Objective: To determine the efficacy of a computerised decision aid in patients with atrial fibrillation making decisions on whether to take warfarin or aspirin therapy. Design: Two-armed open exploratory randomised controlled trial. Setting: Two research clinics deriving participants from general practices in Northeast England. Participants: 109 patients with atrial fibrillation aged over 60. Interventions: Computerised decision aid applied in shared decision-making clinic compared to evidencebased paper guidelines applied as direct advice. Main outcome measures: Primary outcome measure was the decision conflict scale. Secondary outcome measures included anxiety, knowledge, decision-making preference, treatment decision, use of primary and secondary care services and health outcomes. Results: Decision conflict was lower in the computerised decision aid group immediately after the clinic; mean difference 20.18 (95% CI 20.34 to 20.01). Participants in this group not already on warfarin were much less likely to start warfarin than those in the guidelines arm (4/16, 25% compared to the guidelines group 15/16, 93.8%, RR 0.27, 95% CI 0.11 to 0.63). Conclusions: Decision conflict was lower immediately following the use of a computerised decision aid in a shared decision-making consultation than immediately following direct doctor-led advice based on paper guidelines. Furthermore, participants in the computerised decision aid group were significantly much less likely to start warfarin than those in the guidelines arm. The results show that such an approach has a positive impact on decision conflict comparable to other studies of decision aids, but also reduces the uptake of a clinically effective treatment that may have important implications for health outcomes.
Self report measures of voice function are in frequent use, but have had inadequate psychometric evaluation. We aimed to perform a substantial factor analysis of two measures of voice impairment, the Voice Symptom Scale (VoiSS) and the Voice Handicap Index (VHI). Both the 30-item questionnaires were completed by 319 dysphonic voice clinic attenders (99M, 220F). Principal components analysis confirmed that both instruments reflected general voice abnormality. The VoiSS comprised three factors - impairment (15 items), emotional (8 items) and related physical symptoms (7 items) - each with a good internal consistency. Analysis of the VHI suggested that it contains only two subscales. When a three-factor solution was imposed on the data, analysis failed to support the currently advised three 10-item subscale interpretations. Instead, we found a physical (voice impairment) domain (8 items), a psychosocial domain (14 items) and a factor with 8 items related to difficulty in being heard. The VHI requires further statistical refinement to identify its subscale structure. The VoiSS was developed from 800 subjects and is psychometrically the most robust and extensively validated self report voice measure available.
This study aimed to evaluate the reliability and sensitivity to change of three commonly used acoustic parameters as measured by the Multi-Dimensional Voice Programme (MDVP); jitter, shimmer and noise-to-harmonic ratio. A total of 231 subjects' voices were recorded and analysed. The sample comprised 145 dysphonic patients who received intervention (surgery or voice therapy), 36 dysphonic patients who received no intervention, and 50 non-dysphonic (normal) subjects. All voices were recorded and analysed on two occasions (before and after treatment, or test-retest assessment) using a standard procedure. These data were analysed using standard psychometric procedures for assessing reliability and responsiveness. The acoustic analysis measures demonstrated poor to moderate reliability and effect size with respect to their sensitivity to change. Caution should be exercised in the injudicious use of computer-based acoustic analysis systems as an isolated measure of voice outcome in any clinical trial of interventions aimed at improving voice quality.
BackgroundUnderstanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants.MethodsAn iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument.ResultsWe initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: ‘not relevant at this stage’, ‘not relevant to my role’ and ‘not relevant to this intervention’ and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items.ConclusionThe process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants’ experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness.
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