BACKGROUND AND OBJECTIVE

Myeloproliferative disorders are characterized by symptoms that can potentially impair the quality of life of our Filipino patients. The Myeloproliferative Neoplasm Symptom Assessment Form-Total Symptom Score (MPN-SAF TSS) is used to determine symptoms at baseline and during treatment. A validated Filipino version of this questionnaire would be a helpful tool in assessing the burden of symptoms of Filipino patients with MPN. Understanding the symptom burden and symptom experience of patients with MPN is needed in developing a comprehensive wholistic management plan that addresses the physical and emotional aspects of a chronic disease such as MPN. This study aimed to translate the MPN-SAF TSS to the Filipino language.

Translation, validation, and reliability testing of the MPN-SAF TSS was done following the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for linguistic translation and validation.

No major discrepancies were found on forward and backward translation of the MPN-SAF TSS tool. The 0-10 scoring scale (where 0 = absent/as good as it can be and 10 = worst imaginable/daily/as bad as it can be) was deemed appropriate and was retained. Content and face validity as evaluated by Filipino hematologists showed that majority of the translated questions were relevant. Some words were further improved according to their valid recommendations. Ten MPN patients voluntarily answered the updated Filipino version of the questionnaire for face validity and cognitive debriefing was done to further refine the translation according to the patient’s perspective. The back translation was identical to the original versions of MPN-SAF TSS.

Validity and reliability testing of the revised and translated MPN-SAF TSS among 30 patients with MPN demonstrated that the MPN-SAF TSS Filipino version was conceptually equivalent with the English version, with good internal consistency (Cronbach’s alpha=0.89); excellent reliability with an intraclass correlation coefficient of 0.98 and convergent validity of r=0.77. 

The Filipino version of the MPN-SAF TSS was demonstrated to be a valid and reliable tool in evaluating the symptom burden of Filipino patients with MPN.

Background and Objective: Convalescent plasma therapy (CPT) may reduce the risk of disease progression among patients with COVID-19. This study was undertaken to evaluate the efficacy and safety of CPT in preventing ICU admission among hospitalized COVID-19 patients. Methods: In this open-label randomized controlled trial, we randomly assigned hospitalized adult patients with COVID-19 in a 1:1 ratio to receive convalescent plasma as an adjunct to standard of care or standard of care alone. The primary endpoint was ICU admission within first 28 days of enrolment. Primary safety endpoints include rapid deterioration of respiratory or clinical status within four hours of convalescent plasma transfusion and cumulative incidence of serious adverse events during the study period including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), severe allergic reactions, and transfusion-related infections. Results: A total of 22 patients were assigned to receive convalescent plasma as an adjunct to standard of care and 22 to receive standard of care alone. The median time from onset of COVID-19 symptoms to study enrolment was eight days (IQR, 4 to 10). Two patients (9.1%) in the CPT group and one patient (4.5%) in the control group were admitted to the ICU. The primary outcome measure, ICU admission, was not different between the two groups (q-value >0.9). No patient who received convalescent plasma had rapid deterioration of respiratory/clinical status within four hours of transfusion and none developed TRALI, TACO, anaphylaxis, severe allergic reactions, or transfusion-related infections. There was also no significant difference in the secondary outcomes of 28-day mortality (two patients in the CPT group and none in the control group, q-value >0.90), dialysis-free days, vasopressor-free days, and ICU-free days. Conclusions Among hospitalized COVID-19 patients, no significant differences were observed in the need for ICU admission between patients given CPT as adjunct to standard of care and those who received standard of care alone. Interpretation is limited by early termination of the trial which may have been underpowered to detect a clinically important difference.
COVID-19 ; COVID-19 Serotherapy

