Patient perspectives in adverse event reporting after vaginal apical prolapse surgery.

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspectives are often not included in this process. OBJECTIVE: This study aimed to compare clinician vs patient grading of adverse event severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association of patient grading of adverse events with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study (Patient Perspectives in Adverse Event Reporting [PPAR]) to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, adverse events experienced by patients were collected per a standardized protocol every 6 months during which clinicians graded adverse event severity (mild, moderate, severe/life-threatening). In this substudy, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR adverse events." Patients provided their own severity grading (mild, moderate, severe/very severe/life-threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic) for adverse event severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. The association between adverse event severity and the Decision Regret Scale, Satisfaction with Decision Scale, the 12-Item Short-Form Health Survey, and Patient Global Impression of Improvement scores was assessed using the Spearman correlation coefficient (ρ) for continuous scales, the Mantel-Haenszel chi-square test for Patient Global Impression of Improvement, and t tests or chi-square tests comparing the assessments of patients who rated their adverse events or symptoms as severe with those who gave other ratings. To describe patient perspective changes over time, the intraobserver agreement was estimated for adverse event severity grade over time using weighted kappa coefficients. RESULTS: Of the 360 randomly assigned patients, 219 (61%) experienced a total of 527 PPAR adverse events (91% moderate and 9% severe/life-threatening by clinician grading). Mean patient age was 67 years; 87% were White and 12% Hispanic. Among the patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (kappa=0.24 [95% confidence interval, 0.14-0.34]). Of the 414 adverse events that clinicians graded as moderate, patients graded 120 (29%) as mild and 80 (19%) as severe. Of the 39 adverse events graded as severe by clinicians, patients graded 15 (38%) as mild or moderate. Initial patient grading of the most severe reported adverse event was mildly correlated with worse Decision Regret Scale (ρ=0.2; P=.01), 12-Item Short-Form Health Survey (ρ=-0.24; P<.01), and Patient Global Impression of Improvement (P<.01) scores. There was no association between adverse event severity and Satisfaction with Decision Scale score. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (P<.05). Agreement between the patients' initial severity ratings and their ratings at 12 months (kappa=0.48 [95% confidence interval, 0.39-0.58]) and 36 months (kappa=0.45 [95% confidence interval, 0.37-0.53]) was fair. CONCLUSION: Clinician and patient perceptions of adverse event severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial.

Importance: The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective: To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants: This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions: Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures: The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results: Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance: Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02676973.

Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial.

OBJECTIVES: The primary objective of this study is to compare patient versus physician rankings of adverse event (AE) and adverse symptom (AS) severity after pelvic reconstructive surgery. Secondary objectives include to estimate the association between patient rankings of AEs/ASs with decision-making and quality-of-life outcomes and to determine whether patient perspective about AE/AS changes over time. METHODS: This is a supplementary study, Patient-Perspectives in Adverse Event Reporting (PPAR), to the index trial, ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design). During the trial, AEs/ASs will be assessed by physicians longitudinally every 6 months, which includes a determination of the AE/AS grade severity. For PPAR, additional patient perspective will be measured for 19 predetermined AEs/ASs at the time of identification and again at 12 and 36 months postoperatively. Decision-making and quality-of-life questionnaires will be collected at these time points. The primary outcome, the overall interrater agreement between patient and physician rankings for AE/AS severity, will be determined using a repeated-measures concordance correlation coefficient. RESULTS: To date, the index trial has completed enrollment, and follow-up is ongoing. CONCLUSIONS: The PPAR methods for incorporating patient perspective in the measurement of AEs/ASs to determine their agreement with physician ranking, long-term relevance, and impact on treatment decision making and quality of life are described. This will contribute to improved measurements of AEs/ASs in future research with the goal of improving patient counseling and informing expectations and treatment decision making.

The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

Stillbirth 2010-2018: a prospective, population-based, multi-country study from the Global Network.

