Clinical Research Directory

Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41

The main objective of this study is the translation, linguistic adaptation into Spanish, and validation of the Korean quality of life questionnaire KOQUSS-40. This tool will allow us to objectively measure the quality of life of patients in clinical trials.

Validation of the Experience Sampling Dietary Assessment Method

A new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against objective biomarkers and reference methods.

Validation of Turkish Versions Child- and Parent-Rated Scales of Food Allergy Anxiety

This study aims to evaluate the psychometric properties of the Turkish adaptation of the Scale of Food Allergy Anxiety (SOFAA), including both the child-report and parent-report versions. The SOFAA is a validated tool originally developed to assess the specific anxiety related to food allergies. The Turkish versions of the scales will undergo a comprehensive validation process, including assessments of internal consistency, test-retest reliability, and construct validity. Participants will include children diagnosed with IgE-mediated food allergies and their primary caregivers. The study will investigate whether the translated scales maintain the original structure and effectively measure food allergy-related anxiety in the Turkish pediatric population. The findings are expected to contribute to clinical assessment practices and research on food allergy-related psychosocial impacts in Turkeyy.

Validation Study of the Italian Version of the "Assessment of Life Habits 4.0" Scale (LIFE-H) for Measuring Participation in Children With Disabilities Aged 5 to 13 Years

BACKGROUNG In Italy there are still few translated and validated instruments to assess participation. In the field of pediatric rehabilitation, among the tools available internationally, one of the most comprehensive and widely used is the Assessment of Life Habits, or LIFE-H, now in its 4.0 version. The LIFE-H scale was originally developed in French and implemented by the International Network on the Disability Creation Process - INDPC, also known as the Quebec Model or Handicap Creation Process. Internationally, the "LIFE-H" scale has been translated and validated in several languages. The scale is among the most comprehensive and detailed instruments in the literature: it consists of 90 items (life habits), divided into 12 domains, 6 of which are for regular activities (e.g., communication and mobility), and 6 for social roles (responsibility and interpersonal relationships). A study of Italian translation and cultural adaptation of the LIFE-H scale 4.0 for children aged 5 to 13 years, was carried out during 2020-2021. The scale and its related user manual in Italian version have also been insert into the platform of the Canadian originator company "Réseau international sur le Processus de production du handicap" - RIPPH). AIM The goal of the study is to assess the intra- and inter-rater reliability, internal consistency and construct validity of the scale in its Italian version. METHOD Participants will be recruited from the pediatric rehabilitation centers of Toscana Centro , AOU Meyer IRCCS and AORN Santobono-Pausilipon Subjects interviewed will be caregivers of children with disabilities between the ages of 5 and 13 years. Care-givers of children with physical, sensory and cognitive disabilities, regardless of diagnosis, will be included in the study, as per the scale's user manual. First Part Step 1: Presentation of the project through informational documentation to pediatric rehabilitation physical therapists of the territorial services of Toscana Centro and AOU Meyer IRCCS, who will identify candidate families for the study. Step 2: Collection of informed consent by the investigating physical therapist in the referral area. Step 3: TEST: Administration of the LIFE-H 4.0 / 5-13 years scale by an investigator (FT 1). As stipulated among the modes of administration, the questionnaire will be completed by the reference person or parent of the child with support from the experimenter. The administration will be done via video call on Google Meet platform, which platform is deemed most suitable in terms of use for families. Step 4 : RETEST: After an interval of 15 days, second administration of the questionnaire will be carried out in the same manner and by the same experimenter. Step 5 : Analysis and comparison of the collected data. Second part Step 6: Making contact with subjects who had adhered to both phases of the study (as indicated in the informed consent signed in step one) and re-enrollment through informational documentation to pediatric rehabilitation physical therapists from the territorial services of Toscana Centro, AOU Meyer IRCCS, and AORN Santobono-Pausilipon, who will identify candidate families for the study. Step 7: Collection of informed consent from the investigating physical therapist in the target area. Step 8: TEST: Administration of the LIFE-H 4.0 / 5-13 years scale by an investigator (FT 3). As stipulated among the modes of administration, the questionnaire will be completed by the reference person or parent of the child with support from the experimenter. The administration will be done via video call on Google Meet which platform is deemed most suitable in terms of family use. Step 9: RETEST: Administration of the LIFE-H 4.0 / 5-13 years scale by an experimenter (FT 4) 15 days apart in the same manner. Step 10: To complete the validation process (Construct Validity), the PEM-CY questionnaire will be provided to parents participating in the second phase of the study. The instrument was chosen, among the few available in the Italian language, because of features in common with the Life-H scale. The caregivers will be able to fill out the paper version of the questionnaire themselves. The latter will be kept within the child's medical record; the investigators will only be informed of the final score of the questionnaire. step 11: analysis and comparison of collected data SAMPLE SIZING AND STATISTICAL METHODS OF DATA ANALYSIS With respect to the required sample size, contacts have been made with the Canadian authors of the LIFE-H scale (International Network on the Disability Creation Process - INDPC), who suggest a minimum minimum sample size of 30 subjects. Also taking into consideration other scale validation articles, we therefore plan to enroll 30 subjects for Phase 1 (intra-operator concordance and internal consistency) and 130 subjects for Phase 2 (inter-operator concordance and construct validity of construct). Analysis of the results of the LIFE-H questionnaire

