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Biomedical subjects

G Wells

Publications and source records attributed to G Wells.

At least 55 records · Page 3Linked to original sources
PubMed2001

Splints/orthoses in the treatment of rheumatoid arthritis.

BACKGROUND: Splints/orthoses are often recommended to patients with rheumatoid arthritis (RA) to decrease pain, decrease swelling and/or prevent deformity. These orthoses include resting hand splints, wrist supports, finger splints and special shoes and shoe inserts. OBJECTIVES: To assess the effectiveness of splints/orthoses in relieving pain, decreasing swelling and/or preventing deformity and determine the impact of splints/orthoses on strength, mobility and function in people with RA. SEARCH STRATEGY: We searched MEDLINE, EMBASE, the PEDro data base and Current Contents up to January 2002, and the Cochrane Controlled Trials Register to Issue 4, 2001 using the search strategy developed by the Cochrane Collaboration. Unpublished studies were sought by hand searching conference proceeding and contacting key experts. SELECTION CRITERIA: All randomized control trials (RCTs) and controlled clinical trials (CCTs), case-control and cohort studies comparing the use of specific orthoses against placebo, another active intervention (including another type of orthoses) or regular treatment were selected, according to an a priori protocol. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected the studies and abstracted data. The methodological quality of the RCTs and CCTs was assessed using a validated scale. MAIN RESULTS: Twelve papers reporting on 10 studies met the inclusion criteria. These studies dealt with the following: working wrist splints (5), resting hand and wrist splints (2), special shoes and insoles (3). There is evidence that wearing working wrist splints statistically significantly decreases grip strength and does not affect pain, morning stiffness, pinch grip, quality of life after up to 6 months of regular wear. We found no evidence that resting wrist and hand splints change pain, grip strength, Ritchie Index or number of swollen joints. However, patients who wore these splints for 2 months reported that they preferred use to non-use and padded resting splints to unpadded ones. The one study of special shoes provided evidence of significant benefits of wearing extra-depth shoes for 2 months including less pain on walking and stair climbing and more minutes pain free walking time. Extra-depth shoes with semi-rigid insoles provided better pain relief than extra-depth shoes alone when worn over 12 weeks. Posted insoles prevented progression of hallux valgus angle but did not affect pain or function. REVIEWER'S CONCLUSIONS: There is insufficient evidence to make firm conclusions about the effectiveness of working wrist splints in decreasing pain or increasing function for people with RA. Potential adverse effects such as decreased range of motion do not seem to be an issue, although some of these splints decrease grip strength and dexterity. Similarly, preliminary evidence suggests that resting hand and wrist splints do not seem to affect range of motion or pain, although patients preferred wearing a resting splint to not wearing one. There is evidence that extra-depth shoes and molded insoles decreases pain on weight-bearing activities such as standing, walking and stair-climbing. Posted insoles may be effective in preventing progression of hallux abductus angle but do not appear to have an impact on pain.

Arthritis, Rheumatoid↗
PubMed2001

Structured exercise improves physical functioning in women with stages I and II breast cancer: results of a randomized controlled trial.

PURPOSE: Self-directed and supervised exercise were compared with usual care in a clinical trial designed to evaluate the effect of structured exercise on physical functioning and other dimensions of health-related quality of life in women with stages I and II breast cancer. PATIENTS AND METHODS: One hundred twenty-three women with stages I and II breast cancer completed baseline evaluations of generic and disease- and site-specific health-related quality of life, aerobic capacity, and body weight. Participants were randomly allocated to one of three intervention groups: usual care (control group), self-directed exercise, or supervised exercise. Quality of life, aerobic capacity, and body weight measures were repeated at 26 weeks. The primary outcome was the change in the Short Form-36 physical functioning scale between baseline and 26 weeks. RESULTS: Physical functioning in the control group decreased by 4.1 points, whereas it increased by 5.7 points and 2.2 points in the self-directed and supervised exercise groups, respectively (P =.04). Post hoc analysis showed a moderately large (and clinically important) difference between the self-directed and control groups (9.8 points; P =.01) and a more modest difference between the supervised and control groups (6.3 points; P =.09). No significant differences between groups were observed for changes in quality of life scores. In a secondary analysis of participants stratified by type of adjuvant therapy, supervised exercise improved aerobic capacity (+3.5 mL/kg/min; P =.01) and reduced body weight (-4.8 kg; P <.05) compared with usual care only in participants not receiving chemotherapy. CONCLUSION: Physical exercise can blunt some of the negative side effects of breast cancer treatment, including reduced physical functioning. Self-directed exercise is an effective way to improve physical functioning compared with usual care. In participants not receiving chemotherapy, supervised exercise may increase aerobic capacity and reduce body weight compared with usual care.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2001

