Content Validity of a Questionnaire Based on the Theory of Planned Behavior to Assess the Psychosocial Determinants of Insulin Adherence.

OBJECTIVES: To verify the content validity of questions of an insulin adherence questionnaire based on the Theory Planned Behavior in outpatients with type 2 diabetes mellitus. METHODS: The instrument was derived from a tool created to evaluate psychosocial determinants of adherence to oral antidiabetics medications in the Brazilian context, and was submitted for evaluation by a committee of experts and members of the target population. The item-level content validity index, the scale-level content validity index averaging calculation method, and the modified kappa coefficient were used to evaluate agreement among specialists. The comprehensibility of the instrument by members of the target population was qualitatively analyzed. RESULTS: The item-level content validity index was found to be lower than desired in 6 of the 20 items analyzed. Of these, one item was modified and 5 were excluded after the comprehensibility evaluation by members of the target population; one item from the perceived control scale was excluded. Content validation resulted in an instrument with 14 items, distributed in the domains intention (4 items), attitude (3 items), perceived norm (4 items), and perceived control (4 items) scales. CONCLUSIONS: The findings support good evidence of the content validity of the instrument for use among people with type 2 diabetes mellitus receiving insulin therapy.

Linguistic validation of the Diabetic foot ulcer scale short form (DFS-SF): a methodological approach

Objective: to presenting the linguistic validation of the Diabetic Foot Ulcer Scale Short-Form (DFS-SF) among pa-tients with ulcer diabetic foot (DFU) to Brazilian Portuguese and evaluate its content, practicability and acceptability. Methods and casuistry: a cross-sectional, methodological research, was conducted among 30 outpatients in follow--up for DF, assessed regarding QoL, sociodemographic and clinical data. International recommendations provided by the Mapi Research Trust on adaptation procedures were followed: the stages of Forward translation, Backward trans-lation and the Cognitive interview were carried out. The Content Validity Index was calculated and a pre-test were gathered to produce a pre-final version. Practicability and acceptability were also assessed. Results: the semantic, idiomatic, cultural and conceptual equivalences between the linguistic validated and the original version were obtai-ned. The DFS-SF was practical, well accepted and easy to understand. Conclusion: the linguistic validation process of the Brazilian version of the DFS-SF has been completed in accordance with internationally recommended standards. The instrument was easy to apply, to understand and presented short time for administration. (AU)

Objetivo: apresentar a validação linguística do DFS-SF entre pacientes com DFU para o português do Brasil e avaliar seu conteúdo, praticabilidade e aceitabilidade. Metodologia e casuística: foi realizada uma pesquisa metodológica de corte transversal entre 30 pacientes ambulatoriais em acompanhamento para DFU. Seguiram-se recomendações internacionais fornecidas pelo Mapi Research Trust sobre procedimentos de adaptação: tradução direta, tradução reversa e entrevista cognitiva. O Índice de Validade de Conteúdo foi calculado e um pré-teste foi coletado para produzir uma versão pré-final. A praticidade e aceitabilidade também foram avaliadas. Resultados:foram obtidas as equivalências semântica, idiomática, cultural e conceitual entre a versão linguística validada e a versão original. O DFS-SF foi prático, bem aceito e fácil de entender. Conclusão: O DFS-SF da versão brasileira foi concluído de acordo com os padrões internacionalmente recomendados, foi fácil de aplicar, entender e apresentou pouco tempo para administração. (AU)

Action and coping plans related to the behavior of adherence to oral anti-diabetic medication / Planos de ação e de enfrentamento de obstáculos relacionados ao comportamento de adesão aos antidiabéticos orais

