Accuracy of surgical complication rate estimation using ICD-10 codes.

BACKGROUND: The ICD-10 codes are used globally for comparison of diagnoses and complications, and are an important tool for the development of patient safety, healthcare policies and the health economy. The aim of this study was to investigate the accuracy of verified complication rates in surgical admissions identified by ICD-10 codes and to validate these estimates against complications identified using the established Global Trigger Tool (GTT) methodology. METHODS: This was a prospective observational study of a sample of surgical admissions in two Norwegian hospitals. Complications were identified and classified by two expert GTT teams who reviewed patients' medical records. Three trained reviewers verified ICD-10 codes indicating a complication present on admission or emerging in hospital. RESULTS: A total of 700 admissions were drawn randomly from 12 966 procedures. Some 519 possible complications were identified in 332 of 700 admissions (47·4 per cent) from ICD-10 codes. Verification of the ICD-10 codes against information from patients' medical records confirmed 298 as in-hospital complications in 141 of 700 admissions (20·1 per cent). Using GTT methodology, 331 complications were found in 212 of 700 admissions (30·3 per cent). Agreement between the two methods reached 83·3 per cent after verification of ICD-10 codes. The odds ratio for identifying complications using the GTT increased from 5·85 (95 per cent c.i. 4·06 to 8·44) to 25·38 (15·41 to 41·79) when ICD-10 complication codes were verified against patients' medical records. CONCLUSION: Verified ICD-10 codes strengthen the accuracy of complication rates. Use of non-verified complication codes from administrative systems significantly overestimates in-hospital surgical complication rates.

Impact of the World Health Organization's Surgical Safety Checklist on safety culture in the operating theatre: a controlled intervention study.

BACKGROUND: Positive changes in safety culture have been hypothesized to be one of the mechanisms behind the reduction in mortality and morbidity after the introduction of the World Health Organization's Surgical Safety Checklist (SSC). We aimed to study the checklist effects on safety culture perceptions in operating theatre personnel using a prospective controlled intervention design at a single Norwegian university hospital. METHODS: We conducted a study with pre- and post-intervention surveys using the intervention and control groups. The primary outcome was the effects of the Norwegian version of the SSC on safety culture perceptions. Safety culture was measured using the validated Norwegian version of the Hospital Survey on Patient Safety Culture. Descriptive characteristics of operating theatre personnel and checklist compliance data were also recorded. A mixed linear regression model was used to assess changes in safety culture. RESULTS: The response rate was 61% (349/575) at baseline and 51% (292/569) post-intervention. Checklist compliance ranged from 77% to 85%. We found significant positive changes in the checklist intervention group for the culture factors 'frequency of events reported' and 'adequate staffing' with regression coefficients at -0.25 [95% confidence interval (CI), -0.47 to -0.07] and 0.21 (95% CI, 0.07-0.35), respectively. Overall, the intervention group reported significantly more positive culture scores-including at baseline. CONCLUSIONS: Implementation of the SSC had rather limited impact on the safety culture within this hospital.

Prevalence of bladder, bowel and sexual problems among multiple sclerosis patients two to five years after diagnosis.

Most multiple sclerosis (MS) patients experience some sexual, bladder and/or bowel dysfunction during the course of the disease--one of MS most disabling features. This study estimated the frequency of these problems among patients, two to five years after diagnosis, and investigated how these problems are associated with health-related quality of life (using the Multiple Sclerosis Quality of Life-54 questionnaire). The study population comprised a cohort of patients (n = 56), diagnosed in a three-year period, in Hordaland County, Norway. The patients were examined clinically, including scoring of the Expanded Disability Status Scale (EDSS), and completed questionnaires related to bowel and bladder dysfunction, sexual problems and health-related quality of life. More than half the patients had bladder and sexual problems. The frequency of self-reported bladder problems corresponded to the relatively high levels of residual urine found. The presence of these problems was associated with lower scores on the quality of life scales. Further, the bowel problems reported were markedly associated with the quality of life scores. Since treatments and preventive strategies can manage many of these problems, we suggest increasing the focus on these aspects of the disease when consulting patients, including at early stages.

