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PubMed2005

Is preceptorship valuable?

Preceptorship programmes for newly-qualified practitioners have been advocated by the UKCC (1999), therefore a preceptorship programme for midwives was introduced in Oxfordshire in 2000. The programme consisted of a three-month placement in a delivery suite (DS) and a three-month placement in an antenatal/postnatal ward environment. In 2001, it was decided to offer newly-registered midwives the opportunity to work in a community setting, rotating between DS and community on a fortnightly basis. To ascertain whether a community placement in a preceptorship programme provided the right balance between consolidation of skills and confidence, a research project was undertaken. This took the form of semi-structured interviews carried out before and after the completion of the amended programme. The project was conducted over a one-year period by the midwifery practice development team. A professional transcriber interpreted the interviews and the data was analysed by an independent reviewer. The research sample consisted of ten newly-qualified midwives and four preceptors. Findings identified that midwives valued and desired a period of initial support to consolidate their skills and knowledge, which helped to increase their confidence in their abilities regardless of the placement setting. Interestingly, midwives who had opted for a community placement continued to view childbirth as a normal life event, whereas hospital-based preceptees found their philosophy of care had changed at the end of the six-month programme. However, the midwives who had opted for a community placement found the fortnightly rotation too fragmented. The preceptorship programme also had a positive influence on retention rates, which may have been as a result of the midwives feeling more supported. In response to the findings of this research project, it was concluded that the community placement needed to be altered to a three-month placement, but should still be available to newly-qualified midwives as a placement option.

Adult↗
PubMed1988

Neonatologists judge the "Baby Doe" regulations.

The federal regulations now in effect governing the treatment of severely handicapped infants--the so-called Baby Doe regulations--are based on the 1984 amendments to the Child Abuse Prevention and Treatment Act; these regulations require that, except under certain specified conditions, all newborns receive maximal life-prolonging treatment. We sent questionnaires to the 1007 members of the Perinatal Pediatrics Section of the American Academy of Pediatrics to determine their views on the Baby Doe regulations and on whether the regulations had affected their practices; 494 of the members (49 percent) responded. Of the respondents, 76 percent believed that the current regulations were not necessary to protect the rights of handicapped infants; 66 percent believed that the regulations interfered with parents' right to determine what course of action was in the best interest of their children; and 60 percent believed that the regulations did not allow adequate consideration of infants' suffering. In responding to the three hypothetical cases of severely handicapped newborns, up to 32 percent of the respondents said that maximal life-prolonging treatment was not in the best interests of the infants described but that the Baby Doe regulations required such treatment. The responding neonatologists' concerns about the current Baby Doe regulations were similar to those expressed by the United States Supreme Court in rejecting an earlier set of Baby Doe regulations. This similarity suggests that the current Baby Doe regulations should be reevaluated.

Abnormalities, Multiple↗
PubMed1996

Midazolam intravenous conscious sedation in oral surgery. A retrospective study of 372 cases.

In 1987 the Swedish Dental Act was amended to allow Swedish dentists who have undergone a specific accreditation course to administer intra-venous sedation. Midazolam is a benzodiazepin derivate with express sedative and hypnotic qualities, powerful amnesia, a short half-life time and few secondary effects. From 1989-1994 midazolam intravenous conscious sedation (ICS) was administered in 372 cases in the Department of Oral and Maxillofacial Surgery, County Hospital, Falun. This study presents data on the 298 patients. Although surgical removal of impacted wisdom teeth predominated, implant surgery, reduction of fractures and correction of anomalies were also carried out. Supplementary sedative premedication was rarely used. Most patients were treated under local anaesthesia. The mean dosage was 10.45 mg (range 1.25-40 mg). Mean dosage/kg was 0.15 mg (range 0.03-0.50 mg). The average duration of anaesthesia was 50 minutes. The average recovery time was 94 minutes. Three hundred and sixty-nine of 372 planned treatments were completed. No serious complications occurred. The patients were co-operative during surgery and were satisfied with the treatment. Compared with full anaesthesia this method required less resources and is a valuable complement in management of anxious patients undergoing oral surgery.

