Prediction of porcine carcass iodine value based on diet composition and fatty acid intake.

The pig industry uses a variety of fat sources (FS) and fat levels (FL) in diets to increase energy content. The objective was to investigate the impact of FS and FL on rate and efficiency of gain, apparent total tract digestibility of dietary fat, and pork fat composition and test dietary predictors of carcass iodine value (IV). A total of 1,213 pigs (PIC 280 × PIC Camborough 42; PIC, Inc., Hendersonville, TN) with an initial BW of 32.0 ± 0.4 kg were randomly allotted to 1 of 6 dietary treatments on d 0. Treatments were arranged as a 2 × 3 factorial, with 2 FS, choice white grease (CWG; IV = 66.8) and corn oil (COIL; IV = 123.2), and 3 FL, 2, 4, or 6%. Ten pens of approximately 20 pigs each (0.70 m/pig) were randomly assigned to each of the 6 treatments. All pigs were on trial for 105 d. Pigs were harvested in 1 of 3 marketing pulls, to achieve an ideal market BW across differing rates of gain, at which time belly fat samples were collected (d 105 [457 pigs], 117 [309 pigs], or 134 [432 pigs]). Diet and belly fat samples were analyzed for fatty acid profile. Daily rate of gain was not impacted by FS or FL ( ≤ 0.325). Increasing FL and dietary energy concentration increased G:F ( < 0.001). No difference was evident for G:F between FS ( = 0.107). Increasing FL of CWG resulted in greater daily intake of SFA and MUFA than increasing FL of COIL ( < 0.001). Increasing levels of COIL resulted in greater daily intake of PUFA than increasing levels of CWG ( ≤ 0.012). Feeding CWG tended to result in great caloric efficiency adjusted for carcass yield than feeding COIL ( = 0.074). The inclusion of COIL instead of CWG tended to increase true total tract digestion of acid hydrolyzed ether extract on d 39 ( = 0.066) but not on d 104 ( = 0.402). Increasing COIL increased carcass IV at a greater magnitude than increasing CWG, resulting in a FS × FL interaction on d 105, 117, and 134 ( < 0.001). Dietary linoleic acid concentration and daily intake had a stronger linear relationship than IV product (IVP; = 0.95 vs. = 0.94 vs. = 0.85, respectively). In conclusion, limiting linoleic acid dietary concentration and intake is key to lowering carcass IV. To meet a carcass IV standard of 74 g/100 g, linoleic acid concentration had to be <3.4% and intake had to be <88 g/d. Dietary linoleic acid is a superior predictor of carcass IV compared with IVP, especially when high-fat diets are used.

Evaluation of standardized ileal digestible lysine requirement of nursery pigs from seven to fourteen kilograms.

Four experiments were conducted to determine the standardized ileal digestible (SID) Lys requirement of pigs (Sus scrofa) from 7 to 14 kg. In Exp. 1, 294 pigs (6.8 kg BW) were used in a 28-d growth trial with 7 pigs per pen and 7 pens per treatment. Treatment diets were fed from d 0 to 14, and a common diet was fed from d 14 to 28. The 6 SID Lys levels tested were 1.15, 1.23, 1.30, 1.38, 1.45, and 1.53%. The diets were corn- and soybean-meal [Zea mays L. and Glycine max (L.) Merr.] based, with 10% spray-dried whey, 4.5% fish meal, and contained 3.37 Mcal of ME/kg. From d 0 to 14, ADG increased (quadratic, P < 0.001) as SID Lys increased from 1.15 to 1.30% with no further increase at greater levels. Gain:feed increased (linear, P < 0.001) with increasing SID Lys. Experiments 2 to 4 were 14-d growth trials with diets containing 1.22, 1.32, 1.42, 1.52, or 1.62% SID Lys. Diets were corn- and soybean-meal based with 3.45 Mcal of ME/kg. Soybean meal and lactose were constant in all diets at 30 and 7% of the diet, respectively. In Exp. 2, 840 pigs (7.6 kg BW) were used, with 24 pigs per pen and 7 pens per treatment. Increasing SID Lys from 1.22 to 1.42% increased (quadratic, P < 0.01) ADG and G:F with no further improvement observed in pigs fed the 1.52 or 1.62% SID Lys diets during d 0 to 14. In Exp. 3, 1,260 pigs (8.5 kg BW) were used with 42 pigs per feeder (2 pens per feeder) and 6 feeders per treatment. Increasing dietary Lys increased (quadratic, P < 0.02) ADG and G:F with the greatest response observed as SID Lys increased from 1.22 to 1.32% and, then, slight improvements with 1.42 and 1.52% during d 0 to 14. In Exp. 4, 770 pigs (7.4 kg BW) were used with 22 pigs per pen and 7 pens per treatment. Increasing SID Lys increased (quadratic, P = 0.05) ADG with pigs fed 1.32 and 1.42% SID Lys diets having the greatest BW gains during d 0 to 14. Increased SID Lys decreased (linear, P < 0.001) ADFI and increased (linear, P < 0.001; quadratic, P = 0.02) G:F. In conclusion, results of these experiments indicate that the 1998 NRC Lys recommendations (e.g., 1.19% SID Lys for 5 to 10 kg pigs) are less than required for optimal growth for 7 to 14 kg pigs. One-slope straight broken-line analysis indicated that the SID Lys requirement for optimal growth was at least 1.30% for ADG and 1.37% for G:F, or at least 3.86 and 4.18 g SID Lys/Mcal ME, respectively. Quadratic broken-line analysis indicated that the SID Lys requirement for optimal growth was at least 1.37% for ADG and 1.54% for G:F, or at least 4.19 and 4.92 g SID Lys/Mcal ME, respectively.

