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RISE for recovery after acute whiplash injury: protocol for a randomised feasibility trial of a clinician-supported SMS-based behavioural intervention

Por: Elphinston · R. A. · Formosa · J. · Armfield · N. · van der Vegt · A. H. · Ashton-James · C. E. · Brain · K. · Buckley · L. · Papic · C. · Khan · A. · Eather · C.-E. · Liimatainen · J. · Hobbins King · A. · Hansen · K. · Staib · A. · Smith · G. M. · Chen · T. · Wright · K. · Garrad · E.
Introduction

Whiplash-associated disorders (WADs) are the most common and costly consequence of road traffic injury (RTI). Providing early and effective treatment is a healthcare priority; however, current guideline-based care which focuses on education and physiotherapy-led exercise does not routinely address the psychosocial effects of trauma, and access to early integrated treatment is limited. This study aims to evaluate the feasibility of delivering and evaluating recovery, information, support and empowerment (RISE), a co-designed short message service-based intervention integrating psychosocial and exercise/activity support for individuals with acute whiplash injury who are at risk of poor recovery in a randomised feasibility trial. Secondary aims are to explore preliminary changes in candidate clinical outcomes and opportunities for intervention personalisation and future implementation.

Methods and analysis

This mixed-methods randomised controlled feasibility trial with a nested process evaluation will recruit 50 participants (>18 years) with WAD grade II/III who are identified at medium to high risk of poor recovery and within 12 weeks of RTI from Queensland emergency departments and the community. Participants will be randomised in a 1:1 ratio to receive either the RISE intervention (tailored, daily messaging+optional brief clinician support session/s) or an active control (general health-related text messages plus access to an online resource, My Whiplash Navigator). Feasibility outcomes, including recruitment and retention rates, data collection (including wearable-derived and economic data) and intervention uptake will be descriptively summarised and evaluated against pre-defined traffic light progression criteria. Acceptability will be examined using validated questionnaires and purpose-built items, qualitative interviews with intervention participants and focus groups with patients, clinicians and funders. Secondary aims will be addressed through preliminary estimates of between-group differences in patient-reported outcomes with 95% CIs and exploratory analysis of multimodal data (eg, wearable-derived physiological data, intervention engagement metrics) using a large language model where possible to inform future personalisation and implementation planning.

Ethics and dissemination

This trial is approved by the Townsville Hospital Human Research Ethics Committee (HREC/QTHS/121395) and ratified by the Human Research Ethics Committee at The University of Queensland, which is the study sponsor (2025/HE002491). Results will be published in peer-reviewed journals and presented at conferences and professional meetings.

Trial registration

ACTRN12626000506392; date registered: 23 April 2026; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=390706&isReview=true

Availability and gaps in operating theatre structural resources for fracture fixation in Tanzania: a national cross-sectional analysis

Por: Issa · S. A. · Njambilo · G. M. · Mgisha · W. R. · Mrita · F. S. · Muhamedhussein · M. S.
Objectives

To evaluate the availability of operating theatre structural resources for fracture fixation, identify key resource gaps and assess variation across facility tiers in hospitals delivering orthopaedic and trauma services in Tanzania.

Design

National cross-sectional survey.

Setting

Hospitals providing orthopaedic and trauma services across all levels of care and ownership types in Tanzania.

Participants

Licensed orthopaedic and trauma surgeons in Tanzania (n=171) reported on 92 unique hospitals nationwide.

Primary outcome measures

Operating theatre structural resources for fracture fixation across three domains: theatre infrastructure, core orthopaedic equipment and operative support resources. A composite score summarised overall structural resource availability.

Results

Basic operating theatre infrastructure and utilities were widely reported; however, specialised infrastructure components and orthopaedic-specific resources were inconsistently available. Access to traction tables (23.9%), limb positioning systems (27.2%) and disposable sterile drapes and gowns (14.1%) was limited. Adequate orthopaedic instruments were reported in 45.7% of hospitals, while fluoroscopy and digital imaging systems were reported to be available in 47.8% and 29.3%, respectively. Implant supply and equipment maintenance systems were inconsistently reported.

