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PubMed2006

Patient compliance with homeopathic therapy.

The Homeopathic Clinic of the Campo di Marte Hospital, Lucca, Italy (the Homeopathic Reference Centre for Tuscany) registered a total of 1287 patients seen for the first time between September 1998 and 31 December 2004, of these 560 (43.5%) returned for a follow-up visit after a minimum interval of 2 months following the first consultation. In order to ascertain the reasons for patients not returning for follow-up consultations (drop-out) a telephone survey was carried out on every patient who had been seen during the period from 1 June 2002 to 31 May 2003, but had not returned for a follow-up visit. 73/104 eligible patients were contacted. 37/73 referred to the effectiveness of the treatment which led to an improvement in their state of health, naming this as the reason why they did not return for a follow-up visit.

Adult↗
PubMed2006

Data-driven quality improvement in the Emergency Department at a level one trauma and tertiary care hospital.

To demonstrate how a comprehensive and internally driven Continuous Quality Improvement (CQI) program was designed and implemented in our Emergency Department (ED) in 1999. This program involved monthly data collection and analysis, data-driven process change, staff education in the core concepts of quality, and data reanalysis. Data components collected during the program included census data, physician profiling, and focused clinical audits. CQI measures collected at the beginning of the program and quarterly included: (1) CQI metric data (turnaround times [TAT] and rates of left against medical advice [AMA] or left without being seen [LWOBS]), (2) rates and nature of patient complaints, and (3) results of patient satisfaction surveys performed by an outside consulting firm contracted by hospital administration. During the 4 years since its implementation the program demonstrated improvement in all measured areas. Despite an increase in patient volume of 32% to nearly 37,000 visits/year, and only minimal staffing adjustments, the mean quarterly TAT decreased from 183 min to 165 min (9.8% decrease), the rate of complaints dropped by 56.1% (2.1 per 1000 patients to 0.92), and patients leaving AMA or LWOBS decreased 66.7% from 2.7% to 0.9%. Overall, 44.8% of ED patients rated their care as "excellent." In summary, we demonstrate how a comprehensive quality improvement program was structured and implemented at a tertiary care center and how such a program demonstrated improvement in specific CQI parameters.

Academic Medical Centers↗
PubMed2005

Adolescents' experience with the combined estrogen and progestin transdermal contraceptive method Ortho Evra.

BACKGROUND: The new combined estrogen & progestin contraceptive patch Ortho Evra was approved by the FDA in December 2001. To date, there is a paucity of data regarding its use in the adolescent age group. We examined adolescents' experience with this new contraceptive method. METHODS: Using a questionnaire designed by the authors, care providers in a hospital based adolescent clinic interviewed and reviewed the charts of adolescent girls who had initiated Ortho Evra in 2002-2003. RESULTS: Twenty-eight adolescent girls (age 18 +/- 1 years, gyn age 6 +/- 1 years, onset of sexual intercourse at 14 +/- 1 years, body mass index (BMI) 27.6 +/- 1.2, 57% Hispanic, 21% Caucasian, 11% African American, 7% biracial, 4% Indian American) who had used Ortho Evra for 7 +/- 1 months were enrolled. Half (50%) were adolescent mothers, and 57% had a history of irregular menstrual periods. All (100%) girls reported regular menstrual periods while using Ortho Evra, with only 14% experiencing occasional breakthrough bleeding. Half reported a shorter duration and 36% reported a lighter flow of their periods. About a third (39%) reported a decrease and 11% reported an increase in dysmenorrhea symptoms. About a third (29%) of those with a history of recurrent headaches at initiation reported decrease in headaches, and about a third (33%) of those with acne at initiation reported decrease in facial acne while on Ortho Evra. There were no significant BMI changes during Ortho Evra use. Although condom use while on Ortho Evra was poor (only 15% reporting consistent condom use), there were no pregnancies reported. A majority (93%) reported that they remembered to apply the patches on time, and 40% stated that Ortho Evra was easier than previous contraceptive methods. Two thirds (68%) were very satisfied and 29% were somewhat satisfied with the method, and 93% stated that they would recommend the method to a friend/relative. The preferred application site was the buttock (40%) followed by the lower abdomen (32%). About a fifth (21%) experienced at least one episode of complete patch detachment and 32% reported partial peeling of the patch corners. About a third (32%) would prefer another patch color, and 25% would like a fourth week placebo patch. The most common side effects were mild temporary application site reactions (64%), some discomfort on patch removal (32%), nausea (18%), and breast tenderness (18%). Eleven girls (39%) discontinued Ortho Evra (three lost health insurance, three because of application site reactions, two found patch application schedule difficult to remember, two desired pregnancy, two because of nausea, one because of perceived weight gain). CONCLUSIONS: Ortho Evra provides excellent cycle control in adolescents. Most adolescents are satisfied with this method. Intensive efforts should be made to increase condom use by adolescents on Ortho Evra.

