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1.
J Spec Pediatr Nurs ; 23(1)2018 Jan.
Article in English | MEDLINE | ID: mdl-29266743

ABSTRACT

PURPOSE: Understanding parents' perceptions of their child's health status is important as parents are drivers of healthcare utilization in the pediatric setting. Understanding parent-perceived disease-severity and its effects on a child's health-related quality of life (HRQOL) in children with congenital heart disease (CHD) is necessary to evaluate outcomes of care, improve care coordination, and inform policies focused on advancing family-centered care for pediatric cardiac patients. The impact of CHDs and disease-severity on the child's HRQOL has been investigated with inconsistent results. The overall aim of this study was to examine parents' perceptions of HRQOL in their school-age child with CHD, and to compare HRQOL among patients with CHD across severity categories. DESIGN: This was a descriptive correlational study design. METHODS: A total of 71 parents of school-age children aged 5-12 years completed the Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) (including total, physical health, and psychosocial health summary scores) and cardiac-specific HRQOL Scale (PedsQL 3.0). PedsQL scores among CHD severity categories were compared by analysis of variance. RESULTS: School-age children with CHDs had an overall good HRQOL with significant differences among disease severity categories for all scores. Parents reported lower scores on their HRQOL of older children compared to younger children across severity groups (p < .01) and for those children with more severe disease (p < .01). PRACTICE IMPLICATIONS: Based on the results of this study, interventions should focus on targeting psychosocial health in older children with CHD and physical health in younger children with CHD. This information is useful in providing practical recommendations in caring for children with CHDs while informing relevant policies.


Subject(s)
Heart Defects, Congenital/diagnosis , Heart Defects, Congenital/psychology , Parents/psychology , Quality of Life , Surveys and Questionnaires , Adult , Child , Child, Preschool , Cohort Studies , Female , Heart Defects, Congenital/therapy , Humans , Male , Pediatric Nursing/methods , Perception , Self Report , Severity of Illness Index
2.
Hematology ; 23(2): 122-130, 2018 Mar.
Article in English | MEDLINE | ID: mdl-28766464

ABSTRACT

BACKGROUND: Persons with sickle cell disease (SCD) experience multiple medical and physical complications; the disease also has numerous effects on their social and emotional well-being. We hypothesized that adults with SCD in Jamaica experience moderate levels of stigma and illness uncertainty and that these experiences may be associated with socio-demographic factors, such as gender, educational status and economic status. METHODS: We surveyed 101 adults with SCD (54.5% female; mean age 31.6 ± 10.4 years; 72.2% homozygous SCD) using the Stigma in Sickle Cell Disease Scale (Adult), Mishel Uncertainty in Illness Scale (Adult) and a Socio-Demographic questionnaire. RESULTS: The mean stigma score was 33.6 ± 21.6 (range: 2-91) with no significant difference between males and females (32.3 ± 21.3 vs. 34.7 ± 21.9; p-value = 0.58). Illness uncertainty was greater in females than in males, though not statistically significant, (88.7 ± 13.5 vs. 82.6 ± 19.2; p-value: 0.07). Stigma and uncertainty had a significant positive correlation (r: 0.31; p-value: 0.01). In an age and sex controlled model, stigma scores were lower with higher numbers of household items (coef: -2.26; p-value: 0.001) and higher in those living in greater crowding (coef: 7.89; p-value: 0.002). Illness uncertainty was higher in females (coef: 6.94; p-value: 0.02) and lower with tertiary as compared with primary education (coef: -16.68; p-value: 0.03). CONCLUSION: The study highlights socioeconomic factors to be significant to the stigma and illness uncertainty experiences in SCD. Efforts by healthcare workers to reduce patient illness uncertainty may have additional impact, reducing their stigma.


