Deficiencies in reporting inclusion/exclusion criteria and characteristics of patients in randomized controlled trials of therapeutic interventions in pressure injuries: a systematic methodological review.

Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.

Quality of reporting of outcomes in trials of therapeutic interventions for pressure injuries in adults: a systematic methodological survey.

Randomised controlled trials of therapeutic interventions for pressure injuries should include a clear description of outcomes to increase transparency and replicability and improve the construction of scientific evidence. The objective of this study was to assess the completeness of the descriptions of the outcomes of therapeutic interventions in adults with pressure injury (PI) and factors associated with completeness. This was a systematic methodological survey. The completeness of the outcome was assessed according to five criteria: domain (title), specific measure (technique/instrument used), specific metric, or format of the outcome data of each participant that was used for analysis, aggregation (method data from each group were summarised), and time that was used for analysis. Sixty-eight studies were included for analysis. A total of 265 outcomes were reported, and 46 trials (67.6%) had 73 primary outcomes, which were mainly intermediates/substitutes (78.8%). The main outcome evaluated was the ulcer area reduction (36.6%). Approximately 37.2% of the outcomes were incompletely reported, and the least described element was the data aggregation method (72.8%). Only 48.4% of the outcomes with the specified technique had the same reference or validation. Poor quality of reporting outcomes was associated with studies with an older year of publication and a small sample size, single-center studies, and those sponsored by industry. PI studies use many outcomes, mostly surrogates or intermediates, and some of them are incompletely described.

Protocolo de tratamiento de heridas con apósito de hidrofibra reforzada, con plata iónica al 1,2%, potenciado con EDTA y cloruro de bencetonio para evitar la recurrencia de biopelícula.

OBJECTIVE: Present a treatment protocol to avoid biofilm reformation in hard-to-heal wounds, using a hydrofiber dressing with 1.2% ionic silver, ethylenediaminetetraacetic acid and benzethonium chloride. METHOD: A retrospective, descriptive and analytic study on the use of a treatment protocol, including three case studies. Patient records for hard-to-heal wounds were analysed according to an algorithm for biofilm detection and best-practice recommendations for wound hygiene. RESULTS: The adopted protocol was based on three pillars: identifying clinical signs suggesting biofilm, performing wound hygiene, and applying an antibiofilm dressing. CONCLUSION: Wound healing rates can improve after protocol implementation. Adequate control of local signs of infection and exudate, as well as visual and indirect signs of biofilm, were achieved. All patients progressed well towards wound-size reduction and closure using the hydrofiber dressing.

OBJETIVO: Presentar un protocolo para evitar la reformación de biopelícula en heridas de difícil cicatrización con apósito de hidrofibra reforzada, con plata iónica al 1,2%, potenciado con ácido etilendiaminotetraacético (EDTA) y cloruro de bencetonio. MÉTODO: Estudio retrospectivo, descriptivo y analítico de aplicación de un protocolo de tratamiento, con tres casos de estudio de pacientes tratados en un centro de referencia internacional. Los registros de pacientes con úlceras complejas se analizaron y evaluaron de acuerdo con la inserción en el algoritmo de identificación clínica de biopelículas, y en base a las recomendaciones prácticas para la higiene de heridas. RESULTADOS: El protocolo adoptado se basó en tres pilares: identificación de signos clínicos de sugerencia para la presencia de biopelícula, prácticas de higiene en las heridas, y aplicación de la cobertura de antibiopelícula. CONCLUSIÓN: La capacidad de cicatrización de heridas con este protocolo puede considerarse alta. Los pacientes obtuvieron un adecuado control de todos los signos locales de infección y de exceso de exudado, y la desaparición de los signos visuales e indirectos de biopelícula. Todos presentaron una adecuada progresión, disminución de la superficie de la herida, y cicatrización tras el uso del apósito.

Protocolo de tratamiento de heridas con apósito de hidrofibra reforzada, con plata iónica al 1,2%, potenciado con EDTA y cloruro de bencetonio para evitar la recurrencia de biopelícula.

