General Practice and Primary Care - Research Publications

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    A critical interpretive synthesis of the most commonly used self-report measures in Australian mental health research
    Bibb, J ; Baker, FA ; McFerran, KS (SAGE PUBLICATIONS LTD, 2016-10)
    OBJECTIVE: To critically examine the self-report measures most commonly used in Australian mental health research in the last 10 years. METHOD: A critical interpretive synthesis was conducted using seven outcome measures that were identified as most popular in 43 studies from three mental health journals. RESULTS: Results suggest that the amount and type of language used in outcome measures is important in both increasing the accuracy of the data collected and fostering positive experiences of data collection for participants. CONCLUSIONS: Results indicate that many of the measures most often used in Australian mental health research may not align with the current contemporary philosophy of mental health clinical practice in Australia.
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    Stakeholder input into the implementation of a new music therapy program in a mental health service
    Bibb, J ; Castle, D ; McFerran, KS (Emerald, 2018-01-01)
    Purpose: Music therapy programs are increasingly common and necessary in mental health services. However, there is little knowledge of the key factors which influence the successful implementation of new therapeutic programs. The purpose of this paper is to explore how stakeholder input influenced the implementation and sustainability of a new music therapy program in four services within a large government funded mental health department in Melbourne, Australia. Design/methodology/approach: For a period of 12 months, two cycles of assessment, action and evaluation were conducted where data were collected through interviews with staff members, feedback from consumers and attendance in sessions. Findings: A number of influential factors were identified as important in the successful implementation and future sustainability of the music therapy program. These included: the degree of staff support received; how the program was structured and facilitated; promotion of the program within the service; evaluation of the program; and congruence with the existing therapeutic program. Research limitations/implications: Results suggest that successful implementation and future sustainability of a music therapy program is dependent on the flexibility of the program to the context and culture of the existing setting. Originality/value: This is the first study to incorporate contributions from stakeholders in the implementation of a new music therapy program in a mental health service.
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    Healthcare system responses to intimate partner violence in low and middle-income countries: evidence is growing and the challenges become clearer
    Taft, A ; Colombini, M (BIOMED CENTRAL LTD, 2017-07-12)
    The damage to health caused by intimate partner violence demands effective responses from healthcare providers and healthcare systems worldwide. To date, most evidence for the few existing, effective interventions in use comes from high-income countries. Gupta et al. provide rare evidence of a nurse-delivered intimate partner violence screening, supportive care and referral intervention from a large-scale randomised trial in Mexican public health clinics. No difference was found in the primary outcome of reduction in intimate partner violence. There were significant short-term benefits in safety planning and mental health (secondary outcomes) for women in the intervention arm, but these were not sustained.This important study highlights the challenges of primary outcome choices in such studies, and further challenges for the sustainability of healthcare systems and healthcare provider interventions. These challenges include the role of theory for sustainability and the risk that baseline measures of intimate partner violence can wash out intervention effects. We emphasise the importance of studying the processes of adaptation, integration and coordination in the context of the wider healthcare system.Please see related article: https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0880-y.
