Individualizing HbA1c targets for patients with diabetes: impact of an automated algorithm within a primary care network.

AIMS: To develop glycaemic goal individualization algorithms and assess potential impact on a healthcare system and different segments of the population with diabetes. METHODS: A cross-sectional observational study of patients with diabetes in a primary care network age > 18 years with an HbA1c measured between 1 January and 31 December 2011. We applied diabetes guidelines to create targeted algorithms 1 and 2, which assigned HbA1c goals based on age, duration of diabetes (< 15 years or < 10 years), diabetes complications and Charlson co-morbidity score (< 6 or < 4) [targeted algorithm 2 was designed to assign more patients a goal < 64 mmol/mol (8.0%) than targeted algorithm 1]. Each patient's HbA1c was compared with these targeted goals and to the 'standard' goal < 53 mmol/mol (7.0%). Agreement was tested using McNemar's test. RESULTS: Overall, 55.7% of 12 199 patients would be considered controlled under the 'standard' approach, 61.2% under targeted algorithm 1 and 67.5% under targeted algorithm 2. Targeted algorithm 1 reclassified 1213 (23.6%) patients considered uncontrolled under the standard approach to controlled, P < 0.001. Targeted algorithm 2 reclassified 1844 (35.2%) patients, P < 0.001. Compared with those controlled under the standard goal, there was no significant difference in the proportion of those controlled using targeted goals who had Medicaid, had less than a high school diploma or received primary care in a federally qualified health centre. CONCLUSIONS: Two automated targeted algorithms would reclassify one quarter to one third of patients from uncontrolled to controlled within a primary care network without differentially affecting vulnerable patient subgroups.

Processes of care, illness severity, and outcomes in the management of community-acquired pneumonia at academic hospitals.

BACKGROUND: Prompt antibiotic administration, oxygenation measurement, and blood cultures are generally considered markers of high-quality care in the inpatient management of community-acquired pneumonia (CAP). However, few studies have examined the relationship between prompt achievement of process-of-care markers and outcomes for patients with CAP. We examined whether antibiotic administration within 8 hours of hospital arrival, a blood culture within 24 hours, an oxygenation measurement within 24 hours, or performing blood cultures before giving antibiotics was associated with the following: (1) reaching clinical stability within 48 hours of hospital admission, (2) a decreased length of hospital stay, or (3) fewer inpatient deaths. METHODS: A retrospective medical record review identified 1062 eligible patients discharged from the hospital with a diagnosis of CAP between December 1, 1997, and February 28, 1998, among 38 US academic hospitals. We assessed the independent relationship between each process marker and the 3 clinical outcomes, controlling for the Pneumonia Severity Index on admission. We also examined the relationship of pneumonia severity on admission to process marker achievement and clinical outcomes. RESULTS: Overall, there was no consistent or statistically significant relationship between achieving process markers and better clinical outcomes (P>.40 for all). We did observe that performing blood cultures within 24 hours was related to not achieving clinical stability within 48 hours (odds ratio, 1.62; 95% confidence interval, 1.13-2.33). However, this finding likely reflects residual confounding by severity of illness, since increasing pneumonia severity on admission was associated with blood culture performance (P =.009) and with shorter times to antibiotic administration (P =.04). CONCLUSIONS: Achieving process-of-care markers was not associated with improved outcomes, but was related to the severity of pneumonia as assessed on admission. Our results highlight the difficulty in demonstrating a link between process-of-care markers and outcomes in observational studies of CAP. Randomized studies are needed to objectively evaluate the impact of process-of-care markers on CAP outcomes.

Surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: five-year outcomes from the Maine Lumbar Spine Study.

