Evaluation of immunogenicity of enterobactin conjugate vaccine for the control of Escherichia coli mastitis in dairy cows.

Mastitis is the most common disease of dairy cows that incurs severe economic losses to the dairy industry. Currently, environmental mastitis pathogens are a major problem for most dairy farms. A current commercially available Escherichia coli vaccine does not prevent clinical mastitis and production losses, likely due to antibody accessibility and antigenic variation issues. Therefore, a novel vaccine that prevents clinical disease and production losses is critically needed. Recently a nutritional immunity approach, which restricts bacterial iron uptake by immunologically sequestering conserved iron-binding enterobactin (Ent), has been developed. The objective of this study was to evaluate the immunogenicity of the keyhole limpet hemocyanin-enterobactin (KLH-Ent) conjugate vaccine in dairy cows. Twelve pregnant Holstein dairy cows in their first through third lactations were randomized to the control or vaccine group, with 6 cows per group. The vaccine group received 3 subcutaneous vaccinations of KLH-Ent with adjuvants at drying off (D0), 20 (D21), and 40 (D42) days after drying off. The control group was injected with phosphate-buffered saline (pH 7.4) mixed with the same adjuvants at the same time points. Vaccination effects were assessed over the study period until the end of the first month of lactation. The KLH-Ent vaccine did not cause any systemic adverse reactions or reduction in milk production. Compared with the control group, the vaccine elicited significantly higher levels of serum Ent-specific IgG at calving (C0) and 30 d postcalving (C30), mainly its IgG2 fraction, which was significantly higher at D42, C0, C14, and C30 d, with no significant change in IgG1 levels. Milk Ent-specific IgG and IgG2 levels in the vaccine group were significantly higher on C30. Fecal microbial community structures were similar for both control and vaccine groups on the same day and shifted directionally along the sampling days. In conclusion, the KLH-Ent vaccine successfully triggered strong Ent-specific immune responses in dairy cows without significantly affecting the gut microbiota diversity and health. The results show that Ent conjugate vaccine is a promising nutritional immunity approach in control of E. coli mastitis in dairy cows.

EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial.

BACKGROUND: Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is still emerging. This trial aims to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral pressure injuries in medical-surgical patients. METHODS: This is a multicentre, pragmatic, parallel group, randomised controlled trial. A sample size of 1320 was calculated to have >90% power to detect a 5% difference in the primary outcome at an alpha of 0.05. Adult patients admitted to participating medical-surgical wards are screened for eligibility: ≥18 years, admitted to hospital within the previous 36 h, expected length of stay of ≥24 h, and assessed high risk for hospital-acquired pressure injury. Consenting participants are randomly allocated to either prophylactic silicone foam dressing intervention or usual care without any dressing as the control group via a web-based randomisation service independent of the trial. Patients are enrolled across three Australian hospitals. The primary outcome is the cumulative incidence of patients who develop a sacral pressure injury. Secondary outcomes include the time to sacral pressure injury, incidence of severity (stage) of sacral pressure injury, cost-effectiveness of dressings, and process evaluation. Participant outcomes are assessed daily for up to 14 days by blinded independent outcome assessors using de-identified, digitally modified sacral photographs. Those who develop a sacral pressure injury are followed for an additional 14 days to estimate costs of pressure injury treatment. Analysis of clinical outcomes will be based on intention-to-treat, per-protocol, and sensitivity analyses. DISCUSSION: This trial aims to provide definitive evidence on the effect prophylactic dressings have on the development of hospital-acquired sacral pressure injuries in medical-surgical patients. A parallel economic evaluation of pressure injury prevention and treatment will enable evidence-informed decisions and policy. The inclusion of a process evaluation will help to explain the contextual factors that may have a bearing on trial results including the acceptability of the dressings to patients and staff. The trial commenced 5 March 2020 and has been significantly delayed due to COVID-19. TRIAL REGISTRATION: ANZCTR ACTRN12619000763145. Prospectively registered on 22 May 2019.

Effect of negative-pressure wound therapy on wound complications in obese women after caesarean birth: a systematic review and meta-analysis.