Accessibility of Antiretroviral Therapy in Ghana: Convenience of Access

The convenience of accessing antiretroviral therapy (ART) is important for initial access to care and subsequent adherence to ART. We conducted a qualitative study of people living with HIV/AIDS (PLWHA) and ART healthcare providers in Ghana in 2005. The objective of this study was to explore the participants' perceived convenience of accessing ART by PLWHA in Ghana. The convenience of accessing ART was evaluated from the reported travel and waiting times to receive care; the availability; or otherwise; of special considerations; with respect to the waiting time to receive care; for those PLWHA who were in active employment in the formal sector; the frequency of clinic visits before and after initiating ART; and whether the PLWHA saw the same or different providers at each clinic visit (continuity of care). This qualitative study used in-depth interviews based on Yin's case-study research design to collect data from 20 PLWHA and 24 ART healthcare providers as study participants. . Reported travel time to receive ART services ranged from 2 to 12 h for 30 of the PLWHA.. Waiting time to receive care was from 4 to 9 h. . While known government workers; such as teachers; were attended to earlier in some of the centres; this was not a consistent practice in all the four ART centres studied. . The PLWHA corroborated the providers' description of the procedure for initiating and monitoring ART in Ghana. . PLWHA did not see the same provider every time; but they were assured that this did not compromise the continuity of their care. Our study suggests that convenience of accessing ART is important to both PLWHA and ART healthcare providers; but the participants alluded to other factors; including open provider-patient communication; which might explain the PLWHA's understanding of the constraints under which they were receiving care. The current nation-wide coverage of the ART programme in Ghana; however; calls for the replication of this study to identify possible perception changes over time that may need attention. Our study findings can inform interventions to promote access to ART; especially in Africa

Embryonic and fetal development in a commercial dam-line genotype.

During depopulation of a breeding unit within Swine Graphics Enterprises, extensive data were collected and used to examine relationships among ovulation rate, the pattern of prenatal loss, and placental and fetal development. Groups of Large White x Landrace females (n=447) were slaughtered between day 20-30, 50-55 or 85-90 of gestation, with approximately equal numbers of animals representing gilts and parity 1 (G/P1), parity 2-3 (P2/3), and parity >4 (P4+). Ovulation rate and embryo number were recorded for all animals. With the exception of the G/P1 animals, embryonic and placental weight were recorded for four conceptuses per sow on day 20-30; on day 85-90 two conceptuses per sow were dissected to determine placental and fetal development. Ovulation rate (22.7 +/- 0.2 overall) was higher (P <0.05) in P2/3 (23.6 +/- 0.4) and P4+ (24.7 +/- 0.4) than in G/P1 (20.2 +/- 0.5). Embryonic/fetal survival was 61.8 +/- 2.1% at day 20-30, 50.2 +/- 2.2% at day 50-55 and 48.7 +/- 1.9% at day 85-90 and the number of surviving conceptuses was higher (P <0.05) in the P2/3 sows than in other parity groups. There was no relationship between ovulation rate and number of live embryos at day 20-30 or 85-90. At day 20-30 and 85-90, embryo weight was positively correlated with placental weight, but neither placental weight nor embryonic/fetal weight was correlated with number of viable embryos. A parity by gestation day interaction existed; placental weight for P4+ (3.42 +/- 0.43 g) was less than for P2/3 (7.55 +/- 0.40 g) at day 20-30 (P <0.0001), whereas at day 85-90, placental weight of P2/3 (209.5 +/- 8.5 g) was less (P=0.05) than both G/P1 (235.7 +/- 7.3g) and P4+ (235.4 +/- 7.1 g). At day 85-90, fetal brain weight, relative to body weight (R2=0.61, P <0.0001), and fetal brain:liver weight ratio (R2=0.35; P <0.0001) were negatively related to mean fetal weight, and brain:liver weight ratio showed a trend towards a relationship with number of viable fetuses (P=0.08). Parity also affected brain:liver weight ratio (P=0.01). Clearly, high ovulation rates in the higher parity sows have the potential to cause excessive in utero crowding of conceptuses in the post-implantation period. Even with moderate crowding, increased brain:liver weight ratios in smaller fetuses in late gestation indicate that uterine capacity impacts fetal development as well as the number of surviving fetuses.

