Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.

BACKGROUND: Cardiovascular disease (CVD) is a major cause of disability and mortality globally. Premature fatal and non-fatal CVD is considered to be largely preventable through the control of risk factors via lifestyle modifications and preventive medication. Lipid-lowering and antihypertensive drug therapies for primary prevention are cost-effective in reducing CVD morbidity and mortality among high-risk people and are recommended by international guidelines. However, adherence to medication prescribed for the prevention of CVD can be poor. Approximately 9% of CVD cases in the EU are attributed to poor adherence to vascular medications. Low-cost, scalable interventions to improve adherence to medications for the primary prevention of CVD have potential to reduce morbidity, mortality and healthcare costs associated with CVD. OBJECTIVES: To establish the effectiveness of interventions delivered by mobile phone to improve adherence to medication prescribed for the primary prevention of CVD in adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two other databases on 21 June 2017 and two clinical trial registries on 14 July 2017. We searched reference lists of relevant papers. We applied no language or date restrictions. SELECTION CRITERIA: We included randomised controlled trials investigating interventions delivered wholly or partly by mobile phones to improve adherence to cardiovascular medications prescribed for the primary prevention of CVD. We only included trials with a minimum of one-year follow-up in order that the outcome measures related to longer-term, sustained medication adherence behaviours and outcomes. Eligible comparators were usual care or control groups receiving no mobile phone-delivered component of the intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. We contacted study authors for disaggregated data when trials included a subset of eligible participants. MAIN RESULTS: We included four trials with 2429 randomised participants. Participants were recruited from community-based primary care or outpatient clinics in high-income (Canada, Spain) and upper- to middle-income countries (South Africa, China). The interventions received varied widely; one trial evaluated an intervention focused on blood pressure medication adherence delivered solely through short messaging service (SMS), and one intervention involved blood pressure monitoring combined with feedback delivered via smartphone. Two trials involved interventions which targeted a combination of lifestyle modifications, alongside CVD medication adherence, one of which was delivered through text messages, written information pamphlets and self-completion cards for participants, and the other through a multi-component intervention comprising of text messages, a computerised CVD risk evaluation and face-to-face counselling. Due to heterogeneity in the nature and delivery of the interventions, we did not conduct a meta-analysis, and therefore reported results narratively.We judged the body of evidence for the effect of mobile phone-based interventions on objective outcomes (blood pressure and cholesterol) of low quality due to all included trials being at high risk of bias, and inconsistency in outcome effects. Of two trials targeting medication adherence alongside other lifestyle modifications, one reported a small beneficial intervention effect in reducing low-density lipoprotein cholesterol (mean difference (MD) -9.2 mg/dL, 95% confidence interval (CI) -17.70 to -0.70; 304 participants), and the other found no benefit (MD 0.77 mg/dL, 95% CI -4.64 to 6.18; 589 participants). One trial (1372 participants) of a text messaging-based intervention targeting adherence showed a small reduction in systolic blood pressure (SBP) for the intervention arm which delivered information-only text messages (MD -2.2 mmHg, 95% CI -4.4 to -0.04), but uncertain evidence of benefit for the second intervention arm that provided additional interactivity (MD -1.6 mmHg, 95% CI -3.7 to 0.5). One study examined the effect of blood pressure monitoring combined with smartphone messaging, and reported moderate intervention benefits on SBP and diastolic blood pressure (DBP) (SBP: MD -7.10 mmHg, 95% CI -11.61 to -2.59; DBP: -3.90 mmHg, 95% CI -6.45 to -1.35; 105 participants). There was mixed evidence from trials targeting medication adherence alongside lifestyle advice using multi-component interventions. One trial found large benefits for SBP and DBP (SBP: MD -12.45 mmHg, 95% CI -15.02 to -9.88; DBP: MD -12.23 mmHg, 95% CI -14.03 to -10.43; 589 participants), whereas the other trial demonstrated no beneficial effects on SBP or DBP (SBP: MD 0.83 mmHg, 95% CI -2.67 to 4.33; DBP: MD 1.64 mmHg, 95% CI -0.55 to 3.83; 304 participants).Two trials reported on adverse events and provided low-quality evidence that the interventions did not cause harm. One study provided low-quality evidence that there was no intervention effect on reported satisfaction with treatment.Two trials were conducted in high-income countries, and two in upper- to middle-income countries. The interventions evaluated employed between three and 16 behaviour change techniques according to coding using Michie's taxonomic method. Two trials evaluated interventions that involved potential users in their development. AUTHORS' CONCLUSIONS: There is low-quality evidence relating to the effects of mobile phone-delivered interventions to increase adherence to medication prescribed for the primary prevention of CVD; some trials reported small benefits while others found no effect. There is low-quality evidence that these interventions do not result in harm. On the basis of this review, there is currently uncertainty around the effectiveness of these interventions. We identified six ongoing trials being conducted in a range of contexts including low-income settings with potential to generate more precise estimates of the effect of primary prevention medication adherence interventions delivered by mobile phone