STUDY DESIGN: A prospective cohort study. OBJECTIVE: To assess 5-year outcomes for patients with sciatica caused by a lumbar disc herniation treated surgically or nonsurgically. SUMMARY OF BACKGROUND DATA: There is limited knowledge about long-term treatment outcomes of sciatica caused by a lumbar disc herniation, particularly the relative benefits of surgical and conservative therapy in contemporary clinical practice. METHODS: Eligible, consenting patients recruited from the practices of orthopedic surgeons, neurosurgeons, and occupational medicine physicians throughout Maine had baseline interviews with mailed follow-up questionnaires at 3, 6, and 12 months and annually thereafter. Clinical data were obtained at baseline from a physician questionnaire. Outcomes included patient-reported symptoms of leg and back pain, functional status, satisfaction, and employment and compensation status. RESULTS: Of 507 patients initially enrolled, 5-year outcomes were available for 402 (79.3%) patients: 220 (80%) treated surgically and 182 (78.4%) treated nonsurgically. Surgically treated patients had worse baseline symptoms and functional status than those initially treated nonsurgically. By 5 years 19% of surgical patients had undergone at least one additional lumbar spine operation, and 16% of nonsurgical patients had opted for at least one lumbar spine operation. Overall, patients treated initially with surgery reported better outcomes. At the 5-year follow-up, 70% of patients initially treated surgically reported improvement in their predominant symptom (back or leg pain) versus 56% of those initially treated nonsurgically (P < 0.001). Similarly, a larger proportion of surgical patients reported satisfaction with their current status (63% vs. 46%, P < 0.001). These differences persisted after adjustment for other determinants of outcome. The relative advantage of surgery was greatest early in follow-up and narrowed over 5 years. There was no difference in the proportion of patients receiving disability compensation at the 5-year follow-up. The least symptomatic patients at baseline did well regardless of initial treatment, although function improved more in the surgical group. CONCLUSIONS: For patients with moderate or severe sciatica, surgical treatment was associated with greater improvement than nonsurgical treatment at 5 years. However, patients treated surgically were as likely to be receiving disability compensation, and the relative benefit of surgery decreased over time.

Evaluating and managing acute low back pain in the primary care setting.

Acute low back pain is a common reason for patient calls or visits to a primary care clinician. Despite a large differential diagnosis, the precise etiology is rarely identified, although musculoligamentous processes are usually suspected. For most patients, back symptoms are nonspecific, meaning that there is no evidence for radicular symptoms or underlying systemic disease. Because episodes of acute, nonspecific low back pain are usually self-limited, many patients treat themselves without contacting their primary care clinician. When patients do call or schedule a visit, evaluation and management by primary care clinicians is appropriate. The history and physical examination usually provide clues to the rare but potentially serious causes of low back pain, as well as to identify patients at risk for prolonged recovery. Diagnostic testing, including plain x-rays, is often unnecessary during the initial evaluation. For patients with acute, nonspecific low back pain, the primary emphasis of treatment should be conservative care, time, reassurance, and education. Current recommendations focus on activity as tolerated (though not active exercise while pain is severe) and minimal if any bed rest. Referral for physical treatments is most appropriate for patients whose symptoms are not improving over 2 to 4 weeks. Specialty referral should be considered for patients with a progressive neurologic deficit, failure of conservative therapy, or an uncertain or serious diagnosis. The prognosis for most patients is good, although recurrence is common. Thus, educating patients about the natural history of acute low back pain and how to prevent future episodes can help ensure reasonable expectations.

Surgical and nonsurgical management of lumbar spinal stenosis: four-year outcomes from the maine lumbar spine study.

STUDY DESIGN: A prospective cohort study of patients with lumbar spinal stenosis recruited from the practices of orthopedic surgeons and neurosurgeons throughout Maine. OBJECTIVE: To assess 4-year outcomes for patients with lumbar spinal stenosis treated surgically or nonsurgically. SUMMARY OF BACKGROUND DATA: Surgery for lumbar spinal stenosis has increased dramatically despite the lack of randomized trials comparing surgical with nonsurgical treatments. Long-term evaluation of surgical series has documented deterioration in initial symptomatic improvement, but few studies have compared long-term outcomes of surgical and nonsurgical treatment. METHODS: Eligible, consenting patients had baseline interviews with mailed follow-up questionnaires at 3, 6, and 12 months, then annually thereafter. Clinical data were obtained at baseline from a physician questionnaire. Outcomes included patient-reported symptoms of leg and back pain, functional status, and satisfaction. RESULTS: Of 148 patients with lumbar spinal stenosis initially enrolled, 4-year outcomes were available on 119 patients (80.4%): 67 of 81 (83%) treated surgically and 52 of 67 (78%) treated nonsurgically. The surgically treated patients had more severe symptoms and worse functional status at baseline and better outcomes at 4-year evaluation than the nonsurgically treated patients. After 4 years, 70% of the surgically treated and 52% of the nonsurgically treated patients reported that their predominant symptom, either leg or back pain, was better (P = 0.05). Satisfaction of patients with their current state at 4 years was reported by 63% of the surgically treated and 42% of the nonsurgically treated patients (P = 0.04). Surgical treatment remained a significant determinant of 4-year satisfaction, even after adjustment for other independent predictors (P = 0.001). For the nonsurgically treated patients, there was no significant change in outcomes over 4 years, whereas the initial improvement seen in the surgically treated patients modestly decreased over the subsequent 4 years. CONCLUSIONS: For the patients with severe lumbar spinal stenosis, surgical treatment was associated with greater improvement in patient-reported outcomes than nonsurgical treatment at 4-year evaluation, even after adjustment for differences in baseline characteristics among treatment groups. The relative benefit of surgery declined over time but remained superior to nonsurgical treatment. Outcomes for the nonsurgically treated patients improved modestly and remained stable over 4 years. Determining whether outcomes continue to converge will require longer-term evaluation.

