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Utilising a 'Community of Practice to support pharmacists to work in residential aged care: protocol for a longitudinal evaluation

Por: Lee · K. · Etherton-Beer · C. · Johnson · J. · Lobo · E. · Wang · K. · Ailabouni · N. · Mavaddat · N. · Clifford · R. M. · Page · A. T.
Introduction

A Community of Practice is briefly defined as a group of people with a shared interest in a given area of practice who work collaboratively to grow collective knowledge. Communities of Practice have been used to facilitate knowledge exchange and improve evidence-based practice. Knowledge translation within the residential aged care sector is lacking, with barriers such as inadequate staffing and knowledge gaps commonly cited. In Australia, a Federal inquiry into residential aged care practices led to a recommendation to embed pharmacists within residential aged care facilities. Onsite practice in aged care is a new role for pharmacists in Australia. Thus, support is needed to enable pharmacists to practice in this role.

The primary aim is to evaluate the processes and outcomes of a Community of Practice designed to support pharmacists to work in aged care.

Methods and analysis

A longitudinal, single-group, pretest–post-test design in which the intervention is a Community of Practice. The Community of Practice will be established and made available for 3 years to all Australian pharmacists interested in, new to or established in aged care roles. The Community of Practice will be hosted on online discussion platforms, with additional virtual meetings and annual symposia. The following data will be collected from all members of the Community of Practice: self-evaluation of the processes and outcomes of the Community of Practice (via the CoPeval scale) and confidence in evidence-based practice (EPIC scale), collected via online questionnaires annually; and discussion platform usage statistics and discussion transcripts. A subset of members will be invited to participate in annual semi-structured individual interviews.

Data from the online questionnaire will be analysed descriptively. Discussion transcripts will be analysed using topic modelling and content analysis to identify the common topics discussed and their frequencies. Qualitative data from individual interviews will be thematically analysed to explore perceptions and experiences with the intervention for information/knowledge exchange, impact on practice, and sharing/promoting/implementing evidence-based practice.

Ethics and dissemination

Human ethics approval has been granted by the University of Western Australia’s Human Ethics Committee (2023/ET000000). No personal information will be included in any publications and reports to funding bodies.

Findings will be disseminated to all members of the Community of Practice, professional organisations, social and mass media, peer-review journals, research and professional conferences and annual reports to the funding body.

Low-dose naltrexone for post-COVID fatigue syndrome: a study protocol for a double-blind, randomised trial in British Columbia

Por: Naik · H. · Cooke · E. · Boulter · T. · Dyer · R. · Bone · J. N. · Tsai · M. · Cristobal · J. · McKay · R. J. · Song · X. · Nacul · L.
Introduction

A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.

Methods and analysis

A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.

Ethics and dissemination

The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.

Trial registration number

NCT05430152.

Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study

Por: Meng · M. · Ge · B. · Lei · W. · Wu · Y. · Tian · M. · Lu · Y. · Shao · T. · Yang · Y. · Luo · X. · Luo · J. · Gao · Y. · Li · Q. · Chen · Y.
Objective

To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors.

Design

The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis.

Setting

A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020.

Results

We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians.

Conclusion

Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.

Assessing the impact of obesity interventions in the early years: a systematic review of UK-based studies

Por: Michalopoulou · S. · Sifaki · M. · Packer · J. · Lanigan · J. · Stansfield · C. · Viner · R. M. · Russell · S.
Objectives

Childhood obesity rates in the UK are high. The early years of childhood are critical for establishing healthy behaviours and offer interventional opportunities. We aimed to identify studies evaluating the impact of UK-based obesity interventions in early childhood.