A cohort study of the service-users of online contraception.

BACKGROUND: In January 2017, the first free service providing oral contraceptive pills (OCPs) ordered online and posted home became available in the London boroughs of Lambeth and Southwark - ethnically and socioeconomically diverse areas with high rates of unplanned pregnancy. There are concerns that online services can increase health inequalities; therefore, we aimed to describe service-users according to age, ethnicity and Index of Multiple Deprivation (IMD) quintile of area of residence and to examine the association of these with repeated use. METHODS: We analysed routinely collected data from January 2017 to April 2018 and described service-users using available sociodemographic factors and information on patterns of use. Logistic regression analysis examined factors associated with repeat ordering of OCPs. RESULTS: The service was accessed by 726 individuals; most aged between 20 and 29 years (72.5%); self-identified as being of white ethnic group (58.8%); and residents of the first and second most deprived IMD quintiles (79.2%). Compared with those of white ethnic group, those of black ethnic group were significantly less likely to make repeat orders (adjusted OR 0.53, 95% CI 0.31 to 0.89; p=0.001), as were those of Asian and mixed ethnic groups. CONCLUSIONS: These are the first empirical findings on free, online contraception and suggest that early adopters broadly reflect the population of the local area in terms of ethnic diversity and deprivation as measured by IMD. Ongoing service development should prioritise the identification and removal of barriers which may inhibit repeat use for black and minority ethnic groups

Changes in, and factors associated with, frequency of sex in Britain: evidence from three National Surveys of Sexual Attitudes and Lifestyles (Natsal).

OBJECTIVES: To examine changes over time in the reported frequency of occurrence of sex and associations between sexual frequency and selected variables. DESIGN: Repeat, cross sectional, population based National Surveys of Sexual Attitudes and Lifestyles (Natsal-1, Natsal-2, and Natsal-3). SETTING: British general population. PARTICIPANTS: 18 876 men and women aged 16-59 and resident in Britain were interviewed in Natsal-1, completed in 1991; 11 161 aged 16-44 years in Natsal-2, completed in 2001, and 15 162 aged 16-74 years in Natsal-3, completed in 2012. Comparisons of actual and preferred sexual frequency in men and women aged 16-44 (the age range common to all surveys) between the three surveys. Factors associated with sexual frequency of at least once a week were examined using Natsal-3 data. MAIN OUTCOME MEASURES: Sexual activity in the past month; frequency of sex in the past month; preferred frequency of sex. RESULTS: Median number of occasions of sex in the past month was four in Natsal-1 and Natsal-2 and three in Natsal-3 among women; and three in Natsal-1, Natsal-2, and Natsal-3 among men. The proportion reporting no sex in the past month fell between Natsal-1 and Natsal-2 (from 28.5% to 23.0% in women and from 30.9% to 26.0% in men) but increased significantly in Natsal-3 (to 29.3% in women and 29.2% in men). The proportion reporting sex 10 times or more in the past month increased between Natsal-1 and Natsal-2, from 18.4% to 20.6% in women and from 19.9% to 20.2% in men, but fell in Natsal-3, to 13.2% in woman and 14.4% in men. Participants aged 25 and over, and those married or cohabiting, experienced the steepest declines in sexual frequency (P values for interaction <0.05). Alongside the declines in sexual frequency, there was an increase in the proportion reporting that they would prefer sex more often. Age adjusted odds ratios showed that men and women in better physical and mental health had sex more frequently, as did those who were fully employed and those with higher earnings. CONCLUSIONS: Frequency of sex has declined recently in Britain, more markedly among those in early middle age and those who are married or cohabiting. The findings and their implications need to be explained in the context of technological, demographic, and social change in Britain and warrant further investigation

Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis

BACKGROUND: The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH). Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected drug-induced liver injury (DILI) compared to patients with healthy livers. However, currently no regulatory guidelines or position papers systematically address best practices pertaining to DILI in NASH clinical trials. AIMS: This publication focuses on best practices concerning the detection, monitoring, diagnosis and management of suspected acute DILI during clinical trials in patients with NASH. METHODS: This is one of several papers developed by the IQ DILI Initiative, comprised of members from 15 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. This paper is based on extensive literature review, and discussions between industry members with expertise in drug safety and DILI experts from outside industry to achieve consensus on common questions related to this topic. RESULTS: Recommended best practices are outlined pertaining to hepatic inclusion and exclusion criteria, monitoring of liver tests, DILI detection, approach to a suspected DILI signal, causality assessment and hepatic discontinuation rules. CONCLUSIONS: This paper provides a framework for the approach to assessment and management of suspected acute DILI during clinical trials in patients with NASH

Trends in sexual activity and demand for and use of modern contraceptive methods in 74 countries: a retrospective analysis of nationally representative surveys.

BACKGROUND: A quarter of a century ago, two global events-the International Conference on Population and Development in Cairo, and the Fourth World Conference on Women in Beijing-placed gender equality and reproductive health and rights at the centre of the development agenda. Progress towards these goals has been slower than hoped. We used survey data and national-level indicators of social determinants from 74 countries to examine change in satisfaction of contraceptive need from a contextual perspective. METHODS: We searched for individual-level data from repeated nationally representative surveys that included information on sexual and reproductive health, and created a single dataset by harmonising data from each survey to a standard data specification. We described the relative timings of sexual initiation, first union (cohabitation or marriage), and first birth and used logistic regression to show the change in prevalence of sexual activity, demand for contraception, and modern contraceptive use. We used linear regression to examine country-level associations between the gender development index and the expected length of time in education for women and the three outcomes: sexual activity, demand for contraception, and modern contraceptive use. We used principal component analysis to describe countries using a combination of social-structural and behavioural indicators and assessed how well the components explained country-level variation in the proportion of women using contraception with fractional logistic regression. FINDINGS: In 34 of the 74 countries examined, proportions of all women who were sexually active, not wanting to conceive, and not using a modern contraceptive method decreased over time. Proportions of women who had been sexually active in the past year changed over time in 43 countries, with increases in 30 countries; demand for contraception increased in 42 countries, and use of a modern method of contraception increased in 37 countries. Increases over time in met need for contraception were correlated with increases in gender equality and with women's time in education. Regression analysis on the principal components showed that country-level variation in met contraceptive need was largely explained by a single component that combined behavioural and social-contextual variables. INTERPRETATION: Progress towards satisfying demand for contraception should take account of the changing context in which it is practised. To remove the remaining barriers, policy responses-and therefore research priorities-could require a stronger focus on social-structural determinants and broader aspects of sexual health. FUNDING: UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction

Prevalence and correlates of 'sexual competence' at first heterosexual intercourse among young people in Britain.

