Underreporting and Underrepresentation of Racial and Ethnic Minority Patients in Lymphedema Clinical Trials: A Systematic Review.

The generalizability of findings from Clinical Trials (CTs) investigating lymphedema treatment modalities requires an accurate representation of the target population. This study aims to evaluate racial and ethnic reporting and representation in lymphedema CTs. A comprehensive systematic literature search was conducted during May 2023 using multiple databases, following the PRISMA guidelines. All CTs published from 2018 to 2023 were included. A total of 84 articles were included in this review, from which 6,546 participants were included in the analysis. Seventy-four (88.1%) articles addressed secondary lymphedema, of which 60 (81.1%) were related to breast cancer. Only 12 (13%) of CTs reported at some extend race or ethnicity. Of these, five (41.6%) reported race and two (16.6%) reported ethnicity according to FDA guidelines. White race had the highest pooled prevalence (80%; 95% CI 72-86%; I2=90%), followed by Black (7%; 95% CI 2- 15%; I2= 94.3%) and Asian (4%; 95% CI 1-8%; I2= 89.9%). In studies reporting ethnicity, participants were predominantly non-Hispanic (92.1%; 95% CI 90 - 94%). There is an underreporting and underrepresentation of racial and ethnic minorities among lymphedema CTs, limiting their generalizability. It is imperative to future development of strategies to enhance diversity in the study sample.

The Effects of a Pain Management-Focused Mobile Health Behavior Intervention on Older Adults' Self-efficacy, Satisfaction with Functioning, and Quality of Life: a Randomized Pilot Trial.

BACKGROUND: This report investigates the impact of a remote physical activity intervention on self-efficacy, satisfaction with functioning, and health-related quality of life (HRQOL) as assessed by the SF-36 in obese older adults with chronic pain. The intervention was group-mediated in nature and based in social cognitive theory and mindfulness-based relapse prevention. METHODS: Participants (N = 28; 70.21 ± 5.22 years) were randomly assigned to receive either the active intervention, which focused on reducing caloric intake and increasing steps across the day or to a waitlist control condition. RESULTS: Over 12 weeks, intervention participants reported a moderate, positive improvement in self-efficacy for walking relative to control. They also reported large magnitude improvements in satisfaction for physical functioning as well as improvements on pain and the physical functioning subscales of the SF-36. CONCLUSIONS: These findings expand on previous research showing similar effects in response to structured exercise, this time via a protocol that is likely to be scalable and sustainable for many older adults. Additional work on larger and more diverse samples is warranted.

Relationships between respiratory sinus arrhythmia and stress in college students.

The purpose of this study was to examine the relationships between university students' respiratory sinus arrhythmia (RSA) profiles and both retrospective and momentary ratings of stress. Participants were undergraduate students enrolled in an introductory health science course (N = 64). Participants provided RSA data at rest (tonic) and following an orthostatic challenge (phasic), completed the 10-item Perceived Stress Scale (PSS), and completed 6 daily ecological momentary assessments (EMA) of stress for 1 week. Higher tonic RSA was associated with lower perceived stress assessed via PSS and average EMA responses. Those with higher tonic RSA did not differ in their experience of stress across the week, whereas those with lower tonic RSA experienced increased stress across the week, and these trajectories varied as a function of phasic responses. These findings suggest a need for greater emphasis on behavioral strategies for maintaining and enhancing autonomic nervous system health among college students.

Empowered with Movement to Prevent Obesity & Weight Regain (EMPOWER): Design and methods.

Promoting lasting weight loss among older adults is an important public health challenge. Participation in physical activity aids in weight loss and is important for the maintenance of physical function and quality of life. However, traditional intensive lifestyle interventions place a focus on discrete bouts of structured activity, leaving much of the remainder of the day for sedentary behavior. Structured exercise and weight loss programs often produce short-term weight loss that is typically followed by weight regain, and older adults are more likely to regain weight as fat mass rather than lean mass. Preliminary evidence suggests a focus on day-long movement intended to minimize time spent sitting produces better short-term weight loss and weight maintenance. Herein we describe the design and methods for a three-arm randomized controlled trial comparing mHealth-supported weight loss (WL) + structured exercise (EX); WL + a novel daily movement intervention (SitLess); and WL + EX + SitLess. Older adults (N = 180) will be randomly assigned to one of the three interventions, each comprised of a 6-month intensive phase; a 3-month transition phase; and a 9-month maintenance phase. The primary aim of the study is to determine whether the addition of SitLess to a traditional intensive lifestyle intervention comprised of dietary weight loss and structured exercise produces a larger 18-month reduction in body weight relative to WL + EX and WL + SitLess.

