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Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives

Por: Chatters · R. · Dimairo · M. · Cooper · C. · Ditta · S. · Woodward · J. · Biggs · K. · Ogunleye · D. · Thistlethwaite · F. · Yap · C. · Rothman · A.
Objectives

To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

Design

Qualitative interviews analysed using thematic analysis.

Setting and participants

Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

Results

Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

Conclusions

Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

‘Been there, experienced that’: A qualitative study on the experiences and perceptions of online peer volunteers in supporting Singaporean mothers at risk of depression

Abstract

Background

Online peer support is a useful source of support for parents during the perinatal period, associated with improved psychological outcomes. Past research has found that peer support providers themselves gain from providing peer support as well, making it mutually beneficial. As current maternity care services are insufficient to meet the support needs of parents, the Supportive Parenting App (SPA) intervention was developed to offer them informational, appraisal and emotional support during the perinatal period. It consists of mobile health application-based educational support and online peer support provided by trained peer volunteers, to prevent the development of postnatal depression.

Objective

To explore the experiences of peer volunteers with providing online peer support to parents during the perinatal period, as well as to identify areas of improvement for the SPA intervention.

Methods

A qualitative descriptive design was adopted. This study took place from October 2020 to August 2021 in two tertiary public healthcare institutions in Singapore. A total of 18 peer volunteers were invited for individual semi-structured interviews. The interviews were audio recorded and transcribed verbatim, and thematic analysis was used to analyse the data.

Results

Four themes were emerged as follows: (1) ‘Being there’: Reminiscing about and healing of own postnatal depression experience; (2) Building rapport with parents; (3) Parents in mind: Mutual sharing of knowledge and how to support new parents better; (4) Ensuring good quality peer support.

Conclusions

The peer volunteers felt that their experience was fulfilling and healing. Frequent contact, sharing of SPA resources and self-disclosure were found to help engage the new parents and build rapport between peer volunteers and parents. Challenges described by the peer volunteers have identified possible areas in which the SPA intervention can be improved.

Implications for care

Communication between peer program facilitators, managers and peer volunteers can be enhanced to ensure that peer volunteers are more sensitive and precise when providing support or information. This can improve rapport building between parents and peer volunteers, which will in turn maximize the benefits that parents can reap through online peer-to-peer support.

Impact

This study explored the perceptions of peer volunteers who provided online peer support to parents across the perinatal period. Peer volunteers felt that the SPA intervention was meaningful and that providing peer support was a healing experience. They were able to learn about the experiences of other mothers with postpartum depression while sharing their own past experiences. Thus, both parents and peer volunteers can benefit from engaging in online peer support programs. Technology-based interventions like the Supportive Parenting App (SPA) can be a suitable complement to maternity care services by providing parents access to medically accurate information and social support. Additionally, more experienced mothers can engage in fulfilling experiences through volunteering for new mothers who may benefit from informational, appraisal and emotional support.

Reporting method

This study follows the reporting guidelines as stated by the Consolidated criteria for reporting qualitative research (COREQ) checklist.

Patient or Public Contribution

Parents and peer volunteers contributed ideas that aided with the design of the mobile app. Many topics added to the educational materials were suggested by these parents as well.

What does this paper contribute to the wider global clinical community?

This study showed that sufficient training can be provided to lay peer volunteers to help them support other parents, buffering the pressure exerted on the healthcare industry due to the rising demand for healthcare services. The provision of such support is also beneficial for the peer volunteers themselves, as they find it meaningful and educational. Program developers of parenting and peer volunteering interventions can draw on the findings of this study to improve the effectiveness of these programs.

In quest of China sports lottery development path to common prosperity in 2035

Por: Yaping Yao · Bin Wan · Bo Long · Te Bu · Yang Zhang

by Yaping Yao, Bin Wan, Bo Long, Te Bu, Yang Zhang

Objectives

The China sports lottery contributes to sports and welfare causes. This study aims to construct a macro forecasting model supporting its sustained growth aligned with Vision 2035.

Methods

The modeling employed a distributional regression. Sales data of the China sports lottery from 2011 to 2022 were chosen as the response variable, alongside various macro- and event-level explanatory factors.

