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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
711

Effect of arthroscopic lavage and repeated through-and-through joint lavage on systemic and synovial serum amyloid A concentrations; as well as total protein concentrations, nucleated cell count and percentage of neutrophils in synovial fluid from healthy equine joints

2015 June 1900 (has links)
This research evaluated serum amyloid A (SAA) concentration in synovial fluid of healthy horses as a potential marker for use in the diagnosis and monitoring of horses with septic arthritis. The first study evaluated the effect of arthroscopic lavage of healthy joints on concentrations of systemic and synovial SAA; as well as total protein concentration, nucleated cell count and percentage of neutrophils in synovial fluid. The second study, evaluated the effect of repeated through-and-through joint lavage on SAA in systemic blood and SAA, total protein, nucleated cell count and percentage of neutrophils in synovial fluid from healthy joints. In the first study, middle carpal joints of 6 horses were randomly assigned to one of the following treatments 1) arthrocentesis (controls) or 2) arthroscopic lavage. A washout period of 30 days was allowed in between treatments. Synovial fluid and blood samples were collected at 0, 24, 48, 72, 96 and 120 h. Measurements included SAA in blood and synovial fluid, and total protein, nucleated cell count and percentages of neutrophils in synovial fluid. In the second study, one tarsocrural joint was randomly assigned to receive repeated through-and-through joint lavage at 0, 48 and 96 h in 6 horses. Synovial fluid and blood samples were collected at 0, 24, 48, 72, 96 and 120 h. Measurements included SAA in blood and synovial fluid, and total protein, nucleated cell count and percentages of neutrophils in synovial fluid. For this study, synovial fluid samples collected at time 0 were considered as control values. After arthroscopic lavage and repeated through-and-through joint lavage, systemic and synovial SAA did not increase from baseline values (except for systemic SAA at 24h after arthroscopic lavage and in controls). Total protein values were significantly increased at all time points after arthroscopic and through-and-through joint lavages (except at 96h on both lavage procedures) but not in controls. With both lavage procedures, nucleated cell count significantly increased from baseline values at all time points (except at 96h after through-and-through joint lavage). Percentage of neutrophils was significantly increased after arthroscopic lavage at all time points and only at 24h in controls; however, the percentages of neutrophils were not significantly increased after repeated through-and-through joint lavage. Synovial SAA was not affected by arthroscopic or repeated through-and-through joint lavage; however, synovial total protein and nucleated cell counts were significantly increased. Synovial SAA may be a valuable inflammatory marker that is not affected by procedures as arthroscopic or repeated through-and-through joint lavage in horses. Further validation of synovial SAA as a marker for evaluating the progression of septic joints while treatment is installed is warranted.
712

Factors associated with the initiation of biologic disease modifying antirheumatic drugs in Texas Medicaid patients with rheumatoid arthritis

Kim, Gilwan 10 October 2014 (has links)
Rheumatoid arthritis (RA) is a progressive autoimmune disorder of joints that is associated with high health care costs and yet lacks guidance on how early to initiate biologic disease-modifying antirheumatic drugs (DMARDs), a class of medications that is the major cost driver in RA management. The main purpose of this study was to examine patient socio-demographics, medication use patterns, and clinical characteristics associated with initiation of biologic DMARDs. This was a retrospective study using Texas Medicaid prescription and medical claims database during the study period of July 1, 2003 – December 31, 2010. Patients (18 – 63 years) with an RA diagnosis (ICD-9-CM code 714.xx), no non-biologic DMARD or biologic DMARD use during the pre-index period, and a minimum of 2 prescription claims for the same non-biologic DMARD during the post-index period were included in the study. The primary study outcomes were time to initiation of biologic DMARDs and likelihood of initiating biologic DMARDs. There was a total of 2,714 subjects included in the study. The majority had claims for pain medications (92.4%), glucocorticoids (64.9%), and non-biologic DMARD monotherapy (86.4%); while 24.3% initiated on biologic DMARDs and 58.9% had a Charlson Comorbidity Index (CCI) score=1. Compared to time to initiation (days) of biologic DMARDs for methotrexate (539.7±276.9) users, it was longer for sulfasalazine (670.2±167.8) and hydroxychloroquine (680.2±158.7) users and similar to leflunomide users (541.6±286.5; p<0.0001). There were no significant differences in time to initiation between non-biologic DMARD mono vs. dual therapy. Younger age, glucocorticoid use, methotrexate user (vs. sulfasalazine, hydroxychloroquine users), and non-biologic DMARD monotherapy user (vs. dual therapy user) were significantly associated with higher likelihood to initiate biologic DMARDs. In conclusion, age, glucocorticoid use, non-biologic DMARD type and therapy were significant factors associated with initiation of biologic DMARDs. Healthcare providers and Texas Medicaid should recognize these potential driving factors and take efforts to achieve optimal therapy for RA patients through thorough RA medication evaluation, well-structured RA monitoring programs, and patient education. / text
713

Cognitive response to symptoms in women with rheumatoid arthritis.

