Clinical efficacy of Platelet-Rich Plasma versus local Methylprednisolone Injection in Lateral Epicondylitis.

Objective: To compare the results of local administration of platelet-rich plasma (PRP) with methylprednisolone in the treatment of tennis elbow. Methods: This retrospective cohort was conducted at Jinnah Postgraduate Medical Center (JPMC) during January 2017 to April 2018. Patients conservatively managed for lateral epicondylitis with local methylprednisolone injection or PRP injection were approached for possible inclusion in the study at 12 months of treatment. The primary outcome of the study was to determine the Numerical Pain Rating Score (NPRS) on resisted wrist extension. Whereas, the secondary outcomes were quick disability arm, shoulder, and hand score (qDASH), the grip strength and VAS for satisfaction. The baseline, six weeks and three month data on Grip strength, NPRS, and qDASH were extracted from the patients' medical records maintained at the hospital. The data were analyzed by using SPSS software. Results: A total of 91 patients were approached, of them 81 (89.01%) agreed to participate. There were 46 (56.79%) who received local methylprednisolone injection and 35 (43.20%) received PRP. At 12 months follow up, there was no difference in NPRS pain scores between the two groups (p=0.691); pain decreased in both groups at six weeks and at 12 months. There was no significant difference in the functional outcome (qDASH score) in both groups. Both groups were equally satisfied with the treatment they had received. Conclusion: The study concluded that there is no difference between outcome and efficacy of both treatment modalities used for the treatment of tennis elbow in alleviating pain at 12 months.

Public sector rehabilitation services for physical disabilities in tertiary care hospitals of Karachi, Pakistan: A qualitative study.

BACKGROUND: Around the globe there are 2.4 billion people in need of rehabilitation. Disability and rehabilitation have not gained much importance in the public health arena, possibly due to limited research and awareness regarding the significance of rehabilitation. This study aimed to provide an in-depth understanding of the barriers and facilitators to the provision and utilization of rehabilitation services in public sector tertiary care hospitals of Karachi, Pakistan. METHODOLOGY: This qualitative exploratory study was conducted from August to September 2015 in two tertiary care hospitals of Karachi. The criterion for hospital selection included the availability of functional rehabilitation services. Twenty-four key informant interviews were conducted with health professionals, including doctors, physiotherapists, occupational therapists, prosthetists, orthotists, as well as patients and caregivers. Qualitative content analysis was performed using a consensual qualitative research approach. Responses from key informant interviews were coded into free nodes and then categorized into themes. RESULTS: Two themes emerged from the data: constraints to the provision of rehabilitation services, and barriers to the utilization of rehabilitation services. Basic infrastructure was available at both study sites; however, a lack of structured guidelines for referring patients to these services, a lack of information-sharing and guidance to the patients, and a limited supply of equipment (treatment modalities) hampered the provision of services. The barriers to rehabilitation services included cost pertaining to transport, environmental barriers, lack of support from the employer, and strain on and lack of support from caregivers. CONCLUSION: Rehabilitation services require attention and investment in research and allocation of funds to strengthen the service delivery system. Hospitals, alongside the department of health, need to develop a strategic plan to set future directions and standards of available rehabilitation services.

Phenotypic and genotypic (exon 28) characterization of patients diagnosed with von Willebrand disease type 1 in Eastern Saudi Arabia.

Von Willebrand factor (VWF) is a plasma glycoprotein that plays a key role in hemostasis. Mutations in this protein can result in von Willebrand disease (VWD), the most common form of bleeding disorder in humans. Patients with type 1 VWD have a quantitative plasmatic deficiency of normal structural and functional VWF. Our study aimed to investigate the phenotypic and genotypic characteristics of VWD type 1 patients in eastern Saudi Arabia, focusing on exon 28. We included patients previously diagnosed with WWD type 1 at the King Fahad teaching hospital in Al Khobar and their family members. The correlations between various phenotypic data and genotypic (exon 28) were analyzed using statistical software (SPSS) version 21. While these variants were generally considered benign with minor clinical effects, our analysis did identify two pathogenic variants that could lead to severe VWD symptoms. Specifically, we found these two pathogenic variants in three VWD patients from Saudi Arabia, providing essential insights into pathogenic VWD mutations in this population. Our study, therefore, sheds light on the prevalence of VWF variants in the eastern province of the Kingdom and highlights the need for continued research into the genetic causes of VWD in this region.

