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Patient experiences with a smartwatch 1L-ECG versus traditional Holter monitoring for ambulatory cardiac rhythm monitoring: a qualitative study

Por: Karregat · E. P. M. · Vooijs · P. · Wierda · E. · Harskamp · R. · Lucassen · W. · Himmelreich · J. C. L. · Moll van Charante · E. P.
Objective

To explore patients’ experiences and perspectives on using a direct-to-consumer smartwatch with single-lead electrocardiography (1L-ECG) for ambulatory rhythm diagnostics in primary care.

Design

Qualitative study using semi-structured interviews and thematic analysis.

Setting

Primary care patients referred for ambulatory rhythm monitoring in a diagnostic centre.

Participant

Eighteen adults with paroxysmal palpitations, of whom nine were female patients (50%), aged 32–85 (median 66) years.

Intervention

Participants simultaneously wore a smartwatch with 1L-ECG capability (Withings ScanWatch) and a conventional Holter monitor for 7 days.

Outcome measures

Patient experiences and perceived barriers and facilitators to smartwatch use for rhythm monitoring, reported after the monitoring period.

Results

Patients found the smartwatch more user-friendly and feasible than the Holter monitor. Difficulties included uncertainty about when to initiate recordings, challenges capturing brief episodes and anxiety triggered by automated algorithm outputs. Participants emphasised the importance of accessible healthcare support for interpretation and reassurance.

Conclusions

This study shows that smartwatch-based 1L-ECG monitoring is feasible and acceptable for ambulatory rhythm diagnostics in primary care. Prior to routine implementation, it is crucial to address the identified challenges: particularly anxiety related to algorithm results, uncertainty about when to record and accessible clinician support.

Knowledge, perceptions and practices of informal medicine vendors regarding over-the-counter distribution of antibiotics and antibiotic resistance in Nanoro District, Burkina Faso: an exploratory qualitative study

Por: Kouanda · J. S. · Campbell · L. · Meudec · M. · Welgo · A. · Diagne · P. M. · Ingelbeen · B. · van Kleef · E. V. · Valia · D. · van der Sande · M. A. · Tinto · H. · Wouters · E.
Objectives

This study aimed to understand the knowledge possessed by informal medicine vendors regarding antibiotics and antibiotic resistance, identify the perceptions held by informal medicine vendors about antibiotics and their uses and examine the practices employed by informal medicine vendors in the sale and distribution of antibiotics.

Design

Exploratory qualitative study using semi-structured interviews and direct observations.

Setting

Markets and shops across 11 villages in the Nanoro health district, Burkina Faso.

Participants

23 informal medicine vendors, aged between 25 and 55 years and with 8–30 years of experience, were recruited through snowball sampling in the Nanoro health district of Burkina Faso.

Results

Informal medicine vendors exhibited a limited understanding of antibiotics, often confusing them with other treatments and referring to them using local terminologies based on perceived use and effectiveness. Antibiotics were perceived as universal remedies, supported by therapeutic belief, empirical reasoning and community solidarity, with empirical diagnosis, approximate dosing and informal preparation techniques passed on through imitation. These findings emerged across themes including perceptions, symbolic attributes and sales practices.

Conclusion

Informal medicine vendors in rural Burkina Faso demonstrated limited understanding of antibiotics and antimicrobial resistance, with practices shaped by local beliefs and empirical experience. These findings underscore the need for context-sensitive interventions that include tailored education and regulatory engagement to improve antibiotic stewardship and mitigate the spread of resistance.