BACKGROUND: Obesity is associated with increased surgical-site infection (SSI) following caesarean section (CS). OBJECTIVE: To summarise the evidence on the effectiveness of negative-pressure wound therapy (NPWT) for preventing SSI and other wound complications in obese women after CS. SEARCH STRATEGY: MEDLINE, Embase, CINAHL, Cochrane CENTRAL databases and ClinicalTrials.gov were systematically searched in March 2021. SELECTION CRITERIA: Randomised controlled trials (RCTs) of NPWT compared with standard dressings after CS birth. DATA COLLECTION AND ANALYSIS: Pooled effect sizes were calculated using either fixed or random effects models based on heterogeneity. The Cochrane risk of bias and Grading of Recommendations Assessment, Development and Evaluation tools were used to assess the quality of studies and overall quality of evidence. MAIN RESULTS: Ten RCTs with 5583 patients were included; studies were published between 2012 and 2021. Nine RCTs with 5529 patients were pooled for the outcome SSI. Meta-analysis results suggest a significant difference favouring the NPWT group (relative risk [RR] 0.79, 95% CI 0.65-0.95, P < 0.01), indicating an absolute risk reduction of 1.8% among those receiving NPWT compared with usual care. The risk of blistering in the NPWT group was significantly higher (RR 4.13, 95% CI 1.53-11.18, P = 0.005). All studies had high risk of bias relative to blinding of personnel/participants. Only 40% of studies reported blinding of outcome assessments and 50% had incomplete outcome data. CONCLUSIONS: The decision to use NPWT should be considered both in terms of its potential benefits and its limitations. TWEETABLE ABSTRACT: NPWT was associated with fewer SSI in women following CS birth but was not effective in reducing other wound complications.

Response to adrenocorticotropic hormone or corticotrophin-releasing hormone and vasopressin in lactating cows fed an immunomodulatory supplement under thermoneutral or acute heat stress conditions.

Adrenal responsiveness was tested in nonpregnant, lactating Holstein dairy cows fed diets supplemented with OmniGen-AF (OG; Phibro Animal Health Corp., Teaneck, NJ), an immune modulator, and in nonsupplemented control (CON) cows following bolus infusions of a combination of corticotropin-releasing hormone (CRH; 0.3 µg/kg of BW) and arginine vasopressin (VP; 1.0 µg/kg of BW) or ACTH (0.1 IU/kg of BW) in 2 environments: thermoneutral [TN; temperature-humidity index (THI) <60] for 24 h/d and heat stress (HS; THI >68 for 17 h/d). Cows (506) were initially fed OG (n = 254) or CON (n = 252) diets for 44 d before selection of a subgroup of cows (n = 12; 6 OG, 6 CON) for the study. The 2 subgroups were balanced for parity, milk yield, and days in milk. All cows were transported to and housed in 2 environmentally controlled rooms at the University of Arizona Agricultural Research Complex (Tucson). Cows were given 3 d to acclimate to the rooms and then underwent 12 d of TN conditions and then 8 d of HS conditions for a total of 24 d on experiment. Cows were infused with CRH-VP on d 9 of TN and on d 1 of HS and with ACTH on d 10 of TN and on d 2 of HS. Hormone infusions took place at 1000 h (0 h) on each infusion day. Blood samples, taken in 30-min intervals, were first collected at 0800 h (-2 h) and were drawn until 1800 h (8 h). Before infusion, serum progesterone was elevated in OG cows compared with CON cows. Infusion of releasing factors (CRH-VP or ACTH) caused increases in serum cortisol and progesterone, but cortisol release was greater in CON cows than in OG cows during HS, whereas progesterone did not differ between the 2 treatments. Serum ACTH increased following infusion of releasing factors, but this increase was greater following CRH-VP infusion than ACTH infusion. Serum bovine corticosteroid-binding globulin also increased following infusion of releasing factors in both treatment groups, but this increase was greater during HS in cows fed OG. The free cortisol index (FCI) increased following CRH-VP and ACTH and was higher in HS than in TN for both OG and CON cows. However, the FCI response was blunted in OG cows compared with CON cows during HS. Heat stress enhanced the adrenal response to releasing factors. Additionally, the adrenal cortisol and FCI response to releasing factors was reduced during acute heat stress in cows fed OG. Collectively, these data suggest that OG supplementation reduced the adrenal responsiveness to factors regulating cortisol secretion during acute HS.

Immunological responses and evaluation of the protection in dairy cows vaccinated with staphylococcal surface proteins.

