Medical Research Council Recommendations Research Articles

Optimising the treatment of chronic ischemic heart disease by training general practitioners to deliver very brief advice on physical activity (OptiCor): protocol of the systematic development and evaluation of a complex intervention

BackgroundChronic ischemic heart disease (IHD) is one of the leading causes of morbidity and mortality. Physical activity (PA) is an effective secondary preventive strategy in IHD management. The German treatment guideline recommends that general practitioners (GPs) deliver PA advice to patients. This recommendation seems inadequately implemented, often due to GP’s insufficient specific training. International guidelines recommend training GPs in how to deliver such advice effectively and efficiently. Evidence is lacking on whether such training can enhance the frequency and quality of PA advice in routine care. The OptiCor project aims to develop and evaluate a GP training in the delivery of very brief PA advice to optimise the treatment of patients with IHD in general practice.MethodsOptiCor comprises three study phases according to the Medical Research Council recommendations for developing and evaluating complex interventions.Phase 1 (needs analysis): A nationwide representative household survey will be conducted to collect data on the receipt of GP-delivered PA advice in people with IHD. Qualitative interviews and group discussions with GPs and people with IHD will help to explore, e.g., attitudes, experiences with, and barriers and facilitators of PA advice implementation or reception, respectively. Findings will inform the training development.Phase 2 (pilot): A pragmatic cluster randomised controlled trial (cRCT) on the effectiveness of the developed training on proportions of GP-delivered PA advice during routine care of IHD patients will be piloted.Phase 3 (evaluation): A full pragmatic cRCT will be conducted with patient-reported proportions of GP-delivered PA advice as primary endpoint. Collection of health economic and process-related data will facilitate a potential future broad implementation and health economic evaluation of the training.DiscussionIf the developed training successfully improves proportions and quality of GP delivered PA advice to patients with IHD, it could serve as a low-threshold and sustainable strategy for implementing PA recommendations in the secondary prevention of IHD in routine GP practice.Trial registrationWork package (WP) 1, WP5, and WP6 have been prospectively registered at German Clinical Trials Register (WP1: DRKS00031304, 19/06/2023; WP5: DRKS00034641, 10/07/2024; WP6: DRKS00034642; 10/07/2024).

Process evaluation findings from Strong Hearts, Healthy Communities 2.0: a cardiovascular disease prevention intervention for rural women

BackgroundStrong Hearts, Healthy Communities 2.0 (SHHC-2.0) was a 24-week cardiovascular disease prevention program that was effective in improving physical activity and nutrition behaviors and clinical outcomes among women in 11 rural New York, USA towns. This study evaluated the delivery of SHHC-2.0 to prepare the intervention for further dissemination.MethodsThis process evaluation was guided by the Medical Research Council recommendations and engaged program leaders and participants (i.e., women over age 40) using quantitative and qualitative methods. The quantitative evaluation included examination of enrollment and retention data, a participant survey, and a fidelity checklist completed after classes. Descriptive and comparative statistics were used to assess implementation measures: program reach, participant attendance, dose delivered, program length, perceived effectiveness, fidelity, and participant satisfaction. The qualitative evaluation included focus groups (n = 13) and interviews (n = 4) using semi-structured guides; audio was recorded and transcripts were deductively coded and analyzed using directed content analysis and iterative categorization approaches. Comparisons across towns and between intervention and waitlist control groups were explored.ResultsAverage reach within towns was 7.5% of the eligible population (range 0.7-15.7%). Average attendance was 59.8% of sessions (range 42.0-77.4%). Average dose delivered by leaders was 86.4% of curriculum components (range 73.5-95.2%). Average session length was 51.8 ± 4.8 min across 48 sessions. Leaders’ perceived effectiveness rating averaged 4.1 ± 0.3 out of 5. Fidelity to curricular components was 81.8% (range 67.4-93.2%). Participants reported being “more than satisfied” with the overall program (88.8%) and the health benefits they obtained (72.9%). Qualitative analysis revealed that participants: (1) gained new knowledge and enjoyable experiences; (2) perceived improvements in their physical activity, nutrition, and/or health; (3) continued to face some barriers to physical activity and healthy eating, with those relating to social support being reduced; and (4) rated leaders and the group structure highly, with mixed opinions on the research elements.ConclusionsSHHC-2.0 had broad reach, was largely delivered as intended, and participants expressed high levels of satisfaction with the program and its health benefits. Our findings expand on best practices for implementing cardiovascular disease prevention programs in rural communities.Clinical trials Registrationwww.clinicaltrials.gov #NCT03059472.