ABSTRACT: Study Design: This mixed-methods study. Objective: To describe action plans related to the behavior of adher-ence to oral antidiabetic medications produced by people with type 2 diabetes mellitus and identify the challenges and coping strategies for the establishment of this behavior. Methods: The study followed-up 44 people with type 2 diabetes mellitus who used oral antidiabetic medications from southeast Brazil. Adults were invited to build action and coping plans based on the Implementation Intention Theory.The plans were quantitative and qualitatively ana-lyzed. Results: Action plans included three major themes: (1) binding oral antidiabetic medication to time markers or the sleep/wake cycle; (2) in specific environments; (3) associated with daily life activities. The motivation for coping with the perceived barriers focused on placing the pills in visible places, asking for help from family mem-bers, establishing a routine and feeding properly. Conclusions: The most effective way to manage satisfactory oral antidiabetic medication adherence seems to be recognizing the perceived barriers by patients. The implementation of specific and individualized action and coping plans to overcome perceived barriers was the stark difference. (AU)

RESUMO: Desenho do estudo: Estudo de método misto. Objetivo: Descrever planos de ação relacionados ao comportamento de adesão aos antidiabéticos orais elaborados por pessoas com diabetes mellitus tipo 2 e identificar as barreiras percebidas e respectivas estratégias de enfrentamento para efetivação desse comportamento. Métodos: O estudo envolveu 44 pessoas com diabetes mellitus tipo 2 que utilizavam antidiabéticos orais na região sudeste do Brasil. Adultos foram convidados a construir os planos de ação e de enfrentamento de obstáculos baseados sobre a Teoria da Ativação da Intenção. Os planos foram analisados quantitativa e qualitativamente. Resultados: Os planos de ação incluíram três temas principais: (1) Associar a tomada dos antidiabéticos orais aos marcadores de tempo ou ao ciclo de sono / vigília; (2) em ambientes específicos; (3) associados às atividades de vida diária. Os planos de enfrentamento das barreiras percebidas centraram-se em colocar os comprimidos em locais visíveis, pedir ajuda aos familiares para evitar esquecimento, estabelecer rotina e alimentar-se adequadamente. Conclusões: A forma mais eficaz de manejar a tomada de antidiabéticos orais de modo satisfatório parece ser o reconhecimento das barreiras percebidas pela própria pessoa. A implementação de ações específicas e individualizadas bem como de planos de enfrentamento para superar as barreiras percebidas foi o diferencial neste estudo. (AU)

Treatment Satisfaction Questionnaire for Medication (TSQM version 1.4): Ceiling and Floor Effects, Reliability, and Known-Group Validity in Brazilian Outpatients With Hypertension.

OBJECTIVES: Evaluate the acceptability, ceiling and floor effects, reliability, and known-group validity of the Brazilian version of the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 in patients with hypertension. METHODS: The sample consisted of 300 hypertensive patients undergoing treatment in an outpatient department. The acceptability was evaluated from the items not answered in the TSQM. The reliability of the TSQM was estimated through Cronbach's alpha. Known-group validity tested whether the TSQM discriminates satisfaction between different stages of hypertension, diagnoses of left ventricular hypertrophy, medication adherence, and occurrence of side effects. RESULTS: The TSQM had high acceptability (99% of participants answered all items). A substantial ceiling effect was found in the side effect (89%) and global satisfaction (29%) subscales. Reliability evaluated with Cronbach's alpha showed values >0.76 in all subscales. Known-group validity was supported with a statistically significant difference in patient satisfaction effectiveness between the hypertension groups and those without left ventricular hypertrophy. Regarding medication adherence, the TSQM was able to discriminate satisfaction in the side effect and global satisfaction subscales. A significantly higher satisfaction was found in all subscales of the TSQM in those patients without side effects. CONCLUSIONS: The TSQM is a reliable and valid questionnaire to be used in Brazilians with hypertension.

Measurement properties and factor analysis of the Diabetic Foot Ulcer Scale-short form (DFS-SF).

