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Intention-to-treat analysis: who is in? Who is out?

To assess whether the term "intention to treat" (ITT) predicts inclusion of all randomized subjects in the analysis, we reviewed 100 randomly selected reports of randomized trials that mentioned analysis by ITT. Only 42 of 100 reports included all randomized subjects in the ITT analysis. We could not determine which categories of participants were excluded from the ITT analysis in 13 trials. The most common categories of excluded subjects were patients who, after randomization, received no follow-up (16/100), received no treatment (14/100), or were found not to meet study entry criteria (12/100). We could determine the number of participants in the ITT analysis for 92 studies. Nineteen of the 92 studies excluded more than 5% of randomized participants, and 10 excluded more than 10%. There is considerable variation in how researchers define and apply the principle of intention to treat.

Data Interpretation, Statistical↗

Intentional poisoning of animals in southeastern Spain: a review of the veterinary toxicology service from Murcia, Spain.

Data of toxicological analyses carried out over a 10-y period for suspected cases of wild and domestic animal poisonings are summarized. Of the 123 cases suspected as deliberate, 102 were be analyzed and 50 of them were positive to intentional poisoning, a total of 107 dead animals. Pesticides, especially insecticides (72%) and rodenticides (26%), were frequently involved. Aldicarb (n=15), anticoagulant rodenticides (n=8) and strychnine (n=4) were the most common toxins in baits prepared for intentional poisonings; carbofuran, methomyl, endosulfan and paraquat were also used. A coordinated Veterinary Toxicology Services network of collaboration should be set up in Spain to improve the quality of the services provided.

Aldicarb↗

Does sterile or nonsterile technique make a difference in wounds healing by secondary intention?

After observing inconsistencies in care of acute surgical wounds healing by secondary intention and reviewing the potential cost savings of implementing clean dressing change technique policies, surgical nurses at a university-based medical center monitored supply usage and infection rates of these wounds using a nonexperimental, longitudinal study design. Staff from two acute care surgical units provided data for 3 months before and 3 months after standardization of wound care to a clean wound care technique. All adult patients requiring dressing changes three times per day with normal saline moistened gauze of their open surgical wound(s) participated in the study. Before changing the wound care procedures, nine (9) of 1,070 (0.84%) admissions to the two surgical units had a surgical site infection. During the 3 months following implementation of clean wound care protocols, eight (8) surgical site infections were documented in 963 admissions (rate.83%). Dressing supply costs were $380 less. In this study, using nonsterile wound care procedures for wounds healing by secondary intention did not negatively impact infection rates and saved supply costs.

Adult↗

Reproductive intentions of the newlywed Bulgarian families--artificial neural network approach.

INTRODUCTION: The aim of this study was to describe the reproductive intentions of newlywed Bulgarian families, build predictive models of the desired number of children by artificial neural networks (ANN) and compare these models' overall prediction accuracy with conventional statistical analyses. MATERIAL AND METHODS: Data from a large cross-sectional study on family planning knowledge and habits of newlywed couples from the region of Plovdiv (Bulgaria) in the year 2000 were used. A subset of 17 variables was extracted from the database, in order to construct and train a back-propagation multilayer ANN. Desired number of children, separately for male and female spouses, was used as an output variable. The following statistical analyses were used: descriptive statistics, percentage distribution, nonparametric tests and logit regression analysis. RESULTS AND DISCUSSION: Factors that determine the opinion of male and female spouses on desired number of children have different relative importance in the phase space. The reproductive planning of the newly-married family can be better modeled and predicted in women than in men. The reproductive intentions of the modern newlywed Bulgarian family are decided on the basis of mutual agreement and understanding. There is no difference between desired number of children by both partners. The age at marriage of spouses is increasing with a tendency to reach the Western European patterns. Artificial neural networks are found to be a very useful tool in cross-sectional population studies for factor classification and outcome modeling, especially in cases where data are not entirely suitable for logistic regression analyses.

Bulgaria↗

Characteristics and career intentions of Scottish rural and urban GP registrars: cause for concern?

OBJECTIVES: To investigate the differences between the characteristics and career intentions of GP registrars in urban and rural areas, and to make recommendations to reduce a potential work force crisis in rural practice. DESIGN: Postal survey. SETTING: All general practices in Scotland. SUBJECTS: In February 1996, 40/196 (20%) of urban and 45/150 (30%) of rural GP registrar places available in Scotland, were vacant (chi 2 = 4.22, df = 1, p = 0.02). Postal questionnaires were sent to all 261 GP registrars in post. RESULTS: Of 235 respondents (90%), the majority wished to remain in general practice (63% of urban and 53% of rural registrars), but only 22% of urban and 18% of rural registrars intended to apply for principal posts immediately after training. Fewer urban (8%) than rural registrars (21%) stated an intention to go abroad to work after training. Rural registrars tended to want to work in rural areas, and vice versa. Part-time and job-sharing were attractive employment options for both groups, and more flexible career structures were favoured by over 80%. CONCLUSIONS: Though much more attention has been paid to recruitment in inner cities, the findings from this study suggest that in Scotland difficulties in finding principals may occur first in rural areas. As general practitioners have an extended role in rural areas, including that of emergency care, shortages could have a serious impact on patient care.

