The SUMMIT Study: Utilising a written 'Next Steps' information booklet to prepare participants for potential lung cancer screening results and follow-up.

OBJECTIVES: Low-Dose Computed Tomography (LDCT) screening for lung cancer can result in several potential outcomes of varying significance. Communication methods used in Lung Cancer Screening (LCS) programmes must, therefore, ensure that participants are prepared for the range of possible results and follow-up. Here, we assess perceptions of a written preparatory information booklet provided to participants in a large LCS cohort designed to convey this information. MATERIALS AND METHODS: All participants in the SUMMIT Study (NCT03934866) were provided with a results preparation information booklet, entitled 'The SUMMIT Study: Next Steps' at their baseline appointment which outlined potential results, their significance, and timelines for follow up. Results from the LDCT scan and Lung Health Check were subsequently sent by letter. Perceptions of this booklet were assessed among participants with indeterminate pulmonary findings when they attended a face-to-face appointment immediately before their three-month interval scan. Specifically, questions assessed the perceived usefulness of the booklet and the amount of information contained in it. RESULTS: 70.1% (n = 1,412/2,014) participants remembered receiving the booklet at their appointment. Of these participants, 72.0% (n = 1,017/1,412) found it quite or very useful and 68.0% (n = 960/1,412) reported that it contained the right amount of information. Older participants, those from the least deprived socioeconomic quintile and those of Black ethnicity were less likely to report finding the booklet either quite or very useful, or that it contained the right amount of information. Participants who remembered receiving the booklet were more likely to be satisfied with the process of results communication by letter. CONCLUSION: Providing written information that prepares participants for possible LDCT results and their significance appears to be a useful resource and a helpful adjunct to a written method of results communication for large scale LCS programmes.

The reporting of pulmonary nodule results by letter in a lung cancer screening setting.

OBJECTIVES: Pulmonary nodules are commonly found in Lung Cancer Screening (LCS), with results typically communicated by face-to-face or telephone consultation. Providing LCS on a population basis requires resource efficient and scalabe communication methods. Written communication provides one such method. Here, we assess participant satisfaction with this approach in a LCS setting and investigate characteristics associated with dissatisfaction. MATERIALS AND METHODS: The SUMMIT Study is a prospective observational cohort study which aims to assess the implementation of Low-Dose Computed Tomography (LDCT) scanning for LCS in a high-risk population and validate a multi-cancer early detection blood test (NCT03934866). Participants with indeterminate pulmonary nodules requiring a three-month interval LDCT were informed of their result by postal letter and given a face-to-face appointment with a study practitioner at their interval LDCT appointment. At this appointment, having previously received their results letter, participants were verbally asked questions to assess their satisfaction with, and preferences for, methods of results communication. RESULTS: 1,900 participants were included in the analysis. 82.8% (n = 1573) were satisfied with receiving their results by letter, with 2.9% (n = 55) reporting dissatisfaction. 86.3% (n = 1640) stated it was their preferred communication method and 77.3% (n = 1469) reported that their letter contained the right amount of information. Participants from less deprived socioeconomic quintiles were more likely to report that the letter contained insufficient information and individuals aged ≥ 70 years were less likely to do so. Although 13.7% (n = 261) participants had discussed their results with their General Practitioner (GP) prior to the study visit, 83.9% (n = 219) of these participants were satisfied with receiving results by letter, with the same proportion preferring this communication method. CONCLUSION: We report high participant satisfaction with the reporting of pulmonary nodule results by letter in a LCS setting. We believe this provides a feasible route forward for large-scale screening programmes.

"Doing Things Together Is What It's About": An Interpretative Phenomenological Analysis of the Experience of Group Therapeutic Songwriting From the Perspectives of People With Dementia and Their Family Caregivers.

