Self-efficacy instruments for patients with chronic diseases suffer from methodological limitations - a systematic review

BACKGROUND: Measurement of self-efficacy requires carefully developed and validated instruments. It is currently unclear whether available self-efficacy instruments for chronic diseases fulfill these requirements. Our aim was to systematically identify all existing self-efficacy scales for five major chronic diseases and to assess their development and validation process. METHODS: We conducted a systematic literature search in electronic databases (MEDLINE, PSYCHINFO, and EMBASE) to identify studies describing the development and/or validation process of self-efficacy instruments for the five chronic diseases diabetes, chronic obstructive pulmonary disease (COPD), asthma, arthritis, and heart failure. Two members of the review team independently selected articles meeting inclusion criteria. The self-efficacy instruments were evaluated in terms of their development (aim of instrument, a priori considerations, identification of items, selection of items, development of domains, answer options) and validation (test-retest reliability, internal consistency reliability, validity, responsiveness) process. RESULTS: Of 584 potentially eligible papers we included 25 (13 for diabetes, 5 for asthma, 4 for arthritis, 3 for COPD, 0 for heart failure) which covered 26 different self-efficacy instrument versions. For 8 instruments (30.8%), the authors described the aim before the scales were developed whereas for the other instruments the aim was unclear. In one study (3.8%) a priori considerations were specified. In none of the studies a systematic literature search was carried out to identify items. The item selection process was often not clearly described (38.5%). Test-retest reliability was assessed for 9 instruments (34.6%), validity using a correlational approach for 18 (69.2%), and responsiveness to change for 3 (11.5%) instruments. CONCLUSION: The development and validation process of the majority of the self-efficacy instruments had major limitations. The aim of the instruments was often not specified and for most instruments, not all measurement properties that are important to support the specific aim of the instrument (for example responsiveness for evaluative instruments) were assessed. Researchers who develop and validate self-efficacy instruments should adhere more closely to important methodological concepts for development and validation of patient-reported outcomes and report their methods more transparently. We propose a systematic five step approach for the development and validation of self-efficacy instruments

Packages of Care for Attention-Deficit Hyperactivity Disorder in Low- and Middle-Income Countries

In the sixth in a series of six articles on packages of care for mental disorders in low- and middle-income countries, Alan Flisher and colleagues discuss the treatment of attention-deficit hyperactivity disorder

A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION): Rationale and design

<p>Abstract</p> <p>Background</p> <p>The ACTION study (<it>Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant) </it>is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxetine, in children and adolescents with attention deficit hyperactivity disorder (ADHD). The primary aims are to examine the efficacy of atomoxetine for improving cognition and emotional function in ADHD and whether any improvements in these outcomes are more pronounced in participants with comorbid anxiety; and to determine if changes in these outcomes after atomoxetine are more reliable than changes in diagnostic symptoms of ADHD. This manuscript will describe the methodology and rationale for the ACTION study.</p> <p>Methods</p> <p>Children and adolescents aged 6 - 17 y with ADHD will be enrolled. Clinical interview and validated scales will be used to confirm diagnosis and screen for exclusion criteria, which include concurrent stimulant use, and comorbid psychiatric or neurological conditions other than anxiety. Three assessment sessions will be conducted over the 13-week study period: Session 1 (Baseline, pre-treatment), Session 2 (six weeks, atomoxetine or placebo), and Session 3 (13 weeks, cross-over after one-week washout period). The standardized touch-screen battery, "IntegNeuro™", will be used to assess cognitive and emotional function. The primary measure of response will be symptom ratings, while quality of life will be a secondary outcome. Logistic regression will be used to determine predictors of treatment response, while repeated measures of analysis will determine any differences in effect of atomoxetine and placebo.</p> <p>Results</p> <p>The methodology for the ACTION study has been detailed.</p> <p>Conclusions</p> <p>The ACTION study is the first controlled trial to investigate the efficacy of atomoxetine using objective cognitive and emotional function markers, and whether these objective measures predict outcomes with atomoxetine in ADHD with and without comorbid anxiety. First enrollment was in March 2008. The outcomes of this study will be a significant step towards a 'personalized medicine' (and therefore a more efficient) approach to ADHD treatment.</p> <p>Trial registration</p> <p>Australian and New Zealand Clinical Trials Registry <a href="http://www.anzctr.org.au/ANZCTRN12607000535471.aspx">ANZCTRN12607000535471</a>.</p