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OBJECTIVE: Attribution of neuropsychiatric symptoms in systemic lupus erythematosus (SLE) relies heavily on clinician assessment. Limited clinic time, variable knowledge, and symptom under-reporting contributes to discordance between clinician assessments and patient symptoms. We obtained attributional data directly from patients and clinicians in order to estimate and compare potential levels of direct attribution to SLE of multiple neuropsychiatric symptoms using different patient-derived measures. METHODS: Quantitative and qualitative data analysed included: prevalence and frequency of neuropsychiatric symptoms, response to corticosteroids, and concurrence of neuropsychiatric symptoms with non-neuropsychiatric SLE disease activity. SLE patients were also compared with controls and inflammatory arthritis (IA) patients to explore attributability of neuropsychiatric symptoms to the direct disease effects on the brain/nervous system. RESULTS: We recruited 2,817 participants, including 400 clinicians. SLE patients (n = 609) reported significantly higher prevalences of neuropsychiatric symptoms than controls (n = 463) and IA patients (n = 489). SLE and IA patients' quantitative data demonstrated multiple neuropsychiatric symptoms relapsing/remitting with other disease symptoms such as joint pain. Over 45% of SLE patients reported resolution/improvement of fatigue, positive sensory symptoms, severe headache, and cognitive dysfunction with corticosteroids. Evidence of direct attributability in SLE was highest for hallucinations and severe headache. SLE patients had greater reported improvement from corticosteroids (p= 0.008), and greater relapsing-remitting with disease activity (p< 0.001) in the comparisons with IA patients for severe headache. Clinician and patients reported insufficient time to discuss patient-reported attributional evidence. Symptoms viewed as indirectly related/non-attributable were often less prioritised for discussion and treatment. CONCLUSION: We found evidence indicating varying levels of direct attributability of both common and previously unexplored neuropsychiatric symptoms in SLE patients, with hallucinations and severe headache assessed as the most directly attributable. There may also be-currently under-estimated-direct effects on the nervous system in IA and other systemic rheumatological diseases.
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INTRODUCTION: For nonpregnant people unable to quit smoking, the NHS recommends nicotine replacement therapy (NRT) for smoking reduction. This is not recommended during pregnancy due to concerns about higher nicotine intake than smoking alone. We investigated the relationship between daily nicotine dose from NRT and cigarette consumption reported by pregnant women receiving smoking cessation support. METHODS: We conducted secondary analysis of data from currently smoking pregnant women, recruited from antenatal clinics (Nottingham University Hospitals, UK) or online between June 2019-September 2020. Participants set a quit date, received a prototype NRT adherence intervention, and reported cigarettes per day (CPD) and daily NRT dose (mg) via smartphone app for 28 days. RESULTS: 388 women were screened, 32 (8%) were eligible and joined the study. 24 (75%) submitted 510 app reports in total. 17 (71%) reported smoking and using NRT concurrently on at least one day, with concurrent use reported on 109 (21%) of app reports.The relationship between daily NRT dose and CPD followed an exponential decay curve of approximately 7%. In multilevel repeated measures modelling using 4 linear splines (knots 17, 40, and 85 mg/NRT), significant fixed effects of daily NRT dose on CPD were observed for splines 1, 3, and 4. The strongest association was spline 1 (0-17 mg/NRT), where each 10 mg NRT increase was associated with a 0.6 CPD reduction (24% on average). CONCLUSIONS: Among women in a cessation study, many smoked and used NRT concurrently; within these women, daily nicotine dose and heaviness of smoking were inversely related. IMPLICATIONS: Findings have implications for the design of future interventions intended to reduce harm associated with smoking in pregnancy. They suggest using NRT alongside smoking in pregnancy could help some women reduce the number of cigarettes they smoke per day.