Multiple sclerosis and lifestyle factors: the Hordaland Health Study.

This study compared multiple sclerosis (MS) patients (n=87) with the general population and with people reporting angina pectoris (n=109), asthma (n=1,353) and diabetes (n=219) regarding health-related quality of life (SF-12), working status and lifestyle factors including smoking, alcohol consumption, body mass index (BMI) and leisure physical activity. The study was cross-sectional and included the birth cohorts from 1950 to 1957 living in Hordaland County, Norway in 1997. A total of 22,312 people participated, yielding a response rate of 65%. The MS patients had a high rate of smoking and a low mean BMI, despite lower leisure physical activity compared with the rest of the study population. This suggests that it may be advisable to increase the focus on smoking, physical activity and the balance between energy intake and use.

The use of quality of life measures in multiple sclerosis research.

Quality of life research contributes knowledge essential to the health and healthcare of multiple sclerosis (MS) patients. This article reviews 83 MS studies in English that have presented data on quality of life. The studies may be classified into three categories, according to the application and the main focus: 1) evaluating the development and validity of quality of life questionnaires and clinical scales (n = 27); 2) evaluating factors that might influence the quality of life or comparing the quality of life among various groups (n = 37); and 3) using quality of life questionnaires as outcome measures in medical trials and other interventions (n = 19). The studies have shown that quality of life questionnaires more broadly measure the impact of MS than do the most frequently used measures of disease activity and effects. Using quality of life measures provides additional information in evaluating the effects of treatment and in studying the development of the disease. Such information is crucial in planning interventions for MS patients. A challenge in this field is to improve the study designs, including reaching some agreement on how to measure the quality of life.

Reduced quality of life among multiple sclerosis patients with sexual disturbance and bladder dysfunction.

OBJECTIVE: Physical disability explains only part of the reduced quality of life found among multiple sclerosis (MS) patients. Bladder dysfunction and sexual disturbance are frequent and distressing problems for MS patients. We therefore estimated the relationship between the presence and degree of sexual disturbance/bladder dysfunction and the patients' quality of life as measured by the SF-36 Health Survey. METHODS: We performed a cross-sectional study of all individuals with the onset of MS between 1976 and 1986 in Hordaland County, Norway. The disease duration at examination was 9-19 years; 194 patients (94%) participated. RESULTS: Fifty-three per cent of the patients with low physical disability (Expanded Disability Status Scale (EDSS) < or = 4.0) reported disease-related sexual disturbance and 44% had bladder dysfunction according to the Incapacity Status Scale. The corresponding figures for the patients with a high physical disability (EDSS > 4.0) were 86 and 81% respectively. The patients with sexual disturbance had markedly and significantly reduced scores on all eight SF-36 scales, this was after adjustment for disease development measured by the EDSS. The patients without sexual disturbance scored 0.5 s.d. lower than a normal population on the social functioning scale, whereas those with marked sexual disturbance scored 1.5 s.d. lower. Similar results were found for the patients with bladder dysfunction. CONCLUSION: Bladder and sexual problems are associated with a marked reduction in the quality of life, also among patients with otherwise low disability. This underlines the need for identifying and treating these problems.

Disability and prognosis in multiple sclerosis: demographic and clinical variables important for the ability to walk and awarding of disability pension.

