Responsiveness and Minimal Clinically Important Differences after Cholecystectomy: GIQLI Versus SF-36

Introduction  To compare responsiveness and minimal clinically important differences (MCID) between the Gastrointestinal Quality of Life (GIQLI) and the Short Form 36 (SF-36), we prospectively analyze 159 patients undergoing cholecystectomy at two tertiary academic hospitals. Patients and Methods  All patients completed the disease-specific GIQLI and the generic SF-36 before and 3 months after surgery. Scores using these instruments were interpreted by generalized estimating equation before and after cholecystectomy. The bootstrap estimation was used to derive 95% confidence intervals for differences in the responsiveness estimates. Results and Discussion  Mean changes in all GIQLI and the SF-36 subscales were statistically significant (p < 0.05). Comparisons of effect size (ES), standardized response means (SRM), and relative efficiency (>1) indicated that the responsiveness of the GIQLI was superior to that of the SF-36. In the equivalence test, all lower or upper confidence limits presented no equivalence (>5), indicating good MCID. The ES and SRM for emotions and physical function in the GIQLI significantly differed from those of the SF-36 (p < 0.05). Conclusion  The data in this study indicate that clinicians and health researchers should weight disease-specific measures more heavily than generic measures when evaluating treatment outcomes.     

Validation assessment of the Chinese (Taiwan) version of the Gastrointestinal Quality of Life Index for patients with symptomatic gallstone disease

BACKGROUND: Symptomatic gallstone is one of the most common diseases in Taiwan. The aim of this study was to develop a Mandarin Chinese outcomes measure for the assessment on quality of life among gallstone patients. MATERIALS AND METHODS: The Gastrointestinal Quality of Life Index (GIQLI) is a valid, disease-specific measure for the evaluation of health status and treatment effectiveness for adults with chronic gastrointestinal condition. The GIQLI was translated into Mandarin Chinese using a parallel model. The Chinese (Taiwan) version of the GIQLI (CGIQLI) was administered to 102 patients with symptomatic gallstone disease in a prospective manner; the CGIQLI then was validated according to established criteria for reliability, validity, and longitudinal sensitivity. RESULTS: The CGIQLI demonstrates good test-retest reliability (r = 0.92, P = 0.001) and internal consistency (Cronbach's alpha = 0.92). The CGIQLI significantly correlates with the Mandarin Chinese (Taiwan) version of the generic 36-Item Short-Form Health Survey (SF-36). The standardized response mean for the CGIQLI total score is 0.96, indicating excellent sensitivity to clinical change in the study group. CONCLUSION: This validation study demonstrated that the performance characteristics of the CGIQLI are equivalent to the English version, the GIQLI. This study demonstrates that the CGIQLI is a valid tool to evaluate adults with chronic gastrointestinal problems among the Chinese-speaking population.     

A review and evaluation of patient-reported outcome measures for spasticity in persons with spinal cord damage: Recommendations from the Ability Network – an international initiative

Context: Patient-reported outcome measures (PROMs) are valuable for capturing the impact of spasticity on health-related quality of life (HRQoL) in persons with spinal cord damage (SCD) and evaluating the efficacy of interventions.Objective: To provide practical guidance for measuring HRQoL in persons with spasticity following SCD.Methods: Literature reviews identified measures of HRQoL and caregiver burden, utilized in studies addressing spasticity in SCD. Identified measures were evaluated for clinical relevance and practicality for use in clinical practice and research. The PRISM, SCI-SET, EQ-5D and SF-36 instruments were mapped to the International Classification of Functioning, Disability and Health (ICF). The PRISM and SCI-SET were evaluated using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist.Results: Two spasticity-specific, five generic, and four preference-based measures were identified. ICF mapping and the COSMIN checklist supported the use of the PRISM and SCI-SET in SCD. The SF-36 is considered the most useful generic measure; disability-adapted versions may be more acceptable but further studies on psychometric properties are required. The SF-36 can be converted to a preference-based measure (SF-6D), or alternatively the EQ-5D can be used. While no measures specific to caregivers of people with SCD were identified, the Caregiver Burden Scale and the Zarit Burden Interview are considered suitable.Conclusion: Recommended measures include the PRISM and SCI-SET (condition-specific), SF-36 (generic), and Caregiver Burden Scale and Zarit Burden Interview (caregiver burden). Consideration should be given to using condition-specific and generic measures in combination; the PRISM or SCI-SET combined with SF-36 is recommended.     

