What is an "ongoing" clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study

ABSTRACT BACKGROUND: Although the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

Quality of life in caregivers of aged stroke survivors in southern Brazil: Arandomized clinical trial / Qualidade de vida de cuidadores de idosos sobreviventes de AVC no sul do Brasil: Ensaio clínico randomizado / Calidad de vida en cuidadores de adultos mayores sobrevivientes de accidentes cerebrovasculares en el sur de Brasil: Ensayo clínico aleatorizado

Abstract Objective: to evaluate the effect of nursing home care interventions on the quality of life in family caregivers of aged stroke survivors. Method: a Randomized Clinical Trial, blinded for outcome evaluation. Forty-eighty family caregivers of aged stroke survivors participated in the study. The Intervention Group received three home visits by nurses one month after hospital discharge to provide stroke-related education (i.e., how to access health services and perform care activities) and emotional support. The Control Group received the usual guidance from the health services. Quality of life was assessed using the World Health Organization Quality of Life Assessment (WHOQOL-BREF) instrument and the Old Module(WHOQOL-OLD) 1 week, 2 months, and 1 year after discharge. Results: the caregivers were mainly women, children, or spouses. The caregivers in the Intervention Group and Control Group did not significantly differ in terms of their Overall Quality of Life at baseline. There was no interaction effect between group allocation and Overall Quality of Life(p=0.625) over time. However, there was an interaction effect for Social Relations(p=0.019) and Autonomy (p=0.004). Conclusion: the intervention exerted a statistically significant effect on the quality of life of family caregivers with respect to social relationships and autonomy. Trial registration: NCT02807012.

Resumo Objetivo: avaliar o efeito de intervenção educativa domiciliar de enfermagem na qualidade de vida de cuidadores familiares de idosos sobreviventes de acidente vascular cerebral (AVC). Método: Ensaio Clínico Randomizado, cego para avaliação de resultados. Quarenta e oito cuidadores familiares de idosos sobreviventes de AVC participaram do estudo. O Grupo de Intervenção recebeu três visitas domiciliares de enfermeiros, um mês após a alta hospitalar, para fornecer educação relacionada ao AVC (como acessar os serviços de saúde e realizar atividades de cuidado) e apoio emocional. O Grupo Controle recebeu as orientações habituais dos serviços de saúde. A qualidade de vida foi avaliada usando o instrumento Avaliação da Qualidade de Vida da Organização Mundial da Saúde (WHOQOL-BREF) e o Módulo Old (WHOQOL-OLD) em 1 semana, 2 meses e 1 ano após a alta. Resultados: os cuidadores eram principalmente mulheres, filhos ou cônjuges. Os cuidadores do Grupo Intervenção e do Grupo Controle não diferiram significativamente em termos de Qualidade de Vida Geral no início do estudo. Não houve efeito de interação entre a alocação do grupo e a Qualidade de Vida Geral (p=0,625) ao longo do tempo. No entanto, houve efeito de interação para Relações Sociais (p=0,019) e Autonomia (p=0,004). Conclusão: a intervenção apresentou efeito estatisticamente significativo na qualidade de vida dos cuidadores familiares no que diz respeito às relações sociais e autonomia. Registro do ensaio clínico: NCT02807012.

Resumen Objetivo: evaluar el efecto de intervenciones de atención domiciliaria de enfermería sobre la calidad de vida en cuidadores familiares de adultos mayores sobrevivientes de accidentes cerebrovasculares. Método: Ensayo Clínico Aleatorizado, cegado para la evaluación de los desenlaces. Los participantes del estudio fueron 48cuidadores familiares de adultos mayores sobrevivientes de accidentes cerebrovasculares (ACV). El Grupo Intervención recibió tres visitas domiciliarias a cargo de enfermeros un mes después del alta hospitalaria, en las que se les ofreció instrucción relacionada con ACV (es decir, cómo acceder a los servicios de salud y realizar las actividades inherentes a los cuidados) y apoyo emocional. Al Grupo Control se le brindó la orientación habitual de los servicios de salud. La calidad de vida se evaluó mediante el instrumento World Health Organization Quality of Life Assessment (WHOQOL-BREF) y el módulo Old(WHOQOL-OLD) 1semana, 2meses y 1año después del alta. Resultados: en su mayoría, los cuidadores fueron mujeres, hijos o cónyuges. Los cuidadores de los grupos Intervención y Control no presentaron diferencias significativas en términos de su Calidad de Vida general de base. La intervención no ejerció ningún efecto entre la asignación a los grupos y la Calidad de Vida general(p=0,625) con el transcurso del tiempo. Sin embargo, la intervención sí tuvo efecto sobre las Relaciones Sociales (p=0,019) y la Autonomía(p=0,004). Conclusión: la intervención ejerció un efecto estadísticamente significativo sobre la calidad de vida de los cuidadores familiares con respecto a las relaciones sociales y a la autonomía. Registro del ensayo: NCT02807012.

Auriculoterapia para reducir el dolor crónico de la columna vertebral de los trabajadores de la salud: ensayo clínico / Auriculotherapy for reducing chronic spinal pain in health workers: a clinical trial / Auriculoterapia para redução da dor crônica na coluna vertebral em trabalhadores da saúde: ensaio clínico

Objetivo: evaluar la efectividad de la auriculoterapia para reducir el dolor musculoesquelético crónico de la columna vertebral de los trabajadores de la salud. Método: ensayo clínico aleatorizado, triple ciego, realizado con trabajadores de la salud diagnosticados con dolor crónico en la columna vertebral. Se aplicaron ocho sesiones de auriculoterapia con semillas, dos por semana. Los resultados fueron medidos con la Escala Numérica del Dolor, el Inventario Breve del Dolor, el Cuestionario de Discapacidad de Roland-Morris y los instrumentos SF-36, en la 1.ª, 4.ª, 8.ª sesión y follow-up a los 15 días. Análisis descriptivo e inferencial. Resultados: participaron 34 trabajadores del grupo intervención y 33 del grupo control, ambos mostraron una reducción en la intensidad del dolor (p>0,05). En el follow-up se registró una mayor reducción en el grupo intervención (3,32 ± 0,42) que en el grupo control (5,00 ± 0,43) (p=0,007). En cuanto a la calidad de vida, mejoró la vitalidad (p=0,012) y la limitación por aspectos emocionales (p=0,025). La relación entre auriculoterapia, discapacidad física e interferencia del dolor no difirió entre los grupos (p>0,05). El uso de medicamentos en el follow-up se mantuvo en el grupo control (77,8%) con respecto al grupo intervención (22,2%) (p=0,013). Conclusión: la auriculoterapia tuvo el mismo efecto en ambos grupos sobre la intensidad del dolor y duró más en el follow-up. Hubo una mejora en la calidad de vida y una reducción en el consumo de medicamentos. REBEC: RBR-3jvmdn.