Conservative management versus volar plating for dorsally displaced distal radius fractures in the elderly: A randomized control trial.

Objective: This randomized trial aims to compare the clinical, and radiological outcomes between plaster cast and volar plating for distal radius fractures (DRF) in the elderly at six months, and one-year. Methods: A randomized trial was performed at Jinnah Postgraduate Medical Centre between February 2015 and April 2020. The study included patients that were above 60 years but under 75 with an isolated, closed, unilateral, dorsally displaced DRF. Randomization into two groups (casting or plating) was based on a computer-generated algorithm stratified by age group and AO/OTA fracture type. The primary outcome was Patient Rated Wrist Evaluation score. Secondary clinical outcomes were active range of motion, grip strength, the Mayo's wrist score and the quick Disability Arm, Shoulder, Hands scale. Patient's satisfaction was evaluated with use of a SF-12 questionnaire and finally complications were recorded. Results: This trial has shown that there is no significant difference in clinical outcomes of DRF at six and twelve months follow up when treated by cast immobilization or plating. Although, the radiological parameters and the number of complications were significantly higher in the immobilization group. Conclusion: The results of the trial have shown that plating and casting are equally effective in achieving satisfactory patient reported and clinical outcomes at intermediate and final follow-up restoring patient satisfaction.Trial registration: The trial is registered in the Chinese Clinical Trial Registry. The trial registration number is ChiCTR2000032843, and the URL is: http://www.chictr.org.cn/searchprojen.aspx.

The association of thrombophilia in women with severe obstetric complications.

Thrombophilia, where multiple genetic and acquired risk factors interact synergistically, are associated with thrombosis and pregnancy-related complications. Despite being studied profusely, an inconsistent association exists between thrombophilia and pregnancy complications. Between 2018 and 2020, ninety-three women with pregnancy complications were enrolled in the study. Twenty-five healthy pregnant women without pregnancy complications reported to the same hospital were also recruited as controls. Blood samples were tested for homocysteine, coagulation studies, and molecular diagnosis included FVL, PTH and MTHFR genes amplified using PCR strip assay (Vienna Lab Diagnostics, Austria). Other thrombophilia screening, including testing for AT, PC, and LA, were done by chromogenic assays (Dade Diagnostica, Munich, Germany). Homocysteine level was determined by fluorescence polarization immunoassay technology (Axsym, Abbot company, Germany). Overall, 29.03% of women with pregnancy complications had thrombophilia relative to 16% in the control group. However, the difference between the case and control groups did not reach a significant level (p=0.1175). Additionally, combined thrombophilia was more prevalent among cases (10.75%) than in the control group (4%). However, the difference did not reach statistical significance (p=0.1046). Our study demonstrated that the frequency of thrombophilia among healthy women was 16%, and among women with pregnancy-related complications, 29%. Relative to control, all measured thrombophilia markers were more frequent in women with pregnancy-related complications except for LA. Including all the studies on the Saudi population in a meta-analysis study could reveal more information about thrombophilia and pregnancy-related complications in our population.

Molecular Epidemiological Surveillance of CTX-M-15-producing Klebsiella pneumoniae from the patients of a teaching hospital in Sindh, Pakistan.

Background  The presence of Extended-spectrum ß-lactamase (ESBL) positive bacteria in hospital setting is an aggravating influential factor for hospitalized patients, and its consequences may be hazardous. Therefore, there is a need for rapid detection methods for newly emerging drug-resistant bacteria. This study was aimed at the molecular characterization of ESBL-positive  Klebsiella pneumoniae isolates recovered from clinical samples.   Methods  A total of 513  K. pneumoniae isolates were obtained from various clinical samples during June 2019 to May 2020. The collected isolates were investigated for antimicrobial susceptibility (antibiogram), and PCR and DNA sequencing were performed to analyse the ESBL genes.   Results  Among the 513 isolates, as many as 359 (69.9%) were ESBL producers and 87.5% were multi-drug resistant, while none had resistance to imipenem. PCR scored 3% blaTEM, 3% blaSHV, and 60% blaCTX-M-15 genes for the tested isolates.   Conclusion  The study showed that CTX-M-15 was the major prevalent ESBL type among the isolates. Additionally, all the isolates were susceptible to carbapenems. Screening and detection of ESBL tests are necessary among all isolates from the enterobacteriaceae family in routine microbiology laboratory to prevent associated nosocomial infections. A larger study is essential to understand molecular epidemiology of ESBL producing organisms to minimize morbidities due to these multidrug resistant organisms.

