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PubMed1999

Nutritional counselling in general practice: a cost effective analysis.

STUDY OBJECTIVE: To study the clinical and cost outcomes of providing nutritional counselling to patients with one or more of the following conditions: overweight, hypertension and type 2 diabetes. DESIGN: The study was designed as a random controlled trial. Consecutive patients were screened opportunistically for one or more of the above conditions and randomly allocated to one of two intervention groups (doctor/dietitian or dietitian) or a control group. Both intervention groups received six counselling sessions over 12 months from a dietitian. However, in the doctor/dietitian group it was the doctor and not the dietitian who invited the patient to join the study and the same doctor also reviewed progress at two of the six counselling sessions. SETTING: The study was conducted in a university group general practice set in a lower socioeconomic outer suburb of Perth, Western Australia. PATIENTS: Of the 273 patients randomly allocated to a study group, 198 were women. Age ranged from 25 to 65 years. Seventy eight per cent of patients resided in the lower two socioecnomic quartiles, 56 per cent described their occupation as home duties and 78 per cent were partnered. RESULTS: Both intervention groups reduced weight and blood pressure compared with the control group. Patients in the doctor/dietitian group were more likely to complete the 12 month programme than those in the dietitian group. Patients in the doctor/dietitian group lost an average of 6.7 kg at a cost of $A9.76 per kilogram, while the dietitian group lost 5.6 kg at a cost of $A7.30 per kilogram. CONCLUSION: General practitioners, in conjunction with a dietitian, can produce significant weight and blood pressure improvement by health promotion methods.

Adult↗

PubMed1991

A double blind, randomised, multicentre comparison of two doses of intravenous iloprost in the treatment of Raynaud's phenomenon secondary to connective tissue diseases.

OBJECTIVE: To compare low (0.5 ng/kg/min) and standard dose (2 ng/kg/min) iloprost (a stable carbacyclin analogue of prostacyclin) in patients with Raynaud's phenomenon secondary to connective tissue disorders. DESIGN: Double blind, random allocation, three six hour infusions on consecutive days. Follow up period eight weeks. SETTING: Rheumatology units, five teaching hospitals. PATIENTS: 55 Patients with Raynaud's phenomenon (greater than seven attacks per week), 32 secondary to well documented classical progressive systemic sclerosis (American Rheumatism Association criteria), 11 CREST syndrome, 5 mixed connective tissue disease, 1 rheumatoid arthritis, 1 Sjögren's syndrome, 1 childhood dermatomyositis, and 4 abnormal nailfold capillaroscopy and antibody profiles but no definite diagnosis. INTERVENTIONS: All other treatment for Raynaud's phenomenon was discontinued two weeks before entry. 28 Patients were randomly allocated to receive the low dose, 27 the standard dose. Differing dilutions allowed infusion rates to be started at 10 ml/h with increments of 10 ml/h every 15 minutes until infusion rates reached 0.5 ng/kg/min and 2 ng/kg/min respectively. MAIN OUTCOME MEASURE(s)--Reduction in frequency, duration, and severity of attacks of Raynaud's phenomenon. Assessment of ulcer and ischaemic lesion healing. RESULTS: Both dosage regimens were equally effective in reducing severity, frequency, and duration of Raynaud's attacks. Ulcer healing occurred to similar degree in both treatment groups (standard dose 44%, low dose 39%). Low dose was associated with significantly fewer side effects. CONCLUSIONS: Both dosage regimens reduce severity of Raynaud's phenomenon and encourage ulcer healing. Low dose was associated with fewer side effects and was better tolerated by the patients.

Adult↗

PubMed2001

Evaluation of ethnic minorities and gender effects in clinical trials: opportunities lost and rediscovered.

Recent recognition has been given to the notion of demonstrating a beneficial effect of randomly allocated interventions utilized in controlled clinical trials to women and ethnic minorities. However, despite National Institutes of Health (NIH) guidelines on the inclusion of ethnic minorities and women into these studies, clinical trial investigators continue to suffer from an inability to persuasively reach conclusions about the intervention effect in these subgroups. Although a major factor in this limitation has been the inability to recruit large numbers of these patients into controlled clinical trials, an additional dilemma has been the clinical trial community's well demonstrated inability to draw reliable conclusions from the relevant subgroup analyses. As currently designed in clinical trials, subgroup analyses with neither good prospective planning nor concern for the multiplicity of type I error that accompanies the testing of multiple hypotheses are appropriately relegated to exploratory analyses which merely raise questions, not answer them. This article demonstrates that taking advantage of: (a) prospective, subgroup specific endpoint selection; (b) prospective, subgroup specific endpoint event rates; (c) prospective, subgroup specific therapy efficacy, and (d) prospective, subgroup specific nonuniform type I error levels will fortify a subgroup analysis. Thus, the tools traditionally available to clinical trialists, when wielded with renewed vigor and innovation, in concert with energetic, focused recruitment efforts can lead to a confirmatory analysis with appropriate statistical rigor for the effect of the randomly allocated intervention in these important demographic subgroups.