OBJECTIVE: Present a treatment protocol to avoid biofilm reformation in hard-to-heal wounds, using a hydrofiber dressing with 1.2% ionic silver, ethylenediaminetetraacetic acid and benzethonium chloride. METHOD: A retrospective, descriptive and analytic study on the use of a treatment protocol, including three case studies. Patient records for hard-to-heal wounds were analysed according to an algorithm for biofilm detection and best-practice recommendations for wound hygiene. RESULTS: The adopted protocol was based on three pillars: identifying clinical signs suggesting biofilm, performing wound hygiene, and applying an antibiofilm dressing. CONCLUSION: Wound healing rates can improve after protocol implementation. Adequate control of local signs of infection and exudate, as well as visual and indirect signs of biofilm, were achieved. All patients progressed well towards wound-size reduction and closure using the hydrofiber dressing.

OBJETIVO: Presentar un protocolo para evitar la reformación de biopelícula en heridas de difícil cicatrización con apósito de hidrofibra reforzada, con plata iónica al 1,2%, potenciado con ácido etilendiaminotetraacético (EDTA) y cloruro de bencetonio. MÉTODO: Estudio retrospectivo, descriptivo y analítico de aplicación de un protocolo de tratamiento, con tres casos de estudio de pacientes tratados en un centro de referencia internacional. Los registros de pacientes con úlceras complejas se analizaron y evaluaron de acuerdo con la inserción en el algoritmo de identificación clínica de biopelículas, y en base a las recomendaciones prácticas para la higiene de heridas. RESULTADOS: El protocolo adoptado se basó en tres pilares: identificación de signos clínicos de sugerencia para la presencia de biopelícula, prácticas de higiene en las heridas, y aplicación de la cobertura de antibiopelícula. CONCLUSIÓN: La capacidad de cicatrización de heridas con este protocolo puede considerarse alta. Los pacientes obtuvieron un adecuado control de todos los signos locales de infección y de exceso de exudado, y la desaparición de los signos visuales e indirectos de biopelícula. Todos presentaron una adecuada progresión, disminución de la superficie de la herida, y cicatrización tras el uso del apósito.

Quality of reporting of outcomes in trials of therapeutic interventions for pressure ulcers in adults: a protocol for a systematic survey.

Pressure ulcers (PUs) have a high incidence, especially in hospital units. Randomised clinical trials (RCTs) of therapeutic interventions for PU should include a clear description of the outcomes and results to enhance transparency and replicability. OBJECTIVES: The primary objective of this study is to assess the completeness of the descriptions of the outcomes of therapeutic interventions in RCTs in adult patients with PU. The secondary objectives are to evaluate the types of reported primary outcomes, measurement methods or tools used to evaluate the outcomes and the results of reported outcomes. METHODS: We will conduct a systematic survey of RCTs published from January 2006 to April 2018. The selection process of the studies will be done in two stages of screening: title and abstract, and full text revision, always by two researchers independently. The completeness of the outcome will be assessed according to five criteria: domain (outcome title), specific measurement or technique/instrument used, specific metric or format of the outcome data that will be used for analysis, method of aggregation (how data from each group will be summarised) and time-points that will be used for analysis. The quality of the results of the outcome will be classified as either complete, incomplete or unreported. We will conduct a descriptive analysis of the number, type and degrees of outcome specification in the included RCTs. The frequency of categories in each domain of the outcomes will also be reported. The median and IQR will be estimated for each element of the specified outcome (out of five). ETHICS AND DISSEMINATION: This will be the first systematic assessment of the outcomes of therapeutic interventions used for pressure ulcers. After completion, this review will be submitted to a peer-reviewed journals.

[Quality of life of postmenopausal women attended at Primary Health Care]. / Qualidade de vida em mulheres no climatério atendidas na Atenção Primária.

The experience of menopause is increasingly present, and demand strategies to improve the quality of life of women during this period. This research aimed to evaluate the quality of life for women in the climacteric phase, with or without the use of hormone replacement therapy (HRT). This is a longitudinal epidemiological study of a sample of 99 women per group. It was evaluated the sociodemographic, clinical and behavioral characteristics. It was used the Menopause Rating Scale (MRS) and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). For data analysis, it was used the Student t test, chi-square and Tukey. HRT users had an average age of 50.76 ± 3.63 years, and nonusers of 48.95 ± 6,27anos (p = 0.01). It was identified a higher frequency of moderate climacteric symptoms of mild intensity. The social aspects evidenced scores below 50 for the two groups. There were differences between groups with respect to the components of the SF-36 and MRS to general health, functional capacity, lower capacity, depression, insomnia and vasomotor phenomena.