Frequency of osteoarthritis and functional outcome of operated tibial plateau fractures: A minimum of 5 years follow up.

OBJECTIVE: Tibial plateau is an important weight bearing surface and its fractures are the result of axial compressive forces. Post-traumatic osteoarthritis (PTOA) occurs despite anatomical joint reconstruction. In this study we determined the incidence of PTOA after primary management of tibial plateau fractures and determined the risk factors of PTOA of patients whose results were published at 24 months and now we present a five year follow up of the same patients. METHODS: In this study, we presented the prospective data of 109 patients who were managed for tibial plateau fractures, from August 2009 to June 2018 a Jinnah postgraduate medical centre. Data of patients regarding clinical and radiological, functional outcome (according to the American Knee Society criteria), post-procedural visual analogue scale (VAS) pain score was included. Incidence of development of PTOA was noted in each patient using the Ahlbäck classification. RESULTS: Out of 109 patients with tibial plateau fractures, 81 (74.3%) were male and 28 (25.7%) were female. Mean time lag from injury to surgery was 10.14±9.07 days. Overall incidence of osteoarthritis was 50 (45.9%). Advanced age >50 years (odds ratio 9.1 (3.7-22.1), p-value <0.0001), female gender (odds ratio; 3.40 (1.36-8.46), p-value 0.007), VAS score >4 ((odds ratio; 73.28 (15.7-341.5), p-value <0.001)), Articular depression (odds ratio; 35.25 (11.49-108.1), p-value <0.001) and degree of mal-alignment (odds ratio; 25.72 (9.30-71.12), p-value <0.001) were found to be the risk factors of PTOA. While excellent functional outcomes were protective for PTOA (odds ratio; 4.8, p-value <0.001). Thirty out of fifty patients (60%) suffering from secondary arthritis of the knee required knee replacement (TKR). Twenty-one patients (70%) were males that underwent TKR. CONCLUSIONS: There is a high proportion of osteoarthritis following tibial plateau fixation. The risk factors that related to the development of secondary arthritis our cohorts were increased age, male gender, a decrease in AKSS and a higher VAS group. Knee arthroplasty is the only option for our cohorts with severe posttraumatic arthritis.

Osetosynthesis of Fractures neck femur with cannulated screws: Evaluation of risk factors for post-operative complications.

OBJECTIVE: To evaluate the risk factors for postoperative complications in fracture neck femur treated with cannulated screws. METHODS: This cross sectional series was performed at the Department of Trauma and Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi from January 2015 to December 2019. A Total of 149 patients with close fracture neck femur of either gender between 20-60 years of age were included in the study. Patients with hip arthritis and pathological fractures such as tumours were excluded. Minimum three cannulated screws were used to fix the fracture with parallel configuration in compression mode. Patients were followed and evaluated for fracture healing and related complications such as nonunion and Avascular necrosis for two years. Descriptive statistics were calculated and stratification was done. Post stratification chi square test was applied taking p-value ? ≤0.05 as statistically significant. RESULTS: There were 113 (75.8%) male and 36 (24.2%)female patients. Mean age was 37.54±10.66 years. Mean operation time was 38.56±4.61 minutes. Out of these, 93 (62.4%) injuries were caused by motor vehicle accident, 34(22.8%) fall and 22(14.8%) by sports injury. Garden type III fracture was observed in 69 (46.3%) patients followed by 41 (27.5%) fractures of grade-IV. Fracture union was observed in 126 (84.6%) patients at a mean time of 4.0±1.1months and non-union in 23 (15.4%) cases whereas rate of avascular necrosis was noted in 28 (18.8%) cases and were significantly associated with age, injury mode, time from injury to surgery and fracture classification. Non-union was significantly associated with open reduction and delayed fixation of fracture for more than 24 hours. CONCLUSIONS: Although cannulated screws are a universally accepted method of fixation for femoral neck fractures, the incidence of complications such as Avascular necrosis and non-union is quite high particularly in young males meeting a motor vehicle accident, undergoing open reduction for displaced fractures even with early diagnosis and treatment.

Delay in Initial Debridement for Open Tibial Fractures and Its Possible Impact on Patient Outcomes: A Single-Center Prospective Cohort Study.

