Defining practices suitable for care via teleconsultation in gynaecological and obstetrical care: a French Delphi survey

Objective
Delineate the scope of teleconsultation services that can be effectively performed to provide women with comprehensive gynaecological and obstetrical care.

Design
Based on the literature and experts’ insights, we identified a list of gynaecological and obstetrical care practices suitable for teleconsultation. A three-round Delphi consensus survey was then conducted online among a panel of French experts. Experts using a 9-point Likert scale assessed the relevance of each teleconsultation practice in four key domains: prevention, gynaecology and antenatal and postnatal care. Consensus was determined by applying a dual-criteria approach: the median score on a 9-point Likert scale and the percentage of votes either below 5 or 5 and higher.

Setting
The study was conducted at a national level in France and involved multiple healthcare centres and professionals from various geographical locations.

Participants
The panel comprised 22 French experts with 19 healthcare professionals, including 12 midwives, 3 obstetricians-gynaecologists, 4 general practitioners and 3 healthcare system users. Participants were selected to include diverse practice settings encompassing hospital and private practices in both rural and urban areas.

Primary and secondary outcome measures
The study’s primary outcome was the identification of gynaecological and obstetrical care practices suitable for teleconsultation. Secondary outcomes included the level of professional consensus on these practices.

Results
In total, 71 practices were included in the Delphi survey. The practices approved for teleconsultation were distributed as follows: 92% in prevention (n=12/13), 55% in gynaecology (n=18/33), 31% in prenatal care (n=5/16) and 12% in postnatal care (n=1/9). Lastly, 10 practices remained under discussion: 7 in gynaecology, 2 in prenatal care and 1 in postnatal care.

Conclusions
Our consensus survey highlights both the advantages and limitations of teleconsultations for women’s gynaecological and obstetrical care, emphasising the need for careful consideration and tailored implementation.

Leggi
Maggio 2024

Characteristics of patients who seek medical attention for headache and those who do not: cross-sectional survey and linked medical claims data analysis in Japan

Objective
To describe the characteristics of patients who sought medical attention for headache and those who did not.

Design
This observational study used a cross-sectional online survey and linked medical claims data.

Setting
Data from an online self-administered questionnaire survey conducted in November 2020 as well as linked medical claims data spanning December 2017 and November 2020 were provided by DeSC Healthcare Inc.

Participants
Of 21 480 respondents aged 19–74 years whose sex and age data matched the claims data, 7311 reported experiencing headache.

Measures
Outcomes included participant characteristics, status of medical attention seeking, medication use, quality of life (QOL) measured by Migraine-Specific QOL (MSQ) questionnaire V.2.1 and headache intensity.

Results
Of the 7311 respondents with headache, 735 sought medical attention and 6576 did not. Compared with those who did not seek medical attention, those who sought medical attention had more frequent headaches (median: 5 days/3 months vs 10 days/3 months in those who did not vs those who sought medical attention, respectively) had lower MSQ score (mean (SD) MSQ total score: 87.6 (13.0) vs 77.1 (18.1)) and were likely to experience moderately severe to severe headache (19.0% (1252/6576) vs 41.2% (303/735)) without headache medication. The inability to tolerate headache (36.5% (268/735)) was a common reason for seeking medical attention. Since the pain was not severe enough, 35.3% (2323/6576) of patients did not seek medical attention. Furthermore, a subgroup of respondents experiencing headache for ≥15 days were uncertain about which hospital or department to attend.

Conclusions
Patients typically seek help when the pain becomes unbearable. Still, some of them did not seek medical attention while they were experiencing headache for ≥15 days per month. Therefore, it is important to raise awareness and encourage seeking early medical attention before symptoms and associated burdens become too severe to be managed effectively.

Leggi
Aprile 2024

Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial

Introduction
Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

Methods and analysis
The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

Ethics and dissemination
The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

Trial registration number
NCT04273360.

Leggi
Aprile 2024

Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA)

Introduction
Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.

Methods and analysis
We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.

Ethics and dissemination
No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.

PROSPERO registration number
CRD42022347881.

Leggi
Aprile 2024

Design considerations for the migration from paper to screen-based media in current health education for older adults: a scoping review

Objectives
To map the current use of paper-based and/or screen-based media for health education aimed at older people.

Design
A scoping review was reported following the Preferred Reporting Items of Systematic Reviews and Meta-analyses for Scoping Reviews checklist.

Data sources
The search was carried out in seven databases (Scopus, Web of Science, Embase, Medline, CINAHL, ACM Guide to Computing Literature, PsycINFO), with studies available from 2012 to the date of the search in 2022, in English, Portuguese, Italian or Spanish. In addition, Google Scholar was searched to check the grey literature. The terms used in the search strategy were older adults, health education, paper and screen-based media, preferences, intervention and other related terms.

Eligibility criteria
Studies included were those that carried out health education interventions for older individuals using paper and/or screen-based media and that described barriers and/or facilitators to using these media.

Data extraction and synthesis
The selection of studies was carried out by two reviewers. A data extraction form was developed with the aim of extracting and recording the main information from the studies. Data were analysed descriptively using Bardin’s content analysis.

