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Implementing adaptive e-learning for newborn care in Tanzania: an observational study of provider engagement and knowledge gains

Por: Meaney · P. A. · Hokororo · A. · Ndosi · H. · Dahlen · A. · Jacob · T. · Mwanga · J. R. · Kalabamu · F. S. · Joyce · C. L. · Mediratta · R. · Rozenfeld · B. · Berg · M. · Smith · Z. H. · Chami · N. · Mkopi · N. · Mwanga · C. · Diocles · E. · Agweyu · A.
Introduction

To improve healthcare provider knowledge of Tanzanian newborn care guidelines, we developed adaptive Essential and Sick Newborn Care (aESNC), an adaptive e-learning environment. The objectives of this study were to (1) assess implementation success with use of in-person support and nudging strategy and (2) describe baseline provider knowledge and metacognition.

Methods

6-month observational study at one zonal hospital and three health centres in Mwanza, Tanzania. To assess implementation success, we used the Reach, Efficacy, Adoption, Implementation and Maintenance framework and to describe baseline provider knowledge and metacognition we used Howell’s conscious-competence model. Additionally, we explored provider characteristics associated with initial learning completion or persistent activity.

Results

aESNC reached 85% (195/231) of providers: 75 medical, 53 nursing and 21 clinical officers; 110 (56%) were at the zonal hospital and 85 (44%) at health centres. Median clinical experience was 4 years (IQR 1–9) and 45 (23%) had previous in-service training for both newborn essential and sick newborn care. Efficacy was 42% (SD ±17%). Providers averaged 78% (SD ±31%) completion of initial learning and 7% (SD ±11%) of refresher assignments. 130 (67%) providers had ≥1 episode of inactivity >30 day, no episodes were due to lack of internet access. Baseline conscious-competence was 53% (IQR: 38%–63%), unconscious-incompetence 32% (IQR: 23%–42%), conscious-incompetence 7% (IQR: 2%–15%), and unconscious-competence 2% (IQR: 0%–3%). Higher baseline conscious-competence (OR 31.6 (95% CI 5.8 to 183.5)) and being a nursing officer (aOR: 5.6 (95% CI 1.8 to 18.1)), compared with medical officer, were associated with initial learning completion or persistent activity.

Conclusion

aESNC reach was high in a population of frontline providers across diverse levels of care in Tanzania. Use of in-person support and nudging increased reach, initial learning and refresher assignment completion, but refresher assignment completion remains low. Providers were often unaware of knowledge gaps, and lower baseline knowledge may decrease initial learning completion or activity. Further study to identify barriers to adaptive e-learning normalisation is needed.

Analysis of maternal and child health spillover effects in PEPFAR countries

Por: Gaumer · G. · Crown · W. H. · Kates · J. · Luan · Y. · Hariharan · D. · Jordan · M. · Hurley · C. L. · Nandakumar · A.
Objectives

This study examined whether the US President’s Emergency Plan for AIDS Relief (PEPFAR) funding had effects beyond HIV, specifically on several measures of maternal and child health in low-income and middle-income countries (LMICs). The results of previous research on the question of PEPFAR health spillovers have been inconsistent. This study, using a large, multicountry panel data set of 157 LMICs including 90 recipient countries, adds to the literature.

Design

Seven indicators including child and maternal mortality, several child vaccination rates and anaemia among childbearing-age women are important population health indicators. Panel data and difference-in-differences estimators (DID) were used to estimate the impact of the PEPFAR programme from inception in 2004 to 2018 using a comparison group of 67 LMICs. Several different models of baseline (2004) covariates were used to help balance the comparison and treatment groups. Staggered DID was used to estimate impacts since all countries did not start receiving aid at PEPFAR’s inception.

Setting

All 157 LMICs from 1990 to 2018.

Participants

90 LMICs receiving PEPFAR aid and cohorts of those countries, including those required to submit annual country operational plans (COP), other recipient countries (non-COP), and three groupings of countries based on cumulative amount of per capita aid received (high, medium, low).

Interventions

PEPFAR aid to combat the HIV epidemic.

Primary outcome measures

Maternal mortality and child mortality rates, vaccination rates to protect children for diphtheria, whooping cough and tetanus, measles, HepB3, and tetanus, and prevalence of anaemia in women of childbearing age.

Results

Across PEPFAR recipient countries, large, favourable PEPFAR health effects were found for rates of childhood immunisation, child mortality and maternal mortality. These beneficial health effects were large and significant in all segments of PEPFAR recipient countries studied. We also found significant and favourable programme effects on the prevalence of anaemia in women of childbearing age in PEPFAR recipient countries receiving the most intensive financial support from the PEPFAR programme. Other recipient countries did not demonstrate significant effects on anaemia.

