Impact of coronavirus disease 2019 (COVID-19) vaccination on menstrual bleeding quantity: An observational cohort study.

OBJECTIVE: To assess whether coronavirus disease 2019 (COVID-19) vaccination impacts menstrual bleeding quantity. DESIGN: Retrospective cohort. SETTING: Five global regions. POPULATION: Vaccinated and unvaccinated individuals with regular menstrual cycles using the digital fertility-awareness application Natural Cycles°. METHODS: We used prospectively collected menstrual cycle data, multivariable longitudinal Poisson generalised estimating equation (GEE) models and multivariable multinomial logistic regression models to calculate the adjusted difference between vaccination groups. All regression models were adjusted for confounding factors. MAIN OUTCOME MEASURES: The mean number of heavy bleeding days (fewer, no change or more) and changes in bleeding quantity (less, no change or more) at three time points (first dose, second dose and post-exposure menses). RESULTS: We included 9555 individuals (7401 vaccinated and 2154 unvaccinated). About two-thirds of individuals reported no change in the number of heavy bleeding days, regardless of vaccination status. After adjusting for confounding factors, there were no significant differences in the number of heavy bleeding days by vaccination status. A larger proportion of vaccinated individuals experienced an increase in total bleeding quantity (34.5% unvaccinated, 38.4% vaccinated; adjusted difference 4.0%, 99.2% CI 0.7%-7.2%). This translates to an estimated 40 additional people per 1000 individuals with normal menstrual cycles who experience a greater total bleeding quantity following the first vaccine dose' suffice. Differences resolved in the cycle post-exposure. CONCLUSIONS: A small increase in the probability of greater total bleeding quantity occurred following the first COVID-19 vaccine dose, which resolved in the cycle after the post-vaccination cycle. The total number of heavy bleeding days did not differ by vaccination status. Our findings can reassure the public that any changes are small and transient.

The development of the Language-Independent Speech in Noise and Reverberation test (LISiNaR) and evaluation in listeners with English as a second language.

OBJECTIVE: Create a language-independent, ecologically valid auditory processing assessment and evaluate relative stimuli intelligibility in native and non-native English speakers. DESIGN: The Language-Independent Speech in Noise and Reverberation Test (LISiNaR) targets comprised consonant-vowel (CVCV) pseudo-words. Distractors comprised CVCVCVCV pseudo-words. Stimuli were presented over headphones using an iPad either face-to-face or remotely. Scoring occurred adaptively to establish a participant's speech reception threshold in noise (SRT). The listening environment was simulated using reverberant and anechoic head-related transfer functions. In four test conditions, targets originated from 0°. Distractors originated from either ±90°, ±67.5° and ±45° (spatially separated) or 0° azimuth (co-located). Reverberation impact (RI) was calculated as the difference in SRTs between the anechoic and reverberant conditions and spatial advantage (SA) as the difference between the spatially separated and co-located conditions. STUDY SAMPLE: Young adult native speakers of Australian (n = 24) and Canadian (25) and non-native English speakers (34). RESULTS: No significant effects of language occurred for the test conditions, RI or SA. A small but significant effect of delivery mode occurred for RI. Reverberation impacted SRT by 5 dB relative to anechoic conditions. CONCLUSION: Performance on LISiNaR is not affected by the native language or accent of groups tested in this study.

Pain management for medical abortion before 14 weeks' gestation.