Objective: to evaluate the effectiveness of auriculotherapy in reducing chronic musculoskeletal pain in the spine of health workers. Method: a randomized, triple-blind clinical trial conducted with health workers diagnosed with chronic spinal pain. Eight sessions of auriculotherapy with seeds were applied, two per week. The outcomes were measured with the Numerical Pain Scale, Brief Pain Inventory, Rolland-Morris Disability Questionnaire and SF-36 instruments, in the 1st, 4th and 8th session, and in the 15-day follow-up period. Descriptive and inferential analyses were performed. Results: 34 workers took part in the Intervention Group and 33 in the Control Group, and both presented reduced pain intensity (p>0.05). In the follow-up period, there was a greater reduction in the Intervention Group (3.32 ± 0.42), when compared to the Control Group (5.00 ± 0.43) (p=0.007). In quality of life, there was improved vitality (p=0.012) and limitation due to emotional aspects (p=0.025). The relationship between auriculotherapy, physical disability and pain interference did not differ between the groups (p>0.05). Medication use in the follow-up period remained unchanged in the Control Group (77.8%) when compared to the Intervention Group (22.2%) (p=0.013). Conclusion: auriculotherapy exerted the same effect between the groups on pain intensity, lasting longer in the follow-up period. There was an improvement in quality of life and a reduction in medication use. REBEC: RBR-3jvmdn.

Objetivo: avaliar a eficácia da auriculoterapia na redução da dor musculoesquelética crônica na coluna vertebral de trabalhadores da área da saúde. Método: ensaio clínico randomizado, triplo cego, realizado com trabalhadores da saúde com diagnóstico de dor crônica na coluna vertebral. Aplicaram-se oito sessões de auriculoterapia com sementes, duas por semana. Desfechos mensurados com os instrumentos Escala Numérica da Dor, Inventário Breve de Dor, Questionário de Incapacidade de Rolland-Morris e SF-36, na 1ª, 4ª, 8ª sessão, e follow-up de 15 dias. Análise descritiva e inferencial. Resultados: participaram 34 trabalhadores no grupo intervenção e 33 no controle, ambos apresentaram redução da intensidade da dor (p>0,05). No follow-up, maior redução no grupo intervenção (3,32 ± 0,42), comparado ao controle (5,00 ± 0,43) (p=0,007). Na qualidade de vida, melhorou a vitalidade (p=0,012) e limitação por aspectos emocionais (p=0,025). Relação entre auriculoterapia, incapacidade física e interferência da dor não diferiu entre os grupos (p>0,05). O uso de medicamentos, no follow-up, manteve-se no grupo controle (77,8%) se comparado à intervenção (22,2%) (p=0,013). Conclusão: a auriculoterapia apresentou igual efeito entre os grupos na intensidade da dor, com maior durabilidade deste no follow-up. Houve melhora da qualidade de vida e redução do consumo de medicamentos. REBEC: RBR-3jvmdn.

Risk of bias in dentistry-related randomized controlled trials in spanish language journals

Objectives: To assess the risk of bias (RoB) of randomized controlled trials (RCTs) published in dental journals in the Spanish language. Methods: A systematic retrospective survey was conducted of all RCTs published from 1980 to 2019 in dentistry Spanish and Latin American journals. We extracted data and performed RoB assessments using the Cochrane Risk of Bias tool. Results: 292 RCTs published in 51 journals were included. The best-rated domains were incomplete outcome data, selective reporting, and other biases. The domains assessed with higher proportions of an unclear or high risk of bias were sequence generation, allocation concealment, and blinding of outcome assessment. There is a low proportion of RCTs published in Spanish language journals. However, the number has been increasing over the years, and the low risk of bias assessment rates across domains show an increasing trend. Conclusions: A low percentage of Spanish-language dental journals issue RCTs. Our assessment of these RCTs' RoB suggests higher difficulties in the design and conduction phase than in the posterior reporting stage.

Knowledge and perception of health-care professionals on clinical trials in India: A pan-Indian cross-sectional survey

Purpose: The purpose of the study was to evaluate the knowledge and perception of health-care professionals (HCPs), such as doctors/surgeons, pharmacists, nurses, optometrists, and lab technicians, on clinical trials (CTs) in India. Methods: The study was a pan-Indian cross-sectional survey initiated by the Indian Ophthalmology Clinical Trial Network (IOCTN) by using a previously validated questionnaire for three months of data collection. An online survey was used to record information regarding demographics, CT knowledge, and CT perception among HCPs. Results: A total of 630 responses were recorded from HCPs: 207 doctors and surgeons, 159 pharmacists, and 264 laboratory technicians, nurses, and optometrists across India. Over 90% of HCPs had a clear knowledge on the purpose of CTs, the informed consent (IC) process, ethical approval by the Drugs Controller General of India (DCGI). About 80% and 90% were aware of confidentiality of patients, voluntariness of participation, and good clinical practice. Surprisingly, less than 50% had lesser knowledge regarding monetary incentives of CT participants (CTPs). A slightly positive perception was observed regarding the potential benefits of CTPs, compensation related to injury, and importance of obtaining IC. Less than 50% had a negative perception that monetary compensation to CTPs led to bias and deprivation of standard treatments. However, no significant difference was observed between other aspects of demographics and perception regarding CTs. Conclusion: We observed doctors and surgeons to be having the highest regarding CTs, followed by pharmacists. The survey highlighted the necessity of scheduling awareness programs among the HCPs, which would improve their misconceptions and perception of CTs while interacting with patients for CT enrollment.