Results
The review included 21 studies that carried out health education interventions with different purposes, the main ones being promotion of physical activity, hypertension prevention and psychological health. All 21 interventions involved screen-based media on computers, tablets, smartphones and laptops, while only 4 involved paper-based media such as booklets, brochures, diaries, flyers and drawings. This appears to reflect a transition from paper to screen-based media for health education for the older population, in research if not in practice. However, analysis of facilitators and barriers to using both media revealed 10 design factors that could improve or reduce their use, and complementarity in their application to each media type. For example, screen-based media could have multimedia content, additional functionality and interactivity through good interaction design, but have low accessibility and require additional learning due to complex interface design. Conversely, paper-based media had static content and low functionality but high accessibility and availability and a low learning cost.

Conclusions
We recommend having improved screen-based media design, continued use of paper-based media and the possible combination of both media through the new augmented paper technology.

Registration number
Open Science Framework (DOI: 10.17605/OSF.IO/GKEAH).

Leggi
Aprile 2024

ECMO and Prone Position in Patients With Severe ARDS

To the Editor Use of prone ventilation in patients with acute respiratory distress syndrome (ARDS) decreases pulmonary arterial to venous shunt, improves respiratory system compliance, and reduces cyclical airspace opening/closing in dependent lung regions. In their randomized clinical trial of prone positioning in conjunction with extracorporeal membrane oxygenation (ECMO), Dr Schmidt and colleagues used ultraprotective lung ventilation (tidal volume ≤4 mL/kg) to achieve low airspace opening pressures. There were no attempts to vary either the tidal volume or the level of positive end-expiratory pressure to optimize respiratory system compliance in either posture (prone vs supine positioning). The low tidal volumes used would limit the extent to which ventilation in the prone position could open atelectatic areas, increase compliance, and improve ventilation, possibly accounting for their finding that prone positioning did not facilitate earlier weaning from ECMO. The low tidal volumes administered without use of periodic sigh breaths (ie, large inflations to or approaching total lung capacity) could also account for the frequent development of whole lung atelectasis that they observed, and this would further limit the ability of prone ventilation to reduce cyclical airspace opening and closing and time to weaning from ECMO.

Leggi
Aprile 2024

ECMO and Prone Position in Patients With Severe ARDS—Reply

In Reply In their Letter about our recent study, Drs Wiener and Albert suggest that incorporating periodic sigh breaths into ultraprotective lung ventilation during ECMO could potentially enhance the efficacy of prone positioning. They suggest that this approach may help expand atelectatic regions, improve lung compliance, reduce cyclical airspace opening and closing, and subsequently facilitate earlier ECMO weaning. While we acknowledge the potential appeal of this mechanical ventilation strategy, the literature currently lacks data on the utilization of periodic sigh breaths in conjunction with very low tidal volume, reduced driving pressure (ie, plateau pressure minus positive end-expiratory pressure), and respiratory rate. Physiological investigations and randomized clinical trials have primarily focused on patients with tidal volume exceeding 6 mL/kg of predicted body weight and moderately impaired lung compliance. This area warrants further exploration, particularly regarding the determination of safe plateau pressure and the duration and interval of periodic sigh breaths in patients with profoundly reduced respiratory system compliance and normalized gas exchanges (oxygenation and decarboxylation provided by ECMO).

Leggi
Aprile 2024

Effectiveness of a community-based multicomponent lifestyle intervention (the ADA programme) to improve the quality of life of French breast cancer survivors: protocol for a pragmatic cluster randomised trial and embedded qualitative study

Introduction
Breast cancer survivors (BCSs) are often faced with multiple mental and physical sequelae and are at increased risk of emotional distress, degraded health-related quality of life (HRQoL), chronic pain and fatigue.
Physical activity is strongly associated with improved HRQoL and survival rates; however, adherence rates to recommendations for a healthy lifestyle are seldom satisfactory among BCSs. Also, few studies have examined the effectiveness of multicomponent and personalised interventions that integrate physical activity and motivational techniques to improve the HRQoL of BCS.

Method and analysis
“Activité physique adaptée Doublée d’un Accompagnement d’après cancer” (ADA) is an integrated programme of physical activity enriched with a dietary and supportive care approach targeting BCS in the early post-treatment phase. The effectiveness of the ADA intervention will be evaluated using a cluster randomised controlled trial design with two arms (ADA programme vs usual care; 1:1 ratio).
The ADA intervention aims to recruit 160 participants and will be implemented by Siel Bleu, a non-profit association specialised in health prevention via adapted physical activity. Measurements will be performed at baseline, 3, 6 and 12 months after the start of the intervention. The primary outcome will be participants’ HRQoL, at 12 months measured by the Functional Assessment of Chronic Illness Therapy-Fatigue global score. Secondary outcome will include participants’ physical, social, emotional and functional well-being. The effect of the intervention on physical activity level, motivation for physical activity, relation to food and self-efficacy will also be evaluated.

Ethics and dissemination
The study was approved by the ‘CPP Paris XI’ Institutional Review Board on 5 May 2022 (Ref no.: 21.04512.000048-22004). The study’s findings will be shared through various channels, including academic publications, simplified reports for wider audiences and active engagement with medical and institutional organisations as well as patients’ associations.

Trial registration number
NCT05658341.

Leggi
Marzo 2024