Data Collection↗

PubMed2000

Acute endothelin-A receptor antagonism prevents normal reduction of myocardial ischemia on repeated balloon inflations during angioplasty.

BACKGROUND: Myocardial ischemia and reperfusion are associated with increased production of endothelin (ET)-1. METHODS AND RESULTS: We examined the effects of BQ-123, a selective ET(A) receptor antagonist, in 80 patients. All patients were randomly allocated to an intracoronary infusion of saline or BQ-123 (6 micromol/L over 20 minutes). The reference group consisted of 20 patients undergoing coronary angiography. BQ-123 produced a 10% (P:<0.005) increase in distal coronary artery diameter. The main study group consisted of 30 patients undergoing coronary angioplasty. All patients underwent a minimum of 3 balloon inflations (BIs). Surface and intracoronary electrocardiographic ST-segment shift as well as pain score were recorded at the end of each BI. BQ-123 or saline was given by intracoronary infusion between the second and the third BI in random allocation. In the saline group, intracoronary ST-elevation decreased from 1.26+/-0.55 mV during the first BI to 0.77+/-0.56 mV during the third BI (P:<0.05) and the surface ST elevation decreased from 0.20+/-0.15 to 0.10+/-0.07 mV (P:<0.05). In the BQ-123 group, the respective values were 1.22+/-0.48 mV and 1.13+/-0.62 mV (intracoronary) and 0.17+/-0.18 and 0.17+/-0.21 mV (surface) (both P:=NS). The decrease in pain score was significantly higher in the saline group (F:=5.97, P:=0.004). In 30 patients (collateral circulation group), the angioplasty protocol was repeated with the use of a pressure guide wire. BQ-123 produced a significant (F:=3.30, P:=0.04) decrease in coronary wedge pressure. CONCLUSIONS: Acute ET(A) receptor antagonism prevents the normal reduction of myocardial ischemia on repeated BIs during angioplasty. This may be explained by a "steal" effect through coronary collaterals.

Angioplasty, Balloon, Coronary↗

PubMed2004

Transfer of preterm infants from incubator to open cot at lower versus higher body weight.

BACKGROUND: The use of incubators in helping to maintain a thermoneutral environment for preterm infants has become routine practice in neonatal nurseries. As one of the key criteria for discharging preterm infants from nurseries is their ability to maintain temperature, the infant will need to make the transition from incubator to open cot at some time before discharge. The timing of this transition is important because when an infant is challenged by cold, the infant attempts to increase its heat production to maintain body temperature. The increase in energy expenditure may affect weight gain. The practice of transferring infants from incubators to open cots usually occurs once a weight of around 1700-1800 g has been reached; however, this practice varies widely between neonatal units. This preferred weight mark appears to be largely based on tradition or the personal experience of clinicians, with little consideration of the infant's weight or gestational age at birth. OBJECTIVES: The main objective was to assess the effects on weight gain and temperature control of a policy of transferring preterm infants from incubator to open cot at lower versus higher body weight. SEARCH STRATEGY: Searches were undertaken of MEDLINE from June 2003 back to 1966, CINAHL from June 2003 back to 1987 and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2003). The title and abstract of each retrieved study were examined to assess eligibility. If there was uncertainty, the full paper was examined. SELECTION CRITERIA: Trials in which preterm infants were randomly allocated to a policy of transfer from incubators to open cots at a lower body weight versus at a higher body weight. DATA COLLECTION AND ANALYSIS: Quality assessments and data extraction for included trials were conducted independently by the reviewers. Data for individual trial results were analysed using relative risk (RR) and mean difference (MD). Results are presented with 95% confidence intervals (CI). Due to insufficient data, meta-analysis could not be undertaken. MAIN RESULTS: Four studies were identified as potentially eligible for inclusion in this review. Two studies were excluded as random allocation to the exposure was not employed. One study is pending, awaiting additional information from the authors. Therefore, one study involving 60 preterm infants, employing a matched-pairs design, which compared the transfer of infants to open cots at 1700 g versus 1800 g, is included in this review. Only two outcomes could be included from this study; return to incubator and daily weight gain. No statistically significant difference was shown for either return to incubator (RR 2.00, 95% CI 0.40 to 10.11) or daily weight gain [MD 4.00 g/day (95% CI -5.23, 13.23)]. Due to small numbers, effects on clinically important outcomes could not be adequately assessed. REVIEWERS' CONCLUSIONS: There is currently little evidence from randomised trials to inform practice on the preferred weight for transferring preterm infants from incubators to open cots. There is a need for larger randomised controlled trials to address this deficiency.