McNamara, Anne Margaret. January 1992 (has links)
The purpose of this study was to advance knowledge and understanding related to the cognitive response evoked by symptoms in women with rheumatoid arthritis. The mechanisms to achieve this purpose were through: (1) psychometric evaluation of a newly developed instrument: Chronic Fatigue Index (CFI), (2) examining the relationship among the symptoms of RA and components of quality of life for women with RA, and (3) exploring the mechanism by which learned resourcefulness affects the relationship between symptoms and quality of life. The Chronic Fatigue Index (CFI) was evaluated and met minimal levels of reliability and validity. Cronbach alpha reliability estimate for the CFI was.87. Convergent validity was tested through factor analysis. The CFI was found to be a multi-dimensional scale with two distinct factors: chronicity and interference. The factor analytical strategies revealed 46% of the variance in chronic fatigue was supported by these two components. Moderate to strong relationships were found among the symptoms of chronic pain, chronic fatigue, disturbed sleep, and disease flare. To evaluate quality of life in this population a common factor was created through factor analysis. The results of factor analysis revealed three indicators explaining 69% of the variance in quality of life for this population. Chronic pain explained fourteen percent of the variance in learned resourcefulness. The other symptoms and multiplicative terms did not meet the entry criteria. Learned resourcefulness was a weak mediator between the disturbance of chronic pain and quality of life, but successfully moderated the adverse effect of disturbed sleep. Fifty eight percent of the variance in quality of life was explained by the direct path of chronic pain and disturbed sleep on quality of life and the interaction of disturbed sleep and learned resourcefulness. Model respecification suggested that the inclusion of additional variables in the model would increase the explanatory power of the model. The self-regulation framework for symptom appraisal was supported by the findings of this study. Nursing interventions should focus on assisting clients with enhancing their level of learned resourcefulness as it will buffer the adverse effects of the disease process.
714

Maintaining well-being in arthritis: Mediators of the adversive condition.

Arslanian, Christine Lucy. January 1993 (has links)
The purpose of this study was to test the relationships between and among the concepts of severity of illness, dependency, uncertainty, functional status and the mediators of self-esteem and mastery relative to the outcome of wellbeing. The conceptual framework was adapted from various sources in the literature which support the concept of wellbeing as an important outcome in arthritis. Evidence also supports self-esteem and mastery as mediators of the chronic illness experience. Dependency, uncertainty and functional status have been shown to be predictors of wellbeing but have never been tested as a complete paradigm. The sample for the study was 128 patients with either rheumatoid arthritis or osteoarthritis. Subjects completed 7 questionnaires which measured the 7 variables under study. Descriptive statistics were used to examine the demographic characteristics of the sample. Multiple regression technique was used to empirically test the predicted theoretical concepts and to estimate predictive validity for the theoretical concepts. The results demonstrated that when self-esteem was used in the causal model, 58% of the variance in wellbeing was explained by self-esteem and uncertainty. When mastery was included instead of self-esteem 52% of the variance of wellbeing was explained by mastery and uncertainty. When tested as mediators, both self-esteem and mastery emerged as significant mediators of dependency, uncertainty and functional status relative to wellbeing. These results are of clinical use to nurses who, by virtue of working with these patients on a daily basis, are in a position to intervene with actions which encourage positive self-esteem and maintain mastery over the environment. If these actions are successful, then wellbeing can be maintained for those patients diagnosed with arthritis.
715

The Effects of a 16-week Individualized, Intensive Strength Training Program for Patients with Rheumatoid Arthritis

