Neuropsychiatric symptoms in Systemic Lupus Erythematosus: mixed methods analysis of patient-derived attributional evidence in the international INSPIRE project.

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.

Attribution of neuropsychiatric symptoms and prioritisation of evidence in the diagnosis of neuropsychiatric lupus: mixed methods analysis of patient and clinician perspectives from the international INSPIRE study.

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.

Prevalence and identification of neuropsychiatric symptoms in systemic autoimmune rheumatic diseases: an international mixed methods study.

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.

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.

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.

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.

COVID-19 and shielding: experiences of UK patients with lupus and related diseases.

OBJECTIVE: The shielding guidance in the UK for the clinically extremely vulnerable (CEV) commenced on 23 March 2020 in response to the coronavirus disease 2019 (COVID-19) pandemic. The purpose of this study was to explore the impact of the pandemic and shielding on patients with lupus and related systemic autoimmune rheumatic diseases (SARDs). METHODS: This was a mixed-methods cohort study (n = 111) including pre-lockdown baseline surveys (March 2020), follow-up surveys (June 2020) and in-depth interviews during July 2020 (n = 25). RESULTS: Most participants had a high level of anxiety regarding their mortality risk from COVID-19 and supported the concept of shielding. Shielding allocations and communications were perceived as inconsistently applied and delivered. More than half of those not classified as CEV reported feeling abandoned, at increased risk and with no support. Shielding communications increased feelings of being 'cared about', but also increased fear, and the 'vulnerable' labelling was perceived by some to damage social and self-identity. More than 80% of those classified as CEV stated that the classification and subsequent communications had changed their social-mixing behaviour. Despite many negative impacts of COVID-19 and shielding/lockdown being identified, including isolation, fear and reduced medical care, the quantitative data during the pandemic showed increases in most measures of wellbeing (which was low at both time points) from pre-lockdown, including reductions in the impact of fatigue and pain (P-values < 0.001). CONCLUSION: Shielding classifications and communications were, in general, viewed positively, although they were perceived as inconsistently delivered and anxiety-provoking by some participants. More frequent positively framed communication and wellbeing support could benefit all SARD patients. Slower-paced lockdown lifestyles might confer health/wellbeing benefits for some people with chronic diseases.

The impact of the COVID-19 pandemic on the medical care and health-care behaviour of patients with lupus and other systemic autoimmune diseases: a mixed methods longitudinal study.

OBJECTIVE: The aim was to explore the self-reported impact of the COVID-19 pandemic on changes to care and behaviour in UK patients with systemic autoimmune rheumatic diseases, to help ensure that patient experiences are considered in future pandemic planning. METHODS: This was a longitudinal mixed methods study, with a cohort completing baseline surveys in March 2020 and follow-up surveys in June 2020 (n = 111), combined with thematic analysis of the LUPUS UK forum and participant interviews (n = 28). RESULTS: Cancellations of routine care and difficulties in accessing medical support contributed to some participants deteriorating physically, including reports of hospitalizations. The majority of participants reported that fear of COVID-19 and disruptions to their medical care had also adversely impacted their mental health. Feeling medically supported during the pandemic was correlated with multiple measures of mental health and perceptions of care, including the Warwick-Edinburgh mental well-being score (r = 0.44, P = 0.01). Five themes were identified: detrimental reduction in care; disparities in contact and communication (medical security vs abandonment sub-theme); perceived and actual endangerment; the perfect storm of reduced clinician ability to help and increased patient reticence to seek help; and identifying the patients most vulnerable to reduced medical care. CONCLUSION: The diversion of resources away from chronic disease care was perceived by many participants to have caused adverse outcomes. Fear about increased vulnerability to COVID-19 was high, contributing to health-care-avoidant behaviours. This study also highlights the influence of clinician accessibility and patients feeling medically supported on multiple measures of physical and mental health.

'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.

Is it me? The impact of patient-physician interactions on lupus patients' psychological well-being, cognition and health-care-seeking behaviour.

OBJECTIVE: The aim was to explore the impact of patient-physician interactions, pre- and post-diagnosis, on lupus and UCTD patients' psychological well-being, cognition and health-care-seeking behaviour. METHODS: Participants were purposively sampled from the 233 responses to a survey on patient experiences of medical support. Twenty-one semi-structured interviews were conducted and themes generated using thematic analysis. RESULTS: The study identified six principal themes: (i) the impact of the diagnostic journey; (ii) the influence of key physician(s) on patient trust and security, with most participants reporting at least one positive medical relationship; (iii) disparities in patient-physician priorities, with patients desiring more support with quality-of-life concerns; (iv) persisting insecurity and distrust, which was prevalent and largely influenced by previous and anticipated disproportionate (often perceived as dismissive) physician responses to symptoms and experiences of widespread inadequate physician knowledge of systemic autoimmune diseases; (v) changes to health-care-seeking behaviours, such as curtailing help-seeking or under-reporting symptoms; and (vi) empowerment, including shared medical decision-making and knowledge acquisition, which can mitigate insecurity and improve care. CONCLUSION: Negative medical interactions pre- and post-diagnosis can cause a loss of self-confidence and a loss of confidence and trust in the medical profession. This insecurity can persist even in subsequent positive medical relationships and should be addressed. Key physicians implementing empowering and security-inducing strategies, including being available in times of health crises and validating patient-reported symptoms, might lead to more trusting medical relationships and positive health-care-seeking behaviour.

