Patient-based Quality Research Articles

MOS Short Form 36 and Oswestry Disability Index outcomes in lumbar fusion: a multicenter experience

Background context Patient-based quality of life scales have become a critical element of post-op assessment for lumbar fusion surgery. The most extensive outcomes data have been generated through FDA-regulated IDE trials for new technologies, which produce excellent data but are constrained by strict enrollment criteria and limited indications. This raises a question as to whether the excellent results seen in these IDE trials can be reproduced in standard clinical practice. Purpose The purpose of this study was to analyze surgical results based upon standardized outcome tools, across a spectrum of interventions, for one- and two-level lumbar spine fusion procedures. Design/setting This study is a retrospective review of prospectively collected patient based outcomes data. Patient sample Four hundred ninety-seven patients, who underwent 1- or 2-level lumbar spine fusion at five participating spine centers, utilizing a variety of surgical techniques. Enrollment criteria included available demographic, surgical and clinical outcome data. At a minimum, patients had pre-op and one year post-op SF-36 data. In many cases two-year post-op SF-36 data and concomitant Oswestry Disability Index (ODI) data was available. Outcome measures SF36 and ODI. Methods The patient population included 270 females and 227 males, with a mean age of 47 years. Sixty-five percent (N=324) had one level fusions and 35% (N=173) had two level fusions. Demographic data collected included age, gender, BMI, surgical history, smoking history and work status. Data was analyzed with repeated measures analysis of variance (ANOVA). Results SF-36 Physical Composite Score (PCS) improved a mean 9.9 points at one year post-op and 9.5 points at two years post-op. ODI improved a mean 22.2 points at one year post-op and 22.1 points at two years post-op. SF-36 PCS data for surgical approach subgroups revealed greater improvement (p=.03) in the ALIF group as compared to the PSF, PLIF/TLIF, or 360° fusion groups (12.6 points vs. 8.8, 9.3, 8.4 points) at 1 year post-op. At 2 years post-op, there was greater improvement (p=.02) in the ALIF and PSF groups as compared to the PLIF/TLIF and 360° fusion groups (13.8 and 11.2 points vs. 7.7 and 6.3 points). SF-36 PCS data demonstrated similar baseline scores for patients with and without prior decompression, but a significantly greater rate of improvement (11.3 vs. 7.2 points, p=.002) for patients without prior lumbar decompression surgery. The ODI data indicated a significantly greater disability at baseline in the prior decompression group, with greater improvement (21.7 vs. 17.5 points) in patients without prior surgery. Conclusions This study documents improved outcomes, based on SF-36 and ODI scores, in patients undergoing lumbar fusion for one and two level degenerative disc disease. The findings also demonstrate efficacy for all of the surgical techniques studied, suggesting that surgeons can appropriately select the surgical strategy with which they are most adept.

Objective versus Subjective Outcomes Assessment in Rhinology

Prior studies on the relationship between computed tomography scan findings and patient-based quality of life in chronic rhinosinusitis (CRS) have found very low correlations. Whereas surprising, similarfindings have been noted in other diseases. We performed a cross-sectional analysis of the association between objective and subjective findings in nasal septal deformity and a systematic review and synthesis of the literature on CRS and other diseases. We found no association between objective anatomic findings and subjective symptoms in nasal obstruction (R = 0.03; Kruskal-Wallis test, p = 0.97). Multiple studies in CRS and other diseases-sleep apnea, hearing loss, asthma, etc.- have found similarly low correlations between objective and subjective testing. For nasal septal deviation and CRS, the patient's subjective perception of disease severity has, at best, a very weak association with objective assessment of severity. Patient-based outcomes assessment remains important; these instruments apparently quantify an aspect of disease not detected by objective testing.