Development and Initial Evaluation of Web-Based Cognitive Behavioral Therapy for Insomnia in Rural Family Caregivers of People With Dementia (NiteCAPP): Mixed Methods Study.

Informal caregivers of people with dementia frequently experience chronic insomnia, contributing to stress and poor health outcomes. Rural caregivers are particularly vulnerable but have limited access to cognitive behavioral therapy for insomnia (CBT-I), a recommended frontline treatment for chronic insomnia. Web-based delivery promises to improve insomnia, particularly for rural caregivers who have limited access to traditional in-person treatments. Our team translated an efficacious 4-session standard CBT-I content protocol into digital format to create NiteCAPP. This study aimed to (1) adapt NiteCAPP for dementia caregivers to create NiteCAPP CARES, a tailored digital format with standard CBT-I content plus caregiver-focused modifications; (2) conduct usability testing and evaluate acceptability of NiteCAPP CARES' content and features; and (3) pilot-test the adapted intervention to evaluate feasibility and preliminary effects on sleep and related health outcomes. We followed Medical Research Council recommendations for evaluating complex medical interventions to explore user needs and adapt and validate content using a stepwise approach: (1) a rural dementia caregiver (n=5) and primary care provider (n=5) advisory panel gave feedback that was used to adapt NiteCAPP; (2) caregiver (n=5) and primary care provider (n=7) focus groups reviewed the newly adapted NiteCAPP CARES and provided feedback that guided further adaptations; and (3) NiteCAPP CARES was pilot-tested in caregivers (n=5) for feasibility and to establish preliminary effects. Self-report usability measures were collected following intervention. Before and after treatment, 14 daily electronic sleep diaries and questionnaires were collected to evaluate arousal, health, mood, burden, subjective cognition, and interpersonal processes. The stepped approach provided user and expert feedback on satisfaction, usefulness, and content, resulting in a new digital CBT-I tailored for rural dementia caregivers: NiteCAPP CARES. The advisory panel recommended streamlining content, eliminating jargon, and including caregiver-focused content. Focus groups gave NiteCAPP CARES high usefulness ratings (mean score 4.4, SD 0.79, scored from 1=least to 5=most favorable; score range 4.2-4.8). Multiple features were evaluated positively, including the intervention's comprehensive and engaging information, caregiver focus, good layout, easy-to-access intervention material, and easy-to-understand sleep graphs. Suggestions for improvement included the provision of day and night viewing options, collapsible text, font size options, tabbed access to videos, and a glossary of terms. Pilot-test users rated usefulness (mean score 4.3, SD 0.83; range 4.1-4.5) and satisfaction (mean score 8.4, SD 1.41, scored from 1=least to 10=most satisfied; range 7.4-9.0) highly. Preliminary effects on caregiver sleep, arousal, health, mood, burden, cognition, and interpersonal processes (all P<.05) were promising. Adaptations made to standard digital CBT-I created a feasible, tailored digital intervention for rural dementia caregivers. Important next steps include further examination of feasibility and efficacy in a randomized controlled trial with an active control condition, a multisite effectiveness trial, and eventual broad dissemination. ClinicalTrials.gov NCT04632628; https://clinicaltrials.gov/ct2/show/NCT04632628.

