • Kang H
  • Jin HJ
  • Hwang SH
Laryngoscope. 2019 Apr;129(4):800-807 doi: 10.1002/lary.27766.
OBJECTIVES:

Tranexamic acid might help control bleeding during surgery because of antifibrinolytic characteristics. We aimed to evaluate the effectiveness of systemic tranexamic acid compared to control in blood loss, operative time, and surgical field and incidence of postoperative emesis and thromboembolism in endoscopic sinus surgery.

METHODS:

Two authors independently searched six databases (PubMed, SCOPUS, Embase, the Web of Science, Google Scholar, and the Cochrane database) from their inception to July 2018. The included studies compared perioperative tranexamic acid administration (treatment group) with a placebo, and the outcomes of interest were intraoperative morbidities, including surgical time, operative bleeding, and hypotension; postoperative morbidities such as nausea and vomiting; and coagulation profiles.

RESULTS:

Seven studies comprising 562 participants were reviewed in this study. Operative time (standardized mean difference (SMD) = -0.60; 95% confidence interval (CI)[-0.93, -0.29]) and intraoperative blood loss (SMD = -0.66; 95% CI [-0.86, -0.46]) were statistically lower in the treatment group than placebo group; and the quality of the surgical field (SMD = -0.80; 95% CI [-1.12; -0.48]) and surgeon satisfaction (SMD = 1.74; 95% CI [1.36; 2.13]) were statistically higher in the treatment group than the placebo group. By contrast, there were no significant differences in the hemodynamic (SMD = 0.08; 95% CI [-0.20; 0.37]) and coagulation profiles (SMD = -0.18; 95% CI [-0.42, 0.07]) of the two groups. Additionally, tranexamic acid had no significant effect on emetic or thrombotic events compared to placebo.

CONCLUSION:

This meta-analysis showed that the systemic administration of tranexamic acid could decrease operative time and blood loss intraoperatively, increasing the satisfaction of surgeons. It did not provoke intraoperative hemodynamic instability, postoperative emetic events, or coagulation profile abnormality. Only a small number of studies were enrolled, so further trials are needed to confirm the results of this study. Laryngoscope, 129:800-807, 2019.

  • Bang BW
  • Lee DH
  • Kim HK
  • Kwon KS
  • Shin YW
  • et al.
Dig Dis Sci. 2018 Nov;63(11):3026-3032 doi: 10.1007/s10620-018-5208-z.
BACKGROUND:

Endoscopically applicable hemostatic agents have been demonstrated to have high initial hemostasis rates in cases of upper gastrointestinal bleeding (UGIB).

AIMS:

The authors developed a new hemostatic powder (CEGP-003) and evaluated its hemostatic and ulcer healing effects in UGIB.

METHODS:

Patients with peptic ulcer or post-endoscopic resection bleeding were randomly assigned to be treated by epinephrine injection or CEGP-003 spray. All patients were placed under observation for 3 days and underwent second-look endoscopy. The primary outcome was initial hemostasis rate, and the secondary outcomes were rebleeding rate and ulcer healing effect.

RESULTS:

Seventy-two patients with UGIB were enrolled in this study. Causes of bleeding were peptic ulcer (15, 20.5%), post-endoscopic mucosal resection (11, 15.1%), and post-endoscopic submucosal dissection bleeding (47, 64.4%). Initial hemostasis was achieved in 89.2% (34/37) of patients in the epinephrine group and in 100% (35/35) in the CEGP-003 group (p = 0.115). Rebleeding occurred in 2.7% (1/37) and 8.6% (3/35) in the epinephrine and CEGP-003 groups, respectively (p = 0.35). Three days after endoscopic hemostasis, the ulcer healing effects of epinephrine and CEGP-003 were similar (p = 0.79).

CONCLUSION:

This study shows that CEGP-003 spray has a hemostatic effect similar to epinephrine in terms of initial hemostasis and rebleeding rates. The authors consider CEGP-003 a potential therapeutic tool for UGIB as a definitive or bridge therapy and that it is particularly useful for oozing lesions after endoscopic resection.