Adolescent↗
PubMed2000

Gabapentin versus vigabatrin as first add-on for patients with partial seizures that failed to respond to monotherapy: a randomized, double-blind, dose titration study. GREAT Study Investigators Group. Gabapentin in Refractory Epilepsy Add-on Treatment.

PURPOSE: Our objective was to compare the efficacy and safety of gabapentin and vigabatrin as first-line add-on treatment in patients with partial epilepsy. METHODS: This was a multicenter, double-blind, randomized dose titration study. After baseline assessment and randomization, the dose could be increased if seizures persisted and reduced if side effects occurred. Health-related quality of life was assessed at baseline and at the end of the study. By a protocol amendment post hoc, all randomized patients were offered a standardized perimetry examination at the end of the study. Improvement rate was the proportion of patients with a reduction of seizure frequency of at least 50% during an 8-week period without any adverse events causing withdrawal. RESULTS: One hundred two patients were randomized and analyzed on an intent-to-treat basis. The improvement rate was 48% in the gabapentin group and 56% in the vigabatrin group. The improvement rate, when per protocol criteria were fulfilled, was 57% in the gabapentin group and 59% in the vigabatrin group. The proportion of seizure-free patients was 31% in the gabapentin group and 39% in the vigabatrin group. There was no difference in quality-of-life scores between the groups. Perimetry after termination of the study on 64 patients showed abnormal results in 3 of 32 patients in the vigabatrin group. CONCLUSION: Approximately one third of the patients in both groups became seizure-free. Although no major differences were seen in terms of the improvement rate between the groups, equivalence between the two drugs was not found.

Acetates↗
PubMed1985

Infanticide, physicians, and the law: the "Baby Doe" amendments to the Child Abuse Prevention and Treatment Act.

Infanticide, like most other species of homicide, is probably coeval with the human race itself. In modern Western civilization, what were formerly the most powerful incentives to infanticide have virtually disappeared. As with other social problems that affluence has seemed to solve, however, infanticide has reappeared in a new form that seems to have been made possible by affluence itself. This "new infanticide" occurs in a place whose very existence is the result of a tremendously wealthy society's devotion to its most vulnerable and least "useful" members. The modern neonatal intensive care unit, which treats, and often saves, extremely ill newborn children, who during most of history would surely have died, has proven to be a setting where many of the age-old incentives for infanticide have begun to operate again. The "new infanticide" consists of withholding food or needed medical treatment from selected infants who suffer from one or more serious, though treatable, medical problems. The national government has now enacted legislation designed to curtail the practice of infanticide by the medical profession. This paper traces the genesis of that legislation, explores the problem to which it is addressed, and evaluates its prospects for success.

Abnormalities, Multiple↗
PubMed1999

Evaluation of prognostic factors in a tumor volume-adapted treatment strategy for localized Ewing sarcoma of bone: the CESS 86 experience. Cooperative Ewing Sarcoma Study.

BACKGROUND: The Cooperative Ewing Sarcoma Study (CESS 86), conducted by the German Society of Pediatric Oncology and Hematology (GPOH), was planned on the basis of the results of the preceding CESS 81 study. The prognostic significance of tumor volume in localized Ewing sarcoma of bone was well documented in the CESS 81 trial. As a consequence, the treatment intensity was adapted to volume in the follow-up CESS 86 trial: the four-drug combination used in CESS 81 was amended for patients with large tumor volume (> or = 100 ml), where ifosfamide was substituted for cyclophosphamide. PROCEDURE: From January 1986 to June 1991, 177 protocol patients with localized Ewing sarcoma of bone were registered in CESS 86. The prognostic implication of tumor volume and several covariates was evaluated using Kaplan-Meier life table analysis and Cox's proportional hazard model. RESULTS: The estimated 5- and 8-year event-free survival (EFS) rates were both 59%. Age, gender, tumor site, and a tumor volume of 100 ml did not distinguish groups of patients with different prognosis. However, the prognosis of patients with tumors >200 ml (8-year EFS rate: 42%) was significantly inferior compared to patients with tumors both of 100 to 200 ml (70%) and of <100 ml (63%). In contrast to CESS 81, the histological response to chemotherapy was no longer a significant prognostic factor (EFS: 64% for good and 50% for poor responders, respectively). CONCLUSIONS: Despite risk-adapted treatment intensity, tumor volume retained its prognostic significance; the cut point, however, was shifted toward larger volumes.

