by Christina M. Kaul, Brandi E. Moore, Emma Kaplan-Lewis, Eunice Casey, Robert A. Pitts, Patricia Pagan Pirallo, Sahnah Lim, Farzana Kapadia, Gabriel M. Cohen, Maria Khan, Ofole MgbakoBackground
Long-acting injectable HIV pre-exposure prophylaxis (LAI-PrEP) was approved by the U.S. Food and Drug Administration in December 2021. This initial phase of implementation represents a prime opportunity to ensure equitable LAI-PrEP provision to communities often underrepresented in PrEP care before disparities in access and uptake emerge. Herein, we describe the EquiPrEP Project which utilizes an equity-oriented implementation science framework to optimize LAI-PrEP rollout in an urban safety-net clinic in New York City.Methods
The primary objectives of this project are to: (1) increase LAI-PrEP initiation overall; (2) increase uptake among groups disproportionately impacted by the HIV epidemic; (3) preserve high PrEP retention while expanding use; and (4) identify barriers and facilitators to LAI-PrEP use. EquiPrEP will enroll 210 PrEP-eligible participants into LAI-PrEP care with planned follow-up for one year. We will recruit from the following priority populations: Black and/or Latine men who have sex with men, Black and/or Latine cisgender women, and transgender women and nonbinary individuals. To evaluate implementation of LAI-PrEP, we will utilize equity-focused iterations of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and the Consolidated Framework for Implementation Research (CFIR), in addition to longitudinal surveys and qualitative interviews.Discussion
Novel LAI-PrEP formulations carry tremendous potential to revolutionize the field of HIV prevention. Implementation strategies rooted in equity are needed to ensure that marginalized populations have access to LAI-PrEP and to address the structural factors that hinder initiation and retention in care.
To identify how social participation facilitates pre-registration student nurses learning and professional development using social media.
A social survey using thematic analysis to explore Caribbean student nurses' views of social media usage from an open-ended question in a survey.
A qualitative analysis of student nurses from Jamaica and Trinidad and Tobago, who completed an open-ended question in a survey. Data were analysed using thematic analysis.
The three themes identified were: (1) Social media and communication; (2) Social media and self-care; and (3) Social media and learning.
This paper used qualitative evidence to identify and report a new way of viewing SoMe in nursing education as a student-centred educational learning tool. SoMe can improve the effectiveness of student nurses learning, while developing fundamental skills (open-mindedness, critical thinking, professionalism and decision-making) for nursing practice. Social participation and connectivism theory are embedded in student nurses' learning journey. However, it has been used by student nurses outside the traditional university teaching and their capacity to own their personal learning. To meet the new generation of student nurses' learning needs, it is important that higher education institutions develop guidance, support and use of social media for learning to support student nurses in their education as students and also future professionals.
This study addresses how social participation is used in social media to contribute to Caribbean student nurses' education. The main finding is the introduction of a new learning theory supporting learning using social media. This study has an impact on using social media for learning.
No patient or public contribution.
To complete a cultural adaptation of a UK evidence-based problem-solving intervention to support Polish prisoners at risk of suicidal behaviour.
A cross-sectional survey participatory design using an Ecological Validity Model.
The study was a collaboration between: the Academy of Justice, in Warsaw, the University of Lodz, two Polish prisons (ZK Raciborz and ZK Klodzko) and the University of York (UK).
The adaptation process included an examination of the use of language, metaphors and content (ie, culturally appropriate and syntonic language), the changing of case study scenarios (relevance and acceptability) and maintenance of the theoretical underpinning of the problem-solving model (intervention comprehensibility and completeness). Four stages used: (1) a targeted demonstration for Polish prison staff, (2) a wider audit of the skills with Polish prison staff and students, (3) forward and back-translation of the adapted package, and (4) two iterative consultations with participants from stages (1) and (2) and prison officers from two Polish prisons.
Self-selecting volunteer participants included: targeted prison staff (n=10), prison staff from the wider Polish penitentiary system (n=39), students from the University of Lodz (n=28) and prison officers from two Polish prisons (n=12).