The current consensus regarding the management of open fracture indicates that the initial debridement should be performed within the first 6 hours after injury. Unfortunately, in Pakistan, the emergency medical services are not well-established and patient arrival at the hospital is delayed the majority of the time. In this study, we present our experience with delayed surgical management of open tibial fractures. METHODS: A prospective study of patients who presented to the accident and emergency department of the authors' institution was performed. The duration of the study was 4 years. All patients ≥18 years of age with an isolated open fracture of the tibia were included in the study. Open fractures were graded using the Gustilo-Anderson (GA) classification. The study participants were divided into 3 groups based on the timing of the surgery. Infection and nonunion rates were compared using chi-square analysis. P < 0.05 was considered significant. RESULTS: A total of 1,896 patients were included in the study. There was no significant difference between the results of surgery performed before 48 hours and those of surgery performed after 48 hours with regard to the infection rates associated with GA type-I (p = 0.48), type-II (p = 0.70), or type-III (p = 0.87) fractures or the nonunion rates associated with type-I (p = 0.6338), type-II (p = 0.4030), or type-III (p = 0.4808) fractures. A higher GA classification was associated with higher rates of infection and nonunion independent of the timing of the surgery (95% confidence interval [CI] = 1.24 to 1.89, p < 0.01). CONCLUSIONS: Our study indicates that the risks of infection and nonunion remain acceptable despite delays in the management of open tibial fractures within a 24 to 96-hour window. A delay in the initial time to debridement is acceptable only when early care cannot be provided. Prompt initial debridement remains the best possible treatment for open tibial fractures. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Direct DNA Sequencing-Based Analysis of Microbiota Associated with Hematological Malignancies in the Eastern Province of Saudi Arabia.

INTRODUCTION: Bloodstream infections (BSI) among patients with hematological malignancies (HM) could predispose them to higher morbidity and mortality for various underlying conditions. Several microorganisms, either pathogenic or opportunistic normal human flora, could cause severe bacteremia and septicemia. While conventional methods have their own limitations, molecular methods such as next-generation sequencing (NGS) can detect these blood infections with more reliability, specificity, and sensitivity, in addition to information on microbial population landscape. Methodology. Blood samples from HM patients (n = 50) and volunteer blood donor control individuals with no HM (n = 50) were subjected to 16S rRNA gene amplification using standard PCR protocols. A metagenomic library was prepared, and NGS was run on a MiSeq (Illumina) sequencer. Sequence reads were analyzed using MiSeq Reporter, and microbial taxa were aligned using the Green Genes library. RESULTS: 82% of the patients showed BSI with Gram-negative bacteria as the most predominant group. E. coli comprised a major chunk of the bacterial population (19.51%), followed by K. pneumoniae (17.07%). The CoNS and Viridans Streptococci groups are 17.07% and 14.63%, respectively. Other major species were S. aureus (9.75%), P. aeruginosa (7.31%), A. baumannii (4.87%), E. cloacae (4.87%), and P. mirabilis (4.87%). 34.14% of the cases among patients showed a Gram-positive infection, while 14.63% showed polymicrobial infections. CONCLUSION: Most of the BSI in patients were characterized by polymicrobial infections, unlike the control samples. Molecular methods like NGS showed robust, fast, and specific identification of infectious agents in BSI in HM, indicating the possibility of its application in routine follow-up of such patients for infections.

[RETRACTED] Negative pressure wound therapy versus conventional dressing for open fractures in lower extremity trauma

