672 research outputs found

    Strategies to improve retention in randomised trials: a Cochrane systematic review and meta-analysis

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    Objective: To quantify the effect of strategies to improve retention in randomised trials.<p></p> Design: Systematic review and meta-analysis.<p></p> Data sources Sources searched: MEDLINE, EMBASE, PsycINFO, DARE, CENTRAL, CINAHL, C2-SPECTR, ERIC, PreMEDLINE, Cochrane Methodology Register, Current Controlled Trials metaRegister, WHO trials platform, Society for Clinical Trials (SCT) conference proceedings and a survey of all UK clinical trial research units.<p></p> Review: methods Included trials were randomised evaluations of strategies to improve retention embedded within host randomised trials. The primary outcome was retention of trial participants. Data from trials were pooled using the fixed-effect model. Subgroup analyses were used to explore the heterogeneity and to determine whether there were any differences in effect by the type of strategy.<p></p> Results: 38 retention trials were identified. Six broad types of strategies were evaluated. Strategies that increased postal questionnaire responses were: adding, that is, giving a monetary incentive (RR 1.18; 95% CI 1.09 to 1.28) and higher valued incentives (RR 1.12; 95% CI 1.04 to 1.22). Offering a monetary incentive, that is, an incentive given on receipt of a completed questionnaire, also increased electronic questionnaire response (RR 1.25; 95% CI 1.14 to 1.38). The evidence for shorter questionnaires (RR 1.04; 95% CI 1.00 to 1.08) and questionnaires relevant to the disease/condition (RR 1.07; 95% CI 1.01 to 1.14) is less clear. On the basis of the results of single trials, the following strategies appeared effective at increasing questionnaire response: recorded delivery of questionnaires (RR 2.08; 95% CI 1.11 to 3.87); a ‘package’ of postal communication strategies (RR 1.43; 95% CI 1.22 to 1.67) and an open trial design (RR 1.37; 95% CI 1.16 to 1.63). There is no good evidence that the following strategies impact on trial response/retention: adding a non-monetary incentive (RR=1.00; 95% CI 0.98 to 1.02); offering a non-monetary incentive (RR=0.99; 95% CI 0.95 to 1.03); ‘enhanced’ letters (RR=1.01; 95% CI 0.97 to 1.05); monetary incentives compared with offering prize draw entry (RR=1.04; 95% CI 0.91 to 1.19); priority postal delivery (RR=1.02; 95% CI 0.95 to 1.09); behavioural motivational strategies (RR=1.08; 95% CI 0.93 to 1.24); additional reminders to participants (RR=1.03; 95% CI 0.99 to 1.06) and questionnaire question order (RR=1.00, 0.97 to 1.02). Also based on single trials, these strategies do not appear effective: a telephone survey compared with a monetary incentive plus questionnaire (RR=1.08; 95% CI 0.94 to 1.24); offering a charity donation (RR=1.02, 95% CI 0.78 to 1.32); sending sites reminders (RR=0.96; 95% CI 0.83 to 1.11); sending questionnaires early (RR=1.10; 95% CI 0.96 to 1.26); longer and clearer questionnaires (RR=1.01, 0.95 to 1.07) and participant case management by trial assistants (RR=1.00; 95% CI 0.97 to 1.04).<p></p> Conclusions: Most of the trials evaluated questionnaire response rather than ways to improve participants return to site for follow-up. Monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Some strategies need further evaluation. Application of these results would depend on trial context and follow-up procedures.<p></p&gt

    Use of strategies to improve retention in primary care randomised trials: a qualitative study with in-depth interviews