Adolescent↗
PubMed2004

[Contribution of leflunomide to the cost effectiveness of sequential DMARD therapy of rheumatoid arthritis in Germany].

Since November 1999, leflunomide (LEF), an innovative disease-modifying antirheumatic drug (DMARD), is available in Germany for treatment of rheumatoid arthritis (RA). LEF slows radiographic disease progression and improves functional capacity as well as healthrelated quality of life of RA patients. Resources for health care of the patients are limited in Germany as in all other countries. The purpose of the analysis therefore was to compare the cost effectiveness of the following alternatives: LEF in sequential monotherapy with other DMARDs versus sequential monotherapy of other DMARDs. The target variables of this cost-effectiveness comparison were additional direct costs per ACR20-response year (ACR20RY) gained and per quality-adjusted life year (QALY) gained, respectively, each after three years of treatment. The cost-effectiveness comparison was carried out using a modeling study after secondary analysis of relevant data. Oral methotrexate (MTX), sulphasalazine (SSZ), antimalarials (CQ/HCQ), intramuscular gold (IMG), and azathioprine (AZA) were selected as "other" DMARDs representing the current status of sequential monotherapy. Based on health care regulation in Germany-Guidelines on the Prescription of Drugs amended by the Federal Commission of Medical Practitioners and Health Insurance Funds on 10 December 1999-LEF was exclusively considered second within a DMARD sequence. Direct costs were given by outpatient and inpatient treatment, long-term care, and rehabilitation treatment. Prices relate to the period of 1998 to 2001 and were converted to Euro (euro), according to the official exchange rate of 1 euro = 1.95583 DM (1 euro approximately 0.90 US dollars; 2001 values). The comparative cost-effectiveness analysis covered a treatment period of more than one year. To estimate the net present value of future costs and effectiveness, a discount rate of 5% per year was applied. In the case of DMARD-naïve patients with RA, the sequence MTX, LEF, SSZ, IMG, AZA, CQ/HCQ was the most cost effective with direct costs of 7297 euro per ACR20RY and 6499 euro per QALY. In order to estimate the consequences of introducing LEF into the prescribing practice in Germany, the distribution of RA patients by individual DMARD in rheumatological care in 1998 was considered. This distribution was taken from the National Database of the German Collaborative Arthritis Centres. Though the sequences comprising LEF incurred 3% higher direct costs, they led to a higher effectiveness of 6% and 3% in the case of ACR20RYs and QALYs, respectively. Choosing sequences comprising LEF, there were additional direct costs of 5004 euro per ACR20RY gained and 8301 euro per QALY gained, as compared to the corresponding sequences without LEF. In comprehensive sensitivity analyses, the robustness of the model and its results was shown. The contribution of LEF to the cost effectiveness of sequential DMARD therapy is obvious. The modeling study revealed advantages for the patients and the cost carriers. Though there were initially higher medication costs of the sequences comprising LEF, these costs were nearly compensated to remaining excess costs of just 3% after three years. This was caused by cost savings in other sectors of the health care system due to the higher effectiveness of the sequences comprising LEF.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2000

Psychosocial morbidity in prostate cancer: I. Design of a new questionnaire.