Relationships between dispositional mindfulness, health behaviors, and hemoglobin A1c among adults with type 2 diabetes.

Examine cross-sectional relationships between dispositional mindfulness and diabetes self-care behaviors (i.e., medication adherence, diet and exercise behavior, and self-monitoring of blood glucose; SMBG), hemoglobin A1c (HbA1c, %), and body mass index (BMI; continuously and obese vs. not). Adults with type 2 diabetes (N = 148, Mage = 55.7 ± 10.1) who were recruited to participate in a web-based diabetes medication adherence intervention completed all assessments at enrollment. In unadjusted analyses, mindfulness was associated with better dietary habits and worse HbA1c (p < .05). After controlling for a priori covariates (demographics, years since diabetes diagnosis, and insulin status), mindfulness remained associated with better dietary behavior (p < .01) but not HbA1c. Mindfulness was not associated with medication adherence, exercise behavior, SMBG, or body mass index. We found evidence that dispositional mindfulness plays an important role in dietary behaviors, supporting the use of mindful eating techniques in diabetes self-management interventions. Fostering mindfulness may be one of several behavioral tools needed to support key self-care behaviors and improve HbA1c.

Neural network imaging to characterize brain injury in cardiac procedures: the emerging utility of connectomics.

Cognitive dysfunction is a poorly understood but potentially devastating complication of cardiac surgery. Clinically meaningful assessment of cognitive changes after surgery is problematic because of the absence of a means to obtain reproducible, objective, and quantitative measures of the neural disturbances that cause altered brain function. By using both structural and functional connectivity magnetic resonance imaging data to construct a map of the inter-regional connections within the brain, connectomics has the potential to increase the specificity and sensitivity of perioperative neurological assessment, permitting rational individualized assessment and improvement of surgical techniques.

Replacing sedentary time with sleep, light, or moderate-to-vigorous physical activity: effects on self-regulation and executive functioning.

Recent attention has highlighted the importance of reducing sedentary time for maintaining health and quality of life. However, it is unclear how changing sedentary behavior may influence executive functions and self-regulatory strategy use, which are vital for the long-term maintenance of a health behavior regimen. The purpose of this cross-sectional study is to examine the estimated self-regulatory and executive functioning effects of substituting 30 min of sedentary behavior with 30 min of light activity, moderate-to-vigorous physical activity (MVPA), or sleep in a sample of older adults. This study reports baseline data collected from low-active healthy older adults (N = 247, mean age 65.4 ± 4.6 years) recruited to participate in a 6 month randomized controlled exercise trial examining the effects of various modes of exercise on brain health and function. Each participant completed assessments of physical activity self-regulatory strategy use (i.e., self-monitoring, goal-setting, social support, reinforcement, time management, and relapse prevention) and executive functioning. Physical activity and sedentary behaviors were measured using accelerometers during waking hours for seven consecutive days at each time point. Isotemporal substitution analyses were conducted to examine the effect on self-regulation and executive functioning should an individual substitute sedentary time with light activity, MVPA, or sleep. The substitution of sedentary time with both sleep and MVPA influenced both self-regulatory strategy use and executive functioning. Sleep was associated with greater self-monitoring (B = .23, p = .02), goal-setting (B = .32, p < .01), and social support (B = .18, p = .01) behaviors. Substitution of sedentary time with MVPA was associated with higher accuracy on 2-item (B = .03, p = .01) and 3-item (B = .02, p = .04) spatial working memory tasks, and with faster reaction times on single (B = -23.12, p = .03) and mixed-repeated task-switching blocks (B = -27.06, p = .04). Substitution of sedentary time with sleep was associated with marginally faster reaction time on mixed-repeated task-switching blocks (B = -12.20, p = .07) and faster reaction time on mixed-switch blocks (B = 17.21, p = .05), as well as reduced global reaction time switch cost (B = -16.86, p = .01). Substitution for light intensity physical activity did not produce significant effects. By replacing sedentary time with sleep and MVPA, individuals may bolster several important domains of self-regulatory behavior and executive functioning. This has important implications for the design of long-lasting health behavior interventions. Trial Registration clinicaltrials.gov identifier NCT00438347.

Effects of a DVD-delivered exercise program on patterns of sedentary behavior in older adults: a randomized controlled trial.

