Publications
229 results found
Booth HP, Prevost TA, Wright AJ, et al., 2014, Effectiveness of behavioural weight loss interventions delivered in a primary care setting: a systematic review and meta-analysis, Family Practice, Vol: 31, Pages: 643-653, ISSN: 0263-2136
Background.Overweight and obesity have negative health effects. Primary care clinicians are best placed to intervene in weight management. Previous reviews of weight loss interventions have included studies from specialist settings. The aim of this review was to estimate the effect of behavioural interventions delivered in primary care on body weight in overweight and obese adults.Methods.The review included randomized controlled trials (RCTs) of behavioural interventions in obese or overweight adult participants in a primary care setting, with weight loss as the primary outcome, and a minimum of 12 months of follow-up. A systematic search strategy was implemented in Medline, Embase, Web of Science and the Cochrane Central Registry of Controlled Trials. Risk of bias was assessed using the Cochrane Risk of Bias tool and behavioural science components of interventions were evaluated. Data relating to weight loss in kilograms were extracted, and the results combined using meta-analysis.Results.Fifteen RCTs, with 4539 participants randomized, were selected for inclusion. The studies were heterogeneous with respect to inclusion criteria and type of intervention. Few studies reported interventions informed by behavioural science theory. Pooled results from meta-analysis indicated a mean weight loss of −1.36kg (−2.10 to −0.63, P < 0.0001) at 12 months, and −1.23kg (−2.28 to −0.18, P = 0.002) at 24 months.Conclusion.Behavioural weight loss interventions in primary care yield very small reductions in body weight, which are unlikely to be clinically significant. More effective management strategies are needed for the treatment of overweight and obesity.
Sutton S, Kinmonth A-L, Hardeman W, et al., 2014, Does electronic monitoring influence adherence to medication? Randomized controlled trial of measurement reactivity, Annals of Behavioral Medicine, Vol: 48, Pages: 293-299, ISSN: 0883-6612
BackgroundElectronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence.PurposeTo test the reactive effect of electronic monitoring in a randomized controlled trial.MethodsA total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5–25) and HbA1c at 8 weeks.ResultsNon-significantly higher adherence and lower HbA1c were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI −0.1 to 0.8, p = 0.11]; HbA1c (mmol/mol), −1.02 [−2.73 to 0.71, p = 0.25]).ConclusionsElectronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359)
Booth H, Khan O, Prevost T, et al., 2014, Incidence of type 2 diabetes after bariatric surgery: population-based matched cohort study, LANCET DIABETES & ENDOCRINOLOGY, Vol: 2, Pages: 963-968, ISSN: 2213-8587
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- Citations: 58
Sivaprasad S, Arden G, Prevost AT, et al., 2014, A multicentre phase III randomised controlled single-masked clinical trial evaluating the clinical efficacy and safety of light-masks at preventing dark-adaptation in the treatment of early diabetic macular oedema (CLEOPATRA): Study protocol for a randomised controlled trial, Trials, Vol: 15, ISSN: 1745-6215
BackgroundThis study will evaluate hypoxia, as a novel concept in the pathogenesis of diabetic macular oedema (DMO). As the oxygen demand of the eye is maximum during dark-adaptation, we hypothesize that wearing light-masks during sleep will cause regression and prevent the development and progression of DMO. The study protocol comprises both an efficacy and mechanistic evaluation to test this hypothesis.Method/DesignThis is a phase III randomised controlled single-masked multicentre clinical trial to test the clinical efficacy of light-masks at preventing dark-adaptation in the treatment of non-central DMO. Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks (with no light) to be used during sleep at night for a period of 24 months. The primary outcome is regression of non-central oedema by assessing change in the zone of maximal retinal thickness at baseline on optical coherence tomography (SD-OCT). Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula, macular volume, refracted visual acuity and level of retinopathy. Safety parameters will include sleep disturbance. Adverse events and measures of compliance will be assessed over 24 months. Participants recruited to the mechanistic sub-study will have additional retinal oximetry, multifocal electroretinography (ERG) and microperimetry to evaluate the role of hypoxia by assessing and comparing changes induced by supplemental oxygen and the light-masks at 12 months.DiscussionThe outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple, non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes.
