المؤلفون: Messier, Stephen P., Beavers, Daniel P., Queen, Kate, Mihalko, Shannon L., Miller, Gary D., Losina, Elena, Katz, Jeffrey N., Loeser, Richard F., DeVita, Paul, Hunter, David J., Newman, Jovita J., Quandt, Sara A., Lyles, Mary F., Jordan, Joanne M., Callahan, Leigh F.

المصدر: JAMA: Journal of the American Medical Association; 12/13/2022, Vol. 328 Issue 22, p2242-2251, 10p

مصطلحات موضوعية: KNEE pain, CONTROL (Psychology), CLINICAL trials, ATTENTION control, OBESITY, KNEE osteoarthritis

مصطلحات جغرافية: NORTH Carolina

مستخلص: Key Points: Question: Does a weight loss and exercise program in community settings lead to improvement in knee pain in patients with osteoarthritis and overweight or obesity? Findings: This randomized clinical trial included 823 patients with knee osteoarthritis and overweight or obesity treated with diet and exercise vs an attention control. After 18 months, the adjusted mean difference in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score (range, 0-20) was −0.6, a difference that met statistical significance. Meaning: In patients with knee osteoarthritis and overweight or obesity, an 18-month program of weight loss and exercise based in community settings, compared with an attention control group, led to a small difference in knee pain of uncertain clinical importance. Importance: Some weight loss and exercise programs that have been successful in academic center–based trials have not been evaluated in community settings. Objective: To determine whether adaptation of a diet and exercise intervention to community settings resulted in a statistically significant reduction in pain, compared with an attention control group, at 18-month follow-up. Design, Setting, and Participants: Assessor-blinded randomized clinical trial conducted in community settings in urban and rural counties in North Carolina. Patients were men and women aged 50 years or older with knee osteoarthritis and overweight or obesity (body mass index ≥27). Enrollment (N = 823) occurred between May 2016 and August 2019, with follow-up ending in April 2021. Interventions: Patients were randomly assigned to either a diet and exercise intervention (n = 414) or an attention control (n = 409) group for 18 months. Main Outcomes and Measures: The primary outcome was the between-group difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score (range, 0 [none] to 20 [severe]; minimum clinically important difference, 1.6) over 18 months, tested using a repeated-measures mixed linear model with adjustments for covariates. There were 7 secondary outcomes including body weight. Results: Among the 823 randomized patients (mean age, 64.6 years; 637 [77%] women), 658 (80%) completed the trial. At 18-month follow-up, the adjusted mean WOMAC pain score was 5.0 in the diet and exercise group (n = 329) compared with 5.5 in the attention control group (n = 316) (adjusted difference, −0.6; 95% CI, −1.0 to −0.1; P =.02). Of 7 secondary outcomes, 5 were significantly better in the intervention group compared with control. The mean change in unadjusted 18-month body weight for patients with available data was −7.7 kg (8%) in the diet and exercise group (n = 289) and −1.7 kg (2%) in the attention control group (n = 273) (mean difference, −6.0 kg; 95% CI, −7.3 kg to −4.7 kg). There were 169 serious adverse events; none were definitely related to the study. There were 729 adverse events; 32 (4%) were definitely related to the study, including 10 body injuries (9 in diet and exercise; 1 in attention control), 7 muscle strains (6 in diet and exercise; 1 in attention control), and 6 trip/fall events (all 6 in diet and exercise). Conclusions and Relevance: Among patients with knee osteoarthritis and overweight or obesity, diet and exercise compared with an attention control led to a statistically significant but small difference in knee pain over 18 months. The magnitude of the difference in pain between groups is of uncertain clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT02577549 This randomized clinical trial assesses the effect of a diet and exercise intervention vs an attention control condition on knee pain at 18-month follow-up among individuals aged 50 years or older with knee osteoarthritis and overweight or obesity. [ABSTRACT FROM AUTHOR]

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المؤلفون: Losina, Elena, Silva, Genevieve S., Smith, Karen C., Collins, Jamie E., Hunter, David J., Shrestha, Swastina, Messier, Stephen P., Yelin, Ed H., Suter, Lisa G., Paltiel, A. David, Katz, Jeffrey N.

