Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study.

OBJECTIVES: This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia. DESIGN: Real-world, prospective, multicentre, observational, phase IV study. SETTING: 13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore. PARTICIPANTS: Adult patients aged 18-80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain. MAIN OUTCOME MEASURES: Primary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs). RESULTS: Among 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness. CONCLUSION: This study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia.

INTRODUCTION: Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia. METHODS AND ANALYSIS: REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18-80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app. ETHICS AND DISSEMINATION: The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Improving fragility hip fracture care through data: a multicentre experience from a country with an emerging economy during the COVID-19 pandemic.

INTRODUCTION: In low-to-middle-income countries (LMIC), the orthogeriatric model of care is still in its early stages of development. This study describes the initial results of the first online fragility hip fracture database to be setup in the Philippines using a modified minimum common dataset to generate outcomes data based on current hospital practices. METHODS: A multicentre prospective cohort study among 12 Philippine hospitals was conducted from June 2020 to February 2021. Thirty-day mortality, morbidity and mobility were measured. Significant factors associated with mortality were determined. RESULTS: 158 elderly patients with fragility hip fractures were included in the study. Nine patients (5.7%) were confirmed or suspected to have COVID-19 infection. Median time of injury to admission was at least 3 days (IQR: 1.0-13.7). Overall, 80% of patients underwent surgical intervention with a median time from admission to surgery of at least 5 days (IQR: 2.5-13.6). Thirty-day mortality and morbidity rates for acute fragility fractures were 3.7%. Factors significantly associated with early mortality were poor prefracture mobility, COVID-19 infection, radiograph of the abnormal chest and conservative treatment. Non-surgical patients had no functional mobility or were wheelchair users and had a significantly higher morbidity rate than surgically treated patients (13.6% vs 1.8%; p=0.031). CONCLUSION: Despite treatment delays unique to an LMIC, short-term outcomes remain favourable for non-COVID-19 fragility hip fracture patients treated with surgery. Prompt admission and multidisciplinary care for elderly hip fracture patients while maintaining protective measures for COVID-19 infection control are recommended. The quality of data collected illustrates how this online database can provide a framework for a sustainable audit or registry as well as provide a platform for the introduction of orthogeriatric concepts at a multiregional scale.

Unplanned Excision of Soft Tissue Sarcomas of the Extremities in a Low-to-Middle-Income Country.

BACKGROUND: Outcomes of unplanned excisions of extremity soft tissue sarcomas (STSE) range from poor to even superior compared with planned excisions in developed countries. However, little is known regarding outcomes in low-to-middle-income countries. This study aimed to determine whether definitively treated STSE patients with a previous unplanned excision have poorer oncologic outcomes compared with those with planned excisions. PATIENTS AND METHODS: Using the database of a single sarcoma practice, we reviewed 148 patients with STSE managed with definitive surgery-78 with previous unplanned excisions (UE) and 70 with planned excisions (PE). RESULTS: Median follow-up was 4.4 years. UE patients had more surgeries overall and plastic reconstructions (P < 0.001). On multivariate analysis, overall survival (OS), local recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) were not worse among UE patients compared with PE patients. Negative predictors for LRFS were high tumor grade (P = 0.031) and an R1 surgical margin (P < 0.001). High grade (P <0.001), local recurrence (P = 0.001), and planned excisions (P = 0.009) predicted poorer DMFS, while age over 65 years (P = 0.011) and distant metastasis predicted poorer OS (P < 0.001). CONCLUSIONS: We recommend systematic re-excision for patients with unplanned excisions. Our study shows that STSE patients with UE, when subjected to re-excision with appropriate surgical margins, can achieve oncologic results similar to those for PE patients. However, there is an associated increased number of surgeries and plastic reconstruction for UE patients. This underscores the need, especially in a resource-limited setting, for education and collaborative policies to raise awareness about STSE among patients and physicians.

The Effect of a Patient Navigator on Treatment Abandonment and Follow-up for High Grade Osteosarcoma Patients in the Philippine General Hospital.

INTRODUCTION: Treatment abandonment for osteosarcoma is a significant problem in developing countries with rates as high as 70%. This study aimed to determine the effect of a patient navigator on treatment abandonment and patient follow-up of osteosarcoma patients at a tertiary referral center. MATERIALS AND METHODS: A retrospective review of osteosarcoma patients was performed investigating 2 cohorts based on the start of the patient navigator. Group 1 (Pre-Patient Navigator, n=46) were treated from January 2016 to December 2017 while Group 2 (Post-Patient Navigator, n=29) were treated from January 2018 to June 2019. The primary outcome investigated was treatment abandonment defined as missing 4 or more consecutive weeks of treatment. Semi-structured interviews were conducted to investigate the effect of the patient navigator on the cohorts. RESULTS: Treatment abandonment rates for the Pre-Patient Navigator group was significantly higher compared to those with a patient navigator (50% vs 6%, p=0.0001). Abandonment for the pre-navigator group occurred at a mean of 2.9 months (0 - 9 months, median 3 months). Fourteen of 23 patients who abandoned from Group 1 did not proceed to neoadjuvant chemotherapy while 3 patients abandoned after completing 1 cycle of neoadjuvant chemotherapy. In the patient navigator group, no patients abandoned prior to completing 3 cycles of chemotherapy. One patient abandoned after refusing a below knee amputation after 3 cycles of neoadjuvant chemotherapy and 1 patient did not complete further chemotherapy after having a hip disarticulation. Patient feedback on the patient navigator experience was favorable. CONCLUSIONS: Having a patient navigator from diagnosis throughout treatment reduced treatment abandonment rates in osteosarcoma patients and may serve as a model for other low to middle income countries.