Long-term outcome and health-related quality of life after laparoscopic and open colectomy for benign disease

Background: The benefits of laparoscopic colectomy (LC) vs open colectomy (OC) for the treatment of benign disease have not yet been clearly demonstrated with regard to long-term consequences and health-related quality of life (HRQL). The aim of this study was to compare LC and OC in terms of outcome and HRQL and to determine whether a generic nonspecific instrument for HRQL assessment is valid in postoperative follow-up. Methods: Forty-nine patients who underwent LC for elective right hemicolectomy (RH) or sigmoid resection (SR) for benign polyps or uncomplicated diverticular disease between 1992 and 2000 were evaluated and compared to 50 controls treated by OC in the same period. All patients were evaluated by postal questionnaire to determine recurrence rates and surgery-related complications. HRQL was assessed by the SF-36 Physical and Mental Component Summary Score (PCS, MCS) and by the SF-36 Health Survey, which measures eight different health-quality domains, including physical and social functioning (PF, SF), general health perception (GH), physical and emotional role limitations (RP, RE), body pain (BP), vitality (VT), and mental health (MH). Results: The LC and OC patients were similar in age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) classification, and diagnosis. There were significant differences between the two groups in resection type (26 RH:23 SR in LC vs 16 RH:34 SR in OC, p = 0.03) and length of follow-up (median, 39 and 53.5 months, respectively, p = 0.04), but neither parameter was predictive of the main SF-36 scores (PCS and MCS). There were no differences between the groups in recurrence rates (8% in LC vs 11% in OC) or surgery-related complications, including incisional hernias (16.3% in LC vs 17% in OC) and small bowel obstructions (2% in LC vs 10.4% in OC). None of the eight SF-36 Health Survey domains or the PCS or MCS scores showed significant differences between LC and OC patients in HRQL. However, occurrence of hernia after surgery was predictive of lower SF-36 scores, specifically in PF (p = 0.047), GH (p = 0.045), SF (p = 0.047), MH (p = 0.041), and MCS (p = 0.037). In addition, small bowel obstruction was significantly associated with lower scores in BP (p = 0.008), GH (p = 0.008), SF (p = 0.013), RE (p = 0.026), MH (p = 0.003), and MCS (p = 0.003). Conclusion: LC was not different from OC for selected indications that measure long-term outcome and HRQL. SF-36 appears to be an appropriate instrument to measure postoperative HRQL, showing responsiveness to changes in objective outcome measures. Presented at the annual meeting of the Society of Gastrointestinal Endoscopic Surgeons (SAGES), New York, NY, USA, 13–17, March 2002     

Efficacy of the SF-36 Questionnaire in Identifying Obese Patients with Psychological Discomfort

Background: The primary endpoint of this study was to assess the association of health-related quality of life (QoL) and the presence of psychopathology. The association of other patients' characteristics and of Cognitive Behavioral Assessment (CBA) scales with quality of life (QoL) was also evaluated. Methods: 100 consecutive obese patients (WHO grade 2 and 3 obesity), addressed for psychological advice before either invasive or non-invasive treatment of obesity, were investigated. The instruments used were the SF-36 questionnaire (physical and mental component summaries, PCS and MCS), the CBA scales and psychological counselling. The association of PCS and MCS with the presence of psychopathology (Marked or DSM IV discomfort) was assessed by means of logistic regression. Results: SF-36 PCS was 39.5 (95% CI 37.7−41.3) and MCS 49.8 (95% CI 47.7-51.9). PCS only was significantly lower than the average for the reference normal population. The mean PCS score was similar in the No-Moderate (39.6 (SD 7.6)) and Marked-DSM IV (39.1 (SD 7.6)) groups, with an adjusted odds ratios (OR) of 1.07 (95% CI 0.74−1.55), P=0.706, for 5 points increase in PCS. The mean MCS score was 51.7 (SD 10.3) in the No-Moderate group and 42 (SD 8.1) in the MarkedDSM IV group, with an adjusted OR for 5 points increase in score of 0.63 (95% CI 0.43−0.95), P=0.003. Conclusions: SF-36, and particularly the MCS component, is a simple tool of easy use that could be utilized for identifying patients needing a specific psychological intervention in severely obese subjects applying for a weight reduction program.     