Overall, only 17.4% of hospitals reported high structural resource availability, while 55.4% were moderate and 27.2% low. Marked disparities were observed across facility tiers, with 55.0% of zonal and national hospitals reporting high resource availability compared with 8.2% of regional and 4.3% of district hospitals. Higher tier hospitals demonstrated significantly greater availability of orthopaedic equipment, imaging and operative support resources (p

Conclusions

Operating theatre structural resources for fracture fixation are variably available across hospitals in Tanzania, with key deficiencies in orthopaedic-specific equipment, intraoperative imaging, instrument adequacy and operative support systems, including implant supply and equipment maintenance. These gaps are most pronounced at lower tier facilities, highlighting substantial disparities in resource distribution. Strengthening orthopaedic equipment, improving imaging access and reinforcing support systems, particularly at lower level hospitals, is essential to support more equitable delivery of fracture fixation services.

Childhood cancer predisposition study: a prospective registry and biorepository protocol

Por: Perrino · M. R. · MacFarland · S. P. · Maese · L. · Vagher · J. · Kamihara · J. · Rednam · S. · Lupo · P. J. · Brodeur · G. M. · Schiffman · J. · Diller · L. · Desrosiers-Battu · L. · Plon · S. E. · Nichols · K. E. · Volchenboum · S. L. · Malkin · D. · Villani · A. · Porter · C. C.
Introduction

Cancer is the most common cause of disease-related mortality in children, highlighting the urgent need for improved care in this population. It is estimated that >15% of children diagnosed with cancer harbour a germline pathogenic variant in a cancer predisposition gene which confers an increased risk to develop cancer. There are over 100 genes associated with cancer predisposition syndromes (CPSs) and greater availability and acceptability of genetic testing in the last decade has facilitated their recognition in childhood. However, individually, each of these CPSs is rare, impeding robust research and advancement of clinical care. Once a specific CPS is diagnosed, current recommendations for clinical care are based primarily on expert consensus with a ’one size fits all’ approach to management. Detailed knowledge of genotype-phenotype associations and the impact of genetic modifiers is lacking, and due to strong ascertainment bias of children already diagnosed with cancer predominantly being tested for a CPS, the true cancer risk is likely overestimated.

Methods and analyses

The Childhood Cancer Predisposition Study (CCPS) is a multi-centre registry and biorepository for children and adolescents aged 0–21 years with a clinical or molecularly confirmed CPS and their family members (NCT04511806). The study objectives are to characterise the natural history of each CPS, correlate the natural history phenotype with CPS genotype, evaluate the efficacy of standard surveillance strategies and allow future investigation into the feasibility and effectiveness of novel surveillance strategies. The principal study question is whether adherence to recommended tumour surveillance guidelines is associated with earlier detection of tumours and/or improved survival. We will also address what barriers exist that prevent adherence to surveillance guidelines. Data collected from primary subjects includes detail about the CPS, genomic data, cancer history and family cancer history, as well as information about tumour surveillance. Required biospecimen collection includes germline DNA samples, with optional collection of serial blood and stool samples. Planned enrolment is 1050 primary subjects.

Ethics and dissemination

CCPS was reviewed and approved by a central IRB (WCG IRB 2020P002450) and the Research Ethics Board at The Hospital for Sick Children in Toronto (1000072286). Written informed consent is obtained from all participants. Data and specimens are available to qualified investigators by request to address specific research questions through a standardised research application process. In addition, de-identified data are available through the Pediatric Cancer Data Commons for exploration. Analysed data will be disseminated in peer-reviewed publications and at conferences including meetings inclusive of patient and family advocacy groups.

Trial registration number

NCT04511806.

Level and predictors of micronutrient intake inadequacy among pregnant women attending public health facilities in Bahir Dar City, Northwest Ethiopia: a multicentre, cross-sectional study

Por: Ayalew · C. A. · Alemayehu · M. A. · Yirdaw · G. · Ayele · W. M. · Ahmed · A. F. · Andargie Kassa · A. · Tsega · T. D. · Yemata · G. A. · Shimels · T. · Anteneh · R. M. · Temesegen · A. · Bayeh · G. M. · Yeshiwas · A. G. · Mekonen · H. · Mekonnen · B. A. · Tsega · S. S. · Yigzaw · Z. A.
Objective

To determine the level and predictors of micronutrient intake inadequacy among pregnant women attending antenatal public health facilities in Bahir Dar City, Northwest Ethiopia.