Acceptability and feasibility of the training package, reported in a series of knowledge user surveys.
The recognised benefits of using the skills within the training package included: enhancing communication, reflective development, collaborative working, changing behaviour, empowering decision-making, relevance to crisis management situations and use of open-ended questions. The skills were endorsed to be used as part of future penitentiary training for prison officers in Poland.
The skills had widespread appeal for use across the Polish penitentiary system. The materials were deemed relevant while adhering to the comprehensibility of the intervention. Further evaluation of the intervention should be explored using a randomised controlled trial design.
To compare unannounced standardised patient approach (eg, mystery clients) with typical exit interviews for assessing patient experiences in HIV care (eg, unfriendly providers, long waiting times). We hypothesise standardised patients would report more negative experiences than typical exit interviews affected by social desirability bias.
Cross-sectional surveys in 16 government-operated HIV primary care clinics in Lusaka, Zambia providing antiretroviral therapy (ART).
3526 participants aged ≥18 years receiving ART participated in the exit surveys between August 2019 and November 2021.
Systematic sample (every nth file) of patients in clinic waiting area willing to be trained received pre-visit training and post-visit interviews. Providers were unaware of trained patients.
We compared patient experience among patients who received brief training prior to their care visit (explaining each patient experience construct in the exit survey, being anonymous, without manipulating behaviour) with those who did not undergo training on the survey prior to their visit.
Among 3526 participants who participated in exit surveys, 2415 were untrained (56% female, median age 40 (IQR: 32–47)) and 1111 were trained (50% female, median age 37 (IQR: 31–45)). Compared with untrained, trained patients were more likely to report a negative care experience overall (adjusted prevalence ratio (aPR) for aggregate sum score: 1.64 (95% CI: 1.39 to 1.94)), with a greater proportion reporting feeling unwelcome by providers (aPR: 1.71 (95% CI: 1.20 to 2.44)) and witnessing providers behaving rude (aPR: 2.28 (95% CI: 1.63 to 3.19)).
Trained patients were more likely to identify suboptimal care. They may have understood the items solicited better or felt empowered to be more critical. We trained existing patients, unlike studies that use ‘standardised patients’ drawn from outside the patient population. This low-cost strategy could improve patient-centred service delivery elsewhere.
Assessment was nested within a parent study; www.pactr.org registered the parent study (PACTR202101847907585).
To conduct an in-depth exploration of oral hydration care provided to people living with dementia in acute hospital wards, using a person-centred care framework.
Oral hydration care is an important, yet rarely explored aspect of fundamental care for people with dementia admitted to acute hospitals. Using person-centred care as a conceptual framework we investigated how oral hydration care is delivered for people living with dementia in acute hospital wards.
A qualitative, multiple-case study. The cases were three acute wards in one hospital.
Direct observation of care for 13 people with dementia (132 h), semistructured interviews with ward staff (n = 28), ward leaders (n = 4), organisational leaders (n = 5), people with dementia (n = 6), their relatives (n = 5), documentary analysis of clinical inpatient records (n = 26) and relevant hospital policies. Data were analysed using framework analysis.
Four themes were identified: (1) The acute hospital: oral hydration is obscured and not prioritised (2) Overshadowing of oral hydration at ward level (3) Siloed nature of hydration roles (4) Strategies for, and barriers to, delivering person-centred oral hydration care.
This study combines the concept of person-centred care and oral hydration care for people living with dementia admitted to acute hospital wards, demonstrating that person-centred hydration care was complex and not prioritised.
Nurses should consider means of improving prioritisation and cohesive delivery of person-centred hydration care in acute hospital wards.
Chronic venous disease (CVD) occurs because of structural or functional disturbances to the venous system of the lower limbs. Signs and symptoms include leg pain, swelling, varicose veins, and skin changes, with venous ulceration ultimately occurring in severe disease. To assess the prevalence of CVD among health care workers, a scoping review of existing publications exploring the prevalence of CVD among health care workers was conducted in July 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used. A total of 15 papers met the inclusion criteria and these formed the basis of the review. Among health care workers, the mean prevalence of CVD was 58.5% and the mean prevalence for varicose veins was 22.1%. There is an increased prevalence of CVD in health care workers when compared with the general population. Therefore, there is a need for early diagnosis and the use of preventative measures to protect health care workers from CVD and varicose vein development.