Abdomen↗
PubMedDate not supplied

Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D).

In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STAR*D Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.

Clinical Trials as Topic↗
PubMed2006

The effect of ofloxacin on bacillus calmette-guerin induced toxicity in patients with superficial bladder cancer: results of a randomized, prospective, double-blind, placebo controlled, multicenter study.

PURPOSE: We determined whether prophylaxis with ofloxacin could decrease the toxicity of bacillus Calmette-Guerin for transitional cell carcinoma of the bladder. We also investigated the impact of ofloxacin on bacillus Calmette-Guerin antitumor efficacy. MATERIALS AND METHODS: In this randomized, double-blind, multicenter study 115 patients with primary or recurrent superficial bladder cancer (Ta/T1, CIS, G1-G3) and no prior bacillus Calmette-Guerin treatment were randomized to induction treatment with intravesical bacillus Calmette-Guerin (6 plus 3 instillations) plus 200 mg ofloxacin in group 1 or plus placebo in group 2. Adverse events were assessed using a detailed grid of classification for bacillus Calmette-Guerin related adverse events. Mean patient age +/- SD was 65.6 +/- 10.4 years in the 57 group 1 patients and 65.7 +/- 8.7 years in the 58 in group 2. Median followup was 369 and 374 days in groups 1 and 2, respectively. RESULTS: Ofloxacin significantly decreased by 18.5% the incidence of class II or higher moderate and severe adverse events between instillations 4 and 6. The percent of class III adverse events was significantly decreased by ofloxacin between instillations 1 and 9. Although ofloxacin decreased adverse events involving the lower urinary tract, it did not prevent class I adverse events. Compliance with full bacillus Calmette-Guerin treatment was also improved. Of patients in group 1, 80.7% received 9 instillations compared with 65.5% in group 2 (p = 0.092). At 12 months recurrence and progression rates in group 1 and 2 were 12.7% and 17.2%, and 5.5% and 1.7%, respectively. CONCLUSIONS: Prophylactic ofloxacin decreased the incidence of moderate to severe adverse events associated with bacillus Calmette-Guerin intravesical therapy, particularly class III events, which are primarily associated with patient dropout. Compliance with induction and maintenance therapy may be improved by adjuvant ofloxacin therapy. However, long-term comparative studies with other preventive strategies must be done to confirm these initial findings with compliance and recurrence-free survival as the primary end points.

Adjuvants, Immunologic↗
PubMed2004

The effect of continuous oestradiol with intermittent norgestimate on bone mineral density and bone turnover in post-menopausal women.

OBJECTIVE: To assess in post-menopausal women the efficacy and tolerability of a continuous oestradiol/intermittent norgestimate HRT regimen to prevent and to reverse post-menopausal loss of bone mineral density (BMD) and to determine the effects on serum bone turnover markers markers. METHODS: A 1-year, multicentre, international, placebo-controlled, randomised, double-blind clinical trial was conducted in 146 post-menopausal women with an intact uterus in order to assess the effect on bone loss of continuous oral 17beta-oestradiol (1 mg per day) combined with norgestimate (90 microg per day), for 3 consecutive days out of every 6-day treatment period (E2/iNGM). During a second year extension, all women agreeing to continue were on the E2/iNGM regimen. BMD was assessed prior to treatment and after 1 and 2 years or at the end of treatment in women stopping participation prematurely after at least 6 months of treatment. Serum bone turnover markers were determined prior to and at 1 year of treatment Adverse events were collected at three-monthly intervals during clinic visits over the treatment period. RESULTS: BMD in the lumbar spine, the primary endpoint, was evaluable in 117 subjects completing >6 months of treatment. BMD increased on average by 2.4% in women on the intermittent progestin regimen. It decreased by 1.4% in placebo treated women. The change from baseline and the difference between active and placebo treatment (Delta placebo) were highly significant (P < 0.0001). On E2/iNGM, also the BMD in the total hip increased (+1.49%, Delta placebo 3.73%, P < 0.0001). The serum markers for bone formation osteocalcin and type I collagen N-propeptide were significantly reduced compared to baseline by 31 and 44%, respectively and the bone resorption marker C-terminal crosslinked telopeptide of type I collagen by 59%. Minor increases (<10%) of markers in the placebo group were not significant. During a second year extension of the trial, all subjects were on active treatment. Subjects on placebo who lost (median+/-CI 95%) 0.66% (-2.3 to +0.5) of spine BMD during the first year now gained 4.41% (2.7-7.6). They also gained 1.6% (0.1-0.3.6) in the total hip. Subjects continuously on oestradiol/intermittent norgestimate (E2/iNGM) gained an additional 5.7% (2.3-13.5) in the lumbar spine and +0.1% (-0.6 to +2.2) at the total hip. Side effects reported by women on the intermittent progestin regimen significantly in excess over reports from the placebo group were uterine bleeding, abdominal and breast pain, but not headache. Back pain and weight gain was reported by significantly fewer women on active treatment compared to placebo. CONCLUSION: The continuous oestradiol/intermittent norgestimate HRT regimen is well tolerated, reduces bone turnover and prevents post-menopausal bone loss in healthy post-menopausal women.

