Short-term recovery after NovaSure® endometrial ablation: a prospective cohort study.

Background: Endometrial ablation is a frequently performed treatment for heavy menstrual bleeding, but detailed information about recovery to help inform patients is lacking. Objective: To gain more insight into the short-term recovery after NovaSure® endometrial ablation, with the goal of improving preprocedural counselling. Materials and Methods: A total of 61 women who underwent endometrial ablation between March 2019 and November 2021 in a teaching hospital in the Netherlands were included in this prospective cohort study. Main outcome measures: Short-term recovery was investigated through questionnaires in the first week after the procedure. The primary outcome was the Recovery Index (RI-10). Secondary outcomes included health-related quality of life (EQ-5D-5L), pain intensity, use of analgesics, nausea, vaginal discharge, capability of performing activities (domestic chores, sports, work), self-rated health (EQ-VAS) and the feeling of full recovery. Results: A total of 33 women underwent the procedure under local anaesthesia and 28 women under procedural sedation. The RI-10 increased in the first week; median scores on day one, two and seven were 34 (IQR 28.5-41.5), 38.5 (IQR 31-47), and 42 (IQR 37.5-48), respectively. The median time for full recovery was five days. However, 23% of all women were not fully recovered within seven days. Women needed a median time of two days for returning to their work and 5.5 days for sporting activities. There were no differences in recovery between both anaesthesia techniques. Conclusions: Women undergoing endometrial ablation can be informed that most will fully recover within the first week of the procedure and that there is no difference in expected recovery time according to whether the procedure is undertaken with local anaesthesia or conscious sedation. What is New?: The short-term recovery after endometrial ablation has been mapped in this trial. This information can be used in counselling women with heavy menstrual bleeding.

Intrauterine fundal anaesthesia during endometrial ablation in the office: A randomised double-blind, non-inferiority trial.

OBJECTIVE: To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation. STUDY DESIGN: A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods. RESULTS: Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women). CONCLUSION: This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.

Two dietary advice strategies to increase protein intake among community-dwelling older adults: A feasibility study.

BACKGROUND & AIMS: Expert groups propose that recommendations for protein intake for older adults should be increased to compensate for a blunted anabolic response to protein. As many older adults do not meet the (current and higher) recommendations, we examined the feasibility of two dietary advice strategies to increase protein intake following either an even distribution of protein over the day ('even' strategy) or a peak in protein during one meal moment ('peak' strategy). METHODS: This randomized controlled trial examined the feasibility (effectiveness and appreciation) of an 'even' or 'peak' dietary advise strategy on increasing protein intake after four weeks among community-dwelling older adults aged ≥65 y. Participants (n = 60) were randomized into one of the three groups; two intervention groups ('even' or 'peak' strategy) and one control group. Participants of both intervention groups with a baseline protein intake <0.9 g/kg adjusted body weight (aBW)/day received personalized dietary advice and protein enriched food products to increase their protein intake to at least 1.2 g/kg aBW/day, and those with an intake between 0.9 and 1.2 g/kg aBW/day to increase their protein intake with 0.3 g/kg aBW/day. When current intake was higher than 1.2 g/kg aBW/day they received advice to follow the strategy without increasing protein intake. The 'even' group was advised to consume a maximum of 20 g of protein during each meal or snack moment while the 'peak' group was advised to consume at least one daily meal with 35-45 g of protein. Effectiveness to increase protein intake was assessed by three 24-h recalls after four weeks and appreciation of the dietary strategies by a five point scale questionnaire. RESULTS: Baseline protein intake was 71.0 ± 12.1 g/day in participants with a protein intake <1.2 g/kg aBW/day. Protein increased significantly more in both intervention groups (+28.9 ± 22.9 g/day for the 'even' group and +21.8 ± 21.4 g/day for the 'peak' group) versus control (+5.7 ± 13.0 g/day), and participants following the 'peak' strategy more often had at least one meal per day very high in protein (≥35 g). Both intervention groups considered the advice to increase protein as (very) clear (100% and 93.6% for the 'even' and 'peak' strategy), and most reported they would (partly) continue following the advice (81% and 88% for the 'even' and 'peak' strategy). CONCLUSIONS: The 'even' and 'peak' dietary advice strategies were effective in increasing protein intake in four weeks and both well appreciated by community-dwelling older adults. The study is registered in The Netherlands National Trial Register (NTR6849).