Adjacent Two-Level Lumbar Discectomy

A retrospective outcomes study. To examine the outcome following adjacent two-level lumbar discectomy using both surgeon-based evaluation criteria and validated patient-based quality of life instrument (SF-36). Lumbar discectomies have documented success rates between 49% and 98% for single-level procedures. However, no prior study has specifically examined the outcome following adjacent two-level lumbar discectomy in a large series of patients. This study analyzed 55 patients with a minimum 2-year follow-up. All patients underwent adjacent two-level lumbar discectomy for radicular pain attributable to nerve root impingement at the corresponding levels. The patients were divided into two diagnostic groups based on their preoperative radiographic studies. Patients with two-level adjacent posterolateral lumbar disc herniations without concomitant osseous degenerative changes at the same levels constituted Group 1 (22 patients). Patients with associated osseous degenerative changes at the same levels made up Group 2 (33 patients). The patients' clinical outcome was assessed using the MacNab classification and SF-36 questionnaire. The average duration of follow-up was 41 months (range 24-96 months). The group consisted of 35 males and 20 females with average age of 49 years (range 19-82 years). Excellent results were observed in 49%, good in 20%, fair in 15%, and poor in 16%. However, patients in Group 1 have 86% excellent/good results, whereas patients in Group 2 have 57% excellent/good results. Overall, 15% of the patients required reoperation and subsequent spinal fusion. Analysis of the SF-36 scores revealed significant differences based on patient's diagnostic grouping as well. Patients in Group 1 have physical and mental summary scores comparable with age- and sex-adjusted population norms and significantly higher than those in Group 2 (P < 0.01). Two-level discectomy is an effective treatment with clinical outcome comparable with single-level discectomy. Patients with posterolateral disc herniations and definitive radiculopathy without osseous degenerative changes at the same levels have better clinical outcome and quality of life scores compared with those patients having concomitant degenerative arthritis at the same levels. Patients having two-level discectomy may be at increased risk of requiring subsequent lumbar fusion compared with those with single-level discectomy.

Factors associated with reintegration to normal living after subarachnoid hemorrhage.

Recent reports have suggested improvement in the last decade in global outcome measures after subarachnoid hemorrhage (SAH), particularly in patients presenting in good initial neurological status. We used a standardized self-report instrument, the Reintegration to Normal Living (RNL) Index, to assess a patient-based quality of life measure and a self-report of work status. We tested the hypothesis that several patient-based factors were related to these outcomes, including depressive symptoms, physical disability, age, and initial Hunt and Hess grade. Using these data, we report the total management morbidity and mortality at 1 to 5 years after SAH for patients initially presenting in good neurological condition. The study population consisted of 246 consecutive patients admitted to our tertiary care center with aneurysmal SAH in good neurological condition (Hunt and Hess Grades I-III). Patients underwent either surgical (92%), endovascular (7%), or medical (1 %) management of aneurysmal SAH. Eighty-three percent of surviving patients completed a written or telephone questionnaire incorporating the Barthel Index, the Zung Self-rating Depression Scale, the RNL Index, and a work status assessment. An aneurysm-related mortality rate of 6% was observed in the patient population. Fifty-five percent of patients reported a complete reintegration into their normal living situation, as measured by the RNL Index. Sixty-seven percent of previously full-time workers returned to a full-time status. Thirty-six percent of patients reported depressive symptoms, and 23% of patients reported physical disability. In a multivariate model, the two factors that contributed most to an impairment of reintegration were depression and physical disability, whereas a failure to return to work was related to older age and a higher-grade initial neurological status. In this series of patients undergoing multimodality management of lower-grade SAH, more than one-half of patients subsequently reported a normal reintegration into their social situation, as assessed by the RNL Index. Standardized assessments of cofactors associated with impaired reintegration revealed that depressive symptoms and physical disability played a strong role in overall reintegration. Standardized assessments, such as the RNL Index, offer the potential for improved comparison of different treatment regimens and specific therapeutic targeting of factors, such as depression, which contribute to decreased quality of life.

Performance evaluation and planning for patient-based quality control procedures.

