Evaluating the Effectiveness of Remote Behavioral Interventions Facilitated by Health Care Providers at Improving Medication Adherence in Cardiometabolic Conditions: A Systematic Review and Meta-Analysis.

BACKGROUND: Although cardiometabolic conditions account for over 32% of all global deaths, nearly half of the patients with cardiometabolic conditions do not take medication as prescribed. Remote behavioral interventions have been shown to potentially improve adherence in these patients and further support cost effective clinical practice. PURPOSE: To evaluate the effectiveness of remote behavioral interventions at improving treatment adherence and to explore behavioral intervention components associated with it. METHODS: We searched MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science in April 2021. Random-effects meta-analyses were utilized. RESULTS: In total, 40 studies, including 24,672 participants, were included. The overall quality of evidence, assessed using the RoB2 tool, was low. The intervention had a small (odds ratios [OR] = 1.70, 95% CI: 1.47, 1.96, N = 4823 p < .001) to moderate effect (SMD = 0.57, 95% CI: 0.38, 0.76, N = 20,271, p < .001) on the dichotomous and continuous outcomes, respectively. Systolic blood pressure (SBP) was reduced by 3.71 mmHg (95% CI: 3.99, 3.43, N = 6,527, p < .001) and participants receiving the intervention were twice more likely to achieve blood pressure (BP) control (OR = 2.14, 95% CI: 1.61, 2.84, N = 1,172, p < .001). Generally, HBA1c decreased by 0.25% (95% CI: 0.33, 0.17, N = 6,734, p < .001), whereas low-density lipoprotein (LDL)-cholesterol dropped by 6.82 mg/dL (95% CI: 8.33, 5.30, N = 4,550, p < .001) in favor of the intervention. There was a trend suggesting a potential positive effects on reducing visits to emergency department (OR=0.76, 95% CI: 0.57, 1.01, N = 4,182) and mortality rates (OR=0.78, 95% CI: 0.42, 1.42, N = 1,971), and no risk for hospital readmission (OR=1.00, 95% CI: 0.83, 1.20, N = 5,402), favoring the intervention. CONCLUSIONS: Despite low quality of evidence, remote consultations are effective at improving medication adherence and clinical indicators, and potentially cost-effective solution for health care services.

An Automated, Online Feasibility Randomized Controlled Trial of a Just-In-Time Adaptive Intervention for Smoking Cessation (Quit Sense).

INTRODUCTION: Learned smoking cues from a smoker's environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting. METHODS: A two-arm feasibility randomized controlled trial (N = 209) to estimate parameters to inform a definitive evaluation. Smoker's willing to make a quit attempt were recruited using online paid-for adverts and randomized to "usual care" (text message referral to NHS SmokeFree website) or "usual care" plus a text message invitation to install Quit Sense. Procedures, excluding manual follow-up for nonresponders, were automated. Follow-up at 6 weeks and 6 months included feasibility, intervention engagement, smoking-related, and economic outcomes. Abstinence was verified using cotinine assessment from posted saliva samples. RESULTS: Self-reported smoking outcome completion rates at 6 months were 77% (95% CI 71%, 82%), viable saliva sample return rate was 39% (95% CI 24%, 54%), and health economic data 70% (95% CI 64%, 77%). Among Quit Sense participants, 75% (95% CI 67%, 83%) installed the app and set a quit date and, of those, 51% engaged for more than one week. The 6-month biochemically verified sustained abstinence rate (anticipated primary outcome for definitive trial), was 11.5% (12/104) among Quit Sense participants and 2.9% (3/105) for usual care (adjusted odds ratio = 4.57, 95% CIs 1.23, 16.94). No evidence of between-group differences in hypothesized mechanisms of action was found. CONCLUSIONS: Evaluation feasibility was demonstrated alongside evidence supporting the effectiveness potential of Quit Sense. IMPLICATIONS: Running a primarily automated trial to initially evaluate Quit Sense was feasible, resulting in modest recruitment costs and researcher time, and high trial engagement. When invited, as part of trial participation, to install a smoking cessation app, most participants are likely to do so, and, for those using Quit Sense, an estimated one-half will engage with it for more than 1 week. Evidence that Quit Sense may increase verified abstinence at 6-month follow-up, relative to usual care, was generated, although low saliva return rates to verify smoking status contributed to considerable imprecision in the effect size estimate.