Body Temperature Regulation↗

PubMed1997

Community psychiatric nurse aftercare for alcoholics: a five-year follow-up study.

The aim of this study was to determine if community psychiatric nurse (CPN) aftercare for 1 year improved the 5-year outcome in patients following inpatient treatment for alcohol dependence. A 5-year follow-up study, observer blind, with non-random allocation of subjects to aftercare by CPN for 1 year or standard outpatient care, was used. Subjects had all received inpatient treatment for 6 weeks in a rural alcohol treatment unit. Subjects were traced and assessed in the community 5 years after the index admission. The participants consisted of 127 white male alcoholics. All were first admissions, who had been selected for inpatient treatment and who completed a 6-week inpatient stay. Seventy-three subjects received intensive aftercare by CPN for 1 year, 54 subjects received standard outpatient appointments not due to random allocation but because no CPN was available. Data were collected by semi-structured interview at entry to the trial, namely background epidemiological information, details of drinking history, previous hospital admission, educational, employment and criminal information. At 5-year follow-up, data on drinking status, use of other drugs, hospital admissions, criminal behaviour and gambling, attendance at self-help groups, relationships and employment were collected. Thirty-six per cent of the CPN aftercare group was completely abstinent during the 5 years after treatment compared to 6% of the standard aftercare group (p < 0.001). Subjects receiving CPN aftercare were less likely to report blackouts (p < 0.05) or gambling (p < 0.05). They were more likely to attend hospital meetings (p < 0.0001). CPN aftercare is an effective way of maximizing the effects of inpatient treatment. The effects endured for 5 years after treatment.

Adolescent↗

PubMed1992

Effects of lorazepam on psychomotor performance: a comparison of independent-groups and repeated-measures designs.

The purpose of this study was to compare the sensitivity to the effects of lorazepam (2.5 mg) of a design using independent groups (random allocation of subjects to either a placebo or a lorazepam treatment) with a repeated-measures design (subjects tested both before and after lorazepam treatment). With both designs, it was possible to demonstrate significant and equal effects of lorazepam in tests based upon speed of responding: Lorazepam significantly increased simple reaction time and significantly decreased performance in number cancellation and symbol copying tasks. The independent-groups design was more sensitive (i.e., showed effects at a higher level of significance) to the lorazepam-induced impairment in episodic memory, as assessed in a picture recognition task, and to the lorazepam-induced impairment in a word completion task. Comparisons between the two control condition scores indicated that there were unlikely to be significant group differences with random allocation of a relative homogeneous group of volunteers, such as medical students. While either design would be appropriate for homogeneous populations, for a heterogeneous clinical population where groups cannot be matched the repeated-measures design would be preferable.

Adult↗

PubMed1984

Effect of ranitidine and cimetidine on gastric ulcer healing and recurrence.

Fifty-eight patients with endoscopically confirmed benign gastric ulceration were randomly allocated to treatment with 150 mg ranitidine twice daily, placebo matching ranitidine twice daily, or 200 mg cimetidine three times daily and 400 mg at night. Patients were endoscoped at monthly intervals for up to 3 months, the endoscopist being unaware of the treatment. Significantly more ulcers (p less than 0.05) had healed after 2 months of ranitidine (14 of 18, 78%) and cimetidine (17 of 20, 85%) than with placebo (9 of 20, 45%; p less than 0.05) and after 3 months of ranitidine (15 of 18, 88%) and cimetidine (18 of 20, 90%) than with placebo (11 of 20, 55%; p less than 0.05). Forty-eight patients with healed ulcers were randomly allocated in a double-blind prophylactic study to receive 150 mg ranitidine at night or matching placebo. After 6 months recurrent ulcers were found in 2 of 24 (8%) of patients receiving ranitidine and 10 of 24 (42%) of patients receiving placebo (p less than 0.05). These data indicate that H2-receptor antagonists are significantly better than placebo in healing gastric ulceration and that ranitidine and cimetidine are equally effective. Ranitidine is significantly superior to placebo in preventing gastric ulcer recurrence.