Long-term disability and return to work among patients who have a herniated lumbar disc: the effect of disability compensation.

BACKGROUND: Low-back problems are one of the most frequent reasons for disability compensation claims by workers. However, the effect of Workers' Compensation status on the long-term outcome for workers with sciatica has not been studied in detail, to our knowledge. Therefore, we believe that it is important to describe the long-term outcomes for patients who have herniation of a lumbar disc and sciatica according to the Workers' Compensation status at the time of the preoperative consultation. METHODS: We conducted a prospective, observational study of patients who had sciatica and were seeking care from specialist physicians in community-based practices throughout Maine. Among 440 eligible patients, 199 were receiving Workers' Compensation at the time of entry into the study (baseline) and 241 were not. Three hundred and twenty-six patients (74 percent) completed questionnaires at the time of a four-year follow-up. The outcomes that we assessed included disability compensation and work status as well as relief from symptoms, functional status, and quality of life. RESULTS: Patients who were receiving Workers' Compensation at baseline were more likely to be young, male, and employed as laborers. They reported worse functional status; however, the clinical findings for these patients were similar to those for patients who were not receiving Workers' Compensation. Patients who had been receiving Workers' Compensation at baseline were more likely to be receiving disability benefits at the time of the four-year follow-up compared with those who had not (27 percent of 133 compared with 7 percent of 189; p<0.001); however, they were only slightly less likely to be working at the time of the four-year follow-up (80 percent of 133 compared with 87 percent of 190; p = 0.09). Operative management did not influence these comparisons, but it decreased symptoms and improved functional status. Patients who had been receiving Workers' Compensation at baseline also had significantly less relief from symptoms and improvement in quality of life than patients who had not been receiving Workers' Compensation (all p<0.001). In multivariate models, Workers' Compensation status at baseline was an independent predictor of whether the patient would be receiving disability benefits after four years (odds ratio, 3.5; 95 percent confidence interval, 1.7 to 7.6) but was not an independent predictor of whether the patient would be working on a job for pay at the time of the four-year follow-up (odds ratio, 0.6; 95 percent confidence interval, 0.3 to 1.2). CONCLUSIONS: Even after adjustment for the initial treatment of the sciatica and for other clinical factors, patients who had been receiving Workers' Compensation at baseline were more likely to be receiving disability benefits and were less likely to report relief from symptoms and improvement in quality of life at the time of the four-year follow-up than patients who had not been receiving Workers' Compensation at baseline. Nonetheless, most patients returned to work regardless of their initial disability status, and those who had been receiving Workers' Compensation at baseline were only slightly less likely to be working after four years. Whether or not they had been receiving Workers' Compensation at baseline, patients who had been managed with an operation reported greater relief from symptoms and improvement in functional status at the time of the four-year follow-up compared with patients who had been managed nonoperatively, even though the outcomes with regard to disability and work status in these two groups were comparable.

Understanding physician adherence with a pneumonia practice guideline: effects of patient, system, and physician factors.

