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1.
Cochrane Database Syst Rev ; 2: CD006712, 2024 02 13.
Article in English | MEDLINE | ID: mdl-38348912

ABSTRACT

BACKGROUND: Abortions prior to 14 weeks are among the most common outpatient surgical procedures performed on people capable of becoming pregnant. Various methods have been used to control pain; however, many people still experience pain with the procedure. OBJECTIVES: To evaluate the benefits and harms of local anaesthesia given for pain control during surgical abortion at less than 14 weeks' gestation. SEARCH METHODS: We searched CENTRAL (Ovid EBM Reviews), MEDLINE (Ovid), Embase, POPLINE, and Google Scholar to December 2022 for randomized controlled trials of pain control in surgical abortion at less than 14 weeks' gestation using suction aspiration. We searched the reference lists of related reviews and articles. SELECTION CRITERIA: We selected effectiveness and comparative effectiveness randomized controlled trials that studied local anaesthesia with common local anaesthetics and administration routes given for pain control in surgical abortion at less than 14 weeks' gestation using uterine aspiration. Outcomes included intraoperative pain, patient satisfaction, and adverse events. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We computed mean differences (MD) with 95% confidence intervals (CI) for continuous variables reporting a mean. We assessed the certainty of evidence using GRADE. MAIN RESULTS: Thirteen studies with 1992 participants met the inclusion criteria. Due to heterogeneity of interventions, we could not pool more than two studies for any outcome. We used 13 mm improvement on a visual/verbal analogue scale to indicate a clinically meaningful difference in pain with surgical abortion (pain with dilation, aspiration, or during procedure). Based on type of pain control, we divided studies into three groups. Paracervical block (PCB) effectiveness trials A 20 mL 1% lidocaine PCB reduced pain with dilation (MD -37.00, 95% CI -45.64 to -28.36), and aspiration (MD -26.00, 95% CI -33.48 to -18.52) compared to a sham PCB (1 RCT, 120 participants; high-certainty evidence). A PCB with 14 mL of 1% chloroprocaine resulted in a slight reduction in pain with aspiration compared to a PCB with normal saline injected at two or four sites (MD -1.50, 95% CI -2.45 to -0.55; 1 RCT, 79 participants; high-certainty evidence). PCB comparative effectiveness trials An ultracaine PCB probably results in little to no clinically meaningful difference in pain during procedure compared to topical cervical lidocaine spray (median 1 point higher, interquartile range (IQR) 0 to 3; P < 0.001; 1 RCT, 48 participants; moderate-certainty evidence). A 1000 mg dose of intravenous paracetamol probably does not decrease pain as much as ultracaine PCB during procedure (median 2 points higher, IQR 1 to 3; P < 0.001; 1 RCT, 46 participants; moderate-certainty evidence). Various local anaesthetics in PCB comparative effectiveness trials A 10 mL buffered 2% lidocaine PCB probably does not result in a clinically meaningful difference in pain with dilation compared to a plain lidocaine PCB (MD -0.80, 95% CI -0.89 to -0.71; 1 RCT, 167 participants; moderate-certainty evidence). A buffered lidocaine PCB probably does not result in a clinically meaningful difference in pain with aspiration compared to plain lidocaine PCB (MD -0.57, 95% CI -1.01 to -0.06; 2 RCTs, 291 participants; moderate-certainty evidence). Non-PCB local anaesthesia or PCB technique effectiveness trials PCB: waiting versus no waiting Waiting three to five minutes between 1% lidocaine PCB injection and dilation probably does not result in a clinically meaningful difference in pain with dilation compared to not waiting (MD -0.70, 95% CI -1.23 to -0.17; 2 RCTs, 357 participants; moderate-certainty evidence). Topical cervical analgesia Topical 10 mL 2% lignocaine gel probably does not result in a clinically meaningful difference in pain with aspiration compared to KY Jelly (MD -0.87, 95% CI -1.60 to -0.14; 1 RCT, 131 participants; moderate-certainty evidence). In participants who also received a PCB, 20 mg topical cervical lidocaine spray probably does not result in a clinically meaningful difference in pain during the procedure compared to two pumps of normal saline spray (median -1 point, IQR -2 to -1; P < 0.001; 1 RCT, 55 participants; moderate-certainty evidence). Intravenous paracetamol 1000 mg compared to two pumps of cervical lidocaine spray probably does not results in a clinically meaningful difference in pain procedure (median 1 point, IQR -2 to 2; P < 0.001; 1 RCT, 48 participants; low-certainty evidence). Non-PCB local anaesthesia or PCB technique comparative effectiveness trials Depth of PCB The evidence suggests that a 3-cm deep PCB probably does not result in a clinically meaningful difference in pain with aspiration compared to a 1.5-cm deep PCB (MD -1.00, 95% CI -1.09 to -0.91; 2 RCTs, 229 participants; low-certainty evidence). PCB: four sites versus two sites A two-site (4-8 o'clock) 20 mL 1% lidocaine PCB does not result in a clinically meaningful difference in pain with dilation compared to a four-site (2-4-8-10 o'clock) PCB (MD 8.60, 95% CI 0.69 to 16.51; 1 RCT, 163 participants; high-certainty evidence). Overall, participants reported moderately high satisfaction with pain control and studies reported few adverse events. AUTHORS' CONCLUSIONS: Evidence from this updated review indicates that a 20 mL 1% plain lidocaine PCB decreases pain during an abortion procedure. Evidence supports forgoing buffering lidocaine and a wait time between PCB injection and cervical dilation. A 1.5-cm deep injection as opposed to a 3-cm deep injection is sufficient. A two-site PCB injection as opposed to a four-site injection has similar effectiveness. Topical cervical anaesthesia (10 mL 2% lignocaine gel or 20 mg topical cervical lidocaine spray) as compared to placebo did not decrease pain based on moderate-certainty evidence, but then when compared to PCB, pain control was similar. Due to this inconsistency in evidence regarding the effectiveness of topical anaesthesia, its routine use is presently not supported. This review did not include studies of pain management with conscious sedation but, based on the results of our prior Cochrane review and the 2022 WHO guidelines, we recommend that the option of combination of pain management using conscious sedation plus PCB and non-steroidal anti-inflammatory drugs should be offered where conscious sedation is available as it further decreases pain.


Subject(s)
Anesthetics, Local , Pain Management , Pregnancy , Female , Humans , Pain Management/methods , Anesthesia, Local , Acetaminophen , Carticaine , Pregnancy Trimester, First , Saline Solution , Pain , Lidocaine
2.
JAMA ; 331(22): 1931-1946, 2024 06 11.
Article in English | MEDLINE | ID: mdl-38687490

ABSTRACT

Importance: Breast cancer is a leading cause of cancer mortality for US women. Trials have established that screening mammography can reduce mortality risk, but optimal screening ages, intervals, and modalities for population screening guidelines remain unclear. Objective: To review studies comparing different breast cancer screening strategies for the US Preventive Services Task Force. Data Sources: MEDLINE, Cochrane Library through August 22, 2022; literature surveillance through March 2024. Study Selection: English-language publications; randomized clinical trials and nonrandomized studies comparing screening strategies; expanded criteria for screening harms. Data Extraction and Synthesis: Two reviewers independently assessed study eligibility and quality; data extracted from fair- and good-quality studies. Main Outcomes and Measures: Mortality, morbidity, progression to advanced cancer, interval cancers, screening harms. Results: Seven randomized clinical trials and 13 nonrandomized studies were included; 2 nonrandomized studies reported mortality outcomes. A nonrandomized trial emulation study estimated no mortality difference for screening beyond age 74 years (adjusted hazard ratio, 1.00 [95% CI, 0.83 to 1.19]). Advanced cancer detection did not differ following annual or biennial screening intervals in a nonrandomized study. Three trials compared digital breast tomosynthesis (DBT) mammography screening with digital mammography alone. With DBT, more invasive cancers were detected at the first screening round than with digital mammography, but there were no statistically significant differences in interval cancers (pooled relative risk, 0.87 [95% CI, 0.64-1.17]; 3 studies [n = 130 196]; I2 = 0%). Risk of advanced cancer (stage II or higher) at the subsequent screening round was not statistically significant for DBT vs digital mammography in the individual trials. Limited evidence from trials and nonrandomized studies suggested lower recall rates with DBT. An RCT randomizing individuals with dense breasts to invitations for supplemental screening with magnetic resonance imaging reported reduced interval cancer risk (relative risk, 0.47 [95% CI, 0.29-0.77]) and additional false-positive recalls and biopsy results with the intervention; no longer-term advanced breast cancer incidence or morbidity and mortality outcomes were available. One RCT and 1 nonrandomized study of supplemental ultrasound screening reported additional false-positives and no differences in interval cancers. Conclusions and Relevance: Evidence comparing the effectiveness of different breast cancer screening strategies is inconclusive because key studies have not yet been completed and few studies have reported the stage shift or mortality outcomes necessary to assess relative benefits.