AIMS: It has been generally accepted that open fractures require early skeletal stabilization and soft-tissue reconstruction. Traditionally, a standard gauze dressing was applied to open wounds. There has been a recent shift in this paradigm towards negative pressure wound therapy (NPWT). The aim of this study was to compare the clinical outcomes in patients with open tibial fractures receiving standard dressing versus NPWT. METHODS: This multicentre randomized controlled trial was approved by the ethical review board of a public sector tertiary care institute. Wounds were graded using Gustilo-Anderson (GA) classification, and patients with GA-II to III-C were included in the study. To be eligible, the patient had to present within 72 hours of the injury. The primary outcome of the study was patient-reported Disability Rating Index (DRI) at 12 months. Secondary outcomes included quality of life assessment using 12-Item Short-Form Health Survey questionnaire (SF-12), wound infection rates at six weeks and nonunion rates at 12 months. Logistic regression analysis and independent-samples t-test were applied for secondary outcomes. Analyses of primary and secondary outcomes were performed using SPSS v. 22.0.1 and p-values of < 0.05 were considered significant. RESULTS: A total of 486 patients were randomized between January 2016 and December 2018. Overall 206 (49.04%) patients underwent NPWT, while 214 (50.95%) patients were allocated to the standard dressing group. There was no statistically significant difference in DRI at 12 months between NPWT and standard dressing groups (mean difference 0.5; 95% confidence interval (CI) -0.08 to 1.1; p = 0.581). Regarding SF-12 scores at 12 months follow-up, there was no significant difference at any point from injury until 12 months (mean difference 1.4; 95% CI 0.7 to 1.9; p = 0.781). The 30-day deep infection rate was slightly higher in the standard gauze dressing group. The non-union odds were also comparable (odds ratio (OR) 0.90, 95% CI 0.56 to 1.45; p = 0.685). CONCLUSION: Our study concludes that NPWT therapy does not confer benefit over standard dressing technique for open fractures. The DRI, SF-12 scores, wound infection, and nonunion rates were analogous in both study groups. We suggest surgeons continue to use cheaper and more readily available standard dressings. Cite this article: Bone Joint J 2020;102-B(7):912-917.

Transcervical superior wedge resection (osteotomy) and fixation with contoured plate for the non- union of femoral neck fractures.

Study was conducted to determine the healing rate of non-union femoral neck fractures following a new transcervical superior based wedge resection and fixation with contoured plate. This study is based on a concept, that the presence of a residual part of the femoral neck on the trochanteric side of the non-union and removal of a wedge with a superior base not only converts shearing forces into compression forces but also provides fresh bone with an osteogenic potential. This is a descriptive case series 'one group pre-test post-test design', conducted from 2010 to 2016 with a sample size of 18, convenience sampling technique with a minimum follow up of 12 months. Eighteen patients with a mean age of 32.44±8.8 years were operated with transcervical wedge resection and fixation. However, only 14 completed a minimum follow up of twelve months. Thirteen (93%) patients achieved union while, one had stable fibrous union which later on developed avascular necrosis and underwent a total hip replacement. There was a mean shortening of 2.05±0.4 cm. Seven (50%) had post-operative Lurch and 4 (28.6%) required shoe raise while 1 had low grade infection.

A prospective evaluation of clinical and functional outcome of single bundle anatomic anterior cruciate ligament reconstruction with hamstrings autograft.

A case series was conducted at the Department of Orthopaedic surgery, Jinnah Postgraduate Medical Centre, Karachi, from July 2016 to June 2018, to evaluate the functional and clinical outcome of arthroscopic anatomic anterior cruciate ligament (ACL) reconstruction with hamstrings autograft. Patients aged 17 years and above with anterior cruciate ligament (ACL) injuries of duration three months or older, diagnosed on history and clinical examination and confirmed on Magnetic Resonance Imaging were prospectively recruited from outpatient department. Patients with multiligamentous injury were excluded. Information on patient's demographics such as age, duration of injury and mechanism of injury were recorded. In addition, graft length and diameter, associated injuries of lateral or medical menisci were noted peroperatively. Patients were followed for a minimum of 12 months. The functional outcomes were assessed through lysholm knee score, and Tegner activity scale. Clinical outcome was assessed with loss of motion in flexion and extension and residual laxity using Lachman test. Paired sample t-test was applied to compare mean scores pre and post-operatively. The study findings reveal that arthroscopic anatomic Anterior Cruciate Ligament reconstruction using quadruple strand hamstring tendon autograft was an effective method of treatment for the ACL-deficient knee with improved clinical and functional status.

Comparison of Postoperative Outcomes Between Open Reduction and Internal Fixation and Ilizarov for Schatzker Type V and Type VI Fractures.