The Aims of the Study Are to Translate the Index of Professional Governance (IPG 3.0) Into Italian and Validate It and to Assess the State of Professional Governance in an Italian Hospital (ISMETT)

Professional Governance (PG) is a way to actualize better work environments and structural empowerment. PG has a history over many years in the healthcare industry and has been defined as multidimensional organizational characteristics that encompass the structure and processes through which professionals direct, control and regulate one another's goal-oriented efforts. Multiple studies over the years have shown that PG can lead to empowered personnel and quality of care delivered. In many organizations, governance is primarily controlled by management. The responsibility for managing professional practice should, however, be shared by staff and leaders, and in order to empower staff, they should be engaged in identifying areas for improvement. In addition, evidence-based practice should be enabled by allocating sufficient time, research and access to evidence sources. The participation element refers to who creates and participates in governance activities on different levels. Successful professional governance structures have been linked to a positive professional practice environment. An effective structure with true sharing of decision-making between management and personnel will also contribute to optimal patient outcomes. To evaluate whether an organization's governance is empowering and professional, it must be measured. Thus, various instruments to measure nurses' participation in professional governance have been presented. The Index of Professional Nursing Governance (IPNG) has been used in more than 250 international healthcare organizations during the last 20 years to evaluate implementation of their management models. Hess created the IPNG for measuring professional governance along a conceptual continuum from traditional, through shared to self-governance models. Hess has since continued to advance the questionnaire. At the same time, an extended tool was created with all professional figures involved, the so called "Index of Professional Governance" (IPG). Several revisions have been made over time up to the current version of the IPG 3.0 The IPG measures the governance of hospital-based professional, based on a model of governance derived from the literature, in 5 dimensions: personnel, information, resources, participation and practice. Those five dimensions are covered by 50 items. Respondents use a 5-point scale to identify the group that dominates certain areas of governance stated in the items, ranging from 'management/administration only' (1p), through 'equally shared by staff and management/administration' (3p) to 'staff only' (5p). The points for each dimension, and overall governance, are then organized together, analyzed and used to place the organization's governance on the continuum from traditional to self-governance. Previously translated from its original language, English-American into Arabic, British, Finnish, French, German, Korean, Portuguese, it is structured in five dimensions: staff, information, resources, participation and practice. These 5 dimensions are analyzed in 50 items. Aims of the study: 1. To translate the Index of Professional Governance (IPG 3.0) into Italian and validate it; 2. To assess the state of professional governance in an Italian hospital (ISMETT).

Validation of the Greek Postoperative Quality of Recovery Score 15

The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.