Conectar
For individuals with mobility limitations, virtual exercise programmes can address the challenges of in-person participation in community exercise programmes. A synthesis of studies of virtual exercise programmes targeting mobility limitations provided outside of conventional rehabilitation services and strategies used to optimise equitable access and inclusivity in these programmes is lacking. We aim to characterise evaluations of virtual exercise programmes for adults with mobility limitations, and the nature of and extent to which equity, diversity and inclusion considerations are integrated in the research process.
A scoping review following a six-stage methodological framework, including a consultation exercise, is proposed. A comprehensive strategy will be used to search Medline, Embase, PEDro, CINAHL and Scopus to identify peer-reviewed studies evaluating virtual exercise programmes for adults with mobility limitations living in the community. Three trained reviewers will select studies independently. Data (eg, study methodology, programme structure and content, participant characteristics) will be extracted using a standardised form, and collated and summarised using quantitative and qualitative methods. The PROGRESS-Plus and International Classification of Functioning, Disability and Health frameworks will be used to classify participant characteristics and study outcomes, respectively. During the consultation exercise, key knowledge users, including exercise participants, programme providers and coordinators, and members of community organisations for persons living with disabilities and under-represented groups, will be asked to provide insights regarding the applicability of review findings. A directed content analysis of data from the consultation exercise will be performed.
The research ethics board at the University of Toronto approved the consultation exercise. Findings will be disseminated through peer-reviewed publications and conference presentations. Findings will enhance understanding of current research evaluating virtual exercise programmes and inform future research and strategies for promoting equitable access and outcomes for individuals with mobility limitations.
Since the introduction of pneumococcal conjugate vaccines, pneumococcal disease rates have declined for many vaccine-type serotypes. However, serotype 3 (SPN3) continues to cause significant disease and is identified in colonisation epidemiological studies as one of the top circulating serotypes in adults in the UK. Consequently, new vaccines that provide greater protection against SPN3 colonisation/carriage are urgently needed. The Experimental Human Pneumococcal Challenge (EHPC) model is a unique method of determining pneumococcal colonisation rates, understanding acquired immunity, and testing vaccines in a cost-effective manner. To enhance the development of effective pneumococcal vaccines against SPN3, we aim to develop a new relevant and safe SPN3 EHPC model with high attack rates which could be used to test vaccines using small sample size.
This is a human challenge study to establish a new SPN3 EHPC model, consisting of two parts. In the dose-ranging/safety study, cohorts of 10 healthy participants will be challenged with escalating doses of SPN3. If first challenge does not lead into colonisation, participants will receive a second challenge 2 weeks after. Experimental nasopharyngeal (NP) colonisation will be determined using nasal wash sampling. Using the dose that results in ≥50% of participants being colonised, with a high safety profile, we will complete the cohort with another 33 participants to check for reproducibility of the colonisation rate. The primary outcome of this study is to determine the optimal SPN3 dose and inoculation regime to establish the highest rates of NP colonisation in healthy adults. Secondary outcomes include determining density and duration of experimental SPN3 NP colonisation and characterising mucosal and systemic immune responses to SPN3 challenge.
This study is approved by the NHS Research and Ethics Committee (reference 22/NW/0051). Findings will be published in peer-reviewed journals and reports will be made available to participants.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect of neurotoxic chemotherapy. Acute symptoms of CIPN during treatment can lead to dose reduction and cessation. Trials using electroacupuncture (EA) to treat established CIPN postchemotherapy have shown some efficacy. The current trial aims to assess the feasibility and preliminary efficacy of using EA to treat CIPN during chemotherapy.
