Clinicians and patients' welfare: where does academic freedom fit in?
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Biomedical Research↗
Biomedical subjects
James G Wright
Publications and source records attributed to James G Wright.
Perceptions of, and willingness to consider, total joint arthroplasty in a population-based cohort of individuals with disabling hip and knee arthritis.
OBJECTIVE: To examine perceptions of total joint arthroplasty (TJA) and how they relate to willingness to consider TJA. METHODS: A population-based survey in Oxford County, Ontario, Canada identified 1,735 subjects > or =55 years with disabling hip or knee arthritis; 435 English-speaking respondents with no prior TJA and not on a TJA waiting list were invited to participate, and 379 (37.1%) agreed. We assessed demographics; comorbidity; evaluated and perceived arthritis severity; perceived risks, benefits, indications for, and knowledge of TJA; preferred decision-making style; self efficacy; and willingness to consider TJA by questionnaire. RESULTS: Participants' mean age was 67.6 years; 33.5% were willing (definitely or probably) to consider TJA as a treatment option. Willingness was independently associated with younger age (odds ratio [OR] <75 versus > or =75 years 2.42, P = 0.01); worse perceived arthritis severity (OR per unit increase 1.30, P < 0.001); perceiving TJA as appropriate for moderate, controlled joint pain (OR 3.29, P = 0.004); walking limited to <1 block (OR 1.99, P = 0.015); the risk of revision as acceptable (OR 3.73, P < 0.001); and friends as an important health information source (OR 2.49, P = 0.01). CONCLUSIONS: Participants overestimated the pain and disability needed to warrant TJA. These misperceptions were strongly associated with unwillingness to consider TJA and should be addressed at a population level.
Aged↗
Validation exercise of the Ankylosing Spondylitis Assessment Study (ASAS) group response criteria in ankylosing spondylitis patients treated with biologics.
OBJECTIVES: To define what expert clinicians consider a dramatic response in ankylosing spondylitis (AS) patients treated with biologic therapies based on patient and physician assessments of global disease activity. To compare this expert clinician-derived criteria to the Ankylosing Spondylitis Assessment Study (ASAS) Group criteria for improvement. METHODS: Forty consecutive AS patients were treated in a 1-year open-label protocol with infliximab. Response to treatment at week 52 was defined using ASAS response criteria. For the purpose of this exercise, improvement using ASAS criteria was defined by consensus among experts as good with 50% improvement from baseline (ASAS(50)) and dramatic with 70% improvement from baseline (ASAS(70)). Experts established separate criteria for improvement in disease activity as good or dramatic based on patient and physician global assessment of disease activity. RESULTS: Twelve of 40 patients met the ASAS(70) criteria, however, only 8 met the expert definition of a dramatic improvement based on physician global scores and 5 met the expert definition of a dramatic improvement based on patient global assessment of disease activity. Agreement was poor between ASAS(50) or ASAS(70) and expert definition of improvement based on physician global scores (kappa < 0.3), but agreement was moderate to good between ASAS(50) or ASAS(70) and expert definition of improvement based on patient global scores, (kappa = 0.6-0.7). CONCLUSIONS: Differential response experienced by AS patients treated with infliximab was adequately captured by the ASAS composite improvement criteria. Overall, this study demonstrates the validity of the ASAS criteria for the detection of improvement in AS patients treated with biologics. However, the patient global assessment of disease activity may be sufficient to monitor changes in disease activity in these patients.
Adult↗
Urban/rural variation in children's bicycle-related injuries.