Medication decision-making and adherence in lupus: patient-physician discordance and the impact of previous 'adverse medical experiences'.

OBJECTIVES: Medication adherence is critical in the successful management of lupus. There is very limited existing literature on reasons why non-adherence is not reported. This study explores the impact of current and previous medical experiences on patient satisfaction, adherence and reporting of non-adherence. METHODS: Mixed methodology involved thematic analysis of in-depth interviews (n = 23) to further explore the statistically analysed quantitative survey findings (n = 186). RESULTS: This study identified five themes: (i) physician-patient discordance and a 'hierarchy of evidence' in medication decisions; (ii) the association of adherence with satisfaction with care; (iii) the persisting impact of past adverse medical experiences (AMEs); (iv) the dynamic balance of patient-physician control; and (v) holistic care, beyond a purely medication-based focus. Improving quality of life (43% of participants) and a supportive medical relationship (24%) were the main reasons for adherence. Patient-priorities and self-reported symptoms were perceived as less important to physicians than organ-protection and blood results. Non-reporters of non-adherence, non-adherers and those with past AMEs (e.g. psychosomatic misdiagnoses) had statistically significant lower satisfaction with care. The importance of listening to patients was a key component of every theme, and associated with patient satisfaction and adherence. The mean rating for rheumatologist's listening skills was 2.88 for non-adherers compared with 3.53 for other participants (mean difference 0.65, P = 0.003). CONCLUSION: Patients would like more weight and discussion given to self-reported symptoms and quality of life in medication decisions. Greater understanding and interventions are required to alleviate the persisting impact of past AMEs on some patients' wellbeing, behaviour and current medical relationships.

Telemedicine in rheumatology: a mixed methods study exploring acceptability, preferences and experiences among patients and clinicians.

OBJECTIVES: The Covid-19 pandemic necessitated a rapid global transition towards telemedicine; yet much remains unknown about telemedicine's acceptability and safety in rheumatology. To help address this gap and inform practice, this study investigated rheumatology patient and clinician experiences and views of telemedicine. METHODS: Sequential mixed methodology combined analysis of surveys and in-depth interviews. Between and within-group differences in views of telemedicine were examined for patients and clinicians using t-tests. RESULTS: Surveys (patients n = 1340, clinicians n = 111) and interviews (patients n = 31, clinicians n = 29) were completed between April 2021 and July 2021. The majority of patients were from the UK (96%) and had inflammatory arthritis (32%) or lupus (32%). Patients and clinicians rated telemedicine as worse than face-to-face consultations in almost all categories, although >60% found it more convenient. Building trusting medical relationships and assessment accuracy were great concerns (93% of clinicians and 86% of patients rated telemedicine as worse than face-to-face for assessment accuracy). Telemedicine was perceived to have increased misdiagnoses, inequalities and barriers to accessing care. Participants reported highly disparate telemedicine delivery and responsiveness from primary and secondary care. Although rheumatology clinicians highlighted the importance of a quick response to flaring patients, only 55% of patients were confident that their rheumatology department would respond within 48 hours. CONCLUSION: Findings indicate a preference for face-to-face consultations. Some negative experiences may be due to the pandemic rather than telemedicine specifically, although the risk of greater diagnostic inaccuracies using telemedicine is unlikely to be fully resolved. Training, choice, careful patient selection, and further consultation with clinicians and patients is required to increase telemedicine's acceptability and safety. TRIAL REGISTRATION: This telemedicine study is part of a pre-registered longitudinal multi-stage trial, the LISTEN study (ISRCTN-14966097), with later Covid-related additions registered in March 2021, including a pre-registered statistical analysis plan.