Recruitment, retention, and adherence of family caregivers: Lessons from a multisite trial / Reclutamiento, retención y adherencia de los cuidadores familiares: Lecciones de un ensayo clínico multi-sitio / Recrutamento, retenção e adesão de cuidadores familiares: lições de um estudo clínico multi-site

Objective. To describe the recruitment, retention of family caregivers, and adherence to a telephone based intervention evaluated in a multi-site trial and provide recommendations for the design of future studies. Methods.A descriptive study based on a secondary analysis of a multi-site clinical development in Colombia and Brazil. Recruitment was measured by the number of participants eligible and consented. Retention was assessed by the percentage of participants with outcomes data at two follow-ups. The intervention adherence was measured by the percentage of the caregiver who received the intervention. Results. Of the family caregivers assessed, 63% were eligible, and 32.9% declined to be in the study for time restriction or no interest. In Colombia, the total retention rate of caregivers was 63.4% at the first follow-up and 48% at the second follow-up, while in Brazil was Invest Educ Enferm. 2023; 41(2): e04Recruitment, retention, and adherence of family caregivers:Lessons from a multisite trialde 52.8% and 46.2%, respectively. At the end of the study, the sample comprised 28 and 70 caregivers in the intervention and control groups, respectively, for a retention rate of 47%. Of 104 family caregivers allocated to the intervention group, 42 (40.3%) received five sessions. Most reported not completing the Caregiver's Activity Diary. Conclusion.The recruitment of family caregivers, participant retention, and adherence to the telephone intervention was unsuccessful. Future studies should apply an assessment tool during the recruitment of family caregivers and replace the term "caregiver" with "care provider" in the material involved in the research; define a retention protocol before starting the study and involve family caregivers in the design of the interventions

Objetivo. Describir el reclutamiento, la retención y la adherencia de los cuidadores familiares en una intervención educativa telefónica evaluada en un ensayo multi-sitio y ofrecer recomendaciones para el diseño de futuros estudios. Métodos. Estudio descriptivo basado en un análisis secundario de un desarrollo clínico multicéntrico en Colombia y Brasil. El reclutamiento se midió por el número de participantes elegibles y que dieron su consentimiento. La retención se evaluó por el porcentaje de participantes con datos de resultados en dos seguimientos. La adherencia a la intervención se determinó por el porcentaje de cuidadores que recibieron la intervención. Resultados. De los cuidadores familiares evaluados, 63% fueron elegibles, y 32.9% declinaron participar en el estudio por restricción de tiempo o falta de interés. En Colombia, la tasa de retención total de cuidadores fue de 63.4% en el primer seguimiento y de 48% en el segundo, mientras que en Brasil fue de 52.8% y 46.2%, respectivamente. Al final del estudio, la muestra comprendía 28 y 70 cuidadores en los grupos de intervención y control, respectivamente, para una tasa de retención del 47%. De los 104 cuidadores familiares asignados al grupo de intervención, 42 (40,3%) recibieron cinco sesiones. La mayoría no completó el diario de actividades del cuidador.Conclusión. El reclutamiento de cuidadores familiares, la retención de participantes y la adherencia a la intervención telefónica no tuvieron éxito. Los estudios futuros deberían aplicar una herramienta de evaluación durante Invest Educ Enferm. 2023; 41(2): e04Leidy Johanna Rueda Díaz • Erika de Souza GuedesDiná de Almeida Lopes Monteiro da Cruzel reclutamiento de los cuidadores familiares y sustituir el término "cuidador" por "proveedor de cuidados" en el material empleado en la investigación; definir un protocolo de retención antes de iniciar el estudio e involucrar a los cuidadores familiares en el diseño de las intervenciones

Objetivo. Descrever o recrutamento, retenção e adesão de cuidadores familiares em uma intervenção telefônica avaliada num estudo clínico multi-site e oferecer recomendações para o desenho de estudos futuros. Métodos. Estudo descritivo baseado em análise secundária de um desenvolvimento clínico multicêntrico na Colômbia e no Brasil. O recrutamento foi medido pelo número de participantes elegíveis e que deram consentimento. A retenção foi avaliada pela porcentagem de participantes com dados de resultado em dois acompanhamentos. A adesão à intervenção foi determinada pela porcentagem de cuidadores que receberam a intervenção. Resultados. Dos cuidadores familiares avaliados, 63% eram elegíveis, e 32.9% se recusaram a participar do estudo por limitação de tempo ou falta de interesse. Na Colômbia, a taxa de retenção total dos cuidadores foi de 63.4% no primeiro acompanhamento e 48% no segundo, enquanto no Brasil foi de 52.8% e 46.2%, respectivamente. Ao final do estudo, a amostra foi composta por 28 e 70 cuidadores nos grupos intervenção e controle, respectivamente, para uma taxa de retenção de 47%. Dos 104 cuidadores familiares designados para o grupo de intervenção, 42 (40.3%) receberam cinco sessões. A maioria não preencheu o diário de atividades do cuidador. Conclusão. Recrutamento de cuidadores familiares, retenção de participantes e adesão à intervenção telefônica não tiveram sucesso. Estudos futuros devem aplicar uma ferramenta de avaliação durante o recrutamento de cuidadores familiares e substituir o termo 'cuidador' por 'fornecedor de cuidados' em material de pesquisa; definir um protocolo de retenção antes de iniciar o estudo e envolver os cuidadores familiares no desenho das intervenções.Descritores: caregivers; enfermagem; doença crónica; telefone; cooperação e adesão ao tratamento.

Laser de baixa potência na cicatrização e analgesia de lesões mamilares: ensaio clínico / Low lavel laser in the healinh and analgesia of nipples trauma: clinical trial / Láser de baja potencia en la curación y analgesia de pezones juveniles: un ensayo clínico

Objetivo: Analisar a eficácia do laser de baixa potência, modalidade local e sistêmico, para cicatrização e redução da dor ocasionadas por lesões mamilares. Métodos: Ensaio clínico, randomizado e controlado realizado com 54 lactantes atendidas em um Banco de Leite Humano, de dezembro de 2017 a junho de 2018. As lactantes, que somaram um total 101 lesões, receberam orientações referentes ao manejo clínico das mamas e foram alocadas em: Grupo Controle (GC), Grupo Laser Local (GLL), que receberam laser diretamente no mamilo lesionado e Grupo Irradiation Laser Intravascular of Blood (GILIB), que receberam a laserterapia sistêmica. Os dados foram analisados no SPSS para avaliação da homogeneidade dos grupos (Kruskal-Wallis) e regressão linear para identificação do efeito da intervenção no tamanho das lesões mamárias e intensidade da dor. Resultados: Os três grupos de análise se mostaram homogêneos antes do experimento (p=0,191). Após a intervenção, houve cicatrização das lesões nos três grupos, sendo significativamente maior no GLL e GILIB (p<0,050). Quanto à dor, houve redução em até 4.0 pontos no GLL e GILIB (p=0,002). Conclusão: A administração da laserterapia local e sistêmica foi mais eficaz para a cicatrização das lesões mamilares e redução da dor, quando comparadas ao grupo controle. (AU)