المصدر: Arthritis Care & Research; Oct2020, Vol. 72 Issue 10, p1349-1357, 9p

مصطلحات موضوعية: OSTEOARTHRITIS, JOINT diseases, CLINICAL trials, CLINICAL medicine research, MEDICAL research

مستخلص: Objective: One‐half of the 14 million persons in the US with knee osteoarthritis (OA) are not physically active, despite evidence that physical activity (PA) is associated with improved health. We undertook this study to estimate both the quality‐adjusted life‐year (QALY) losses in a US population with knee OA due to physical inactivity and the health benefits associated with higher PA levels. Methods: We used data from the Osteoarthritis Initiative and the Centers for Disease Control and Prevention to estimate the proportions of a US population with knee OA ages ≥45 years that are inactive, insufficiently active, and active, and the likelihood of a shift in their PA level. We used the OA Policy Model, a computer simulation of knee OA, to determine QALYs lost due to inactivity and to measure potential benefits of increased PA (comorbidities averted and QALYs saved). Results: Among 13.7 million persons with knee OA, a total of 7.5 million QALYs, or 0.55 QALYs per person, were lost due to inactivity or insufficient PA relative to activity over their remaining lifetimes. Black Hispanic women experienced the highest losses, at 0.76 QALYs per person. Women of all races/ethnicities had ~20% higher loss burdens than men. According to our model, if 20% of the inactive population were instead active, 95,920 cases of cancer, 222,413 of cardiovascular disease, and 214,725 of diabetes mellitus would potentially be averted, and 871,541 potential QALYs would be saved. Conclusion: Physical inactivity leads to substantial QALY losses in a US population with knee OA. Increases in the activity levels in even a fraction of this population may have considerable collateral health benefits, potentially averting cases of cancer, cardiovascular disease, and diabetes mellitus. [ABSTRACT FROM AUTHOR]

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المؤلفون: Alves, Kristin, Penny, Norgrove, Kobusingye, Olive, Olupot, Robert, Katz, Jeffrey N., Sabatini, Coleen S.

المصدر: International Orthopaedics; Aug2018, Vol. 42 Issue 8, p1967-1973, 7p

مصطلحات موضوعية: MUSCULOSKELETAL system diseases, CHILDREN'S health, KNEE injury treatment, CLINICAL trials, QUADRICEPS muscle

مستخلص: Purpose: The purpose of this study is to estimate the burden of musculoskeletal disease among children treated in Kumi District, Uganda, to inform training, capacity-building efforts, and resource allocation.Methods: We conducted a retrospective cohort study by reviewing the musculoskeletal (MSK) clinic and community outreach logs for children (age < 18 years) seen at Kumi Hospital in Kumi, Uganda, between January 2013 and December 2015. For each patient, we recorded the age, sex, diagnosis, and treatment recommendation.Results: Of the 4852 children, the most common diagnoses were gluteal and quadriceps contractures (29.4% (95% CI 28.1-30.7%), 96% of which were gluteal fibrosis), post-injection paralysis (12.7% (95% CI 11.8-13.6%)), infection (10.5% (95% CI 9.7-11.4%)), trauma (6.9% (95% CI 6.2-7.6%)), cerebral palsy (6.9% (95% CI 6.2-7.7%)), and clubfoot (4.3% (95% CI 3.8-4.9%)). Gluteal fibrosis, musculoskeletal infections, and angular knee deformities create a large surgical burden with 88.1%, 59.1%, and 54.1% of patients seen with these diagnoses referred for surgery, respectively. Post-injection paralysis, clubfoot, and cerebral palsy were treated non-operatively in over 75% of cases.Conclusion: While population-based estimates of disease burden and resource utilization are needed, this data offers insight into burden of musculoskeletal disease for this region of Sub-Saharan Africa. We estimate that 50% of the surgical conditions could be prevented with policy changes and education regarding injection practices and early care for traumatic injuries, clubfeet, and infection. This study highlights a need to increase capacity to care for specific musculoskeletal conditions, including gluteal fibrosis, post-injection paralysis, infection, and trauma in the paediatric population of Uganda. [ABSTRACT FROM AUTHOR]

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المؤلفون: Losina, Elena, Smith, Savannah R., Usiskin, Ilana M., Klara, Kristina M., Michl, Griffin L., Deshpande, Bhushan R., Yang, Heidi Y., Smith, Karen C., Collins, Jamie E., Katz, Jeffrey N.