BACKGROUND: Adherence with clinical practice guidelines is highly variable. Reasons for their inconsistent performance have not been well studied. OBJECTIVE: To determine the patient, system, and physician factors that may explain why physicians may not follow guidelines. METHODS: We used chart review and physician surveys to measure adherence with an actively implemented guideline to reduce hospitalizations for patients coming to the emergency department with community-acquired pneumonia. Logistic regression analyses were used to identify factors associated with guideline nonadherence. RESULTS: Overall nonadherence with the guideline was 43.6%, with 71 of 163 low-risk patients with pneumonia being hospitalized despite the recommendation for outpatient therapy. In univariate analyses, nonadherence to the guideline was more likely for patients who were aged 65 years or older, were male, were employed, and had multilobar disease or other comorbid conditions (P<.05). Active involvement of a primary care physician in the admission decision also increased nonadherence (odds ratio, 4.9; 95% confidence interval, 2.2-11.0). Physicians with more pneumonia experience were more likely not to follow the guideline (P<.001). In multivariate models, the odds of nonadherence were 2 to 3 times greater when patients were 65 years or older, were male, or had multilobar disease, or the primary care physician was involved in the triage decision (P<.05). Physicians' reasons for admission were the presence of active comorbidities (55%), the primary care physician's wish for hospitalization (41%), the presence of worse pneumonia than the guideline indicated (36%), patient preference (17%), and inadequate home support (16%). CONCLUSIONS: Nonadherence to a pneumonia guideline was associated with a variety of patient, system, and physician factors. Guideline implementation strategies should take into account the heterogeneous forces that can influence physician decision making.

Change in physician knowledge and attitudes after implementation of a pneumonia practice guideline.

OBJECTIVE: To assess physicians' response to implementation of an emergency department (ED) pneumonia practice guideline and determine if the guideline changed physicians' knowledge and attitudes about pneumonia care. DESIGN: Prospective intervention study with cross-sectional and longitudinal physician surveys. SETTING: An urban, university teaching hospital ED. PARTICIPANTS: One hundred forty physicians who were responsible for the triage of at least one of 166 patients presenting to the ED with community-acquired pneumonia. MEASUREMENTS: Physician characteristics, attitudes about pneumonia care and guidelines, and ratings of guideline helpfulness and effects on patient care were obtained by self administered questionnaire before, during, and after a yearlong intervention. MAIN RESULTS: More than 73% of the physicians reported the guideline as helpful and more than 94% wanted it to be continued in the future. Most reported that the guideline would decrease costs and improve quality without any increase in adverse outcomes. Two thirds said they were more likely to treat patients with pneumonia as outpatients in the future because of the guideline. Among the 58 physicians with matching preintervention and postintervention survey data, the guideline decreased the beliefs that "all patients> 65 years old with pneumonia should be admitted," from 52% to 14% ( p <. 001), and that "patients with pneumonia have a> 15% mortality rate," from 11% to 5% ( p <.007). The intervention did not significantly change general attitudes about practice guidelines. House officers rated the guideline as more helpful than attending physicians ( p <. 02). CONCLUSIONS: This locally developed, actively implemented guideline was well regarded by physicians. Guidelines can change practice and also alter underlying knowledge and attitudes about disease management. They may be most useful to those with less experience.

Relationship between rates and outcomes of operative treatment for lumbar disc herniation and spinal stenosis.

BACKGROUND: Population-based variations in rates of operations for the treatment of lumbar disc herniation and spinal stenosis are well known. This variability may occur in part because of differences in the threshold at which physicians recommend an operation, reflecting uncertainty about the optimum use of an operative procedure. To the best of our knowledge, no previous reports have indicated whether differences in population-based rates of operative treatment are associated with patient outcomes. METHODS: The Maine Lumbar Spine Study is an ongoing prospective study of 655 patients who had a herniated lumbar disc or spinal stenosis. The patients were enrolled by their physicians, who provided baseline demographic and treatment-related data. The patients completed baseline and follow-up questionnaires that focused on symptoms, function, satisfaction, and quality of life. Small-area variation analysis was used to develop three distinct so-called spine service areas in Maine. The outcomes (usually at four years; minimum, two years) were compared among these areas, in which a total of 250 patients had been managed operatively and had answered questionnaires. RESULTS: Population-based rates of operative treatment derived from statewide data that had been collected over five years in the state of Maine ranged from 38 percent below to 72 percent above the average rate in the state (a greater than fourfold difference). The outcomes for the patients who had been managed by surgeons in the lowest-rate area were superior to those for the patients in the two higher-rate areas. Seventy-nine percent (fifty-seven) of seventy-two patients in the lowest-rate area had marked or complete relief of pain in the lower extremity compared with 60 percent (eighteen) of thirty patients in the highest-rate area. The improvements in the Roland disability score (p < or = 0.01), quality of life (p < or = 0.01), and satisfaction (p < or = 0.05) were significantly greater among the patients in the lowest-rate area. The patients in the higher-rate areas generally had less severe symptoms and findings at baseline than those in the lowest-rate area did. CONCLUSIONS: Higher population-based rates of elective spinal operations may be associated with inferior outcomes. This variability is possibly related to differences in physicians' preferences with regard to recommending an operation and in their criteria for the selection of patients. Physicians cannot assume that their outcomes will be the same as those of others, and therefore they need to evaluate their own results.

