Dataset Information

Quantification of 7 cannabinoids in cannabis oil using GC-MS: Method development, validation and application to therapeutic preparations in Friuli Venezia Giulia region, Italy.

ABSTRACT: The use of therapeutic cannabis preparations in Friuli Venezia Giulia is increasingly expanding. Even if cannabis oil finds its applications in several disorders affecting adults and children, it is not yet a standardized product and, to ensure the quality of the preparation, a quantitative analysis must be carried out before dispensing it to patients. Gas chromatography coupled to mass spectrometry (GC-MS) is a frequently used technique for quantification of cannabinoids, the active compounds of C. sativa. In this context, we developed a GC-MS method for the simultaneous quantification of 7 cannabinoids (CBD, CBDA, CBG, CBN, THCA, THCV and Δ⁹-THC) that is not time and sample consuming: 10 μL of cannabis oil were used for the sample preparation, that consists in derivatization of analytes through silylation. Calibration curves were built from 0.2 to 2 μg/mL. The percentage of accuracy and precision did not exceed the values recommended by validation guidelines. The limit of detection was 0.01 μg/mL; whereas the lower limit of quantification was 0.2 μg/mL. There was no carry over. The proposed GC-MS method showed good sensitivity, specificity, linearity, accuracy, precision and applicability to therapeutic preparations.

SUBMITTER: Franzin M

PROVIDER: S-EPMC10161710 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Quantification of 7 cannabinoids in cannabis oil using GC-MS: Method development, validation and application to therapeutic preparations in Friuli Venezia Giulia region, Italy.

Franzin Martina M Ruoso Rachele R Del Savio Rossella R Niaki Eugenia Akhavan EA Pettinelli Aba A Decorti Giuliana G Stocco Gabriele G Addobbati Riccardo R

Heliyon 20230417 4

The use of therapeutic cannabis preparations in Friuli Venezia Giulia is increasingly expanding. Even if cannabis oil finds its applications in several disorders affecting adults and children, it is not yet a standardized product and, to ensure the quality of the preparation, a quantitative analysis must be carried out before dispensing it to patients. Gas chromatography coupled to mass spectrometry (GC-MS) is a frequently used technique for quantification of cannabinoids, the active compounds o ...[more]

PMID: 37151683

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Project description:BackgroundProblem-Based Learning (PBL) is extensively used in pre- and post-graduate teaching programmes. However, it has been seldom used for in-service training and continuing medical education. We aimed to develop a PBL curriculum for a short in-service training on breastfeeding for maternal and child health professionals, and to assess the effect of these courses on their knowledge and skills. Also, the project aimed at increasing exclusive breastfeeding rates and duration in an Italian region.MethodsAfter initial training on PBL and an assessment of the learning needs of about 400 health professionals, a small working group developed learning objectives, designed a curriculum, produced manuals, and shaped assessment tools for a new PBL course on breastfeeding. The field test of the new course allowed selection of the tutors for the scaling up of the training to the whole region. During this extension phase, participants were asked to complete an evaluation questionnaire. In addition, the health professionals who attended the PBL courses in 2019 were asked to complete an online survey to assess knowledge, attitudes and practices (KAP) just before, soon after the course, and 4-6 months later.ResultsThe new 29 - hour PBL course, to be delivered in four days over four consecutive weeks, gives priority to tutorial groups and practical activities (71% of the total time). Supervised clinical practices absorb 16% of time. Ethics, communication and woman-centred clinical management content run throughout the four days and all activities. The three manuals, for tutors, participants and practical activities, facilitate the tasks and performance of tutors and participants. After the field test, 32 regional tutors ran courses for 562 health professionals. The analysis of the evaluation showed a high level of satisfaction for perceived effectiveness, relevance to practice, and educational quality. The KAP questionnaires indicated a general improvement after the course and retention after 4-6 months.ConclusionsDespite some predictable shortcomings, this new PBL approach for short in-service training courses on breastfeeding showed encouraging results as far as participants' satisfaction and KAP are concerned. The possible effects on rates and duration of exclusive breastfeeding need further research.

