Publications

29

Jul, 2021

Effect of dolutegravir on folate and vitamin B12 status among HIV- infected children and adolescents in the ODYSSEY trial

 

Authors: L. Barlow-Mosha, G. Ahimbisibwe, E. Chappell, P.M. Amuge, A. Nanduudu, E. Kaudha, T. Amukele, D. Balamusani, B. Kafufu, A. Nimwesiga, C. Kityo, A.R Kekitiinwa, R. Namwanje, G. Kasangaki, A. Mulindwa, G.A. Muzorah, D. Bbuye, M. Nolan, C. Giaquinto, D.M Gibb, D. Ford, P. Musoke, A. Turkova, The ODYSSEY Trial Team

Published in: IAS 2021

 

Abstract

Background: Neural tube defects (NTDs) are known to be associated with maternal folate and vitamin B12 deficiency, and initial surveillance studies suggested an increased risk of NTDs among infants conceived by women taking dolutegravir (DTG). We, therefore, compared folate and vitamin B12 levels among HIV-infected children aged 6-<18 years starting first- or second-line DTG-based antiretroviral treatment (ART) versus Standard of Care (SOC) at 3 Ugandan sites in the ODYSSEY trial.

Methods: Plasma folate was measured on stored samples at baseline and 4 weeks. Red blood cell (RBC) folate and vitamin B12 levels were measured using samples collected prospectively at ≥96 weeks. Samples were analysed in one laboratory using Elecys assays. Normal regression was used to compare change in plasma folate from baseline to 4 weeks (adjusted for baseline) and cross-sectional RBC folate and vitamin B12 between randomised arms, adjusting for site, sample date, first-/ second-line ART and randomisation stratification factors

Results: 229 children ≥6 years were randomised; 51% female, median(IQR) age was 12.3 years (9.0,14.7), CD4  501cells/mm3  (228,795); 67% started second-line ART; 114 started DTG, 115 started SOC (40% lopinavir/ritonavir-, 37% efavarinez-, 23% atazanavir/ritonavir-based ART). By 4 weeks, mean plasma folate was higher in DTG arm versus SOC (difference (DTG-SOC) 1.6 ng/mL; 95%CI 0.8, 2.3; p<0.01). At week ≥96, mean RBC folate was higher in the DTG arm vs SOC (difference 73 ng/mL; 95%CI 3, 143; p=0.04). Plasma and RBC folate levels varied by site, but there was no evidence for heterogeneity of treatment effects (Table). Vitamin B12 levels were similar between arms (p=0.42). 

Conclusions: We found no evidence that DTG-based ART was associated with decreased levels of plasma folate or RBC folate; levels were higher than on NNRTI-/PI-based ART though the mechanism is unclear. Vitamin B12 levels were similar in both arms. These results suggest any increased risk of NTDs in infants conceived on DTG is unlikely to be due to DTG causing decreased folate and vitamin B12 levels.   

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29

Jul, 2021

Dolutegravir-Based ART is Superior to Standard of Care in Young Children Living With HIV

 

Authors: P Amuge on behalf of the ODYSSEY trial team

Published in: International workshop on HIV pediatrics 2021

 

Abstract

Background: ODYSSEY, a multi-country randomised trial, demonstrated superior treatment efficacy for dolutegravir (DTG) plus two NRTIs versus standard-ofcare (SOC) in 707 children ≥14kg (median age 12 years) starting first- or second-line ART. We report results for an additional cohort of 85 children <14kg, who completed 96 weeks follow-up on 28th June 2021. 

