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☐ ☆ ✇ BMJ Open

Spatial distribution of HIV prevalence and associated factors in Guinea: retrospective cross-sectional study using Demographic and Health Surveys (DHS) data from 2012 and 2018

Por: Balde · I. · Toure · A. A. · Abbate · J. L. · Sow · A. · Sow · M. S. · Bangoura · S. T. · Hounmenou · C. G. · Sidibe · S. · Camara · A. · Delamou · A. · Ouattara · C. A. · Dieng · S. · Toure · A. — Marzo 19th 2026 at 15:12
Objectives

In Guinea, around 17 new cases of HIV occurred each day and it was responsible for 10 deaths a day in 2022. In addition to this burden, regional disparities have emerged over the years. This study aimed to describe and explain the uneven distribution of HIV infection in Guinea using spatial analysis.

Design

This is a retrospective cross-sectional secondary analysis using data from the 2012 and 2018 Guinea Demographic and Health Survey (DHS).

Setting

This study was conducted in Guinea.

Participants and methods

We conducted a secondary analysis of data from 300 and 400 enumeration areas, respectively, included in the 2012 and 2018 DHS Program for participants aged 15 to 49 who underwent HIV testing. Spatial analysis methods, including Moran I, interpolation and Kulldorff’s scan statistic, were applied to examine variation and identify high-risk spatial clusters of HIV prevalence rate. The potential relationship between HIV status and socio-demographic, biological, behavioural and socio-environmental explanatory variables was explored using logistic regression at individual level.

Results

In total, 7922 individuals in 2012 and 8539 in 2018 participated in the study. HIV prevalence rate in 2012 and 2018 was 1.9% and 1.5%, respectively. Across Guinea’s 33 prefectures, HIV prevalence rate varied from 0% to 3.9% in 2012 and from 0% to 3.5% in 2018. Spatial analysis identified four significant high-risk spatial clusters in 2012 and one high-risk cluster in 2018. The high-risk clusters in 2012 were in Kissidougou (relative risk (RR)=3.97; p value=0.037), Matam (RR=2.80; p value=0.019), Pita (RR=3.46; p value=0.035) and N’zerekore prefectures (RR=6.08; p value=0.027), the high-risk cluster in 2018 was located in Boffa prefecture (RR=3.95; p value=0.022). Factors significantly and positively associated with HIV infection in 2012 included age class 25–34 (aOR: 2.20; 95% CI 1.40 to 3.47), age class 35–49 (aOR: 2.43; 95% CI 1.51 to 3.92), number of HIV healthcare facilities>30 (aOR: 2.14; 95% CI 1.34 to 3.43). HIV infection was significantly lower in men (aOR: 0.52; 95% CI 0.35 to 0.77). In 2018, in addition to age groups 25–34 years (aOR=1.90; 95% CI 1.18 to 3.04) and 35–49 years (aOR=2.25; 95% CI 1.40 to 3.64), the Soussou ethnicity group (aOR=1.73; 95% CI 1.04 to 2.87) was also positively associated with HIV infection.

Conclusion

This study describes the spatial distribution of HIV prevalence rate and identified high-risk clusters in Guinea. In addition, risk factors associated with HIV status were identified. The information can help prioritise surveillance and response efforts to control HIV in Guinea.

☐ ☆ ✇ BMJ Open

Stimulating amyloid-{beta} clearance in cerebral amyloid angiopathy with low-sodium oxybate and/or non-invasive vagus nerve stimulation (Clear-Brain): study protocol for a randomised pre-post trial

Por: Schriemer · S. E. · Hirschler · L. · van Etten · E. S. · van Zwet · E. W. · Lammers · G. J. · Liebler · E. J. · van Walderveen · M. A. A. · Slats · A. M. · van Es · A. C. G. M. · Verbeek · M. M. · van Osch · M. J. P. · Wermer · M. J. H. · Fronczek · R. — Marzo 11th 2026 at 15:50
Introduction

Cerebral amyloid angiopathy (CAA) is caused by the accumulation of amyloid-beta (Aβ) in the cerebrovasculature. The glymphatic system is thought to be involved in the clearance of cerebral waste products, including Aβ. Stimulation of the glymphatic system through enhancing deep sleep with low-sodium oxybate (LXB) or inhibition of cortical spreading depolarisations via non-invasive vagus nerve stimulation (nVNS) could potentially increase clearance of Aβ and hence improve disease course.