Design

A multicentre, cross-sectional study.

Setting

The study was conducted in public health facilities in Bahir Dar City, Northwest Ethiopia from January to March 2024.

Participants

About 420 pregnant women aged 18 years and older attending antenatal care at public health facilities in Bahir Dar. Pregnant women diagnosed with chronic diseases, sick and unable to communicate, and who had attended weddings, birthday celebrations or religious festivals within the past 24 hours were excluded.

Primary outcome measures

Micronutrient intake inadequacy among pregnant women was measured using a single multiphasic 24-hour dietary recall. The Nutria-Survey Food Processor software, the Ethiopian food composition table and the World food composition table were used for the calculation of the nutrient value of micronutrients. The nutrient intakes were assessed by nutrient adequacy ratio and mean adequacy ratio. Data were analysed using SPSS V.26. Multivariable logistic regression analysis was done to identify the predictors of micronutrient intake inadequacy.

Results

A total of 411 pregnant women were recruited in the study, yielding a 97.8% response rate. The overall prevalence of micronutrient intake inadequacy was 76.4% (95% CI 72.0% to 80.3%). The proportions of zinc, vitamin A, iron and calcium intake inadequacies were 48.2%, 66.7%, 14.8% and 74%, respectively. Having nutrition counselling (adjusted ORs (AOR)=3.5; 95% CI 2.00 to 6.48), having

Conclusions

Micronutrient intake among pregnant women was lower than the recommended levels. Therefore, strengthening community efforts to promote the consumption of a diversified diet for pregnant women, encourage nutrient-dense food production and enhance food security is essential.

A multidisciplinary active lifestyle aftercare programme for individuals with acquired brain injury (ABI-MOTION): protocol of a practice-based implementation study

Por: de Vries · E. A. · Grauwmeijer · E. · Ista · E. · Blom-De Heer · S. J. · Cramm · J. M. · Ribbers · G. M. · van den Berg-Emons · R. J. G. · Heijenbrok-Kal · M. H.
Introduction

This study aims to enhance aftercare for individuals with acquired brain injury (ABI), focusing on an active lifestyle and health-related quality of life, by implementing a multidisciplinary intervention using a network of outpatient rehabilitation and community-based services, and by evaluating its implementation process and outcomes.

Methods and analysis

The ABI-MOTION intervention includes 5 activities delivered through a network of outpatient rehabilitation and community-based services: outpatient rehabilitation, education flyer, introduction to a sports consultant, maximum of 8 hours of sports consultancy and follow-up by a rehabilitation physician. This hybrid type 2 implementation study focuses on implementation outcomes and uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework for a process evaluation (primary) and effect evaluation (secondary). Sixty individuals with ABI will be followed over time, allowing interim evaluation and optimisation of ABI-MOTION. The first group (control) receives outpatient rehabilitation and follow-up, the intervention group receives all 5 activities of the ABI-MOTION intervention. Data related to the implementation will be collected using field notes, focus groups and semi-structured interviews. To explore the effects of the ABI-MOTION intervention, functional and cognitive tests, self-report questionnaires and home measurements will be conducted just before the intervention and at 3, 6 and 12 months post-discharge.

Ethics and dissemination

The study protocol is approved by the Medical Ethics Committee of Erasmus MC (MEC-2023-0623). The results of the study will be disseminated in peer-reviewed journals, conferences and stakeholder meetings.

Trial registration number

NCT06058351.

Knowledge, attitudes and practices regarding immediate breast reconstruction after mastectomy: a cross-sectional study in Jordan

Por: Rataan · A. O. · Alameri · M. · Al-Taani · G. M. · Shreim · H. K. · Al-Shalakhti · L. H. · AlRefai · B. A. · Shqeer · L.
Objectives

This study aimed to evaluate the knowledge, attitudes and practices (KAP) of Jordanian women regarding post-mastectomy breast reconstruction (PMBR), and to recognise key sociodemographic factors influencing these outcomes.