To assess patients' and nurses' perceptions and experiences of subepidermal moisture scanning acceptability.
Descriptive, qualitative, sub-study, embedded within a pilot randomized control trial.
Ten patients who were in the intervention arm of the pilot trial and 10 registered nurses providing care for these patients on medical-surgical units participated in individual semi-structured interviews. Data were collected from October 2021 to January 2022. Interviews were analysed using inductive qualitative content analysis, and perspectives (patient and nurse), were triangulated.
Four categories were found. The first category ‘Subepidermal moisture scanning is acceptable as part of care’ showed that patients and nurses were willing to use subepidermal moisture scanning and viewed subepidermal moisture scanning as non-burdensome. The category ‘Subepidermal moisture scanning may improve pressure injury outcomes’ demonstrated that although subepidermal moisture scanning was believed to prevent pressure injuries, more research evidence about its benefits was required. ‘Subepidermal moisture scanning augments existing pressure injury prevention practices’, the third category, highlighted that subepidermal moisture scanning aligns with current pressure injury prevention practices while making these practices more patient-centred. In the final category, ‘Important considerations when making subepidermal moisture scanning routine practice’, practical issues were raised relating to training, guidelines, infection control, device availability and patient modesty.
Our study demonstrates that using subepidermal moisture scanning is acceptable for patients and nurses. Building the evidence base for subepidermal moisture scanning and then addressing practical issues prior to implementation, are important next steps. Our research suggests that subepidermal moisture scanning enhances individualized and patient-centred care, persuasive reasons to continue investigating subepidermal moisture scanning.
For an intervention to be successfully implemented it must be both effective and acceptable, however, there is limited evidence of patients' and nurses' views of SEMS acceptability. SEM scanners are acceptable to use in practice for patients and nurses. There are many procedural aspects that need to be considered when using SEMS such as frequency of measurements. This research may have benefit for patients, as SEMS may promote a more individualized and patient-centred approach to pressure injury prevention. Further, these findings can assist researchers, providing justification to proceed with effectiveness research.
A consumer advisor was involved in study design, interpretation of data and preparation of manuscript.
by Alexander L. Young, Willem van den Boom, Rebecca A. Schroeder, Vijay Krishnamoorthy, Karthik Raghunathan, Hau-Tieng Wu, David B. DunsonGiven a large clinical database of longitudinal patient information including many covariates, it is computationally prohibitive to consider all types of interdependence between patient variables of interest. This challenge motivates the use of mutual information (MI), a statistical summary of data interdependence with appealing properties that make it a suitable alternative or addition to correlation for identifying relationships in data. MI: (i) captures all types of dependence, both linear and nonlinear, (ii) is zero only when random variables are independent, (iii) serves as a measure of relationship strength (similar to but more general than R2), and (iv) is interpreted the same way for numerical and categorical data. Unfortunately, MI typically receives little to no attention in introductory statistics courses and is more difficult than correlation to estimate from data. In this article, we motivate the use of MI in the analyses of epidemiologic data, while providing a general introduction to estimation and interpretation. We illustrate its utility through a retrospective study relating intraoperative heart rate (HR) and mean arterial pressure (MAP). We: (i) show postoperative mortality is associated with decreased MI between HR and MAP and (ii) improve existing postoperative mortality risk assessment by including MI and additional hemodynamic statistics.
Cardiovascular diseases are the most common cause of death in Germany and among the most frequent reasons for encounters in primary care. Most patients with cardiovascular risks (CVRs) have difficulties implementing health-promoting behavioural changes. In this study, a complex intervention containing evidence-based patient materials and structured follow-up consultations are intended to strengthen patients’ self-management to improve health behaviour.
