The Intensive Diet and Exercise for Arthritis (IDEA) trial: 18-month radiographic and MRI outcomes.

PURPOSE: Report the radiographic and magnetic resonance imaging (MRI) structural outcomes of an 18-month study of diet-induced weight loss, with or without exercise, compared to exercise alone in older, overweight and obese adults with symptomatic knee osteoarthritis (OA). METHODS: Prospective, single-blind, randomized controlled trial that enrolled 454 overweight and obese (body mass index, BMI = 27-41 kg m(-2)) older (age ≥ 55 yrs) adults with knee pain and radiographic evidence of femorotibial OA. Participants were randomized to one of three 18-month interventions: diet-induced weight loss only (D); diet-induced weight loss plus exercise (D + E); or exercise-only control (E). X-rays (N = 325) and MRIs (N = 105) were acquired at baseline and 18 months follow-up. X-ray and MRI (cartilage thickness and semi-quantitative (SQ)) results were analyzed to compare change between groups at 18-month follow-up using analysis of covariance (ANCOVA) adjusted for baseline values, baseline BMI, and gender. RESULTS: Mean baseline descriptive characteristics of the cohort included: age, 65.6 yrs; BMI 33.6 kg m(-2); 72% female; 81% white. There was no significant difference between groups in joint space width (JSW) loss; D -0.07 (SE 0.22) mm, D + E -0.27 (SE 0.22) mm and E -0.16 (SE 0.24) mm (P = 0.79). There was also no significant difference in MRI cartilage loss between groups; D -0.10(0.05) mm, D + E -0.13(0.04) mm and E -0.05(0.04) mm (P = 0.42). CONCLUSION: Despite the potent effects of weight loss in this study on symptoms as well as mechanistic outcomes (such as joint compressive force and markers of inflammation), there was no statistically significant difference between the three active interventions on the rate of structural progression either on X-ray or MRI over 18-months.

Influences of alignment and obesity on knee joint loading in osteoarthritic gait.

OBJECTIVE: To determine the influences of frontal plane knee alignment and obesity on knee joint loads in older, overweight and obese adults with knee osteoarthritis (OA). METHODS: Cross-sectional investigation of alignment and obesity on knee joint loads using community dwelling older adults (age ≥ 55 years; 27 kg m(-2) ≥ body mass or body mass index (BMI) ≤ 41 kg m(-2); 69% female) with radiographic knee OA that were a subset of participants (157 out of 454) enrolled in the Intensive Diet and Exercise for Arthritis (IDEA) clinical trial. RESULTS: A higher BMI was associated with greater (P = 0.0006) peak knee compressive forces [overweight, 2411 N (2182, 2639), class 1 obesity, 2772 N (2602, 2943), class 2+ obesity, 2993 N (2796, 3190)] and greater (P = 0.004) shear forces [overweight, 369 N (322, 415), class 1 obesity, 418 N (384, 453), class 2+ obesity, 472 N (432, 513)], independent of alignment, and varus alignment was associated (P < 0.0001) with greater peak external knee adduction moments, independent of BMI [valgus, 18.7 Nm (15.1, 22.4), neutral, 27.7 Nm (24.0, 31.4), varus, 37.0 Nm (34.4, 39.7)]. CONCLUSION: BMI and alignment were associated with different joint loading measures; alignment was more closely associated with the asymmetry or imbalance of loads across the medial and lateral knee compartments as reflected by the frontal plane external adduction moment, while BMI was associated with the magnitude of total tibiofemoral force. These data may be useful in selecting treatment options for knee OA patients (e.g., diet to reduce compressive loads or bracing to change alignment).

Does high weight loss in older adults with knee osteoarthritis affect bone-on-bone joint loads and muscle forces during walking?