Design

Systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

Nine databases were searched in March 2023. Eligibility criteria: We included UK-based obesity intervention studies delivered to children aged 6 months to 5 years that had diet and/or physical activity components and reported anthropometric outcomes. The primary outcome of interest was z-score Body Mass Index (zBMI) change (within and between subjects). Studies evaluating the effects of breastfeeding interventions were not included as obesity prevention interventions, given that best-practice formula feeding is also likely to encourage healthy growth. The publication date for studies was limited to the previous 12 years (2011–23), as earlier reviews found few evaluations of interventions in the UK.

Data extraction and synthesis

The reviewers worked independently using standardised approach to search, screen and code the included studies. Risk of bias was assessed using Cochrane tools (ROB 2 or ROBINS-I).

Results

Six trials (five studies) were identified, including two randomised controlled trials (RCT), one cluster randomised trial (CRT), two feasibility CRTs and one impact assessment. The total number of participants was 566. Three trials focused on disadvantaged families and two included high-risk children categorised as having overweight or obesity. Compared with baseline, five interventions reported reductions in zBMI, three of which were statistically significant (p

Conclusion

UK evidence was limited but some interventions showed promising results in promoting healthy growth. As part of a programme of policies, interventions in the early years may have an important role in reducing the risk of childhood obesity.

PROSPERO registration number

CRD42021290676

Exploring opportunities to strengthen rural tuberculosis health service delivery: a qualitative study with health workers in Tibet autonomous region, China

Por: Haldane · V. · Zhang · Z. · Yin · T. · Zhang · B. · Li · Y. · Pan · Q. · Dainty · K. N. · Rea · E. · Pasang · P. · Hu · J. · Wei · X.
Objectives

This qualitative study aimed to explore opportunities to strengthen tuberculosis (TB) health service delivery from the perspectives of health workers providing TB care in Shigatse prefecture of Tibet Autonomous Region, China.

Design

Qualitative research, semi-structured in-depth interviews.

Setting

The TB care ecosystem in Shigatse, including primary and community care.

Participants

Participants: 37 semi-structured interviews were conducted with village doctors (14), township doctors and nurses (14), county hospital doctors (7) and Shigatse Centre for Disease Control staff (2).

Results

The three main themes reported include (1) the importance of training primary and community health workers to identify people with symptoms of TB, ensure TB is diagnosed and link people with TB to further care; (2) the need to engage community health workers to ensure retention in care and adherence to TB medications; and (3) the opportunity for innovative technologies to support coordinated care, retention in care and adherence to medication in Shigatse.

Conclusions

The quality of TB care could be improved across the care cascade in Tibet and other high-burden, remote settings by strengthening primary care through ongoing training, greater support and inclusion of community health workers and by leveraging technology to create a circle of care. Future formative and implementation research should include the perspectives of health workers at all levels to improve care organisation and delivery.

Interdisciplinary research approach based on a mixed-methods design to explore patient altruism at the end of life: a study protocol

Por: Bernard · M. · Gamondi · C. · Sterie · A.-C. · Larkin · P. J. · Jox · R. · Borasio · G. D.
Introduction

In the end of life context, patients are often seen as somewhat passive recipients of care provided by health professionals and relatives, with little opportunity to be perceived as autonomous and active agents. Since studies show a very high prevalence of altruistic dispositions in palliative care patients, we strive to investigate the concept of patient altruism in a set of six interdisciplinary studies by considering three settings: (1) in the general palliative context—by studying to what extent patient altruism is associated with essential psychological outcomes of palliative care (subproject 1a), how altruism is understood by patients (subproject 1b) and how altruism expressed by patients is experienced by palliative care nurses (subproject 1c); (2) in two concrete decision-making contexts—advance care planning (subproject 2a) and assisted suicide (subproject 2b); and (3) through verbal and non-verbal patient communication in palliative care settings (subproject 3).