Subject(s)
Anemia, Sickle Cell , Cost of Illness , Adult , Anemia, Sickle Cell/epidemiology , Anemia, Sickle Cell/genetics , Anemia, Sickle Cell/psychology , Female , Humans , Male , Middle Aged , Socioeconomic Factors
3.
J Man Manip Ther ; 24(2): 53-61, 2016 May.
Article in English | MEDLINE | ID: mdl-27559274

ABSTRACT

BACKGROUND: To date, no research has examined the reliability or predictive validity of manual unloading tests of the lumbar spine to identify potential responders to lumbar mechanical traction. PURPOSE: To determine: (1) the intra and inter-rater reliability of a manual unloading test of the lumbar spine and (2) the criterion referenced predictive validity for the manual unloading test. METHODS: Ten volunteers with low back pain (LBP) underwent a manual unloading test to establish reliability. In a separate procedure, 30 consecutive patients with LBP (age 50·86±11·51) were assessed for pain in their most provocative standing position (visual analog scale (VAS) 49·53±25·52 mm). Patients were assessed with a manual unloading test in their most provocative position followed by a single application of intermittent mechanical traction. Post traction, pain in the provocative position was reassessed and utilized as the outcome criterion. RESULTS: The test of unloading demonstrated substantial intra and inter-rater reliability K = 1·00, P = 0·002, K = 0·737, P = 0·001, respectively. There were statistically significant within group differences for pain response following traction for patients with a positive manual unloading test (P<0·001), while patients with a negative manual unloading test did not demonstrate a statistically significant change (P>0·05). There were significant between group differences for proportion of responders to traction based on manual unloading response (P = 0·031), and manual unloading response demonstrated a moderate to strong relationship with traction response Phi = 0·443, P = 0·015. DISCUSSION AND CONCLUSION: The manual unloading test appears to be a reliable test and has a moderate to strong correlation with pain relief that exceeds minimal clinically important difference (MCID) following traction supporting the validity of this test.

4.
Nurs Sci Q ; 28(4): 322-4, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26396217

ABSTRACT

This article is about Camp Hope, a two-week summer day program for children age 6-12 from low income families and violent neighborhoods and for children who are struggling academically or identified as having behavioral health issues. The camp is operated by House of Peace and Education (HOPE) a 501(c)(3) nonprofit company that began in 1996. The program is designed to offer enrichment activities in a caring community for young children. The theoretical framework behind the vision and policies is Parse's humanbecoming paradigm. In particular, the camp administrators and staff try to see all persons as co-creating of their everchanging humanuniverse process.


Subject(s)
Camping , Humanism , Tai Ji , Child , Child Welfare , Humans , Nursing Theory , Poverty
5.
J Man Manip Ther ; 23(1): 3-11, 2015 Feb.
Article in English | MEDLINE | ID: mdl-26309376

ABSTRACT

STUDY DESIGN: Randomized clinical trial. OBJECTIVES: To evaluate the effects of high-velocity, low-amplitude thrust manipulations (HVLATMs) and various messages on patients with musculoskeletal shoulder symptoms. BACKGROUND: Previous studies indicated that HVLATM directed at the thoracic spine and ribs resulted in improvements of shoulder range of motion, pain, and disability in patients with musculoskeletal shoulder symptoms. These studies did not explore if the outcome was dependent on thrust location, clinician communication with the patient, or if there were any lasting effects. METHODS: A consecutive sample of 100 patients with shoulder pain was randomized into four groups. Patients received one intervention session including: six thoracic HVLATM (spine versus scapula), a message about HVLATM (neutral versus positive), and standardized home exercises. Outcome measures included shoulder Numeric Pain Rating Scale (NPRS), NPRS with impingement testing, and Shoulder Pain and Disability Index (SPADI). Measurements were recorded prior to intervention, immediately following intervention, and at short-term follow-up. Kruskal-Wallis statistics were used for between-group comparisons and Wilcoxon signed ranks for within-group comparisons. RESULTS: Eighty-eight patients (22 per group) completed the study. Statistically significant differences were found for within-group comparisons for most time points assessed. No statistical differences were found for between-group comparisons. CONCLUSION: Patients improved following the interventions. Neither the type of HVLATM nor the message conveyed to the patients had a significant effect on the patients' improvements. LEVEL OF EVIDENCE: 1b.

