Estimating marine reservoir effects in archaeological chronologies: Comparing ΔR calculations in Prince Rupert Harbour, British Columbia, Canada

The best method for quantifying the marine reservoir effect (MRE) using the global IntCal Marine13 calibration curve remains unresolved. Archaeologists frequently quantify uncertainty on MRE values as errors computed from single pairs of marineterrestrial radiocarbon ages, which we argue significantly overstates their accuracy and precision. Here, we review the assumptions, methods, and applications of estimating MRE via an estimate of the additional regional offset between the marine and terrestrial calibration curves (ΔR) for the Prince Rupert Harbour (PRH) region of British Columbia, Canada.We acknowledge the influence on ΔR of MRE variation as (1) a dynamic oceanographic process, (2) its variable expression in biochemical and geochemical pathways, and (3) compounding errors in sample selection, measurement, and calculation. We examine a large set of marine-terrestrial pairs (n = 63) from PRH to compare a common archaeological practice of estimating uncertainty from means that generate an uncertainty value of ±49 years with a revised, more appropriate estimate of error of ± 230 years. However, we argue that the use of multiple-pair samples estimates the PRH ΔR as 273 ± 38 years for the last 5,000 years. Calculations of error that do not consider these issues may generate more inaccurate age estimates with unjustifiable precision

Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials

BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. METHODS/DESIGN: The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. DISCUSSION: Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. TRIAL REGISTRATION: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial

Does prospective acceptability of an intervention influence refusal to participate in a randomised controlled trial? An interview study.

Background: The generalizability of findings of Randomised Controlled Trials (RCTs) is undermined by low or biased recruitment. Reasons for participant refusal are infrequently reported in published literature. Aims: To apply the Theoretical Framework of Acceptability (TFA) to: (1) explore patient-reported reasons for declining to participate in a RCT comparing a new service model (patient-initiated appointments) with standard care (appointments scheduled by clinician) for managing blepharospasm and hemifacial spasm; (2) to explore associations between decliners' perceptions of acceptability and non-participation. Method: Eligible patients (n = 242) were approached to participate in the trial. Phase 1: decliners provided a brief reason for refusal. Reasons were analysed descriptively and reviewed against TFA constructs. Phase 2: Consecutive decliners participated in short semi-structured interviews, to explore their reasons for refusal in more depth. Interviews were transcribed and analysed, with the TFA as a coding framework. Results: Eighty-seven (36%) eligible patients refused trial participation; all provided a reason. From interviews with 15 decliners (17%), four key beliefs about acceptability were identified: happy with standard care (n = 41) (49%), anticipated burden of patient-initiated service, lack of confidence in ability to engage with new service and uncertainties about effectiveness of new service. Two themes reflected non-TFA factors: trial participation a low priority and burden of completing trial documentation. Conclusion: Reasons for refusal trial participation included: (a) reasons directly associated with intervention acceptability, and (b) reasons associated with trial participation more broadly. The TFA facilitated identification of problematic aspects of the new appointment booking system which could be addressed to enhance acceptability

Successful Reach and Adoption of a workplace health promotion RCT targeting a group of high-risk workers

<p>Abstract</p> <p>Background</p> <p>Cleaners are rarely introduced to workplace health promotion programs. The study's objective was to evaluate the reach and adoption of a workplace randomized controlled trial (RCT) among cleaners in Denmark.</p> <p>Methods</p> <p>Cleaning businesses with at least 30 employees, that could offer a weekly 1-hour intervention during working hours, were invited to participate. Employees working at least 20 hours/week were invited to answer a screening questionnaire and consent to participate. Analyses determined the differences in health variables between responders and non-responders, consenters and non-consenters, participants and non-participants and between participants of the RCT's three groups: physical coordination training, cognitive-behavioural theory-based training and reference group.</p> <p>Results</p> <p>From 16 eligible workplaces, a representative sample of 50% adopted the trial. Of 758 eligible employees, 78% responded to the screening questionnaire and 49% consented to participate. Consenters and participants differed from non-consenters and non-participants by having higher BMI, more chronic diseases and poorer musculoskeletal health.</p> <p>Conclusions</p> <p>This study indicates that workplace health promotion programs directed at health risk factors among cleaners enable significant adoption and reach to a high-risk subgroup of the Danish workforce.</p> <p>Trial registration</p> <p>Trial registration ISRCTN96241850</p

Home-based health promotion for older people with mild frailty: the HomeHealth intervention development and feasibility RCT.