A Case–Control Study of Quality of Life and Functional Impairment in Women with Long–Standing Vertebral Osteoporotic Fracture

There have been several studies of the impact of vertebral osteoporotic fracture on the quality of life and functionality of individual subjects. To date, however, no direct comparisons with age-matched normal subjects without vertebral fracture have been made. The radiographs of 145 female clinic patients with vertebral fractures were reviewed by the study physicians. The controls were recruited from the electoral role and by media appeal. One hundred and sixty-seven women had radiographs taken to determine those without vertebral fracture. Fracture subjects and controls had to be ambulant and were excluded if they had significant radiologic evidence of degenerative disk or joint disease of the spine. One hundred cases and one hundred controls were matched by 5-year age groups. The number, position and severity of the vertebral fracture on the lateral radiographs of the cases was recorded. Quality of life was measured using the Short Form-36 (SF-36) (maximum score 100) and a utility score calculated from thesese results (maximum score 1). Two measurements of functionality were employed: the Modified Barthel Index (MBI) to assess the activities of daily living (maximum score 100) and the Timed ‘Up & Go’ (TUG) that measured the time taken for the subject to rise from sitting in a chair, walk 3 m along a line, return to the chair and sit down. The fracture subjects had 2.9 + 1.6 (mean + SD) vertebral fractures and the time since last fracture was 5.1 + 4.8 years. The SF-36 physical function component summary index results were: fracture subjects 36 + 11, controls 48 + 9 (p < 0.001). The SF-36 mental health component summary index results were: fracture subjects 50 + 11, controls 54 + 8 (p <0.05). The utility scores were: fracture subjects 0.64 + 0.08, controls 0.72 + 0.07 (p <0.001). The MBI results were: fracture subjects 97 + 5, controls 99 + 1 (p< 0.01). The TUG results were: fracture subjects 13.8 + 7.3 s, controls 10.1 + 4.1 s (p <0.01). TUG and MBI scores correlated well with SF-36 scores; however, no domain of the SF-36 or functional measure correlated with either the number of vertebral fractures or the time since last vertebral fracture. Thus, clinically reported vertebral fractures impair both the quality of life and functionality of these subjects. The adverse impact of vertebral fracture on quality of life and functionality needs to be recognized by medical practitioners, subjects and the community, so that adequate health resources can be devoted to the prevention and treatment of this debilitating condition condition. Received: 17 June 1998 / Accepted: 28 October 1998     

Relationships between SF-36 health profile and bone mineral density: the Hertfordshire Cohort Study

We utilised the Hertfordshire Cohort Study (HCS) to relate bone mineral density (BMD) to SF-36 health-related quality of life scores. We studied 737 men and 675 women who had completed a home interview and clinic. Four hundred and ninety-eight men and 468 women subsequently attended for bone densitometry [dual-energy X-ray absorptiometry (DXA)]. SF-36 questionnaire responses were mapped to eight domains: physical function (PF), role physical (RP), role emotional (RE), social functioning (SF), mental health (MH), vitality (VT), bodily pain (BP) and general health perception (GH). Subjects with scores in the lowest gender-specific fifth of the distribution were classified as having “poor” status for each domain. Odds ratios (OR) for poor status for each domain were calculated per unit increase in lumbar spine or total femoral BMD t score. Among men after adjustment for age, BMI, social class, lifestyle (including physical activity) and known comorbidity, higher total femoral t score was associated with decreased prevalence of poor SF-36 scores for PF [OR 0.72 (95%CI 0.53, 0.97), p=0.03], SF [OR 0.70 (95%CI 0.53, 0.94), p=0.02] or GH domains [OR 0.74 (95%CI 0.56, 0.99), p=0.05], but no relationships were apparent between SF-36 scores and lumbar spine t score. Among women, the adjusted relationship between higher total femoral t score and decreased prevalence of poor PF was consistent [OR 0.71 (95%CI 0.50, 1.00), p=0.05], but no other relationships were significant. Poorer functioning (assessed by SF-36 questionnaire) is associated with lower total femoral BMD in older men (but less so in women) after adjustment for lifestyle factors and comorbidity.     

