Interactive digital interventions for prevention of sexually transmitted HIV.

BACKGROUND: Digital technology offers good opportunities for HIV prevention. This systematic review assesses the effectiveness of interactive digital interventions (IDIs) for prevention of sexually transmitted HIV. METHODS: We conducted a systematic search for randomized controlled trials (RCTs) of IDIs for HIV prevention, defining 'interactive' as producing personally tailored material. We searched databases including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, PsycINFO, grey literature, reference lists, and contacted authors if needed.Two authors screened abstracts, applied eligibility and quality criteria and extracted data. Meta-analyses used random-effects models with standardized mean differences (SMD) for continuous outcomes and odds ratios (OR) for binary outcomes, assessing heterogeneity using the I2 statistic. RESULTS: We included 31 RCTs of IDIs for HIV prevention. Meta-analyses of 29 RCTs comparing IDIs with minimal interventions (e.g. leaflet, waiting list) showed a moderate increase in knowledge (SMD 0.56, 95% CI 0.33 to 0.80), no effect on self-efficacy (SMD 0.13, 95% CI 0.00 to 0.27), a small improvement in intention (SMD 0.16, 95% CI 0.06 to 0.26), improvement in HIV prevention behaviours (OR 1.28, 95% CI 1.04 to 1.57) and a possible increase in viral load, but this finding is unreliable.We found no evidence of difference between IDIs and face-to-face interventions for knowledge, self-efficacy, intention, or HIV-related behaviours in meta-analyses of five small RCTs. We found no health economic studies. CONCLUSION: There is good evidence that IDIs have positive effects on knowledge, intention and HIV prevention behaviours. IDIs are appropriate for HIV prevention in a variety of settings.Supplementary Video Abstract, http://links.lww.com/QAD/B934.

The acceptability and feasibility of an anxiety reduction intervention for emergency department patients with non-cardiac chest pain.

Despite good physical prognosis, patients who receive a diagnosis of non-cardiac chest pain (NCCP) may experience persistent pain and distress. While cognitive-behavioural interventions have been found to be effective for this group, they are difficult to deliver in busy emergency department (ED) settings. Addressing the acceptability and relevance of self-help interventions is an important initial step in addressing this need. This study sought to examine the acceptability and relevance of an evidence-based self-help intervention for ED patients with persistent NCCP and anxiety. Patient (interviews: N = 11) and specialist chest pain nurse (focus group: N = 4) views on acceptability and feasibility were examined. Data were analysed using thematic analysis. Patients and nurses reported that there was a need for the intervention, as stress and anxiety are common among patients with NCCP, and provision of psychosocial support is currently lacking. Both patients and nurses reported that the intervention was relevant, acceptable, and potentially useful. Some changes to the intervention were suggested. Nurses reported that the intervention could be used within the existing staff resources available in an ED setting. This study represents an important first step towards developing a brief self-help intervention for ED patients with NCCP and anxiety. Further research should seek to determine the efficacy of the intervention in a pilot trial.

The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

BACKGROUND: This report details the development of the Men's Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation. OBJECTIVES: (1) Develop the Men's Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men's views of online research methodology. METHODS: (1) Website development: we combined evidence from research literature and the views of experts (n = 18) and male clinic users (n = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men's Safer Sex website plus usual care (n = 84) or usual clinic care only (n = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires. RESULTS: (1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men's Safer Sex website and technical problems were frustrating. Men's views of the Men's Safer Sex website and research procedures were largely positive. CONCLUSIONS: It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18649610. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.

The assessment of depression in people with multiple sclerosis: a systematic review of psychometric validation studies.

BACKGROUND: The prevalence of depression in people with multiple sclerosis (PwMS) is high; however, symptoms common to both conditions makes measurement difficult. There is no high quality overview of validation studies to guide the choice of depression inventory for this population. METHODS: A systematic review of studies validating the use of generic depression inventories in people with MS was conducted using MEDLINE and PsycINFO. Studies validating the use of depression inventories in PwMS and published in English were included; validation studies of tests for cognitive function and general mental health were excluded. Eligible studies were then quality assessed using the COSMIN checklist and findings synthesised narratively by instrument and validity domain. RESULTS: Twenty-one studies (N = 5,991 PwMS) evaluating 12 instruments were included in the review. Risk of bias varied greatly between instrument and validity domain. CONCLUSIONS: The review of validation studies was constrained by poor quality reporting and outcome reporting bias. Well-conducted evaluations of some instruments are unavailable for some validity domains. This systematic review provides an evidence base for trade-offs in the selection of an instrument for assessing self-reported symptoms of depression in research or clinical practice involving people with MS. We make detailed and specific recommendations for where further research is needed. TRIAL REGISTRATION: PROSPERO CRD42014010597.

