Biomedical subjects

Martin McCarthy

Publications and source records attributed to Martin McCarthy.

16 recordsLinked to original sources

PubMed2006

Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial.

CONTEXT: Many men with inguinal hernia have minimal symptoms. Whether deferring surgical repair is a safe and acceptable option has not been assessed. OBJECTIVE: To compare pain and the physical component score (PCS) of the Short Form-36 Version 2 survey at 2 years in men with minimally symptomatic inguinal hernias treated with watchful waiting or surgical repair. DESIGN, SETTING, AND PARTICIPANTS: Randomized trial conducted January 1, 1999, through December 31, 2004, at 5 North American centers and enrolling 720 men (364 watchful waiting, 356 surgical repair) followed up for 2 to 4.5 years. INTERVENTIONS: Watchful-waiting patients were followed up at 6 months and annually and watched for hernia symptoms; repair patients received standard open tension-free repair and were followed up at 3 and 6 months and annually. MAIN OUTCOME MEASURES: Pain and discomfort interfering with usual activities at 2 years and change in PCS from baseline to 2 years. Secondary outcomes were complications, patient-reported pain, functional status, activity levels, and satisfaction with care. RESULTS: Primary intention-to-treat outcomes were similar at 2 years for watchful waiting vs surgical repair: pain limiting activities (5.1% vs 2.2%, respectively; P = .06 [corrected]); PCS (improvement over baseline, 0.29 points vs 0.13 points; P = .79). Twenty-three percent of patients assigned to watchful waiting crossed over to receive surgical repair (increase in hernia-related pain was the most common reason offered); 17% assigned to receive repair crossed over to watchful waiting. Self-reported pain in watchful-waiting patients crossing over improved after repair. Occurrence of postoperative hernia-related complications was similar in patients who received repair as assigned and in watchful-waiting patients who crossed over. One watchful-waiting patient (0.3%) experienced acute hernia incarceration without strangulation within 2 years; a second had acute incarceration with bowel obstruction at 4 years, with a frequency of 1.8/1000 patient-years inclusive of patients followed up for as long as 4.5 years. CONCLUSIONS: Watchful waiting is an acceptable option for men with minimally symptomatic inguinal hernias. Delaying surgical repair until symptoms increase is safe because acute hernia incarcerations occur rarely.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00263250.

Adult↗

PubMed2006

Impact of inguinal hernia repair on family and other informal caregivers.

HYPOTHESIS: Inguinal hernia significantly affects family and other informal caregivers, and hernia repair will significantly reduce caregiver burden. METHODS: We analyzed data from a Veterans Affairs Cooperative Study with mixed models to compare the level of burden among caregivers of inguinal hernia patients from preoperative measurement to measurement at 2 weeks and at 3 months postoperatively. RESULTS: Most caregivers were wives (73%) and lived with the patients (88%). There were no differences in caregiver burden by type of treatment. The time caregivers spent assisting patients increased significantly over the 2 weeks following treatment (odds ratio, 4.34). In contrast, 3 months after treatment, caregivers reported spending less time on additional chores than before treatment (odds ratio, 0.12). Furthermore, caregivers' concerns about patients' abilities to perform normal household activities decreased by 2 weeks posttreatment (odds ratio, 0.52). Wives/girlfriends and caregivers of patients with complications were more likely to report these concerns. CONCLUSIONS: Inguinal hernia and its repair significantly affect informal caregivers. Caregivers assumed the heaviest time and effort-related burden 2 weeks following hernia repair and expended additional effort if the patient experienced complications. Interventions should reflect when burden is greatest and target the subgroups of caregivers who most need support.

Adult↗

PubMed2006

Patient-reported outcomes after inguinal herniorrhaphy.