Methods and analysis

Subproject 1a: a cross-sectional study using validated and standardised questionnaires. Subprojects 1b and 1c: a constructivist grounded theory method aiming at developing a novel theory from semistructured interviews in both patients and nurses. Subproject 2a: a thematic analysis based on (1) audio-recordings of advance care planning encounters and (2) follow-up semidirective interviews with patients and their relatives. Subproject 2b: a qualitative study based on thematic analysis of interviews with patients actively pursuing assisted suicide and one of their relatives.Subproject 3: a conversation analysis based on audio and video-recorded interactions in two settings: (1) palliative inpatient unit and (2) advance care planning discussions.

Ethics and dissemination

The study project was approved by the Ethics Committees of the Canton of Vaud, Bern and Ticino (no: 2023-00088). In addition to participation in national and international conferences, each project will be the subject of two scientific publications in peer-reviewed journals. Additional publications will be realised according to result triangulation between projects. A symposium opened to professionals, patients and the public will be organised in Switzerland at the end of the project.

Tobacco policies and changes in the tendency of smoking cessation in cigarette users in Chile: a longitudinal cross-sectional study

Objective

To assess the impact of tobacco control regulations and policy implementation on smoking cessation tendencies in cigarette users born between 1982 and 1991 in Chile.

Design

Longitudinal cross-sectional study.

Setting

National level.

Participants

Data from the National Survey of Drug Consumption (Service of Prevention and Rehabilitation for Drug and Alcohol Consumption). A pseudo-cohort of smokers born between 1982 and 1991 (N=17 905) was tracked from 2002 to 2016.

Primary and secondary outcomes measures

Primary outcome was the tendency to cease smoking conceptualised as the report of using cigarettes 1 month or more ago relative to using cigarettes in the last 30 days. The main exposure variable was the Tobacco Policy Index—tracking tobacco policy changes over time. Logistic regression, controlling for various factors, was applied.

Results

Models suggested a 14% increase in the smoking cessation tendency of individuals using cigarettes 1 month or more ago relative to those using cigarettes in the last 30 days (OR 1.14, CI 95% CI 1.10 to 1.19) for each point increment in the Tobacco Policy index.

Conclusions

Our study contributes to documenting a positive impact of the implementation of interventions considered in the MPOWER strategy in the progression of smoking cessation tendencies in smokers born between 1982 and 1991 in Chile.

Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies

Por: van Gils · L. · de Boer · M. A. · Bosmans · J. · Duijnhoven · R. · Schoenmakers · S. · Derks · J. B. · Prins · J. R. · Al-Nasiry · S. · Lutke Holzik · M. · Lopriore · E. · van Drongelen · J. · Knol · M. H. · van Laar · J. O. E. H. · Jacquemyn · Y. · van Holsbeke · C. · Dehaene · I. · L
Introduction

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

Methods and analysis

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

Ethics and dissemination

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

Trial registration number

ClinicalTrials.gov, NCT05968794.

SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema

Por: Devoogdt · N. · De Vrieze · T. · Heroes · A.-K. · Bechter-Hugl · B. · Fieuws · S. · Godderis · L. · Segers · K. · Maleux · G. · Deltombe · T. · Frippiat · J. · Servaes · M. · Berners · A. · Fosseprez · P. · Krug · B. · Kayser · F. · Falticeanu · A. · Randon · C. · Monten · C. · Van Landuyt
Introduction

Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema.

Methods and analysis

A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient’s own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased.

Ethics and dissemination

The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations.

Trial registration number

NCT05064176

What recovery domains are important following a total knee replacement? A qualitative, interview-based study

Por: Khatri · C. · Dhaif · F. · Ellard · D. · Rodrigues · J. N. · Underwood · M. · Mitchell · P. · Metcalfe · A.
Objectives

To explore people’s views of recovery from total knee replacement (TKR) and which recovery domains they felt were important.

Design

Semi-structured interviews exploring the views of individuals about to undergo or who have undergone TKR. A constant-comparative approach with thematic analysis was used to identify themes. The process of sampling, collecting data and analysis were continuous and iterative throughout the study, with interviews ceasing once thematic saturation was achieved.

Setting

Tertiary care centre.