The objective of this study was to examine bicycle-related injury rates for children living in urban and rural areas. Data on all Canadian children hospitalised because of bicycling-related injuries (1994-1998) were obtained from the Canadian Institute for Health Information (CIHI). Injured children were classified as residing in urban, mixed urban, mixed rural or rural areas. Incidence rates for bicycle-related head injuries and other bicycle-related injuries were calculated. Logistic regression was used to estimate the odds of head injury, controlling for age, sex, socio-economic status (SES), collision with a motor vehicle, and the presence of provincial helmet legislation. In total, 9367 children were hospitalised for a bicycling-related injury over the 4-year-study period. Of these, 21% occurred in rural areas, 18% in mixed rural, 17% in mixed urban, while the remaining 44% occurred in urban areas. The average annual incidence rate for bicycle-related head injuries in children was 18.49 per 100000 for children living in rural areas compared with 10.93 per 100000 for those living in urban areas, 15.49 for children in mixed urban areas and 17.38 for children living in mixed rural areas. This variation may be explained by differences in bicycling exposure, helmet use, hospital admission criteria, or road environments across geographic areas.
Accidents, Traffic↗
Testing a new theory of patient satisfaction with treatment outcome.
OBJECTIVES: Theories of patient satisfaction with treatment outcome have not been developed and tested in healthcare settings. The objectives of this study were to test a new theory linking patient satisfaction and embodiment (body--self unity) and examine it in relation to other competing theories. DESIGN: We conducted a prospective cohort study. SETTING: This study was conducted at a tertiary care hospital. PATIENTS: We studied 122 individuals undergoing elective hand surgery. METHODS: Satisfaction with treatment outcome approximately 4 months after surgery was examined against the following factors (representing 7 theories of satisfaction): 1) overall clinical outcome, 2) patients' a priori self-selected important clinical outcomes, 3) foresight expectations, 4) hindsight expectations, 5) psychologic state, 6) psychologic state in those with poor outcomes, and 7) embodiment. ANALYSIS: Seven hypotheses were tested first using univariate analyses and then multivariable regression analysis. RESULTS: Satisfaction with treatment outcome was significantly associated with embodiment. Three confounders--the extent to which surgery successfully addressed patients' most important reason for surgery, hindsight expectations, and workers' compensation--were also significant. The final model explained 84% of the variance in a multidimensional measure of satisfaction with treatment outcome. CONCLUSION: This research suggests that satisfaction with treatment outcome could be facilitated by developing strategies to improve body--self unity, and eliciting and addressing the patient's most important reason for undergoing treatment.
Adolescent↗
Understanding the meaning of satisfaction with treatment outcome.
OBJECTIVE: Although satisfying patients is an important goal in health care, what is meant by satisfaction in relation to treatment outcome is not clear. The objective of this study was to explore patients' perspectives on the meaning of satisfaction with treatment outcome. DESIGN: We conducted a qualitative exploratory study. SETTING: This study was conducted at an adult tertiary care hospital. PATIENTS: Individuals who had undergone elective hand surgery were included in this study. INTERVENTION: In-depth, open-ended interviews in which 31 participants described their experience of a hand condition, how they evaluated the outcome of surgical interventions, and what it meant to be satisfied or dissatisfied with these outcomes were examined. ANALYSIS: : Interview transcripts were analyzed using Gadow's conceptualization of embodiment states: "object body" (disunity between the affected hand and the self) or "cultivated immediacy" (harmony between the hand and the self). RESULTS: Eight of 9 dissatisfied individuals were categorized as "object body" and 15 of 19 satisfied individuals were in, or in transition to, "cultivated immediacy". These states fluctuated and were also dependent on context (eg, social setting) and time since surgery. CONCLUSION: In relation to the outcome of hand surgery, satisfaction was experienced as a relative lack of tension between the patient's sense of self and the affected hand (ie, satisfaction was having a hand that could be lived with unself-consciously). Emotional and social effects of interventions and the influence of context should be considered in future measures of satisfaction with treatment outcome. Finally, interventions directed toward facilitating patients' experience of body-self unity could promote satisfaction with treatment outcome.
Adult↗
An AOA critical issue. The outcome of the outcomes movement.
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Age Distribution↗
Interobserver agreement in the application of levels of evidence to scientific papers in the American volume of the Journal of Bone and Joint Surgery.