A novel inhibitor of beta-glucuronidase: L-aspartic acid.

Infants who consume casein hydrolysate formula have been shown to have lower neonatal jaundice levels than infants who consume routine formula or breast milk. Because casein hydrolysate has been shown to contain a beta-glucuronidase inhibitor, one possible mechanism to explain this finding is blockage of the enterohepatic circulation of bilirubin by a component of the formula. The aim of this research was to identify the source of the beta-glucuronidase inhibition in hydrolyzed casein. A beta-glucuronidase inhibition assay and measurements of physical and kinetic parameters were used to analyze the components of hydrolyzed casein and infant formulas. Kinetic studies used purified beta-glucuronidase. The L-aspartic acid in hydrolyzed casein accounts for the majority of the beta-glucuronidase inhibition present. Kinetic studies indicate a competitive inhibition mechanism. L-aspartic acid is a newly identified competitive inhibitor of beta-glucuronidase.

Transcutaneous bilirubin measurement: a multicenter evaluation of a new device.

OBJECTIVES: The early discharge of neonates from hospitals makes transcutaneous measurement of total bilirubin concentration a useful tool to monitor neonatal jaundice. The objectives of this study were to determine whether 1) transcutaneous bilirubin (TcB) measurement, as performed using BiliCheck (BC), correlates with total serum bilirubin (TSB) levels, measured with standard laboratory methods and with high-pressure liquid chromatography (HPLC-B); 2) infant race, gestational age, postnatal age, or body weight interferes with the measurement of TcB levels in newborn infants; 3) the variability of the TcB measurement is comparable to the variability of TSB measurements; and 4) TcB measurements obtained from the forehead (BCF) and sternum (BCS) generate comparable results. STUDY DESIGN: Newborn infants who were <28 days and >30 weeks' gestational age and who underwent tests for TSB as part of their normal care in 6 different European hospitals were studied. A total of 210 infants were enrolled in the study, 35 at each site. Near simultaneous (within +/- 30 minutes) blood collection for TSB and BCF and BCS measurements were performed. TSB levels were determined by the serum bilirubin method in use at each site, and all HPLC-B determinations were made at the same, independent laboratory. RESULTS: The study group consisted of 140 white, 31 Asian, 14 Hispanic, 9 African, and another 16 newborns of different races. The correlation coefficient (r) between BCF and HPLC-B was 0.890 (95% confidence interval = 0.858-0.915). BCF and BCS generated similar results (r value = 0.890 for BCF and 0.881 for BCS), even if BCS slightly overestimated (mean error = -0.04 mg/dL) and BCF slightly underestimated (mean error = 0.96 mg/dL) in comparison with HPLC-B. Analysis of covariance demonstrated that BC accuracy was independent of race, birth weight, gestational age, and postnatal age of the newborn. Receiver operating characteristic curves were evaluated for BCF and TSB, each compared with HPLC-B. With the use of a cutoff point for HPLC-B of 13 mg/dL (222 micromol/L) and a cutoff of 11 mg/dL on the BCF and TSB, similar sensitivity/specificity (93%/73% for BCF, 95%/76% for TSB) were observed. The use of a cutoff point for HPLC-B of 17 mg/dL (290 micromol/L) and 14 mg/dL (240 micromol/L) for BCF and TSB also produced similar sensitivity/specificity (90%/87% for the BC and 87%/83% for TSB). CONCLUSIONS: Because the correlation coefficient for HPLC-B and BCF is very similar to that found for HPLC-B and laboratory TSB, BC could be used not only as a screening device but also as a reliable substitute of TSB determination. At higher levels of TSB, in which phototherapy and/or exchange transfusion might be considered, BC performed slightly better than the laboratory. The accuracy and precision of the TcB measurement in this study was observed to be comparable to the standard of care laboratory test.