The Effectiveness of Prompts to Promote Engagement With Digital Interventions: A Systematic Review.

BACKGROUND: Digital interventions have been effective in improving numerous health outcomes and health behaviors; furthermore, they are increasingly being used in different health care areas, including self-management of long-term conditions, mental health, and health promotion. The full potential of digital interventions is hindered by a lack of user engagement. There is an urgent need to develop effective strategies that can promote users' engagement with digital interventions. One potential method is the use of technology-based reminders or prompts. OBJECTIVE: To evaluate the effectiveness of technology-based strategies for promoting engagement with digital interventions. METHODS: Cochrane Collaboration guidelines on systematic review methodology were followed. The search strategy was executed across 7 electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, the Education Resources Information Center (ERIC), PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). Databases were searched from inception to September 13, 2013, with no language or publication type restrictions, using three concepts: randomized controlled trials, digital interventions, and engagement. Gray literature and reference lists of included studies were also searched. Titles and abstracts were independently screened by 2 authors, then the full texts of potentially eligible papers were obtained and double-screened. Data from eligible papers were extracted by one author and checked for accuracy by another author. Bias was assessed using the Cochrane risk of bias assessment tool. Narrative synthesis was performed on all included studies and, where appropriate, data were pooled using meta-analysis. All findings were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: A total of 14 studies were included in the review with 8774 participants. Of the 14 studies, 9 had sufficient data to be included in the meta-analyses. The meta-analyses suggested that technology-based strategies can potentially promote engagement compared to no strategy for dichotomous outcomes (relative risk [RR] 1.27, 95% CI 1.01-1.60, I(2)=71%), but due to considerable heterogeneity and the small sample sizes in most studies, this result should be treated with caution. No studies reported adverse or economic outcomes. Only one study with a small sample size compared different characteristics; the study found that strategies promoting new digital intervention content and those sent to users shortly after they started using the digital intervention were more likely to engage users. CONCLUSIONS: Overall, studies reported borderline positive effects of technology-based strategies on engagement compared to no strategy. However, the results have to be interpreted with caution. More research is needed to replicate findings and understand which characteristics of the strategies are effective in promoting engagement and how cost-effective they are.

The Men's Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

OBJECTIVES: We aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men's Safer Sex website, measuring condom use and sexually transmitted infection (STI). METHODS: For this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care (n = 84), or usual clinic care only (n = 75). Online outcome data were solicited at 3, 6, and 12 months. RESULTS: Men were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website (n = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90). CONCLUSION: It is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings.Trial registration number: ISRCTN18649610.

Defining the Content of an Online Sexual Health Intervention: The MenSS Website.

BACKGROUND: Health promotion and risk reduction are essential components of sexual health care. However, it can be difficult to prioritize these within busy clinical services. Digital interventions may provide a new method for supporting these. OBJECTIVE: The MenSS (Men's Safer Sex) website is an interactive digital intervention developed by a multidisciplinary team, which aims to improve condom use in men who have sex with women (MSW). This paper describes the content of this intervention, and the rationale for it. METHODS: Content was informed by a literature review regarding men's barriers to condom use, workshops with experts in sexual health and technology (N=16) and interviews with men in sexual health clinics (N=20). Data from these sources were analyzed thematically, and synthesized using the Behavior Change Wheel framework. RESULTS: The MenSS intervention is a website optimized for delivery via tablet computer within a clinic waiting room setting. Key targets identified were condom use skills, beliefs about pleasure and knowledge about risk. Content was developed using behavior change techniques, and interactive website features provided feedback tailored for individual users. CONCLUSIONS: This paper provides a detailed description of an evidence-based interactive digital intervention for sexual health, including how behavior change techniques were translated into practice within the design of the MenSS website. Triangulation between a targeted literature review, expert workshops, and interviews with men ensured that a range of potential influences on condom use were captured.

'Everything's fine, so why does it happen?' A qualitative investigation of patients' perceptions of noncardiac chest pain.