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Cese del Hábito de Fumar , Reducción del Consumo de Tabaco , Productos de Tabaco , Femenino , Humanos , Embarazo , Nicotina , Mujeres Embarazadas , Dispositivos para Dejar de Fumar TabacoRESUMEN
INTRODUCTION: Unsupported attempts to quit smoking during pregnancy have a low success rate. Chances of quitting successfully are higher with an interpersonal treatment programme but there is low uptake of this in the United Kingdom (UK). Delivering a pregnancy-specific treatment programme digitally may provide an alternative treatment route. This study explored pregnant smokers' perceptions of barriers and facilitators to using digital cessation support, along with identifying modes of delivery and engagement enhancers. METHODS: Semi-structured interviews were carried out with an ethnically and socioeconomically diverse sample of 25 participants with recent experience of attempting to quit smoking in pregnancy, aged 20 - 40, from the UK. An inductive thematic analysis approach was used. RESULTS: Digital smoking cessation support, particularly a smartphone app, for pregnancy was felt to overcome many barriers to engaging with interpersonal support, being viewed as more convenient and non-judgemental, providing better consistency of advice, and enhancing privacy and autonomy. However, some participants felt that removing access to a human could undermine a digital support package and reduce engagement. Popular engagement enhancers included self-monitoring (e.g. digital recording of smoking; smartphone-linked carbon monoxide monitoring), online communities, and remote access to nicotine substitution options. Digital support was viewed as having potential as a stand-alone intervention or working in conjunction with standard interpersonal treatment. CONCLUSIONS: The findings support the investigation of a digital support package as both a stand-alone and adjunct to standard interpersonal cessation support in pregnancy to increase the proportion of pregnant smokers who make a supported quit attempt. IMPLICATIONS: In many countries like the UK, there are few smoking cessation options routinely available that provide effective support for smoking cessation in pregnancy. To maximise impact, health services need an effective range of strategies to engage with and support quit attempts made by all pregnant smokers, particularly as interpersonal support options are not often well engaged with. Development of a pregnancy-specific digital support package for smoking cessation in pregnancy may represent a means to help address this gap.
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INTRODUCTION: Digital cessation support appeals to pregnant smokers. In two pooled RCTs, MiQuit, a pregnancy-specific tailored text messaging intervention, did not show effectiveness for validated prolonged abstinence. However, secondary outcomes and potential moderators and mediators have not been investigated. We aimed to determine, using pooled RCT data: (1) MiQuit effectiveness on a range of smoking outcomes; (2) whether baseline tobacco dependence or quit motivation moderate effectiveness; (3) whether hypothesized mechanisms of action (quitting determination, self-efficacy, baby harm beliefs, lapse prevention strategies) mediate effectiveness. METHODS: Pooled data analysis from two procedurally identical RCTs comparing MiQuit (Nâ =â 704) to usual care (Nâ =â 705). Participants were smokers, <25 weeks pregnant, recruited from 40 English antenatal clinics. Outcomes included self-reported 7-day abstinence at 4 weeks post-baseline and late pregnancy, and prolonged abstinence. Late pregnancy outcomes were also biochemically validated. We used hierarchical regression and structural equation modeling. RESULTS: MiQuit increased self-reported, 7-day abstinence at 4 weeks (ORâ =â 1.73 [95% CI 1.10-2.74]) and was borderline significant at late pregnancy (ORâ =â 1.34 [0.99-1.82]) but not for prolonged or validated outcomes. Effectiveness was not moderated by baseline dependence (heaviness of smoking "low" vs. "moderate-high") or motivation (planning to quit ≤30 days [high] vs. >30 days [low]), but effects on self-reported outcomes were larger for the high motivation sub-group. MiQuit had a small effect on mean lapse prevention strategies (MiQuit 8.6 [SE 0.17], UC 8.1 [SE 0.17]; Pâ =â .030) but not other mechanisms. CONCLUSIONS: MiQuit increased short-term but not prolonged or validated abstinence and may be most effective for those motivated to quit sooner. IMPLICATIONS: Digital cessation support appeals to pregnant smokers. MiQuit, a tailored, theory-guided text messaging program for quitting smoking in pregnancy, has not shown effectiveness for validated prolonged abstinence in two previous RCTs but its impact on other smoking outcomes and potential mechanisms of action are unknown. When pooling trial data, MiQuit increased self-reported short-term abstinence, including making a quit attempt and abstinence at 4-week follow-up, but not late pregnancy, sustained, or validated abstinence. MiQuit appeared effective at late pregnancy for participants with high quitting motivation, but its mechanisms of action remain uncertain. Additional support components are likely required to enhance effectiveness.