BACKGROUND: Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks' gestation using medical methods, specifically using a combination of mifepristone and misoprostol. Medical abortion is known to be a painful process, but the optimal method of pain management is unclear. We sought to identify and compare pain management regimens for medical abortion before 14 weeks' gestation.  OBJECTIVES: Primary objective To determine if there is evidence of superiority of any particular pain relief regimen in the management of combination medical abortion (mifepristone + misoprostol) under 14 weeks' gestation (i.e. up to 13 + 6 weeks or 97 days). Secondary objectives To compare the rate of gastrointestinal side effects resulting from different methods of analgesia To compare the rate of complete abortion resulting from different methods of analgesia during medical abortion To determine if the induction-to-abortion interval is associated with different methods of analgesia To determine if any method of analgesia is associated with unscheduled contact with the care provider in relation to pain. SEARCH METHODS: On 21 August 2019 we searched CENTRAL, MEDLINE, Embase, CINAHL, LILACs, PsycINFO, the World Health Organization International Clinical Trials Registry and ClinicalTrials.gov together with reference checking and handsearching of conference abstracts of relevant learned societies and professional organisations to identify further studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and observational studies (non-randomised studies of interventions (NRSIs)) of any pain relief intervention (pharmacological and non-pharmacological) for mifepristone-misoprostol combination medical abortion of pregnancies less than 14 weeks' gestation. DATA COLLECTION AND ANALYSIS: Two review authors (JRW and MA) independently assessed all identified papers for inclusion and risks of bias, resolving any discrepancies through discussion with a third and fourth author as required (CM and SC). Two review authors independently conducted data extraction, including calculations of pain relief scores, and checked for accuracy. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included four RCTs and one NRSI. Due to the heterogeneity of study designs, interventions and outcome reporting, we were unable to perform meta-analysis for any of the primary or secondary outcomes in this review. Only one study found evidence of an effect between interventions on pain score: a prophylactic dose of ibuprofen 1600 mg likely reduces the pain score when compared to a dose of paracetamol 2000 mg (mean difference (MD) 2.26 out of 10 lower, 95% confidence interval (CI) 3.00 to 1.52 lower; 1 RCT 108 women; moderate-certainty evidence). There may be little to no difference in pain score when comparing pregabalin 300 mg with placebo (MD 0.5 out of 10 lower, 95% CI 1.41 lower to 0.41 higher; 1 RCT, 107 women; low-certainty evidence).  There may be little to no difference in pain score when comparing ibuprofen 800 mg with placebo (MD 1.4 out of 10 lower, 95% CI 3.33 lower to 0.53 higher; 1 RCT, 61 women; low-certainty evidence). Ambulation or non-ambulation during medical abortion treatment may have little to no effect on pain score, but the evidence is very uncertain (MD 0.1 out of 5 higher, 95% CI 0.26 lower to 0.46 higher; 1 NRSI, 130 women; very low-certainty evidence). There may be little to no difference in pain score when comparing therapeutic versus prophylactic administration of ibuprofen 800 mg (MD 0.2 out of 10 higher, 95% CI 0.41 lower to 0.81 higher; 1 RCT, 228 women; low-certainty evidence).   Other outcomes of interest were reported inconsistently across studies. Where these outcomes were reported, there was no evidence of difference in incidence of gastrointestinal side effects, complete abortion rate, interval between misoprostol administration to pregnancy expulsion, unscheduled contact with a care provider, patient satisfaction with analgesia regimen nor patient satisfaction with abortion experience overall. However, the certainty of evidence was very low to low. AUTHORS' CONCLUSIONS: The findings of this review provide some support for the use of ibuprofen as a single dose given with misoprostol prophylactically, or in response to pain as needed. The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600 mg was shown to be effective, and it was less certain whether 800 mg was effective. Paracetamol 2000 mg does not improve pain scores as much as ibuprofen 1600 mg, however its use does not appear to cause greater frequency of side effects or reduce the success of the abortion. A single dose of pregabalin 300 mg does not affect pain scores during medical abortion, but like paracetamol, does not appear to cause harm. Ambulation or non-ambulation during the medical abortion procedure does not appear to affect pain scores, outcomes, or duration of treatment and so women can be advised to mobilise or not, as they wish. The majority of outcomes in this review had low- to very low-certainty evidence, primarily due to small sample sizes and two studies at high risk of bias. High-quality, large-scale RCT research is needed for pain management during medical abortion at gestations less than 14 weeks. Consistent recording of pain with a validated measure would be of value to the field going forward.

Uptake of long-acting reversible contraception after telemedicine delivered abortion during Covid-19.