Design

A descriptive cross-sectional study.

Setting

Community-based settings across Jordan, representing a general population sample.

Participants

A total of 752 adult women were enrolled in the study. Eligible participants were women aged 18 years or older who were living in Jordan. Recruitment took place across a variety of community settings. Data were collected on sociodemographic variables such as age, level of education, insurance coverage and any personal history of breast disease.

Primary and secondary outcome measures

The primary outcomes were KAP related to PMBR, measured using a standardised, pretested Arabic questionnaire. Secondary outcomes included identifying sociodemographic factors associated with KAP.

Results

Participants demonstrated moderate knowledge (56.2%), a generally positive attitude (48.6%) and moderate practice levels (42.0%) toward PMBR. Regression analysis indicated that age, level of education, insurance status and personal history of breast disease were significant predictors of KAP outcomes.

Conclusions

Awareness and use of PMBR among Jordanian women remain inadequate. These results highlight the need for culturally tailored educational initiatives, improved communication between patients and healthcare providers, and the establishment of national guidelines to facilitate informed decision-making. Further studies are warranted to identify barriers to PMBR uptake and to evaluate the impact of targeted awareness interventions.

Incidence and predictors of immediate postoperative haemodynamic instability among adult surgical patients in Ethiopia, 2024: a multicentre prospective observational study

Por: Deress · G. M. · Seid Mohammed · A. · Tegegne · S. S. · Wubet · H. B. · Asmare · T. B. · Belete · K. G. · Gobezie · N. Z. · Mossie · K. D. · Mengistu · T. D. · Mengistu · W. E. · Eshetie · D.
Objective

This study aimed to find the incidence and predictors of postoperative haemodynamic instability among adult surgical patients in the postanaesthesia care unit (PACU).

Study design

A multicentre prospective observational study was conducted from 1 June to 30 September 2024.

Setting

The study was conducted at three hospitals in the South Gondar Zone, north-west Ethiopia.

Participants

The study included 404 elective surgical patients undergoing surgery who were in the PACU. All adult patients who were fit, stable and underwent elective surgery under anaesthesia and were admitted to the PACU for monitoring and stabilisation were included in the study. Patients who were directly admitted to an intensive care unit or ward after an operation and those who refused to give consent were excluded from the study.

Outcome measures

The study investigates the incidence and predictors of immediate postoperative haemodynamic instability in adult surgical patients.

Result

The incidence of postoperative haemodynamic instability in the PACU was 47.8% (95% CI 43.1% to 52.5%). Multivariable logistic regression analysis shows that American Society of Anesthesiologists class III patients (adjusted OR (AOR): 3.04, 95% CI 1.48 to 6.25), patients with preoperative anxiety (AOR: 2.9, 95% CI 1.73 to 4.78), preoperative use of beta-blocker medication (AOR: 1.9, 95% CI 1.11 to 3.32), patients who experienced intraoperative haemodynamic instability (AOR: 1.8, 95% CI 1.2 to 3.14) and patients with a procedure lasting more than 4 hours (AOR: 3.7, 95% CI 3.26 to 9.67) were significantly associated with haemodynamic instability.

Conclusion

The incidence of postoperative haemodynamic instability in this study was high. Our findings highlight the urgent need for hospital quality improvement initiatives and healthcare professionals assigned to the PACU should monitor the patients continuously. We also recommend that future researchers monitor the patients for 24 hours.

Policy monitoring indexes targeting non-communicable diseases: protocol for a scoping review

Por: Bjornara · H. B. · Flodgren · G. M. · Helleve · A.
Introduction

Cost-effective and feasible policy actions to prevent non-communicable diseases (NCDs) are identified, for example, WHO’s Best buys. Monitoring implementation of policy action can be a key indicator of progress in NCD prevention. Several policy monitoring indices have been developed to assess policies targeting NCDs. The objective of this scoping review is to map and synthesise scientific publications and relevant grey literature reporting on the design, characteristics and use of such indexes.

