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Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

Por: Ben · A. J. · van der Vaart · L. R. · E. Bosmans · J. · Roovers · J.-P. W. R. · Lagro-Janssen · A. L. M. · van der Vaart · C. H. · Vollebregt · A. · PEOPLE group · Milani · Bon · Bongers · Bos · Broekman · Dietz · van Eijndhoven · Hakvoort · Janszen · Kluivers · Link · Massop-Hel
Objective

To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.

Design

Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

Setting

21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

Participants

1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.

Interventions

Pessary therapy and surgery.

Primary and secondary outcome measures

The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of –10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.

Results

For the PGI-I, the mean difference between pessary therapy and surgery was –0.05 (95% CI –0.14; 0.03) and –0.03 (95% CI –0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=–1807, 95% CI –2172; –1446 and mean difference=–1850, 95% CI –2349; –1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between 0 and 20 000/QALY gained from both perspectives.

Conclusions

Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.

Trial registration number

NTR4883.

The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema - study protocol of a multicentre, randomised sham-controlled trial

Por: Kleeven · A. · Jonis · Y. M. J. · Tielemans · H. · van Kuijk · S. · Kimman · M. · van der Hulst · R. · Vasilic · D. · Hummelink · S. · Qiu · S. S.
Introduction

Cancer-related lymphoedema is one of the most debilitating side-effects of cancer treatment with an overall incidence of 15.5%. Patients may suffer from a variety of symptoms, possibly resulting in a diminished health-related quality of life (HRQoL). A microsurgical technique known as lymphaticovenous anastomosis (LVA) might be a promising treatment option. The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL.

Methods and analysis

A multicentre, double-blind, randomised sham-controlled trial conducted in three university hospitals in the Netherlands. The study population comprises 110 patients over the age of 18 years with unilateral, peripheral cancer-related lymphoedema, including 70 patients with upper limb lymphoedema and 40 patients with lower limb lymphoedema. A total of 55 patients will undergo the LVA operation, while the remaining 55 will undergo sham surgery. The follow-up will be at least 24 months. Patients are encouraged to complete the follow-up by explaining the importance of the study. Furthermore, patients may benefit from regular monitoring moments for their lymphoedema. The primary outcome is the HRQoL. The secondary outcomes are the limb circumference, excess limb volume, changes in conservative therapy, postoperative complications, patency of the LVA and incremental cost-effectiveness.

Ethics and dissemination

The study was approved by the Medical Ethical Committee of Maastricht University Medical Center on 20 September 2023 (NL84169.068.23). The results will be presented at scientific conferences and published in peer-reviewed medical journals.

Trial registration number

NCT06082349.

Nurse and Physician Perceptions and Decision Making During Interdisciplinary Communication: Factors That Influence Communication Channel Selection

imageErrors in decision making and communication play a key role in poor patient outcomes. Safe patient care requires effective decision making during interdisciplinary communication through communication channels. Research on factors that influence nurse and physician decision making during interdisciplinary communication is limited. Understanding influences on nurse and physician decision making during communication channel selection is needed to support effective communication and improved patient outcomes. The purpose of the study was to explore nurse and physician perceptions of and decision-making processes for selecting interruptive or noninterruptive interdisciplinary communication channels in medical-surgical and intermediate acute care settings. Twenty-six participants (10 RNs, 10 resident physicians, and six attending physicians) participated in semistructured interviews in two acute care metropolitan hospitals for this qualitative descriptive study. The Practice Primed Decision Model guided interview question development and early data analysis. Findings include a core category, Development of Trust in the Communication Process, supported by three main themes: (1) Understanding of Patient Status Drives Communication Decision Making; (2) Previous Interdisciplinary Communication Experience Guides Channel Selection; and (3) Perceived Usefulness Influences Communication Channel Selection. Findings from this study provide support for future design and research of communication channels within the EHR and clinical decision support systems.

Non-communicable disease care in Sierra Leone: a mixed-methods study of the drivers and barriers to retention in care for hypertension

Por: Dibba · Y. · Kachimanga · C. · Gassimu · J. · Kulinkina · A. V. · Bukhman · G. · Gilbert · H. N. · Adler · A. J. · Mukherjee · J. S.
Objective

To retrospectively analyse routinely collected data on the drivers and barriers to retention in chronic care for patients with hypertension in the Kono District of Sierra Leone.

Design

Convergent mixed-methods study.

Setting

Koidu Government Hospital, a secondary-level hospital in Kono District.

Participants

We conducted a descriptive analysis of key variables for 1628 patients with hypertension attending the non-communicable disease (NCD) clinic between February 2018 and August 2019 and qualitative interviews with 21 patients and 7 staff to assess factors shaping patients’ retention in care at the clinic.

Outcomes

Three mutually exclusive outcomes were defined for the study period: adherence to the treatment protocol (attending >80% of scheduled visits); loss-to-follow-up (LTFU) (consecutive 6 months of missed appointments) and engaged in (but not fully adherent) with treatment (

Results

57% of patients were adherent, 20% were engaged in treatment and 22% were LTFU. At enrolment, in the unadjusted variables, patients with higher systolic and diastolic blood pressures had better adherence than those with lower blood pressures (OR 1.005, 95% CI 1.002 to 1.009, p=0.004 and OR 1.008, 95% CI 1.004 to 1.012, p

Conclusion

Free medications, high-quality services and health education may be effective ways of helping NCD patients stay engaged in care. Facility and socioeconomic factors can pose challenges to retention in care.

