Under the Universal Health Care Act of the Philippines, all health technologies should undergo health technology assessment. This manuscript details the process of the development of the Philippine guidance document for the use of real-world evidence (RWE) in the clinical evaluation of health technologies.

This study consisted of two phases. Phase 1 was a comprehensive, systematic review of all available HTA methods guides and literature related to the use of RWE in the clinical evaluation of health technologies. Based on the results of the review, a draft HTA methods guide on the use of RWE was created. Phase 2 was a validation study by expert consultation through key informant interviews (KIIs), and pilot assessment of the methods guide.

Seventy-nine articles and nine guidance papers were included, with pertinent information extracted and organized into sections. The first draft covered definitions of RWE, guidance for RWE utilization, scoping and selecting RWE, critical appraisal, data extraction, and synthesis and analysis of RWE. Changes were made to this draft based on the KIIs and pilot assessment results to produce the final output of the methods guide.

This document describes the process of creating a Philippine guidance document that covers the definition of RWE and the appropriate methods for conducting systematic search, screening, critical appraisal, data extraction, data analysis, and synthesis of RWE.

Eating disorders (EDS) have become in recent decades an important focus of interest for basic and clinical research due to the increase in prevalence and incidence observed and, therefore, the evident need to prevent and provide a therapeutic response to situations that affect important sectors of the population. Normal eating behavior and its pathological deviations can only be understood if they are studied under the biopsychosocial approach, since, attending only to the eating aspect, we are ignoring a series of determining factors in the development of this process. Within these factors, important changes have been observed in recent times in relation to the demographic profile, going from being a disease studied predominantly in women, to extending to men and non-binary people or with other sexual and/or gender options.

The aim of this study is to propose a new model for the representation of Eating Disorders (EDS) using nursing care languages, which allows us to approach the description of people affected by this pathology and their environment, implementing the perspective of gender, and that facilitates the realization of better diagnoses.

A systematic bibliographic review on EDS was carried out using databases from the different areas involved. The information was ordered and summarized in tables and concept maps. Next, a comparison was made between the traditional EDS model, described using medical language, and the new model proposed by the nursing discipline, where all the information previously obtained is codified in languages proposed by the North American Nursing Diagnosis Association (NANDA) and the Nursing Development Foundation (FUDEN) in the manual on Standardized Nursing Knowledge (CENES).

The results obtained indicate that, after coding and organizing the existing information through nursing languages, the diagnostic view can be broadened by incorporating a greater number of variables to carry out a more complete approach to EDs. This would make it possible to propose a new conceptual model of these disorders, addressing them not only as a disease, but as a product of the failure of a healthy individualization that leads people who suffer from them to not carry out their self-care adequately, exerting on their person a act of anti-self care.

The energetic representation of care, characteristic of nursing, could be useful in care practice, so that the description of the phenomenology of care for each individual could be established, and it would also provide a series of action algorithms that would favor its implementation for health prevention.

None Declared

Diagnostic stability is a controversial issue in first episode psychosis (FEP) due to heterogenous symptoms and unclear affective symptoms. Differencing affective and non-affective psychoses is important as treatment strategies are different. Initial affective symptomatology has low specificity for predicting the subsequent diagnosis of affective psychosis. Sex has proven to be relevant for clinical and functional outcomes but it remains unclear how sex may contribute to diagnosis switch of FEP.

To determine the role of sex in diagnostic stability in a sample of FEP after 1-year follow-up.

Diagnoses of FEP patients from Hospital del Mar of Barcelona were assessed at baseline and 1 year after. Univariate analyses was perfomed for all diagnoses and dichotomic variable (affective/non-affective). Logistic regression model was perfomed to know which variables predict diagnosis switch.

256 patients were enrolled. No differences were found at baseline between completers and non-completers (Table 1). No significant differences between men and women at baseline diagnosis were found, neither all diagnoses (p=0.274) nor the dichotomic variable affective/non-affective (p=0.829) (Table 2AB). Significant differences were found at 1-year follow-up between men and women, for all diagnoses (p=0.043) and the dichotomic variable (p=0.039). Sex was the only variable that predicted diagnosis switch (Figure 1), PANSS, CDSS, YMRS, GAF and cannabis did not.Table 1.