Development and validation of the pharmaceutical care satisfaction questionnaire.

The development and validation of a survey instrument to assess consumer satisfaction with pharmacy services is discussed. The Pharmaceutical Care Satisfaction Questionnaire (PCSQ) is a 30-item instrument administered by someone other than the pharmacist that uses a Likert scale to score respondents' answers. The PCSQ is written approximately at a seventh grade reading level. Following initial development, the PCSQ was administered to 360 consumers in ambulatory pharmacies and to 311 patients in a multicenter hyperlipidemia outcomes study. The Cronbach coefficient alpha was .94 for the consumer data, with a 64.8% variance accounted for by the 4-factor solution. A coefficient alpha of .84 was found on all 30 items in the hyperlipidemia study, with a variance of 63.78% in control patients and 60.16% in treatment patients. The PCSQ is easy to administer and score, with minimal cost. Unlike other satisfaction surveys, the PCSQ contains patient evaluations regarding outcomes of care. A primary limitation of the PCSQ is that it is a newly developed instrument that needs to be used in more studies to strengthen its validity.

Use of maternal plasma level of zinc-coproporphyrin in the prediction of intrauterine passage of meconium: a pilot study.

OBJECTIVE: To evaluate the usefulness of maternal plasma zinc-coproporphyrin (ZCP) level as a marker for intrauterine passage of meconium. METHODS: A pilot study consisting of 10 pregnancies with meconium-stained amniotic fluid and 10 pregnancies with clear amniotic fluid was used. The corresponding plasma and amniotic fluid levels of ZCP were measured using spectrofluorometry. ZCP levels in plasma and amniotic fluid were compared between the two groups and the relation between plasma and amniotic fluid ZCP levels in the clear and meconium-stained groups was assessed using Spearman rank-order correlation. RESULTS: Mean amniotic fluid ZCP was significantly higher in the meconium-stained amniotic fluid as compared to the clear amniotic fluid group. Although mean plasma ZCP levels were higher in the meconium-stained amniotic fluid group, this difference was not statistically significant. There was no significant correlation between plasma ZCP levels and amniotic fluid ZCP, but we could categorize patients according to plasma ZCP levels into four categories with different risks for having meconium-stained amniotic fluid. CONCLUSIONS: Plasma ZCP might be a promising test for prediction of intrauterine passage of meconium in high-risk patients if confirmed by larger studies. The implications of this prediction on management remain unknown.

The impact of angiotensin-converting enzyme inhibitors on managed care: economic, clinical, and humanistic outcomes.

This article examines evidence of the improved clinical, economic, and humanistic outcomes associated with the use of angiotensin-converting enzyme inhibitors (ACEIs) in clinical practice, in particular in the areas of hypertension, diabetic nephropathies, post-myocardial infarction, and congestive heart failure. Pharmacodynamic and pharmacokinetic differences may exist among this class, however, these may not be clinically relevant when the drugs are given in equivalent doses. Although additional studies are necessary before a class effect can be assumed for each of these outcomes, it is important for clinicians to consider all of these outcomes when using ACEIs.

Noninvasive measurement of total serum bilirubin in a multiracial predischarge newborn population to assess the risk of severe hyperbilirubinemia.

