METHODS: This is a retrospective observational study involving 58 pregnancies from 1st January 2013 to 31st December 2019. Inclusion criteria were previous mid-trimester miscarriage and/or preterm birth, previous cervical surgery or short cervical length on routine sonogram. The demographic data, characteristics of each pregnancy and details of outcomes and management were described.
RESULTS: The majority of women were Malay with mean age and body mass index of 32.9 ± 4.2 years and 27.1 ± 6.3 kg/m2 respectively. The most frequent indications for Arabin pessary insertion were previous mid-trimester miscarriage (46.4%) and early preterm birth (17.2%). A total of 73.4% of these women had the pessary inserted electively at a mean cervical length of 31.6 ± 9.1 mm at median gestation of 15.0 weeks. They were managed as outpatient (56.9%), inpatient (24.1%) or mixed (19.0%) with combination of progestogen (81.0%) and 53.4% received antenatal corticosteroids. Spontaneous preterm birth at or more than 34 weeks gestation occurred in 74.1% with birthweight at or more than 2000 g (82.4%). Despite cervical funneling in 12 women (20.7%), 66.7% delivered at or later than 34 weeks gestation and 2 (16.7%) resulted in miscarriage.
CONCLUSIONS: Insertion of the Arabin pessary is beneficial to prevent spontaneous preterm birth in pregnant women who are at high risk. In particular, early insertion and close monitoring allows the best possible outcomes.
TRIAL REGISTRATION: This study was retrospectively registered with ClinicalTrials.gov ( NCT04638023 ) on 20/11/2020.
METHODS: The translation of the English version of the valid 10-item TAI questionnaire into BM was followed by subjecting it to a series of tests establishing factorial, concurrent and known group validities. Concurrent validity was assessed through Spearman's rank correlation coefficient against pharmacy refill-based adherence scores. Known group validity was assessed by cross-tabulation against asthma symptom control and using chi-square test. The internal consistency of the test scale was determined by a test-retest method using Cronbach's alpha (α) value and intraclass correlation coefficients.
RESULTS: A total of 120 adult asthma patients participated in the study. A 2-factor structure was obtained and confirmed with acceptable fit indices; CFI, NFI, IFI, TLI >0.9 and, RMSEA was 0.08. The reliability of the scale was 0.871. The test-retest reliability coefficient for the total sum score was 0.832 (p 85%.
CONCLUSIONS: The scale successfully translated into BM and validated. The 10-item TAI-BM appears fit for use in testing inhaler adherence of Malaysian patients with asthma.
OBJECTIVES: To assess the effects of peri-operative tranexamic acid versus no therapy or placebo on operative parameters in patients with chronic rhinosinusitis (with or without nasal polyps) who are undergoing functional endoscopic sinus surgery (FESS).
SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 10 February 2022.
SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing intravenous, oral or topical tranexamic acid with no therapy or placebo in the treatment of patients (adults and children) with chronic rhinosinusitis, with or without nasal polyps, undergoing FESS.
DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Primary outcome measures were surgical field bleeding score (e.g. Wormald or Boezaart grading system), intraoperative blood loss and significant adverse effects (seizures or thromboembolism within 12 weeks of surgery). Secondary outcomes were duration of surgery, incomplete surgery, surgical complications and postoperative bleeding (placing of packing or revision surgery) in the first two weeks after surgery. We performed subgroup analyses for methods of administration, different dosages, different forms of anaesthesia, use of thromboembolic prophylaxis and children versus adults. We evaluated each included study for risk of bias and used GRADE to assess the certainty of the evidence.
MAIN RESULTS: We included 14 studies in the review, with a total of 942 participants. Sample sizes in the included studies ranged from 10 to 170. All but two studies included adult patients (≥ 18 years). Two studies included children. Most studies had more male patients (range 46.6% to 80%). All studies were placebo-controlled and four studies had three treatment arms. Three studies investigated topical tranexamic acid; the other studies reported the use of intravenous tranexamic acid. For our primary outcome, surgical field bleeding score measured with the Boezaart or Wormald grading score, we pooled data from 13 studies. The pooled result demonstrated that tranexamic acid probably reduces the surgical field bleeding score, with a standardised mean difference (SMD) of -0.87 (95% confidence interval (CI) -1.23 to -0.51; 13 studies, 772 participants; moderate-certainty evidence). A SMD below -0.70 represents a large effect (in either direction). Tranexamic acid may result in a slight reduction in blood loss during surgery compared to placebo with a mean difference (MD) of -70.32 mL (95% CI -92.28 to -48.35 mL; 12 studies, 802 participants; low-certainty evidence). Tranexamic acid probably has little to no effect on the development of significant adverse events (seizures or thromboembolism) within 24 hours of surgery, with no events in either group and a risk difference (RD) of 0.00 (95% CI -0.02 to 0.02; 8 studies, 664 participants; moderate-certainty evidence). However, there were no studies reporting significant adverse event data with a longer duration of follow-up. Tranexamic acid probably results in little difference in the duration of surgery with a MD of -13.04 minutes (95% CI -19.27 to -6.81; 10 studies, 666 participants; moderate-certainty evidence). Tranexamic acid probably results in little to no difference in the incidence of incomplete surgery, with no events in either group and a RD of 0.00 (95% CI -0.09 to 0.09; 2 studies, 58 participants; moderate-certainty evidence) and likely results in little to no difference in surgical complications, again with no events in either group and a RD of 0.00 (95% CI -0.09 to 0.09; 2 studies, 58 participants; moderate-certainty evidence), although these numbers are too small to draw robust conclusions. Tranexamic acid may result in little to no difference in the likelihood of postoperative bleeding (placement of packing or revision surgery within three days of surgery) (RD -0.01, 95% CI -0.04 to 0.02; 6 studies, 404 participants; low-certainty evidence). There were no studies with longer follow-up.