Objective: To analyze the effectiveness of the low-potency laser, local and systemic, for the healing and reduction of pain caused by nipple trauma. Methods: Clinical, randomized and controlled trial carried out with 54 lactating women assisted in a Human Milk Bank, from December 2017 to June 2018. The lactating women, which totaled 101 lesions, received guidance on the clinical management of their breasts and breasts designated in: Control Group (CG), Local Laser Group (GLL), which received laser directly on the injured nipple, and Intravascular Blood Laser Irradiation Group (GILIB), which received systemic laser therapy. Data were analyzed using the SPSS to assess the homogeneity of the groups (Kruskal-Wallis) and the linear regression to identify the effect of the intervention on the size of breast lesions and the intensity of pain. Results: The three analysis groups were homogeneous before the experiment (p=0.191). After the intervention, the healing of the lesions in the three groups was significantly higher in GLL and GILIB (p<0.050). As for the pain, there is a reduction of up to 4.0 points in GLL and GILIB (p=0.002). Conclusion: The administration of local and systemic laser therapy was more effective for the cure of nipple trauma and pain reduction, in comparison with the control group. (AU)

Objetivo: Analizar la efectividad del láser de baja potencia, local y sistémico, para la cicatrización y reducción del dolor causado por las lesiones del pezón. Métodos: Ensayo clínico, aleatorizado y controlado realizado con 54 mujeres lactantes atendidas en un Banco de Leche Humana, de diciembre de 2017 a junio de 2018. Las mujeres lactantes, que totalizaron 101 lesiones, recibieron orientación sobre el manejo clínico de las mamas y fueron asignadas en: Grupo de Control (CG), Grupo de Láser Local (GLL), que recibió láser directamente en el pezón lesionado, y Grupo de Irradiación de Láser Intravascular de Sangre (GILIB), que recibió terapia con láser sistémico. Los datos se analizaron mediante el SPSS para evaluar la homogeneidad de los grupos (Kruskal-Wallis) y la regresión lineal para identificar el efecto de la intervención sobre el tamaño de las lesiones mamarias y la intensidad del dolor. Resultados: Los tres grupos de análisis eran homogéneos antes del experimento (p=0,191). Tras la intervención, hubo curación de las lesiones en los tres grupos, siendo significativamente mayor en GLL y GILIB (p<0,050). En cuanto al dolor, hubo una reducción de hasta 4,0 puntos en GLL y GILIB (p=0,002). Conclusión: La administración de la terapia con láser local y sistémica fue más efectiva para la curación de las lesiones del pezón y la reducción del dolor, en comparación con el grupo de control. (AU)

Avaliação do programa comportamental em diabetes mellitus tipo 2: ensaio clínico randomizado / Evaluation of the behavioral program in type 2 diabetes mellitus: a randomized clinical trial

Resumo O objetivo deste artigo é avaliar o efeito do programa comportamental educação em grupo e intervenção telefônica na modificação das atitudes psicológicas, melhora do empoderamento e das práticas de autocuidado visando à melhora do controle clínico em diabetes mellitus tipo 2. Trata-se de um ensaio clínico com cluster randomizado, realizado em 199 pessoas com diabetes. Para realizar as comparações intragrupos (tempos final e inicial) e entre grupos quanto aos valores das variáveis atitudes psicológicas, empoderamento, autocuidado e medidas da hemoglobina glicada, foi utilizada a abordagem das Generalizing Estimating Equations (GEE). Em todas as análises, utilizou-se um nível de significância de 5% e intervalos de 95% de confiança. Quando comparado ao GC, o GI apresentou uma redução significativa nos valores médios de hemoglobina glicada (IC95%: -1,49 a - 0,45), aumento estatisticamente significativo na modificação dos escores de atitudes psicológicas (IC95%: 9,70 a 15,40), na escala do empoderamento (IC95%: 0,81 a 2,72) e na adesão às práticas de autocuidado (IC95%: 1,44 a 2,10) ao final do estudo. O programa comportamental se mostrou capaz de modificar as atitudes psicológicas, melhorar o empoderamento, as práticas de autocuidado e o controle clínico.

Abstract The scope of this article was to evaluate the effect of the behavioral group education program and telephone intervention in modifying psychological attitudes, enhancing empowerment, and self-care practices aimed at improving clinical control in type 2 diabetes mellitus. It involved a randomized cluster clinical trial, carried out with 199 people with diabetes. In order to perform intragroup comparisons (final and initial phases) and between groups with respect to the indices of the psychological attitude, empowerment, self-care and glycated hemoglobin level variables, the Generalizing Estimating Equation (GEE) approach was used. In all analyses, a 5% significance level and 95% confidence interval were used. When compared to the CG, the IG showed a significant reduction in the mean values of glycated hemoglobin (95%CI: -1.49 to -0.45), a statistically significant increase in the change in psychological attitude scores (95%CI: 9.70 to 15.40), on the empowerment scale (95%CI: 0.81 to 2.72) and adherence to self-care practices (95%CI: 1.44 to 2.10) at the end of the study. The behavioral program proved to be capable of modifying psychological attitudes, improving empowerment, self-care practices and clinical control.

Pesquisas cadastradas por enfermeiros no registro brasileiro de ensaios clínicos / Research registered by nurses in the brazilian registry of clinical trials / Investigación registrada por enfermeros en el registro brasileño de ensayos clínicos

Objetivo: Caracterizar os estudos de intervenção cadastrados por enfermeiros no Registro Brasileiro de Ensaios Clínicos. Métodos: Estudo descritivo, com abordagem quantitativa, realizado mediante acesso virtual ao Registro Brasileiro de Ensaios Clínicos, para busca dos estudos cadastrados na plataforma. Após leitura dos 3350 resumos disponíveis, os 320 cadastrados por enfermeiros foram selecionados para compor a amostra. Foi realizada a análise descritiva, no software R. Resultados: Foram encontrados estudos registrados entre 2010 e 2019, dos quais 49,7% localizavam-se na região Sudeste, 49,3% cadastrados por doutores, 46,3% filiados a universidades federais. A área da enfermagem mais estudada (18,8%) tratou-se de saúde do adulto, 72,9% possuíam dois braços, 53,1% com recrutamento concluído, 50,3% realizados com cegamento e o tipo de intervenções mais estudado (21,9%) foi a educativa. Conclusão: A maioria dos estudos de intervenção cadastrados por enfermeiros no Registro Brasileiro de Ensaios Clínicos testaram intervenções educativas, em adultos, possuíram cegamento e foram randomizados. (AU)

