The aim of this study is to evaluate intra- and interobserver agreement for measurement of intracranial, cerebellar, and thalamic volume with the Virtual Organ Computer-aided AnaLysis (VOCAL) technique in three-dimensional ultrasound images, in comparison to two-dimensional measurements of these brain structures. Three-dimensional ultrasound images of the brains of 80 fetuses at 20-24 weeks' gestational age were obtained from YOUth, a Dutch prospective cohort study. Two observers performed offline measurement of the occipitofrontal diameter, intracranial volume, transcerebellar diameter, cerebellar volume, and thalamic width, area, and volume, independently. VOCAL was used for calculation of the volumes. The two-way random, single measures intraclass correlation coefficient (ICC) was used for analysis of agreement and Bland-Altman plots were configured. Intra- and interobserver agreement was almost perfect for occipitofrontal diameter (intra ICC 0.88, 95% CI 0.82-0.92; inter ICC 0.91, 95% CI 0.85-0.94), intracranial volume (intra ICC 0.96, 95% CI 0.91-0.98; inter ICC 0.97, 95% CI 0.96-0.98) and transcerebellar diameter (intra ICC 0.91, 95% CI 0.86-0.94; inter ICC 0.86, 95% CI 0.78-0.910). For cerebellar volume, the intraobserver agreement was almost perfect (0.85, 95% CI 0.76-0.90), whereas the interobserver agreement was substantial (0.75, 95% CI 0.44-0.88). Agreement was only moderate for thalamic measurements. Bland-Altman plots for the volume measurements are normally distributed with acceptable mean differences and 95% limits of agreement. The intra- and interobserver agreement of the measurement of intracranial and cerebellar volume with VOCAL was almost perfect. These measurements are therefore reliable, and can be used to investigate fetal brain development. Thalamic measurements are not reliable enough.
STUDY QUESTION What is the methodological validity and usefulness of randomised controlled trials (RCTs) on pain relief during oocyte retrieval for IVF and ICSI? SUMMARY ANSWER Key methodological characteristics such as randomisation, allocation concealment, primary outcome measure, and sample size calculation were inadequately reported in 33 to 43% of the included RCTs, and a broad heterogeneity is revealed in the studied outcome measures. WHAT IS KNOWN ALREADY A Cochrane review on conscious sedation and analgesia (CSA) for women undergoing oocyte retrieval concluded that the overall quality of evidence was low or very low, mainly owing to poor reporting. This, and heterogeneity of studied outcome measures limits generalisability, and eligibility of results for meta-analysis. STUDY DESIGN, SIZE AND DURATION For this review, a systematic search for RCTs on pain relief during oocyte retrieval was performed on July 20th 2020 in CENTRAL CRSO, MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov, WHO ICTRP, Web of science, Portal Regional da BVS, and Open Grey. PARTICIPANTS/MATERIALS, SETTING, METHODS RCTs with pain or patient satisfaction as an outcome were included and analysed on a set of methodological and clinical characteristics, to determine their validity and usefulness. MAIN RESULTS AND THE ROLE OF CHANCE Screening of 2531 articles led to an inclusion of 51 RCTs. Randomisation was described inadequately in 33% of the RCTs. A low-risk method of allocation concealment was reported in 55% of the RCTs. Forty-nine percent of the RCTs reported blinding of participants, 33% of blinding personnel, and 43% of blinding the outcome assessor. In 63% of the RCTs, the primary outcome was stated, but a sample size calculation was described in only 57%. Data was analysed according to the intention-to-treat principle in 73%. Treatment groups were not treated identically other than the intervention of interest in 10% of the RCTs. The primary outcome was intraoperative pain in 28%, and postoperative pain in 2%. The visual analogue scale (VAS) was the most used pain scale, in 69% of the RCTs in which pain was measured. Overall, nine other scales were used. Patient satisfaction was measured in 49% of the RCTs, for which 12 different methods were used. Occurrence of side-effects and complications were assessed in 77% and 49% of the RCTs: a definition for these was lacking in 13% and 20% of the RCTs, respectively. Pregnancy rate was reported in 55% of the RCTs and, of these, 75% did not adequately define pregnancy. To improve the quality of future research, we provide recommendations for the design of future trials. These include use of the VAS for pain measurement, use of validated questionnaires for measurement of patient satisfaction, and the minimal clinically relevant difference to use for sample size calculations. LIMITATIONS, REASONS FOR CAUTION Consensus has not been reached on some methodological characteristics, for which we formulated recommendations. To prevent further heterogeneity in research on this topic, recommendations were formulated based on expert opinion, or on the most used method thus far. Future research may provide evidence to base new recommendations on. WIDER IMPLICATIONS OF THE FINDINGS Use of the recommendations given for design of trials on this topic can increase the generalisability of future research, increasing eligibility for meta-analyses, and preventing wastefulness. STUDY FUNDING/COMPETING INTEREST(S) No specific funding was obtained for this study. S.B. reports being the editor-in-chief of Human Reproduction Open. For this manuscript, he was not involved with the handling process within Human Reproduction Open, or with the final decision. Further, S.B. reports personal fees from Remuneration from Oxford University Press as editor-in-chief of Human Reproduction Open, personal fees from Editor and contributing author, Reproductive Medicine for the MRCOG, Cambridge University Press. The remaining authors declare no conflict of interest in relation to the work presented. TRIAL REGISTRATION NUMBER Not applicable.
Objective Which analgesia methods are used during oocyte retrieval in the Netherlands? StudyDesign In April 2017, an online survey containing questions on the analgesia protocol used for IVF/ICSI oocyte retrieval was sent to all clinics in the Netherlands that perform oocyte retrievals. Results The response rate was 97%. We uncovered the large variety of medication protocols used for pain relief during oocyte retrieval in the Netherlands. Based on the main component of the given analgesia, we distinguished the three most frequently used analgesia protocols: intravenously (i.v.) administered opioids, intramuscularly (i.m) administered opioids, and non-sedative oral analgesics. Aside from analgesia, 61% provided anxiolysis with a benzodiazepine. Nearly half of the clinics registered pain scores. The vital functions were monitored at all clinics administering opioids i.v., but at none of the clinics administering opioids i.m. Conclusions A wide variety of analgesia protocols are used. The three most frequently used are i.v. administered opioids, i.m. administered opioids, and non-sedative oral analgesics. The variety of analgesia protocols is not desirable in the context of good clinical practice, and considering the risks of combining opioids and benzodiazepines. Monitoring of vital functions was only performed after administration of i.v. medication. A comparison of the pain scores could be a first step in finding the optimal method of analgesia, thereby forming the basis of guidelines for analgesia during oocyte retrieval.
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