Parents' and clinicians' views of an interactive booklet about respiratory tract infections in children: a qualitative process evaluation of the EQUIP randomised controlled trial

Background: ‘When should I worry?’ is an interactive booklet for parents of children presenting with respiratory tract infections (RTIs) in primary care and associated training for clinicians. A randomised controlled trial (the EQUIP study) demonstrated that this intervention reduced antibiotic prescribing and future consulting intentions. The aims of this qualitative process evaluation were to understand how acceptable the intervention was to clinicians and parents, how it was implemented, the mechanisms for any observed effects, and contextual factors that could have influenced its effects.<p></p> Methods: Semi-structured interviews were conducted with 20 parents and 13 clinicians who participated in the trial. Interviews were audio-recorded and transcribed verbatim. Data were analysed using a framework approach, which involved five stages; familiarisation, development of a thematic framework, indexing, charting, and interpretation.<p></p> Results: Most parents and clinicians reported that the ‘When should I worry’ interactive booklet (and online training for clinicians) was easy to use and valuable. Information on recognising signs of serious illness and the usual duration of illness were most valued. The interactive use of the booklet during consultations was considered to be important, but this did not always happen. Clinicians reported lack of time, lack of familiarity with using the booklet, and difficulty in modifying their treatment plan/style of consultation as barriers to use. Increased knowledge and confidence amongst clinicians and patients were seen as key components that contributed to the reductions in antibiotic prescribing and intention to consult seen in the trial. This was particularly pertinent in a context where decisions about the safe and appropriate management of childhood RTIs were viewed as complex and parents reported frequently receiving inconsistent messages. Conclusions: The ‘When should I worry’ booklet, which is effective in reducing antibiotic prescribing, has high acceptability for clinicians and parents, helps address gaps in knowledge, increases confidence, and provides a consistent message. However, it is not always implemented as intended. Plans for wider implementation of the intervention in health care settings would need to address clinician-related barriers to implementation

Economic modeling of the combined effects of HIV-disease, cholesterol and lipoatrophy based on ACTG 5142 trial data

<p>Abstract</p> <p>Background</p> <p>This study examines the cost and consequences of initiating an ARV regimen including Lopinavir/ritonavir (LPV/r) or Efavirenz (EFV), using data from a recent clinical trial in a previously published model of HIV-disease.</p> <p>Methods</p> <p>We populated the Markov model of HIV-disease with data from ACTG 5142 study to estimate the economic outcomes of starting ARV therapy with a PI-containing regimen as compared to an NNRTI-containing regimen, given their virologic and immunologic efficacy and effects on cholesterol and lipoatrophy. CNS toxicities and GI tolerability were not included in the model because of their transient nature or low cost remedies, and therefore lack of economic impact. CD4+ T-cell counts and the HIV-1 RNA (viral load) values from the study were used to assign a specific health state (HS) to each patient for each quarter year. The resulting frequencies used as "raw" data directly into the model obviate the reliance on statistical tests, and allow the model to reflect actual patient behavior in the clinical trial. An HS just below the last observed HS was used to replace a missing value.</p> <p>Results</p> <p>The modeled estimates (undiscounted) for the LPV/r-based regimen resulted in 1.41 quality-adjusted life months (QALMs) gained over a lifetime compared to the EFV-based regimen. The LPV/r-based regimen incurred $7,458 (1.8$88,829/QALY. Most of the higher costs accrue before the 7th year of treatment and were offset by subsequent savings. The estimates are highly sensitive to the effect of lipoatrophy on Health-related Quality of Life (HRQOL), but not to the effect of cholesterol levels.</p> <p>Conclusions</p> <p>The cost effectiveness of ARV regimens may be strongly affected by enduring AEs, such as lipoatrophy. It is important to consider specific AE effects from all drugs in a regimen when ARVs are compared.</p> <p>Trial registration</p> <p>(ClinicalTrials.gov number, <a href="http://www.clinicaltrials.gov/ct2/show/NCT00050895">NCT00050895</a><url>http://[ClinicalTrials.gov]</url>).</p

A peer-led, school-based social network intervention for young people in the UK, promoting sexual health via social media and conversations with friends: intervention development and optimisation of STASH