Objective: To characterize the intervention studies registered by nurses in the Brazilian Registry of Clinical Trials. Methods: Descriptive study, with quantitative approach, carried out through virtual access to the Brazilian Registry of Clinical Trials, to search for the studies registered on the platform. After reading the 3350 abstracts available, the 320 registered by nurses were selected to make up the sample. Descriptive analysis was performed in the software R. Results: Studies registered between 2010 and 2019 were found, of which 49.7% were in the Southeast region, 49.3% registered by doctors, 46.3% affiliated to federal universities. The most studied nursing area (18.8%) it was adult health, 72.9% had two arms, 53.1% with completed recruitment, 50.3% performed blinding and the most studied type of interventions (21.9%) was the educational. Conclusion: Most intervention studies registered by nurses in the Brazilian Registry of Clinical Trials tested educational interventions in adults, blinded and randomized. (AU)

Objetivo: Caracterizar los estudios de intervención registrados por enfermeros en el Registro Brasileño de Ensayos Clínicos. Métodos: Estudio descriptivo, con enfoque cuantitativo, realizado a través del acceso virtual al Registro Brasileño de Ensayos Clínicos, para buscar estudios registrados en la plataforma. Después de leer los 3350 resúmenes disponibles, los 320 registrados por enfermeros fueron seleccionados para componer la muestra. Se realizó análisis descriptivo en el software R. Resultados: Se encontraron estudios registrados entre 2010 y 2019, de los cuales el 49,7% se ubicaron en la región Sudeste, el 49,3% fueron registrados por médicos, el 46,3% fueron afiliados a universidades federales. El área de enfermería más estudiada (18,8 %) fue la salud del adulto, el 72,9 % tenía dos brazos, el 53,1 % había completado el reclutamiento, el 50,3 % estaba cegada y el tipo de intervenciones más estudiadas (21,9 %) fue la educativa. Conclusión: La mayoría de los estudios de intervención registrados por enfermeros en el Registro Brasileño de Ensayos Clínicos probaron intervenciones educativas en adultos, fueron ciegos y aleatorizados. (AU)

A Single Centre Open Label Non-Randomized Phase-IV Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Roop Mantra Ayurvedic Medicinal Cream

Objectives: The objective of the study was to evaluate the efficacy and safety of a polyherbal Roop Mantra Ayurvedic Medicinal Cream in subjects with acne, facial scars, pimples, blemishes, dull and dry skin. Methods: This was a 60-day, single-centre, open-labelled, non-randomized phase-IV surveillance study with 120 subjects. Subjects were selected based on the study's inclusion criteria. The study included three scheduled clinical visits on days 0 (screening and baseline visit), 30 (follow-up visit), and 60 (final visit). Following an evaluation of baseline data, all subjects were given Roop Mantra Ayurvedic Medicinal Cream for 60 days. The primary outcome of the study was to assess the efficacy of Roop Mantra Ayurvedic Medicinal Cream based on changes in parameters such as skin texture, skin health, global acne assessment parameters and an investigator assessment scale. The secondary outcome of the study was the determination of local intolerance and adverse effects to Roop Mantra Ayurvedic Medicinal Cream . Results: The study findings revealed that the use of Roop Mantra Ayurvedic Medicinal Cream for 60 days improved skin texture and appearance while significantly reducing acne, pimples, blemishes, and skin dryness. Roop Mantra Ayurvedic Medicinal Cream was likewise dermatologically well tolerated and did not cause any adverse effects during the study period. Conclusion: Roop Mantra Ayurvedic Medicinal Cream showed highly satisfactory results in terms of skin texture, skin appearance and general acne parameters without having any adverse effects on the skin. Given the positive outcomes, Roop Mantra Ayurvedic Medicinal Cream is clinically effective and safe alternative for treating various skin problems.

A Single Centre Open Label Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash

The objective of the study was to assess the safety and efficacy of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash in subjects with acne, facial scars, pimples, blemishes, dull skin and dry skin. Methods: This was a single-center, open-label, non-randomized post-marketing surveillance study with 120 subjects. Subjects were selected on the basis of inclusion criteria. The study included three scheduled clinical visits on days 0 (screening and baseline visit), 15 (follow-up visit), and 30 (final visit). Following an assessment of baseline data, all subjects were given Roop Mantra Cucumber Ayurvedic Medicinal Face Wash for 30 days. The efficacy of Roop Matra Cucumber Ayurvedic Medicinal Face Wash was determined by measuring changes in parameters such as skin characteristics, skin appearance, and Global Acne Assessment (GAA) score. Product safety was assessed by determining local intolerance and adverse effects of Roop Mantra Cucumber Ayurvedic Medicinal Face Wash. Results: The results of the study showed that applying Roop Mantra Cucumber Ayurvedic Medicinal Face Wash for 30 days significantly improved skin’s characteristic and appearance. Roop Mantra Cucumber Ayurvedic Medicinal Face Wash was also found to be dermatologically well tolerated and had no negative impacts over the course of the study. Conclusion: The polyherbal Roop Mantra Cucumber Ayurvedic Medicinal Face Wash was found to be very safe and effective in reducing acne, pimples, blemishes, and skin dryness with improved skin texture and appearance. Roop Mantra Cucumber Ayurvedic Medicinal Face Wash is therefore a clinically feasible and safe alternative for treating the aforementioned skin conditions.

Smartphone-assisted online brief cognitive behavioral therapy to treat maternal depression: findings of a randomized controlled trial

Objective: To test the efficacy of smartphone-assisted online brief cognitive behavioral therapy (b-CBT) to treat maternal depression compared to online brief CBT plus an active control app. Methods: A randomized controlled trial was conducted. Assessments were performed at baseline (T0), midpoint (T1, week 4-5), post-treatment (T2, week 8), and follow-up (T3, 2-month postnatal follow-up) by blinded interviewers. The primary outcome was depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at T2. We also assessed anxiety, stress, sleep quality, well-being, physical activity, treatment response, and offspring child behavior problems. Results: Eighty-one participants were randomized to the intervention (n=37) or active control (n=44) groups. Seventy-one participants completed the post-treatment assessment or reported primary outcome data. No differences were found between the intervention and active control groups regarding maternal depression or other mental health outcomes. Overall, we found large within-group effect sizes, with 80% of the total sample responding to treatment. Conclusions: Our data showed no difference between the groups, suggesting that adding apps to psychotherapy treatment may not enhance treatment effects on prenatal depression. A within-groups analysis showed that most participants with depression responded to treatment; however, future studies are needed to confirm whether this effect is related to factors other than the intervention.