BACKGROUND: Jaundice in near-term and term newborns is a frequent diagnosis that may prompt hospital readmission in the first postnatal week. Hyperbilirubinemia, when excessive, can lead to potentially irreversible bilirubin-induced neurotoxicity. Predischarge risk assessment (at 24-72 hours of age) for subsequent excessive hyperbilirubinemia is feasible by a laboratory-based assay of total serum bilirubin (TSB). Hypothesis. Noninvasive, transcutaneous, point-of-care measurement of transcutaneous bilirubin (TcB) predischarge by multiwavelength spectral analysis, using a portable BiliCheck device (SpectRx Inc, Norcross, GA), is clinically equivalent to measurement of TSB in a diverse, multiracial term and near-term newborn population and predictive of subsequent hyperbilirubinemia. METHODOLOGY: We evaluated a hand-held device that uses multiwavelength spectral reflectance analysis to measure TcB (BiliCheck). The study population (490 term and near-term newborns) was racially diverse (59.1% white, 29.5% black, 3.46% Hispanic, 4.48% Asian, and 3.46% other) and was evaluated at 2 separate institutions using multiple (11) devices. The postnatal age ranged from 12 to 98 hours and the ranges of birth weights and gestational ages were 2000 to 5665 g and 35 to 42 weeks, respectively. All transcutaneous evaluations were performed contemporaneously and paired with a heelstick TSB measurement. All TSB assays were performed by high performance liquid chromatography, as well as by diazo dichlorophenyldiazonium tetrafluoroborate techniques. RESULTS: TSB values ranged from .2 to 18.2 mg/dL (mean +/- standard deviation: 7.65 +/- 3.35 mg/dL). The overall correlation of TSB (by high performance liquid chromatography technique) to TcB (by BiliCheck devices) was linear and statistically significant (r =.91; r(2) =.83; TcB =.84; TSB = +.75; standard error of regression line = 1.38; P <.001; n = 490 infants; 1788 samples). Similar regression statistics were evident in subset populations categorized by race (white: r =.91 [n = 289 infants]; black: r =.91 [n = 145 infants]) as well as by gestation (term: r =. 91 [n = 1625 samples]; near-term: r =.89 [n = 163 samples]). Intradevice precision was determined to be.59 mg/dL (2-3 measurements per infant with 1 device; n = 210 infants; 510 samples in a separate subset). Interdevice evaluation of 11 devices determined the precision to be.68 mg/dL (2-4 devices used for measurements per patient). In 23 of 419 of the study population infants who were in the 24- to 72-hour age range, the predischarge TSB values designated them to be at high risk for subsequent excessive hyperbilirubinemia (above the 95th percentile track on the hour-specific bilirubin nomogram). For these infants, the paired BiliCheck TcB values were all above the 75th percentile track (negative predictive value = 100%; positive predictive value = 32. 86%; sensitivity = 100%; specificity = 88.1%; likelihood ratio = 8. 43). CONCLUSIONS: Our data demonstrate the accuracy and reproducibility of the predischarge BiliCheck measurements in term and near-term newborn infants of diverse races and ethnicities. Infants with predischarge BiliCheck values above the 75th percentile of hour-specific TSB values on the bilirubin nomogram may be considered to be at high risk for subsequent excessive hyperbilirubinemia. Further studies are needed to assess the efficacy of this technique in preterm infants, those undergoing phototherapy, and those with TSB values of >/=15 mg/dL (>/=256 micromol/L).

Clinical and humanistic outcomes of a lipid management program in the community pharmacy setting.

OBJECTIVES: To identify patients at risk for coronary artery disease (CAD) through a search of a community pharmacy's prescription database, to screen and identify patients with elevated cholesterol and at risk for CAD, to enroll patients in a pharmacist-directed lipid management program, and to evaluate selected clinical and humanistic outcomes. DESIGN: Randomized, pretest-posttest control groups. SETTING: Independent community pharmacy in a suburban metropolitan area. PATIENTS: 51 patients who were not at National Cholesterol Education Program low-density lipoprotein cholesterol (LDL-C) or defined triglyceride goals and who met inclusion criteria. INTERVENTION: Pharmacist-directed lipid management program. MAIN OUTCOME MEASURES: Clinical outcome measures included total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels; achievement of LDL-C goal; and risk factor prediction scores. Humanistic outcome measures included patient satisfaction with pharmaceutical care and patient knowledge of hyperlipidemia. RESULTS: LDL-C was decreased in the pharmacist intervention group (n = 25), compared with an increase in the control group at study end. HDL-C levels increased and triglyceride levels decreased in both groups. Of treatment group patients, 32% achieved their cholesterol goals, compared with 15% of control group patients. Risk factor prediction scores improved in the treatment group and worsened in the control group. The treatment group's hyperlipidemia knowledge scores improved significantly from pretest to posttest. Both treatment and control group patient satisfaction scores for the pharmacist investigator were favorable at study end. CONCLUSION: Both treatment and control patients benefited from participating in this study. Patients enrolled in the lipid management program made greater improvements in their knowledge of hyperlipidemia, risk factor scores, and cholesterol levels.