Implementing a tailored, co-designed goal-setting implementation package in rehabilitation services: a process evaluation

Purpose This study aims to evaluate the process of implementing an evidence-based goal-setting package into five rehabilitation services across the continuum of rehabilitation. Materials and methods This study used a mixed methods approach guided by Medical Research Council (MRC) recommendations for conducting process evaluations, the RE-AIM framework, and the Theoretical Domains Framework (TDF). This study will evaluate the reach, adoption, implementation, and maintenance of the goal-setting package over six months. Results Environmental context and resources, the clinician’s social and professional role and identity, social influences and clinician beliefs about goal-setting consequences and individuals’ capabilities were all identified as barriers or enablers throughout the implementation process. Community rehabilitation services faced challenges implementing paper-based resources, whilst inpatient rehabilitation sites faced challenges engaging nursing staff in the interdisciplinary approach to goal-setting. Social influences were an enabler in two sites that used the case conference format to facilitate setting common goals. Clinicians in all sites continued to express difficulties implementing shared decision-making with people who had cognitive impairments or were no longer progressing in their rehabilitation. Conclusions A team-based approach to implementing the goal-setting interventions centred around the case conference format appeared to be the most successful mode for implementing interdisciplinary person-centred goal-setting.

Implementation of offering choice of pulmonary rehabilitation location to people with COPD: a protocol for the process evaluation of a cluster randomised controlled trial

BackgroundPulmonary rehabilitation (PR) is a core component of management people with chronic obstructive pulmonary disease (COPD); yet, people with COPD face significant barriers to attending centre-based PR programs. The emergence of new models of PR, remotely delivered directly into people’s homes, has the potential to improve rehabilitation access and completion by providing patients with a choice of rehabilitation location (centre or home). However, offering patients a choice of rehabilitation model is not usual practice. We are undertaking a 14-site cluster randomised controlled trial to determine whether offering choice of PR location improves rehabilitation completion rates resulting in reduced all-cause unplanned hospitalisation over 12 months. The aim of this paper is to describe the protocol for the process evaluation of the HomeBase2 trial.MethodsA mixed methods process evaluation, to be undertaken in real time, has been developed in accordance with UK Medical Research Council (MRC) recommendations on process evaluation of complex interventions. This protocol describes the intended use of two theoretical frameworks (RE-AIM framework (Reach; Effectiveness; Adoption; Implementation; Maintenance) and Theoretical Domains Framework (TDF)) to synthesise findings and interpret data from a combination of qualitative (semi-structured interviews) and quantitative (questionnaires, clinical outcome data, intervention fidelity) methodologies. Data will be collected at an intervention, patient and clinician level. Qualitative and quantitative data will be used to derive context-specific potential and actual barriers and facilitators to offering patients choice of rehabilitation location. Acceptability and sustainability of the intervention will be evaluated for future scale-up.DiscussionThe process evaluation described here will appraise the clinical implementation of offering a choice of rehabilitation program location for people with COPD. It will identify and evaluate key factors for future scale-up and sustainability and scale-up of offering choice of pulmonary rehabilitation program model for people.Trial registrationClinicalTrials.gov NCT04217330 Registration date: January 3 2020.

The effectiveness and safety of mindfulness-based interventions for posttraumatic stress disorder - a systematic review and meta-analysis

Following the British Medical Research Council recommendations for pilot trials, this study aims to increase experience with a complex integrative medicine (IM) intervention in a randomized controlled design to assess the feasibility for studying this intervention in a larger trial. Specific objectives are to: 1) assess the feasibility of implementing this IM approach to improve dysfunction from tinnitus in a large clinical trial; 2) evaluate patient satisfaction with this complex intervention; and 3) obtain preliminary clinical efficacy data using the planned procedures and measures.This NIDCD-funded pilot study targets retention of 40 participants with significant tinnitus-related dysfunction, recruited from a conventional otolaryngology clinic. To maximize experience with the intervention, enrolled participants are randomized in a 3:1 ratio to IM + a commonly applied sound-based and educational therapy (SBE) or to SBE alone. The 6-month IM treatment includes the same SBE, modeled after the Veteran’s Affairs Progressive Tinnitus Management approach, as well as 3 cognitive behavioral psychotherapy sessions, an 8-week Mindfulness Based Stress Reduction course, 5 acupuncture sessions, and 9 telephonic health coaching sessions. Enrollment, retention, patient satisfaction and lessons learned by the trial team will determine the feasibility of using this complex IM intervention in a large trial. Baseline, post-treatment, and 3-months follow-up measures and trial procedures planned for the larger trial are also piloted, with change in tinnitus-dysfunction over the intervention slated to provide preliminary clinical efficacy data.This pilot protocol will inform decisions regarding the feasibility of using this complex IM intervention in a large clinical trial. The larger trial would potentially offer patients an IM treatment to amplify conventional SBE for those who are unable to habituate to tinnitus.

