Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial.

BACKGROUND: Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed 'hard-to-reach' in research. Here we report the recruitment strategies and costs for the Trial for Healthy Relationship Initiatives in the Very Early years (THRIVE), an RCT evaluating two group-based parenting interventions for pregnant women. METHODS: THRIVE aimed to recruit 500 pregnant women with additional health and social care needs in Scotland between 2014 and 2018. Three recruitment strategies were employed: (1) referrals from a health or social care practitioner or voluntary/community organisation (practitioner-led referral), (2) direct engagement with potential participants by research staff (researcher-led recruitment) and (3) self-referral in response to study advertising (self-referral). The number of referrals and recruited participants from each strategy is reported along with the overall cost of recruitment. The impact of recruitment activities and the changes in maternity policy/context on recruitment throughout the study are examined. RESULTS: THRIVE received 973 referrals: 684 (70%) from practitioners (mainly specialist and general midwives), 273 (28%) from research nurses and 16 (2%) self-referrals. The time spent in antenatal clinics by research nurses each month was positively correlated with the number of referrals received (r = 0.57; p < 0.001). Changes in maternity policies and contexts were reflected in the number of referrals received each month, with both positive and negative impacts throughout the trial. Overall, 50% of referred women were recruited to the trial. Women referred via self-referral, THRIVE research nurses and specialist midwives were most likely to go on to be recruited (81%, 58% and 57%, respectively). Key contributors to recruitment included engaging key groups of referrers, establishing a large flexible workforce to enable recruitment activities to adapt to changes in context throughout the study and identifying the most appropriate setting to engage with potential participants. The overall cost of recruitment was £377 per randomised participant. CONCLUSIONS: Recruitment resulted from a combination of all three strategies. Our reflections on the successes and challenges of these strategies highlight the need for recruitment strategies to be flexible to adapt to complex interventions and real-world challenges. These findings will inform future research in similar hard-to-reach populations. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number Registry ISRCTN21656568 . Retrospectively registered on 28 February 2014.

Electronic clinical decision support tool for assessing stomach symptoms in primary care (ECASS): a feasibility study.

OBJECTIVE: To determine the feasibility of a definitive trial in primary care of electronic clinical decision support (eCDS) for possible oesophago-gastric (O-G) cancer. DESIGN AND SETTING: Feasibility study in 42 general practices in two regions of England, cluster randomised controlled trial design without blinding, nested qualitative and health economic evaluation. PARTICIPANTS: Patients aged 55 years or older, presenting to their general practitioner (GP) with symptoms associated with O-G cancer. 530 patients (mean age 68 years, 58% female) participated. INTERVENTION: Practices randomised 1:1 to usual care (control) or to receive a previously piloted eCDS tool for suspected cancer (intervention), for use at the discretion of the GPs, supported by a theory-based implementation package and ongoing support. We conducted semistructured interviews with GPs in intervention practices. Recruitment lasted 22 months. OUTCOMES: Patient participation rate, use of eCDS, referrals and route to diagnosis, O-G cancer diagnoses; acceptability to GPs; cost-effectiveness. Participants followed up 6 months after index encounter. RESULTS: From control and intervention practices, we screened 3841 and 1303 patients, respectively; 1189 and 434 were eligible, 392 and 138 consented to participate. Ten patients (1.9%) had O-G cancer. eCDS was used eight times in total by five unique users. GPs experienced interoperability problems between the eCDS tool and their clinical system and also found it did not fit with their workflow. Unexpected restrictions on software installation caused major problems with implementation. CONCLUSIONS: The conduct of this study was hampered by technical limitations not evident during an earlier pilot of the eCDS tool, and by regulatory controls on software installation introduced by primary care trusts early in the study. This eCDS tool needed to integrate better with clinical workflow; even then, its use for suspected cancer may be infrequent. Any definitive trial of eCDS for cancer diagnosis should only proceed after addressing these constraints. TRIAL REGISTRATION NUMBER: ISRCTN125595588.

Poly-substance use and sexual risk behaviours: a cross-sectional comparison of adolescents in mainstream and alternative education settings.

