The use of consent-to-treatment forms at the state hospital: an audit in 1996 and 2000.
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Commitment of Persons with Psychiatric Disorders↗
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Why literacy matters. Links between reading ability and health.
The ability to understand verbal and written materials is central to modern life. Yet, the US Department of Education estimated that 47% of all adult Americans in 1993 had poor reading and comprehension skills. Analyses of the readability of patient education materials, discharge instructions, and consent forms throughout many specialties within medicine have found almost uniformly that these materials are written at too complex a level for many or most patients. For example, a study of the patient ophthalmic education materials of the American Academy of Ophthalmology by Ebrahimzadeh et al found large amounts of the material exceeded the reading abilities of much of the American adult population. Yet, this is only one small part of understanding the effects of literacy and reading abilities on our patient's health and their use of our increasingly complex health care system.
Adult↗
Reducing missed opportunities for immunizations. Easier said than done.
BACKGROUND: Missed opportunities for immunizations are associated with underimmunization of preschool-age children. Practice policies limiting immunizations to scheduled preventive visits and guidelines requiring legal guardians to sign consent forms for vaccinations are 2 factors contributing to missed opportunities. However, methods to change these policies have not been sufficiently evaluated. OBJECTIVE: To measure the effectiveness of (1) changing practice policies to incorporate the new national standard to screen and vaccinate eligible children at all office visits and (2) eliminating legal guardian signature requirements. DESIGN: A randomized controlled trial of 2 interventions: (1) changing practice policy and routine to have office nurses screen for immunization status at all visits, attach immunization reminder cards to medical charts for eligible patients, and have providers vaccinate eligible children ("no missed opportunities" intervention) and (2) changing practice guidelines to allow vaccinations without a legal guardian's signature. The first intervention was performed at both sites; the second only at the neighborhood health center (NHC). SETTING: A Pediatric Continuity Clinic in a teaching hospital (hereafter referred to as Clinic), and an NHC. PATIENTS: Enrolled in the trial were 1005 Clinic patients and 983 NHC patients, 0 to 2 years of age. MAIN OUTCOME MEASURES: Missed opportunity rates, immunization rates, and rates of preventive services. RESULTS: Eliminating the requirement for a legal guardian's signature had no effect on any of the outcome measures. The no missed opportunities intervention was partially effective. Study patients had slightly fewer missed opportunities than control patients at each site: (0.60 vs 0.90 per patient per year at the Clinic, P = .01; 1.1 vs 1.3 per patient per year at the NHC, P = .02). For study group patients, immunization reminder cards were attached to medical charts in only one third of vaccine-eligible visits; when attached, they markedly increased vaccination by providers (odds ratio for vaccinating at a visit was 6.9 comparing visits when immunization reminder cards were attached vs not attached). However, at the end of the study, immunization rates were similar for study and control groups at each site. The number of undervaccinated days was slightly lower for the no missed opportunities study group at the Clinic than for the control group (56 days vs 77 days, P < .001), but they were similar for both groups at the NHC. There were no differences in rates of preventive visits or screening tests between study and control groups. CONCLUSIONS: The interventions evaluated to reduce missed opportunities did not increase immunization rates. The key problem was failure to screen for immunization status at all visits. More effective interventions will be needed to overcome barriers within busy primary care practices to substantially reduce missed opportunities.
Female↗
Resection with external beam and intraoperative radiotherapy for recurrent colon cancer.