BACKGROUND: A greater understanding of the circumstances of first sexual intercourse, as opposed to an exclusive focus on age at occurrence, is required in order that sexual health and well-being can be promoted from the onset of sexual activity. METHODS: We used data from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3) conducted in Britain. Participants were categorised as 'sexually competent' at first heterosexual intercourse if the following self-reported criteria applied to the event: contraceptive use, autonomy of decision, both partners 'equally willing', and occurrence at the perceived 'right time'. We examined the prevalence of 'sexual competence', and its component parts, by age at first intercourse among 17-24-year-olds. Using multivariable logistic regression, we explored associations between sexual competence and potential explanatory factors. RESULTS: Variation in 'sexual competence' and its component parts was associated with, but not fully explained by, age at first sex: 22.4% and 36.2% of men and women who had first sex at age 13-14 years were categorised as 'sexually competent', rising to 63.7% and 60.4% among those aged ≥18 years at first intercourse. Lack of sexual competence was independently associated with: first intercourse before the age of 16 years, area-level deprivation (men only), lower educational level, black ethnicity (women only), reporting 'friends' as main source of learning about sex (women only), non-'steady' relationship at first sex, and uncertainty of first partner's virginity status. CONCLUSIONS: A substantial proportion of young people in Britain transition into sexual activity under circumstances incompatible with positive sexual health. Social inequalities in sexual health are reflected in the context of first intercourse

School life expectancy and risk for tuberculosis in Europe.

OBJECTIVE: This study aims to investigate the effect of country-level school life expectancy on Tuberculosis (TB) incidence to gain further understanding of substantial variation in TB incidence across Europe. METHODS: An ecological study examined the prospective association between baseline country-level education in 2000 measured by school life expectancy and TB incidence in 2000-2010 in 40 countries of the WHO European region using quantile regression. Subsequently, to validate the ecological associations between education and TB incidence, an individual-level analysis was performed using case-based data in 29 EU/EEA countries from the European Surveillance System (TESSy) and simulating a theoretical control group. RESULTS: The ecological analysis showed that baseline school life expectancy had a negative prospective association with TB incidence. We observed consistent negative effects of school life expectancy on individuals' TB infections prospectively. CONCLUSIONS: These findings suggests that country-level education is an important determinant of individual-level TB infection in the region, and in the absence of a social determinants indicator that is routinely collected for reportable infectious diseases, the adoption of country-level education for reportable infectious diseases would significantly advance the field

Contraception in Person-Contraception Online (CiP-CO) cohort study.

BACKGROUND: Online contraception services increasingly provide information, clinical assessment and home-delivered oral contraceptives (OCs). Evidence is lacking on the effects of online contraceptive service use on short-term contraceptive continuation. METHODS: Cohort study comparing contraceptive continuation between new users of a free-to-access online OC service in South East London with those from other, face-to-face services in the same area. Online questionnaires collected data on participants' sociodemographic characteristics, motivations for OC access, service ratings, OC knowledge and contraceptive use. Contraceptive use in the 4-month study period was measured using health service records. Unadjusted and multivariable logistic regression models compared outcomes between the online service group and those using other services. RESULTS: Online service-users (n=138) were more likely to experience short-term continuation of OCs compared with participants using other services (n=98) after adjusting for sociodemographic and other characteristics (adjusted OR 2.94, 95% CI 1.52 to 5.70). Online service-users rated their service more highly (mean 25.22, SD 3.77) than the other services group (mean 22.70, SD 4.35; p<0.001), valuing convenience and speed of access. Among progestogen-only pill users, knowledge scores were higher for the online group (mean 4.83, SD 1.90) than the other services group (mean 3.87, SD 1.73; p=0.007). Among combined oral contraceptive users, knowledge scores were similar between groups. CONCLUSIONS: Free-to-access, online contraception has the potential to improve short-term continuation of OCs. Further research using a larger study population and analysis of longer-term outcomes are required to understand the impact of online services on unintended pregnancy