Bovine mastitis is a significant cause of economic losses in the dairy industry. Staphylococcus aureus is one of the most common contagious mastitis pathogens, whereas Staphylococcus chromogenes increasingly became a significant cause of subclinical mastitis in dairy cows. Current mastitis control measures are not effective on all mastitis pathogens. There is no effective vaccine to control Staphylococcal mastitis in dairy cows. The objective of this study was to evaluate the immune responses and protection in dairy cows vaccinated with S. aureus surface proteins (SASP) or S. chromogenes surface proteins (SCSP). We divided eighteen Holstein dairy cows randomly into three groups of 6 animals each. We vaccinated group 1 and 2 animals with SASP and SCSP with Emulsigen-D adjuvant, respectively. We injected control (group 3) animals with PBS (pH 7.2) in Emulsigen®-D. We vaccinated animals three times at 28 and 14 days before drying off, and at dry off. Two weeks after the third vaccination, we challenged each animal by dipping all teats in S. aureus culture suspension once daily for 14 consecutive days. We evaluated milk or mammary secretion and serum antibody titers during vaccination and challenge periods. We evaluated milk samples for the number of bacteria shedding and somatic cell counts (SCC). Out of six cows vaccinated with SASP, one cow was removed from the study due to injury, two were infected clinically, another two were infected subclinically, and the remaining cow was not infected. No SCSP vaccinated cows developed clinical or subclinical mastitis. Out of six control cows, two developed clinical mastitis whereas four were infected subclinically. The SCSP vaccine cross-protected against S. aureus mastitis and reduced number of S. aureus shedding in milk. We concluded that the SCSP is a promising vaccine to control Staphylococcal mastitis in dairy cows.

Development and psychometric testing of an inventory to measure patient-centred care in dietetic practice - dietitian version.

BACKGROUND: The lack of a valid instrument to measure patient-centred care (PCC) in dietetic practice makes it challenging to evaluate how patient-centred dietitians are. The present study aimed to develop and psychometrically test a dietitian-reported inventory to measure PCC in dietetic practice. METHODS: The inventory was compiled based on a literature review of existing validated scales that measured the dimensions of PCC. Next, the inventory was distributed as a cross-sectional survey to 180 Australian Accredited Practicing Dietitians who worked in primary care. Exploratory factor analysis was performed using principal factor analysis with Promax rotation. Cronbach's alpha (criteria ≥0.80), inter-item correlations and corrected item-total correlations (criteria 0.30-0.70) were computed to evaluate the internal consistency of each scale. RESULTS: Five factors were extracted accounting for 56.9% of the variance. Most variables had strong loadings on only one factor. Factors were labelled as: shared decision-making; holistic and individualised care; patient-dietitian communication; knowing the patient; and caring patient-dietitian relationships. Cronbach's alpha was 0.94 for the total inventory and ranged from 0.73 to 0.91 for the individual factors. Inter-item correlations and corrected item-total correlations mostly fell in the desired range. CONCLUSIONS: The present study offers a preliminary, conceptually grounded dietitian-reported inventory, which is the first instrument developed and tested to measure PCC in dietetic practice. These findings illustrate the underlying factor structure of the inventory and support the reliability of the scales. With further testing, this inventory may provide useful to clinicians and researchers working to better understand and improve dietetic practice.

Risk factors for measles among infants in Tianjin, China.

OBJECTIVES: Infants aged <8 months are ineligible for measles vaccination in China but represent a disproportionate number of cases. We examined the risk factors for measles among infants in Tianjin, China. STUDY DESIGN: Case-control study. METHODS: Cases were enrolled from a surveillance system, and IgG-negative controls were sampled from registries at immunization clinics. A logistic regression model assessed for risk factors. RESULTS: Among 82 cases and 485 controls, exposure to a municipal hospital (OR [odds ratio]: 5.21; 95% confidence interval [CI]: 1.19-22.82) or a specialty hospital (OR: 13.22; 95% CI: 6.13-28.51) was associated with the disease, whereas visiting a township or district hospitals was not associated with increased odds of measles. CONCLUSIONS: Hospitals were an important focal point of measles transmission for infants. Hospitals, particularly higher-level municipal and specialty hospitals, should enforce infection control programs to separate infants with highly communicable diseases to prevent transmission.

Nurses' practice in preventing postoperative wound infections: an observational study.