In a recent publication, the effect of the length of time between the routine testing of quality-control (QC) samples on QC performance was studied using a newly proposed performance measure: the average number of patient samples that contain unacceptable analytic error due to an out-of-control error condition (ANPTE). We show that ANPTE also perfectly suits the evaluation of patient-based QC procedures. We used ANPTE to study the effect of the number of patient results averaged and the width of the truncation limits on an average of normals QC procedure. Estimates of ANPTE were obtained by using computer simulations that use actual patient result distributions. Based on ANPTE, the conclusions about the effects of truncation limits and number of patient results averaged on the performance of an average of normals QC procedure are substantially different from those described by others using the probability of error detection to characterize QC performance.

Using Qualitative and Quantitative Patient Satisfaction Data to Improve the Quality of Cardiac Care

In early 1993 leaders within the Hitchcock Clinic and cardiac services section at Dartmouth-Hitchcock Medical Center (Lebanon, NH) formed the Cardiac Services Improvement Group (CSIG) as a pilot program for patient-centered quality improvement (QI) at the sectional level. For open heart surgery (OHS) and percutaneous transluminal coronary angioplasty (PTCA), a flowchart was constructed of sequential patient experiences. Content analysis of focus group discussions resulted in six key patient-defined quality characteristics: comfort, caring, certainty, convenience, communication, and cost. Linking of patient comments to points on the patient experience flowchart made it possible to determine where particular quality characteristics were most relevant. A patient satisfaction survey with questions that were specific to a patient experience and to a quality characteristic was mailed to 100 consecutively discharged OHS and PTCA patients; 35 of the 50 patients in each group responded. Analysis of the survey results led to the formation of two QI teams. One team began work on development of a critical pathway for discharge preparation and identified marker questions to track and monitor pathway success in subsequent surveys. Another team began the development of protocols for more effective pain management during and after the PTCA procedure. A repeat patient satisfaction survey that took place from November 1994 to March 1995 suggested a global improvement in patient satisfaction for all patient experiences and all key quality characteristics. The CSIG pilot program of patients-based quality measurement and management at the sectional level has been successful in fostering QI team formation and has been associated with a positive deflection in patient-based quality measures. Additional sections of the medical center have initiated similar projects, beginning with process definition and focus groups.

Methodological and Statistical Problems in Sleep Apnea Research: The Literature on Uvulopalatopharyngoplasty

A comprehensive review of the literature on the surgical treatment of sleep apnea found 37 appropriate papers (total n = 992) on uvulopalatopharyngoplasty (UPPP). Methodological and statistical problems in these papers included the following: 1) There were no randomized studies and few (n = 4) with control groups. 2) Median sample size was only 21.5; thus statistical power was low and clinically important associations were routinely classified as "not statistically significant". 3) Only one paper presented the confidence bounds that might distinguish between statistical and clinical significance. 4) Because of short follow-up time and infrequent repeat follow-ups, little is known about whether UPPP results deteriorate with time. 5) In at least 15 papers, bias caused by retrospective designs and nonrandom loss to follow-up raised questions about the generalizability of results. 6) Few papers associated polysomnographic data with patient-based quality of life measures. 7) Missing data and missing and inconsistent definitions were common. 8) Baseline measures were often biased because the same assessment was inappropriately but routinely used for both screening and baseline. We conclude that because of these and other problems, there is much that is needlessly unknown about UPPP. It is the responsibility of the research and professional communities to define training, editorial and review procedures that will raise the methodological and statistical quality of published research.

Patient-based quality measurement systems

Continual improvement of health care can be accelerated and evaluated by the development of patient-based measurement systems. This article provides (1) design principles to guide the development of patient-based measurement systems; (2) a specific, yet flexible method for designing and testing patient-based measurement systems; and (3) real-world examples of patient-based systems that offer a glimpse of the future. These systems can provide direct measures of successes and failures, strengths and weaknesses, and improvements and declines in the provider's capacity to produce desired health outcomes at a cost that represents value.

Patient-based quality measurement systems

Patient-based quality measurement systems