Immune Profiling in Early Cognitive Disorders (IMPRINT) study protocol: a longitudinal cohort study exploring biomarkers of inflammation in early dementia with Lewy bodies and Alzheimers disease, as part of the Dementias Platform UK

Por: Crook · H. · Swann · P. · Fye · H. · Kigar · S. · Savulich · G. · Mckeever · A. · Herrero · E. · Turner · L. · Aimola · L. · Grey · G. D. · Blackburn · D. · Matthews · P. M. · Su · L. · Chouliaras · L. · Rowe · J. B. · Malhotra · P. · OBrien · J. T.
Introduction

Growing evidence points towards the integral role of both central and peripheral inflammation across all neurodegenerative diseases, including dementia with Lewy bodies (DLB) and Alzheimer’s disease (AD). The immune alterations observed in these diseases may occur long before the onset of clinical and cognitive symptoms; however, the exact timing and role of inflammation in the pathogenesis of neurodegenerative disease remains unclear. Findings to date are conflicting, with most work focused on AD rather than other dementias and most studies from single sites and cross-sectional. Through longitudinally examining detailed phenotypes of the peripheral immune system using mass cytometry, the Immune Profiling in Early Cognitive Disorders study aims to uncover specific immune signatures in early AD and DLB, how these signatures change over time and how they relate to disease progression and cognitive changes.

Methods and analysis

Blood, cerebrospinal fluid, saliva and urine samples will be collected from a cohort of participants with either prodromal (mild cognitive impairment) or early dementia due to Lewy bodies or AD (MCI-LB and DLB; and MCI-AD and AD), alongside healthy controls. Through immunophenotyping with mass cytometry, detailed immune fingerprints will be identified for these groups. We will assess which key combinations of immune cell clusters are predictive of disease phenotype, cognitive decline and progression to dementia. Samples will also be evaluated with novel techniques to measure markers of degenerative pathology and inflammation.

Ethics and dissemination

This study was approved by the Preston North West Research Ethics committee (21/NW/0314) and is registered with the ISRCTN registry (ISRCTN62392656). The study is ongoing (since June 2022). Baseline visits are being undertaken, and follow-up visits have started for some participants. Full data analyses will be completed and submitted for publication upon conclusion of the study.

Awareness of colorectal cancer symptoms and risk factors: a cross-sectional study at the largest tertiary care centre in Sri Lanka

Por: Wickramasinghe · D. G. · Nugaliyadda · T. · Perera · P. M. · Samarasekera · D. N. · Wickramasinghe · D.
Objectives

To assess awareness of colorectal cancer (CRC) symptoms and risk factors among adults attending Sri Lanka’s largest tertiary care hospital, and to identify sociodemographic predictors of awareness.

Design

Descriptive cross-sectional study.

Setting

Outpatient clinics at the National Hospital of Sri Lanka (NHSL), the country’s largest tertiary care centre.

Participants

A total of 506 adults (≥18 years) recruited via convenience sampling. Data were collected from May 2022 to May 2023 at the outpatient clinics of the NHSL, the country’s largest tertiary care centre. Eligible participants included clinic attendees as well as accompanying persons of attendees, provided they met inclusion criteria. Individuals with known gastrointestinal conditions or malignancies were excluded.

Primary and secondary outcome measures

Primary outcomes: awareness scores of CRC symptoms and risk factors using a culturally adapted Bowel Cancer Awareness Measure questionnaire.

Secondary outcomes: predictors of awareness based on sociodemographic variables.

Results

58.7% (n=297) of participants could not name any CRC symptoms unprompted; blood in stools (n=93, 18.4%) was the most identified symptom unprompted. Prompted awareness improved markedly, with 75.3% (n=381) identifying blood in stools when provided with a list. Similarly, 44.3% (n=224) could not identify any CRC risk factors unprompted; excessive alcohol intake (n=368, 72.7%) and low fibre intake (n=324, 64.0%) were the most commonly recognised risk factors when prompted. The mean symptom awareness score was 5.63 (SD=2.55), corresponding to ‘fair’ awareness, and the mean risk factor awareness score was 5.47 (SD=2.63), also indicating ‘fair’ awareness. Female gender (B=0.669, p=0.008; n=237) and older age (B=0.023, p=0.034) were significantly associated with higher symptom awareness. Awareness was significantly lower among participants with lower education (B = –0.104, p=0.018; n=219) and among the unemployed (B = –0.175, p=0.045; n=152).