Integrative medicine for significant dysfunction from tinnitus: Treatment rationale and protocol for a randomized clinical pilot trial

ObjectivesFollowing the British Medical Research Council recommendations for pilot trials, this study aims to increase experience with a complex integrative medicine (IM) intervention in a randomized controlled design to assess the feasibility for studying this intervention in a larger trial. Specific objectives are to: 1) assess the feasibility of implementing this IM approach to improve dysfunction from tinnitus in a large clinical trial; 2) evaluate patient satisfaction with this complex intervention; and 3) obtain preliminary clinical efficacy data using the planned procedures and measures. Design & methodsThis NIDCD-funded pilot study targets retention of 40 participants with significant tinnitus-related dysfunction, recruited from a conventional otolaryngology clinic. To maximize experience with the intervention, enrolled participants are randomized in a 3:1 ratio to IM + a commonly applied sound-based and educational therapy (SBE) or to SBE alone. The 6-month IM treatment includes the same SBE, modeled after the Veteran’s Affairs Progressive Tinnitus Management approach, as well as 3 cognitive behavioral psychotherapy sessions, an 8-week Mindfulness Based Stress Reduction course, 5 acupuncture sessions, and 9 telephonic health coaching sessions. Enrollment, retention, patient satisfaction and lessons learned by the trial team will determine the feasibility of using this complex IM intervention in a large trial. Baseline, post-treatment, and 3-months follow-up measures and trial procedures planned for the larger trial are also piloted, with change in tinnitus-dysfunction over the intervention slated to provide preliminary clinical efficacy data. DiscussionThis pilot protocol will inform decisions regarding the feasibility of using this complex IM intervention in a large clinical trial. The larger trial would potentially offer patients an IM treatment to amplify conventional SBE for those who are unable to habituate to tinnitus.

Mobilising knowledge between practitioners and researchers to iteratively refine a complex intervention (DAFNEplus) pre-trial: protocol for a structured, collaborative working group process

BackgroundRandomised controlled trials (RCTs) of complex interventions often begin with a pilot phase to test the proposed methods and refine the intervention before it is trialled. Although the Medical Research Council (MRC) recommends regular communication between the practitioners delivering the intervention and the researchers evaluating it during the pilot phase, there is a lack of practical guidance about how to undertake this aspect of pre-trial work. This paper describes a novel structured process for collaborative working, which we developed to iteratively refine a complex intervention prior to an RCT. We also describe an in-built qualitative study to learn lessons about how this approach could be used by future study teams.MethodsThis work forms part of a broader research programme to develop and trial a complex intervention for people with type 1 diabetes, called DAFNEplus. The intervention is being piloted in three National Health Service (NHS) diabetes centres in two waves, with refinements being incrementally implemented between each wave in response to real-time, collective learning (combining practitioner experience, process evaluation data and patient and public involvement via an advisory group). A structured ‘Collaborative Working Group’ (CWG) process, comprising monthly teleconferences and four strategically timed face-to-face meetings, is being used to identify and respond systematically to emerging implementation challenges and research findings. The group involves 25 members of the study team, including the multi-disciplinary practitioners delivering the intervention, the research teams conducting the process evaluation, the study manager and Chief Investigator. An in-built qualitative study comprising documentary analysis of meeting materials, discourse analysis of meeting transcripts, reflexive note taking, and thematic analysis of focus groups and interviews with CWG members is being undertaken to explore how the CWG works and how its processes and procedures might be improved.DiscussionThe CWG process offers a potential model for collaborative working in future pre-trial pilot phases and intervention development studies that operationalises MRC guidance to progressively develop a complex intervention and foster shared ownership through genuine collaboration. The findings from the qualitative study will provide insight into how to best support collaborative working to achieve optimal intervention design.