Flint-Wagner, Hilary January 2005 (has links)
Objective. This study was designed to test the hypotheses that a 16-week, individualized, intensive strength training program in rheumatoid arthritis (RA) patients taking Remicade™ (Infliximab) would improve strength, body composition, disease activity, physical function, pain and quality of life outcomes , as compared to RA patients on Remicade™ with no strength training program. Methods. Twenty-four patients with RA taking Remicade™, participated in a randomized, controlled trial. The exercise group carried out a three time a week strength training program, with the control group continuing standard of care. Assessments were completed at baseline, 8-week, and 16-week time points . Maximal strength, physical function, disease activity, body composition, quality of life, and pain were measured with active tests and via questionnaires. Patients also completed exit evaluations on their satisfaction with the study. Results. Highly significant strength gains were seen in the exercise group according to 3 repetition maximums (3RMs) (p<.01), as well as in all 8 exercises performed in the gym (p<.01). The mean exercise attendance for the 16 weeks was 82.0±10.6%. Compared to the control group, there was a significant increase in right hand grip strength (p<.1), and lean tissue in the trunk (p<.01). Significant improvements were also seen in physical function according to 50-foot walk time (p<.01), the Arthritis Impact Measurement Scale 2 (AIMS2) hand and arm function subscales (p<.05), and the Medical Outcomes Study Short Form 36 (MOS SF-36) (p<.1), as compared to controls. The exercise group showed clinically important differences via the Health Assessment Questionnaire Disability Index (HAQ DI), with a mean change of -0.41±0.42. Significant reductions in pain, as measured by the Pain Visual Analogue Scale (VAS), also occurred (p<.1). The individualization of the strength training program and personal attention received by the patients was critical to the success of the study. Patient satisfaction with the study was high, with limitations due primarily to funding constraints. Conclusion. This 16-week high intensity strength training program led to statistically significant improvements in strength, lean soft tissue, disease activity, function, pain and quality of life in this RA population. No detrimental effects on the disease were seen in this study.
716

The prevalence of inflammatory rheumatic diseases in Vilnius, Lithuania / Uždegiminių reumatinių ligų paplitimas Vilniaus mieste

Miltinienė, Dalia 11 June 2009 (has links)
Objective: to assess the prevalence of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and spondyloarthropathy (SpA) in Vilnius, Lithuania. Methods: 3 prevalence studies were conducted: 1. Registry-based study of the prevalence of RA and SLE; 2. Population-based study of the prevalence of RA and SLE (interview conducted by mail); 3. Poulation-based study of the prevalence of RA and SpA (interview conducted by telephone). Results: according to the Vilnius RA and SLE registry, the prevalence of RA in Vilnius at the end of year 2004 was 0,14% (95% CI 0,13-0,15), and the prevalence of SLE was 0,0174% or 17,4/100 000 (95% CI 0,0137-0,0218). The population-based study, conducted by mail, revealed 15 RA and 2 SLE cases, accounting for a prevalence rate of RA of 0,37% (95% CI 0,21-0,62), and a prevalence of SLE rate of 0,0498% (95% CI 0,006-0,180). The standardized prevalence rate according to age and sex in the Vilnius population showed an RA prevalence of 0,32% (95% CI 0,18-0,57). The population-based study, conducted be telephone, detected 16 RA and 13 SpA cases, resulting in a crude prevalence of 0,76% (95% CI 0,44-1,24) for RA and 0,62% (95% CI 0,33-1,06) for SpA. The standardized prevalence rate according to age and sex in the Vilnius population showed an RA prevalence of 0,51% (95% CI 0,29-0,96) and a SpA prevalence of – 0,75% (95% CI 0,38-1,40). / Darbo tikslas: nustatyti reumatoidinio artrito (RA), seronegatyvių spondiloartropatijų (SpA) bei sisteminės raudonosios vilkligės (SRV) paplitimą Vilniaus mieste. Darbo metodika: Buvo atlikti 3 tyrimai: 1. RA ir SRV paplitimo Vilniaus mieste apskaičiavimas, remiantis Vilniaus miesto RA ir SRV sergančių asmenų duomenų baze; 2. RA ir SRV paplitimo Vilniaus mieste populiacinis tyrimas, apklausiant Vilniaus miesto gyventojus paštu; 3. RA ir SpA paplitimo Vilniaus mieste populiacinis tyrimas, apklausiant Vilniaus miesto gyventojus telefonu. Rezultatai: remiantis Vilniaus miesto RA ir SRV sergančiųjų duomenų baze, RA paplitimas Vilniaus mieste 2004m. pabaigoje buvo 0,14% (95% PI 0,13-0,15). Apskaičiuotas SRV paplitimas Vilniuje 2004m. pabaigoje buvo 0,0174% arba 17,4/100 000 gyventojų (95% PI 0,0137-0,0218). Atlikus RA ir SRV paplitimo tyrimą (apklausą paštu), nustatyta, kad RA paplitimas Vilniuje yra 0,37% (95% PI 0,21-0,62), o SRV paplitimas – 0,0498% (95% PI 0,006-0,180). RA paplitimas buvo standartizuotas pagal amžių ir lytį, remiantis 2004m. pradžios Vilniaus miesto populiacija, apskaičiuotas standartizuotas RA paplitimas yra 0,32% (95% PI 0,18-0,57). Atlikus RA ir SpA paplitimo tyrimą (apklausą telefonu), apskaičiuotas RA paplitimas buvo 0,76% (95% PI 0,44-1,24), o SpA paplitimas - 0,62% (95% PI 0,33-1,06). RA ir SpA paplitimas buvo standartizuotas pagal amžių ir lytį, remiantis 2004m. pradžios Lietuvos populiacija, apskaičiuotas standartizuotas RA paplitimas yra 0,51% (95%... [toliau žr. visą tekstą]
717