Methods: The primary outcome is a Kaplan-Meier (KM) estimated proportion of treatment failure defined as confirmed viral load (VL) ≥400c/mL after week 36, lack of virological response by 24 weeks with ART switch for failure, death, or new/recurrent WHO 4 or severe WHO 3 event by 96 weeks. Bayesian estimation was pre-specified as the primary analysis of participants <14kg, incorporating evidence obtained from the ≥14kg participants as a prior distribution, with relative weight 78%, based on clinical opinion elicited before availability of results for children ≥14kg. Results: 85 children <14kg were randomised (Uganda 43, Zimbabwe 22, South Africa 20); 42 to DTG and 43 to SOC. Median (range) age was 1.4 years (0.1-5.9); 23 were 3-<6kg, 40 were 6-<10kg and 22 were 10-<14kg. 72 children started first-line (29/37 PI-based among SOC); 13 second-line (3/6 PI-, 2 raltegravir- and 1 nevirapine-based among SOC). Median (IQR) followup was 120 (97-132) weeks; 5 (6%) children were lost to follow-up. 11 children in the DTG arm had treatment failure by 96 weeks (K-M estimated proportion 28%) vs 21 (48%) SOC; 8 vs. 16 failures were virological. 8 (25%) DTG vs 17 (46%) SOC failed on first line; 3 (48%) vs 4 (60%) failed on second-line. The Bayesian estimated difference in treatment failure (DTG-SOC) in participants <14kg was -11% (95% CI -19%, -2%; P=0.02). A standalone analysis of the <14kg cohort provided an estimated difference in treatment failure of -20% (95% CI -38%, -1%; P=0.04). At 96 weeks, 77% of children in the DTG arm had VL<50c/mL compared with 50% in SOC (P=0.02); corresponding proportions with VL<400c/mL were 91% vs. 71% (P=0.03). There were 15 SAEs (11 children) in the DTG arm versus 19 (11 children) in SOC (P=0.92, comparing children), including 2 versus 4 deaths; 36 (19 children) had grade ≥3 adverse events in DTG vs 34 (21 children) in SOC (p=0.79). In the DTG arm, 41/42 children remained on DTG at last visit, with no changes to NRTI backbone; 1 child in DTG stopped ART 3 weeks post enrolment and withdrew 2 weeks later. In the SOC arm, 37/43 children remained on their initial treatment regimen at last visit; changes included 4 children who switched ART due to treatment failure.

Conclusions: DTG-based ART was superior to SOC (predominantly PI-based) in young children starting first or second-line, judged on treatment failure by 96 weeks. The treatment benefit for DTG in the <14kg cohort was consistent with that observed in children enrolled ≥14kg. There were no safety concerns on DTG. These results strongly support WHO guidelines recommending DTG-based regimens for young children and provide impetus for rapid procurement of dispersible dolutegravir.

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29

Jul, 2021

Weight Gain in Children and Adolescents on Dolutegravir vs Standard-of-Care in the ODYSSEY Trial

 

Authors: Mujuru H , Lugemwa A, Puthanakit T, Amuge P, Kityo C, Compagnucci A, Variava E, Kekitiinwa A, Musiime V, BarlowMosha L, Ngampiyaskul C, Zuidewind P, Tumusiime J, Mngqbisa R, Kaudha E, Behuhuma N, Kataike H, Musoro G, Nandudu A, Bwakura M, Ahimbisibwe G, Ounchanum P, Mulindwa A, Nazzinda R, Ssenyonga M, Kanjanavanit S, Nathoo K, Makumbi S, Danaviah S, Nakabuye S, Chalermpantmetagul S, Rutebarika D, Nalusiba S, Srirompotong U, Ali S, Wynne B, Riault Y, Welch S, Cressey T, Violari A, Giaquinto C, Rojo P, Gibb D, Ford D, Turkova A

Published in: IAS 2021 and International Workshop on HIV Pediatrics 2021

 

Abstract:

Background: Dolutegravir is associated with excessive weight gain in adults. We present the first randomised data in children and adolescents.

Methods: ODYSSEY is a randomised multi-country trial evaluating dolutegravir (DTG) + 2NRTIs versus standard-of-care (SOC) in children starting first or second-line ART. We compared weight, height and BMI-for-age Z-scores (BAZ) between treatment arms using normal regression models adjusting for first- /second-line, randomisation stratification factors and baseline measurements. Proportions becoming newly overweight (BAZ>1-≤2) or newly obese (BAZ>2) are described. 