BACKGROUND: The quality of school-based sex and relationships education (SRE) is variable in the UK. Digitally-based interventions can usefully supplement teacher-delivered lessons and positively impact sexual health knowledge. Designed to address gaps in core SRE knowledge, STASH (Sexually Transmitted infections And Sexual Health) is a peer-led social network intervention adapted from the successful ASSIST (A Stop Smoking in Schools Trial) model, and based on Diffusion of Innovation theory. This paper describes how the STASH intervention was developed and refined. METHODS: Drawing on the Six Steps in Quality Intervention Development (6SQuID) framework, we tested a provisional programme theory through three iterative stages -: 1) evidence synthesis; 2) intervention co-production; and 3) adaptation - which incorporated evidence review, stakeholder consultation, and website co-development and piloting with young people, sexual health specialists, and educators. Multi-method results were analysed in a matrix of commonalities and differences. RESULTS: Over 21 months, intervention development comprised 20 activities within the three stages. 1) We identified gaps in SRE provision and online resources (e.g. around sexual consent, pleasure, digital literacy), and confirmed critical components including the core ASSIST peer nomination process, the support of schools, and alignment to the national curriculum. We reviewed candidate social media platforms, ruling out all except Facebook on basis of functionality restrictions which precluded their use for our purposes. 2) Drawing on these findings, as well as relevant behaviour change theories and core elements of the ASSIST model, we co-developed new content with young people and other stakeholders, tailored to sexual health and to delivery via closed Facebook groups, as well as face-to-face conversations. 3) A pilot in one school highlighted practical considerations, including around peer nomination, recruitment, awareness raising, and boundaries to message sharing. From this, a revised STASH intervention and programme theory were co-developed with stakeholders. CONCLUSIONS: STASH intervention development required extensive adaptation from the ASSIST model. Although labour intensive, our robust co-development approach ensured that an optimised intervention was taken forward for feasibility testing. Evidencing a rigorous approach to operationalising existing intervention development guidance, this paper also highlights the significance of balancing competing stakeholder concerns, resource availability, and an ever-changing landscape for implementation. TRIAL REGISTRATION: ISRCTN97369178

Internet-based psychoeducation for bipolar disorder: a qualitative analysis of feasibility, acceptability and impact

&lt;p&gt;Background: In a recent exploratory randomised trial we found that a novel, internet-based psychoeducation programme for bipolar disorder (Beating Bipolar) was relatively easy to deliver and had a modest effect on psychological quality of life. We sought to explore the experiences of participants with respect to feasibility, acceptability and impact of Beating Bipolar.&lt;/p&gt; &lt;p&gt;Methods: Participants were invited to take part in a semi-structured interview. Thematic analysis techniques were employed; to explore and describe participants’ experiences, the data were analysed for emerging themes which were identified and coded.&lt;/p&gt; &lt;p&gt;Results: The programme was feasible to deliver and acceptable to participants where they felt comfortable using a computer. It was found to impact upon insight into illness, health behaviour, personal routines and positive attitudes towards medication. Many participants regarded the programme as likely to be most beneficial for those recently diagnosed.&lt;/p&gt; &lt;p&gt;Conclusions: An online psychoeducation package for bipolar disorder, such as Beating Bipolar, is feasible and acceptable to patients, has a positive impact on self-management behaviours and may be particularly suited to early intervention. Alternative (non-internet) formats should also be made available to patients.&lt;/p&gt

A peer-led intervention to promote sexual health in secondary schools: the STASH feasibility study

Background: Young people report higher levels of unsafe sex and have higher rates of sexually transmitted infections than any other age group. Schools are well placed to facilitate early intervention, but more effective approaches are required. Peer-led approaches can augment school-based education, but often fail to capitalise on mechanisms of social influence. The potential of using social media in sexual health has not been tested in school settings. Objectives: Finalise the design of the Sexually Transmitted infections And Sexual Health (STASH) intervention; assess the recruitment and retention of peer supporters, and acceptability to participants and stakeholders; assess the fidelity and reach, in addition to the barriers to and facilitators of, implementation; refine programme theory; understand the potential of social media; determine design parameters for a future randomised controlled trial, including economic evaluation; and establish whether or not progression criteria were met. Design: This was a feasibility study comprising intervention development and refinement of the STASH pilot and non-randomised feasibility trial in six schools. Control data were provided by students in the year above the intervention group. Setting: Secondary schools in Scotland. Participants: Students aged 14–16 years, teachers and intervention delivery partners. Interventions: The STASH intervention was adapted from A Stop Smoking In Schools Trial (ASSIST) (an effective peer-led smoking intervention). Based on diffusion of innovation theory, the STASH study involves peer nomination to identify the most influential students, with the aim of recruiting and training 15% of the year group as peer supporters. The peer supporters deliver sexual health messages to friends in their year group via conversations and use of Facebook (www.facebook.com; Facebook, Inc., Menlo Park, CA, USA) to share varied content from a curated set of web-based resources. Peer supporters are given support themselves via follow-up sessions and via trainer membership of Facebook groups. Main outcome measures: The primary outcome was whether or not progression criteria were met in relation to intervention acceptability and feasibility. The study also piloted indicative primary outcomes for a full-scale evaluation. Data sources: Peer supporter questionnaire; observations of activities; interviews with trainers, teachers, peer supporters and students; monitoring log of peer supporter activities (including on Facebook and meeting attendance); questionnaire to control year group (baseline characteristics, social networks, mediators and sexual health outcomes); baseline and follow-up questionnaire (approximately 6 months later) for intervention year group. Results: A total of 104 students were trained as peer supporters (just over half of those nominated for the role by their peers). Role retention was very high (97%). Of 611 students completing the follow-up questionnaire, 58% reported exposure to STASH study activities. Intervention acceptability was high among students and stakeholders. Activities were delivered with good fidelity. The peer supporters were active, representative of their year group and well connected within their social network. Carefully managed social media use by peer supporters augmented conversations. A primary outcome of ‘always safer sex’ was identified, measured as no sex or always condom use for vaginal or anal sex in the last 6 months. The intervention cost £42 per student. Six progression criteria were met. A seventh criterion (regarding uptake of role by peer supporters) was not. Limitations: Small feasibility study that cannot comment on effectiveness. Conclusions: The STASH intervention is feasible and acceptable within the context of Scottish secondary schools. The results support continuation to a full-scale evaluation. Future work: Small-scale improvements to the intervention, refinement to programme theory and funding sought for full-scale evaluation. Trial registration Current Controlled Trials ISRCTN97369178. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 15. See the NIHR Journals Library website for further project information