Development and validation of a brief measure of sexual wellbeing for population surveys: the Natsal Sexual Wellbeing Measure (Natsal-SW)

Sexual wellbeing is an important aspect of population health. Addressing and monitoring it as a distinct issue requires valid measures. Our previous conceptual work identified seven domains of sexual wellbeing: security; respect; self-esteem; resilience; forgiveness; self-determination; and comfort. Here, we describe the development and validation of a measure of sexual wellbeing reflecting these domains. Based on the analysis of 40 semi-structured interviews, we operationalized domains into items, and refined them via cognitive interviews, workshops, and expert review. We tested the items via two web-based surveys (n = 590; n = 814). Using data from the first survey, we carried out exploratory factor analysis to assess and eliminate poor performing items. Using data from the second survey, we carried out confirmatory factor analysis to examine model fit and associations between the item reduced measure and external variables hypothesized to correlate with sexual wellbeing (external validity). A sub-sample (n = 113) repeated the second survey after 2 weeks to evaluate test–retest reliability. Confirmatory factor analysis indicated that a “general specific model” had best fit (RMSEA: 0.064; CFI: 0.975, TLI: 0.962), and functioned equivalently across age group, gender, sexual orientation, and relationship status. The final Natsal-SW measure comprised 13 items (from an initial set of 25). It was associated with external variables in the directions hypothesized (all p &lt;.001), including mental wellbeing (0.454), self-esteem (0.564), body image (0.232), depression (−0.384), anxiety (−0.340), sexual satisfaction (0.680) and sexual distress (−0.615), and demonstrated good test–retest reliability (ICC = 0.78). The measure enables sexual wellbeing to be quantified and understood within and across populations

Help-seeking for genitourinary symptoms: a mixed methods study from Britain’s Third National Survey of Sexual Attitudes and Lifestyles (Natsal-3)

Objectives: Quantify non-attendance at sexual health clinics and explore help-seeking strategies for genitourinary symptoms. Design: Sequential mixed methods using survey data and semistructured interviews. Setting: General population in Britain. Participants: 1403 participants (1182 women) from Britain’s Third National Survey of Sexual Attitudes and Lifestyles (Natsal-3; undertaken 2010–2012), aged 16–44 years who experienced specific genitourinary symptoms (past 4 weeks), of whom 27 (16 women) who reported they had never attended a sexual health clinic also participated in semistructured interviews, conducted May 2014–March 2015. Primary and secondary outcome measures: From survey data, non-attendance at sexual health clinic (past year) and preferred service for STI care; semistructured interview domains were STI social representations, symptom experiences, help-seeking responses and STI stigma. Results: Most women (85.9% (95% CI 83.7 to 87.9)) and men (87.6% (95% CI 82.3 to 91.5)) who reported genitourinary symptoms in Natsal-3 had not attended a sexual health clinic in the past year. Around half of these participants cited general practice (GP) as their preferred hypothetical service for STI care (women: 58.5% (95% CI 55.2% to 61.6%); men: 54.3% (95% CI 47.1% to 61.3%)). Semistructured interviews elucidated four main responses to symptoms: not seeking healthcare, seeking information to self-diagnose and self-treat, seeking care at non-specialist services and seeking care at sexual health clinics. Collectively, responses suggested individuals sought to gain control over their symptoms, and they prioritised emotional reassurance over accessing medical expertise. Integrating survey and interview data strengthened the evidence that participants preferred their general practitioner for STI care and extended understanding of help-seeking strategies. Conclusions: Help-seeking is important to access appropriate healthcare for genitourinary symptoms. Most participants did not attend a sexual health clinic but sought help from other sources. This study supports current service provision options in Britain, facilitating individual autonomy about where to seek help