Methods and analysis

We will perform a pre-post trial to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 participants, 30 with sporadic CAA and 30 with Dutch-type CAA, will be randomly assigned to receive either LXB, nVNS or both interventions, resulting in three groups (20 in each group: LXB, nVNS and both). The study spans 6 months, comprising a 3-month observational phase and a 3-month intervention phase. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. We will assess possible disease progression with (non-)haemorrhagic imaging markers on 7-Tesla MRI at baseline, before and after intervention, as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed with CSF-Selective T2-weighted Readout with Acceleration and Mobility encoding (CSF-STREAM) on 7-Tesla MRI.

Ethics and dissemination

The study was reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft (P23.100) on 8 April 2024. The first participant was enrolled on 27 March 2025. Study results will be published in peer-reviewed journals and presented at scientific conferences. Additionally, study updates and results will be shared with participants via our newsletter twice a year.

Trial registration

EU CT number 2023–5 06 128-10-00, Universal Trial Number U1111-1295-1113, ClinicalTrials.gov NCT06421532.

☐ ☆ ✇ BMJ Open

Cognitive and physical exercise to improve outcomes after surgery (COPE-iOS) study: protocol for a randomised, controlled trial in the USA examining the efficacy of a combined cognitive and physical exercise programme performed before and after major surg

Por: Rengel · K. F. · Archer · K. R. · Jackson · J. C. · Raman · R. · Orun · O. M. · Ellison · T. · Vanston · S. W. · Ervin · H. · Lauck · A. · Provin · M. · Pandharipande · P. P. · Hughes · C. G. — Febrero 12th 2026 at 19:06
Introduction

Surgery and its resulting hospitalisation are associated with subsequent cognitive and functional decline. Interventions to reduce this decline have exhibited limited success. Prehabilitation is the process of enhancing capacity and reserve before an acute stressor to improve tolerance of the acute physiologic insult. Older adults requiring major surgery are an ideal population for prehabilitation. Prehabilitation exercise studies have mostly focused on physical training to improve physical outcomes after specific surgery types, and data on cognitive outcomes and in broader surgical populations are needed. Computerised cognitive training (CCT) has been shown to enhance memory, processing speed, attention and multitasking. Combining CCT with a physical exercise may be most effective in reducing cognitive and functional decline in older patients undergoing major surgery, but has yet to be evaluated.

Methods and analysis

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is a randomised, controlled, participant and assessor blinded clinical trial testing the hypothesis that a pragmatic programme combining CCT and physical exercise throughout the perioperative (ie, preoperative and postoperative) period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. The trial aims to randomise 250 patients who undergo major surgery for a treatment period of approximately 1 month prior to surgery and 3 months after surgery, with a follow-up period of 12 months after surgery. The primary outcome is global cognition at 3 months after surgery. Key secondary outcomes include global cognition at 12 months after surgery and disability in activities of daily living and depression at 3 and 12 months after surgery.

Ethics and dissemination

Trial protocol has been approved by Vanderbilt Human Research Protections Programme (#202496) and an independent Data Safety Monitoring Board. Results will be presented at scientific conferences and submitted for publication.

Trial registration number

ClinicalTrials.gov Registry NCT04889417.