Baseline characteristics of participants

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Sex has proven to be the main predictor of switching initial diagnosis of FEP.

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Long-acting injectable antipsychotics (LAIs) offer advantages for schizophrenic patients compared to oral antipsychotics: less frequent dosing, lower relapse rates, better adherence, and lower healthcare costs. LAIs include paliperidone, aripiprazole, olanzapine, risperidone, and zuclopenthixol. Paliperidone palmitate is the only antipsychotic with two formulations with an administration interval longer than one month (3-monthly and 6-monthly), which could be better for the patient and help ensure treatment continuity, especially in cases of limited access to the health care system.

To assess the satisfaction of patients under treatment with 6-month paliperidone palmitate compared to other long-acting injectable antipsychotics with a higher frequency of administration.

We analyzed the satisfaction level of a sample of patients receiving treatment with LAIs at the Mental Health Center of El Escorial. All patients had a diagnosis of schizophrenia or other psychotic disorders (according to DSM-5). Patients who met the inclusion criteria completed the Treatment Satisfaction Questionnaire for Medication (TSQM), a generic questionnaire of treatment satisfaction that measures four dimensions: side effects, treatment efficacy, comfort of use, and overall satisfaction. Other clinical and socio-demographic variables were collected, as well as the type of injectable, dose, and frequency of administration.

Data from approximately 30 patients will be analyzed and discussed later.

Less frequent administration of LAIs may result in greater patient satisfaction and be just as beneficial clinically. Treatment satisfaction is positively associated with an improvement in psychotic symptoms and seems to be related to better adherence.

None Declared

Children who have undergone an oncological process and have received treatment with chemotherapy or radiotherapy on the central nervous system may have significant neurocognitive sequelae. Some video games have shown neurocognitive benefits in people with impairments in different areas, such as attention or memory.

This work aims to demonstrate the benefit of a video game-based training program to improve the neurocognitive profile in a child survivor of cancer.

The patient is a 9-year-old female who was diagnosed with acute lymphoblastic leukemia at the age of 4 years. She received routine treatment of this disease by chemotherapy, including high-dose chemotherapy (with blood-brain barrier crossing) and intrathecal chemotherapy. She is currently 3 years after the end of treatment.

The Continuous Performance Test 3 (CPT-3) (sustained attention/vigilance) was administered before and after a multifaceted training program consisting of playing 3 video games for 12 weeks, as follows: a brain-training game (4 days per week, 7-12 minutes per day), a skill-training game (2 days per week, 10 minutes per day) and an exergaming game (2 days per week, 10 minutes per day).

Prior to intervention, the patient had 3 atypical z-scores on the CPT-3 (z scores: mean = 0, S.D. = 1), with a pattern compatible with ADHD (omissions z = 1.2; hit reaction time z = 3.4; hit reaction time block change z = 1.2). After intervention, she had only an atypical z-score (hit reaction time z = 3.6), with a pattern compatible with slowing, without ADHD.

The neuropsychological evaluation of this patient showed an improvement in his attentional pattern on the CPT-3 after the video game-based training.

None Declared

Childhood cancer survivors have neurocognitive sequelae that in most survivor follow-up programs are underdiagnosed and for which there is usually no treatment plan.

Video games have demonstrated various psychological and neurocognitive benefits in different subpopulations, such as patients with organic neurological deficits or children with ADHD. However, few studies have been carried out using video games-based interventions in the paediatric oncology population.

The aim of this work is to present the WINNERS study protocol, the objectives of which are to diagnose the neurological and cognitive sequelae in child cancer survivors, and to demonstrate the benefit in these areas of a training program based on video games.

A randomized controlled and unblinded trial is presented. Fifty-six patients aged 8 to 17 years stratified into two age groups (8-12 and 13-17) who had received any of the following treatments 1 to 6 years before the enrolment will be selected: high-dose chemotherapy with blood-brain barrier crossing, intrathecal or intraventricular chemotherapy, CNS radiotherapy or hematopoietic stem cell transplantation.