OBJECTIVE: To review treatment outcomes for patients with locoregional recurrent colon cancer who underwent resection, intraoperative radiotherapy (IORT), and external beam radiotherapy (EBRT). DESIGN: Retrospective study of patients treated between January 1990 and June 1994. SETTING: Tertiary care cancer center. PATIENTS: Eleven patients with bulky recurrent colon cancer extending to adjacent organs or structures signed informed consent forms to receive IORT. INTERVENTION: Of 10 patients who underwent exploratory laparotomy, 5 had no metastatic disease and underwent resection, IORT, and EBRT. Complete resection was accomplished in 4 patients. Doses of IORT ranged from 13 to 20 Gy depending on residual tumor burden; EBRT was typically delivered postoperatively to a dose of 45 Gy. MAIN OUTCOME MEASURES: Survival and locoregional tumor control. RESULTS: All 4 patients who underwent complete resection, IORT, and EBRT are alive without locoregional recurrence 53 to 77 months after treatment. Of these, only 1 patient developed distant metastases. The fifth patient, who had gross residual tumor, developed local recurrence 5 months after IORT. One patient developed an IORT complication-ureteral fibrosis leading to ipsilateral nephrectomy. CONCLUSION: Long-term disease-free survival can be achieved in selected patients with bulky regional recurrence of colon cancer with complete tumor resection, IORT, and EBRT.
Adult↗
Professional integrity in clinical research.
In response to public concern over abuses in human medical experimentation, the dominant approach to the ethics of clinical research during the past 30 years has been regulation, particularly via institutional review board review and approval of scientific protocols and written consent forms. However, the effectiveness of regulatory mechanisms in ensuring the ethical conduct of clinical research is limited. Little attention has been devoted to the nature and role of professional integrity of physician investigators, a conscientious framework for guiding investigators in the socially important but morally complex activity of clinical research. Professional integrity is vital in forging an ethically sound relationship between investigators and patient volunteers, a relationship that differs in important ways from the patient-physician relationship in standard clinical practice. We examine critically 2 models of the moral identity of physician investigators, the investigator as clinician and the investigator as scientist; in neither of these 2 models can the physician investigator eliminate completely the moral conflicts posed by clinical research. The professional integrity of physician investigators depends on a coherent moral identity that is proper to the enterprise of clinical research. The roles of clinician and scientist must be integrated to manage conscientiously the ethical complexity, ambiguity, and tensions between the potentially competing loyalties of science and care of volunteer patients.
Beneficence↗
Lymphedema management training for physical therapy students in the United States.
BACKGROUND: The objective of this study was to determine to what extent accredited physical therapy programs in the United States were presenting the principles of lymphedema management and whether regional differences existed. METHODS: States were grouped into four geographic regions: Northeast, South, Midwest, and West. From mid-June to mid-July, 1997, 63 of 148 (42.6%) accredited physical therapy (PT) programs in the United States completed and returned the questionnaires. Participants received a cover letter, consent form, and lymphedema survey by e-mail, facsimile, or regular post. The lymphedema survey covered a wide variety of issues relating to five areas: 1) general and 2) specific anatomy and physiology of the lymphatic system, 3) pathogenesis of lymphedema, 4) traditional (compression pumps/garments), and 5) innovative (European/Australian) treatment techniques for lymphedema. "Yes" responses indicated that specific information was included in the curriculum. Frequency of yes responses for each of the five areas were counted and converted into percentages. Regional responses were compared with the total combined responses with a modified binomial technique. RESULTS: PT programs in the United States were providing 89% of our designated content in the general anatomy and physiology of the lymphatic system, 73% in the pathogenesis of lymphedema, 65% in traditional treatment techniques, 48% in innovative treatment techniques, and 42% in the specific anatomy and physiology of the lymphatic system. No individual region differed significantly (P > 0.05) from the combined results. CONCLUSIONS: The participating PT programs appeared to be providing instruction in general anatomy and physiology of the lymphatic system, pathogenesis of lymphedema, and traditional treatment techniques. However, far less instruction on the specific anatomy and physiology of the lymphatic system and innovative treatment techniques is offered. We believe that PT students would benefit with more curricular content in these latter two categories in order to acquire the knowledge and skills to combat the devastating effects of lymphedema.
Breast Neoplasms↗
Couple-based prenatal screening for cystic fibrosis in primary care settings.
