Post-cholecystectomy Quality of Life: A Prospective Multicenter Cohort Study of Its Associations with Preoperative Functional Status and Patient Demographics

Purpose  This study analyzed patient demographics and preoperative functional status for associations with post-cholecystectomy quality of life (QOL). Methods  This prospective study analyzed 159 cholecystectomy patients at two tertiary academic hospitals. All patients completed the SF-36 and the gastrointestinal quality of life index (GIQLI) at baseline and at 3 and 6 months postoperatively. The 95% confidence intervals for differences in responsiveness estimates were derived by bootstrap estimation. Scores derived by these instruments were interpreted by generalized estimating equation (GEE) before and after cholecystectomy. Results  The examined population significantly (p < 0.05) improved in both SF-36 subscales and GIQLI subscales. After adjusting for time effects (time, and time²) and baseline predictors, GEE approaches revealed the following explanatory variables for QOL: time, time², age, gender, preoperative GIQLI score, body mass index, and number of comorbidities. Conclusion  The data revealed dramatically improved post-cholecystectomy QOL. However, QOL change was simultaneously associated with preoperative functional status and demographic characteristics.     

Patient-centered measures for achalasia

Background Various instruments may be used to measure health-related quality of life in patients with achalasia. Methods We administered four patient-centered measures used for evaluation of achalasia severity [an achalasia severity questionnaire we developed previously, an achalasia symptom checklist, the Gastrointestinal Quality-of-Life Index (GIQLI), and the Medical Outcomes Study 36-item Short-Form survey (SF-36)] to 25 subjects enrolled in a randomized controlled trial comparing pneumatic dilatation and laparoscopic Heller myotomy. We estimated correlations between the different measures. Results Twenty-five patients (13 male, 12 female) were studied; 12 were treated by pneumatic dilatation and 13 by laparoscopic myotomy. The average age of patients was 48.5 [range 25–69, standard deviation (SD) 13.7] years. Baseline scores demonstrated a substantial burden of impairment. The mean (SD) score on the achalasia severity measure [ranges from 0 (best) to 100 (worst)] was 62.3 (13.4). The mean (SD) symptom checklist score [ranges from 0 (best) to 36 (worst)] was 23.2 (6.6). The mean (SD) GIQLI [ranges from 0 (worst) to 144 (best)] was 77.04 (19.4). The SF-36 mean (SD) for the physical component score (PCS) was 45.29 (9.21) and the mean for the mental component score (MCS) was 37.61 (14.97). The achalasia severity measure correlated highly with the GIQLI (r = −0.57, p = 0.01), and the symptom checklist (r = 0.65, p = 0.004). The achalasia severity measure correlated well with the SF-36 PCS (r = −0.42, p = 0.039), but not with the MCS (r = −0.14, p = 0.501). Conclusion Subjects recruited to a randomized controlled trial of achalasia treatment demonstrated impairment in both generic quality-of-life and disease-specific measures. Scores on achalasia-specific measures correlated well with each other, but less well with measures of generic quality-of-life and mental health scales. Because of the multidimensional nature of achalasia, disease-specific measures should be combined with generic health measures for the best assessment of patient outcome.     

Comparison of responsiveness of the Japanese Society for Surgery of the Hand version of the carpal tunnel syndrome instrument to surgical treatment with DASH, SF-36, and physical findings