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    Objective To explore the strategies used to improve retention in primary care randomised trials.<p></p> Design Qualitative in-depth interviews and thematic analysis.<p></p> Participants 29 UK primary care chief and principal investigators, trial managers and research nurses.<p></p> Methods In-depth face-to-face interviews.<p></p> Results Primary care researchers use incentive and communication strategies to improve retention in trials, but were unsure of their effect. Small monetary incentives were used to increase response to postal questionnaires. Non-monetary incentives were used although there was scepticism about the impact of these on retention. Nurses routinely used telephone communication to encourage participants to return for trial follow-up. Trial managers used first class post, shorter questionnaires and improved questionnaire designs with the aim of improving questionnaire response. Interviewees thought an open trial design could lead to biased results and were negative about using behavioural strategies to improve retention. There was consensus among the interviewees that effective communication and rapport with participants, participant altruism, respect for participant's time, flexibility of trial personnel and appointment schedules and trial information improve retention. Interviewees noted particular challenges with retention in mental health trials and those involving teenagers.<p></p> Conclusions The findings of this qualitative study have allowed us to reflect on research practice around retention and highlight a gap between such practice and current evidence. Interviewees describe acting from experience without evidence from the literature, which supports the use of small monetary incentives to improve the questionnaire response. No such evidence exists for non-monetary incentives or first class post, use of which may need reconsideration. An exploration of barriers and facilitators to retention in other research contexts may be justified.<p></p&gt

    Association between parental and offspring BMI: results from EPACI Portugal 2012

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    Objective: To assess the longitudinal association between parental BMI and offspring's BMI, in EPACI Portugal 2012. Design: Longitudinal study with retrospective collection of children's anthropometry data since birth. Children's anthropometric data were gathered from individual child health bulletins, and parents' anthropometrics were self-reported. Children's and parents' BMI were classified according to WHO cut-offs. Linear mixed models with random intercept and slope for age were applied to quantify the association between parental BMI and children BMI Z-score (zBMI). Setting: EPACI Portugal 2012. Participants: Representative sample from the Portuguese population (n 2230) aged from 12 to 36 months. Results: 58·9 % of the fathers and 35·6 % of the mothers were overweight (OW) or obese. Prevalence of infants who were, at least, at risk of OW increased from 17·0 % to 30·3 % since birth to 12 months. About half of the mothers with pre-pregnancy OW and obesity (OB) gained gestational weight above the recommendations. The children from mothers with gestational weight gain (GWG) below the recommendations showed a -0·15 SD lower zBMI (95 % CI -0·23, -0·06) in early life, comparing with mothers within GWG recommendations. Children of obese mothers were more likely to present a higher zBMI (0·24 SD, 95 % CI 0·13, 0·35) throughout the first months of life. Conclusions: A high prevalence of OW and OB was observed in Portuguese young adults and toddlers. Mothers' pre-pregnancy BMI and insufficient GWG had a direct effect on offspring BMI. Early effective interventions are needed in order to prevent the transgenerational transmission of OB.EPACI Portugal 2012 was funded by Nutricia Early Life Nutrition. The work of M.N. was supported by FCT – Fundação para a Ciência e a Tecnologia through the PhD Grant SFRH/BD/89293/2012. This work was supported by National Funds from FCT through project UIDB/Multi/50016/2020. Nutricia Early Life Nutrition and FCT had no role in the article elaboration, as well as in its design or analysis

    Ear wax management in primary care: what the busy GP needs to know

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    Cerumen (or earwax), a self-cleaning agent, protects the outer ear. Sometimes this does not work and wax gets impacted, blocking the ear canal. This is a major reason for primary care consultation. Hearing difficulty due to untreated wax impaction can lead to social isolation and depression.1 Yet there is little quality evidence to guide practice for such a common condition. Further, people find it difficult to access NHS earwax services. This article provides new data on symptoms and severity, and reviews management options and patient preferences

    257 Challenges in CFRD: The advantages of continuous glucose monitoring (CGM)

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    A New Biomarker to Examine the Role of Hippocampal Function in the Development of Spatial Reorientation in Children: A Review