Conclusions

Unprompted awareness of CRC symptoms and risk factors was suboptimal in this population, with marked gaps in spontaneous recall. Public health campaigns should prioritise men, younger adults and individuals with lower education to enhance CRC literacy and promote earlier detection.

Predicting 30-day mortality in emergency department patients with suspected infection: external validation of the RISE UP score in a single tertiary centre

Por: van Baar de Knegt · S. M. E. · Uffen · J. W. · de Hond · T. A. P. · Stassen · P. M. · Zelis · N. · Kaasjager · K. A. H.
Objective

Rapid identification of high-risk and low-risk patients presenting to the emergency department (ED) influences clinical management and can help optimise patient outcomes as well as resource allocation. This study aims to externally validate the Risk Stratification in the Emergency Department in Acutely Ill Older Patients (RISE UP) score in adult patients in the ED with suspected infection. Furthermore, generalisability was assessed by comparing the discriminatory ability of the RISE UP with the quick Sequential Organ Failure Assessment (qSOFA) as well as the Modified Early Warning Score (MEWS) and National Early Warning Score (NEWS).

Design

Retrospective cohort study.

Setting

Single-centre study in the ED of a tertiary, university-affiliated hospital.

Participants

Adult patients with suspected infection presenting at the ED for internal medicine from 2016 to 2022.

Outcomes

The primary outcome was all-cause 30-day mortality. Secondary outcomes were all-cause 14-day mortality, 7-day mortality and intensive care unit (ICU) admission.

Methods

Prognostic performance was evaluated using discrimination (area under the receiver operating characteristic curve (AUC)) and a calibration plot.

Results

Of the included 5038 ED visits, there was a 30-day mortality of 7.1%. Discrimination of RISE UP for 30-day mortality was good (AUC 0.809; 95% CI 0.786 to 0.832) and significantly higher than that for the other risk scores: qSOFA (AUC 0.675; 95% CI 0.644 to 0.707), MEWS (AUC 0.688; 95% CI 0.658 to 0.718) and NEWS (AUC 0.725; 95% CI 0.696 to 0.754) (p

Conclusions

The RISE UP score outperformed the qSOFA, MEWS and NEWS in predicting 30-day mortality. It is generalisable to an adult infection-specific cohort and may facilitate distinction between high-risk and low-risk patients in the ED, particularly to rule out poor outcomes.

Big data in modelling geographical accessibility to healthcare: a scoping review protocol

Por: Njogu · A. · Libertini · L. · Avahoundje · E. M. · Grovogui · F. M. · Ba · O. A. · Ray · N. · Benova · L. · Macharia · P. M.
Introduction

Research on modelling geographical accessibility to healthcare services has witnessed rapid methodological advancement and refinement. One of the contributing factors is the increasing availability of big data detailing the link between the population in need of care and the health facility such as infrastructure, travel modes and speeds, traffic congestion and the quality of road network. This has allowed more granular computation of geographic access metrics, particularly in low-and-middle income countries where data are scarce. However, there are no reviews providing a comprehensive overview of the availability and use of big data for assessing geographical accessibility to healthcare. This protocol aims to describe a methodological approach that will be used to review the existing literature on the application of big data (past or potential) in evaluating geographical accessibility to healthcare.

Methods and analysis

To characterise the big data that can be used to model geographical accessibility to healthcare, a scoping review will be undertaken and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extensions for Scoping Reviews guidelines. We will search seven scientific databases (PubMed, Scopus, Web of Science, EBSCOhost-CINAHL, Cochrane, Embase and MEDLINE via Ovid), grey literature, reference lists of identified publications and conference proceedings. Search engines will be used to identify relevant big data services not yet used in published academic literature. All literature published in English or French will be included, regardless of publication type, geographical location or year of publication provided it describes or mentions big data that may be useful for evaluating geographical accessibility to healthcare. Study selection and data extraction will be performed independently by two researchers with a third resolving any discrepancies. Analysis will be conducted to summarise big data providers, their characteristics and their usefulness in terms of types of spatial accessibility metrics that can be derived.