BACKGROUND: During COVID-19, early medical abortion (EMA) at home in Scotland was largely delivered by telemedicine. Short-acting post-abortion contraception was provided with EMA medications, but long-acting reversible contraception (LARC) (implant, injectable and intrauterine device) required an in-person visit. We wished to assess LARC uptake following telemedicine abortion, and factors associated with method receipt. METHODS: A prospective observational cohort study of patients accessing abortion via NHS Lothian (October 2020 to February 2021). Patients were offered contraception at telemedicine consultation and their choice was recorded in their clinical notes. Those wishing LARC were directed to the service's rapid-access LARC clinic. We reviewed electronic patient records six weeks post-abortion to determine whether patients received their chosen method. RESULTS: 944 patients had an abortion; 768 (81.4%) had EMA, 131 (13.9%) had a medical or surgical abortion in hospital. The most popular contraceptive method was the progestogen-only pill (n = 324, 34%). 330 patients (35%) requested LARC but less than half (153/330; 46%) received this. Of patients choosing LARC, those who attended the clinic for a pre-abortion ultrasound, or had an abortion in hospital, were more likely to initiate LARC than those having full telemedicine EMA. Nulliparity, gestation over 7 weeks, and age under-26 years were also positively associated with initiating LARC. CONCLUSION: During COVID-19 there was demand for post-abortion LARC but less than half of patients received this by six weeks. Provision was enhanced when in-person clinical interactions took place. Interventions are required to facilitate timely access and initiation of LARC with telemedicine delivered abortion care.

Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.

BACKGROUND: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception. METHODS: We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 µg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete). FINDINGS: Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred. INTERPRETATION: Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception. FUNDING: National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).

Separating the Causes of Listening Difficulties in Children.

Auditory processing disorder, defined here as a deficit in the way sounds are analyzed by the brain, has remained a controversial topic within audiology for decades. Some of the controversy concerns what it is called. More substantively, even its existence has been questioned. That view has likely emerged because there has not been sufficient rigor in determining when difficulty in understanding speech has been the consequence of some type of auditory processing deficit, versus when it is the consequence of a cognitive deficit or a language deficit. This article suggests that the field use the term "listening difficulty" as an umbrella term to indicate a reported deficit in recognizing sounds or understanding speech, one possible cause of which is an auditory processing disorder. Other possible causes are hearing deficits, cognitive deficits, and language deficits. This article uses a plausible, and hopefully noncontroversial, model of speech understanding that comprises auditory processing, speech processing, and language processing, all potentially affected by the degree of attention applied and the listener's memory ability. In a fresh approach to the construction of test batteries, the stages of the model are linked to tests designed to assess either all or selected parts of the processes involved. For two of the stages, a listener's performance is quantified as the additional signal to noise ratio that he or she needs to function equivalently to his or her age peers. Subtraction of the deficits revealed by each test enables the contributions of each processing stage to a listening deficit to be quantified. As a further novel contribution, the impact of memory and attention on each test score is quantitatively allowed for, by an amount that depends on each test's dependence on memory and attention. Attention displayed during the test is estimated from the fluctuations in performance during the test. The article concludes with a summary of the research that must be conducted before the structured tests can be used to quantify the extent to which different potential causes of listening difficulties are responsible for real-life difficulties in an individual child.

Expulsion at home for early medical abortion: A systematic review with meta-analyses.

INTRODUCTION: The safety and acceptability of medical abortion using mifepristone and misoprostol at home at ≤9+0  weeks' gestation is well established. However, the upper gestational limit at which the procedure remains safe and acceptable at home is not known. To inform a national guideline on abortion care we conducted a systematic review to determine what gestational limit for expulsion at home offers the best balance of benefits and harms for women who are having medical abortion. MATERIAL AND METHODS: We searched Embase, MEDLINE, Cochrane Library, Cinahl Plus and Web-of-Science on 2 January 2020 for prospective and retrospective cohort studies with ≥50 women per gestational age group, published in English from 1995 onwards, that included women undergoing medical abortion and compared home expulsion of pregnancies of ≤9+0  weeks' gestational age with pregnancies of 9+1 -10+0  weeks or >10+1  weeks' gestational age, or compared the latter two gestational age groups. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were meta-analyzed as risk ratios (RR) using the Mantel-Haenszel method. The certainty of the evidence was assessed using GRADE. RESULTS: Six studies (n = 3381) were included. The "need for emergency care/admission to hospital" (RR = 0.79, 95% confidence interval [CI] 0.45-1.4), "hemorrhage requiring transfusion/≥500 mL blood loss" (RR = 0.62, 95% CI 0.11-3.55), patient satisfaction (RR = 0.99, 95% CI 0.95-1.03), pain (RR = 0.91, 95% CI 0.82-1.02), and "complete abortion without the need for surgical intervention" (RR = 1.03, 95% CI 1-1.05) did not differ statistically significantly between the ≤9+0 and >9+0  weeks' gestation groups. The rates of vomiting (RR = 0.8, 95% CI 0.69-0.93) and diarrhea (RR = 0.85, 95% CI 0.73-0.99) were statistically significantly lower in the ≤9+0  weeks group but these differences were not considered clinically important. We found no studies comparing pregnancies of 9+1 -10+0  weeks' gestation with pregnancies of >10+0  weeks' gestation. The certainty of this evidence was predominantly low and mainly compromised by low event rates and loss to follow up. CONCLUSIONS: Women who are having a medical abortion and will be taking mifepristone up to and including 10+0  weeks' gestation should be offered the option of expulsion at home after they have taken the misoprostol. Further research needs to determine whether the gestational limit for home expulsion can be extended beyond 10+0  weeks.