Results: 707 children were randomised (sub-Saharan Africa 88%, Thailand 9%, Europe 4%); 311 started first-line (80% ABC/3TC, 19% TDF/3TC(FTC); 92% efavirenz-based in SOC); 396 second-line (54% ABC/3TC, 26% TDF/3TC(FTC); 72% lopinavir/ritonavir in SOC); 49% were female. At baseline, median age (IQR; range) was 12.2 (9.1, 14.9; 2.9-18.0) years; weight (IQR) 31(23, 43)kg, height 138(125, 153)cm, BMI 16.3(14.9, 18.5)kg/m2, BAZ -0.6(-1.4, 0.1); 11% had WHO-defined severe thinness/thinness, 5% were overweight, 1% obese; 50% were pubertal/postpubertal. Median follow-up was 142(124, 159) weeks. Weight, height and BAZ increased more in DTG than SOC with adjusted difference in means (DTG-SOC) at 96 weeks of 1kg (95%CI 0.3, 1.7; p=0.004), 0.8cm (95%CI 0.2, 1.4; p=0.007) and 0.14 Z-score (95%CI 0.02, 0.26; p=0.018) respectively. Early differences between groups stabilised. Treatment differences at 96 weeks in BAZ were similar in males and females (heterogeneity p=0.42), children aged <12 and ≥12 years (p=0.95), prepubertal and pubertal/postpubertal participants (p=0.54), participants starting first- and second-line ART (p=0.746), and those starting TDF vs other (p=0.61). Findings were similar for weight and height. Overall, 14(4%) children/adolescents in DTG and 9(3%) in SOC were newly overweight or obese at 96 weeks (p=0.29). 

Conclusions: Children grew better after starting DTG. Small differences between arms in weight, height and BMI stabilized before 2 years, with few becoming newly overweight/ obese in either arm. DTG-based ART was not associated with excessive weight gain in children and adolescents.

View International Workshop on HIV Pediatrics abstract book

29

Jul, 2021

A randomised comparison of DTG-based ART vs Standard of Care in infants and young children living with HIV weighing 3 to 14kg: results from the ODYSSEY trial

 

Authors: A Lugemwa, H Mujuru, B Wynne, A Violari, AR Kekitiinwa, CM Kity, M Archary, E Variava, T Sarfati, C Shakeshaft, R Turner, K Nathoo, E Chidziva, L Atwine, N Ramsagar, A Liberty, P Amuge, E Kaudha, A Nanduudu, R Mngqibisa, R Mosia, MF Cotton, TR Cressey, T Puthanakit, A Compagnucci, C Giaquinto, P Rojo, D Ford, DM Gibb, A Turkova, the ODYSSEY trial team

Published in: IAS 2021

 

Abstract

Background:  Dolutegravir is associated with neuropsychiatric adverse events (NPAEs) in adults. We present first randomised data in children and adolescents.

Methods: ODYSSEY is an open-label, multi-centre, randomised trial, comparing efficacy and safety of dolutegravir-based ART(DTG) with standard of care (SOC) in children initiating first- or second-line therapy.   We compared NPAEs, including serious adverse events (SAEs), grade ≥3 events, ART-modifying events and suicidality-related events, and patient/carer mood-and-sleep questionnaire responses in DTG versus SOC.

Results: 707 children ≥14kg were randomised (sub-Saharan Africa 88%, Thailand 9%, Europe 4%); 311 children started first-line (92% efavirenzbased in SOC); 396 second-line(98% PI-based). Median(IQR) age was 12.2 (9.1,14.9); 362 (51%) were male; median follow-up 142 (124,159) weeks. There were 31 NPAEs (in 23 children): 18 (15) in DTG vs 13 (8) in SOC (Table). Median (IQR) age and time from enrolment at first event were 15.9 (10.4,17.5) years and 72 (47,124) weeks respectively. Most NPAEs (23) were in children starting first-line; and most (22) occurred in males. Ten participants (5 DTG;5 SOC) had 13 SAEs: 7 DTG (3 epilepsy/convulsions, 1 headache/hypertension, 1 depression, 1 parasuicide, 1 psychosis) vs 6 SOC (3 epilepsy/convulsions, 1 dizziness, 2 parasuicide). 12 children (8 DTG;4 SOC) experienced 15 suicidality events: 10 suicidality ideation (6 DTG;4 SOC) and 5 parasuicide (2 DTG;3 SOC). ART-modifying NPAE(s) included 3 DTG (2 depression, 1 psychosis) and 2 SOC (1 parasuicide, 1 dizziness). Small number of participants/carers reported symptoms of self-harm (8 DTG;1 SOC, p=0.04), “life was not worth living” (17 DTG; 5 SOC, p=0.009) or suicidal thoughts (13 DTG; 0 SOC, p<0.001) in mood-and-sleep questionnaires; the reported symptoms were transient and did not lead to treatment change. There were no differences between treatment groups in low mood/feeling sad, problems concentrating, feeling worried or feeling angry/aggressive, time to fall asleep, nightmares/ vivid dreams or sleep quality.

