Showing papers by "Stephen Sutton published in 2019"

Evaluating diagnostic strategies for early detection of cancer: the CanTest Framework

Abstract: Novel diagnostic triage and testing strategies to support early detection of cancer could improve clinical outcomes. Most apparently promising diagnostic tests ultimately fail because of inadequate performance in real-world, low prevalence populations such as primary care or general community populations. They should therefore be systematically evaluated before implementation to determine whether they lead to earlier detection, are cost-effective, and improve patient safety and quality of care, while minimising over-investigation and over-diagnosis. We performed a systematic scoping review of frameworks for the evaluation of tests and diagnostic approaches. We identified 16 frameworks: none addressed the entire continuum from test development to impact on diagnosis and patient outcomes in the intended population, nor the way in which tests may be used for triage purposes as part of a wider diagnostic strategy. Informed by these findings, we developed a new framework, the ‘CanTest Framework’, which proposes five iterative research phases forming a clear translational pathway from new test development to health system implementation and evaluation. This framework is suitable for testing in low prevalence populations, where tests are often applied for triage testing and incorporated into a wider diagnostic strategy. It has relevance for a wide range of stakeholders including patients, policymakers, purchasers, healthcare providers and industry.

Differences in objectively measured physical activity and sedentary behaviour between white Europeans and south Asians recruited from primary care: cross-sectional analysis of the PROPELS trial

Abstract: Self-reported data have consistently shown South Asians (SAs) to be less physically active than White Europeans (WEs) in developed countries, however objective data is lacking. Differences in sedentary time have not been elucidated in this population. This study aimed to quantify differences in objectively measured physical activity and sedentary behaviour between WEs and SAs recruited from primary care and to investigate differences in demographic and lifestyle correlates of these behaviours. Baseline data were utilised from a randomised control trial recruiting individuals identified at high risk of type 2 diabetes from primary care. Light intensity physical activity, moderate-to-vigorous intensity physical activity (MVPA) and steps were measured using the Actigraph GT3X+, while sitting, standing and stepping time were measured using the activPAL3™. Devices were worn concurrently for seven days. Demographic (employment, sex, age, education, postcode) and behavioural (fruit and vegetable consumption, alcohol consumption, smoking status) characteristics were measured via self and interview administered questionnaires. A total of 963 WE (age = 62 ± 8, female 51%) and 289 SA (age = 55 ± 11, female 43%) were included. Compared to WEs, SAs did less MVPA (24 vs 33 min/day, p = 0.001) and fewer steps (6404 vs 7405 per day, p ≤ 0.001), but sat less (516 vs 552 min/day, p ≤ 0.001) and stood more (328 vs 283 min/day, p ≤ 0.001). Ethnicity also modified the extent to which demographic and behavioural factors act as correlates of physical activity and sedentary behaviour. Differences between sex in levels of MVPA and sitting time were greater in SAs compared to WEs, with SA women undertaking the least amount of MVPA (19 min/day), the least sitting time (475 min/day) and most standing time (377 min/day) than any other group. Smoking and alcohol status also acted as stronger correlates of sitting time in SAs compared to WEs. In contrast, education level acted as a stronger correlate of physical activity in WEs compared to SAs. SAs were less active yet less sedentary than WEs, which demonstrates the need to tailor the behavioural targets of interventions in multi-ethnic communities. Common correlates of physical activity and sedentary behaviour also differed between ethnicities. ISRCTN83465245 Trial registration date: 14/06/2012.

Behavioural analysis of postnatal physical activity in the UK according to the COM-B model: a multi-methods study.

Abstract: Objective Develop a behavioural analysis of factors influencing postnatal physical activity (PA) according to the ‘capability, opportunity, motivation and behaviour’ (COM-B) model of behaviour to inform intervention development using the Behaviour Change Wheel (BCW). Design Cross-sectional, multi-method study using semi-structured interviews and a quantitative questionnaire. Setting Children’s centres and mother and baby groups in Hertfordshire and Cambridgeshire, UK. Participants Convenience samples of postnatal women were interviewed (n=16) and completed the questionnaire (n=158). Methods Semi-structured interviews followed a preprepared topic guide exploring the COM-B model components and analysed using framework analysis. The questionnaire, based on the self-evaluation of behaviour questionnaire, was adapted using patient and public involvement and findings from the interviews. Questionnaire participants rated their agreement with 22 predefined statements related to COM-B model components. Mean, SD and 95% CI were calculated and each item categorised according to importance. Demographic data were collected. Results The questionnaire identified that new mothers would be more active if they had more time, felt less tired, had accessible childcare, were part of a group, advised by a healthcare professional, able to develop a habit and had more motivation. Additional themes emerging from qualitative data were engaging in PA groups with other new mothers, limited physical stamina following complicated births, social interaction, enjoyment and parental beliefs as motivation, provision of child-friendly PA facilities and environments and babies’ unpredictable routines. Conclusion The behavioural analysis presented in this paper identifies and adds detail on the range of factors influencing the target behaviour. Some are unique to the target population, requiring targeted interventions for postnatal women, whereas some are individualised, suggesting the need for individually tailored interventions. We will use the behavioural analysis presented to design an intervention using the subsequent steps in the BCW.