OBJECTIVE: The aim of this study was to examine the effects of high weight loss on knee joint loads during walking in participants with knee osteoarthritis (OA). DESIGN: Data were obtained from a subset of participants enrolled in the Arthritis, Diet, and Activity Promotion Trial (ADAPT). Complete baseline and 18-month follow-up data were obtained on 76 sedentary, overweight or obese older adults with radiographic knee OA. Three-dimensional gait analysis was used to calculate knee joint forces and moments. The cohort was divided into high (>5%), low (<5%), and no (0% or gain) weight loss groups. RESULTS: From baseline body weight, the high weight loss group lost an average of 10.2%, the low weight loss group lost an average of 2.7%, and the no weight loss group gained 1.5%. Adjusted 18-month outcome data revealed lower maximum knee compressive forces with greater weight loss (P=0.05). The difference in compressive forces between the high weight loss and no weight loss groups was due primarily to lower hamstring forces (P=0.04). Quadriceps forces were similar between the groups at 18-month follow-up. There was no difference between the groups in 18-month joint space width or Kellgren-Lawrence scores. CONCLUSIONS: These results suggest that a 10% weight loss in an overweight and obese osteoarthritic population elicits positive changes in the mechanical pathway to knee OA by having lower knee joint compressive loads during walking compared to low and no weight loss groups. The difference in compressive forces was due, in large part, to reductions in hamstring co-contraction during the initial portion of the stance phase.

Effect of an exercise and dietary intervention on serum biomarkers in overweight and obese adults with osteoarthritis of the knee.

OBJECTIVE: To determine the effects of exercise and weight loss interventions on serum levels of four biomarkers and to examine if changes in biomarker levels correlate with clinical outcome measures in obese and overweight adults with knee osteoarthritis (OA). METHODS: Serum was obtained at baseline, 6 and 18 months from 193 participants in Arthritis, Diet and Activity Promotion Trial. This was a single-blind 18-month trial with subjects randomized to four groups: healthy-lifestyle (HL), diet (D), exercise (E) and diet plus exercise (D+E). Serum levels of cartilage oligomeric matrix protein (COMP), hyaluronan (HA), antigenic keratan sulfate (AgKS), and transforming growth factor-beta1 (TGF-beta1) were measured by enzyme linked immunosorbent assay. RESULTS: At baseline there were no significant differences in biomarker levels between intervention groups. When results for all the intervention groups were combined, the levels of HA were found to be negatively correlated with medial joint space width and positively correlated with Kellgren-Lawrence scores (K-L scores) while TGF-beta1 levels negatively correlated with K-L scores. When biomarker levels measured at 6 and 18 months were adjusted for baseline values, age, gender, and body mass index, weak but significant differences between intervention groups were present for mean levels of COMP and TGF-beta1. Furthermore, AgKS levels averaged over all groups tended to decrease over time. There were no significant associations of baseline biomarkers and the follow-up outcomes. Weak associations were noted between change in the biomarkers at 18 months and change in outcome measures that included change in weight with AgKS and COMP and change in Western Ontario and McMaster Universities Osteoarthritis Index pain with AgKS. CONCLUSION: Overall, the E and D interventions did not show a consistent effect on levels of potential OA biomarkers. The four biomarkers showed differences in correlations with outcome measures suggesting that they may measure different aspects of disease activity in OA. The strongest correlations were between serum HA and radiographic measures of OA at baseline.

Effect of postmenopausal hormones on inflammation-sensitive proteins: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Study.