INTRODUCTION: In the present study, we examined the influence of a home-based, DVD-delivered exercise intervention on daily sedentary time and breaks in sedentary time in older adults. METHODS: Between 2010 and 2012, older adults (i.e., aged 65 or older) residing in Illinois (N = 307) were randomized into a 6-month home-based, DVD-delivered exercise program (i.e., FlexToBa; FTB) or a waitlist control. Participants completed measurements prior to the first week (baseline), following the intervention period (month 6), and after a 6 month no-contact follow-up (month 12). Sedentary behavior was measured objectively using accelerometers for 7 consecutive days at each time point. Differences in daily sedentary time and breaks between groups and across the three time points were examined using mixed-factor analysis of variance (mixed ANOVA) and analysis of covariance (ANCOVA). RESULTS: Mixed ANOVA models revealed that daily minutes of sedentary time did not differ by group or time. The FTB condition, however, demonstrated a greater number of daily breaks in sedentary time relative to the control condition (p = .02). ANCOVA models revealed a non-significant effect favoring FTB at month 6, and a significant difference between groups at month 12 (p = .02). CONCLUSIONS: While overall sedentary time did not differ between groups, the DVD-delivered exercise intervention was effective for maintaining a greater number of breaks when compared with the control condition. Given the accumulating evidence emphasizing the importance of breaking up sedentary time, these findings have important implications for the design of future health behavior interventions.

Application of multiple locus variable number of tandem repeat analysis (MLVA), phage typing and antimicrobial susceptibility testing to subtype Salmonella enterica serovar Typhimurium isolated from pig farms, pork slaughterhouses and meat producing plants in Ireland.

Salmonella enterica subsp. enterica serovar Typhimurium is a common zoonotic pathogen encountered in Irish pigs and the pork industry and its characterisation using highly discriminatory typing methods is necessary for epidemiological studies, outbreak investigation and control. Multiple locus variable number of tandem repeat analysis (MLVA), phage typing and antimicrobial susceptibility testing were applied to characterise 301 S. typhimurium isolates of porcine origin isolated from farms, slaughterhouses and pork meat producing plants in Ireland over a four-year period. 154 MLVA patterns were obtained compared to 19 phage types and 38 AMR patterns, and MLVA was particularly useful for discriminating isolates of the same phage type, e.g. DT104 and DT104b, or isolates that were Untypable or in the category of "react with phage but does not conform to a recognised phage type" (RDNC) by the phage typing method. Cluster analysis of MLVA profiles using a minimum spanning tree (MST) demonstrated two major clusters (I and II), which showed to have a clear association with phage types, cluster I associated to phage types DT104, U302 and DT120 and cluster II associated to DT193 and U288. The results of this present study showed that MLVA is highly discriminatory and permitted the identification of identical profiles among isolates obtained at different points of the pork food chain. The same MLVA profile was observed in some cases among isolates with different phage types. While this can be explained by the fact that some phage types are closely related, it also indicates that combining phage typing and MLVA enhances strain typing of S. typhimurium.

Robotic radical hysterectomy.

Robotic radical hysterectomy is increasingly being utilized in the treatment of cervical cancer and initial studies are promising. Compared to open radical hysterectomy, robotic radical hysterectomy is expected to result in decreased pain, infection, length of stay, and adhesions and quicker return to activity. Prospective randomized controlled trials are needed to compare robotic, laparoscopic and open radical hysterectomy for the treatment of cervical cancer.

Immunohistochemical evaluation is not prognostic for recurrence in fully staged high-risk endometrial cancer.

The objective of this study was to determine the prognostic significance of common immunohistochemical pathologic risk factors in fully staged high-risk endometrial cancers. Sixty-two of 265 consecutive endometrioid adenocarcinomas were considered high risk for recurrence because of deep myometrial invasion and poor differentiation (stage IC, G3), cervical metastasis (stage II), ovarian metastasis (stage IIIA) or lymph node metastasis (stage IIIC). All patients underwent complete surgical staging with bilateral pelvic and aortic lymphadenectomy. Expression of estrogen receptors, progesterone receptors, p53, HER-2/neu, c-myc, bcl-2, FVIII, and Ki-67 were analyzed by immunohistochemistry using commercially available monoclonal antibodies. A general linear model multiple regression analysis was used to determine if any of the immunostains, along with grade or stage, were predictors of recurrence. Mean age was 68 years and mean weight 188 pounds. Sixty-eight percent of patients had associated medical illness. The majority of tumors were poorly differentiated (44%) and were stage IIIC (29%). Mean follow-up was 4.3 years. Fourteen patients (22%) developed tumor recurrence. Using multiple regression analysis, none of the immunostains were predictive for recurrence (P = 0.19-.96). Only stage and grade were predictive of tumor recurrence (P = 0.04,.02). We conclude that in completely staged high risk endometrial cancer, commonly used immunohistochemical risk factors are not predictive for recurrence.

