Qualitative Exploration of the Visual Function Impairments and Health-Related Quality of Life Impacts of Amblyopia in Adult and Pediatric Populations.

INTRODUCTION: Amblyopia is a reduction in vision in one or both eyes due to impaired development of the visual pathway. This study explored the experience of amblyopia and treatment from the patient, caregiver, and clinician perspectives. METHODS: A targeted literature review, including a review of social media listening (SML) studies, was conducted. Next, qualitative interviews were conducted with amblyopia patients, caregivers of children with amblyopia, and ophthalmologists with experience treating patients with amblyopia. The findings informed the development of a disease model. Amblyopia clinical experts provided input at key stages. RESULTS: Twelve data sources were reviewed, including qualitative studies in the literature and SML studies. Overall, 133 patients/caregivers were interviewed (23 adults, 16 adolescents, 47 child-caregiver dyads), plus 10 ophthalmologists from the United States, France, and Germany. Reduced visual acuity, impaired depth perception, impaired peripheral vision, and double vision were the most frequently reported symptoms. Amblyopia impacted daily activities (reading, using digital devices), the ability to move around, school/work (productivity, seeing the board in class), emotional well-being (frustration, sadness), and social functioning (difficulty socializing). Treatments, including patching and corrective lens, also impacted daily activities (using digital devices, sports/leisure), mobility (bumping into things), and work/school (tasks taking longer) as well as emotional well-being (embarrassment), and social functioning (bullying/stigma). CONCLUSION: The findings contribute valuable insights into the adult and pediatric experience of amblyopia from a multi-stakeholder perspective. The findings were used to critically assess existing clinical outcome assessments and supported the development of patient- and observer-reported outcome measures for use in amblyopia clinical trials.

Content Validity of Sjögren's Syndrome Symptom Diary and Functional Assessment of Chronic Illness Therapy-Fatigue in Patients with Sjögren's.

INTRODUCTION: Sjögren's Syndrome Symptom Diary (SSSD) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) are patient-reported outcome (PRO) instruments assessing Sjögren's symptoms. Original SSSD items have demonstrated content validity, however qualitative evidence supporting the updated 'tiredness' item and two new supplementary items is lacking. Although well established and validated in other rheumatic diseases, there is no qualitative evidence supporting content validity of FACIT-F in Sjögren's. This study addressed these evidence gaps to support use of SSSD and FACIT-F as clinical trial endpoints, in clinical practice and in other research settings. METHODS: Qualitative, semi-structured telephone interviews were conducted with patients with Sjögren's (n = 12) and expert Sjögren's physicians (n = 10). Patient interviews explored content validity (e.g., understanding and relevance) of the new and updated SSSD items, perceptions of item and total score meaningful change on SSSD, and understanding and relevance of FACIT-F items. Physician interviews explored opinions on various SSSD scoring approaches. RESULTS: The new and updated SSSD items and FACIT-F demonstrated good content validity. Most patients considered a two-point improvement on most SSSD items meaningful, as well as a one- or two-point total score improvement. Most physicians reported tracking changes in patient responses to individual items as the most appropriate SSSD scoring approach. CONCLUSIONS: SSSD and FACIT-F are content valid in a Sjögren's population, meeting an important criterion to support their use as clinical trial endpoints, but also their use in clinical practice and other research settings. Qualitative data exploring meaningful change will be valuable in supporting psychometrically derived responder definitions.

Sjögren's Syndrome Symptom Diary (SSSD) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) are questionnaires completed by individuals with Sjögren's to assess the severity of their symptoms. It is important to show that these questionnaires are well understood and relevant to the individuals who complete them. Therefore, interviews were conducted with individuals with Sjögren's to explore their understanding and relevance of new and updated SSSD questions. Similarly, the interviews explored whether the FACIT-F questionnaire was well understood and relevant to individuals with Sjögren's, as this has not been explored before. Interviews were also conducted with expert Sjögren's physicians to explore the best approach to scoring SSSD (e.g., calculating a total score or looking at scores on individual items). The new and updated SSSD questions and the FACIT-F questionnaire were well understood and considered relevant by most individuals with Sjögren's. This suggests these questionnaires are appropriate for use in Sjögren's clinical trials, clinical practice, and other research settings. Most individuals with Sjögren's considered an improvement of two points on individual SSSD questions to be important, as well as a one- or two-point improvement in their total SSSD score. Most physicians agreed on the best approach to scoring SSSD.

A pilot study of a new bereavement program for children: Lionheart Camp for Kids.

We assessed the acceptability and effectiveness of a new childhood bereavement service known as Lionheart Camp for Kids. Using a pre-post-follow-up design, data pertaining to 12 bereaved children (aged 5-12 years) and their primary caregivers were obtained. Results showed that caregivers reported decreases in children's peer relationship problems, improvements in parental consistency, and reductions in coercive parenting, and there was a trend toward lower self-reported grief by the children. Caregivers were highly satisfied with the program. There is a need for a wait-list or randomized controlled trial over a longer time period to determine the full benefits of the camp.

Expectations of parents on low incomes and therapists who work with parents on low incomes of the first therapy session.

BACKGROUND/AIM: Family-centred practice involves allowing families' needs to direct therapy. Parents and therapists often come from different socio-economic positions, yet little is known about how this impacts family-centred practice. This study aimed to explore expectations of care among parents on low incomes and among occupational therapists who work with these families. METHOD: Ten parents who were holders of a low-income Health Care Card and had a child on a waiting list for publicly funded occupational therapy services, and nine paediatric occupational therapists were asked about perceptions of therapy using semi-structured, in-depth interviews. Interview transcripts were analysed using a qualitative descriptive approach. RESULTS: While therapists recognised families' expectations that therapy would 'fix' their child, some of the concerns of parents such as how their child's behaviour reflected on their parenting skills went largely unrecognised. In addition, no therapists recognised parents' primary concerns about their child's physical health, their desires for a structured approach to therapy or the somewhat fatalistic approach some parents were taking to therapy. Some therapists recognised the complexities they encountered in engaging with parents from low socio-economic positions and tried to adapt their practice with some taking less of a family-centred approach and focussing on the needs of either the parent or the child while others continued to practice with a focus on the family as a whole. CONCLUSION: These findings have implications for therapists seeking to work within a framework of family-centred practice with clients from low socio-economic positions.

A randomised controlled trial of a brief online mindfulness-based intervention.

OBJECTIVES: There is growing evidence that mindfulness has positive consequences for both psychological and physical health in both clinical and non-clinical populations. The potential benefits of mindfulness underpin a range of therapeutic intervention approaches designed to increase mindfulness in both clinical and community contexts. Self-guided mindfulness-based interventions may be a way to increase access to the benefits of mindfulness. This study explored whether a brief, online, mindfulness-based intervention can increase mindfulness and reduce perceived stress and anxiety/depression symptoms within a student population. METHOD: One hundred and four students were randomly allocated to either immediately start a two-week, self-guided, online, mindfulness-based intervention or a wait-list control. Measures of mindfulness, perceived stress and anxiety/depression were administered before and after the intervention period. RESULTS: Intention to treat analysis identified significant group by time interactions for mindfulness skills, perceived stress and anxiety/depression symptoms. Participation in the intervention was associated with significant improvements in all measured domains, where no significant changes on these measures were found for the control group. CONCLUSIONS: This provides evidence in support of the feasibility and effectiveness of shorter self-guided mindfulness-based interventions. The limitations and implications of this study for clinical practice are discussed.