Revisiting global cognitive and functional state 13 years after a clinical trial of lithium for mild cognitive impairment

Objectives: To re-evaluate a sample of older adults enrolled in a randomized controlled trial of lithium for amnestic mild cognitive impairment (MCI) after 11 to 15 years, re-assessing their current (or last available) global cognitive and functional state. Methods: We recalled all former participants of the Lithium-MCI trial conducted by our group between 2009 and 2012 to perform a single-blinded, cross-sectional evaluation of their global clinical state to compare the long-term outcome of those who received lithium vs. those who received placebo. Results: Of the original sample (n=61), we were able to reach 36 participants (59% of retention), of whom 22 had previously received lithium (61% of the recall sample) and 14 (39%) had received placebo. Since 30.5% of the recalled sample was deceased, psychometric data were collected only for 69.5% of the participants. We found statistically significant differences in current mean Mini Mental State Examination score according to previous treatment group (25.5 [SD, 5.3] vs. 18.3 [SD, 10.9], p = 0.04). The lithium group also had better performance in the phonemic Verbal Fluency Test than the control group (34.4 [SD, 14.4] vs. 11.6 [SD, 10.10], p < 0.001). Differences in these measures also had large effect sizes, as shown by Cohen's d values of 0.92 and 1.78, respectively. Conclusion: This data set suggests that older adults with amnestic MCI who had been treated with lithium during a previous randomized controlled trial had a better long-term global cognitive outcome than those from a matched sample who did not receive the intervention.

Clinical efficacy evaluation of crisaborole ointment in the treatment of vulvar leukoplakia

SUMMARY OBJECTIVE: The aim of this study was to evaluate the clinical efficacy of crisaborole ointment in the treatment of vulvar leukoplakia. METHODS: A prospective, randomized controlled clinical trial was conducted, and a total of 100 patients with vulvar leukoplakia were divided into the observation group (n=50) treated with crisaborole ointment and the control group (n=50) treated with vitamin E. The symptom improvement and vulvar leukoplakia score after 2 weeks of treatment were analyzed, and the clinical efficacy of vulvar leukoplakia was evaluated by referring to the Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine (2018 Edition). RESULTS: After 2 weeks of treatment, the overall score of lesions in the observation group decreased, and the total treatment efficiency of patients in the observation group was 92% (46/50), which was significantly higher than that of 52% (26/50) in the control group P<0.05). CONCLUSION: Crisaborole ointment can effectively treat vulvar leukoplakia, improving the symptoms and pathological changes of the vulvar skin.

Evaluating the efficacy of Etoricoxib in reducing post-operative pain associated with minor oral surgery. A randomized clinical trial / Avaliação da eficácia do Etoricoxibe na redução da dor pós-operatória associada à cirurgia oral menor: ensaio clínico randomizado

Etoricoxib, a new cyclooxygenase-2-selective inhibitor has demonstrated a rapid onset analgesic effect for relieving acute pain especially when prescribed as a pre-emptive medication. On these bases, this study may provide useful information and guidance for clinicians working in the field of oral surgery, as regards handling odontogenic pain and postoperative pain precisely with cyclooxygenase-2 inhibitors. Objective: the study aimed to measure the quantifiable efficacy of Etoricoxib in reducing post-extraction pain in subjects undergoing minor oral surgical intervention as compared to Naproxen (a traditional NSAID) which is commonly used to control postoperative pain. Material and Methods: a 120 mg film-coated tablet of Etoricoxib was given to each of the twenty patients representing the study group, and a 500 mg tablet of Naproxen was given to each of the other twenty subjects representing the positive control group. According to manufacturer instructions, the tablets were given to the subjects 30 minutes pre-operatively (before dental extraction). Post-operative pain was assessed for each subject using eleven points from zero to ten, visual analog scale. Results: showed no statistically significant difference between Etoricoxib and Naproxen in decreasing post-extraction odontogenic pain, suggesting that Etoricoxib is as efficient as Naproxen in the control of discomfort with dental origin taking into consideration the patient's status when prescribing the medication. Conclusion: this study suggests that Etoricoxib can be handled as a pre-emptive medication to reduce post-operative pain for subjects seeking traditional or surgical extraction of any of their teeth (AU)

O Etoricoxibe, um novo inibidor seletivo da ciclooxigenase-2, demonstrou um efeito analgésico de início rápido para aliviar a dor aguda, especialmente quando prescrito como medicação preventiva. Com base nesses fundamentos, este estudo pode fornecer informações úteis e orientação para clínicos que trabalham no campo da cirurgia oral, no que diz respeito ao manejo da dor odontogênica e da dor pós-operatória de forma precisa com inibidores da ciclooxigenase-2. Objetivo: o estudo teve como objetivo medir a eficácia quantificável do Etoricoxibe na redução da dor pós-extração em indivíduos submetidos a intervenção cirúrgica oral menor, comparado ao Naproxeno (AINE tradicional) que é comumente usado para controlar a dor pós-operatória. Material e Métodos: um comprimido revestido com um filme de 120 mg de Etoricoxibe foi administrado a cada um dos 20 pacientes representando o grupo de estudo, e um comprimido de 500 mg de Naproxeno foi administrado a cada um dos outros vinte sujeitos representando o grupo de controle positivo. De acordo com as instruções do fabricante, os comprimidos foram administrados aos indivíduos 30 minutos antes da cirurgia (antes da extração dentária). A dor pós-operatória foi avaliada para cada sujeito usando uma escala analógica visual de onze pontos, de zero a dez. Resultados: não mostraram diferença estatisticamente significativa entre o Etoricoxibe e o Naproxeno na diminuição da dor odontogênica pós-extração, sugerindo que o Etoricoxibe é tão eficiente quanto o Naproxeno no controle do desconforto de origem dentária, levando em consideração o estado do paciente ao prescrever a medicação. Conclusão: este estudo sugere que o Etoricoxibe pode ser administrado como medicação preventiva para reduzir a dor pós-operatória em indivíduos que buscam extração dentária tradicional ou cirúrgica de qualquer um de seus dentes. (AU)

Influence of daily usage times on patients' compliance during at-home bleaching: a randomized clinical trial