Background: Virgin coconut oil (VCO) has anti-viral and anti-inflammatory properties, making it a potential therapeutic candidate against COVID-19 infection. Objective: To determine the efficacy and safety of VCO as adjunctive therapy for hospitalized patients with COVID-19. Methods: We conducted a randomized, open-label controlled trial involving laboratory-confirmed COVID-19 patients admitted at the Philippine General Hospital. The study participants were randomized to the intervention group who received virgin coconut oil with local standard of care, or to the control group who received local standard of care alone. Results: We enrolled 39 participants into the VCO group and 38 participants into the control group. Significantly fewer participants in the VCO group had abnormal CRP levels at the end of treatment compared to control. (relative risk [RR] 0.75, 95% confidence interval [CI] 0.58 to 0.95; p=0.02) No significant difference was found in the duration of hospital stay (mean 9.33 days for VCO vs. 10.29 days for control; p=0.45) and time to symptom resolution (mean 6.8 days for VCO, vs. 6.74 days for control; p=0.91). Although the proportion of patients who developed the secondary outcomes of mortality, need for ICU admission, need for invasive ventilation, and negative viral conversion was lower in the VCO group, results did not reach statistical significance. The VCO group had larger reduction in the inflammatory markers ferritin, lactate dehydrogenase, TNF-alpha, IP-10 and IL-6, but results did not reach statistical significance. Adverse events were significantly higher in the VCO group (RR 4.87, 95% CI 1.14 to 20.79; p=0.03). Conclusion This clinical trial on hospitalized patients showed significant benefit in CRP levels of participants given VCO compared to control. There was no significant benefit in the use of VCO as adjunctive therapy in reducing duration of hospital stay. Larger studies are needed to conclusively demonstrate the effect of VCO on other clinical outcomes and inflammatory markers.
COVID-19 ; Clinical Trial

BACKGROUND

Myeloproliferative neoplasms (MPN) are a heterogeneous group of disorders characterized by the cellular proliferation of one or more hematologic cell lines. Patients with MPN who are Philadelphia-negative such as those with Polycythemia Vera (PV), Essential Thrombocytosis (ET), or Myelofibrosis (MF) experience a cluster of symptoms related to the disease activity which can affect their quality of life.

This study aimed to explore the symptoms and symptom experience as well as lived experience of Filipino patients with MPN using a qualitative phenomenological approach to get a deeper understanding of the disease symptomatology.

Twenty-three patients with myeloproliferative neoplasms were purposively selected according to: 1) type of MPN (PV, ET, MF) 2) status of MPN disease (newly diagnosed vs. chronic) 3) age (≤50 years old; >50 years) and 4) sex (male vs. female). The investigators conducted key informant interviews using a semi-structured interview guide. Interview scripts and narratives were transcribed and analyzed using categorical aggregation and thematic analysis.

Twenty patients proceeded with the interview (8 PV, 6 ET, 6 MF). The meta-themes identified were 1) symptom experience and 2) disease perception. Three sub-themes under symptom experience were a) heterogenous and complex symptomatology; b) dynamic nature of symptoms; c) living and coping with symptoms. Three sub-themes under disease perception were a) struggle with the concept of the disease; b) anxiety and uncertainty; c) acceptance and hope. The most common symptoms experienced by the patients were fatigue, bone pain, and abdominal discomfort. Vascular symptoms specifically headache, numbness, and problems in concentration were commonly reported by patients with PV. Fever and weight loss were the least common. Sources of anxiety/uncertainty include the unpredictability of symptom occurrence and blood counts, the burden of taking maintenance medications, the financial burden of living with MPN, and the unpredictability of disease and complications.

Patients with MPN had heterogenous, co-occurring, and dynamic symptoms which affected their overall productivity both at home and at work. Patients with MF had the most symptom burden while patients with ET had the least. This study provided valuable insights on disease perceptions, sources of anxiety, and coping mechanisms of patients with MPN. A deeper understanding of the symptom experience and disease perceptions of the patients will enhance the physician-patient interaction especially when discussing management options.