Will 'the feeling of abandonment' remain? Persisting impacts of the COVID-19 pandemic on rheumatology patients and clinicians.

OBJECTIVE: To better understand rheumatology patient and clinician pandemic-related experiences, medical relationships and behaviours in order to help identify the persisting impacts of the COVID-19 pandemic and inform efforts to ameliorate the negative impacts and build upon the positive ones. METHODS: Rheumatology patients and clinicians completed surveys (patients n = 1543, clinicians n = 111) and interviews (patients n = 41, clinicians n = 32) between April 2021 and August 2021. A cohort (n = 139) of systemic autoimmune rheumatic disease patients was also followed up from March 2020 to April 2021. Analyses used sequential mixed methods. Pre-specified outcome measures included the Warwick-Edinburgh Mental wellbeing score (WEMWBS), satisfaction with care and healthcare behaviours. RESULTS: We identified multiple ongoing pandemic-induced/increased barriers to receiving care. The percentage of patients agreeing they were medically supported reduced from 74.4% pre-pandemic to 39.7% during-pandemic. Ratings for medical support, medical security and trust were significantly (P <0.001) positively correlated with patient WEMWBS and healthcare behaviours, and decreased during the pandemic. Healthcare-seeking was reduced, potentially long-term, including from patients feeling 'abandoned' by clinicians, and a 'burden' from government messaging to protect the NHS. Blame and distrust were frequent, particularly between primary and secondary care, and towards the UK government, who <10% of clinicians felt had supported clinicians during the pandemic. Clinicians' efforts were reported to be impeded by inefficient administration systems and chronic understaffing, suggestive of the pandemic having exposed and exacerbated existing healthcare system weaknesses. CONCLUSION: Without concerted action-such as rebuilding trust, improved administrative systems and more support for clinicians-barriers to care and negative impacts of the pandemic on trust, medical relationships, medical security and patient help-seeking may persist in the longer term. TRIAL REGISTRATION: This study is part of a pre-registered longitudinal multi-stage trial, the LISTEN study (ISRCTN-14966097), with later COVID-related additions registered in March 2021, including a pre-registered statistical analysis plan.

A Systematic Review and Meta-analysis of Face-to-face Medication Adherence Interventions for Patients with Long Term Health Conditions.

BACKGROUND: Although previous reviews demonstrated effectiveness related to medication adherence interventions, they incorporated various digital platforms and other multiple delivery modes, which makes difficult to distinguish what aspects of the interventions led to effectiveness. PURPOSE: This review aimed to (i) estimate the efficacy of face-to-face medication adherence interventions on adherence outcomes, in adults with Long Term Health Conditions (LTHCs) and (ii) identify the Behaviour Change Techniques (BCTs) used in the interventions and examine their potential impact on efficacy. METHODS: Cochrane Controlled Register of Trials, Embase, MEDLINE (Ovid), PsycINFO, Web of Science, PubMed, and Scopus databases were searched. Randomized controlled trials were included if they described an intervention to improve medication adherence, delivered via face-to-face only, and included patients with LTHCs. Studies were excluded if they used additional delivery modes, involved family members or used a group format. In addition, use of BCTs was coded. RESULTS: 20 studies were included (n = 3667). Statistically significant pooled effects were found favoring the intervention than control, for the following MEMS (electronic monitoring) measures: percentage of prescribed doses taken on time over a period of 3 weeks to 2 months (MD 9.34, 95% CI 4.36-14.33, p = .0002; I2 =0%); percentage of prescribed doses taken for a period of 1 week to 2 months (MD 5.63, 95% CI 1.62-9.64, p = .006; I2 = 51%) and for 1 month (OR = 2.51, 95% CI 1.37-4.57, p = .003; I2 = 0%); percentage of days correct doses taken for 1 month to 14 weeks (MD 6.59, 95% CI 0.74-13.15, p = .03; I2 = 68%). Studies using the Morisky scale showed a significant between group difference for 1-3 months (MD 0.86, 95% CI 0.59-1.13, p < .00001; I2 = 0%). Overall, more BCTs were identified in intervention conditions than in comparison conditions (22 vs. 10). The impact of BCTs on intervention effectiveness could not be established as the analyses were underpowered. CONCLUSIONS: Face-to-face interventions increased adherence to medication among adult patients with LTHCs. Although we were able to identify BCTs among interventions, data were insufficient to determine the impact of particular BCTs on intervention effectiveness.

Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial.

BACKGROUND: Physical activity is associated with a reduced risk of type 2 diabetes and cardiovascular disease but limited evidence exists for the sustained promotion of increased physical activity within diabetes prevention trials. The aim of the study was to investigate the long-term effectiveness of the Walking Away programme, an established group-based behavioural physical activity intervention with pedometer use, when delivered alone or with a supporting mHealth intervention. METHODS: Those at risk of diabetes (nondiabetic hyperglycaemia) were recruited from primary care, 2013-2015, and randomised to (1) Control (information leaflet); (2) Walking Away (WA), a structured group education session followed by annual group-based support; or (3) Walking Away Plus (WAP), comprising WA annual group-based support and an mHealth intervention delivering tailored text messages supported by telephone calls. Follow-up was conducted at 12 and 48 months. The primary outcome was accelerometer measured ambulatory activity (steps/day). Change in primary outcome was analysed using analysis of covariance with adjustment for baseline, randomisation and stratification variables. RESULTS: One thousand three hundred sixty-six individuals were randomised (median age = 61 years, ambulatory activity = 6638 steps/day, women = 49%, ethnic minorities = 28%). Accelerometer data were available for 1017 (74%) individuals at 12 months and 993 (73%) at 48 months. At 12 months, WAP increased their ambulatory activity by 547 (97.5% CI 211, 882) steps/day compared to control and were 1.61 (97.5% CI 1.05, 2.45) times more likely to achieve 150 min/week of moderate-to-vigorous physical activity. Differences were not maintained at 48 months. WA was no different to control at 12 or 48 months. Secondary anthropometric and health outcomes were largely unaltered in both intervention groups apart from small reductions in body weight in WA (~ 1 kg) at 12- and 48-month follow-up. CONCLUSIONS: Combining a pragmatic group-based intervention with text messaging and telephone support resulted in modest changes to physical activity at 12 months, but changes were not maintained at 48 months. TRIAL REGISTRATION: ISRCTN 83465245 (registered on 14 June 2012).

'But you don't look sick': a qualitative analysis of the LUPUS UK online forum.

Lupus is a multi-system autoimmune rheumatic disease with increased morbidity and mortality. Some manifestations are life-threatening with many aspects of living with the disease, difficulties in diagnosis and accessing appropriate medical care, having an impact on quality of life. The disease itself, and these patients' perspectives, are currently poorly understood and under-researched. The LUPUS UK forum of conversations between over 25,000 members provides a rich environment to explore the views of these patients. Conversations on the LUPUS UK online forum were qualitatively explored using virtual ethnography and thematic analysis. The forum itself and positive medical relationships were widely considered to provide a means of support, understanding and validation. Forum members expressed difficulties in diagnosis, disease management, and the psychological and physical impact of living with an unpredictable, poorly understood disease, often with life-changing symptoms. Invalidating personal, social and medical environments were perceived as exacerbating these difficulties. Delays in diagnosis and misdiagnoses were frequently discussed as causing significant damage, especially when symptoms were disbelieved or dismissed. Invalidation was the key theme with further themes of: Uncertainty, Medical (mis)communications and misunderstandings, Navigating health systems and Resilience and support. Although effective care and support was reported by some members, the negative impact of living with an incurable, life-changing disease was often exacerbated by perceived invalidation, uncertainty, and difficulties in multiple areas of members' lives. Improved knowledge of the disease and greater support at all stages of the diagnostic journey could improve outcomes and quality of life for these patients.

Incorporating a brief intervention for personalised cancer risk assessment to promote behaviour change into primary care: a multi-methods pilot study.