Subject(s)
Breast Neoplasms , Early Detection of Cancer , Mammography , Humans , Breast Neoplasms/diagnosis , Breast Neoplasms/mortality , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/prevention & control , Female , Aged , Middle Aged , Ultrasonography, Mammary , Mass Screening , United States/epidemiology , Practice Guidelines as Topic
3.
Clin Infect Dis ; 76(3): e51-e59, 2023 02 08.
Article in English | MEDLINE | ID: mdl-35959949

ABSTRACT

BACKGROUND: Identifying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections during peripartum hospitalizations is important to guide care, implement prevention measures, and understand infection burden. METHODS: This cross-sectional analysis used electronic health record data from hospitalizations during which pregnancies ended (peripartum hospitalizations) among a cohort of pregnant persons at 3 US integrated healthcare networks (sites 1-3). Maternal demographic, medical encounter, SARS-CoV-2 testing, and pregnancy and neonatal outcome information was extracted for persons with estimated delivery and pregnancy end dates during March 2020-February 2021 and ≥1 antenatal care record. Site-stratified multivariable logistic regression was used to identify factors associated with testing and compare pregnancy and neonatal outcomes among persons tested. RESULTS: Among 17 858 pregnant persons, 10 863 (60.8%) had peripartum SARS-CoV-2 testing; 222/10 683 (2.0%) had positive results. Testing prevalence varied by site and was lower during March-May 2020. Factors associated with higher peripartum SARS-CoV-2 testing odds were Asian race (adjusted odds ratio [aOR]: 1.36; 95% confidence interval [CI]: 1.03-1.79; referent: White) (site 1), Hispanic or Latino ethnicity (aOR: 1.33; 95% CI: 1.08-1.64) (site 2), peripartum Medicaid coverage (aOR: 1.33; 95% CI: 1.06-1.66) (site 1), and preterm hospitalization (aOR: 1.69; 95% CI: 1.19-2.39 [site 1]; aOR: 1.39; 95% CI: 1.03-1.88 [site 2]). CONCLUSIONS: Findings highlight potential disparities in SARS-CoV-2 peripartum testing by demographic and pregnancy characteristics. Testing practice variations should be considered when interpreting studies relying on convenience samples of pregnant persons testing positive for SARS-CoV-2. Efforts to address testing differences between groups could improve equitable testing practices and care for pregnant persons with SARS-CoV-2 infections.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Infant, Newborn , Female , Pregnancy , Humans , SARS-CoV-2 , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , Cross-Sectional Studies , Peripartum Period , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/epidemiology , Hospitalization
4.
Cochrane Database Syst Rev ; 1: CD014908, 2023 01 09.
Article in English | MEDLINE | ID: mdl-36622724

ABSTRACT

BACKGROUND: The novel coronavirus disease (COVID-19) has led to significant mortality and morbidity, including a high incidence of related thrombotic events. There has been concern regarding hormonal contraception use during the COVID-19 pandemic, as this is an independent risk factor for thrombosis, particularly with estrogen-containing formulations. However, higher estrogen levels may be protective against severe COVID-19 disease. Evidence for risks of hormonal contraception use during the COVID-19 pandemic is sparse. We therefore conducted a living systematic review that will be updated as new data emerge on the risk of thromboembolism with hormonal contraception use in patients with COVID-19. OBJECTIVES: To determine if use of hormonal contraception increases risk of venous and arterial thromboembolism in women with COVID-19. To determine if use of hormonal contraception increases other markers of COVID-19 severity including hospitalization in the intensive care unit, acute respiratory distress syndrome, intubation, and mortality. A secondary objective is to maintain the currency of the evidence, using a living systematic review approach. SEARCH METHODS: ⁠⁠⁠⁠⁠⁠We searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Global Health, and Scopus from inception to search update in March 2022. For the living systematic review, we monitored the literature monthly. SELECTION CRITERIA: We included all published and ongoing studies of patients with COVID-19 comparing outcomes of those on hormonal contraception versus those not on hormonal contraception. This included case series and non-randomized studies of interventions (NRSI). DATA COLLECTION AND ANALYSIS: One review author extracted study data and this was checked by a second author. Two authors individually assessed risk of bias for the comparative studies using the ROBINS-I tool and a third author helped reconcile differences. For the living systematic review, we will publish updates to our synthesis every six months. In the event that we identify a study with a more rigorous study design than the current included evidence prior to the planned six-month update, we will expedite the synthesis publication. MAIN RESULTS: We included three comparative NRSIs with 314,704 participants total and two case series describing 13 patients. The three NRSIs had serious to critical risk of bias in several domains and low study quality. Only one NRSI ascertained current use of contraceptives based on patient report; the other two used diagnostic codes within medical records to assess hormonal contraception use, but did not confirm current use nor indication for use. None of the NRSIs included thromboembolism as an outcome. Studies were not similar enough in terms of their outcomes, interventions, and study populations to combine with meta-analyses. We therefore narratively synthesized all included studies. Based on results from one NRSI, there may be little to no effect of combined hormonal contraception use on odds of mortality for COVID-19 positive patients (odds ratio (OR) 1.00, 95% confidence interval (CI) 0.41 to 2.40; 1 study, 18,892 participants; very low-certainty evidence). Two NRSIs examined hospitalization rates for hormonal contraception users versus non-users. Based on results from one NRSI, the odds of hospitalization for COVID-19 positive combined hormonal contraception users may be slightly decreased compared with non-users for patients with body mass index (BMI) under 35 kg/m2 (OR 0.79, 95% CI 0.64 to 0.97; 1 study, 295,689 participants; very low-certainty evidence). According to results of the other NRSI assessing use of any type of hormonal contraception, there may be little to no effect on hospitalization rates for COVID-19 positive individuals (OR 0.99, 95% CI 0.68 to 1.44; 1 study, 123 participants; very low-certainty evidence). We included two case series because no comparative studies directly assessed thromboembolism as an outcome. In a case series of six pediatric COVID-19 positive patients with pulmonary embolism, one (older than 15 years of age) was using combined hormonal contraception. In a second case series of seven COVID-19 positive patients with cerebral venous thrombosis, one was using oral contraceptives. One comparative study and one case series reported on intubation rates, but the evidence for both is very uncertain. In the comparative study of 123 COVID-19 positive patients (N = 44 using hormonal contraception and N = 79 not using hormonal contraception), no patients in either group required intubation. In the case series of seven individuals with cerebral venous thromboembolism, one oral contraceptive user and one non-user required intubation. AUTHORS' CONCLUSIONS: There are no comparative studies assessing risk of thromboembolism in COVID-19 patients who use hormonal contraception, which was the primary objective of this review. Very little evidence exists examining the risk of increased COVID-19 disease severity for combined hormonal contraception users compared to non-users of hormonal contraception, and the evidence that does exist is of very low certainty. The odds of hospitalization for COVID-19 positive users of combined hormonal contraceptives may be slightly decreased compared with those of hormonal contraceptive non-users, but the evidence is very uncertain as this is based on one study restricted to patients with BMI under 35 kg/m2. There may be little to no effect of combined hormonal contraception use on odds of intubation or mortality among COVID-19 positive patients, and little to no effect of using any type of hormonal contraception on odds of hospitalization and intubation for COVID-19 patients. At a minimum, we noted no large effect for risk of increased COVID-19 disease severity among hormonal contraception users. We specifically noted gaps in pertinent data collection regarding hormonal contraception use such as formulation, hormone doses, and duration or timing of contraceptive use. Differing estrogens may have different thrombogenic potential given differing potency, so it would be important to know if a formulation contained, for example, ethinyl estradiol versus estradiol valerate. Additionally, we downgraded several studies for risk of bias because information on the timing of contraceptive use relative to COVID-19 infection and method adherence were not ascertained. No studies reported indication for hormonal contraceptive use, which is important as individuals who use hormonal management for medical conditions like heavy menstrual bleeding might have different risk profiles compared to individuals using hormones for contraception. Future studies should focus on including pertinent confounders like age, obesity, history of prior venous thromboembolism, risk factors for venous thromboembolism, and recent pregnancy.