This study examines a couple-based screening protocol for cystic fibrosis (CF) during pregnancy. The screening test is positive only when both partners carry an identifiable mutation. The risk for the fetus to be homozygous is 1 in 4, and definitive prenatal diagnostic testing can be offered. Between six and seven of every ten CF cases can be identified by testing for seven CF mutations. Couple screening for CF has not been evaluated in a decentralized health-care system. Office guides, informational materials, and consent forms were provided to 69 physicians in Maine. Women sent buccal samples to the study centre and brought sampling materials to their partners. Samples from both individuals were required. When a mutation was identified in the woman's sample, the partner's sample was tested. Screening results were reported to the physician. Standardized follow-up surveys were carried out in selected women, key office staff, and physicians. 1770 women and 1682 partners submitted samples. Testing was successfully completed for 1645 couples. Screening results were positive in one couple; the fetus was homozygous for CF. Physicians, office staff, and nearly all women were satisfied with the screening process. Couple screening for CF is feasible and acceptable in decentralized primary care settings.
Adult↗
Temozolomide in the treatment of recurrent malignant glioma.
BACKGROUND: Options for chemotherapy at the time of recurrence in patients with malignant glioma are limited. The authors describe the efficacy and safety results of their institution's open-label, compassionate-use protocol of temozolomide for patients with recurrent malignant glioma. METHODS: Patients with recurrent malignant glioma at any time during recurrence were treated with oral temozolomide at a dose of 150 mg/m2 per day on a 5-day schedule every 28 days. If this dose was tolerated, then escalation to 200 mg/m2 was allowed. Clinical evaluations and assessments of tumor response were performed every 2 months. All patients or their surrogates signed approved Institutional Review Board consent forms. RESULTS: Among 213 patients who were treated, 33% had Grade 3 tumors, and 67% had Grade 4 tumors. The overall objective response rate was 16% in both of these patient groups; and an additional 51% and 30% of patients with Grade 3 and Grade 4 tumors, respectively, had stable disease as their best response. The 6-month progression-free survival rates were 41% and 18% for patients with Grade 3 and Grade 4 tumors, respectively. The median survival was 49 weeks for patients with Grade 3 tumors and 32 weeks for patients with Grade 4 tumors. The major toxicity was hematologic toxicity. In multivariate analysis, the Karnofsky performance score was a significant predictor of survival for patients with Grade 4 tumors. CONCLUSIONS: Temozolomide was well tolerated in patients with recurrent malignant glioma and had modest efficacy, even at the time of multiple recurrences.
Adolescent↗
The Iranian Human Mutation Gene Bank: a data and sample resource for worldwide collaborative genetics research.
As Human Genome Project exploration continues, the necessity of having a broader spectrum of genomic DNA material from different nationalities to study various aspects of hereditary disease becomes more obvious. The existence of high genetic polymorphism within and between different communities in the world makes it necessary for the gene hunters to investigate many different populations. Iran, a large country with close to 66 million people, is a land of different nationalities, tribes, and religions that offers a highly heterogeneous gene pool to the genetics researcher. The purity of many different races in this country has been highly conserved by geographical borders and by an ancient culture that has always encouraged intrafamilial marriages. All these have created a population that is remarkably heterogeneous yet high in consanguinity rate. During the last five years of investigation we have established a DNA bank, the Iranian Human Mutation Gene Bank (www.IHMGB.com), which contains all genetic diseases studied in Iran that have the Mendelian mode of inheritance. Some of the samples are assigned to common or novel mutations and others belong to patients with clinical profiles associated with particular genetic diseases but undefined mutation. This bank stores samples of DNA from the patient and his/her first-degree relatives together with a comprehensive pedigree and clinical profile for each sample. To facilitate collaboration with other scientists around the world with the same interests, we decided to present our experimental projects online. This DNA bank provides opportunities for us to collaborate with scientists outside Iran. It offers a sample resource to research scientists around the world, at no charge, for the purpose of investigating the various aspects of genetic disorders from prenatal diagnosis to gene structure and function. It is strongly stressed that no commercial benefit is involved in the establishment of this DNA bank and the DNA samples are free of charge. However, to meet our goals and to respect ethical values, DNA samples can only be used under certain conditions stated in the User Consent Form.