BACKGROUND: Approximately 40% of cancers could be prevented if people lived healthier lifestyles. We have developed a theory-based brief intervention to share personalised cancer risk information and promote behaviour change within primary care. This study aimed to assess the feasibility and acceptability of incorporating this intervention into primary care consultations. METHOD: Patients eligible for an NHS Health Check or annual chronic disease review at five general practices were invited to participate in a non-randomised pilot study. In addition to the NHS Health Check or chronic disease review, those receiving the intervention were provided with their estimated risk of developing the most common preventable cancers alongside tailored behaviour change advice. Patients completed online questionnaires at baseline, immediately post-consultation and at 3-month follow-up. Consultations were audio/video recorded. Patients (n = 12) and healthcare professionals (HCPs) (n = 7) participated in post-intervention qualitative interviews that were analysed using thematic analysis. RESULTS: 62 patients took part. Thirty-four attended for an NHS Health Check plus the intervention; 7 for a standard NHS Health Check; 16 for a chronic disease review plus the intervention; and 5 for a standard chronic disease review. The mean time for delivery of the intervention was 9.6 min (SD 3) within NHS Health Checks and 9 min (SD 4) within chronic disease reviews. Fidelity of delivery of the intervention was high. Data from the questionnaires demonstrates potential improvements in health-related behaviours following the intervention. Patients receiving the intervention found the cancer risk information and lifestyle advice understandable, useful and motivating. HCPs felt that the intervention fitted well within NHS Health Checks and facilitated conversations around behaviour change. Integrating the intervention within chronic disease reviews was more challenging. CONCLUSIONS: Incorporating a risk-based intervention to promote behaviour change for cancer prevention into primary care consultations is feasible and acceptable to both patients and HCPs. A randomised trial is now needed to assess the effect on health behaviours. When designing that trial, and other prevention activities within primary care, it is necessary to consider challenges around patient recruitment, the HCP contact time needed for delivery of interventions, and how best to integrate discussions about disease risk within routine care.

Evaluation of a very brief pedometer-based physical activity intervention delivered in NHS Health Checks in England: The VBI randomised controlled trial.

BACKGROUND: The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS) Health Checks in primary care. METHODS AND FINDINGS: The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study's limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment. CONCLUSIONS: In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up. TRIAL REGISTRATION: Current Controlled Trials (ISRCTN72691150).

A general method for elicitation, imputation, and sensitivity analysis for incomplete repeated binary data.

We develop and demonstrate methods to perform sensitivity analyses to assess sensitivity to plausible departures from missing at random in incomplete repeated binary outcome data. We use multiple imputation in the not at random fully conditional specification framework, which includes one or more sensitivity parameters (SPs) for each incomplete variable. The use of an online elicitation questionnaire is demonstrated to obtain expert opinion on the SPs, and highest prior density regions are used alongside opinion pooling methods to display credible regions for SPs. We demonstrate that substantive conclusions can be far more sensitive to departures from the missing at random assumption (MAR) when control and intervention nonresponders depart from MAR differently, and show that the correlation of arm specific SPs in expert opinion is particularly important. We illustrate these methods on the iQuit in Practice smoking cessation trial, which compared the impact of a tailored text messaging system versus standard care on smoking cessation. We show that conclusions about the effect of intervention on smoking cessation outcomes at 8 week and 6 months are broadly insensitive to departures from MAR, with conclusions significantly affected only when the differences in behavior between the nonresponders in the two trial arms is larger than expert opinion judges to be realistic.

A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers.

Few trial data are available concerning the impact of personalised cancer risk information on behaviour. This study assessed the short-term effects of providing personalised cancer risk information on cancer risk beliefs and self-reported behaviour. We randomised 1018 participants, recruited through the online platform Prolific, to either a control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice. The primary outcome was change from baseline in computed risk relative to an individual with a recommended lifestyle (RRI)1 at three months. Secondary outcomes included: health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction. After three months there were no between-group differences in change in RRI (p = 0.71). At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group. The increases in accuracy and conviction were only seen in individuals with high numeracy and low baseline conviction, respectively. These findings suggest that personalised cancer risk information alongside lifestyle advice can increase short-term risk accuracy and conviction without increasing worry or anxiety but has little impact on health-related behaviour. Trial registration: ISRCTN17450583. Registered 30 January 2018.