Maternal iodine dietary supplements and neonatal thyroid stimulating hormone in Gippsland, Australia.

Pregnant women are at particular risk of iodine deficiency due to their higher iodine requirements. Iodine is known to be essential for normal growth and brain development, therefore neonatal outcomes in mildly iodine deficient areas, such as Gippsland, are a critical consideration. This study aimed to investigate whether iodine supplementation prevented iodine insufficiency as determined by neonatal thyroid stimulating hormone (TSH) screening criteria. Gippsland-based women aged >=18 years, in their third trimester of pregnancy, provided self-reported information regarding their iodine supplement use and consent to access their offspring's neonatal TSH screening data. 126 women consented to participate, with 111 women completing all components of this study. Only 18.9% of participants followed the National Health and Medical Research Council (NHMRC) recommendation of 150 μg/day iodine supplement, with 42.3% of participants not taking any supplements, or taking supplements with no iodine or insufficient iodine. The remaining women (38.7%) were taking supplements with doses of iodine much higher (200-300 μg) than the NHMRC recommended dose or were taking multiple supplements containing iodine. When correlating iodine intake to their neonates' TSH, no correlation was found. When iodine supplementation usage was categorised as below, equal to, or above NHMRC recommendations there was no significant difference in neonatal TSH. This study found that iodine supplementation appeared to prevent maternal iodine insufficiency when measured against neonatal TSH screening criteria.

Workplace delivery of a dietitian‐led cardiovascular disease and type 2 diabetes prevention programme: A qualitative study of participants’ experiences in the context of Basic Needs Theory

AbstractThe Medical Research Council recommends strong theoretical underpinning in the design and evaluation of lifestyle intervention programmes (LIPs). This qualitative study aimed to use Basic Needs Theory (BNT) as a framework to explore participants’ perspectives on a workplace dietitian‐led LIP. Specifically, experiences with LIP engagement and initiation and maintenance of behaviour change were evaluated. Fifteen semi‐structured face‐to‐face interviews were conducted with participants who had previously completed a workplace cardiovascular disease and type 2 diabetes prevention programme, which involved advice and motivational support with making dietary and lifestyle changes. Interviews were audio recorded and transcribed verbatim. To evaluate the narrative, interpretative phenomenological analyses were used with BNT as the theoretical framework. A total of 12 themes were identified in relation to the three concepts of BNT – autonomy, competence and relatedness – and organised into three domains: intervention engagement, behaviour change initiation and behaviour change maintenance. Line manager and colleague support to attend was reported to have a strong influence on intervention engagement, and the importance of dietitian and peer guidance in initiating behaviour changes was highlighted. Differences between participants who maintained behavioural changes compared to those who relapsed included autonomously seeking support (relatedness) through family, friends, healthcare professionals and commercial slimming organisations. BNT provided an insightful theoretical framework to evaluate factors that underpinned the effectiveness of a dietitian‐led cardiovascular and type 2 diabetes prevention LIP. Attendance and retention in workplace LIPs can depend on participants’ managerial and colleague support, so recruitment processes should consider targeting managers in marketing and promotional activities. Workplace LIPs may increase the likelihood of behaviour change maintenance by including methods that foster longer term participant relatedness and emotional support.

Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study

BackgroundAs pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users’ perceptions of it, in order to give a deeper understanding of its effects.MethodsA pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis.ResultsIn the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care.ConclusionsThis process evaluation found no major failures relating to implementation of the intervention. The care bundle was found to be easy to understand and deliver, and it reached a large proportion of the target population and was found to be acceptable to patients and nurses; therefore, it may be an effective way of engaging patients in their pressure ulcer prevention care and promoting evidence-based practise.

Iodine, ingesting or not?