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    Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial protocol
    Mazza, D ; Black, K ; Taft, A ; Lucke, J ; McGeechan, K ; Haas, M ; McKay, H ; Peipert, JF (BMJ PUBLISHING GROUP, 2016)
    INTRODUCTION: The increased use of long-acting reversible contraceptives (LARCs), such as intrauterine devices and hormonal implants, has the potential to reduce unintended pregnancy and abortion rates. However, use of LARCs in Australia is very low, despite clinical practice guidance and statements by national and international peak bodies advocating their increased use. This protocol paper describes the Australian Contraceptive ChOice pRojet (ACCORd), a cluster randomised control trial that aims to test whether an educational intervention targeting general practitioners (GPs) and establishing a rapid referral service are a cost-effective means of increasing LARC uptake. METHODS AND ANALYSIS: The ACCORd intervention is adapted from the successful US Contraceptive CHOICE study and involves training GPs to provide 'LARC First' structured contraceptive counselling to women seeking contraception, and implementing rapid referral pathways for LARC insertion. Letters of invitation will be sent to 600 GPs in South-Eastern Melbourne. Using randomisation stratified by whether the GP inserts LARCs or not, a total of 54 groups will be allocated to the intervention (online 'LARC First' training and rapid referral pathways) or control arm (usual care). We aim to recruit 729 women from each arm. The primary outcome will be the number of LARCs inserted; secondary outcomes include the women's choice of contraceptive method and quality of life (Short Form Health Survey, SF-36). The costs and outcomes of the intervention and control will be compared in a cost-effectiveness analysis. ETHICS AND DISSEMINATION: The ACCORd study has been approved by the Monash University Human Research Ethics Committee: CF14/3990-2014002066 and CF16/188-2016000080. Any protocol modifications will be communicated to Ethics Committee and Trial Registration registry. The authors plan to disseminate trial outcomes through formal academic pathways comprising journal articles, nation and international conferences and reports, as well as using more 'popular' strategies including seminars, workshops and media engagements. TRIAL REGISTRATION NUMBER: ACTRN12615001346561.
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    Regional variations in definitions and rates of hypoglycaemia: findings from the global HAT observational study of 27 585 people with Type 1 and insulin-treated Type 2 diabetes mellitus
    Khunti, K ; Berkovic, MC ; Ludvik, B ; Moberg, E ; Lekdorf, JB ; Gydesen, H ; Pedersen-Bjergaard, U (WILEY, 2018-09)
    AIM: To determine participant knowledge and reporting of hypoglycaemia in the non-interventional Hypoglycaemia Assessment Tool (HAT) study. METHODS: HAT was conducted in 24 countries over a 6-month retrospective/4-week prospective period in 27 585 adults with Type 1 or insulin-treated Type 2 diabetes mellitus. Participants recorded whether hypoglycaemia was based on blood glucose levels, symptoms or both. RESULTS: Hypoglycaemia rates were consistently higher in the prospective compared with the retrospective period. Most respondents (96.8% Type 1 diabetes; 85.6% Type 2 diabetes) knew the American Diabetes Association/European Association for the Study of Diabetes hypoglycaemia definition, but there were regional differences in the use of blood glucose measurements and/or symptoms to define events. Confirmed symptomatic hypoglycaemia rates were highest in Northern Europe/Canada for Type 1 diabetes (63.9 events/year) and in Eastern Europe for Type 2 diabetes (19.4 events/year), and lowest in South East Asia (Type 1 diabetes: 6.0 events/year; Type 2 diabetes: 3.2 events/year). Unconfirmed symptomatic hypoglycaemia rates were highest in Eastern Europe for Type 1 diabetes (5.6 events/year) and South East Asia for Type 2 diabetes (4.7 events/year), and lowest for both in Russia (Type 1 diabetes: 2.1 events/year; Type 2 diabetes: 0.4 events/year). Participants in Latin America reported the highest rates of severe hypoglycaemia (Type 1 diabetes: 10.8 events/year; Type 2 diabetes 3.7 events/year) and severe hypoglycaemia requiring hospitalization (Type 1 diabetes: 0.56 events/year; Type 2 diabetes: 0.44 events/year). The lowest rates of severe hypoglycaemia were reported in South East Asia (Type 1 diabetes: 2.0 events/year) and Northern Europe/Canada (Type 2 diabetes: 1.3 events/year), and the lowest rates of severe hypoglycaemia requiring hospitalization were in Russia (Type 1 diabetes: 0.15 events/year; Type 2 diabetes: 0.09 events/year). The blood glucose cut-off used to define hypoglycaemia varied between regions (Type 1 diabetes: 3.1-3.6 mmol/l; Type 2 diabetes: 3.5-3.8 mmol/l). CONCLUSIONS: Under-reporting of hypoglycaemia rates in retrospective recall and regional variations in participant definitions of hypoglycaemia may contribute to the global differences in reported rates. Discrepancies between participant definitions and guidelines may highlight a need to redefine hypoglycaemia criteria. (Clinical Trials Registry No: NCT01696266).