Farquhar MC, Prevost AT, McCrone P, et al., 2014, Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial, BMC Medicine, Vol: 12, ISSN: 1741-7015
BackgroundBreathlessness is common in advanced cancer. The Breathlessness Intervention Service (BIS) is a multi-disciplinary complex intervention theoretically underpinned by a palliative care approach, utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease. We sought to establish whether BIS was more effective, and cost-effective, for patients with advanced cancer and their carers than standard care.MethodsA single-centre Phase III fast-track single-blind mixed-method randomised controlled trial (RCT) of BIS versus standard care was conducted. Participants were randomised to one of two groups (randomly permuted blocks). A total of 67 patients referred to BIS were randomised (intervention arm n = 35; control arm n = 32 received BIS after a two-week wait); 54 completed to the key outcome measurement. The primary outcome measure was a 0 to 10 numerical rating scale for patient distress due to breathlessness at two-weeks. Secondary outcomes were evaluated using the Chronic Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Client Services Receipt Inventory, EQ-5D and topic-guided interviews.ResultsBIS reduced patient distress due to breathlessness (primary outcome: -1.29; 95% CI -2.57 to -0.005; P = 0.049) significantly more than the control group; 94% of respondents reported a positive impact (51/53). BIS reduced fear and worry, and increased confidence in managing breathlessness. Patients and carers consistently identified specific and repeatable aspects of the BIS model and interventions that helped. How interventions were delivered was important. BIS legitimised breathlessness and increased knowledge whilst making patients and carers feel `not alone’. BIS had a 66% likelihood of better outcomes in terms of reduced distress due to breathlessness at lower health/social care costs than standard care (81% with informal care costs included).ConclusionsBIS appears to be more effective
Stevenson JM, Williams JL, Burnham TG, et al., 2014, Predicting adverse drug reactions in older adults; a systematic review of the risk prediction models, Clinical Interventions in Aging, Vol: 9, Pages: 1581-1593, ISSN: 1176-9092
Adverse drug reaction (ADR) risk-prediction models for use in older adults have been developed, but it is not clear if they are suitable for use in clinical practice. This systematic review aimed to identify and investigate the quality of validated ADR risk-prediction models for use in older adults. Standard computerized databases, the gray literature, bibliographies, and citations were searched (2012) to identify relevant peer-reviewed studies. Studies that developed and validated an ADR prediction model for use in patients over 65 years old, using a multivariable approach in the design and analysis, were included. Data were extracted and their quality assessed by independent reviewers using a standard approach. Of the 13,423 titles identified, only 549 were associated with adverse outcomes of medicines use. Four met the inclusion criteria. All were conducted in inpatient cohorts in Western Europe. None of the models satisfied the four key stages in the creation of a quality risk prediction model; development and validation were completed, but impact and implementation were not assessed. Model performance was modest; area under the receiver operator curve ranged from 0.623 to 0.73. Study quality was difficult to assess due to poor reporting, but inappropriate methods were apparent. Further work needs to be conducted concerning the existing models to enable the development of a robust ADR risk-prediction model that is externally validated, with practical design and good performance. Only then can implementation and impact be assessed with the aim of generating a model of high enough quality to be considered for use in clinical care to prioritize older people at high risk of suffering an ADR.
Birt L, Emery JD, Prevost AT, et al., 2014, Psychological impact of family history risk assessment in primary care: a mixed methods study, FAMILY PRACTICE, Vol: 31, Pages: 409-418, ISSN: 0263-2136
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- Citations: 6
Naughton F, Jamison J, Boase S, et al., 2014, Randomized controlled trial to assess the short-term effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care (iQuit in Practice), Addiction, Vol: 109, Pages: 1184-1193, ISSN: 0965-2140
