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Values and preferences of patients with severe mental illness regarding smoking cessation interventions: a systematic review with best-fit framework synthesis

Por: Coteur · K. · Tops · L. · Bekkering · G. E. · de Almeida Ferreira Fonseca · L. · van den Brand · F. · Cloetens · H. · Zeng · L. · Aertgeerts · B. · Delvaux · N. · Agarwal · A. · Agoritsas · T. · Vermandere · M.
Objective

To identify values and preferences regarding smoking cessation interventions among adults with severe mental illness

Design

Systematic review with best-fit framework synthesis

Data sources

MEDLINE, EMBASE, Web of Science, CINAHL and Scopus from inception to 14 November 2025.

Study selection

Studies with any design, in any clinical and geographical setting, reporting on adult (18+) current or past smokers with a diagnosis of schizophrenia, bipolar or mood disorder, including major depressive disorder or post-traumatic stress disorder. We selected all quantitative and qualitative findings regarding patients’ values and preferences, including beliefs, attitudes, behaviours and perceived barriers and facilitators, in relation to smoking cessation interventions.

Data extraction and synthesis

Two reviewers independently screened studies. After a pilot to increase accuracy, data were extracted by one reviewer and verified by another. Risk of bias was assessed using the Mixed Methods Appraisal Tool. We used the best-fit framework synthesis methodology to synthesise the data.

Results

Of 14 970 identified articles, 65 were included. Most studies were of moderate to high quality. Financial costs posed a significant barrier, while education and social support emerged as important facilitators. Patients preferred personal interactions with healthcare providers. Their motivation for cessation varied and was influenced by habits and perceived nicotine dependence. Health concerns and financial savings were primary drivers for reflective motivation. Beliefs regarding treatment varied. Although commonly used, scepticism about nicotine replacement therapy and concerns about the long-term safety of electronic delivery systems were reported. Overall, patients preferred personalised, flexible programmes and emphasised the need for tailored approaches. Digital interventions, especially mobile apps, that provide support, motivational content and relevant information, were perceived as appealing and helpful when sufficiently considering accessibility and usability aspects. Patients commonly perceived smoking as a coping mechanism for negative emotions. Developing new coping strategies and creating smoke-free environments were deemed to contribute to successful cessation.

Conclusions

Patient-centred care for people with severe mental illness should leverage behavioural and pharmacological strategies for smoking cessation. Flexibility, accessibility and ongoing support appeared important for addressing stress, withdrawal symptom interpretation and relapse vulnerability in this population.

PROSPERO registration number

CRD42022337933.

Safety and potential efficacy of DM199, a tissue kallikrein-1 analogue, for treating pre-eclampsia and fetal growth restriction: study protocol for a South African, hospital-based phase I/II open-label trial

Por: Cluver · C. A. · Thake · J. · Hassim · T. · van Greunen · A. · Budhram · S. · Knipe · K. · Decloedt · E. · Brink · L. · Langenegger · E. · Bergman · L. · Imberg · H. · Bekker · A. · Walker · S. P. · Tong · S.
Introduction

Pre-eclampsia and fetal growth restriction are leading causes of perinatal morbidity and mortality. A therapy that enhances maternal vascular function and promotes vasodilation to increase placental perfusion could treat both conditions.

Tissue kallikrein-1 is an endogenous enzyme that releases bradykinin to activate the bradykinin 2 receptor on endothelial cells. This induces potent vasodilation and pro-angiogenic, anti-oxidant and anti-inflammatory effects.

DM199 is a recombinant form of tissue kallikrein which can be administered intravenously or subcutaneously. Clinical trials in non-pregnant populations have demonstrated its safety. Being a protein, it is unlikely to cross the placenta. This protocol describes an early-phase trial for DM199 for pre-eclampsia and fetal growth restriction.

Methods and analysis

This phase IB/IIA open-label trial at Tygerberg Hospital, Western Cape Province, South Africa, will determine the safety and effective dose of DM199 for pre-eclampsia and/or fetal growth restriction. The trial consists of two parts. Part 1 will be an ascending dose finding study, treating women with pre-eclampsia and severe hypertension who are for planned birth within 72 hours. This will search for doses that safely lower blood pressure (n=3/dose, recruiting up to 42 participants). Part 2 is a safety and efficacy study of three cohorts of pregnant women (n=30/cohort): (1) with pre-eclampsia and severe hypertension requiring delivery within 72 hours, (2) with preterm pre-eclampsia (

Ethics and dissemination

The trial has ethical approval (Health Research Ethics Committee, Stellenbosch University, Protocol number M24/04/009) and is registered (Pan African Clinical Trial Registry, PACTR202404895013782) and approved by the South African Health Products Regulatory Authority (20240801). Data will be presented at international conferences and published in peer-reviewed journals.

Consensus-based development and practice testing of a generic quality indicator set for parenteral medication administration at home: a RAND appropriateness method study

Por: Lok-Visser · J. · Hunneman · R. · Bekkers · C. H. J. · Filius · P. M. G. · Lenferink · A. · Leeftink · G. · Maring · J. G.
Objectives

Due to nursing shortages, an ageing population and increasing care demand, there is a growing interest in parenteral medication administration at home (PMAaH), comprising the administration of parenteral medication in the home situation of patients. The operational design of such PMAaH care pathways is complex, resulting in many variations of adoptions, showing a need for a quality framework. Although quality indicators (QIs) have been proposed to monitor the quality of specific care pathways, a generic quality framework for all types of PMAaH is lacking. Therefore, this study proposes a generic quality set for PMAaH, which includes structure and process QIs, to benchmark and redesign PMAaH care pathways to ensure high quality.

Design

A generic QI set was developed for PMAaH using a systematic RAND appropriateness method adapted at the third phase. This method consisted of a scoping review to identify indicators, an expert panel rating phase including an online questionnaire and subsequent panel meeting to assess the appropriateness of the indicators and a retrospective practice testing to evaluate the feasibility, clarity and measurability of the indicators. After the practice testing, which consisted of an online questionnaire where experts could indicate the implementation state of all indicators in their hospital, a third expert panel adjusted the set to increase the likelihood of implementation in practice.

Setting

The experts, all healthcare professionals involved in PMAaH processes, were recruited using the snowball sampling technique from three large Dutch, teaching hospitals. Subsequently, a practice testing by self-assessment was conducted in seven large Dutch teaching hospitals.

Participants

17 and seven healthcare professionals with diverse backgrounds participated in the online questionnaire and panel meeting, respectively.

Results

The scoping review resulted in 36 QIs for PMAaH. After two expert panel rating rounds (online questionnaire and panel meeting), two indicators were removed: a QI related to travel distance policy since it was irrelevant and redundant, and a QI stating that a clinician should take the lead in a PMAaH-team, which was deemed too restrictive. After the practice testing, two QIs were removed: a QI related to clinical response documentation, which was unclear for the practice testing respondents and already covered by other QIs, and a QI related to survival documentation, which was deemed infeasible and undesirable to measure this differently than other patients by the third expert panel.

The final set consists of 32 indicators (of which 15 were structure indicators and 17 were process indicators). The final set predominately includes QIs that are aimed at patient safety but also QIs focusing on the working conditions of the healthcare workers. 17.6% of the QIs are currently fully implemented in general in all seven hospitals. The practice testing revealed that operational QIs are more frequently implemented in practice than systemic QIs and that a structured quality assurance programme is needed in the hospitals.

Conclusions

This study proposes a generic quality set for PMAaH that hospitals can use to redesign and benchmark PMAaH care pathways to assure high quality. The practice testing confirmed that there is a need for this structured quality set.

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