Subject(s)
COVID-19 , Hormonal Contraception , Venous Thromboembolism , Female , Humans , Contraceptive Agents/adverse effects , COVID-19/epidemiology , Estrogens/adverse effects , Hormonal Contraception/adverse effects , Pandemics , Thrombosis/epidemiology , Venous Thromboembolism/epidemiology
5.
Cochrane Database Syst Rev ; 2: CD013744, 2023 02 27.
Article in English | MEDLINE | ID: mdl-36847591

ABSTRACT

BACKGROUND: The copper intrauterine device (Cu-IUD) is a highly effective method of contraception that can also be used for emergency contraception (EC). It is the most effective form of EC, and is more effective than other existing oral regimens also used for EC. The Cu-IUD provides the unique benefit of providing ongoing contraception after it is inserted for EC; however, uptake of this intervention has been limited. Progestin IUDs are a popular method of long-acting, reversible contraception. If these devices were also found to be effective for EC, they would provide a critical additional option for women. These IUDs could not only provide EC and ongoing contraception, but additional non-contraceptive benefits, including a reduction in menstrual bleeding, cancer prevention, and pain management. OBJECTIVES: To examine the safety and effectiveness of progestin-containing IUDs for emergency contraception, compared with copper-containing IUDs, or compared with dedicated oral hormonal methods. SEARCH METHODS: We considered all randomized controlled trials and non-randomized studies of interventions that compared outcomes for individuals seeking a levonorgestrel IUD (LNG-IUD) for EC to a Cu-IUD or dedicated oral EC method. We considered full-text studies, conference abstracts, and unpublished data. We considered studies irrespective of their publication status and language of publication. SELECTION CRITERIA: We included studies comparing progestin IUDs with copper-containing IUDs, or oral EC methods for emergency contraception. DATA COLLECTION AND ANALYSIS: We systematically searched nine medical databases, two trials registries, and one gray literature site. We downloaded all titles and abstracts retrieved by electronic searching to a reference management database, and removed duplicates. Three review authors independently screened titles, abstracts, and full-text reports to determine studies eligible for inclusion. We followed standard Cochrane methodology to assess risk of bias, and analyze and interpret the data. We used GRADE methodology to assess the certainty of the evidence. MAIN RESULTS: We included only one relevant study (711 women); a randomized, controlled, non-inferiority trial comparing LNG-IUDs to Cu-IUDs for EC, with a one-month follow-up. With one study, the evidence was very uncertain for the difference in pregnancy rates, failed insertion rates, expulsion rates, removal rates and the difference in the acceptability of the IUDs. There was also uncertain evidence suggesting the Cu-IUD may slightly increase rates of cramping and the LNG-IUD may slightly increase bleeding and spotting days.  AUTHORS' CONCLUSIONS: This review is limited in its ability to provide definitive evidence regarding the LNG-IUD's equivalence, superiority, or inferiority to the Cu-IUD for EC. Only one study was identified in the review, which had possible risks of bias related to randomization and rare outcomes. Additional studies are needed to provide definitive evidence related to the effectiveness of the LNG-IUD for EC.


Subject(s)
Contraception, Postcoital , Intrauterine Devices, Copper , Intrauterine Devices , Female , Humans , Pregnancy , Copper , Intrauterine Devices, Copper/adverse effects , Progestins , Randomized Controlled Trials as Topic , Steroids
6.
Cochrane Database Syst Rev ; 5: CD014908, 2023 05 15.
Article in English | MEDLINE | ID: mdl-37184292

ABSTRACT

BACKGROUND: The novel coronavirus disease (COVID-19) has led to significant mortality and morbidity, including a high incidence of related thrombotic events. There has been concern regarding hormonal contraception use during the COVID-19 pandemic, as this is an independent risk factor for thrombosis, particularly with estrogen-containing formulations. However, higher estrogen levels may be protective against severe COVID-19 disease. Evidence for risks of hormonal contraception use during the COVID-19 pandemic is sparse. We conducted a living systematic review that will be updated as new data emerge on the risk of thromboembolism with hormonal contraception use in patients with COVID-19. OBJECTIVES: To determine if use of hormonal contraception increases risk of venous and arterial thromboembolism in women with COVID-19. To determine if use of hormonal contraception increases other markers of COVID-19 severity including hospitalization in the intensive care unit, acute respiratory distress syndrome, intubation, and mortality. A secondary objective is to maintain the currency of the evidence, using a living systematic review approach. SEARCH METHODS: ⁠⁠⁠⁠⁠⁠We searched CENTRAL, MEDLINE, Embase, CINAHL, Global Index Medicus, Global Health, and Scopus from inception on March 2023, and monitored the literature monthly. We updated the search strategies with new terms and added the database Global Index Medicus in lieu of LILACS. SELECTION CRITERIA: We included all published and ongoing studies of patients with COVID-19 comparing outcomes of those on hormonal contraception versus those not on hormonal contraception. This included case series and non-randomized studies of interventions (NRSI). DATA COLLECTION AND ANALYSIS: One review author extracted study data and this was checked by a second author. Two authors individually assessed risk of bias for the comparative studies using the ROBINS-I tool and a third helped reconcile differences. For the living systematic review, we will publish updates to our synthesis every six months. In the event that we identify a study with a more rigorous study design than the current included evidence prior to the planned six-month update, we will expedite the synthesis publication. MAIN RESULTS: We included three comparative NRSIs with 314,704 participants total and two case series describing 13 patients. The three NRSIs had serious to critical risk of bias in several domains and low study quality. Only one NRSI ascertained current use of contraceptives based on patient report; the other two used diagnostic codes within medical records to assess hormonal contraception use, but did not confirm current use nor indication for use. None of the NRSIs included thromboembolism as an outcome. Studies were not similar enough in terms of their outcomes, interventions, and study populations to combine with meta-analyses. We therefore narratively synthesized all included studies. Based on results from one NRSI, there may be little to no effect of combined hormonal contraception use on odds of mortality for COVID-19 positive patients (OR 1.00, 95% CI 0.41 to 2.40; 1 study, 18,892 participants; very low-certainty evidence). Two NRSIs examined hospitalization rates for hormonal contraception users versus non-users. Based on results from one NRSI, the odds of hospitalization for COVID-19 positive combined hormonal contraception users may be slightly decreased compared with non-users for patients with BMI under 35 kg/m2 (OR 0.79, 95% CI 0.64 to 0.97; 1 study, 295,689 participants; very low-certainty evidence). According to results of the other NRSI assessing use of any type of hormonal contraception, there may be little to no effect on hospitalization rates for COVID-19 positive individuals (OR 0.99, 95% CI 0.68 to 1.44; 1 study, 123 participants; very low-certainty evidence). We included two case series because no comparative studies directly assessed thromboembolism as an outcome. In a case series of six pediatric COVID-19 positive patients with pulmonary embolism, one (older than 15 years of age) was using combined hormonal contraception. In a second case series of seven COVID-19 positive patients with cerebral venous thrombosis, one was using oral contraceptives. One comparative study and one case series reported on intubation rates, but the evidence for both is very uncertain. In the comparative study of 123 COVID-19 positive patients (N = 44 using hormonal contraception and N = 79 not using hormonal contraception), no patients in either group required intubation. In the case series of seven individuals with cerebral venous thromboembolism, one oral contraceptive user and one non-user required intubation. AUTHORS' CONCLUSIONS: There are no comparative studies assessing risk of thromboembolism in COVID-19 patients who use hormonal contraception, which was the primary objective of this review. Very little evidence exists examining the risk of increased COVID-19 disease severity for combined hormonal contraception users compared to non-users of hormonal contraception, and the evidence that does exist is of very low certainty. The odds of hospitalization for COVID-19 positive users of combined hormonal contraceptives may be slightly decreased compared with those of hormonal contraceptive non-users, but the evidence is very uncertain as this is based on one study restricted to patients with BMI under 35 kg/m2. There may be little to no effect of combined hormonal contraception use on odds of intubation or mortality among COVID-19 positive patients, and little to no effect of using any type of hormonal contraception on odds of hospitalization and intubation for COVID-19 patients. We noted no large effect for risk of increased COVID-19 disease severity among hormonal contraception users. We specifically noted gaps in pertinent data collection regarding hormonal contraception use such as formulation, hormone doses, and duration or timing of contraceptive use. Differing estrogens may have different thrombogenic potential given differing potency, so it would be important to know if a formulation contained, for example, ethinyl estradiol versus estradiol valerate. Additionally, we downgraded several studies for risk of bias because information on the timing of contraceptive use relative to COVID-19 infection and method adherence were not ascertained. No studies reported indication for hormonal contraceptive use, which is important as individuals who use hormonal management for medical conditions like heavy menstrual bleeding might have different risk profiles compared to individuals using hormones for contraception. Future studies should focus on including pertinent confounders like age, obesity, history of prior venous thromboembolism, risk factors for venous thromboembolism, and recent pregnancy.