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    Study design and protocol for a mixed methods evaluation of an intervention to reduce and break up sitting time in primary school classrooms in the UK: The CLASS PAL (Physically Active Learning) Programme
    Routen, AC ; Biddle, SJH ; Bodicoat, DH ; Cale, L ; Clemes, S ; Edwardson, CL ; Glazebrook, C ; Harrington, DM ; Khunti, K ; Pearson, N ; Salmon, J ; Sherar, LB (BMJ PUBLISHING GROUP, 2017-11)
    INTRODUCTION: Children engage in a high volume of sitting in school, particularly in the classroom. A number of strategies, such as physically active lessons (termed movement integration (MI)), have been developed to integrate physical activity into this learning environment; however, no single approach is likely to meet the needs of all pupils and teachers. This protocol outlines an implementation study of a primary school-based MI intervention: CLASS PAL (Physically Active Learning) programme. This study aims to (A) determine the degree of implementation of CLASS PAL, (B) identify processes by which teachers and schools implement CLASS PAL and (C) investigate individual (pupil and teacher) level and school-level characteristics associated with implementation of CLASS PAL. METHODS AND ANALYSIS: The intervention will provide teachers with a professional development workshop and a bespoke teaching resources website. The study will use a single group before-and-after design, strengthened by multiple interim measurements. Six state-funded primary schools will be recruited within Leicestershire, UK.Evaluation data will be collected prior to implementation and at four discrete time points during implementation: At measurement 0 (October 2016), school, teacher and pupil characteristics will be collected. At measurements 0 and 3 (June-July 2017), accelerometry, cognitive functioning, self-reported sitting and classroom engagement data will be collected. At measurements 1(December 2016-March 2017) and 3 , teacher interviews (also at measurement 4; September-October 2017) and pupil focus groups will be conducted, and at measurements 1 and 2 (April-May 2017), classroom observations. Implementation will be captured through website analytics and ongoing teacher completed logs. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Loughborough University Human Participants Ethics Sub-Committee (Reference number: R16-P115). Findings will be disseminated via practitioner and/or research journals and to relevant regional and national stakeholders through print and online media and dissemination event(s).
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    Barrett's oESophagus trial 3 (BEST3): study protocol for a randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care patients with chronic acid reflux
    Offman, J ; Muldrew, B ; O'Donovan, M ; Debiram-Beecham, I ; Pesola, F ; Kaimi, I ; Smith, SG ; Wilson, A ; Khan, Z ; Lao-Sirieix, P ; Aigret, B ; Walter, FM ; Rubin, G ; Morris, S ; Jackson, C ; Sasieni, P ; Fitzgerald, RC (BMC, 2018-08-03)
    BACKGROUND: Early detection of oesophageal cancer improves outcomes; however, the optimal strategy for identifying patients at increased risk from the pre-cancerous lesion Barrett's oesophagus (BE) is not clear. The Cytosponge, a novel non-endoscopic sponge device, combined with the biomarker Trefoil Factor 3 (TFF3) has been tested in four clinical studies. It was found to be safe, accurate and acceptable to patients. The aim of the BEST3 trial is to evaluate if the offer of a Cytosponge-TFF3 test in primary care for patients on long term acid suppressants leads to an increase in the number of patients diagnosed with BE. METHODS: The BEST3 trial is a pragmatic multi-site cluster-randomised controlled trial set in primary care in England. Approximately 120 practices will be randomised 1:1 to either the intervention arm, invitation to a Cytosponge-TFF3 test, or the control arm usual care. Inclusion criteria are men and women aged 50 or over with records of at least 6 months of prescriptions for acid-suppressants in the last year. Patients in the intervention arm will receive an invitation to have a Cytosponge-TFF3 test in their general practice. Patients with a positive TFF3 test will receive an invitation for an upper gastro-intestinal endoscopy at their local hospital-based endoscopy clinic to test for BE. The primary objective is to compare histologically confirmed BE diagnosis between the intervention and control arms to determine whether the offer of the Cytosponge-TFF3 test in primary care results in an increase in BE diagnosis within 12 months of study entry. DISCUSSION: The BEST3 trial is a well-powered pragmatic trial testing the use of the Cytosponge-TFF3 test in the same population that we envisage it being used in clinical practice. The data generated from this trial will enable NICE and other clinical bodies to decide whether this test is suitable for routine clinical use. TRIAL REGISTRATION: This trial was prospectively registered with the ISRCTN Registry on 19/01/2017, trial number ISRCTN68382401 .
