A randomized controlled trial comparing two types of retractors at caesarean delivery.

The aim of this study was to determine if the use of a self-retaining, symmetrical retractor (OB/Mobius®) during caesarean delivery is associated with differences in post-operative pain experience. Consenting women undergoing caesarean delivery were randomly assigned to OB/Mobius® versus conventional retraction instruments. Women were blinded to retractor type and filled out surgical pain surveys each post-operative day. Additional outcome variables were collected through a provider survey and chart review. Of the 154 randomised women, 144 completed the study. There was no difference in the symmetry, quality or intensity of postoperative pain based on the method of retraction. The OB/Mobius® retractor did not confer an improvement in the quality or intensity of post-caesarean discomfort in the first three days following delivery. Nor did the groups differ in operative times, blood loss or pain medication usage. However, the retractor may offer improved visualisation and retraction in obese women. Impact statement Use of a plastic sheath self-retaining retractor has been minimally studied in caesarean deliveries. Recently it was found that the use of such a retractor reduced wound infection, but another study in obese women did not show improved rates of infection (Hinkson et al. 2016 ; Scolari Childress et al. 2016 ). The study of sheath self-retaining retractors to decrease post-operative pain has not been reported previously. This study offers an investigation into a generalisable population of parturients who undergo caesarean delivery and if the primary use of a self-retaining retractor versus sole use of traditional hand-held retractors decreased post-operative pain while in the hospital. Although this study did not show an improvement in post-operative pain, provider experience reports demonstrated some improvement in visualisation, particularly in the obese population with the use of this novel retractor, thus making it an option for providers who do caesarean deliveries without an assistant and find hand-held retractors inadequate.

Intensity and unpleasantness of pain following vaginal and cesarean delivery: a prospective evaluation.

BACKGROUND: To date, most studies evaluating pain associated with cesarean birth have focused on delivery procedures or postoperative pain control methods rather than on the nature or severity of the pain experience of women, despite the increasing incidence and maternal requests for cesarean delivery. The objective in this study was to evaluate sensory, affective, and laterality aspects of pain after cesarean delivery and vaginal delivery. METHODS: A prospective cohort study using a seven-item visual analog scale assessed pain at rest and with activity, and the unpleasantness and location of pain on postpartum days 1 and 2. Chart review identified demographic and clinical factors influencing pain. Multivariable regression and propensity score analyses were used to evaluate patient-level outcomes. RESULTS: Of 126 consenting women, 48 underwent cesarean delivery and 78 had vaginal delivery. No statistically significant differences in pain at rest and pain unpleasantness were found between groups on postpartum day 1, but women undergoing cesarean delivery reported more pain with activity than those who had a vaginal delivery (p < 0.0002). On postpartum day 2, cesarean delivery women reported significantly more pain when compared with those with a vaginal delivery (p < 0.04), and more cesarean delivery women reported lateralized pain (p < 0.0001). In multivariate regression analyses, cesarean delivery was the most significant predictor of activity-related pain on postpartum day 1 (p < 0.00001), followed by current substance abuse (p < 0.01). Women undergoing cesarean delivery required twice the dosage of analgesics on postpartum day 1 and four times greater amounts on postpartum day 2 relative to those with a vaginal delivery (p < 0.01 and p < 0.001). CONCLUSIONS: Cesarean delivery was associated with higher levels of pain, more unpleasant pain, more lateralized pain, and greater narcotic use than vaginal delivery. Evaluation of factors associated with postpartum pain can help practitioners to counsel women better about their delivery alternatives and can promote improved management of women undergoing both types of delivery experiences.

A clinician's guide to patient selection for watchful waiting management of inguinal hernia.