AimsTo estimate the short‐term effectiveness, feasibility and acceptability of a smoking cessation intervention (the iQuit system) that consists of tailored printed and Short Message Service (SMS) text message self‐help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial.DesignA stratified two parallel‐group randomized controlled trial comparing usual care (control) with usual care plus the iQuit system (intervention), delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence.SettingThirty‐two general practice (GP) surgeries in England, UK.ParticipantsA total of 602 smokers initiating smoking cessation support from their local GP surgery were randomized (control n = 303, intervention n = 299).MeasurementsPrimary outcome was self‐reported 2‐week point prevalence abstinence at 8 weeks follow‐up. Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date, 8 weeks and 6 months follow‐up.FindingsThere were no significant between‐group differences in the primary outcome [control 40.3%, iQuit 45.2%; odds ratio (OR) = 1.22, 95% confidence interval (CI) = 0.88–1.69] or in secondary short‐term smoking outcomes. Six‐month prolonged abstinence was significantly higher in the iQuit arm (control 8.9%, iQuit 15.1%; OR = 1.81, 95% CI = 1.09–3.01). iQuit support took on average 7.7 minutes (standard deviation = 4.0) to deliver and 18.9% (95% CI = 14.8–23.7%) of intervention participants discontinued the text message support during the programme.ConclusionsTailored printed and text message self‐help delivered alongside routine smoking cessation support in primary care does not significantly increase short‐term abstinence, but may increase long‐term abstinence and demonstrated feasibility and acceptability compare
Griffin SJ, Simmons RK, Prevost AT, et al., 2014, Multiple behaviour change intervention and outcomes in recently diagnosed type 2 diabetes: The ADDITION-Plus randomised controlled trial, Diabetologia, Vol: 57, Pages: 1308-1319, ISSN: 0012-186X
Aims/hypothesisThe aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed type 2 diabetes.MethodsAn explanatory randomised controlled trial was conducted in 34 general practices in Eastern England (Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus [ADDITION-Plus]). In all, 478 patients meeting eligibility criteria (age 40 to 69 years with recently diagnosed screen or clinically detected diabetes) were individually randomised to receive either intensive treatment (n = 239) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team (n = 239). Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms. Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours, including goal setting, self-monitoring and building habits. Primary outcomes included physical activity energy expenditure (individually calibrated heart rate monitoring and movement sensing), change in objectively measured fruit and vegetable intake (plasma vitamin C), medication adherence (plasma drug levels) and smoking status (plasma cotinine levels) at 1 year. Measurements, data entry and laboratory analysis were conducted with staff unaware of participants’ study group allocation.ResultsOf 475 participants still alive, 444 (93%; intervention group 95%, comparison group 92%) attended 1-year follow-up. There were no significant differences between groups in physical activity (difference: +1.50 kJ kg−1 day−1; 95% CI −1.74, 4.74), plasma vitamin C (difference:
Emery JD, Reid G, Prevost AT, et al., 2014, Development and Validation of a Family History Screening Questionnaire in Australian Primary Care, ANNALS OF FAMILY MEDICINE, Vol: 12, Pages: 241-249, ISSN: 1544-1709
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- Citations: 23
Marcovecchio ML, Woodside J, Jones T, et al., 2014, Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT): Urinary Screening and Baseline Biochemical and Cardiovascular Assessments, DIABETES CARE, Vol: 37, Pages: 805-813, ISSN: 0149-5992
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- Citations: 47
Booth HP, Prevost AT, Gulliford MC, 2014, Impact of body mass index on prevalence of multimorbidity in primary care: Cohort study, Family Practice, Vol: 31, Pages: 38-43, ISSN: 0263-2136
Background.Multimorbidity is the co-occurrence of long-term conditions. Obesity is associated with an increased risk of long-term conditions including type 2 diabetes and depression.Objective.To quantify the association between body mass index (BMI) category and multimorbidity in a large cohort registered in primary care.Methods.The sample comprised primary care electronic health records of adults aged ≥30 years, sampled from the Clinical Practice Research Datalink between 2005 and 2011. Multimorbidity was defined as the co-occurrence of ≥2 of 11 conditions affecting seven organ systems. Age- and sex-standardized prevalence of multimorbidity was estimated by BMI category. Adjusted odds ratios associating BMI with additional morbidity were estimated adjusting for socioeconomic deprivation and smoking.Results.The sample comprised 300 006 adults. After excluding participants with BMI never recorded, data were analysed for 223 089 (74%) contributing 1 374 109 person–years. In normal weight men, the standardized prevalence of multimorbidity was 23%, rising to 27% in overweight, 33% in category I obesity, 38% in category II and 44% in category III obesity. In women, the corresponding values were 28%, 34%, 41%, 45% and 51%. In category III obesity, the adjusted odds, relative to normal BMI, were 2.24 (2.13–2.36) for a first condition; 2.63 (2.51–2.76) for a second condition and 3.09 (2.92–3.28) for three or more conditions. In a cross-sectional analysis, 32% of multimorbidity was attributable to overweight and obesity.Conclusions.Multiple morbidity is highly associated with increasing BMI category and obesity, highlighting the potential for targeted primary and secondary prevention interventions in primary care.