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.     

Relationship between objective measures of peripheral arterial disease severity to self-reported quality of life in older adults with intermittent claudication

OBJECTIVES: The aim of this study was to determine the relation between functional measures of peripheral arterial disease (PAD) severity with both disease-specific and generic self-reported health-related quality-of-life (HR-QOL) measures, as well as the relation between the two types of HR-QOL measures. METHODS: This was a cross-sectional observation of participants from the community and primary care or vascular surgery clinics in an academic Veterans Administration medical center. Eighty patients with symptomatic Fontaine stage II PAD provided physiologic measures and self-response questionnaires. Objective measures included the ankle-brachial index (ABI), time to maximum claudication pain on a graded exercise test, and a 6-minute floor-walking distance. Self-reports included the Walking Impairment Questionnaire (WIQ), a disease-specific HR-QOL measure and the Medical Outcomes Study (MOS) Short-Form 36 (SF-36), a generic HR-QOL measure. RESULTS: Patients (mean age 70 +/- 8 [+/- SD] and 85% men) exhibited moderate-to-severe PAD by objective measures of ABI (0.65 +/- 0.19) and time in minutes to maximal claudication on a graded exercise test (7:54 +/- 4:58). Significant correlations were found between these measures and the WIQ distance, MOS-Physical Function, and MOS-Role Limitations due to physical dysfunction. The SF-36 and the WIQ subscales were significantly correlated. CONCLUSION: In older PAD patients with intermittent claudication, objective measures of disease severity are correlated with a self-reported, disease-specific and generic HR-QOL.     

Relation Between Depression,Some Laboratory Parameters,and Quality of Life in Hemodialysis Patients

Depression is common in patients with end-stage renal disease (ESRD) and is associated with increased mortality and morbidity. Several investigators have estimated that depression occurs in about 20% to 30% of dialysis patients. The aim of this study was to investigate the relationship between depression, some laboratory parameters, and quality of life (QOL) in hemodialysis patients. Forty-three hemodialysis patients (mean age 40.5 ± 15.2; M = 28, F = 15) were included in the study. Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), and short form with 36 (SF-36) were used for evaluation. Subsequently, patients were divided into two groups according to HAMD scores: group 1, those who had a low HAMD score (between 0 and 7), and group 2, those who had a high HAMD score (over 7). The two groups were compared in terms of anxiety scores, QOL scores, and some laboratory parameters. The group 2 patients (n = 21; M = 13, F = 8) had lower levels of hemoglobin than the group 1 patients (9.5 ± 1.7 vs. 10.7 ± 1.4 g/dL, respectively; p< 0.01). Group 2 patients also had lower SF-36 scores than group 1 patients (91.5 ± 21.3 vs. 74.9 ± 13.6, respectively; p = 0.03). On the contrary, the patients of group 2 had higher HAMA scores than group 1 patients (16.6 ± 6.9 vs. 6.3 ± 3.5, respectively; p< 0.01) and CRP level (10.7 ± 4.6 vs. 4.5 ± 3.8, respectively; p< 0.001). A significant correlation was found between depression scores and C-reactive protein (CRP) (r = 0.57, p< 0.001) and HAMA scores (r = ? 0.43, p< 0.05). In contrast, a negative correlation was found between HAMD scores and albumin (r = ? 0.43, p< 0.05), hemoglobin (r = ? 0.38, p =0.015) and SF-36 scores (r = 0.39, p = 0.032). These findings demonstrate that there is a relationship among high depression score, low levels of hemoglobin and albumin, high CRP level, low SF-36 score, and high anxiety score. Evaluation of psychiatric status should be part of the care provided to hemodialysis patients.     

