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.

Dihydrocytochalasin B. Biological effects and binding to 3T3 cells.

Dihydrocytochalasin B (H2CB) does not inhibit sugar uptake in BALB/c 3T3 cells. Excess H2CB does not affect inhibition of sugar uptake by cytochalasin B (CB), indicating that it does not compete with CB for binding to high-affinity sites. As in the case of CB, H2CB inhibits cytokinesis and changes the morphology of the cells. These results demonstrate that the effects of CB on sugar transport and on cell motility and morphology involve separate and independent sites. Comparison of the effects of H2CB, CB, and cytochalasin D (CD) indicates that treatment of cells with any one of the compounds results in the same series of morphological changes; the cells undergo zeiosis and elongation at 2-4 microM CB and become arborized and rounded up at 10-50 microM CB. H2CB is slightly less potent than CB, whereas CD is five to eight times more potent than CB in causing a given state of morphological change. These results indicate that the cytochalasin-induced changes in cell morphology are mediated by a specific site(s) which can distinguish the subtle differences in the structures of the three compounds. Competitive binding studies indicate that excess H2CB displaces essentially all of the high-affinity bound [3H]CB, but, at less than 5 x 10(-5) M H2CB is not so efficient as unlabeled CB in the displacement reaction. In contrast, excess CD displaces up to 40% of the bound [3H]CB. These results suggest that three different classes of high-affinity CB binding sites exist in 3T3 cells: sites related to sugar transport, sites related to cell motility and morphology, and sites with undetermined function.

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.

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.

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.

Are ovarian steroids required for ovum maturation and fertilization? Effects of cyanoketone on the in vitro perfused rabbit ovary.

An isolated perfused rabbit ovary preparation was used to determine the effects of cyanoketone, a potent inhibitor of 3 beta-hydroxysteroid dehydrogenase, on ovulation, ovum maturation and fertilizability, and steroid production. In the first experiment, cyanoketone (10(-4) M) was added to the perfusate of one ovary. The contralateral control ovary was perfused with medium alone. Thirty minutes after the onset of perfusion, hCG (50 IU) was added to the perfusate of both ovaries. The ovulatory efficiency of ovaries treated with cyanoketone plus hCG (82.3 +/- 4.6%) was similar to that of ovaries treated with hCG alone (84.8 +/- 4.4%). No difference was observed in the degree of ovum maturity or degeneration between control and cyanoketone-treated ovaries. Progesterone and estradiol production were significantly reduced by cyanoketone treatment; concentrations in the perfusate of ovaries treated with cyanoketone were 9.7% and 8.0% of the control values, respectively, 2 h after exposure to hCG. The concentration of 17-hydroxypregnenolone was not affected by cyanoketone treatment. Exposure to cyanoketone resulted in a significant (P less than 0.005) reduction in the fertilizability of ova ovulated and fertilized in vitro. In the second experiment, the percentage of ova that showed evidence of normal fertilization was significantly (P less than 0.025) increased in ovaries perfused with cyanoketone plus estradiol (64.5%) compared to that in ovaries perfused with cyanoketone alone (32.4%). In the third experiment, the addition of progesterone to the perfusate did not affect fertilizability of ovulated ova in ovaries perfused with cyanoketone plus estradiol. These results suggest that the presence of estradiol in the ovarian steroid environment may be essential for fertilizability of ova, but not for the processes of ovulation or meiotic maturation.

Epidermal growth factor inhibits follicular response to human chorionic gonadotropin: possible role of cell to cell communication in the response to gonadotropin.

Epidermal growth factor (EGF) affects follicular steroidogenesis and expression of gonadotropin receptors. The effects of EGF on hCG-induced estradiol and progesterone secretion and ovulation were examined in the in vitro perfused rabbit ovary. We also examined the effects of EGF on hCG-induced progesterone secretion by isolated granulosa cells. In addition, distribution of hCG within the follicle was probed by immunohistochemical means 30 min after its administration to the in vitro perfused ovary. EGF significantly (P less than 0.05) reduced hCG-induced secretion of estradiol (control, 117 +/- 12 pg/min.follicle; 10 ng/ml EGF, 55 +/- 10) and progesterone (control, 18.2 +/- 1.2 ng/min.follicle; 10 ng/ml EGF, 11.9 +/- 0.8) by the perfused ovary. In contrast, EGF did not inhibit hCG-induced progesterone secretion by isolated granulosa cells. Ovulatory efficiency (number of ovulated ova per number of mature follicles x 100) when EGF was given 30 min before hCG was reduced dose-dependently from 58.2% with no EGF to 8.3% with 10 ng/ml EGF (P less than 0.001). Ovulation was not inhibited by EGF when it was given 30 min after hCG. Distribution of hCG in the preovulatory follicle was confined to the basement membrane, thecal cell layer, and a small fraction of the outer granulosa cell layer. These observations suggest that gonadotropin stimulates the follicle through the release of a secondary signal(s) from ligand-bound granulosa cells near the follicle wall to unexposed cells of the inner avascular area. EGF may inhibit the follicular response to hCG by attenuation of this cell to cell communication.