Cimetidine↗

PubMed2002

[Comparison of zopiclone and midazolam premedication for preoperative anxiolysis].

To compare the anxiolysis property of zopiclone (ZPC) and midazolam (MDZ), 117 patients were given zopiclone 7.5 mg p.o. or midazolam 0.05 mg.kg-1 i.m. as premedication. In the study 1, patients were randomly allocated to 4 groups: ZZ group (n = 16) received ZPC in the night before operation and 2 h before operation, ZM group (n = 18) received ZPC in the night before operation and MDZ 1 h before operation, Z group (n = 18) received ZPC 2 h before operation, and M group (n = 24) received MDZ 1 h before operation. The degree of anxiety was evaluated using the state-trait anxiety inventory (STAI) on the day before operation and after receiving premedication. ZPC showed a significant reduction in the STAI score in the ZZ and Z group, but premedication with MDZ showed no changes in the STAI score. In the study 2, patients were randomly allocated to 2 groups: ZPC group (n = 22) received ZPC 2 h before operation, and M group (n = 19) received MDZ 1 h before operation. The degree of anxiety was evaluated using the visual analog scale (VAS) on the day before operation and after receiving premedication. ZPC showed a significant reduction in the VAS score, but MDZ showed no changes in the VAS. It is concluded that ZPC (7.5 mg p.o.) is suitable to reduce the preoperative anxiety in patients who are to undergo surgery as compared to MDZ (0.05 mg.kg-1 i.m.).

Adult↗

PubMed1997

Randomised controlled trial of aspirin and aspirin plus heparin in pregnant women with recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies)

OBJECTIVE: To determine whether treatment with low dose aspirin and heparin leads to a higher rate of live births than that achieved with low dose aspirin alone in women with a history of recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies), lupus anticoagulant, and cardiolipin antibodies (or anticardiolipin antibodies). DESIGN: Randomised controlled trial. SETTING: Specialist clinic for recurrent miscarriages. SUBJECTS: 90 women (median age 33 (range 22-43)) with a history of recurrent miscarriage (median number 4 (range 3-15)) and persistently positive results for phospholipid antibodies. INTERVENTION: Either low dose aspirin (75 mg daily) or low dose aspirin and 5000 U of unfractionated heparin subcutaneously 12 hourly. All women started treatment with low dose aspirin when they had a positive urine pregnancy test. Women were randomly allocated an intervention when fetal heart activity was seen on ultrasonography. Treatment was stopped at the time of miscarriage or at 34 weeks' gestation. MAIN OUTCOME MEASURES: Rate of live births with the two treatments. RESULTS: There was no significant difference in the two groups in age or the number and gestation of previous miscarriages. The rate of live births with low dose aspirin and heparin was 71% (32/45 pregnancies) and 42% (19/45 pregnancies) with low dose aspirin alone (odds ratio 3.37 (95% confidence interval 1.40 to 8.10)). More than 90% of miscarriages occurred in the first trimester. There was no difference in outcome between the two treatments in pregnancies that advanced beyond 13 weeks' gestation. Twelve of the 51 successful pregnancies (24%) were delivered before 37 weeks' gestation. Women randomly allocated aspirin and heparin had a median decrease in lumbar spine bone density of 5.4% (range -8.6% to 1.7%). CONCLUSION: Treatment with aspirin and heparin leads to a significantly higher rate of live births in women with a history of recurrent miscarriage associated with phospholipid antibodies than that achieved with aspirin alone.

Abortion, Habitual↗

PubMed1994

Comparison of different approaches to assess bleeding on probing as indicators of gingivitis.