Project description:Although length of stay (LoS) after childbirth has been diminishing in several high-income countries in recent decades, the evidence on the impact of early discharge (ED) on healthy mothers and term newborns after vaginal deliveries (VD) is still inconclusive and little is known on the characteristics of those discharged early. We conducted a population-based study in Friuli Venezia Giulia (FVG) during 2005-2015, to investigate the mean LoS and the percentage of LoS longer than our proposed ED benchmarks following VD: 2 days after spontaneous vaginal deliveries (SVD) and 3 days post instrumental vaginal deliveries (IVD). We employed a multivariable logistic as well as a linear regression model, adjusting for a considerable number of factors pertaining to health-care setting and timeframe, maternal health factors, newborn clinical factors, obstetric history factors, socio-demographic background and present obstetric conditions. Results were expressed as odds ratios (OR) and regression coefficients (RC) with 95% confidence interval (95%CI). The adjusted mean LoS was calculated by level of pregnancy risk (high vs. low). Due to a very high number of multiple tests performed we employed the procedure proposed by Benjamini-Hochberg (BH) as a further selection criterion to calculate the BH p-value for the respective estimates. During 2005-2015, the average LoS in FVG was 2.9 and 3.3 days after SVD and IVD respectively, and the pooled regional proportion of LoS > ED was 64.4% for SVD and 32.0% for IVD. The variation of LoS across calendar years was marginal for both vaginal delivery modes (VDM). The adjusted mean LoS was higher in IVD than SVD, and although a decline of LoS > ED and mean LoS over time was observed for both VDM, there was little variation of the adjusted mean LoS by nationality of the woman and by level of pregnancy risk (high vs. low). By contrast, the adjusted figures for hospitals with shortest (centres A and G) and longest (centre B) mean LoS were 2.3 and 3.4 days respectively, among "low risk" pregnancies. The corresponding figures for "high risk" pregnancies were 2.5 days for centre A/G and 3.6 days for centre B. Therefore, the shift from "low" to "high" risk pregnancies in all three latter centres (A, B and G) increased the mean adjusted LoS just by 0.2 days. By contrast, the discrepancy between maternity centres with highest and lowest adjusted mean LoS post SVD (hospital B vs. A/G) was 1.1 days both among "low risk" (1.1 = 3.4-2.3 days) and "high risk" (1.1 = 3.6-2.5) pregnanices. Similar patterns were obseved also for IVD. Our adjusted regression models confirmed that maternity centres were the main explanatory factor for LoS after childbirth in both VDM. Therefore, health and clinical factors were less influential than practice patterns in determining LoS after VD. Hospitalization and discharge policies following childbirth in FVG should follow standardized guidelines, to be enforced at hospital level. Any prolonged LoS post VD (LoS > ED) should be reviewed and audited if need be. Primary care services within the catchment areas of the maternity centres of FVG should be improved to implement the follow up of puerperae undergoing ED after VD.

Project description:BACKGROUND:Births by cesarean section (CS) usually require longer recovery time, and as a result women remain hospitalized longer following CS than vaginal delivery (VD). A number of strategies have been proposed to reduce avoidable health care costs associated with childbirth. Among these, the containment of length of hospital stay (LoS) has been identified as an important quality indicator of obstetric care and performance efficiency of maternity centres. Since improvement of obstetric care at hospital level needs quantitative evidence, we compared the maternity services of an Italian region on LoS post CS. METHODS:We conducted a population-based study in Friuli Venezia Giulia (FVG), a region of North-Eastern Italy, collecting data from all its 12 maternity centres (coded from A to K) during 2005-2015. We fitted a multivariable logistic regression using LoS as a binary outcome, higher/lower than the international early discharge (ED) cutoffs for CS (4 days), controlling for hospitals as well as several factors related to the clinical conditions of the mothers and the newborn, the obstetric history and socio-demographic background. Results were expressed as adjusted odds ratios (aOR) with 95% confidence interval (95%CI). Population attributable risks (PARs) were also calculated as proportional variation of LoS>ED for each hospital in the ideal scenario of having the same performance as centre J (the reference) during calendar year 2015. Results were expressed as PAR with 95%CI. Differences in mean LoS were also investigated with a multivariable linear regression model including the same explanatory factors of the above multiple logistic regression. Results were expressed as adjusted regression coefficients (aRC) with 95%CI. RESULTS:Although decreasing over the years (5.0 ± 1.7 days in 2005 vs. 4.4 ± 1.7 days in 2015), the pooled mean LoS in the whole FVG during these 11 years was still 4.7 ± 1.7 days, higher than respective international ED benchmark. The significant decreasing trend of LoS>ED over time in FVG (aOR = 0.89; 95%CI: 0.88; 0.90) was marginal as compared to the variability of LoS>ED observed among the various maternity services. Regardless it was expressed as aRC or aOR, LoS after CS was lowest in hospital C, highest in hospital D and intermediate in centres I, K, G, F, A, H, E, B and J (in descending order). The aOR of LoS being longer than ED ranged from 1.63 (95%CI:1.46; 1.81) in hospital B up to 32.09 (95%CI: 25.68; 40.10) in facility D. When hospitals were ranked by PAR the same pattern was found, even if restricting the analysis to low risk pregnancies. CONCLUSIONS:Although significantly decreasing over time, the mean LoS in FVG during 2005-2015 was 4.7 days, higher than the international threshold recommended for CS. There was substantial variability in LoS by facility centre, suggesting that internal organizational processes of single hospitals should be improved by enforcing standardized guidelines and using audits, economic incentives and penalties if need be.