Qualidade de vida em mulheres no climatério atendidas na Atenção Primária / Quality of life of postmenopausal women attended at Primary Health Care / Calidad de vida de las mujeres en climaterio tratadas en la Atención Primaria

A vivência do climatério está cada vez mais presente, e demanda estratégias que melhorem a qualidade de vida das mulheres nesse período. A pesquisa objetivou avaliar a qualidade de vida de mulheres na fase do climatério, com ou sem uso da terapia de reposição hormonal (TRH). Estudo epidemiológico longitudinal, com amostra de 99 mulheres para cada grupo. Avaliaram-se as características sociodemográficas, clínicas e comportamentais. Foram aplicados à amostra a Menopause Rating Scale (MRS) e o Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Utilizaram-se os testes t de student, Qui-quadrado e Tukey. As usuárias de TRH apresentaram média etária de 50,76 ± 3,63 anos, e as não usuárias de 48,95 ± 6,27anos (p=0,01). Relataram maior frequência de sintomas climatéricos de intensidade leve a moderada. Os aspectos sociais apresentaram escore abaixo de 50 para os dois grupos. Houve diferenças entre os grupos em relação aos componentes do SF-36 e MRS para estado geral de saúde, capacidade funcional, menor capacidade, depressão, insônia e fenômenos vasomotores.

The experience of menopause is increasingly present, and demand strategies to improve the quality of life of women during this period. This research aimed to evaluate the quality of life for women in the climacteric phase, with or without the use of hormone replacement therapy (HRT). This is a longitudinal epidemiological study of a sample of 99 women per group. It was evaluated the sociodemographic, clinical and behavioral characteristics. It was used the Menopause Rating Scale (MRS) and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). For data analysis, it was used the Student t test, chi-square and Tukey. HRT users had an average age of 50.76 ± 3.63 years, and nonusers of 48.95 ± 6,27anos (p = 0.01). It was identified a higher frequency of moderate climacteric symptoms of mild intensity. The social aspects evidenced scores below 50 for the two groups. There were differences between groups with respect to the components of the SF-36 and MRS to general health, functional capacity, lower capacity, depression, insomnia and vasomotor phenomena.

La experiencia de la menopausia es cada vez más presente, demandando estrategias para mejorar la calidad de vida de las mujeres durante este periodo. Esa investigación tuvo como objetivo evaluar la calidad de vida de las mujeres en la fase climatérica, con o sin el uso de la terapia de reemplazo hormonal (TRH). Trata-se dé un estudio epidemiológico longitudinal, con una muestra de 99 mujeres por grupo. Fueran evaluadas las características sociodemográficas, clínicas y de comportamiento. Fueran aplicados a la muestra el Menopause Rating Scale (MRS) e el Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Utilizaran-se los testes t de Student, Qui-quadrado e Tukey. Las usuarias de TRH tenían una edad media de 50,76 ± 3,63 años, y las no usuarias de 48,95 ± 6,27anos (p = 0,01). Fue reportada una mayor frecuencia de síntomas climatéricos intensidad leve o moderada. Los aspectos sociales tuvieran puntuaciones por debajo de 50 para los dos grupos. Hubo diferencias entre los grupos con respecto a los componentes del SF-36 y el MRS para la salud en general, la capacidad funcional, la capacidad más baja, la depresión, el insomnio y los fenómenos vasomotores.

Qualidade de vida em mulheres no climatério atendidas na atenção básica de Promissão-SP / Quality of life in climacterium women answered in primary care of Promissão/SP

A atenção integral à saúde da mulher pressupõe assistência em todas as fases de sua vida. O climatério, por compreender um período relativamente longo da vida da mulher, deve merecer atenção crescente da sociedade, pois a expectativa de vida após a menopausa é atualmente equivalente ao período de vida reprodutiva. A presente pesquisa objetivou avaliar a qualidade de vida das mulheres do município de Promissão/SP que estão passando por essa fase, com ou sem uso da terapia de reposição hormonal. Tratou-se de um estudo epidemiológico longitudinal, com amostra de 99 mulheres para cada grupo. Avaliaram-se as características sociodemográficas, clínicas e comportamentais. Aplicou-se Menopause Rating Scale (MRS) para avaliar a intensidade dos sintomas climatéricos, e o questionário Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) para avaliação da qualidade de vida. Na análise dos dados utilizaram-se os testes t de Student, Qui-quadrado e Tukey. As usuárias de TRH apresentaram média etária de 50,76 ± 3,63 anos e as não usuárias de 48,95 ± 6,27anos (p=0,01). Houve diferença estatisticamente significativa em relação ao estado marital (p=<0,001). As usuárias relataram maior frequência de sintomas climatéricos de intensidade leve a moderada. Dos oito domínios de qualidade de vida avaliados, apenas aspectos sociais apresentou escore abaixo de 50 para os dois grupos. Destaca-se o domínio dor com escores por volta de 60. Fenômenos vasomotores com escores também acima de 50 para o MRS foram evidenciados. Houve diferenças entre os grupos em relação aos componentes do SF-36 e MRS para estado geral de saúde, capacidade funcional, menor capacidade, depressão, insônia e fenômenos vasomotores...

