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Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis

Por: Preesman · E. · Drechsel · K. · Crommelin · H. · Broekmans · F. · Verpoest · W. · Broer · S. · On behalf of the LUMO Study Group · LUMO Study Group · Musters · Cantineau · Heusden · Heteren · Koks · Koning · Lashley · Kuijper · Santbrink · Janse · Mol · Tecklenburg · Krom · Verhoe
Introduction

Couples diagnosed with unexplained subfertility are advised to start mild ovarian hyperstimulation and intrauterine insemination (MOH-IUI) as a primary treatment. Natural feedback mechanisms and hormone release are affected by artificially stimulated cycles and induced ovulation. Additional luteal support could positively affect progesterone patterns in the luteal phase. The LUMO study evaluates whether the addition of exogenous progesterone in the luteal phase following MOH-IUI treatment cycle will improve pregnancy and live birth rates.

Methods and analysis

A multicentre randomised, double-blind, controlled trial will be conducted in Dutch fertility clinics, academic and non-academic hospitals. There are two treatment arms: group A progesterone luteal phase support; group B placebo, without crossover. All initiated MOH-IUI cycles within 6 months after randomisation are included (study period). Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure. Treatment is continued until the onset of menstruation, a negative pregnancy test (IUI+14 days), a miscarriage or until 7 weeks of gestation in case of a viable pregnancy. Follow-up ends at 12 months after the end of study period (18 months after study randomisation). The primary outcome is cumulative pregnancy rate, achieved within 6 months after randomisation, leading to live birth. A total of 1008 patients (504 patients in each group) will be included.

Ethics and dissemination

The study was approved by the Central Committee on Research Involving Human Subjects on 30 January 2023. All participating sites have the approval of the local Board of Directors to participate in the LUMO study. An informed consent form will be signed by all participants. Study results will be presented at (inter)national conferences and published in peer-reviewed journals. It is expected that the results of this trial will be used to draft national guidelines on this issue.

Trial registration number

The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461).

Is the Active Involvement of Family Caregivers in Adult Hospital Care Effective to Improve Patient Outcomes? A Systematic Review

ABSTRACT

Aim

To investigate the effects of active involvement of family caregivers in adult in-hospital care on patients' readmissions, complications, mortality, length of hospital stay, quality of life, psychological distress and activities of daily living, as well as on the satisfaction of patients, HCPs and family caregivers.

Design

Systematic review.

Data Sources

Ovid Medline, Ovid Embase, EBSCO CINAHL, Cochrane Library (from inception to February 2024).

Methods

The PRISMA 2020 statement was followed. Prospective controlled studies focusing on active involvement of family caregivers in adult in-hospital care were included. Two independent teams of authors conducted study selection, quality assessment and data extraction.

Results

Thirteen studies were included, comprising 11 randomised controlled trials. The clinical and methodological heterogeneity precluded a meta-analysis. Six of these studies were performed in stroke patients. Some studies reported statistically significant benefits of active family involvement on readmission rates, hospital LOS, ADL, psychological distress for patients and family members, QoL and satisfaction of family caregivers. However, others did not observe differences in these outcomes. For complication rates, mortality and satisfaction of patients and HCPs, no studies demonstrated significant differences between groups.

Conclusion

Further research is needed to provide a conclusive answer as to whether active family caregiver involvement improves outcomes of adult hospitalised patients.

Implications for Patient Care

Despite the inconclusive findings of this review, advocating for active involvement of family caregivers in adult in-hospital care fits the perspective of patient- and family-centred care.

Impact

As the care of hospitalised adults is shifting to a more family-centric approach, investigating the effects of an active role of family caregivers in adult in-hospital care is necessary. However, the small number of studies available and heterogeneity between studies included in this review hamper firm conclusions. Further evaluations through well-designed studies are required.

Experiences of healthcare professionals, patients and families with video calls to stimulate patient‐ and family‐centred care during hospitalization: A scoping review

Abstract

Aim

To synthesize the literature on the experiences of patients, families and healthcare professionals with video calls during hospital admission. Second, to investigate facilitators and barriers of implementation of video calls in hospital wards.

Design

Scoping review.

Methods

PubMed, CINAHL and Google Scholar were searched for relevant publications in the period between 2011 and 2023. Publications were selected if they focused on experiences of patients, families or healthcare professionals with video calls between patients and their families; or between families of hospitalized patients and healthcare professionals. Quantitative and qualitative data were summarized in data charting forms.

Results

Forty-three studies were included. Patients and families were satisfied with video calls as it facilitated daily communication. Family members felt more engaged and felt they could provide support to their loved ones during admission. Healthcare professionals experienced video calls as an effective way to communicate when in-person visits were not allowed. However, they felt that video calls were emotionally difficult as it was hard to provide support at distance and to use communication skills effectively. Assigning local champions and training of healthcare professionals were identified as facilitators for implementation. Technical issues and increased workload were mentioned as main barriers.

Conclusion

Patients, families and healthcare professionals consider video calls as a good alternative when in-person visits are not allowed. Healthcare professionals experience more hesitation towards video calls during admission, as it increases perceived workload. In addition, they are uncertain whether video calls are as effective as in-person conservations.

Implications for the Clinical Practice

When implementing video calls in hospital wards, policymakers and healthcare professionals should select strategies that address the positive aspects of family involvement at distance and the use of digital communication skills.

Patient Contribution

No patient or public contribution.

Post‐operative nursing activities to prevent wound complications in patients undergoing colorectal surgeries: A scoping review

Abstract

Aims

To identify postoperative interventions and quality improvement initiatives used to prevent wound complications in patients undergoing colorectal surgeries, the types of activities nurses undertake in these interventions/initiatives and how these activities align with nurses' scope of practice.

Design

A scoping review.

Data Sources

Three health databases were searched, and backward and forward citation searching occurred in April 2022. Research and quality improvement initiatives included focussed on adult patients undergoing colorectal surgery, from 2010 onwards. Data were extracted about study characteristics, nursing activities and outcomes. The ‘Dimensions of the scope of nursing practice’ framework was used to classify nursing activities and then the Patterns, Advances, Gaps, Evidence for practice and Research recommendations framework was used to synthesise the review findings.

Results

Thirty-seven studies were included. These studies often reported negative wound pressure therapy and surgical site infection bundle interventions/initiatives. Nurses' scope of practice was most frequently ‘Technical procedure and delegated medical care’ meaning nurses frequently acted under doctors' orders, with the most common delegated activity being dressing removal.

Conclusion

The full extent of possible interventions nurses could undertake independently in the postoperative period requires further exploration to improve wound outcomes and capitalise on nurses' professional role.

Impact Statement

Nurses' role in preventing postoperative wound complications is unclear, which may inhibit their ability to influence postoperative outcomes. In the postoperative period, nurses undertake technical activities, under doctors' orders to prevent wound infections. For practice, nurses need to upkeep and audit their technical skills. New avenues for researchers include exploration of independent activities for postoperative nurses and the outcomes of these activities.

Implications for the Profession and/or Patient Care

There may be opportunities to broaden nurses' scope of practice to act more autonomously to prevent wound complication.

Reporting Method

Scoping Reviews (PRISMA-ScR) checklist.

Patient or Public Contribution

A health consumer interpreted the data and prepared the manuscript.

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