BACKGROUND: Patient-reported outcomes (PRO) reflect the functional outcomes of inguinal herniorrhaphy. We studied the effect of hernia recurrence and complications on PRO for participants in the Veterans Affairs trial of Open or Laparoscopic Repair of Inguinal Hernia. METHODS: Analyzed PRO included (1) the Medical Outcomes Study Short Form 36, version 2, (2) the Surgical Pain Scale, (3) the Activities Assessment Scale, and (4) patient satisfaction. Recurrences and complications were recorded at follow-up visits. Complications were categorized by (1) hematoma/seroma, (2) orchitis, (3) neuralgia, and (4) other. Univariate and multivariable regression analyses identified variables significantly associated with postoperative PRO. RESULTS: Of the 1603 patients with PRO data, 105 had a recurrence and 342 had a complication at 2 years. Multivariable analyses showed neuralgia (P < .0005) adversely affected all PRO, and recurrence (P < .05) affected patient-reported pain, activity, and satisfaction, but not the score for the Medical Outcomes Study Short Form 3. Patients with a recurrence after open repair had more pain than those with a recurrence after laparoscopic repair (P = .0001). Patients with other complications after laparoscopic repair reported more pain and less activity than those with other complications after open repair (P = .003 and P = .009, respectively). CONCLUSIONS: The effectiveness of inguinal herniorrhaphy should be measured by the rate of recurrence and neuralgia. Postoperative neuralgias have a deleterious effect on all patient-reported outcomes.

Activities of Daily Living↗

PubMed2005

Depression predicts mortality following cardiac valve surgery.

BACKGROUND: Depression is associated with mortality in several cardiovascular populations, but has not been evaluated in patients undergoing cardiac valve surgery. Because identifying nonsurgical mediators of survival is important for accurate risk adjustment and the development of interventions to improve outcomes of care, we evaluated the hypothesis that depression predicts mortality following cardiac valve surgery. METHODS: This prospective cohort study enrolled 648 patients undergoing valve surgery at 14 Veteran Administration hospitals. A preoperative mental health inventory (MHI) depression screen was performed in all patients and patients were classified as depressed or not depressed using the standard MHI cutoff score of less than or equal to 52. Multivariable logistic regression was used to evaluate the association between depression and 6-month all-cause mortality, adjusting for other clinical risk variables. RESULTS: Overall, 29.2% (189/648) of the patients were depressed at baseline. Depressed patients were younger, more frequently had New York Heart Association class III/IV symptoms, and more likely required emergent surgery, preoperative intravenous nitroglycerin, or intraaortic balloon pump. Unadjusted 6-month mortality was 13.2% for depressed patients compared with 7.6% for nondepressed patients (p = 0.03). In multivariable analyses, depression remained significantly associated with mortality (odds ratio 1.90; 95% confidence interval 1.07 to 3.40, p = 0.03). These findings were consistent across subgroups of patients undergoing aortic valve replacement, mitral valve replacement and valve replacement without coronary artery bypass graft. CONCLUSIONS: Preoperative depression is an independent risk factor for mortality following cardiac valve surgery. Depression screening should be incorporated into preoperative risk stratification, and future studies are warranted to determine if preoperative or postoperative interventions to treat depression can improve outcomes.

Adult↗

PubMed2005

Does surgeon frustration and satisfaction with the operation predict outcomes of open or laparoscopic inguinal hernia repair?

BACKGROUND: A surgeon's level of frustration when performing an operation and level of satisfaction at completion may be correlated with patients' outcomes. We evaluated the relationship between the attending surgeons' frustration and satisfaction and recurrence and complications of open and laparoscopic inguinal hernia repair. STUDY DESIGN: Men with detectable inguinal hernias were randomized to undergo open or laparoscopic herniorrhaphy at 14 Veterans Affairs hospitals. After completion of the procedure, surgeons were asked to assess their level of frustration during the operation and their overall satisfaction with the operative result. Two subjective scales ranging from 1 (not frustrated/not satisfied) to 5 (very frustrated/very satisfied) were used to independently assess both parameters. Reasons for surgeon frustration were evaluated. Patients were followed for 2 years for recurrence and complications. RESULTS: Of 1,983 patients who underwent hernia repair, 1,622 were available for analysis; 808 had open repair and 813 had laparoscopic repair. Surgeons reported less frustration and more satisfaction with open than with laparoscopic repair (p = 0.0001 and 0.0001, respectively). Frustration was associated with a higher rate of hernia recurrence at 2 years (adjusted odds ratio, 2.01, 95% CI, 1.15-3.51) in open repair, and a higher overall rate of postoperative complications (adjusted odds ratio, 1.27, 95% CI, 1.03-1.56) in both open and laparoscopic hernia repair. Satisfaction was not correlated with recurrence or complications. CONCLUSIONS: The level of a surgeon's frustration during performance of an inguinal herniorrhaphy was a better predictor of outcomes of the operation than was satisfaction with the procedure. Sources of intraoperative frustration should be controlled to improve outcomes.