The prospective relationship between loneliness, life satisfaction, and psychological distress before and during the Covid-19 pandemic in the UK

Aim: Mental wellbeing in the UK seems to have deteriorated significantly during the COVID-19 pandemic, with the rates of loneliness, life satisfaction and psychological distress taking longer to return to the pre-pandemic levels than elsewhere. Nevertheless, there is little knowledge about the interactions between these outcomes, or the factors that played a role in the rates of change. The current study aims to address this gap by simultaneously investigating changes in loneliness, life satisfaction and psychological distress in the UK from pre-pandemic levels to those between April and November 2020, while critically assessing the role of a range of social ecological influencing factors. Subject and Methods: Longitudinal data from Understanding Society (N=3475) were used to explore the changes in loneliness, life satisfaction and psychological distress from pre-pandemic levels (2017-2019) through November 2020, the interactions between these outcomes, and the role of individual, social, community and geographic factors in the rates of change, using multivariate latent growth curve model. Results: Loneliness, life satisfaction and psychological distress deteriorated minimally between April and November 2020, compared to the pre-pandemic levels (2017–2019), while the rate of change in each outcome influenced the rates of change in the other two. Key individual (age, gender, physical health), social (number of friends and similarity to them), and environmental (neighbourhood quality) variables influenced baseline scores and the rates of change. Conclusion: Considering significant dynamic associations between loneliness, life satisfaction and psychological distress, we argue that interventions to tackle any one of the outcomes may have beneficial effects on others, while highlighting malleable factors and individual and community-level interventions to tackle loneliness

A peer-led, school-based social network intervention for young people in the UK, promoting sexual health via social media and conversations with friends: intervention development and optimisation of STASH

Background The quality of school-based sex and relationships education (SRE) is variable in the UK. Digitally-based interventions can usefully supplement teacher-delivered lessons and positively impact sexual health knowledge. Designed to address gaps in core SRE knowledge, STASH (Sexually Transmitted infections And Sexual Health) is a peer-led social network intervention adapted from the successful ASSIST (A Stop Smoking in Schools Trial) model, and based on Diffusion of Innovation theory. This paper describes how the STASH intervention was developed and refined. Methods Drawing on the Six Steps in Quality Intervention Development (6SQuID) framework, we tested a provisional programme theory through three iterative stages -: 1) evidence synthesis; 2) intervention co-production; and 3) adaptation - which incorporated evidence review, stakeholder consultation, and website co-development and piloting with young people, sexual health specialists, and educators. Multi-method results were analysed in a matrix of commonalities and differences. Results Over 21 months, intervention development comprised 20 activities within the three stages. 1) We identified gaps in SRE provision and online resources (e.g. around sexual consent, pleasure, digital literacy), and confirmed critical components including the core ASSIST peer nomination process, the support of schools, and alignment to the national curriculum. We reviewed candidate social media platforms, ruling out all except Facebook on basis of functionality restrictions which precluded their use for our purposes. 2) Drawing on these findings, as well as relevant behaviour change theories and core elements of the ASSIST model, we co-developed new content with young people and other stakeholders, tailored to sexual health and to delivery via closed Facebook groups, as well as face-to-face conversations. 3) A pilot in one school highlighted practical considerations, including around peer nomination, recruitment, awareness raising, and boundaries to message sharing. From this, a revised STASH intervention and programme theory were co-developed with stakeholders. Conclusions STASH intervention development required extensive adaptation from the ASSIST model. Although labour intensive, our robust co-development approach ensured that an optimised intervention was taken forward for feasibility testing. Evidencing a rigorous approach to operationalising existing intervention development guidance, this paper also highlights the significance of balancing competing stakeholder concerns, resource availability, and an ever-changing landscape for implementation. Trial registration ISRCTN97369178