Uždegiminių reumatinių ligų paplitimas Vilniaus mieste / The prevalence of inflammatory rheumatic diseases in Vilnius, Lithuania

Miltinienė, Dalia 11 June 2009 (has links)
Darbo tikslas: nustatyti reumatoidinio artrito (RA), seronegatyvių spondiloartropatijų (SpA) bei sisteminės raudonosios vilkligės (SRV) paplitimą Vilniaus mieste. Darbo metodika: Buvo atlikti 3 tyrimai: 1. RA ir SRV paplitimo Vilniaus mieste apskaičiavimas, remiantis Vilniaus miesto RA ir SRV sergančių asmenų duomenų baze; 2. RA ir SRV paplitimo Vilniaus mieste populiacinis tyrimas, apklausiant Vilniaus miesto gyventojus paštu; 3. RA ir SpA paplitimo Vilniaus mieste populiacinis tyrimas, apklausiant Vilniaus miesto gyventojus telefonu. Rezultatai: remiantis Vilniaus miesto RA ir SRV sergančiųjų duomenų baze, RA paplitimas Vilniaus mieste 2004m. pabaigoje buvo 0,14% (95% PI 0,13-0,15). Apskaičiuotas SRV paplitimas Vilniuje 2004m. pabaigoje buvo 0,0174% arba 17,4/100 000 gyventojų (95% PI 0,0137-0,0218). Atlikus RA ir SRV paplitimo tyrimą (apklausą paštu), nustatyta, kad RA paplitimas Vilniuje yra 0,37% (95% PI 0,21-0,62), o SRV paplitimas – 0,0498% (95% PI 0,006-0,180). RA paplitimas buvo standartizuotas pagal amžių ir lytį, remiantis 2004m. pradžios Vilniaus miesto populiacija, apskaičiuotas standartizuotas RA paplitimas yra 0,32% (95% PI 0,18-0,57). Atlikus RA ir SpA paplitimo tyrimą (apklausą telefonu), apskaičiuotas RA paplitimas buvo 0,76% (95% PI 0,44-1,24), o SpA paplitimas - 0,62% (95% PI 0,33-1,06). RA ir SpA paplitimas buvo standartizuotas pagal amžių ir lytį, remiantis 2004m. pradžios Lietuvos populiacija, apskaičiuotas standartizuotas RA paplitimas yra 0,51% (95%... [toliau žr. visą tekstą] / Objective: to assess the prevalence of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and spondyloarthropathy (SpA) in Vilnius, Lithuania. Methods: 3 prevalence studies were conducted: 1. Registry-based study of the prevalence of RA and SLE; 2. Population-based study of the prevalence of RA and SLE (interview conducted by mail); 3. Poulation-based study of the prevalence of RA and SpA (interview conducted by telephone). Results: according to the Vilnius RA and SLE registry, the prevalence of RA in Vilnius at the end of year 2004 was 0,14% (95% CI 0,13-0,15), and the prevalence of SLE was 0,0174% or 17,4/100 000 (95% CI 0,0137-0,0218). The population-based study, conducted by mail, revealed 15 RA and 2 SLE cases, accounting for a prevalence rate of RA of 0,37% (95% CI 0,21-0,62), and a prevalence of SLE rate of 0,0498% (95% CI 0,006-0,180). The standardized prevalence rate according to age and sex in the Vilnius population showed an RA prevalence of 0,32% (95% CI 0,18-0,57). The population-based study, conducted be telephone, detected 16 RA and 13 SpA cases, resulting in a crude prevalence of 0,76% (95% CI 0,44-1,24) for RA and 0,62% (95% CI 0,33-1,06) for SpA. The standardized prevalence rate according to age and sex in the Vilnius population showed an RA prevalence of 0,51% (95% CI 0,29-0,96) and a SpA prevalence of – 0,75% (95% CI 0,38-1,40).
718