The relation between expectations and outcomes in surgery for sciatica.

OBJECTIVE: To describe the expectations that patients and their physicians have for outcomes after surgical treatment for sciatica and to examine the associations between expectations and outcomes. DESIGN: Prospective cohort study. SETTING/PATIENTS: We recruited 273 patients, from the offices of orthopedic surgeons, neurosurgeons, and occupational medicine physicians in Maine, who had diskectomy for sciatica. MEASUREMENTS AND MAIN RESULTS: Patients' and physicians' expectations were measured before surgery. Satisfaction with care and changes in symptoms and functional status were measured 12 months after surgery. More patients who expected a shorter recovery tJgie after surgery were "delighted," "pleased," or "mostly satisfied" with their outcomes 12 months after surgery than patients who expected a longer recovery tJgie (odds ratio [OR] 2.2; 95% confidence interval [CI] 1.1, 4.4). Also, more patients who preferred surgery after learning that sciatica could get better without surgery had good symptom scores 12 months after surgery than patients who did not prefer surgery (OR 2.9; 95% CI 1.2, 7.0). When physicians predicted a "great deal of Jgiprovement" after surgery, 39% of patients were not satisfied with their outcomes and 25% said their symptoms had not Jgiproved. CONCLUSIONS: More patients with favorable expectations about surgery had good outcomes than patients with unfavorable expectations. Physicians' expectations were overly optJgiistic. Patient expectations appear to be Jgiportant predictors of outcomes, and eliciting them may help physicians identify patients more likely to benefit from diskectomy for sciatica.

Safely increasing the proportion of patients with community-acquired pneumonia treated as outpatients: an interventional trial.

BACKGROUND: Patients with community-acquired pneumonia who are at low risk for short-term mortality can be identified using a validated prediction rule, the Pneumonia Severity Index. Such patients should be candidates for outpatient treatment, yet many are hospitalized. OBJECTIVE: To assess a program to safely increase the proportion of low-risk patients with pneumonia treated at home. METHODS: The intervention provided physicians with the Pneumonia Severity Index score and corresponding mortality risk for eligible patients and offered enhanced visiting nurse services and the antibiotic clarithromycin. Prospectively enrolled, consecutive low-risk patients with pneumonia presenting to an emergency department during the intervention period (n = 166) were compared with consecutive retrospective controls (n = 147) identified during the prior year. A second group of 208 patients from the study hospital who participated in the Pneumonia Patient Outcomes Research Team cohort study served as controls for patient-reported measures of recovery. RESULTS: There were no significant baseline differences between patients in the intervention and control groups. The percentage initially treated as outpatients increased from 42% in the control period to 57% in the intervention period (36% relative increase; 95% confidence interval, 8%-72%; P = .01). However, more outpatients during the intervention period were subsequently admitted to the study hospital (9% vs 0%). When any admission to the study hospital within 4 weeks of presentation was considered, there was a trend toward more patients receiving all their care as outpatients in the intervention group (42% vs 52%; 25% relative increase; 95% confidence interval -2% to 59%; P = .07). No patient in the intervention group died in the 4-week follow-up period. Symptom resolution and functional status were not diminished. Satisfaction with overall care was similar, but patients treated in the outpatient setting during the intervention were less frequently satisfied with the initial treatment location than comparable control patients (71% vs 90%; P = .04). CONCLUSIONS: Use of a risk-based algorithm coupled with enhanced outpatient services effectively identified low-risk patients with community-acquired pneumonia in the emergency department and safely increased the proportion initially treated as outpatients. Outpatients in the intervention group were more likely to be subsequently admitted than were controls, lessening the net impact of the intervention.