Subject(s)
COVID-19 , Thrombosis , Venous Thromboembolism , Child , Female , Humans , Pregnancy , Contraceptive Agents , Estrogens/adverse effects , Hormonal Contraception , Pandemics , Venous Thromboembolism/chemically induced , Venous Thromboembolism/epidemiology
7.
Aging Ment Health ; 27(8): 1506-1517, 2023.
Article in English | MEDLINE | ID: mdl-36193565

ABSTRACT

OBJECTIVES: To understand patient and caregiver perspectives on the experience of being screened or diagnosed with cognitive impairment to inform preventive clinical care. METHODS: Systematic review and synthesis of qualitative studies with searches in Ovid MEDLINE ALL, EBSCOHost CINAHL, and Scopus in February 2021. Included studies were assessed for quality and coded with descriptive, deductive, and inductive codes and findings were rated using GRADE-CER-qual. RESULTS: We included 15 qualitative studies representing 153 patients and 179 caregivers. Most studies involved in-depth interviews. No studies examined screening experiences for older adults presenting without cognitive function concerns; nearly all patients received a diagnosis of cognitive impairment. Seven themes emerged with moderate to high confidence. Findings showed the role of caregivers in pursuing assessment and its benefits in validating concerns and for future planning. Patients were less inclined to be evaluated, fearing judgements or social consequences from the diagnostic label. Caregivers and patients were at times frustrated with the assessment process yet believed it might result in treatments to cure or slow disease progression. CONCLUSION: Clinicians and care systems can support caregivers and patients by providing timely and informative resources to support their shared and separate motivations, needs, and concerns.

8.
JAMA ; 330(11): 1083-1091, 2023 09 19.
Article in English | MEDLINE | ID: mdl-37721606

ABSTRACT

Importance: Hypertensive disorders of pregnancy are a leading cause of pregnancy-related morbidity and mortality in the US. Objective: To conduct a targeted systematic review to update the evidence on the effectiveness of screening for hypertensive disorders of pregnancy to inform the US Preventive Services Task Force. Data Sources: MEDLINE and the Cochrane Central Register of Controlled Trials for relevant studies published between January 1, 2014, and January 4, 2022; surveillance through February 21, 2023. Study Selection: English-language comparative effectiveness studies comparing screening strategies in pregnant or postpartum individuals. Data Extraction and Synthesis: Two reviewers independently appraised articles and extracted relevant data from fair-or good-quality studies; no quantitative synthesis was conducted. Main outcomes and measures: Morbidity or mortality, measures of health-related quality of life. Results: The review included 6 fair-quality studies (5 trials and 1 nonrandomized study; N = 10 165) comparing changes in prenatal screening practices with usual care, which was routine screening at in-person office visits. No studies addressed screening for new-onset hypertensive disorders of pregnancy in the postpartum period. One trial (n = 2521) evaluated home blood pressure measurement as a supplement to usual care; 3 trials (total n = 5203) evaluated reduced prenatal visit schedules. One study (n = 2441) evaluated proteinuria screening conducted only for specific clinical indications, compared with a historical control group that received routine proteinuria screening. One additional trial (n = 80) only addressed the comparative harms of home blood pressure measurement. The studies did not report statistically significant differences in maternal and infant complications with alternate strategies compared with usual care; however, estimates were imprecise for serious, rare health outcomes. Home blood pressure measurement added to prenatal care visits was not associated with earlier diagnosis of a hypertensive disorder of pregnancy (104.3 vs 106.2 days), and incidence was not different between groups in 3 trials of reduced prenatal visit schedules. No harms of the different screening strategies were identified. Conclusions and Relevance: This review did not identify evidence that any alternative screening strategies for hypertensive disorders of pregnancy were more effective than routine blood pressure measurement at in-person prenatal visits. Morbidity and mortality from hypertensive disorders of pregnancy can be prevented, yet American Indian/Alaska Native persons and Black persons experience inequitable rates of adverse outcomes. Further research is needed to identify screening approaches that may lead to improved disease detection and health outcomes.


Subject(s)
Blood Pressure Determination , Hypertension, Pregnancy-Induced , Female , Humans , Infant , Pregnancy , Advisory Committees , Hypertension, Pregnancy-Induced/diagnosis , Quality of Life , United States , Pregnancy Outcome , Black or African American , American Indian or Alaska Native
9.
J Gen Intern Med ; 36(7): 1883-1889, 2021 07.
Article in English | MEDLINE | ID: mdl-33145695

ABSTRACT

BACKGROUND: Concern regarding pelvic examinations may be more common among women experiencing intimate partner violence. OBJECTIVE: We examined women's attitudes towards pelvic examination with history of intimate partner violence (pressured to have sex, or verbal, or physical abuse). DESIGN: Secondary analysis of data from a cluster randomized trial on contraceptive access. PARTICIPANTS: Women aged 18-25 were recruited at 40 reproductive health centers across the USA (2011-2013). MAIN MEASURES: Delays in clinic visits for contraception and preference to avoid pelvic examinations, by history of ever experiencing pressured sex, verbal, or physical abuse from a sexual partner, reported by frequency (never, rarely, sometimes, often). We used multivariable logistic regression with generalized estimating equations for clustered data. KEY RESULTS: A total of 1490 women were included. Ever experiencing pressured sex was reported by 32.4% of participants, with 16.5% reporting it rarely, 12.1% reporting it sometimes, and 3.8% reporting it often. Ever experiencing verbal abuse was reported by 19.4% and physical abuse by 10.2% of participants. Overall, 13.2% of participants reported ever having delayed going to the clinic for contraception to avoid having a pelvic examination, and 38.2% reported a preference to avoid pelvic examinations. In multivariable analysis, women reporting that they experienced pressured sex often had significantly higher odds of delaying a clinic visit for birth control (aOR 3.10 95% CI 1.39-6.84) and for reporting a preference to avoid pelvic examinations (aOR 2.91 95% CI 1.57-5.40). We found no associations between delay of clinic visits or preferences to avoid a pelvic examination and verbal or physical abuse. CONCLUSIONS: History of pressured sex from an intimate partner is common. Among women who have experienced pressured sex, concern regarding pelvic examinations is a potential barrier to contraception. Communicating that routine pelvic examinations are no longer recommended by professional societies could potentially reduce barriers and increase preventive healthcare visits.