Mapping the Gastrointestinal Quality of Life Index to Short-Form 6D utility scores

Purpose

The Gastrointestinal Quality of Life Index (GIQLI) is a disease-specific quality of life instrument that is commonly used in gastrointestinal disorders. However, no preference weights, which are used to calculate quality-adjusted life years for cost-effectiveness analyses, for this instrument have been assigned. Therefore, the objective of this study was to develop a mapping function to derive utility scores for the GIQLI.

Methods

Patients undergoing elective laparoscopic cholecystectomy completed the short-form 6D (SF-6D), a preference-weighted utility measure, and the GIQLI at baseline and at 1 wk and 1 mo postoperatively. The responsiveness of the SF-6D to expected postoperative changes as well as the correlation between the SF-6D and the GIQLI was investigated. Ordinary least squares regression was performed to derive a mapping function using the baseline values, which was then validated using postoperative values. Adjusted r², mean absolute error, and root mean square error was used to determine model performance.

Results

A total of 50 patients were included in the study (mean age 51.1 [standard deviation 16.8], 28% male). The SF-6D and GIQLI domains were responsive to expected postoperative changes, and there was high correlation between the SF-6D and four of the five GIQLI domains (excluding treatment effects). The final mapping function explained 63% of the variance in the derivation sample but had relatively high mean absolute error (0.075 and 0.067 in the 1-wk and 1-mo samples, respectively) and adjusted root mean square error (13.1% and 12.0% in the 1-wk and 1-mo samples, respectively).

Conclusions

The GIQLI can be accurately mapped to SF-6D preference weights at the group level but may be too inexact at the individual level.     

Fear of movement/(re)injury and activity avoidance in persons with neurogenic versus vascular claudication

Background contextActivity avoidance and fear of movement/(re)injury are increasingly being recognized as important factors in the rehabilitation of persons suffering from chronic low back pain, yet these factors have not been thoroughly explored in persons suffering from neurogenic claudication resulting from lumbar spinal stenosis.PurposeTo determine, compare, and explain differences in the degree of fear of movement/(re)injury and activity avoidance in persons with neurogenic claudication, vascular claudication, and asymptomatic volunteers.Study designProspective controlled cohort study at an academic medical center.Patient sampleEighty-two adults aged between 55 and 90 years with neurogenic claudication, vascular claudication, or no back and leg symptoms.MethodsSubjects completed a visual analog scale for pain, the Center for Epidemiological Studies Depression Scale, the Quebec Back Pain Disability Scale, Short Form 36 (SF-36), and the 13-item version of the Tampa Scale for Kinesiophobia (Tampa). They were also asked to estimate their maximum walking distance.Outcome measuresThe difference in the level of fear of movement/(re)injury and activity avoidance in the two symptomatic populations, as well as the predictive validity of self-reported measures such as pain level, functional impairment, and depression in determining fear avoidance.ResultsThe total Tampa score was significantly higher in individuals with neurogenic claudication (M=31.68; standard deviation [SD]=7.56; N=39) than vascular claudication (M=24.07; SD=6.57; N=15) (p=.002), whereas both symptomatic groups were significantly different from controls (M=18.71; SD=6.3; N=28) (p<.001 vs. neurogenic; p<.05 vs. vascular). Tampa scores were strongly correlated to the Center for Epidemiological Studies Depression Scale score (r=0.515; p<.001), SF-36 Physical Functioning score (r=?0.632; p<.001), and the visual analog scale average level of pain in a week (r=0.461; p<.001). Using a standard multiple regression model (R²=0.406; F(3,62)=13.47; p<.001), the amount of functional impairment, that is, the SF-36 Physical Functioning score, was the strongest contributor to the variance in the Tampa total score (β=?0.371; p=.014). The average level of pain did not make a significant or unique contribution in predicting the Tampa total score. Functional impairment as measured by the SF-36 Physical Functioning was strongly correlated with both pain (r=?0.740; p<.001) and depression (r=?0.488; p<.001).ConclusionsPersons with neurogenic claudication have important elevations in fear and avoidance, higher than those with claudication from another source (vascular insufficiency). The impact of fear and avoidance along with other factors such as depression on pain, disability, and quality of life for persons with claudication and spinal stenosis need to be explored.     