Ethics and dissemination

Formal ethical approval is not required, as primary data will not be collected in this review. Findings will be disseminated through peer-reviewed publication in a journal, conference presentation and condensed summaries for stakeholders through professional networks and social media summaries.

Registration

Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/S496F.

Surrogacy in Ghana: a qualitative study exploring recruitment processes, eligibility criteria, stigma and postnatal care experiences among surrogate mothers

Por: Amarteifio · D. A. · Hiadzi · R. A. · Tetteh · P. M. · Boafo · I. M.
Objective

Surrogacy has become a vital reproductive option for individuals and couples who are unable to conceive naturally. This study explores the experiences of surrogate mothers in Ghana, focusing on recruitment pathways, eligibility criteria, societal stigma and postnatal care experiences.

Design

Qualitative phenomenological research design was used, and data were collected through semi-structured interviews and analysed using thematic content analysis.

Setting

Three private agencies that source surrogate mothers for assisted reproduction facilities in Accra, Ghana. Data were collected between December 2020 and June 2021.

Participants

Twenty-one surrogate mothers aged 20–40 years who were either pregnant (gestational age ≥16 weeks) or had delivered within the past 2 years were recruited from three private agencies in Accra.

Results

Thematic analysis generated four themes: (1) recruitment pathways into surrogacy, (2) eligibility criteria and assessments, (3) experiences of stigma and concealment and (4) postnatal care and recovery. These themes illustrate how surrogate mothers in Ghana navigate recruitment processes, psychosocial and medical evaluations, societal stigma and challenges with discharge and follow-up care.

Conclusion

These findings underscore the need for systemic changes, including enhanced postnatal care, structured psychological evaluations and culturally sensitive interventions to reduce stigma.

Continuous physiological monitoring for the detection of postoperative deterioration: a protocol for a multistage, multicentre, international, prospective cohort study

Por: Jiwa · A. · Cameron · M. M. · Ademuyiwa · A. O. · Adisa · A. · Aguilera Arevalo · M. L. · Bahrami Hessari · M. · Bhangu · A. · Brennan · P. M. · Clark · N. · Cresswell · K. · Czerwinska · I. · DAdderio · L. · Gunn · E. · Haque · P. D. · Ikegwuonu · T. · Lawani · I. · Morton · D. · Nganwa
Introduction

Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.

Methods and analysis

This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.

Ethics and dissemination

Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.

Trial registration number

NCT06565559.

E-Prem checklist-driven strategy to improve outcomes in extremely preterm and low birth weight infants: a quasi-experimental study at a national referral hospital in Indonesia

Por: Marsubrin · P. M. T. · Sugiyarto · K. L. J. · Oswari · J. S. · Yulianti · D. A. · Rohsiswatmo · R. · Roeslani · R. D. · Iskandar · R. A. T. P. · Sukarja · D. · Sjahrullah · M. A. R. · Kautsar · A. · Chaudhari · T.
Objectives

This study aims to assess how implementing a checklist for managing extremely preterm or extremely low birth weight infants can reduce mortality rates and morbidities.

Design

A quasi-experimental, before-and-after study.

Setting

Neonatal intensive care unit at Dr. Cipto Mangunkusumo National General Hospital, a national referral hospital in Indonesia.

Participant

86 infants were born at

Interventions

Implementation of a modified Canberra Health Services extremely preterm-early management checklist during the initial management of extremely preterm or low birth weight infants, including humidified gas resuscitation, thermal management, early surfactant administration and standardised first-hour care protocols.

Main outcome measures

The primary outcome was the mortality rate. Secondary outcomes included comorbidities such as hypothermia, hypoglycaemia, acidosis, intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL) and retinopathy of prematurity (ROP).