OBJECTIVE: To evaluate disability and prognosis in an untreated population-based incidence cohort of multiple sclerosis (MS) patients. METHODS: The Expanded Disability Status Scale (EDSS) score was recorded in 220 MS patients. Disease progression was assessed by life table analysis with different endpoints and multivariate Cox regression analysis was performed for evaluation of prognostic factors. RESULTS: The probability of being alive after 15 years was 94.8 +/- 1.8% (s.e.), of managing without a wheelchair (EDSS < 7.0) 75.8 +/- 3.2%, of walking without walking assistance (EDSS<6.0) 60.3 +/- 3.6%, and of not being awarded a disability pension 46.0 +/- 3.7%. The probability of still having a relapsing-remitting (RR) course after 15 years was 62.0 +/- 4.1%. A RR course and long interval between the initial (onset) and second episode (> 3 years) predicted favorable outcome. There was also a trend towards favorable outcome in patients with optic neuritis, sensory symptoms and low age at onset but these factors were associated with the RR course. Motor symptoms and high age at onset indicated unfavorable outcome, but these factors were associated with the primary progressive course. CONCLUSIONS: A RR course and long inter-episode intervals in the early phase of the disease were associated with a better outcome. Other onset characteristics indicating a favorable outcome were associated with the RR course while characteristics indicating an unfavorable outcome were associated with the PP course.

Performance of the SF-36, SF-12, and RAND-36 summary scales in a multiple sclerosis population.

BACKGROUND: Multiple sclerosis (MS) patients accumulate both physical and mental health problems along with disease progression. Valid and sensitive outcome measures are important to measure disease effects and the effect of treatment. OBJECTIVE: The objective of this study was to test the performance of the physical and mental summary scales of SF-36, SF-12, and RAND-36. METHODS: The scales were evaluated by comparing the scores of a cohort of 194 MS patients with general population data and using the Expanded Disability Status Scale (EDSS) and the Incapacity Status Scale-mental as criterion variables for physical functioning and mental health. RESULTS: All 3 physical summary scales were markedly reduced and correlated highly with the EDSS. The SF-36 mental summary score was only slightly reduced among MS patients (0.2 SD) compared with the general population, despite significantly reduced scores on all 4 health scales being most related to mental health and despite a high prevalence of mental health problems. This results from the poor physical functioning (mean scale score, 2.3 SD below the general population) and the orthogonal factor rotation used to derive independent measures of physical and mental health. Similar results were found for the SF-12. The nonorthogonal RAND-36 physical and mental summary scores were both markedly reduced. This is more compatible with the disease progression in MS and the results of the other measures of physical and mental health used in the study. CONCLUSIONS: The SF-36 and SF-12 mental health summary scales appear to overestimate mental health in people with MS.

Quality of life as a predictor for change in disability in MS.

OBJECTIVE: To investigate the predictive value of quality of life on changes in disability measured by the Expanded Disability Status Scale (EDSS). BACKGROUND: There are few good prognostic factors for disease development in MS. Quality of life and self-rated health have been shown to be highly predictive of morbidity and disease development in heart disease and cancer. METHODS: Data on quality of life (SF-36 Health Survey) were ascertained at baseline for 97 relapsing-remitting patients with MS participating in a short-term clinical trial on interferon alpha-2a. These scores were correlated with change in EDSS scores 1 year later, 6 months after treatment ended. RESULTS: Low scores on the SF-36 mental health scale were correlated with increased (worsened) EDSS scores 1 year later (r = -0.29, p = 0.006). The results were not altered by adjusting for disease activity at baseline, which was measured by the number gadolinium-enhanced MRI lesions, relapse rate for the preceding 2 years, and baseline EDSS score. Similar results were found for self-rated health (according to the first question of the SF-36). CONCLUSIONS: These findings reinforce the importance of incorporating the patients' evaluation of their quality of life during treatment. Further, assessing such measures is important in evaluating effects in treatment trials in MS.

Type I interferons and the quality of life of multiple sclerosis patients. Results from a clinical trial on interferon alfa-2a.

