General Practice and Primary Care - Research Publications
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ItemStakeholder input into the implementation of a new music therapy program in a mental health service(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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ItemThe Safe Pregnancy study - promoting safety behaviours in antenatal care among Norwegian, Pakistani and Somali pregnant women: a study protocol for a randomized controlled trial.(Springer Science and Business Media LLC, 2019-06-10)BACKGROUND: Intimate partner violence (IPV) around the time of pregnancy is a recognized global health problem with damaging consequences. However, little is known about the effect of violence assessment and intervention during pregnancy. We hypothesise that routine enquiry about IPV during pregnancy, in combination with information about IPV and safety behaviours, has the potential to increase the use of these behaviours and prevent and reduce IPV. METHODS: The Safe Pregnancy study is a randomised controlled trial (RCT) to test the effectiveness of a tablet-based intervention to promote safety behaviours among pregnant women. Midwives include women who attend routine antenatal care. The intervention consists of a screening questionnaire for violence and information about violence and safety behaviours through a short video shown on a tablet. The materials are available in different languages to ensure participation of Norwegian, Urdu, Somali and English-speaking women. Eligible women answer baseline questions on the tablet including the Abuse Assessment Scale (AAS). Women who screen positive on the AAS will be randomized to an intervention video that contains information about violence and safety behaviours and women in the control group to a video with general information about a healthy and a safe pregnancy. All women receive information about referral resources. Follow up will be at three months post-partum, when the woman attends the maternal and child health centre (MCHC) for the baby's check-up. Outcome measures are: Use of safety behaviours and quality of life (primary outcomes), prevalence of violence, mental health measures and birth outcomes (secondary outcomes). Intention to treat analysis will be performed. DISCUSSION: The project will provide evidence on whether enquiry about violence and a short video intervention on a tablet is effective and feasible to prevent or reduce harm from IPV among women who attend antenatal care. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov. Identifier: NCT03397277 (Registered 11th January 2018).
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ItemCreatine and pregnancy outcomes, a prospective cohort study in low-risk pregnant women: study protocol.(BMJ, 2019-01-15)INTRODUCTION: The creatine kinase circuit is central to the regulation of high-energy phosphate metabolism and the maintenance of cellular energy turnover. This circuit is fuelled by creatine, an amino acid derivative that can be obtained from a diet containing animal products, and by synthesis in the body de novo. A recent retrospective study conducted in a cohort of 287 pregnant women determined that maternal excreted levels of creatine may be associated with fetal growth. This prospective study aims to overcome some of the limitations associated with the previous study and thoroughly characterise creatine homeostasis throughout gestation in a low-risk pregnant population. METHODS AND ANALYSIS: This study is recruiting women with a singleton low-risk pregnancy who are attending Monash Health, in Melbourne, Australia. Maternal blood and urine samples, along with dietary surveys, are collected at five time points during pregnancy and then at delivery. Cord blood and placenta (including membranes and cord) are collected at birth. A biobank of tissue samples for future research is being established. Primary outcome measures will include creatine, creatine kinase and associated metabolites in antenatal bloods and urine, cord bloods and placenta, along with molecular analysis of the creatine transporter (SLC6A8) and synthesising enzymes L - arginine:glycine amidinotransferase (AGAT) and guanidinoacetate methyltransferase (GAMT) in placental tissues. Secondary outcome measures include dietary protein intake over pregnancy and any associations with maternal creatine, pregnancy events and birth outcomes. ETHICS AND DISSEMINATION: Ethical approval was granted in August 2015 from Monash Health (Ref: 14140B) and Monash University (Ref: 7785). Study outcomes will be disseminated at international conferences and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: ACTRN12618001558213; Pre-results.
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ItemImproving Primary Care After Stroke (IPCAS) trial: protocol of a randomised controlled trial to evaluate a novel model of care for stroke survivors living in the community(BMJ PUBLISHING GROUP, 2019-08)INTRODUCTION: Survival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. No formal primary care-based holistic model of care with clinical trial evidence exists to support stroke survivors living in the community, and stroke survivors report that many of their needs are not being met. We have developed a multifactorial primary care model to address these longer term needs. We aim to evaluate the clinical and cost-effectiveness of this new model of primary care for stroke survivors compared with standard care. METHODS AND ANALYSIS: Improving Primary Care After Stroke (IPCAS) is a two-arm cluster-randomised controlled trial with general practice as the unit of randomisation. People on the stroke registers of general practices will be invited to participate. One arm will receive the IPCAS model of care including a structured review using a checklist; a self-management programme; enhanced communication pathways between primary care and specialist services; and direct point of contact for patients. The other arm will receive usual care. We aim to recruit 920 people with stroke registered with 46 general practices. The primary endpoint is two subscales (emotion and handicap) of the Stroke Impact Scale (SIS) as coprimary outcomes at 12 months (adjusted for baseline). Secondary outcomes include: SIS Short Form, EuroQol EQ-5D-5L, ICEpop CAPability measure for Adults, Southampton Stroke Self-management Questionnaire, Health Literacy Questionnaire and medication use. Cost-effectiveness of the new model will be determined in a within-trial economic evaluation. ETHICS AND DISSEMINATION: Favourable ethical opinion was gained from Yorkshire and the Humber-Bradford Leeds NHS Research Ethics Committee. Approval to start was given by the Health Research Authority prior to recruitment of participants at any NHS site. Data will be presented at national and international conferences and published in peer-reviewed journals. Patient and public involvement helped develop the dissemination plan. TRIAL REGISTRATION NUMBER: NCT03353519.