A neuropsychological evaluation will be performed consisting of a battery of neuropsychological tests to assess parameters such as attention, memory, visuospatial ability or speed of response, as well as a neuroimaging evaluation by structural and functional magnetic resonance imaging. The evaluation will be repeated 3 months and 6 months after the enrolment. Patients will be randomized to a treatment group or to a recycled waiting group. Intervention will consist on a 12-week training at home using 3 video games: a brain training game, an exergaming game and a skill training game.

According to the hypotheses of this study, it is expected that the proposed program of videogame-based interventions will improve neurocognitive and other wellbeing parameters in the intervention group.

This study aims to improve the quality of care for patients who have survived a cancer disease by detecting sequelae that have so far been poorly attended, and by proposing a gamification-based intervention program that is effective and attractive for this population.

None Declared

Psychotic disorders are strongly linked to a higher risk of mandatory hospitalization, often affecting men more, though some studies report the opposite. Recent investigations also show a higher rate of involuntary admissions in younger individuals. Knowledge in this area is still limited despite extensive research.

Analyze whether there is an association between sex and age with involuntary admissions of individuals with psychotic disorders.

Retrospectively, 254 people with psychotic disorders admitted between 2018-2023 to the adult psychiatric inpatient unit at Hospital Universitari Germans Trias i Pujol were selected, collecting their nature of admission, sex, age, and discharge diagnosis. Comparisons between voluntary and involuntary admissions, with respect to sex and age variables, were conducted using independent sample t-tests, Mann-Whitney U tests, Fisher’s exact test, and chi-square tests. A logistic regression model was used to identify variables significantly associated with mandatory admission.

In both the male and female groups, there were no statistically significant differences in terms of the mean age at admission (p = 0.162) or the nature of admission (p = 0.586) (Table 1). When analyzing the voluntary nature of admission based on age and sex, statistically significant differences were only found in the female group (p = 0.01), resulting in a 9.18 year age difference among those admitted voluntarily (Table 2). The model that best predicted the probability of involuntary admission in individuals with psychotic disorders included the sex variable (OR = 4.88) and the interaction between sex and age (OR = 0.97) (Table 3).Table 1:

Differences between sex regarding voluntariness of patients with psychotic disorders.

Young women with psychotic disorders face a higher risk of involuntary admissions, emphasizing the need for gender-specific strategies to improve care of these patients.

None Declared

Paediatric cancer survivors have a risk for neuropsychological impairment due to the disease and the treatment received. These affections have been neglected in the follow-up of these patients. It is important to identify the most valid outcomes in the evaluation of neurocognitive sequelae in childhood cancer survivors.

This work aims to compare the results obtained between subjective perception of caregivers and objective cognitive performance based on validated attention tests.

In a randomized controlled and unblinded trial to demonstrate the benefit of video games on different neurocognitive areas in cancer survivors, we studied attention functioning before and after the intervention program. The attention deficit subscale from the Behavior Assessment System for Children 3rd edition (BASC-3), self- and parent-reported versions, and the Continuous Performance Test, 3rd edition (CPT 3) will be used as outcomes (z scores: mean = 0, S.D. = 1).

We observed an improvement in attention after intervention using the CPT-3 (omissions z = 1.2; hit reaction time z = 3.4; hit reaction time block change z = 1.2 versus hit reaction time z = 3.6 without other atipycal z scores after intervention), changing the attentional pattern from “ADHD” to “slowed”. However, in the parent-reported version of the BASC-3, a worsening in the attention subscale is observed (z = 0.3 pre-intervention vs z = 1.0 post-intervention) while the self-reported version of the patient didn’t show any significant changes (z = 1.4 pre-intervention vs z = 1.1 post-intervention).

It is essential to use objective tests to measure neurocognitive sequelae in these patients. Subjective surveys can provide additional information, but not substitute the above.

None Declared

Extensive evidence supports that the use of long-acting inyectable antipsychotics (LAIs) reduces the risk of relapses and maintains functional and symptomatic improvements in patients with schizophrenia, both in the initial stages and in chronic cases. Several LAIs are available but paliperidone palmitate is the only antipsychotic with formulations lasting 3 (PP3M) and 6 (PP6M) months. Longer-duration LAIs achieve stable treatment with fewer injections. Recent studies with PP3M support a reduction in hospitalizations and emergency room visits compared to monthly paliperidone and aripiprazole or oral antipsychotics.