BACKGROUND: Surveys of young people under-represent those in alternative education settings (AES), potentially disguising health inequalities. We present the first quantitative UK evidence of health inequalities between AES and mainstream education school (MES) pupils, assessing whether observed inequalities are attributable to socioeconomic, familial, educational and peer factors. METHODS: Cross-sectional, self-reported data on individual- and poly-substance use (PSU: combined tobacco, alcohol and cannabis use) and sexual risk-taking from 219 pupils in AES (mean age 15.9 years) were compared with data from 4024 pupils in MES (mean age 15.5 years). Data were collected from 2008 to 2009 as part of the quasi-experimental evaluation of Healthy Respect 2 (HR2). RESULTS: AES pupils reported higher levels of substance use, including tobacco use, weekly drunkenness, using cannabis at least once a week and engaging in PSU at least once a week. AES pupils also reported higher levels of sexual health risk behaviours than their MES counterparts, including: earlier sexual activity; less protection against sexually transmitted infections (STIs); and having 3+ lifetime sexual partners. In multivariate analyses, inequalities in sexual risk-taking were fully explained after adjusting for higher deprivation, lower parental monitoring, lower parent-child connectedness, school disengagement and heightened intentions towards early parenthood among AES vs MES pupils. However, an increased risk (OR = 1.73, 95% CI 1.15, 2.60) of weekly PSU was found for AES vs MES pupils after adjusting for these factors and the influence of peer behaviours. CONCLUSION: AES pupils are more likely to engage in health risk behaviours, including PSU and sexual risk-taking, compared with MES pupils. AES pupils are a vulnerable group who may not be easily targeted by conventional population-level public health programmes. Health promotion interventions need to be tailored and contextualised for AES pupils, in particular for sexual health and PSU. These could be included within interventions designed to promote broader outcomes such as mental wellbeing, educational engagement, raise future aspirations and promote resilience.

Providing sex and relationships education for looked-after children: a qualitative exploration of how personal and institutional factors promote or limit the experience of role ambiguity, conflict and overload among caregivers.

OBJECTIVES: To explore how personal and institutional factors promote or limit caregivers promoting sexual health and relationships (SHR) among looked-after children (LAC). In so doing, develop existing research dominated by atheoretical accounts of the facilitators and barriers of SHR promotion in care settings. DESIGN: Qualitative semistructured interview study. SETTING: UK social services, residential children's homes and foster care. PARTICIPANTS: 22 caregivers of LAC, including 9 foster carers, 8 residential carers and 5 social workers; half of whom had received SHR training. METHODS: In-depth interviews explored barriers/facilitators to SHR discussions, and how these shaped caregivers' experiences of discussing SHR with LAC. Data were systematically analysed using predetermined research questions and themes identified from reading transcripts. Role theory was used to explore caregivers' understanding of their role. RESULTS: SHR policies clarified role expectations and increased acceptability of discussing SHR. Training increased knowledge and confidence, and supported caregivers to reflect on how personally held values impacted practice. Identified training gaps were how to: (1) Discuss SHR with LAC demonstrating problematic sexual behaviours. (2) Record the SHR discussions that had occurred in LAC's health plans. Contrary to previous findings, caregivers regularly discussed SHR with LAC. Competing demands on time resulted in prioritisation of discussions for sexually active LAC and those 'at risk' of sexual exploitation/harm. Interagency working addressed gaps in SHR provision. SHR discussions placed emotional burdens on caregivers. Caregivers worried about allegations being made against them by LAC. Managerial/pastoral support and 'safe care' procedures minimised these harms. CONCLUSIONS: While acknowledging the existing level of SHR promotion for LAC there is scope to more firmly embed this into the role of caregivers. Care needs to be taken to avoid role ambiguity and tension when doing so. Providing SHR policies and training, promoting interagency working and providing pastoral support are important steps towards achieving this.

Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial.