In this cluster randomised controlled trial, we investigate the effects of the intervention "Decision aid, action planning and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases" (DECADE) using a 2x2 design. All patients, including the control group (CG), receive a CVR calculation. Three intervention groups (IGs) receive one or both of two different components of the DECADE intervention: IG1 (patient materials), IG2 (follow-up consultations) and IG3 (patient materials and follow-up consultations). The study was planned to be conducted with 77 general practitioners in 3 German regions and a target sample size of 924 patients. The observation period for each patient amounts to 12 months with three patient surveys: baseline (t0), after 6 and 12 months (t1 and t2). The primary outcome is patient activation (Patient Activation Measure 13 (PAM13-D)) at t1. Secondary outcomes include PAM13-D at t2 and further patient-reported and clinical outcomes at t1 and t2. We will also analyse the cost-effectiveness of the intervention, the degree of usage and satisfaction with the intervention.
The study was first approved by the lead ethics committee of the University of Freiburg on 15 April 2021 (vote number: 21-1078) and subsequently by the other ethics committees in the study regions (Ethics committee of medical association Baden-Württemberg (B-F-2021-078), Ethics Committee of the Technische Universität Dresden, Dresden (BO-EK-251052021), Ethics Committee of the State Chamber of Physicians of Saxony (EK-BR-92/21-1), Ethics Committee of the Hamburg Medical Association (2021-200013-BO-bet)). Informed consent is required for patients to participate in the study. The results of this study will be published in peer-reviewed journals and presented at congresses by the DECADE team. The DECADE lead management will communicate the results to the funder of this study.
German Clinical Trials Register, DRKS00025401 (registration date: 21 June 2021); International Clinical Trials Registry Platform, DRKS00025401.
Examine patterns of adult medical use of amphetamine and methylphenidate stimulant drugs, classified in the USA as Schedule II controlled substances with a high potential for psychological or physical dependence.
Prescription drug claims for US adults, age 19–64 years, included in a commercial insurance claims database with 9.1 million continuously enrolled adults from 1 October 2019, through 31 December 2020. Stimulant use was defined as adults filling one or more stimulant prescriptions during calendar 2020.
The primary outcome was an outpatient prescription claim, service date and days’ supply for central nervous system (CNS)-active drugs. Combination-2 was defined as 60 days or more of combination treatment with a Schedule II stimulant and one or more additional CNS-active drugs. Combination-3 therapy was defined as the addition of 2 or more additional CNS-active drugs. Using service date and days’ supply, we examined the number of stimulant and other CNS-active drugs for each of the 366 days of 2020.
Among 9 141 877 continuously enrolled adults, the study identified 276 223 individuals (3.0%) using Schedule II stimulants during 2020. They filled a median of 8 (IQR, 4–11) prescriptions for these stimulant drugs that provided 227 (IQR, 110–322) treatment days of exposure. Among this group, 125 781 (45.5%) combined use of one or more additional CNS active drugs for a median of 213 (IQR, 126–301) treatment days. Also, 66 996 (24.3%) stimulant users used two or more additional CNS-active drugs for a median of 182 (IQR, 108–276) days. Among stimulants users, 131 485 (47.6%) were exposed to an antidepressant, 85 166 (30.8%) filled prescriptions for anxiety/sedative/hypnotic medications and 54 035 (19.6%) received opioid prescriptions.
A large proportion of adults using Schedule II stimulants are simultaneously exposed to one or more other CNS-active drugs, many with tolerance, withdrawal effects or potential for non-medical use. There are no approved indications and limited clinical trial testing of these multi-drug combinations, and discontinuation may be challenging.
This study aims to quantify the relationship between societal volunteering and the impact of COVID-19 in that society.
Data on societal volunteering were collected for 32 high-income countries (international analysis) and 50 US states (US analysis). Using regression analysis, the ability of this variable to explain COVID-19 mortality was compared with other variables put forward in the public debate (eg, vaccination rate, obesity, age). COVID-19 mortality was measured as the number of deaths due to COVID-19 per million inhabitants, from January 2020 until January 2022.