BACKGROUND: Since January 2003, all clinical scientific articles published in the American volume of The Journal of Bone and Joint Surgery (JBJS-A) have included a level-of-evidence rating. The aim of the current study was to evaluate the interobserver agreement among reviewers, with varying levels of epidemiology training, in categorizing the levels of evidence of these clinical studies. METHODS: Fifty-one consecutive clinical papers published in the American volume of JBJS were identified by a computerized search of the table of contents from January 2003 through June 2003. Each paper was blinded so that only the title, abstract (without the level of evidence designated), and methods section were provided to the reviewers. The papers were coded and were randomly organized in a binder. Six surgeons graded each blinded paper for (1) the type of study (therapeutic, prognostic, diagnostic test, or economic or decision analysis), (2) the level of evidence (on a scale of I through V), and (3) the subcategory within the particular level of evidence. Three surgeons were members of JBJS American Editorial Board, two surgeons were reviewers for JBJS-A, and one surgeon was an active researcher not formally associated with JBJS-A. The reviewers did not receive any formal training in the application of the classification system, but each was provided with a detailed description of the classification system used by JBJS-A. Intraclass correlation coefficients with 95% confidence intervals were determined for the reviewers' agreement regarding the type of study, level of evidence, and subcategory within the level of evidence. RESULTS: The majority (69%) of the fifty-one included articles were studies of therapy, and 57% of the studies constituted Level-IV evidence. The intraclass correlation coefficients for the agreement among all reviewers with regard to the study type, level of evidence, and subcategory within the level of evidence ranged from 0.61 to 0.75. Reviewers trained in epidemiology demonstrated greater agreement (range in intraclass correlation coefficients, 0.99 to 1.0), across all aspects of the classification system, than did reviewers who were not trained in epidemiology (range in intraclass correlation coefficients, 0.60 to 0.75). CONCLUSIONS: These findings suggest that epidemiology and non-epidemiology-trained reviewers can apply the levels-of-evidence guide to published studies with acceptable interobserver agreement. The validity of this system remains a question for future research.
Evidence-Based Medicine↗
The moving target: a qualitative study of elderly patients' decision-making regarding total joint replacement surgery.
BACKGROUND: Total joint replacement is an accepted, cost-effective, and underutilized treatment for moderate-to-severe hip and knee arthritis. Yet, research has suggested that many patients with arthritis are unwilling to consider total joint replacement surgery. We sought to understand these patients' unwillingness by exploring the nature of their decision-making processes. METHODS: In-depth interviews were conducted with seventeen individuals with moderate-to-severe arthritis who were appropriate candidates for, but unwilling to consider, total joint replacement. The interviews were analyzed with use of qualitative methods and content analysis techniques. RESULTS: Symptoms and information sources were the two main factors influencing patient decision-making. Participants engaged in individualized processes of trading off perceived costs and benefits. Accommodation to pain and disability and minimization of the quality-of-life benefit, in view of decreasing life span, led to a process whereby the threshold at which the benefits compared with the risks would tilt in favor of total joint replacement was constantly shifting, a phenomenon we called "the moving target." CONCLUSIONS AND CLINICAL RELEVANCE: The moving-target characterization sheds light on patients' conceptions of their arthritis and on their unwillingness to consider total joint replacement. This process needs to be considered when developing ways to aid decision-making.
Age Factors↗
Using publicly available directories to trace survey nonresponders and calculate adjusted response rates.