OBJECTIVE: The goal of this study was to assist surgeons in managing patients with minimally symptomatic inguinal hernia by identifying characteristics that predict crossover to surgery or worsening of hernia symptoms. BACKGROUND: Randomized trials have suggested that watchful waiting management of minimally symptomatic inguinal hernia is an acceptable alternative to surgical repair. However, these trials found that roughly a quarter of patients would elect for repair in the first 2 years, suggesting that not all patients are good candidates for watchful waiting. METHODS: The 336 patients randomized to watchful waiting in the American College of Surgeons Watchful Waiting Hernia Trial constituted the study population. Preoperative patient characteristics were used to predict 2 outcomes, either crossover to surgery or the development of hernia pain limiting activities and/or crossover to surgery. Patients in our study were part of a previously registered randomized trial: NCT00263250. RESULTS: At 2 years, 72 patients crossed over to surgery, with pain with strenuous activities [odds ratio (OR), 1.3 per 10-mm visual analog scale pain scale], chronic constipation (OR, 4.9), prostatism (OR, 2.9), being married (OR, 2.3), and good health [OR, 3.0 American Society of Anesthesiologists Class (ASA) 1 vs 2], predicting crossover. An additional 28 patients developed pain, limiting their activities, with pain during strenuous activities (OR, 1.3 per 10-mm visual analog scale) and chronic constipation (OR, 4.5), predicting the combined outcome of pain limiting activities and/or crossover to surgery. Higher levels of activity reduced the risk (OR, 0.95) of this combined outcome. CONCLUSIONS: Readily identifiable patient characteristics can predict those patients with minimally symptomatic inguinal hernia who are likely to "fail" watchful waiting hernia management. Consideration of these factors will allow surgeons to optimally tailor hernia management.

Intraocular lens power calculations after myopic laser refractive surgery: a comparison of methods in 173 eyes.

PURPOSE: To evaluate and compare published methods of intraocular lens (IOL) power calculation after myopic laser refractive surgery in a large, multi-surgeon study. DESIGN: Retrospective case series. PARTICIPANTS: A total of 173 eyes of 117 patients who had uneventful LASIK (89) or photorefractive keratectomy (84) for myopia and subsequent cataract surgery. METHODS: Data were collected from primary sources in patient charts. The Clinical History Method (vertex corrected to the corneal plane), the Aramberri Double-K, the Latkany Flat-K, the Feiz and Mannis, the R-Factor, the Corneal Bypass, the Masket (2006), the Haigis-L, and the Shammas.cd postrefractive adjustment methods were evaluated in conjunction with third- and fourth-generation optical vergence formulas, as appropriate. Intraocular lens power required for emmetropia was back-calculated using stable post-cataract surgery manifest refraction and implanted IOL power, and then formula accuracy was compared. MAIN OUTCOME MEASURES: Prediction error arithmetic mean ± standard deviation (SD), range (minimum and maximum), and percent within 0 to -1.0 diopters (D), ±0.5 D, ±1.0 D, and ±2.0 D relative to target refraction. RESULTS: The top 5 corneal power adjustment techniques and formula combinations in terms of mean prediction errors, standard deviations, and minimizing hyperopic "refractive surprises" were the Masket with the Hoffer Q formula, the Shammas.cd with the Shammas-PL formula, the Haigis-L, the Clinical History Method with the Hoffer Q, and the Latkany Flat-K with the SRK/T with mean arithmetic prediction errors and standard deviations of -0.18±0.87 D, -0.10±1.02 D, -0.26±1.13 D, -0.27±1.04 D, and -0.37±0.91 D, respectively. CONCLUSIONS: By using these methods, 70% to 85% of eyes could achieve visual outcomes within 1.0 D of target refraction. The Shammas and the Haigis-L methods have the advantage of not requiring potentially inaccurate historical information.

Artiflex phakic intraocular lens implantation after corneal collagen cross-linking in keratoconic eyes.