Technology assessment and the drug use process.

UNLABELLED: This activity is designed for pharmacists, physicians, physician assistants, nurses, and other healthcare team members, payers for health services, and healthcare executives. OBJECTIVES: Upon completion of this activity, the participant should be able to: 1. Describe the rationale behind, the development of, and the advantages arising from the formulary process, and discuss the health professionals involved in the creation of formularies. 2. Describe the impact of new drug development and technology on the drug use process. 3. Discuss the functions of the pharmacy and therapeutics committee. 4. Describe the impact of consumers on the drug use process.

Neonatal jaundice and diet.

OBJECTIVE: To determine whether an earlier observation, that infants fed a casein-hydrolysate formula (Nutramigen) have lower neonatal jaundice levels than those fed standard formulas, would be repeated in a larger independent group of infants with more frequent measurements and more rigorous statistical analysis. DESIGN: Newborn infants were fed human milk, a standard whey-predominant formula (Enfamil), or Nutramigen (n = 20 for each group) during the first 3 weeks of life. Transcutaneous jaundice index was measured daily for the first week of life and every 2 to 3 days thereafter, using a noninvasive jaundice meter. Linear regression models of the data were constructed, validated, and compared statistically. SETTING: General community hospital with subsequent home visitation. PARTICIPANTS: Healthy, term newborn infants selected by convenience, based on time of birth. INTERVENTION: Infants were exclusively fed human milk, Enfamil, or Nutramigen. Formulas were randomly assigned. MAIN OUTCOME MEASURE: Jaundice index, a transcutaneous measurement of jaundice. RESULTS: The jaundice index differed significantly among the 3 groups. Paired comparisons showed that the jaundice index of the Nutramigen group was significantly lower than that of the Enfamil group (on days 6-16) and the human milk group (on days 3-20). The jaundice index of the Enfamil-fed group was significantly lower than that of the human milk group on days 13 to 19. CONCLUSIONS: Jaundice levels are lower in neonates fed Nutramigen rather than Enfamil and both these groups have lower jaundice levels than breast-fed infants.

Clinical and economic outcomes in the hypertension and COPD arms of a multicenter outcomes study.

OBJECTIVE: To evaluate the impact of pharmaceutical care on selected clinical and economic outcomes in patients with hypertension or chronic obstructive pulmonary disease (COPD) in ambulatory care settings. DESIGN: Clinic patients with hypertension or COPD were randomly assigned to a treatment group (pharmaceutical care) or a control group (traditional pharmacy care) over a six-month period. Clinical pharmacists and pharmacy residents conducted the protocols. There were 133 evaluable patients (63 treatment and 70 control) in the hypertension study arm and 98 evaluable patients (43 treatment and 55 control) in the COPD study arm. SETTING: 10 Departments of Veterans Affairs medical centers and 1 academic medical center. INTERVENTIONS: Patient-centered pharmaceutical care model (employing standardized care) implemented by clinical pharmacy residents. MAIN OUTCOME MEASURES: Patient knowledge, medication compliance, and health resource use. RESULTS: The hypertension treatment group had a significantly greater reduction in systolic blood pressure from visit 1 to visit 5 than did the control group. In the COPD study arm, trends were positive in the treatment group for patients ratings of symptom interference with activities and dyspnea measures. There was a significant difference between the hypertension treatment and control group for compliance. There were no significant changes in compliance scores in the COPD study arm. Mean number of hospitalizations and other health care provider visits was higher for the hypertension control group. For patients with COPD, hospitalizations increased in the control group, and the number of other health care provider visits was higher in the control group. CONCLUSION: Pharmacists' participation in a pharmaceutical care program resulted in disease state improvement in ambulatory patients with hypertension and COPD.

Development, implementation, and evaluation of a multicenter pharmaceutical care outcomes study.