Participants

A purposive sample was used to account for variables including pre, early or late postoperative status.

Results

12 participants were interviewed, 4 who were preoperative, 4 early postoperative and 4 late postoperative. Themes of pain, function, fear of complications, awareness of the artificial knee joint and return to work were identified. Subthemes of balancing acute and chronic pain were identified.

Conclusions

The results of this interview-based study identify pain and function, in particular mobility, that were universally important to those undergoing TKR. Surgeons should consider exploring these domains when taking informed consent to enhance shared decision-making. Researchers should consider these recovery domains when designing interventional studies.

Understanding associations between the COVID-19 pandemic and menstrual hygiene management among adolescent girls in Ethiopia: findings from a mixed-methods longitudinal study

Por: Murphy · M. · Dutton · R. · Gezahegne · K. · Jones · N. · Seager · J. · Baird · S.
Objective

To understand the relationship between the COVID-19 pandemic and menstrual hygiene management (MHM) among adolescent girls in Ethiopia and to explore which girls were most affected by pandemic disruptions.

Design

Two rounds of data from surveys and interviews were collected with adolescent girls immediately prior to and during the COVID-19 pandemic. The primary analysis is cross-sectional, controlling for pre-COVID-19 covariates.

Setting

The setting was three zones in two regions of Ethiopia: East Hararghe and East Shewa Zones in Oromia and South Gondar Zone in Amhara. Data were collected in December 2019–March 2020 and September 2020–February 2021.

Participants

742 adolescent girls, ages 11–25 years.

Outcome measures

Four primary outcomes were explored (1) the number of challenges girls experienced; (2) adolescent-identified challenges managing menstrual hygiene; (3) adolescent-identified difficulties accessing MHM products and (4) adolescent-identified difficulties accessing soap or water.

Results

Girls who were more vulnerable to COVID-19 were more likely to have worse MHM outcomes. An SD increase in household vulnerability to COVID-19 was associated with an 8.7 percentage point increase in the likelihood that the respondent had difficulty getting MHM products (p

Conclusions

The results of this study suggest that MHM was left behind in the COVID-19 response. New programming and policy interventions need to address financial hardship and disruptions to supplies to manage menstruation as well as tackle the inequitable gender norms that stigmatise menstruation during emergencies.

Interventions to promote medical student well-being: an overview of systematic reviews

Por: Bennett-Weston · A. · Keshtkar · L. · Jones · M. · Sanders · C. · Lewis · C. · Nockels · K. · Solomon · J. · Howick · J.
Objective

To conduct an overview of systematic reviews that explore the effectiveness of interventions to enhance medical student well-being.

Design

Overview of systematic reviews.

Data sources

The Cochrane Library of Systematic Reviews, MEDLINE, APA PsychInfo, CINAHL and Scopus were searched from database inception until 31 May 2023 to identify systematic reviews of interventions to enhance medical student well-being. Ancestry searching and citation chasing were also conducted.

Data extraction and synthesis

The Assessing the Methodological Quality of Systematic Reviews V.2 tool was used to appraise the quality of the included reviews. A narrative synthesis was conducted, and the evidence of effectiveness for each intervention was rated.

Results

13 reviews (with 94 independent studies and 17 616 students) were included. The reviews covered individual-level and curriculum-level interventions. Individual interventions included mindfulness (n=12), hypnosis (n=6), mental health programmes (n=7), yoga (n=4), cognitive and behavioural interventions (n=1), mind-sound technology (n=1), music-based interventions (n=1), omega-3 supplementation (n=1), electroacupuncture (n=1) and osteopathic manipulative treatment (n=1). The curriculum-level interventions included pass/fail grading (n=4), problem-based curriculum (n=2) and multicomponent curriculum reform (n=2). Most interventions were not supported by sufficient evidence to establish effectiveness. Eleven reviews were rated as having ‘critically low’ quality, and two reviews were rated as having ‘low’ quality.