Long-term survival of intermediate risk endometrial cancer (stage IG3, IC, II) treated with full lymphadenectomy and brachytherapy without teletherapy.

OBJECTIVES: The aim of this study was to determine long-term survival and late complications of intermediate risk endometrial cancer (Stage IG3, IC, and II) treated with full lymphadenectomy and brachytherapy without teletherapy. METHODS: Two-hundred sixty-five consecutive patients underwent surgical staging for endometrial cancer consisting of hysterectomy, oophorectomy, and bilateral pelvic and periaortic lymphadenectomy. Sixty-six patients had intermediate risk endometrial cancer (Stage IG3, IC, and II) and received postoperative brachytherapy without teletherapy. Mean age was 68 years and mean weight was 188 lb. Seventy-seven percent had associated medical illness. RESULTS: At a mean follow-up of 4.4 years, Kaplan-Meier estimated 5-year progression free survival is 97%. Two patients (3%) developed distant recurrence (abdomen, lungs) with no vaginal or pelvic recurrence. Major complications occurred in 6% of patients. CONCLUSIONS: Complete lymphadenectomy with brachytherapy without teletherapy for intermediate risk endometrial cancer results in excellent progression-free survival and minimal major morbidity.

Early postoperative feeding after major gynecologic surgery: evidence-based scientific medicine.

Postoperative gastrointestinal care after major gynecologic surgery has evolved considerably over the last decade. According to evidence-based scientific medicine, the following conclusions can be drawn: (1) Postoperative colonic stasis occurs after major abdominal surgery and persists for approximately 3 days (classes I and IIA). (2) Elective postoperative nasogastric decompression after major abdominal surgery is unnecessary (class I). (3) Early feeding after major gynecologic surgery results in emesis but does not increase the incidence of aspiration pneumonia, dehiscence, or intestinal leaks and decreases hospital stay (class I). (4) Slow advancement of postoperative diet after major gynecologic surgery is probably unnecessary (class III). (5) After major abdominal gynecologic surgery, there appear to be minimal medical benefits (decreased infection rate) of early postoperative feeding (class III). (6) After radical hysterectomy, postoperative bowel stimulation decreases length of hospital stay (class IIA).

Prospective analysis of a fever evaluation algorithm after major gynecologic surgery.

OBJECTIVE: We performed a prospective trial to evaluate the feasibility, accuracy, and safety of a postoperative fever algorithm that is based on symptoms and physical examination in an attempt to decrease the random use of urine cultures, blood cultures, and chest radiographs. STUDY DESIGN: Our fever algorithm consisted of assessing all febrile postoperative patients for signs and symptoms of infection. If none were present, no tests were ordered. RESULTS: Twenty-eight of 105 consecutive patients (27%) had postoperative fever after major gynecologic surgery. Three of 28 febrile patients (11%) were evaluated with tests according to the algorithm. Two of 28 febrile patients (7%) were evaluated in violation of the algorithm. Four febrile patients (14%) had documented infections. Two patients had infections within the first 30 days after discharge. Compared with our previous retrospective review, significantly fewer febrile patients were evaluated with testing with a significantly increased yield of positive test results. CONCLUSIONS: Our postoperative fever evaluation algorithm that is based on symptoms and physical examination is feasible, is safe, decreases random testing, and increases the yield of positive test results.

Survival after multimodality treatment for stage IIIC endometrial cancer.

OBJECTIVE: Our purpose was to review our results of multimodality treatment of lymph node metastasis in endometrial cancer (stage IIIC). STUDY DESIGN: All patients underwent surgical staging for endometrial cancer with complete pelvic and aortic lymphadenectomy. All macroscopic nodal metastases were resected. Patients with microscopic nodal metastasis received adjuvant teletherapy, whereas those with macroscopic nodal metastasis received chemotherapy (carboplatin AUC 5 and paclitaxel 135 mg/m2 every 3 weeks for 6 courses) followed by teletherapy. RESULTS: Twenty-one patients had stage IIIC disease, and one had stage IVB (inguinal nodal metastasis). Sixty-four percent of tumors were poorly differentiated. Fifty-five percent of patients had pelvic nodal metastasis only and 41% had macroscopic nodal metastasis. At a median follow-up of 3.8 years, 32% of patients had recurrence, all extrapelvic. Overall mean survival was 48 months and progression-free survival was 40 months. Overall survival for microscopic nodal metastasis was >60 months versus 35 months for macroscopic metastasis. Overall survival for pelvic nodal metastasis was 53 months versus 42 months for aorticinguinal metastasis. There were no complications from lymphadenectomy, a 22% chemotherapeutic toxicity, and a 14% radiation toxicity. CONCLUSION: Our surgical, chemotherapeutic, and radiation treatment protocol for stage IIIC endometrial cancer produced minimal toxicity and good survival.