Introduction Open reduction and internal fixation (ORIF), hybrid fixation, and external fixation are available treatment options for bicondylar fractures of the proximal tibia but which one is superior to the others is not yet established. Therefore, the study aimed to establish a gold standard treatment option for bicondylar fractures by comparing the clinical, functional, and radiological outcomes managed by Ilizarov and ORIF at 24 months. Methods This was a retrospective study conducted from 2009 to 2014 at a public sector, tertiary care, level I trauma center. Patients with Schatzker type V and type VI open and closed fractures were included. Floating knee, pathological fractures of the tibia, and patients having medical conditions were excluded from the study. Honkonen and Jarvinen (HJ) criteria for subjective, clinical, radiological, and functional outcomes were used to compare between the two groups at 24 months. Demographic data included age, gender, Schatzker type, mechanism of injury, and range of knee flexion. Chi-square was used to find the level of significance, which was 0.05. Results A total of 137 patients were included in this study, with 68 patients in the ORIF group and 69 in the Ilizarov group during the study period. The mean age of the patients was 45.08 ± 10.52, respectively. The male to female distribution was 107/30 (78.1% and 21.89%). According to the mechanism of injury, road traffic accidents (RTA) were the primary cause of injury: 96 (70.07%), falls were 21 (15.32%), and gunshots were 18 (13.13%). Seventy-four were Schatzker type VI (54.01%) whereas 63 (45.98) were Shcatzker V. The average knee flexion at 24 months was 115.51 ± 16.82. There were no differences in the clinical, functional, and radiological outcomes at 24 months between the two treatment groups. Conclusion No single treatment option can be applied in all cases, and the decision depends on the complexity of the injury, the surgeon's expertise, and host factors.

Effectiveness and safety of certolizumab pegol in rheumatoid arthritis patients in Canadian practice: 2-year results from the observational FαsT-CAN study.

BACKGROUND: The aim of this study was to assess the real-world effectiveness and safety of certolizumab pegol (CZP) in rheumatoid arthritis (RA) patients, and the impact on patients' productivity, pain, and fatigue, in Canadian practice. METHODS: FαsT-CAN, a 2-year prospective, observational study, evaluated CZP use in Canadian adults with moderate to severe, active RA. The primary objective was to assess the proportion of patients achieving 28-joint Disease Activity Scores (DAS28) <2.6 at Week 104. Secondary and additional endpoints assessed the improvements in Patients' Assessment of Arthritis Pain (PtAAP), fatigue, Health Assessment Questionnaire-Disability Index (HAQ-DI), and the proportion of patients achieving minimal clinically important differences (MCID) in HAQ-DI. Validated arthritis-specific Work Productivity Surveys (WPS-RA) assessed the RA-associated impact on productivity. Incidence of CZP-related treatment-emergent adverse events (TEAEs) was reported for patients receiving ⩾1 dose of CZP (safety set). RESULTS: The full analysis set (baseline DAS28 ⩾ 2.6, ⩾1 dose of CZP and ⩾1 valid post-baseline DAS28 measurement) included 451 of the 546 patients recruited into the study; a total of 229/451 (50.8%) patients completed Week 104. At Week 104, 90/451 (20.0%) patients achieved DAS28 < 2.6. Rapid improvements in disease activity, pain, and fatigue were observed. At Week 104, 66.2% of patients achieved HAQ-DI MCID. Patients employed at Week 104, reported reduced absenteeism, and improved productivity. CZP-related TEAEs were consistent with the known CZP safety profile. CONCLUSIONS: CZP was an effective RA treatment in Canadian practice, and no new CZP-related safety signals were identified. The improvements in household and workplace productivity are the first observations in a real-world Canadian setting.

Prevalence of Hepatitis B Virus (HBV) Among Blood Donors in Eastern Saudi Arabia: Results From a Five-Year Retrospective Study of HBV Seromarkers.

BACKGROUND: Transfusion-transmissible hepatitis B virus (HBV) infection is a major problem worldwide. Recently, confirmatory nucleic acid tests (NATs) for HBV DNA have been employed in several countries. We assessed the prevalence and yearly trends of HBV infection in blood donors in the Eastern Province of Saudi Arabia, screening for HBV surface antigen (HBsAg), antibody against HBV core antigen (anti-HBc), and HBV DNA. METHODS: Between 2011 and 2015, a total of 22,842 donors were screenedfor HBsAg, anti-HBc, and HBV DNA using the HBsAg Qualitative II kit (Abbott, Ireland Diagnostics Division, Sligo, Ireland), ARCHITECT Anti-hepatitis B core antigen antibody (HBc) II Assay kit (Abbott GmbH & Co. KG, Wiesbaden, Germany), and NAT Procleix Ultrio Elite Assay kit (Grifols Diagnostic Solutions Inc., Los Angeles, CA, USA), respectively. RESULTS: A total of 739 (3.24%) donors were HbsAg(+), anti-HBc(+), or HBV DNA(+); 63 (0.28%) were HbsAg(+), anti-HBc(+), and HBV DNA(+). Twelve (0.05%) were anti-HBc(+) and HBV DNA(+) but HBsAg(-); they were considered to have occult infection. Further, 664 (2.91%) were HBsAg(-) but anti-HBc(+), indicating chronic or resolving infection. HBV prevalence increased significantly from 2011 to 2012, increased marginally till 2013, and showed a decreasing trend from 2013 (P>0.05). CONCLUSIONS: The five-year prevalence of HBV infection among blood donors in the Eastern Province of Saudi Arabia (3.24%) is lower than that reported for other regions in the country. The occult HBV infection rate of 0.05% emphasizes the importance of NATs in isolating potential infectious blood units.

Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment.

BACKGROUND: This study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and naïve to biological DMARDs. METHODS: Patients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models. RESULTS: Compared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52. CONCLUSIONS: In this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01711359 . Registered on 18 October 2012.

Acinetobacter baumannii Infection in Transfusion Dependent Thalassemia Patients with Sepsis.

PURPOSE: To identify the Acinetobacter baumannii infection among transfusion dependent thalassemia patients. METHODS: A quantitative approach was employed to assess Acinetobacter baumannii infection in transfusion dependent thalassemia patients. Samples were collected from 916 patients, which have shown bacterial growth on MacConkey and blood agar culture media. A. baumannii strains were identified by microbiological methods and Gram's staining. API 20 E kit (Biomerieux, USA) was used for final identification. RESULTS: From 916 cultured blood specimens, 107 (11.6%) showed growth of A. baumannii. Serum ferritin in thalassemic patients without bacterial infections was 3849.5 ± 1513.5 µg/L versus 6413.5 ± 2103.9 µg/L in those with bacterial infections (p = 0.0001). Acinetobacter baumannii infected patients have shown higher serum ferritin levels (p = 0.0001). Serum ferritin in thalassemic patients was 3849.5 ± 1513.5 µg/L versus 6413.5 ± 2103.9 µg/L in those with bacterial infections (p = 0.0001). Acinetobacter baumannii infected patients showed high serum ferritin levels (p = 0.0001). The clinical symptoms have been found with A. baumannii +ve with a mean and standard deviation of 47 (5.1%) and A. baumannii -ve with mean and standard deviation of 60 (6.5%). CONCLUSION: Isolation of asymptomatic A. baumannii from the thalassemia patients shows an alarming situation of bacterial infections. A continuous surveillance of transfusion dependent thalassemia patients is recommended for bacterial sepsis.

Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis.

OBJECTIVES: To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world. SETTING: 46 primary care rheumatology practices across Canada. PARTICIPANTS: 303 biological-naïve patients with AS or patients previously treated with a biological for <6 months and who were eligible for infliximab treatment as per routine care within the Biologic Treatment Registry Across Canada (BioTRAC). INTERVENTION: Not applicable (non-interventional study). PRIMARY AND SECONDARY OUTCOMES: Effectiveness was assessed with changes in disease parameters (AS Disease Activity Score (ASDAS), Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Health Assessment Questionnaire Disease Index (HAQ-DI), physician global assessment of disease activity (MDGA), patient global disease activity (PtGA), back pain, C-reactive protein, erythrocyte sedimentation rate (ESR), morning stiffness). Safety was assessed with the incidence of adverse events (AEs). RESULTS: Of the 303 patients included, 44.6% were enrolled in 2005-2007 and 55.4% in 2008-2013. Patients enrolled in 2005-2007 had significantly higher MDGA and ESR at baseline while all other disease parameters examined were numerically higher with the exception of PtGA. Treatment with infliximab significantly (p<0.001) improved all disease parameters over time in both groups. At 6 months, 56% and 31% of patients achieved clinically important (change≥1.1) and major (change≥2.0) improvement in ASDAS, respectively; at 48 months, these proportions increased to 75% and 50%, respectively. Among patients unemployed due to disability at baseline, 12.1% returned to work (mean Kaplan-Meier (KM)-based time=38.8 months). The estimated retention rate at 12 and 24 months was 78.3% and 60.1%, respectively. The profile and incidence of AEs were comparable to data previously reported for tumour necrosis factor-α inhibitors. CONCLUSIONS: Characteristics of patients with AS at infliximab initiation changed over time towards lower disease activity and shorter disease duration. Infliximab treatment significantly reduced disease activity independent of treatment initiation year, although patients enrolled in recent years achieved lower disease activity over 48 months. TRIAL REGISTRATION NUMBER: NCT00741793.