Aged↗
PubMed1998

Compliance with depot medroxyprogesterone acetate: a randomized, controlled trial of intensive reminders.

We enrolled women in a prospective, randomized study to determine whether an intensive reminder system would improve compliance in women receiving depot medroxyprogesterone injections. Women selecting this treatment were assigned to a group that received both mail and telephone reminders or to a second group that received only a scheduled appointment at the time of the previous injection. The rate of continuation and the rate of on-time injections did not differ between groups. Women who had prolonged bleeding were more likely to discontinue depot medroxyprogesterone injections.

Adult↗
PubMed2001

Effect of counseling to improve compliance in Mexican women receiving depot-medroxyprogesterone acetate.

This study purported to determine the effect of pretreatment counseling upon discontinuation of 150 mg depot-medroxyprogesterone acetate (Depo-Provera) given for contraception. A total of 350 Mexican women participated: 175 received detailed structured pretreatment counseling about the hormonal effects of the injectable vs. routine counseling upon duration of use and efficacy of the method. Study termination rates were significantly lower in the structured counseling group than in the control group. Cumulative life table discontinuation rates were 17% (30/175) and 43.4% (76/175), respectively (p <0.05). The most common reasons for terminating DMPA were menstrual changes (8.6 and 32% for counseling and control group, respectively). The findings suggest that pretreatment counseling on expected side effects increases the continuation rates of DMPA users.

Adult↗
PubMed1996

Comparative phase III clinical trial of two injectable contraceptive preparations, depot-medroxyprogesterone acetate and Cyclofem, in Vietnamese women.

A multicenter clinical trial was conducted in Viet Nam, comparing two injectable contraceptive preparations: the three-monthly injectable depot-medroxyprogesterone acetate (DMPA) and the once-a-month injectable Cyclofem. A total of 600 volunteers were randomized to the two treatment groups and followed for one year. No pregnancy occurred during the trial. Approximately one quarter of the women in each group discontinued early from the trial. In the DMPA group, this was mostly because of amenorrhea and vaginal bleeding irregularities. In the Cyclofem group, an equal number discontinued because of menstrual problems and personal reasons. These personal reasons are probably related to the inconvenience of having to return to the clinic for injection on a monthly basis. Thus, Vietnamese women experience less side effects with Cyclofem than with DMPA, and once Cyclofem is made more widely available and is more accessible, it may better meet their needs than does DMPA.

Adult↗
PubMed1997

A multicenter comparative study on the efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant and Norplant-II.

In order to assess efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant and Norplant-II in Mexican women, a comparative phase III clinical trial was undertaken in eight clinics across the country. The study involved 1052 women who were followed-up trimonthly for three years. Cumulative pregnancy rates were 0.29% and 0.34% for Norplant and Norplant-II implants, respectively. Similar overall cumulative discontinuation rates were observed at three years: 50.38% for Norplant capsules, and 50.44% for Norplant-II rods. The main method-related reason for termination was endometrial bleeding irregularity which led to discontinuation rates of 11.94% and 11.62% for Norplant and Norplant-II contraceptive systems, respectively. In 15,279 woman-months of experience accumulated with Norplant implants and 14,092 with Norplant-II implants, there were few adverse events reported. No difference was found between the two groups in either difficulty for implants placement and removal or women's discomfort, even though the time required for insertion and removal of Norplant capsules was longer than for Norplant-II rods. It is concluded that during the first three years of use, both implants systems are equally effective, safe, and acceptable.

Adult↗
PubMed1999

Preregistration study on the safety and contraceptive efficacy of a progesterone-releasing vaginal ring in Chilean nursing women.