AUTHORS' CONCLUSIONS: There is moderate-certainty evidence to support the beneficial value of topical or intravenous tranexamic acid during endoscopic sinus surgery with respect to surgical field bleeding score. Low- to moderate-certainty evidence suggests a slight decrease in total blood loss during surgery and duration of surgery. Whilst there is moderate-certainty evidence that tranexamic acid does not lead to more immediate significant adverse events compared to placebo, there is no evidence regarding the risk of serious adverse events more than 24 hours after surgery. There is low-certainty evidence that tranexamic acid may not change postoperative bleeding. There is not enough evidence available to draw robust conclusions about incomplete surgery or surgical complications.
METHODS: Seven licensed practicing community pharmacists (from the Klang Valley, Malaysia) were interviewed between 23rd September to 14th November 2021. These were CPs participating in the questionnaire study who agreed to be interviewed. NVIVO 11 software was used for data analysis. Codes and themes were generated and agreed on by the researchers.
RESULTS: The major themes identified related to the process mentioned of providing information to patients, the issues addressed by CPs during the counselling (including steroid phobia, overuse of TCS, patients asking for a specific preparation by name), less counselling support material, language barriers, lesser knowledge about certain conditions, information sources used by CPs (material provided by Ministry of Health and Malaysian Pharmacists Association, MIMS) and suggestions to strengthen the quality of counselling (specialization in skin diseases, webinars, shared care models). For patients requesting a particular preparation by name, the pharmacist will decide whether the preparation requested is suitable or suggest an alternative. Steroid phobia was seen more commonly among parents of young children and young patients. MIMS was available as a smartphone application making it easier to use. Advanced training for CPs in the management of skin conditions like that provided for diabetes mellitus can be considered.
CONCLUSIONS: Counselling was conducted while dispensing TCS in the open area of the pharmacy. Challenges to counselling were lack of time, limited counselling materials, and language barriers. Steroid phobia requires attention. Initiatives to strengthen counselling were mentioned by respondents and appear feasible. Further research covering the entire country is required.
OBJECTIVE: To perform a systematic review and meta-analysis to determine the prevalence, risk factors for contracting COVID-19, and complications of COVID-19, in children with CLD.
METHODS: This systematic review was based on articles published between January 1, 2020 and July 25, 2022. Children under 18 years old, with any CLD and infected with COVID-19 were included.
RESULTS: Ten articles involving children with asthma and four involving children with cystic fibrosis (CF) were included in the analyses. The prevalence of COVID-19 in children with asthma varied between 0.14% and 19.1%. The use of inhaled corticosteroids (ICS) was associated with reduced risk for COVID-19 (risk ratio [RR]: 0.60, 95% confidence interval [CI]: 0.40-0.90). Uncontrolled asthma, younger age, AND moderate-severe asthma were not significant risk factors for contracting COVID-19. Children with asthma had an increased risk for hospitalization (RR: 1.62, 95% CI: 1.07-2.45) but were not more likely to require assisted ventilation (RR: 0.51, 95% CI: 0.14-1.90). The risk of COVID-19 infection among children with CF was <1%. Posttransplant and cystic fibrosis-related diabetes mellitus (CFRDM) patients were at an increased risk for hospitalization and intensive care treatment.
CONCLUSION: Hospitalizations were higher in children with asthma with COVID-19 infection. However, using ICS reduced the risk of COVID-19 infection. As for CF, postlung transplantation and CFRDM were risk factors for severe disease.