Conclusions

Individual-level interventions (mindfulness and mental health programmes) and curriculum-level interventions (pass/fail grading) can improve medical student well-being. These conclusions should be tempered by the low quality of the evidence. Further high-quality research is required to explore additional effective interventions to enhance medical student well-being and the most efficient ways to implement and combine these for maximum benefit.

Helping patients prepare their dependent children for parental death: mixed-methods evaluation of a codeveloped training programme for palliative and allied healthcare professionals in the UK

Por: Cockle-Hearne · J. · Groothuizen · J. E. · Ream · E.
Objectives

To evaluate how the codesigned training programme, ‘No conversation too tough’, can help cancer, palliative and wider healthcare professionals support patients to communicate with their dependent children when a parent is dying. We examined perceptions of learning provided by the training, its contribution to confidence in communicating with families when a parent is dying, and subjective experience of, and reactions to, the training. We also explored potential changes in practice behaviours.

Design

Pre–post, convergent, parallel, mixed-methods study. Motivations for practice change were measured quantitatively, and qualitatively through semi-structured interviews. Non-parametric analysis was conducted for self-efficacy and outcome expectancy measures; descriptive statistics examined perceptions of usefulness; intentions to use learning in practice and reactions to the training. Semi-structured interviews examined motivations and perceptions of learning in depth. A 6-week, practice log recorded immediate practice effects and reflections.

Setting

1-day training delivered 3 times, total delegates 36: online December 2021, February 2022, face-to-face March 2022. Questionnaires delivered correspondingly in online or paper formats, semi-structured interviews online.

Participants

Pre–post: palliative care professionals (n=14/12), acute cancer clinical nurse specialists (n=16/11), other healthcare professionals (n=5/5).

Results

Positive changes were observed in self-efficacy (17 of 19 dimensions p

Conclusions

The training programme has the potential to effect change in practice behaviours. A large-scale study will evaluate the roll-out of the training delivered to individual professionals and whole teams across the UK. It will provide longer-term feedback to understand practice behaviour and mediators of change across professional roles.

Assessing the mediating role of family resilience between caregiver burden and caregiver capacity: a cross-sectional study among Chinese stroke survivors and family caregivers in a real-world setting

Por: Xu · Q. · Ge · Q. · Shi · L. · Zhang · Y. · Ma · J.
Objectives

To investigate the relationships among caregiver burden, family resilience, and caregiver capacity in the care of stroke survivors. We hypothesised that family resilience would mediate the relationship between caregiver burden and caregiver capacity.

Design

A cross-sectional study design was used.

Setting

The study was conducted in a tertiary care setting in Ningbo City, Zhejiang Province, China.

Participants

The study involved 413 stroke survivors and their primary caregivers.

Outcome measures

The primary caregivers completed the Shortened Chinese Version of the Family Resilience Assessment Scale, Zarit Caregiver Burden Interview and Family Caregiver Task Inventor and provided their sociodemographic information. Stroke survivors were assessed for activities of daily living, and their sociodemographic information was provided. Data were analysed, controlling for sociodemographic variables and focusing on the mediating effect of family resilience.

Results

Caregiver burden was influenced by the activities of daily living of stroke survivors, caregiver age and caregiver health status (p

Conclusions

Enhancing family resilience can reduce caregiver burden and improve caregiver capacity in stroke care. These findings underscore the importance of developing interventions focused on nursing skills and family resilience.

Perfusion outcomes with near-infrared indocyanine green imaging system in laparoscopic total mesorectal excision for mid-rectal or low-rectal cancer (POSTER): a study protocol

Por: Sun · L. · Gao · J. · Wu · G. · Meng · C. · Yang · Z. · Wei · P. · Yao · H. · Zhang · Z.
Introduction

Anastomotic leakage (AL) is defined as the failure of complete healing or disruption of the anastomosis subsequent to rectal cancer surgery, resulting in the extravasation of intestinal contents into the intra-abdominal or pelvic cavity. It is a serious complication of rectal cancer surgery, accounting for a considerable increase in morbidity and mortality. The use of fluorescence imaging technology in surgery allows surgeons to better evaluate blood perfusion. However, the conclusions of some existing studies are not consistent, so a consensus on whether the near-infrared indocyanine green (NIR–ICG) imaging system can reduce the incidence of AL is needed.