The contraceptive efficacy and safety of a progesterone-releasing vaginal ring (PVR) manufactured in Chile were compared to that of the Copper T 380A IUD (T-Cu) in nursing women enrolled at three Chilean clinics. A total of 285 volunteers chose to use the PVR and 262 the T-Cu. Plasma progesterone levels attained with the ring decreased from 25 to 14 nmol/L from month 1 to month 3 of use. Ring replacement was scheduled every 3 months. Volunteers continued in the study until weaning or completing the continuous use of four PVRs. No pregnancies occurred in 2320 and 2183 woman-months of exposure with the PVR and the T-Cu, respectively. Lower continuation rates in the first 6 months because of problems with use and a longer lactational amenorrhea were observed in the PVR than in the T-Cu group. Breast-feeding performance and infant growth were similar in both groups. These results confirm the high efficacy and safety of the PVR for nursing women and have led to the registration of the PVR by Chilean health authorities.

Adult↗
PubMed1999

Analysis of client characteristics that may affect early discontinuation of the TCu-380A IUD.

The purpose of this study was to analyze the reasons for early discontinuation of the TCu-380A IUD in women participating in a large multicenter trial. The study relates specific characteristics of the women at the time of TCu-380A insertion with specific 1-year reasons for discontinuation. A secondary analysis was performed on data obtained from 2748 women from sites in Africa, Asia, and Latin America. By the end of the year, 321 discontinuations were observed. The gross cumulative 12-month life table rates of reasons for discontinuation were 13.3 for all reasons and 3.1, 4.5, and 4.3 for expulsion, removals for bleeding/pain, and personal reasons, respectively. Study site, age, and religion had a significant effect on early discontinuation. Women who had IUD insertions in the African centers had significantly higher expulsion rates than women from other centers. Women < 20 years old had significantly higher expulsion rates than older women. Muslim women had significantly higher rates of removal for bleeding and pain than women of other religions. This information may guide the counseling and follow-up process of women with such characteristics and result in a more satisfactory use and improved continuation rates of the TCu 380A.

Adolescent↗
PubMed2006

[Linkage to care after first hospitalisation for psychosis].

BACKGROUND: First hospitalisation for a psychotic episode causes intense distress to patients and families, but offers an opportunity to make a diagnosis and start treatment. However, linkage to outpatient psychiatric care remains a notoriously difficult step for young psychotic patients, who frequently interrupt treatment after hospitalisation. Persistence of symptoms, and untreated psychosis may therefore remain a problem despite hospitalisation and proper diagnosis. With persisting psychotic symptoms, numerous complications may arise: breakdown in relationships, loss of family and social support, loss of employment or study interruption, denial of disease, depression, suicide, substance abuse and violence. Understanding mechanisms that might promote linkage to outpatient psychiatric care is therefore a critical issue, especially in early intervention in psychotic disorders. OBJECTIVE: To study which factors hinder or promote linkage of young psychotic patients to outpatient psychiatric care after a first hospitalisation, in the absence of a vertically integrated program for early psychosis. Method. File audit study of all patients aged 18 to 30 who were admitted for the first time to the psychiatric University Hospital of Lausanne in the year 2000. For statistical analysis, chi2 tests were used for categorical variables and t-test for dimensional variables; p<0.05 was considered as statistically significant. RESULTS: 230 patients aged 18 to 30 were admitted to the Lausanne University psychiatric hospital for the first time during the year 2000, 52 of them with a diagnosis of psychosis (23%). Patients with psychosis were mostly male (83%) when compared with non-psychosis patients (49%). Furthermore, they had (1) 10 days longer mean duration of stay (24 vs 14 days), (2) a higher rate of compulsory admissions (53% vs 22%) and (3) were more often hospitalised by a psychiatrist rather than by a general practitioner (83% vs 53%). Other socio-demographic and clinical features at admission were similar in the two groups. Among the 52 psychotic patients, 10 did not stay in the catchment area for subsequent treatment. Among the 42 psychotic patients who remained in the catchment area after discharge, 20 (48%) did not attend the scheduled or rescheduled outpatient appointment. None of the socio demographic characteristics were associated with attendance to outpatient appointments. On the other hand, voluntary admission and suicidal ideation before admission were significantly related to attending the initial appointment. Moreover, some elements of treatment seemed to be associated with higher likelihood to attend outpatient treatment: (1) provision of information to the patient regarding diagnosis, (2) discussion about the treatment plan between in- and outpatient staff, (3) involvement of outpatient team during hospitalisation, and (4) elaboration of concrete strategies to face basic needs, organise daily activities or education and reach for help in case of need. CONCLUSION: As in other studies, half of the patients admitted for a first psychotic episode failed to link to outpatient psychiatric care. Our study suggests that treatment rather than patient's characteristics play a critical role in this phenomenon. Development of a partnership and involvement of patients in the decision process, provision of good information regarding the illness, clear definition of the treatment plan, development of concrete strategies to cope with the illness and its potential complications, and involvement of the outpatient treating team already during hospitalisation, all came out as critical strategies to facilitate adherence to outpatient care. While the current rate of disengagement after admission is highly concerning, our finding are encouraging since they constitute strategies that can easily be implemented. An open approach to psychosis, the development of partnership with patients and a better coordination between inpatient and outpatient teams should therefore be among the targets of early intervention programs. These observations might help setting up priorities when conceptualising new programs and facilitate the implementation of services that facilitate engagement of patients in treatment during the critical initial phase of psychotic disorders.

