Systematic Literature Review and Meta-analysis of Venous Thromboembolism Events in Systemic Lupus Erythematosus.

The objective of this work was to conduct a systematic literature review (SLR) and meta-analysis (MA) to evaluate the relative risk (RR) of venous thromboembolism (VTE) events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients with systemic lupus erythematosus (SLE) compared with patients without SLE, as well as the absolute risk (AR) (measured by incidence proportion) and incidence rate (IR) of VTE events in patients with SLE. The SLR was conducted using Embase, MEDLINE, and MEDLINE In-Process to identify observational studies evaluating the risk of VTE, DVT, and PE events in adult patients with SLE compared with the general population, published January 2000 to September 2020. Random-effects models were used as the primary approach in the MA. Heterogeneity was assessed on the basis of the I2 value. Sensitivity analyses were performed to assess the robustness of results to various conditions, and subgroup analysis was performed for the AR of VTE by antiphospholipid status (aPLs) and antiphospholipid syndrome (APS). Of the 50 publications included for data extraction, 44 contained data for consideration in the MA of any one of the measures of interest (RR, AR, or IR) for VTE, DVT, or PE. The pooled RR indicates statistically significantly higher risk of VTE (RR 4.38, 95% confidence interval 2.63-7.29) in patients with SLE compared with the general population. Considerable heterogeneity was present in nearly all MA (I2 = 75-100%). Moreover, a higher pooled AR of VTE was estimated in patients with SLE with aPLs (n/N = 0.13) and APS (n/N = 0.63) compared with patients with SLE without aPLs/APS (n/N = 0.07). Overall, there was evidence of an increased risk of VTE, DVT, and PE in patients with SLE compared with the general population.

A Mobile App for the Self-Report of Psychological Well-Being During Pregnancy (BrightSelf): Qualitative Design Study.

BACKGROUND: Maternal mental health impacts both parental well-being and childhood development. In the United Kingdom, 15% of women are affected by depression during pregnancy or within 1 year of giving birth. Suicide is a leading cause of perinatal maternal mortality, and it is estimated that >50% of perinatal depression cases go undiagnosed. Mobile technologies are potentially valuable tools for the early recognition of depressive symptoms, but complex design challenges must be addressed to enable their use in public health screening. OBJECTIVE: The aim of this study was to explore the issues and challenges surrounding the use of mobile phones for the self-report of psychological well-being during pregnancy. METHODS: This paper presents design research carried out as part of the development of BrightSelf, a mobile app for the self-report of psychological well-being during pregnancy. Design sessions were carried out with 38 participants, including pregnant women, mothers, midwives, and other health professionals. Overall, 19 hours of audio were fully transcribed and used as the basis of thematic analysis. RESULTS: The study highlighted anxieties concerning the pregnancy journey, challenges surrounding current approaches to the appraisal of well-being in perinatal care, and the midwife-patient relationship. Designers should consider the framing of perinatal mental health technologies, the experience of self-report, supporting self-awareness and disclosure, providing value to users through both self-report and supplementary features, and designing for longitudinal engagement. CONCLUSIONS: This study highlights the needs, motivations, and anxieties of women with respect to technology use in pregnancy and implications for the design of mobile health technologies.

Implementation of depression screening in antenatal clinics through tablet computers: results of a feasibility study.