Project description:BackgroundLengths of hospital stay (LoS) after childbirth that are too long have a number of health, social and economic drawbacks. For this reason, in several high-income countries LoS has been reduced over the past decades and early discharge (ED) is increasingly applied to low-risk mothers and newborns.MethodsWe conducted a population-based study investigating LoS after chilbirth across all 12 maternity centres of Friuli Venezia-Giulia (FVG), North-Eastern Italy, using a database capturing all registered births in the region from 2005 to 2015 (11 years). Adjusting for clinical factors (clinical conditions of the mother and the newborn), socio-demographic bakground and obstetric history with multivariable logistic regression, we ranked facility centres for LoS that were longer than our proposed ED benchmarks (defined as >2 days for spontaneous vaginal deliveries and >3 days for instrumental vaginal deliveries). The reference was hospital A, a national excellence centre for maternal and child health.ResultsThe total number of births examined in our database was 109,550, of which 109,257 occurred in hospitals. During these 11 years, the number of births significantly diminished over time, and the pooled mean LoS for spontaneous vaginal deliveries in the whole FVG was 2.9 days. There was a significantly decreasing trend in the proportion of women remaining admitted more than the respective ED cutoffs for both delivery modes. The percentage of women staying longer that the ED benchmarks varied extensively by facility centre, ranging from 32% to 97% for spontaneous vaginal deliveries and 15% to 64% for instrumental vaginal deliveries. All hospitals but G were by far more likely to surpass the ED cutoff for spontaneous deliveries. As compared with hospital A, the most significant adjusted ORs for LoS overcoming the ED thresholds for spontaneous vaginal deliveries were: 89.38 (78.49-101.78); 26.47 (22.35-31.36); 10.42 (9.49-11.44); 10.30 (9.45-11.21) and 8.40 (7.68-9.19) for centres B, D, I, K and E respectively. By contrast the OR was 0.77 (95%CI: 0.72-0.83) for centre G. Similar mitigated patterns were observed also for instrumental vaginal deliveiries.ConclusionsFor spontaneous vaginal deliveries the mean LoS in the whole FVG was shorter than 3.4 days, the average figure most recently reported for the whole of Italy, but higher than other countries' with health systems similar to Italy's. Since our results are controlled for the effect of all other factors, the between-hospital variability we found is likely attributable to the health care provider itself. It can be argued that some maternity centres of FVG may have had ecocomic interest in longer LoS after childbirth, although fear of medico-legal backlashes, internal organizational malfunctions of hospitals and scarce attention of ward staff on performance efficiency shall not be ruled out. It would be therefore important to ensure higher level of coordination between the various maternity services of FVG, which should follow standardized protocols to pursue efficiency of care and allow comparability of health outcomes and costs among them. Improving the performance of FVG and Italian hospitals requires investment in primary care services.

Dataset Information

Quantification of 7 cannabinoids in cannabis oil using GC-MS: Method development, validation and application to therapeutic preparations in Friuli Venezia Giulia region, Italy.

Publications

Quantification of 7 cannabinoids in cannabis oil using GC-MS: Method development, validation and application to therapeutic preparations in Friuli Venezia Giulia region, Italy.

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