OBJECTIVES: To: (1) develop a pharmaceutical care multicenter outcomes research project using clinical pharmacy residents and preceptors; (2) develop two research protocols to document pharmacists' impact on clinical, economic, and humanistic outcomes of therapy; (3) develop and implement a data collection process and methodology for outcomes research; (4) evaluate the effectiveness of the multicenter outcomes research process; and (5) prepare clinical pharmacy preceptors and residents to conduct outcomes research. DESIGN AND SETTING: Two research protocols were developed, each a randomized, parallel, open-label evaluation of patients at 10 Department of Veterans Affairs and 1 university medical center. One protocol focused on patients with chronic obstructive pulmonary disease (COPD) and the other on patients with hypertension. The study evaluated pharmacists' management of these two patient groups. PATIENTS AND OTHER PARTICIPANTS: 133 patients with hypertension and 98 patients with COPD; 33 pharmacy directors and preceptors; 45 pharmacy residents. MAIN OUTCOME MEASURES: Clinical, economic, and humanistic outcomes of pharmacists' interventions. The processes of developing a multicenter outcomes study were evaluated, including the data collection process. RESULTS: The two study protocols and an educational program for study participants were developed. A data collection process was developed and implemented, with the paper process being successful and the computer data collection process not implemented due to time constraints. Overall, the multicenter outcomes research process was successful. CONCLUSION: The study provides a framework of processes and sites for the future development of other outcomes research studies. Clinical, economic, and humanistic outcomes are reported in Parts 2 and 3.

Humanistic outcomes in the hypertension and COPD arms of a multicenter outcomes study.

OBJECTIVE: To evaluate the effects of pharmaceutical care on selected humanistic outcomes in patients with hypertension or chronic obstructive pulmonary disease (COPD). DESIGN: Clinic patients with hypertension or COPD were randomly assigned to a treatment group (pharmaceutical care) or a control group (traditional pharmacy care) over a six-month period. Clinical pharmacists and pharmacy residents conducted the protocols. There were 133 evaluable patients (63 treatment, 70 control) in the hypertension study arm and 98 evaluable patients (43 treatment, 55 control) in the COPD study arm. The Pharmaceutical Care Questionnaire evaluated patient satisfaction with care. Tests specific to the disease states assessed disease and disease management knowledge. Quality of life (QOL) was evaluated using the Health Status Questionnaire 2.0 (HSQ 2.0) in the COPD arm; in the hypertension arm, the Hypertension/Lipid TyPE Specification Form 5.1 was used. SETTING: Ambulatory care centers of 10 Department of Veterans Affairs (DVA) medical centers and 1 university medical center. INTERVENTIONS: Patient-centered pharmaceutical care model (employing standardized care) implemented by clinical pharmacy residents. MAIN OUTCOME MEASURES: Satisfaction with pharmaceutical care, disease and disease management knowledge, and QOL. RESULTS: Statistically significant differences in most satisfaction items were found, with treatment patients expressing greater satisfaction. Treatment groups in both arms strongly agreed that pharmacists helped them with confidence in use of their medication and understanding of their illness, gave complete explanations about their medications, made them feel that their care was a priority, and followed up on their questions and concerns. In the hypertension arm, treatment patients demonstrated significant increases in knowledge scores. Trends in QOL were positive for both hypertension groups, with a significant decrease found in number of treatment patients reporting problems with sexual function. In the COPD arm, improvement trends were significantly stronger for treatment patients. CONCLUSION: Although patients were not dissatisfied with traditional pharmacy care, they were more satisfied overall with the pharmaceutical care model.

Gilbert syndrome accelerates development of neonatal jaundice.

OBJECTIVE: Gilbert Syndrome (GS), associated with unconjugated hyperbilirubinemia and decreased bilirubin UDP-glucuronosyltransferase activity, is usually diagnosed after puberty. The role of GS in neonatal jaundice is unknown. This study tested the hypothesis that a recently identified molecular marker for GS (a TA insertion in the promoter of UGT1A, the gene encoding bilirubin UDP-glucuronosyltransferase) is associated with neonatal jaundice. STUDY DESIGN: Transcutaneous jaundice index was measured shortly after birth and daily for the first week of life in 151 healthy infants. Genomic DNA was isolated from blood or buccal brushings, and the UGT1A promoter was amplified by the polymerase chain reaction to yield 90 (A[TA]6TAA, normal) or 92 (A[TA]7TAA, GS) base pair products. Statistical analysis used Kruskal-Wallis, Wilcoxon, and Fisher's exact tests. RESULTS: Nineteen (13%) subjects were homozygous for the A(TA)7TAA polymorphism associated with GS. The A(TA)7TAA homozygotes had a greater increase in jaundice index during the first 2 days of life than heterozygotes or A(TA)6TAA homozygotes. CONCLUSION: Although peak jaundice levels did not differ among groups, newborn infants with the molecular marker for GS have an accelerated increase in neonatal jaundice during the first 2 days of life.