المصدر: BMC Public Health; 12/1/2017, Vol. 17, p1-9, 9p, 1 Chart, 3 Graphs

مصطلحات موضوعية: WOMEN'S health, PHYSICAL activity, SEDENTARY behavior, PATIENT compliance, TERTIARY care, FEASIBILITY studies, EXERCISE & psychology, PREVENTION of obesity, CLINICAL trials, HEALTH promotion, INDUSTRIAL hygiene, MEDICAL protocols, MOTIVATION (Psychology), REWARD (Psychology), SELF-evaluation, PILOT projects, SPECIALTY hospitals, SEDENTARY lifestyles

مصطلحات جغرافية: UNITED States

الشركة/الكيان: CENTERS for Disease Control & Prevention (U.S.)

مستخلص: Background: We designed and implemented the Brigham and Women's Wellness Initiative (B-Well), a single-arm study to examine the feasibility of a workplace program that used individual and team-based financial incentives to increase physical activity among sedentary hospital employees.Methods: We enrolled sedentary, non-clinician employees of a tertiary medical center who self-reported low physical activity. Eligible participants formed or joined teams of three members and wore Fitbit Flex activity monitors for two pre-intervention weeks followed by 24 weeks during which they could earn monetary rewards. Participants were rewarded for increasing their moderate-to-vigorous physical activity (MVPA) by 10% from the previous week or for meeting the Centers for Disease Control and Prevention (CDC) physical activity guidelines (150 min of MVPA per week). Our primary outcome was the proportion of participants meeting weekly MVPA goals and CDC physical activity guidelines. Secondary outcomes included Fitbit-wear adherence and factors associated with meeting CDC guidelines more consistently.Results: B-Well included 292 hospital employees. Participants had a mean age of 38 years (SD 11), 83% were female, 38% were obese, and 62% were non-Hispanic White. Sixty-three percent of participants wore the Fitbit ≥4 days per week for ≥20 weeks. Two-thirds were satisfied with the B-Well program, with 79% indicating that they would participate again. Eighty-six percent met either their personal weekly goal or CDC physical activity guidelines for at least 6 out of 24 weeks, and 52% met their goals or CDC physical activity guidelines for at least 12 weeks. African Americans, non-obese subjects, and those with lower impulsivity scores reached CDC guidelines more consistently.Conclusions: Our data suggest that a financial incentives-based workplace wellness program can increase MVPA among sedentary employees. These results should be reproduced in a randomized controlled trial.Trial Registration: Clinicaltrials.gov, NCT02850094 . Registered July 27, 2016 [retrospectively registered]. [ABSTRACT FROM AUTHOR]

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المؤلفون: Solomon, Daniel H., Losina, Elena, Lu, Bing, Zak, Agnes, Corrigan, Cassandra, Lee, Sara B., Agosti, Jenifer, Bitton, Asaf, Harrold, Leslie R., Pincus, Theodore, Radner, Helga, Yu, Zhi, Smolen, Josef S., Fraenkel, Liana, Katz, Jeffrey N.

المصدر: Arthritis & Rheumatology; Jul2017, Vol. 69 Issue 7, p1374-1380, 7p

مصطلحات موضوعية: CLINICAL trials, INTERPROFESSIONAL relations, LEARNING strategies, MEDICAL cooperation, PROBABILITY theory, PROFESSIONAL employee training, QUALITY assurance, REGRESSION analysis, RESEARCH, RHEUMATOID arthritis, STATISTICAL sampling, RANDOMIZED controlled trials, DESCRIPTIVE statistics

مصطلحات جغرافية: UNITED States

مستخلص: Objective Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. Methods We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Results Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. Conclusion A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. [ABSTRACT FROM AUTHOR]

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المؤلفون: Losina, Elena¹ elosina@bwh.harvard.edu, Katz, Jeffrey N.¹

المصدر: Annals of Internal Medicine. 7/4/2017, Vol. 167 Issue 1, p55-56. 3p.

مصطلحات موضوعية: *RHEUMATOID arthritis treatment, *COST effectiveness, *ANTIRHEUMATIC agents, *DRUG dosage, *CLINICAL trials

مستخلص: The authors share insight on the art and science of choosing treatment strategies for rheumatoid arthritis, with reference to a research which analyzed the cost effectiveness of biologic disease-modifying antirheumatic drugs (bDMARD) and triple conventional DMARD (cDMARD) therapy. They argue on the researchers' reliance on the dose-response relationship between health status score and utility score, as well as the lack of consistency between the trial design and reporting of cost-effectiveness.