  • Lee EH
  • Kim WJ
  • Kim JY
  • Chin JH
  • Choi DK
  • et al.
Anesthesiology. 2016 May;124(5):1001-11 doi: 10.1097/ALN.0000000000001051.
BACKGROUND:

Hypoalbuminemia may increase the risk of acute kidney injury (AKI). The authors investigated whether the immediate preoperative administration of 20% albumin solution affects the incidence of AKI after off-pump coronary artery bypass surgery.

METHODS:

In this prospective, single-center, randomized, parallel-arm double-blind trial, 220 patients with preoperative serum albumin levels less than 4.0 g/dl were administered 100, 200, or 300 ml of 20% human albumin according to the preoperative serum albumin level (3.5 to 3.9, 3.0 to 3.4, or less than 3.0 g/dl, respectively) or with an equal volume of saline before surgery. The primary outcome measure was AKI incidence after surgery. Postoperative AKI was defined by maximal AKI Network criteria based on creatinine changes.

RESULTS:

Patient characteristics and perioperative data except urine output during surgery were similar between the two groups studied, the albumin group and the control group. Urine output (median [interquartile range]) during surgery was higher in the albumin group (550 ml [315 to 980]) than in the control group (370 ml [230 to 670]; P = 0.006). The incidence of postoperative AKI in the albumin group was lower than that in the control group (14 [13.7%] vs. 26 [25.7%]; P = 0.048). There were no significant between-group differences in severe AKI, including renal replacement therapy, 30-day mortality, and other clinical outcomes. There were no significant adverse events.

CONCLUSION:

Administration of 20% exogenous albumin immediately before surgery increases urine output during surgery and reduces the risk of AKI after off-pump coronary artery bypass surgery in patients with a preoperative serum albumin level of less than 4.0 g/dl.

  • Ng O
  • Keeler BD
  • Mishra A
  • Simpson A
  • Neal K
  • et al.
Cochrane Database Syst Rev. 2015 Dec 22;(12):CD011588 doi: 10.1002/14651858.CD011588.pub2.
BACKGROUND:

Pre-operative anaemia is common and occurs in up to 76% of patients. It is associated with increased peri-operative allogeneic blood transfusions, longer hospital lengths of stay and increased morbidity and mortality. Iron deficiency is one of the most common causes of this anaemia. Oral iron therapy has traditionally been used to treat anaemia but newer, safer parenteral iron preparations have been shown to be more effective in other conditions such as inflammatory bowel disease, chronic heart failure and post-partum haemorrhage. A limited number of studies look at iron therapy for the treatment of pre-operative anaemia. The aim of this Cochrane review is to summarise the evidence for use of iron supplementation, both enteral and parenteral, for the management of pre-operative anaemia.

OBJECTIVES:

The objective of this review is to evaluate the effects of pre-operative iron therapy (enteral or parenteral) in reducing the need for allogeneic blood transfusions in anaemic patients undergoing surgery.

SEARCH METHODS:

We ran the search on 25 March 2015. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), EMBASE Classic and EMBASE (Ovid), CINAHL Plus (EBSCO), PubMed, clinical trials registries, conference abstracts, and we screened reference lists.

SELECTION CRITERIA:

We included all randomised controlled trials (RCTs) which compared pre-operative iron monotherapy to placebo, no treatment, standard of care or another form of iron therapy for anaemic adults undergoing surgery. Anaemia was defined by haemoglobin values less than 13 g/dL for males and 12 g/dL for non-pregnant females.

DATA COLLECTION AND ANALYSIS:

Data were collected by two authors on the proportion of patients who receive a blood transfusion, amount of blood transfused per patient (units) and haemoglobin measured as continuous variables at pre-determined time-points: pre-treatment, pre-operatively but post-treatment, and post-operatively. Statistical analysis was performed using the Cochrane statistical software, Review Manager 2014. Outcome data were summarised in tables and a forest plot.