The effect of music in gynaecological office procedures on pain, anxiety and satisfaction: a randomized controlled trial.

BACKGROUND: Pain can interfere with office procedures in gynaecology. The aim of this study is to measure the positive effect of music in gynaecological office procedures. METHODS: A randomized controlled trial was performed between October 2014 and January 2016. Women scheduled for an office hysteroscopy or colposcopy were eligible for randomization in the music group or control group. Stratification for hysteroscopy and colposcopy took place. The primary outcome is patients' level of pain during the procedure measured by the visual analogue scale (VAS). Secondary outcomes include patients' level of pain after the procedure, anxiety and satisfaction of patient and doctor. RESULTS: No positive effect of music on patients' perception of pain during the procedure was measured, neither for the hysteroscopy group (57 mm vs. 52 mm) nor for the colposcopy group (32 mm vs. 32 mm). Secondary outcomes were also similar for both groups. CONCLUSIONS: This study showed no positive effect of music on patients' level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. We believe a multimodal approach has to be used to decrease patient distress in terms of pain and anxiety, with or without music. TRIAL REGISTRATION: Dutch Trial Register, NTR4924.

Polyunsaturated fatty acids in relation to incident mobility disability and decline in gait speed; the Age, Gene/Environment Susceptibility-Reykjavik Study.

BACKGROUND/OBJECTIVES: Low intake of long chain polyunsaturated fatty acids (PUFAs) are associated with physical disability; however, prospective studies of circulating PUFAs are scarce. We examined associations between plasma phospholipid n-3 and n-6 PUFAs with risk of incident mobility disability and gait speed decline. SUBJECTS/METHODS: Data are from a subgroup of the Age, Gene/Environment Susceptibility-Reykjavik Study, a population-based study of risk factors for disease and disability in old age. In this subgroup (n = 556, mean age 75.1 ± 5.0 years, 47.5% men), plasma phospholipid PUFAs were assessed at baseline using gas chromatography. Mobility disability and usual gait speed were assessed at baseline and after 5.2 ± 0.2 years. Mobility disability was defined as the following: having much difficulty, or being unable to walk 500 m or climb up 10 steps; decline in gait speed was defined as change ⩾ 0.10 m/s. Logistic regression analyses were performed to determine associations between sex-specific s.d. increments in PUFAs with risk of incident mobility disability and gait speed decline. Odds ratios (95% confidence intervals) adjusted for demographics, follow-up time, risk factors and serum vitamin D were reported. RESULTS: In women, but not men, every s.d. increment increase of total n-3 PUFAs and docosahexaenoic acid (DHA) was associated with lower mobility disability risk, odds ratio 0.48 (0.25; 0.93) and odds ratio 0.45 (0.24; 0.83), respectively. There was no association between n-6 PUFAs and the risk of incident mobility disability or gait speed decline. CONCLUSIONS: Higher concentrations of n-3 PUFAs and, particularly, DHA may protect women from impaired mobility but does not appear to have such an effect in men.

Associations of serum n-3 and n-6 polyunsaturated fatty acids with echocardiographic measures among older adults: the Hoorn Study.

BACKGROUND/OBJECTIVES: Lower circulating polyunsaturated fatty acids (PUFAs) may induce loss of heart function. We investigated whether lower concentrations of n-3 and n-6 PUFAs were associated with less favourable echocardiographic measures and higher heart rate in older Caucasians, cross-sectionally and after 7 years of follow-up. SUBJECTS/METHODS: We used data from the Hoorn Study, a population-based cohort. Cross-sectional data were available for 621 participants and longitudinal data for 336 participants. Mean age was 68.6±6.8 years at baseline. We performed linear regression analyses using n-3 and n-6 PUFAs quartiles-assayed by gas liquid chromatography-with left ventricular ejection fraction (LVEF), left ventricular mass index, left atrial volume index and heart rate. RESULTS: In multivariable analyses (regression coefficient (95% confidence interval)), the lowest eicosapentaenoic acid and docosahexaenoic acid quartiles compared with the highest quartiles were cross-sectionally associated with lower LVEF. Lower eicosapentaenoic acid and docosahexaenoic acid concentrations were associated with higher heart rate: 3.7 b.p.m. (1.5, 6.0; P for trend <0.001) and 3.4 b.p.m. (1.2, 5.6; P for trend 0.001), respectively. Multivariate longitudinal analyses showed a significant trend across quartiles for alpha-linolenic acid in relation to LVEF. The lowest linoleic acid quartile was significantly associated with a decreased LVEF of -4.0% compared with the highest quartile. CONCLUSIONS: This study found no strong evidence of longitudinal associations of eicosapentaenoic acid and docosahexaenoic acid with echocardiographic measures, however, lower concentrations of alpha-linolenic acid and linoleic acid were associated with decreased LVEF. These results provide evidence for a potential protective role of alpha-linolenic acid and linoleic acid in relation to systolic function.