PURPOSE: To evaluate the safety, efficacy, and stability of the Artiflex (Ophtec BV) foldable anterior iris-claw phakic intraocular lens (PIOL) following corneal collagen cross-linking (CXL) in select cases of progressive keratoconus. METHODS: This prospective, comparative study, conducted between March 2007 and June 2008, involved 11 eyes with progressive keratoconus. Inclusion criteria were progressive keratoconus (Amsler-Krumeich classification grades I and II) with no corneal opacities, corneal thickness >450 µm, endothelial cell count >2500 cells/mm(2), anterior chamber depth >3.2 mm, spherical equivalent refraction >4.50 diopters (D) (with a cylinder component <2.00 D), and no other treatment for keratoconus other than contact lens. Each patient underwent CXL in the keratoconic eye with implantation of the Artiflex IOL 6 months thereafter. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and refraction and topographic profiles were examined at 1, 6, and 12 months after the CXL procedure. RESULTS: All eyes achieved UDVA of 0.3 logMAR or better. Final spherical and cylindrical error ranged from 0 to -1.50 D and 0 to -1.75 D, respectively. No eyes lost lines of preoperative CDVA. Statistically significant reductions in mean maximum (2.14 D, P<.001) and minimum (1.17 D, P=.02) keratometry values were present 12 months after the CXL procedure. No complications were observed. CONCLUSIONS: Combined CXL and Artiflex implantation was a safe and effective treatment in this subset of eyes with progressive keratoconus. Good results in terms of visual acuity, postoperative residual refractive error, and keratometry values were identified.

Incidence and Outcomes of Cystoid Macular Edema after Descemet Membrane Endothelial Keratoplasty (DMEK) and DMEK Combined with Cataract Surgery.

PURPOSE: To investigate the incidence and outcomes of cystoid macular edema (CME) after Descemet membrane endothelial keratoplasty (DMEK) alone and DMEK combined with cataract surgery (DMEK triple). MATERIALS AND METHODS: A retrospective chart review was performed for patients who underwent DMEK and DMEK triple between January 2014 and March 2018 at two tertiary hospitals. Patients with minimum of 6 months of follow-up were included. Logistic regression analysis was used to identify potential risk factors for CME including gender, age, glaucoma, uveitis, epiretinal membrane, diabetes mellitus, iridotomy, and rebubbling. RESULTS: 09 eyes of 193 patients who underwent DMEK (124 eyes) and DMEK triple (85 eyes) were included. The 6-month incidence of CME was 3.8% (8/209) for all cases, 2.4% (2/85) for DMEK triple, and 4.8% (6/124) for DMEK alone. CME was treated with topical prednisolone acetate 1% and nepafenac four times daily, and/or periocular triamcinolone acetonide, with resolution in all cases. On average, CME was detected 8.9 ± 2.1 weeks postoperatively, with a mean time to resolution of 4.1 ± 1.7 months. The 6-month best-corrected distance visual acuity of eyes that developed CME was not significantly different compared to eyes that did not develop CME (0.17 ± 0.15 logMAR vs. 0.23 ± 0.27 logMAR; p = .76). On logistic regression analysis, no risk factors for developing CME were identified. CONCLUSIONS: The incidence of CME after DMEK was low and not associated with decreased long-term visual acuity. Most cases of CME occurred between 1 and 3 months postoperatively. Predictive factors for CME after DMEK require further study.

Multimodal e-mental health treatment for depression: a feasibility trial.

BACKGROUND: Internet interventions for depression have shown less than optimal adherence. This study describes the feasibility trial of a multimodal e-mental health intervention designed to enhance adherence and outcomes for depression. The intervention required frequent brief log-ins for self-monitoring and feedback as well as email and brief telephone support guided by a theory-driven manualized protocol. OBJECTIVE: The objective of this feasibility trial was to examine if our Internet intervention plus manualized telephone support program would result in increased adherence rates and improvement in depression outcomes. METHODS: This was a single arm feasibility trial of a 7-week intervention. RESULTS: Of the 21 patients enrolled, 2 (9.5%) dropped out of treatment. Patients logged in 23.2 ± 12.2 times over the 7 weeks. Significant reductions in depression were found on all measures, including the Patient Health Questionnaire depression scale (PHQ-8) (Cohen's d = 1.96, P < .001), the Hamilton Rating Scale for Depression (d = 1.34, P < .001), and diagnosis of major depressive episode (P < .001). CONCLUSIONS: The attrition rate was far lower than seen either in Internet studies or trials of face-to-face interventions, and depression outcomes were substantial. These findings support the feasibility of providing a multimodal e-mental health treatment to patients with depression. Although it is premature to make any firm conclusions based on these data, they do support the initiation of a randomized controlled trial examining the independent and joint effects of Internet and telephone administered treatments for depression.