Savory LA, Griffin SJ, Williams KM, et al., 2014, Changes in diet, cardiovascular risk factors and modelled cardiovascular risk following diagnosis of diabetes: 1-year results from the ADDITION-Cambridge trial cohort, Diabetic Medicine, Vol: 31, Pages: 148-155, ISSN: 0742-3071
AimsTo describe change in self‐reported diet and plasma vitamin C, and to examine associations between change in diet and cardiovascular disease risk factors and modelled 10‐year cardiovascular disease risk in the year following diagnosis of Type 2 diabetes.MethodsEight hundred and sixty‐seven individuals with screen‐detected diabetes underwent assessment of self‐reported diet, plasma vitamin C, cardiovascular disease risk factors and modelled cardiovascular disease risk at baseline and 1 year (n = 736) in the ADDITION‐Cambridge trial. Multivariable linear regression was used to quantify the association between change in diet and cardiovascular disease risk at 1 year, adjusting for change in physical activity and cardio‐protective medication.ResultsParticipants reported significant reductions in energy, fat and sodium intake, and increases in fruit, vegetable and fibre intake over 1 year. The reduction in energy was equivalent to an average‐sized chocolate bar; the increase in fruit was equal to one plum per day. There was a small increase in plasma vitamin C levels. Increases in fruit intake and plasma vitamin C were associated with small reductions in anthropometric and metabolic risk factors. Increased vegetable intake was associated with an increase in BMI and waist circumference. Reductions in fat, energy and sodium intake were associated with reduction in HbA1c, waist circumference and total cholesterol/modelled cardiovascular disease risk, respectively.ConclusionsImprovements in dietary behaviour in this screen‐detected population were associated with small reductions in cardiovascular disease risk, independently of change in cardio‐protective medication and physical activity. Dietary change may have a role to play in the reduction of cardiovascular disease risk following diagnosis of diabetes.
Farquhar MC, Prevost A, McCrone P, et al., 2014, Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial, BMC Medicine, Vol: 12, Pages: 194-194, ISSN: 1741-7015
Bhattarai N, Prevost AT, Wright AJ, et al., 2013, Effectiveness of interventions to promote healthy diet in primary care: Systematic review and meta-analysis of randomised controlled trials, BMC Public Health, Vol: 13, ISSN: 1471-2458
BackgroundA diet rich in fruit, vegetables and dietary fibre and low in fat is associated with reduced risk of chronic disease. This review aimed to estimate the effectiveness of interventions to promote healthy diet for primary prevention among participants attending primary care.MethodsA systematic review of trials using individual or cluster randomisation of interventions delivered in primary care to promote dietary change over 12 months in healthy participants free from chronic disease or defined high risk states. Outcomes were change in fruit and vegetable intake, consumption of total fat and fibre and changes in serum cholesterol concentration.ResultsTen studies were included with 12,414 participants. The design and delivery of interventions were diverse with respect to grounding in behavioural theory and intervention intensity. A meta-analysis of three studies showed an increase in fruit consumption of 0.25 (0.01 to 0.49) servings per day, with an increase in vegetable consumption of 0.25 (0.06 to 0.44) serving per day. A further three studies that reported on fruit and vegetable consumption together showed a pooled increment of 0.50 (0.13 to 0.87) servings per day. The pooled effect on consumption of dietary fibre, from four studies, was estimated to be 1.97 (0.43 to 3.52) gm fibre per day. Data from five studies showed a mean decrease in total fat intake of 5.2% of total energy (1.5 to 8.8%). Data from three studies showed a mean decrease in serum cholesterol of 0.10 (-0.19 to 0.00) mmol/L.ConclusionPresently-reported interventions to promote healthy diet for primary prevention in primary care, which illustrate a diverse range of intervention methods, may yield small beneficial changes in consumption of fruit, vegetables, fibre and fat over 12 months. The present results do not exclude the possibility that more effective intervention strategies might be developed.
