Publications by authors named "Hussein El Khechen"

7 Publications

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Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study.

Pilot Feasibility Stud 2021 Nov 30;7(1):211. Epub 2021 Nov 30.

Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4L8, Canada.

Background: Pilot studies are essential in determining if a larger study is feasible. This is especially true when targeting populations that experience stigma and may be difficult to include in research, such as people with HIV. We sought to describe how pilot studies have been used to inform HIV clinical trials.

Methods: We conducted a methodological study of pilot studies of interventions in people living with HIV published until November 25, 2020, using Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL). We extracted data on their nomenclature, primary objective, use of progression criteria, sample size, use of qualitative methods, and other contextual information (region, income, level, type of intervention, study design).

Results: Our search retrieved 10,597 studies, of which 248 were eligible. The number of pilot studies increased steadily over time. We found that 179 studies (72.2%) used the terms "pilot" or "feasibility" in their title, 65.3% tested feasibility as a primary objective, only 2% used progression criteria, 23.9% provided a sample size estimation and only 30.2% used qualitative methods.

Conclusions: Pilot studies are increasingly being used to inform HIV research. However, the titles and objectives are not always consistent with piloting. The design and reporting of pilot studies in HIV could be improved.
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http://dx.doi.org/10.1186/s40814-021-00934-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8630899PMC
November 2021

Gynecologic and obstetric management of women with von Willebrand disease: summary of 3 systematic reviews of the literature.

Blood Adv 2021 Oct 21. Epub 2021 Oct 21.

McMaster University, Canada.

Von Willebrand disease, (VWD) disproportionately affects women due to potential issues with heavy menstrual bleeding (HMB), delivery complications, and postpartum hemorrhage (PPH). To systematically synthesize the evidence regarding first line management of HMB, treatment of women requiring/desiring neuraxial analgesia, and management of PPH. We searched Medline and EMBASE through October 2019 for randomized trials, comparative observational studies, and case series comparing the effects of desmopressin, hormonal therapy, and tranexamic acid (TXA) on HMB, comparing different von Willebrand factor (VWF) levels in women with VWD undergoing labor and receiving neuraxial anesthesia and the effects of TXA on PPH We conducted duplicate study selection, data abstraction, and appraisal of risk of bias. Whenever possible, we conducted meta-analyses. We assessed the quality of the evidence using the GRADE approach. We included 1 randomized trial, 3 comparative observational studies and 10 case series. Moderate certainty evidence showed that desmopressin results in a smaller reduction of menstrual blood loss (difference in mean change from baseline, 41.6 [95% CI, 16.6 to 63.6] points in pictorial blood assessment chart score as compared to TXA. There was very low certainty evidence about how first line treatments compare against each other, the effects of different VWF levels in women receiving neuraxial anesthesia, and the effects of TXA administration postpartum. Most of the evidence relevant to the gynecologic and obstetric management of women with VWD addressed by most guidelines is very low quality. Future studies addressing research priorities will be key when updating such guidelines.
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http://dx.doi.org/10.1182/bloodadvances.2021005589DOI Listing
October 2021

Surgical management of patients with von Willebrand Disease: summary of 2 systematic reviews of the literature.

Blood Adv 2021 Oct 15. Epub 2021 Oct 15.

Department of Health Research Methods, Evidence and Impact, McMaster University, Canada.

Von Willebrand disease (VWD) is the most common inherited bleeding disorder. The management of patients with VWD undergoing surgeries is crucial to prevent bleeding complications. To systematically summarize the evidence on the management of patients with VWD undergoing major and minor surgeries to support the development of practice guidelines. We searched Medline and EMBASE through October 2019 for randomized clinical trials (RCTs), comparative observational studies and case series comparing maintaining factor VIII levels or VWF levels >0.50 IU/mL for at least 3 days in patients undergoing major surgery, and options for perioperative management of patients undergoing minor surgery. Two authors screened, abstracted data, and assessed the risk of bias. We conducted meta-analysis when possible. We evaluated the certainty of the evidence using the GRADE approach. We included 7 case series for major surgeries and 2 RCTs and 12 case series for minor surgeries. Very low certainty evidence showed that maintaining factor VIII levels, or VWF levels > 0.50 IU/mL for at least 3 consecutive days showed excellent hemostatic efficacy (as labeled by the researchers) after 74-100% of major surgeries. Low to very low certainty evidence showed that prescribing tranexamic acid and increasing VWF levels to 0.50 IU/mL resulted in less bleeding complications after minor procedures compared to increasing VWF levels to 0.50 IU/mL alone. Given the low-quality evidence to guide management decisions, a shared-decision model leading to individualized therapy plans will be important in patients with VWD undergoing surgical and invasive procedures.
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http://dx.doi.org/10.1182/bloodadvances.2021005666DOI Listing
October 2021

The efficacy of teriparatide on lumbar spine bone mineral density, vertebral fracture incidence and pain in post-menopausal osteoporotic patients: A systematic review and meta-analysis.