The purpose of this study was to evaluate different methods of eliciting gingival bleeding as indicators of gingival inflammation in the experimental gingivitis model. Following a period of stringent oral hygiene, 103 dental students were scored for plaque and gingival bleeding assessed by 4 methods. From this group, 41 volunteers were randomly allocated to 2 treatment groups. Dental students with clean teeth and healthy gingivae were asked to abolish all mechanical tooth cleaning in the lower jaw for a period of 3-weeks. During the 21-day experimental period, chlorhexidine (Peridex) or a placebo mouthrinse was applied to the lower jaw. Subjects brushed the upper jaw with a standard toothpaste. In principal, 2 different methods were employed to provoke bleeding: (1) at the marginal gingival tissue by running a probe along the soft tissue wall at the orifice of the pocket, and (2) by probing to the "bottom" of the pocket. Variations in the methods were based on angulation (AngBI, ParBI) of the probe in relation to the tooth surface and to the probing force (PPBI.25N, PPBI.75N). 1 randomly selected quadrant in the lower jaw was scored using the AngBI. The opposing quadrant was scored with a randomly-allocated bleeding index, either ParBI, PPBI.25N or PPBI.75N. The results of this study confirm earlier findings that the angulation of the probe determines the number of sites with bleeding observed. It also indicates that bleeding as elicited by probing to the bottom of the pocket is a poor indicator of early gingivitis. It is recommended that gingivitis should be assessed by probing the marginal gingiva.

Chlorhexidine↗

PubMed1992

Alternatives to randomization in surgical studies.

The purpose of randomization is to provide unbiased estimates of treatment effects and valid probability statements for hypothesis tests in comparative studies. Difficulties with randomized allocation of patients in surgical studies include: patient selection--due to protocol limitations, possible changes in referral patterns, the need for patient consent, and physician co-operation; disruption of the patient-physician relationship; static protocol not responsive to changes as surgical skill evolves and experience regarding patient selection is acquired; the larger number of patients required causes a longer study and more patients receiving what may be a worse therapy. Moreover, for evaluating a new heart valve, the primary purpose should be estimation rather than comparison with a current device. This can be accomplished faster, in a more generalizable way and with more concern for patient care by using non-randomized comparison groups.

Ethics, Medical↗

PubMed2003

Effectiveness of out-of-home day care for disadvantaged families: randomised controlled trial.

OBJECTIVE: To assess the effects of providing daycare facilities for young children on the health and welfare of disadvantaged families. DESIGN: Randomised controlled trial. Eligible children from the application list to a daycare facility were randomly allocated to receive a daycare place or not. SETTING: Early Years daycare centre in Borough of Hackney, London. PARTICIPANTS: 120 mothers and 143 eligible children (aged between 6 months and 3.5 years). INTERVENTION: A place at the centre, which provided high quality day care. Control families used other child care that they secured for themselves. MAIN OUTCOME MEASURES: Maternal paid employment, household income, child health and development. RESULTS: At 18 months' follow up, 67% of intervention group mothers and 60% of control group mothers were in paid employment (adjusted risk ratio 1.23 (95% confidence interval 0.99 to 1.52)), but were no more likely to have a weekly household income of above pound 200 (risk ratio 0.88 (0.70 to 1.09)). Intervention group children had more otitis media with effusion (risk ratio 1.74 (1.02 to 2.96)) and used more health services (1.58 (1.05 to 2.38)), but both estimates were imprecise. CONCLUSION: The provision of child day care may have increased maternal employment, but it did not seem to increase household income. The results suggest that providing day care may be insufficient as a strategy to reduce poverty. The study shows how random allocation can be used to ration and evaluate interventions where demand exceeds supply.

Child Day Care Centers↗

PubMed2001

Socioeconomic status and breast cancer incidence in California for different race/ethnic groups.

OBJECTIVE: The majority of research on breast cancer risk and socioeconomic status (SES) has been conducted for blacks and whites. This study evaluates the relationship between SES and breast cancer incidence in California for four race/ethnic groups. METHODS: Principal component analysis was used to create an SES index using 1990 Census data. Untracted cases were randomly allocated to census block groups within their county of residence. A total of 97,227 female breast cancer cases diagnosed in California between 1988 and 1992 were evaluated. Incidence rates and rate ratios (RRs) were estimated and a chi2 test for trend across SES levels was performed. RESULTS: SES was positively related to breast cancer incidence, and this effect was stronger for Hispanics and Asian/others than for whites and blacks. Adjusting by SES did not eliminate the differences in breast cancer rates among race/ethnic groups. RR differences between the race/ethnic groups were greatest in the lowest SES category and attenuated with increasing SES. An increasing trend over SES was statistically significant for all race/ethnic groups. Including randomly allocated cases affected RR estimates for white women only. CONCLUSIONS: Our results are consistent with similar findings for the Los Angeles area but differ from previous results for the San Francisco Bay area.