Time course of symptom resolution in patients with community-acquired pneumonia.

The majority of patients with community-acquired pneumonia are at low risk for short-term mortality or serious morbidity and are increasingly managed in the outpatient setting. Efforts to improve the quality of care for these patients will need to measure patient outcomes such as disease-specific symptom resolution. The aims of this study were to (1) develop a self-administered daily version of a symptom questionnaire for patients with pneumonia, (2) measure the reliability of this instrument, and (3) provide estimates for recovery rates based on symptom resolution in a cohort of low-risk patients with community-acquired pneumonia. This study was conducted as part of a prospective study of a new emergency department protocol for pneumonia at the Massachusetts General Hospital. Eligible study subjects included all adult patients with pneumonia presenting to the emergency department with a predicted low risk of short-term mortality. The main outcome measures were based on a new five item symptom questionnaire which rates the severity of cough, fatigue, dyspnea, myalgia, and fever. The questionnaires were self-administered on days 0-7, 14, 21 and 28 from the time of diagnosis of pneumonia. The symptom questions were also administered during patient interviews on days 0, 7, 14 and 28 in order to assess the questionnaire's reliability. Of the 166 eligible patients, 134 (81%) consented to participate in this study. The mean intra-class reliability coefficient of the symptom questionnaire was 0.75. The median times to resolution of individual symptoms ranged from 3 days for fever to 14 days for cough and fatigue. Thirty-five percent of patients had at least one symptom still present at the end of the 28-day study period. We found that a daily self-report questionnaire is a reliable measure of symptom resolution for patients with pneumonia. Full resolution of symptoms takes more than 28 days for a significant proportion of patients with pneumonia.

Classics from the spine literature revisited: a randomized trial of 2 versus 7 days of recommended bed rest for acute low back pain.

STUDY DESIGN: Review of a trial of bed rest for patients with acute low back pain. OBJECTIVES: To assess the validity and results of the study, and their applicability to and influence on current clinical practice and recommendations. SUMMARY OF BACKGROUND DATA: Although bed rest has been a cornerstone of treatment for acute low back pain, historically this recommendation was largely based on "expert opinion." In 1986, Deyo et al. published a randomized study of 2 versus 7 days of recommended bed rest for acute low back pain. Despite results from this and other studies, current clinical practice and treatment recommendations continue to overemphasize bed rest. METHODS: The study was reviewed using structured criteria adopted from the medical literature that focus on the validity of the study design, the results of the treatment, and the relevance of the findings to clinical practice. RESULTS: Two hundred and three patients were randomized to 2 versus 7 days of recommended bed rest. Groups were similar at baseline evaluation. Outcomes assessed at 3 and 12 weeks were similar between groups, except that patients receiving a recommendation for 2 days of bed rest had significantly fewer days of work absence than those recommended 7 days. Limitations of the study included poor compliance with recommended bed rest, especially in the 7-day group, a marginal sample size without information on relevant confidence intervals, and patient characteristics that may have affected the generalizability of these findings to others with acute low back pain. CONCLUSIONS: Despite limitations, this study provided strong evidence that less bed rest was associated with similar outcomes for acute low back pain along with quicker return to work. Results from this and other studies support a shift away from bed rest as a primary recommendation in the initial management of low back pain. In spite of this, bed rest recommendations for episodes of low back pain remain common. Additional efforts are needed to change clinical practice.

The Quebec Task Force classification for Spinal Disorders and the severity, treatment, and outcomes of sciatica and lumbar spinal stenosis.