OBJECTIVE: To design a questionnaire capable of measuring psychosocial morbidity in patients with prostate cancer and in their partners. METHODS: Issues to be covered in the questionnaire were determined by discussion among professionals, a literature review and semi-structured interviews with a group of seven patients and their partners. The potential issues were analysed and condensed, then re-presented to a further group of professionals, and to 10 patients and partners for comment and amendment. This process aimed to confirm the completeness and relevance of the list of issues. Questions were then constructed around the final list of issues and the questionnaire adjusted continually while testing on patients, until it was completed easily. RESULTS: The questionnaire consisted of 10 items; three items related to the general threat of cancer (concern about the diagnosis itself, fear of the future and difficulty dealing with the emotional response to the disease). Two items covered social and role functioning and there were five items to determine the severity of psychological morbidity caused by pain, urinary symptoms, treatment, physical limitation and sexual dysfunction. The questionnaire appeared to cover those areas of morbidity most consistently raised by patients and partners; it was also rapidly and easily completed by most respondents. CONCLUSION: The questionnaire constructed may be easily applied as part of routine clinical practice; it addresses aspects of psychosocial morbidity related to prostate cancer in patients and their partners. Although it appears to have content validity, further psychometric testing is required.

Aged↗
PubMed2004

Systematic review and economic evaluation of a long-acting insulin analogue, insulin glargine.

OBJECTIVES: To evaluate the use of insulin glargine in its licensed basal-bolus indication in terms of both clinical and cost-effectiveness. DATA SOURCES: Electronic databases. REVIEW METHODS: A systematic review of the literature, involving a range of databases, was performed to identify all papers relating to insulin glargine. RESULTS: Nineteen studies met the inclusion criteria but full reports were available for only six. For type 1 diabetes patients, insulin glargine appears to be more effective than neutral protamine Hagedorn (NPH) in reducing fasting blood glucose (FBG) but not in reducing glycosylated haemoglobin (HbA1c) and there is some evidence that both insulins are as effective as each other in both FBG and HbA1c control. For type 2 patients for whom oral antidiabetic agents provide inadequate glycaemic control, there is no evidence that insulin glargine is more effective than NPH in reducing either FBG or HbA1c and some evidence that both insulins are as effective as each other in both FBG and HbA1c control. Evidence for control of hypoglycaemia is equivocal. In studies where insulin glargine is demonstrated to be superior to NPH in controlling nocturnal hypoglycaemia, this may be only apparent when compared with once-daily NPH and not twice-daily NPH. Further, this superiority of glargine over NPH in the control of nocturnal hypoglycaemia may relate to one formulation of insulin glargine (HOE901[80]) and not another (HOE901[30]). There is no conclusive evidence that insulin glargine is superior to NPH in controlling symptomatic hypoglycaemia and severe hypoglycaemia. Insufficient data are available to conclude whether insulin glargine is different from each of the commonly used NPH dosing regimens: once daily and more than once daily. Given the lack of a published evidence base for the cost-effectiveness of insulin glargine, the economic review concentrates on a review of the industry submission and an amended model. Three economic models are provided in the submission, two relating to type 1 diabetes and one relating to type 2 diabetes. All three models compare the cost--utility of insulin glargine against NPH insulin. In general, the structures of the models are poor and in all three models, mistakes relating to assumptions and calculations have been made. The assessment team believe that the cost per QALY estimates generated by the Aventis model may be an underestimate for several reasons. The cost-effectiveness of insulin glargine in both type 1 and type 2 diabetes is highly sensitive to the amount of utility associated with reducing the fear of hypoglycaemia. CONCLUSIONS: The evidence suggests that, compared with NPH insulin, insulin glargine is effective in reducing the number of nocturnal hypoglycaemic episodes, especially when compared with once-daily NPH. There appears to be no improvement in long-term glycaemic control and therefore insulin glargine is unlikely to reduce the incidence of the long-term microvascular and cardiovascular complications of diabetes. Further research into insulin glargine is needed that addresses the quality of life issues associated with fear of hypoglycaemia and also the economic impact of balance of HbA1c control and incidence of hypoglycaemia achieved in practice. Studies examining the economic evidence on insulin glargine should be published.

Adult↗
PubMed2002

Phase I trial of the cryptophycin analogue LY355703 administered as an intravenous infusion on a day 1 and 8 schedule every 21 days.