Conclusions:  Numbers of NPAEs and reported neuropsychiatric symptoms were low. More participants reported neuropsychiatric symptoms in the DTG arm vs SOC, however this difference should be interpreted with caution in an open-label trial.

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29

Jul, 2021

Virological failures and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care in the ODYSSEY trial

 

Authors: C. Kityo, E. White, A. Turkova, H.A Mujuru, I. Nankya, B. Wynne, S. Ali, A. Kekitiinwa, A. Lugemwa, E. Kaudha, A. Liberty, H. Cassim, M. Archary, M. Cotton, L. Barlow-Mosha, T.R Cressey, C. Ngampiyasakul, U. Srirompotong, O. Behuhuma, Y. Saidi, A. Bamford, R. Kobbe, P. Rojo, C. Giaquinto, D. Gibb, D. Ford

Published in: IAS 2021

 

Abstract

Background: ODYSSEY demonstrated superiority of dolutegravir (DTG) based ART versus standard-of-care (SOC) in children ≥14kg starting first- or second-line. We evaluate drug resistance by 96 weeks.

Methods: Virological failure (VF) was defined as confirmed viral load (VL)≥400c/mL after week 36 or lack of virological response at week 24 with ART switch. Children with VF were tested for post-failure resistance (major IAS mutation); if resistance was identified, a baseline sample was sequenced. The proportion with emergent resistance post-failure was estimated in those exposed to each drug class in ODYSSEY.

Results: 311 children started first-line ART (154 DTG,157 SOC[92% efavirenz]) and 396 second-line (196 DTG,200 SOC[72% lopinavir/r,25% atazanavir/r]). On first-line, 11(7%) DTG vs 30(19%) SOC experienced VF by 96 weeks, and on second-line, 31(16%) DTG vs 40(20%) SOC. First-line: no new DTG or NRTI resistance on first-line DTG versus estimated 62% and 88% children with new NRTI and NNRTI resistance respectively among failures in SOC (Table). Second-line: no new resistance to NRTIs on DTG vs estimated 9% among failures in SOC. One child (estimated 3%) with VF on PIs had new PI resistance and two children (100%on NNRTIs had new NNRTI resistance. 4(18%) with VF on DTG had INSTI mutations.

Conclusion: ODYSSEY demonstrated that DTG has a high genetic resistance barrier and prevents emergent resistance to NRTIs in children. We identified no post-failure resistance on first-line DTG, significantly less than first-line SOC. On second-line DTG, there was no new NRTI resistance, however 4 children developed new INSTI resistance, highlighting the need for ongoing adherence support among children.

 

Table: Genotypic resistance in the ODYSSEY trial

First-line Second-line
DTG SOC DTG vs. SOC DTG SOC DTG vs. SOC

 

Children with resistance post-failureƪ 

 

NRTI 0/11 0% 18/29 62% p<0.001 20/28 71% 28/39 72% P=0.97
NNRTI 0/11 0% 27/29 93% p<0.001 21/28 75% 35/39 90% p=0.18
PI 0/11 0% 0/29 0% 2/28 7% 2/39 5% p=1.00
INSTI 0/10 0% 4/22 18%

 

Children and estimated proportion with emergent resistance post-failure~

 

NRTI 0 0% 13 62% 0 0% 3 9%
NNRTI 18 88% 2 100%
PI 1 3%
INSTI 0 0% 4 18%

 

ƪPost-failure resistance up to week 96, using the latest sample with VL≥1000c/mL after VF and prior to ART switch. % with resistance post-failure, of those with post-failure resistance test available

~Among those with VF and exposed to drug-class, estimated assuming same proportion of new resistance in those with and without available baseline test

 

29

Jul, 2021

Increasing burden of viral bronchiolitis in the pediatric intensive care unit; an observational study

 

Authors: RS. Linssen, AC. Teirlinck, Mv Boven, D Biarent, L Stona, A Amigoni, RI. Comoretto, S Leteurtre , A Bruandet, GK. Bentsen, IM Drage, X Wang, H Campbell, JBM. van Woensel, L Bont, RA. Bem

Published in: Journal of critical care

 

Abstract

Purpose: Viral bronchiolitis is a major cause of pediatric intensive care unit (PICU) admission. Insight in the trends of bronchiolitis-associated PICU admissions is limited, but imperative for future PICU resource and capacity planning.