The purpose of this paper is to provide measurement properties evaluation and factor analysis of the Brazilian version of the diabetic foot ulcer scale-short form (DFS-SF). This methodological study evaluated the measurement properties of the DFS-SF by ceiling and floor effect reliability, responsiveness, and structural construct validity. The study included 290 people with diabetic foot under regular follow-up in a specialised outpatient clinic in inland São Paulo. Reliability was assessed by internal consistency using Cronbach's alpha and composite reliability. Ceiling and floor effects were assessed by the percentage of participants who scored the 15% worst (floor) and 15% best (ceiling) possible scale results. Validity was tested by correlating the instrument values with the domains of the Brazilian version of the Short Form Health Survey (SF-36). Responsiveness (n = 34) was accessed through the wound area obtained by photography and evaluated by the Image J Features program and the DFS-SF score at two moments, with a 4-week interval between them. The instrument had good evidence of reliability, shown by adequate internal consistency (Cronbach's alpha in domains >0.70) and compound reliability (0.84 > CC > 0.92); and of convergent validity, by significant positive correlations of moderate to strong magnitude with SF-36. Structural construct validity was examined by applying the DFS-SF confirmatory factor analysis, which indicated that the Brazilian version of the instrument is properly fitted to the original dimensional structure. The ceiling and floor effect analysis showed no ceiling or floor effects. Responsiveness was observed in the wound area, but not in the DFS-SF scores in the times. The Brazilian version of the DFS-SF presented evidence of validity and reliability, suggesting that this instrument is a valid tool for assessing the quality of life of people with diabetic foot in the Brazilian population.

Psychosocial determinants of adherence to oral antidiabetic medication among people with type 2 diabetes.

AIMS AND OBJECTIVES: The aim of this study was to identify the psychosocial determinants of adherence to oral antidiabetic medication, according to the Theory of Planned Behaviour (TPB). BACKGROUND: Appropriate adherence to oral antidiabetic medication contributes to long-term glycaemic control. However, glycaemic control is often poor in people with type 2 diabetes, mainly due to the poor adherence to oral antidiabetic agents. DESIGN: Prospective study with 2 waves of data collection, based on STROBE checklist was conducted. One hundred and fifty-seven adults with type 2 diabetes, in chronic use of oral antidiabetic agents, composed the sample. At baseline, self-reported measures of medication adherence (proportion and global evaluation of adherence) and of metabolic control (glycated haemoglobin) of diabetes were obtained. METHODS: The TPB main constructs (attitude, subjective norm and perceived control) and related beliefs were measured. Adherence and metabolic control measurements were obtained in a two-month follow-up (n = 157). RESULTS: Attitude and subjective norm, together, explained 30% of the variability in intention; their underlying belief-based measures (behavioural and normative beliefs) explained 28% of the variability in intention. In addition, intention predicted behaviour at follow-up. However, when added to the prediction model, past behaviour was the only explanatory factor of adherence behaviour. CONCLUSION: Adherence behaviour to oral antidiabetic medication was predicted by intention, which, in turn, was determined by attitude and subjective norm. In order to promote adherence to oral antidiabetic agents, health professionals should include motivational strategies as well as strategies targeted to attitude and subjective norm when designing interventions. RELEVANCE TO CLINICAL PRACTICE: The nonadherence to antidiabetic medication contributes to lack of control of diabetes and ensuing complications. The comprehension of the factors explaining the variability in medication adherence can inform the design of theory-based interventions aimed at promoting this behaviour.

A randomized controlled trial on the effect of behavioral strategies for adherence to oral antidiabetic drugs: study protocol.

BACKGROUND: Non-adherence to oral antidiabetics drugs (OADs) has been a common problem and may contribute to poor glycemic control. AIM: To describe an experimental study protocol that aims at implementing and evaluating the effect of the "action planning and coping planning" interventions on medication adherence to OADs in patients with type 2 diabetes mellitus (T2DM) in follow-up at primary care services. DESIGN: A randomized controlled trial. METHODS: Two groups (intervention and control) will be followed over a period of 105 days. The intervention group will receive a combination of the "action planning" and "coping planning" intervention strategies. There will be in-person meetings and phone calls to reinforce the intervention. The control group will receive the usual care from the health unit. CONCLUSIONS: It is hoped that this study will help health professionals to improve their approach with patients who have T2DM in relation to medication adherence.