Adult↗

Rural elementary school teachers' intent to manage children with asthma symptoms.

A study of 212 rural elementary school teachers sought to determine the relationships among the variables of their general knowledge about asthma, attitude toward asthma, self-efficacy in helping children with asthma manage their asthma, and social support for initial management of children's asthma with the teachers' intent to manage children who present with signs and symptoms of asthma in the classroom. The situational variables of number of years teaching experience, number of children with asthma that teachers have had in their classroom during their teaching profession, and whether or not the teacher had asthma or knew of someone with asthma also were explored in relation to intent to manage asthma. Results indicate that although teachers had a favorable attitude toward asthma and were tolerant of students with asthma, their knowledge about asthma was low. Because asthma can be life-threatening, it is essential to assist those involved in monitoring and managing children with asthma to provide timely, appropriate care. In this way, the goal of having a child with asthma live as normal a life as possible, including all school activities, can be realized.

Asthma↗

Results of radiotherapy with curative intent in non-small cell lung cancer. An analysis of 130 patients.

Between 1970 and 1985, 130 patients were irradiated with curative intent at the Center of Oncology in Kraków. The histological diagnosis was squamous-cell carcinoma in 60.8% of patients, adenocarcinoma in 25.4% of patients and other non-small cell cancer in 13.8% of patients. Out of 130 irradiated patients 21.5% refused surgery, 26.2% were inoperable for medical reasons, and 52.3% had unresectable tumors. According to the UICC TNM 1987 classification, 62 (47.7%) patients had early (stages I and II) disease. The remaining 68 (52.3%) patients had stage III A cancer. Additional criteria for patients selection to radiotherapy with curative intent were: Karnofsky performance status > or = 50, and no respiratory insufficiency. All patients were treated with megavoltage radiation. Patients with stage I were treated by three isocentric beams. Tumor dose was 6000 cGy in 24 fractions over five weeks. In patients with stage II and III A disease the radiotherapy was started with two parallel opposed beams encompassing primary lesion and mediastinum. The dose of 4000 cGy was given in 20 fractions over four weeks, followed by a "boost" dose of 2000 cGy in the fractions over two weeks, delivered with three isocentric beams. 54% of patients were disease-free at the twelfth month, 24.6% at the 36th month, and 18.5% of patients survived five years without evidence of cancer. A significantly better survival has been observed in patients with stages I and II, with Karnofsky performance status > or = 70, and with complete radiological regression eight weeks after radiation therapy. The main cause of failure of the treatment were distant metastases.

Adenocarcinoma↗

The association between teacher attitudes, behavioral intentions, and smoking and the prevalence of smoking among seventh-grade students.

Seventh-grade students and teachers from twenty-three middle and junior high schools were surveyed to determine the association between teacher attitudes, behavioral intentions, and smoking behavior and the prevalence of student smoking. Teacher attitudes toward smoking policies were found to be strongly related to the current smoking behavior of the teacher but not consistently related to student smoking. In addition, teacher likelihood of intervening showed a modest association with teacher smoking status, with current smokers generally indicating being the least likely to intervene for student possession or use of cigarettes. Teacher intentions to intervene were strongly associated with the prevalence of smoking among boys but not girls.

Adolescent↗

Stereotypic attitudes and behavioral intentions toward handicapped children.

Fifty-six junion-high-school pupils were questioned about their attitudes toward mentally retarded and crippled children. Same- and opposite-sex ratings of stereotypes and behavioral intentions were obtained. Results indicated a significant main effect for handicap condition, with stereotypic attitudes toward the crippled child being more favorable than attitudes toward the mentally retarded child. No differences in attitudes toward the two handicapping conditions emerged on the measure of behavioral intentions. Sex of the subject and sex of the handicapped child being rated did not significantly affect attitude scores in this study. The data were discussed in relation to the many methodological difficulties encountered in attitude research toward handicapped populations.

Adolescent↗

Neurophysiological experiments on intention tremor (author's transl).

During a postural innervation, cerebellar intention tremor can be produced by applying direct stimulus to the muscle. The stimulus is followed by a silent period of 160 to 200 ms, which exceeds the normal variation. Simultaneously, a massive rebound in the antagonistic muscle is evoked due to the tension reflex in the agonistic muscle. Passive shortening or stretching of the voluntarily activated muscle has no effect: there is no silent period in the shortened muscle, no rebound in the stretched muscle, and, consequently, little or no oscillation follows. The spindle apparatus seems irrelevant to the development of intention tremor. The feedback mechanism of the Golgi-inhibition systems is discussed. These findings cannot be explained by assuming a central pacemaker.

Cerebellum↗

Laparoscopic colorectal resection with curative intent. Own results and review of the literature.

