To test the agreement and usability of a novel quality appraisal tool: A MeaSurement Tool to Assess systematic Reviews of Prognostic Factor studies (AMSTAR-PF).
Observational study.
14 appraisers of varied experience levels and backgrounds, including undergraduate, master’s and PhD students, postgraduate researchers, research fellows and clinicians.
Eight systematic reviews were rated by all reviewers using AMSTAR-PF.
Planned measures included intrapair and inter-pair agreement using Cohen’s and Fleiss’ kappa, time of use and time to reach consensus. Interrater agreement was an added measure, and Gwet’s agreement coefficient was calculated and presented due to its greater stability across agreement levels. The percentage of intrapair agreements identical or one category apart was also presented.
Interrater agreement averaged 0.59 (range 0.21–0.90), inter-pair agreement 0.61 (range 0.24–0.91) and intrapair agreement 0.75 (range 0.45–0.95) across the domains, with agreement for the overall rating 0.46 (95% CI 0.30 to 0.62) for interrater agreement, 0.46 (95% CI 0.17 to 0.74) for inter-pair agreement and 0.68 (range of averages 0.22–1.00) for intrapair agreement. The majority (60.7%) of intrapair ratings were identical, with 94.6% of final ratings either identical or only one category different for the overall appraisal. The time taken to appraise a study with AMSTAR-PF improved with use and averaged around 34 min after the first two appraisals.
Despite some variance in agreement for different domains and between different appraisers, the testing results suggest that AMSTAR-PF has clear utility for appraising the quality of systematic reviews of prognostic factor studies.
Overweight and obesity impacts approximately 50% of pregnant women. Professional medical colleges worldwide recommend women with a higher body mass index (BMI) lose weight before conception. While diet and lifestyle interventions before pregnancy are associated with improvements in diet and modest weight loss, subsequent clinical pregnancy outcomes are poorly reported.
Our aim is to conduct a randomised controlled trial of a comprehensive lifestyle intervention for women with overweight or obesity who are planning pregnancy. We will evaluate the impact of this intervention on maternal health and well-being prior to conception; and pregnancy, birth and newborn health outcomes in a subsequent pregnancy.
Women with a BMI ≥25.0 kg/m2 who plan to conceive within 2 years will be recruited.
Women randomised to the ‘Educational Control Group’ will attend a pre-conception health consultation with a research midwife, providing limited information about obesity and associated risks in pregnancy, nutrition, exercise and weight management.
Women randomised to the ‘Pre-pregnancy Lifestyle Intervention Group’ will attend a pre-conception health consultation with a research midwife, as above, and additionally consult with a research dietitian and trained health coaches throughout the 6-month intervention period. Women will also have access to a specifically designed mHealth application providing tailored content and interactive tasks delivered bi-weekly during this time.
Secondary outcomes will include a range of maternal pre-conception health outcomes; maternal and infant pregnancy and birth outcomes; diet and physical activity changes; and quality of life.
We estimate a mean birth weight z-score of 0.43 (SD 1.09) and will recruit 800 women to detect 0.4 SD difference (alpha 0.05 (two-tailed); power 80%). Analyses will be intention to treat with estimates reported as relative risks and 95% CIs.
The study protocol was approved by the Human Research and Ethics Committee of the Women’s and Children’s Hospital, Adelaide, South Australia (HREC/17/WCHN/177; 2020/HRE01445) on 17 August 2018. The first participant was recruited in June 2021, with recruitment anticipated through 2025. The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders.
ACTRN 12621000128897. This study has been registered at (https://www.anzctr.org.au/).
Community health workers (CHWs) are critical to healthcare delivery in low-resource settings but often lack formal clinical training, limiting their decision-making. Large language models (LLMs) could provide real-time, context-specific support to improve referrals and management plans. This study aims to evaluate the potential utility of LLMs in assisting CHW decision-making in Rwanda.
This is a prospective, observational study conducted in Nyabihu and Musanze districts, Rwanda. Audio recordings of CHW-patient consultations will be transcribed and analysed by an LLM to generate referral decisions, differential diagnoses and management plans. These outputs, alongside CHW decisions, will be evaluated against a clinical expert panel’s consensus. The primary outcome is the appropriateness of referral decisions. Secondary outcomes include diagnostic accuracy, management plan quality, and patient and user perceptions to ambient recording of consultations. Sample size is set at 800 consultations (400 per district), powered to detect a 15–20 percentage point improvement in referral appropriateness.
Ethical approval has been obtained from the Rwandan National Ethics Committee (RNEC) (Ref number: RNEC 853/2025) in June 2025, recruitment started in July 2025 and results are expected in late 2025. Results will be disseminated via stakeholder meetings, academic conferences and peer-reviewed publication.
PACTR202504601308784.