Kaulų mineralų tankio pokyčiai sergant spondiloartropatijomis / Bone mineral density changes in patients with spondyloarthropathies

Vencevičienė, Lina 11 June 2009 (has links)
Disertacija skirta nustatyti sergančiųjų spondiloartropatijomis (SpA) (AS, ReA, PsA, EnA) KMT pokyčių dėsningumus stuburo juosmeninėje ir šlaunikaulių proksimalinėse dalyse bei įvertinti ryšį tarp kaulų masės pokyčių ir ligos specifinių veiksnių (ligos trukmės, fizinės negalios ir judėjimo funkcijos sumažėjimo, vartojamų medikamentų, ligos aktyvumo). Darbe nustatyta, kad sergančiųjų SpA KMT nesiskiria nuo sergančiųjų reumatoidiniu artritu, ir yra reikšmingai mažesnis lyginant su sveikų asmenų KMT ir stuburo juosmeninėje, ir šlaunikaulių proksimalinėse dalyse. Panašūs KMT pokyčiai stuburo juosmeninėje ir šlaunikaulių proksimalinėse dalyse būdingi SpA pacientams, sergantiems įvairiomis SpA grupės ligomis, bei nepriklauso nuo vyraujančio sąnarių pažeidimo tipo. KMT pokyčius geriau atspindi ligos trukmė, skaičiuojant ją ne nuo klinikinės diagnozės nustatymo momento, o nuo pirmųjų ligos simptomų pasireiškimo. Ligos trukmei ilgėjant – šlaunikaulių KMT mažėja, o stubure – didėja. Vidutinis ir didelis ligos aktyvumas, kurį nustatė gydytojas reumatologas, turi įtakos stuburo juosmeninės ir šlaunikaulių proksimalinių dalių KMT sumažėjimui. KMT mažėjimas ir stuburo juosmeninėje, ir šlaunikaulių proksimalinėse dalyse susijęs su SpA sergančiojo judėjimo funkcijos sumažėjimu. Šį ryšį tiksliausiai atspindi tarpkulkšnelinio atstumo matmuo – šlaunikaulių proksimalinių dalių KMT rodmenys mažiausi, kai stuburo paslankumas įvertintas sunkiu sumažėjimo lygiu. Gliukokortikoidų kumuliacinė dozė... [toliau žr. visą tekstą] / The aim of this work was to determine consistent patterns of BMD changes at the lumbar spine and the upper part of the left and right femur in patients with SpA (AS, ReA, PsA, EnA) and to assess relation between changes of bone mass and specific factors of the disease (duration of the disease, physical disability and immobility, activity of the disease, medications in use). It was established that in patients with SpA BMD is the same as in patients with rheumatoid arthritis and is significantly lower in comparison with BMD of healthy subjects measured at the lumbar spine and upper part of the left and right femur. Similar BMD changes at the lumbar spine and upper part of the left and right femur are characteristic of SpA patients with various diseases belonging to SpA group and do not depend on the predominant type of joint lesion. The duration of the disease reflects changes in BMD better when it is calculated not from the time of the establishment of clinical diagnosis, but from the time of onset of first clinical symptoms. BMD decrease at the upper part of the left and right femur and increase at the spine with the increase of the duration of disease. Moderate and high activity of the disease established by rheumatologist contribute to BMD loss at the lumbar spine and upper parts of the both femurs. BMD reduction at the lumbar spine and the upper part of the left and right femur is associated with the decrease of mmobility of SpA patients. Intermalleolar distance is the... [to full text]
719

Kaulų mineralų tankio pokyčiai sergant spondiloartropatijomis / Bone mineral density changes in patients with spondyloarthropathies