Mindfulness based interventions in multiple sclerosis: a systematic review

&lt;b&gt;Background&lt;/b&gt; Multiple sclerosis (MS) is a stressful condition; depression, anxiety, pain and fatigue are all common problems. Mindfulness based interventions (MBIs) mitigate stress and prevent relapse in depression and are increasingly being used in healthcare. However, there are currently no systematic reviews of MBIs in people with MS. This review aims to evaluate the effectiveness of MBIs in people with MS.&lt;p&gt;&lt;/p&gt; &lt;b&gt;Methods&lt;/b&gt; Systematic searches were carried out in seven major databases, using both subject headings and key words. Papers were screened, data extracted, quality appraised, and analysed by two reviewers independently, using predefined criteria. Study quality was assessed using the Cochrane Collaboration risk of bias tool. Perceived stress was the primary outcome. Secondary outcomes include mental health, physical health, quality of life, and health service utilisation. Statistical meta-analysis was not possible. Disagreements were adjudicated by a third party reviewer.&lt;p&gt;&lt;/p&gt; &lt;b&gt;Results&lt;/b&gt; Three studies (n = 183 participants) were included in the final analysis. The studies were undertaken in Wales (n = 16, randomised controlled trial - (RCT)), Switzerland (n = 150, RCT), and the United States (n = 17, controlled trial). 146 (80%) participants were female; mean age (SD) was 48.6 (9.4) years. Relapsing remitting MS was the main diagnostic category (n = 123, 67%); 43 (26%) had secondary progressive disease; and the remainder were unspecified. MBIs lasted 6–8 weeks; attrition rates were variable (5-43%); all employed pre- post- measures; two had longer follow up; one at 3, and one at 6 months. Socio-economic status of participants was not made explicit; health service utilisation and costs were not reported. No study reported on perceived stress. All studies reported quality of life (QOL), mental health (anxiety and depression), physical (fatigue, standing balance, pain), and psychosocial measures. Statistically significant beneficial effects relating to QOL, mental health, and selected physical health measures were sustained at 3- and 6- month follow up.&lt;p&gt;&lt;/p&gt; &lt;b&gt;Conclusion&lt;/b&gt; From the limited data available, MBIs may benefit some MS patients in terms of QOL, mental health, and some physical health measures. Further studies are needed to clarify how MBIs might best serve the MS population.&lt;p&gt;&lt;/p&gt

Diet and physical activity in pregnancy to prevent gestational diabetes:A protocol for an individual participant data (IPD) meta-analysis on the differential effects of interventions with economic evaluation

Introduction: Mothers with gestational diabetes mellitus (GDM) are at increased risk of pregnancy-related complications and developing type 2 diabetes after delivery. Diet and physical activity-based interventions may prevent GDM, but variations in populations, interventions and outcomes in primary trials have limited the translation of available evidence into practice. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to assess the differential effects and cost-effectiveness of diet and physical activity-based interventions in preventing GDM and its complications. Methods: The International Weight Management in Pregnancy Collaborative Network database is a living repository of IPD from randomised trials on diet and physical activity in pregnancy identified through a systematic literature search. We shall update our existing search on MEDLINE, Embase, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects and Health Technology Assessment Database without language restriction to identify relevant trials until March 2021. Primary researchers will be invited to join the Network and share their IPD. Trials including women with GDM at baseline will be excluded. We shall perform a one and two stage random-effect meta-analysis for each intervention type (all interventions, diet-based, physical activity-based and mixed approach) to obtain summary intervention effects on GDM with 95% CIs and summary treatment–covariate interactions. Heterogeneity will be summarised using I2 and tau2 statistics with 95% prediction intervals. Publication and availability bias will be assessed by examining small study effects. Study quality of included trials will be assessed by the Cochrane Risk of Bias tool, and the Grading of Recommendations, Assessment, Development and Evaluations approach will be used to grade the evidence in the results. A model-based economic analysis will be carried out to assess the cost-effectiveness of interventions to prevent GDM and its complications compared with usual care. Ethics and dissemination: Ethics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42020212884). Results will be submitted for publication in peer-reviewed journals