The effects of bradykinin on ovulation and prostaglandin production by the perfused rabbit ovary.

Involvement of the vasoactive peptide bradykinin (BK) in ovulation, oocyte maturation, and prostaglandin (PG) production was assessed using an in vitro perfused rabbit ovary preparation. In the first experiment, BK at a concentration of 0.033, 0.33, or 3.3 micrograms/ml was added to the perfusate of one ovary at hourly intervals for the first 10 h of perfusion. The contralateral control ovary was treated with medium alone parallel to the experimental ovary. Ovaries were perfused for a total of 12 h. BK induced ovulation in the absence of gonadotropin in a dose-related fashion, but did not induce maturation of ovulated ova or follicular oocytes. BK significantly stimulated PG production at all concentrations tested, but the effect was not dose related. Prostacyclin, as reflected by the concentration of 6-keto-PGF1 alpha in the perfusate, was the major PG produced. Smaller quantities of PGE2 and PGF2 alpha were present in the perfusate. After a single injection of BK (3.3 micrograms/ml), 6-keto-PGF1 alpha and PGF2 alpha production increased within 15 min and reached a maximum at 60-90 min. PGE2 did not change significantly over this time period. The addition of 1 microgram/ml indomethacin to the perfusate completely inhibited BK-stimulated PG production. However, indomethacin did not significantly affect the ovulatory efficiency of BK-treated ovaries. Neither BK nor indomethacin induced any degenerative changes in ovulated ova or follicular oocytes. The addition of a BK antagonist at 1 microgram/ml every 30 min to the perfusate resulted in an effective blockade of hCG-induced ovulation. These results suggest that BK is involved in the process of follicle rupture, but BK may induce ovulation by a mechanism(s) other than through PG stimulation.

Prostaglandins and progesterone secretion in the in vitro perfused pseudopregnant rabbit ovary.

The relationship between progesterone and prostaglandin (PG) secretion in the pseudopregnant rabbit corpus luteum was investigated using isolated in vitro perfused ovaries. Progesterone and PG secretion were measured on days 1, 11, and 18 of hCG-induced pseudopregnancy. The mean progesterone secretion increased significantly from days 1 to 11, and then decreased significantly by day 18. PG secretion was inversely correlated with progesterone secretion, suggesting that PG might inhibit progesterone secretion. To test this hypothesis, indomethacin, an inhibitor of PG secretion, was administered to intact rabbits from days 11-18 of pseudopregnancy and/or on day 18 ovaries were perfused in vitro with indomethacin. Indomethacin administered in vivo, in vitro, or both in vivo and in vitro significantly reduced PG secretion compared to that in controls, but did not affect progesterone secretion. In addition, perfusion of ovaries in vitro with PGF2 alpha did not alter progesterone secretion on either day 11 or day 18. Thus, although there is an inverse relationship between progesterone and PG secretion during pseudopregnancy, PGF2 alpha alone had no effect on progesterone secretion. These results question the hypothesis that PGF2 alpha alone is the luteolytic factor.

Effect of clomiphene citrate on in vitro ovulated ova.

The effect of clomiphene citrate (CC) on developmental capacity of ovulated ova was studied with isolated in vitro perfused rabbit ovaries. Fifty-two ovulated ova were recovered from ovaries perfused with human chorionic gonadotropin (hCG) in a medium containing CC and 45 ova from ovaries perfused with hCG in a CC-free medium. Ova were cultured and inseminated with capacitated sperm and observed serially for evidence of fertilization and stage of development. CC did not affect the fertilization of ovulated ova. However, the percentage of ova which had reached the morula stage by 60 hours was significantly reduced in the CC-treated (15.4%) group, compared with the control group of ovaries (48.9%). A significant percentage of inseminated ova from CC-treated ovaries (65.4%) showed evidence of degeneration, as compared with control ovaries (37.8%). Thus, a partial loss of developmental capacity may explain the discrepancy observed between the rate of successful ovulation induction and the establishment of pregnancy associated with CC administration in humans.