Results

A total of 86 extremely premature and/or extremely low birth weight infants were enrolled, 48 neonates prior to and 38 neonates after the use of the checklist. Baseline characteristics were comparable between groups (median gestational age 27 weeks in both groups, median birth weight 795 g vs 868.5 g, p=0.09). Mortality at discharge showed a non-significant reduction from 52.1% to 47.4% (p=0.664, 0.91, 95% CI 0.64 to 1.30). Significant reductions were observed in IVH (79.2% to 28.9%, p

Conclusions

Implementation of a systematic checklist was associated with significant reductions in IVH and ROP, though mortality reduction was not statistically significant. These findings suggest potential benefits of structured early care protocols, but the observational design limits causal inference.

Predicting dysglycaemia in individuals with gestational diabetes immediately postpartum using continuous glucose monitoring (PREDISPOSE) in a multicentre prospective cohort study in Canada: a study protocol

Por: Sigurdson · S. M. · Bernier · K. J. · Donovan · L. E. · Feig · D. S. · Lemieux · P. · Pylypjuk · C. · Shen · G. X. · Jiang · D. · Nerenberg · K. · Chrisp · M. M. · Katz · P. M. · Benham · J. L. · Yamamoto · J. M.
Introduction

Gestational diabetes is a common metabolic disorder in pregnancy which identifies a substantial increased risk of future diabetes. Despite this risk, many individuals are not screened for dysglycaemia in the postpartum period. Continuous glucose monitoring (CGM) is an evolving technology that provides details of an individual’s glucose levels throughout the day; however, it has not yet been evaluated as a screening tool for postpartum dysglycaemia. To address this gap, this prospective cohort study will examine the use of CGM in the early postpartum period to predict the risk of maternal dysglycaemia after delivery.

Methods and analysis

The Predicting Dysglycaemia in Individuals with Gestational Diabetes Immediately Postpartum using CGM (PREDISPOSE) study is a prospective cohort study designed to assess the ability of a CGM device (Freestyle Libre 2) worn in the postpartum period to detect persistent dysglycaemia in individuals with gestational diabetes. The study will recruit 240 individuals with gestational diabetes. Each participant will wear the CGM immediately postpartum and before attending routine postpartum diabetes screening, consisting of a 75-gram oral glucose tolerance test (OGTT) and related blood work (haemoglobin A1c (HbA1c), complete blood count and lipid profile). The primary outcome is the accuracy of the area under the curve for all glucose measurements from the first CGM wear to detect postpartum dysglycaemia. We will perform sensitivity and specificity analyses to determine optimal CGM cut-offs to diagnose diabetes or prediabetes. Secondary outcomes include the incidence of postpartum dysglycaemia (based on 75-gram OGTT and/or HbA1c), incidence of postpartum dyslipidaemia, patient acceptability of CGM testing, data variability from CGM and cardiometabolic health outcomes diagnosed in years one, two and five after delivery.

Ethics and dissemination

All participating sites have received ethics approval of the current protocol and have started recruitment of participants to the study. The ethics boards that approved this study are the Biomedical Research Ethics Board at the University of Manitoba, the Conjoint Health Research Ethics Board at the University of Calgary, the Mount Sinai Hospital Research Ethics Board at Mount Sinai Hospital and the Comité d'éthique de la Recherche at Université Laval. Study results will be disseminated through conference presentations and publication in a peer-reviewed journal, regardless of study findings.

Trial registration number

NCT04972955. Registration date: 28 June 2021.

Pain management and patient education interventions to increase physical activity in people with intermittent claudication (PrEPAID): a feasibility randomised controlled trial in the UK

Por: Seenan · C. · Abaraogu · U. · Dall · P. M. · Gilmour · L. · Tew · G. · Stuart · W. · Elders · A. · Brittenden · J.
Objectives

To explore the feasibility and acceptability of pain management (transcutaneous electrical nerve stimulation (TENS)) and patient education (PE) to increase physical activity in people with peripheral arterial disease and intermittent claudication (IC).