OBJECTIVE: Surgical site infections (SSIs) are serious postoperative complications that may lead to undesired patient outcomes. Previous research has used survey and chart audit methods to describe wound care practices. However, little research has been published using contemporaneous observations to describe the surgical wound management practices of nurses. The aim of this study was to prospectively describe surgical nurses' postoperative wound care practices and the extent to which observed surgical wound practices aligned with evidence-based guideline recommendations. METHOD: In this cross-sectional prospective study, we observed a convenience sample of 60 nurses from four surgical units using a specifically developed observational audit tool. Inter-rater reliability for this tool was assessed during the observation period. RESULTS: Of 60 observed episodes of wound care, post-procedure hand hygiene (n=49, 81.7%) was less evident compared with pre-procedure hand hygiene practice (n=57, 95%). Over one-third of nurses observed did not correctly use clean gloves (n=16, 38.1%) and one in five did not properly use sterile gloves (n=4, 22%). More than half of surgical nurses (n=37, 61.7%) did not educate patients on post-discharge wound management. Fewer than a quarter (n=14, 23.3%) of wound care events were recorded on both wound assessment charts and patients' progress notes. Inter-rater reliability testing indicated good agreement (intra-class correlation coefficient 0.859; 95% CI: 0.771-0.923; p<0.0005). CONCLUSION: Despite surgical wound care guideline recommendations on aseptic technique compliance, patient education, wound assessment and documentation practices, there is a clear gap between recommended and observed wound care practice. This study highlights an area where clinical practice is not reflective of evidence-based recommendations, suggesting that to minimise SSI as an adverse event, practice should be evaluated and strategies incorporating evidence into practice are explored.

Economic case for intraoperative interventions to prevent surgical-site infection.

BACKGROUND: Surgical-site infection (SSI) occurs in 1-10 per cent of all patients undergoing surgery; rates can be higher depending on the type of surgery. The aim of this review was to establish whether (or not) surgical hand asepsis, intraoperative skin antisepsis and selected surgical dressings are cost-effective in SSI prevention, and to examine the quality of reporting. METHODS: The authors searched MEDLINE via Ovid, CINAHL via EBSCO, Cochrane Central and Scopus databases systematically from 1990 to 2016. Included were RCTs and quasi-experimental studies published in English, evaluating the economic impact of interventions to prevent SSI relative to surgical hand and skin antisepsis, and wound dressings. Characteristics and results of included studies were extracted using a standard data collection tool. Study and reporting quality were assessed using SIGN and CHEERS checklists. RESULTS: Across the three areas of SSI prevention, the combined searches identified 1214 articles. Of these, five health economic studies evaluating the cost-effectiveness of selected surgical dressings were eligible. Study authors concluded that the interventions being assessed were cost-effective, or were potentially cost-saving. Still, there is high uncertainty around the decision to adopt these dressings/devices in practice. The studies' reporting quality was reasonable; three reported at least 15 of the 24 CHEERS items appropriately. Assessment of methodological quality found that two studies were considered to be of high quality. CONCLUSION: With few economic studies undertaken in this area, the cost-effectiveness of these strategies is unclear. Incorporating economic evaluations alongside RCTs will help towards evidence-informed decisions.

Social and Financial Outcomes of Living Liver Donation: A Prospective Investigation Within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2).

Because results from single-center (mostly kidney) donor studies demonstrate interpersonal relationship and financial strains for some donors, we conducted a liver donor study involving nine centers within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2) consortium. Among other initiatives, A2ALL-2 examined the nature of these outcomes following donation. Using validated measures, donors were prospectively surveyed before donation and at 3, 6, 12, and 24 mo after donation. Repeated-measures regression models were used to examine social relationship and financial outcomes over time and to identify relevant predictors. Of 297 eligible donors, 271 (91%) consented and were interviewed at least once. Relationship changes were positive overall across postdonation time points, with nearly one-third reporting improved donor family and spousal or partner relationships and >50% reporting improved recipient relationships. The majority of donors, however, reported cumulative out-of-pocket medical and nonmedical expenses, which were judged burdensome by 44% of donors. Lower income predicted burdensome donation costs. Those who anticipated financial concerns and who held nonprofessional positions before donation were more likely to experience adverse financial outcomes. These data support the need for initiatives to reduce financial burden.

Psychological Outcomes of Living Liver Donors From a Multicenter Prospective Study: Results From the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2).