Methods and analysis

The scoping review will follow Johanna Briggs Institute guidance and reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. We will search eight databases (MEDLINE, Embase, Cochrane CENTRAL, Global Health, PsycINFO, Web of Science Core Collection, Scopus and FRANCIS) from 1 January 2013 onwards for eligible observational, quasi-experimental and mixed-methods studies in any language and reference lists of included studies and relevant reviews. Criteria for studies to be included are as follows: Population—any composite index designed to monitor the implementation of NCD relevant policies; Concept—monitoring, that is, the systematic collection, analysis and use of data targeting the implementation of policies aimed at reducing the prevalence of major NCDs and/or related behavioural risk factors; Context—national and/or supranational government-initiated policies implemented within the WHO European region. Conceptual-only papers, commentaries, conference abstracts, editorials and letters will be excluded. Screening and data extraction will be done in duplicate. Results will be synthesised narratively using descriptive statistics and visuals.

Ethics and dissemination

Ethical approval is not required because the review does not involve primary data collection or direct interaction with human participants. The review is part of the Joint Action PreventNCD project, co-funded by the European Commission and involving 25 European countries. It will contribute to the project’s objectives of advancing monitoring systems for NCDs and behavioural risk factors. We plan to disseminate findings at international conferences and to publish the full review in an international peer-reviewed journal.

Weaning from invasive ventilation with levosimendan (WEANLESS): study protocol for a multicentre randomised clinical trial

Por: De Leijer · E. · Hofma · C. · Serpa Neto · A. · Hunfeld · N. G. M. · Schultz · M. J. · Doorduin · J. · Heunks · L.
Background

Prolonged weaning from invasive mechanical ventilation is a major challenge in critically ill patients failing a spontaneous breathing trial. Levosimendan, a calcium sensitiser, has been shown to improve respiratory muscle function. However, its effect on clinically relevant endpoints in difficult to wean patients has not yet been investigated. We aim to assess whether levosimendan shortens the weaning process in invasively ventilated intensive care unit (ICU) patients who fail a separation attempt. The objective is to assess the effect of levosimendan on the number of ventilator-free days and alive at day 28.

Methods

The WEANing with LEvoSimendan Study (WEANLESS) is an investigator-initiated, multicentre, double-blind, parallel-group, randomised clinical superiority trial. Adult invasively ventilated patients who failed a separation attempt are randomly assigned to receive either intravenous levosimendan (intervention) or placebo (control). The primary outcome is the number of ventilator-free days and alive at day 28 from randomisation. WEANLESS also evaluates the effects of levosimendan on patient-reported outcomes, measured through daily dyspnoea scores and uses an EQ-5D-5L questionnaire. Additionally, we will evaluate healthcare resource utilisation and intensive care capacity, assessed through reintubation rates, ICU readmissions within 90 days, the need for non-invasive respiratory support and ICU length of stay. WEANLESS includes a pharmacokinetic analysis of levosimendan and its metabolites.

Discussion

WEANLESS is the first clinical study that is sufficiently powered to determine the effect of intravenous levosimendan in difficult to wean patients on the duration of weaning from invasive ventilation.

Ethics and dissemination

WEANLESS is registered before the inclusion of the first patient at clinicaltrials.gov; the study protocol has been approved by the relevant ethics committee. Its findings will be disseminated through presentations at scientific conferences and publications in a peer-reviewed journal.

Trial registration number

NCT07105202.

In their own words: experiences surrounding masculinising chest surgery among transgender and gender-diverse adolescents - a secondary analysis of GENDER-Q data

Por: Armstrong · K. · Quan · I. · Kennedy · S. L. · Kaur · M. N. · Cornacchi · S. D. · Rae · C. · Johnson · N. · Khatchadourian · K. · Marinkovic · M. · Sequeira · G. M. · Bradley · B. · Cheung · K. · Morrison · S. D. · Klassen · A. F.
Objective

Masculinising chest surgery, also known as top surgery, is the most requested gender-affirming procedure among transgender and gender-diverse (TGD) adolescents, yet research on patient experiences remains limited. This study explored the experiences of TGD adolescents who were seeking or had undergone masculinising chest surgery.