Transcutaneous electrical nerve stimulation (TENS) for chronic low back pain.

BACKGROUND: Low back pain (LBP) affects a large proportion of the population. Transcutaneous electrical nerve stimulation (TENS) was introduced more than 30 years ago as an alternative therapy to pharmacological treatments for chronic pain. However, despite its widespread use, the effectiveness of TENS is still controversial. OBJECTIVES: The aim of this systematic review was to determine the efficacy of TENS in the treatment of chronic LBP. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PEDro and the Cochrane Controlled Trials Register up to June 1, 2000. SELECTION CRITERIA: Only randomized controlled clinical trials of TENS for the treatment of patients with a clinical diagnosis of chronic LBP were included. Abstracts were excluded unless further data could be obtained from the authors. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochran's Q test. A fixed effects model was used throughout for continuous variables, except where heterogeneity existed, in which case, a random effects model was used. Results are presented as weighted mean differences (WMD) with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences (SMD) were calculated by dividing the difference between the treated and control by the baseline variance. SMD were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. MAIN RESULTS: Five trials were included, with 170 subjects randomized to the placebo group receiving sham-TENS and 251 subjects receiving active TENS (153 for conventional mode, 98 for acupuncture-like TENS). The schedule of treatments varied greatly between studies ranging from one treatment/day for two consecutive days, to three treatments/day for four weeks. There were no statistically significant differences between the active TENS group when compared to the placebo TENS group for any outcome measures. Subgroup analysis performed on TENS application and methodological quality did not demonstrate a significant statistical difference. Remaining pre-planned subgroup analysis was not conducted due to the small number of included trials and the variety of outcome measures reported. REVIEWER'S CONCLUSIONS: The results of the meta-analysis present no evidence to support the use of TENS in the treatment of chronic low back pain. Clinicians and researchers should consistently report the characteristics of the TENS device and the application techniques used. New trials on TENS should make use of standardized outcome measures. This meta-analysis lacked data on how TENS effectiveness is affected by four important factors: type of applications, site of application, treatment duration of TENS, optimal frequencies and intensities.

Chronic Disease↗
PubMed2001

Therapeutic ultrasound for osteoarthritis of the knee.

BACKGROUND: Therapeutic ultrasound is one of several physical therapy modalities suggested for the management of pain and loss of function due to OA. OBJECTIVES: To assess the effectiveness of therapeutic ultrasound therapy for treating OA. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group trials register, and MEDLINE, up to the end of December 2000, using the sensitive search strategy developed by the Cochrane Collaboration. The search was complemented with bibliography searching of the reference list of the trials retrieved from the electronic search. Key experts in the area were contacted for further published and unpublished articles. SELECTION CRITERIA: All randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing therapeutic ultrasound against placebo or another active intervention in patients with OA were selected. DATA COLLECTION AND ANALYSIS: Two reviewers determined the studies to be included based on inclusion and exclusion criteria (LB, VW). Data were independently abstracted by two reviewers (VW, LB), and checked by a third reviewer (BS) using a pre-developed adapted form for the OA sub-group of the Cochrane Musculoskeletal Group. The same two reviewers, using a validated scale, assessed the methodological quality of the RCTs and CCTs independently. OA outcome measures were extracted from the publications. The pooled analysis was performed using weighted mean differences (WMDs) for joint counts, pain, global and functional assessments. A chi-square test was used to assess heterogeneity among trials. Fixed effects models were used throughout and random effects for outcomes showing heterogeneity. MAIN RESULTS: Three trials, including 294 patients with knee OA were included. Only one trial (n=74) compared therapeutic ultrasound to placebo. This trial showed no difference in range of motion, pain or gait velocity after 4 weeks of therapeutic ultrasound. Two trials compared therapeutic ultrasound to an active therapy (n=220). These trials showed no statistical difference between galvanic current or short wave diathermy for the outcomes of pain and patient-assessed improvement. REVIEWER'S CONCLUSIONS: Ultrasound therapy appears to have no benefit over placebo or short wave diathermy for patients with knee OA. These conclusions are limited by the poor reporting of the characteristics of the device, of the population, of the OA,and therapeutic application of the ultrasound and low methodological quality of the trials included. No conclusions can be drawn about the use of ultrasound in smaller joints such as the wrists or hands.