Currently, the population use medicines that contain fluorine/chlorine and ingest bromide that is found in breads, thus they occupy the place iodine injuring the thyroid. Iodine deficiency is a major public health problem thus as medical iodophobia. This mini-review addresses the effect of iodine supplementation in the prevention and treatment of chronic diseases. In this baseline, there are six systematic reviews published in the last 6 years beyond WHO/UNICEF encourage the safe use iodine in the dosages of 200 µg/day during in pregnancy and 250 µg/day in lactating women. However, one study Australian showed that of 396 healthcare providers only 71% were aware of the National Health and Medical Research Council's recommendation for iodine supplementation, (38%) were aware of the recommended dose or and (44%) duration. Beyond of knowing therapeutic property iodine, a clinical trial showed that iodine supplementation in overweight women reduces the prevalence of hypercholesterolemia. Although there is strong evidence showed that iodine prevents and fight various diseases some doctors and gynecologists still not prescribe iodine in pregnancy and lactation by fear, ignorance or lack of knowledge. Thereby, one change of paradigm in the current medical model in relation in to iodine intake needs to be urgently done.

Knowledge and practices regarding iodine supplementation: A national survey of healthcare providers.

Little is known of healthcare providers' awareness and implementation of the National Health and Medical Research Council's recommendation regarding iodine supplementation during pre-conception, pregnancy and lactation. To assess knowledge and practices of Australian healthcare providers in relation to the National Health and Medical Research Council's iodine supplement recommendation. Obstetricians, gynaecologists, general practitioners, dietitians and midwives were recruited through their relevant professional bodies to participate in an online survey. The survey was completed by 396 healthcare providers Australia-wide. While 71% of healthcare providers' were aware of the National Health and Medical Research Council's recommendation for iodine supplementation, fewer were aware of the recommended dose (38%) or duration (44%). Seventy-three percent of healthcare providers recommended iodine supplements in pregnancy, 56% when planning pregnancy and 52% during lactation. The main reasons for not recommending iodine supplements included belief there was no need for iodine supplements due to mandatory iodine fortification of food (28%) and unawareness of the recommendation (25%). Awareness of the recommendation was positively associated with recommending iodine supplements while length of practice, time spent per consultation, age or area of practice were not associated with recommending iodine supplements. There is a need to improve healthcare providers' knowledge of and adherence to the National Health and Medical Research Council's iodine supplement recommendation. Strategies within antenatal and postnatal services, as well as public health initiatives, are required to improve the knowledge and practices of healthcare providers.

Karyotype complexity and prognosis in acute myeloid leukemia.

A complex aberrant karyotype consisting of multiple unrelated cytogenetic abnormalities is associated with poor prognosis in patients with acute myeloid leukemia (AML). The European Leukemia Net classification and the UK Medical Research Council recommendation provide prognostic categories that differ in the definition of unbalanced aberrations as well as the number of single aberrations. The aim of this study on 3526 AML patients was to redefine and validate a cutoff for karyotype complexity in AML with regard to adverse prognosis. Our study demonstrated that (1) patients with a pure hyperdiploid karyotype have an adverse risk irrespective of the number of chromosomal gains, (2) patients with translocation t(9;11)(p21∼22;q23) have an intermediate risk independent of the number of additional aberrations, (3) patients with ⩾4 abnormalities have an adverse risk per se and (4) patients with three aberrations in the absence of abnormalities of strong influence (hyperdiploid karyotype, t(9;11)(p21∼22;q23), CBF-AML, unique adverse-risk aberrations) have borderline intermediate/adverse risk with a reduced overall survival compared with patients with a normal karyotype.