METHODS: This is a systematic review and a meta-analysis evaluating the evidence from clinical trials on the effect of colchicine and corticosteroids against COVID-19. In this review, we have systematically searched five databases [(PubMed, Embase, clinicaltrials.gov, ICTRP, CINAHL (EBSCO)]. Cochrane's data extraction sheet was used to collect the required information, and RevMan-5.4.1 was used to conduct the meta-analysis and to assess the risk of bias. The review was registered in Prospero (CRD42022299718).
RESULTS: The total number of included studies was 17, with 18,956 participants; the majority were male 12,001. Out of which, 8772 participants were on colchicine, 569 took methylprednisolone, and 64 patients received prednisolone. The meta-analysis has shown that colchicine had no significant effect on reducing the mortality rate among COVID-19 patients [OR 0.98(95% CI 0.90-1.08), p = .70), I2:1%)], corticosteroids have significantly reduced the mortality rates [OR 0.55 (95% CI 0.33-0.91), p = .02, I2:40]. Colchicine did not reduce the incidence of ICU admissions [OR 0.74 (95% CI 0.39-1.40), p = .35, I2:0%], while steroidal drugs significantly reduced the ICU admissions [OR 0.42 (95% CI 0.23-0.78), p = .005, I2:0%]. Unlike steroidal drugs [OR 0.53 (95% CI 0.30-0.95), p = .03, I2:61%], colchicine failed to reduce the need for mechanical ventilation [OR 0.73 (95% CI 0.48-1.10), p = .13, I2:76%]. Steroidal drugs significantly reduced the duration of hospitalization among COVID-19 patients [OR -0.50 (95% CI -0.79-0.21), p = .0007, I2:36%].
CONCLUSIONS: The use of colchicine did not significantly reduce the mortality rate, ICU admissions, and mechanical ventilation among COVID-19 patients. Conversely, corticosteroids significantly reduced the mortality rate, ICU admissions, mechanical ventilation, and hospitalization duration among COVID-19 patients.
METHODS: This was a retrospective cohort study of severe COVID-19 patients who were admitted to a single tertiary centre from 1 January 2021 to 30 June 2021. The clinical data of the patients during admission and clinic follow-up, including radiological images, were traced using electronic medical records.
RESULTS: In our cohort, the mortality rate for those with severe COVID-19 was 23.1% (173/749). Among the survivors, 46.2% (266/576) had persistent respiratory failure (PRF) after 14 days of illness. Of them, 70.3% (187/266) were followed up, and 68% (128/187) received oral corticosteroid (prednisolone) maintenance treatment. OP pattern made up the majority (81%) of the radiological pattern with a mean severity CT score of 10 (SD±3). The mean prednisolone dose was 0.68mg/kg/day with a mean treatment duration of 47 days (SD±18). About one-third of patients (67/187) had respiratory symptoms at 4 weeks (SD±3). Among 78.1% (146/187) who had a repeated CXR during follow-up, only 12 patients (8.2%, SD±3) had radiological improvement of less than 50% at 6 weeks (SD±3), with 2 of them later diagnosed as pulmonary tuberculosis. Functional assessments, such as the 6-minute walk test and the spirometry, were only performed in 52.4% and 15.5% of the patients, respectively.
CONCLUSION: Almost half of the patients with severe COVID-19 had PRF, with a predominant radiological OP pattern. More than two-thirds of the PRF patients required prolonged oral corticosteroid treatment. Familiarising clinicians with the disease course, radiological patterns, and potential outcomes of this group of patients may better equip them to manage their patients.
METHODS: Electronic databases and country-specific healthcare databases were searched to identify relevant studies/reports. The quality assessment of individual studies was conducted using the Newcastle-Ottawa Scale. Country-specific proportion of individuals with COVID-19 who developed ARDS and reported death were combined in a random-effect meta-analysis to give a pooled mortality estimate of ARDS.
RESULTS: The overall pooled mortality estimate among 10,815 ARDS cases in COVID-19 patients was 39% (95% CI: 23-56%). The pooled mortality estimate for China was 69% (95% CI: 67-72%). In Europe, the highest mortality estimate among COVID-19 patients with ARDS was reported in Poland (73%; 95% CI: 58-86%) while Germany had the lowest mortality estimate (13%; 95% CI: 2-29%) among COVID-19 patients with ARDS. The median crude mortality rate of COVID-19 patients with reported corticosteroid use was 28.0% (lower quartile: 13.9%; upper quartile: 53.6%).
CONCLUSIONS: The high mortality in COVID-19 associated ARDS necessitates a prompt and aggressive treatment strategy which includes corticosteroids. Most of the studies included no information on the dosing regimen of corticosteroid therapy, however, low-dose corticosteroid therapy or pulse corticosteroid therapy appears to have a beneficial role in the management of severely ill COVID-19 patients.