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Background: The American Academy of Orthopaedic Surgeons (AAOS) has developed an array of outcomes assessment instruments designed for the efficient collection of outcomes data from patients of all ages with musculoskeletal conditions in all body regions. The Lower Limb Instruments were developed through a process of literature review, consensus-building, and field-testing.Methods: The instruments were distributed to a total of 290 subjects in twenty orthopaedic practices throughout the United States and Canada. Of the 290 patients, seventy each had a diagnosis in the categories of foot and ankle, sports/knee, and hip and knee and forty each had a diagnosis in the categories of trauma and rehabilitation. Retests to be taken twenty-four hours after the first test were distributed to subsamples of patients for each instrument. Seventy-one one-year follow-up questionnaires (twenty-five Sports/Knee, twenty-five Foot and Ankle, sixteen Hip and Knee, and five Lower Limb Core instruments) were returned.Results: The Lower Limb Core Scale and the Hip and Knee Core Scale, each consisting of seven items addressing pain, stiffness and swelling, and function, performed at an acceptable level. Additional Sports/Knee and Foot and Ankle Modules proved to have internal and retest reliability of 0.80 or better, comparable with the values for well-established measures such as the Short Form-36 (SF-36). All of the new scales were moderately to strongly correlated with other measures of pain and function, such as physician ratings, the SF-36, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Seventy-one patients provided follow-up information for the analysis of sensitivity to change. The Lower Limb Core was found to contribute independently to the prediction of the transition score based on the patient and physician assessments of change.Conclusions: The AAOS Lower Limb Instruments for outcomes assessment are highly reliable and are correlated with other measures for similar constructs. They are also sensitive to change in patient status. The Lower Limb Core Scale may be used with attribution of pain either to the lower limb or to a specific joint or side without sacrificing reliability. Combined with the SF-36, the AAOS outcomes assessment instruments comprehensively and efficiently measure outcomes in orthopaedic patients with lower-limb conditions. [ABSTRACT FROM AUTHOR]

This evidence-based clinical practice guideline for the prevention, diagnosis, and treatment of Lyme disease was developed by a multidisciplinary panel representing the Infectious Diseases Society of America (IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR). The scope of this guideline includes prevention of Lyme disease, and the diagnosis and treatment of Lyme disease presenting as erythema migrans, Lyme disease complicated by neurologic, cardiac, and rheumatologic manifestations, Eurasian manifestations of Lyme disease, and Lyme disease complicated by coinfection with other tick-borne pathogens. This guideline does not include comprehensive recommendations for babesiosis and tick-borne rickettsial infections, which are published in separate guidelines. The target audience for this guideline includes primary care physicians and specialists caring for this condition such as infectious diseases specialists, emergency physicians, internists, pediatricians, family physicians, neurologists, rheumatologists, cardiologists and dermatologists in North America., (© 2020 American Academy of Neurology.)

A long-term randomized trial of unstable patients with schizophrenia found no benefit of long-acting injectable (LAI) risperidone over oral treatment in preventing or delaying time to psychiatric hospitalizations or on clinical outcomes. The initial analyses did not examine whether benefits of LAI emerged in selected subgroups.Patients with schizophrenia or schizoaffective disorder who had been hospitalized within the past 2 years or judged to be at risk for hospitalization because of increasing psychiatric service use were randomly assigned to LAI risperidone 12.5 to 50 mg per injection biweekly or to the psychiatrist's choice of oral antipsychotics and followed for up to 2 years. The primary endpoint was psychiatric rehospitalization. Symptoms, quality of life, and global functioning were assessed through blinded videoconference interviews. Cox's regression and mixed effects models were used to assess difference in treatment effect within 12 subgroups defined by hospitalization at study entry, substance abuse, race, symptom severity, quality of life, body mass index, age, race or sex, or reported medication compliance.Mixed models and Cox's regression using up to 24 months of follow-up data showed no significant differences in treatment effect in 10 of 12 subgroups on psychiatric symptoms, quality of life, or time to hospitalization. With adjustment for multiple comparisons, treatment effect differed by race on substance use outcomes, with white participants showing more benefit from LAI than other groups.LAI risperidone showed no superiority to psychiatrist's choice of oral treatment in most clinically defined subgroups, although the white patients benefited more than the other groups on substance abuse outcomes.