The current study is a single-centre, 1:1 randomised, sham-controlled pilot study set in a tertiary cancer hospital in Sydney, Australia, and will recruit 40 adult patients with early breast cancer undergoing adjuvant or neoadjuvant paclitaxel chemotherapy. Patients who develop CIPN within the first 6 weeks of chemotherapy will receive either true EA or sham-EA once a week for 10 weeks. The coprimary endpoints are recruitment and adherence rate, successful blinding of patients and compliance with the follow-up period. Secondary endpoints are mean change of CIPN symptoms from randomisation to end of treatment, sustained change in CIPN symptoms at 8-week and 24-week follow-up postchemotherapy, proportion of subjects attaining completion of 12 weeks of chemotherapy without dose reduction or cessation, change in acupuncture expectancy response pretreatment, during treatment and posttreatment. The primary assessment tool for the secondary endpoints will be a validated patient-reported outcome measure (European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy) captured weekly from randomisation to week 12 of chemotherapy.
The study protocol (2021/ETH12123) has been approved by the institutional Human Research Ethics Committee at St Vincent’s Hospital Sydney and Chris O’Brien Lifehouse. Informed consent will be obtained prior to starting study-related procedures. The results will be disseminated in peer-reviewed journals and at scientific conferences.
ACTRN12622000081718.
The study was conducted to assess potential drug–drug interactions (PDDIs) and its determinants among patients with cancer receiving chemotherapy.
An institutional-based cross-sectional study was used. This study was conducted from 1 June 2021 to 15 December 2021, in Northwest Ethiopia oncology centres.
All eligible patients with cancer received a combination of chemotherapy.
The prevalence and severity of PDDIs were evaluated using three drug interaction databases. Characteristics of participants were presented, arranged and summarised using descriptive statistics. The predictors and outcome variables were examined using logistic regression. The cut-off point was a p value of 0.05.
Of 422 patients included in the study, 304 patients were exposed to at least one PDDI with a prevalence of 72.1% (95 % CI: 68% to 76%) using three drug interaction databases. There were varied reports of the severity of PDDI among databases, but the test agreement using the kappa index was 0.57 (95% CI: 0.52 to 0.62, p=0.0001) which is interpreted as a moderate agreement among three databases. Patients aged ≥50 years old had the risk to be exposed to PDDI by odds of 3.1 times (adjusted OR (AOR)=3.1, 95% CI (1.8 to 5.3); p=0.001) as compared with patients
The main finding of this study is the high prevalence of PDDI, signifying the need for strict patient monitoring for PDDIs among patients with cancer receiving chemotherapy. We suggest the use of at least three drug databases for quality screening. Patients with an age ≥50 years old, polypharmacy and comorbidity were significantly associated with PDDIs. The establishment of oncology clinical pharmacists and computerised reminder mechanisms for PDDIs through drug utilisation review is suggested.
Clinic-based or community-based interventions can improve adherence to guideline-directed medication therapies (GDMTs) among patients with heart failure (HF). However, opportunities for such interventions are frequently missed, as providers may be unable to recognise risk patterns for medication non-adherence. Machine learning algorithms can help in identifying patients with high likelihood of non-adherence. While a number of multilevel factors influence adherence, prior models predicting non-adherence have been limited by data availability. We have established an electronic health record (EHR)-based cohort with comprehensive data elements from multiple sources to improve on existing models. We linked EHR data with pharmacy refill data for real-time incorporation of prescription fills and with social determinants data to incorporate neighbourhood factors.
Patients seen at a large health system in New York City (NYC), who were >18 years old with diagnosis of HF or reduced ejection fraction (
Among 39 963 patients in the cohort, the average age was 73±14 years old, 44% were female and 48% were current/former smokers. The common comorbid conditions were hypertension (77%), cardiac arrhythmias (56%), obesity (33%) and valvular disease (33%). During the study period, 33 606 (84%) patients had an active prescription of beta blocker, 32 626 (82%) had ACEi/ARB/ARNI, 11 611 (29%) MRA and 7472 (19%) SGLT2i. Ninety-nine per cent were from urban metropolitan areas.
We will use the established cohort to develop a machine learning model to predict medication adherence, and to support ancillary studies assessing associates of adherence. For external validation, we will include data from an additional hospital system in NYC.