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    Associations between diagnostic activity and measures of patient experience in primary care: a cross-sectional ecological study of English general practices
    Lyratzopoulos, G ; Mendonca, SC ; Gildea, C ; McPhail, S ; Peake, MD ; Rubin, G ; Singh, H ; Hamilton, W ; Walter, FM ; Roland, M ; Abel, GA (ROYAL COLL GENERAL PRACTITIONERS, 2018-01)
    BACKGROUND: Lower use of endoscopies and urgent referrals for suspected cancer has been linked to poorer outcomes for patients with cancer; it is important to examine potential predictors of variable use. AIM: To examine the associations between general practice measures of patient experience and practice use of endoscopies or urgent referrals for suspected cancer. DESIGN AND SETTING: Cross-sectional ecological analysis in English general practices. METHOD: Data were taken from the GP Patient Survey and the Cancer Services Public Health Profiles. After adjustment for practice population characteristics, practice-level associations were examined between the use of endoscopy and urgent referrals for suspected cancer, and the ability to book an appointment (used as proxy for ease of access), the ability to see a preferred doctor (used as proxy for relational continuity), and doctor/nurse communication skills. RESULTS: Taking into account practice scores for the ability to book an appointment, practices rated higher for the proxy measure of relational continuity used urgent referrals and endoscopies less often (for example, 30% lower urgent referral and 15% lower gastroscopy rates between practices in the 90th/10th centiles, respectively). In contrast, practices rated higher for doctor communication skills used urgent referrals and endoscopies more often (for example, 26% higher urgent referral and 17% higher gastroscopy rates between practices in the 90th/10th centiles, respectively). Patients with cancer in practices that were rated higher for doctor communication skills were less likely to be diagnosed as emergencies (1.7% lower between practices in the 90th than in the 10th centile). CONCLUSION: Practices where patients rated doctor communication highly were more likely to investigate and refer patients urgently but, in contrast, practices where patients could see their preferred doctor more readily were less likely to do so. This article discusses the possible implications of these findings for clinical practice.