Competence committees: The steep climb from concept to implementation.

INTRODUCTION: Competence committees (CCs) are groups of educators tasked with reviewing resident progress throughout their training, making decisions regarding the achievement of Entrustable Professional Activities and recommendations regarding promotion and remediation. CCs have been mandated as part of competency-based medical education programmes worldwide; however, there has yet to be a thorough examination of the implementation challenges they face and how this impacts their functioning and decision-making processes. This study examined CC implementation at a Canadian institution, documenting the shared and unique challenges that CCs faced and overcame over a 3-year period. METHODS: This study consisted of three phases, which were conceptually and analytically linked using Moran-Ellis and colleagues' notion of 'following a thread.' Phase 1 examined the early perceptions and experiences of 30 key informants using a survey and semi-structured interviews. Phase 2 provided insight into CCs' operations through a survey sent to 35 CC chairs 1-year post-implementation. Phase 3 invited 20 CC members to participate in semi-structured interviews to follow up on initial themes 2 years post-implementation. Detailed observation notes from 16 CC meetings across nine disciplines were used to corroborate the findings from each phase. RESULTS: Response rates in each phase were 83% (n = 25), 43% (n = 15) and 60% (n = 12), respectively. Despite the high degree of support for CCs among faculty and resident members, several ongoing challenges were highlighted: adapting to programme size, optimising membership, engaging residents, maintaining capacity among members, sharing and aggregating data and developing a clear mandate. DISCUSSION: Findings of this study reinforce the importance of resident engagement and information sharing between disciplines. Challenges faced by CCs are discussed in relation to the existing literature to inform a better understanding of group decision-making processes in medical education. Future research could compare implementation practices across sites and explore which adaptations lead to better or worse decision-making outcomes.

Listening in Spatialized Noise - Universal Test (LiSN-U) test-retest reliability study.

OBJECTIVE: To assess test-retest reliability of the Listening in Spatialised Noise - Universal test (LiSN-U). DESIGN: Test-retest reliability study. Participants completed the LiSN-U twice, four to eight weeks apart. Study sample: Test-retest reliability was analysed for 23 adults and 109 children. RESULTS: ANOVA showed significant group average score improvement on LiSN-U spatially-separated and co-located conditions on retest (by 1.3 and 0.9 dB, respectively), but not on the difference between them (spatial advantage). Critical difference scores for children were -3.6 dB for the spatially-separated condition, -5.8 dB for the co-located condition, and 5.5 dB for spatial advantage. Critical difference scores for adults were -2.0 dB for the spatially-separated condition, -4.9 dB for the co-located condition, and 5.4 dB for spatial advantage. A correlation analysis was run to determine the relationship between test and retest speech reception thresholds. The correlation was r = 0.63, p < 0.001 for the spatially-separated condition, r = 0.50, p < 0.001 for the co-located condition, and r = 0.37, p < 0.001 for the spatial advantage measure. CONCLUSIONS: The LiSN-U, which is potentially useable for speakers of any language, shows mean test-retest difference and test-retest reliability comparable to other tests that have proven useful in clinical practice.

Follow-up strategies to confirm the success of medical abortion of pregnancies up to 10 weeks' gestation: a systematic review with meta-analyses.

