Assessment of patient functional status after surgery
ABSTRACT 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.
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.
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.
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.
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ABSTRACT: Persistent postoperative pain is a well-established clinical problem with potential severe personal and socioeconomic implications. The prevalence of persistent pain varies across surgery types. Severe persistent pain and related impairment occur in 5% to 10% of patients after groin hernia repair. The substantial interindividual variability in pain-related phenotypes within each surgery type cannot be explained by environmental factors alone, suggesting that genetic variation may play a role. We investigated the contribution of COMT and GCH1 to persistent postherniotomy pain (PPP)-related functional impairment. Prospective data from 429 Caucasian male patients with hernia were collected. Three COMT and 2 GCH1 tagging single-nucleotide polymorphisms (SNPs) were genotyped and analyzed for association with PPP-related activity impairment at 6 months after herniotomy. Fifty-five (12.8%) patients had moderate-to-severe pain-related activity impairment 6 months postoperatively as measured by Activity Assessment Scale (≥8.3). Patients with the G allele of COMT SNP rs6269 and C allele of COMT SNP rs4633 had less impairment (P = 0.03 and 0.01, respectively); in addition, the COMT haplotype GCG was associated with less impairment. For GCH1, the A allele of SNP rs3783641, T allele of rs8007267, and AT haplotype showed a protective effect trend (although nonsignificant; P = 0.08, 0.06, and 0.08, respectively). A prediction model of substantial PPP-related activity impairment, combining COMT and GCH1 SNPs with clinical, psychophysical, and psychological risk factors, had a "good" (0.8 < area under curve < 0.9) discriminatory power. These data suggest that functional variations in COMT and GCH1 combined with clinical factors are predictive of PPP-related impairment after groin herniotomy.Pain 02/2015; 156(2):273-9. DOI:10.1097/01.j.pain.0000460307.48701.b0 · 5.84 Impact Factor
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ABSTRACT: Patient-related outcome measures (PROM) such as quality of life (QoL) after hernia repair are important to monitor, since QoL is an important indication of a hernia repair. Carolinas Comfort Scale (CCS) is a hernia-specific questionnaire regarding health-related QoL after a mesh hernia repair. The primary objective of this study was to monitor changes in health-related QoL over time after different mesh hernia repair procedures using the CCS. We performed a prospective study with an exploratory, intraobserver design enrolling consecutive patients who were to undergo elective mesh hernia repair. Four different hernia repair techniques were included and analyzed specifically for each surgical group. Patients scored themselves using CCS preoperatively and at several fixed times postoperatively. Since no gold standard exists for either hernia-specific QoL questionnaires or change of scores on PROMs as a function of time after hernia repair, we compared the CCS scores with the visual analog scale (VAS) scores reflecting the subdomains of the CCS. A total of 166 patients completed the study. CCS scores for QoL, pain, sensation of mesh, and activity limitations changed significantly with time during the 90-day study period. Furthermore, CCS and VAS showed significant agreement and correlation (ρ = 0.52-0.82, P < 0.001). The present study is the first to demonstrate significant changes over time in health-related QoL using the CCS after four different types of hernia repair with mesh.World Journal of Surgery 12/2013; DOI:10.1007/s00268-013-2411-0 · 2.35 Impact Factor
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ABSTRACT: Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches . This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial. ACCESS is a randomized comparative effectiveness trial enrolling patients at two academic teaching facilities, UCLA (Los Angeles, CA) and Loyola University (Chicago, IL). The primary aim is to compare costs of robotic assisted versus pure laparoscopic abdominal sacrocolpopexy (RASC vs LASC). Following a clinical decision for minimally-invasive abdominal sacrocolpopexy (ASC) and research consent, participants with symptomatic stage≥II pelvic organ prolapse are randomized to LASC or RASC on the day of surgery. Costs of care are based on each patient's billing record and equipment costs at each hospital. All costs associated with surgical procedure including costs for robot and initial hospitalization and any re-hospitalization in the first 6weeks are compared between groups. Secondary outcomes include post-operative pain, anatomic outcomes, symptom severity and quality of life, and adverse events. Power calculation determined that 32 women in each arm would provide 95% power to detect a $2500 difference in total charges, using a two-sided two sample t-test with a significance level of 0.05. Enrollment was completed in May 2011. The 12-month follow-up was completed in May 2012. This is a multi-center study to assess cost as a primary outcome in a comparative effectiveness trial of LASC versus RASC.Contemporary clinical trials 05/2012; 33(5):1011-8. DOI:10.1016/j.cct.2012.05.007 · 1.99 Impact Factor