BACKGROUND: Mobile devices may facilitate depression screening in the waiting area of antenatal clinics. This can present implementation challenges, of which we focused on survey layout and technology deployment. METHODS: We assessed the feasibility of using tablet computers to administer a socio-demographic survey, the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to 530 pregnant women attending National Health Service (NHS) antenatal clinics across England. We randomised participants to one of two layout versions of these surveys: (i) a scrolling layout where each survey was presented on a single screen; or (ii) a paging layout where only one question appeared on the screen at any given time. RESULTS: Overall, 85.10% of eligible pregnant women agreed to take part. Of these, 90.95% completed the study procedures. Approximately 23% of participants answered Yes to at least one Whooley question, and approximately 13% of them scored 10 points of more on the EPDS. We observed no association between survey layout and the responses given to the Whooley questions, the median EPDS scores, the number of participants at increased risk of self-harm, and the number of participants asking for technical assistance. However, we observed a difference in the number of participants at each EPDS scoring interval (p = 0.008), which provide an indication of a woman's risk of depression. A scrolling layout resulted in faster completion times (median = 4 min 46 s) than a paging layout (median = 5 min 33 s) (p = 0.024). However, the clinical significance of this difference (47.5 s) is yet to be determined. CONCLUSIONS: Tablet computers can be used for depression screening in the waiting area of antenatal clinics. This requires the careful consideration of clinical workflows, and technology-related issues such as connectivity and security. An association between survey layout and EPDS scoring intervals needs to be explored further to determine if it corresponds to a survey layout effect. Future research needs to evaluate the effect of this type of antenatal depression screening on clinical outcomes and clinic workflows. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov under the identifier NCT02516982 on 20 July 2015.

A bespoke mobile application for the longitudinal assessment of depression and mood during pregnancy: protocol of a feasibility study.

INTRODUCTION: Depression is a common mental health disorder during pregnancy, with important consequences for mothers and their children. Despite this, it goes undiagnosed and untreated in many women attending antenatal care. Smartphones could help support the prompt identification of antenatal depression in this setting. In addition, these devices enable the implementation of ecological momentary assessment techniques, which could be used to assess how mood is experienced during pregnancy. With this study, we will assess the feasibility of using a bespoke mobile application (app) running on participants' own handsets for the longitudinal (6 months) monitoring of antenatal mood and screening of depression. METHODS AND ANALYSIS: We will use a randomised controlled study design to compare two types of assessment strategies: retrospective + momentary (consisting of the Edinburgh Postnatal Depression Scale plus five momentary and two contextual questions), and retrospective (consisting of the Edinburgh Postnatal Depression Scale only). We will assess the impact that these strategies have on participant adherence to a prespecified sampling protocol, dropout rates and timeliness of data completion. We will evaluate differences in acceptance of the technology through a short quantitative survey and open-ended questions. We will also assess the potential effect that momentary assessments could have on retrospective data. We will attempt to identify any patterns in app usage through the analysis of log data. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the National Research Ethics Service Committee South East Coast-Surrey on 15 April 2016 as a notice of substantial amendment to the original submission (9 July 2015) under the Research Ethics Committee (REC) reference 15/LO/0977. This study is being sponsored by Imperial College London under the reference number 15IC2687 and has been included in the UK Clinical Research Network Study Portfolio under the Central Portfolio Management System number 19280. The findings of this study will be disseminated through academic peer-reviewed publications, poster presentations and abstracts at academic and professional conferences, discussion with peers, and social media. The findings of this study will also inform the PhD theses of JSMB and KD.

Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study.

INTRODUCTION: Depression is one of the most common mental health disorders that may affect women during pregnancy. The prompt identification of this disorder, and the provision of treatment, may help to reduce the likelihood of post-partum depression, prevent severe forms of the disease, and reduce its intergenerational impact. Despite women's repeated encounters with health services throughout their antenatal care, depression often goes undiagnosed. This is one area where mobile health could prove useful. We will assess the feasibility of using tablets to incorporate depression screening into antenatal pathways. We will also assess if survey layout could affect the quality of the data collected through these devices. METHODS AND ANALYSIS: We will test the feasibility of using iPad Airs for the administration of the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to pregnant women attending antenatal clinics in England. We will assess the impact of survey layout on the quality of the responses given to these screening scales using a parallel, randomised controlled study design. We will calculate the positive predictive value, the negative predictive value and the false omission rate of the Whooley questions in comparison with the EPDS. We will calculate differences in data equivalence, time needed to complete the surveys, break-off rates, data completeness and requests for help between the 2 experimental groups: using all questions in one screen and navigation by vertical scrolling, or a single question per screen and navigation by multiple pages. ETHICS AND DISSEMINATION: This study has been approved by the National Research Ethics Service Committee South East Coast--Surrey. Our findings will be disseminated through academic peer-reviewed publications, conferences and discussion with peers.

Comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods.

BACKGROUND: Self-administered survey questionnaires are an important data collection tool in clinical practice, public health research and epidemiology. They are ideal for achieving a wide geographic coverage of the target population, dealing with sensitive topics and are less resource-intensive than other data collection methods. These survey questionnaires can be delivered electronically, which can maximise the scalability and speed of data collection while reducing cost. In recent years, the use of apps running on consumer smart devices (i.e., smartphones and tablets) for this purpose has received considerable attention. However, variation in the mode of delivering a survey questionnaire could affect the quality of the responses collected. OBJECTIVES: To assess the impact that smartphone and tablet apps as a delivery mode have on the quality of survey questionnaire responses compared to any other alternative delivery mode: paper, laptop computer, tablet computer (manufactured before 2007), short message service (SMS) and plastic objects. SEARCH METHODS: We searched MEDLINE, EMBASE, PsycINFO, IEEEXplore, Web of Science, CABI: CAB Abstracts, Current Contents Connect, ACM Digital, ERIC, Sociological Abstracts, Health Management Information Consortium, the Campbell Library and CENTRAL. We also searched registers of current and ongoing clinical trials such as ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform. We also searched the grey literature in OpenGrey, Mobile Active and ProQuest Dissertation & Theses. Lastly, we searched Google Scholar and the reference lists of included studies and relevant systematic reviews. We performed all searches up to 12 and 13 April 2015. SELECTION CRITERIA: We included parallel randomised controlled trials (RCTs), crossover trials and paired repeated measures studies that compared the electronic delivery of self-administered survey questionnaires via a smartphone or tablet app with any other delivery mode. We included data obtained from participants completing health-related self-administered survey questionnaire, both validated and non-validated. We also included data offered by both healthy volunteers and by those with any clinical diagnosis. We included studies that reported any of the following outcomes: data equivalence; data accuracy; data completeness; response rates; differences in the time taken to complete a survey questionnaire; differences in respondent's adherence to the original sampling protocol; and acceptability to respondents of the delivery mode. We included studies that were published in 2007 or after, as devices that became available during this time are compatible with the mobile operating system (OS) framework that focuses on apps. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from the included studies using a standardised form created for this systematic review in REDCap. They then compared their forms to reach consensus. Through an initial systematic mapping on the included studies, we identified two settings in which survey completion took place: controlled and uncontrolled. These settings differed in terms of (i) the location where surveys were completed, (ii) the frequency and intensity of sampling protocols, and (iii) the level of control over potential confounders (e.g., type of technology, level of help offered to respondents). We conducted a narrative synthesis of the evidence because a meta-analysis was not appropriate due to high levels of clinical and methodological diversity. We reported our findings for each outcome according to the setting in which the studies were conducted. MAIN RESULTS: We included 14 studies (15 records) with a total of 2275 participants; although we included only 2272 participants in the final analyses as there were missing data for three participants from one included study.Regarding data equivalence, in both controlled and uncontrolled settings, the included studies found no significant differences in the mean overall scores between apps and other delivery modes, and that all correlation coefficients exceeded the recommended thresholds for data equivalence. Concerning the time taken to complete a survey questionnaire in a controlled setting, one study found that an app was faster than paper, whereas the other study did not find a significant difference between the two delivery modes. In an uncontrolled setting, one study found that an app was faster than SMS. Data completeness and adherence to sampling protocols were only reported in uncontrolled settings. Regarding the former, an app was found to result in more complete records than paper, and in significantly more data entries than an SMS-based survey questionnaire. Regarding adherence to the sampling protocol, apps may be better than paper but no different from SMS. We identified multiple definitions of acceptability to respondents, with inconclusive results: preference; ease of use; willingness to use a delivery mode; satisfaction; effectiveness of the system informativeness; perceived time taken to complete the survey questionnaire; perceived benefit of a delivery mode; perceived usefulness of a delivery mode; perceived ability to complete a survey questionnaire; maximum length of time that participants would be willing to use a delivery mode; and reactivity to the delivery mode and its successful integration into respondents' daily routine. Finally, regardless of the study setting, none of the included studies reported data accuracy or response rates. AUTHORS' CONCLUSIONS: Our results, based on a narrative synthesis of the evidence, suggest that apps might not affect data equivalence as long as the intended clinical application of the survey questionnaire, its intended frequency of administration and the setting in which it was validated remain unchanged. There were no data on data accuracy or response rates, and findings on the time taken to complete a self-administered survey questionnaire were contradictory. Furthermore, although apps might improve data completeness, there is not enough evidence to assess their impact on adherence to sampling protocols. None of the included studies assessed how elements of user interaction design, survey questionnaire design and intervention design might influence mode effects. Those conducting research in public health and epidemiology should not assume that mode effects relevant to other delivery modes apply to apps running on consumer smart devices. Those conducting methodological research might wish to explore the issues highlighted by this systematic review.