6.
Hand (N Y) ; 9(4): 488-93, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25414610

ABSTRACT

PURPOSE: Distal radius fractures are a common injury. In the emergency room, trainees regularly assess these fractures using visual estimation. Our hypothesis is that assessment of radiographic parameters has sufficient accuracy for rendering treatment consistent with formal measurements. METHODS: This study compared visual measurements made by 25 orthopaedic residents and attending physicians to formal measurements made by a single fellowship trained musculoskeletal radiologist in a series of patients with distal radius fractures. A search was performed utilizing the ICD-9 code for distal radius fracture in all patients presenting to a single institution emergency department. Participants used visual estimation to rate 25 radiographs. Parameters estimated included radial inclination, radial height, volar tilt, and the presence of intra-articular displacement. Analysis using Lin concordance coefficients, Bland Altman plots, and the Kappa statistic evaluated the agreement between visual estimation and formal measurements. The proportion of raters whose estimates would have resulted in a course of treatment that conflicted with the formal reading quantified the potential impact of visual estimation on treatment. RESULTS: Concordance coefficients were poor for radial inclination (ρc = 0.13), radial height (ρc = 0.24), and volar tilt (ρc = 0.46). The Kappa statistic for intra-articular displacement was 0.4. Analysis performed according to level of training did not result in substantial improvements in these statistics. Treatment based on visual estimates conflicted with formal readings 34 % of the time for radial inclination, 38 % of the time for radial height, 27 % of the time for volar tilt, and 31 % of the time for intra-articular displacement. DISCUSSION: Visual estimation is not an adequate form of measurement for evaluation of patients with distal radius fractures. Physicians should be mindful of these results when developing treatment plans based solely upon visual estimation.

7.
J Hand Surg Am ; 38(4): 721-8, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23474155

ABSTRACT

PURPOSE: The reproductive hormone relaxin acts to loosen pelvic ligaments in preparation for childbirth and is thought to be a mediator of joint laxity. The purpose of this study was to evaluate the correlation of serum relaxin with radiographic laxity at the trapezial-metacarpal joint and with generalized joint laxity. METHODS: We enrolled 289 healthy subjects prospectively. Participants completed a demographic questionnaire and were examined for generalized joint hypermobility using the Beighton-Horan scale. Stress radiographs of the trapezial-metacarpal joint were obtained in 163 subjects (56%). Blood samples were collected, and serum relaxin was measured for 287 subjects using enzyme-linked immunosorbent assay for human relaxin-2. RESULTS: The mean serum relaxin level among all subjects was 1.84 pg/mL (range, 0-45.25 pg/mL). Relaxin was not detectable in 166 of 287 samples, whereas the mean serum relaxin level among the 121 subjects with a detectable relaxin level (of 287 total relaxin samples) was 4.37 pg/mL (range, 0.46-45.25 pg/mL). Mean trapezial-metacarpal subluxation ratio scores were higher among those with a detectable relaxin level compared to those without a detectable relaxin level (0.34 vs 0.30 pg/mL). The average Beighton-Horan laxity score was 1.8 (range, 0-9). There was no correlation between generalized joint laxity measures and serum relaxin levels. CONCLUSIONS: In a large volunteer population, we demonstrated a relationship between circulating relaxin and trapezial-metacarpal joint laxity. However, we were unable to show a direct link between serum relaxin and generalized joint laxity. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic II.


Subject(s)
Joint Instability/blood , Joint Instability/diagnostic imaging , Metacarpophalangeal Joint/diagnostic imaging , Relaxin/blood , Adult , Age Factors , Aged , Aged, 80 and over , Analysis of Variance , Biomarkers/blood , Cohort Studies , Enzyme-Linked Immunosorbent Assay , Female , Humans , Logistic Models , Male , Metacarpophalangeal Joint/physiology , Middle Aged , Predictive Value of Tests , Prospective Studies , Radiography , Reference Values , Sensitivity and Specificity , Trapezium Bone/diagnostic imaging , Trapezium Bone/physiology , Young Adult
8.
Clin Orthop Relat Res ; 471(2): 472-7, 2013 Feb.
Article in English | MEDLINE | ID: mdl-22948521