BACKGROUND: For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the 'alarm' symptoms of dysphagia and weight loss are reported by only 32 and 8 % of patients, respectively, and their presence correlates with advanced-stage disease. Electronic clinical decision-support tools that integrate with clinical computer systems have been developed for general practice, although uncertainty remains concerning their effectiveness. The objectives of this trial are to optimise the intervention and establish the acceptability of both the intervention and randomisation, confirm the suitability and selection of outcome measures, finalise the design for the phase III definitive trial, and obtain preliminary estimates of the intervention effect. METHODS/DESIGN: This is a two-arm, multi-centre, cluster-randomised, controlled phase II trial design, which will extend over a 16-month period, across 60 general practices within the North East and North Cumbria and the Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (the electronic clinical decision-support tool) or to act as a control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms suggestive of gastro-oesophageal cancer. The main measures are the process data, which include the practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes, and patient outcomes. One-on-one interviews in a sub-sample of 30 patient-GP dyads will be undertaken to understand the impact of the use or non-use of the electronic clinical decision-support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision-support tool in practice. DISCUSSION: We aim to generate new knowledge on the process measures regarding the use of electronic clinical decision-support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact of the support tool on resource utilisation and health care costs will also be collected. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12595588 .

Factors influencing change in clinical practice: A qualitative evaluation of the implementation of the quality improvement in colonoscopy study.

PURPOSE: The quality improvement in colonoscopy study was a region wide service improvement study to improve adenoma detection rate at colonoscopy by implementing evidence into routine colonoscopy practice. Implementing evidence into clinical practice can be challenging. The purpose of this paper is to perform a qualitative interview study to evaluate factors that influenced implementation within the study. DESIGN/METHODOLOGY/APPROACH: Semi-structured interviews were conducted with staff in endoscopy units taking part in the quality improvement in colonoscopy study, after study completion. Units and interviewees were purposefully sampled to ensure a range of experiences was represented. Interviews were conducted with 11 participants. FINDINGS: Key themes influencing uptake of the quality improvement in colonoscopy evidence bundle included time, study promotion, training, engagement, positive outcomes and modifications. Areas within themes were increased awareness of quality in colonoscopy (QIC), emphasis on withdrawal time and empowerment of endoscopy nurses to encourage the use of quality measures were positive outcomes of the study. The simple, visible study posters were reported as useful in aiding study promotion. Feedback sessions improved engagement. Challenges included difficulty arranging set-up meetings and engaging certain speciality groups. ORIGINALITY/VALUE: This evaluation suggests that methods to implement evidence into clinical practice should include identification and empowerment of team members who can positively influence engagement, simple, visible reminders and feedback. Emphasis on timing of meetings and strategies to engage speciality groups should also be given consideration. Qualitative evaluations can provide important insights into why quality improvement initiatives are successful or not, across different sites.

A community practitioner abroad: listening to women in Dailekh, Nepal.

Nepal is one of the poorest countries in the world, and has a strongly patriarchal culture. This study reports on methods used to explore women's opportunities in decision-making roles in Dailekh, Nepal. Action-based research was used to support women to identify barriers and to enable them to find solutions which could increase meaningful, practical and genuine representation. Participants were women in nominal positions of leadership in the community and subsequently also men in leadership roles. Focus groups and interviews enabled data to be collected and analysed using participatory and 'rich picture' tools. A five-stage framework approach was used to analyse data. A major theme of 'power' emerged comprised of supporting themes; 'place in society 'formal power,' informal power and 'voice'. These outcomes formed the basis for identifying viable action plans generated by the participants of both genders to promote meaningful involvement of women in community decision making. Women were clear that involving men and women in the actions was key to increasing success.

Patient-derived measures of GI endoscopy: a meta-narrative review of the literature.

BACKGROUND AND AIMS: GI endoscopy (GIE) is widely performed, with 1 in 3 people requiring an endoscopic procedure at some point. Patient experience of medical procedures is important, but, to date, experience measures of GIE are derived from clinician opinion rather than from patients themselves. In this meta-narrative review, the literature on methods of assessing patient experience in GIE is reported. METHODS: ScienceDirect, MEDLINE, Web of Knowledge, Web of Science, CINAHL, and PsycINFO were searched to November 2013 using meta-narrative standards. Search terms included those related to endoscopic procedures, combined with those related to patient experience. RESULTS: A total of 3688 abstracts were identified and reviewed for relevance. A total of 3549 were excluded, leaving 139 for full-text review. We subsequently included 48 articles. Three sub-groups of studies were identified--those developing original measures of endoscopy-specific patient experience (27 articles), those modifying existing measures (10 articles), and those testing existing measures for reliability or validity (11 articles). Most measures focused on pain, discomfort, anxiety, and embarrassment. Three studies explored wider aspects of experience, including preparation, unit organization, and endoscopist preference. Likert scales, visual analog scale scores, and questionnaires were used most commonly. The Global Rating Scale was validated for use in 2 studies, confirming that those domains cover all aspects of endoscopy experience. Other measures were modified to assess endoscopic experience, such as the modified Group Health Association of America survey (mGHAA-9) (modified by 5 studies). CONCLUSIONS: No patient-derived and validated endoscopy-specific experience measures were found. Patient-derived and validated experience measures should be developed and used to model optimal healthcare delivery.