Design

Qualitative secondary analysis using existing themes framework and data from the GENDER-Q (GQ) and GENDER-Q Youth (GQY) research programmes, which aim to develop comprehensive patient-reported outcome measures for gender-affirming care.

Setting

Participants were sampled from five high-volume gender-affirming care clinics, three in Canada and two in the United States. Interviews were conducted online.

Participants

35 GQ and GQY participants aged 13–18 years who were assigned female at birth, identified as trans men or non-binary, and were pursuing (n=19) or had undergone (n=16) masculinising chest surgery.

Results

Three major themes emerged: chest appearance, health-related quality of life (HRQL) and gender practices. Most participants expected a flatter chest that aesthetically aligned with their gender identity. Presurgery participants anticipated that surgery would allow them to engage in previously avoided physical activities and would enhance their relationships. Postoperative participants reported increased physical activity, mental resilience, bodily connection and social comfort. Most reported binder use and related reliance or discomfort as motivators for pursuing surgery.

Conclusions

This study highlights the multidimensional experiences surrounding masculinising chest surgery on TGD adolescents with impacts on chest appearance, HRQL and gender practices. Centering adolescents’ perspectives, these findings underscore the importance of accessible, affirming surgical care and provide valuable insights for clinicians, policymakers and future research.

Blended adapted sailing therapy with telerehabilitation for rare skeletal disorders: protocol for a pilot randomised controlled feasibility trial in Italy (PaS2-EXTEND)

Por: Boarini · M. · Banchelli · F. · Scognamiglio · D. · Farella · G. M. · Platano · D. · Rizzo · S. · Cavina · U. · Rogati · G. · Ramaglia Amadasi · R. · Villa · G. · Leardini · A. · Berti · L. · Sartini · S. · Magnanelli · L. · Locatelli · A. · Scopinaro · A. M. · Sangiorgi · L.
Introduction

Rare skeletal disorders (RSDs) cause lifelong functional impairment, chronic pain and reduced quality of life. Evidence-based rehabilitation strategies remain underdeveloped, particularly for adolescents and young adults. We previously demonstrated preliminary feasibility of a 5-day adapted sailing intervention but observed benefit attenuation at 3-month follow-up. This pilot trial evaluates feasibility, acceptability and safety of intensive adapted sailing therapy followed by home-based telerehabilitation maintenance versus telerehabilitation alone.

Methods and analysis

This is a prospective, randomised, assessor-blinded, parallel two-arm pilot feasibility trial. 24 participants aged 12–30 years with confirmed RSDs will randomise with a 1:1 allocation ratio to: (1) 5-day adapted sailing therapy followed by 3-month telerehabilitation (n=12) or (2) 3-month telerehabilitation alone (n=12). Primary outcomes assess feasibility through recruitment efficiency (≥80% eligible patients enrolled), intervention adherence (≥75% sessions completed), participant retention (≥80% at 6-month follow-up), and safety (zero serious adverse events attributable to interventions). Secondary outcomes include sensor-based motor function (balance, gait, upper extremity mobility via inertial measurement units) and patient-reported outcomes (health-related quality of life, functional capacity, kinesiophobia, pain), measured at baseline, 3-month and 6-month follow-up. Exploratory analyses will estimate preliminary between-group effect sizes. Statistical analysis uses intention-to-treat principles with linear mixed-effects models.

Ethics and dissemination

The study received approval from the Area Vasta Emilia Centro Ethics Committee (363/2025/Sper/IOR) on 7 July 2025. The study is ongoing, and data collection is expected to be completed by March 2026. Results will be disseminated through peer-reviewed open-access publications, conference presentations, patient organisation partnerships and plain-language summaries.

Trial registration number

NCT07102875.

