Using a theoretically informed process evaluation alongside a trial to improve oral health for care home residents

BACKGROUND: Poor oral health is common among older adults residing in care homes impacting their diet, quality of life, self-esteem, general health and well-being. The care home setting is complex and many factors may affect the successful implementation of oral care interventions. Exploring these factors and their embedded context is key to understanding how and why interventions may or may not be successfully implemented within their intended setting. OBJECTIVES: This methodology paper describes the approach to a theoretically informed process evaluation alongside a pragmatic randomised controlled trial, so as to understand contextual factors, how the intervention was implemented and important elements that may influence the pathways to impact. MATERIALS AND METHODS: SENIOR is a pragmatic randomised controlled trial designed to improve the oral health of care home residents in the United Kingdom. The trial uses a complex intervention to promote and provide oral care for residents, including education and training for staff. RESULTS: An embedded, theoretically informed process evaluation, drawing on the PAHRIS framework and utilising a qualitative approach, will help to understand the important contextual factors within the care home that influence both the trial processes and the implementation of the intervention. CONCLUSION: Utilising an implementation framework as the basis for a theoretically informed process evaluation provides an approach that specifically focuses on the contextual factors that may influence and shape the pathways to impact a given complex intervention a priori, while also providing an understanding of how and why an intervention may be effective. This contrasts with the more common post hoc approach that only focuses on implementation after the empirical results have emerged

Context and the evidence based paradigm: The potential for participatory research and systems thinking in oral health

The implementation of research evidence to promote oral health is critical, given the intransigent and emerging challenges for policy-makers at a population level. Despite this, little attention has been paid to implementation research within the evidence-based paradigm. This is important as getting research evidence into clinical practice is not a linear path that consists of simple sequential steps. In this article, we argue that we need to consider a broader range of conceptual and methodological approaches to increase the value of information generated. This should be undertaken either in parallel with empirical and experimental designs, or in some cases, instead of. This is important if we are going to understand the complexity and contextual knowledge of the ‘system’, within which interventions are implemented. Involving key stakeholders alongside empirical and experimental designs is one helpful approach. Examples of these approaches include Patient and Public Involvement and the development of Core Outcome Sets, where the views of those that will be potentially affected by the research, are included. The use of theoretical frameworks and process evaluations alongside trials are also important, if they are fully integrated into the approach taken to address the research question. A more radical approach is using participatory designs and ‘systems thinking’. Participatory approaches include subject matter 'experts by experience’. These include patients, their families, carers, healthcare professionals, services managers, policy-makers, commissioners and researchers. Participatory approaches raise important questions about who facilitates the process, when it should happen and how the diverse actors become meaningfully engaged so that their involvement is active, democratic and on-going. We argue that the issues of control, power and language are central to this and represent a paradigmatic shift to conventional approaches. Systems thinking captures the idea that public health problems commonly involve multiple interdependent and interconnected factors, which interact with each other dynamically. This approach challenges the simplicity of the hierarchy of evidence and linear sequential logic, when it doesn’t account for context. In contrast, systems thinking accepts complexity de novo and emphasises the need to understand the whole system rather than its individual component parts. We conclude with the idea that participatory and systems thinking helps to unpack the diverse agents that are often involved in the generation and translation of evidence into clinical dental practice. It moves our conception of research away from a simple exchange between ‘knowledge producers’ and ‘knowledge users’ and raises both methodological and epistemological challenges

Molecular and Atomic Excitation Stratification in the Outflow of the Planetary Nebula M27

High resolution spectroscopy with FUSE and STIS of atomic and molecular velocity stratification in the nebular outflow of M27 challenge models for the abundance kinematics in planetary nebulae. The simple picture of a very high speed (~ 1000 km/s), high ionization, radiation driven stellar wind surrounded by a slower (~ 10 km/s) mostly molecular outflow, with low ionization and neutral atomic species residing at the wind interaction interface, is not supported... We find ...there is a fast (33 -- 65 km/s) low ionization zone, surrounding a slower (<~ 33 km/s) high ionization zone and, at the transition velocity (33 km/s), vibrationally excited H_2 is intermixed with a predominately neutral atomic medium... Far-UV continuum fluorescence of H_2 is not detected, but Lyman alpha (Lya) fluorescence is present. The diffuse nebular medium is inhospitable to molecules and dust. Maintaining the modest equilibrium abundance of H_2 (N(H_2)/N(HI) << 1) in the diffuse nebular medium requires a source of H_2, mostly likely the clumpy nebular medium. The stellar SED shows no signs of reddening (E(B-V) < 0.01), but paradoxically measurements of Ha/Hb ... indicate E(B-V) ~ 0.1. ...the apparent enhancement of Ha/Hb in the absence of dust may result from a two step process of H_2 ionization by Lyman continuum (Lyc) photons followed by dissociative recombination (H_2 + gamma -> H_2^+ + e -> H(1s) + H (nl)), which ultimately produces fluorescence of Ha and Lya. In the optically thin limit at the inferred radius of the velocity transition we find dissociation of H_2 by stellar Lyc photons is an order of magnitude more efficient than spontaneous dissociation by far-UV photons. We suggest that the importance of this H_2 destruction process in HII regions has been overlooked.Comment: In emulateapj 2 column, 28 pages total, 18 figures. Accepted for publication in the Astrophysical Journal on 5 January 2007. Abstract abridge

Alternative scenarios: harnessing mid-level providers and evidence-based practice in primary dental care in England through operational research