Societal volunteering explains 43% (resp. 34%) of observed variation in COVID-19 mortality (R²) in the international (resp. US states) analysis. Compared with other variables, societal volunteering better explains the variation in COVID-19 mortality across countries and US states, with only the prevalence of smokers displaying a higher R² in the international analysis.
Countries and states with more societal volunteering have been less impacted by COVID-19, even after accounting for differences in demographics, gross domestic product, healthcare investments and vaccination rates. Although this evidence is not causal, our findings suggest that factors beyond the public-private debate might impact the resilience of societies to a pandemic, with societal volunteering being one such factor.
Historically, neurology research has demonstrated a sex bias with mainly male subjects included in clinical trials as well as lack of reporting of data by sex. In recent years, emphasis has been placed on increased participation of female participants and explicit declaration/evaluation of sex differences in clinical research.
We aimed to review the available literature examining sex differences across four subspecialty areas in neurology (demyelination, headache, stroke, epilepsy) and whether sex and gender terms have been used appropriately.
This scoping review was performed by searching Ovid MEDLINE, Cochrane Central Registry of Controlled Trials, EMBASE, Ovid Emcare and APA PsycINFO databases from 2014 to 2020. Four independent pairs of reviewers screened titles, abstracts and full texts. Studies whose primary objective was to assess sex or gender differences among adults with one of four neurological conditions were included. We report the scope, content and trends of previous studies that have evaluated sex differences in neurology.
The search retrieved 22 745 articles. Five hundred and eighty-five studies met the inclusion criteria in the review. The majority of studies were observational, often examining similar concepts designed for a different country or regional population, with rare randomised controlled trials designed specifically to assess sex differences in neurology. There was heterogeneity observed in areas of sex-specific focus between the four subspecialty areas. Thirty-six per cent (n=212) of articles used the terms sex and gender interchangeably or incorrectly.
Sex and gender are important biological and social determinants of health. However, the more explicit recognition of these factors in clinical literature has not been adequately translated to significant change in neuroscience research regarding sex differences. This study illustrates the ongoing need for more urgent informed action to recognise and act on sex differences in scientific discovery and correct the use of sex and gender terminology.
The protocol for this scoping review was registered with Open Science Framework.
Prostate MRI is a well-established tool for the diagnostic work-up for men with suspected prostate cancer (PCa). Current recommendations advocate the use of multiparametric MRI (mpMRI), which is composed of three sequences: T2-weighted sequence (T2W), diffusion-weighted sequence (DWI) and dynamic contrast-enhanced sequence (DCE). Prior studies suggest that a biparametric MRI (bpMRI) approach, omitting the DCE sequences, may not compromise clinically significant cancer detection, though there are limitations to these studies, and it is not known how this may affect treatment eligibility. A bpMRI approach will reduce scanning time, may be more cost-effective and, at a population level, will allow more men to gain access to an MRI than an mpMRI approach.
Prostate Imaging Using MRI±Contrast Enhancement (PRIME) is a prospective, international, multicentre, within-patient diagnostic yield trial assessing whether bpMRI is non-inferior to mpMRI in the diagnosis of clinically significant PCa. Patients will undergo the full mpMRI scan. Radiologists will be blinded to the DCE and will initially report the MRI using only the bpMRI (T2W and DWI) sequences. They will then be unblinded to the DCE sequence and will then re-report the MRI using the mpMRI sequences (T2W, DWI and DCE). Men with suspicious lesions on either bpMRI or mpMRI will undergo prostate biopsy. The main inclusion criteria are men with suspected PCa, with a serum PSA of ≤20 ng/mL and without prior prostate biopsy. The primary outcome is the proportion of men with clinically significant PCa detected (Gleason score ≥3+4 or Gleason grade group ≥2). A sample size of at least 500 patients is required. Key secondary outcomes include the proportion of clinically insignificant PCa detected and treatment decision.
Ethical approval was obtained from the National Research Ethics Committee West Midlands, Nottingham (21/WM/0091). Results of this trial will be disseminated through peer-reviewed publications. Participants and relevant patient support groups will be informed about the results of the trial.
We sought to assess depression among healthcare workers (HCWs) in the context of COVID-19 in Lusaka Province, Zambia.