☐ ☆ ✇ BMJ Open

Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial

Por: Nunes · S. M. · Rizzo · R. R. · Franco · M. R. · Ferreira · F. R. · Barros · L. J. G. · Maciel · I. T. · Santos · R. L. · Nascimento · R. R. · Couto · A. J. · Quaresma · L. S. · Fontes · R. M. · Ferreira · E. M. R. · Maher · C. G. · McAuley · J. H. · Pinto · R. Z. — Enero 28th 2026 at 14:51
Introduction

Yoga has been shown to improve pain and function compared with no exercise in people with chronic low back pain (LBP), but treatment effects are small. Given that yoga is a mind–body intervention that addresses physical as well as psychological factors, it may be more effective for patients with chronic LBP who are at high risk of poor prognosis. The study aims to investigate the efficacy of a 12-week yoga programme combined with education in reducing pain and disability for individuals with chronic LBP at high risk of poor prognosis at short (12 weeks) and intermediate (24 weeks) terms, compared with a control group receiving education only.

Methods and analysis

A randomised controlled trial will include 110 adults with chronic non-specific LBP reporting an average pain intensity of 3 points or more on a 0–10 scale over the past week and classified as high risk of poor prognosis (ie, scoring 50 points or above) on the Orebro Musculoskeletal Pain Questionnaire short-form. Participants in the control group will receive an educational booklet and attend three face-to-face lectures over a 3-month period. In the intervention group, in addition to the booklet and lectures, participants will attend group yoga sessions twice a week for 12 weeks, totalling 24 yoga sessions. The primary outcome is disability assessed at 12 weeks, measured using the Roland-Morris Disability Questionnaire.

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidade Federal de Minas Gerais (Protocol number CAAE: 57028022.0.0000.5149). Findings will be disseminated to trial participants, clinicians and the broader public and scientific community.

Trial registration number

NCT05953155.

☐ ☆ ✇ BMJ Open

Decisional needs among patients and physicians in the treatment of chronic myeloid leukaemia: a qualitative analysis in the Netherlands

Por: Mingels · S. · Cloots · M. J. J. · Smit · Y. · Blijlevens · N. M. A. · Posthuma · E. F. M. · Dekker · A. L. A. J. · Fijten · R. R. R. · Wener · E. · Kromkamp · C. C. G. — Enero 22nd 2026 at 13:48
Objective

Treatment advancements in chronic myeloid leukaemia (CML) have made the disease manageable but carry significant risk of side effects. Bridging information gaps between patients and physicians through shared decision-making (SDM) is increasingly favoured, yet understanding treatment complexities remains a challenge. This study sought to identify decisional and informational needs of both patients and physicians in CML care.

Design

A qualitative study using semi-structured interviews was conducted to investigate the opinions, attitudes and preferences of both patients with chronic myeloid leukaemia and physicians.

Setting

Patients and physicians were recruited through the Dutch CMyLife platform, an initiative of haematologists, patients and patient organisations. They were provided with the participant information and invited to participate if interested.

Participants

A total of 15 interviews (n=10 patients, n=5 physicians) were conducted between April and October 2023.

Primary and secondary outcome measures

A pre-defined interview guide was developed based on the Decisional Needs Assessment questionnaire. Interview transcripts were thematically analysed.

Results

Eight themes and 28 sub-themes were observed, highlighting patient needs, treatment choices and informational preferences. Patients emphasised the importance of understanding medication options and side effects, while physicians stressed the necessity of delivering up-to-date and comprehensible information. Almost all participants had experienced professionals making the treatment decision, without patient involvement, especially when initiating treatment. Some patients expressed too little information and missed partnership with professionals at treatment onset. Peer support, decision-making dynamics and the role of caregivers were also significant considerations.

Conclusions

Both shared and distinct perspectives on CML treatment decision-making between patients and physicians were revealed, underscoring the complexity of decisional needs in CML management. The findings emphasise the importance of patient-centred care, SDM and tailored communication strategies to optimise patient outcomes and satisfaction. Improved communication and evidence-based decision-making tools can significantly impact patient well-being. Further research and interventions are necessary to address the challenges in decision-making processes in CML care.