Background: In primary care dentistry, strategies to reconfigure the traditional boundaries of various dental professional groups by task sharing and role substitution have been encouraged in order to meet changing oral health needs. Aim: The aim of this research was to investigate the potential for skill mix use in primary dental care in England based on the undergraduate training experience in a primary care team training centre for dentists and mid-level dental providers. Methods: An operational research model and four alternative scenarios to test the potential for skill mix use in primary care in England were developed, informed by the model of care at a primary dental care training centre in the south of England, professional policy including scope of practice and contemporary evidence-based preventative practice. The model was developed in Excel and drew on published national timings and salary costs. The scenarios included the following: “No Skill Mix”, “Minimal Direct Access”, “More Prevention” and “Maximum Delegation”. The scenario outputs comprised clinical time, workforce numbers and salary costs required for state-funded primary dental care in England. Results: The operational research model suggested that 73% of clinical time in England’s state-funded primary dental care in 2011/12 was spent on tasks that may be delegated to dental care professionals (DCPs), and 45- to 54-year-old patients received the most clinical time overall. Using estimated National Health Service (NHS) clinical working patterns, the model suggested alternative NHS workforce numbers and salary costs to meet the dental demand based on each developed scenario. For scenario 1:“No Skill Mix”, the dentist-only scenario, 81% of the dentists currently registered in England would be required to participate. In scenario 2: “Minimal Direct Access”, where 70% of examinations were delegated and the primary care training centre delegation patterns for other treatments were practised, 40% of registered dentists and eight times the number of dental therapists currently registered would be required; this would save 38% of current salary costs cf. “No Skill Mix”. Scenario 3: “More Prevention”, that is, the current model with no direct access and increasing fluoride varnish from 13.1% to 50% and maintaining the same model of delegation as scenario 2 for other care, would require 57% of registered dentists and 4.7 times the number of dental therapists. It would achieve a 1% salary cost saving cf. “No Skill Mix”. Scenario 4 “Maximum Delegation” where all care within dental therapists’ jurisdiction is delegated at 100%, together with 50% of restorations and radiographs, suggested that only 30% of registered dentists would be required and 10 times the number of dental therapists registered; this scenario would achieve a 52% salary cost saving cf. “No Skill Mix”. Conclusion: Alternative scenarios based on wider expressed treatment need in national primary dental care in England, changing regulations on the scope of practice and increased evidence-based preventive practice suggest that the majority of care in primary dental practice may be delegated to dental therapists, and there is potential time and salary cost saving if the majority of diagnostic tasks and prevention are delegated. However, this would require an increase in trained DCPs, including role enhancement, as part of rebalancing the dental workforce

Is chloroquine chemoprophylaxis still effective to prevent low birth weight? Results of a study in Benin

BACKGROUND: In areas of stable transmission, malaria during pregnancy is associated with severe maternal and foetal outcomes, especially low birth weight (LBW). To prevent these complications, weekly chloroquine (CQ) chemoprophylaxis is now being replaced by intermittent preventive treatment with sulfadoxine-pyrimethamine in West Africa. The prevalence of placental malaria and its burden on LBW were assessed in Benin to evaluate the efficacy of weekly CQ chemoprophylaxis, prior to its replacement by intermittent preventive treatment. METHODS: In two maternity clinics in Ouidah, an observational study was conducted between April 2004 and April 2005. At each delivery, placental blood smears were examined for malaria infection and women were interviewed on their pregnancy history including CQ intake and dosage. CQ was measured in the urine of a sub-sample (n = 166). Multiple logistic and linear regression were used to assess factors associated with LBW and placental malaria. RESULTS: Among 1090 singleton live births, prevalence of placental malaria and LBW were 16% and 17% respectively. After adjustment, there was a non-significant association between placental malaria and LBW (adjusted OR = 1.43; P = 0.10). Multiple linear regression showed a positive association between placental malaria and decreased birth weight in primigravidae. More than 98% of the women reported regular chemoprophylaxis and CQ was detectable in 99% of urine samples. Protection from LBW was high in women reporting regular CQ prophylaxis, with a strong duration-effect relationship (test for linear trend: P < 0,001). CONCLUSION: Despite high parasite resistance and limited effect on placental malaria, a CQ chemoprophylaxis taken at adequate doses showed to be still effective in reducing LBW in Benin

ADEPT - Abnormal Doppler Enteral Prescription Trial

<p>Abstract</p> <p>Background</p> <p>Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk feeding and late milk feeding are widely used. This randomised controlled trial aims to determine whether a policy of early initiation of milk feeds is beneficial compared with late initiation. Optimising neonatal feeding for this group of babies may have long-term health implications and if either of these policies is shown to be beneficial it can be immediately adopted into clinical practice.</p> <p>Methods and Design</p> <p>Babies with gestational age below 35 weeks, and with birth weight below 10th centile for gestational age, will be randomly allocated to an "early" or "late" enteral feeding regimen, commencing milk feeds on day 2 and day 6 after birth, respectively. Feeds will be gradually increased over 9-13 days (depending on gestational age) using a schedule derived from those used in hospitals in the Eastern and South Western Regions of England, based on surveys of feeding practice. Primary outcome measures are time to establish full enteral feeding and necrotising enterocolitis; secondary outcomes include sepsis and growth. The target sample size is 400 babies. This sample size is large enough to detect a clinically meaningful difference of 3 days in time to establish full enteral feeds between the two feeding policies, with 90% power and a 5% 2-sided significance level. Initial recruitment period was 24 months, subsequently extended to 38 months.</p> <p>Discussion</p> <p>There is limited evidence from randomised controlled trials on which to base decisions regarding feeding policy in high risk preterm infants. This multicentre trial will help to guide clinical practice and may also provide pointers for future research.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN: 87351483</p