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A comparison of patient pain during cataract surgery with topical anesthesia in Prechop Manual Phacofragmentation versus phacoemulsification.

OBJECTIVE: To compare the pain level and complications during cataract surgery with topical anesthesia in Prechop MPF versus phacoemulsification. STUDY DESIGN: Prospective randomized comparative study. MATERIAL AND METHOD: One hundred patients, undergoing small incision cataract surgery under topical anesthesia, were allocated randomly to perform Prechop MPF (n = 50) or phacoemulsification (n = 50). Patients were asked to rate their pain level on a 10-point visual analog pain scale during the administration of the anesthetic, during the surgery and after surgery. The surgeon recorded his subjective assessment of patient cooperation and surgical complications. RESULTS: The mean pain score during surgery was 1.64 +/- 1.48 (SD) in the prechop MPF group and 0.92 +/- 1.34 (SD) in the phacoemulsification group. The difference between groups was statistically significant (p = .001). There was no significant difference in pain scores for delivery of anesthesia (p = .077), or after surgery (p = .221) and no significant difference in patient cooperation (p = .446) and surgical complications in either group. CONCLUSION: Patients having cataract surgery under topical anesthesia in the prechop MPF group had more intraoperative pain than patients in the phacoemulsification group. However there was no significant difference in patient cooperation and surgical complications between the groups.

Administration, Topical↗

A review and analysis of the effectiveness of early intervention programs.

A review was made of 27 studies describing early intervention for biologically impaired infants and young children. Although every study provided some type of documentation of outcome, most studies failed to meet common criteria for scientific research, such as specification of inclusion criteria, documentation of reliability, random assignment, and/or the use of control/contrast groups. Studies were grouped into four classifications on the basis of experimental design as follows: retrospective, prospective-no control group, prospective-control/contrast group, and prospective-random group assignment. A comparative analysis was made of the effectiveness of findings on the basis of statistical evidence and clinical support. Statistical procedures were used in 59% of the studies and statistical support for the effectiveness of early intervention was reported in 48% of the studies. Effectiveness on the basis of subjective, clinical conclusions was reported in 93% of the studies. Implications of the discrepancy between effectiveness based on statistical evidence and clinical conclusions are discussed.

Child↗

Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma--a comparison of lipiodol-transcatheter arterial embolization with and without adriamycin (first cooperative study). The Cooperative Study Group for Liver Cancer Treatment of Japan.

A randomized, controlled clinical trial comparing the use of lipiodol-transcatheter arterial embolization (L-TAE) in the presence versus the absence of Adriamycin (ADR) for the treatment of hepatocellular carcinoma was conducted from August 1988 through September 1989. In all, 125 Japanese hospitals participated in this study and 289 patients were entered in the trial. The patients were randomly allocated into group A (L-TAE) or group B (L-TAE + ADR) by telephone registration. There was no significant difference in background factors between group A and group B. Additional treatment, including repeated TAE or hepatic resection, was given to 189 patients. Among the four endpoints analyzed, the rate of tumor reduction and lipiodol accumulation in the tumor did not significantly differ between the two groups. The 3-year survival values for groups A and B were 33.6% and 34.9%, respectively; the difference was not significant. The serum alpha-fetoprotein level, however, decreased to a significantly greater extent in the group that received ADR than in the group that did not (P < 0.05). This result suggests that ADR has some favorable additional effect in L-TAE for the treatment of hepatocellular carcinoma.

Adult↗

Molecular ecology of social behaviour: analyses of breeding systems and genetic structure.

Molecular genetic studies of group kin composition and local genetic structure in social organisms are becoming increasingly common. A conceptual and mathematical framework that links attributes of the breeding system to group composition and genetic structure is presented here, and recent empirical studies are reviewed in the context of this framework. Breeding system properties, including the number of breeders in a social group, their genetic relatedness, and skew in their parentage, determine group composition and the distribution of genetic variation within and between social units. This group genetic structure in turn influences the opportunities for conflict and cooperation to evolve within groups and for selection to occur among groups or clusters of groups. Thus, molecular studies of social groups provide the starting point for analyses of the selective forces involved in social evolution, as well as for analyses of other fundamental evolutionary problems related to sex allocation, reproductive skew, life history evolution, and the nature of selection in hierarchically structured populations. The framework presented here provides a standard system for interpreting and integrating genetic and natural history data from social organisms for application to a broad range of evolutionary questions.

Animals↗

Contracting in the National Health Service (NHS): recognizing the need for co-operation.

Within the reorganized National Health Service hierarchical relationships between Health Authorities and Trusts have been replaced by functional differentiation. However, differentiation of function cannot be seen as an end in itself and management of the relationship between purchasers and providers must include managing the differentiation as well as the function. This paper suggests that collaborative and administrative activities have a distinct role to play in health service management. The paper suggests that in health service management market strategies are likely to dominate in relation to resource allocation activities. The paper also argues that administrative strategies are likely to be necessary within the internal market system--to bridge the gap resulting from the differentiation of function.

Contract Services↗

Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma--a comparison between L-TAE with farmorubicin and L-TAE with adriamycin: preliminary results (second cooperative study). Cooperative Study Group for Liver Cancer Treatment of Japan.