Materials and methods: We retrospectively studied trends in PICU admissions for bronchiolitis in six European sites, including three full national registries, between 2000 and 2019 and calculated population-based estimates per 100,000 children where appropriate. Information concerning risk factors for severe disease and use of invasive mechanical ventilation was also collected when available.

Results: In total, there were 15,606 PICU admissions for bronchiolitis. We observed an increase in the annual number, rate and estimates per 100,000 children of PICU admissions for bronchiolitis at all sites over the last two decades, while the proportion of patients at high risk for severe disease remained relatively stable.

Conclusions: The international increased burden of bronchiolitis for the PICU is concerning, and warrants further international attention and investigation.

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20

Jul, 2021

Global estimates of the relative pediatric consumption and cost of oral amoxicillin and amoxicillin plus clavulanic acid

 

Authors: G. A. Levine, M. Sharland, S. Ellis, Y. Ferrisse, C. Loze, Y. Hsia, G. Fink, J. Bielicki; for the PediCAP project

Published in: ECCMID 2021

 

Abstract

Background: Amoxicillin and co-amoxiclav are commonly used antibiotics for community-acquired infections in young children. Both are classified as Access antibiotics for pediatric respiratory infections in the WHO EMLc. Despite higher cost, robust data to support the additional clinical benefit of co-amoxiclav in primary care settings are lacking. Relative consumption and their economic implications globally are unknown.

Materials/Methods: We estimated consumption and costs of oral amoxicillin and co-amoxiclav for young children and identified variations across countries. 2015 IQVIA-MIDAS antibiotic wholesale data for 75 low-, lower-middle-, upper-middle- and high-income countries/regions were used to determine sales volume of all child-appropriate formulations (CAF). Value was estimated by applying 2015 median global buyer prices from the International Medical Products Price Guide. We estimated value and consumption in standard units (SU) (single tablet/capsule solid or 5 mL liquid preparation) per child-year for each country using United Nations Population data annual population estimates. Cost and consumption estimates for each World Bank income group were applied to the size of the pediatric population not represented in IQVIA to estimate total global consumption and costs. We modelled cost savings compared with 2015 observed estimates under different plausible scenarios.

Results: CAFs of amoxicillin and co-amoxiclav had estimated global sales values of 171 million and 540 million USD in 2015, respectively. Co-amoxiclav accounted for 45.8% of consumption and 75.5% of sales value. Co-amoxiclav consumption ranged from 3.3% (Norway) to 99.7% (Kuwait) of the two antibiotics. The median consumption was 11.6 SUs of amoxicillin (IQR 3.5- 20.5) and 8.2 SUs of co-amoxiclav per child-year (IQR: 3.2, 16.0). 71 million USD (10% reduction) could be saved if all amoxicillin consumption was in solid rather than liquid formulations. Targeting co-amoxiclav use to a maximum of 10% of combined use would save approximately 219 million USD (38% reduction).

Conclusions: Co-amoxiclav use is very common in some countries and accounts for a disproportionate fraction of cost, relative to consumption. Estimates represent wholesale purchases specifically and are only a fraction of total cost and consumption. Large efficiency gains seem feasible by encouraging amoxicillin for treating non-severe infections and limiting co-amoxiclav use to target severe infections.

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19

Jul, 2021

Once daily integrase inhibitor (INSTI) with boosted darunavir is non-inferior to standard of care in virologically suppressed children – Week 48 results of the SMILE Penta-17 Trial

 

Authors: Compagnucci A, Chan M, Saïdi Y, Cressey T, Bamford A, Riault Y, Coelho A, Nolan A, Chalermpantmetagul S, Amuge P, Musiime V, Violari A, Cotton M, Kekitiinwa A, Kaudha E,Groenewald M, Liberty A, Kanjanavanit S, Volokha A, Bologna R, Pavia Ruz N, Prieto Tato L, Paioni P, Marques L, Reliquet V, Welch S, Ford D, Giaquinto C, Gibb D, Babiker A, Ramos Amador JT, The SMILE-PENTA17-ANRS 152 Trial Group

Presented at: IAS 2021

 

Abstract

Background and overall aim: Current antiretroviral therapy (ART) guidelines recommend triple-drug ART as treatment of choice in HIV-infected adolescents and children with NRTI as backbone. However, NRTIs can be a potent source of adverse effects which are usually dose-related and cumulative. To reduce cumulative NRTI exposure in children, alternative NRTI-sparing ART regimens with a high generic barrier to resistance are available and may be an attractive switching option for children. The overall aim of SMILE is to evaluate antiviral efficacy and safety of once daily INSTI+DRV/r compared to current SOC therapy in HIV-1 infected, virologically suppressed paediatric participants.