Relationship between subjective and objective outcome measures after Heller myotomy and Dor fundoplication for achalasia

BACKGROUND: The purpose of this study is to assess how subjective evaluation (heartburn, dysphagia, quality of life, and satisfaction) correlates with objective data after Heller myotomy and Dor fundoplication for achalasia. METHODS: A total of 53 consecutive patients with achalasia undergoing laparoscopic Heller myotomy and Dor fundoplication were studied prospectively. Subjective evaluation was done preop and postop using the Gastroesophageal Reflux Disease Health-Related Quality of Life instrument (GERD-HRQL; 0 = best, 45 = worse), 4-point dysphagia and heartburn scales (0 = best, 3 = worst), patient satisfaction scale (0 = very satisfied, 5 = incapacitated), and the SF-12 general health-related quality-of-life score. At 3 months postop, patients were asked to undergo objective evaluation with 24-h pH testing, manometry, and endoscopy. Data are expressed as median (interquartile range) and analyzed by Wilcoxon signed rank test or Mann-Whitney U test. RESULTS: Forty-nine patients were more than 3 months postsurgery. Comparing preop to postop, improvements were found in dysphagia [3 (2-3) to 0 (0-1)], heartburn [1 (0-2) to 0 (0-1)], GERD-HRQL [13.5 (6.3-22.5) to 2 (0-5)], satisfaction [3 (3-4) to 1 (0-1)], and SF-12 mental component summary [46 (37-56) to 58 (50-59)] and physical component summary [46 (36-53) to 55 (48-56)] scores (p < 0.0001 for all). Thirty-eight patients (78%) agreed to undergo objective testing, and complete data were available for 32 (65%). Four of 32 patients (12.5%) had evidence of reflux based on 24-h pH testing. Of nine patients with GERD-HRQL >5, only two had positive pH test (22%). Of 23 patients with GERD-HRQL <5, two had positive pH test (7%). Of four tested patients with moderate to severe heartburn, two had an abnormal pH test. There was no significant relationship between GERD-HRQL score and pH test results. Lower esophageal sphincter pressure (LESP) decreased from 24 (16-35) to 13 mmHg (11-17) (p < 0.001). There was no relationship between dysphagia score and postop absolute LESP or a decrease in LESP after operation. CONCLUSIONS: Laparoscopic Heller myotomy and Dor fundoplication is an effective treatment for achalasia. Subjective evaluation can document patient satisfaction and health-related quality of life but does not accurately reflect postop reflux. Twenty-four-hour pH study is required to accurately assess reflux disease.     

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.     

The NFTI-QOL: A Disease-Specific Quality of Life Questionnaire for Neurofibromatosis 2

The objective of this study was to develop a reliable, validated disease-specific score measuring quality of life (QOL) in clinical practice and treatment trials in Neurofibromatosis 2 (NF2) individuals. In NF2 patients, qualitative interviews (n = 15) and a focus group session (n = 30) generated items for a pilot questionnaire. This was tested and refined (n = 20). The final version (NFTI-QOL) was validated (n = 50) with two generic QOL questionnaires (SF-36 and EuroQOL). The NFTI-QOL was also administered to patients with solitary vestibular schwannoma (SVS) (n = 30) and normal controls (n = 30). The participants were NF2 patients, SVS patients, and normal controls. NFTI-QOL score, SF-36 score, and EuroQOL score were the main outcome measures. Mean NFTI-QOL score was 9.4 (range: 0 to 20, maximum possible score = 24). The NFTI-QOL score correlated strongly with EuroQOL (r = 0.71, p < 0.001) and SF-36 (r = 0.81, p < 0.001). NF2 individuals were significantly worse than the SVS patients, who in turn were worse than the controls on the NIFTI-QOL. The NFTI-QOL showed good internal reliability (Cronbach''s α = 0.87). We developed an eight-item disease-specific QOL score for NF2 patients, validated against SF-36 and EuroQOL. It correlated strongly with clinician-rated disease severity in NF2, with better correlation than the SF-36 in this regard.     

