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Contraceptive Challenges in Women With Common Medical Conditions

Author/s: 
Gave, C.J., Marnach, M.L., Casey, P.M.

Women have the opportunity to meet personal contraceptive goals with convenient, highly reliable, and easily reversible methods. Long-acting reversible contraception represents an increasingly popular option for most women throughout the reproductive lifespan. Nonetheless, many women and their health care providers are challenged by coexisting medical issues. We aim to help clinicians individualize contraception and use shared decision-making to enhance patient satisfaction and continuation with their method.

Copyright © 2020. Published by Elsevier Inc.

Association of Menopausal Hormone Therapy With Breast Cancer Incidence and Mortality During Long-term Follow-up of the Women's Health Initiative Randomized Clinical Trials

Author/s: 
Chlebowski, R.T., Anderson, G.L., Aragaki, A.K., Manson, J.E., Stefanick, M.L., Pan, K., Barrington, W., Kuller, K.H., Simon, M.S., Lane, D., Johnson, K.C., Rohan, T.E., Gass, M.L.S., Cauler, C.A., Paskett, E.D., Sattari, M., Prentice, M.L.

Abstract

Importance: The influence of menopausal hormone therapy on breast cancer remains unsettled with discordant findings from observational studies and randomized clinical trials.

Objective: To assess the association of prior randomized use of estrogen plus progestin or prior randomized use of estrogen alone with breast cancer incidence and mortality in the Women's Health Initiative clinical trials.

Design, setting, and participants: Long-term follow-up of 2 placebo-controlled randomized clinical trials that involved 27 347 postmenopausal women aged 50 through 79 years with no prior breast cancer and negative baseline screening mammogram. Women were enrolled at 40 US centers from 1993 to 1998 with follow-up through December 31, 2017.

Interventions: In the trial involving 16 608 women with a uterus, 8506 were randomized to receive 0.625 mg/d of conjugated equine estrogen (CEE) plus 2.5 mg/d of medroxyprogesterone acetate (MPA) and 8102, placebo. In the trial involving 10 739 women with prior hysterectomy, 5310 were randomized to receive 0.625 mg/d of CEE alone and 5429, placebo. The CEE-plus-MPA trial was stopped in 2002 after 5.6 years' median intervention duration, and the CEE-only trial was stopped in 2004 after 7.2 years' median intervention duration.

Main outcomes and measures: The primary outcome was breast cancer incidence (protocol prespecified primary monitoring outcome for harm) and secondary outcomes were deaths from breast cancer and deaths after breast cancer.

Results: Among 27 347 postmenopausal women who were randomized in both trials (baseline mean [SD] age, 63.4 years [7.2 years]), after more than 20 years of median cumulative follow-up, mortality information was available for more than 98%. CEE alone compared with placebo among 10 739 women with a prior hysterectomy was associated with statistically significantly lower breast cancer incidence with 238 cases (annualized rate, 0.30%) vs 296 cases (annualized rate, 0.37%; hazard ratio [HR], 0.78; 95% CI, 0.65-0.93; P = .005) and was associated with statistically significantly lower breast cancer mortality with 30 deaths (annualized mortality rate, 0.031%) vs 46 deaths (annualized mortality rate, 0.046%; HR, 0.60; 95% CI, 0.37-0.97; P = .04). In contrast, CEE plus MPA compared with placebo among 16 608 women with a uterus was associated with statistically significantly higher breast cancer incidence with 584 cases (annualized rate, 0.45%) vs 447 cases (annualized rate, 0.36%; HR, 1.28; 95% CI, 1.13-1.45; P < .001) and no significant difference in breast cancer mortality with 71 deaths (annualized mortality rate, 0.045%) vs 53 deaths (annualized mortality rate, 0.035%; HR, 1.35; 95% CI, 0.94-1.95; P= .11).

Conclusions and relevance: 

In this long-term follow-up study of 2 randomized trials, prior randomized use of CEE alone, compared with placebo, among women who had a previous hysterectomy, was significantly associated with lower breast cancer incidence and lower breast cancer mortality, whereas prior randomized use of CEE plus MPA, compared with placebo, among women who had an intact uterus, was significantly associated with a higher breast cancer incidence but no significant difference in breast cancer mortality.

Association Between Plant and Animal Protein Intake and Overall and Cause-Specific Mortality

Author/s: 
Huang, J., Liao, L.M., Weinstein, S.J., Sinha, R., Graubard, B.I., Albanes, D.

Importance: Although emphasis has recently been placed on the importance of high-protein diets to overall health, a comprehensive analysis of long-term cause-specific mortality in association with the intake of plant protein and animal protein has not been reported.

Objective: To examine the associations between overall mortality and cause-specific mortality and plant protein intake.

Design, setting, and participants: This prospective cohort study analyzed data from 416 104 men and women in the US National Institutes of Health-AARP Diet and Health Study from 1995 to 2011. Data were analyzed from October 2018 through April 2020.

Exposures: Validated baseline food frequency questionnaire dietary information, including intake of plant protein and animal protein.