Abstract The effectiveness of at-home dental bleaching treatments depends on the time that bleaching products are in contact with the teeth surface and, consequently, on the adequate use of associated custom acetate trays. Objective This randomized single-blinded trial aimed to analyze if the daily usage time of these products influences the patient's compliance behavior when submitted to monitored at-home dental bleaching. Secondary outcomes were color change and tooth sensitivity. Methodology Sixty-six volunteers were randomly distributed into three groups (n=22): patients were instructed to use the trays for 2 (G2), 4 (G4), and 8 (G8) hours daily. The daily dental bleaching compliance behavior was measured using a microsensor inserted into the trays. Subjective and objective color evaluation assessments were adopted at baseline (T0), one (T1), two (T2), and three weeks (T3) after the beginning of the bleaching treatment, as well as two weeks after the treatment (T4). Tooth sensitivity was analyzed using the VAS scale, ranging from T1 to T4. Results G2 showed a greater degree of cooperation than G8 and cooperation was inversely proportional to the recommended usage time. Significantly higher color change was observed in the upper arch for G8 when compared to G2 in subjective analysis, from T1 to T4. There were no statistical differences between the groups in objective analysis. Conclusion Shorter recommended usage time of the bleaching product may improve the patient's compliance with at-home dental bleaching treatments. However, increased daily usage time may promote better subjective color change. Bleaching sensitivity was more significant in the first week for a longer time of use.

Evaluation of two polyethylene bags in preventing admission hypothermia in preterm infants: a quasirandomized clinical trial

Abstract Objective: To compare two polyethylene bags in preventing admission hypothermia in preterm infants born at <34 weeks gestation. Method: Quasi-randomized unblinded clinical trial conducted at a level III neonatal unit between June 2018 to September 2019. The authors assign infants between 240/7 and 336/7 weeks' gestation to receive NeoHelpTM bag (intervention group) or a usual plastic bag (control group). The primary outcome was admission hypothermia, considering an axillary temperature at admission to the neonatal unit of <36.0 °C. Hyperthermia was considered if the admission temperature reached 37.5 °Cor more. Results: The authors evaluated 171 preterm infants (76, intervention group; 95, control group). The rate of admission hypothermia was significantly lower in the intervention group (2.6% vs. 14.7%, p = 0.007), with an 86% reduction in the admission hypothermia rate (OR, 0.14; 95% CI, 0.03-0.64), particularly for infants weighing >1000 g and >28 weeks gestation. The intervention group also had a higher median of temperature at admission - 36.8 °C (interquartile range 36.5-37.1) vs. 36.5 °C (interquartile range 36.1-36.9 °C), p = 0.001, and showed à higher hyperthermia rate (9.2% vs. 1.0%, p = 0.023). Birth weight was also associated to the outcome, and it represented a 30% chance reduction for every 100-g increase (OR, 0.997; 95% CI, 0.996-0.999). The in-hospital mortality rate was similar between groups. Conclusion: The intervention polyethylene bag was more effective in preventing admission hypothermia. Nonetheless, the risk of hyperthermia is a concern during its use.

Ensayo controlado y aleatorizado del uso de Heberkinasa® en el derrame pleural paraneumónico en niños

Introducción: El derrame pleural paraneumónico resulta la complicación más frecuente de la neumonía bacteriana, de manejo complejo y muchas veces quirúrgico. No existen publicaciones en Cuba provenientes de ensayos clínicos controlados y aleatorizados ni del uso de la estreptoquinasa recombinante (Heberkinasa®) en el derrame pleural. Objetivo: Evaluar la eficacia y la seguridad de la Heberkinasa® en el tratamiento del derrame pleural paraneumónico complicado complejo y el empiema en niños. Métodos: Ensayo clínico fase III, abierto, aleatorizado (2:1), en grupos paralelos y controlado. Se concluyó la inclusión prevista de 48 niños (1-18 años de edad), que cumplieron los criterios de selección. Los progenitores otorgaron el consentimiento informado. Los pacientes se distribuyeron en dos grupos: I- experimental: terapia estándar y administración intrapleural diaria de 200 000 UI de Heberkinasa® durante 3-5 días y II-control: tratamiento estándar. Las variables principales: necesidad de cirugía y la estadía hospitalaria. Se evaluaron los eventos adversos. Resultados: Ningún paciente del grupo I-experimental requirió cirugía, a diferencia del grupo II-control en el que 37,5 % necesitó cirugía video-toracoscópica, con diferencia altamente significativa. Se redujo la estadía hospitalaria (en cuatro días), las complicaciones intratorácicas y las infecciones asociadas a la asistencia sanitaria en el grupo que recibió Heberkinasa®. No se presentaron eventos adversos graves atribuibles al producto. Conclusiones: La Heberkinasa® en el derrame pleural paraneumónico complicado complejo y empiema resultó eficaz y segura para la evacuación del foco séptico, con reducción de la necesidad de tratamiento quirúrgico, de la estadía hospitalaria y de las complicaciones, sin eventos adversos relacionados con su administración.

Introduction: Paraneumonic pleural effusion is the most frequent complication of bacterial pneumonia, with complex and often surgical management. There are no publications in Cuba from randomized controlled clinical trials or the use of recombinant streptokinase (Heberkinase®) in pleural effusion. Objective: To evaluate the efficacy and safety of Heberkinase® in the treatment of complex complicated parapneumonic pleural effusion and empyema in children. Methods: Phase III, open-label, randomized (2:1), parallel-group, controlled clinical trial. The planned inclusion of 48 children (1-18 years of age), who met the selection criteria, was completed. Parents gave informed consent. The patients were divided into two groups: I-experimental: standard therapy and daily intrapleural administration of 200,000 IU of Heberkinase® for 3-5 days; and II-control: standard treatment. The main variables: need for surgery and hospital stay. Adverse events were evaluated. Results: No patient in group I-experimental required surgery, unlike group II-control in which 37.5% required video-assisted thoracoscopic surgery, with a highly significant difference. Hospital stay (to 4 days), intrathoracic complications and infections associated to healthcare in the group that received Heberkinase® was reduced. No serious adverse events attributable to the product occurred. Conclusions: Heberkinase® in complex complicated parapneumonic pleural effusion and empyema was effective and safe for the draining of the septic focus, with reduction of the need for surgical treatment, hospital stay and complications, with no adverse events related to its administration.