Methods

This POSTER trial is designed as a multicentre, prospective, randomised controlled clinical study adhering to the "population, interventions, comparisons, outcomes (PICO)" principles. It is scheduled to take place from August 2019 to December 2024 across eight esteemed hospitals in China. The target population consists of patients diagnosed with rectal cancer through pathological confirmation, with tumours located≤10 cm from the anal verge, eligible for laparoscopic surgery. Enrolled patients will be randomly assigned to either the intervention group or the control group. The intervention group will receive intravenous injections of ICG twice, with intraoperative assessment of anastomotic blood flow using the near-infrared NIR–ICG system during total mesorectal excision (TME) surgery. Conversely, the control group will undergo conventional TME surgery without the use of the NIR-ICG system. A 30-day follow-up period postoperation will be conducted to monitor and evaluate occurrences of AL. The primary endpoint of this study is the incidence of AL within 30 days postsurgery in both groups. The primary outcome investigators will be blinded to the application of ICG angiography. Based on prior literature, we hypothesise an AL rate of 10.3% in the control group and 3% in the experimental group for this study. With a planned ratio of 2:1 between the number of cases in the experimental and control groups, and an expected 20% lost-to-follow-up rate, the initial estimated sample size for this study is 712, comprising 474 in the experimental group and 238 in the control group.

Ethics and dissemination

This study has been approved by Ethics committee of Beijing Friendship Hospital, Capital Medical University (approval number: 2019-P2-055-02). The results will be disseminated in major international conferences and peer-reviewed journals.

Trial registration number

NCT04012645.

Six aspects of female genital mutilation education (SAFE) model: findings from a qualitative study

Por: Waigwa · S. · Bradbury-Jones · C. · Doos · L. · Taylor · J.
Objectives

Recent figures show that over 200 million women and girls, globally, live with the consequences of female genital mutilation (FGM). Complex debilitating physical, psychological and social problems result from the practice. Health education interventions have proven to be essential in both preventing the practice and informing support of survivors. In this study, we aimed to explore factors that affect the effectiveness of health education interventions.

Design

A generic qualitative approach was applied using semistructured individual and focus group interviews with women and men from communities with a history of FGM in Birmingham, UK. Framework analysis was used to group recurring themes from the data. Intersectionality was used as a theoretical lens to synthesise findings.

Participants

Twenty-one individuals (18 women and 3 men) participated in semistructured individual and focus group interviews about their views and experiences of health and well-being intervention programmes related to FGM.

Results

Six themes emerged from the data and were developed into a model of issues relating to FGM education. These six themes are (1) active communication, (2) attitudes and beliefs, (3) knowledge about FGM, (4) social structures, (5) programme approach and (6) the better future. A combined discussion of all these issues was compressed into three groupings: social structures, culture and media.

Conclusion

The results of this study depict aspects associated with FGM education that should be considered by future interventions aiming to prevent the practice and inform support services for survivors in a holistic way.

Did COVID-19 ICU patient mortality risk increase as Colorado hospitals filled? A retrospective cohort study

Por: Johnson · D. R. · Ghosh · D. · Wagner · B. D. · Carlton · E. J.
Objectives

To assess whether increasing levels of hospital stress—measured by intensive care unit (ICU) bed occupancy (primary), ventilators in use and emergency department (ED) overflow—were associated with decreasing COVID-19 ICU patient survival in Colorado ICUs during the pre-Delta, Delta and Omicron variant eras.

Design

A retrospective cohort study using discrete-time survival models, fit with generalised estimating equations.