BACKGROUND: Stillbirth rates are high and represent a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC). In LMIC, where nearly 98% of stillbirths worldwide occur, few population-based studies have documented cause of stillbirths or the trends in rate of stillbirth over time. METHODS: We undertook a prospective, population-based multi-country research study of all pregnant women in defined geographic areas across 7 sites in low-resource settings (Kenya, Zambia, Democratic Republic of Congo, India, Pakistan, and Guatemala). Staff collected demographic and health care characteristics with outcomes obtained at delivery. Cause of stillbirth was assigned by algorithm. RESULTS: From 2010 through 2018, 573,148 women were enrolled with delivery data obtained. Of the 552,547 births that reached 500 g or 20 weeks gestation, 15,604 were stillbirths; a rate of 28.2 stillbirths per 1000 births. The stillbirth rates were 19.3 in the Guatemala site, 23.8 in the African sites, and 33.3 in the Asian sites. Specifically, stillbirth rates were highest in the Pakistan site, which also documented a substantial decrease in stillbirth rates over the study period, from 56.0 per 1000 (95% CI 51.0, 61.0) in 2010 to 44.4 per 1000 (95% CI 39.1, 49.7) in 2018. The Nagpur, India site also documented a substantial decrease in stillbirths from 32.5 (95% CI 29.0, 36.1) to 16.9 (95% CI 13.9, 19.9) per 1000 in 2018; however, other sites had only small declines in stillbirth over the same period. Women who were less educated and older as well as those with less access to antenatal care and with vaginal assisted delivery were at increased risk of stillbirth. The major fetal causes of stillbirth were birth asphyxia (44.0% of stillbirths) and infectious causes (22.2%). The maternal conditions that were observed among those with stillbirth were obstructed or prolonged labor, antepartum hemorrhage and maternal infections. CONCLUSIONS: Over the study period, stillbirth rates have remained relatively high across all sites. With the exceptions of the Pakistan and Nagpur sites, Global Network sites did not observe substantial changes in their stillbirth rates. Women who were less educated and had less access to antenatal and obstetric care remained at the highest burden of stillbirth. STUDY REGISTRATION: Clinicaltrials.gov (ID# NCT01073475).

Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair.

OBJECTIVE: To assess independent risk factors for surgical failure and worsening pelvic floor symptoms within 5 years after vaginal prolapse surgery. METHODS: This secondary analysis includes OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) (n=374) and E-OPTIMAL (Extended) (n=285) trial participants. Surgical failure was defined as apical descent greater than one third of the total vaginal length, anterior or posterior vaginal wall past the hymen, subsequent surgery or bothersome vaginal bulge. Worsening pelvic floor symptoms were defined as increases from baseline as large as the minimally important difference for subscale scores of the Pelvic Floor Distress Inventory: 11 for the Urinary Distress Inventory and Colorectal-Anal Distress Inventory and 34.3 for the Pelvic Organ Prolapse Distress Inventory. Outcomes were measured at 6 months then 1, 2, 3, 4, and 5 years. Chi-square and t test results from bivariate models and clinical relevance were used to inform final models. RESULTS: Baseline risk factors for surgical failure were Hispanic ethnicity (adjusted odds ratio [aOR] 1.92, 95% CI 1.17-3.15), perineal body (aOR 1.34, 95% CI 1.09-1.63), and pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 1.16, 95% CI 1.05-1.28). Risk factors for worsening of pelvic floor symptoms were pretreatment Pelvic Organ Prolapse Distress Inventory score (aOR 0.75, 95% CI 0.60-0.94) for worsening Pelvic Organ Prolapse Distress Inventory score, vaginal deliveries (aOR 1.26, 95% CI 1.10-1.44) and pretreatment Urinary Distress Inventory score (aOR 0.86, 95% CI 0.80-0.93) for worsening Urinary Distress Inventory score, and age (aOR 1.03, 95% CI 1.01-1.05) and pretreatment Colorectal-Anal Distress Inventory score (aOR 0.95, 95% CI 0.92-0.98) for worsening Colorectal-Anal Distress Inventory score. CONCLUSIONS: Hispanic ethnicity, larger preoperative perineal body, and higher pretreatment Pelvic Organ Prolapse Distress Inventory scores were risk factors for surgical failure up to 5 years after vaginal prolapse repair. Participants with higher baseline Pelvic Floor Distress Inventory scores were less likely to worsen. Risk factors for worsening Urinary Distress Inventory and Colorectal-Anal Distress Inventory scores included more vaginal deliveries and increased age, respectively. CLINICAL TRIAL REGISTRATION: NCT00597935, NCT01166373.

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence. METHODS: This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse. RESULTS: Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II. CONCLUSIONS: Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

BACKGROUND/AIMS: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. RESULTS: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. CONCLUSION: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Interaction of healthcare worker hands and portable medical equipment: a sequence analysis to show potential transmission opportunities.