Background The Japanese Society for Surgery of -the Hand version of the Carpal Tunnel Syndrome Instrument (CTSI-JSSH), which consists of two parts — one for symptom severity (CTSI-SS) and the other for functional status (CTSI-FS) — is a self-administered questionnaire specifically designed for carpal tunnel syndrome. The responsiveness of the CTSI-JSSH was compared with that of the JSSH version of the Disability of Arm, Shoulder, and Hand questionnaire (DASH), the official Japanese version of the 36-Item Short Form Health Survey (SF-36, version 1.2), and physical examinations to elucidate the role of the CTSI-JSSH for evaluating patients with carpal tunnel syndrome. Methods Preoperatively, a series of 60 patients with carpal tunnel syndrome completed the CTSI-JSSH, DASH, and SF-36. Results of physical examinations, including grip strength, pulp pinch, and static two-point discrimination of the thumb, index, and long fingers, were recorded. Three months after carpal tunnel release surgery the patients were asked to fill out the same questionnaires, and the physical examinations were repeated. The responsiveness of all the instruments was examined by calculating the standardized response mean (SRM) and effect size (ES). Correlation coefficients were calculated between questionnaire change scores and patient satisfaction scores as well as between the CTSI change scores and those of the DASH and SF-36. Results The largest responsiveness was observed in the CTSI-SS (SRM/ES: −1.00/−1.08) followed by the CTSI-FS (−0.76/−0.63), and bodily pain subscale of SF-36 (SF-36-BP, 0.45/0.55), and the DASH (−0.46/−0.47). Only the change scores of the CTSI-SS had significant correlation with patient satisfaction (r = 0.34, P < 0.01). An absolute value of Spearman's correlation coefficient of >0.5 was observed between the change scores of the CTSI-SS and the DASH, the CTSI-SS and the SF-36-BP, the CTSI-FS and the DASH, and the DASH and the SF-36-BP. Conclusion The CTSI-JSSH was proven to be more sensitive to clinical changes after carpal tunnel release than the other outcome measures and should be used to evaluate patients with carpal tunnel syndrome who speak Japanese as their native language.     

Responsiveness of the PROMIS physical function measure in orthopaedic trauma patients

ObjectivesTo compare the responsiveness of the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) to the 36-Item Short Form Survey Physical Component Score (SF36-PCS) in orthopaedic trauma patients from pre-injury to one year recovery.Design and SettingProspective cohort study at a Level 1 trauma centre.ParticipantsPatients over the age of 18 with orthopaedic trauma injuries to the pelvis, lower extremity or upper extremity between 2017 and 2018.Main Outcomes MeasurementsThe PROMIS-PF and SF36-PCS assessments were conducted at baseline, 3 months, 6 months and 12 months. Responsiveness of each measure was assessed between time points by calculating the standardized response mean (SRM), the proportions of patients exceeding minimal clinically important difference (MCID), and the floor and ceiling effects.ResultsSixty-eight patients with completed assessments at every timepoint were included: mean age 44.7 years, 39 were male and mean Injury Severity Score (ISS) was 7.4 (range: 4–16). Mean time of completion for the SF-36 at all the time points was 5.6 min vs 1.7 min for the PROMIS-PF (p<0.01). The SRM was comparable between measures at all the time points. Although a greater proportion of patients achieved MCID for SF36-PCS between all the time points, this only approached statistical significance between the 6- and 12-month assessments (47.1% vs 33.8%; p = 0.15). There was a significant ceiling effect demonstrated with the PROMIS-PF at baseline and 12-month assessments, with 34 (50.0%) patients and 7 (10.3%) patients achieving the maximum scores at each time point, respectively.Discussion and ConclusionsPROMIS-PF has a more favourable responder burden based on lower time to completion and comparable responsiveness to the SF-36 PCS. However, there are limitations in responsiveness with the PROMIS-PF in patients who are higher functioning as demonstrated by the ceiling effects in patients at baseline pre-injury and at 12 months post-injury timepoints.     

Psychometric analysis of measuring functional outcomes in tibial plateau fractures using the Short Form 36 (SF-36), Short Musculoskeletal Function Assessment (SMFA) and the Western Ontario McMaster Osteoarthritis (WOMAC) questionnaires