DEVELOPMENT OF COMPLEX INTERVENTION IN EMERGENCY CARE OF FALLS FOR EVALUATION:IMPLEMENTATION OF THE MRC GUIDANCE

BackgroundThe Medical Research Council (MRC) guidance for the development and evaluation of complex interventions describes such an intervention as one which has several interacting components; the MRC recommends that complex interventions are developed through literature identification, modelling of processes and theory development. We describe the utilisation of this guidance to develop the SAFER 2 (Support and Assessment for Fall Emergency Referrals) study intervention—a multi-centre randomised controlled trial (RCT) looking to improve the care Ambulance Services provide to elderly patients who fall.MethodsLiterature was identified using MedLine and through applicant's previous work in this field. Two pilot studies were undertaken in two UK ambulance services; an economic evaluation was identified. A workshop, incorporating stakeholders from ambulance services, acute trusts and primary care, allowed further development and finalisation of the intervention. Specialist sub-groups were set-up to develop specific components of the interventionResultsLiterature review identified previous RCTs and a recent systematic review, highlighting the need for a comprehensive evaluation of the ability of paramedics to safely make decisions to not convey elderly patients who fall to hospital and the effect of direct referral to multi-factorial community interventions on such patients. Pilot studies reinforced the need for an intervention that improves paramedic's decision making. The workshop resulted in the amalgamation of all evidence and agreement of the final intervention by all stakeholders.The final definition of the intervention comprised of paramedic training, patient assessment tool, referral tool, process of referral, clinical support and Falls Prevention Service make-up and response.DiscussionThorough intervention development and effective implementation are vital to the success of SAFER 2 and other studies in this field. In order to produce generalisable evidence about clinical and cost effectiveness that is reproducible, the intervention needs to be clearly defined with input and agreement from study stakeholders.

Limited knowledge about folic acid and iodine nutrition in pregnant women reflected in supplementation practices

AbstractAimIn order to reduce the risk of neural tube defects (NTDs) and iodine deficiency in pregnancy, the National Health and Medical Research Council recommends that pregnant women supplement their diet with folic acid and iodine. This study aimed to identify the knowledge, attitudes and practices of pregnant women regarding intake of these nutrients in order to assess whether women are adequately exposed to this health message.MethodsOne hundred and fifty‐two conveniently sampled pregnant women residing in a regional area of New South Wales, Australia, completed a pretested questionnaire on knowledge and practices regarding nutritional supplement use during pregnancy and dietary sources of folic acid and iodine.ResultsEighty‐two per cent of women reported using supplements during their pregnancy, with the majority (67.7%) taking supplement brands containing both folic acid and iodine. Supplement use was significantly higher among women in the highest household income category (30.8 vs 69.2%; P = 0.001). Seventy‐six per cent of the participants correctly identified NTDs to be associated with inadequate intake of folic acid, whereas only 40% correctly identified health problems associated with inadequate iodine intake. Women's knowledge of dietary sources of folic acid and iodine was limited.ConclusionsA third of the pregnant women surveyed were not adhering to clinical recommendations for supplement use during pregnancy, and many had knowledge deficits with regard to the need for an adequate dietary intake of folic acid and iodine from both food and supplements during pregnancy.

Folic acid and iodine supplementation during pregnancy: how much do pharmacists know and which products are readily available?

Background To reduce risk of neural tube defects and iodine deficiency in pregnancy, pharmacists are well placed to provide information about folic acid and iodine supplementation during pregnancy. Little research has been conducted regarding pharmacists’ knowledge about nutrient supplementation. Aims To assess pharmacists’ knowledge about folic acid and iodine supplementation during pregnancy and to conduct an audit of pregnancy supplements available online. Methods A cross-sectional survey of community pharmacists working in regional NSW and an audit of pregnancy supplements available from Australian-based online pharmacies were conducted. Results All of the 41 community pharmacists surveyed had a good understanding about the need for folic acid during pregnancy, as compared to 73% in the case of iodine. In contrast to a high level of knowledge about the National Health and Medical Research Council recommendation of folic acid 400 micrograms/day in the first trimester, 73% of pharmacists did not know the National Health and Medical Research Council recommended dosage of 150 micrograms/day for iodine for the duration of pregnancy. In many cases, pharmacists’ knowledge about the mandatory fortification program and dietary sources of both folic acid and iodine was also limited. Elevit, Blackmores and Megafol are pregnancy supplement brands most commonly recommended by pharmacists and also available for purchase online. Conclusion Additional education of pharmacists about iodine supplementation for pregnancy, the mandatory fortification program and good dietary sources of both folic acid and iodine would help to ensure that they are providing up-to-date evidence-based nutritional advice for pregnancy.