Objectives: Although widely used and reported in research for the evaluation of groups, measures of health status and health-related quality of life have had little application in clinical practice for the assessment of individual patients. One of the principal barriers is the demonstration that these measures add clinically significant information to measures of function or symptoms alone. Here, we review the methods for evaluation of construct validity in longitudinal studies and make recommendations for nomenclature, reporting of study results, and future research agenda., Methods: Analytical review., Results: The terms "sensitivity" and "responsiveness" have been used interchangeably, and there are few studies that evaluate the extent to which health status or health-related quality-of life measures capture clinically important changes ("responsiveness"). Current methods of evaluating responsiveness are not standardized or evaluated. Approaches for the assessment of a clinically significant or meaningful change are described; rather than normative information, however, standardized transition questions are proposed. They would be reported routinely and as separate axes of description to capture individual perceptions., Conclusions: Research in methods to assess the subject's evaluation of the importance and magnitude of a measured change are critical if health status and health-related quality-of-life measures are to have an impact on patient care.

The goal of orthopaedic interventions is to improve the functional health of patients, particularly physical function. The American Academy of Orthopaedic Surgeons and the Pediatric Orthopaedic Society of North America (POSNA) commissioned a work group to construct functional health outcomes scales for children and adolescents, focusing on musculoskeletal health. The work group developed scales assessing upper extremity function, transfers and mobility, physical function and sports, comfort (pain free), happiness and satisfaction, and expectations for treatment. Parent and adolescent self-report forms were developed and tested on 470 subjects aged 2-18 years. The POSNA scales demonstrated good reliability, construct validity, sensitivity to change over a 9-month period, and ability to outperform a standard instrument, the Child Health Questionnaire physical functioning scale. They were useful for a wide variety of ages and diagnoses. They appear to be ideally suited for orthopaedic surgeons to assess the functional health and efficacy of treatment of their patients at baseline and follow-up.

Design: A prospective, multicenter observational study., Objectives: 1) Identify correlates of the decision to perform arthrodesis in patients undergoing laminectomy for lumbar spinal stenosis. 2) Compare symptoms, walking capacity, and satisfaction 6 and 24 months after laminectomy alone and laminectomy with noninstrumented and with instrumented arthrodesis., Background Data: Few prospective studies have compared outcomes of laminectomy alone or laminectomy with noninstrumented or with instrumented arthrodesis in patients with degenerative lumbar spinal stenosis. There is uncertainty regarding the optimal use of arthrodesis and instrumentation., Methods: Two hundred seventy--two patients undergoing--surgery for degenerative lumbar stenosis by eight surgeons at four centers were included in the study cohort. Of these, 37 had noninstrumented and 41 had instrumented arthrodesis. Logistic regression identified factors associated with arthrodesis. The principal outcomes-health status, walking capacity, back and leg pain, and satisfaction with surgery-were assessed 6 and 24 months postoperatively with univariate and multivariate techniques. Outcomes also were assessed in a restricted cohort of patients with at least 5 mm spondylolisthesis and/or 15 degrees scoliosis. Hospital costs were obtained from a computerized hospital cost accounting system., Results: The major predictor of the decision to perform arthrodesis was the individual surgeon (P = 0.0001). Noninstrumented arthrodesis was associated with superior relief of low back pain at 6 months (P = 0.004) and 24 months (P = 0.01). This difference persisted in multivariate analyses, with borderline statistical significance. There were no significant differences in the other outcomes across treatment groups. Mean hospital costs of laminectomy alone and noninstrumented and instrumented arthrodesis were $12,615, $18,495, and $25,914, respectively (P = 0.0001)., Conclusion: Findings were limited by the small number of participating surgeons, modest sample size that produced P values of borderline significance, and nonrandomized design. With these caveats in mind, the authors conclude: (1) The individual surgeon was a more important correlate of the decision to perform arthrodesis than clinical variables such as spondylolisthesis. (2) Noninstrumented arthrodesis resulted in superior relief of back pain after 6 and 24 months. (3) Instrumented arthrodesis was the most costly option. These results highlight the need for randomized controlled trials and cost effectiveness analyses of lumbar arthrodesis and instrumentation in patients with degenerative lumbar spinal stenosis.

Study Design: A cross-sectional study of a convenience sample of lumbar spine patients, with a subsample followed for retest reliability., Objectives: To assess the instrument's reliability, validity, and acceptability to patients., Summary of Background Data: Patients with eight diagnoses, four before surgery and four after surgery, were recruited from six orthopedic practices to test the questionnaire., Methods: One hundred sixty-seven patients were approached through the physician's office, yielding 136 usable questionnaires (84%) and 24-hour retests on 64 patients., Results: The questionnaire took about 20 minutes to administer and was acceptable to patients. The lumbar spine pain and disability and neurogenic symptoms subscales discriminated among patient groups as hypothesized and showed significantly better scores for patients independently judged successful by their physicians after surgery. Test-retest reliability and internal reliability were high (range, 0.85-0.97). Sample sizes of 20-37 would be needed to detect a 20% difference between two groups (alpha, 0.05; beta, 0.20)., Conclusions: The questionnaire should be considered for monitoring of individual patient's progress in treatment and for clinical trials.