Conclusions

This study demonstrated that important health indicators, beyond HIV, have been consistently and favourably influenced by PEPFAR presence. Child and maternal mortality have been substantially reduced, and childhood immunisation rates increased. We also found no evidence of ‘crowding out’ or negative spillovers in these resource-poor countries. These findings add to the body of evidence that PEPFAR has had favourable health effects beyond HIV. The implications of these findings are that foreign aid for health in one area may have favourable health effects in other areas in recipient countries. More research is needed on the influence of the mechanisms at work that create these spillover health effects of PEPFAR.

Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial

Por: Mandetta · A. R. H. · Bortoletto · C. C. · Sobral · A. P. T. · Goncalves · M. L. L. · Motta · L. J. · Horliana · A. C. R. T. · Ferrari · R. A. M. · Prates · R. A. · Deana · A. M. · Cordeiro · R. d. C. L. · Pinto · L. A. M. d. S. · Fernandes · K. P. S. · Bussadori · S. K.
Introduction

Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.

Methods and analysis

Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the 2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

Ethics and dissemination

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.

Trial registration number

NCT05443035.

'Super Rehab: can we achieve coronary artery disease regression? A feasibility study protocol

Por: Graby · J. · Khavandi · A. · Gillison · F. · Smith · T. · Murphy · D. · Peacock · O. · McLeod · H. · Dastidar · A. · Antoniades · C. · Thompson · D. · Rodrigues · J. C. L.
Introduction

Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management.

Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression.

This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting.

Methods and analysis

This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18–75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT.

Ethics and dissemination

Ethics approval was granted by South West—Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications.

Trial registration number

ISRCTN14603929.

ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden--a phase III randomised double-blinded placebo-controll

Por: Rodriguez-Wallberg · K. A. · Nilsson · H. P. · Bergh · J. · Malmros · J. · Ljungman · P. · Foukakis · T. · Stragliotto · C. L. · Friman · E. I. · Linderholm · B. · Valachis · A. · Andersson · A. · Harrysson · S. · Vennström · L. · Frisk · P. · Mörse · H. · Eloranta · S.
Background

Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial.

Methods and analysis

A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14–42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer.

Ethics and dissemination

This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database.

Study registration

The National Institutional review board in Sweden dnr:2021–03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253.

Trial registration number

NCT05328258; EudraCT number:2020-004780-71.

Clinical characteristics and outcomes of patients with post-stroke epilepsy: protocol for an individual patient data meta-analysis from the International Post-stroke Epilepsy Research Repository (IPSERR)

Por: Mishra · N. K. · Kwan · P. · Tanaka · T. · Sunnerhagen · K. S. · Dawson · J. · Zhao · Y. · Misra · S. · Wang · S. · Sharma · V. K. · Mazumder · R. · Funaro · M. C. · Ihara · M. · Nicolo · J.-P. · Liebeskind · D. S. · Yasuda · C. L. · Cendes · F. · Quinn · T. J. · Ge · Z. · Scalzo · F. · Zela
Introduction

Despite significant advances in managing acute stroke and reducing stroke mortality, preventing complications like post-stroke epilepsy (PSE) has seen limited progress. PSE research has been scattered worldwide with varying methodologies and data reporting. To address this, we established the International Post-stroke Epilepsy Research Consortium (IPSERC) to integrate global PSE research efforts. This protocol outlines an individual patient data meta-analysis (IPD-MA) to determine outcomes in patients with post-stroke seizures (PSS) and develop/validate PSE prediction models, comparing them with existing models. This protocol informs about creating the International Post-stroke Epilepsy Research Repository (IPSERR) to support future collaborative research.

Methods and analysis

We utilised a comprehensive search strategy and searched MEDLINE, Embase, PsycInfo, Cochrane, and Web of Science databases until 30 January 2023. We extracted observational studies of stroke patients aged ≥18 years, presenting early or late PSS with data on patient outcome measures, and conducted the risk of bias assessment. We did not apply any restriction based on the date or language of publication. We will invite these study authors and the IPSERC collaborators to contribute IPD to IPSERR. We will review the IPD lodged within IPSERR to identify patients who developed epileptic seizures and those who did not. We will merge the IPD files of individual data and standardise the variables where possible for consistency. We will conduct an IPD-MA to estimate the prognostic value of clinical characteristics in predicting PSE.

Ethics and dissemination

Ethics approval is not required for this study. The results will be published in peer-reviewed journals. This study will contribute to IPSERR, which will be available to researchers for future PSE research projects. It will also serve as a platform to anchor future clinical trials.

Trial registration number

NCT06108102

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