BACKGROUND: Observational studies in healthy women suggest postmenopausal hormone therapy reduces risk of coronary events. In contrast, in a recent clinical trial of women with coronary disease, a subgroup analysis demonstrated increased risk during the early months of therapy. Because higher levels of inflammation factors predict vascular disease outcomes, the effect of hormones on these factors is of interest. METHODS AND RESULTS: Four inflammation-sensitive factors, C-reactive protein, soluble E-selectin, von Willebrand factor antigen, and coagulation factor VIIIc were measured at baseline, 12, and 36 months in 365 participants of the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial, a randomized, placebo-controlled trial of the effects of 4 hormone preparations on cardiovascular disease risk factors. Compared with placebo, all 4 active preparations resulted in a large sustained increase in the concentration of C-reactive protein and a decrease in soluble E-selectin (P=0.0001). There were no effects of treatment on concentrations of von Willebrand factor or factor VIIIc. There were no differences in effects among treatment arms. Relative to placebo, when combining active treatment arms, final concentrations of C-reactive protein were 85% higher whereas E-selectin was 18% lower compared with baseline. CONCLUSIONS: Postmenopausal hormones rapidly increased the concentration of the inflammation factor C-reactive protein. Such an effect may be related to adverse early effects of estrogen therapy. In contrast, hormones reduced the concentration of soluble E-selectin, and this might be considered an anti-inflammatory effect. Because PEPI was not designed to assess clinical endpoints, studies of the impact of hormone-mediated changes in inflammation on risk of subsequent coronary events are needed.

Development of new jet injector for insulin therapy.

To improve diabetic patients' compliance to multiple injection protocols, we developed and tested a new insulin jet injector, the Preci-Jet 50. The prototype has the following features: small size (14 X 2 cm) and weight (160 g), capability of mixing two types of insulin, accuracy and reliability of the ejected volume (dose), ease of use and sterilization, simplicity of design, and capacity of adjusting jet pressure to individual skin resistance. The ejected volume, evaluated by gravimetry, was more accurate and more reliable with the injectors (N = 18) than with 0.5-cc disposable plastic syringes (N = 18). The dead space of the injectors (N = 16), as evaluated by isotopic recuperation of radioactive insulin, was minimal, allowing mixed insulin injections. The human-device interface evaluation demonstrated that diabetic patients (N = 13) learned easily to manipulate the injector and that their ability to use it properly improved after 1 mo of use. We conclude that this injector may be a practical tool for insulin-dependent diabetic patients.

Twice-daily mixed regular and NPH insulin injections with new jet injector versus conventional syringes: pharmacokinetics of insulin absorption.

The purpose of the present study was to evaluate the feasibility of using a jet injector in a split and mixed regular and NPH insulin regimen and to compare serum glucose and free-insulin profiles obtained with the injector and the conventional syringe and needle. Twelve insulin-dependent diabetic patients were hospitalized for 5 days. After a stabilization day, six patients received their insulin injection with the injector for 2 days and with the syringe and needle for the following 2 days; the regimen was reversed for the other six patients. Diet, exercise, and insulin dosage remained constant. The serum glucose levels with the injector were consistently lower than those obtained with the syringe at all times of the day except at 5:00 a.m. and 7:30 a.m., when mean values were similar for both treatments. Free-insulin levels were higher with the injector from 10:30 a.m. to 4:30 p.m. These findings suggest that insulin absorption is faster and possibly greater with the injector than with the syringe. When switching from a syringe to an injector insulin program, insulin dose adjustment may be necessary.

Effect of hormone replacement therapy on the validity of the Friedewald equation in postmenopausal women: the postmenopausal estrogen/progestins interventions (PEPI) trial.

The Friedewald equation is often used to estimate low-density lipoprotein cholesterol (LDL-C). Hormone therapy is known to raise triglyceride (TG) and high-density lipoprotein cholesterol (HDL-C) and alter lipid contents of lipoproteins. We compared Friedewald estimated LDL-C to measured LDL-C in PEPI participants on placebo or four different hormone treatment groups. At baseline, the 0.2 coefficient for triglyceride (TG) was accurate for all five treatment groups. Among women who took >80% of their pills and whose TG was <4.5 mmol/l (400 mg/dl), LDL-C was underestimated for 69-82% of the participants in the active treatment groups, compared to 50% in the placebo group. After 3 years of therapy, the TG coefficient that offered a better fit of the Friedewald equation in the active treatment groups was 0.39 for the equation in mmol/l (0.17 for the equation in mg/dl). Using this coefficient is clearly warranted for greater accuracy in research studies.