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    Spatial navigation is an adaptive skill that involves determining the route to a particular goal or location, and then traveling that path. A major component of spatial navigation is spatial reorientation, or the ability to reestablish a sense of direction after being disoriented. The hippocampus is known to be critical for navigating, and has more recently been implicated in reorienting in adults, but relatively little is known about the development of the hippocampus in relation to these large-scale spatial abilities in children. It has been established that, compared to school-aged children, preschool children tend to perform poorly on certain spatial reorientation tasks, suggesting that their hippocampi may not be mature enough to process the demands of such a task. Currently, common techniques used to examine underlying brain activity, such as electroencephalography (EEG) and functional magnetic resonance imaging (fMRI), are not suitable for examining hippocampal development in young children. In the present paper, we argue instead for the use of eyeblink conditioning (EBC), a relatively under-utilized, inexpensive, and safe method that is easy to implement in developing populations. In addition, EBC has a well defined neural circuitry, which includes the hippocampus, making it an ideal tool to indirectly measure hippocampal functioning in young children. In this review, we will evaluate the literature on EBC and its relation to hippocampal development, and discuss the possibility of using EBC as an objective measure of associative learning in relation to large-scale spatial skills. We support the use of EBC as a way to indirectly access hippocampal function in typical and atypical populations in order to characterize the neural substrates associated with the development of spatial reorientation abilities in early childhood. As such, EBC is a potential, simple biomarker for success in tasks that require the hippocampus, including spatial reorientation

    Combined horizontal and vertical integration of care: a goal of practice-based commissioning

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    Practice-based commissioning (PBC) in the UK is intended to improve both the vertical and horizontal integration of health care, in order to avoid escalating costs and enhance population health. Vertical integration involves patient pathways to treat named medical conditions that transcend organisational boundaries and connect communitybased generalists with largely hospital-sited specialists, whereas horizontal integration involves peerbased and cross-sectoral collaboration to improve overall health. Effective mechanisms are now needed to permit ongoing dialogue between the vertical and horizontal dimensions to ensure that medical and nonmedical care are both used to their best advantage. This paper proposes three different models for combining vertical and horizontal integration – each is a hybrid of internationally recognised ideal types of primary care organisation. Leaders of PBC should consider a range of models and apply them in ways that are relevant to the local context. General practitioners, policy makers and others whose job it is to facilitate horizontal and vertical integration must learn to lead such combined approaches to integration if the UK is to avoid the mistakes of the USA in over-medicalising health issues

    A double-blind study to determine the maximum tolerated dose of ethionamide, when administered twice-weekly to patients with pulmonary tuberculosis

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    ATI earlier report from this Centre (Tuber-culosis Chemotherapy Centre, Madras, 1964) showed that a fully supervised twice-weekly regimen of streptomycin plus high-dosage isoniazid was highly effective in the treatment of patients with newly-diagnosed bacteriologi-cally confirmed pulmonary tuberculosis. How-ever, this regimen involves intramuscular injections of streptomycin and may not always be easy to organize, especially in rural areas and in developing countries with limited resources. For this reason, it was decided to investigate the possibility of replacing strepto-mycin in the twice-weekly regimen by two oral drugs, namely ethionamide and PAS. Ethiona-mide was chosen since, apart from isoniazid and streptomycin, it was the most potent drug available at the time, and PAS was included with a view to enhance the efficacy of the regimen. Finally, it was decided that the patients should be given an intensive phase of daily treatment with streptomycin, PAS and isoniazid for two weeks. Experiments in the guinea-pig had shown that the size of the individual dose of a drug needed to be increased as the interval between successive doses was increased (Dickinson & Mitchison, 1966). As PAS is bulky and the dosage of isoniazid in the twice-weekly regimen was already high, namely 15 mg./kg. body-weight, it was decided to explore the possibility of increasing the dosage of ethionamide to a level higher than that usually employed (0.5— 1.0 g.) in daily regimens. An investigation was therefore undertaken to determine the maximum tolerated dose of ethionamide. when administered twice-weekly together with isonia-zid plus PAS. Since the assessment of ethio-namide intolerance is largely subjective, the study was conducted ‘double-blind’ with respect to the dosage of ethionamide
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