Estradiol reverses the limiting effects of clomiphene citrate on early embryonic development in the in vitro perfused rabbit ovary.

This study examined whether the addition of estradiol (E2) to the perfused rabbit ovary would reverse the deleterious effects of clomiphene citrate (CC) on early embryonic development. Ovaries were perfused with CC (10(-5) M) or CC + E2 (1 to 1000 ng/ml). Human chorionic gonadotropin (hCG, 50 IU) was added to the perfusate of each ovary. In vitro ovulated ova in cumulus were retrieved and inseminated in vitro. E2 significantly increased the percentage of ovulated ova achieving (1) the 2-cell stage at 36 hours, (2) the morula stage by 84 hours, and (3) the blastocyst stage at 132 hours. The percentage of inseminated ova showing evidence of degeneration was reduced in ovaries treated with E2. These data suggest that CC may exert an antiestrogenic effect on the intrafollicular oocyte, which interferes with postfertilization development.

Effect of the exposure of intrafollicular oocytes to clomiphene citrate on pregnancy outcome in the rabbit.

This study was designed to determine if exposure of rabbit intrafollicular oocytes to clomiphene citrate (CC) affects pregnancy outcome after in vitro ovulation, in vitro fertilization (IVF), and embryo transfer (ET). Ovaries were perfused in the presence or absence of CC (10(-5) M) and estradiol (E2, 100 ng/ml). Human chorionic gonadotropin (hCG, 50 IU) was added to the perfusate of all ovaries. In vitro ovulated ova were retrieved, inseminated, and transferred to host rabbits. Neither CC nor CC + E2 significantly affected hCG-induced ovulation or fertilization. CC significantly reduced (P less than 0.025) percentage of ovulated ova resulting in offspring. Addition of E2 significantly (P less than 0.05) reversed the reduction in offspring associated with CC alone. These results may be due to the antiestrogenic effects of CC on the intrafollicular oocyte, which compromises postfertilization development.

The effect of a carbon dioxide pneumoperitoneum on rabbit follicular oocytes and early embryonic development.

The effect of a carbon dioxide (CO2) pneumoperitoneum and its duration on rabbit follicular oocytes was assessed by evaluating fertilization and subsequent embryonic development rates. CO2 may cross the plasma membrane and form carbonic acid, which liberates H+, thus lowering the intracellular pH. There were no significant differences in arterial pH and [HCO3-] between CO2 and air treatment groups, whereas arterial pCO2 and pO2 were significantly increased in the CO2 treatment group. We found that the duration of pneumoperitoneum, irrespective of type of gas used, was negatively correlated with success of embryonic development. These findings necessitate that more attention be given to the gas used for creation of a pneumoperitoneum during egg retrieval for in vitro fertilization and an attempt be made to minimize duration of the pneumoperitoneum.

Do prostaglandins lead to ovulation in the rabbit by stimulating proteolytic enzyme activity?

OBJECTIVE: To determine if prostaglandins (PGs) have a direct effect on the ovarian proteolytic enzyme system by examining ultrastructure of the follicle wall and the microvasculature in the presence and absence of indomethacin and by using the isolated perfused rabbit ovary. DESIGN: Nine hours after administration of human chorionic gonadotropin (hCG) or hCG plus indomethacin, follicles were removed and processed for scanning and transmission electron microscopy. Isolated perfused rabbit ovaries were induced to ovulate with PGF2 alpha (100 ng/mL) in the presence and absence of tranexamic acid (0.1, 1.0, or 10 mM), a plasminogen activator inhibitor. RESULTS: The addition of indomethacin to hCG inhibited ovulation and production of PGs without affecting the follicular microvasculature. However, the changes in follicle wall architecture were less pronounced after treatment with indomethacin. Ovulatory efficiency in response to PGF2 alpha (the percent of follicles greater than 1.5 mm that ovulate) was significantly reduced (P less than 0.01) by 10 mM tranexamic acid. CONCLUSIONS: These results suggest that PGs induce follicular rupture by activation of proteolytic enzymes located in the follicle wall.

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.

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.

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.

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.

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.

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.