Vencevičienė, Lina 11 June 2009 (has links)
Disertacija skirta nustatyti sergančiųjų spondiloartropatijomis (SpA) (AS, ReA, PsA, EnA) KMT pokyčių dėsningumus stuburo juosmeninėje ir šlaunikaulių proksimalinėse dalyse bei įvertinti ryšį tarp kaulų masės pokyčių ir ligos specifinių veiksnių (ligos trukmės, fizinės negalios ir judėjimo funkcijos sumažėjimo, vartojamų medikamentų, ligos aktyvumo). Darbe nustatyta, kad sergančiųjų SpA KMT nesiskiria nuo sergančiųjų reumatoidiniu artritu, ir yra reikšmingai mažesnis lyginant su sveikų asmenų KMT ir stuburo juosmeninėje, ir šlaunikaulių proksimalinėse dalyse. Panašūs KMT pokyčiai stuburo juosmeninėje ir šlaunikaulių proksimalinėse dalyse būdingi SpA pacientams, sergantiems įvairiomis SpA grupės ligomis, bei nepriklauso nuo vyraujančio sąnarių pažeidimo tipo. KMT pokyčius geriau atspindi ligos trukmė, skaičiuojant ją ne nuo klinikinės diagnozės nustatymo momento, o nuo pirmųjų ligos simptomų pasireiškimo. Ligos trukmei ilgėjant – šlaunikaulių KMT mažėja, o stubure – didėja. Vidutinis ir didelis ligos aktyvumas, kurį nustatė gydytojas reumatologas, turi įtakos stuburo juosmeninės ir šlaunikaulių proksimalinių dalių KMT sumažėjimui. KMT mažėjimas ir stuburo juosmeninėje, ir šlaunikaulių proksimalinėse dalyse susijęs su SpA sergančiojo judėjimo funkcijos sumažėjimu. Šį ryšį tiksliausiai atspindi tarpkulkšnelinio atstumo matmuo – šlaunikaulių proksimalinių dalių KMT rodmenys mažiausi, kai stuburo paslankumas įvertintas sunkiu sumažėjimo lygiu. Gliukokortikoidų kumuliacinė dozė... [toliau žr. visą tekstą] / The aim of this work was to determine consistent patterns of BMD changes at the lumbar spine and the upper part of the left and right femur in patients with SpA (AS, ReA, PsA, EnA) and to assess relation between changes of bone mass and specific factors of the disease (duration of the disease, physical disability and immobility, activity of the disease, medications in use). It was established that in patients with SpA BMD is the same as in patients with rheumatoid arthritis and is significantly lower in comparison with BMD of healthy subjects measured at the lumbar spine and upper part of the left and right femur. Similar BMD changes at the lumbar spine and upper part of the left and right femur are characteristic of SpA patients with various diseases belonging to SpA group and do not depend on the predominant type of joint lesion. The duration of the disease reflects changes in BMD better when it is calculated not from the time of the establishment of clinical diagnosis, but from the time of onset of first clinical symptoms. BMD decrease at the upper part of the left and right femur and increase at the spine with the increase of the duration of disease. Moderate and high activity of the disease established by rheumatologist contribute to BMD loss at the lumbar spine and upper parts of the both femurs. BMD reduction at the lumbar spine and the upper part of the left and right femur is associated with the decrease of mmobility of SpA patients. Intermalleolar distance is the... [to full text]
720

Statistical Information Included in Labeling for Disease-Modifying Anti-Rheumatic Drugs for Rheumatoid Arthritis

Hatch, Lashley January 2012 (has links)
Class of 2012 / Specific Aims: To evaluate the presence of statistical information from clinical studies in official product labeling specific for disease-modifying anti-rheumatic drugs (DMARDs) used in the treatment of rheumatoid arthritis. Methods: Data were abstracted from official product labeling DMARDs with FDA approval for treatment of rheumatoid arthritis. Each document was examined for the presence of statement regarding a priori type 1 error rate, p-values, and measures of variance. Medications were classified as either biologic or non-biologic. Main Results: A total of 14 DMARDs, 7 biologics (50%) and 7 non-biologics (50%), were found to be FDA approved for the treatment of rheumatoid arthritis. Primary outcomes consisted of American College of Rheumatology (ACR) response rates, radiographic changes, and health assessment questionnaire score (HAQ). Any measure of variance and the presence of a p-value were both found in six (43%) of the drug labels. Inclusion of p- values was found to be significantly greater in biologics compared to non-biologics for both ACR and radiographic results. Inclusion of variance was found to be significantly greater in biologics compared to non-biologics for radiographic changes only. No package inserts contained statements regarding the a priori type I error rate. Conclusions: Measures of variance are not frequently included in product labeling for either biologic or non-biologic DMARDs. However, inclusion of variance and p-values for ACR response rates and radiographic changes were more likely to be reported for biologics therapies as compared to non-biologics. A statement regarding Type 1 error rates were absent from labels regardless of outcome assessed.

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