Smartphone and tablet self management apps for asthma.

BACKGROUND: Asthma is one of the most common long-term conditions worldwide, which places considerable pressure on patients, communities and health systems. The major international clinical guidelines now recommend the inclusion of self management programmes in the routine management of patients with asthma. These programmes have been associated with improved outcomes in patients with asthma. However, the implementation of self management programmes in clinical practice, and their uptake by patients, is still poor. Recent developments in mobile technology, such as smartphone and tablet computer apps, could help develop a platform for the delivery of self management interventions that are highly customisable, low-cost and easily accessible. OBJECTIVES: To assess the effectiveness, cost-effectiveness and feasibility of using smartphone and tablet apps to facilitate the self management of individuals with asthma. SEARCH METHODS: We searched the Cochrane Airways Group Register (CAGR), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, Global Health Library, Compendex/Inspec/Referex, IEEEXplore, ACM Digital Library, CiteSeer(x) and CAB abstracts via Web of Knowledge. We also searched registers of current and ongoing trials and the grey literature. We checked the reference lists of all primary studies and review articles for additional references. We searched for studies published from 2000 onwards. The latest search was run in June 2013. SELECTION CRITERIA: We included parallel randomised controlled trials (RCTs) that compared self management interventions for patients with clinician-diagnosed asthma delivered via smartphone apps to self management interventions delivered via traditional methods (e.g. paper-based asthma diaries). DATA COLLECTION AND ANALYSIS: We used standard methods expected by the Cochrane Collaboration. Our primary outcomes were symptom scores; frequency of healthcare visits due to asthma exacerbations or complications and health-related quality of life. MAIN RESULTS: We included two RCTs with a total of 408 participants. We found no cluster RCTs, controlled before and after studies or interrupted time series studies that met the inclusion criteria for this systematic review. Both RCTs evaluated the effect of a mobile phone-based asthma self management intervention on asthma control by comparing it to traditional, paper-based asthma self management. One study allowed participants to keep daily entries of their asthma symptoms, asthma medication usage, peak flow readings and peak flow variability on their mobile phone, from which their level of asthma control was calculated remotely and displayed together with the corresponding asthma self management recommendations. In the other study, participants recorded the same readings twice daily, and they received immediate self management feedback in the form of a three-colour traffic light display on their phones. Participants falling into the amber zone of their action plan twice, or into the red zone once, received a phone call from an asthma nurse who enquired about the reasons for their uncontrolled asthma.We did not conduct a meta-analysis of the data extracted due to the considerable degree of heterogeneity between these studies. Instead we adopted a narrative synthesis approach. Overall, the results were inconclusive and we judged the evidence to have a GRADE rating of low quality because further evidence is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. In addition, there was not enough information in one of the included studies to assess the risk of bias for the majority of the domains. Although the other included study was methodologically rigorous, it was not possible to blind participants or personnel in the study. Moreover, there are concerns in both studies in relation to attrition bias and other sources of bias.One study showed that the use of a smartphone app for the delivery of an asthma self management programme had no statistically significant effect on asthma symptom scores (mean difference (MD) 0.01, 95% confidence interval (CI) -0.23 to 0.25), asthma-related quality of life (MD of mean scores 0.02, 95% CI -0.35 to 0.39), unscheduled visits to the emergency department (OR 7.20, 95% CI 0.37 to 140.76) or frequency of hospital admissions (odds ratio (OR) 3.07, 95% CI 0.32 to 29.83). The other included study found that the use of a smartphone app resulted in higher asthma-related quality of life scores at six-month follow-up (MD 5.50, 95% CI 1.48 to 9.52 for the physical component score of the SF-12 questionnaire; MD 6.00, 95% CI 2.51 to 9.49 for the mental component score of the SF-12 questionnaire), improved lung function (PEFR) at four (MD 27.80, 95% CI 4.51 to 51.09), five (MD 31.40, 95% CI 8.51 to 54.29) and six months (MD 39.20, 95% CI 16.58 to 61.82), and reduced visits to the emergency department due to asthma-related complications (OR 0.20, 95% CI 0.04 to 0.99). Both studies failed to find any statistical differences in terms of adherence to the intervention and occurrence of other asthma-related complications. AUTHORS' CONCLUSIONS: The current evidence base is not sufficient to advise clinical practitioners, policy-makers and the general public with regards to the use of smartphone and tablet computer apps for the delivery of asthma self management programmes. In order to understand the efficacy of apps as standalone interventions, future research should attempt to minimise the differential clinical management of patients between control and intervention groups. Those studies evaluating apps as part of complex, multicomponent interventions, should attempt to tease out the relative contribution of each intervention component. Consideration of the theoretical constructs used to inform the development of the intervention would help to achieve this goal. Finally, researchers should also take into account: the role of ancillary components in moderating the observed effects, the seasonal nature of asthma and long-term adherence to self management practices.