Adult↗
PubMed2001

Therapeutic ultrasound for treating patellofemoral pain syndrome.

BACKGROUND: Therapeutic ultrasound is one of several rehabilitation interventions suggested for the management of pain due to patellofemoral pain syndrome. OBJECTIVES: To assess the effectiveness and side effects of ultrasound therapy for treating patellofemoral pain syndrome. SEARCH STRATEGY: We searched MEDLINE, Embase, Healthstar, Sports Discus, CINAHL, the Cochrane Controlled Trials Register, the PEDro database, the specialized registry of the Cochrane musculoskeletal group and the Cochrane field of physical and related therapies up to December 2000 according to the sensitive search strategy for RCTs designed for the Cochrane Collaboration. The search was complemented with handsearching of the reference lists. Key experts in the area were contacted for further articles. SELECTION CRITERIA: All randomized controlled trials (RCTs) and controlled clinical trials (CCTs), case-control and cohort studies comparing therapeutic ultrasound against placebo or another active intervention in patients with patellofemoral pain syndrome were selected, according to an a priori protocol. DATA COLLECTION AND ANALYSIS: Two reviewers determined the studies to be included based on a priori inclusion criteria (LB, VAR). Data were independently abstracted by the same two reviewers, and checked by a third reviewer (BS) using a pre-developed form. The same two reviewers, using a validated scale, independently assessed the methodological quality of the RCTs and CCTs. The data analysis was performed using Peto Odds ratios. MAIN RESULTS: The search retrieved 85 articles. Of the 8 that were potentially relevant, only one RCT, including 53 patients with patellofemoral pain syndrome, was included. All patients received exercises as a concurrent therapy. Ultrasound combined with ice massage contrast (n=13) was not statistically different from ice massage alone (n=16) in terms of patient-rated pain relief improvement, quadriceps and hamstring strength. In the ultrasound and ice massage group, 46% (6/13) reported improved pain relief compared to 31% (4/13) in the ice massage alone group. This difference of 15% does not meet international standards for clinically important improvement in osteoarthritis of 20%. Side effects were not reported. REVIEWER'S CONCLUSIONS: Ultrasound therapy was not shown to have a clinically important effect on pain relief for patients with patellofemoral pain syndrome. These conclusions are limited by the poor reporting of the therapeutic application of the ultrasound and low methodological quality of the trial included. No conclusions can be drawn concerning the use or non use of ultrasound for treating patellofemoral pain syndrome. More well-designed studies are needed.

Humans↗
PubMed2001

Etidronate for treating and preventing postmenopausal osteoporosis.