Hernia, Inguinal↗

PubMed2005

Visual analog scales for assessing surgical pain.

BACKGROUND: Four visual analog scales were constructed to assess sensory and affective components of operative pain. The Surgical Pain Scales (SPS) measure pain while at rest, pain during normal activities, pain during work or exercise, and pain unpleasantness. STUDY DESIGN: Longitudinal data from 2,164 patients in a randomized trial of laparoscopic versus open hernia repair established the reliability, validity, and sensitivity to change of the SPS. Correlations and t-tests were used to determine their psychometric properties compared with the SF-36 health status instrument. RESULTS: Intraclass correlation coefficients of 0.95 for the sensory scales and 0.94 for the unpleasantness rating confirmed that the SPS produced reliable measurements. Correlations ranging from 0.44 to 0.60 between the visual analog scales and the bodily pain dimension on the SF-36 and significant differences between SPS levels for patients requiring more and less time to resume normal activities (p< or =0.015 to p< or =0.002) supported the validity of the scales. Clinical responsiveness was demonstrated by a 33.5-mm reduction (standard error = 1.4 mm) in the mean rating on a 150-mm scale measuring pain during normal activities for patients reporting postoperative improvement on the bodily pain dimension (p< or =0.0001). CONCLUSIONS: The Surgical Pain Scales demonstrated excellent psychometric properties in this study population. The SPS can be used to compare pain levels between groups at a single point in time or to track change for individual patients over time or after operations. Individualized pain management interventions can be tailored based on the sensory and effective ratings.

Activities of Daily Living↗

PubMed2005

Assessment of patient functional status after surgery.

BACKGROUND: Improvement in day-to-day functioning is a valued outcome of surgical intervention. A new functional status assessment instrument, the Activities Assessment Scale (AAS), was designed for a randomized clinical trial evaluating laparoscopic versus open hernia repair procedures. STUDY DESIGN: The study data set included 2,164 patients at baseline and 1,562 patients at 3-month followup. Only male patients were enrolled in the trial. The psychometric characteristics of the AAS were examined in statistical analyses of cross-sectional and longitudinal data from the trial. Correlational analyses, factor analyses, and t-tests were used to evaluate scale performance. RESULTS: We found that the AAS was a reliable measure (Cronbach's Coefficient Alpha =0.85) in the patient population studied. Factor analyses identified three subscales (sedentary activities; ambulatory activities; work and exercise activities). Construct validity was demonstrated by a correlation of 0.65 between the AAS and the physical functioning (PF) dimension of the SF-36 (p < 0.001); comparisons between clinical subgroups further confirmed its validity (p < 0.001). Patients reporting improvement on the physical functioning dimension after surgery showed an effect size of 1.20 for preoperative-postoperative change in their AAS scores. CONCLUSIONS: The AAS has been demonstrated to be a reliable, valid, and clinically responsive instrument that can be used to evaluate patient functioning after hernia surgery. It is easy to administer and requires less than 5 minutes of patient time to complete. This measurement system may prove useful in assessing surgical outcomes in both research and office practice settings.

Activities of Daily Living↗

PubMed2005

Biological age--a concept whose time has come: a preliminary study.