Serum parathyroid hormone in relation to all-cause and cardiovascular mortality: the Hoorn study.

CONTEXT: Higher PTH concentrations have been associated with fatal cardiovascular diseases (CVDs), but data in the general population are scarce. OBJECTIVE: We investigated whether higher PTH concentrations are prospectively associated with all-cause and CVD mortality. DESIGN, SETTING, PARTICIPANTS: This study used data from the Hoorn Study, a prospective population-based cohort with baseline measurements between 2000 and 2001. We included 633 participants, mean age 70.1 ± 6.6 years, 51% female. Serum intact PTH was measured using a 2-site immunoassay. MAIN OUTCOME MEASURES: Outcomes were all-cause and CVD mortality based on clinical files and coded according to the International Classification of Diseases, ninth revision. We used Kaplan-Meier plots to estimate survival curves and Cox regression to estimate hazard ratios (HRs) using season-specific PTH quartiles. RESULTS: During a median follow-up of 7.8 years, 112 participants died, of which 26 deaths (23%) were cardiovascular. Survival curves by PTH quartiles differed for all-cause mortality (log-rank P = .054) and CVD mortality (log-rank P = .022). In a multivariate model, the highest PTH quartile was associated with all-cause mortality; HR = 1.98 (1.08, 3.64). Kidney function slightly attenuated the PTH risk association, but risk persisted; HR = 1.93 (1.04, 3.58). The results for CVD mortality showed a similar pattern, although the association was significant only in a threshold model (quartile 4 vs quartile 1-3); HR = 2.56 (1.11, 5.94). CONCLUSIONS: Among a general older population, higher PTH concentrations were associated with higher all-cause mortality risk, mostly explained by fatal CVD events. We suggest to evaluate whether individuals with high PTH concentrations benefit from therapeutic approaches targeted to decrease PTH concentrations.

Association of serum n-3 polyunsaturated fatty acids with C-reactive protein in men.

BACKGROUND/OBJECTIVES: N-3 polyunsaturated fatty acids (PUFAs) have been associated with reduced inflammation. We tested the hypothesis that high serum concentrations of the n-3 PUFAs are associated with lower serum C-reactive protein (CRP) concentrations in healthy middle-aged Finnish men. We also examined whether exposure to mercury, an environmental contaminant in fish, which is also a major source of long-chain n-3 PUFA, was associated with CRP. SUBJECTS/METHODS: Data from the prospective, population-based Kuopio Ischaemic Heart Disease Risk Factor Study were analyzed cross-sectionally to determine the associations between serum n-3 PUFAs, hair mercury and serum CRP in 1395 healthy men, aged 42-60 years. Linear regression analyses were performed to analyze the associations. RESULTS: In the multivariate models, the mean serum CRP in quartiles of serum total n-3 PUFA concentration was 1.23, 1.27, 1.18 and 1.08 mg/l, P for trend = 0.01. Statistically significant inverse associations were also observed with the total serum long-chain n-3 PUFA concentration and with the individual long-chain n-3 PUFAs docosapentaenoic acid and docosahexaenoic acid, but not with eicosapentaenoic acid or with the intermediate-chain n-3 PUFA alpha-linolenic acid. Hair methylmercury content was not associated with serum CRP levels and it did not modify the associations between serum n-3 PUFAs and CRP either. CONCLUSIONS: Serum n-3 PUFAs and especially the long-chain n-3 PUFA concentration, a marker of fish or fish oil consumption, were inversely associated with serum CRP in men. Exposure to mercury was not associated with serum CRP.