Surgical stapling technique for radical hysterectomy: survival, recurrence, and late complications.

OBJECTIVE: The aim of this study was to conduct a long-term follow-up of the surgical stapling technique of radical hysterectomy to determine survival, recurrence, and late complications. METHODS: One hundred consecutive eligible patients treated with the surgical stapling technique of radical hysterectomy were prospectively evaluated. RESULTS: Median operative time was 3.2 h. Median blood loss was 500 ml. There was an 18% acute postoperative complication rate and a 10% long-term complication rate. There was a 6% recurrence rate and a 92% disease-free survival. CONCLUSION: The surgical stapling technique of radical hysterectomy results in acceptable survival, recurrence, and complication rates, which appear similar to those of the traditional type of radical hysterectomy, while operative time and blood loss appear to be reduced.

Cisplatin-paclitaxel-cyclophosphamide with G-CSF in primary advanced epithelial ovarian cancer.

INTRODUCTION: In an attempt to increase survival, we performed a prospective trial of high-dose cisplatin-paclitaxel-cyclophosphamide with granulocyte colony-stimulating factor (G-CSF) for three cycles followed by carboplatin-paclitaxel for three cycles after cytoreduction of primary advanced epithelial ovarian cancer. MATERIALS AND METHODS: Thirty consecutive women with Stage 3 or 4 invasive primary epithelial ovarian cancer were treated with cytoreductive surgery. Postoperatively patients received 100 mg/m(2) of cisplatin, 200 mg/m(2) of paclitaxel, and 500 mg/m(2) of cyclophosphamide IV q 21 days x 3 cycles with 300 microg of G-CSF daily x5 beginning the first day following chemotherapy. This was followed by carboplatin AUC-5 and 135 mg/m(2) of paclitaxel IV q 21 days x3. All administration was outpatient and paclitaxel was administered over 3 h. RESULTS: Eighty percent of tumors were Stage 3C, 77% were serous, and 60% were Grade 3. Maximum cytoreduction to <2 cm was performed in 96%. Median follow-up is 30 months. Sixty-three percent of patients developed recurrence. Currently 50% of patients are alive with no evidence of disease. Estimated mean survival is 61 months and estimated mean progression-free survival is 29 months. No patient developed thrombocytopenia, neutropenic sepsis, significant neuropathy, or renal toxicity. CONCLUSION: This treatment regimen resulted in minimal toxicity and, following aggressive cytoreduction, produced good progression-free and overall survival.

National Cancer Data Base/Surveillance Epidemiology and End Results: potential insensitive-measure bias.

OBJECTIVES: Abstraction of data from National Cancer Data Base (NCDB)/Surveillance Epidemiology and End Results (SEER) for reasons other than incidence, mortality, and patterns of care has risen. A potential problem with these data is that insensitive-measure bias can exist because of possible inaccuracies in hospital tumor registry staging. The purpose of this study is to assess the accuracy of tumor registry staging from six community hospitals. METHODS: Staging of 103 consecutive cancers operated on by a gynecologic oncologist (one of the authors) as a surgical consultant to a gynecologist or surgeon was reviewed. Hospital tumor registry staging forms were arbitrarily assigned to be completed by the nongynecologic oncologist versus the gynecologic oncologist by the medical records department. The authors reassessed cancer staging by medical chart review. The tumor registry staging was compared with the actual staging as determined by the authors. Major staging violations were defined as errors that would significantly change stage enough to alter prognosis or change recommended adjuvant treatment. All other violations were defined as minor. RESULTS: Twenty-eight (27%) cancers were staged by the gynecologic oncologist and 75 (73%) by nongynecologic oncologists. Eighty (78%) cancers were endometrial and 14 (13%) ovarian. Eighty-three (81%) tumors were stage I or II. Major staging violations occurred in 0% of cancers staged by the gynecologic oncologist and 22% (16/75) by a nongynecologic oncologist (P = 0.002). Minor staging violations occurred in 14% (4/28) of cancers staged by the gynecologic oncologist and 42% (32/75) by a nongynecologic oncologist (P = 0. 005). Minor violations were due to omission of histologic subtype and/or grade. CONCLUSION: The 22% major staging violation rate represents significant insensitive-measure bias. If additional studies produce similar results, abstraction of data from NCDB/SEER for reasons other than incidence, mortality, and patterns of care cannot be accepted as evidence-based scientific medicine.