المؤلفون: Bassett, Ingrid V., Giddy, Janet, Chaisson, Christine E., Ross, Douglas, Bogart, Laura M., Coleman, Sharon M., Govender, Tessa, Robine, Marion, Erlwanger, Alison, Freedberg, Kenneth A., Katz, Jeffrey N., Walensky, Rochelle P., Losina, Elena

المصدر: BMC Infectious Diseases; 2013, Vol. 13 Issue 1, p1-9, 9p, 2 Diagrams, 2 Charts

مصطلحات موضوعية: HIV-positive persons, HIV infections, CLINICAL trials, CD4 lymphocyte count

مصطلحات جغرافية: DURBAN (South Africa)

مستخلص: Background: Despite increases in HIV testing, only a fraction of people newly diagnosed with HIV infection enter the care system and initiate antiretroviral therapy (ART) in South Africa. We report on the design and initial enrollment of a randomized trial of a health system navigator intervention to improve linkage to HIV care and TB treatment completion in Durban, South Africa. Methods/Design: We employed a multi-site randomized controlled trial design. Patients at 4 outpatient sites were enrolled prior to HIV testing. For all HIV-infected participants, routine TB screening with sputum for mycobacterial smear and culture were collected. HIV-infected participants were randomized to receive the health system navigator intervention or usual care. Participants in the navigator arm underwent a baseline interview using a strengths-based case management approach to assist in identifying barriers to entering care and devising solutions to best cope with perceived barriers. Over 4 months, participants in the navigator arm received scheduled phone and text messages. The primary outcome of the study is linkage and retention in care, assessed 9 months after enrollment. For ART-eligible participants without TB, the primary outcome is 3 months on ART as documented in the medical record; participants co-infected with TB are also eligible to meet the primary outcome of completion of 6 months of TB treatment, as documented by the TB clinic. Secondary outcomes include mortality, receipt of CD4 count and TB test results, and repeat CD4 counts for those not ART-eligible at baseline. We hypothesize that a health system navigator can help identify and positively affect modifiable patient factors, including self-efficacy and social support, that in turn can improve linkage to and retention in HIV and TB care. Discussion: We are currently evaluating the clinical impact of a novel health system navigator intervention to promote entry to and retention in HIV and TB care for people newly diagnosed with HIV. The details of this study protocol will inform clinicians, investigators, and policy makers of strategies to best support HIV-infected patients in resource-limited settings. [ABSTRACT FROM AUTHOR]

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المؤلفون: Mi, Michael Y., Collins, Jamie E., Lerner, Vladislav, Losina, Elena, Katz, Jeffrey N.

المصدر: BMC Musculoskeletal Disorders; 2013, Vol. 14 Issue 1, p1-7, 7p, 6 Charts

مصطلحات موضوعية: CLINICAL trials, RELIABILITY (Personality trait), ORTHOPEDIC nursing, TOTAL knee replacement, MEDICAL informatics, HOSPITAL records

مستخلص: Background: Medical record review (MRR) is one of the most commonly used research methods in clinical studies because it provides rich clinical detail. However, because MRR involves subjective interpretation of information found in the medical record, it is critically important to understand the reproducibility of data obtained from MRR. Furthermore, because medical record review is both technically demanding and time intensive, it is important to establish whether trained research staff with no clinical training can abstract medical records reliably. Methods: We assessed the reliability of abstraction of medical record information in a sample of patients who underwent total knee replacement (TKR) at a referral center. An orthopedic surgeon instructed two research coordinators (RCs) in the abstraction of inpatient medical records and operative notes for patients undergoing primary TKR. The two RCs and the surgeon each independently reviewed 75 patients' records and one RC reviewed the records twice. Agreement was assessed using the proportion of items on which reviewers agreed and the kappa statistic. Results: The kappa for agreement between the surgeon and each RC ranged from 0.59 to 1 for one RC and 0.49 to 1 for the other; the percent agreement ranged from 82% to 100% for one RC and 70% to 100% for the other. The repeated abstractions by the same RC showed high intra-rater agreement, with kappas ranging from 0.66 to 1 and percent agreement ranging from 97% to 100%. Inter-rater agreement between the two RCs was moderate with kappa ranging from 0.49 to 1 and percent agreement ranging from 76% to 100%. Conclusion: The MRR method used in this study showed excellent reliability for abstraction of information that had low technical complexity and moderate to good reliability for information that had greater complexity. Overall, these findings support the use of non-surgeons to abstract surgical data from operative notes. [ABSTRACT FROM AUTHOR]

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المؤلفون: Chu, Constance R., Beynnon, Bruce D., Buckwalter, Joseph A., Garrett, William E., Katz, Jeffrey N., Rodeo, Scott A., Spindler, Kurt P., Stanton, Robert A.