In population-based surveys, sample lists are often out of date by the time data collection begins. Consequently, response rates, and the perceived validity of the survey, may be compromised by the unknowing inclusion of ineligible subjects. A strategy to address this issue is ascertainment of survey nonrespondents' eligibility status, enabling post hoc adjustment of response rates. In 1995-1996, population surveys were carried out in two Ontario, Canada, communities. Despite intensive follow-up, the status of 8949 (18.6%) of the 48218 potential subjects in these surveys remained unknown. In response, 500 "unknowns" from each community were randomly selected for tracing by using publicly available telephone directories and, where applicable, city directories. These tracing efforts classified persons into one of three groups: "ineligible" (moved before the mailing), "true nonresponder" (present when the survey was mailed), and "remains unknown" (no directory listing found). Publicly available directories clarified the status of 76.0% of potential participants, reducing the proportion of "unknowns" from 18.6% to 4.6%. Applying the estimated proportions of "ineligibles" from each area resulted in response rates adjusted from 63.8% to 71.2% and from 72.8% to 74.9% in the survey areas. Publicly available directories were used to successfully trace the majority of survey nonresponders, thus strengthening confidence in the survey's results.
Aged↗
A population pharmacokinetic model for doxorubicin and doxorubicinol in the presence of a novel MDR modulator, zosuquidar trihydrochloride (LY335979).
PURPOSE: To develop a population pharmacokinetic model for doxorubicin and doxorubicinol in the presence of zosuquidar.3HCl, a potent P-glycoprotein inhibitor. METHODS: The population approach was used (implemented with NONMEM) to analyse doxorubicin-doxorubicinol pharmacokinetic data from 40 patients who had received zosuquidar.3HCl and doxorubicin intravenously (separately in cycle 1 and concomitantly in cycle 2 over 48 h and 0.5 h, respectively). RESULTS: A five-compartment pharmacokinetic model (including three compartments for doxorubicin pharmacokinetics with two pathways for doxorubicinol formation) best described the doxorubicin-doxorubicinol pharmacokinetics in the presence of zosuquidar.3HCl. Doxorubicin clearance (CL), peripheral volume of distribution (V2) and doxorubicinol apparent clearance (CLm/fm) and apparent volume of distribution (Vm/fm) were 62.3 l/h, 2360 l, 143 l/h and 3150 l, respectively, in the absence or presence of low doses of zosuquidar.3HCl (<500 mg). In the presence of high doses of zosuquidar.3HCl (>or=500 mg), these values decreased by 25%, 26%, 48% and 73%, respectively, and doxorubicinol pharmacokinetics were characterized by a delayed t(max) (24 h versus 4 h), which led to the inclusion of the parallel pathways. A decrease in the objective function ( P<0.005) was observed when the impact of zosuquidar.3HCl was accounted for. CONCLUSIONS: This integrated parent-metabolite population pharmacokinetic model accurately characterized the increase in doxorubicin and doxorubicinol exposure (1.33- and 2-fold, respectively) in the presence of zosuquidar.3HCl (>or=500 mg) and provided insights into the pharmacokinetic interaction, which may be useful in designing future clinical trials.
Adult↗
The metaphor of patients as customers: implications for measuring satisfaction.
The use of satisfaction surveys in health care reflects the current tendency to think metaphorically of patients as "customers." This article reflects critically on the logic underlying this metaphor because metaphors are integral to the meaning of concepts. We argue that because the metaphor works differently when considering satisfaction with the process of care and satisfaction with treatment outcome, there are theoretical reasons for assessing these concepts from different perspectives. It seems reasonable to ask patients to rate their satisfaction with the processes of care or services received (e.g., hospital food, the physical environment) in much the same way they would rate services received at a repair shop or restaurant. When evaluating satisfaction with treatment outcome, however, the customer metaphor is problematic because the body is made an object when it is conceived of as the repairable possession of a customer. We conclude that measures of satisfaction with treatment outcome should be based on the assumption that rather than having bodies, people are embodied. Hence, the validity of satisfaction with treatment outcome would be enhanced by questions about psychologic, social, and experiental aspects of treatment outcome.
Health Services Research↗
Delphi as a method to establish consensus for diagnostic criteria.