Although single-center and cross-sectional studies have suggested a modest impact of liver donation on donor psychological well-being, few studies have assessed these outcomes prospectively among a large cohort. We conducted one of the largest, prospective, multicenter studies of psychological outcomes in living liver donors within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2) consortium. In total, 271 (91%) of 297 eligible donors were interviewed at least once before donation and at 3, 6, 12, and 24 mo after donation using validated measures. We found that living liver donors reported low rates of major depressive (0-3%), alcohol abuse (2-5%), and anxiety syndromes (2-3%) at any given assessment in their first 2 years after donation. Between 4.7% and 9.6% of donors reported impaired mental well-being at various time points. We identified significant predictors for donors' perceptions of being better people and experiencing psychological growth following donation, including age, sex, relationship to recipient, ambivalence and motivation regarding donation, and feeling that donation would make life more worthwhile. Our results highlight the need for close psychosocial monitoring for those donors whose recipients died (n=27); some of those donors experienced guilt and concerns about responsibility. Careful screening and targeted, data-driven follow-up hold promise for optimizing psychological outcomes following this procedure for potentially vulnerable donors.

Surgical wound assessment and documentation of nurses: an integrative review.

OBJECTIVE: Surgical site infections (SSI) are serious complications that can lead to adverse patient outcomes such as prolonged hospital length of stay, increased health-care costs, and even death. There is an imperative worldwide to reduce the morbidity associated with SSIs. The importance of surgical wound assessment and documentation to reduce SSI complications is increasingly recognised. Evidence-based guidelines have been published internationally to highlight recommended practices. The aim of this integrated review is to evaluate current surgical wound assessment and documentation practices of nurses in order to inform future evidence-based research on acute wound care practices. METHOD: Databases including CINAHL, Cochrane, Medline and Proquest Nursing were searched using key terms of 'wound assessment' AND 'surgical, wound assessment' AND 'documentation, wound assessment' AND 'practice, wound assessment' AND 'postoperative, wound assessment' AND 'nurse, and wound assessment' AND 'surgical site infection'. RESULTS: A total of 188 articles were identified from the database searches; searching the reference lists provided an additional 8 articles. After careful exclusion processes, a total of six papers were included in the review. Despite the recommendations around wound assessment, there is little discussion on how the clinical characteristics of surgical wounds should be assessed, the frequency of the wound assessments and to what extent wound assessments are documented in the literature. CONCLUSION: There is limited research evidence on acute wound assessment and documentation. Therefore, further research is needed to provide evidence for surgical nurses in relation to wound assessment and documentation practices. DECLARATION OF INTEREST: The authors declare that they have no conflict of interest.

Moving evidence into clinical practice: Implementing surgical safety checklists in the operating room.

Surgical safety checklists have been shown to improve teamwork and reduce the risk of wrong site surgery (WHO, 2008).

Redesigning a General Education Science Course to Promote Critical Thinking.

Recent studies question the effectiveness of a traditional university curriculum in helping students improve their critical thinking and scientific literacy. We developed an introductory, general education (gen ed) science course to overcome both deficiencies. The course, titled Foundations of Science, differs from most gen ed science offerings in that it is interdisciplinary; emphasizes the nature of science along with, rather than primarily, the findings of science; incorporates case studies, such as the vaccine-autism controversy; teaches the basics of argumentation and logical fallacies; contrasts science with pseudoscience; and addresses psychological factors that might otherwise lead students to reject scientific ideas they find uncomfortable. Using a pretest versus posttest design, we show that students who completed the experimental course significantly improved their critical-thinking skills and were more willing to engage scientific theories the general public finds controversial (e.g., evolution), while students who completed a traditional gen ed science course did not. Our results demonstrate that a gen ed science course emphasizing the process and application of science rather than just scientific facts can lead to improved critical thinking and scientific literacy.

Emotional well-being of living kidney donors: findings from the RELIVE Study.

Following kidney donation, short-term quality of life outcomes compare favorably to US normative data but long-term effects on mood are not known. In the Renal and Lung Living Donors Evaluation Study (RELIVE), records from donations performed 1963-2005 were reviewed for depression and antidepressant use predonation. Postdonation, in a cross-sectional cohort design 2010-2012, donors completed the Patient Health Questionnaire (PHQ-9) depression screening instrument, the Life Orientation Test-Revised, 36-Item Short Form Health Survey and donation experience questions. Of 6909 eligible donors, 3470 were contacted and 2455 participated (71%). The percent with depressive symptoms (8%; PHQ-9>10) was similar to National Health and Nutrition Examination Survey participants (7%, p=0.30). Predonation psychiatric disorders were more common in unrelated than related donors (p=0.05). Postdonation predictors of depressive symptoms included nonwhite race OR=2.00, p=0.020), younger age at donation (OR=1.33 per 10 years, p=0.002), longer recovery time from donation (OR=1.74, p=0.0009), greater financial burden (OR=1.32, p=0.013) and feeling morally obligated to donate (OR=1.23, p=0.003). While cross-sectional prevalence of depression is comparable to population normative data, some factors identifiable around time of donation, including longer recovery, financial stressors, younger age and moral obligation to donate may identify donors more likely to develop future depression, providing an opportunity for intervention.