Setting

34 hospital systems in Colorado, USA, with the highest patient volume ICUs during the COVID-19 pandemic.

Participants

9196 non-paediatric SARS-CoV-2 patients in Colorado hospitals admitted once to an ICU between 1 August 2020 and 1 March 2022 and followed for 28 days.

Outcome measures

Death or discharge to hospice.

Results

For Delta-era COVID-19 ICU patients in Colorado, the odds of death were estimated to be 26% greater for patients exposed every day of their ICU admission to a facility experiencing its all-era 75th percentile ICU fullness or above, versus patients exposed for none of their days (OR: 1.26; 95% CI: 1.04 to 1.54; p=0.0102), adjusting for age, sex, length of ICU stay, vaccination status and hospital quality rating. For both Delta-era and Omicron-era patients, we also detected significantly increased mortality hazard associated with high ventilator utilisation rates and (in a subset of facilities) states of ED overflow. For pre-Delta-era patients, we estimated relatively null or even protective effects for the same fullness exposures, something which provides a meaningful contrast to previous studies that found increased hazards but were limited to pre-Delta study windows.

Conclusions

Overall, and especially during the Delta era (when most Colorado facilities were at their fullest), increasing exposure to a fuller hospital was associated with an increasing mortality hazard for COVID-19 ICU patients.

Cognitive stimulation for people with dementia in nursing homes: a protocol for a feasibility study examining a new 24/7 approach (CogStim24)

Por: Folkerts · A.-K. · Seven · U. S. · Guicheteau · J. · N Dichter · M. · Hellmich · M. · Köpke · S. · Kalbe · E.
Introduction

Based on the available evidence, cognitive stimulation is recommended as an intervention for people with dementia (PwD). Currently, cognitive stimulation is regularly offered as a group programme in care facilities. However, some residents, such as those who are bedridden, cannot participate. Furthermore, group programmes were not feasible during the pandemic. A concept that accompanies everyday life and enables cognitive stimulation in everyday communication (ie, ‘24/7’) has been missing. Therefore, this feasibility study aims to (1) assess the feasibility of a new continuous 24/7 cognitive stimulation programme (CogStim24) based on a process evaluation and (2) examine the possible effects of CogStim24 on the primary outcome of global cognition in PwD and further PwD-related and staff-related outcomes.

Methods and analysis

The complex CogStim24 programme is developed to be conducted as an everyday intervention during routine care including cognitively stimulating techniques, such as reminiscence therapy, multisensory stimulation and physical activity. In this unblinded single-arm study with pre-assessments and post-assessments, four nursing homes with a total of N=20 nursing and care staff will participate in an 11-week CogStim24 training programme. The intervention will be conducted to N=60 PwD. Neuropsychological assessments will be conducted pre-staff and post-staff training, as well as after a 6-week implementation phase. A process evaluation will be performed.

Ethics and dissemination

Ethics approval was obtained from the ethics committee of the Faculty of Medicine of the University of Cologne, Cologne, Germany. Although cognitive stimulation is known to be effective for enhancing global cognition and quality of life in PwD, it is currently undersupplied to PwD. Therefore, CogStim24 has the potential to reach many more PwD. This study has the potential to serve as a basis for a large multicentre cluster randomised controlled trial. An interdisciplinarity team and mixed-methods approach will help generate information on the practicality and mechanisms of impact of CogStim24. This is important for the further development of the intervention and for facilitating its implementation. The study results will be disseminated via presentations at scientific conferences and meetings for healthcare professionals and PwD and their relatives. Several manuscripts presenting results of the different study parts will be published in peer-reviewed journals.

Trial registration number

DRKS00024381.