BACKGROUND/OBJECTIVES: To achieve a consensus, among a panel of experts, on the best clinical criteria for the clinical diagnosis of carpal tunnel syndrome (CTS). METHODS: Experts rated the diagnostic importance of items from the clinical history and physical examination for CTS. The ratings were expressed on a 10-cm visual analog scale. The average and standard deviation of the scores for each item were returned to the panelists. The panel members evaluated the items a second time with knowledge of the group responses from the first round. The scores were standardized to minimize scaling variations and, after the second round, the items were ranked in order of importance assigned by the group. Cronbach's alpha was used as a measure of homogeneity for the rankings. Increasing homogeneity was considered to be an indication of consensus among the panelists. RESULTS: Cronbach's alpha increased from 0.86 after the first round to 0.91 after the second iteration. Panelists who were relative outliers on the first round demonstrated a much higher correlation with the entire group after the second round. CONCLUSIONS: Delphi is an effective method of establishing consensus for certain clinical questions. Cronbach's alpha was a useful statistic for measuring the extent of consensus among the panel members. Delphi was chosen from the possible methods of group process because of its inherent feasibility. The absence of a need by the panelists to meet in person removed any constraint on the geographic location of the panel members. In addition, the anonymous nature of Delphi was thought to be a key factor in avoiding a result that might be skewed by one or more persuasive panelists. Both of these characteristics were felt to be particularly important to the topic on which consensus was sought, the clinical diagnostic criteria for CTS. This movement in the opinions of some of the panelists appeared to result from the feedback of information describing the group opinion.
Carpal Tunnel Syndrome↗
Interpreting health-related quality of life scores: the simple rule of seven may not be so simple.
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Data Interpretation, Statistical↗
Long-term outcome after tibial shaft fracture.
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Casts, Surgical↗
Introducing levels of evidence to the journal.
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Evidence-Based Medicine↗
Patient and provider factors related to comprehensive arthritis care in a community setting in Ontario, Canada.
OBJECTIVE: To determine factors that correlate with recommendations for nonpharmacologic and pharmacologic interventions (comprehensive therapy) in community dwelling adults. METHODS: Eligible participants were >/= 55 years of age with hip and knee arthritis symptoms and disability. Comprehensive therapy was classified as a recommendation for exercise and weight loss (if required) and any pharmacotherapy. RESULTS: Only one-half of participants received a recommendation for comprehensive therapy. Participants who had seen a specialist and a therapist were almost twice as likely to receive a recommendation for comprehensive therapy. CONCLUSION: In our setting, many people with hip or knee arthritis were not receiving even minimum recommended treatment. Changes in educational and organizational policies are needed to address this situation.
Comprehensive Health Care↗
Are seat belt restraints as effective in school age children as in adults? A prospective crash study.
OBJECTIVE: To study effectiveness of seat belts for protecting school age children in road vehicle crashes. DESIGN: Crash examinations by trained investigators. SETTING: Ten Canadian university based crash investigation centres. SUBJECTS: 470 children aged 4-14 years, with 168 selected for detailed analysis, and 1301 adults. MAIN OUTCOME MEASURES: Use of seat belts by vehicle occupants; severity of injury adjusted for age and crash severity. RESULTS: Overall, 40% (189/470) of children were unbelted. Of the 335 children in cars driven by belted adults, 73 (22%) were unbelted. The odds of sustaining fatal or moderately severe injury (injury severity score > or =4) for children in the front passenger seat was more than nine times higher for unbelted children than for belted ones (odds ratio 9.8 (95% confidence interval 2.4 to 39.4)) and for those in the rear left seat was more than two times higher for unbelted than for belted children (2.6 (1.1 to 5.9)). The protection afforded by seat belts compared favourably with the results for adults in the same seat positions (odds ratios for unbelted v belted adults of 2.4 and 2.7 for front and rear seat passengers respectively). CONCLUSIONS: Seat belts helped to protect school age children from injury in road vehicle crashes. However, 40% of children were unbelted. Despite standard seat belts being designed for adults, school age children were at least as well protected as adults.
Accidents, Traffic↗