☐ ☆ ✇ BMJ Open

Multifactorial approach training for anterior shoulder instability after a Latarjet procedure: protocol for a randomised controlled trial

Por: Soares · M. N. · Shirinskiy · I. J. · Schachner · J. · MATASI collaborator group · M. c. g. · Macken · A. A. · Kling · A. · Lafosse · T. · van den Bekerom · M. P. J. · Buijze · G. A. — Enero 21st 2026 at 14:38
Introduction

The Latarjet procedure is the mainstay treatment in high-demand patients with substantial glenoid bone loss or after failed capsulolabral repairs. Patients typically return to sport (RTS) within 6 months postoperatively, requiring intensive rehabilitation. Current rehabilitation protocols focus on mobility, strength and stability. Yet, psychological factors, such as fear of reinjury, are the main reason not to RTS. Therefore, this study aims to determine whether integrating psychological interventions into postoperative rehabilitation improves patient-reported shoulder function compared with physical therapy alone.

Methods and analysis

This monocentric randomised controlled trial will enrol 52 patients undergoing a Latarjet procedure for anterior shoulder instability. Participants will be equally and randomly assigned to either postoperative physical therapy combined with cognitive behavioural therapy or physical therapy alone. Eligibility criteria include patients aged 18–67 years undergoing an open or arthroscopic Latarjet procedure at our institution. Exclusion criteria include posterior or multidirectional instability, rotator cuff tear, prior shoulder surgery, anxiety disorder, using anxiolytics, neurological disorder, systemic disease, previous hospitalisation for shoulder pain and proximal humerus fractures.

The primary outcome is the Western Ontario Shoulder Index at 6 months postoperatively. Secondary outcomes include incidence of recurrent dislocations, RTS and return-to-work rates, Tampa Scale of Kinesiophobia for Shoulder Instability, subjective shoulder value and visual analogue score for pain at 6 months postoperatively as well as the Shoulder Instability Return to Sport after Injury scale at 4.5 months postoperatively.

Ethics and dissemination

This study was approved by the French Committee of Person Protection West I. The national registration number is 2023-A02057-38. The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. Patients are not financially compensated for participation and are allowed to withdraw from the study at any time without any preconditions. The final results of the study will be submitted for publication in a peer-reviewed journal and an abstract of the study will be submitted to international scientific meetings by the end of 2026. Data will be made available by the corresponding author on reasonable request.

Registration details

The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. The trial sponsor is Vivalto Santé.

Trial registration number

NCT06154889.

☐ ☆ ✇ BMJ Open

UNIversity students LIFEstyle behaviours and Mental health cohort (UNILIFE-M): study protocol of a multicentre, prospective cohort study

Por: Schuch · F. B. · Waclawoscky · A. · Tornquist · D. · Oyeyemi · A. L. · Sadarangani · K. P. · Takano · K. · Teychenne · M. · Balanza-Martinez · V. · ONeil · A. · Romain · A. J. · McGrath · A. · Alselmi · A. · Andrade-Lima · A. · Zanetti · A. C. G. · Trompetero-Gonzalez · A.-C. · Heiss — Enero 12th 2026 at 15:08
Introduction

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

Methods and analysis

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

Ethics and dissemination

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

☐ ☆ ✇ BMJ Open

Neurological immune-related adverse events after ICI treatment: a protocol for an overview of systematic reviews

Por: Erritzoe-Jervild · M. · Riberholt · C. G. · Hougaard · A. · Stenor · C. · Svane · I. M. · Kruuse · C. · Olsen · M. H. — Noviembre 25th 2025 at 06:15
Introduction

Immune checkpoint inhibitors (ICIs) have become an important treatment option for selected cancer patients in recent years. In this overview of systematic reviews, we aim to present a comprehensive summary of the evidence on neurological immune-related adverse events (irAEs) in patients treated with ICIs.