Bone Rep 2020 Dec 16;13:100728. Epub 2020 Oct 16.

Department of Orthopaedic Surgery, University of Michigan, United States of America.

Objective: Teriparatide has been increasingly utilized in the management of osteoporosis. The efficacy of low and high dose teriparatide on lumbar spine bone mineral density, vertebral fracture incidence and pain is unknown. We sought to determine the efficacy of teriparatide on these patient-important outcomes using a systematic review and meta-analysis.

Methods: A systematic search of electronic databases (MEDLINE, EMBASE, CENTRAL, CINAHL) was performed to identify randomized controlled trials (RCTs) that evaluate teriparatide to any comparator for the treatment of osteoporosis in postmenopausal women. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria were used by two independent reviewers to assess the strength and quality of evidence.

Results: A total of 20 studies (n = 6024) were included in this review, with 2855 patients receiving teriparatide and 3169 patients receiving placebo or control treatment. A teriparatide dose of 20 μg/day increased lumbar spine bone mineral density (BMD) (standardized mean difference (SMD) 0.34 standard deviation (SD) units higher (95% CI 0.19-0.48 SDs higher) in comparison to placebo. Relative to anti-resorptive agents, 20 μg/day of teriparatide had a range from 0.14 SD units to 0.96 SD units higher (95% CI, 0.08 SDs lower to 0.36 SDs higher, CI, 0.33-1.59 SDs higher, respectively). 20 μg/day teriparatide had a significant effect on pain severity to placebo or control (SMD 0.80, 95% CI, 1.16-0.43 SDs lower) and also decreased the incidence of vertebral fractures compared to placebo (relative risk 0.31, 95% CI 0.21 to 0.46). Arthralgia and extremity pain incidence were also calculated; there were 15 and 8 fewer events per 1000 patients with the use of 20 μg/day of teriparatide compared to placebo or control, respectively.

Conclusion: High quality evidence supports the utilization of teriparatide 20 μg/day dose to significantly improve lumbar spine BMD and decrease incidence of vertebral fractures and pain severity relative to all comparators. 40 μg/day dose of teriparatide demonstrated significantly better results with prolonged treatment. This data is valuable for clinicians involved in the care of this growing demographic of patients. Further investigation on the safety and efficacy of teriparatide in higher doses for the long-term treatment of osteoporosis in postmenopausal women should be conducted through high-quality clinical trials.
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http://dx.doi.org/10.1016/j.bonr.2020.100728DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7591342PMC
December 2020

Vertical transmission risk of SARS-CoV-2 infection in the third trimester: a systematic scoping review.

J Matern Fetal Neonatal Med 2020 Jul 1:1-8. Epub 2020 Jul 1.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.

Studies on COVID-19 infection in pregnancy thus far have largely focused on characterizing maternal and neonatal clinical characteristics. However, another evolving focus is assessing and mitigating the risk of vertical transmission amongst COVID-19-positive mothers. The objective of this review was to summarize the current evidence on the vertical transmission potential of COVID-19 infection in the third trimester and its effects on the neonate. OVID MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trial (CENTRAL) were searched from January 2020 to May 2020, with continuous surveillance. 18 studies met the inclusion criteria, consisting of 157 mothers and 160 neonates. The mean age of the pregnant patients was 30.8 years and the mean gestational period was 37 weeks and 1 d. Currently, there is currently no conclusive evidence to suggest that vertical transmission of SARS-CoV-2 occurs. Amongst 81 (69%) neonates who were tested for SARS-CoV-2, 5 (6%) had a positive result. However, amongst these 5 neonates, the earliest test was performed at 16 h after birth, and only 1 neonate was positive when they were later re-tested. However, this neonate initially tested negative at birth, suggesting that the SARS-CoV-2 infection was likely hospital-acquired rather than vertically transmitted. 13 (8%) neonates had complications or symptoms. The findings of this rapid descriptive review based on early clinical evidence suggest that vertical transmission of SARS-CoV-2 from mother to neonate/newborn did not occur. Future studies are needed to determine the optimal management of neonates born to COVID-19-positive mothers.
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http://dx.doi.org/10.1080/14767058.2020.1786055DOI Listing
July 2020

Efficacy of Electrical Stimulation for Spinal Fusion: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Sci Rep 2020 03 12;10(1):4568. Epub 2020 Mar 12.

Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, MI, USA.

Spinal fusion is one of the most common procedures performed in spine surgery. As rates of spinal fusion continue to increase, rates of complications such as nonunions continue to increase as well. Current evidence supporting the use of electrical stimulation to promote fusion is inconclusive. This review aimed to determine if postoperative electrical stimulation is more efficacious than no stimulation or placebo in promoting radiographic fusion in patients undergoing spinal fusion. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, CINAHL and MEDLINE from date of inception to current. Ongoing clinical trials were also identified and reference lists of included studies were manually searched for relevant articles. Two reviewers independently screened studies, extracted data, and assessed risk of bias. Data were pooled using the Mantel-Haenszel method. Trialists were contacted for any missing or incomplete data. Of 1184 articles screened, 7 studies were eligible for final inclusion (n = 941). A total of 487 patients received postoperative electrical stimulation and 454 patients received control or sham stimulation. All evidence was of moderate quality. Electrical stimulation (pulsed electromagnetic fields, direct current, and capacitive coupling) increased the odds of a successful fusion by 2.5-fold relative to control (OR = 2.53, 95% CI 1.86 to 3.43, p < 0.00001). A test for subgroup interaction by stimulation type, smoking status, and number of levels fused was not significant (p = 0.93, p = 0.82 and p = 0.65, respectively). This systematic review and meta-analysis found moderate-quality evidence supporting the use of postoperative electrical stimulation as an adjunct to spinal fusion surgery. Patients treated with electrical stimulation have significantly greater rates of successful fusion. The level of evidence for this study is therapeutic level I.
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http://dx.doi.org/10.1038/s41598-020-61266-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7067864PMC
March 2020

Arthroscopic versus Open Osteochondral Autograft Transplantation (Mosaicplasty) for Cartilage Damage of the Knee: A Systematic Review.

J Knee Surg 2021 Jan 9;34(1):94-107. Epub 2019 Jul 9.

McMaster University, Division of Orthopaedic Surgery, Hamilton, Ontario, Canada.

Osteochondral autograft transplantation (OAT) is a surgical option for repairing cartilage damage in knees, and can be performed using open or arthroscopic procedures. The aim of this review was to report clinical outcomes, postoperative complications, defect location, and defect size between open and arthroscopic OATs. Three electronic databases (EMBASE, PUBMED, and MEDLINE) were searched for relevant articles. In regard to eligibility criteria, knee articular damage cases solely treated with OAT were included and cases concomitant with ligament reconstruction, limb realignment, and meniscus repair were excluded. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and descriptive statistics are presented. A total of 24 studies were included with a total sample of 1,139 patients (532 in open OAT vs. 607 in arthroscopic OAT). Defect size in open OAT was three times larger than that of arthroscopic OAT (2.96 ± 0.76 vs. 0.97 ± 0.48 cm). In terms of defect location, the medial femoral condyle (MFC) was the most common (75.4%), followed by the lateral femoral condyle (LFC; 12.1%), patella (6.7%), and trochlea (5.7%). All of these defect locations were treated with open OAT, whereas arthroscopic OAT treatments were restricted to the MFC and LFC. The clinical outcomes were overall favorable with the modified Hospital for Special Surgery knee scores being 89.6 ± 8.0 (36.1-month follow-up) versus 90.4 ± 6.0 (89.5-month follow-up) and the Lysholm scores being 81.6 ± 8.9 (44.2-month follow-up) and 83.3 ± 7.4 (12.0-month follow-up) between open and arthroscopic OATs, respectively. Fifty-three postoperative complications were observed (39/279 vs. 14/594) and the most common complication was hemarthrosis (13/39 in open, vs. 1/14 in arthroscopic OAT). The overall clinical outcomes were favorable in open and arthroscopic OATs, whereas open OAT allowed for treatment of lesions approximately three times greater in dimension than in arthroscopic OAT. Also, defect location was restricted to MFC and LFC in arthroscopic OAT. The most common complication was hemarthrosis.
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http://dx.doi.org/10.1055/s-0039-1692999DOI Listing
January 2021
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