Patients participating in a modern prospective orthopaedic trauma database may be asked to complete many functional outcome measures, adding to the burden of study participation. This prospective study assessed the utility and responsiveness of the generic Short Form 36 (SF-36) and the disease specific Short Musculoskeletal Function Assessment (SMFA) and the Western Ontario McMaster Osteoarthritis (WOMAC) questionnaires in 55 patients treated operatively for tibial plateau fractures with the goal of determining if there was clear benefit of using multiple measures in a lower extremity peri-articular fracture population. There was very good correlation between all three scores at 6 and 12 months, indicating they are measuring similar factors. Responsiveness was assessed using the standard response mean (SRM), proportion of patients attaining the minimal clinically important difference (MCID) between 6 and 12 months, and floor and ceiling effects. The SRM for the SF-36 was statistically higher than the SRM for the SMFA or the WOMAC. Significantly more patients were found to have a MCID between 6 and 12 months post-surgery based on the SF-36 than the other two functional scores. There was no floor effect found on any of the 3 functional scores evaluated; however, a significant ceiling effect was noted with the WOMAC but not with the SF-36 or the SMFA.These results, along with the usefulness of the SF-36 for comparing disease burden across populations, favour the SF-36 as the instrument of choice in assessing functional outcome in patients with tibial plateau fractures.     

Laparoscopic versus small-incision cholecystectomy: Health status in a blind randomised trial

BACKGROUND: Gallstones are a major cause of morbidity, and cholecystectomy is a commonly performed procedure. Minimal invasive procedures, laparoscopic cholecystectomy (LC) and small-incision cholecystectomy (SIC), have replaced the classical open cholecystectomy. No differences have been found in primary outcome measures between LC and SIC, therefore secondary outcome measures have to be considered to determine preferences. The aim of our study was to examine health status applying evidence-based guidelines in LC and SIC in a randomised trial. METHODS: Patients with symptomatic cholecystolithiasis were included in a blind randomised trial. Operative procedures, anaesthesia, analgesics and postoperative care were standardised in order to limit bias. Questionnaires were filled in preoperatively, the first day postoperatively, and at outpatients follow-up at 2, 6 and 12 weeks. In accordance with evidence-based guidelines, the generic short form (SF-36) and the disease-specific gastrointestinal quality-of-life index (GIQLI) questionnaires were used in addition to the body image questionnaire (BIQ). RESULTS: A total of 257 patients were randomised between LC (120) and SIC (137). Analyses were performed according to intention-to-treat (converted procedures included) and also distinguishing converted from minimal invasive (nonconverted) procedures. Questionnaires were obtained with a response rate varying from 87.5% preoperatively to 77.4% three months postoperatively. Except for two time-specific measurements in one SF-36 subscale, there were no differences between LC and SIC. There were significant differences in several subscales in all three questionnaires comparing minimal invasive versus converted procedures. CONCLUSIONS: Applying adequate methodological quality and evidence-based guidelines (by using SF-36 and GIQLI), there are no significant differences in health status between LC and SIC.     

Recurrence and Quality of Life Following Perineal Proctectomy for Rectal Prolapse

Background  Surgical outcome and quality of life (QOL) following perineal proctectomy for rectal prolapse remain poorly documented. Methods  From 1994 to 2004, patients with full-thickness rectal prolapse were treated exclusively with perineal proctectomy independent of age or comorbidities. Subjective patient assessments and recurrences were determined retrospectively from hospital and clinic records. Consenting patients completed the gastrointestinal quality of life index (GIQLI). Results  Perineal proctectomy was performed in 103 consecutive patients with a median age of 75 years (range 30–94). Most patients underwent concurrent levatorplasty (anterior 85.8%, posterior 67.9%). Durable results were obtained in all patients; the recurrence rate was 8.5% over a mean follow-up of 36 months. Preoperatively, 75.5% of patients reported fecal incontinence, and 32.1% had obstructed defecation. Incontinence significantly improved post-proctectomy (41.5%, p < 0.001), as did constipation (10.4%, p < 0.001). GIQLI respondents reported satisfaction following proctectomy with 63% scoring within one standard deviation of healthy controls. Patients with recurrent prolapse reported a lower QOL. Risk factors for recurrence included duration of prolapse, need for posterior levatorplasty, and prior anorectal surgery. Conclusions  Perineal proctectomy provides significant relief from fecal incontinence and obstructive symptoms caused by rectal prolapse, with an acceptable recurrence rate and low morbidity. This study was supported exclusively using institutional funding.     