Brain microemboli associated with cardiopulmonary bypass: a histologic and magnetic resonance imaging study.

Emboli in brain tissue after cardiopulmonary bypass were reported in the literature 30 years ago, but there is little objective evidence confirming the presence of emboli in the brain after cardiopulmonary bypass with more modern equipment and techniques. Recently, with alkaline phosphatase vascular staining, we found an acellular fatty material in brain microvasculature from autopsy material of patients who died shortly after cardiopulmonary bypass. These fatty intravascular collections range in diameter from 10 to 70 microns, a size that lodges in the smallest vessels of the microvasculature. They have been found in numbers sufficient to cause detectable neurologic dysfunction and are believed, but not proved, to be emboli. By sequentially injecting colored microspheres, we can determine when emboli occur during experimental cardiopulmonary bypass. In ongoing related studies, magnetic resonance imaging was performed before cardiac valve replacement in 39 patients for whom preoperative and postoperative neurologic and neuropsychologic testing was available. Preliminary results suggest that magnetic resonance imaging evidence of prior stroke is not a significant risk factor for cognitive or motor decrement after cardiopulmonary bypass.

Determinants of health counseling practices in hospitals: the patient's perspective.

We conducted a survey of 518 patients who had been admitted to three hospitals for selected medical, surgical, and obstetrical conditions. All patients came from the same city. One of the hospitals had put forward health promotion and disease prevention as a formal goal. Almost 40% of the respondents reported that they received health counseling during their hospital stay. Logistic regression analyses revealed that medical care processes and organizational factors were more important than patient characteristics in determining health counseling. The only patient characteristic that was positively related to health counseling was "perceived poor health status." Favorable conditions for the development of health counseling included having an attending physician different from the one who treated the patient before entering the hospital, an adequate number of physician visits, and a longer length of stay. Being admitted to a medical ward rather than a surgical or an obstetrical ward also was associated with more frequent health counseling. No significant differences were found among hospitals. Finally, having a general practitioner rather than a specialist as attending physician did not make a difference. These findings support the view that although hospitals have an important and legitimate role to play in health promotion, organizational and institutional obstacles to implementing such practices must not be ignored.

Eating quality of meat from European × Chinese crossbred pigs.

Meat from half-Chinese crossbred pigs was compared with meat from purebred European pigs for chemical composition and eating quality. In a first experiment, purebred Pietrain pigs were compared to Pietrain × Chinese (Meishan or Jia Xin ) pigs for sensory qualities as assessed by a taste panel. In a second experiment, purebred Large Whites were compared to Large White × Meishan pigs for chemical composition and eating quality as assessed by both taste panel and consumer testing. The lipid and collagen content in the meat were higher in the Large White × Chinese crossbred pigs than in the purebred Large White pigs. In both experiments, meat from half-Chinese cross bred pigs was judged more tender, more juicy and more tasty than meat from purebred European pigs by the taste panel as well as by consumers. However, the latter judged that the overall acceptability of the meat from half-Chinese pigs was not better, probably due to the excessive amount of visible fat.

Lipid composition of adipose tissue and muscle in pigs with an increasing proportion of Meishan genes.

The purpose of this study was to estimate the effect of the proportion of Meishan (MS) genes upon the lipid composition of longissimus dorsi and trapezius muscles and perirenal and s.c. dorsal adipose tissues. Five groups of 11-15 pigs with 0, 12·5, 25, 37·5 and 50% MS genes were made up from a large herd of crossbred animals (0-100% MS dams × Piétrain sires). Results showed that: (1) the i.m. lipid content was higher in 1 2 MS than in controls and 1 4 MS pigs. Differences in the fatty acid composition of i.m. lipids, as related to genotype, depended more particularly on muscle fatness as the fatty acid compositions of triglycerides and phospholipids were little affected by the genotype. (2) The weight of perirenal and s.c. dorsal adipose tissues increased with the proportion of MS genes. Differences in the chemical composition of the adipose tissues were not related to the proportion of MS genes. The fatty acid composition was little affected by the genotype. Although the levels of polyunsaturated fatty acids decreased with increasing proportion of MS genes, these small variations had no marked influence on adipose tissue quality.