Consanguinity↗
A revised Spanish version of the Beck Depression Inventory: psychometric properties with a Puerto Rican sample of college students.
The Beck Depression Inventory (BDI) is a widely used self-report measure for depression. This study has two objectives: (a) to revise, develop, and adapt a Spanish language BDI (BDI-S) that takes the criteria for the diagnosis of major depression according to the DSM-IV into consideration; and (b) to evaluate the psychometric properties (internal reliability and construct validity) of the revised version of the BDI (BDI-S). A sample of 351 undergraduate students at the University of Puerto Rico participated in this study. The participants who agreed to participate in the study and signed the consent form completed self-report measures related to depression (BDI-S, CES-D, and LCSd-7), dysfunctional cognition (DAS-A and IBT), stressful life events (LES), and social support (CAS). The coefficient of internal consistency obtained for the 22 BDI-S items was.88. The correlation coefficients between the BDI-S and instruments that measured other constructs (not depression) were lower than the correlation coefficients between instruments that measured the same constructs. Factor analysis revealed that the factor loading for the BDI-S was congruent with dimensions of depression reported in the literature. These results generally support the internal consistency and the construct validity of the BDI-S.
Adolescent↗
Using community pharmacies to conduct an HSV-1 prevalence study.
PURPOSE: To describe the effectiveness of community-based pharmacists in conducting a study to measure the baseline prevalence of Herpes simplex virus, type-1 susceptibility to two antiviral medications in subjects with recurrent Herpes labialis. METHOD: A cross-sectional study conducted in 47 US community pharmacies. The pharmacist obtained a viral sample from the surface of the lesion, placed the virus-laden swab in a vial of holding medium, and stored it in a refrigerator until shipment to a central laboratory. RESULTS: The population that had swabs processed for viral isolation (1795) was predominantly white (90.1%) and female (67.9%) with a mean age of 37.5 years. A total of 1087 (60.3%) swabs were positive for HSV-1. On-site monitoring revealed 219 protocol deviations related to the stage of the lesion (124), not properly dating or signing the consent form (80), and indeterminate age (15). CONCLUSIONS: This study demonstrates the ability of pharmacists to conduct a large surveillance study in busy community pharmacies. A population of RHL sufferers with active lesions was recruited to study pharmacies during a 5-month period. Pharmacists successfully obtained viral samples from cold sore lesions at a rate comparable to physician-conducted studies. Protocol deviations were generally not serious, and did not compromise the study results or endanger the rights or welfare of participants.
Adolescent↗
Leukotriene synthesis during respiratory syncytial virus bronchiolitis: influence of age and atopy.
Respiratory syncytial virus (RSV) infection is the most common cause of bronchiolitis in infants and an important risk factor for the development of recurrent wheezing and asthma. Cysteinyl leukotrienes were implicated in the pathophysiology of these diseases, and are being targeted for their diagnosis and therapy. We measured urinary leukotriene E4 (LTE4) in infants with RSV bronchiolitis in comparison with controls without respiratory infection, and investigated whether medical and family history, age, and passive exposure to tobacco smoke are related to urinary leukotriene excretion. We studied 33 infants with bronchiolitis and 25 controls, 1-12 months of age. Demographic and historical data were obtained from informed-consent forms and questionnaires completed by the parents. RSV was detected in nasal secretions by enzyme-linked immunoassay. Urine samples were collected on day of admission and were analyzed for LTE4 with an enzyme-linked immunoassay. Urinary LTE4 was 8-fold higher in infants with bronchiolitis than in controls. Leukotriene excretion was significantly higher in infected infants <6 months of age with a medical history of eczema or dry cough and/or family history of asthma. Multivariate analysis revealed that eczema and dry cough are independently associated with high LTE4 excretion during bronchiolitis. Exposure to tobacco smoke did not affect urinary LTE4. Our study shows that leukotriene synthesis during bronchiolitis is particularly elevated in younger infants with an atopic/asthmatic background. Urinary LTE4 may become a valuable, noninvasive marker for the identification of patients who will benefit most from therapy with leukotriene modifiers for management of bronchiolitis.