This cross-sectional study is nested within a larger study, the Person-Centred Public Health for HIV Treatment in Zambia (PCPH), a cluster-randomised trial to assess HIV care and outcomes.
The research was conducted in 24 government-run health facilities from 11 August to 15 October 2020 during the first wave of the COVID-19 pandemic in Lusaka, Zambia.
We used convenience sampling to recruit HCW participants who were previously enrolled in the PCPH study, had more than 6 months’ experience working at the facility and were voluntarily willing to participate.
We implemented the well-validated 9-question Patient Health Questionnaire (PHQ-9) to assess HCW depression. We used mixed-effects, adjusted Poisson regression to estimate the marginal probability of HCWs experiencing depression that may warrant intervention (PHQ-9 score ≥5) by healthcare facility.
We collected PHQ-9 survey responses from 713 professional and lay HCWs. Overall, 334 (46.8%, 95% CI 43.1%, 50.6%) HCWs recorded a PHQ-9 score ≥5, indicating the need for further assessment and potential intervention for depression. We identified significant heterogeneity across facilities and observed a greater proportion of HCWs with symptoms of depression in facilities providing COVID-19 testing and treatment services.
Depression may be a concern for a large proportion of HCWs in Zambia. Further work to understand the magnitude and aetiologies of depression among HCWs in the public sector is needed to design effective prevention and treatment interventions to meet the needs for mental health support and to minimise poor health outcomes.
Evidence-based practice and decision-making have been consistently linked to improved quality of care, patient safety, and many positive clinical outcomes in isolated reports throughout the literature. However, a comprehensive summary and review of the extent and type of evidence-based practices (EBPs) and their associated outcomes across clinical settings are lacking.
The purpose of this scoping review was to provide a thorough summary of published literature on the implementation of EBPs on patient outcomes in healthcare settings.
A comprehensive librarian-assisted search was done with three databases, and two reviewers independently performed title/abstract and full-text reviews within a systematic review software system. Extraction was performed by the eight review team members.
Of 8537 articles included in the review, 636 (7.5%) met the inclusion criteria. Most articles (63.3%) were published in the United States, and 90% took place in the acute care setting. There was substantial heterogeneity in project definitions, designs, and outcomes. Various EBPs were implemented, with just over a third including some aspect of infection prevention, and most (91.2%) linked to reimbursement. Only 19% measured return on investment (ROI); 94% showed a positive ROI, and none showed a negative ROI. The two most reported outcomes were length of stay (15%), followed by mortality (12%).
Findings indicate that EBPs improve patient outcomes and ROI for healthcare systems. Coordinated and consistent use of established nomenclature and methods to evaluate EBP and patient outcomes are needed to effectively increase the growth and impact of EBP across care settings. Leaders, clinicians, publishers, and educators all have a professional responsibility related to improving the current state of EBP. Several key actions are needed to mitigate confusion around EBP and to help clinicians understand the differences between quality improvement, implementation science, EBP, and research.
Attention deficit/hyperactivity disorder (ADHD) is a prevalent and impairing cluster of traits affecting 2%–5% of children. These children are at risk of negative health, social and educational outcomes and often experience severe difficulties at school, so effective psychosocial interventions are needed. There is mixed evidence for existing school-based interventions for ADHD, which are complex and resource-intensive, contradicting teachers’ preferences for short, flexible strategies that suit a range of ADHD-related classroom-based problems. They are also poorly evaluated. In this study, a prototype intervention comprising a digital ‘toolkit’ of behavioural strategies will be tested and refined. We aim to refine the prototype so that its use is feasible and acceptable within school settings, and to establish whether a future definitive, appropriately powered, trial of effectiveness is feasible. This novel iterative study aims to pre-emptively address implementation and evaluation challenges that have hampered previous randomised controlled trials of non-pharmacological interventions.