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Cese del Hábito de Fumar , Envío de Mensajes de Texto , Humanos , Femenino , Embarazo , Cese del Hábito de Fumar/métodos , Cese del Hábito de Fumar/psicología , Adulto , Motivación , Adulto JovenRESUMEN
INTRODUCTION: Poor retention in clinical trials can impact on statistical power, reliability, validity and generalisability of findings and is a particular challenge in smoking cessation studies. In online trials with automated follow up mechanisms, poor response also increases resource-need for manual follow up. This study compared two financial incentives on response rates at 6 months follow up, in an online, automated smoking cessation feasibility trial of a cessation smartphone app (Quit Sense). METHODS: A study within a trial (SWAT), embedded within a host randomised controlled trial. Host trial participants were randomised 1:1 to receive either a £10 or £20 voucher incentive, for completing the 6-month questionnaire. Stratification for randomisation to the SWAT was by minimisation to ensure an even split of host trial arm participants, and by 6-week response rate. Outcome measures were: questionnaire completion rate, time to completion, number of completers requiring manual follow up and completeness of responses. RESULTS: 204 participants were randomised to the SWAT. The £20 and £10 incentives did not differ in completion rate at 6 months (79% versus 74%; p=0.362) but did reduce the proportion of participants requiring manual follow up (46% versus 62%; p=0.018) and the median completion time (7 days versus 15 days; p=0.008). Measure response completeness rates were higher among £20 incentive participants, though differences were small for the host trial's primary smoking outcome. CONCLUSIONS: Benefits to using relatively modest increases in incentive for online smoking cessation trials include more rapid completion of follow up questionnaires and reduced manual follow up. IMPLICATIONS: A modest increase in incentive (from £10 to £20) to promote the completion of follow up questionnaires in online smoking cessation trials may not increase overall response rates but could lead to more rapid data collection, a reduced need for manual follow-up and reduced missing data among those who initiate completing a questionnaire. Such an improvement may help to reduce bias, increase validity and generalisability, and improve statistical power in smoking cessation trials.
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INTRODUCTION: The aim of our study was to assess the feasibility and acceptability of a brief behavioral intervention for tobacco cessation delivered via mobile phone text messaging in India. AIMS AND METHODS: We conducted an uncontrolled intervention cohort study in adult current users of tobacco. The participants received intervention messages on their mobile phones for eight weeks. We collected qualitative data about participants' perceptions of intervention delivery and receipt, acceptability, and feasibility of the intervention. The outcomes measured at 3 months post-recruitment were self-reported 7- and 28-day point-prevalence abstinence, and Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) risk categories for tobacco-low (0-3), moderate (4-26), and high (≥27). RESULTS: We recruited 26 eligible participants, and 22 completed the outcome assessments. The participants generally perceived the intervention content to be simple to access and useful in facilitating a change in tobacco use. None of the participants indicated that they wanted to discontinue receiving the intervention messages. Some suggestions for enhancing acceptability included supplementing text messaging with more intensive counseling and the use of multimedia content. Eighteen percent of participants reported abstinence in the past 7 and 28 days. A greater proportion of those who used smokeless tobacco were abstinent at follow-up compared to those who smoked (42.9% vs. 6.7%; pâ =â .04). CONCLUSIONS: If effective, simple and low-cost mobile phone text messaging can be used to deliver interventions for tobacco use, and has the potential to be scaled up so it can be delivered to populations of smokers interested in receiving cessation support. IMPLICATIONS: Our study is an important step towards the development of a contextually relevant intervention suited for low- and middle-income countries and which is responsive to the needs of both those who use smoked and smokeless tobacco. If found to be effective, our intervention would be a scalable solution to overcome the human resource related barrier to accessing tobacco cessation services in low resource settings.