STUDY DESIGN: A prospective cohort study of patients in Maine with sciatica and lumbar spinal stenosis treated surgically and nonsurgically. SUMMARY OF BACKGROUND DATA: In 1987, the Quebec Task Force on Spinal Disorders proposed a diagnostic classification to help make clinical decisions, evaluate quality of care, assess prognosis, and conduct research. OBJECTIVES: To assess the Quebec Task Force classification's ability to stratify patients according to severity and treatment at baseline, and to assess changes over time in health-related quality of life, including symptoms, functional status, and disability. METHODS: Five hundred sixteen patients participating in the Maine Lumbar Spine Study who completed baseline and 1-year follow-up evaluations were classified successfully according to the Quebec Task Force classification. Patient characteristics and treatments were compared across Quebec Task Force classification categories. Changes in health-related quality of life over 1 year were assessed according to Quebec Task Force classification category and type of treatment. RESULTS: Among patients with sciatica (n = 370), higher Quebec Task Force classification categories (from 2, pain radiating to the proximal extremity, to 6, sciatica with evidence of nerve root compression) were associated with increased severity of symptoms at baseline. There was no association between Quebec Task Force classification and baseline functional status. Quebec Task Force classification was associated strongly with the likelihood of receiving surgical treatment (P < or = 0.005). Among patients with sciatica treated nonsurgically, improvement at 1 year in back-specific and generic physical function increased with higher Quebec Task Force classification category (P < or = 0.05). Only a nonsignificant trend was observed for surgically treated patients. Patients with lumbar spinal stenosis (Quebec Task Force classification 7, n = 131) had baseline features and outcomes distinct from patients with sciatica. CONCLUSIONS: For patients with sciatica, the Quebec Task Force classification was highly associated with the severity of symptoms and the probability of subsequent surgical treatment. Nonsurgically treated patients in Quebec Task Force classification categories reflecting nerve root compression had greater improvement than those with pain symptoms alone. Among surgical patients, the Quebec Task Force classification was not associated with outcome. These results provide validation for the classification and its wider adoption. Nonetheless, improved diagnostic classifications are needed to predict outcomes better in patients with sciatica who undergo surgery.

The Maine Lumbar Spine Study, Part I. Background and concepts.

STUDY DESIGN: This paper describes the background and factors that led to the development and implementation of the Maine Lumbar Spine Study, a prospective cohort study of patients undergoing surgical and nonsurgical treatment of herniated lumbar disc with sciatica and symptomatic spinal stenosis. OBJECTIVES: To define the factors leading to the study and the methods of designing and implementing a community-based effectiveness study to evaluate the outcomes of herniated lumbar intervertebral disc and spinal stenosis. SUMMARY OF BACKGROUND DATA: Variations in the utilization of surgery for these conditions and physicians' uncertainty regarding the best way to manage them resulted in support of a community-based study of the effectiveness of treatment alternatives. METHODS: A prospective cohort design was used. Methods of patient enrollment, data collection, management, and analysis are described. An innovative method of ascertaining the representativeness of the enrolled versus nonenrolled patient population is presented. RESULTS: The importance of developing community-based networks of physicians is discussed. CONCLUSIONS: These networks play an important role in analyzing practice pattern variations and in stimulating and participating in effectiveness research. Because effectiveness studies must be conducted at the community level, mechanisms must be developed with which to support and implement these efforts.

The Maine Lumbar Spine Study, Part II. 1-year outcomes of surgical and nonsurgical management of sciatica.

STUDY DESIGN: The Maine Lumbar Spine Study is a prospective cohort study of patients recruited from the practices of orthopedic surgeons, neurosurgeons, and occupational medicine physicians throughout Maine. OBJECTIVE: To assess 1-year outcomes of patients with sciatica believed to be due to a herniated lumbar disc treated surgically or nonsurgically. SUMMARY OF BACKGROUND DATA: Lumbar spine surgery rates vary by geographic region and may reflect uncertainty about optimal clinical use. METHODS: Eligible consenting patients participated in a baseline interview performed by study personnel and then were mailed follow-up questionnaires at 3, 6, and 12 months. Clinical data were obtained from a physician questionnaire. Outcomes included patient-reported symptoms of leg and back pain, functional status, disability, quality of life, and satisfaction with care. RESULTS: Five hundred seven patients with sciatica, 275 treated surgically and 232 treated nonsurgically initially, were enrolled. Surgically treated patients, on average, had more severe symptoms and had more severe physical and imaging findings than nonsurgically treated patients at entry. Although few surgically treated patients had mild symptoms and few nonsurgically treated patients had severe symptoms, about half in each treatment group had symptoms that fell into a moderate category. At the 1-year evaluation, improvement in symptoms, functional status, and disability were found in both treatment groups. However, surgically treated patients reported significantly greater improvement. For the predominant symptom, either back or leg pain, 71% of surgically treated and 43% of nonsurgically treated patients reported definite improvement (P < 0.001). This effect was even greater after adjustment for differences between treatment groups at entry (relative odds of definite improvement, 4.3; P < 0.001). For patients with moderate symptoms and abnormal physical examination findings, surgical treatment also resulted in greater improvement than nonsurgical treatment. However, there was little difference in the employment or workers' compensation status of patients treated surgically versus nonsurgically (5% vs. 7% unemployed at 1-year follow-up if employed at entry [P = 0.68]; 46% vs. 55% receiving workers' compensation at 1-year follow-up if receiving it at entry [P = 0.30] for surgical and nonsurgical management, respectively). For patients with mild symptoms, the benefits of surgical and nonsurgical treatment were similar. CONCLUSIONS: Although surgically treated patients were on average more symptomatic at entry, there was substantial overlap in symptoms between surgically treated and nonsurgically treated patients. Surgically treated patients with sciatica reported substantially greater improvement at 1-year follow-up. However, employment and compensation outcomes were similar between the two treatment groups, and surgery appeared to provide little advantage for the subset of patients with mild symptoms. These results should be interpreted cautiously, because surgical treatment was not assigned randomly. Long-term follow-up will determine if these differences persist.

