Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial.

BACKGROUND: The TANDEM multicentre, pragmatic, randomised controlled trial evaluated whether a tailored psychological intervention based on a cognitive behavioural approach for people with COPD and symptoms of anxiety and/or depression improved anxiety or depression compared with usual care (control). METHODS: People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscale scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D) were randomised 1.25:1 (242 intervention and 181 control). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured 6 months post-randomisation. Secondary outcomes at 6 and 12 months included: HADS-A and HADS-D (12 months), Beck Depression Inventory II, Beck Anxiety Inventory, St George's Respiratory Questionnaire, social engagement, the EuroQol instrument five-level version (EQ-5D-5L), smoking status, completion of pulmonary rehabilitation, and health and social care resource use. RESULTS: The intervention did not improve anxiety (HADS-A mean difference -0.60, 95% CI -1.40-0.21) or depression (HADS-D mean difference -0.66, 95% CI -1.39-0.07) at 6 months. The intervention did not improve any secondary outcomes at either time-point, nor did it influence completion of pulmonary rehabilitation or healthcare resource use. Deaths in the intervention arm (13/242; 5%) exceeded those in the control arm (3/181; 2%), but none were associated with the intervention. Health economic analysis found the intervention highly unlikely to be cost-effective. CONCLUSION: This trial has shown, beyond reasonable doubt, that this cognitive behavioural intervention delivered by trained and supervised respiratory health professionals does not improve psychological comorbidity in people with advanced COPD and depression or anxiety.

Father Involvement in Early Childhood Care: Insights From a MEL System in a Behavior Change Intervention Among Rural Indian Parents.

Introduction: Fathers' involvement in care and early initiation of cognitive development activities have a positive impact on a child's social-behavioral, cognitive-academic and emotional-psychological development. This research study, conducted in Tamil Nadu in south India (2017-19), employed a Cluster Randomized Trial to test the impact of techno-social innovations in improving the involvement of fathers in child-care on child development outcomes. Qualitative studies were used to inform the trial and provide insights into pathways of change. Objective: This paper discusses the design, implementation and results of the study through the monitoring, evaluation and learning (MEL) framework to provide an understanding of the perceptions among parents and service providers surrounding early child development, the adaptations and learnings through the intervention period, and changes that were brought about through the intervention. Methods: The study was at a Proof of Concept stage, and the primary learning objective was to keep the learning process going through the period of the study, as well as obtain evidence to inform future model development. The measurement for change process in the study occurred in three distinct yet interconnected stages. In the first stage, the program was planned, and the design was refined for both the implementation and evaluation of the project. The next stage was the actual implementation: with a learning loop during the execution of the main intervention. The third stage was intended to reflect on the adaptations and pathways to change through the project period and collate evidence for model refinement. Results and Discussion: The data collected from the formative research was used to design, develop and implement the intervention. Lessons in coordination with the government program not only brought policy visibility, access to secondary data, and enabled field research, but also provided access to a workforce with immense field knowledge and presence in the rural underserved population. In order to continuously inform the implementation process of the intervention, the feedback loops allowed for adaptions to be made at each stage. The findings provide insights for programming early childhood development interventions, especially interventions regarding improving father's involvement in child-care, and ways to leverage evidence in these interventions.

Interstitial lung disease in patients with rheumatoid arthritis: comparison with cryptogenic fibrosing alveolitis over 5 years.

OBJECTIVE: There is little information on the natural history of patients with rheumatoid arthritis (RA) and associated interstitial lung disease (ILD). Cryptogenic fibrosing alveolitis (CFA) is known to have a poor longterm prognosis, and we compared the 2 conditions through a longitudinal prospective study. METHODS: We previously compared baseline clinical, physiological, and radiological characteristics in 18 RA-ILD patients with 18 case controls with CFA. Clinical, physiological, and radiological assessment was repeated in all survivors at 5 years, and data on treatment and mortality were collected. RESULTS: The median age in each group was 77 years and 10 patients in each group were male. More patients with RA-ILD survived to 5 years (8 RA-ILD vs 2 CFA; p = 0.03), and median survival was significantly longer for patients with RA-ILD (60 mo) compared to CFA (27 mo; p