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Cese del Hábito de Fumar , Envío de Mensajes de Texto , Cese del Uso de Tabaco , Adulto , Humanos , Cese del Hábito de Fumar/psicología , Estudios de Factibilidad , Estudios de Cohortes , Productos de TabacoRESUMEN
INTRODUCTION: Despite the high burden of tobacco use in India, users do not have access to adequate help. This pilot trial aimed to evaluate the feasibility and acceptability of a text messaging intervention for tobacco cessation, generate preliminary estimates of its impact, and fine-tune procedures for a definitive trial. METHODS: Parallel two-arm single blind individually randomised controlled pilot trial with nested qualitative study. Participants included adult current tobacco users (smoked and smokeless). Eligible and consenting participants were randomised to receive either (a) text messaging intervention (ToQuit) which covered specific content areas such as psychoeducation about consequences of tobacco use and benefits of quitting and tobacco avoidance strategies or (b) information about tobacco cessation helplines such as the helpline number and the languages in which tobacco cessation support was available (control). Feasibility data included screening and consent rates, treatment dropouts and outcome ascertainment. The primary abstinence outcome was self-reported abstinence from tobacco in the past seven days at three months post-randomisation. In-depth interviews were conducted with a sub-sample of participants primarily to collect acceptability data. The primary abstinence analysis used a chi-squared test and logistic regression (complete-case), and qualitative data analysed using thematic analysis. RESULTS: Ninety eight participants were randomised into the two trial arms; 77 (79%) completed outcome evaluation. No between-arm differences in abstinence were found though findings favoured the intervention (7-day abstinence: ToQuit 23%, control 19%; adjusted odds ratio 1.23, 95% confidence interval 0.38, 3.97). Participants appreciated the language, comprehensibility, and relevance of the messages; and reported overall satisfaction with and positive impact from the intervention on their lives. CONCLUSION: The findings indicate the acceptability and feasibility of ToQuit and if found effective, it could be a potentially scalable first-line response to tobacco use in low resource settings. IMPLICATIONS: Our pilot RCT provides sufficient findings supporting the acceptability and feasibility of an intervention for tobacco cessation which is suitable for a context which has a shortage of healthcare workers and for individuals who use smoked or smokeless tobacco. This is critical on a background of limited contextually relevant interventions for a problem with a high burden in low- and middle- income countries such as India.
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INTRODUCTION: India is the second largest consumer of tobacco in the world and accounts for 70% of global deaths due to smokeless tobacco (SLT) use. AIM: The aim of this study is to understand the perspectives of tobacco users (smokers and SLT users) and practitioners in India to inform cessation interventions. METHOD: Semi-structured in-depth interviews with tobacco users (smoked and smokeless; n=23), and healthcare practitioners (n=13). Perspectives were triangulated using thematic analysis to examine convergence, divergence and complementarity of findings. RESULTS: We present the results in a socio-ecological framework to highlight reasons for initiation and continuation of tobacco and motives to quit at the individual, interpersonal, occupational, societal and policy levels. SLT is seen as culturally acceptable compared to smoked forms of tobacco. Emotionally framed messages highlighting negative effects of tobacco on loved ones were perceived to be a better motivator than other types of cessation messages. DISCUSSION: Nuanced differences exist between smokers and SLT user perspectives which have implications for cessation programs. Our findings supplement similar studies with other South Asian populations. IMPLICATIONS FOR PRACTICE: Our study provides useful insights to tailor cessation interventions to the type of tobacco consumed in order to enhance their acceptability and effectiveness.
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Investigación Cualitativa , Fumadores , Tabaco sin Humo , Humanos , India , Masculino , Femenino , Adulto , Fumadores/psicología , Fumadores/estadística & datos numéricos , Cese del Uso de Tabaco/psicología , Entrevistas como Asunto , Motivación , Persona de Mediana Edad , Cese del Hábito de Fumar/psicologíaRESUMEN
OBJECTIVE: A limited range of neuropsychiatric symptoms have been reported in systemic autoimmune rheumatic diseases (SARDs), with varied symptom prevalence. This study aimed to investigate a wider range of potential symptoms than previous studies, compare patient self-reports with clinician estimates, and explore barriers to symptom identification. METHODS: Mixed methods were used. Data from SARDs patients (n = 1853) were compared with controls (n = 463) and clinicians (n = 289). In-depth interviews (n = 113) were analysed thematically. Statistical tests compared means of survey items between: patients and controls, 8 different SARD groups, and clinician specialities. RESULTS: Self-reported lifetime prevalences of all 30 neuropsychiatric symptoms investigated (including cognitive, sensorimotor and psychiatric) were significantly higher in SARDs than controls. Validated instruments assessed 55% of SARDs patients as currently having depression and 57% anxiety. Barriers to identifying neuropsychiatric symptoms included: 1) limits to knowledge, guidelines, objective tests, and inter-specialty cooperation; 2) subjectivity, invisibility and believability of symptoms; and 3) under-eliciting, under-reporting and under-documenting. A lower proportion of clinicians (4%) reported never/rarely asking patients about mental health symptoms than the 74% of patients who reported never/rarely being asked in clinic (p< 0.001). Over 50% of SARDs patients had never/rarely reported their mental health symptoms to clinicians; a proportion under-estimated at < 10% by clinicians (p< 0.001). CONCLUSION: Neuropsychiatric symptom self-reported prevalences are significantly higher in SARDs than controls, and greatly underestimated by most clinicians. Research relying on medical records and current guidelines is unlikely to accurately reflect patients' experiences of neuropsychiatric symptoms. Improved inter-specialty communication and greater patient involvement is needed in SARD care and research.