Role of Prophylactic Antibiotics in Laparoscopic Cholecystectomy: A Meta-Analysis

Background   The role of prophylactic antibiotics in laparoscopic cholecystectomy in low-risk patients is controversial. We conducted a meta-analysis to evaluate the efficacy of prophylactic antibiotics in low-risk patients (those without cholelithiasis or cholangitis) undergoing laparoscopic cholecystectomy. Methods   Multiple databases and abstracts were searched. Randomized controlled trials (RCTs) comparing prophylactic antibiotics to placebo or no antibiotics in low-risk laparoscopic cholecystectomy were included. The effects of prophylactic antibiotics were analyzed by calculating pooled estimates of overall infections, superficial wound infections, major infections, distant infections, and length of hospital stay. Separate analyses were performed for each outcome by using odds ratio or weighted mean difference. Both random and fixed effects models were used. Publication bias was assessed by funnel plot. Heterogeneity among studies was assessed by calculating I ² measure of inconsistency. Results   Nine RCTs (N = 1,437) met the inclusion criteria. No statistically significant reduction was noted for those receiving prophylactic antibiotics and those who did not for overall infectious complications (p = 0.20), superficial wound infections (p = 0.36), major infections (p = 0.97), distant infections (p = 0.28), or length of hospital stay (p = 0.77). No statistically significant publication bias or heterogeneity were noted. Conclusions   Prophylactic antibiotics do not prevent infections in low-risk patients undergoing laparoscopic cholecystectomy. Scientific Meeting: Data presented at Digestive Disease Week on 19 May 2008 at San Diego, CA.     

Responsiveness of the foot function index, AOFAS clinical rating systems, and SF-36 after foot and ankle surgery

BACKGROUND: There is uncertainty regarding which outcomes tools should be used to report the results of treatment for patients with foot and ankle disorders. This study compared the responsiveness of the Foot Function Index (FFI), American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating Systems, and Medical Outcomes Study Short Form-36 (SF-36) in patients with foot and ankle surgery. METHODS: Twenty-five patients were recruited at a tertiary referral foot and ankle practice. The mean age of the patient sample was 40 years (range 21 to 69) and 19 were women (76%). Thirteen patients (52%) had conditions affecting the ankle, hindfoot, or midfoot, while 12 patients (48%) had conditions affecting the forefoot. Patients completed packets preoperatively and 6-months postoperatively which included informed consent forms, the FFI, the AOFAS, and the SF-36 questionnaires. Standardized response means (SRM) and effect sizes (ES) were used as the measures of responsiveness and were calculated for the AOFAS scores, the three domains of the FFI, the eight SF-36 sub-scales, and the two SF-36 summary scales. RESULTS: The standardized response mean (SRM) for the AOFAS scores was 1.10 and the effect size (ES) was 1.12. The SRM for the three FFI domains ranged from -0.39 to -0.83, while the ES ranged from -0.55 to -0.86. The SRM for the SF-36 ranged from 0.09 to 0.72 (ES ranged from 0.09 to 0.77) with the highest values occurring with the Bodily Pain sub-scale (SRM 0.72, ES 0.77) and Physical Component Summary scale (SRM 0.76, ES 0.68). CONCLUSIONS: This study demonstrated increased responsiveness of foot and ankle specific outcomes tools compared to the SF-36. However, the Bodily Pain sub-scale and Physical Component Summary scale of the SF-36 had levels of responsiveness approaching those of the FFI and AOFAS Systems after foot and ankle surgery. This suggests that the SF-36 may be used alone to monitor the outcomes in these patients without sacrificing adequate sensitivity to clinical change.     

Changes in Quality of Life After Balloon Treatment Followed by Gastric Banding in Severely Obese Patients—The Use of Two Different Quality of Life Questionnaires