ABSTRACT

BACKGROUND: Industry and orthopaedic surgeons often partner to develop new technology, which can lead to orthopaedic surgeons having financial conflicts of interest (FCOI). It is essential these FCOI be conveyed clearly to patients. It is unclear, however, whether and to what degree patients understand the ramifications of physician FCOI. QUESTIONS/PURPOSES: We evaluated (1) patients' concerns regarding their surgeon having FCOI or the presence of institutional FCOI, (2) the effect of surgeon FCOI on patients' willingness to have surgery, and (3) patients' understanding of FCOI. METHODS: We asked 101 patients (66% female) receiving total joint arthroplasty from the orthopaedic practices of two surgeons at an academic health center to complete a descriptive, correlational designed survey at their 6-week followup appointment. The data collected included patient demographics, knowledge of FCOI, and the influence of FCOI on patient attitudes toward surgery and their surgeon. RESULTS: A minority of patients (13%) reported discussing FCOI with prior physicians and only 55% agreed or strongly agreed a surgeon should disclose FCOI. Only 15% of patients believed such conflicts would make them less likely to have their surgeon operate on them. Level of education was weakly correlated (Spearman's rho = 0.29) with patient understanding of FCOI. CONCLUSIONS: Overall, patients had a poor understanding of FCOI. Both level of education and previous discussions of FCOI predicted better understanding. This study emphasizes communication of FCOI with patients needs to be enhanced.


Subject(s)
Arthroplasty, Replacement/economics , Conflict of Interest , Orthopedic Procedures/economics , Physician-Patient Relations , Truth Disclosure , Adult , Aged , Aged, 80 and over , Communication , Comprehension , Female , Humans , Male , Middle Aged , Physicians , Surveys and Questionnaires
9.
Am J Orthop (Belle Mead NJ) ; 41(6): 262-7, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22837989

ABSTRACT

The purpose of this study was to evaluate carpal anatomy proficiency in orthopedic residents as well as emergency medicine physicians. Orthopedic surgery residents and emergency medicine physicians were tested on their understanding of normal carpal anatomy using a Wrist Anatomy Assessment (WAA) score, which consists of both palpation of carpal bony landmarks and radiographic interpretation of the carpal bones. There were 89 participants in this study. Cohorts of orthopedic residents (n = 20), emergency medicine residents (n = 21), emergency medicine attending physicians (n = 26), and 4th-year medical students (22) were used. Group size was based on 100% orthopedic resident involvement. Total WAA scores (score of 17 = 100% correct) ranged from 2 to 16, with a mean of 8.6. Carpal palpation and radiographic interpretation means were both significantly better in the orthopedic resident cohort (total WAA score, 13.8), compared with either of the emergency medicine groups (resident total WAA score, 7.5; attending total WAA score, 7.2). Orthopedic residents have a better understanding of the clinical and radiographic anatomy of the carpal bones than emergency medicine residents and attending physicians. Future research to test educational interventions to improve carpal anatomy education is warranted.


Subject(s)
Carpal Bones/diagnostic imaging , Clinical Competence , Emergency Medicine/education , Orthopedics/education , Carpal Bones/anatomy & histology , Humans , Internship and Residency , Medical Staff, Hospital/education , Physical Examination , Radiography
10.
J Hand Surg Am ; 37(1): 3-8, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22133704

ABSTRACT

PURPOSE: In this prospective, randomized, controlled study, we hypothesized that there would be no difference in short-term functional, subjective, and blinded wound outcome measures between patients treated after mini-open carpal tunnel release (CTR) with a postoperative bulky dressing for 2 weeks and those with dressing removal and placement of an adhesive strip after 48 to 72 hours. METHODS: A total of 94 consecutive patients underwent mini-open CTR and placement of a bulky dressing and were randomized to either bandage removal at 48 to 72 hours with placement of an adhesive strip or continuation of the postoperative dressing until initial follow-up at approximately 2 weeks. We evaluated patient demographics, Levine-Katz scores, range of motion, strength, and a blinded assessment of wound healing at approximately 2 weeks and between 6 and 12 weeks. We conducted paired and independent sample t-tests to evaluate for statistical significance. RESULTS: There was no significant difference in Levine-Katz scores between groups at either the first follow-up or final visit. One patient with a longer dressing duration had evidence of a wound dehiscence. CONCLUSIONS: Removal of a bulky dressing after mini-open CTR and replacement with an adhesive strip at 48 to 72 hours causes no wound complications and results in equal short-term clinical and subjective outcome measures compared with using a bulky dressing for 2 weeks. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.