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OBJECTIVE: Neuropsychiatric lupus (NPSLE) is challenging to diagnose. Many neuropsychiatric symptoms, such as headache and hallucinations, cannot be verified by tests or clinician assessment. We investigated prioritisations of methods for diagnosing NPSLE and attributional views. METHODS: Thematic and comparative analyses were used to investigate how clinicians prioritise sources of evidence from a 13-item list, and explore discordances in clinician and patient perspectives on attribution. RESULTS: We identified high levels of variability and uncertainty in clinicians' assessments of neuropsychiatric symptoms in SLE patients. In attributional decisions, clinicians (surveys n = 400, interviews n = 50) ranked clinicians' assessments above diagnostic tests (many of which they reported were often unenlightening in NPSLE). Clinicians ranked patient opinion of disease activity last, and 46% of patients reported never/rarely having been asked if their SLE was flaring, despite experienced patients often having "attributional insight". SLE Patients (surveys n = 676, interviews n = 27) estimated higher attributability of neuropsychiatric symptoms to the direct effects of SLE on the nervous system than clinicians (p < 0.001 for all symptoms excluding mania), and 24% reported that their self-assessment of disease activity was never/rarely concordant with their clinicians. Reports of misattributions were common, particularly of non-verifiable diffuse symptoms. Terminology differed between clinicians and influenced attribution estimates. CONCLUSION: NPSLE diagnostic tests and clinician assessments have numerous limitations, particularly in detecting diffuse neuropsychiatric symptoms that can be directly attributable and benefit from immunosuppression. Our findings suggest that incorporating patient attributional insights-although also subject to limitations-may improve attribution decision-making. Consensus regarding terminology and interpretations of "direct attributability" is required.
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INTRODUCTION: Smoking lapses after the quit date often lead to full relapse. To inform the development of real time, tailored lapse prevention support, we used observational data from a popular smoking cessation app to develop supervised machine learning algorithms to distinguish lapse from non-lapse reports. AIMS AND METHODS: We used data from app users with ≥20 unprompted data entries, which included information about craving severity, mood, activity, social context, and lapse incidence. A series of group-level supervised machine learning algorithms (eg, Random Forest, XGBoost) were trained and tested. Their ability to classify lapses for out-of-sample (1) observations and (2) individuals were evaluated. Next, a series of individual-level and hybrid algorithms were trained and tested. RESULTS: Participants (N = 791) provided 37 002 data entries (7.6% lapses). The best-performing group-level algorithm had an area under the receiver operating characteristic curve (AUC) of 0.969 (95% confidence interval [CI] = 0.961 to 0.978). Its ability to classify lapses for out-of-sample individuals ranged from poor to excellent (AUC = 0.482-1.000). Individual-level algorithms could be constructed for 39/791 participants with sufficient data, with a median AUC of 0.938 (range: 0.518-1.000). Hybrid algorithms could be constructed for 184/791 participants and had a median AUC of 0.825 (range: 0.375-1.000). CONCLUSIONS: Using unprompted app data appeared feasible for constructing a high-performing group-level lapse classification algorithm but its performance was variable when applied to unseen individuals. Algorithms trained on each individual's dataset, in addition to hybrid algorithms trained on the group plus a proportion of each individual's data, had improved performance but could only be constructed for a minority of participants. IMPLICATIONS: This study used routinely collected data from a popular smartphone app to train and test a series of supervised machine learning algorithms to distinguish lapse from non-lapse events. Although a high-performing group-level algorithm was developed, it had variable performance when applied to new, unseen individuals. Individual-level and hybrid algorithms had somewhat greater performance but could not be constructed for all participants because of the lack of variability in the outcome measure. Triangulation of results with those from a prompted study design is recommended prior to intervention development, with real-world lapse prediction likely requiring a balance between unprompted and prompted app data.