Results

A gamma distribution best fit the data. In the stable model spanning 2011–2019, urbanization, population dynamics, and FIFA emerged as significant contributors (Chi–square p Conclusions

Beyond offering original insights into the sales trajectory until 2035, specifically concerning new urbanization, negative population growth, and the FIFA effect, this macro forecasting framework can assist in addressing the policy priority of balancing growth with risk mitigation. We recommend policymakers connect market development with mass sports, potentially garnering a dual boost from the growing population of older consumers and the inherent benefits of a “FIFA (mass sports)” effect. A people-centered approach to the China sports lottery could significantly contribute to the long–range objectives of achieving common prosperity outlined in Vision 2035.

Yoga therapy on elderly patients with fear of fall: an open-label randomised controlled trial (YOFEAR trial)

Por: Kashyap · K. · Dhar · M. · Bisht · K. · Bahurupi · Y. · Pathania · M.
Introduction

Fear of fall is experienced by the elderly irrespective of the presence or absence of history of fall. Falls contribute to injuries that culminate in hospitalisation that incur unwarranted medical expenses. Yoga is unique to Indian cultural practices, with a potential to enhance proprioception. It increases self-body awareness, ultimately improving the balancing capacity of older adults. Thus, the objective of this study is to compare the effect of yoga therapy in the study and control groups at 12 weeks from the baseline.

Methods and analysis

This study is designed as an open-label, randomised controlled trial (1:1) with a sample size of 62 elderly patients more than or equal to 60 years of age. Participation of either sex, male or female with a fear of fall will be considered. Two randomised groups of 31 participants each will receive standard therapy for their primary diseases as per the local, national or international guidelines. However, participants in the intervention arm will receive additional structured yoga therapy sessions. The primary objective of this study is to assess and compare the change in fear of fall score of participants in each group using Falls Efficacy Scale (FES) and Berg Balance Scale (BBS) at 12 weeks versus baseline. The secondary endpoint will assess the change in the quality of life of participants at 3 months compared with the baseline.

Data will be gathered, entered into Microsoft Excel and further analysed by R software (V.4.3.0). Changes in FES-Intervention and BBS of two groups will be compared either by Student’s t-test for parametric data or Mann-Whitney U test for non-parametric data. Statistical significance will be considered if p

Ethics and dissemination

Ethical approval for this study protocol (version 1.0, 22 April 2022) was obtained from the institute ethics committee (AIIMS/IEC/22/195).

Trial registration number

CTRI/2022/06/043287.

Geospatial mapping of 2-hour access to timely essential surgery in the Philippines

Por: Lim · X. · Ayyappan · M. · Zaw · M. W. W. · Mandyam · N. K. · Chia · H. X. · Lucero-Prisno · D. E.
Objectives

Timely access to safe and affordable surgery is essential for universal health coverage. To date, there are no studies evaluating 2-hour access to Bellwether procedures (caesarean section, laparotomy, open fracture management) in the Philippines. The objectives of this study were to measure the proportion of the population able to reach a Bellwether hospital within 2 hours in the Philippines and to identify areas in the country with the most surgically underserved populations.

Methods

All public hospitals with Bellwether capacities were identified from the Philippines Ministry of Health website. The service area tool in ArcGIS Pro was used to determine the population within a 2-hour drive time of a Bellwether facility. Finally, suitability modelling was conducted to identify potential future sites for a surgical facility that targets the most underserved regions in the Philippines.

Results

428 Bellwether capable hospitals were identified. 85.1% of the population lived within 2 hours of one of these facilities. However, 6 regions had less than 80% of its population living within 2 hours of a Bellwether capable facility: Bicol, Eastern Visayas, Zamboanga, Autonomous region of Muslim Mindanao, Caraga and Mimaropa. Suitability analysis identified four regions—Caraga, Mimaropa, Calabarzon and Zamboanga—as ideal locations to build a new hospital with surgical capacity to improve access rates.