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    Global burden of hypoglycaemia-related mortality in 109 countries, from 2000 to 2014: an analysis of death certificates
    Zaccardi, F ; Dhalwani, NN ; Webb, DR ; Davies, MJ ; Khunti, K (SPRINGER, 2018-07)
    AIMS/HYPOTHESIS: In the context of increasing prevalence of diabetes in elderly people with multimorbidity, intensive glucose control may increase the risk of severe hypoglycaemia, potentially leading to death. While rising trends of severe hypoglycaemia rates have been reported in some European, North American and Asian countries, the global burden of hypoglycaemia-related mortality is unknown. We aimed to investigate global differences and trends of hypoglycaemia-related mortality. METHODS: We used the WHO mortality database to extract information on death certificates reporting hypoglycaemia or diabetes as the underlying cause of death, and the United Nations demographic database to obtain data on mid-year population estimates from 2000 to 2014. We calculated crude and age-standardised proportions (defined as number of hypoglycaemia-related deaths divided by total number of deaths from diabetes [i.e. the sum of hypoglycaemia- and diabetes-related deaths]) and rates (hypoglycaemia-related deaths divided by mid-year population) of hypoglycaemia-related mortality and compared estimates across countries and over time. RESULTS: Data for proportions were extracted from 109 countries (31 had data from all years analysed [2000-2014] available). Combining all countries, the age-standardised proportion of hypoglycaemia-related deaths was 4.49 (95% CI 4.44, 4.55) per 1000 total diabetes deaths. Compared with the overall mean, most Central American, South American and (mainly) Caribbean countries reported higher proportions (five more age-standardised hypoglycaemia-related deaths per 1000 total diabetes deaths in Chile, six in Uruguay, 11 in Belize and 22 in Aruba), as well as Japan (11 more age-standardised hypoglycaemia-related deaths per 1000 total diabetes deaths). In comparison, lower proportions were noted in most European countries, the USA, Canada, New Zealand and Australia. For countries with data available for all years analysed, trend analysis showed a 60% increase in hypoglycaemia-related deaths until 2010 and stable trends onwards. Rising trends were most evident for Argentina, Brazil, Chile, the USA and Japan. Data for rates were available for 105 countries (30 had data for all years analysed [2000-2014] available). Combining all countries, the age-standardised hypoglycaemia-related death rate was 0.79 (95% CI 0.77, 0.80) per 1 million person-years. Most Central American, South American and Caribbean countries similarly reported higher rates of hypoglycaemia-related death, whilst virtually all European countries, the USA, Canada, Japan, New Zealand and Australia reported lower rates compared with the overall mean. Age-standardised rates were very low for most countries (lower than five per 1 million person-years in 89.5% of countries), resulting in small absolute differences among countries. As noted with the proportions analysis, trend analysis showed an overall 60% increase in hypoglycaemia-related deaths until 2010 and stable rate trends onwards; rising rates were particularly evident for Brazil, Chile and the USA. CONCLUSIONS/INTERPRETATION: Most countries in South America, Central America and the Caribbean showed the highest proportions of diabetes-related deaths attributable to hypoglycaemia and the highest rates of hypoglycaemia-related deaths. Between 2000 and 2014, rising trends were observed in Brazil, Chile and the USA for both rates and proportions of hypoglycaemia-related death, and in Argentina and Japan for proportions only. Further studies are required to unravel the contribution of clinical and socioeconomic factors, difference in diabetes prevalence and heterogeneity of death certification in determining lower rates and proportions of hypoglycaemia-related deaths in high-income countries in Europe, North America and Asia. DATA AVAILABILITY: Data used for these analyses are available at https://doi.org/10.17632/ndp52fbz8r.1.
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    Relevance of positive cardiovascular outcome trial results in clinical practice: perspectives from the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D)
    Schernthaner, G ; Khunti, K ; Lotan, C ; Burnier, M ; Drexel, H ; Prazny, M (DOVE MEDICAL PRESS LTD, 2017)
    Type 2 diabetes (T2D) imposes a substantial disease burden, predominantly from cardiovascular disease (CVD), which accounts for >50% of deaths in this population and leads to a 12-year reduction in the life expectancy of a 60-year-old male patient with T2D and CVD compared with the general population. The results from mandatory cardiovascular outcome trials (CVOTs) are therefore of great interest in the field. The Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes meeting program aims to bring together experts from several associated disciplines to provide fair and balanced resources for those involved in the management of patients with T2D. This publication represents the opinions of the faculty on the key learnings from the meeting held in Vienna in the spring of 2017. In particular, we detail how data from the EMPA-REG OUTCOME® [cardiovascular outcomes trial of empagliflozin] and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER®) (liraglutide) CVOTs can be practically interpreted across clinical specialities. It is hoped that this translation of CVOT data will achieve a dual treatment paradigm for the management of both raised glucose levels and CV risk in patients with T2D.