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Aplicaciones Móviles , Cese del Hábito de Fumar , Humanos , Cese del Hábito de Fumar/métodos , Fumadores , Fumar , Aprendizaje Automático Supervisado , Teléfono InteligenteRESUMEN
BACKGROUND: The effectiveness of Nicotine Replacement Therapy (NRT) for smoking cessation in pregnancy is limited by inconsistent and incorrect use. This paper describes the development process for "Baby, Me, & NRT", a novel pregnancy-specific intervention aimed at enhancing adherence to NRT. METHODS: An integrated approach to intervention development was used, combining evidence, theory, stakeholders' feedback, and tailoring principles. The process involved six iterative steps: (1) synthesizing relevant published evidence and guidance, (2) collecting primary qualitative data on barriers and facilitators to NRT adherence along with potential intervention design features, (3) identifying relevant behavioral theories and mapping the evidence against these, (4) prioritizing behavioral determinants identified in steps 1 and 2, generating intervention objectives, and identifying behavior change techniques which target the prioritized determinants, (5) consulting with stakeholders on intervention components, key content and tailoring features, and (6) producing a prototype intervention along with implementation guidance. RESULTS: The prototype intervention comprises of a multi-component, 1-month cessation programme, which includes six enhanced behavioral support sessions delivered by a trained advisor, tailored text messages, a website, and an illustrated booklet. It promotes the uptake of high-dose and combination NRT, emphasizes the importance of adherence, addresses motivation to use NRT, proactively helps problem solve NRT use issues, and provides guidance on preventing and managing smoking lapses. CONCLUSION: The development process generated an evidence- and theory-guided intervention, designed with stakeholder input, aimed at improving NRT effectiveness for smoking cessation in pregnancy. The prototype intervention has since been optimized and is being evaluated in a randomized controlled trial.
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Terapia Conductista , Cese del Hábito de Fumar , Femenino , Humanos , Embarazo , Fumar , Cese del Hábito de Fumar/métodos , Fumar Tabaco , Dispositivos para Dejar de Fumar TabacoRESUMEN
INTRODUCTION: Improving adherence to nicotine replacement therapy (NRT) in pregnancy may result in higher smoking cessation rates. Informed by the Necessities and Concerns Framework, we developed an intervention targeting pregnancy NRT adherence. To evaluate this, we derived the NRT in pregnancy necessities and concerns questionnaire (NiP-NCQ), which measures perceived need for NRT and concerns about potential consequences. AIMS AND METHODS: Here we describe the development and content validation of NiP-NCQ. From qualitative work, we identified potentially modifiable determinants of pregnancy NRT adherence and classed these as necessity beliefs or concerns. We translated these into draft self-report items and piloted items on 39 pregnant women offered NRT and a prototype NRT adherence intervention, assessing distributions and sensitivity to change. After removing poorly performing items, smoking cessation experts (N = 16) completed an online discriminant content validation (DCV) task to determine whether retained items measure a necessity belief, concern, both, or neither construct. RESULTS: Draft NRT concern items encompassed safety for the baby, side effects, too much or insufficient nicotine, and addictiveness. Draft necessity belief items included perceived need for NRT for short- and longer-term abstinence, and desire to minimize or cope without NRT. Of 22 out of 29 items retained after piloting, four were removed following the DCV task: three were judged to measure neither construct and one possibly both. The final NiP-NCQ comprised nine items per construct (18 total). CONCLUSIONS: The NiP-NCQ measures potentially modifiable determinants of pregnancy NRT adherence within two distinct constructs and may have research and clinical utility for evaluating interventions targeting these. IMPLICATIONS: Poor adherence to NRT in pregnancy may result from low perceived need and concerns about consequences; interventions challenging these beliefs may yield higher smoking cessation rates. To evaluate an NRT adherence intervention informed by the Necessities and Concerns Framework, we developed the NiP-NCQ. Through the content development and refinement processes described in this paper, we derived an evidence-based, 18-item questionnaire measuring two distinct constructs within two nine-item subscales. Higher concerns and lower necessity beliefs indicate more negative NRT beliefs; NiP-NCQ may have research and clinical utility for interventions targeting these.