Subject(s)
Gynecological Examination , Intimate Partner Violence , Adolescent , Adult , Contraception , Cross-Sectional Studies , Female , Humans , Sexual Behavior , Sexual Partners , Young Adult
10.
JAMA ; 325(3): 280-298, 2021 01 19.
Article in English | MEDLINE | ID: mdl-33464342

ABSTRACT

Importance: It has been estimated that in 2018 nearly 20% of adults in the US were currently using a tobacco product. Objective: To systematically review the effectiveness and safety of pharmacotherapy, behavioral interventions, and electronic cigarettes for tobacco cessation among adults, including pregnant persons, to inform the US Preventive Services Task Force. Data Sources: PubMed, PsycInfo, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination of Health Technology Assessment; surveillance through September 25, 2020. Study Selection: Systematic reviews of tobacco cessation interventions and randomized clinical trials that evaluated the effects of electronic cigarettes (e-cigarettes) or pharmacotherapy among pregnant persons. Data Extraction and Synthesis: Independent critical appraisal and data abstraction; qualitative synthesis and random-effects meta-analyses. Main Outcomes and Measures: Health outcomes, tobacco cessation at 6 months or more, and adverse events. Results: Sixty-seven reviews addressing pharmacotherapy and behavioral interventions were included as well as 9 trials (N = 3942) addressing e-cigarettes for smoking cessation and 7 trials (N = 2285) of nicotine replacement therapy (NRT) use in pregnancy. Combined pharmacotherapy and behavioral interventions (pooled risk ratio [RR], 1.83 [95% CI, 1.68-1.98]), NRT (RR, 1.55 [95% CI, 1.49-1.61]), bupropion (RR, 1.64 [95% CI, 1.52-1.77]), varenicline (RR, 2.24 [95% CI, 2.06-2.43]), and behavioral interventions such as advice from clinicians (RR, 1.76 [95% CI, 1.58-1.96]) were all associated with increased quit rates compared with minimal support or placebo at 6 months or longer. None of the drugs were associated with serious adverse events. Five trials (n = 3117) reported inconsistent findings on the effectiveness of electronic cigarettes on smoking cessation at 6 to 12 months among smokers when compared with placebo or NRT, and none suggested higher rates of serious adverse events. Among pregnant persons, behavioral interventions were associated with greater smoking cessation during late pregnancy (RR, 1.35 [95% CI, 1.23-1.48]), compared with no intervention. Rates of validated cessation among pregnant women allocated to NRT compared with placebo were not significantly different (pooled RR, 1.11 [95% CI, 0.79-1.56], n = 2033). Conclusions and Relevance: There is strong evidence that a range of pharmacologic and behavioral interventions, both individually and in combination, are effective in increasing smoking cessation in nonpregnant adults. In pregnancy, behavioral interventions are effective for smoking cessation, but data are limited on the use of pharmacotherapy for smoking cessation. Data on the effectiveness and safety of electronic cigarettes for smoking cessation among adults are also limited and results are inconsistent.


Subject(s)
Behavior Therapy , Electronic Nicotine Delivery Systems , Smoking Cessation Agents/therapeutic use , Tobacco Use Cessation/methods , Tobacco Use Disorder/therapy , Adult , Combined Modality Therapy , Female , Humans , Male , Practice Guidelines as Topic , Pregnancy , Primary Health Care , Smoking Cessation/methods , Smoking Cessation Agents/adverse effects , Tobacco Use Cessation Devices/adverse effects , Tobacco Use Disorder/drug therapy
11.
JAMA ; 326(12): 1192-1206, 2021 09 28.
Article in English | MEDLINE | ID: mdl-34581730

ABSTRACT

Importance: Preeclampsia is a hypertensive disorder of pregnancy that poses serious maternal and infant health risks. Previous systematic reviews have established benefits of low-dose aspirin taken during pregnancy to prevent preeclampsia and its sequelae. Objective: To update evidence for the US Preventive Services Task Force (USPSTF) on effectiveness of aspirin use in preventing preeclampsia in individuals at increased risk based on clinical risk factors or measurements associated with higher disease incidence than in the general population. Data Sources: Studies from previous USPSTF review (2014), literature published January 2013 through May 15, 2020, in MEDLINE, PubMed (for publisher-supplied records only), EMBASE, and Cochrane Central Register of Controlled Trials. Ongoing surveillance through January 22, 2021. Study Selection: Good- and fair-quality randomized clinical trials (RCTs) of low-dose aspirin use during pregnancy to prevent preeclampsia among individuals at increased risk; studies conducted in general populations to evaluate potential harms. Data Extraction and Synthesis: Dual article screening and risk-of-bias assessment. Study data abstracted into prespecified forms, checked for accuracy. Random-effects meta-analysis. Main Outcomes and Measures: Diagnosis of preeclampsia; adverse pregnancy health outcomes and complications including eclampsia, perinatal mortality, preterm birth, small for gestational age, and potential bleeding harms or infant/child harms from aspirin exposure. Results: A total of 23 randomized clinical trials (RCTs) (N = 26 952) were included; 18 were conducted among participants at increased preeclampsia risk. Aspirin dosages ranged from 50 mg/d to 150 mg/d. Most trials enrolled majority White populations selected based on a range of risk factors. The incidence of preeclampsia among the trials of participants at increased risk ranged from 4% to 30%. Aspirin use was significantly associated with lower risk of preeclampsia (pooled relative risk [RR], 0.85 [95% CI, 0.75-0.95]; 16 RCTs [n = 14 093]; I2 = 0%), perinatal mortality (pooled RR, 0.79 [95% CI, 0.66-0.96]; 11 RCTs [n = 13 860]; I2 = 0%), preterm birth (pooled RR, 0.80 [95% CI, 0.67-0.95]; 13 RCTs [n = 13 619]; I2 = 49%), and intrauterine growth restriction (pooled RR, 0.82 [95% CI, 0.68-0.99]; 16 RCTs [n = 14 385]; I2 = 41%). There were no significant associations of aspirin use with risk of postpartum hemorrhage (pooled RR, 1.03 [95% CI, 0.94-1.12]; 9 RCTs [n = 23 133]; I2 = 0%) and other bleeding-related harms, or with rare perinatal or longer-term harms. Absolute risk reductions for preeclampsia associated with aspirin use ranged from -1% to -6% across larger trials (n >300) and were greater in smaller trials. For perinatal mortality, absolute risk reductions ranged from 0.5% to 1.1% in the 3 largest trials. Conclusions and Relevance: Daily low-dose aspirin during pregnancy was associated with lower risks of serious perinatal outcomes for individuals at increased risk for preeclampsia, without evident harms.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Aspirin/therapeutic use , Pre-Eclampsia/prevention & control , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Aspirin/administration & dosage , Aspirin/adverse effects , Female , Humans , Infant, Newborn , Infant, Small for Gestational Age , Perinatal Death/prevention & control , Postpartum Hemorrhage/etiology , Practice Guidelines as Topic , Pregnancy , Premature Birth/prevention & control , Randomized Controlled Trials as Topic , Risk Factors
12.
JAMA ; 326(19): 1953-1961, 2021 11 16.
Article in English | MEDLINE | ID: mdl-34694343

ABSTRACT

Clinical preventive service recommendations from the US Preventive Services Task Force (USPSTF) are based on transparent, systematic, and rigorous methods that consider the certainty of the evidence and magnitude of net benefit. These guidelines aim to address the needs of diverse populations. Biological sex and gender identity are sources of diversity that are not often considered in studies of clinical preventive services that inform the recommendations, resulting in challenges when evaluating the evidence and communicating recommendations for persons in specific gender identification categories (man/woman/gender nonbinary/gender nonconforming/transgender). To advance its methods, the USPSTF reviewed its past recommendations that included the use of sex and gender terms, reviewed the approaches of other guideline-making bodies, and pilot tested strategies to address sex and gender diversity. Based on the findings, the USPSTF intends to use an inclusive approach to identify issues related to sex and gender at the start of the guideline development process; assess the applicability, variability, and quality of evidence as a function of sex and gender; ensure clarity in the use of language regarding sex and gender; and identify evidence gaps related to sex and gender. Evidence reviews will identify the limitations of applying findings to diverse groups from underlying studies that used unclear terminology regarding sex and gender. The USPSTF will use gender-neutral language when appropriate to communicate that recommendations are inclusive of people of any gender and will clearly state when recommendations apply to individuals with specific anatomy associated with biological sex (male/female) or to specific categories of gender identity. The USPSTF recognizes limited evidence to inform the preventive care of populations based on gender identity.