Assessment of long-term quality of life after laparoscopic and open surgery for Crohn''s disease

OBJECTIVE: Surgery for Crohn's disease (CD) is associated with a high recurrence rate and quality of life (QOL) in these patients is controversial. The aim of this study was to assess QOL in patients after laparoscopic and open surgery for CD by two different validated instruments, a generic nonspecific score and a specific gastrointestinal QOL index. PATIENTS AND METHODS: Patients with CD who underwent elective laparoscopic or open ileocaecal resection with primary anastomosis between 1992 and 2000 were followed for recurrence and surgery-related complications. QOL was assessed by the SF-36 Health Survey containing a mental (MCS) and a physical (PCS) component summary score and by the Gastrointestinal Quality of Life Index (GIQLI) developed by Eypasch. RESULTS: Thirty-seven patients with a mean age of 48.8 +/- 18.4 years including 23 females and 14 males were evaluated at a mean follow-up of 42.6 +/-25.8 months (minimum of 8 months). Twenty-one (57%) patients underwent laparoscopic resection and 16 (43%) open surgery. Both groups were well matched for age, gender, ASA class and body mass index. Fourteen (38%) patients developed recurrent disease and 3 (8%) had postoperative incisional hernias. Overall, QOL scores were 103 +/- 26.8 for the GIQLI, 47.2 +/- 11.8 for the PCS, and 49.2 +/- 11.5 for the MCS. The GIQLI correlated well with the SF36, correlation coefficient = 0.68 for GIQLI vs PCS (95% CI, 0.41,0.95) and 0.67 for GIQLI vs MCS (95%CI, 0.39, 0.95), respectively. When compared to the general US population, mean GIQLI scores (-13.8, P = 0.002) and mean PCS scores (-4.7, P = 0.001) were significantly lower in these patients than in healthy individuals. In a multivariate analysis of impact factors on QOL, recurrence within the follow-up period was the single significant determinant reducing the PCS (-35.1, P = 0.026) and the GIQLI (-36.1, P = 0.018). CONCLUSION: QOL is significantly reduced in patients with CD at long-term follow-up after both laparoscopic and open surgery. Recurrence is the only factor adversely affecting QOL of CD patients in remission irrespective of the operative technique applied.     

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.     

Short and long term results of the laparoscopic Heller–Dor myotomy. The influence of age and previous conservative therapies

Aims To evaluate the long-term outcome and quality of life (QoL) data, and to assess the potential influence of age and different conservative procedures on laparoscopic surgery. Background Current therapies for achalasia can palliate dysphagia, but other symptoms may persist, making it difficult to quantify and compare. To understand if they could influence results, we analized short- and long-term results and correlated them to age and previous conservative treatments using a specific QoL test. Methods Functional examinations (endoscopy, 24-hr pH manometry, upper GI X-rays) and the gastrointestinal quality of life index (GIQLI) were used before and after a laparoscopic Heller–Dor myotomy. Data were analyzed by the Mann–Whitney U test, Wilcoxon signed rank test, and Spearman’s ρ coefficient for bivariate correlations (p < 0.05). Results From January 1996 to January 2004, 31 consecutive patients out of 35 diagnosed with achalasia, in clinical stages I–III, were operated on by laparoscopy . Two groups were identified using the break point of 70 years of age, (20 younger and 15 older) and two subgroups according to the conservative therapy performed (20, none; 15, some). Patients underwent a clinical manometry evaluation at six and 12 months, and then yearly, and pH-metry at six, 24, and 60 months. In 78% of patients dysphagia disappeared and the incidence of reflux was 13%. Age and previous treatments did not influence surgical outcome. Patients completed a GIQLI questionnaire before surgery, six months after surgery, and then yearly (for five years). The median preoperative GIQLI score was 78 (range 38–109) out of a theoretical maximum score of 144. At a median follow-up of 49 months (range 24–72 months), the score had significantly improved to 115 (range 71–140). There was no significant statistical difference between the groups. Conclusions Laparoscopic Heller–Dor myotomy is an effective palliation for achalasia; the long-term outcome is not significantly affected by preoperative conservative treatments or by the age of the patients. The GIQLI questionnaire is a reliable instrument to compare the impact of achalasia symptoms on health-related QoL before and after surgery.     