Hypothesis: Children with chronic HIV infection on ART with suppressed viral load will maintain similar levels of viral suppression with once daily INSTI + DRV/r compared to continued standard of care triple ART.

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19

Jul, 2021

Once-Daily Integrase Inhibitor (Insti) With Boosted Darunavir is Non- Inferior to Standard of Care in Virogically Suppressed Children, Week 48 Results of the SMILE PENTA-17 Trial

 

Authors: Compagnucci A , Chan M , Saïdi Y , Cressey T , Bamford A , Riault Y , Coelho A , Nolan A ,Chalermpantmetagul S , Amuge P , Musiime V , Violari A , Cotton M , Kekitiinwa A , Kaudha E , Groenewald M, Liberty A , Kanjanavanit S , Volokha A , Bologna R , Muñoz Hernández R , Fortuny-Guasch C , Paioni P , Marques L , Reliquet V , Welch S , Ford D , Giaquinto C , Gibb D , Babiker A , Ramos Amador J and The SMILE-PENTA17-ANRS 152 Trial Group

Published in: International Workshop of HIV Pediatrics 2021

 

Abstract

Background:
– Children start ART very early and for life – Can we reduce number of drugs (sparing NRTIs)?
– Drugs with high genetic barrier to resistance are available for children

Overall Aim: To evaluate antiviral efficacy and safety of once daily INSTI+DRV/r compared to current SOC therapy in HIV-1 infected, virologically suppressed paediatric participants

Hypothesis: Children with chronic HIV infection on ART with suppressed viral load will maintain similar levels of suppression with once daily INSTI + darunavir/r compared to continued standard of care triple ART

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16

Jul, 2021

Measuring research capacity development in healthcare workers: a systematic review

Tags:

Authors: D Bilardi, E Rapa, S Bernays, T Lang

Published in: BMJ open

 

Abstract

Objectives A key barrier in supporting health research capacity development (HRCD) is the lack of empirical measurement of competencies to assess skills and identify gaps in research activities. An effective tool to measure HRCD in healthcare workers would help inform teams to undertake more locally led research. The objective of this systematic review is to identify tools measuring healthcare workers’ individual capacities to conduct research.

Design Systematic review and narrative synthesis using Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist for reporting systematic reviews and narrative synthesis and the Critical Appraisals Skills Programme (CASP) checklist for qualitative studies.

Data sources 11 databases were searched from inception to 16 January 2020. The first 10 pages of Google Scholar results were also screened.

Eligibility criteria We included papers describing the use of tools/to measure/assess HRCD at an individual level among healthcare workers involved in research. Qualitative, mixed and quantitative methods were all eligible. Search was limited to English language only. Data extraction and synthesis Two authors independently screened and reviewed studies using Covidence software, and performed quality assessments using the extraction log validated against the CASP qualitative checklist. The content method was used to define a narrative synthesis.

Results The titles and abstracts for 7474 unique records were screened and the full texts of 178 references were reviewed. 16 papers were selected: 7 quantitative studies; 1 qualitative study; 5 mixed methods studies; and 3 studies describing the creation of a tool. Tools with different levels of accuracy in measuring HRCD in healthcare workers at the individual level were described. The Research Capacity and Culture tool and the ‘Research Spider’ tool were the most commonly defined. Other tools designed for ad hoc interventions with good generalisability potential were identified. Three papers described health research core competency frameworks. All tools measured HRCD in healthcare workers at an individual level with the majority adding a measurement at the team/organisational level, or data about perceived barriers and motivators for conducting health research. Conclusions Capacity building is commonly identified with pre/postintervention evaluations without using a specific tool. This shows the need for a clear distinction between measuring the outcomes of training activities in a team/organisation, and effective actions promoting HRCD. This review highlights the lack of globally applicable comprehensive tools to provide comparable, standardised and consistent measurements of research competencies.

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