Conclusion

85.1% of the population of the Philippines are able to reach Bellwether capable hospitals within 2 hours, with regional disparities in terms of access rates. However, other factors such as weather, traffic conditions, financial access, availability of 24-hour surgical services and access to motorised vehicles should also be taken into consideration, as they also affect actual access rates.

mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial

Por: Cheng · Q. · Dang · T. · Nguyen · T.-A. · Velen · K. · Nguyen · V. N. · Nguyen · B. H. · Vu · D. H. · Long · C. H. · Do · T. T. · Vu · T.-M. · Marks · G. B. · Yapa · M. · Fox · G. J. · Wiseman · V.
Introduction

The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuberculosis (MDR-TB) undergoing treatment in Vietnam. This economic evaluation seeks to quantify the cost-effectiveness of this mHealth intervention from a healthcare provider and societal perspective.

Methods and analysis

The V-SMART trial will recruit 902 patients treated for MDR-TB across seven participating provinces in Vietnam. Participants in both intervention and control groups will receive standard community-based therapy for MDR-TB. Participants in the intervention group will also have a purpose-designed App installed on their smartphones to report AEs to health workers and to facilitate timely management of AEs. This economic evaluation will compare the costs and health outcomes between the intervention group (mHealth) and the control group (standard of care). Costs associated with delivering the intervention and health service utilisation will be recorded, as well as patient out-of-pocket costs. The health-related quality of life (HRQoL) of study participants will be captured using the 36-Item Short Form Survey (SF-36) questionnaire and used to calculate quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) will be based on the primary outcome (proportion of patients with treatment success after 24 months) and QALYs gained. Sensitivity analysis will be conducted to test the robustness of the ICERs. A budget impact analysis will be conducted from a payer perspective to provide an estimate of the total budget required to scale-up delivery of the intervention.

Ethics and dissemination

Ethical approval for the study was granted by the University of Sydney Human Research Ethics Committee (2019/676), the Scientific Committee of the Ministry of Science and Technology, Vietnam (08/QD-HDQL-NAFOSTED) and the Institutional Review Board of the National Lung Hospital, Vietnam (13/19/CT-HDDD). Study findings will be published in peer-reviewed journals and conference proceedings.

Trial registration number

ACTRN12620000681954.

Staff's experiences of a culturally specific DEmentia Competence Education for Nursing home Taskforce (DECENT) programme: A qualitative process evaluation

Abstract

Aim

To understand participants' experiences with a culturally specific DEmentia Competence Education for Nursing home Taskforce programme within the contexts which was delivered.

Design

An exploratory descriptive qualitative approach.

Methods

Semi-structured individual interviews were conducted within one week with the participants upon their completion of the programme from July 2020 to January 2021. A purposive sample of participants with different demographic characteristics in five nursing homes was recruited to maximize the sample variation. Interviews were audiotaped and transcribed verbatim for qualitative content analysis. Participation was on voluntary and anonymous basis.

Results

Four major themes were identified, including perceived benefits of the programme (i.e., enhanced sensitivity to the needs of residents with dementia, increased communication with families of residents with dementia, facilitated guidance on care for residents with dementia), facilitators (i.e., comprehensive content, active learning, qualified trainer, intrinsic motivation and organizational support), barriers (i.e., busy working schedules, discrimination against care assistants' learning capability) and suggestions for improvement.

Conclusion

The results suggested the acceptability of the programme. The participants positively appraised the programme in enhancing their dementia-care competence. The facilitators, barriers and suggestions identified provide insights on improving programme implementation.

Impact

The qualitative findings from the process evaluation are pertinent to support the sustainability of dementia competence programme in nursing home setting. Future studies could address the modifiable barriers to enhance its effectiveness.

Reporting Method

This study was reported in adherence to the Consolidated criteria for reporting qualitatve studies (COREQ) checklist.

Patient and Public Contribution

Nursing-home staff was involved in intervention development and delivery.

Implications for Practice/Policy

The educational programme could be integrated into the routine practice in nursing homes to improve staff's dementia-care competence. More attention should be paid on the educational needs of the taskforce when implementing the educational programme in nursing homes. Organizational support is the precondition for the educational programme and cultivates a culture for practice change.

Insights of healthcare professionals regarding waterbirths and water immersion during labour: A mixed studies review

Abstract

Aim

To consolidate healthcare professionals' insights about waterbirths and water immersion during labour.