PP6M seems to be at least as effective and well tolerated as other LAIs in preventing relapses in previously stabilized patients with schizophrenia.

to assess efficacy and tolerability of PP6M in a real clinical practice compared to previous treatment (oral antipsychotics or other LAIs)

Patients with a diagnosis of psychotic disorder and treatment with PP6M have been recruited consecutively in a Mental Health Centre in the Community of Madrid (Spain). Clinical stability (CGI and emergency visits and hospitalizations since the start of treatment), tolerability (adverse effects), functionality (PSP scale) and satisfaction with treatment (TMSQ scale) have been studied.

16 patients were included throughout the first 6 months of treatment with PP6M treated at a CSM in the Community (CSM) of Madrid, of which 2 abandoned the study. Among the 14 patients included, aged between 26 and 60 years, 13 had a diagnosis of schizophrenia and one of schizoaffective disorder (according to DSM5). No significant adverse effects were recorded, except for pain at the injection site. The majority were psychopathologically stable patients - 2 of them of recent onset (up to 36 months of evolution) and 7 psychopathological decompensations, measured as visits to the emergency room or psychiatric readmissions, have been detected during the first 6 months of follow-up in CSM. All patients had previously been admitted to treatment with PP6M (minimum 1 admission, maximum 20 admissions). The results of the baseline scores obtained on the psychometric scales applied were: CGI (15.35/35), PSP (62.78/100) and TMSQ (53.35/80).

The existing scientific evidence to date indicates that the application of PP6M is giving safe results in the first months of follow-up, with few side effects recorded, and a low rate of decompensations. This study based on data from real clinical practice in a CSM, despite the limitation due to the small sample size, obtains similar results consistent with those described in previous clinical trials.

I. Garcia Del Castillo Paid Instructor of: Training on drug use paid, A. Balaguer: None Declared, B. Esteban: None Declared, M. García del Castillo: None Declared, H. García del Castillo: None Declared, S. Castelao-Almodovar: None Declared, A. Arce de la Riva: None Declared, F. Neira Serrano: None Declared

Bipolar disorder (BD) is a serious and chronic mental disease of mood. Lithium is used for treatment and studies have demonstrated that it is the most efficient drug, reducing suicide risk in a high percentage of patients. However, this drug has well known side effects, such as kidney damage. Lithium could cause chronic kidney disease, specially with the presence of other risk factors.

Observational and retrospective study of creatinine levels and glomerular filtration rates observed in blood analysis (follow-up period of 11 years). Sample size of 263 patients diagnosed of BD I and BD II in treatment with lithium. We used socio-demographic (age, sex) and clinic variables (diabetes mellitus, hypertension, use of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or diuretics) to generate bivariate and multivariate analysis.

Our main objective is to analyze the deterioration of kidney function and the development of chronic kidney disease that chronic treatment with lithium can induce in patients with BD. Our secondary objective is to determine variables which could promote the development of chronic kidney disease, and to assess if these variables could be considered as risk factors during the treatment with lithium.

11,3 % of patients in our study developed chronic kidney disease during monitoring. The deterioration of GFR in patients in treatment with lithium was significantly associated with female sex and NSAIDs consumption. A trend towards statistical significance was found regarding the use of diuretics (p=0,060). No statistical significance was found between diabetes mellitus, hypertension or type of BD and the deterioration of kidney function in our sample. An inverse association was found between the GFR decline and the age but no statistical significance was demonstrated.

We conclude that female sex and use of NSAIDs are predicting factors of GFR decline in patients with BD in chronic treatment with lithium. We must take into account these drugs or even avoid concomitant treatment (lithium and NSAIDs) in order to prevent chronic kidney disease. In addition to it, we should recommend careful use of diuretics during treatment with lithium because of risk of dehydration. Diabetes mellitus and hypertension have universally been associated to increase risk of development of chronic kidney disease. However, we have not found statistical significance in our study. Therefore, research should be done in order to determine specific risk factors in this group of patients and, consequently, optimize their treatment.

None Declared