BACKGROUND: While research has demonstrated the importance of a clean health care environment, there is a lack of research on the role portable medical equipment (PME) play in the transmission cycle of healthcare-acquired infections (HAIs). This study investigated the patterns and sequence of contact events among health care workers, patients, surfaces, and medical equipment in a hospital environment. METHODS: Research staff observed patient care events over six different 24 h periods on six different hospital units. Each encounter was recorded as a sequence of events and analyzed using sequence analysis and visually represented by network plots. In addition, a point prevalence microbial sample was taken from the computer on wheels (COW). RESULTS: The most touched items during patient care was the individual patient (850), bedrail (375), bed-surface (302), and bed side Table (223). Three of the top ten most common subsequences included touching PME and the patient: computer on wheels ➔ patient (62 of 274 total sequences, 22.6%, contained this sequence), patient ➔ COW (20.4%), and patient ➔ IV pump (16.1%). The network plots revealed large interconnectedness among objects in the room, the patient, PME, and the healthcare worker. CONCLUSIONS: Our results demonstrated that PME such as COW and IV pump were two of the most highly-touched items during patient care. Even with proper hand sanitization and personal protective equipment, this sequence analysis reveals the potential for contamination from the patient and environment, to a vector such as portable medical equipment, and ultimately to another patient in the hospital.

The Need for Standardized Methods for Measuring the Aorta: Multimodality Core Lab Experience From the GenTAC Registry.

OBJECTIVES: This study sought to evaluate variability in aortic measurements with multiple imaging modalities in clinical centers by comparing with a standardized measuring protocol implemented in a core laboratory. BACKGROUND: In patients with aortic disease, imaging of thoracic aorta plays a major role in risk stratifying individuals for life-threatening complications and in determining timing of surgical intervention. However, standardization of the procedures for performance of aortic measurements is lacking. METHODS: To characterize the diversity of methods used in clinical practice, we compared aortic measurements performed by echocardiography, computed tomography (CT), and magnetic resonance imaging (MRI) at the 6 GenTAC (National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions) clinical centers to those performed at the imaging core laboratory in 965 studies. Each center acquired and analyzed their images according to local protocols. The same images were subsequently analyzed blindly by the core laboratory, on the basis of a standardized protocol for all imaging modalities. Paired measurements from clinical centers and core laboratory were compared by mean of differences and intraclass correlation coefficient (ICC). RESULTS: For all segments of the ascending aorta, echocardiography showed a higher ICC (0.84 to 0.93) than CT (0.84) and MRI (0.82 to 0.90), with smaller mean of differences. MRI showed higher ICC for the arch and descending aorta (0.91 and 0.93). In a mixed adjusted model, the different imaging modalities and clinical centers were identified as sources of variability between clinical and core laboratory measurements, whereas age groups or diagnosis at enrollment were not. CONCLUSIONS: By comparing core laboratory with measurements from clinical centers, our study identified important sources of variability in aortic measurements. Furthermore, our findings with regard to CT and MRI suggest a need for imaging societies to work toward the development of unifying acquisition protocols and common measuring methods.

A deleterious gene-by-environment interaction imposed by calcium channel blockers in Marfan syndrome.

Calcium channel blockers (CCBs) are prescribed to patients with Marfan syndrome for prophylaxis against aortic aneurysm progression, despite limited evidence for their efficacy and safety in the disorder. Unexpectedly, Marfan mice treated with CCBs show accelerated aneurysm expansion, rupture, and premature lethality. This effect is both extracellular signal-regulated kinase (ERK1/2) dependent and angiotensin-II type 1 receptor (AT1R) dependent. We have identified protein kinase C beta (PKCß) as a critical mediator of this pathway and demonstrate that the PKCß inhibitor enzastaurin, and the clinically available anti-hypertensive agent hydralazine, both normalize aortic growth in Marfan mice, in association with reduced PKCß and ERK1/2 activation. Furthermore, patients with Marfan syndrome and other forms of inherited thoracic aortic aneurysm taking CCBs display increased risk of aortic dissection and need for aortic surgery, compared to patients on other antihypertensive agents.

Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women.