The cryptophycin analogue LY355703 is a potent inhibitor of microtubule polymerization that displays in vitro and in vivo activity in cell lines and tumor xenografts displaying the multidrug-resistant phenotype. In a Phase I trial, 25 patients received LY355703 as a 2-h i.v. infusion on day 1 and day 8 repeated every 3 weeks. Doses were escalated from 0.1 to 2.22 mg/m2 using a modified continual reassessment method. Neurological toxicity was found to be dose-limiting at 1.84 and 2.22 mg/m2. Among four patients treated at these doses, two had grade 4 constipation/ileus, one with severe myalgias, and one had grade 3 motor neuropathy. These findings were reversible. The 1.5 mg/m2 dose level was well tolerated. An amended twice-weekly schedule was pursued in 11 patients in an attempt to improve dose intensity and avoid dose-limiting neurotoxicity. Doses of >0.75 mg/m2 on a day 1, 4, 8, and 11 schedule every 21 days were not tolerated as a result of nausea/constipation, suggesting that LY335703 toxicity is not schedule dependent and is related to cumulative dose. LY355703 plasma concentrations measured by liquid chromatography with tandem mass spectrometry were evaluated using a population pharmacokinetic model. LY355703 was eliminated rapidly with a short terminal half-life that ranged from 0.8 to 3.9 h. Interpatient variability with respect to plasma clearance and volume of distribution, including covariates, was moderate at 32% and 39%, respectively. Maximum plasma concentration and area under the plasma concentration-time curve were linear over the dose range studied. A patient with non-small cell lung cancer previously treated with taxanes experienced a partial response lasting 4 months, and five patients had stable disease lasting > or =3 months. LY355703 at a dose of 1.5 mg/m2 is recommended for Phase II evaluation on a days 1 and 8 schedule. Twice-weekly dosing did not allow improvement in dose intensity or tolerability.

Adult↗
PubMedDate not supplied

Prehospital care and outcome of pediatric out-of-hospital cardiac arrest.

UNLABELLED: Cardiac arrest in children outside the hospital is associated with high mortality rates. Recent investigations have suggested that the use of advanced life support (ALS) measures by emergency medical services (EMS) personnel may decrease survival. These studies have used the pediatric Utstein style of defining ALS and basic life support (BLS) measures. The pediatric Utstein style defines BLS as "an attempt to restore effective ventilation and circulation" using noninvasive means to open the airway but specifically excludes the use of bag-valve-mask devices. Advanced life support is defined as the "addition of invasive maneuvers to restore effective ventilation and circulation." The authors of the study described below believe that using this definition would categorize some patients into an ALS group who would otherwise be categorized as having received BLS (i.e., "bag-valve-mask only"). OBJECTIVE: To compare survival rates among children receiving BLS or ALS following out-of-hospital cardiac arrest using amended definitions of prehospital life support measures. Specifically, the definition of BLS was expanded to include the use of bag-valve-mask devices only. METHODS: This was a retrospective chart review in an urban, pediatric emergency department. Patients included all children presenting to the emergency department between January 1, 1986, and December 31, 1999, following out-of-hospital cardiac arrest. The main outcome measure was survival to hospital discharge. RESULTS: Two hundred ten children were identified. Twenty-one patients were excluded from further analysis because of absent or incomplete medical records. One hundred eighty-nine patients were studied. Five children (2.6%) survived to discharge from the hospital. Of 189 children, 39 (20.6%) were provided BLS measures by prehospital personnel; 150 (79.4%) received ALS. There was no significant difference between groups in survival to hospital discharge. Patients who survived to hospital discharge were more likely to be in sinus rhythm upon arrival in the emergency department (p < 0.001) and to have received fewer doses of standard-dose epinephrine in the emergency department (p < 0.001). CONCLUSION: The use of ALS by prehospital personnel for children with out-of-hospital cardiac arrest did not improve survival to discharge from the hospital when compared with the use of BLS.

Cardiopulmonary Resuscitation↗
PubMed2002

Should therapeutic abortion be legal in Nicaragua: the response of Nicaraguan obstetrician-gynaecologists.