Interest in and Use of Smoking Cessation Support Across Pregnancy and Postpartum.

BACKGROUND: Limited research exists on interest in and use of smoking cessation support in pregnancy and postpartum. METHODS: A longitudinal cohort of pregnant smokers and recent ex-smokers were recruited in Nottinghamshire, United Kingdom (N = 850). Data were collected at 8-26 weeks gestation, 34-36 weeks gestation, and 3 months postpartum and used as three cross-sectional surveys. Interest and use of cessation support and belief and behavior measures were collected at all waves. Key data were adjusted for nonresponse and analyzed descriptively, and multiple regression was used to identify associations. RESULTS: In early and late pregnancy, 44% (95% CI 40% to 48%) and 43% (95% CI 37% to 49%) of smokers, respectively, were interested in cessation support with 33% (95% CI 27% to 39%) interested postpartum. In early pregnancy, 43% of smokers reported discussing cessation with a midwife and, in late pregnancy, 27% did so. Over one-third (38%) did not report discussing quitting with a health professional during pregnancy. Twenty-seven percent of smokers reported using any National Health Service (NHS) cessation support and 12% accessed NHS Stop Smoking Services during pregnancy. Lower quitting confidence (self-efficacy), higher confidence in stopping with support, higher quitting motivation, and higher age were associated with higher interest in support (ps ≤ .001). A recent quit attempt and greater interest in support was associated with speaking to a health professional about quitting and use of NHS cessation support (ps ≤ .001). CONCLUSIONS: When asked in early or late pregnancy, about half of pregnant smokers were interested in cessation support, though most did not engage. Cessation support should be offered throughout pregnancy and after delivery. IMPLICATIONS: There is relatively high interest in cessation support in early and late pregnancy and postpartum among smokers; however, a much smaller proportion of pregnant or postpartum women access any cessation support, highlighting a gap between interest and engagement. Reflecting women's interest, offers of cessation support should be provided throughout pregnancy and after delivery. Increasing motivation to quit and confidence in quitting with assistance may enhance interest in support, and promoting the discussion of stopping smoking between women and health practitioners may contribute to higher support engagement rates.

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.

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.

Evaluating diagnostic strategies for early detection of cancer: the CanTest framework.

BACKGROUND: 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. METHODS: We performed a systematic scoping review of frameworks for the evaluation of tests and diagnostic approaches. RESULTS: 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. CONCLUSION: 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.

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

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.

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.

BACKGROUND: 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. METHODOLOGY: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: ISRCTN83465245 Trial registration date: 14/06/2012.

Effectiveness of personalised risk information and taster sessions to increase the uptake of smoking cessation services (Start2quit): a randomised controlled trial.