Evaluation of sampling methods in research reported in selected clinical nursing journals: implications for nursing practice.

This article summarizes standards relating to sampling methodology, identifies deviations from these standards in research studies reported in selected clinical nursing journals, and provides suggestions for improving sampling methods to enhance the applicability of research for nursing practice. A random sample of 30 research reports published in 1986 in five clinical nursing journals was examined. Nearly 97 per cent of the published studies contained at least one major deficiency in sampling methodology. More than two thirds failed to describe the sampling frame, sample size, or number of refusals, withdrawals, and/or cases lost. Thirteen per cent did not report sampling methods. More than half made generalizations that were inappropriate for the sampling method used; 43 per cent did not acknowledge any limitations of their sample. Sample sizes were small, and statistical power to detect significant differences was low. These deficiencies in sampling procedures could detract from the value of the research that nurses are encouraged to use as a basis for practice. This article provides specific recommendations for remedying these deficiencies to help ensure the scientific merit of the research published for nursing practice.

Master's degree-level community health nursing educational needs: a national survey of leaders in service and education.

This study identified the core components of the curriculum for master's degree-level community health nurses (CHNs) and assessed whether existing educational programs provide this knowledge base. According to 588 leaders in community health nursing (CHN) service and education, all master's degree-prepared CHNs require skills in the administrative role. Interdisciplinary core content areas needed to fulfill role responsibilities include a practicum experience; epidemiology; community health assessment and diagnosis; administration and management, including program planning and evaluation, financial management, budgeting, and quality assurance; research methods and biostatistics; health promotion and disease prevention; interventions at the aggregate level; and leadership theory. There were notable discrepancies between what was considered essential and what actually was included in CHN education. This article provides suggestions and possible alternatives for initiating change to ensure adequate educational preparation for graduate-level CHN practice.

Basal growth hormone concentration increased following a weight loss focused dietary intervention in older overweight and obese women.

OBJECTIVES: Growth and sex steroid hormones decrease with aging and obesity. The effect of dietary weight loss and exercise training lifestyle interventions was examined on hormones as well as determining their relationships with physical function in older obese and overweight adults. DESIGN: Individuals were randomized into one of four 18 month interventions: Healthy Lifestyle (HL), Exercise, Diet, and Exercise-Diet. SETTING: Clinical research setting with facility based exercise and nutrition education and behavior classrooms. PARTICIPANTS: Older (≥60 yrs) overweight and obese (BMI≥28 kg/m(2)) adults with knee osteoarthritis (n=309) were recruited for the study. INTERVENTION: Weight loss goal for Diet groups was ≥5%. Exercise groups trained (mostly walking and resistance training) 3 days/week for 60 min/session. MEASUREMENTS: Body weight, growth hormone (GH), corticosterone, sex-hormone binding globulin (SHBG), testosterone, and dehydroepiandrosterone (DHEA) were measured at baseline, 6, and 18 months. Physical function was determined through performance task (6-min walking distance) and self-reported questionnaires (Western Ontario McMaster University Osteoarthritis Index-WOMAC) at similar time points. RESULTS: Diet, Exercise, and Exercise-Diet groups lost 4.9%, 3.5%, and 6.2% of their weight at 18 months, respectively. There was a significant diet treatment effect on GH levels in women as higher concentrations of this hormone were apparent following dietary weight loss intervention (p=0.01). No other hormones were affected by either diet or exercise treatments in men or women. A significant inverse correlation between baseline 6-minute walking distance and SHBG (r=-0.33) was found in men. CONCLUSION: The increase in basal GH levels from the diet treatment in women suggests that this lifestyle behavior intervention may mitigate the age- and obesity-related decreases in growth hormone levels, to help preserve muscle mass, strength, and physical function in older adults.