The relationship between parental attitudes and children's alcohol use: a systematic review and meta-analysis.

Abstract: Aims : The main aim of this study was to assess the relationship between parental attitudes towards children's alcohol use and their child's alcohol use. Secondary aims included assessing the relationship between attitudes reported by parents and those perceived by children, and between perceived parental attitudes and children's alcohol use. Methods : Meta-analysis of studies reporting on the associations between parental attitudes towards children's alcohol use and children's self-reported alcohol use. Published, peer-reviewed cross-sectional and longitudinal studies were identified from the following databases up to April 2018: Medline, PsycINFO, EMBASE, Scopus and Web of Science. Quality assessment was performed by using guidelines developed by Hayden, Cote & Bombardier. Pooled effect sizes were calculated by using random-effects meta-analyses, if there were at least two studies that could be included per analysis. Of 7471 articles screened, 29 were included comprising data from 16 477 children and 15 229 parents. Results : Less restrictive parental attitudes towards children's alcohol use were related to higher rates of alcohol use initiation [odds ratio (OR) = 1.45, 95% confidence interval (CI) = 1.17–1.80], alcohol use frequency (OR = 1.52, 95% CI = 1.24–1.86) and drunkenness (OR = 1.58, 95% CI = 1.35–1.85) among children. Less perceived restrictive parental attitudes were related to higher alcohol use frequency (OR = 1.76, 95% CI = 1.29–2.40). Perceived parental attitudes were not clearly related to alcohol use initiation. Parent-reported attitudes and perceived parental attitudes were weakly positively correlated (r = 0.27, P = ≤ 0.001). The strength of the relationship between parental attitudes and children's alcohol use frequency attenuated with children's age. Study design, sample size, study location and levels of alcohol use frequency did not have a detectable effect on the relationship. Conclusions : Less restrictive parental attitudes towards children's alcohol use are associated with increases in children's alcohol use onset, alcohol use frequency and drunkenness. Children's perception of less restrictive parental attitudes is associated with children's alcohol use.

Extent of predation bias present in migration survival and timing of Atlantic salmon smolt ( Salmo salar ) as suggested by a novel acoustic tag

Abstract: Acoustic telemetry is increasingly being used as a tool to measure survival, migration timing and behaviour of fish. Tagged fish may fall prey to other animals with the tag continuing to be detected whilst it remains in the gastrointestinal tract of the predator. Failure to identify post-predation detections introduces “predation bias” into the data. We employed a new predator tag technology in the first known field trial to understand the extent these tags could reduce predation bias in Atlantic salmon (Salmo salar L.) smolt migration through a 65-km zone beginning in freshwater and extending through an estuary. These tags signal predation by detecting a pH change in the predators’ gut during digestion of a tagged prey. We quantified survival and timing bias by comparing measurements from non- and post-predated detections of tagged individuals’ to only those detections where predation was not signalled. Of the 50 fish tagged, 41 were detected with 24 of these signalling as predated. Predation bias was greatest in the upper estuary and decreased towards the bay. Survival bias peaked at 11.6% at river km 54. Minimum and maximum migration time were both biased long and were 16% and 4% greater than bias corrected timing at river km 66 and 54, respectively. After correcting for bias, the apparent survival from release through freshwater and estuary was 19% and minimum and maximum migration timing was 6.6 and 7.0 days, respectively. Using this tag, we identified a high proportion of predation events that may have otherwise gone unnoticed using conventional acoustic tags. Estimated survival presented the greatest predation bias in the upper estuary which gradually declined to nearly no apparent bias in the lower estuary as predated tags failed through time to be detected. This is most likely due to tag expulsion from the predator between or upstream of receiver arrays. Whilst we have demonstrated that predation can bias telemetry results, it appears to be rather short-lived given the apparent retention times of these tags within the predators introducing the bias.

Do cognitive heuristics underpin symptom appraisal for symptoms of cancer?: A secondary qualitative analysis across seven cancers.

Abstract: Objectives To explore the evidence for cognitive heuristics or "rules of thumb" used within patients' reports of symptom appraisal and decisions to seek help for symptoms of cancer. Methods A secondary analysis of interviews from existing studies that explored symptom appraisal in patients who had sought help for potential symptoms of cancer. Transcripts from n = 50 in-depth interviews with patients referred with symptoms suspicious of cancer (pancreas, colorectal, oral, lung, melanoma, breast, and prostate) were re-analysed using a deductive thematic approach underpinned by the heuristics outlined in the Common Sense Model of Illness Self-regulation as set within the Model of Pathways to Treatment. Results The most dominant heuristic in patient reports was the Rate of change rule (ie, symptoms that are worsening, increasing, or have a sudden onset [rather than improving, stable or decreasing in number] are more likely to indicate illness). There was also support for the Duration rule, Pattern rule, Chronology rule, Severity (of interference) rule, Age-illness rule, Novelty rule, Similarity rule, Location rule, and Optimistic bias rule. There was a lack of evidence for the Prevalence and Stress-illness rules. Conclusions People do appear to use heuristics to guide their appraisal of symptoms and their perceived need for healthcare. Heuristics may be an important aspect underlying symptom misinterpretation, thus making them key targets for interventions. For instance, campaigns could tackle cognitive biases rather than focusing on specific symptom awareness. Myth-busting messages could highlight that intermittent, mild symptoms, and symptoms that are not worsening can be signs of a serious health problem.