Methods and analysis

The overview will follow the preferred reporting items for overview of reviews statement. All systematic reviews reporting on neurological irAEs in adult patients treated with ICIs will be included. We will search PubMed, EMBASE and Cochrane’s Database of Systematic Reviews. Two authors will independently screen studies and extract data, with disagreements resolved by discussion or a third reviewer. Methodological quality will be assessed using AMSTAR-2. We will assess overlap by identifying shared primary studies and summarising their frequency in a table. Data will be presented narratively and in tables; when possible, frequencies of neurological irAEs and weighted means, along with associated distributions, will be reported.

Ethics and dissemination

As this study involves secondary analysis of published literature and does not include primary data collection, ethical approval is not required. Findings will be disseminated through peer-reviewed publications.

PROSPERO registration number

CRD420251020892.

☐ ☆ ✇ BMJ Open

Long-term effects of psychotherapy in children and adolescents: protocol for database development and a systematic review in the LaKiJu META project

Por: Schäfer · S. K. · Burmeister · C. F. · Lottermoser · E. · Schäfer · C. G. · Cascant Ortolano · L. · Stoffers-Winterling · J. · Flasinksi · T. · Equit · M. · Schneider · S. · Lieb · K. · de Haan · A. — Noviembre 20th 2025 at 07:42
Introduction

Approximately one in every six children and adolescents is affected by mental disorders, which impose significant costs on patients, their families and societies. Psychotherapy is the first-line treatment for many of these disorders, and systematic reviews of post-intervention effects show small to moderate favourable outcomes compared with control groups. However, the long-term effects of psychotherapy remain less well understood.

Methods and analysis

The LaKiJu META project aims to address this gap by developing an open-access database, which will subsequently be used for data synthesis. This database will be established through literature searches in nine databases for (cluster) randomised controlled trials (RCTs) investigating the long-term effects (≥6 months) of any type of psychotherapy in school-aged children and adolescents (ages 6;00 to 17;11 years) with mental disorders. Outcomes will be prioritised based on their relevance to patients, caregivers and clinicians and will encompass a broad range of measures, including symptom changes, response rates and reliable changes. Syntheses will use multilevel meta-analyses to compare intervention and control groups at follow-up assessments, across both transdiagnostic and disorder-specific symptom outcomes. In secondary analyses, we will examine changes within intervention groups over time. Moderator analyses will focus on the effects of study-, intervention- and patient-level characteristics.

Ethics and dissemination

Ethical approval for public involvement was obtained from the ethics committee of the Faculty of Psychology of the Ruhr University Bochum. For dissemination, we will employ tailored strategies to reach researchers, clinicians, patients and their caregivers, with all groups involved in the development of dissemination plans.

PROSPERO registration number

CRD420251003208 (preregistered on 10 March 2025).

☐ ☆ ✇ BMJ Open

Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol

Por: Cirisola · R. W. C. · Moya · L. E. P. · Olazabal · M. V. G. · Wagmann · D. A. A. · Suarez · G. P. · Wince · C. · Bruno · M. L. H. · Salaberry · D. R. · Sobral · A. P. T. · Longo · P. L. · Motta · L. J. · Bussadori · S. K. · Duran · C. C. G. · Fernandes · K. P. S. · Mesquita-Ferrari — Noviembre 11th 2025 at 10:50
Introduction

Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.

Methods and analysis

A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.

Trial registration number

NCT05935306.

☐ ☆ ✇ BMJ Open

Transcranial direct current stimulation combined with physical exercise in knee osteoarthritis: a protocol for a randomised controlled clinical trial

Por: Lima · V. B. · Silva · C. A. M. · Silva · S. G. D. d. · Macedo · L. d. B. · de Souza · M. C. · Lins · C. A. d. A. · de Souza · C. G. — Septiembre 5th 2025 at 13:49
Introduction

Osteoarthritis (OA) is a degenerative and progressive joint condition causing pain and disability. Physical exercise is recognised as the most effective intervention since individuals with this condition often experience muscle weakness, balance deficits and chronic pain. Additionally, knee osteoarthritis (KOA) is associated with central sensitisation, contributing to chronic pain conditions. Transcranial Direct Current Stimulation (tDCS), a non-invasive neuromodulation technique, has been employed to induce changes in pain perception by altering cortical excitability, potentially reducing chronic pain.