Study Design: This article reviews the criteria for evaluating the quality of clinical trials., Objectives: To outline the current methodologic standards by which the validity of controlled trials need to be evaluated., Summary of Background Data: Weber's study, published in 1983 in Spine, is the only randomized trial comparing surgery and conservative management of sciatica in herniated lumbar discs., Methods: Weber's article is revisited to illustrate basic principles in the design of clinical trials., Results: Weber's study is a classic in spine surgery and has changed thinking regarding the benefit of surgery in sciatica related to herniated lumbar discs. However, the authors found potentially critical flaws in this study: a large number of crossovers, inadequate sample size, and insensitive outcome measurements., Conclusions: A randomized, controlled trial is the most rigorous way to evaluate health intervention. Despite the difficulties of performing such studies, investigators should use the most appropriate scientific methodology.

Study Design: Retrospective review and prospective follow-up of 88 patients who had decompressive laminectomy with or without fusion from 1983 to 1986., Objective: To determine the 7- to 10-year outcome of surgery for degenerative lumbar spinal stenosis., Summary of Background Data: There is limited information on the impact of surgery for lumbar spinal stenosis on symptoms, walking ability, and satisfaction, as well as reoperation., Methods: Patients completed standardized questionnaires in 1993 that included items about reoperations, back pain, leg pain, walking capacity, and satisfaction with surgery. Associations between preoperative demographic and clinical variables and outcomes 7 to 10 years after surgery were evaluated in univariate and multivariate analyses., Results: Average preoperative age was 69 years and eight patients received fusion. Of 88 patients in the original cohort, 20 (23%) were deceased and 20 (23%) had undergone reoperation by 7- to 10-year follow-up. Fifty-five patients answered questionnaires. Average duration of follow-up was 8.1 years. Thirty-three percent of the respondents had severe back pain at follow-up, 53% were unable to walk two blocks, and 75% were satisfied with the results of surgery. The severity of current spine-related symptoms was a stronger correlate of physical functional status at the time of follow-up than age or nonspinal comorbid conditions., Conclusions: Seven to 10 years after decompressive surgery for spinal stenosis, 23% of patients had undergone reoperation and 33% of respondents had severe back pain. Despite a high prevalence of nonspinal problems in this elderly cohort, spinal symptoms were the most important correlate of reduced functional status.

Study Design: Prospective multicenter observational study of the outcome of surgery for degenerative lumbar spinal stenosis., Objectives: To identify correlates of patient satisfaction with the results of surgery., Summary of Background Data: Little published information exists on correlates of patient satisfaction after surgery for spinal stenosis., Methods: Preoperative and 6-month follow-up data for 194 patients were analyzed. Associations between preoperative variables and satisfaction with the results of surgery were examined in univariate and multivariate models., Results: In multiple linear regression models that adjusted for the effects of age, gender, individual surgeon, number of interspaces decompressed, whether a fusion was performed, depression score, and overall level of pain, the predominance of back (as opposed to leg) pain, greater comorbidity, and worse preoperative functional status were associated with lower patient satisfaction. The regression model explained just 15% of the variance in patient satisfaction., Conclusions: Patients bothered predominantly by back pain preoperatively and those with greater medical comorbidity and functional disability are significantly less satisfied with the results of surgery for degenerative lumbar spinal stenosis.

Responsiveness, the ability to detect meaningful clinical change, is a critical attribute of instruments used to evaluate outcomes of treatments. The authors hypothesized that self-administered symptom severity and functional status questionnaires are more responsive to clinical improvement after carpal tunnel release than traditional physical examination measures of strength and sensibility. Data were obtained from a randomized clinical trial of endoscopic versus open carpal tunnel release conducted in four university medical centers. Patients were evaluated before surgery and 3 months after surgery. Seventy-four patients indicating that they were more than 80% satisfied with the results of surgery were assumed to have clinically meaningful improvement and were the focus of the analysis. Evaluations included questionnaires assessing symptom severity, functional status, and activities of daily living as well as measurement of grip, pinch, and abductor pollicus brevis strength, and 2-point discrimination and Semmes-Weinstein pressure sensibility. Responsiveness was calculated with the standardized response mean (mean change/standard deviation of change) as well as the effect size (mean change/standard deviation of baseline values). The symptom severity scale was four times as responsive, and the functional status and activities of daily living scales were twice as responsive, as the measures of strength and sensibility. Self-administered symptom severity and functional status scales are much more responsive to clinical improvement than measures of neuromuscular impairment and should severe as primary outcomes in clinical studies of therapy for carpal tunnel syndrome.