المصدر: American Journal of Sports Medicine; Jul2011, Vol. 39 Issue 7, p1569-1578, 10p

مصطلحات موضوعية: OSTEOARTHRITIS treatment, SPORTS medicine associations, ANTERIOR cruciate ligament injuries, BIOMARKERS, CONFERENCES & conventions, DIAGNOSTIC imaging, KINEMATICS, KNEE diseases, MEDICAL needs assessment, OSTEOARTHRITIS, ACTIVITIES of daily living, PREVENTION

مصطلحات جغرافية: UNITED States

الشركة/الكيان: NATIONAL Institutes of Health (U.S.)

مستخلص: This report summarizes the 2010 AOSSM/NIH (American Orthopaedic Society for Sports Medicine/National Institutes of Health) U13 Post–Joint Injury Osteoarthritis II Conference to include the discussion concerning potential study cohorts, assessment considerations, and research priorities. There was strong consensus and enthusiasm for approaching the development of disease-modifying treatments for osteoarthritis through study of “pre-osteoarthritic” cohorts, particularly human subjects under 30 years of age following acute anterior cruciate ligament injuries. Clinical study of acute treatment strategies initiated within a few days after injury will need development of recruitment pathways and short-term proof-of-concept outcome measures that are specific to the intervention being studied. For example, measures of joint inflammation can be used in short-term prospective randomized controlled trials to determine whether an anti-inflammatory intervention was effective in decreasing early inflammation. These short-term clinical trials will need to be followed by longer-term evaluation of the clinical cohorts for joint and cartilage degeneration to determine if the acute intervention affected later development of osteoarthritis. Research priorities were identified in several disciplines, particularly regarding development and validation of quantitative imaging, biomechanics, and biomarker measures of joint structure, composition, and function that predict the accelerated development of osteoarthritis. Systematic study of posttraumatic osteoarthritis is anticipated to advance understanding and treatment of all forms of osteoarthritis. [ABSTRACT FROM AUTHOR]

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المؤلفون: Sepucha, Karen R., Stacey, Dawn, Clay, Catharine F, Chang, Yuchiao, Cosenza, Carol, Dervin, Geoffrey, Dorrwachter, Janet, Feibelmann, Sandra, Katz, Jeffrey N., Kearing, Stephen A., Malchau, Henrik, Taljaard, Monica, Tomek, Ivan, Tugwell, Peter, Levin, Carrie A.

المصدر: BMC Musculoskeletal Disorders; 2011, Vol. 12 Issue 1, p149-160, 12p

مصطلحات موضوعية: OSTEOARTHRITIS, CLINICAL trials, KNEE diseases, HEALTH surveys, PUBLIC health research

مستخلص: Background: A high quality decision requires that patients who meet clinical criteria for surgery are informed about the options (including non-surgical alternatives) and receive treatments that match their goals. The aim of this study was to evaluate the psychometric properties and clinical sensibility of a patient self report instrument, to measure the quality of decisions about total joint replacement for knee or hip osteoarthritis. Methods: The performance of the Hip/Knee Osteoarthritis Decision Quality Instrument (HK-DQI) was evaluated in two samples: (1) a cross-sectional mail survey with 489 patients and 77 providers (study 1); and (2) a randomized controlled trial of a patient decision aid with 138 osteoarthritis patients considering total joint replacement (study 2). The HK-DQI results in two scores. Knowledge items are summed to create a total knowledge score, and a set of goals and concerns are used in a logistic regression model to develop a concordance score. The concordance score measures the proportion of patients whose treatment matched their goals. Hypotheses related to acceptability, feasibility, reliability and validity of the knowledge and concordance scores were examined. Results: In study 1, the HK-DQI was completed by 382 patients (79%) and 45 providers (58%), and in study 2 by 127 patients (92%), with low rates of missing data. The DQI-knowledge score was reproducible (ICC = 0.81) and demonstrated discriminant validity (68% decision aid vs. 54% control, and 78% providers vs. 61% patients) and content validity. The concordance score demonstrated predictive validity, as patients whose treatments were concordant with their goals had more confidence and less regret with their decision compared to those who did not. Conclusions: The HK-DQI is feasible and acceptable to patients. It can be used to assess whether patients with osteoarthritis are making informed decisions about surgery that are concordant with their goals. [ABSTRACT FROM AUTHOR]

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