ABSTRACT INTRODUCTION Quality of life measurement is an important aspect of comprehensive clinical assessment. It does not have a set definition, but changes according to sociocultural context. Head and neck cancer patients experience substantially decreased health-related quality of life. The Cuban public health system needs to develop its own instrument to measure these patients’ quality of life. OBJECTIVES Construct and validate an instrument to measure quality of life in Cuban patients with nasopharyngeal, laryngeal, oral or mesopharyngeal cancer. METHOD The sample comprised adult patients treated for nasopharyngeal, laryngeal, oral or mesopharyngeal cancer in Cuba’s National Oncology and Radiobiology Institute in 2013 and 2014. To construct and validate the instrument, we selected a sample of 520 patients. Initial interviews were held until no substantially new information emerged; 40 patients were selected to participate in focus groups to identify important problems leading to decreased health-related quality of life. Face validity of the preliminary questionnaire was assessed with 40 patients. Internal consistency and validity were assessed with 400 patients. Score stability was assessed with another 40 patients using a test-retest design. There were 24 experts who participated in the process, 15 in the construction phase and 9 in the content validity evaluation of the preliminary version. Assessment of reliability and validity was based on internationally recognized approaches, including Cronbach alpha and empirical verification of convergent, discriminant, clinical and predictive validity. Response burden was also assessed (completion time and item nonresponse). RESULTS A 65-item questionnaire, CV-I0R-CyC-01, was developed and validated, with three domains (physical functioning, psychosocial functioning and family relationships, disease symptoms and treatment side effects) and two ungrouped questions on perceived general health and perceived health-related quality of life. The instrument displayed satisfactory reliability (homogeneity and stability) and validity (face, content, convergent, discriminant, clinical and predictive). Test–retest correlation was strong. Large differences and a downward trend in health-related quality of life across clinical stages and moderate or high standardized response mean values reflect good clinical and predictive validity. Response burden was acceptable (completion time 6.2 minutes, item nonresponse rate 1.3%–3.8%). CONCLUSIONS CV-I0R-CyC-01’s psychometric properties justify its use in clinical trial protocols with patients with nasopharyngeal, laryngeal, oral or mesopharyngeal cancer.

Introduction: the child of a diabetic mother (CDM) can suffer alterations during pregnancy by this maternal disease. When it appears in the second half of gestation, we talk of diabetic foetopathy, which is more frequent in women with uncontrolled metabolic and gestational diabetes mellitus (GDM). Age, parity, obesity, weight gain during pregnancy, degree of glucose intolerance, among others, can influence fetal growth determinants. The research sought to understand the relationship of these factors with birth weight. Objective: to identify modifiable factors, which increase the frequency of newborns with appropriate weight for gestational age in diabetic pregnant women. Methods: results are analyzed in 2 038 live births born from diabetic mothers (350 diabetic pre-gestational and diabetic gestational 1 688), during 14 years. Results: occurrence of excess neonatal weight was 11.83%, its reduction was achieved, but with no increase in weight. No significant differences were observed in the frequency of excess body weight among pre-gestational and gestational diabetic patients. Neonatal overweight is associated with parity, maternal pre- pregnancy overweight, excessive weight gain and degree of metabolic control during pregnancy. Underweight was associated with low maternal weight before pregnancy, gestational hypertensive disease and mother vascular glomerular injury. Conclusion: the excess or low weights in infants in relation with their gestational age were associated with different risk factors.

Introducción: el hijo de madre con diabetes (HMD) puede sufrir alteraciones durante el embarazo por la enfermedad materna. Cuando aparece en la segunda mitad de la gestación hablamos de fetopatía diabética, más frecuente en mujeres con descontrol metabólico y en la diabetes mellitus gestacional (DMG). La edad, paridad, obesidad, ganancia de peso durante el embarazo, grado de intolerancia a la glucosa, entre otros, pueden influir como determinantes del crecimiento fetal. Los autores se propusieron conocer la relación de estos factores con el peso del neonato. Objetivo: identificar factores modificables en las embarazadas con diabetes que permitan aumentar la frecuencia de recién nacidos de adecuado peso según edad gestacional. Métodos: se analizaron los resultados en 2 038 nacidos vivos hijos de madres con diabetes (350 diabéticas pregestacionales y 1 688 diabéticas gestacionales), durante 14 años. Resultados: la frecuencia de exceso de peso corporal neonatal resultó 11,83 %, se alcanzó su reducción, pero sin aumento del bajo peso. No existieron diferencias significativas en frecuencia de exceso de peso corporal entre las diabéticas pregestacionales y las gestacionales. El exceso de peso neonatal se relacionó con: multiparidad, exceso de peso materno pregestacional, ganancia de peso excesiva y grado de control metabólico durante el embarazo. El bajo peso se relacionó con: bajo peso materno pregestacional, enfermedad hipertensiva gravídica y lesión vascular materna a nivel glomerular. Conclusión: los recién nacidos con exceso o bajo peso para la edad gestacional se relacionaron con factores de riesgo diferentes.