Abortion is legal in Nicaragua only to save the life of the woman. In 2002, amendments to the Penal Code to change the penalties for obtaining and providing illegal abortions and regulations on the authorization of legal abortions are due to be debated in the legislature. In a context of extensive media coverage and debate between women's health and rights groups and a powerful movement to make all abortions illegal, medical professionals have also been effective in influencing law and policy. In May 2001, the Nicaraguan Society of Obstetrics and Gynecology presented the results of a study of the views of 198 obstetrician-gynaecologists on pending legislation regulating therapeutic abortion and the medical and ethical implications of providing therapeutic abortion services. All but nine of the 198 participants in the study, who comprised 76% of all registered obstetrician-gynaecologists in Nicaragua, believed that therapeutic abortion should not be criminalized and over 90% believed that there were cases in which therapeutic abortion was necessary to save women's lives. Some also supported legislative reform to allow abortion in cases of rape and fetal malformation. These results countered claims by the Nicaraguan Medical Association (AMN), taken up by the Church and anti-abortion legislators and groups, that therapeutic abortion was no longer necessary due to modern medicine. The election of anti-abortion politicians to powerful positions in early 2002 has created a formidable challenge when the proposed revisions to the Penal Code are debated.

Abortion, Therapeutic↗
PubMed1995

Chinese Confucian culture and the medical ethical tradition.

The Confucian culture, rich in its contents and great in its significance, exerted on the thinking, culture and political life of ancient China immense influences, unparalleled by any other school of thought or culture. Confucian theories on morality and ethics, with 'goodness' as the core and 'rites' as the norm, served as the 'key notes' of the traditional medical ethics of China. The viewpoints of Confucianism on benevolence and material interests, on good and evil, on kindheartedness, and on character cultivation were all inherited by the medical workers and thus became prominent in Chinese traditional medical ethics. Hence, it is clear that the medical profession and Confucianism have long shared common goals in terms of ethics. Influenced by the excellent Confucian thinking and culture, a rather highly-developed system of Chinese traditional medical ethics emerged with a well-defined basic content, and the system has been followed and amended by medical professionals of all generations throughout Chinese history. This system, just to mention briefly, contains concepts such as the need: to attach great importance to the value of life; to do one's best to rescue the dying and to heal the wounded; to show concern to those who suffer from diseases; to practise medicine with honesty; to study medical skills painstakingly; to oppose a careless style of work; to comfort oneself in a dignified manner; to respect local customs and to be polite; to treat patients, noble or humble, equally, and to respect the academic achievements of others, etc. Of course, at the same time, Confucian culture has its own historical and class limitations, which exerted negative influences on traditional medical ethics. Now, if we are to keep up with the development of modern medicine, a serious topic must be addressed. That is how to retain the essence of our traditional medical ethics so as to maintain historic continuity and yet, at the same time, add on the new contents of medical ethics so as to incorporate modern features into our system. Therefore, when trying to reform medical practice in China, we are faced with the urgent need to inherit and promulgate the essence of Confucian ethics--discarding its obsolete concepts--while at the same time building up the new medical ethics that can meet the requirements of the outside world and the future.

Beneficence↗
PubMed2001

[Is it possible to measure illness intensity degree?].

First Dr. Abad gave thanks to his teachers, to Excelentísimo Mr. President and to the Illustrious Academics of the Royal National Academy of Medicine, to other people and to the auditory. This investigation belongs to Objective Medicine being applicable to Medicine, Pharmacy and Veterinary, that is to say, to the Sciences of the Health. After examining the clinical history he made an analysis of the selected research premises. Among others he analysed what are denominated bigger and smaller symptoms, what means the penetration and the symptomatic invasion, what is a hidden illness, the metastatic condition, what is typical and atypical of a clinical diagram, the problem of previous illnesses with repercussion on the current one (comorbility), the influence of the syntomatology, the immunity and the psyche about the quality of life; lastly the histopatologic factors. These concepts belong to the nosology and the propedeutics (semiotecnics and semiology). The material of the investigation consists on a database, for the time being of more that 6.600 terms, corresponding to the pathology, which is enlargeable and amendable. Each term has been classified by seven concepts. It has been proceeded to an unification of the language, avoiding the polisemia, by means of another database of more than 5.000 key-words that later on have transformed in determinants. The Method, starting from the determinants, built a Biological Scientific Model of 30 groups, applicable to the Medicine which produces a Virtual Real Image of the sintomatology. The results obtained are those that next are described. Grouping the data of the 30 groups he finally obtained a Virtual Real Image of the illness, of eight bases, denominated Nosoma which indicates the variations, from the psychic to the organic field, during the evolution and pursuit of the illness. You can make a quality of life analysis on the different stages of the illness that, together with the value of the symptoms, by means of an algorithm, produces an Nosométric Index, which indicates a valuation of improvement or sick person worsening. This index serves as a control of the therapeutic effectiveness on studies or clinical rehearsals. The system also obtains the valuation of sequels and inabilities upon an illness or accident, and either it's adequate to value patient's death caused by illness in course or for the comorbility, confronting it with the autopsy. By means of this Index, together with the data describing patient's evolution obtained by the computer's program, it's possible to establish doctor's defence parameters against juridical problems.