Health knowledge and iodine intake in pregnancy

Pregnant women have much higher iodine requirements as compared to all other population groups. The National Health and Medical Research Council (NHMRC) recommends pregnant women take a daily iodine supplement of 150μg to meet their high iodine requirements. To investigate iodine supplement use and health knowledge among pregnant women. A cross-sectional sample of 200 pregnant women aged 18years or older, in their third trimester based in Gippsland (Victoria, Australia) undertook a self-administered questionnaire from August 2011-May 2012. The women were recruited from antenatal classes and clinics from all birthing hospitals across Gippsland. Data were analysed using descriptive statistics and logistic regression. A total of 46% of participants did not follow the NHMRC recommendation of 150μg/day iodine supplement. The participants lacked knowledge about iodine and the need for supplementation. Only 18.5% of pregnant women believed they needed an iodine supplement. The majority of participants (83.5%) indicated their medical practitioners were the main source of health information, yet only 34.5% indicated being made aware of the importance of increasing iodine intake during pregnancy by their medical practitioner. The predictors of iodine supplementation are general supplementation use and knowledge of the importance of iodine. Despite NHMRC guidelines for iodine supplementation during pregnancy, many women were not taking a sufficient iodine supplement. Pregnant women may be inclined to take an iodine supplement if they had greater knowledge of their increased iodine needs during pregnancy. Medical practitioners are best placed to provide this information to pregnant women.

Development of clinical guidelines for the prescription of a seated wheelchair or mobility scooter for people with traumatic brain injury or spinal cord injury

Providing a wheelchair or scooter is a complex therapy intervention aimed at enhancing the person's functioning. The research and experience has shown that a wheelchair which is poorly matched to the individual, adversely affects potential activities and participation, lifestyle goals, health status and can be costly. The development of an evidence-based clinical guideline will provide a synthesis of the evidence and recommendations for best practice. The guidelines were developed using a rigorous methodology of systematic search for primary studies, critical appraisal and synthesis of the evidence using an adaptation of the National Health and Medical Research Council recommendation grades in conjunction with a multidisciplinary working party. Seventy-six recommendations were developed from 44 clinical questions related to goals, assessment and review, capacity and performance, upper limb capacity and injury risk, wheelchair features, propulsion, training, transport and maintenance. Resources were developed to support the use of the guidelines. Only examples of recommendations are provided here. The complete guidelines and technical report should be downloaded from http://www.lifetimecare.nsw.gov.au/Brain_Injury.aspx. The guidelines provide appraisal and synthesis of the literature and recommendations for best practice on the prescription of a wheelchair or scooter for adults with spinal cord injury and/or traumatic brain injury. The guidelines are intended to reduce the potential for poor wheelchair prescription, inform and guide practice to enhance outcomes. Through judicious application of the available research, these guidelines provide best practice recommendations for prescribing the most appropriate wheelchair for a person with a traumatic brain injury/spinal cord injury.

Are the national orthopaedic thromboprophylaxis guidelines appropriate?

To identify enablers and barriers to thromboprophylaxis prescribing following hip and knee arthroplasty, from the perspective of orthopaedic surgeons. An invitation to participate in an online survey was distributed electronically to Arthroplasty Society of Australia members (n = 103). The survey collected demographic details, thromboprophylaxis attitudes and clinical practice of the orthopaedic surgeons, and explored their familiarity with contemporary national and international guidelines. Twenty-five surgeons (24%) completed the survey, all male with a median of 20 years of practice as orthopaedic surgeons (range: 8-27 years). Most surgeons (92%) practised predominantly in the private sector, and conducted both hip and knee arthroplasties each month. While all surgeons prescribed chemoprophylaxis following arthroplasty, most surgeons (64%) were uncertain to what extent it would prevent fatal pulmonary embolism (PE). The pharmacological agents of choice were low molecular weight heparin (48%) and aspirin (44%). One-third of surgeons were not familiar with the National Health and Medical Research Council recommendations for thromboprophylaxis in hip and knee arthroplasty patients. After reviewing a summary of the recommendations, most surgeons (80%) indicated they were inappropriate, commonly citing that they were grounded on an insufficient evidence base and should include aspirin as a sole chemoprophylaxis option. There are clearly strong barriers to the translation of current thromboprophylaxis guidelines into practice. Many surgeons doubt the effectiveness of chemoprophylaxis to prevent fatal PE, perceive the risk of venous thromboembolism following surgery to be low, are unfamiliar with current national guidelines or believe the guidelines are grounded on inappropriate evidence.