Subject(s)
Bandages , Carpal Tunnel Syndrome/surgery , Decompression, Surgical/methods , Wound Healing/physiology , Adult , Female , Follow-Up Studies , Humans , Male , Middle Aged , Minimally Invasive Surgical Procedures/methods , Postoperative Care/methods , Prospective Studies , Time Factors
11.
Arthroscopy ; 28(2): 154-9, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22019235

ABSTRACT

PURPOSE: The purpose of this study was to determine the interobserver reliability of 3 commonly used classification systems in describing preoperative magnetic resonance imaging (MRI) studies of patients undergoing surgery for full-thickness rotator cuff tears. METHODS: Thirty-one patients who underwent arthroscopic rotator cuff repair and had preoperative MRI studies available were selected over a 2-year period. Three board-certified shoulder surgeons independently reviewed these images. Each was instructed in the published method for determining the Patte score on the T2 coronal images, supraspinatus and infraspinatus atrophy on the T1 sagittal images as described by Warner et al., and the Goutallier score of fatty infiltration of the supraspinatus on the T1 coronal/sagittal images. Statistical analysis was then performed to determine the interobserver agreement using the κ statistic, with the level of significance set a priori at P < .01. RESULTS: None of the classification systems studied yielded excellent or high interobserver reliability. The strongest agreement was found with the Patte classification assessing tendon retraction in the frontal plane (κ = 0.58). The Goutallier classification, which grades fatty infiltration of the supraspinatus, showed moderate interobserver agreement (κ = 0.53) when dichotomized into none to mild (grades 0, 1, and 2) and moderate to severe (grades 3 and 4). Muscle atrophy of both the supraspinatus and infraspinatus yielded the worst interobserver reliability, with only 28% agreement. CONCLUSIONS: The Goutallier, Patte, and Warner MRI classification systems for describing rotator cuff tears did not have high interobserver reliability among 3 experienced orthopaedic surgeons. Fatty infiltration of the supraspinatus and tendon retraction in the frontal planes showed only moderate reliability and moderate to high reliability, respectively. These findings have potential implications in the evaluation of the literature regarding the preoperative classification of rotator cuff tears and subsequent treatment algorithms. LEVEL OF EVIDENCE: Level III, diagnostic agreement study with nonconsecutive patients.


Subject(s)
Arthroscopy , Magnetic Resonance Imaging , Rotator Cuff Injuries , Humans , Observer Variation , Rotator Cuff/pathology , Rotator Cuff/surgery
12.
J Arthroplasty ; 26(8): 1161-4, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21802255

ABSTRACT

Despite the high volume of total hip arthroplasties (THAs) performed in North America, there is no consensus regarding postoperative implant surveillance. Therefore, an Internet survey of Hip Society members was performed to determine the timing of follow-up visits after THA. The surgeons were queried with respect to the time until the first and second postoperative visits and the interval of follow-up for the first and second decades. The average time until the first follow-up visit is 4.9 weeks, and 63% of patients are seen by 6 weeks after surgery. Ninety percent of respondents saw patients at 1 year after THA. Follow-up visits after year 1 were more variable. Guidelines for follow-up should be established to enhance patient outcomes over time.


Subject(s)
Arthroplasty, Replacement, Hip , Follow-Up Studies , Population Surveillance , Postoperative Period , Practice Patterns, Physicians' , Adult , Aged , Aged, 80 and over , Cost-Benefit Analysis , Data Collection , Female , Humans , Male , Middle Aged , North America , Office Visits/economics , Physician-Patient Relations , Time Factors
13.
Am J Sports Med ; 38(8): 1564-74, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20445013