Algorithms↗
PubMed2002

"As needed" pharmacotherapy combined with stimulus control treatment in chronic insomnia--assessment of a novel intervention strategy in a primary care setting.

Discontinuous, nonnightly hypnotic therapy in the treatment of chronic insomnia is likely to offer benefits such as maintained efficacy while preventing unnecessary long-term nightly use associated with the risk of tolerance and dependence. Based on the favorable results seen in four zolpidem studies using increasing degrees of flexibility in drug intake schedule, we developed the concept further and investigated "as needed" zolpidem pharmacotherapy amended by the optional use of stimulus control in conditions close to the "real life" practice. In a prospective, observational open study in 550 primary care settings throughout Germany, 2690 patients with chronic insomnia (mean age 59 years, 66% female, 50% with pharmacotherapy pretreatment) were treated with zolpidem according to an "as-needed" (pro re nata) administration treatment schedule (up to five tablets per week, intake nights chosen by the patient), amended by the optional use of behavioral therapy (stimulus control) during drug-free nights. After the three weeks' treatment period, in two thirds of patients (63%) the weekly number of tablets used was reduced in contrast to baseline. The average zolpidem tablet number taken decreased by 28% (from 3.7 to 2.6 per week; p < 0.00001) without any significant impact on the treatment efficacy assessed through the CGI. The subjective latency to sleep onset was reduced from a mean of 74 27 min (p < 0.00001) and total sleep time increased from 5.0 to 6.8 h (p < 0.00001). Efficacy of treatment was rated as very good or good in 93% by the investigators. Adverse events were observed only in 1.2% of patients and were generally of mild nature. No serious adverse event occurred. These results underline the validity of the zolpidem "as needed" treatment concept. It is feasible in a safe and effective manner also in a primary care setting and can be amended by stimulus control. Further research is warranted on the contributions of both treatment components to effectiveness and on the efficacy and safety issues of long-term use.

Adolescent↗
PubMed2005

An approach to develop effective health care decision making for women in prison.

BACKGROUND: Decision making about medical treatment, advance care planning and end-of-life care often is limited or influenced by a patient's capacity to read or comprehend crucial information. Ineffective communication between patient and physician, and the complex nature of serious illness and dying also affect these decisions. America's incarcerated have virtually no autonomy in decision making, especially with regard to medical care and treatment. For the nearly 100,000 incarcerated women in the United States, medical issues differ significantly from those of male prisoners. Many women enter prison with chronic illnesses or are diagnosed with such illnesses while in prison. In addition, America's prison population reflects our country's unsolved literacy problems with almost two thirds of aging inmates lacking basic literacy skills. Maintaining a balance between the Eighth Amendment rights of prisoners and their status as wards of the state is a concern for inmates and for those responsible for their care. OBJECTIVE: The purpose of this study was to identify informational barriers to people making medical care and treatment decisions, particularly those with low literacy. Findings were used to in the development of a tool to assist patients to initiate discussion and become active participants in their own care. DESIGN: Female inmates of diverse ethnicity and literacy levels were recruited through self-selection from the Central California Women's Facility near Sacramento to participate in focus group discussions. The focus groups were guided by a set of research questions and were facilitated by the first author to identify informational barriers to medical care needs. SETTING: The female prison setting was identified as an appropriate setting for the development of a new approach to stimulate effective decision making by introducing basic information on medical care and treatment, advance care planning, and end-of-life care. A total of 113 inmates participated in 16 focus group, each 2 hours in length. RESULTS: Findings were used to develop a handbook to assist low literacy populations in general, and female inmates in particular, to obtain appropriate medical care and treatment and to make advance care decisions regarding the end of life. CONCLUSION: Those who face chronic, potentially life-limiting illness cannot make meaningful decisions regarding medical care and treatment without having a basic foundation of health information. Acquiring knowledge and improving communication skills reduce stress and vulnerability, assuring individuals of some control over decision making.