A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

Abstract: Background: The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective: This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods: This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results: A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions: Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

Development and piloting of a highly tailored digital intervention to support adherence to antihypertensive medications as an adjunct to primary care consultations.

Abstract: Objectives This paper describes the systematic development and piloting of a highly tailored text and voice message intervention to increase adherence to medication in primary care. Methods Following the Medical Research Council guidance, this paper describes (a) the systematic development of the theoretical framework, based on review of theories and meta-analyses of effectiveness; (b) the systematic development of the delivery mode, intervention content and implementation procedures, based on consultations, face-to-face interviews, think-aloud protocols, focus groups, systematic reviews, patient and public involvement/engagement input, intervention pre-test; and (c) the piloting of the intervention, based on a 1-month intervention; and follow-up assessment including interviews and questionnaires. The mixed-methods analysis combined findings from the parallel studies complementarily. Results intervention development suggested the target behaviour of the intervention should be the tablets taken at a regular time of the day. It recommended that patients could be more receptive to intervention content when they initiate medication taking or they change prescription plan; and more emphasis is needed to patients’ consent process. Intervention piloting suggested high intervention engagement with, and fidelity of, the intervention content; which included a combination of behaviour change techniques, and was highly tailored to patients’ beliefs and prescription plan. Patients reported that the intervention content increased awareness about the necessity to take and maintain adherent to medication, reinforced social support and habit formation, and reminded them to take medication as prescribed. Conclusion Tailored automated text and voice message interventions are feasible ways to improve medication adherence as an adjunct to primary care. Trial registration number ISRCTN10668149.

Development and piloting of a highly tailored digital intervention to support adherence to antihypertensive medications as an adjunct to primary care consultations

Abstract: Objectives This paper describes the systematic development and piloting of a highly tailored text and voice message intervention to increase adherence to medication in primary care. Methods Following the Medical Research Council guidance, this paper describes (a) the systematic development of the theoretical framework, based on review of theories and meta-analyses of effectiveness; (b) the systematic development of the delivery mode, intervention content and implementation procedures, based on consultations, face-to-face interviews, think-aloud protocols, focus groups, systematic reviews, patient and public involvement/engagement input, intervention pre-test; and (c) the piloting of the intervention, based on a 1-month intervention; and follow-up assessment including interviews and questionnaires. The mixed-methods analysis combined findings from the parallel studies complementarily. Results intervention development suggested the target behaviour of the intervention should be the tablets taken at a regular time of the day. It recommended that patients could be more receptive to intervention content when they initiate medication taking or they change prescription plan; and more emphasis is needed to patients’ consent process. Intervention piloting suggested high intervention engagement with, and fidelity of, the intervention content; which included a combination of behaviour change techniques, and was highly tailored to patients’ beliefs and prescription plan. Patients reported that the intervention content increased awareness about the necessity to take and maintain adherent to medication, reinforced social support and habit formation, and reminded them to take medication as prescribed. Conclusion Tailored automated text and voice message interventions are feasible ways to improve medication adherence as an adjunct to primary care. Trial registration number ISRCTN10668149.

Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis.

Abstract: Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called ‘MiQuit’ to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit’s evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy. This is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks’ gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks’ gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate. If effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking. ClinicalTrials.gov, ID: NCT03231553 . Registered on 20 July 2017.

Comparing the Developmental Process of Consumptive Orientation Across Different Population Groups

Abstract: Recreational fishing provokes conservation concerns given the growing recreational demands on fisheries resources in different countries. Despite the negative impact of recreational fishing on fish...

Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial

Abstract: Background: The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. Objective: This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. Methods: The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)—the control—with usual care plus iQuit—the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. Results: The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. Conclusions: iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004.

Comparing intended, self-reported, and observed behavior of snorkelers in the Mombasa Marine Park and Reserve, Kenya.

Abstract: Recreational marine resource use is conducted by a varied group of visitors. Regardless of how minimal this resource use is, or what intentions these visitors have, potentially damaging contacts with these resources are unavoidable. Management authorities need a clear understanding of these contacts so that resource management can be conducted effectively. Traditional monitoring of visitors in the past has relied on self-reported behavior by visitors themselves. Self-reporting of behavior is not always accurate or reliable. This research article illustrates that even though recreational marine visitors (snorkelers) in the Mombasa Marine Park and Reserve had intentions to not disturb the reef when they snorkel and indicated having positive attitudes about not disturbing the reef when they snorkel, they still created contacts with the reef. Furthermore, their self-reported behavior did not correspond with their actual monitored behavior. Monitoring snorkeler behavior is time-consuming and is therefore paired with financial investment; however, this method is the most accurate method of gathering impact data to be used for management purposes. When accurate data on snorkelers' behavior is necessary, in-water behavior monitoring should be used rather than self-reports.