The Maine Lumbar Spine Study, Part III. 1-year outcomes of surgical and nonsurgical management of lumbar spinal stenosis.

STUDY DESIGN: A prospective cohort study of patients with lumbar spinal stenosis recruited from the practices of orthopedic surgeons and neurosurgeons throughout Maine. OBJECTIVE: To assess 1-year outcomes of patients with lumbar spinal stenosis treated surgically or nonsurgically. SUMMARY OF BACKGROUND DATA: No randomized trials and few nonexperimental studies have compared surgical and nonsurgical treatment of patients with lumbar spinal stenosis. The authors' goal was to assess 1-year outcomes of patients with lumbar spinal stenosis treated surgically or nonsurgically. METHODS: Eligible, consenting patients participated in baseline interviews and were then mailed follow-up questionnaires at 3, 6, and 12 months. Clinical data were obtained from a physician questionnaire. Outcomes included patient-reported symptoms of leg and back pain, functional status, disability, and satisfaction with care. RESULTS: One hundred forty-eight patients with lumbar spinal stenosis were enrolled, of whom 81 were treated surgically and 67 treated nonsurgically. On average, patients in the surgical group had more severe imaging findings and symptoms and worse functional status than patients in the nonsurgical group at entry. Few patients with mild symptoms were treated surgically, and few patients with severe symptoms were treated nonsurgically. However, of the patients with moderate symptoms, a similar percent were treated surgically or nonsurgically. One year after study entry, 28% of nonsurgically and 55% of surgically treated patients reported definite improvement in their predominant symptoms (P = 0.003). For patients with moderate symptoms, outcomes for surgically treated patients were also improved compared with those of nonsurgically treated patients. Surgical treatment remained a significant determinant of 1-year outcome, even after adjustment for differences between treatment groups at entry (P = 0.05). The maximal benefit of surgery was observed by the time of the first follow-up evaluation, which was at 3 months. Although few nonsurgically treated patients experienced a worsening of their condition, there was little improvement in symptoms and functional status compared with study entry. CONCLUSIONS: At a 1-year evaluation of patient-reported outcomes, patients with severe lumbar spinal stenosis who were treated surgically had greater improvement than patients treated nonsurgically. Comparisons of outcomes by treatment received must be made cautiously because of differences in baseline characteristics. A determination of whether the outcomes observed persist requires long-term follow-up.

Application of outcomes research in occupational low back pain: the Maine Lumbar Spine Study.

Outcomes research represents an expansion of traditional clinical research to include issues of cost and quality of care in usual clinical practice, emphasizing outcomes that matter most to patients. In low back disorders, outcomes research has focused on the lack of reliable information to support much of clinical practice and has demonstrated marked variability in the treatment of these common problems. The Maine Lumbar Spine Study represents an example of an outcomes research study to investigate the treatment of patients with sciatica in usual clinical practice. Because low back symptoms are a frequent cause of occupational disability, Workers' Compensation patients were explicitly oversampled. Baseline features were significantly different in those patients who were receiving Workers' Compensation versus those who were not. Efforts to compare outcomes by disability status need to control for these differences. Whereas most Workers' Compensation patients were still receiving disability compensation regardless of treatment at 6 months, patients who were treated surgically were more likely to have come off disability and returned to work than nonsurgically treated patients. Long-term follow-up is necessary to determine whether these differences persist.