OBJECTIVES: To systematically review the efficacy of etidronate on bone density, fractures and toxicity in postmenopausal women. SEARCH STRATEGY: We searched MEDLINE from 1966 to December 1998, examined citations of relevant articles, and the proceedings of international osteoporosis meetings. We contacted osteoporosis investigators to identify additional studies, primary authors, and pharmaceutical industry sources for unpublished data. SELECTION CRITERIA: We included thirteen trials (with 1010 participants) that randomized women to etidronate or an alternative (placebo or calcium and/or vitamin D) and measured bone density for at least one year. DATA COLLECTION AND ANALYSIS: For each trial, three independent reviewers assessed the methodological quality and abstracted data. MAIN RESULTS: The data suggested a reduction in vertebral fractures with a pooled relative risk of 0.60% (95% CI 0.41 to 0.88). There was no effect on non-vertebral fractures (pooled relative risk 1.00, (95% CI 0.68 to 1.42)). Etidronate, relative to control, increased bone density after three years of treatment in the lumbar spine by 4.27% (95% CI 2.66 to 5.88), in the femoral neck by 2.19% (95% CI 0.43, 3.95) and in the total body by 0.97% (95% CI 0.39, 1.55). Effects were larger at 4 years, though the number of patients followed was much smaller. REVIEWER'S CONCLUSIONS: Etidronate increases bone density in the lumbar spine and femoral neck. The pooled estimates of fracture reduction with etidronate are consistent with a reduction in vertebral fractures, but no effect on non-vertebral fractures.

Bone Density↗
PubMed2001

Do silicone breast implants cause rheumatologic disorders? A systematic review for a court-appointed national science panel.

OBJECTIVE: To assist in evaluating expert testimony and scientific evidence presented in law suits brought against silicone breast implant manufacturers, a US District Court Order established a National Science Panel to assess whether existing studies provide scientific evidence of an association between silicone breast implants and systemic classic/accepted connective disease, atypical connective disease, and certain signs and symptoms identified by plaintiffs in the law suits. Local disorders potentially associated with these implants were not addressed in this review. Therefore, we performed a systematic review of published studies on the association between silicone breast implants and systemic connective tissue disorders. METHODS: Data from relevant studies (human cohort, case-control, or cross-sectional studies with > or = 10 participants and appropriate controls) were identified through literature searches of Medline, Current Contents, HealthStar, Biological Abstracts, EMBase, Toxline, and Dissertation Abstracts. Two independent reviewers, using standard collection forms, extracted data from the included studies. Adjusted relative risks (RRs) in cohort studies and odds ratios (ORs) in case-control and cross-sectional studies were reported if provided; otherwise, unadjusted RRs and ORs were calculated. RESULTS: Twenty-four studies meeting inclusion criteria were identified. No association was evident between breast implants and any established or atypical connective tissue disorder. There was discordance among studies in reports of arthralgias, lymphadenopathy, myalgias, sicca symptoms, skin changes, and stiffness. CONCLUSION: The panel found no evidence to support expert testimony suggesting an association between silicone breast implants and connective diseases. Discordance for symptoms may reflect differences in symptoms included in various categories, the small number of cases, and the effect of having single subjects with > 1 symptom represented in analyses of each symptom reported. The process presented here is an early example of the use of independent scientific panels to help courts clarify scientific evidence in legal proceedings.

Breast Implants↗
PubMed2001

A meta-analysis of etidronate for the treatment of postmenopausal osteoporosis.

The aim of the study was to review the effect of etidronate on bone density and fractures in postmenopausal women. We searched MEDLINE from 1966 to 1998, examined citations of relevant articles, and the proceedings of international osteoporosis meetings. We contacted osteoporosis investigators to identify additional studies, primary authors, and pharmaceutical industry sources for unpublished data. We included 13 trials that randomized women to etidronate or an alternative (placebo or calcium and/or vitamin D) and measured bone density for at least 1 year. For each trial, three independent reviewers assessed the methodologic quality and abstracted data. The data suggested a reduction in vertebral fractures with a pooled relative risk of 0.63 (95% CI 0.44 to 0.92). There was no effect on nonvertebral fractures (relative risk 0.99, (95% CI 0.69 to 1.42). Etidronate, relative to control, increased bone density after 1-3 years of treatment in the lumbar spine by 4.06% (95% CI 3.12 to 5.00), in the femoral neck by 2.35% (95% CI 1.66 to 3.04) and in the total body by 0.97% (95% CI 0.39 to 1.55). Effects were larger at 4 years, though the number of patients followed much smaller. Etidronate increases bone density in the lumbar spine and femoral neck for up to 4 years. The pooled estimates of fracture reduction with etidronate suggest a reduction in vertebral fractures, but no effect on nonvertebral fractures.

Aged↗
PubMed2001

Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia.