OBJECTIVE: Chronology poorly predicts biological age (BA) or physiologic reserve (PR). An objective approach to the heterogeneity of aging would greatly help clinical decision making in the elderly. MATERIALS AND METHODS: The first pilot study evaluated 130 "healthy" volunteers, ages 70 to 95 years. A summary BA/PR index was developed, using measures of endurance, strength, flexibility, balance, cognition, depression, comorbidity, and exercise. The second study applied the BA/PR concept to prediction of death after a first elective coronary artery bypass graft, using a Veterans Administration database. RESULTS: The BA/PR index was a better predictor of 3-year functional outcomes and death than was chronological age. In the coronary artery bypass graft study, the inclusion of BA/PR variables significantly improved prediction of 6-month and long-term death for Veterans Administration patients. CONCLUSIONS: The usefulness of a biological age (BA/PR) approach in predicting outcomes in the elderly was supported. Needed research should develop tools for routine "tracking" of the aging process.

Activities of Daily Living↗

PubMed2004

Predictors of health-related quality of life after coronary artery bypass surgery.

BACKGROUND: Little is known about the determinants of health-related quality of life after coronary artery bypass surgery. We determined the predictors of overall physical and mental health status 6 months after the operation. METHODS: We evaluated 1,973 patients enrolled in a multicenter Veterans Affairs prospective cohort study who completed preoperative and 6-month postoperative Short Form-36 (SF-36) health status surveys. Multiple linear regression was used to identify the significant independent predictors of 6-month physical and mental component summary scores from the SF-36. RESULTS: In multivariable analyses adjusting for baseline health status, significant predictors of postoperative physical health status were a history of neurologic disease, peripheral vascular disease, chronic obstructive pulmonary disease, hypertension, current smoking, forced expiratory volume, left ventricular ejection fraction, and serum creatinine. Significant predictors of postoperative mental health status were a history of psychiatric disease, chronic obstructive pulmonary disease, current smoking, age, and New York Heart Association functional class. CONCLUSIONS: These predictors of health-related quality of life after coronary artery bypass surgery may be useful for preoperative risk assessment and counseling of patients with regard to anticipated health status outcomes. Factors such as current smoking and psychiatric disease may be targets for interventions to improve health-related quality of life outcomes.

Coronary Artery Bypass↗

PubMed2004

Success with oral contraceptives: a pilot study.

The objective of this pilot study was to examine the effectiveness of a postpartum educational intervention aimed at increasing compliance with oral contraception (OCs) and decreasing repeat pregnancies in young, African American women in the year following an unplanned pregnancy. In this longitudinal study, 43 young, pregnant women attending Prentice Ambulatory Care, Northwestern Hospital, were enrolled and 33 were randomized to receive an antepartum, multicomponent intervention consisting of counseling, a videotape about OCs and written material or resident-physician counseling (usual care). Questionnaire data were collected at enrollment, immediately following the intervention, at 6 weeks, 6 months and 12 months. At 1 year, 25 women remained in the study. More women in the intervention group were not pregnant and still using contraception, and were able to successfully switch contraceptive methods compared to women in the control group. There was no decrease in repeat pregnancy in the intervention group at 1 year compared to the control group. Our intervention resulted in a sustained increase in knowledge of OCs throughout the study period. However, more is needed to promote postpartum contraceptive compliance and decrease repeat pregnancies in young, low-income African Americans with unintended pregnancies.

Adolescent↗

PubMed2004

Predictors of cognitive decline following coronary artery bypass graft surgery.

BACKGROUND: A significant number of patients develop cognitive impairment that persists for months following coronary artery bypass grafting (CABG) surgery. Our objectives were to identify patient-related risk factors, processes of care, and the occurrence of any perioperative complications associated with cognitive decline. METHODS: Nine hundred thirty-nine patients enrolled in the Processes, Structures, and Outcomes of Care in Cardiac Surgery study undergoing CABG-only surgery at 14 Veterans Administration medical centers between 1992 and 1996 completed a short battery of cognitive tests at baseline and 6-months post-CABG. The composite cognitive score was based on the sum of errors for each individual item in the battery. Multiple linear regression analyses were used to identify independent predictors of the 6-month composite cognitive score. RESULTS: In multivariable analyses, patient characteristics associated with cognitive decline included cerebrovascular disease (p = 0.009), peripheral vascular disease (p = 0.007), history of chronic disabling neurologic illness (p = 0.016), and living alone (p = 0.049), while the number of years of education (p = 0.001) was inversely related to cognitive decline. After adjustment for baseline patient risk factors, the presence of any postoperative complication(s) (p = 0.001) was also associated with cognitive decline while cardiopulmonary bypass time (p = 0.008) was inversely related to cognitive decline. CONCLUSIONS: Patients with noncoronary manifestations of atherosclerosis, chronic disabling neurologic illness, or limited social support are at risk for cognitive decline after CABG surgery. In contrast, more years of education were associated with less cognitive decline. Preoperative assessment of risk factors identified in this study may be useful when counseling patients about the risk for cognitive decline following CABG surgery.