The objective of the study was to examine whether the beneficial effect of treatment of interferon alfa-2a on multiple sclerosis seen by magnetic resonance imaging is reflected in a corresponding improvement in the quality of life (QoL) and to address the impact of adverse events related to this treatment on the QoL. The study was a randomised double-blinded placebo-controlled treatment trial including 97 relapsing-remitting multiple sclerosis patients. Thirty-two patients received 4.5 MIU recombinant interferon alfa-2a, 32 patients received 9.0 MIU recombinant interferon alfa-2a and 33 patients received placebo treatment for 6 months. All patients were followed up 6 months after end of treatment. QoL was assessed according to the eight scales of the SF-36 Health Survey and measured at baseline, month 3, 6 and 12. The effect found on MRI was not reflected in a corresponding change in the QoL. We found a relationship between the presence of new enhancing lesions and reduced QoL among the placebo patients, whereas this was not found among the patients treated with interferon. The presence of the adverse events fatigue, myalgia, headache and weakness were significantly negatively correlated to several of the QoL dimensions. Conclusively, the treatment with interferon alfa-2a does not seem to improve the patients' QoL after 6 months of treatment, in spite of a marked effect measured by MRI. The treatment is followed by adverse events that negatively affected the QoL.

Quality of life in multiple sclerosis: measuring the disease effects more broadly.

OBJECTIVE: To compare the Expanded Disability Status Scale (EDSS) and self-rated quality of life scores (SF-36 Health Survey) as measures of disease impact in a representative sample of MS patients. BACKGROUND: The EDSS is the most common outcome measure of impairment/disability for MS patients but is heavily weighted toward mobility. Sensitive outcome measures are needed that also capture other aspects of the effects of MS. METHODS: The authors performed a cross-sectional study of the cohort of all individuals with onset of MS between 1976 and 1986 who were diagnosed before 1995 in Hordaland County, Norway. A total of 194 patients (94%) participated. RESULTS: The patients had lower mean scores for all eight SF-36 health dimensions compared with sex- and age-adjusted scores in a general population. EDSS scores correlated highly with physical functioning (r = -0.86, R2 = 0.73), and explained some of the variation in social functioning (r = -0.48, R2 = 0.23) and general health (r = -0.46, R2 = 0.21) but little for the other dimensions. CONCLUSIONS: The SF-36 captures the broad effects of MS, and the results showed that patients also are bothered frequently with health problems such as bodily pain and low vitality. These problems, which are not reflected in the Expanded Disability Status Scale, should be given more attention in the treatment of MS and when evaluating interventions.

Interferon-alpha2a reduces MRI disease activity in relapsing-remitting multiple sclerosis. Norwegian Study Group on Interferon-alpha in Multiple Sclerosis.

OBJECTIVE: To evaluate the efficacy and safety of interferon-alpha2a (IFN-alpha2a) in relapsing-remitting MS (RRMS). BACKGROUND: Several immune-modulating therapy regimens of IFN-alpha have shown varying results in MS. A recent pilot study suggested benefits from IFN-alpha2a. METHODS: Ninety-seven patients were randomized to receive subcutaneous injections of placebo (33 patients) or 4.5 million international units (mIU) (32 patients) or 9.0 mIU (32 patients) of IFN-alpha2a three times weekly for 6 months, with a further 6 months of follow-up. Monthly gadodiamide-enhanced MRI was the primary method of evaluating efficacy. RESULTS: IFN-alpha2a treatment resulted in fewer new MRI lesions during the treatment period (p < 0.003). The probability of no new lesions during treatment was >2.5 times higher with 9.0 mIU IFN-alpha2a than with placebo (p < 0.005). The median number of lesions at the end of treatment was lower with IFN-alpha2a treatment than with placebo (p = 0.0004), but the difference disappeared during follow-up. The total number of lesions (mean) increased by 4.78 with placebo, 0.86 with 4.5 mIU IFN-alpha2a, and 0.28 with 9.0 mIU IFN-alpha2a during treatment (p = 0.030). No treatment effect on exacerbation rate, progression of disability, or quality of life was detected. Nine patients discontinued treatment, five because of adverse events. CONCLUSIONS: IFN-alpha2a treatment significantly reduced disease activity as measured by MRI, but the efficacy disappeared within 6 months after discontinuation of treatment. A long-term study of more patients using disability as a primary outcome measure is needed to evaluate the clinical impact.