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Cese del Hábito de Fumar , Embarazo , Femenino , Humanos , Dispositivos para Dejar de Fumar Tabaco/efectos adversos , Nicotina/uso terapéutico , Mujeres Embarazadas , AutoinformeRESUMEN
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.
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Aplicaciones Móviles , Cese del Hábito de Fumar , Humanos , Cese del Hábito de Fumar/métodos , Estudios de Factibilidad , Fumar , AutoinformeRESUMEN
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.
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Médicos , Calidad de Vida , Humanos , Cumplimiento de la Medicación , Satisfacción del Paciente , Relaciones Médico-PacienteRESUMEN
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.
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COVID-19 , Reumatología , Telemedicina , COVID-19/epidemiología , Humanos , Pandemias , Encuestas y Cuestionarios , Telemedicina/métodosRESUMEN
BACKGROUND: Digital health promotion programs tailored to the individual are a potential cost-effective and scalable solution to enable self-management and provide support to people with excess body weight. However, solutions that are widely accessible, personalized, and theory- and evidence-based are still limited. OBJECTIVE: This study aimed to develop a digital behavior change program, Choosing Health, that could identify modifiable predictors of weight loss and maintenance for each individual and use these to provide tailored support. METHODS: We applied an Intervention Mapping protocol to design the program. This systematic approach to develop theory- and evidence-based health promotion programs consisted of 6 steps: development of a logic model of the problem, a model of change, intervention design and intervention production, the implementation plan, and the evaluation plan. The decisions made during the Intervention Mapping process were guided by theory, existing evidence, and our own research-including 4 focus groups (n=40), expert consultations (n=12), and interviews (n=11). The stakeholders included researchers, public representatives (including individuals with overweight and obesity), and experts from a variety of relevant backgrounds (including nutrition, physical activity, and the health care sector). RESULTS: Following a structured process, we developed a tailored intervention that has the potential to reduce excess body weight and support behavior changes in people with overweight and obesity. The Choosing Health intervention consists of tailored, personalized text messages and email support that correspond with theoretical domains potentially predictive of weight outcomes for each participant. The intervention content includes behavior change techniques to support motivation maintenance, self-regulation, habit formation, environmental restructuring, social support, and addressing physical and psychological resources. CONCLUSIONS: The use of an Intervention Mapping protocol enabled the systematic development of the Choosing Health intervention and guided the implementation and evaluation of the program. Through the involvement of different stakeholders, including representatives of the general public, we were able to map out program facilitators and barriers while increasing the ecological validity of the program to ensure that we build an intervention that is useful, user-friendly, and informative. We also summarized the lessons learned for the Choosing Health intervention development and for other health promotion programs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2020-040183.
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Sobrepeso , Pérdida de Peso , Humanos , Promoción de la Salud/métodos , Obesidad/terapia , Ejercicio Físico , Aumento de PesoRESUMEN
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.
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Adaptación Fisiológica , Lupus Eritematoso Sistémico/psicología , Calidad de Vida/psicología , Apoyo Social , Errores Diagnósticos , Femenino , Conocimientos, Actitudes y Práctica en Salud , Accesibilidad a los Servicios de Salud , Humanos , Lupus Eritematoso Sistémico/epidemiología , Relaciones Médico-Paciente , Investigación Cualitativa , Resiliencia Psicológica , Reino Unido/epidemiologíaRESUMEN
Understanding the preferences of potential users of digital health products is beneficial for digital health policy and planning. Stated preference methods could help elicit individuals' preferences in the absence of observational data. A discrete choice experiment (DCE) is a commonly used stated preference method-a quantitative methodology that argues that individuals make trade-offs when engaging in a decision by choosing an alternative of a product or a service that offers the greatest utility, or benefit. This methodology is widely used in health economics in situations in which revealed preferences are difficult to collect but is much less used in the field of digital health. This paper outlines the stages involved in developing a DCE. As a case study, it uses the application of a DCE to reveal preferences in targeting the uptake of smoking cessation apps. It describes the establishment of attributes, the construction of choice tasks of 2 or more alternatives, and the development of the experimental design. This tutorial offers a guide for researchers with no prior knowledge of this research technique.
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Conducta de Elección , Prioridad del Paciente , Teorema de Bayes , Política de Salud , Servicios de Salud , HumanosRESUMEN
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.