Objectives: To describe the clinical profile and factors associated with mortality among the first 200 patients confirmed to have COVID-19 infection admitted in the University of the Philippines – Philippine General Hospital (UP-PGH) Methodology: We conducted a retrospective review of adult patients with confirmed COVID-19 infection admitted in PGH, a designated COVID-19 referral center. Demographic, clinical data, and clinical outcomes were extracted from medical records. Frequencies and distributions of various clinical characteristics were described, and factors associated with mortality were investigated. Results: Of the 200 patients in our cohort, majority were male (55.5%), and more than half (58%) were over 60 years old. Underlying co-morbid illnesses (67.5%) included hypertension (49.5%), diabetes mellitus (26.5%), and cardiovascular disease (20.5%). Most frequent presenting symptoms were cough (69.0%), fever (58.5%), or shortness of breath (53.0%). Most patients presented with mild (n=41, 20.5%) to moderate illness (n=99, 49.5%) and only 60 were considered severely (n=32, 16.0%) or critically ill (n=28, 14.0%). Many (61%) received empiric antibiotics, while 44.5% received either repurposed drugs or investigational therapies for COVID-19. Bacterial co-infection was documented in 11%, with Klebsiella pneumoniae commonly isolated. In-hospital mortality was 17.5%, which was highest for critical COVID-19 (71.4%). Mortality was observed to be higher among patients age 60 and above, those requiring oxygen, ventilatory support and ICU admission, and among those who developed acute kidney injury, acute stroke, sepsis, and nosocomial pneumonia. Conclusion: Our study confirms that COVID-19 affects males, older individuals and those with underlying co-morbid conditions. Empiric antimicrobial treatment was given for majority of patients, despite documentation of bacterial infection in only 11%. K. pneumoniae was commonly isolated, reflecting local epidemiology. Mortality rate during this early period of the pandemic was high and comparable to other institutions. Factors associated with mortality were related to critical COVID-19 and are similar to other studies.
COVID-19 ; Philippines

Introduction. In the attempt to control the spread of the disease and the pandemic, numerous COVID-19 vaccines are in development. A review of the evidence on their efficacy and safety are critical. Methods. A search for trials was done using the COVID-19 Living OVerview of Evidence (L·OVE) platform. We also searched for relevant authorization documents and trial reports for COVID-19 vaccines of the US-Food and Drug Authority (US-FDA), the European Medicines Agency (EMA), the United Kingdom Medicines and Health Products Regulatory Agency (MHRA), and the WHO website. We included studies that fulfilled the following inclusion criteria: population – humans; intervention – COVID-19 vaccines; comparison – control or placebo; outcomes – efficacy and adverse events; methods – phase 3 randomized trials. Two reviewers independently screened the reports, assessed the methodological quality, and extracted the data on the trial characteristics and results on vaccine efficacy and safety. The date of last search was March 11, 2021. Results. Interim results of trials investigating five vaccines were identified and included in the review. All five vaccines demonstrated satisfactory vaccine efficacy (VE) against symptomatic COVID-19 infection among adults in the short term with moderate certainty of evidence: BNT162b2, VE 95% (95% CI 90.3, 97.6); mRNA-1273, VE 93.6% (95% CI 88.6, 96.5); ChAdOx1, VE 66.7% (95% CI 57.4, 74.0), Gam-COVID-Vac, VE 91.1% (95% CI 83.6, 95.1); and Ad26.CoV2.S, VE 67.2% (95% CI 59.3, 73.7). Data on the efficacy against severe COVID-19 infection and asymptomatic COVID-19 infection are still inconclusive, except for Ad26.CoV2.S, which demonstrated good efficacy in preventing moderate and/or severe COVID-19 infection and acceptable protection against asymptomatic COVID-19 infection 28 days after vaccination (moderate certainty of evidence). Efficacy data on preventing death from COVID-19 infection are still inconclusive. Very limited phase 3 trial data is available to inform vaccine efficacy against the different variants of SARS-CoV-2. Vaccination with these five vaccines was associated with higher adverse reactions compared to control. These adverse events, due to reactions to the vaccines, were mild to moderate and of short duration. Available evidence on vaccine efficacy and safety is limited, mainly due to the short follow up and the small sample size of specific populations. Conclusion. BNT162b2, mRNA-1273, ChAdOx1, Gam-COVID-Vac and Ad26.CoV.S vaccines demonstrated satisfactory vaccine efficacy against symptomatic COVID-19 infection among adults in the short term with moderate certainty of evidence. Data on the efficacy against severe COVID-19 infection, asymptomatic COVID-19 infection, and death from COVID-19 infection are still inconclusive. Long-term efficacy and safety data, and data on the efficacy against variant strains of SARS-CoV-2 are still lacking.
Humans ; COVID-19 Vaccines ; COVID-19