Análise da qualidade das evidências científicas sobre a eficácia e segurança nas bulas de anticoagulantes orais diretos comercializados no Brasil / Analysis of the quality of scientific evidence on efficacy and safety in the package leaflets of direct oral anticoagulants marketed in Brazil

Objetivo: Identificar e analisar a qualidade das evidências científicas sobre a eficácia e segurança dos anticoagulantes orais direto (DOAC) disponíveis nos ensaios clínicos referenciados nas bulas dos medicamentos comercializados no Brasil. Método: Trata-se de um descritivo documental dividido em duas etapas, sendo elas: (i) identificação e análise da disponibilidade das referências bibliográficas contidas nas bulas dos DOAC e (ii) análise da qualidade dos estudos contidos nas bulas através da ferramenta da Cochrane Risk of Bias RevMan versão 5.4. Foram analisados setes domínios de importâncias para ensino clínico, sendo que cada domínio foi classificado como alto, incerto ou baixo risco de viés, segundo a avaliação dos colaboradores. Resultados: Foram analisadas 10 bulas destinadas aos profissionais da saúde. Sendo que destas, foram avaliados 25 ensaios clínicos. A análise da qualidade das evidências científicas, referenciadas nas bulas para profissionais dos DOAC, mostrou que os estudos citados apresentaram consistência metodológica. Entretanto, na maioria dos estudos, os domínios foram classificados como viés incerto, ou seja, não foi possível identificar como esses pontos foram abordados nos estudos. Conclusão: Portanto, o presente estudo evidenciou que a qualidade dos ensaios clínicos referenciados nas bulas dos DOAC apresentou incertezas metodológicas em seus ensaios. Sugere-se a necessidade de normativas que estabeleçam atualizações do conteúdo informativo presente nas bulas profissionais e estabeleçam descrição dos métodos de forma clara e coesa (AU).

Objective: Identify and analyze the quality of scientific evidence on the efficacy and safety of direct oral anticoagulants (DOAC) available in clinical trials referenced in the package leaflets of drugs marketed in Brazil. Method: This is a descriptive documentary study divided into two stages: (i) identification and analysis of the availability of the bibliographic references contained in the package leaflets of DOACs and (ii) analysis of the quality of the studies contained in the package leaflets through the Cochrane Risk of Bias RevMan tool version 5.4. Seven domains of importance for clinical teaching were analyzed, and each domain was classified as high, uncertain or low risk of bias, according to the assessment of the collaborators. Results: Ten package leaflets intended for health professionals were analyzed. Of these, 25 clinical trials were evaluated. The analysis of the quality of the scientific evidence referenced in the package leaflets for health professionals showed that the cited studies presented methodological consistency. However, in most studies, the domains were classified as uncertain bias, i.e., it was not possible to identify how these points were addressed in the studies. Conclusion: Therefore, the present study evidenced that the quality of clinical trials referenced in the package leaflets of DOACs presented methodological uncertainties in their trials. It is suggested the need for regulations that establish updates of the information content present in the professional package inserts and establish a description of the methods in a clear and cohesive way (AU).

Estratégias para favorecer a compreensão do termo de consentimento pelos participantes de ensaios clínicos: revisão integrativa / Strategies to favor comprehension of the consent form by clinical trial participants: an integrative review / Estrategias para facilitar la comprensión del formulario de consentimiento por parte de los participantes en ensayos clínicos: una revisión integradora

Objetivo: analisar as estratégias utilizadas para favorecer a compreensão de participantes de pesquisas clínicas sobre o termo de consentimento livre e esclarecido, bem como, as bases teóricas em que se apoiam. Métodos: revisão integrativa da literatura realizada no ano de 2019 e atualizada em 2021 em seis bases de dados eletrônicas, adicionada de busca reversa a partir das referências dos artigos incluídos. Resultados: dos 21 artigos selecionados, foram identificadas estratégias de mudanças no conteúdo, da forma de apresentação do termo de consentimento, bem como estratégias multimodais. As estratégias identificadas relacionam-se, em sua maioria, ao referencial tradicional de aprendizagem e resultaram em melhor compreensão por parte dos indivíduos que estavam em processo de obtenção do consentimento para participar de ensaios clínicos, em comparação com as estratégias usuais, mas, para a maioria o patamar de compreensão manteve-se abaixo de 60,0%. Conclusões: as estratégias resultaram na melhora da compreensão geral, porém, com persistência da incompreensão ou compreensão limitada de conceitos fundamentais inerentes à participação em pesquisas clínicas, reforçando que o processo de obtenção do consentimento é um fenômeno complexo e que requer atenção especial dos pesquisadores, na busca de garantir a compreensão adequada das informações, garantindo, de fato, a tomada de decisão esclarecida.

Objective: to analyze the strategies used to favor the comprehension of clinical trial participants about the informed consent form, as well as the theoretical bases on which these are based. Methods: integrative literature review performed in 2019 and updated in 2021 in six electronic databases, plus a reverse search based on references of the included articles. Results: strategies of changing the content and the form of presentation of the consent form, as well as multimodal strategies were identified in the 21 selected articles. The identified strategies are mostly related to the traditional learning framework and resulted in a better understanding by individuals in the process of obtaining consent to participate in clinical trials, compared to the usual strategies. For the most part, the level of comprehension remained below 60.0%. Conclusions: the strategies resulted in an improvement in general understanding, although with persisting misunderstanding or limited understanding of fundamental concepts inherent to participation in clinical trials, reinforcing that the process of obtaining consent is a complex phenomenon that requires special attention from researchers, in the quest to ensure proper understanding of information, and an actually informed decision-making.

Objetivo: analizar las estrategias utilizadas para favorecer la comprensión de los participantes en la investigación clínica sobre el formulario de consentimiento informado, así como las bases teóricas en las que se fundamentan. Métodos: revisión bibliográfica integradora realizada en 2019 y actualizada en 2021 en seis bases de datos electrónicas, además de búsqueda inversa a partir de las referencias de los artículos incluidos. Resultados:de los 21 artículos seleccionados, se identificaron estrategias para modificar el contenido y la forma de presentación del formulario de consentimiento, así como estrategias multimodales. Las estrategias identificadas estaban relacionadas en su mayoría con el marco de aprendizaje tradicional y dieron lugar a una mejor comprensión por parte de las personas que estaban en proceso de obtener el consentimiento para participar en ensayos clínicos, en comparación con las estrategias habituales, pero para la mayoría de ellas el nivel de comprensión se mantuvo por debajo del 60%. Conclusiones: las estrategias resultaron en una mejora de la comprensión general, sin embargo, con la persistencia de incomprensión o comprensión limitada de conceptos fundamentales inherentes a la participación en la investigación clínica, reforzando que el proceso de obtención del consentimiento es un fenómeno complejo que requiere especial atención por parte de los investigadores, en la búsqueda de garantizar la adecuada comprensión de la información, asegurando, de hecho, la toma de una decisión informada