Refractive Outcomes of Descemet Membrane Endothelial Keratoplasty Combined With Cataract Surgery in Fuchs Endothelial Dystrophy.

PURPOSE: To evaluate the refractive outcomes of Descemet membrane endothelial keratoplasty combined with cataract surgery (DMEK triple) in patients with Fuchs endothelial dystrophy. METHODS: A retrospective analysis of 68 eyes of 68 patients with Fuchs endothelial dystrophy who underwent DMEK triple between 2014 and 2018. RESULTS: The mean age of patients was 66.5 ± 8.6 years, and 65% (44 of 68) were female. Mean target refraction was -0.69 diopters (D) (interquartile range: -0.80 to -0.50 D). At 6 months, 47% (32 of 68) and 63% (43 of 68) of eyes were within ±0.50 and ±1.00 D of target refraction, respectively. Among eyes greater than 0.50 D from target, 78% (28 of 36) were hyperopic surprises. Mean spherical equivalent at 6 months was -0.14 ± 1.26 D, representing a mean hyperopic shift of 0.55 D from target. Preoperative pachymetry was higher in eyes with greater than 0.50 D of hyperopic surprise (648 ± 60 vs 613 ± 49 µm, P = .04). Refractive shift was greater in eyes with a preoperative central corneal thickness of 640 µm or greater versus eyes with a central corneal thickness of less than 640 µm (+1.20 ± 0.92 vs +0.40 ± 0.99 D, P = .02). None of the eyes with a preoperative central corneal thickness of 640 µm or greater shifted myopically compared to target (range: -0.09 to +2.89 D). CONCLUSIONS: A mean hyperopic shift of 0.55 D from target refraction occurred after DMEK triple, and 47% of eyes were within 0.50 D of target refraction at 6 months postoperatively. Thicker corneas preoperatively had greater hyperopic shift. A greater myopic target refraction may be warranted in eyes with a preoperative central corneal thickness of 640 µm or greater. [J Refract Surg. 2020;36(10):661-666.].

Epidemiology of bacterial corneal ulcers at tertiary centres in Vancouver, B.C.

OBJECTIVE: To report the epidemiology of culture-positive bacterial corneal ulcers in Vancouver, B.C., Canada. DESIGN: Retrospective, observational case series. METHODS: Predetermined search terms were entered into the hospitals' electronic microbiology databases to create a cohort of patients who had undergone corneal scrapings for ulcers from April 2006 to March 2011. All specimens were plated on culture media. Cultured species were identified, and antimicrobial sensitivities were obtained. Clinical charts were then reviewed to identify associated risk factors. RESULTS: In total 281 corneal scrapings were included, with a positive culture recovery rate of 75%. Bacterial keratitis accounted for 84.8% of culture-positive ulcers, followed by fungi (10%) and finally Acanthamoeba (5.2%); 73% of ulcers were monomicrobial in origin and 28% polymicrobial. We found an increase in Gram-negative micro-organisms over time. General sensitivity to antibiotics did not change over time. A major risk factor for Gram-positive involvement was ocular surface disease, whereas contact lens wear was a major risk factor for Gram-negative involvement. CONCLUSIONS: Bacterial keratitis was found to be the major cause of infectious keratitis in Vancouver, B.C. The majority of bacterial ulcers were caused by Gram-positive bacteria. However, we found an increase in Gram-negative involvement over time. Contact lens wear was identified as the major risk factor for development of Gram-negative ulcers. Pre-existing ocular disease was associated with Gram-positive infection. Susceptibility of Gram-negative bacteria to common broad-spectrum antibiotics was high, but susceptibility of Gram-positive bacteria to these antibiotics was lower and more variable.