ABSTRACT

BACKGROUND: Injuries to the posterolateral corner of the knee remain a challenging problem and have been cited frequently as a reason for failure of anterior and posterior cruciate ligament reconstructions. Although several reconstructive techniques currently exist, there are relatively few clinical outcomes data after reconstruction of the posterolateral corner. PURPOSE: The study was undertaken to examine the clinical outcomes and provide objective data using arthrometry and stress radiography of a posterolateral corner reconstruction technique. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A retrospective cohort study of a consecutive series of patients who underwent posterolateral corner reconstruction of the knee was evaluated. The surgery featured dual femoral tunnels, a transfibular tunnel, and a free graft to reconstruct the posterolateral corner of the knee. All patients had concomitant reconstruction of one or both cruciate ligaments. Outcomes were assessed using the Short Form-12, Lysholm, and Tegner knee scores. A clinical examination, KT-2000 arthrometry measurements, single-legged hop quotient, and varus and posterior Telos stress radiographs were obtained and compared with results for the contralateral, uninjured knees. RESULTS: Twenty-four (83%) of 29 consecutive patients were evaluated at a mean 39 months postoperatively (range, 24-81 months). The mean Lysholm and Tegner knee scores were 83 and 6, respectively. The mean difference (+/- standard deviation) in total anterior-posterior side-to-side KT arthrometry measurements was 1.4 +/- 1.3 mm. The varus stress radiographic mean side-to-side difference measured at 20 degrees of flexion was 0.2 +/- 1.9 mm. The mean radiographic posterior tibial displacement with a 15-kg stress at 90 degrees of flexion was 3.2 +/- 4.5 mm in patients undergoing posterior cruciate ligament reconstruction. CONCLUSION: This reconstruction of the posterolateral corner of the knee with concomitant cruciate ligament reconstruction restores varus and rotational stability at a minimum of 2 years postoperatively.


Subject(s)
Arthroplasty/methods , Knee Joint/surgery , Posterior Cruciate Ligament/surgery , Adolescent , Adult , Cohort Studies , Female , Humans , Knee Joint/diagnostic imaging , Male , Middle Aged , Posterior Cruciate Ligament/injuries , Radiography , Retrospective Studies , Surveys and Questionnaires , Treatment Outcome , Young Adult
14.
J Bone Joint Surg Am ; 91(9): 2287-95, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19724008

ABSTRACT

BACKGROUND: Many residency and fellowship programs have cadaver laboratories to teach and practice arthroscopic skills. However, there is currently no validated method of evaluating arthroscopic skill in this setting. The purpose of the present study was to develop and validate an objective model for evaluating basic arthroscopic proficiency on a cadaver knee in a bioskills laboratory. METHODS: Two measures from the educational literature were adapted for use specifically for arthroscopy: a task-specific checklist and a global rating scale were combined to create the Basic Arthroscopic Knee Skill Scoring System. Fifty-nine residents, three sports medicine fellows, and six sports medicine fellowship-trained attending surgeons were recruited. After completing a demographic survey, including the postgraduate year and number of knee and shoulder arthroscopies performed, each subject performed a diagnostic knee arthroscopy and a partial meniscectomy on a cadaver knee while being assessed by a single evaluator using the Basic Arthroscopic Knee Skill Scoring System. RESULTS: There was a strong positive correlation between global rating scale scores and both the postgraduate year (r = 0.93, p < 0.01) and the ranked number of knee arthroscopies performed (r = 0.88, p < 0.01). These scores detected significant differences between postgraduate years 1 and 2, and years 4 and 5 at the p

Subject(s)
Arthroscopy , Educational Measurement , Knee Joint/surgery , Models, Educational , Orthopedics/education , Adult , Benchmarking , Cadaver , Clinical Competence , Fellowships and Scholarships , Female , Humans , Internship and Residency , Male , Middle Aged , Models, Anatomic , Motor Skills , Pilot Projects
15.
Am J Sports Med ; 35(6): 979-85, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17395958

ABSTRACT

BACKGROUND: While hylan G-F 20 is an approved therapy for the treatment of knee osteoarthritis, there are few reports of its use in shoulder osteoarthritis. HYPOTHESIS: Hylan G-F 20 can reduce pain and improve function in patients with glenohumeral osteoarthritis. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Thirty consecutive patients with idiopathic glenohumeral osteoarthritis who failed to respond to standard conservative measures were enrolled. Patients received 3 weekly intra-articular hylan G-F 20 injections in their affected shoulder and completed a visual analog scale for pain, the UCLA score, and the Simple Shoulder Test at baseline and at 1, 3, and 6 months after the third injection. RESULTS: Of the 30 patients, 3 withdrew during the washout period before treatment; the remaining patients (17 men and 10 women) had an average age of 62 years. The mean baseline visual analog scale score was 54, UCLA score was 15.7, and Simple Shoulder Test score was 5.7 (of 12 possible "yes" responses). At the 6-month follow-up, hylan G-F 20 significantly improved visual analog scale (mean 30, P < .001), UCLA (mean 24, P < .001), and Simple Shoulder Test (7.6 "yes" responses, P < .001) scores. More patients slept comfortably after treatment (56%) versus before treatment (15%). Nine patients had a visual analog scale improvement >40 points after 6 months. No device-related adverse events were observed. CONCLUSION: Hylan G-F 20 may have a beneficial therapeutic effect on some symptomatic patients with glenohumeral osteoarthritis.