Design

Mixed studies review.

Data Sources

Seven electronic databases were searched from their inception dates till June 2023: PubMed, Embase, CINAHL, PsycINFO, Web of Science, Scopus, ProQuest Dissertations and Theses Global.

Methods

The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and Pluye and Hong's mixed studies review framework guided this review. The quality of included studies was evaluated using the Mixed Methods Appraisal Tool. Findings were synthesized using the convergent qualitative synthesis method, and results were thematically analysed using Braun and Clarke's framework.

Results

Three main themes were identified from the 22 included studies: (1) believing in waterbirths, (2) opposing forces and (3) plotting the course ahead.

Conclusion

Healthcare professionals reported different views about waterbirths and water immersion practices; midwives were most likely to support these practices, followed by nurses and lastly, few physicians supported them. Reasons for opposing waterbirths include insufficient training and support from colleagues as well as concerns about work efficiency, waterbirth safety and litigation issues.

Impact

The available evidence suggests the need to provide waterbirth training for healthcare professionals, equip healthcare facilities with necessary waterbirth-related infrastructure and develop appropriate waterbirth policies/guidelines. Healthcare professionals could also consider providing antenatal waterbirth education to women and obtain women's feedback to improve current policies/guidelines. Future research should explore the views of different types of healthcare professionals from more diverse cultures.

Reporting Method

The PRISMA guidelines.

No Patient or Public Contribution

Systematic review.

Exploring the outcomes of research engagement using the observation method in an online setting

Por: Marshall · D. A. · Suryaprakash · N. · Lavallee · D. C. · Barker · K. L. · Mackean · G. · Zelinsky · S. · McCarron · T. L. · Santana · M. J. · Moayyedi · P. · Bryan · S.
Objective

The objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research.

Design

We observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis.

Setting

The study was conducted online.

Participants

Patient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study.

Main outcome measures

Transcripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE.

Results

Both projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups.

Conclusions

Our findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

Salmonella Vaccine Study in Oxford (SALVO) trial: protocol for an observer-participant blind randomised placebo-controlled trial of the iNTS-GMMA vaccine within a European cohort

Por: Hanumunthadu · B. · Kanji · N. · Owino · N. · Ferreira Da Silva · C. · Robinson · H. · White · R. · Ferruzzi · P. · Nakakana · U. · Canals · R. · Pollard · A. J. · Ramasamy · M. · Vacc-iNTS Consortium · Agyapong · Breghi · Crump · Fiorino · Gordon · Jacobs · Kariuki · Malvolti · Mante
Introduction

Invasive non-typhoidal Salmonellosis (iNTS) is mainly caused by Salmonella enterica serovars Typhimurium and Enteritidis and is estimated to result in 77 500 deaths per year, disproportionately affecting children under 5 years of age in sub-Saharan Africa. Invasive non-typhoidal Salmonellae serovars are increasingly acquiring resistance to first-line antibiotics, thus an effective vaccine would be a valuable tool in reducing morbidity and mortality from infection. While NTS livestock vaccines are in wide use, no licensed vaccines exist for use in humans. Here, a first-in-human study of a novel vaccine (iNTS-GMMA) containing S. Typhimurium and S. Enteritidis Generalised Modules for Membrane Antigens (GMMA) outer membrane vesicles is presented.

Method and analysis

The Salmonella Vaccine Study in Oxford is a randomised placebo-controlled participant-observer blind phase I study of the iNTS-GMMA vaccine. Healthy adult volunteers will be randomised to receive three intramuscular injections of the iNTS-GMMA vaccine, containing equal quantities of S. Typhimurium and S. Enteritidis GMMA particles adsorbed on Alhydrogel, or an Alhydrogel placebo at 0, 2 and 6 months. Participants will be sequentially enrolled into three groups: group 1, 1:1 randomisation to low dose iNTS-GMMA vaccine or placebo; group 2, 1:1 randomisation to full dose iNTS-GMMA vaccine or placebo; group 3, 2:1 randomisation to full dose or lower dose (dependant on DSMC reviews of groups 1 and 2) iNTS-GMMA vaccine or placebo.