Glucosamine/chondroitin combined with exercise for the treatment of knee osteoarthritis: a preliminary study.

OBJECTIVE: This preliminary study sought to determine whether using 1500/1200mg of glucosamine hydrochloride and chondroitin sulfate (GH/CS) is effective, both separately and combined with exercise, compared to a placebo plus exercise program in improving physical function, pain, strength, balance, and mobility in older adults with knee osteoarthritis (OA). METHODS: This double-blind, placebo-controlled, randomized clinical trial lasted 12 months. Participants included 89 older adults (age>/=50 years) with knee OA randomized to either GH/CS or placebo group. Phase I was a 6-month trial comparing the effects of assignment to either GH/CS or placebo. Phase II added 6 months of exercise for both groups. The primary outcome measure was Western Ontario and McMaster University Osteoarthritis Index (WOMAC) function, and secondary outcome measures included WOMAC pain, 6-min walk, balance, and knee strength. RESULTS: Of the 89 randomized participants, 72 (81%) completed the study. The median pill compliance was 94% and 95% in Phase I, and, in Phase II, 97% and 91% for the GH/CS and placebo groups, respectively. Median exercise compliance during Phase II was 77% for the GH/CS group and 78% for the placebo group. WOMAC function and pain did not differ significantly between the groups at 6- or 12-month follow-up. There were also no significant differences between the groups in 6-min walk or knee strength; however, balance was better in the placebo group with approximately a 10% difference compared to the GH/CS group. CONCLUSIONS: The GH/CS group was not superior to the placebo group in function, pain, or mobility after both phases of the intervention (pill only and pill plus exercise).

Selection of breeds, strains and individual pigs for prolificacy.

Prolificacy, defined as litter size at birth, is currently considered to be the most important component of sow productivity. However, in spite of a spectacular increase in productivity due to management advances, litter size at birth has remained constant for the past 20 years. This situation seems to question the long-term efficiency of the classical methods of genetic improvement such as within-herd selection and crossbreeding between European or American breeds. Some recent developments and research results suggest that one can be optimistic about the possibilities of increasing litter size in the near future. A survey of available breeds world-wide illustrates the important differences in average litter size (5-15 piglets), embryo mortality (15-40%) and heterosis (ranging from 5 to over 30%) on litter size. In particular the high prolificacy of some Chinese breeds can be used to speed up gentic progress in improving litter size either through systematic 3-way (3-4 additional piglets per litter in the F1 compared with European breeds) or 4-way crosses with Western breeds, or by developing composite lines selected for heritable traits such as growth rate and backfat thickness. The efficiency of this system might be improved by combining Chinese breeds with 'hyperprolific' western strains. When using Chinese breeds, special attention should be paid to the choice of the terminal boar, which should be as lean as possible, in order to produce acceptable carcasses for sale. Another potential solution would be to use modern computerized recording systems to detect extreme individuals and then to apply a strong selection intensity. Using this approach, it is then possible to develop a gene pool for prolificacy. Results obtained in France, Great Britain and Australia are encouraging. The expected progress is about 0.5 piglets per litter when strain selection is limited to one sex and about 1 piglet when it includes both sexes. Moreover, using crossbreeding, the heterosis effect seems to be cumulated with the genetic changes mentioned above. The computer can also be an aid in eliminating chromosomal translocations responsible for a reduction in prolificacy ranging from 5 to 50%.

Increasing response rates in physicians' mail surveys: an experimental study.

It is becoming increasingly difficult to obtain high response rates in physicians' mail surveys. In 1983-84, we tested the effectiveness of two techniques among 604 Quebec physicians who had not responded to an initial letter. A handwritten thank you note at the bottom of the letter accompanying the questionnaire and a more personalized mailout package increased response rates by 40.7 per cent and 53.1 per cent, respectively, compared to control groups.