OBJECTIVES: To compare the efficacy and safety of finasteride 5 mg in older (65 years old or older) versus younger (45 to younger than 65 years old) men with benign prostatic hyperplasia (BPH). METHODS: The Proscar Long-Term Efficacy and Safety Study (PLESS) was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men 45 to 78 years old with symptomatic BPH, enlarged prostates, and no evidence of prostate cancer. The endpoints included urinary symptoms, prostate volume, occurrence of acute urinary retention and/or BPH-related surgery, and safety. RESULTS: In both age cohorts, finasteride treatment led to a 51% reduction (P <0.001) in the relative risk for acute urinary retention and/or BPH-related surgery, a significant (P <0.001) and durable improvement in symptom score, and a significant (P <0.001) and sustained reduction in prostate volume. Within each age cohort, no significant differences were found between the placebo and finasteride-treated patients in the incidence of cardiovascular adverse events. Significant differences were evident between the placebo and finasteride groups in the incidence of the typical, known, drug-related adverse events, but no specific differences were associated with age. No drug interactions of clinical importance were observed in the finasteride-treated patients. CONCLUSIONS: The present analysis from PLESS demonstrates that in both older (65 years old or older) and younger men with symptomatic BPH and enlarged prostates, finasteride is highly effective in improving symptoms and reducing prostate volume in many men and in reducing the risk of acute urinary retention and BPH-related surgery. In addition, the safety profile of finasteride in both older and younger men is similar and no drug interactions of clinical importance were observed.

Aged↗
PubMed2001

Awareness and use of the Ottawa ankle and knee rules in 5 countries: can publication alone be enough to change practice?

STUDY OBJECTIVES: We evaluate the international diffusion of the Ottawa Ankle and Knee Rules and determine emergency physicians' attitudes toward clinical decision rules in general. METHODS: We conducted a cross-sectional, self-administered mail survey of random samples of 500 members each of the American College of Emergency Physicians, Canadian Association of Emergency Physicians, British Association for Accident and Emergency Medicine, Spanish Society for Emergency Medicine, and all members (n=1,350) of the French Speaking Society of Emergency Physicians, France. Main outcome measures were awareness of the Ottawa Ankle and Knee Rules, reported use of these rules, and attitudes toward clinical decision rules in general. RESULTS: A total of 1,769 (57%) emergency physicians responded, with country-specific response rates between 49% (United States and France) and 79% (Canada). More than 69% of physicians in all countries, except Spain, were aware of the Ottawa Ankle Rules. Use of the Ottawa Ankle Rules differed by country with more than 70% of all responding Canadian and United Kingdom physicians reporting frequent use of the rules compared with fewer than one third of US, French, and Spanish physicians. The Ottawa Knee Rule was less well known and less used by physicians in all countries. Most physicians in all countries viewed decision rules as intended to improve the quality of health care (>78%), a convenient source of advice (>67%), and good educational tools (>61%). Of all physicians, those from the United States held the least positive attitudes toward decision rules. CONCLUSION: This constitutes the largest international survey of emergency physicians' attitudes toward and use of clinical decision rules. Striking differences were apparent among countries with regard to knowledge and use of decision rules. Despite similar awareness in the United States, Canada, and the United Kingdom, US physicians appeared much less likely to use the Ottawa Ankle Rules. Future research should investigate factors leading to differences in rates of diffusion among countries and address strategies to enhance dissemination and implementation of such rules in the emergency department.

Adult↗
PubMed2001

Is a low transfusion threshold safe in critically ill patients with cardiovascular diseases?