Mapping mental health service access: achieving equity through quality improvement.

BACKGROUND: Improving access to psychological therapies (IAPTs) services deliver evidence-based care to people with depression and anxiety. A quality improvement (QI) initiative was undertaken by an IAPT service to improve referrals providing an opportunity to evaluate equitable access. METHODS: QI methodologies were used by the clinical team to improve referrals to the service. The collection of geo-coded data allowed referrals to be mapped to small geographical areas according to deprivation. RESULTS: A total of 6078 patients were referred to the IAPT service during the period of analysis and mapped to 120 unique lower super output areas (LSOAs). The average weekly referral rate rose from 17 during the baseline phase to 43 during the QI implementation phase. Spatial analysis demonstrated all 15 of the high deprivation/low referral LSOAs were converted to high deprivation/high or medium referral LSOAs following the QI initiative. CONCLUSION: This work highlights the importance of QI in developing clinical services aligned to the needs of the population through the analysis of routine data matched to health needs. Mapping can be utilized to communicate complex information to inform the planning and organization of clinical service delivery and evaluate the progress and sustainability of QI initiatives.

Interventions for recruiting smokers into cessation programmes.

BACKGROUND: Tobacco control is a top public health priority around the globe due to the high prevalence of cigarette smoking and its associated morbidity and mortality. Much effort has been focused on establishing the effectiveness of different smoking cessation strategies. This review, however, aims to address the initial challenge faced by smoking cessation programmes: recruitment of smokers. OBJECTIVES: The primary objective of this review was to determine the effectiveness of different strategies for recruiting smokers into cessation programmes. The secondary objective was to determine the impact that these strategies had on smoking cessation rates at least six months after enrolment into a cessation programme. SEARCH METHODS: We searched the specialised register of the Cochrane Tobacco Addiction Group using a search strategy which included the terms ('recruit$', 'invit$', 'enter', 'entry', 'enrolment') combined with ('smok$', 'cigarette', 'smoking cessation', 'tobacco') in the title, abstract or keyword fields. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and registers of current and ongoing trials. We also searched the reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials and cluster randomised controlled trials that compared at least two different methods of recruiting current smokers into a smoking cessation programme. We also included those studies which focused on the effectiveness of a smoking cessation programme as long as the study involved multiple recruitment methods and reported results of the recruitment phase. DATA COLLECTION AND ANALYSIS: From each included study, we extracted data on the type of participants, type of recruitment strategies (i.e., setting, mode of communication used, intensity and duration) and comparisons, and on randomisation, allocation concealment, and blinding procedures.Our primary outcome was the proportion of smokers successfully recruited to each cessation programme compared to alternative modalities of recruitment. Our secondary outcome was smoking cessation for at least six months. Given the substantial heterogeneity across recruitment interventions and participants, we adopted a narrative