Communication Barriers↗
PubMed2005

[Cardiac arrest management in outpatient clinics: integration between hospital emergency care and the 118 emergency system in the model of Turin ASL 3].

The incidence of sudden cardiac death ranges from 0.4 to 1.28 every 1000 inhabitants per year. Sudden cardiac death is responsible for about 10% of all deaths in Italy in 2000. It is unpredictable and is related to malignant ventricular arrhythmias that may be interrupted in more than 70% of cases. Survival rates generally do not exceed 5% in out-of-hospital cardiac arrest, but, as previously reported, early defibrillation may increase survival rate by 3 times. The Italian law of April 3, 2001, and its recent amendments authorized healthcare providers and trained lay rescuers to use automated external defibrillators either for in-hospital or out-of-hospital settings. We planned a program for early defibrillation in ASL 3 in four outpatient clinics where a transit of 300,000 patients was expected in 2004. Defibrillators were placed in wall-mounted boxes. Opening of these boxes enable an automatic calling to the 118 emergency service that is able to dispatch an advanced cardiac life support team to the pertinent outpatient clinic. The system of wall-mounted boxes automatically communicates by modem with a programmable rate, the state of repair and efficiency of the single boxes, in order to simplify the control of the whole system of defibrillators. This plan of Turin ASL 3 is innovative in the metropolitan area and emphasizes the central role of the 118 emergency system in the management of out-of-hospital cardiac arrest, even in hospital settings such as outpatient clinics with a high number of old users at higher risk of cardiac events. This plan with the availability of automatic calling of the 118 emergency service will be proposed to remaining local hospital utilities for their outpatient settings as well as to other public utilities such as general stores, drugstores, airports where a significant transit mat be expected. The plan will include a specific training for the use of automated external defibrillators by first responders.

Ambulatory Care Facilities↗
PubMed2002

The impact of drug administration sequence and pharmacokinetic interaction in a phase I study of the combination of docetaxel and gemcitabine in patients with advanced solid tumors.

Our objective was to determine the maximum tolerated dose (MTD) of two administration sequences of docetaxel and gemcitabine in cancer patients, and to describe the pharmacokinetics of both drugs. Patients were treated in a 4-weekly schedule at two dose levels: gemcitabine 800 mg/m2 on days 1, 8 and 15, and docetaxel 85 or 100 mg/m2 on day 15 (levels I and II). The protocol was amended to a 3-weekly schedule, testing gemcitabine 800 or 1000 mg/m2 on days 1 and 8, with docetaxel 85 mg/m2 on day 8 given initially (dose levels IIIa and IV). At the recommended dose, an extra cohort of patients initially received gemcitabine (dose level IIIb). Eleven patients were treated with the 4-week schedule; 29% of cycles were delayed predominantly because of hematological toxicity. Four patients developed dose-limiting toxicities (DLTs), predominantly hematological. In the 3-week schedule, 14 patients were treated. At level IV, three of four patients developed DLTs, defining the MTD. With the reverse sequence, three patients received a total of 10 cycles. Overall, nine partial remissions were observed. We conclude the recommended dose for phase II studies is gemcitabine 800 mg/m2 on days 1 and 8, combined with docetaxel 85 mg/m2 on day 8, on a 3-weekly schedule. Gemcitabine distribution is significantly altered upon docetaxel administration.

Adult↗