A randomised iterative mixed-methods case-series design will be used. Schools will be randomised to the time (school term) they implement the toolkit. Eight primary schools and 16–32 children with impairing traits of ADHD will participate, along with school staff and parents. The toolkit will be refined after each term, or more frequently if needed. Small, theory-based and data driven changes hypothesised as relevant across school contexts will be made, as well as reactive changes addressing implementation barriers. Feasibility and acceptability will be assessed through quantitative and qualitative data collection and analyses in relation to study continuation criteria, and ADHD symptoms and classroom functioning will be tracked and visually evaluated to assess whether there are early indications of toolkit utility.
Ethical approval has been obtained. Results will be presented in journal articles, conferences and through varied forms of media to reach policymakers, stakeholders and the public.
Globally, 20 million children are born with a birth weight below 2500 g every year, which is considered as a low birthweight (LBW) baby. This study investigates the contribution of modifiable risk factors in a nationally representative Welsh e-cohort of children and their mothers to inform opportunities to reduce LBW prevalence.
A longitudinal cohort study based on anonymously linked, routinely collected multiple administrative data sets.
The cohort, (N=693 377) comprising of children born between 1 January 1998 and 31 December 2018 in Wales, was selected from the National Community Child Health Database.
The risk factors associated with a binary LBW (outcome) variable were investigated with multivariable logistic regression (MLR) and decision tree (DT) models.
The MLR model showed that non-singleton children had the highest risk of LBW (adjusted OR 21.74 (95% CI 21.09 to 22.40)), followed by pregnancy interval less than 1 year (2.92 (95% CI 2.70 to 3.15)), maternal physical and mental health conditions including diabetes (2.03 (1.81 to 2.28)), anaemia (1.26 (95% CI 1.16 to 1.36)), depression (1.58 (95% CI 1.43 to 1.75)), serious mental illness (1.46 (95% CI 1.04 to 2.05)), anxiety (1.22 (95% CI 1.08 to 1.38)) and use of antidepressant medication during pregnancy (1.92 (95% CI 1.20 to 3.07)). Additional maternal risk factors include smoking (1.80 (95% CI 1.76 to 1.84)), alcohol-related hospital admission (1.60 (95% CI 1.30 to 1.97)), substance misuse (1.35 (95% CI 1.29 to 1.41)) and evidence of domestic abuse (1.98 (95% CI 1.39 to 2.81)). Living in less deprived area has lower risk of LBW (0.70 (95% CI 0.67 to 0.72)). The most important risk factors from the DT models include maternal factors such as smoking, maternal weight, substance misuse record, maternal age along with deprivation—Welsh Index of Multiple Deprivation score, pregnancy interval and birth order of the child.
Resources to reduce the prevalence of LBW should focus on improving maternal health, reducing preterm births, increasing awareness of what is a sufficient pregnancy interval, and to provide adequate support for mothers’ mental health and well-being.
Women with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, memory and psychological distress. We developed four intervention components, each targeting a different barrier. This pilot trial is part of the preparation phase of the Multiphase Optimisation Strategy, and aims to establish key trial parameters, establish intervention component adherence, establish availability and feasibility of outcome and process data, estimate variability in planned outcome measures and estimate cost of developing and delivering each intervention component.
The four intervention components are as follows: short message service text reminders (target: memory); a written information leaflet (target: medication beliefs); a guided self-help Acceptance and Commitment Therapy programme (target: psychological flexibility to reduce distress) and a self-management website (target: side-effect management). To evaluate the feasibility of recruitment, acceptability of the intervention components and the availability of outcome data, we will conduct a multisite, exploratory pilot trial using a 24-1 fractional factorial design, with a nested process evaluation. We will randomise 80 women with early-stage breast cancer who have been prescribed AET to one of eight experimental conditions. This will determine the combination of intervention components they receive, ranging from zero to four, with all conditions receiving usual care. Key outcomes of interest include medication adherence and quality of life. Progression to the optimisation phase will be based on predefined criteria for consent rates, patient adherence to intervention components and availability of medication adherence data.
The study was reviewed by the Wales Research Authority Research Ethics Committee 3 (21/WA/0322). Written informed consent will be obtained from all patients before randomisation. The results of this trial will be disseminated in a peer-reviewed journal.