Patients' experiences of shared decision‐making in nursing care: A qualitative study

Abstract

Aim

To explore patients' experiences of shared decision-making, in nursing care during their stay in a healthcare institution.

Design

This study employed a qualitative descriptive design.

Methods

Twenty participants were interviewed from two rehabilitation centres, a nephrology ward of a hospital, and a rehabilitation ward of a long-term care facility. A constant comparative method was used for the inductive analysis.

Results

The main theme was ‘feeling seen and understood’, in the context of person-centred care, which served as the unifying thread across five themes. The five themes included the importance of a positive nurse–patient relationship as a foundation for shared decision-making. Next, patients experienced collaboration, and this was influenced by verbal and non-verbal communication. Another theme was that patients often felt overwhelmed during their stay, affecting shared decision-making. The fourth theme was that many decisions were not made through the shared decision-making process but were still perceived as satisfactory. The final theme highlighted patients' perspectives on their role in decision-making and influencing factors.

Conclusion

Patients describe how feeling seen and understood is a prerequisite for shared decision-making as a part of person-centred care. For nurses, this implies that they should focus on aspects such as building a good relationship and acknowledgement of patients' feelings and circumstances, next to empowering patients to feel knowledgeable and valued. This way patient's motivation to participate in shared decision-making will be enhanced.

Reporting Method

Following the EQUATOR guidelines, reporting was guided by the Consolidated Criteria for Reporting Qualitative Research (COREQ).

Patient or Public Contribution

Patients were involved in the study through interviews during the research process and member checks during analysis.

Implications for the profession and/or patient care

Before initiating shared decision-making processes, prioritise making the patient feel seen and understood. Be mindful that patients often feel overwhelmed during their stay. Use a person-centred approach to make patients feel knowledgeable—this empowers them for shared decision-making.

Impact

Research on patients' experiences of shared decision-making in nursing care is limited, yet crucial for understanding patients' needs in shared decision-making. This study highlights patients' perceptions that shared decision-making is best facilitated within the nurse–patient relationship by nurses who primarily focus on ensuring that patients feel acknowledged and understood.

Public controversy and citizens’ attitude formation about animal research: A case for scholarship and recommendations on conflicts at the science-society interface

by Elena Link, Katharina Emde-Lachmund, Sophie Bruns, Anja Dittrich, Meike Stiesch, Axel Haverich, Stefan Treue, Christoph Klimmt

Activist groups attack animal research and put scientists and their institutions under pressure, whereas scientists often remain silent. We report an interdisciplinary research project driven by a communication science perspective on how citizens respond to news reports about animal research (3 experiments, overall N = 765) and a German science-initiated information platform (“Tierversuche verstehen”; controlled user study, N = 100). Findings demonstrate that a critical journalist perspective within neutral, two-sided news reports (e.g., skeptical expert statements or images of suffering animals) does not affect citizen opinion strongly. Information media provided by scientific institutions seem to be welcomed even by citizens who hold critical prior attitudes. From these results, we develop a set of recommendations for future public communication of animal research that builds on best practices in organizational and crisis communication. These suggestions are intended to empower animal researchers to actively participate in public debate to support citizens’ informed attitude formation.

Delphi consensus study to develop guidelines for the management of adults with borderline personality disorder in the emergency department: a protocol

Por: Prosser · A. · Hong · V. · Helfer · B. · Fudge · D. · Patterson · J. · Rosebush · P. · Frey · B. N. · Links · P.
Introduction

Clinicians caring for adults with borderline personality disorder (BPD) in acute settings such as the emergency department (ED) have little evidence/guidance to base decisions on. Specific/detailed guidance for managing BPD in the ED is needed given the morbidity and mortality risks, high service utilisation, unique challenges and risk of iatrogenic interventions. The primary objective of this study is to use a consensus method to develop a guideline for managing adults with BPD in the ED. This protocol and the key questions for the guideline were developed with the advice of people with BPD and their family members/support persons.

Methods and analysis

We will perform a four-phase Delphi study of an expert panel of clinicians, researchers, adults with BPD and their family members/support persons. Various disciplines (psychiatry, psychology, emergency medicine, nursing, social work) and treatment approaches will be included in the expert panel. An online questionnaire will be developed from systematic reviews, qualitative assessments of pivotal literature, and opinions suggested by the panel (phase 1). The panel will rate their agreement on opinions for each key question covering areas of emergency care of adults with BPD using two rounds of this questionnaire (phases 2 and 3). Opinions meeting predefined thresholds for consensus will be brought to consensus meetings moderated by an independent chair (phase 4). The purpose of these meetings is to finalise the set and phrasing of the opinions for each area of emergency care. These final opinions will be the recommendations in the guideline. If there are significant differences of opinion, the guideline will present both recommendations alongside one another.

Ethics and dissemination

This study has received ethics approval by the Hamilton Integrated Research Ethics Board in Hamilton, Ontario, Canada. The results of this study will be disseminated through peer-reviewed publications, conferences and national professional and patient/family/support associations.

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