Subject(s)
Adjuvants, Immunologic/therapeutic use , Hyaluronic Acid/therapeutic use , Osteoarthritis/drug therapy , Shoulder Joint/drug effects , Adjuvants, Immunologic/pharmacology , Aged , Female , Humans , Hyaluronic Acid/pharmacology , Injections, Intra-Articular , Middle Aged , Outcome Assessment, Health Care , Shoulder Joint/physiopathology , United States
16.
Contemp Clin Trials ; 27(3): 295-303, 2006 Jun.
Article in English | MEDLINE | ID: mdl-16624631

ABSTRACT

Widely accepted standards and safeguards for research participants now include systematic surveillance and recording of adverse events. In the absence of a uniform regulation or structure for such reporting, each institution must now establish suitable yet efficient procedures to accomplish this task. We report herein our single center experience with a customized data collection, storage and review system specifically designed to identify and react appropriately to adverse events. Adverse events are classified by each investigator using three criteria in specific order: seriousness, expectedness and relatedness to the investigational intervention. Once classified, events are entered into an online database that includes collation, retrieval and search capabilities. Events meeting specified criteria are reviewed and adjudicated on a weekly basis by The University of Connecticut Research Adverse Events Committee, which makes advisory recommendations to the hospital's two Institutional Research Boards ranging from modification of informed consent to study suspension. Three hundred and seventy-one serious adverse events from > 900 studies were reviewed in the previous academic year. Our system, which combines timely on-line reporting with regular surveillance, provides a potential model that meets the need for comprehensive yet practical adverse events assessment and reporting.


Subject(s)
Adverse Drug Reaction Reporting Systems/standards , Algorithms , Biomedical Research/methods , Data Collection/standards , Ethics Committees, Research/standards , Human Experimentation/standards , Ethics, Research , Humans
17.
Rehabil Nurs ; 30(5): 180-7; discussion 188, 2005.
Article in English | MEDLINE | ID: mdl-16175923

ABSTRACT

Knowledge regarding the health status, functional status, and health-related quality of life (HRQOL) of youths with spina bifida is important in promoting optimal health care and preventing secondary conditions. A descriptive study using a convenience sample of 60 youth (15- to 25-year olds) with spina bifida from the northeastern United States was conducted to examine the relationship among health status (severity of illness), functional status, and HRQOL. The findings indicated that 28% (n = 17) of the youths were healthy other than having spina bifida, 72% (n = 43) reported secondary health conditions, and 32% (n = 19) reported additional comorbid conditions. The sample reported a high level of functional status on the FIM; the mean was 116.8 (SD = 7.07, range = 90-126). Bowel and bladder incontinence, the inability to traverse stairs, and select memory deficits were identified as more frequent functional limitations. The youth reported a high level of HRQOL; mean was 200.8 (SD = 19.54, range = 155-232). A regression analysis was performed, with HRQOL entered as the criterion; the results were not statistically significant (r2 = .02, df = 2, 57, p = .57). The researcher concluded that youths with spina bifida reported a high level of satisfaction with HRQOL, are succeeding at college, participating in recreation, sport activities, and other aspects of young adult living, and yet they are experiencing a number of secondary health conditions that leave them with concerns for their future.


Subject(s)
Activities of Daily Living , Health Status , Health Surveys , Quality of Life , Spinal Dysraphism/rehabilitation , Adolescent , Adult , Comorbidity , Female , Humans , Male , New England/epidemiology , Pilot Projects , Regression Analysis , Reproducibility of Results , Severity of Illness Index , Spinal Dysraphism/epidemiology
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