OBJECTIVE: To compare a restrictive red blood cell transfusion strategy with a more liberal strategy in volume-resuscitated critically ill patients with cardiovascular disease. SETTING: Twenty-two academic and three community critical care units across Canada. STUDY DESIGN: Randomized controlled clinical trial. STUDY POPULATION: Three hundred fifty-seven critically ill patients with cardiovascular diseases from the Transfusion Requirements in Critical Care trial who had a hemoglobin concentration of <90 g/L within 72 hrs of admission to the intensive care unit. INTERVENTIONS: Patients were randomized to a restrictive strategy to receive allogeneic red blood cell transfusions at a hemoglobin concentration of 70 g/L (and maintained between 70 and 90 g/L) or a liberal strategy to receive red blood cells at 100 g/L (and maintained between 100 and 120 g/L). RESULTS: Baseline characteristics in the restrictive (n = 160) and the liberal group (n = 197) were comparable, except for the use of cardiac and anesthetic drugs (p <.02). Average hemoglobin concentrations (85 +/- 6.2 vs. 103 +/- 6.7 g/L; p <.01) and red blood cell units transfused (2.4 +/- 4.1 vs. 5.2 +/- 5.0 red blood cell units; p <.01) were significantly lower in the restrictive compared with the liberal group. Overall, all mortality rates were similar in both study groups, including 30-day (23% vs. 23%; p = 1.00), 60-day, hospital, and intensive care unit rates. Changes in multiple organ dysfunction from baseline scores were significantly less in the restrictive transfusion group overall (0.2 +/- 4.2 vs. 1.3 +/- 4.4; p =.02). In the 257 patients with severe ischemic heart disease, there were no statistically significant differences in all survival measures, but this is the only subgroup where the restrictive group had lower but nonsignificant absolute survival rates compared with the patients in the liberal group. CONCLUSION: A restrictive red blood cell transfusion strategy generally appears to be safe in most critically ill patients with cardiovascular disease, with the possible exception of patients with acute myocardial infarcts and unstable angina.

APACHE↗
PubMed2001

Do blood transfusions improve outcomes related to mechanical ventilation?

BACKGROUND: Correcting the decrease in oxygen delivery from anemia using allogeneic RBC transfusions has been hypothesized to help with increased oxygen demands during weaning from mechanical ventilation. However, it is also possible that transfusions hinder the process because RBCs may not be able to adequately increase oxygen delivery. In this study, we determined whether a liberal RBC transfusion strategy improved outcomes related to mechanical ventilation. METHODS: Seven hundred thirteen patients receiving mechanical ventilation, representing a subgroup of patients from a larger trial, were randomized to either a restrictive transfusion strategy, receiving allogeneic RBC transfusions at a hemoglobin concentration of 7.0 g/dL (and maintained between 7.0 g/dL and to 9.0 g/dL), or to a liberal transfusion strategy, receiving RBCs at 10.0 g/dL (and maintained between 10.0 g/dL and 12.0 g/dL). The larger trial was designed to evaluate transfusion practice rather than weaning per se. RESULTS: Baseline characteristics in the restrictive-strategy group (n = 357) and the liberal-strategy group (n = 356) were comparable. The average durations of mechanical ventilation were 8.3 +/- 8.1 days and 8.3 +/- 8.1 days (95% confidence interval [CI] around difference, - 0.79 to 1.68; p = 0.48), while ventilator-free days were 17.5 +/- 10.9 days and 16.1 +/- 11.4 days (95% CI around difference, - 3.07 to 0.21; p = 0.09) in the restrictive-strategy group vs the liberal-strategy group, respectively. Eighty-two percent of the patients in the restrictive-strategy group were considered successfully weaned and extubated for at least 24 h, compared to 78% for the liberal-strategy group (p = 0.19). The relative risk (RR) of extubation success in the restrictive-strategy group compared to the liberal-strategy group, adjusted for the confounding effects of age, APACHE (acute physiology and chronic health evaluation) II score, and comorbid illness, was 1.07 (95% CI, 0.96 to 1.26; p = 0.43). The adjusted RR of extubation success associated with restrictive transfusion in the 219 patients who received mechanical ventilation for > 7 days was 1.1 (95% CI, 0.84 to 1.45; p = 0.47). CONCLUSION: In this study, there was no evidence that a liberal RBC transfusion strategy decreased the duration of mechanical ventilation in a heterogeneous population of critically ill patients.

APACHE↗
PubMed2001

The psychometric properties of patient preferences in osteoporosis.