Background  Improvements in quality of life (QOL) obtained by weight loss have mainly been reported after bariatric surgery. QOL has not been investigated in surgical patients first losing weight by nonsurgical means followed by a surgical intervention and never simultaneously by two QOL—a generic and a disease-specific—questionnaires. Methods  Prospective data were obtained from 40 consecutive patients (mean age 36.6 years, body weight 142.4 kg, body mass index (BMI) 46.5 kg/m²). Two different QOL questionnaires, the generic Medical Outcomes Study Short Form-36 (SF-36) and the disease-specific Health-Related Quality of Life (HRQL) questionnaire, were evaluated at three points in time: at the start, 3 months after the placement of an intragastric balloon that remained in situ for 6 months, and 3 months after subsequent gastric banding. Results  QOL scores revealed a significant improvement in many health domains, with an earlier improvement with the disease-specific HRQL, whereas the generic QOL questionnaire lagged behind. However, in the end, the SF-36 caught up completely to normal-weight levels, whereas some scales of the HRQL remained below these levels. Work productivity and involvement in sports improved significantly. BMI declined significantly over time, but no correlation with SF-36 and HRQL score changes was found. Conclusion  The QOL improved substantially independent of changes in BMI. Because of the divergent outcomes of generic and disease-specific QOL questionnaires, prospective studies should examine the sensitivity to changes of both kinds of QOL questionnaires.     

The minimal clinically important difference in the Gastrointestinal Quality-of-Life Index after cholecystectomy

Background  

The minimal clinically important difference (MCID) for the Gastrointestinal Quality of Life Index (GIQLI) is unknown, which limits its application and interpretation. This study aimed to estimate MCIDs for the GIQLI scores of patients after they had undergone cholecystectomy.     

Short-term results of bilateral S2–S4 sacral neuromodulation for the treatment of refractory interstitial cystitis,painful baldder syndrome,and chronic pelvic pain

We evaluated the efficacy of bilateral caudal epidural sacral neuromodulation for the treatment of refractory chronic pelvic pain (CPP), painful bladder syndrome, and interstitial cystitis (IC). Thirty consecutive patients (21 female, 9 male) with severe refractory symptoms underwent bilateral S2–S4 sacral neuromodulation for CPP/IC. Patients were evaluated with the O’Leary IC symptom and problem index (ICSI, ICPI), the short form of the Urogenital Distress Inventory (UDI-6), and the RAND 36-item health survey (SF-36) preoperatively and 6 months postoperatively. The mean and minimum follow-up were 15 and 6 months, respectively. Of the 30 patients, 23 (77%) had a successful trial stimulation and were permanently implanted. Among these patients, the ICSI and ICPI scores improved by 35 (p = 0.005) and 38% (p = 0.007), respectively. The pain score improved by 40% (p = 0.04) and the UDI-6 score by 26% (p = 0.05). On average, patients reported a 42% improvement in their symptoms. SF-36 scores did not improve significantly. In refractory patients, bilateral caudal epidural sacral neuromodulation is another possible mode of treatment, which appears to improve both pelvic pain and voiding symptoms.     

Use of Endoluminal Antireflux Therapies for Obese Patients with GERD

Background  Obese patients with gastroesophageal reflux disease (GERD) refractory to medical therapy are a challenging patient population as obesity is a preoperative predictor of failure after antireflux surgery. We therefore sought to evaluate outcomes using one of two commercially available endoluminal therapies in this population. Methods  Consecutive obese patients (body mass index (BMI) > 30) with GERD (DeMeester >14.5) undergoing either Plicator (NDO) or Stretta (Curon) were identified in our single-institution prospective database. Outcomes assessed were: (1) failure rate (absolutely no symptomatic improvement after procedure and/or need for subsequent antireflux surgery), (2) postoperative vs. preoperative symptom (heartburn, chest pain, regurgitation, dysphagia, cough, hoarseness, and asthma) scores, and (3) proton-pump inhibitor (PPI) medication use. Results  Twenty-two patients each underwent an endoluminal therapy (ten Plicator patients and 12 Stretta patients) with mean follow-up of 1.5 years. There were no treatment-associated complications. Mean BMI was not different between Plicator and Stretta groups (39.6 vs. 38.6, respectively, p = 0.33). The failure rate for the entire cohort was 28% (10% Plicator vs. 42% Stretta, p = 0.11). The proportion of patients reporting moderate/severe symptoms postop was significantly less than preop: chest pain 9% vs. 13% (p = 0.04), cough 22% vs. 36% preop (p = 0.025), voice changes 9% vs. 36% preop (p = 0.012), and dysphagia 9% vs. 32% preop (p = 0.04). The proportion of patients on PPI medications postop was also less than preop (45% vs. 81%, p = 0.1) Conclusion  Endoluminal treatment can provide a safe means of improving GERD symptoms for some obese patients, though many will continue to require medication therapy also. Further work aimed at understanding optimal candidates for endoluminal therapy in this patient population is warranted.     