Aged↗

PubMed2004

Relationship between processes of care and coronary bypass operative mortality and morbidity.

BACKGROUND: Information is limited regarding the effects of processes of care on cardiac surgical outcomes. Correspondingly, many recommended cardiac surgical processes of care are derived from animal experiments or clinical judgment. This report from the VA Cooperative Study in Health Services, "Processes, Structures, and Outcomes of Cardiac Surgery," focuses on the relationships between 3 process groups (preoperative evaluation, intraoperative care, and supervision by senior physicians) and a composite outcome, perioperative mortality and morbidity. METHODS: Data on 734 risk, process, and structure variables were collected prospectively on 3,988 patients who underwent coronary artery bypass grafting at 14 VA medical centers between 1992 and 1996. Data reduction was accomplished by examining data completeness and variation across sites and surgeon, using previously published data and clinical judgment. We then applied multivariable logistic regression to the 39 remaining processes of care to determine which were related to the composite outcome after adjusting for 17 patient-related risk factors and controlling for intraoperative complications. RESULTS: Our first analysis showed several measures of operative duration, the use of inotropic agents, transesophageal echo, lowest systemic temperature, and hemoconcentration/ultrafiltration, to be powerful predictors of the composite outcome. Because the use of inotropic agents and operative duration may be related to an intermediate outcome (eg, intraoperative complications), we performed a second analysis omitting these processes. The use of intraoperative transesophageal echo and hemoconcentration/ultrafiltration remained significantly associated with an increased risk of an event (odds ratios 1.60 and 1.36, respectively). CONCLUSIONS: Our results viewed in the context of past studies suggest the possibility that inotropic use, TEE, and hemoconcentration/ultrafiltration may have adverse effects on operative outcome. Further evaluation of these processes of care using observational data, as well as randomized trials when feasible, would be of interest.

Coronary Artery Bypass↗

PubMed2003

Importance and knowledge of oral contraceptives in antepartum, low-income, African American adolescents.

STUDY OBJECTIVE: To assess motivation, sense of self-efficacy and knowledge of oral contraceptives (OC) in antepartum, African-American Adolescents and young adults following OC counseling. METHODS: Gravid African-American females, less than 25 years of age, receiving prenatal care at the Prentice Ambulatory Clinic at Northwestern Memorial Hospital were eligible for this study. Participants were enrolled after 34 weeks gestation, received one session of standardized OC counseling and then completed a series of questions regarding importance, confidence and knowledge of OCs. RESULTS: Forty-three adolescents and young adults participated in this study. Almost all participants agreed that it was important to plan their next pregnancy and to avoid unplanned pregnancies. On average, participants were extremely confident they could take a pill each day. Yet, while most were confident that they knew what to do if they missed one pill, only 37% actually knew what to do if they missed one pill. CONCLUSION: Despite high motivation and confidence in their ability to take OCs following pregnancy, many in this cohort did not fully understand the counseling that they had received. It is important for clinicians to bear in mind that patients may express motivation and confidence about using OCs, but still lack knowledge of the more complex and critical aspects of OC use. Additional education and support are needed in high-risk populations to ensure effective contraceptive knowledge.

Adolescent↗

PubMed2003

The development of a clinical trial to determine if watchful waiting is an acceptable alternative to routine herniorrhaphy for patients with minimal or no hernia symptoms.