Subject(s)
Gender Identity , Preventive Health Services , Sex , Advisory Committees , Evidence-Based Medicine , Female , Humans , Male , Preventive Health Services/standards , Transgender Persons , United States
13.
JAMA ; 324(7): 682-699, 2020 08 18.
Article in English | MEDLINE | ID: mdl-32809007

ABSTRACT

Importance: Increasing rates of preventable sexually transmitted infections (STIs) in the US pose substantial burdens to health and well-being. Objective: To update evidence for the US Preventive Services Task Force (USPSTF) on effectiveness of behavioral counseling interventions for preventing STIs. Data Sources: Studies from the previous USPSTF review (2014); literature published January 2013 through May 31, 2019, in MEDLINE, PubMed (for publisher-supplied records only), PsycINFO, and Cochrane Central Register of Controlled Trials. Ongoing surveillance through May 22, 2020. Study Selection: Good- and fair-quality randomized and nonrandomized controlled intervention studies of behavioral counseling interventions for adolescents and adults conducted in primary care settings were included. Studies with active comparators only or limited to individuals requiring specialist care for STI risk-related comorbidities were excluded. Data Extraction and Synthesis: Dual risk of bias assessment, with inconsistent ratings adjudicated by a third team member. Study data were abstracted into prespecified forms. Pooled odds ratios (ORs) were estimated using the DerSimonian and Laird method or the restricted maximum likelihood method with Knapp-Hartung adjustment. Main Outcomes and Measures: Differences in STI diagnoses, self-reported condom use, and self-reported unprotected sex at 3 months or more after baseline. Results: The review included 37 randomized trials and 2 nonrandomized controlled intervention studies (N = 65 888; 13 good-quality, 26 fair-quality) recruited from primary care settings in the US. Study populations were composed predominantly of heterosexual adolescents and young adults (12 to 25 years), females, and racial and ethnic minorities at increased risk for STIs. Nineteen trials (n = 52 072) reported STI diagnoses as outcomes (3 to 17 months' follow-up); intervention was associated with reduced STI incidence (OR, 0.66 [95% CI, 0.54-0.81; I2 = 74%]). Absolute differences in STI acquisition between groups varied widely depending on baseline population STI risk and intervention effectiveness, ranging from 19% fewer to 4% more people acquiring STI. Thirty-four trials (n = 21 417) reported behavioral change outcomes. Interventions were associated with self-reported behavioral change (eg, increased condom use) that reduce STI risk (OR, 1.31 [95% CI, 1.10-1.56; I2 = 40%, n = 5253). There was limited evidence on persistence of intervention effects beyond 1 year. No harms were identified in 7 studies (n = 3458) reporting adverse outcomes. Conclusions and Relevance: Behavioral counseling interventions for individuals seeking primary health care were associated with reduced incidence of STIs. Group or individual counseling sessions lasting more than 2 hours were associated with larger reductions in STI incidence, and interventions of shorter duration also were associated with STI prevention, although evidence was limited on whether the STI reductions associated with these interventions persisted beyond 1 year.


Subject(s)
Behavior Therapy , Counseling , Sexual Behavior , Sexually Transmitted Diseases/prevention & control , Adolescent , Adult , Age Factors , Behavior Therapy/methods , Counseling/methods , Female , Humans , Male , Odds Ratio , Practice Guidelines as Topic , Pregnancy , Primary Health Care , Risk Reduction Behavior , Young Adult
14.
JAMA ; 322(12): 1195-1205, 2019 09 24.
Article in English | MEDLINE | ID: mdl-31550037

ABSTRACT

Importance: Screening for asymptomatic bacteriuria can identify patients for whom treatment might be beneficial for preventing symptomatic infection and other health outcomes. Objective: To systematically review benefits and harms of asymptomatic bacteriuria screening and treatment in adults, including during pregnancy, to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed (publisher-supplied records), and Cochrane Collaboration Central Registry of Controlled Trials; surveillance through May 24, 2019. Study Selection: Randomized clinical trials (RCTs) and observational studies on benefits and harms of screening for asymptomatic bacteriuria; RCTs on benefits and harms of asymptomatic bacteriuria treatment. Eligible populations included unselected, asymptomatic individuals without known urinary tract conditions. Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers. Random-effects meta-analysis was conducted to estimate benefits of the interventions. Main Outcomes and Measures: Symptomatic infection; function, morbidity, mortality; pregnancy complications and birth outcomes. Results: Nineteen studies (N = 8443) meeting inclusion criteria were identified. Two cohort studies (n = 5289) found fewer cases of pyelonephritis in the cohorts of screened pregnant women (0.5%) than within retrospective comparisons of unscreened cohorts (2.2% and 1.8%); the larger study estimated a statistically significant relative risk of 0.30 (95% CI, 0.15-0.60). No studies examined screening in nonpregnant populations. Among 12 trials of asymptomatic bacteriuria screening and treatment during pregnancy (n = 2377; 1 conducted within past 30 years), there were reduced rates of pyelonephritis (range, 0%-16.5% for the intervention group and 2.2%-36.4% for the control group; pooled risk ratio [RR], 0.24 [95% CI, 0.14-0.40]; 12 trials) and low birth weight (range, 2.5%-14.8% for the intervention group and 6.7%-21.4% for the control group; pooled RR, 0.64 [95% CI, 0.46-0.90]; 7 trials). There was no significant difference in infant mortality (pooled RR, 0.98 [95% CI, 0.29-3.26]; 6 trials). Five RCTs of asymptomatic bacteriuria treatment in nonpregnant adults (n = 777) did not report any significant differences in risk of infection, mobility, or mortality. Limited evidence on harms of screening or treatment was available, and no statistically significant differences were identified. Conclusions and Relevance: Screening and treatment for asymptomatic bacteriuria during pregnancy was associated with reduced rates of pyelonephritis and low birth weights, but the available evidence was not current, with only 1 study conducted in the past 30 years. Benefits of asymptomatic bacteriuria treatment in nonpregnant adult populations were not found. Trial evidence on harms of asymptomatic bacteriuria antibiotic treatment was limited.


Subject(s)
Bacteriuria/diagnosis , Mass Screening , Pregnancy Complications, Infectious/diagnosis , Adult , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/therapeutic use , Bacteriuria/drug therapy , Female , Humans , Infant, Low Birth Weight , Male , Mass Screening/adverse effects , Microbiota/drug effects , Practice Guidelines as Topic , Pregnancy , Pregnancy Complications, Infectious/drug therapy , Pyelonephritis/prevention & control , Risk Factors , Urinary Tract Infections/diagnosis
15.
JAMA ; 319(6): 595-606, 2018 02 13.
Article in English | MEDLINE | ID: mdl-29450530

ABSTRACT

Importance: Ovarian cancer is relatively rare but the fifth-leading cause of cancer mortality among United States women. Objective: To systematically review evidence on benefits and harms of ovarian cancer screening among average-risk women to inform the United States Preventive Services Task Force. Data Sources: MEDLINE, PubMed, Cochrane Collaboration Registry of Controlled Trials; studies published in English from January 1, 2003, through January 31, 2017; ongoing surveillance in targeted publications through November 22, 2017. Study Selection: Randomized clinical trials of ovarian cancer screening in average-risk women that reported mortality or quality-of-life outcomes. Interventions included transvaginal ultrasound, cancer antigen 125 (CA-125) testing, or their combination. Comparators were usual care or no screening. Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers. Meta-analytic pooling of results was not conducted because of the small number of studies and heterogeneity of interventions. Main Outcomes and Measures: Ovarian cancer mortality, false-positive screening results and surgery, surgical complications, and psychological effects of screening. Results: Four trials (N = 293 587) were included; of these, 3 (n = 293 038) assessed ovarian cancer mortality, and 1 (n = 549) reported only on psychological outcomes. Evaluated screening interventions included transvaginal ultrasound alone, transvaginal ultrasound plus CA-125 testing, and CA-125 testing alone. Test positivity for CA-125 was defined by a fixed serum level cutpoint or by a proprietary risk algorithm based on CA-125 level, change in CA-125 level over time, and age (risk of ovarian cancer algorithm [ROCA]). No trial found a significant difference in ovarian cancer mortality with screening. In the 2 large screening trials (PLCO and UKCTOCS, n = 271 103), there was not a statistically significant difference in complete intention-to-screen analyses of ovarian, fallopian, and peritoneal cancer cases associated with screening (PLCO: rate ratio, 1.18 [95% CI, 0.82-1.71]; UKCTOCS: hazard ratio [HR], 0.91 [95% CI, 0.76-1.09] for transvaginal ultrasound and HR, 0.89 [95% CI, 0.74-1.08] for CA-125 ROCA). Within these 2 trials, screening led to surgery for suspected ovarian cancer in 1% of women without cancer for CA-125 ROCA and in 3% for transvaginal ultrasound with or without CA-125 screening, with major complications occurring among 3% to 15% of surgery. Evidence on psychological harms was limited but nonsignificant except in the case of repeat follow-up scans and tests, which increased the risk of psychological morbidity in a subsample of UKCTOCS participants based on the General Health Questionnaire 12 (score ≥4) (odds ratio, 1.28 [95% CI, 1.18-1.39]). Conclusions and Relevance: In randomized trials conducted among average-risk, asymptomatic women, ovarian cancer mortality did not significantly differ between screened women and those with no screening or in usual care. Screening harms included surgery (with major surgical complications) in women found to not have cancer. Further research is needed to identify effective approaches for reducing ovarian cancer incidence and mortality.


