A systematic review of methods used to conduct decentralised clinical trials.

AIMS: To evaluate, using quantitative and qualitative approaches, published data on the design and conduct of decentralised clinical trials (DCTs). METHODS: We searched MEDLINE, EMBASE, CENTRAL, PsycINFO, ProQuest Dissertations and Theses, ClinicalTrials.gov, OpenGrey and Google Scholar for publications reporting, discussing, or evaluating decentralised clinical research methods. Reports of randomised clinical trials using decentralised methods were included in a focused quantitative analysis with a primary outcome of number of randomised participants. All publications discussing or evaluating DCTs were included in a wider qualitative analysis to identify advantages, disadvantages, facilitators, barriers and stakeholder opinions of decentralised clinical trials. Quantitative data were summarised using descriptive statistics, and qualitative data analysed using a thematic approach. RESULTS: Initial searches identified 19 704 articles. After removal of duplicates, 18 553 were screened, resulting in 237 eligible for full-text assessment. Forty-five trials were included in the quantitative analysis; 117 documents were included in the qualitative analysis. Trials were widely heterogeneous in design and reporting, precluding meta-analysis of the effect of DCT methods on the primary recruitment outcome. Qualitative analysis formulated 4 broad themes: value, burden, safety and equity. Participant and stakeholder experiences of DCTs were incompletely represented. CONCLUSION: DCTs are developing rapidly. However, there is insufficient evidence to confirm which methods are most effective in trial recruitment, retention, or overall cost. The identified advantages, disadvantages, facilitators and barriers should inform the development of DCT methods. We recommend further research on how DCTs are experienced and perceived by participants and stakeholders to maximise potential benefits.

An open repository of real-time COVID-19 indicators.

The COVID-19 pandemic presented enormous data challenges in the United States. Policy makers, epidemiological modelers, and health researchers all require up-to-date data on the pandemic and relevant public behavior, ideally at fine spatial and temporal resolution. The COVIDcast API is our attempt to fill this need: Operational since April 2020, it provides open access to both traditional public health surveillance signals (cases, deaths, and hospitalizations) and many auxiliary indicators of COVID-19 activity, such as signals extracted from deidentified medical claims data, massive online surveys, cell phone mobility data, and internet search trends. These are available at a fine geographic resolution (mostly at the county level) and are updated daily. The COVIDcast API also tracks all revisions to historical data, allowing modelers to account for the frequent revisions and backfill that are common for many public health data sources. All of the data are available in a common format through the API and accompanying R and Python software packages. This paper describes the data sources and signals, and provides examples demonstrating that the auxiliary signals in the COVIDcast API present information relevant to tracking COVID activity, augmenting traditional public health reporting and empowering research and decision-making.

Cognitive behavioural therapy (CBT) for anxiety in people with dementia: study protocol for a randomised controlled trial.

BACKGROUND: Many people with dementia experience anxiety, which can lead to decreased independence, relationship difficulties and increased admittance to care homes. Anxiety is often treated with antipsychotic medication, which has limited efficacy and serious side effects. Cognitive behavioural therapy (CBT) is widely used to treat anxiety in a range of populations, yet no RCTs on CBT for anxiety in dementia exist. This study aims to develop a CBT for anxiety in dementia manual and to determine its feasibility in a pilot RCT. METHODS/DESIGN: Phase I involves the development of a CBT for anxiety in dementia manual, through a process of (1) focus groups, (2) comprehensive literature reviews, (3) expert consultation, (4) a consensus conference and (5) field testing. Phase II involves the evaluation of the manual with 50 participants with mild to moderate dementia and anxiety (and their carers) in a pilot, two-armed RCT. Participants will receive either ten sessions of CBT or treatment as usual. Primary outcome measures are anxiety and costs. Secondary outcome measures are participant quality of life, behavioural disturbance, cognition, depression, mood and perceived relationship with the carer, and carer mood and perceived relationship with the person with dementia. Measures will be administered at baseline, 15 weeks and 6 months. Approximately 12 qualitative interviews will be used to gather service-users' perspectives on the intervention. DISCUSSION: This study aims to determine the feasibility of CBT for people with anxiety and dementia and provide data on the effect size of the intervention in order to conduct a power analysis for a definitive RCT. The manual will be revised according to qualitative and quantitative findings. Its publication will enable its availability throughout the NHS and beyond. TRIAL REGISTRATION: ISRCTN64806852.

First-time mothers' expectations of parenthood: What happens when optimistic expectations are not matched by later experiences?

Becoming a parent is a major developmental transition of adulthood. Individuals often have optimistic expectations about parenthood, yet this transition also presents a number of challenges. The authors investigated whether new parents have overly optimistic expectations about parenthood and, if they do, how this influences their adjustment to this role. The sample consisted of 71 first-time mothers who completed questionnaires during pregnancy and at 4 months postpartum. The study assessed women's expectations of caring for their infant and the influence parenthood would have on their well-being and their relationships with others. Most women's expectations were matched or exceeded by their parenting experiences. However, where experiences were negative relative to expectations, there was greater depression symptomatology and poorer relationship adjustment.

Evaluating the clinical significance of responses by psychiatric inpatients to the mental health subscales of the SF-36.

BACKGROUND: The Mental Health subscales of the Medical Outcomes Short Form Questionnaire (SF-36; [Ware, J.E., Snow, K.K., Kosinski, M., Gandek, B., 1993. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center]) are increasingly being used to evaluate treatment outcomes, but data to assess the clinical significance of changes are absent. The present study applied Jacobson and Truax's [Jacobson, N.S., Truax, P. 1991. CLINICAL SIGNIFICANCE: a statistical approach to defining meaningful change in psychotherapy research. Journal of Consulting and Clinical Psychology 59, 12-19] criteria for clinical significance to the mental health items of the SF-36. METHOD: Admission and discharge data were collated from 1830 consecutive inpatients at a psychiatric hospital, using the SF-36, the Depression Anxiety Stress Scale, the Quality of Life Enjoyment and Satisfaction Questionnaire and the clinician-rated Health of the Nation Outcome Scale. RESULTS: Appropriate improvement cut-off scores for the mental health subscales of the SF-36 are reported, and significant differences were found between outcome groups according to clinically significant improvement. LIMITATIONS: CLINICAL SIGNIFICANCE as a means of assessing outcome should be used with caution in inpatient settings, as further improvement is often expected upon discharge from the hospital. CONCLUSIONS: Assessing clinically significant improvement is an effective means of measuring treatment outcome in terms of quality of life and symptom improvement in psychiatric care.