BACKGROUND: This article describes the development and implementation of a randomized clinical trial designed to answer the question: Is watchful waiting an acceptable alternative to operation for men with asymptomatic or minimally symptomatic inguinal hernias? STUDY DESIGN: A clinical trial has been designed to compare watchful waiting and operation for men with an asymptomatic or a relatively asymptomatic inguinal hernia. Men are randomized to watchful waiting or a standard open operation, the Lichtenstein tension-free hernia repair, and are followed for a minimum of 2 years. The target sample size of 753 patients was chosen so that the trial would have power sufficiently high to detect a clinically meaningful difference between treatment groups in either of the two primary outcomes as measured at 2 years: pain or discomfort interfering with normal activities and the physical component summary score of the SF-36 health-related quality-of-life survey. The study was begun in five centers located in both community and academic environments. At 18 months, a sixth site was added and at 28 months, after enrollment of 145 patients, one of the centers was terminated for reasons related to inadequate followup; all data from this center were deleted. As a routine measure, an independent experienced trial manager audited all clinical sites. RESULTS: Enrollment of patients began in January 2000 and will end on December 31, 2002. As of November 1, 2002, 637 patients had been randomized, 85% of the target enrollment. An additional 2,115 patients were screened but not randomized, yielding a recruitment rate of 23.1%. Analysis and publication of the results of the study will take place on completion of the minimum 2-year followup period for all patients. CONCLUSIONS: A trial to compare the outcomes of watchful waiting and operation for management of inguinal hernias in men is needed to provide data to surgeons and to patients that can aid in choice of treatment. A description of the design of such a trial is presented.

Follow-Up Studies↗

PubMed2003

Tension-free inguinal hernia repair: the design of a trial to compare open and laparoscopic surgical techniques.

BACKGROUND: Inguinal hernia is a common condition in men and represents a large component of health-care expenditures. Approximately 700,000 herniorrhaphies are performed each year in the United States. The most effective method of repair of an inguinal hernia is not known. STUDY DESIGN: A multicenter, randomized, clinical trial was designed to compare open tension-free inguinal hernia repair with laparoscopic tension-free repair on recurrence rates, complications, patient-centered outcomes, and cost. The study design called for randomization of 2,200 men over a period of 3 years. These men will be followed for a minimum of 2 years. This will allow determination of as little as a 3% absolute difference in recurrence rates with 80% power. Randomization is stratified by hospital, whether the hernia is unilateral or bilateral and whether the hernia is primary or recurrent. RESULTS: This is a report of the study design and current status. The study involves 14 Veterans Affairs medical centers with previous experience in laparoscopic hernia repair. After 35 months of enrollment, 2,165 men were randomized and recruitment was then closed. The majority of the patients (82.3%) had unilateral hernias and 90.6% of the hernias were primary. Sixty-seven percent of the patients had an outpatient operation. CONCLUSIONS: We report successful recruitment into a large multicenter trial comparing open and laparoscopic hernia repair. When followup is complete, this study will provide data regarding both clinical (recurrence rates) and patient-centered outcomes.

Costs and Cost Analysis↗

PubMedDate not supplied

Health-related quality of life predicts mortality in older but not younger patients following cardiac surgery.

The investigators assessed preoperative health-related quality of life as a predictor of 6-month mortality after cardiac surgery in older (65 years of age and older) vs. younger patients. Multivariable regression, stratified by age groups, was used to compare the association between preoperative Physical Component Summary and Mental Component Summary scores from the Short Form-36 health status survey and mortality. In multivariable analyses of older patients, lower preoperative Physical Component Summary (odds ratio, 1.54; 95% confidence interval, 1.19-2.00; p=0.01) and Mental Component Summary (odds ratio, 1.26; 95% confidence interval, 1.06-1.49; p=0.03) scores were independently associated with mortality. In contrast, neither Physical Component Summary (p=0.82) nor Mental Component Summary (p=0.79) scores were associated with mortality in the younger subgroup. This study demonstrated that preoperative health status is an independent predictor of mortality following cardiac surgery in older but not younger patients. Preoperative patient self-report of health status may be particularly useful in refining risk stratification and informing decision-making before and following cardiac surgery in older patients.

Adult↗