Main outcomes and measures: Hazard ratios and 16-year absolute risk differences for overall mortality and cause-specific mortality.

Results: The final analytic cohort included 237 036 men (57%) and 179 068 women. Their overall median (SD) ages were 62.2 (5.4) years for men and 62.0 (5.4) years for women. Based on 6 009 748 person-years of observation, 77 614 deaths (18.7%; 49 297 men and 28 317 women) were analyzed. Adjusting for several important clinical and other risk factors, greater dietary plant protein intake was associated with reduced overall mortality in both sexes (hazard ratio per 1 SD was 0.95 [95% CI, 0.94-0.97] for men and 0.95 [95% CI, 0.93-0.96] for women; adjusted absolute risk difference per 1 SD was -0.36% [95% CI, -0.48% to -0.25%] for men and -0.33% [95% CI, -0.48% to -0.21%] for women; hazard ratio per 10 g/1000 kcal was 0.88 [95% CI, 0.84-0.91] for men and 0.86 [95% CI, 0.82-0.90] for women; adjusted absolute risk difference per 10 g/1000 kcal was -0.95% [95% CI, -1.3% to -0.68%] for men and -0.86% [95% CI, -1.3% to -0.55%] for women; all P < .001). The association between plant protein intake and overall mortality was similar across the subgroups of smoking status, diabetes, fruit consumption, vitamin supplement use, and self-reported health status. Replacement of 3% energy from animal protein with plant protein was inversely associated with overall mortality (risk decreased 10% in both men and women) and cardiovascular disease mortality (11% lower risk in men and 12% lower risk in women). In particular, the lower overall mortality was attributable primarily to substitution of plant protein for egg protein (24% lower risk in men and 21% lower risk in women) and red meat protein (13% lower risk in men and 15% lower risk in women).

Conclusions and relevance: In this large prospective cohort, higher plant protein intake was associated with small reductions in risk of overall and cardiovascular disease mortality. Our findings provide evidence that dietary modification in choice of protein sources may influence health and longevity.

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Association Between Age and Complications After Outpatient Colonoscopy

Author/s: 
Causada-Calo, N., Bishay, K., Albashir, S., Mazroui, A.A., Armstrong, D.

Abstract

Importance: There are insufficient data describing the incidence and risk factors of postcolonoscopy complications in older individuals.

Objective: To assess the association between older age (≥75 years) and the risk of postcolonoscopy complications.

Design, setting, and participants: This population-based retrospective cohort study included adults (≥50 years) undergoing outpatient colonoscopy between April 2008 and September 2017, identified from Ontario administrative databases. Individuals with inflammatory bowel disease and hereditary colorectal cancer syndromes were excluded. The study population was subdivided into a colorectal cancer screening-eligible cohort (patients aged 50-74 years) and an older cohort (patients aged ≥75 years). The statistical analysis was conducted from December 2018 to September 2019.

Exposures: Older age (≥75 years).

Main outcomes and measures: The primary outcome was postcolonoscopy complications, defined as the composite of hospitalization or emergency department visits in the 30-day period after the outpatient colonoscopy. Secondary outcomes included incidence of surgically treated colorectal cancer and all-cause mortality at 30 days. Independent variables associated with postcolonoscopy complications were also assessed.

Results: The study sample included 38 069 patients; the mean (SD) age was 65.2 (10.1) years, there were 19 037 women (50.0%), and 27 831 patients (73.1%) underwent a first colonoscopy. The cumulative incidence of complications was 3.4% (1310 patients) in the overall population, and it was higher in individuals aged 75 years or older (515 of 7627 patients [6.8%]) than in screening-eligible cohort (795 of 30 443 patients [2.6%]) (P < .001). Independent risk factors for postcolonoscopy complications were age 75 years or older (odds ratio [OR], 2.3; 95% CI, 2.0-2.6), anemia (OR, 1.4; 95% CI, 1.2-1.7), cardiac arrhythmia (OR, 1.7; 95% CI, 1.2-2.2), congestive heart failure (OR, 3.4; 95% CI, 2.5-4.6), hypertension (OR, 1.2; 95% CI, 1.0-1.5), chronic kidney disease (OR, 1.8; 95% CI, 1.1-3.0), liver disease (OR, 4.7; 95% CI, 3.5-6.5), smoking history (OR, 3.2; 95% CI, 2.4-4.3), and obesity (OR, 2.3; 95% CI, 1.2-4.2). The number of previous colonoscopies was associated with a lower risk of complications (OR, 0.9; 95% CI, 0.7-1.0). The incidence of surgically treated colorectal cancer was higher in the older cohort than the screening-eligible cohort (119 patients [1.6%] vs 144 patients [0.5%]; P < .001). All-cause mortality rates were 0.1% overall (39 patients) and 0.1% (19 patients) for individuals aged 50 to 74 years and 0.2% (20 patients) for those aged 75 years and older (P < .001).

Conclusions and relevance: In this population-based cohort study of individuals living in southern Ontario, age of 75 years and older was associated with a higher risk of 30-day postprocedure complications after outpatient colonoscopy. These findings suggest that the decision to perform a colonoscopy should be carefully considered in patients older than 75 years, especially in the presence of comorbidities. Further studies are needed to better understand the benefits of invasive procedures as opposed to less invasive approaches for colorectal cancer screening and surveillance among older patients.

Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care on Reducing Pneumonia Incidence: A Cluster Randomized Trial

Author/s: 
Zimmerman, S., Sloane, P.D., Ward, K., Wretman, C.J., Stearns, S.C., Poole, P., Preisser, J.S.

Abstract

Importance: Pneumonia affects more than 250 000 nursing home (NH) residents annually. A strategy to reduce pneumonia is to provide daily mouth care, especially to residents with dementia.

Objective: To evaluate the effectiveness of Mouth Care Without a Battle, a program that increases staff knowledge and attitudes regarding oral hygiene, changes mouth care, and improves oral hygiene, in reducing the incidence of pneumonia among NH residents.

Design, setting, and participants: This pragmatic cluster randomized trial observing 2152 NH residents for up to 2 years was conducted from September 2014 to May 2017. Data collectors were masked to study group. The study included 14 NHs from regions of North Carolina that evidenced proportionately high rehospitalization rates for pneumonia and long-term care residents. Nursing homes were pair matched and randomly assigned to intervention or control groups.

Intervention: Mouth Care Without a Battle is a standardized program that teaches that mouth care is health care, provides instruction on individualized techniques and products for mouth care, and trains caregivers to provide care to residents who are resistant and in special situations. The control condition was standard mouth care.

Main outcomes and measures: Pneumonia incidence (primary) and hospitalization and mortality (secondary), obtained from medical records.

Results: Overall, the study enrolled 2152 residents (mean [SD] age, 79.4 [12.4] years; 1281 [66.2%] women; 1180 [62.2%] white residents). Participants included 1219 residents (56.6%) in 7 intervention NHs and 933 residents (43.4%) in 7 control NHs. During the 2-year study period, the incidence rate of pneumonia per 1000 resident-days was 0.67 and 0.72 in the intervention and control NHs, respectively. Neither the primary (unadjusted) nor secondary (covariate-adjusted) analyses found a significant reduction in pneumonia due to Mouth Care Without a Battle during 2 years (unadjusted incidence rate ratio, 0.90; upper bound of 1-sided 95% CI, 1.24; P = .27; adjusted incidence rate ratio, 0.92; upper bound of 1-sided 95% CI, 1.27; P = .30). In the second year, the rate of pneumonia was nonsignificantly higher in intervention NHs. Adjusted post hoc analyses limited to the first year found a significant reduction in pneumonia incidence in intervention NHs (IRR, 0.69; upper bound of 1-sided 95% CI, 0.94; P = .03).

Conclusions and relevance: This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year. The lack of significant results in the second year may be associated with sustainability. Improving mouth care in US NHs may require the presence and support of dedicated oral care aides.

Return to Sport Following Adolescent Concussion: Epidemiologic Findings From a High School Population

Author/s: 
Jildeh, T.R., Okoroha, K.R., Denha, E., Eyers, C., Johnson, A., Shehab, R.

Abstract

High school athletes sustaining a concussion require careful attention when determining return-to-sport (RTS) readiness. The purpose of this study was to determine epidemiological and RTS data of a large cohort of high school athletes who sustained 1 or more concussions. Records of 357 consecutive youth patients who sustained concussions and presented to a single health care system between September 2013 and December 2016 were reviewed. Demographic data, RTS, and concussion-related variables were obtained via chart review. Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) scores at baseline and following concussions were performed by neuropsychologists. The average age at injury was 15.5 years (range, 14-18 years), 61.9% of patients were male, 6.7% reported a loss of consciousness, and 14.3% reported amnesia, requiring 30.4±23.3 days of recovery prior to RTS. The most common sport of injury was football (27.7%). There was a high incidence of previous concussion (33.1%), and 32 athletes sustained a recurrent concussion. A multivariate model demonstrated that females, players with a history of concussion, and those diagnosed in-clinic rather than in-game required increased time to RTS. Memory ImPACT scores were found to increase as players had recurrent concussions. Visual motor speed and reaction time scores decreased with recurrent concussions. [Orthopedics. 2020;43(x):xx-xx.].

Copyright 2020, SLACK Incorporated.

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Author/s: 
Cohen, C.R., Wierzbicki, C.R., French, A.L., Morris, S., Newmann, S., Reno, H., Green, L., Miller, S., Powell, J., Parks, T., Hemmerling, S.

Abstract

Background: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.

Methods: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.

Results: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.

Conclusions: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

Copyright © 2020 Massachusetts Medical Society.

Management of Kidney Stones in 2020

Author/s: 
Rule, AD, Lieske, JC, Pais, VM Jr

Kidney stones are common, painful, and frequently recur. Although precise estimates of the incidence of symptomatic kidney stones for the entire US are unavailable, a Minnesota population-based study reported that between 1984 and 2012, the incidence of symptomatic kidney stones that required treatment increased from 51 to 217 per 100 000 person-years in women and from 145 to 299 per 100 000 person-years in men.

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