Age Factors↗
Data management of an inflammatory bowel disease registry.
The history and etiology of inflammatory bowel disease which is characterized by two major disease processes: ulcerative colitis and Crohn's disease, remain unknown. Research is focussing on seven major areas of genetic, environmental and physiologic factors that apparently relate to this disease. Based on this background, a population based Inflammatory Bowel Disease Registry was established in 1987 in the Lehigh Valley area of southeastern Pennsylvania. Consent forms, patient data forms and protocols for operation and implementation were developed, and databases were designed to accommodate demographic, basic history, follow-up and relative history data. The databases were correlated with an IBD registry ID number which both enabled relational analyses and ensured confidentiality of data information. The registry continues to grow, providing feedback for both continued medical research and supportive information for IBD patients and their physicians.
Database Management Systems↗
Dysgraphia in elderly delirious medical inpatients.
BACKGROUND AND AIMS: Dysgraphia is a recognized clinical finding in delirium, but few studies have evaluated handwriting, and results have been inconsistent. In particular, handwritten signatures, which may be a motor automatism, have not been previously evaluated in delirious patients. The aim was to assess abnormalities of signature and spontaneous writing in delirious patients and to investigate their clinical utility in the detection of delirium. METHODS: Secondary analysis of data was collected from a prospective observational study of acutely ill inpatients 70 years or older. Mini-Mental State Examination, Confusion Assessment Method, Delirium Rating Scale, Activities of Daily Living, and APACHE II were administered to each subject, their signatures were evaluated from the consent form, and their handwriting from the spontaneous sentence written as part of the MMSE. RESULTS: The signatures of patients with delirium were significantly more impaired than those without (Chi-square= 14.749, df=1, p<0.0001). The sensitivity of the signature for delirium as defined by CAM was 0.54, with specificity of 0.88. Handwriting abnormalities of omission (p=0.018), illegibility (p=0.034) and spelling (p=0.035) were significantly more common in delirious patients than others (Chi-square with Fisher's Exact tests. This difference was mainly attributable to the fact that a large number of delirious patients were unable to provide any response to the handwriting questions. CONCLUSIONS: An abnormal signature may be an indicator of delirium. People with delirium have handwriting problems, which may be partly caused by cognitive impairment but also by disorders of motor function.
APACHE↗
Digital radiogrammetry of the hand in a pediatric and adolescent Dutch Caucasian population: normative data and measurements in children with inflammatory bowel disease and juvenile chronic arthritis.
We have evaluated the applicability of a new Digital X-ray Radiogrammetry (DXR) system in a Dutch Caucasian pediatric population. For this study we enrolled 535 healthy participants who all signed an informed consent form. In addition, 20 children suffering from inflammatory bowel disease (IBD) and juvenile chronic arthritis (JCA) were enrolled. Radiographs of the left hand were obtained from all participants. From the healthy population a subset of children with a history of forearm fractures were separately analyzed. Measurements consisted of DXR (X-posure; Pronosco-Sectra, Linköping, Sweden). Five hundred thirty-five subjects were enrolled in the study. Twenty-two subjects (4.3%) were discontinued (age 3-10 years), all because of a nonrecognizable radiograph by the DXR system. The short-term coefficient of variation of DXR in this population was 0.59%. Significant differences in DXR-BMD between boys and girls for the ages of 11, 12, 16, 17, and 18 years were found. There were also significant differences in DXR-BMD between the sequential Tanner stages. For 88 subjects repeat radiographs were available (mean interval 1.8 years). In all cases an increase in DXR-BMD was seen. Girls with IBD, JCA, or a history of forearm fractures and boys with IBD showed a significantly lower DXR-BMD compared with healthy controls. We show that DXR is an applicable technique in children. Also, in a small subpopulation it is possible to discriminate children with a high risk of low BMD.
Adolescent↗
Systems of protocol review, quality assurance, and data audit.