Booth HP, Prevost AT, Gulliford MC, 2013, Validity of smoking prevalence estimates from primary care electronic health records compared with national population survey data for England, 2007 to 2011, PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Vol: 22, Pages: 1357-1361, ISSN: 1053-8569
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- Citations: 46
Jackson TL, Nicod E, Angelis A, et al., 2013, PARS PLANA VITRECTOMY FOR VITREOMACULAR TRACTION SYNDROME A Systematic Review and Metaanalysis of Safety and Efficacy, Annual Congress of the Royal-College-of-Ophthalmologists, Publisher: LIPPINCOTT WILLIAMS & WILKINS, Pages: 2012-2017, ISSN: 0275-004X
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- Citations: 70
Corrie PG, Moody AM, Armstrong G, et al., 2013, Is community treatment best? A randomised trial comparing delivery of cancer treatment in the hospital, home and GP surgery, British Journal of Cancer, Vol: 109, Pages: 1549-1555, ISSN: 0007-0920
Background:Care closer to home is being explored as a means of improving patient experience as well as efficiency in terms of cost savings. Evidence that community cancer services improve care quality and/or generate cost savings is currently limited. A randomised study was undertaken to compare delivery of cancer treatment in the hospital with two different community settings.Methods:Ninety-seven patients being offered outpatient-based cancer treatment were randomised to treatment delivered in a hospital day unit, at the patient’s home or in local general practice (GP) surgeries. The primary outcome was patient-perceived benefits, using the emotional function domain of the EORTC quality of life (QOL) QLQC30 questionnaire evaluated after 12 weeks. Secondary outcomes included additional QOL measures, patient satisfaction, safety and health economics.Results:There was no statistically significant QOL difference between treatment in the combined community locations relative to hospital (difference of −7.2, 95% confidence interval: −19·5 to +5·2, P=0.25). There was a significant difference between the two community locations in favour of home (+15·2, 1·3 to 29·1, P=0.033). Hospital anxiety and depression scale scores were consistent with the primary outcome measure. There was no evidence that community treatment compromised patient safety and no significant difference between treatment arms in terms of overall costs or Quality Adjusted Life Year. Seventy-eight percent of patients expressed satisfaction with their treatment whatever their location, whereas 57% of patients preferred future treatment to continue at the hospital, 81% at GP surgeries and 90% at home. Although initial pre-trial interviews revealed concerns among health-care professionals and some patients regarding community treatment, opinions were largely more favourable in post-trial interviews.Interpretation:Patient QOL favours delivering cancer treatme
Oestoer AJK, Richards CA, Tytherleigh-Strong G, et al., 2013, Validation of clinical examination versus magnetic resonance imaging and arthroscopy for the detection of rotator cuff lesions, CLINICAL RHEUMATOLOGY, Vol: 32, Pages: 1283-1291, ISSN: 0770-3198
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- Citations: 18
Villanova F, Di Meglio P, Inokuma M, et al., 2013, Integration of lyoplate based flow cytometry and computational analysis for standardized immunological biomarker discovery, PLoS ONE, Vol: 8, ISSN: 1932-6203
Discovery of novel immune biomarkers for monitoring of disease prognosis and response to therapy in immune-mediated inflammatory diseases is an important unmet clinical need. Here, we establish a novel framework for immunological biomarker discovery, comparing a conventional (liquid) flow cytometry platform (CFP) and a unique lyoplate-based flow cytometry platform (LFP) in combination with advanced computational data analysis. We demonstrate that LFP had higher sensitivity compared to CFP, with increased detection of cytokines (IFN-γ and IL-10) and activation markers (Foxp3 and CD25). Fluorescent intensity of cells stained with lyophilized antibodies was increased compared to cells stained with liquid antibodies. LFP, using a plate loader, allowed medium-throughput processing of samples with comparable intra- and inter-assay variability between platforms. Automated computational analysis identified novel immunophenotypes that were not detected with manual analysis. Our results establish a new flow cytometry platform for standardized and rapid immunological biomarker discovery with wide application to immune-mediated diseases.