Objective. This study aimed to assess compliance with current best practice guidelines on the use of antibiotics in the Department of Surgery in the Philippine General Hospital and to determine the impact of the dissemination of an institution-based guideline on compliance and on patient outcomes. Methods. Two antibiotic use surveys were performed 4 weeks before and 4 weeks after the implementation and dissemination of the PGH Surgical Antibiotic Use Guidelines in the Department of Surgery. The medical records of eligible patients were reviewed regarding patient and case characteristics, details on the administration of antibiotics and the collection of specimen for culture studies. Data relating to the occurrence of surgical site infection within 30 days of the operation was extracted. Compliance with antibiotic use guidelines was assessed for each case. The compliance rates in the pre- and post-intervention periods were compared. Results. The study included a total of 477 patients, 213 in the pre-implementation and 264 in the post-implementation period. Compared with the pre-intervention period, rates of compliance with guidelines improved for all parameters in the post-implementation period except for correct dosing. The greatest improvement was seen in the selection of the recommended drug, and proper duration. There was modest improvement in the timing of the preoperative drug administration. There was poor compliance with recommendations for appropriate specimen collection for culture studies, with marked improvement in collection in the pediatric group post-intervention. Overall, the in-hospital SSI rate was reduced from 6.8% to 1.1%, while there was little change in the 30-day SSI rate, post-intervention. Conclusion. A simple intervention to raise awareness of institutional guidelines on antibiotic use in the surgical setting lead to a modest improvement on overall compliance, although rates of total compliance with all relevant guidance on antibiotic use, choice, dose, timing and duration remained low. The impact on surgical site infection rates based on such compliance was modest.
Anti-Bacterial Agents

Objective: This rapid review aimed to summarize data on the accuracy, benefits, harms, and cost-effectiveness of preoperative COVID-19 clinical risk assessment for asymptomatic individuals. Methods: A comprehensive search in MEDLINE, Cochrane CENTRAL, ChinaXiv, medRxiv, and bioRxiv was done until March 10, 2021, using the keywords “COVID-19”, “surgery”, “RT-PCR”, “clinical risk assessment” and “cost-effectiveness”. We searched for studies that assessed the diagnostic accuracy of preoperative clinical risk assessment in COVID-19 screening among asymptomatic individuals, its cost-effectiveness, and its impact on surgical outcomes and management decisions. Risk of bias was assessed using Evaluation of Articles on Diagnosis (Painless Evidence Based Medicine)10 for accuracy studies, Newcastle-Ottawa Scale11 for cohort studies, and Drummond’s checklist12 for economic evaluations. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach was used to evaluate the overall evidence. Data from included studies were collated qualitatively using summary tables and analyzed in Review Manager 5.4. Pooling of sensitivity and specificity, odds ratio or adjusted odds ratio, and cost-effectiveness measures using a random-effects model was planned. Heterogeneity was determined using I2. Subgroup and sensitivity analyses were preplanned in case significant heterogeneity was found. Results: Three observational studies were included. Preoperative clinical risk assessment for COVID-19 demonstrated a sensitivity of 0.42 (95% CI 0.15-0.72) and a specificity of 0.85 (95% CI 0.76-0.92), using RT-PCR as a reference standard. Indirect evidence showed that any positive clinical risk assessment, COVID-19 antigen or RT-PCR test is done within 0–7 weeks from surgery was associated with a higher 30-day postoperative mortality (RR 3.96, 95% CI 3.41, 4.59) and pulmonary complications (RR 3.41, 95% CI 3.04, 3.83). Delaying surgery at least seven weeks from COVID-19 diagnosis was associated with lower post-surgical complications. Universal pre-endoscopy virus testing using the antigen rapid diagnostic test (Ag-RDT) (ICER = -26,286 €), standard RT-PCR (ICER = -11,128€), or rapid PCR (ICER = -13,703 €) combined with high-risk personal protective equipment (PPE) use in all patients irrespective of test results were found to be more cost-effective compared to no pre-endoscopy testing and no high-risk PPE use, at an, assumed COVID-19 prevalence of 1% or higher among asymptomatic individuals. Overall certainty of evidence was very low. Conclusion Preoperative clinical risk assessment has poor sensitivity but high specificity for detecting COVID-19 among asymptomatic individuals undergoing elective surgery. Objective diagnostic tests such as RT-PCR or Ag-RDT may still be needed to inform surgery schedules.
COVID-19 ; Mass Screening