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

BACKGROUND: The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. OBJECTIVE: This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. METHODS: The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. RESULTS: The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. CONCLUSIONS: iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17160.

Medically explained symptoms: a mixed methods study of diagnostic, symptom and support experiences of patients with lupus and related systemic autoimmune diseases.

OBJECTIVES: The aim was to explore patient experiences and views of their symptoms, delays in diagnosis, misdiagnoses and medical support, to identify common experiences, preferences and unmet needs. METHODS: Following a review of LUPUS UK's online forum, a questionnaire was posted online during December 2018. This was an exploratory mixed methods study, with qualitative data analysed thematically and combined with descriptive and statistically analysed quantitative data. RESULTS: There were 233 eligible respondents. The mean time to diagnosis from first experiencing symptoms was 6 years 11 months. Seventy-six per cent reported at least one misdiagnosis for symptoms subsequently attributed to their systemic autoimmune rheumatic disease. Mental health/non-organic misdiagnoses constituted 47% of reported misdiagnoses and were indicated to have reduced trust in physicians and to have changed future health-care-seeking behaviour. Perceptions of physician knowledge and listening skills were highly correlated with patient ratings of trust. The symptom burden was high. Fatigue had the greatest impact on activities of daily living, yet the majority reported receiving no support or poor support in managing it. Assessing and treating patients holistically and with empathy was strongly felt to increase diagnostic accuracy and improve medical relationships. CONCLUSION: Patient responses indicated that timely diagnosis could be facilitated if physicians had greater knowledge of lupus/related systemic autoimmune diseases and were more amenable to listening to and believing patient reports of their symptoms. Patient priorities included physicians viewing them holistically, with more emotional support and assistance in improving quality of life, especially in relation to fatigue.

Lifeline for the front lines: blood products to support the warfighter.

BACKGROUND: Hemorrhage is the leading cause of death on the battlefield. Damage control resuscitation guidelines in the US military recommend whole blood as the preferred resuscitation product. The Armed Services Blood Program (ASBP) has initiated low-titer group O whole blood (LTOWB) production and predeployment donor screening to make whole blood more available to military forces. STUDY DESIGN AND METHODS: ASBP donor centers updated procedures and labeling for LTOWB production. Donors are screened according to US Food and Drug Administration regulations and standard operating procedures. Group O donors are tested for anti-A and anti-B titer levels. Additionally, military personnel notified for pending deployment coordinate with their local ASBP donor center to complete whole blood donor prescreening. The process consists of completing a donor history questionnaire, processing of blood samples for blood group and infectious disease testing, and titer determination for group O personnel. RESULTS: Since March 2016, 7940 LTOWB units have been manufactured at ASBP donor centers and shipped in support of combat operations. Additionally, ASBP donor centers have screened several thousand service members before deployment. From these screenings, the donor low titer rate was 68% and infectious disease reactive test rate was extremely low (≤0.004). CONCLUSION: Whole blood is now the preferred blood product for resuscitation of combat trauma patients. The ASBP partnered with combat forces to screen personnel before deployment. Additionally, LTOWB is manufactured and shipped in support of combat operations. These efforts are expanding the availability of LTOWB for the warfighter.

Smoking Cessation Support by Text Message During Pregnancy: A Qualitative Study of Views and Experiences of the MiQuit Intervention.