The environment can explain differences in adolescents' daily physical activity levels living in a deprived urban area: cross-sectional study using accelerometry, GPS, and focus groups.

BACKGROUND: Evidence suggests that many contemporary urban environments do not support healthy lifestyle choices and are implicated in the obesity pandemic. Middlesbrough, in the northeast of England is one such environment and a prime target for investigation. METHODS: To measure physical activity (PA) levels in a sample of 28 adolescents (aged 11 to 14 years) and describe the environmental context of their activity and explore where they are most and least active over a 7-day period, accelerometry and Global Positioning System (GPS) technology were used. Twenty-five of these participants also took part in focus groups about their experiences and perceptions of PA engagement. RESULTS: Findings indicated that all participants were relatively inactive throughout the observed period although bouts of moderate-vigorous physical activity (MVPA) were identified in 4 contexts: school, home, street, and rural/urban green spaces, with MVPA levels highest in the school setting. Providing access to local facilities and services (such as leisure centers) is not in itself sufficient to engage adolescents in MVPA. CONCLUSION: Factors influencing engagement in MVPA were identified within and across contexts, including 'time' as both a facilitator and barrier, perceptions of 'gendered' PA, and the social influences of peer groups and family members.

Has untargeted sexual health promotion for young people reached its limit? A quasi-experimental study.

BACKGROUND: Theoretically, there may be benefit in augmenting school-based sexual health education with sexual health services, but the outcomes are poorly understood. Healthy Respect 2 (HR2) combined sex education with youth-friendly sexual health services, media campaigns and branding, and encouraged joint working between health services, local government and the voluntary sector. This study examined whether HR2: (1) improved young people's sexual health knowledge, attitudes, behaviour and use of sexual health services and (2) reduced socioeconomic inequalities in sexual health. METHODS: A quasi-experiment in which the intervention and comparison areas were matched for teenage pregnancy and terminations, and schools were matched by social deprivation. 5283 pupils aged 15-16 years (2269 intervention, 3014 comparison) were recruited to cross-sectional surveys in 2007, 2008 and 2009. RESULTS: The intervention improved males' and, to a lesser extent, females' sexual health knowledge. Males' intention to use condoms, and reported use of condoms, was unaffected, compared with a reduction in both among males in the comparison arm. Although females exposed to the intervention became less accepting of condoms, there was no change in their intention to use condoms and reported condom use. Pupils became more tolerant of sexual coercion in both the intervention and comparison arms. Attitudes towards same-sex relationships remained largely unaffected. More pupils in the HR2 area used sexual health services, including those from lower socioeconomic backgrounds. This aside, sexual health inequalities remained. CONCLUSIONS: Combining school-based sex education and sexual health clinics has a limited impact. Interventions that address the upstream causes of poor sexual health, such as a detrimental sociocultural environment, represent promising alternatives. These should prioritise the most vulnerable young people.

A community-based health promotion intervention using brief negotiation techniques and a pledge on dietary intake, physical activity levels and weight outcomes: lessons learnt from an exploratory trial.