Determinants of access to anticancer medicines in South Asia: a multimethod study

Por: Shukar · S. · Hussain · I. · Iqbal · A. · Rahimi · A. · Shirol · G. M. · Shirzad · I. · Tenzin · J. · Dewan · S. M. R. · Kumari Mishra · S. · Saeed · A. · Babar · Z.-U.-D. · Yang · C. · Fang · Y.
Objective

South Asia bears a high cancer burden, low universal health coverage and high out-of-pocket expenditure. Access to anticancer medicines is challenging and is influenced by determinants—National Essential Medicines List (NEML), registration and local production—yet these are rarely evaluated. This study evaluates these determinants in eight South Asian countries.

Design

Multimethod study using a document analysis phase and semistructured interviews.

Setting

Eight South Asian countries (Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka) for document analysis, with stakeholder interviews conducted in six countries, excluding Bhutan and Maldives.

Participants

Data were collected from eight regulatory authorities and 30 interviews with drug supply chain stakeholders across six South Asian countries.

Main outcome measures

The inclusion of 67 anticancer medicines from the 2023 WHO Essential Medicines List (EML) into NEML, their registration and local production, along with macrolevel indicators and stakeholders’ perspectives regarding them.

Results

The median number of medicines included in NEMLs, registered and locally produced was 23.5, 45 and 6.5, respectively. Local production correlated positively with NEML inclusion (=0.884, p=0.004) and negatively with healthcare expenditure (r = –0.732, p=0.039). Three countries listed >50% of the WHO EML medicines on their NEMLs; six had >50% registered. Local production remained limited, with imports dominating supply. Qualitative analysis identified three key barriers to improving availability: financial constraints, a weak regulatory system and insufficient strategic planning.

Conclusions

Access to anticancer medicines is constrained by systemic misalignment between NEML inclusion, registration and local production, undermined by weak regulatory coordination, limited strategic planning and financial constraints. Strengthening regulatory coordination, improving registration efficiency and supporting regional production strategies aligned with guided WHO guidance may help improve equitable access to cancer medicines in the region.

Study protocol for a hybrid I randomised clinical trial to evaluate an audit and feedback and a pharmacist-led intervention to reduce potentially inappropriate medications in older adults: the AIM study

Por: Leiva · A. · Gallardo Alfaro · L. · Bejarano · F. · Sempere · E. · Soler · A. · Huguet · A. · Llarena · M. · Lekue · I. · Campabadal Prats · C. · Salom · C. · Solaz · R. B. · Socias Canellas · C. · Gonzalez · A. · Campins · G. M. · Vanrell · A. · Rovira · M. · Ponsa Mir · G. · Vicens-Cal
Introduction

Potentially inappropriate prescriptions (PIPs) in older adults, such as long-term use of benzodiazepines, proton pump inhibitors without indication or antipsychotics in dementia, are associated with adverse events and increased healthcare utilisation. Despite clinical guidelines discouraging their use, PIPs remain frequent in primary care. An audit and feedback (A&F) intervention of PIPs to general practitioners (GPs), led by pharmacists, may reduce the prescription of PIPs in primary care.

Methods and analysis

A two-arm, pragmatic, controlled trial will be conducted to evaluate the effectiveness of an A&F-based intervention and a pharmacist-led intervention to reduce the proportion of patients aged ≥65 years receiving inappropriate prescriptions. A total of 170 participating GPs, 85 per group, are required. GPs will be randomised into intervention or control groups (1:1). The intervention includes feedback reports, pharmacist-led academic detailing and access to online training modules. The primary outcome is the proportion of older adults receiving at least one PIP at 12 months as well as the total number of PIPs. A random effects Tobit regression model, censored at 0 and 100, will be used to estimate between-group differences adjusted for baseline prescribing. Subgroup analyses will explore heterogeneity of effect by baseline prescribing level and healthcare region. Implementation outcomes, including reach, fidelity, engagement and maintenance, will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, combining quantitative and qualitative data.

Ethics and dissemination

Ethical approval was obtained by the Balearic Island Committee Ethics (IB5219/23PI). Study findings, including primary and secondary outcomes and qualitative implementation results, will be disseminated through peer-reviewed publications and stakeholder reports.

Trial registration number

ISRCTN14449434.

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