The comprehensive care to women’s health requires assistance in all phases of his life. The climacteric, it comprises a relatively long period of woman’s life, deserves increased attention from society because life expectancy after menopause is currently equivalent to the period of reproductive life. This study aimed to evaluate the quality of life of women in the municipality of Promissão/SP who are going through this phase with or without use of hormone replacement therapy (HRT). This was a longitudinal epidemiological study with a sample of 99 women in each group. We evaluated the sociodemographic, clinical and behavioral. Applied Menopause Rating Scale (MRS) to assess the intensity of climacteric symptoms and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) to assess quality of life. In the data analysis used the Student t test, chi-square and Tukey. HRT users had a mean age of 50.76 ± 3.63 years and nonusers of 48.95 ± 6.27 years (p = 0.01). There was no statistically significant difference in marital status (p = <0.001). Users reported a higher frequency of climacteric symptoms of mild to moderate intensity. Of the eight domains of quality of life assessed only social scored below 50 for the two groups. It stands out with the pain domain scores around 60. Vasomotor phenomena also with scores above 50 were shown to MRS. There were differences between the groups in relation to the components of the SF-36 and MRS to general health, functional capacity, lower capacity, depression, insomnia and vasomotor phenomena...

Prevalência e características do tabagismo na população universitária da região de Lins-SP / Prevalence and smoking characteristics in the university population of the region of Lins-SP / Predominio y características del tabaquismo en la población universitaria de la región de Lins-SP

O estudo objetivou conhecer a prevalência do tabagismo e descrever o perfil e hábitos tabágicos entre universitários de Lins-SP. Uma amostra de 368 alunos respondeu a um questionário com perguntas dirigidas a fumantes, ex-fumantes e não fumantes. A prevalência de tabagismo foi de 11,7%; 85,3% dos alunos não eram fumantes e 4,0% foram classificados como ex-fumantes. Do total de alunos entrevistados, 54,1% eram mulheres. Foi observado consumo médio de 5,1 ± 5,4 cigarros por dia, sendo que todos os universitários tabagistas utilizavam o cigarro industrializado. Este índice de prevalência assemelha-se aos de outros Centros Universitários e demanda políticas de controle do tabagismo nos meios universitários.

The study aimed to know the prevalence of smoking and to describe the profile and smoking habits of undergraduate students of Lins-SP. A sample of 368 undergraduate students answered a questionnaire with questions directed at smokers, ex-smokers and nonsmokers The prevalence of smoking was of 11,7%; about 85,3% of the students were nonsmokers and 4,0% were classified as ex-smokers. Of the students interviewed, 54,1% were women. It was noted that the average use was from 5,1 to 5,4 cigarettes per day, and that the students used industrialized cigarettes. This index of prevalence correlates to the ones of others University Centers and demands politics of smoking control among the university environment.

El estudio tuvo como objetivo conocer la prevalencia del tabaquismo y describir el perfil y hábitos de tabaquismo entre estudiantes universitarios de Lins-SP. Una muestra de 368 estudiantes respondieron a un cuestionario con preguntas dirigidas a fumadores, ex fumadores y no fumadores. La prevalencia de tabaquismo fue de 11,7%; 85,3% de los estudiantes eran no fumadores y 4,0% fueron clasificados como ex fumadores. Entre los encuestados, el 54,1% eran mujeres. Fue observado un consumo medio de 5,1 ± 5,4 cigarrillos por día, y todos los estudiantes fumadores utilizaban cigarrillos comerciales. Esta tasa de prevalencia es similar a otros centros universitarios y demanda políticas de control del tabaco en los círculos universitarios.