OBJECTIVE: To compare the effectiveness, safety, and acceptability of in-clinic and remote/self-assessment, as well as different remote/self-assessments, for confirming the success of medical abortion at ≤10+0 weeks' gestation. DATA SOURCES: Ovid Embase Classic and Embase; Ovid MEDLINE(R) and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations and Daily; and the Cochrane Library. We also consulted experts in this field for any ongoing or missed trials. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials published in English from 2000 onward, comparing in-clinic assessment with ultrasound to remote or self-assessment or comparing different remote or self-assessment strategies to confirm the success of medical abortion of pregnancies up to and including 10+0 weeks gestation, reporting any of the following outcomes: "missed ongoing pregnancy," "correct implementation of the follow-up strategy," patient satisfaction/preference, "adherence to follow-up strategy," "unscheduled visits/telephone calls to the abortion service," and surgical intervention. STUDY APPRAISAL AND SYNTHESIS METHODS: One author assessed the risk of bias in the studies using the Cochrane Collaboration checklist for randomized controlled trials. All outcomes were analyzed as risk ratios and meta-analysed in Review Manager 5.3 using the Mantel-Haenszel statistical method and a fixed effect model. The overall quality of the evidence was assessed using GRADE. RESULTS: Four randomized controlled trials (n = 5761) compared in-clinic to remote self-assessment and found no clinically significant differences apart from higher preference rates for remote follow-up, especially in the remote follow-up groups. The quality of this evidence was compromised by attrition, no blinding, inconsistency, indirectness, and low event rates. Two randomized controlled trials (n = 1125) compared different remote assessment strategies (using urine pregnancy tests) and also found no clinically significant differences apart from a clinically significantly lower rate of unscheduled visits to the abortion service in the remote follow-up group using a multilevel urine pregnancy test compared to remote follow-up using a high-sensitivity urine pregnancy test. The quality of this evidence was compromised by small event rates, lack of blinding, indirectness and high attrition rates. CONCLUSION: The published data support offering women who have had a medical abortion up to and including 10+0 weeks' gestation the choice of self-assessment, remote assessment, or clinic follow-up.

Initiation of abortion before there is definitive ultrasound evidence of intrauterine pregnancy: A systematic review with meta-analyses.

INTRODUCTION: Women are increasingly presenting for abortion at very early gestation. However, providers may be reluctant to conduct abortion at this stage as they may be concerned that they cannot exclude an ectopic pregnancy or that they may terminate a non-viable pregnancy, or may be concerned that both medical and surgical methods may be less effective at this stage of gestation. This provider concern may result in delays in the abortion as additional investigations may be required until an intrauterine pregnancy can be confirmed. Additional unnecessary visits may be distressing for women and waste health service resources. The objective of this systematic review was to determine whether it is safe and effective to initiate abortion before there is ultrasound evidence of an intrauterine pregnancy. MATERIAL AND METHODS: We searched Embase Classic, Embase; Ovid MEDLINE® Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE® Daily, Ovid MEDLINE®; and Cochrane Library on 25 October 2019. Eligible studies were randomized and non-randomized comparative studies, published in English from 1985, comparing initiation of abortion before there is definitive evidence of an intrauterine pregnancy with initiation afterwards. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were analyzed as risk ratios (RR) and meta-analyzed using the Mantel-Haenszel method. The quality of the evidence was assessed using GRADE. RESULTS: Two non-randomized studies (n = 3785) showed no differences in "missed ectopic pregnancy" (RR = 0.26, 95% CI 0.03-2.12), "ongoing pregnancy" (RR = 1.06, 95% CI 0.34-3.34), or "complete abortion without surgical intervention" (RR = 1, 95% CI 0.98-1.02) between initiation of medical abortion before or after ultrasound evidence of an intrauterine pregnancy. A third non-randomized study (n = 1530) showed no differences between initiation of surgical abortion before or after ultrasound evidence of an intrauterine pregnancy in "missed ectopic pregnancy" (no events), "ongoing pregnancy" (RR = 0.56, 95% CI 0.03-11.59) or "complete abortion without repeat surgical intervention" (RR = 1, 95% CI 0.99-1.01). The quality of evidence was very low. CONCLUSIONS: Initiation of abortion before there is definitive ultrasound evidence of an intrauterine pregnancy in women without signs or symptoms of an ectopic pregnancy should be considered.

Information on early medical abortion for women using an audiovisual animation vs face-to-face consultation: A consortium randomized and quasi-randomized trial.