Adolescent↗

PubMed2001

Effect of different dietary energy level intakes on efficiency of estrus synchronization and fertility in Mashona goat does.

The objective of the study was to determine the effects of three dietary energy levels: 0.27 (low level: LL); 0.53 (medium level: ML), and 1.06 (high level: HL) MJMEkg(-1)W(0.75) on estrus synchronization and fertility in Mashona goat does. Forty-five multiparous Mashona goat does of average bodyweight 19.9+/-2.5kg were randomly allocated in equal numbers to the three dietary energy levels. The diets were made from a complete feed ration providing 9.83MJMEkg(-1)DM and 15.5% CPkg(-1)DM. Does were fed initially during a 60-day pre-synchronization period, and blood samples were collected twice a week for the determination of plasma progesterone concentrations to ascertain ovarian activity. Intramuscular injections of cloprostenol (100µg each) were administered 11 days apart. Immediately after the second injection of cloprostenol, three fertile bucks were introduced to the does and were left with the does for 21 days. The does were maintained on their dietary treatments throughout gestation except for those does in the LL treatment. Pregnancy was diagnosed 90 days post-mating using an ultrasound scanner. After pregnancy diagnosis, does on the LL treatment were randomly allocated to ML (n=7) and HL (n=8) treatments. During the pre-synchronization period, does on the LL treatment lost 12.3% whereas those on ML and HL treatments gained 2.1 and 28.8% of their initial bodymasses, respectively. The proportion of does exhibiting overt estrus within 96h after the last cloprostenol injection was significantly lower (P<0.05) for does on the LL treatment (60%) than for those on ML (93%) or HL (100%) treatments, respectively. However, based on plasma progesterone concentrations, the percentage of does on the LL treatment that exhibited ovarian cycles was numerically lower than that of does that were bred (40 versus 73%). Conception, fecundity and twinning rates were significantly lower (P<0.05) on the LL treatment than on the ML and HL treatments. These results indicate that feeding Mashona goat does 0.27MJMEkg(-1)W(0.75) compared to 0.53 and 1.06MJMEkg(-1)W(0.75) reduces the expression of estrus, conception, fecundity and twinning rates, and that feeding 0.53MJMEkg(-1)W(0.75) suffices for optimum reproduction. In addition, the results suggest that cloprostenol administration may induce ovarian cycles in reproductively quiescent does on dietary energy restriction.

Journal Article↗

PubMedDate not supplied

Randomized controlled trials in long-term care residents with dementia: a systematic review.

OBJECTIVE: To evaluate the quality of reporting of randomized controlled trials for pharmacologic interventions in long-term care residents with dementia. DATA SOURCES: We performed electronic searches of AMED, CINAHL, E-PSYCHE, Cochrane Controlled Trials Register, and MEDLINE. We also searched the reference lists of included studies and bibliographies of relevant review articles. STUDY SELECTION: All randomized controlled trials for pharmacologic interventions in patients with dementia residing in long-term care facilities. DATA ABSTRACTION: We abstracted data independently, in duplicate, using a data abstraction sheet and a quality checklist. DATA SYNTHESIS: Fifteen trials met inclusion criteria. Five trials lacked institutional ethical review, while two lacked informed consent. Eleven trials gave adequate description of withdrawals and 14 trials reported adverse events adequately. We found incomplete reporting of methods of randomization, allocation concealment, restriction, blinding, sample size estimation and intention-to-treat analysis. Sensitivity analysis indicated that reporting of allocation concealment was associated with increased quality of trial according to the quality scale (P = 0.007). CONCLUSIONS: Clinicians and the public do not have high-quality information to guide pharmacologic decision making for long-term care residents with dementia. The reporting quality is highly variable in the trials reviewed, and concerns exist surrounding the conduct of several trials.

Aged↗

PubMed2003

A needle-free jet-injection system with lidocaine for peripheral intravenous cannula insertion: a randomized controlled trial with cost-effectiveness analysis.