A randomized controlled clinical trial was conducted to compare the use of farmorubicin (FARM) and adriamycin (ADR) in Lipiodol transcatheter arterial chemoembolization (L-TAE) as a treatment of hepatocellular carcinoma. In all, 192 hospitals participated, and 415 patients were enrolled in the study during the period from October 1989 through December 1990, and their data were collected. The patients were randomly allocated to group A (FARM) or group B (ADR) by a central telephone registration. Several clinical characteristics were slightly worse in group A than in group B, but there was no statistically significant difference. The actual doses of FARM and ADR were 72 mg/body and 48 mg/body, respectively. Additional treatments, including repeated TAE or surgery, were given to 248 patients. The 1- and 2-year survival rates were 69% and 44% for group A and 74% and 57% for group B, respectively. The difference was marginally significant (P value in the log-rank test, 0.038). When each group of patients was classified into two subgroups, i.e., high-risk and low-risk categories, based on the severity index calculated by the Cox regression model from significant prognostic factors, the ADR subgroup was significantly superior to the FARM subgroup in the low-risk category, but there was no significant difference between the subgroups in the high-risk category. The change in the serum alpha-fetoprotein level, the extent of Lipiodol accumulation in the tumor, and the extent of tumor reduction did not show any significant difference between the groups. At the above-mentioned doses, ADR seemed to have efficacy almost the same as or slightly superior to that of FARM in L-TAE for the treatment of hepatocellular carcinoma.

Adult↗

[A comparative study among ftorafur, ftorafur plus tamoxifen, and tamoxifen in adjuvant therapy for breast cancer. The Chubu Cooperative Study Group of Adjuvant Chemoendocrine Therapy for Breast Cancer, Japan].

A randomized study assessing the efficacy of three treatment of ftorafur (FT), ftorafur plus Tamoxifen (TAM), and Tamoxifen in patients diagnosed as having stage II (N1b) or stage III breast cancer was carried out at 90 institutions in the Chubu district of Japan. After 10 mg of MMC administration on the day of surgery and the next day, patients were allocated to one of three treatments: FT 600 mg/day for 2 years, FT 600 mg/day plus TAM 20 mg/day for 2 years, or TAM 20 mg/day for 2 years. A total of 647 cases were analyzed. No significant differences were observed in the 5-year disease-free survival rates or in the 5-year survival rates. In the stratified analysis, however, a beneficial effect of adding FT to TAM was observed in the patients with ER-positive tumors in the 5-year survival rate, and FT plus TAM treatment was favorable compared with the other two treatments for postmenopausal patients with ER-positive tumors.

Adult↗

Clinical correlates of in-hospital costs for acute myocardial infarction in patients 65 years of age and older.

Although cost estimates for acute myocardial infarction are necessary for decisions about allocating scarce resources, there is a relative paucity of studies that estimate these costs across the entire spectrum of hospitals in actual clinical practice. This study sought to determine the correlates of in-hospital costs for acute myocardial infarction in patients 65 years of age and older. In the Cooperative Cardiovascular Project pilot, medical records were abstracted for acute myocardial infarction hospitalizations in Connecticut from June 1, 1992, through May 20, 1993. In-hospital costs were calculated by multiplying charges from cost centers by the Medicare ratio of cost-to-charge. Among the 2628 patients in the study sample, the total mean in-hospital cost was $14,772, and the median in-hospital cost was $10,409 (twenty-fifth to seventy-fifth percentile, $6960 to $17,225). The largest proportion of the costs were concentrated in room costs (43% of the total). Although several demographic and clinical characteristics were significantly associated with cost, they accounted for only 7% of the variation. In-hospital procedures and adverse outcomes accounted for 53% of the variation.

Aged↗

Propofol versus midazolam for conscious sedation guided by processed EEG during endoscopic retrograde cholangiopancreatography: a prospective, randomized, double-blind study.

BACKGROUND AND STUDY AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure, which requires appropriate sedation. The aim of this prospective, randomized, double-blind study was to compare the quality and characteristics of sedation with midazolam or propofol in patients undergoing ERCP. PATIENTS AND METHODS: A total of 32 patients undergoing ERCP were randomly allocated for sedation with propofol (n = 15) or midazolam (n = 17). Blood pressure, heart rate, and O2 saturation were monitored. Sedation was maintained at near constant levels by use of the spectral edge frequency (SEF) technique, an EEG-based method for measuring the depth of sedation. Clinical variables, patient cooperation, time to recovery, and amnesia served as outcome variables. RESULTS: There was no significant difference between the two study groups in patient characteristics. The "target SEF" was 13.6 +/- 0.7 Hz for the propofol group and 14.8 +/- 1.1 Hz for the midazolam group (n.s.). The only clinical parameter with a significant difference between the groups was the percent of time in which the heart rate deviated more than 20% from baseline for at least 2 minutes, i.e. 14.6 +/- 2.0 % for propofol and 48.2 +/- 38.0% for midazolam (P<0.01). Patient cooperation was better in the propofol group than in the midazolam group (full cooperation, 13/15 vs. 1/17, respectively; P<0.001). Patient recovery was significantly quicker in the propofol group (P<0.001). The degree of amnesia was similar in both groups; no patient in either group remembered details of the procedure. CONCLUSIONS: ERCP is better tolerated by patients sedated with propofol compared with midazolam, with a shorter recovery time and lesser hemodynamic side effects. Propofol should be considered to be the sedative drug of choice for ERCP.

Adolescent↗

Do aid agencies have an ethical duty to comply with researchers? A response to Rennie.

Medical AID organisations such as Médecins Sans Frontières receive several requests from individuals and international academic institutions to conduct research at their implementation sites in Africa. Do AID agencies have an ethical duty to comply with research requests? In this paper we respond to the views and constructed theories (albeit unfounded) of one such researcher, whose request to conduct research at one of our sites in the Democratic Republic of Congo was turned down.

Cooperative Behavior↗