Design

Feasibility randomised controlled trial with embedded process evaluation.

Setting

One secondary care UK vascular centre.

Participants

56 community-dwelling adults with a history of stable IC and ankle-brachial pressure index ≤0.9 were recruited via claudication clinics.

Interventions

Participants randomised to 6 weeks of: TENS+PE, TENS, Placebo TENS+PE or Placebo TENS. PE was a 3-hour workshop plus three follow-up phone calls. The TENS machine was worn during walking (TENS: 120 Hz, 200 μs, intensity ‘strong but comfortable’; Placebo TENS: intensity below sensation threshold).

Outcomes

Primary feasibility outcomes included rates of recruitment, retention and adherence. Acceptability of the intervention and trial procedures was explored with semistructured interviews. Measures of walking capacity, walking behaviour, quality of life, disease perception and pain were recorded at baseline, end of intervention (6 weeks) and follow-up (3 months).

Results

56 participants were randomised from 95 who completed baseline screening. Of the 39 excluded, 97% (38/39) had >20% variability in absolute claudication distance. All participants received their allocated intervention. Outcome completion was 91% at 6 weeks and 80% at 3 months. Attendance at group education was 96% with 63% taking follow-up phone calls. Compliance with TENS was 70% according to participant-completed logs. Interviewed participants (n=9) were generally positive about the acceptability of the interventions and trial procedures; however, experience of TENS use was mixed. Some participants were dissatisfied with the size of the device and electrode wires.

Conclusions

The PrEPAID (Pain management and Patient Education for Physical Activity in Intermittent claudication) trial was feasible to run; however, 40% of potential participants were excluded at screening due to issues of research fidelity rather than participant suitability or willingness to participate. A future definitive trial should consider a revised primary outcome measure and smaller wireless TENS machines.

Trial registration number

ClinicalTrials.gov, NCT03204825. Registered on 2 July 2017.

Trial funding

Chief Scientist Office, Scottish Government. Translational grant award (TCS/16/55).

Systematic mapping review of statistical methods applied to the relationships between cancer diagnosis and geographical level factors in UK

Por: Mendes · J. A. · Keegan · T. · Jones · L. · Atkinson · P. M. · Sedda · L.
Objectives

We examined studies that analysed the spatial association of cancers with demographic, environmental, behavioural and/or socioeconomic factors and the statistical methods applied.

Design

Systematic mapping review.

Data sources

Web of Science (SSCI) (search on 28 July 2022), MEDLINE, SocINDEX and CINAHL (search on 4 August 2022), additional searches included grey literature.

Eligibility criteria for selecting studies

(1) Focused on the constituent countries of the UK (England, Wales, Scotland and Northern Ireland) and its major regions (eg, the North West); (2) compared cancer(s) outcomes with demographic, environmental, behavioural and socioeconomic characteristics by applying methods to identify their spatial association; (3) reported cancer prevalence, incidence rates, relative risk or ORs for a risk factor or to an average level of cancer.

Data extraction and synthesis

A standardised data extraction form was developed and for all studies, core data were extracted including bibliographic information, study design, geographical factors analysed, data aggregation level, methods applied and main findings. We described and synthesised the characteristics of the studies using summary tables, charts and graphs.

Results

52 studies were included covering a variety of objectives and geographical scales. These studies considered different types of cancer, with the most common cancer types analysed being blood and lymphoid cell cancers. The most common methods used to assess the association between cancers and geographical level factors were regression analyses, with the majority being Poisson regression, then logistic and linear regression. Studies were usually conducted at ward and local authority level, or by exact point location when distances from putative risk sources were considered. The results were usually presented in plots or as tables, instead of maps.

Conclusion

Our results highlight the lack of consideration of spatially explicit models in the analysed studies, with the risk of having failed the assumption of independence in the data.

PROSPERO registration number

CRD42022349165.

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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