INTRODUCTION: SMS text messaging is increasingly used for delivering smoking cessation support and pilot studies suggest this may also be useful in pregnancy. This study explores the views of women who received a tailored text messaging cessation intervention (MiQuit) during pregnancy, focusing on acceptability, perceived impact, and suggestions for improvements. METHODS: Semi-structured interviews were undertaken with 15 purposively sampled women who had received the MiQuit intervention during pregnancy as part of a randomized controlled trial. Data were analyzed thematically. RESULTS: Three main themes were identified: "impact", "approach," and "optimization." Participants described an immediate, yet often short-lived, impact from the texts that distracted and delayed them from smoking and they perceived that texts focusing on the development of and risk to the baby generated more enduring emotional impacts. Most women found receiving support by text preferable to face-to-face cessation support, with participants citing the greater regularity, convenience, and non-judgmental style as particular advantages. Participants would have preferred a longer support program with increased tailoring, greater customization of text timings and consideration of cutting down as an alternative/precursor to quitting. CONCLUSION: Pregnancy-specific cessation support by text message was well received and participants considered the support increased their motivation to stop smoking. The focus on the developing baby, the regularity of contact and the provision of gentle, encouraging messages were highlighted as particularly important elements of the program. IMPLICATIONS: This study adds further evidence to the acceptability and perceived positive impact of text-messaging programs in aiding smoking cessation in pregnancy. The findings indicate that for some women, this type of support is preferable to face-to-face methods and could be utilized by health professionals, either in addition to current methods or as an alternative. This study is also relevant to researchers developing health-related text programs to consider participants' desire for greater tailoring. Further research is required into adapting and continuing text support for women postpartum.

Antenatal Clinic and Stop Smoking Services Staff Views on "Opt-Out" Referrals for Smoking Cessation in Pregnancy: A Framework Analysis.

Introduction: UK guidance recommends routine exhaled carbon monoxide (CO) screening for pregnant women and "opt-out" referrals to stop smoking services (SSS) of those with CO ≥ 4 ppm. We explored staff views on this referral pathway when implemented in one UK hospital Trust. Methods: Seventeen semi-structured interviews with staff involved in the implementation of the new referral pathway: six antenatal clinic staff (before and after implementation); five SSS staff (after). Data were analyzed using framework analysis. Results: Two themes were identified: (1) views on implementation of the pathway and (2) impact of the pathway on the women. Generally, staff felt that following training, referrals were less arduous to implement and better received than expected. The majority believed this pathway helped engage women motivated to quit and offered a unique chance to impart smoking cessation knowledge to hard-to-reach women, who might not otherwise contact SSS. An unexpected issue arose during implementation-dealing with non-smokers with high CO readings. Conclusions: According to staff, the "opt-out" referral pathway is an acceptable addition to routine antenatal care. It can help engage hard-to-reach women and educate them about the dangers of smoking in pregnancy. Incorporating advice on dealing with non-smokers with high CO into routine staff training could help future implementations.

Pregnant Women's Experiences and Views on an "Opt-Out" Referral Pathway to Specialist Smoking Cessation Support: A Qualitative Evaluation.

INTRODUCTION: Smoking in pregnancy remains an important and costly public health concern with policy makers worldwide researching methods to aid cessation. UK government guidelines recommend implementation of an "opt-out" (ie, whether requested or not) referral pathway for pregnant smokers to specialist smoking cessation support using carbon monoxide (CO) screening. This study explores the views of pregnant smokers who experienced this new pathway in one UK hospital trust. METHODS: Eighteen semi-structured telephone interviews with women who experienced the opt-out pathway were undertaken. Data were analyzed thematically. RESULTS: Three themes were identified relating to expectations, acceptability and impact of the pathway. Women were generally very accepting of the CO testing especially when it met their prior expectations and was perceived as being a routine component of antenatal care. They considered the visual feedback from the CO monitoring improved their motivation to quit. Views on the automatic referral for cessation support were divided with questions raised as to the removal of choice, with many women also expressing dissatisfaction about perceived lack of contact by Stop Smoking Services (SSS) following referral. CONCLUSION: The opt-out pathway is potentially an acceptable addition to current practice. The women considered CO monitoring to be the most valuable element of the pathway. Women keen to engage with SSS desired a more efficient system of contact. IMPLICATIONS: This study presents a unique insight into pregnant women's views on the implementation of opt-out referrals for smoking cessation. Introducing CO testing and opt-out referrals at the time of antenatal ultrasound examination can potentially increase motivation to stop smoking in pregnancy. The findings demonstrate that facilitating access to SSS was not always achieved, and further refinement is needed to ensure more effective contact procedures. Ensuring all women are fully informed prior to the CO testing may further improve both the impact of the opt-out referral pathway and the chance of successfully engaging with SSS.

Are Nurses and Auxiliary Healthcare Workers Equally Effective in Delivering Smoking Cessation Support in Primary Care?