OBJECTIVE: Osteoporosis is a chronic disease manifested by wrist, vertebral, and hip fractures that results in significant morbidity and burden to society. About 30% of postmenopausal women have osteoporosis according to the WHO criteria. Women with one vertebral fracture have a 4-fold increased risk of a subsequent fracture. The goal of treatment is to prevent fractures and improve quality of life. Preferences or utilities are now recommended for incorporating quality of life into evaluations of the cost effectiveness of new therapeutic interventions. We evaluated the psychometric properties of preference based measures in osteoporosis. METHODS: Preference scenarios were constructed with a health state classification system. The reliability and validity of the feeling thermometer and the standard gamble was assessed by interviewing 42 women from 4 different patient groups. The sensitivity to change of the feeling thermometer and standard gamble was compared with the Health Utilities Index Mark 2 (HUI2) and SF-36. All subgroups were reassessed about 2 months after their first interview. RESULTS: Preference measurement was feasible in women of different age groups. The reliability coefficients for health states ranged from 0.65 to 0.87. The preference scores for the marker states demonstrated content validity. Convergent validity of the feeling thermometer was supported by a significant correlation with the HUI2 (r = 0.38, p < 0.05) and the physical health summary of the SF-36 (r = 0.56, p < 0.005). The standard gamble did not correlate with the HUI2 (r = 0.15) or the feeling thermometer (r = 0.09), but correlated with 2 domains of the SF-36. The preference measures were sensitive to change, with the efficiency scores ranging from 0.78 to 1.0. CONCLUSION: Preference measurements in the evaluation of osteoporosis are feasible. The feeling thermometer and standard gamble appear to be related to different aspects of health related quality of life. Both instruments were sensitive to change over a 2 month period.

Aged↗
PubMed2001

Looking for important change/differences in studies of responsiveness. OMERACT MCID Working Group. Outcome Measures in Rheumatology. Minimal Clinically Important Difference.

The purpose of this paper is to describe a classification system for studies of responsiveness that was designed to help organize these studies, and identify those with the potential to provide information on minimal clinically important difference (MCID). We developed a 3 dimensional cube into which studies of responsiveness can be categorized based on their evaluation of 3 attributes: 1. individual or group setting; 2. which scores are contrasted; and 3. the type of change or difference being assessed. We present and discuss examples of studies that fit into categories in the classification cube. This classification system helps to focus attention on whether the literature is able to provide information on the specific type of change a person is interested in. It reinforces that the ability of an instrument to detect a certain category of discrimination within the cube does not mean it will necessarily be responsive to another category. The cube has been shown here as a means to separate out studies that address important change. These studies can then be examined as the source of information on MCID.

Clinical Trials as Topic↗
PubMed2001

Minimal clinically important differences: review of methods.

Determining a minimal clinically important difference to be detected in a clinical trial is a critical methodological step in the design of a study. In this review, the different methods that have been used in detecting important changes or differences are considered and categorized according to a classification system consisting of which groups are contrasted, the setting of the results, and the type of change of difference being quantified. It was found that most methods and procedures for deriving minimal clinically important differences considered important changes from the viewpoint of a group of patients. Development of methods that focus on individuals should be a goal of the future.

Clinical Trials as Topic↗
PubMed2001

Discrimination of changes in osteoporosis outcomes.

The purpose of this paper was to identify existing work related to discrimination, responsiveness, and minimal clinically important differences (MCID) for 4 key clinical outcomes in osteoporosis, to serve as a background to discussions about how to define MCID for both individuals and groups. The outcomes assessed were bone density, fractures, quality of life, and function. We conducted a systematic literature search in MEDLINE, EMBASE, and Current Contents for articles that discussed responsiveness, detectable difference, improvement criteria, and clinical importance. We used the Beaton cube to classify the studies depending on whether they compared differences between or changes within individuals or groups. Although a number of studies were identified that presented data on detectable differences beyond error and observed differences, few studies presented data on how to define clinically important differences. A key priority for future research is to define minimally clinical important differences for clinically important osteoporosis outcomes using a consensus based approach that will be accepted by the osteoporosis community at large. Furthermore, these MCID will likely be different for individual patients seen in clinical practice than for individuals in a clinical trial.

Clinical Trials as Topic↗