synthesis approach for summarising results. MAIN RESULTS: This review includes 19 studies with a total of 14,890 participants. We categorised the included studies according to the modes used to deliver the recruitment strategy: head to head comparison of individual recruitment strategies; comparison of the same delivery mode but with different content or intensity; and the addition of another mode to an existing recruitment method.We identified three studies that made head-to-head comparisons of different types of recruitment strategies. Of these, only one study detected a significant effect, finding that a personal phone call was more effective than a generic invitation letter (RR 40.73, 95% CI 2.53 to 654.74). Five studies compared interventions using the same delivery modes but different content. Results showed that tailored messages through an interactive voice response system resulted in a higher recruitment rate than assessment of smoking status alone using the same system (RR 8.64, 95% CI 4.41 to 16.93), and that text messages indicating scarcity of places available were more effective than generic text message reminders (RR 1.45, 95% CI 1.07 to 1.96). One study compared interventions using the same delivery mode but different intensity and found that allowing for more phone call attempts to reach potential participants can result in better recruitment (RR 1.87, 95% CI 1.61 to 2.18). Finally, 10 studies investigated the effect of adding a recruitment mode to existing recruitment strategies. Findings showed that: adding a text message reminder or real quotes from participants to a personal phone call improved recruitment of participants (RR 3.38, 95% CI 1.26 to 9.08 and RR 29.07, 95% CI 1.74 to 485.70, respectively); that adding a personal phone call to an existing newsletter can also increase recruitment rates (RR 65.12, 95% CI 4.06 to 1045.4]); that a reactive-proactive recruitment phase is more effective than a proactive phase alone (63.8% versus 47.5%, RR not available); and that active recruitment at schools is more effective than passive recruitment (p < 0.001, denominator not available for calculation of RR). Additionally, a number of studies in this category showed that providing incentives can effectively increase the number of participants recruited into smoking cessation programmes.Out of the 19 included studies, only four reported on the effect of recruitment strategy on smoking cessation at six months or longer. Three of these studies compared strategies that used the same delivery mode with different content. Their results were non-significant. The remaining three studies evaluated adding an additional mode to an existing recruitment intervention. Only one of them showed a significant difference in the levels of smoking cessation that favoured the enhanced recruitment strategy, but this may have reflected the offer of incentives once in the programme rather than the recruitment strategy itself (RR at 15 or 18 months 2.60, 95% CI 1.48 to 4.56). AUTHORS' CONCLUSIONS: The substantial heterogeneity across the included studies restricts our ability to draw firm conclusions about the effectiveness of different recruitment strategies in relation to recruitment of participants into smoking cessation programmes or levels of smoking cessation. The limited evidence, however, suggests that the following elements may improve the recruitment of smokers into cessation programmes: personal, tailored interventions; recruitment methods that are proactive in nature; and more intensive recruitment strategies (i.e., those strategies that require increased contact with potential participants).