OBJECTIVE: This study aimed to describe the incidence of fecal incontinence (FI) at 6, 12, and 24 weeks postpartum; anal incontinence (AI) and fecal urgency at 24 weeks; and identify predictors of AI in women with obstetric anal sphincter injury (OASI). METHODS: Primiparous women sustaining OASIs were identified at 8 clinical sites. Third-degree OASIs were characterized using World Health Organization criteria, 3a (<50%) or 3b (>50%) tear through the sphincter. Fecal incontinence was defined as leakage of liquid/solid stool and/or mucus in the past month; AI was defined as leakage of liquid/solid stool and/or mucus and/or gas in the past month and was assessed at 6, 12, and 24 weeks postpartum using the Fecal Incontinence Severity Index. Logistic regression identified variables associated with AI. RESULTS: Three hundred forty-three women participated: 297 subjects sustained a third-degree OASI, 168 type 3a, 98 type 3b and 31 indeterminant; 45 had a fourth-degree OASI. Overall FI incidence at 6, 12, and 24 weeks was 7% [23/326; 95% confidence interval (CI), 4%-10%], 4% (6/145; 95% CI, 2%-9%), and 9% (13/138; 95% CI, 5%-16%), respectively. At 24 weeks, AI incidence was 24% (95% CI, 17%-32%) and fecal urgency 21% (95% CI, 15%-29%). No significant differences in FI and AI rates were noted by third-degree type or between groups with third and fourth OASI. Flatal incontinence was greater in women sustaining a fourth-degree tear (35% vs 16%, P = 0.04). White race (adjusted odds ratio, 4.64; 95% CI, 1.35-16.02) and shorter duration of second stage (adjusted odds ratio, 1.47 per 30 minute decrease; 95% CI, 1.12-1.92) were associated with AI at 24 weeks. CONCLUSIONS: Overall 24-week incidence of FI is 9% (95% CI, 5%-16%) and AI is 24% (95% CI, 17%-32%). In women with OASI, white race and shorter second-stage labor were associated with postpartum AI. CLINICAL TRIAL REGISTRATION: NCT01166399 (http://clinicaltrials.gov).

Acute occupational injury among adolescent farmworkers from South Texas.

PURPOSE: This combined cross-sectional/cohort study addressed research gaps by estimating the rate of non-fatal occupational injury and identifying potential determinants among a population of adolescent farmworkers who are largely Hispanic and migrant. METHODS: The cohort included 410 farmworkers (aged 13-19 years) attending high school in South Texas along the border with Mexico. Data collection involved a self-administered, Web-based survey that solicited information on demographics, farm work variables including person-time at risk, occupational injury, health status and health risk behaviours. Cox regression was used to identify potential risk factors for non-fatal injury events experienced during a 9-month recall period. RESULTS: Depending on the definition of injury, the rate of non-fatal injury ranged from 27.0-73.6/100 full time equivalents. Variables with an increased and statistically significant HR in an adjusted Cox model included: age groups <15 years-old (5.82) and 16 years-old (4.47), usually sleeping <8 h during the week (2.10), feeling tense, stressed or anxious sometimes/often (2.25), not watching TV (2.65), working around ditches (2.01) and detasseling (2.70). CONCLUSIONS: The high observed rates of non-fatal injury combined with the potential negative consequences and cost of these injuries signifies a compelling need for injury prevention efforts targeting adolescent, Hispanic, farmworkers.

Home birth attendants in low income countries: who are they and what do they do?

BACKGROUND: Nearly half the world's babies are born at home. We sought to evaluate the training, knowledge, skills, and access to medical equipment and testing for home birth attendants across 7 international sites. METHODS: Face-to-face interviews were done by trained interviewers to assess level of training, knowledge and practices regarding care during the antenatal, intrapartum and postpartum periods. The survey was administered to a sample of birth attendants conducting home or out-of-facility deliveries in 7 sites in 6 countries (India, Pakistan, Guatemala, Democratic Republic of the Congo, Kenya and Zambia). RESULTS: A total of 1226 home birth attendants were surveyed. Less than half the birth attendants were literate. Eighty percent had one month or less of formal training. Most home birth attendants did not have basic equipment (e.g., blood pressure apparatus, stethoscope, infant bag and mask manual resuscitator). Reporting of births and maternal and neonatal deaths to government agencies was low. Indian auxilliary nurse midwives, who perform some home but mainly clinic births, were far better trained and differed in many characteristics from the birth attendants who only performed deliveries at home. CONCLUSIONS: Home birth attendants in low-income countries were often illiterate, could not read numbers and had little formal training. Most had few of the skills or access to tests, medications and equipment that are necessary to reduce maternal, fetal or neonatal mortality.

Chronic back pain and associated work and non-work variables among farmworkers from Starr County, Texas.