INTRODUCTION: There is some evidence that audiovisual formats can be an effective way of providing information about early medical abortion (EMA). A short animation (3 minutes) was developed about EMA in three languages that summarized the EMA process for use in the UK, France and Sweden. MATERIAL AND METHODS: We conducted a multicenter randomized controlled trial to compare information on EMA delivered by an animated film vs a face-to-face consultation. Women requesting EMA (≤9 weeks' gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited. The primary outcome was women's recall of prespecified key information on EMA. Secondary outcomes were acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale. The study was prospectively registered with clinicaltrials.gov, ID number: NCT03417362. RESULTS: 172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48). There was no statistically significant difference in recall scores between the animation and standard arms in Edinburgh and Stockholm sites. However, the difference between arms at the Paris site was statistically significant (P = .007) in favor of the animation. All participants in the animation arm rated it as an acceptable way to receive information on EMA. CONCLUSIONS: A "short" audiovisual animation can adequately and acceptably deliver key information about EMA. This intervention could be used routinely to provide standardized and high-quality information to women seeking EMA.

Provision of immediate postpartum intrauterine contraception after vaginal birth within a public maternity setting: Health services research evaluation.

INTRODUCTION: Expanding access to postpartum intrauterine contraception (PPIUC) can reduce unintended pregnancies and short inter-pregnancy intervals; however, provision across Europe is limited. Our aim was to determine the feasibility, clinical outcomes and patient satisfaction of providing immediate PPIUC after vaginal birth using a health services research model. MATERIAL AND METHODS: Phased introduction of PPIUC across two Lothian maternity hospitals; all women intending vaginal birth during the study period without a contraindication to use of the method were eligible to receive PPIUC. Midwives and obstetric doctors were trained in vaginal PPIUC insertion using Kelly forceps. Women received information antenatally and had PPIUC insertion of either a levonorgestrel intrauterine system or a copper intrauterine device within 48 hours of vaginal birth. Follow-up was conducted in-person at 6 weeks postpartum and by telephone at 3, 6 and 12 months. Primary outcomes were: uptake, complications (infection, uterine perforation), expulsion and patient satisfaction at 6 weeks; and method of continuation up to 12 months. Secondary outcomes included hazard ratio for expulsion adjusted for demographic and insertion-related variables. RESULTS: Uptake of PPIUC was 4.6% of all vaginal births; 465/447 (96.1%) of those requesting PPIUC successfully received it and most chose a levonorgestrel intrauterine system (73%). At 6 weeks postpartum, the infection rate was 0.8%, there were no perforations and 98.3% of women said they would recommend the service. The complete expulsion rate was 29.8% (n = 113) and most had symptoms (n = 79). Of the additional 121 devices removed, 118 were because of partial expulsion. The rate of complete/partial expulsion was higher for insertions by midwives compared with those by doctors. The re-insertion rate after expulsion/removal was 87.6% and method continuation at 12 months was 79.6%. CONCLUSIONS: Routine PPIUC at vaginal birth is feasible. Complications were extremely rare. High expulsion rates may be observed in early stages of service introduction and with inexperienced providers. Re-insertion and therefore longer-term continuation rates of intrauterine contraception were very high. In settings with low rates of attendance for interval postpartum intrauterine contraception insertion, PPIUC could be a useful intervention to prevent unintended and closely spaced pregnancies.

Correlating performance on the Listening in Spatialised Noise - Sentences test (LiSN-S) with the Listening in Spatialised Noise - Universal test (LiSN-U).

Objective: The aim of this study was to correlate 6- to 7-year-old children's results on each condition of the Listening in Spatialised Noise - Sentences test (LiSN-S) with the new language-independent version, the Listening in Spatialised Noise - Universal test (LiSN-U), to examine the strength of the relationship between them and with memory in a small sample of typically developing children.Design: Correlational analysis.Study samples: Sixteen typically developing 6- to 7-year-old children completed the LiSN-S and LiSN-U as well as the Test of Auditory Processing Skills - Third Edition (TAPS-3) number memory forward and reversed subtests which assess short-term memory and working memory, respectively.Results: Moderate positive correlations were found between LiSN-S and LiSN-U spatially separated conditions (though this did not reach significance), and co-located conditions. Correlations between the LiSN-S and LiSN-U conditions and number memory forward and reversed subtests were not significant.Conclusion: This study shows a moderate relationship between the LiSN-S and LiSN-U when the distractors and target speech are co-located. A study with a larger sample of participants is needed to further understand the relationship between the two tests, especially for the spatially separated condition.