Use of artificial intelligence in obstetric and gynaecological diagnostics: a protocol for a systematic review and meta-analysis

Por: Chaurasia · A. · Curry · G. · Zhao · Y. · Dawoodbhoy · F. · Green · J. · Vaninetti · M. · Shah · N. · Greer · O.
Introduction

Emerging developments in applications of artificial intelligence (AI) in healthcare offer the opportunity to improve diagnostic capabilities in obstetrics and gynaecology (O&G), ensuring early detection of pathology, optimal management and improving survival. Consensus on a robust AI healthcare framework is crucial for standardising protocols that promote data privacy and transparency, minimise bias, and ensure patient safety. Here, we describe the study protocol for a systematic review and meta-analysis to evaluate current applications of AI in O&G diagnostics with consideration of reporting standards used and their ethical implications. This protocol is written following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 checklist.

Methods and analysis

The study objective is to explore the current application of AI in O&G diagnostics and assess the reporting standards used in these studies. Electronic bibliographic databases MEDLINE, EMBASE and Cochrane will be searched. Study selection, data extraction and subsequent narrative synthesis and meta-analyses will be carried out following the PRISMA-P guidelines. Included papers will be English-language full-text articles from May 2015 to March 2024, which provide original data, as AI has been redefined in recent literature. Papers must use AI as the predictive method, focusing on improving O&G diagnostic outcomes.

We will evaluate the reporting standards including the risk of bias, lack of transparency and consider the ethical implications and potential harm to patients. Outcome measures will involve assessing the included studies against gold-standard criteria for robustness of model development (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis, model predictive performance, model risk of bias and applicability (Prediction model Risk Of Bias Assessment Tool and study reporting (Consolidated Standards of Reporting Trials-AI) guidance.

Ethics and dissemination

Ethical approval is not required for this systematic review. Findings will be shared through peer-reviewed publications.There will be no patient or public involvement in this study.

PROSPERO registration number

CRD42022357024.

Cohort profile: the Environmental Reproductive and Glucose Outcomes (ERGO) Study (Boston, Massachusetts, USA) -- a prospective pregnancy cohort study of the impacts of environmental exposures on parental cardiometabolic health

Por: Preston · E. V. · Quinn · M. R. · Williams · P. L. · McElrath · T. F. · Cantonwine · D. E. · Seely · E. W. · Wylie · B. J. · Hacker · M. R. · O'Brien · K. · Brown · F. M. · Powe · C. E. · Bellavia · A. · Wang · Z. · Tomsho · K. S. · Hauser · R. · James-Todd · T. · the Environmental Rep
Purpose

Pregnancy and the postpartum period are increasingly recognised as sensitive windows for cardiometabolic disease risk. Growing evidence suggests environmental exposures, including endocrine-disrupting chemicals (EDCs), are associated with an increased risk of pregnancy complications that are associated with long-term cardiometabolic risk. However, the impact of perinatal EDC exposure on subsequent cardiometabolic risk post-pregnancy is less understood. The Environmental Reproductive and Glucose Outcomes (ERGO) Study was established to investigate the associations of environmental exposures during the perinatal period with post-pregnancy parental cardiometabolic health.

Participants

Pregnant individuals aged ≥18 years without pre-existing diabetes were recruited at

Findings to date

We enrolled 653 unique pregnancies and retained 633 through delivery. Participants had a mean age of 33 years, 10% (n=61) developed gestational diabetes and 8% (n=50) developed pre-eclampsia. Participant pregnancy and postpartum urinary phthalate metabolite concentrations and postpartum glycaemic biomarkers were quantified. To date, studies within ERGO found higher exposure to phthalates and phthalate mixtures, and separately, higher exposure to radioactive ambient particulate matter, were associated with adverse gestational glycaemic outcomes. Additionally, certain personal care products used in pregnancy, notably hair oils, were associated with higher urinary phthalate metabolite concentrations, earlier gestational age at delivery and lower birth weight.

Future plans

Future work will leverage the longitudinal data collected on pregnancy and cardiometabolic outcomes, environmental exposures, questionnaires, banked biospecimens and paediatric data within the ERGO Study.

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