Validation of an English Version of the Padova Quality of Life Instrument to Assess Quality of Life Following Ileal Pouch Anal Anastomosis

Objective  Ileal pouch anal anastomosis (IPAA) is the procedure of choice for most patients requiring surgery for ulcerative colitis and familial adenomatous polyposis because of its perceived improvement in health-related quality of life (HRQL). The aims of this cross-sectional study were to validate an English version of the Padova Inflammatory Bowel Disease Quality of Life questionnaire (PIBDQL) in patients undergoing IPAA and to investigate the pre- and postoperative predictors of long-term HRQL. Materials and Methods  In May 2005, the English version of the PIBDQL, Short Inflammatory Bowel Disease Questionnaire, and the SF-36 were mailed to 1,379 patients who underwent IPAA at the Mount Sinai Hospital between 1982 and 2004. The test–retest reliability, internal consistency, construct validity, and discriminative ability of the English version of the PIBDQL were assessed. Results  Nine hundred fifty-five patients (69%) (475 female, 480 male; mean, age 43 years) returned the questionnaires. The mean PIBDQL score was 21.1 (3.4), suggesting good quality of life. Test–retest reliability [intraclass correlation coefficient (ICC) = 0.784] and internal consistency (Cronbach’s α = 0.83) were good. Construct validity and discriminative ability of the English version of PIBDQL were adequate. Multivariate analysis revealed that women (p < 0.01) and Crohn’s disease patients (p < 0.01) had significantly worse PIBDQL scores. Conclusions  The English version PIBDQL is a reliable and valid disease-specific instrument for assessing quality of life in patients with IPAA. In this series, female gender and CD were significant predictors of worse HRQL. Presented as a poster at Digestive Disease Week, San Diego, California, May 21, 2008.     

Ten-year Outcome of Laparoscopic Antireflux Surgery

Background  Reflux recurrence is the most common long-term complication of fundoplication. Its frequency was independent from the type of fundoplication in randomized studies. Results for different techniques of laparoscopic antireflux surgery were retrospectively evaluated after 10 years. Methods  From 1992 to 1997, 120 patients had primary laparoscopic fundoplication with a “tailored approach” (type of wrap chosen according to esophageal peristalsis): 88 received a Nissen, 22 an anterior, and 10 a Toupet fundoplication. Follow-up of 87% of the patients included disease-related questions and the gastrointestinal quality-of-life index (GIQLI). Results  Of the patients, 89% would select surgery again. Heartburn was reported by 30% of the patients. Regurgitations were noted from 15% of patients after a Nissen, 44% after anterior fundoplication, and 10% after a Toupet (p = 0.04). Twenty-eight percent were on acid-suppressive drugs again. Following Nissen fundoplication, proton pump inhibitors were less frequently used (p = 0.01) and on postoperative pH-metry reflux recurrence rate was lower (p = 0.04). The GIQLI was 110 ± 24 without significant differences for the type of fundoplication. Discussion  Ten years after laparoscopic fundoplication, overall outcome is good. A quarter of the patients are on acid-suppressive drugs. Nissen fundoplication appears to control reflux better than a partial fundoplication. The results of the questionnaire have already been published in German in the journal ‘Der Chirurg’.     