Adolescent↗
PubMed2003

A randomized placebo-controlled study of the effect of transdermal vs. oral estradiol with or without gestodene on homocysteine levels.

OBJECTIVE: To assess the effect of transdermal vs. oral administration of E2 on plasma homocysteine levels and to evaluate the impact of adding a progestogen to these regimens. DESIGN: Prospective, double-blind, double-dummy, placebo-controlled study. SETTING: Outpatient clinics in two university hospitals and two teaching hospitals in The Netherlands. PATIENT(S): One hundred fifty-two healthy hysterectomized postmenopausal women. INTERVENTION(S): Thirteen 28-day treatment cycles with placebo (n = 49); transdermal 17beta-E2, 50 microg (n = 33), oral E2, 1 mg (n = 37), or oral E2, 1 mg, plus gestodene, 25 microg (n = 33), followed by four cycles of placebo in each group. MAIN OUTCOME MEASURE(S): Fasting plasma total homocysteine concentrations at baseline and cycle 4, 13, and 17. RESULT(S): Mean (+/-SD) homocysteine concentrations in the oral E2 group decreased from baseline to cycle 4 (9.0 +/- 2.5 micromol/L vs. 8.2 +/- 2.0 micromol/L; mean change, -7.6%). Homocystine values in the oral E2 plus gestodene group did not change substantially from baseline to cycle 4 (8.9 +/- 1.6 micromol/L vs. 8.6 +/- 2.0 micromol/L; mean change, -4.4%). No significant changes were observed in the transdermal E2 group. After four washout cycles, the homocysteine concentration had returned to baseline values in all groups. CONCLUSION(S): Oral E2 therapy reduced the homocysteine concentration more than did therapy with transdermal E2 or oral E2 plus gestodene. This finding may indicate a role of liver metabolism and suggests that gestodene has a negative effect on these changes.

Administration, Cutaneous↗
PubMed1994

Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR).

OBJECTIVES: To measure and compare the incidence of adverse events during use of two medicated intrauterine devices (IUDs). DESIGN: A multicenter prospective 7-year randomized study. SETTING: Family planning clinics, primarily in developing countries. SUBJECTS: Women age 18 to 38 years at admission, desiring contraception and without contraindications to IUDs. MAIN OUTCOME MEASURES: Incidence of complaints, conditions, and rates of specific termination for each IUD. METHODS: Subjects recorded menstrual events, and clinical staff registered all complaints and conditions found on examination at four first-year clinic visits and at semiannual visits thereafter. Difference in rates were analyzed by chi 2 statistics. RESULTS: Annual pregnancy rates for each IUD averaged 0.2/100 women whereas upper genital tract infection occurred at rates of 0.6 to 0.7 per 100 years of use. The levonorgestrel-releasing IUD significantly decreased bleeding and spotting days in comparison with historical data for noncontraceptors and with the copper-medicated IUD. Dysmenorrhea, vaginitis, and myoma in women with the levonorgestrel IUD were markedly decreased in comparison with the experience of copper IUD users. Significantly higher rates of amenorrhea, delayed ovarian follicular atresia, skin and hair conditions, and headache were observed with the steroid IUD than with the copper-releasing IUD. Rates of reported adverse effects for either IUD were highest in the first 2 years of use and among women under age 25. CONCLUSIONS: Long-term use of copper or levonorgestrel IUDs is characterized by very low rates of pregnancy and by a low and declining annual incidence of side effects, including pelvic infection and borderline anemia. The levonorgestrel-releasing IUD reduced the incidence of bleeding and, in the long term, of myoma and myoma-related surgery in comparison with the copper T IUD. Both IUDs proved highly acceptable and had few unanticipated side effects.

Adolescent↗