The US National Cancer Institute (NCI) is the world's largest sponsor of clinical trials in cancer treatment and biology, and it is responsible for the reliability of data generated by means of its funding. The cooperative groups supported by the NCI consist of main academic institutions and smaller affiliates of these institutions. The size of these groups, their geographical dispersion, and the number of studies accruing patients at any one time make it a challenge to ensure that all requirements of institutional oversight, patient consent, protocol compliance, and data submission and quality are met. Each cooperative group has established various procedures for quality assurance. These include data coordinators at the data management center of the group, study chairs, and statisticians. In addition, each group has a committee of physician-investigators and clinical research associates who make periodic site visits to all member institutions to audit the on-site medical records of a sample of patients entered at that institution. The study records are compared with the medical records for all aspects of protocol management and data generation. In addition, adherence to requirements for consent-form signing and oversight by an institutional review board is assessed. Deviations from the study requirements are evaluated as being minor or major. A written report of the audit result is provided to both the NCI and the relevant administrative components of the cooperative group. The audit process has uncovered rare instances of scientific improprieties in these NCI-funded clinical trials, but more importantly it has educated investigators and support staff to improve adherence to research and data-collection requirements, which has resulted in greater reliability of study results.
Data Collection↗
Laparoscopic vs open hemicolectomy for colon cancer.
BACKGROUND: The role of laparoscopic resection in the management of colon cancer is still a subject of debate. In this clinical study, we compared the perioperative results and long-term outcome for two unselected groups of patients undergoing either laparoscopic or open hemicolectomy for colon cancer. METHODS: This prospective nonrandomized study was based on a series of 248 consecutive patients operated on by the same surgical team using the same type of surgical technique for right (RHC) and left (LHC) hemicolectomy, excluding segmental resections; the only difference was the type of access, which was either laparoscopic or open. The choice of type of access was left up to the patient after he or she had read the informed consent form. Operative time, length of stay, complications, and long-term outcome for the two groups were compared. Follow-up time ranged between 12 and 92 months (mean, 42). RESULTS: Between March 1992 and January 2000, 140 patients underwent a laparoscopic hemicolectomy (55 RHC and 86 LHC); at the same time, 107 patients (44 RHC and 63 LHC) were treated via an open approach. There were no conversions to open surgery in the laparoscopic RHC group, but six patients (7%) in the laparoscopic LHC group were converted. The mean operative time for laparoscopic surgery was significantly longer than the time for open surgery (190 vs 140 min for RHC, 240 vs 190 min for LHC,); however, with increasing experience, this time decreased significantly. The mean hospital stay for the patients who underwent laparoscopic procedures was significantly shorter in both the RHC and the LHC groups (9.2 vs 13.2 days for RHC, 10.0 vs 13.2 days for LHC). No statistically significant difference between the two laparoscopic and open groups was observed for the major complication rate (1.9% vs 2.3% for RHC, 7.5% vs 6.3% for LHC). The patient in the laparoscopic RHC group were lost to follow-up. The local recurrence rate was lower after laparoscopic surgery in both arms (5.4% vs 9% for RHC, 1.5% vs 7.5% for LHC), but the differences were not statistically significant. Two port site recurrences were observed in the laparoscopic groups, one after RHC (2.7%) and one after LHC (1.5%). Metachronous metastases rates were similar for the two groups (16.2% vs 15.1% for RHC, 4.4% vs 5.7% for LHC). Cumulative survival probability at 48 months after laparoscopic RHC was 0.865, as compared to 0.818 after open surgery, and 0.971 after laparoscopic LHC, as compared to 0.887 after open surgery. CONCLUSION: These results suggest that laparoscopic hemicolectomy for colonic cancer can be performed safely, with morbidity, mortality, and long-term results comparable to those of open surgery.
Aged↗
[Information of patients in complementary medicine: acupuncture].
Complementary medicine is not a therapy without side effects. Undergoing acupuncture can result in hazardous complications. Therefore patients should be advised of adverse events associated with acupuncture. A consent form for acupuncture is presented. Only physicians with good anatomical and clinical skills should use acupuncture.
English Abstract↗