Quality of Life and Symptomatic Response to Gastric Neurostimulation for Gastroparesis

Background  Gastroparesis can be a difficult problem with patients suffering from nausea, vomiting, bloating, and pain intractable to medical management. Gastric neurostimulation has been developed as an adjunctive treatment for patients with diabetic and idiopathic gastroparesis unresponsive to pharmacologic and dietary treatment. The purpose of this study is to report symptomatic and quality-of-life response to gastric neurostimulation. Methods  This study was approved by the institutional review board, and patients had informed consent. The gastric neurostimulation device (Enterra therapy, Medtronic, Inc., Minneapolis, MN, USA) is approved by the Food and Drug Administration under the Humanitarian Device Exemption. Candidates for placement were patients with either idiopathic or diabetic gastroparesis who had symptomatic failure to dietary changes and to prokinetic and antiemetic drugs. Before placement, the patients’ symptoms were recorded, and patients completed the Gastrointestinal Symptom Rating Scale (GSRS, three domains: dyspeptic syndrome, indigestion syndrome, and bowel dysfunction syndrome) and the Short Form-36 (SF-36, eight domains: physical functioning, role-physical, role-emotional, bodily pain, vitality, mental health, social functioning, general health, plus a health transition item). The device was surgically placed using a hybrid laparoscopic/open technique. Patients were followed and adjustments made on the device until satisfactory symptom control was achieved. At that time, patients completed both the GSRS and SF-36, and comparisons were made to preoperative values. Results  Forty-two patients had the device placed, 29 women, aged 41 (SD +14) years, 24 diabetic patients, 17 idiopathic patients, one postgastrectomy patient. Median follow-up was 12 months (range 1–42 months). There was a 2% immediate postoperative morbidity rate and 7% long-term morbidity rate (device extrusion). Thirty-one patients (74%) responded to gastric neurostimulation of variable degrees. Eleven patients had no response or had worsening symptoms. Of the patients who responded, there were statistically significant improvements in all three domains of the GSRS. Median scores (with interquartile ranges): dyspeptic syndrome, 9 (7–11.5) to 4 (2.5–6), p = 0.02; indigestion syndrome, 5 (2–7) to 4 (0–5), p = 0.05; bowel dysfunction syndrome, 3 (2–3) to 1 (0–1), p = 0.01. In the SF-36, there were statistically significant improvement in the health transition item, 4 (4–5) to 1.5 (1–3), p = 0.01; and social functioning domain, 25 (12.5–62.5) to 75 (50–87.5), p = 0.03. Conclusions  Three quarters of gastroparesis patients responded to gastric neurostimulation to variable degrees. Gastrointestinal-specific symptoms are improved in responders. Patients felt that there health and social functioning (SF) improved, although there was no significant difference in the other domains. These results are encouraging considering that these patients had intractable symptoms with no other effective treatments available. Presented in part at the Annual Meeting of the Society for Surgery of the Alimentary Tract, San Diego, CA, May 18–21, 2008 [oral presentation].     

An evaluation of quality of life of mothers of children with enuresis nocturna

The aim of this study was to evaluate the impact of enuresis nocturna on quality of life of the mothers. Mothers who have a child with monosymptomatic nocturnal enuresis (n = 28) and mothers who have a child without any health problems (n = 38) were enrolled in the study. Groups were in balance for background variables (child’s age, gender, and number of siblings; mother’s age, marital status, highest year of education completed, and occupation; presence of health insurance; and type of residence). Short-Form Health Survey (SF-36) Questionnaire, the Beck Depression Inventory (BDI), and Spielberg’s State-Trait Anxiety Inventory (STAI) were applied to all mothers. The mothers of children with enuresis had significantly lower quality-of-life scores in the SF-36 for the bodily pain (p = 0.015) and role emotional (p = 0.014) subscales. We observed significant difference between groups according to BDI; mean score was higher in mothers who have a child with enuresis nocturna (p = 0.017). There was no significant difference between groups according to the STAI. Significant differences according to bodily pain and role emotional subscales of SF-36, and the BDI scores, show that the mothers were negatively affected by having a child with monosymptomatic nocturnal enuresis.     