INTRODUCTION: Smoking cessation support is increasingly delivered in primary care by auxiliary healthcare workers in place of healthcare professionals. However, it is unknown whether this shift might affect the quality and impact of the support delivered. METHODS: Data from the iQuit in Practice randomized control trial of cessation support in General Practice was used (N = 602). Analyses assessed whether cessation advisor type (nurse or healthcare assistant [HCA]) was associated with abstinence (primary outcome: self-reported 2-week point prevalence abstinence at 8 weeks follow-up), the advice delivered during the initial consultation, pharmacotherapies prescribed, patient satisfaction, initial consultation length, and the number and type of interim contacts. RESULTS: There were no statistically significant differences in abstinence for support delivered by HCAs versus nurses at 8 weeks (HCAs 42.8%, nurses 42.6%; unadjusted odds ratio [OR] = 1.01, 95% confidence interval [CI] = 0.73 to 1.40), or at 4 weeks or 6 months follow-up. There were no statistically significant differences in advice delivered, the types of pharmacotherapies prescribed or patient satisfaction. Compared with nurses, HCA consultations were longer on average (HCAs 23.6 minutes, nurses 20.8 minutes; P = .002) and they undertook more interim contacts (HCAs median 2, nurses median 1; P < .001), with contact more likely to be face-to-face than phone call (HCAs 91.2%, nurses 70.9%; OR = 4.23, 95% CI = 2.86 to 6.26). CONCLUSIONS: HCAs appear equally effective as nurses in supporting smoking cessation, although they do this with greater patient contact. Using auxiliary practitioners to deliver cessation support could free up nurse time and reduce costs. IMPLICATIONS: This study found that primary care patients receiving smoking cessation support from auxiliary healthcare workers were just as likely to be abstinent up to 6 months later as those patients seen by nurses. While the auxiliary healthcare workers achieved this with slightly increased patient contact time, the advice delivered, pharmacotherapies provided and patient satisfaction were similar to that of nurses. Expanding the auxiliary healthcare worker role to include smoking cessation support could increase role satisfaction and reduce the costs of cessation support delivery in primary care.

Adaptation and uptake evaluation of an SMS text message smoking cessation programme (MiQuit) for use in antenatal care.

OBJECTIVES: To adapt a tailored short message service (SMS) text message smoking cessation intervention (MiQuit) for use without active health professional endorsement in routine antenatal care settings, to estimate 'real-world' uptake and test the feasibility of its use. DESIGN: Single-site service evaluation. SETTING: A Nottinghamshire (UK) antenatal clinic. PARTICIPANTS: Pregnant women accessing the antenatal clinic (N=1750) over 6 months. INTERVENTION: A single-sheet A5 leaflet provided in the women's maternity notes folder describing the MiQuit text service. Similar materials were left on clinic desks and noticeboards. OUTCOME MEASURES: MiQuit activation requests and system interactions were logged for two time frames: 6 months (strict) and 8 months (extended). Local hospital data were used to estimate the denominator of pregnant smokers exposed to the materials. RESULTS: During the strict and extended time frames, 13 and 25 activation requests were received, representing 3% (95% CI 2% to 5%) and 4% (95% CI 3% to 6%) of estimated smokers, respectively. Only 11 (44%) of the 25 requesting activation sent a correctly formatted initiation text. Of those activating MiQuit, and invited to complete tailoring questions (used to tailor support), 6 (67%) completed all 12 questions by text or website and 5 (56%) texted a quit date to the system. Of the 11 activating MiQuit, 5 (45%, 95% CI 21% to 72%) stopped the programme prematurely. CONCLUSIONS: A low-intensity, cheap cessation intervention promoted at very low cost, resulted in a small but potentially impactful uptake rate by pregnant smokers.

Randomized controlled trial to assess the short-term effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care (iQuit in practice).

AIMS: To estimate the short-term effectiveness, feasibility and acceptability of a smoking cessation intervention (the iQuit system) that consists of tailored printed and Short Message Service (SMS) text message self-help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial. DESIGN: A stratified two parallel-group randomized controlled trial comparing usual care (control) with usual care plus the iQuit system (intervention), delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence. SETTING: Thirty-two general practice (GP) surgeries in England, UK. PARTICIPANTS: A total of 602 smokers initiating smoking cessation support from their local GP surgery were randomized (control n = 303, intervention n = 299). MEASUREMENTS: Primary outcome was self-reported 2-week point prevalence abstinence at 8 weeks follow-up. Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date, 8 weeks and 6 months follow-up. FINDINGS: There were no significant between-group differences in the primary outcome [control 40.3%, iQuit 45.2%; odds ratio (OR) = 1.22, 95% confidence interval (CI) = 0.88-1.69] or in secondary short-term smoking outcomes. Six-month prolonged abstinence was significantly higher in the iQuit arm (control 8.9%, iQuit 15.1%; OR = 1.81, 95% CI = 1.09-3.01). iQuit support took on average 7.7 minutes (standard deviation = 4.0) to deliver and 18.9% (95% CI = 14.8-23.7%) of intervention participants discontinued the text message support during the programme. CONCLUSIONS: Tailored printed and text message self-help delivered alongside routine smoking cessation support in primary care does not significantly increase short-term abstinence, but may increase long-term abstinence and demonstrated feasibility and acceptability compared with routine cessation support alone.