The primary objective is safety and tolerability of the vaccine. The secondary objective is immunogenicity as measured by O-antigen based ELISA. Further exploratory objectives will characterise the expanded human immune profile.

Ethics and dissemination

Ethical approval for this study has been obtained from the South Central—Oxford A Research Ethics Committee (Ethics REF:22/SC/0059). Appropriate documentation and regulatory approvals have been acquired. Results will be disseminated via peer-reviewed articles and conferences.

Trial registration number

EudraCT Number: 2020-000510-14.

Systematic review of the effect of metabolic syndrome on outcomes due to acute respiratory distress syndrome: a protocol

Por: Stone · G. · Sisk · A. · Brown · M. · Corder · A. · Tea · K. · Zu · Y. · Shaffer · J. · Kashyap · R. · Qadir · N. · Denson · J. L.
Introduction

Acute respiratory distress syndrome (ARDS) is a life-threatening condition commonly seen in the intensive care unit. COVID-19 has dramatically increased the incidence of ARDS—with this rise in cases comes the ability to detect predisposing factors perhaps not recognised before, such as metabolic syndrome (MetS) and its associated conditions (hypertension, obesity, dyslipidaemia and type 2 diabetes mellitus). In this systematic review, we seek to describe the complex relationship between MetS, its associated conditions and ARDS (including COVID-19 ARDS).

Methods and analysis

A systematic search of PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL and Web of Science will be conducted. The population of interest is adults with ARDS and MetS (as defined according to the study author recognising that MetS definitions vary) or any MetS-associated condition. The control group will be adult patients with ARDS without MetS or any individual MetS-associated condition. We will search studies published in English, with a date restriction from the year 2000 to June 2023 and employ the search phrases ‘metabolic syndrome’, ‘acute respiratory distress syndrome’ and related terms. Search terms including ‘dyslipidaemia’, ‘hypertension’, ‘diabetes mellitus’ and ‘obesity’ will also be utilised. Outcomes of interest will include mortality (in-hospital, ICU, 28-day, 60-day and 90-day), days requiring mechanical ventilation and hospital and/or ICU length of stay. Study bias will be assessed using the NIH Bias Scale.

Ethics and dissemination

Ethical approval is not required because this study includes previously published and publicly accessible data. Findings from this review will be disseminated via publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023405816.

Estimating the value of repositioning timing to streamline pressure injury prevention efforts in nursing homes: A cost‐effectiveness analysis of the ‘TEAM‐UP’ clinical trial

Abstract

Pressure injury (PrI) prevention guidelines recommend 2-h repositioning intervals in healthcare settings, requiring significant nursing time investment. We analysed the cost-effectiveness of PrI prevention protocols with 2-, 3- and 4-h repositioning intervals in US nursing homes according to ‘Turn Everyone and Move for Ulcer Prevention’ (TEAM-UP) randomized controlled trial findings. Markov modelling compared 2-, 3- and 4-h repositioning intervals, controlling for other practice guidelines, to prevent PrIs in nursing home residents from a US health sector perspective over one year using TEAM-UP trial data for model structure, sampling and parameterization. Costs, captured in 2020 US dollars, and quality-adjusted life years (QALYs) were used to derive an incremental cost-effectiveness ratio and net monetary benefit (NMB) at $50 000/QALY-$150 000/QALY cost-effectiveness thresholds. Sensitivity analyses tested model uncertainty. Repositioning intervals between 3 and 4 h were cost-effective based on reduced costs at slightly lower QALYs than 2 h at a $50 000/QALY threshold, and the NMB of 4-h repositioning was also more efficient than at 3 h ($9610). Repositioning labour cost and prevention routines were among the most sensitive parameters. Sensitivity analyses demonstrated that 3- and 4-h intervals were cost-effective in over 65% of simulations at any cost-effectiveness threshold. Repositioning intervals of 3 to 4 h have potential to reduce nursing time costs without significant decrements in clinical benefits to nursing home residents. Clinical guidelines for PrI prevention should be updated to reflect TEAM-UP clinical and economic findings. Facilities can use cost-savings recuperated from nursing time to deploy to other patient safety priorities without seriously jeopardizing PrI safety.

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