BACKGROUND: The wellbeing of people living with dementia and their family caregivers may be impacted by stigma, changing roles, and limited access to meaningful opportunities as a dyad. Group therapeutic songwriting (TSW) and qualitative interviews have been utilized in music therapy research to promote the voices of people with dementia and family caregivers participating in separate songwriting groups but not together as dyads. PROCEDURES: This study aimed to explore how ten people with dementia/family caregiver dyads experienced a 6-week group TSW program. Dyads participated in homogenous TSW groups involving 2-4 dyads who were either living together in the community (2 spousal groups) or living separately because the person with dementia resided in a care home (1 family group, 1 spousal group). The TSW program, informed by personhood, couplehood, family centered and group process frameworks, involved creating original lyrics through song parody and song collage. Qualified Music Therapists facilitated sessions and interviewed each dyad separately. Interviews were analyzed using interpretative phenomenological analysis. FINDINGS: Five recurrent group themes were developed, indicating group TSW: (1) was a positive shared experience, benefiting both members of the dyad and motivating further engagement with music; (2) stimulated mental processes and reignited participants' interests and skills; (3) provided meaningful opportunities for reflection and connection with memories and life experiences; and (4) prompted interaction and collaboration, leading to social connections, empathic relationships and experiences of inclusion. Participants also highlighted how: (5) the facilitated process supported engagement, highlighting abilities and challenging doubts. CONCLUSION: Dyads identified group TSW as an opportunity to recognize strengths, voice ideas and opinions, share meaningful experiences, and do "more with music." Participants valued TSW as a new, creative and stimulating experience that enabled connection with self and others and led to feelings of pride and achievement. Our findings further recognize how therapeutic intention and approach were reflected in participants' engagement and responses regardless of dementia stage and type, dyad relationship, or musical background. This research may broaden perspectives and expand understanding about how people with dementia and their family caregivers access and engage in music therapy.

Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team.

BACKGROUND: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. This paper describes process and resource assessment during recruitment, collection of outcome measures and intervention delivery, and presents learnings and considerations for conducting trials in RACFs with people living with dementia. METHODS: Data were collected across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as reasons for participant non-attendance at the interventions. RESULTS: Time between contacting next of kin and receiving formal consent often exceeded 45 days. The ratio of time between direct and indirect research activity was approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. CONCLUSIONS: Research planning should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. TRIAL REGISTRATION AUSTRALIAN AND NEW ZEALAND CLINICAL TRIAL REGISTRY ANZCTR12618000156280 1/02/2018 HTTP//ANZCTRORGAU/TRIAL/REGISTRATION/TRIALREVIEWASPX?ACTRN=12618000156280: A.

Prevalence of Advanced Liver Fibrosis in Patients With Severe Psoriasis.

IMPORTANCE: Advanced liver fibrosis is a precursor to cirrhosis, a leading cause of mortality. People with severe psoriasis are at risk for liver disease, but our understanding of advanced fibrosis in individuals with psoriasis is limited. OBJECTIVES: To describe the prevalence of and evaluate the clinical factors associated with advanced liver fibrosis in people with severe psoriasis. DESIGN, SETTING, AND PARTICIPANTS: The Co-morbidities in Severe Psoriasis study, a prospective observational cohort study in a large center serving London and Southeast England, was conducted from October 18, 2012, to April 2, 2015; 400 adults with severe psoriasis (Psoriasis Area Severity Index score, ≥10) were recruited from outpatient clinics. Statistical analysis was conducted from October 2, 2016, to March 3, 2017. MAIN OUTCOMES AND MEASURES: The primary outcome was a diagnosis of advanced liver fibrosis determined by transient elastography, a noninvasive criterion standard test. Clinical factors evaluated included psoriasis-specific and metabolic indices, alcohol use, and methotrexate exposure. RESULTS: Of 400 patients recruited (108 women and 289 men; mean [SD] age, 49.5 [13] years), 333 had a successful transient elastography scan and were included in final analysis. Forty-seven patients (14.1%; 95% CI, 10.4%-17.9%) had advanced liver fibrosis as diagnosed by transient elastography. The clinical factors that produced the best-fit model for advanced fibrosis were central obesity (waist circumference), insulin resistance, aspartate aminotransferase level, platelet count, psoriasis disease severity, and reduced alcohol use (R2 = 0.54). CONCLUSIONS AND RELEVANCE: Findings from this study suggest that advanced fibrosis is common in severe psoriasis. Abdominal obesity (by waist circumference) and insulin resistance were associated with the presence of advanced fibrosis. Longitudinal work to characterize the hepatic sequelae of central obesity, insulin resistance, and inflammation as well as the influence of systemic drugs (methotrexate and biologics) will inform future personalized therapeutic decision-making. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02174367.

Outcome measures of disease activity for rare autoimmune rheumatic diseases.

Systemic lupus erythematosus, scleroderma, myositis and Sjögren's syndrome are rare, complex, multi-systemic rheumatic diseases associated with significant morbidity and mortality. Thorough assessments of disease activity are required to guide clinical management and assess response to new therapies in clinical trials. This article reviews the commonly used outcome measures to assess this group of diseases and discusses the limitations of their use.

Outcome measures of disease activity in inflammatory arthritis.

The most common types of chronic inflammatory arthritis are rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. In order to assess the activity of these diseases and tailor therapy, several outcome measures have been developed. They include composite scores based on clinical findings, biochemical markers and patient questionnaires. This article discusses the most commonly used outcome measures and looks at their limitations in quantifying the complex clinical features of different types of inflammatory arthritis, focusing in particular on rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.