Jackson TL, Nicod E, Angelis A, et al., 2013, VITREOUS ATTACHMENT IN AGE-RELATED MACULAR DEGENERATION, DIABETIC MACULAR EDEMA, AND RETINAL VEIN OCCLUSION A Systematic Review and Metaanalysis, RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, Vol: 33, Pages: 1099-1108, ISSN: 0275-004X
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- Citations: 52
Walter FM, Prevost AT, Birt L, et al., 2013, Development and evaluation of a brief self-completed family history screening tool for common chronic disease prevention in primary care, BRITISH JOURNAL OF GENERAL PRACTICE, Vol: 63, Pages: E393-E400, ISSN: 0960-1643
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- Citations: 19
Papa S, Popat S, Shah R, et al., 2013, Phase 2 Study of Sorafenib in Malignant Mesothelioma Previously Treated with Platinum-Containing Chemotherapy, JOURNAL OF THORACIC ONCOLOGY, Vol: 8, Pages: 783-787, ISSN: 1556-0864
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- Citations: 59
Walter FM, Prevost AT, Vasconcelos J, et al., 2013, Using the 7-point checklist as a diagnostic aid for pigmented skin lesions in general practice: a diagnostic validation study, BRITISH JOURNAL OF GENERAL PRACTICE, Vol: 63, Pages: E345-E353, ISSN: 0960-1643
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- Citations: 41
Sutton S, Smith S, Jamison J, et al., 2013, Study protocol for iQuit in Practice: A randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care, BMC Public Health, Vol: 13, ISSN: 1471-2458
BackgroundPrimary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker’s mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone.Methods/designThe design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking.DiscussionThis trial will focus on acceptability, feasibility
Booth HP, Prevost AT, Gulliford MC, 2013, Epidemiology of clinical body mass index recording in an obese population in primary care: a cohort study, JOURNAL OF PUBLIC HEALTH, Vol: 35, Pages: 67-74, ISSN: 1741-3842
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- Citations: 23
Barakat A, Williams KM, Prevost AT, et al., 2013, Changes in physical activity and modelled cardiovascular risk following diagnosis of diabetes: 1-year results from the ADDITION-Cambridge trial cohort, Diabetic Medicine, Vol: 30, Pages: 233-238, ISSN: 0742-3071
Aims To describe change in physical activity over 1 year and associations with change in cardiovascular disease risk factors in a population with screen‐detected Type 2 diabetes.Methods Eight hundred and sixty‐seven individuals with screen‐detected diabetes underwent measurement of self‐reported physical activity, cardiovascular disease risk factors and modelled cardiovascular disease risk at baseline and 1 year (n = 736) in the ADDITION‐Cambridge trial. Multiple linear regression was used to quantify the association between change in different physical activity domains and cardiovascular disease risk factors at 1 year.Results There was no change in self‐reported physical activity over 12 months. Even relatively large changes in physical activity were associated with relatively small changes in cardiovascular disease risk factors after allowing for changes in self‐reported medication and diet. For every 30 metabolic equivalent‐h increase in recreational activity (equivalent to 10 h/brisk walking/week), there was an average reduction of 0.1% in HbA1c in men (95% CI −0.15 to −0.01, P = 0.021) and an average reduction of 2 mmHg in systolic blood pressure in women (95% CI −4.0 to −0.05, P = 0.045).Conclusions Few associations were observed between change in different physical activity domains and cardiovascular disease risk factors in this trial cohort. Cardiovascular disease risk reduction appeared to be driven largely by factors other than changes in self‐reported physical activity in the first year following diagnosis.
Hardeman W, Prevost AT, Parker RA, et al., 2013, Constructing multiplicative measures of beliefs in the theory of planned behaviour, BRITISH JOURNAL OF HEALTH PSYCHOLOGY, Vol: 18, Pages: 122-138, ISSN: 1359-107X
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- Citations: 8
Simmons D, Cohn S, Bunn C, et al., 2013, Testing a peer support intervention for people with type 2 diabetes: a pilot for a randomised controlled trial, BMC Family Practice, Vol: 14, ISSN: 1471-2296
BackgroundPeople with Type 2 diabetes face various psycho-social, self-management and clinical care issues and evidence is mixed whether support from others with diabetes, ‘peer support’, can help. We now describe a 2 month pilot study of different peer support interventions.MethodsThe intervention was informed by formative evaluation using semi-structured interviews with health professionals, community support groups and observation of diabetes education and support groups. Invitations to participate were mailed from 4 general practices and included a survey of barriers to care. Participants were randomized by practice to receive individual, group, combined (both individual and group) or no peer support. Evaluation included ethnographic observation, semi-structured interviews and questionnaires at baseline and post-intervention.ResultsOf 1,101 invited, 15% expressed an interest in participating in the pilot. Sufficient numbers volunteered to become peer supporters, although 50% of these (8/16) withdrew. Those in the pilot were similar to other patients, but were less likely to feel they knew enough about diabetes (60.8% vs 44.6% p = 0.035) and less likely to be happy with the diabetes education/care to date (75.4% vs 55.4% p = 0.013). Key issues identified were the need to recruit peer supporters directly rather than through clinicians, to address participant diabetes educational needs early and the potential for group sessions to have lower participation rates than 1:1 sessions.ConclusionsRecruitment to a full trial of peer support within the existing study design is feasible with some amendments. Attendance emerged as a key issue needing close monitoring and additional intervention during the trial.
Wilson ECF, Emery JD, Kinmonth AL, et al., 2012, The Cost-Effectiveness of a Novel SIAscopic Diagnostic Aid for the Management of Pigmented Skin Lesions in Primary Care: A Decision-Analytic Model, VALUE IN HEALTH, Vol: 16, Pages: 356-366, ISSN: 1098-3015
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- Citations: 19
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