Responsiveness of SF-36 and Lower Extremity Functional Scale for assessing outcomes in traumatic injuries of lower extremities

ObjectiveTo assess the responsiveness of one generic questionnaire, Medical Outcomes Study Short Form-36 (SF-36), and one region-specific outcome measure, Lower Extremity Functional Scale (LEFS), in patients with traumatic injuries of lower extremities.DesignA prospective and observational study of patients after traumatic injuries of lower extremities. Assessments were performed at baseline and 3 months later.SettingIn-patients and out-patients in two university hospitals in Taiwan.ParticipantsA convenience sample of 109 subjects were evaluated and 94 (86%) were followed.InterventionsNot applicable. Main Outcome Measure(s): Assessments of responsiveness with distribution-based approach (effect size, standardized response mean [SRM], minimal detectable change) and anchor-based approach (receiver's operating curve analysis, ROC analysis).ResultsLEFS and physical component score (PCS) of SF-36 were all responsive to global improvement, with fair-to-good accuracy in discriminating between participants with and without improvement. The area under curve gained by ROC analysis for LEFS and SF-36 PCS was similar (0.65 vs. 0.70, p = 0.26).ConclusionsOur findings revealed comparable responsiveness of LEFS and PCS of SF-36 in a sample of subjects with traumatic injuries of lower limbs. Either type of functional measure would be suitable for use in clinical trials where improvement in function was an endpoint of interest.     

Influence of different conditioning methods on the shear bond strength of novel light-curing nano-ionomer restorative to enamel and dentin

The purpose of this study was to investigate shear bond strength (SBS) between a light-curing nano-ionomer restorative and enamel or dentin after acid etching, after erbium:yttrium–aluminum–garnet (Er:YAG) laser etching, or after combined treatment. Forty third molars were selected, the crowns were sectioned, and 80 tooth slabs were obtained. The specimens were assigned to two groups, which were divided into four subgroups(n = 10). Group 1 [enamel (e)], treated with 37% phosphoric acid (A) + Ketac nano-primer (K); group 2 [dentin (d)], (A) + (K); group 3(e), Er:YAG laser etching (L) + (A) + (K); group 4(d), (L) + (A) + (K); group 5(e), (L) + (K); group 6(d), (L) + (K); group 7(e), (K); group 8(d), (K). The SBS of the specimens was measured with a universal test machine (1 mm/min). Data were analyzed by independent samples t-test, one-way analysis of variance (ANOVA) and a post-hoc Duncan test (p < 0.05). No difference was determined between groups 3 and 5 (p > 0.05). Group 7 exhibited higher SBS values than those of groups 3 and 5 (p < 0.05). Group 1 showed higher SBSs than those of groups 3, 5 and 7 (p < 0.05). There was no significant difference between groups 4 and 6 (p > 0.05). No difference was observed between groups 2 and 4 (p > 0.05). However, group 2 presented higher SBSs than did group 6 (p < 0.05). Group 8 exhibited the highest SBS values when compared with groups 2, 4 and 6 (p < 0.05). Er:YAG laser adversely affected the adhesion of the light-curing nano-ionomer restorative to both enamel and dentin.     

Influence of Activity on Quality of Life Scores After RYGBP

Gastric bypass is one of the medically acceptable interventions for weight loss for the obese. Quality of life greatly improves after surgery. Most improvements in quality of life (QOL) after these surgeries are attributed to the weight loss. Few studies have demonstrated any contribution of other variables to positive outcomes in QOL. The purpose of this study was to suggest variables that improve QOL in this post-surgical population. The Arizona Activity Frequency Questionnaire, the Arizona Food Frequency Questionnaire, and the SF-36 survey were sent to all of the Roux-en-Y gastric bypass procedure (RYGBP) patients who had surgery 1–5 years prior to the study and performed through the same bariatric surgery center (n = 805; respondents = 265; 33%). Analysis was performed through ANOVA testing to determine relationships between selected behaviors and the SF-36 of the respondents. Comparisons of differences in SF-36 scores were analyzed using the variables of hours of activity/day (HOAD) and energy in activity/day (EEAD). Patients with more EEAD and HOAD demonstrated significantly better SF-36 scores in both mental component and physical component scores (p = 0.05) when compared to those with less EEAD or HOAD. Outcomes measured by the SF-36 tool were improved after RYGBP, if the patient expended more energy/day or was active more hours/day. The post-bariatric surgery populations will have improved QOL if the patients expend more energy and are active more hours as demonstrated in activity/day after their surgery.