To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.
A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.
Three inner-city UK National Health Service hospitals in London.
Pregnant women with gestational diabetes treated with medication.
2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.
Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.
Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.
Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.
It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.
Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population.
An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.
Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.
Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).
Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives’ and women’s perspectives.
Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings.
Little research exists on how risk scores are used in counselling. We examined (a) how Breast Cancer Risk Assessment Tool (BCRAT) scores are presented during counselling; (b) how women react and (c) discuss them afterwards.
Consultations were video-recorded and participants were interviewed after the consultation as part of the NRG Oncology/National Surgical Adjuvant Breast and Bowel Project Decision-Making Project 1 (NSABP DMP-1).
Two NSABP DMP-1 breast cancer care centres in the USA: one large comprehensive cancer centre serving a high-risk population and an academic safety-net medical centre in an urban setting.
Thirty women evaluated for breast cancer risk and their counselling providers were included.
Participants who were identified as at increased risk of breast cancer were recruited to participate in qualitative study with a video-recorded consultation and subsequent semi-structured interview that included giving feedback and input after viewing their own consultation. Consultation videos were summarised jointly and inductively as a team.tThe interview material was searched deductively for text segments that contained the inductively derived themes related to risk assessment. Subgroup analysis according to demographic variables such as age and Gail score were conducted, investigating reactions to risk scores and contrasting and comparing them with the pertinent video analysis data. From this, four descriptive categories of reactions to risk scores emerged. The descriptive categories were clearly defined after 19 interviews; all 30 interviews fit principally into one of the four descriptive categories.
Risk scores were individualised and given meaning by providers through: (a) presenting thresholds, (b) making comparisons and (c) emphasising or minimising the calculated risk. The risk score information elicited little reaction from participants during consultations, though some added to, agreed with or qualified the provider’s information. During interviews, participants reacted to the numbers in four primary ways: (a) engaging easily with numbers; (b) expressing greater anxiety after discussing the risk score; (c) accepting the risk score and (d) not talking about the risk score.
Our study highlights the necessity that patients’ experiences must be understood and put into relation to risk assessment information to become a meaningful treatment decision-making tool, for instance by categorising patients’ information engagement into types.
Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.
In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.
Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
Poor medication adherence remains highly prevalent and adversely affects health outcomes. Patients frequently describe properties of the pills themselves, like size and shape, as barriers, but this has not been evaluated objectively. We sought to determine the extent to which oral medication properties thought to be influential translate into lower objectively-measured adherence.
Retrospective cohort study.
US nationwide commercial claims database, 2016–2019.
Among patients initiating first-line hypertension, diabetes or hyperlipidaemia treatment based on clinical guidelines, we measured pill size, shape, colour and flavouring, number of pills/day and fixed-dose combination status as properties.
Outcomes included discontinuation after the first fill (ie, never filling again over a minimum of 1-year follow-up) and long-term non-adherence (1-year proportion of days covered
Across 604 323 patients, 14.6% discontinued after filling once (ie, were non-persistent), and 54.0% were non-adherent over 1-year follow-up. Large pill size was associated with non-adherence, except for thiazides (eg, metformin adjusted OR (aOR): 1.12, 95% CI: 1.06 to 1.18). Greater pill burden was associated with a higher risk of non-adherence across all classes (eg, metformin aOR: 1.58, 95% CI: 1.53 to 1.64 for two pills/day). Taking less than one pill/day was also associated with higher risk of non-adherence and non-persistence (eg, non-persistence statin aOR: 1.29, 95% CI: 1.20 to 1.38). Pill shape, colour, flavouring and combination status were associated with mixed effects across classes.
Pill burden and pill size are key properties affecting adherence for almost all classes; others, like size and combination, could modestly affect medication adherence. Clinical interventions could screen patients for potential intolerance to medication and potentially implement more convenient dosing schedules.
FreshRSS 