MAIN RESULTS:

Three prospective randomised controlled studies evaluated pre-operative iron therapy to correct anaemia (two in colorectal and one in gynaecological surgery) and included 114 patients in total. One compared oral iron versus standard care (Lidder 2007); one intravenous iron versus control (Edwards 2009); and one study compared oral versus intravenous iron (Kim 2009). Both colorectal trials reported the primary outcome (proportion of patients who received allogeneic blood transfusions) and meta-analysis showed a reduction in blood transfusions with the administration of iron therapy, but the reduction was not statistically significant (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.27 to 1.18). All studies reported haemoglobin change but data for the anaemic patients were only available for two studies (Edwards 2009 and Kim 2009). Edwards 2009 showed no difference in haemoglobin at the end of treatment pre-operatively. The intravenous versus oral iron study showed an increase in haemoglobin with intravenous iron at the end of treatment pre-operatively (MD 1.90 g/dL, 95% CI 1.16 to 2.64; participants = 56), but the results are at high risk of bias because participants with less than 80% compliance with therapy were excluded from the analysis and compliance was lower in the oral iron group due to the side-effects of treatment (Kim 2009).None of the studies reported quality of life, short- or long-term mortality or post-operative morbidity.

AUTHORS' CONCLUSIONS:

The use of iron therapy for pre-operative anaemia does not show a statistically significant reduction in the proportion of patients who received an allogeneic blood transfusion compared to no iron therapy. However, the 38 patients in our analysis falls far short of the 819 patients our information size calculation recommended to detect a 30% reduction in blood transfusions. Intravenous iron may be more effective than oral iron at increasing haemoglobin. However, all these conclusions are drawn from only three small randomised controlled studies. Further well designed, adequately powered randomised controlled studies are required to determine the true effectiveness of iron therapy for pre-operative anaemia.

  • Lee DH
  • Ryu KJ
  • Kim JW
  • Kang KC
  • Choi YR
Clin Orthop Relat Res. 2014 Dec;472(12):3789-97 doi: 10.1007/s11999-014-3548-3.
BACKGROUND:

During lower limb lengthening, poor bone regeneration is a devastating complication. Several local or systemic applications have been used to promote osteogenesis, and biologic stimulations are gaining attention, but their utility has not been proven in this setting.

QUESTIONS/PURPOSES:

In patients undergoing bilateral tibial lengthening, we compared those receiving an osteotomy site injection of autologous bone marrow aspirate concentrate (BMAC) plus platelet-rich plasma (PRP) with those not receiving such an injection in terms of external fixator index (time in external fixation divided by amount of lengthening), full weightbearing index (time until a patient was permitted to do full weightbearing divided by amount of lengthening), four cortical healing indexes (time until each cortical union divided by amount of lengthening), and callus shape and type.

METHODS:

Twenty-two patients (44 tibias) undergoing bilateral tibial lengthening enrolled in this randomized trial. Two patients were excluded, one due to insufficient radiographic evaluation and one who was lost to followup, leaving 20 patients (40 segments) for inclusion. Ten patients (20 segments) received BMAC combined with PRP injection (treatment group) and 10 patients (20 segments) received no injection (control group). All patients underwent stature lengthening for familial short stature with the lengthening over nail technique. Autologous BMAC combined with PRP was injected at the tibial osteotomy site at the end of the index surgery. Mean distraction rates were similar between groups (0.75 mm/day in the treatment group versus 0.72 mm/day in the control group; p = 0.24). Full weightbearing was permitted when we observed radiographic evidence of healing at two cortices; this assessment was made by the surgeon who was blinded to the treatment each patient received. Minimum followup was 24 months (mean, 28 months; range, 24-34 months).

RESULTS:

There was no difference in mean external fixator index between groups. However, mean cortical healing indexes (anterior/posterior/medial/lateral) were 1.14/0.81/0.96/0.88 months/cm in the treatment group and 1.47/1.26/1.42/1.22 months/cm in the control group (all p < 0.001), showing faster healing in the treatment group at each cortex. Full weightbearing was permitted earlier in the treatment group than in the control group (index: 0.99 months/cm and 1.38 months/cm, respectively, p < 0.001). Callus shape and type were not different between groups.

CONCLUSIONS:

Autologous BMAC combined with PRP injection at the osteotomy site helped improve bone healing in distraction osteogenesis of the tibia, although the effect size was small.

LEVEL OF EVIDENCE:

Level I, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.