BACKGROUND: National Health Service Stop Smoking Services (SSSs) offer help to smokers motivated to quit; however, attendance rates are low and recent figures show a downward trend. We aimed to assess the effectiveness of a two-component personalised intervention on attendance at SSSs. METHODS: We did this randomised controlled trial in 18 SSSs in England. Current smokers (aged ≥16 years) were identified from medical records in 99 general practices and invited to participate by their general practitioner. Individuals who gave consent, were motivated to quit, and had not attended the SSS within the past 12 months, were randomly assigned (3:2), via computer-generated randomisation with permuted blocks (block size of five), to receive either an individually tailored risk letter and invitation to attend a no-commitment introductory session run by the local SSS (intervention group) or a standard generic letter advertising the local SSS (control group). Randomisation was stratified by sex. Masking of participants to receipt of a personal letter and invitation to a taster session was not possible. The personal letter was generated by a research assistant, but the remainder of the research team were masked to group allocation. General practitioners, practice staff, and SSS advisers were unaware of their patients' allocation. The primary outcome was attendance at the first session of an SSS course within 6 months from randomisation. We did analysis by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN 76561916. FINDINGS: Recruitment, collection of baseline data, delivery of the intervention, and follow up of participants took place between Jan 31, 2011, and July 12, 2014. We randomly assigned 4384 smokers to the intervention group (n=2636) or the control group (n=1748); 4383 participants comprised the intention-to-treat population. Attendance at the first session of an SSS course was significantly higher in the intervention group than in the control group (458 [17·4%] vs 158 [9·0%] participants; unadjusted odds ratio 2·12 [95% CI 1·75-2·57]; p<0·0001). INTERPRETATION: Delivery of personalised risk information alongside an invitation to an introductory session more than doubled the odds of attending the SSS compared with a standard generic invitation to contact the service. This result suggests that a more proactive approach, combined with an opportunity to experience local services, can reduce patient barriers to receiving treatment and has high potential to increase uptake. FUNDING: National Institutes of Health Research Health Technology Assessment.

Cost-Effectiveness and Value of Information Analysis of Brief Interventions to Promote Physical Activity in Primary Care.

BACKGROUND: Brief interventions (BIs) delivered in primary care have shown potential to increase physical activity levels and may be cost-effective, at least in the short-term, when compared with usual care. Nevertheless, there is limited evidence on their longer term costs and health benefits. OBJECTIVES: To estimate the cost-effectiveness of BIs to promote physical activity in primary care and to guide future research priorities using value of information analysis. METHODS: A decision model was used to compare the cost-effectiveness of three classes of BIs that have been used, or could be used, to promote physical activity in primary care: 1) pedometer interventions, 2) advice/counseling on physical activity, and (3) action planning interventions. Published risk equations and data from the available literature or routine data sources were used to inform model parameters. Uncertainty was investigated with probabilistic sensitivity analysis, and value of information analysis was conducted to estimate the value of undertaking further research. RESULTS: In the base-case, pedometer interventions yielded the highest expected net benefit at a willingness to pay of £20,000 per quality-adjusted life-year. There was, however, a great deal of decision uncertainty: the expected value of perfect information surrounding the decision problem for the National Health Service Health Check population was estimated at £1.85 billion. CONCLUSIONS: Our analysis suggests that the use of pedometer BIs is the most cost-effective strategy to promote physical activity in primary care, and that there is potential value in further research into the cost-effectiveness of brief (i.e., <30 minutes) and very brief (i.e., <5 minutes) pedometer interventions in this setting.

A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers: study protocol.

BACKGROUND: Cancer is a leading cause of mortality and morbidity worldwide. Prevention is recognised by many, including the World Health Organization, to offer the most cost-effective long-term strategy for the control of cancer. One approach that focuses on individuals is the provision of personalised risk information. However, whether such information motivates behaviour change and whether the effect is different with varying formats of risk presentation is unclear. We aim to assess the short-term effect of providing information about personalised risk of cancer in three different formats alongside lifestyle advice on health-related behaviours, risk perception and risk conviction. METHODS: In a parallel group, randomised controlled trial 1000 participants will be recruited through the online platform Prolific. Participants will be allocated to either a control group receiving cancer-specific lifestyle advice alone or one of three intervention groups receiving the same lifestyle advice alongside their estimated 10-year risk of developing one of the five most common preventable cancers, calculated from self-reported modifiable behavioural risk factors, in one of three different formats (bar chart, pictograph or qualitative scale). The primary outcome is change from baseline in computed risk relative to an individual with a recommended lifestyle at three months. Secondary outcomes include: perceived risk of cancer; anxiety; cancer-related worry; intention to change behaviour; and awareness of cancer risk factors. DISCUSSION: This study will provide evidence on the short-term effect of providing online information about personalised risk of cancer alongside lifestyle advice on risk perception and health-related behaviours and inform the development of interventions. TRIAL REGISTRATION: ISRCTN17450583. Registered 30 January 2018.