UNLABELLED: Insertion of a peripheral IV cannula is a common, although painful, procedure. We tested the analgesic efficacy, adverse effects, and cost-effectiveness of a needle-free intradermal drug delivery system (Jet) with lidocaine for the insertion of an IV cannula (18-gauge; dorsum of hand). Four-hundred patients were randomly allocated to one of four groups: (a) no treatment, (b) Jet (J-Tip), National Medical Products Inc, CA; $3.0 per device) with 0.5 mL of saline, (3) Jet with 0.5 mL of lidocaine 1%, and (4) Jet with 0.5 mL of lidocaine 2%. Pain was evaluated using a numerical verbal scale (NVS 0-10). A NVS < or =3 was considered as acceptable in this context. Incremental cost-effectiveness ratios were calculated. Without treatment, 42.4% of patients had a NVS < or = 3, 39.3% with saline, 60.7% with 1% lidocaine (relative risk [RR] compared with no treatment, 0.70; 95% confidence interval [CI], 0.53-0.93), and 86.7% with 2% lidocaine (RR, 0.49; 95% CI, 0.38-0.62). Nineteen and one-half percent of patients had a NVS >3 because of Jet treatment, 13.5% had local hyperemia, and 16.9% had minor local bleeding. Of all Jet treatments, 10.5% were technical failures, and there were 17.6% cannula insertion failures (10.1% without treatment [RR, 1.74; 95% CI, 0.92-3.32]). Compared with no treatment, costs to generate one additional patient with a NVS < or =3 were $23 with lidocaine 1% and $10 with lidocaine 2%. On insertion of an IV cannula on the back of the hand, 58% of patients report at least moderate pain. Lidocaine-Jet is analgesic; there is dose-responsiveness. However, Jet treatment is not painless, and costs incurred to achieve one success compared with doing nothing are not negligible. IMPLICATIONS: Insertion of an IV cannula is painful. Four-hundred patients were randomly allocated to test the analgesic efficacy, adverse effects, and cost-effectiveness of the needle-free intradermal drug delivery system (J-Tip); Jet). Jet with lidocaine is effective, but its application is not painless. Costs to achieve one patient with no more than moderate pain (numerical verbal scale < or =3 of 10) on insertion of an IV cannula are $10.

Adolescent↗

PubMed1992

Relationship between the onset of oestrus, the preovulatory surge in luteinizing hormone and ovulation following oestrous synchronization and superovulation of farmed red deer (Cervus elaphus).

The timing of ovulation relative to the onset of oestrus and the preovulatory surge in luteinizing hormone (LH) was studied in red deer following treatments to synchronize oestrus and induce either a monovulatory or superovulatory response. Mature hinds (n = 36) were allocated randomly to two mating groups (n = 16 + 20), with respective treatments staggered by 4 weeks during the 1990 rut (March-April). Each hind was treated with an intravaginal controlled internal drug releasing (CIDR)-type S device for 14 days. Treatments to induce a monovulatory response included CIDR device alone (treatment A; n = 4 + 8) and additional injection of 200 iu pregnant mares' serum gonadotrophin (PMSG) at device removal (treatment B; n = 4 + 4). Treatments to induce a superovulatory response included injections of 200 iu PMSG and 0.5 units ovine follicle-stimulating hormone (FSH) at about time of removal of CIDR devices (treatment C; n = 4 + 4) and further treatment with gonadotrophin-releasing hormone (GnRH) analogue 18 h after removal of CIDR devices (treatment D; n = 4 + 4). The hinds were run with crayon-harnessed stags from insertion of CIDR devices (12 March or 9 April) and blood samples were taken every second day to determine plasma progesterone. Further blood samples were collected for determination of plasma LH and progesterone via indwelling jugular cannulae every 2 h for 72 h from removal of CIDR devices. Hinds were allocated randomly to an initial ovarian examination by laparoscopy at either 16 or 20 h (A and B), or 12 or 16 h (C and D) after the onset of oestrus, with laparoscopy repeated at intervals of 8 h until either ovulation was recorded (A and B), or for four successive occasions (C and D). All hinds received cloprostenol injections 15 days after device removal. A total of 28 hinds (78%) exhibited oestrus and a preovulatory LH surge, with mean (+/- SEM) times to onset of oestrus of 44.6 +/- 1.0 h (A; n = 7), 37.4 +/- 2.0 h (B; n = 7), 16.3 +/- 1.7 h (C; n = 6) or 14.0 +/- 1.7 h (D; n = 8). Failure to exhibit oestrus or LH surge was most prevalent among hinds in treatment A early in the rut.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