Does delay of hernia repair in minimally symptomatic men burden the patient's family?

BACKGROUND: Although inguinal hernia repair is a common and safe procedure, a significant portion of patients who undergo surgical repair experience postoperative chronic pain. We conducted a clinical trial to determine if delay of repair is a safe and acceptable alternative for men with minimally symptomatic inguinal hernias. Here we report on the effects of delay on the patient's family. STUDY DESIGN: Data are from a randomized trial in which men with asymptomatic or minimally symptomatic inguinal hernia were randomly assigned to either open tension-free repair (TFR) or watchful waiting (WW). Patients indicated a person who could assist them if necessary because of their hernia or hernia operation, and these persons (mostly spouses) answered a questionnaire at baseline and followup addressing concern about the patient's ability to perform home, social, and recreational activities and time spent assisting the patient with chores because of his hernia condition. RESULTS: In both intention-to-treat and as-treated analyses, at 2 years after enrollment, family members of patients assigned to WW were more likely to report concern about the patient's ability to perform the four types of activities. But a majority of respondents in both the WW and TFR groups indicated no concern about performance of any of the activities. In the as-treated analysis, family members of patients assigned to TFR who did not receive repair reported more time assisting the patient than those of TFR patients who received the assigned treatment. CONCLUSIONS: The results favor repair, but the low level of concern about the patient's functioning reported for both TFR and WW patients suggests that this is not a major issue in delaying repair of inguinal hernias in minimally symptomatic men.

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.

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.

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.

Corneal Cross-Linking in Pediatric Patients With Progressive Keratoconus.

PURPOSE: To evaluate corneal cross-linking (CXL) in the treatment of keratoconus in pediatric patients. Specifically, this study investigates the impact of CXL on uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (BDVA), manifest refraction, keratometry (K) measurements, and higher order aberrations. METHODS: This is a retrospective, observational case series of patients 18 years old or younger with progressive keratoconus who underwent CXL from January 2009 to August 2013. Preoperative and 1-year postoperative data including BDVA, manifest refraction, mean K readings, and corneal aberration measurements were extracted from clinical charts and topographical imaging. Visual acuity was converted to logarithm of the minimum angle of resolution (logMAR) scale, and mean refractive spherical equivalent (MRSE) was calculated from manifest refraction. RESULTS: The group consisted of 39 eyes from 28 patients, including 21 males and 7 females (mean age = 16.3 years, range: 11-18, standard deviation [SD] = 1.81). UDVA did not change significantly (preoperative UDVA = 1.20 logMAR, SD = 0.57, and postoperative UDVA = 0.90 logMAR, SD = 0.67, P = 0.19). BDVA did not change significantly (preoperative BDVA = 0.34 logMAR, SD = 0.27, and postoperative BDVA = 0.34 logMAR, SD = 0.23, P = 0.50). There was no significant change in mean K (preoperative K = 48.49, SD = 5.44, and postoperative K = 48.25, SD = 4.74, P = 0.34). Mean MRSE did not change significantly (preoperative MRSE = -3.29 D, SD = 4.04, and postoperative MRSE = -3.53 D, SD = 4.07, P = 0.31). Corneal aberration measurements were available for 10 eyes, and stability of measurements was demonstrated. There were no complications noted. CONCLUSIONS: This study suggests that CXL is a safe and effective procedure that halts the progression of keratoconus in pediatric patients at 1-year follow-up. To validate these findings, longer follow-up is required.

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.

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.

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.

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.

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.

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.