Methods and analysis

This is a protocol for a randomised controlled trial. Participants will be allocated to two groups: G1 (active tDCS combined with exercise) and G2 (sham tDCS combined with exercise). The intervention protocol will last for 5 weeks, with two sessions per week on non-consecutive days. Pain intensity will be assessed as the primary outcome using the Numeric Rating Scale (NRS). The sample size was calculated based on a minimum clinically important difference of 3 points on the NRS between groups, with a statistical power of 80% and a significance level of 5%. Secondary outcomes will include physical function and global perceived change.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Trairi School of Health Sciences, Federal University of Rio Grande do Norte (Approval Number: 6.801.827), and it is in accordance with the Declaration of Helsinki for human research. Results will be published in peer-reviewed journals and presented at scientific events. This trial is registered in the Brazilian Clinical Trials Registry.

Trial registration number

Brazilian Clinical Trials Registry (RBR-5pb2g33).

☐ ☆ ✇ BMJ Open

Time-lapse imaging systems for embryo incubation and assessment to improve reproductive outcomes in women undergoing in vitro fertilisation: study protocol for an individual participant data meta-analysis of randomised controlled trials

Por: Bhide · P. · Chan · D. Y. L. · Ahlström · A. · del Campo · L. · Kieslinger · D. · Lundin · K. · Park · H. · Fauque · P. · Kahraman · S. · Khan · K. S. · Kovacs · P. · Lambalk · C. B. · Thangaratinam · S. · Vergouw · C. G. · van Wely · M. · Zamora · J. — Julio 29th 2025 at 06:15
Introduction

Time-lapse imaging (TLI) systems for embryo incubation and assessment are hypothesised to improve the success rates of in vitro fertilisation (IVF) treatment by providing undisturbed culture conditions for embryos and/or providing more information on embryo development (morphokinetic parameters) to improve predictive accuracy for embryo selection. Despite numerous aggregate meta-analyses showing uncertainty of benefit, IVF clinics globally continue to invest significant resources into this technology with little translation of evidence into guidelines or policy frameworks. This may be attributed to heterogeneity in participant populations and/or variations in the use of TLI, as highlighted in the aggregate meta-analyses.

Methods and analysis

Our research proposal for evidence synthesis using individual participant data meta-analysis will provide greater power than aggregate meta-analysis to detect differential treatment effects for effectiveness (live birth, clinical pregnancy) and safety (pregnancy loss, multiple births, congenital malformations) outcomes across three comparisons (overall effect, undisturbed culture and morphokinetic parameters). We will also analyse if there are specific subgroups of women who may benefit from the intervention and if variations in use of the intervention show any benefits. We have incorporated the results of the literature search used for the latest Cochrane review (7 January 2019) into this review and will include all the trials included therein. We will further update the literature search to include new evidence by searching the electronic databases MEDLINE, EMBASE, CINAHL and CENTRAL from 07/01/2019 to date, outcomes for all ongoing trials reported in the 2019 Cochrane review, trial registers for newer ongoing/completed trials and the citation lists of all the newly identified trials for any relevant references. The search strategy will include a combination of subject headings and text words relating to or describing the participants and the intervention, with no language restrictions. Two authors will independently screen the titles and abstracts, and full text of articles retrieved from the search, to finalise a list of trials suitable for inclusion in the review. We will include randomised controlled trials that assess TLI systems for either undisturbed culture and/or use of morphokinetic parameters for embryo selection in women having IVF/ICSI treatment using their own oocytes.

Ethics and dissemination

Ethical approval is not required for this study. We plan to disseminate the findings of the research to all stakeholders, including the National Institute for Health and Care Excellence and other international guideline development groups, through publication in peer-reviewed journals, presentation at conferences, newsletters, meetings and websites of the funders, fertility charities and patient support groups.

PROSPERO registration number

CRD42024564332.

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