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ItemQuality of the diagnostic process in patients presenting with symptoms suggestive of bladder or kidney cancer: a systematic review(BMJ PUBLISHING GROUP, 2019-10)OBJECTIVES: In urological cancers, sex disparity exists for survival, with women doing worse than men. Suboptimal evaluation of presenting symptoms may contribute. DESIGN: We performed a systematic review examining factors affecting the quality of the diagnostic process of patients presenting with symptoms of bladder or kidney cancer. DATA SOURCES: We searched Medline, Embase and the Cochrane Library from 1 January 2000 to 13 June 2019. ELIGIBLE CRITERIA: We focused on one of the six domains of quality of healthcare: timeliness, and examined the quality of the diagnostic process more broadly, by assessing whether guideline-concordant history, examination, tests and referrals were performed. Studies describing the factors that affect the timeliness or quality of the assessment of urinary tract infections, haematuria and lower urinary tract symptoms in the context of bladder or kidney cancer, were included. DATA EXTRACTION AND SYNTHESIS: Data extraction and quality assessment were independently performed by two authors. Due to the heterogeneity of study design and outcomes, the results could not be pooled. A narrative synthesis was performed. RESULTS: 28 studies met review criteria, representing 583 636 people from 9 high-income countries. Studies were based in primary care (n=8), specialty care (n=12), or both (n=8). Up to two-thirds of patients with haematuria received no further evaluation in the 6 months after their initial visit. Urinary tract infections, nephrolithiasis and benign prostatic conditions before cancer diagnosis were associated with diagnostic delay. Women were more likely to experience diagnostic delay than men. Patients who first saw a urologist were less likely to experience delayed evaluation and cancer diagnosis. CONCLUSIONS: Women, and patients with non-cancerous urological diagnoses just prior to their cancer diagnosis, were more likely to experience lower quality diagnostic processes. Risk prediction tools, and improving guideline ambiguity, may improve outcomes and reduce sex disparity in survival for these cancers.
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ItemRegional 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(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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ItemDevelopment and validation of the African Women Awareness of CANcer (AWACAN) tool for breast and cervical cancer(PUBLIC LIBRARY SCIENCE, 2019-08-06)BACKGROUND: Measuring factors influencing time to presentation is important in developing and evaluating interventions to promote timely cancer diagnosis, yet there is a lack of validated, culturally relevant measurement tools. This study aimed to develop and validate the African Women Awareness of CANcer (AWACAN) tool to measure awareness of breast and cervical cancer in Sub-Saharan Africa (SSA). METHODS: Development of the AWACAN tool followed 4 steps: 1) Item generation based on existing measures and relevant literature. 2) Refinement of items via assessment of content and face validity using cancer experts' ratings and think aloud interviews with community participants in Uganda and South Africa. 3) Administration of the tool to community participants, university staff and cancer experts for assessment of validity using test-retest reliability (using Intra-Class Correlation (ICC) and adjusted Kappa coefficients), construct validity (comparing expert and community participant responses using t-tests) and internal reliability (using the Kuder-Richarson (KR-20) coefficient). 4) Translation of the final AWACAN tool into isiXhosa and Acholi. RESULTS: ICC scores indicated good test-retest reliability (≥ 0.7) for all breast cancer knowledge domains and cervical cancer risk factor and lay belief domains. Experts had higher knowledge of breast cancer risk factors (p < 0.001), and cervical cancer risk factors (p = 0.003) and symptoms (p = 0.001) than community participants, but similar knowledge of breast cancer symptoms (p = 0.066). Internal reliability for breast cancer risk factors, lay beliefs and symptom and cervical cancer symptom subscales was good with KR-20 values > 0.7, and lower (0.6) for the cervical cancer risk subscale. CONCLUSION: The final AWACAN tool includes items on socio-demographic details; breast and cervical cancer symptom awareness, risk factor awareness, lay beliefs, anticipated help-seeking behaviour; and barriers to seeking care. The tools showed evidence of content, face, construct and internal validity and test-retrest reliability and are available for use in SSA in three languages.
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ItemBarrett'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(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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ItemAssociations between diagnostic activity and measures of patient experience in primary care: a cross-sectional ecological study of English general practices(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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ItemBOADICEA: a comprehensive breast cancer risk prediction model incorporating genetic and nongenetic risk factors (vol 21, pg 1462, 2019)(SPRINGERNATURE, 2019-06)This has now been corrected in both the PDF and HTML versions of the Article. The authors regret this error.