Subject(s)
Early Detection of Cancer , Mass Screening , Ovarian Neoplasms/diagnosis , Asymptomatic Diseases , CA-125 Antigen/blood , Early Detection of Cancer/methods , False Positive Reactions , Female , Humans , Mass Screening/adverse effects , Ovarian Neoplasms/mortality , Randomized Controlled Trials as Topic , Risk Assessment , Ultrasonography
16.
JAMA ; 320(7): 687-705, 2018 08 21.
Article in English | MEDLINE | ID: mdl-30140883

ABSTRACT

Importance: Cervical cancer can be prevented with detection and treatment of precancerous cell changes caused primarily by high-risk types of human papillomavirus (hrHPV), the causative agents in more than 90% of cervical cancers. Objective: To systematically review benefits and harms of cervical cancer screening for hrHPV to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, PsycINFO, and the Cochrane Collaboration Registry of Controlled Trials from January 2011 through February 15, 2017; surveillance through May 25, 2018. Study Selection: Randomized clinical trials (RCTs) and cohort studies comparing primary hrHPV screening alone or hrHPV cotesting (both hrHPV testing and cytology) with cytology (Papanicolaou [Pap] test) screening alone. Data Extraction and Synthesis: Two investigators independently reviewed abstracts and full-text articles and quality rated included studies; data were qualitatively synthesized. Main Outcomes and Measures: Invasive cervical cancer; cervical intraepithelial neoplasia (CIN); false-positive, colposcopy, and biopsy rates; psychological harms. Results: Eight RCTs (n = 410 556), 5 cohort studies (n = 402 615), and 1 individual participant data (IPD) meta-analysis (n = 176 464) were included. Trials were heterogeneous for screening interval, number of rounds, and protocol. For primary hrHPV screening, evidence was consistent across 4 trials demonstrating increased detection of CIN 3 or worse (CIN 3+) in round 1 (relative risk [RR] range, 1.61 [95% CI, 1.09-2.37] to 7.46 [95% CI, 1.02-54.66]). Among 4 hrHPV cotesting trials, first-round CIN 3+ detection was not significantly different between screening groups; RRs for cumulative CIN 3+ detection over 2 screening rounds ranged from 0.91 to 1.13. In first-round screening, false-positive rates for primary hrHPV screening ranged from 6.6% to 7.4%, compared with 2.6% to 6.5% for cytology. For cotesting, false-positives ranged from 5.8% to 19.9% in the first round of screening, compared with 2.6% to 10.9% for cytology. First-round colposcopy rates were also higher, ranging 1.2% to 7.9% for primary hrHPV testing, compared with 1.1% to 3.1% for cytology alone; colposcopy rates for cotesting ranged from 6.8% to 10.9%, compared with 3.3% to 5.2% for cytology alone. The IPD meta-analysis of data from 4 cotesting trials and 1 primary hrHPV screening trial found lower risk of invasive cervical cancer with any hrHPV screening compared with cytology alone (pooled RR, 0.60 [95% CI, 0.40-0.89]). Conclusions and Relevance: Primary hrHPV screening detected higher rates of CIN 3+ at first-round screening compared with cytology. Cotesting trials did not show initial increased CIN 3+ detection. Both hrHPV screening strategies had higher false-positive and colposcopy rates than cytology, which could lead to more treatments with potential harms.


Subject(s)
Early Detection of Cancer , Papillomaviridae/isolation & purification , Uterine Cervical Neoplasms/diagnosis , Vaginal Smears , Adult , Aged , Cervix Uteri/pathology , Cervix Uteri/virology , Early Detection of Cancer/methods , Female , Humans , Mass Screening , Middle Aged , Papanicolaou Test , Process Assessment, Health Care , Uterine Cervical Neoplasms/prevention & control
17.
JAMA ; 317(9): 954-966, 2017 03 07.
Article in English | MEDLINE | ID: mdl-28267861

ABSTRACT

Importance: Recent changes in the periodicity of cervical cancer screening have led to questions about the role of screening pelvic examinations among asymptomatic women. Objective: To systematically review literature on health benefits, accuracy, and harms of the screening pelvic examination for gynecologic conditions for the US Preventive Services Task Force (USPSTF). Data Sources: MEDLINE, PubMed, and Cochrane Central Register of Controlled Trials for relevant English-language studies published through January 13, 2016, with surveillance through August 3, 2016. Study Selection: Two reviewers independently screened abstracts and studies. The search yielded 8678 unique citations; 316 full-text articles were reviewed, and 9 studies including 27 630 patients met inclusion criteria. Data Extraction and Synthesis: Two reviewers rated study quality using USPSTF criteria. Main Outcomes and Measures: Morbidity; mortality; diagnostic accuracy for any gynecologic cancer or condition except cervical cancer, gonorrhea, and chlamydia, which are covered by other USPSTF screening recommendations; harms (false-positive rates, false-negative rates, surgery rates). Results: No trials examined the effectiveness of the pelvic examination in reducing all-cause mortality, reducing cancer- and disease-specific morbidity and mortality, or improving quality of life. Eight studies reported accuracy for the screening pelvic examination: ovarian cancer (4 studies; n = 26 432), bacterial vaginosis (2 studies; n = 930), trichomoniasis (1 study; n = 779), and genital herpes (1 study; n = 779). In the 4 ovarian cancer screening studies, low prevalence of ovarian cancer consistently resulted in low positive predictive values (PPVs) and false-positive rates, with a lack of precision in accuracy estimates (sensitivity range, 0%-100%; specificity range, 91%-99%; PPV range, 0%-3.6%; negative predictive value [NPV] range, ≥99%). Each diagnostic accuracy study for bacterial vaginosis, trichomoniasis, and genital herpes was performed in a high-prevalence population with substantial proportions of symptomatic patients and reported accuracy characteristics for individual physical examination findings (bacterial vaginosis, homogeneous discharge: sensitivity range, 69%-79%; specificity range, 54%-97%; PPV range, 52%-95%; NPV range, 79%-80%; herpes simplex virus, vulvar ulcerations: sensitivity, 20%; specificity, 98%; PPV, 88%; NPV, 57%; trichomoniasis, colpitis macularis: sensitivity, 2%; specificity, 100%; PPV, 100%; NPV, 85%). Surgery rates resulting from an abnormal screening pelvic examination for ovarian cancer ranged from 5% to 36% at 1 year, with the largest study reporting an 11% surgery rate and 1% complication rate within 1 year of a screening pelvic examination with abnormal findings. Conclusions and Relevance: No direct evidence was identified for overall benefits and harms of the pelvic examination as a 1-time or periodic screening test. Limited evidence was identified regarding the diagnostic accuracy and harms of routine screening pelvic examinations in asymptomatic primary care populations.