OBJECTIVE: To assess the effectiveness of a brief face-to-face health promotion intervention which included a 'pledge' using brief negotiation techniques, compared with standard advice-giving techniques, delivered in a community setting. DESIGN: A parallel group pre-post design using randomised matched groups. Lifestyle helpers delivered the intervention (one consultation per participant). Diet, physical activity and anthropometric measurements were collected at baseline, 6 months and 12 months. Qualitative data were also collected. SETTING: Middlesbrough (UK). SUBJECTS: Adults living in low socio-economic areas. RESULTS: Recruitment and engagement of lifestyle helpers was difficult, and initial expectations that local health authority staff working in the community and community champions would act as lifestyle helpers were not realised. As a consequence, recruitment of participants was lower than anticipated. One hundred and twenty-eight adults were recruited and the retention rate was 48 % at 12 months. Barriers to participation included poor health and competing commitments. No significant differences in change in diet or physical activity behaviours, or BMI, between the intervention and control groups were observed. The control group had a significantly greater decrease in waist circumference at 12 months compared with the intervention group. CONCLUSIONS: This exploratory trial provides important insights in terms of recruiting lifestyle helpers for community-based health promotion interventions, specifically (i) the priorities and limitations in terms of time (regardless of their general enthusiasm) for staff employed by the local health authority, and (ii) the willingness of potential community champions to serve their local community in areas where community identity and 'spirit' are seen as lacking.

Is parenting associated with teenagers' early sexual risk-taking, autonomy and relationship with sexual partners?

CONTEXT: Extensive research has explored the relationship between parenting and teenagers' sexual risk-taking. Whether parenting is associated with wider aspects of teenagers' capacity to form satisfying sexual relationships is unknown. METHODS: Self-reported data were collected in 2007 from 1,854 students, whose average age was 15.5 years, in central Scotland. Multivariate analyses examined associations between parenting processes and sexual outcomes (delayed first intercourse, condom use and several measures reflecting the context or anticipated context of first sex). RESULTS: Parental supportiveness was positively associated with all outcomes (betas, 0.1-0.4), and parental values restricting intercourse were positively associated with all outcomes except condom use (0.1-0.5). Parental monitoring was associated only with delayed intercourse (0.2) and condom use (0.2); parental rules about TV content were associated with delayed intercourse (0.7) and expecting sex in a relationship, rather than casually (0.8). Frequency of parental communication about sex and parental values endorsing contraceptive use were negatively associated with teenagers' delayed intercourse (-0.5 and -0.3, respectively), and parents' contraceptive values were negatively associated with teenagers' expecting sex in a relationship (-0.5). Associations were partly mediated by teenagers' attitudes, including value placed on having sex in a relationship. CONCLUSIONS: Parents may develop teenagers' capacity for positive and safe early sex by promoting skills and values that build autonomy and encourage sex only within a relationship. Interventions should promote supportive parenting and transmission of values, avoid mixed messages about abstinence and contraception, and acknowledge that teenagers may learn more indirectly than directly from parents about sex.

Retaining young people in a longitudinal sexual health survey: a trial of strategies to maintain participation.

BACKGROUND: There is an increasing trend towards lower participation in questionnaire surveys. This reduces representativeness, increases costs and introduces particular challenges to longitudinal surveys, as researchers have to use complex statistical techniques which attempt to address attrition. This paper describes a trial of incentives to retain longitudinal survey cohorts from ages 16 to 20, to question them on the sensitive topic of sexual health. METHODS: A longitudinal survey was conducted with 8,430 eligible pupils from two sequential year groups from 25 Scottish schools. Wave 1 (14 years) and Wave 2 (16 years) were conducted largely within schools. For Wave 3 (18 years), when everyone had left school, the sample was split into 4 groups that were balanced across predictors of survey participation: 1) no incentive; 2) chance of winning one of twenty-five vouchers worth 20 pounds; 3) chance of winning one 500 pounds voucher; 4) a definite reward of a 10 pounds voucher sent on receipt of their completed questionnaire. Outcomes were participation at Wave 3 and two years later at Wave 4. Analysis used logistic regression and adjusted for clustering at school level. RESULTS: The only condition that had a significant and beneficial impact for pupils was to offer a definite reward for participation (Group 4). Forty-one percent of Group 4 participated in Wave 3 versus 27% or less for Groups 1 to 3. At Wave 4, 35% of Group 4 took part versus 25% or less for the other groups. Similarly, 22% of Group 4 participated in all four Waves of the longitudinal study, whereas for the other three groups it was 16% or less that participated in full. CONCLUSIONS: The best strategy for retaining all groups of pupils and one that improved retention at both age 18 and age 20 was to offer a definite reward for participation. This is expensive, however, given the many benefits of retaining a longitudinal sample, we recommend inclusion of this as a research cost for cohort and other repeat-contact studies.