OBJECTIVES: To determine the effect of prolonged cotrimoxazole prophylaxis (CP) in reducing hospitalization and opportunistic infection rates among people living with HIV (PLHIV) with CD4 count >200 cells/mm3.
METHODS:  We retrospectively reviewed 349 medical charts of PLHIV with CD4 count (or T-cell count) of >200 cells/mm3 enrolled in an HIV treatment hub in Manila, Philippines, from January 2004 to July 2016. Demographic, clinical characteristics and outcomes were extracted. Descriptive statistics were generated. Chi-square test for two proportions was done to compare the difference in outcomes between the CP and non-CP groups.
RESULTS:  Of the 349 patients, majority (96.6%) were male with a mean age of 28 years (SD 6.4) and mean CD4 count of 373 cells/mm3 (SD 148). CP was continued in 103 patients (29.5%) with mean duration of 1.7 (SD 1.9) years. The prolonged CP group had more events of adverse drug reactions (p<0.001), specifically minor cutaneous reactions (p<0.001) and immunologic failures (p<0.001), compared to the non-CP group. There were no statistically significant differences in the frequency of hospitalization, PJP (Pneumocystis jirovecii pneumonia), non-PJP, other respiratory illnesses, diarrhea, toxoplasmosis, tuberculosis, stage 3/4 events and mortality, between the prolonged CP and non-CP groups.
CONCLUSION: We did not observe any additional benefit in giving prolonged CP among PLHIV with CD4 count >200 cells/mm3. More adverse effects were also seen in the CP group.

OBJECTIVE: This study aimed to describe dengue burden in the Philippines. Specifically, health and economic costs of the disease were estimated.

METHODS: A published serotype-specific and age-stratified dengue dynamic transmission model was populated with Philippine-specific dengue epidemiology and cost data. Data were gathered from literature and record reviews. Dengue experts were consulted to validate the model parameters. Sensitivity analyses were performed to test the uncertainty of input parameters on model outcomes.

RESULTS: By 2016 to 2020, it is estimated that annually, average hospitalized cases will amount to 401,191 and ambulatory cases will amount to 239,497; resulting to USD 139 million (PhP 5.9 billion) and USD 19 million (PhP 827 million) worth of aggregate costs shouldered by the public payer for hospitalized and ambulatory cases, respectively. Average annual productivity losses may amount to USD 19 million (PhP 821 million) and DALY lost is expected to be 50,622.

CONCLUSION: The cost of dengue is high especially since the Philippines is an endemic country. Thus, there is a need to optimize government interventions such as vector control and vaccination that aim to prevent dengue infections.