Subject(s)
Genital Diseases, Female/diagnosis , Gynecological Examination , Mass Screening , Adult , Clinical Trials as Topic , Female , Gynecological Examination/adverse effects , Gynecological Examination/methods , Humans
18.
JAMA ; 317(16): 1668-1683, 2017 Apr 25.
Article in English | MEDLINE | ID: mdl-28444285

ABSTRACT

IMPORTANCE: Preeclampsia is a complex disease of pregnancy with sometimes serious effects on maternal and infant morbidity and mortality. It is defined by hypertension after 20 weeks' gestation and proteinuria or other evidence of multisystem involvement. OBJECTIVE: To systematically review the benefits and harms of preeclampsia screening and risk assessment for the US Preventive Services Task Force. DATA SOURCES: MEDLINE, PubMed, and Cochrane Central Register of Controlled Trials databases from 1990 through September 1, 2015. Surveillance for new evidence in targeted publications was conducted through October 5, 2016. STUDY SELECTION: English-language trials and observational studies, including externally validated prediction models, of screening effectiveness, benefits, and harms from routine preeclampsia screening during pregnancy. DATA EXTRACTION AND SYNTHESIS: Independent dual review of article abstracts and full texts against a priori inclusion criteria. Meta-analysis was not performed because of clinical and statistical heterogeneity of included studies. MAIN OUTCOMES AND MEASURES: Maternal and infant health outcomes, including eclampsia, stroke, stillbirth, preterm birth, and low birth weight; screening and risk prediction test performance; harms of screening and risk assessment. RESULTS: Twenty-one studies (13 982 participants) were included. No studies directly compared the effectiveness of preeclampsia screening in a screened population vs an unscreened population; 1 US trial (n = 2764) found no difference in benefits or harms with fewer prenatal visits but was underpowered for rare, serious outcomes. For harms, a before-after comparison cohort noninferiority study of urine protein screening for specific indications compared with routine screening (n = 1952) did not identify harms with fewer urine screening tests. Four studies (n = 7123) reported external validation performance of 16 risk prediction models, 5 of which had good or better discrimination (c statistic >0.80) for prediction of preeclampsia, and positive predictive values of 4% in the largest, most applicable validation cohorts. Calibration was not reported despite being a key model performance measure. There were no studies of urine screening test performance conducted in asymptomatic primary care populations; 14 studies of protein urine test performance among women being evaluated for suspected preeclampsia (n = 1888) had wide-ranging test accuracy (sensitivity, 22%-100%; specificity, 36%-100%) and high statistical and clinical heterogeneity in tests used, eligibility criteria, and proteinuria prevalence (8.7%-93.8%). CONCLUSIONS AND RELEVANCE: Evidence to estimate benefits and harms of preeclampsia screening and the test performance of different screening approaches over the course of pregnancy was limited. Externally validated risk prediction models had limited applicability and lacked calibration and clinical implementation data needed to support routine use. Further research is needed to better inform risk-based screening approaches and improve screening strategies, given the complex pathophysiology and clinical unpredictability of preeclampsia.


Subject(s)
Pre-Eclampsia/diagnosis , Prenatal Care/standards , Adult , Advisory Committees , Female , Humans , Infant, Newborn , Mass Screening , Middle Aged , Practice Guidelines as Topic , Pregnancy , Premature Birth/prevention & control , Risk , Sensitivity and Specificity , Young Adult
19.
Am J Obstet Gynecol ; 215(1): 78.e1-9, 2016 07.
Article in English | MEDLINE | ID: mdl-26827879

ABSTRACT

BACKGROUND: Health communication and interpersonal skills are increasingly emphasized in the measurement of health care quality, yet there is limited research on the association of interpersonal care with health outcomes. As approximately 50% of pregnancies in the United States are unintended, whether interpersonal communication influences contraceptive use is of public health importance. OBJECTIVE: The aim of this study was to determine whether the quality of interpersonal care during contraceptive counseling is associated with contraceptive use over time. STUDY DESIGN: The Patient-Provider Communication about Contraception study is a prospective cohort study of 348 English-speaking women seen for contraceptive care, conducted between 2009 and 2012 in the San Francisco Bay Area. Quality of communication was assessed using a patient-reported interpersonal quality in family planning care measure based on the dimensions of patient-centered care. In addition, the clinical visit was audio recorded and its content coded according to the validated Four Habits Coding Scheme to assess interpersonal communication behaviors of clinicians. The outcome measures were 6-month continuation of the selected contraceptive method and use of a highly or moderately effective method at 6 months. Results were analyzed using mixed effect logistic regression models controlling for patient demographics, the clinic and the provider at which the visit occurred, and the method selected. RESULTS: Patient participants had a mean age of 26.8 years (SD 6.9 years); 46% were white, 26% Latina, and 28% black. Almost two-thirds of participants had an income of <200% of the Federal Poverty Level. Most of the women (73%) were making visits to a provider whom they had not seen before. Of the patient participants, 41% were still using their chosen contraceptive method at 6-month follow-up. Patients who reported high interpersonal quality of family planning care were more likely to maintain use of their chosen contraceptive method (adjusted odds ratio [aOR], 1.8; 95% CI, 1.1-3.0) and to be using a highly or moderately effective method at 6 months (aOR, 2.0; 95% CI, 1.2-3.5). In addition, 2 of the Four Habits were associated with contraceptive continuation; "invests in the beginning" (aOR, 2.3; 95% CI, 1.2-4.3) and "elicits the patient's perspective" (aOR, 1.8; 95% CI, 1.0-3.2). CONCLUSION: Our study provides evidence that the quality of interpersonal care, measured using both patient report and observation of provider behaviors, influences contraceptive use. These results provide support for ongoing attention to interpersonal communication as an important aspect of health care quality. The associations of establishing rapport and eliciting the patient perspective with contraceptive continuation are suggestive of areas of focus for provider communication skills training for contraceptive care.


Subject(s)
Communication , Contraception Behavior , Contraceptive Agents/therapeutic use , Family Planning Services , Professional-Patient Relations , Quality of Health Care , Adolescent , Adult , Contraception/methods , Family Planning Services/standards , Female , Humans , Middle Aged , Patient-Centered Care , Prospective Studies , Public Health , Young Adult
20.
Ann Intern Med ; 163(8): 608-21, 2015 Oct 20.
Article in English | MEDLINE | ID: mdl-26389650

ABSTRACT

BACKGROUND: Tobacco use is the leading cause of preventable death in the United States. PURPOSE: To review the effectiveness and safety of pharmacotherapy and behavioral interventions for tobacco cessation. DATA SOURCES: 5 databases and 8 organizational Web sites were searched through 1 August 2014 for systematic reviews, and PubMed was searched through 1 March 2015 for trials on electronic nicotine delivery systems. STUDY SELECTION: Two reviewers examined 114 articles to identify English-language reviews that reported health, cessation, or adverse outcomes. DATA EXTRACTION: One reviewer abstracted data from good- and fair-quality reviews, and a second checked for accuracy. DATA SYNTHESIS: 54 reviews were included. Behavioral interventions increased smoking cessation at 6 months or more (physician advice had a pooled risk ratio [RR] of 1.76 [95% CI, 1.58 to 1.96]). Nicotine replacement therapy (RR, 1.60 [CI, 1.53 to 1.68]), bupropion (RR, 1.62 [CI, 1.49 to 1.76]), and varenicline (RR, 2.27 [CI, 2.02 to 2.55]) were also effective for smoking cessation. Combined behavioral and pharmacotherapy interventions increased cessation by 82% compared with minimal intervention or usual care (RR, 1.82 [CI, 1.66 to 2.00]). None of the drugs were associated with major cardiovascular adverse events. Only 2 trials addressed efficacy of electronic cigarettes for smoking cessation and found no benefit. Among pregnant women, behavioral interventions benefited cessation and perinatal health; effects of nicotine replacement therapy were not significant. LIMITATION: Evidence published after each review's last search date was not included. CONCLUSION: Behavioral and pharmacotherapy interventions improve rates of smoking cessation among the general adult population, alone or in combination. Data on the effectiveness and safety of electronic nicotine delivery systems are limited. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.


Subject(s)
Behavior Therapy , Counseling , Smoking Cessation/methods , Smoking Prevention , Tobacco Use Cessation Devices , Adult , Bupropion/adverse effects , Bupropion/therapeutic use , Electronic Nicotine Delivery Systems/adverse effects , Female , Humans , Nicotinic Agonists/adverse effects , Nicotinic Agonists/therapeutic use , Pregnancy , Tobacco Use Cessation Devices/adverse effects , United States , Varenicline/adverse effects , Varenicline/therapeutic use
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