OBJECTIVES: This study estimated the prevalence of chronic back pain among migrant farmworker family members and identified associated work and non-work variables. METHODS: Migrant farmworkers (n = 390 from 267 families) from Starr County, Texas were interviewed in their home once a year for 2 years. The original survey included items measuring demographics, smoking, sleep, farm work, and chronic back pain. For this cross-sectional analysis, multi-level logistic regression was used to identify associated work and other variables associated with chronic back pain while accounting for intraclass correlations due to repeated measures and multiple family members. RESULTS: The prevalence of chronic back pain during the last migration season ranged from 9.5% among the youngest children to 33.3% among mothers. Variables significantly associated with chronic back pain were age (odds ratio [OR], 1.03, per year increase), depressive symptoms while migrating (OR, 8.72), fewer than 8 hours of sleep at home in Starr County (OR, 2.26), fairly bad/very bad quality of sleep while migrating (OR, 3.25), sorting crops at work (OR, 0.18), and working tree crops (OR, 11.72). CONCLUSION: The role of work exposures, depressive symptoms, and sleep in chronic back pain among farmworkers warrants further examination. Refinements in outcome and exposure assessments are also needed given the lack of a standardized case definition and the variety of tasks and crops involved in farm work in the United States.

Risk of childhood cancers associated with residence in agriculturally intense areas in the United States.

BACKGROUND: The potential for widespread exposure to agricultural pesticides through drift during application raises concerns about possible health effects to exposed children living in areas of high agricultural activity. OBJECTIVES: We evaluated whether residence in a county with greater agricultural activity was associated with risk of developing cancer in children < 15 years of age. METHODS: Incidence data for U.S. children 0-14 years of age diagnosed with cancer between 1995 and 2001 were provided by member registries of the North American Association of Central Cancer Registries. We determined percent cropland for each county using agricultural census data, and used the overall study distribution to classify agriculturally intense counties. We estimated odds ratios and 95% confidence intervals for all ages and 5-year age groups for total cancers and selected cancer sites using logistic regression. RESULTS: Our study results showed statistically significant increased risk estimates for many types of childhood cancers associated with residence at diagnosis in counties having a moderate to high level of agricultural activity, with a remarkably consistent dose-response effect seen for counties having >or= 60% of the total county acreage devoted to farming. Risk for different cancers varied by type of crop. CONCLUSIONS: Although interpretation is limited by the ecologic design, in this study we were able to evaluate rarer childhood cancers across a diverse agricultural topography. The findings of this exploratory study support a continued interest in the possible impact of long-term, low-level pesticide exposure in communities located in agriculturally intense areas.

Web-based data collection: detailed methods of a questionnaire and data gathering tool.

There have been dramatic advances in the development of web-based data collection instruments. This paper outlines a systematic web-based approach to facilitate this process through locally developed code and to describe the results of using this process after two years of data collection. We provide a detailed example of a web-based method that we developed for a study in Starr County, Texas, assessing high school students' work and health status. This web-based application includes data instrument design, data entry and management, and data tables needed to store the results that attempt to maximize the advantages of this data collection method. The software also efficiently produces a coding manual, web-based statistical summary and crosstab reports, as well as input templates for use by statistical packages.Overall, web-based data entry using a dynamic approach proved to be a very efficient and effective data collection system. This data collection method expedited data processing and analysis and eliminated the need for cumbersome and expensive transfer and tracking of forms, data entry, and verification. The code has been made available for non-profit use only to the public health research community as a free download..

A cohort study of injuries in migrant farm worker families in South Texas.

PURPOSE: This cohort study estimated the frequency of and risk factors for work injuries among migrant farmworker families over a two-year period. METHODS: The cohort consisted of 267 families. Bilingual interviewers asked mothers to respond for their family soliciting demographic, psychosocial, employment, and work-related injury information. Cox regression was used to examine risk factors for first injury events. RESULTS: Of the 267 families, nearly 60% migrated and 96% of these completed the follow-up interviews. These families represented about 310 individuals each year who had participated in farmwork on average 6 days a week, 10 hours a day, for 2.7 months in the past year. Twenty-five work-related injuries were reported with an overall rate of 12.5/100 FTE (95% C.I., 8.6-19.0). Working for a contractor increased the hazard ratio, and use of car seat belts and working for more than one employer during the season decreased it. CONCLUSIONS: If person-time at risk for injuries is taken into account the reported injuries are substantial. Because the injuries were quite diverse, specific interventions may have to focus on improved working conditions (physical and economic), ergonomic modifications, and enhanced enforcement of existing regulations.