AIMS AND OBJECTIVES: To examine patients' perceptions and experiences of noncardiac chest pain, within the framework of the common sense model. BACKGROUND: Patients with noncardiac chest pain have good physical prognosis, but frequently suffer prolonged pain and psychological distress. The common sense model may provide a good framework for examining outcomes in patients with noncardiac chest pain. DESIGN: Qualitative thematic analysis with semi-structured interviews. METHODS: In 2010, participants recruited from an emergency department (N = 7) with persistent noncardiac chest pain and distress were interviewed using a semi-structured schedule, and data were analysed using thematic analysis. RESULTS: Seven themes were identified; six of which mapped onto core dimensions of the common sense model (identity, cause, timeline, consequences, personal control, treatment control). Contrary to previous research on medically unexplained symptoms, most participants perceived psychological factors to play a causal role in their chest pain. Participants' perceptions largely mapped onto the common sense model, although there was a lack of coherence across dimensions, particularly with regard to cause. CONCLUSION: Patients with noncardiac chest pain lack understanding with regard to their condition and may be accepting of psychological causes of their pain. RELEVANCE TO CLINICAL PRACTICE: Brief psychological interventions aimed at improving understanding of the causes of noncardiac chest pain and providing techniques for managing pain and stress may be useful for patients with noncardiac chest pain.

The effectiveness of technology-based strategies to promote engagement with digital interventions: a systematic review protocol.

BACKGROUND: Digital interventions provide effective and potentially cost-effective models for improving health outcomes as they deliver health information and services that are widely disseminated, confidential, and can be tailored to needs of the individual user. Digital interventions have been used successfully for health promotion, mental health, and for enabling self-management of long-term conditions. However, their effectiveness is limited by low usage rates, with non-engagement a major challenge. Hence, it is crucial to find effective strategies to increase user engagement with digital interventions. OBJECTIVE: This systematic review will aim to evaluate the effectiveness of technology-based strategies to promote engagement with digital interventions. METHODS: We will follow Cochrane Collaboration guidelines on systematic review methodology. The search strategy will be executed across seven e-databases (including MEDLINE, EMBASE, PsycINFO, CINAHL) using the concepts "digital intervention" and "engagement", limited by study type (randomized controlled trial). Grey literature and reference lists of included studies will be searched. Titles and abstracts will be independently screened by 2 authors. Then the full text of potentially eligible papers will be obtained and double screened. Data from eligible papers will be extracted by 1 author and checked for accuracy by another author. Bias will be assessed using the Cochrane bias assessment tool. Narrative synthesis will report on all included studies, and where appropriate, data will be pooled using meta-analysis. All findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Sources of heterogeneity will be further investigated if required. RESULTS: Our research is in progress. The final draft of the systematic review is being written and will be submitted before the end of 2015. CONCLUSIONS: The review findings will inform researchers and digital intervention providers about optimal use of technology-based strategies to promote engagement with digital interventions. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews: CRD42014010164; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014010164#.VTZmmiFViko (Archived by WebCite at http://www.webcitation.org/6XxQC8fT8).

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men.

INTRODUCTION: Sexually transmitted infections (STI) are a major public health problem. Condoms provide effective protection but there are many barriers to use. Face-to-face health promotion interventions are resource-intensive and show mixed results. Interactive digital interventions may provide a suitable alternative, allowing private access to personally tailored behaviour change support. We have developed an interactive digital intervention (the Men's Safer Sex (MenSS) website) which aims to increase condom use in men. We describe the protocol for a pilot trial to assess the feasibility of a full-scale randomised controlled trial of the MenSS website in addition to usual sexual health clinical care. PARTICIPANTS: Men aged 16 or over who report female sexual partners and recent unprotected sex or suspected acute STI. PARTICIPANTS (N=166) will be enrolled using a tablet computer in clinic waiting rooms. All trial procedures will be online, that is, eligibility checks; study consent; trial registration; automated random allocation; and data submission. At baseline and at 3, 6 and 12 months, an online questionnaire will assess condom use, self-reported STI diagnoses, and mediators of condom use (eg, knowledge, intention). Reminders will be by email and mobile phone. The primary outcome is condom use, measured at 3 months. STI rates will be recorded from sexual health clinic medical records at 12 months. The feasibility of a cost-effectiveness analysis will be assessed, to calculate incremental cost per STI prevented (Chlamydia or Gonorrhoea), from the NHS perspective. ETHICS AND DISSEMINATION: Ethical approval: City and East NHS Research Ethics Committee (reference number 13 LO 1801). Findings will be made available through publication in peer-reviewed journals, and to participants and members of the public via Twitter and from the University College London eHealth Unit website. Raw data will be made available on request. TRIAL REGISTRATION NUMBER: Current Controlled Trials. ISRCTN18649610. Registered 15 October 2013 http://www.controlled-trials.com/ISRCTN18649610.