Morbidity and mortality of live lung donation: results from the RELIVE study.

The Renal and Lung Living Donors Evaluation Study assesses outcomes of live lung (lobectomy) donors. This is a retrospective cohort study at University of Southern California (USC) and Washington University (WASHU) Medical Centers (1993­2006), using medical records to assess morbidity and national databases to ascertain postdonation survival and lung transplantation. Serious complications were defined as those that required significant treatment, were potentially life-threatening or led to prolonged hospitalization. The 369 live lung donors (287 USC, 82 WASHU) were predominantly white, non-Hispanic and male; 72% had a biological relationship to the recipient, and 30% were recipient parents. Serious complications occurred in 18% of donors; 2.2% underwent reoperation and 6.5% had an early rehospitalization. The two centers had significantly different incidences of serious complications (p < 0.001). No deaths occurred and no donors underwent lung transplantation during 4000+ person-years of follow-up (death: minimum 4, maximum 17 years; transplant: minimum 5, maximum 19). Live lung donation remains a potential option for recipients when using deceased donor lungs lacks feasibility. However, the use of two live donors for each recipient and the risk of morbidity associated with live lung donation do not justify this approach when deceased lung donors remain available. Center effects and long-term live donor outcomes require further evaluation.

Health-related quality of life in kidney donors from the last five decades: results from the RELIVE study.

Live donation benefits recipients, but the long-term consequences for donors remain uncertain. Renal and Lung Living Donors Evaluation Study surveyed kidney donors (N = 2455; 61% women; mean age 58, aged 24-94; mean time from donation 17 years, range 5-48 years) using the Short Form-36 Health Survey (SF-36). The 95% confidence intervals for White and African-American donors included or exceeded SF-36 norms. Over 80% of donors reported average or above average health for their age and sex (p < 0.0001). Donors' age-sex adjusted physical component summary (PCS) scores declined by half a point each decade after donation (p = 0.0027); there was no decline in mental component summary (MCS) scores. White donors' PCS scores were three points higher (p = 0.0004) than non-Whites'; this difference remained constant over time. Nine percent of donors had impaired health (PCS or MCS score >1 SD below norm). Obesity, history of psychiatric difficulties and non-White race were risk factors for impaired physical health; history of psychiatric difficulties was a risk factor for impaired mental health. Education, older donation age and a first-degree relation to the recipient were protective factors. One percent reported that donation affected their health very negatively. Enhanced predonation evaluation and counseling may be warranted, along with ongoing monitoring for overweight donors.

Oral contraceptive use and risk of vulvodynia: a population-based longitudinal study.

OBJECTIVE: To assess whether the risk of vulvodynia is associated with previous use of oral contraceptives (OCs). DESIGN: Longitudinal population-based study. SETTING: Four counties in south-east Michigan, USA. POPULATION: A population-based sample of women, aged 18 years and older, enrolled using random-digit dialling. METHODS: Enrolled women completed surveys that included information on demographic characteristics, health status, current symptoms, past and present OC use, and a validated screen for vulvodynia. The temporal relationship between OC use and subsequent symptoms of vulvodynia was assessed using Cox regression, with OC exposure modelled as a time-varying covariate. MAIN OUTCOME MEASURE: Vulvodynia, as determined by validated screen. RESULTS: Women aged <50 years who provided data on OC use, completed all questions required for the vulvodynia screen, and had first sexual intercourse prior to the onset of vulvodynia symptoms were eligible (n = 906). Of these, 71.2% (n = 645) had used OCs. The vulvodynia screen was positive in 8.2% (n = 74) for current vulvodynia and in 20.8% (n = 188) for past vulvodynia. Although crude cross-tabulation suggested that women with current or past vulvodynia were less likely to have been exposed to OCs prior to the onset of pain (60.7%), compared with those without this disorder (69.3%), the Cox regression analysis identified no association between vulvodynia and previous OC use (HR 1.08, 95% CI 0.81-1.43, P = 0.60). This null finding persisted after controlling for ethnicity, marital status, educational level, duration of use, and age at first OC use. CONCLUSION: For women aged <50 years of age, OC use did not increase the risk of subsequent vulvodynia.