Can Dialysis Modality Influence Quality of Life in Chronic Hemodialysis Patients? Low-Flux Hemodialysis versus High-Flux Hemodiafiltration: A Cross-Over Study

Background: Hemodiafiltration with online preparation of the substitution [online high-flux hemodiafiltration (OHDF)] and hemodiafiltration with prepared bags of substitution (HDF) are important, recently widely used renal replacement therapies in patients with end-stage renal disease. However, there is little information on the comparative impacts of these modalities versus conventional low-flux hemodialysis (HD) on the quality of life (QoL) of HD patients. This study investigates the effect of dialysis modality on QoL in chronic HD patients. Methods: In this prospective, randomized, cross-over, open label study, 24 patients were enrolled. Their age were 62 ± 13.34 years (mean ± SD), with the duration of dialysis of 31 ± 23.28 months (mean ± SD). Five of the patients were women. QoL was measured by the Short-Form Health Survey with 36 questions (SF-36) and subscale scores were calculated. Each patient received HD, OHDF, and HDF for 3 months, with the dialysis modality subsequently being altered. They completed the questionnaire of QoL at the end of each period. Results: There were statistical significant differences in QoL for the total SF-36 [36.1 (26.7–45.7) and 40.7 (30.2–62.8)], for classic low-flux HD and high-flux hemodiafiltration, for bodily pain [45 (26.9–66.9) and 55 (35.6–87.5)], and for role limitations due to emotional functioning [0 (0–33.3) and 33.3 (0–100)], respectively. The scores did not differ significantly between the two types of hemodiafiltration. Conclusions: Our study indicates that QoL differs significantly among patients receiving low-flux HD and high-flux hemodiafiltration, on total SF-36, bodily pain, and role limitations due to emotional functioning. Convective modalities may offer better QoL than diffusive HD.     

Validation of the SF-36 as a measure of postoperative recovery after colorectal surgery

Introduction

Surgery is evolving, and new techniques are introduced to improve “recovery.” Postoperative recovery is complex, and evaluating the effectiveness of surgical innovations requires assessment of patient-reported outcomes. The Short-Form-36 (SF-36), a generic health-related quality of life questionnaire, is the most commonly used instrument in this context. The objective of this study was to contribute evidence for the validity of the SF-36 as a metric of postoperative recovery.

Methods

Data from 128 patients undergoing planned colorectal surgery at one university hospital between 2005 and 2010 were analyzed. In the absence of a gold standard, the responsiveness and construct validity (known groups and convergent) of the SF-36 were evaluated. Standardized response means were computed for the former and non-parametric tests were used to assess the statistical significance of the changes observed. Multiple linear regression was used to determine whether the SF-36 discriminates between patients with versus without complications and between laparoscopic and open surgery (known groups); correlations between the SF-36 and the 6-min walk test, a measure of functional walking capacity (convergent) was investigated with Spearman’s rank correlation.

Results

The SF-36 was sensitive to clinically important changes. Scores on six of eight domains and the physical component summary score deteriorated postoperatively (SRM 0.86 for the PCS, p < 0.01) and improved to baseline thereafter. Patients with complications had significantly lower scores on five SF-36 domains (with differences from ?9 (?18, ?1), p = 0.04 to ?18 (?32, ?2), p = 0.03), and scores on all subscales were lower than those in a healthy population (p < 0.01 to p = 0.04). The SF-36 did not differentiate between laparoscopic and open surgery. Physical functioning scores correlated with 6MWT distance at 1 and 2 months (Spearman’s r = 0.31 and 0.36, p < 0.01).

Conclusions

The SF-36 is responsive to expected physiological changes in the postoperative period, demonstrates construct validity, and thus constitutes a valid measure of postoperative recovery after planned colorectal surgery. The SF-36 did not, however, discriminate between recovery after laparoscopic and open surgery.