BACKGROUND: Mild frailty or pre-frailty is common and yet is potentially reversible. Preventing progression to worsening frailty may benefit individuals and lower health/social care costs. However, we know little about effective approaches to preventing frailty progression. OBJECTIVES: (1) To develop an evidence- and theory-based home-based health promotion intervention for older people with mild frailty. (2) To assess feasibility, costs and acceptability of (i) the intervention and (ii) a full-scale clinical effectiveness and cost-effectiveness randomised controlled trial (RCT). DESIGN: Evidence reviews, qualitative studies, intervention development and a feasibility RCT with process evaluation. INTERVENTION DEVELOPMENT: Two systematic reviews (including systematic searches of 14 databases and registries, 1990-2016 and 1980-2014), a state-of-the-art review (from inception to 2015) and policy review identified effective components for our intervention. We collected data on health priorities and potential intervention components from semistructured interviews and focus groups with older people (aged 65-94 years) (n = 44), carers (n = 12) and health/social care professionals (n = 27). These data, and our evidence reviews, fed into development of the 'HomeHealth' intervention in collaboration with older people and multidisciplinary stakeholders. 'HomeHealth' comprised 3-6 sessions with a support worker trained in behaviour change techniques, communication skills, exercise, nutrition and mood. Participants addressed self-directed independence and well-being goals, supported through education, skills training, enabling individuals to overcome barriers, providing feedback, maximising motivation and promoting habit formation. FEASIBILITY RCT: Single-blind RCT, individually randomised to 'HomeHealth' or treatment as usual (TAU). SETTING: Community settings in London and Hertfordshire, UK. PARTICIPANTS: A total of 51 community-dwelling adults aged ≥ 65 years with mild frailty. MAIN OUTCOME MEASURES: Feasibility - recruitment, retention, acceptability and intervention costs. Clinical and health economic outcome data at 6 months included functioning, frailty status, well-being, psychological distress, quality of life, capability and NHS and societal service utilisation/costs. RESULTS: We successfully recruited to target, with good 6-month retention (94%). Trial procedures were acceptable with minimal missing data. Individual randomisation was feasible. The intervention was acceptable, with good fidelity and modest delivery costs (£307 per patient). A total of 96% of participants identified at least one goal, which were mostly exercise related (73%). We found significantly better functioning (Barthel Index +1.68; p = 0.004), better grip strength (+6.48 kg; p = 0.02), reduced psychological distress (12-item General Health Questionnaire -3.92; p = 0.01) and increased capability-adjusted life-years [+0.017; 95% confidence interval (CI) 0.001 to 0.031] at 6 months in the intervention arm than the TAU arm, with no differences in other outcomes. NHS and carer support costs were variable but, overall, were lower in the intervention arm than the TAU arm. The main limitation was difficulty maintaining outcome assessor blinding. CONCLUSIONS: Evidence is lacking to inform frailty prevention service design, with no large-scale trials of multidomain interventions. From stakeholder/public perspectives, new frailty prevention services should be personalised and encompass multiple domains, particularly socialising and mobility, and can be delivered by trained non-specialists. Our multicomponent health promotion intervention was acceptable and delivered at modest cost. Our small study shows promise for improving clinical outcomes, including functioning and independence. A full-scale individually RCT is feasible. FUTURE WORK: A large, definitive RCT of the HomeHealth service is warranted. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014010370 and Current Controlled Trials ISRCTN11986672. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 73. See the NIHR Journals Library website for further project information

Collaborative case management to aid return to work after long-term sickness absence: a pilot randomised controlled trial

Background: Despite high levels of employment among working-age adults in the UK, there is still a significant minority who are off work with ill health at any one time (so-called ‘sickness absence’). Long-term sickness absence results in significant costs to the individual, to the employer and to wider society. Objective: The overall objective of the intervention was to improve employee well-being with a view to aiding return to work. To meet this aim, a collaborative case management intervention was adapted to the needs of UK employees who were entering or experiencing long-term sickness absence. Design: A pilot randomised controlled trial, using permuted block randomisation. Recruitment of patients with long-term conditions in settings such as primary care was achieved by screening of routine records, followed by mass mailing of invitations to participants. However, the proportion of patients responding to such invitations can be low, raising concerns about external validity. Recruitment in the Case Management to Enhance Occupational Support (CAMEOS) study used this method to test whether or not it would transfer to a population with long-term sickness absence in the context of occupational health (OH). Participants: Employed people on long-term sickness absence (between 4 weeks and 12 months). The pilot was run with two different collaborators: a large organisation that provided OH services for a number of clients and a non-profit community-based organisation. Intervention: Collaborative case management was delivered by specially trained case managers from the host organisations. Sessions were delivered by telephone and supported use of a self-help handbook. The comparator was usual care as provided by participants’ general practitioner (GP) or OH provider. This varied for participants according to the services available to them. Neither participants nor the research team were blind to randomisation