Short measures of health status are used increasingly in health services research, yet their sensitivities to clinical change have not been compared with longer, established instruments. In this study, 5 health status measures were administered preoperatively and 3 months postoperatively to 54 patients undergoing total hip arthroplasty. These instruments included the Sickness Impact Profile (SIP)--an established, long measure--and 4 short forms: the SF-36, Functional Status Questionnaire, shortened Arthritis Impact Measurement Scales, and Modified Health Assessment Questionnaire. Scores for physical, psychological, and global dimensions were constructed by aggregating subscales. Sensitivity to change, or responsiveness, was expressed with the standardized response mean (SRM), calculated as the mean change in score divided by the standard deviation of the change in score. The sampling distribution of the SRM was estimated with a jackknife procedure. Preoperative scores were moderately to highly correlated across instruments. The physical and global dimension SRMs of the brief health status measures ranged from 0.85 to 1.27 and were as large as or larger than the corresponding SIP SRMs. The SIP had the highest SRM on the psychological dimension. None of the instruments was significantly more sensitive than the others at the critical value (P = 0.005) adjusted for multiple comparisons. The brief health status measures were equally or more responsive than the SIP after total hip arthroplasty in the physical and global dimensions. Much larger samples are required to demonstrate statistically significant differences in SRMs among instruments.

This study represents a long-term effort to find optimal techniques for evaluating outcome in patients who have undergone total joint arthroplasty. Sensitivity of five health status questionnaires was studied in a longitudinal evaluation of orthopedic surgery. The questionnaires (Arthritis Impact Measurement Scales [AIMS], Functional Status Index [FSI], Health Assessment Questionnaire [HAQ], Index of Well Being [IWB], and Sickness Impact Profile [SIP]) were administered to 38 patients with end-stage arthritis at three points in time: two weeks before hip or knee arthroplasty, and at three-month and 12- to 15-month follow-up. Response values (i.e., changes within patients) were calculated on four scales: global health, pain, mobility, and social function. By the three-month follow-up, most instruments detected large mean responses in global health, pain scores, and mobility. Smaller changes on these scales were found between three and 12 to 15 months. Social function showed small to modest gains at successive follow-ups. Standardized response means were calculated to assess sensitivity to detect change. Confidence intervals for these indices were constructed using a jackknife procedure, and significance tests were performed by pairing selected indices. Finally, the study projected sample sizes required to assess a new therapy, using each response. These statistical tools facilitated comparisons among instruments and may prove useful in other settings.

Risk factors for rheumatoid arthritis were examined in a cohort of 121,700 female nurses aged 30-55, followed in the Nurses' Health Study. Baseline information on reproductive variables, cigarette smoking, obesity, and other variables was obtained in 1976 and updated every 2 years. Cases of rheumatoid arthritis were defined by standardized questionnaire and review of medical records. During 883,187 person-years of follow-up, 217 new cases of rheumatoid arthritis were identified (115 had definite rheumatoid arthritis and 102 had "undifferentiated polyarthritis"). When compared with women who experienced menarche at age 13 years, the age-adjusted relative risk of rheumatoid arthritis among women with early menarche was 1.9 (95% confidence interval, 0.9-2.4). There were, however, no significant associations between parity, age at birth of the first child, menopause, or obesity and the incidence of rheumatoid arthritis. Cigarette smokers had a slight apparent increase in the risk of rheumatoid arthritis. Among current smokers, the age-adjusted relative risk for RA rheumatoid arthritis was 1.3 (0.9-2.1); among former smokers, the relative risk was 1.5 (0.9-2.3).

A natural experiment provided an opportunity to determine whether physical therapy (PT) service reduction would affect the outcomes of total joint arthroplasty. A sample of 200 patients with rheumatoid arthritis or osteoarthritis who underwent total hip or total knee replacement during successive reduction of services was randomly selected. The demographic and clinical characteristics of patients in each period were similar. Despite large differences between groups in hours of PT per patient, there were no major differences in length of stay between the groups, or compared to similar hospitals, functional status at discharge, or numbers of surgical complications. Implications for health services organization are discussed.