The development of the listening in spatialised noise - universal test (LiSN-U) and preliminary evaluation in English-speaking listeners.

Objective: To create a language independent version of the Listening in Spatialised Noise - Sentences test (LiSN-S) and evaluate it in an English-speaking population.Design: Test development and normative data collection. LiSN-Universal (LiSN-U) targets consisted of CVCV pseudo-words (e.g. /mupa/). Two looped distracter tracks consisted of CVCVCVCV pseudo-words. The listener's task was to repeat back the target pseudo-words. Stimuli were presented over headphones using an iPad. Speech reception thresholds were measured adaptively. In the co-located condition all stimuli came from directly in front. In the spatially-separated condition the distracters emanated from +90° and -90° azimuth. Perceived location was manipulated using head-related transfer functions. Spatial advantage was calculated as the difference in dB between the co-located and spatially separated conditions.Study samples: Stimulus intelligibility data were collected from 20 adults. Normative data were collected from native English speakers (23 adults and 127 children).Results: Children's spatially separated, co-located, and spatial advantage results improved significantly with age. Spatial advantage was 4-6 dB larger in the LiSN-U than LiSN-S depending on age group.Conclusion: Whereas additional research in non-native English populations is required, the LiSN-U appears to be an effective tool for measuring spatial processing ability.

Women's experiences of accessing postpartum intrauterine contraception in a public maternity setting: a qualitative service evaluation.

OBJECTIVES: The aims of the study were to explore women's experiences of an immediate postpartum intrauterine contraception (PPIUC) service recently introduced in a UK maternity setting, to identify areas for improvement and inform service provision. METHODS: Qualitative research was carried out in hospital and community maternity services in Lothian, UK. In-depth interviews were conducted with 35 women who had received PPIUC at vaginal or caesarean delivery. The interview data were analysed thematically to explore the women's experiences of PPIUC service provision. RESULTS: Women's decisions to choose PPIUC were influenced by their perception of intrauterine contraception (IUC) as a suitable and effective method and the convenience of immediate postpartum insertion. Most women were satisfied with their experience of PPIUC. Women delivering vaginally sometimes reported concerns about delays to insertion, particularly where they perceived a lack of communication from staff about when and where insertion would occur. PPIUC information was described as being difficult to absorb in the context of ante/postnatal information overload. Those receiving PPIUC at caesarean delivery sometimes expressed concerns about what post-insertion support might be available in primary care. CONCLUSION: Women typically reported satisfaction with their decision to have PPIUC. For maternity services considering introducing PPIUC, our findings reinforce the importance of anticipating and addressing implementation challenges in order to enhance women's experience of the service. These include ensuring that: clear and appropriate PPIUC information and support are provided antenatally; women are able to access PPIUC immediately after delivery; robust clinical pathways are in place to support post-insertion IUC care; and both staff and women are familiar with the clinical pathways.

Understanding the attitudes and acceptability of extra-genital Chlamydia testing in young women: evaluation of a feasibility study.

BACKGROUND: Chlamydia trachomatis (C. trachomatis) is the most common bacterial sexually transmitted infection in the UK. Recent studies suggest that in addition to the genital tract, C. trachomatis is found in the throat and rectum, suggesting the number of infections is under-reported. There is an urgent need to study the impact of extending diagnosis to include extra-genital samples; however, there is a lack of evidence on the acceptability of asking young women to provide these samples. METHOD: A mixed methods single group feasibility study explored the acceptability of combined genital and extra-genital testing in young women aged 16-25 years consecutively attending a sexual health centre in Edinburgh, Scotland. Young women were asked to complete a self- administered anonymous questionnaire whether they would be willing to give self-taken throat and ano-rectal samples. Interviews with women (n = 20) willing to self-sample were conducted before and after self-sampling, and these explored the underlying reasons behind their decision, and feelings about the tests. RESULTS: Of 500 women recruited to the study, 422 (84.4%) women provided sufficient data for analysis. From completed questionnaires, 86.3% of respondents reported willingness to self-sample from the throat. Willingness of ano-rectal self-sampling was lower (59.1%), particularly in women under 20 (< 20 years: 44.4%; ≥20 years, 68.2%). Willingness of ano-rectal self-sampling was higher in women who had more sexual partners in the last 6 months (0 partners, 48.3%, n = 14, 3 or more partners, 67.4%, n = 60) and in those who have previous experience of a positive test for a sexually transmitted infection (STI) (positive: 64.5%; negative: 57%). Interviewed women suggested that a lack of knowledge of STIs, embarrassment and lack of confidence in the ability to carry out the sampling were barriers towards acceptability. CONCLUSIONS: In this study, self-sampling of throat samples is largely acceptable; however, the acceptability of taking an ano-rectal sample for C. trachomatis testing in young women was lower in younger women. The study suggests further research to investigate the acceptability of extra-genital testing as an addition to routine C. trachomatis testing, and whether this increases detection and prevents infective sequelae for women.

Self-assessment of success of early medical abortion using a self-performed urine pregnancy test.

Purpose: The European Society of Contraception Expert Group on Abortion identified as one of its priorities the need to disseminate up-to-date evidence-based information on the use of urine pregnancy tests by women for the self assessment of the success of early medical abortion (EMA). Methods and materials: A concise communication was produced which summarises the latest research in an easy-to-read format suitable for busy clinicians. Information about individual urinary pregnancy tests is presented in boxes for ease of reference. Results: Urinary pregnancy tests (low sensitivity, high sensitivity and multilevel) can be used in combination with signs and symptoms of pregnancy to exclude an ongoing pregnancy after EMA. Conclusion: Women are able to determine the success of early medical abortion (EMA) themselves using a combination of signs, symptoms and a urine pregnancy test. This simplifies EMA, expands the range of professionals able to provide EMA and most importantly gives women greater control over their bodies and treatment.

Outcome of first trimester medical termination of pregnancy: definitions and management.

OBJECTIVE: Medical termination of pregnancy (MToP, or medical abortion) is a highly effective method with a reported efficacy of 95-98%. However, different criteria are currently used to define success, and there are different recommendations for the treatment of what is considered a failure of MToP. This work was undertaken to develop a consensus around a set of well-defined MToP outcomes, as recommended by the Core Outcomes in Women's and Newborn Health initiative. METHODS: A literature search was made of national and international guidelines and of recommendations of expert groups for various outcomes of MToP and subsequent management. Based on a review of the findings, a group of European experts in MToP undertook a consensus process to agree on a set of core MToP outcomes. RESULTS: The following core MToP outcomes were defined: success, failure (ongoing pregnancy), need for additional treatment (medical or surgical) to complete MToP (missed abortion, incomplete abortion), complications and the woman's request for additional treatment (medical or surgical). Recommendations for the management of unsuccessful outcomes were also formulated. CONCLUSION: New definitions of MToP outcomes that are more focused on objective criteria and consequently less dependent on provider interpretation are proposed. This should allow better comparison of the efficacy of different regimens and improve the management of failed or incomplete abortion.

Routine provision of intrauterine contraception at elective cesarean section in a national public health service: a service evaluation.

INTRODUCTION: We conducted a prospective health service evaluation to assess the feasibility and acceptability of routinely offering insertion of intrauterine contraception at cesarean section in a maternity setting in the UK. MATERIAL AND METHODS: One month before scheduled cesarean section, women were sent information about postpartum contraception including the option of insertion of an intrauterine contraception at cesarean. Women choosing intrauterine contraception (copper intrauterine device or levonorgestrel intrauterine system) were followed up in person at six weeks, and telephone contact was made at three, six and 12 months postpartum. Our main outcome measures were uptake of intrauterine contraception and complications by six weeks. Secondary outcomes were continuation and satisfaction with intrauterine contraception at 12 months. RESULTS: 120/877 women opted to have intrauterine contraception (13.7%), of which 114 were fitted. By six weeks, there were seven expulsions (6.1%). The expulsion rate by one year was 8.8%. There were no cases of uterine perforations and one case of infection (0.8%). Follow-up rates were 82.5% at 12 months, and continuation rates with intrauterine contraception at 12 months were 84.8% of those contacted. At 12 months, 92.7% of respondents asked were either 'very' or 'fairly' happy with their intrauterine contraception. CONCLUSIONS: Routine provision of intrauterine contraception at elective cesarean for women in a public maternity service is feasible and acceptable to women. It is associated with good uptake and good continuation rates for the first year. This could be an important strategy to increase use of intrauterine contraception and prevent short inter-pregnancy intervals and unintended pregnancies.