AIM: Laparoscopic surgery is without a doubt one of the most important innovations in the field of surgery in the last 15 years. Since the 1st laparoscopic colorectal resection in 1991, this modality has spread like wildfire. Nevertheless, laparoscopic surgery in the field of oncology is still regarded as controversial. On the basis of our current knowledge, the present study considers the advantages and disadvantages of laparoscopic surgery performed with a curative intent - with emphasis on oncological radicalness and long-term outcome - and evaluates them against our own results. METHODS: In principle, the extent of the resection, compliance with margins of clearance, radicalness of lymphadenectomy and the avoidance of intra-abdominal tumour dissemination (for example, no touch technique) must be applied equally to the laparoscopic modality, too. RESULTS: At present there would not appear to be any restrictions vis-à-vis open surgery in any of the oncological parameters. Nor do currently available long-term results provide any evidence that laparoscopic colorectal surgery is in any way inferior. CONCLUSION: Colorectal oncological interventions with curative intent are still recommended to be done only in controlled studies. A final assessment will not be possible until the results of ongoing prospective randomized multicentre studies become available.

Adenocarcinoma↗

[Clinicopathologic features of small-sized peripheral lung cancer; is intentional limited resection appropriate for selected patients?].

We sought to determine the eligibility of patients with early peripheral lung cancer for intentional limited resection. The clinicopathologic features of 103 patients who underwent lobectomy and mediastinal nodal dissection for early stage peripheral lung cancer measuring 2 cm or less in maximum dimension between 1992 and 2002 were examined retrospectively. The lymph node metastasis and residual cancer after thoracoscopic partial resection were analyzed by the following categories. Three groups were divided by maximum dimension of the primary lesion in the resected specimen; 10 mm or less (n = 11), 15 mm or less (n = 33), and 20 mm or less (n = 59). Two groups were divided by lesion histology; bronchioloalveolar adenocarcinoma (BAC) [n = 42] and invasive lung cancer (n = 61). Residual cancer was found in the residual lobe after thoracoscopic partial resection in 3 of 43 patients who had no diagnosis preoperatively. Their maximum dimensions were 15 mm or less. No lymph node metastasis was detected in the patients with tumor measuring 10 mm or less, and BAC. Intentional limited resection without mediastinal nodal dissection is appropriate for patients with tumor measuring 10 mm or less and BAC. Further investigation associated with partial resection is necessary.

Adenocarcinoma, Bronchiolo-Alveolar↗

What is "safe" about the government's recent interpretation of the anti-kickback statute safe harbors? ... and since when was Stark an intent-based statute?

The volume-or-value standard is an element of several anti-kickback safe harbors and Stark exceptions. It provides that compensation may not be determined in a manner that takes into account the volume or value of business generated between the parties. The government has recently indicated that it may interpret the standard to exclude arrangements that are merely influenced by the volume or value of referrals. The author contends that this opens the door to examination of the parties' intent, which is contrary to legislative intent. The Article argues that the volume-or-value standard should be interpreted objectively.

Fraud↗

Management of intentional overdose in A&E departments.

This guided reflection article discusses the biological, psychological and social causes of intentional overdose and how the A&E nurse can treat the suicidal patient. The author shows how nurses in A&E can provide interventions that address patients' physical and psychosocial needs. The correct acute response to the medications commonly taken in an intentional overdose case are described. These interventions promote patient survival, improve concordance with mental health follow-up and reduce recidivism.

Acute Disease↗

[Intention to leave the nursing profession].

BACKGROUND: The NEXT Study (Nurses' Exit Study) was initiated in 10 European countries in order to shed light on nurses' working conditions and reasons of shortage. OBJECTIVES: The study objective was to determine organisation and psychosocial conditions that lead to premature departure from the nursing profession. METHODS: The questionnaire we used took into account aspects such as work history, work demands and organisation, career prospectives and individual resources. This article describes steps related to the construction and validation of the questionnaire and sampling methods. Preliminary results are also reported. Data analysis, performed in relation to the intention to leave the nursing profession, showed the distinctiveness of the situation in Italy compared to other European countries. RESULTS: Conditions related to intention to leave are multifaceted, but they can be summarized as inadequacy of facilities to support the family needs of staff low level of trust in official structures, together with poor support by colleagues and superiors, work overload, and lack of independence at work--although the latter is foreseen in current legislation--and scant career and development possibilities. CONCLUSIONS: These results confirm the existence of a difficult situation, although certain legislative changes are aimed at solving these problems.

Adult↗

Intentional tremor on a helium-oxygen chamber dive to 49.5 ATA.

Tremor is a well-recognized manifestation of the high pressure nervous syndrome (HPNS). As such, its measurement and analysis during deep hyperbaric exposures can be an important index of central nervous system integrity. During the U.S. Navy's experimental chamber dive to a depth equivalent to 1600 fsw (49.5 ATA), objective measures of intentional tremor were obtained at several depths. Six subjects were pressurized in 6 days to 49.5 ATA. After spending 7 days at this pressure, they were decompressed in 19 days to the surface. Measures of intentional tremor were obtained predive and at pressure levels of 13.1, 31.3, 49.5, 40.4, and 31.3 ATA using the Naval Medical Research Institute Mark 3 Mod 1 tremor device. Each subject's microtremor was measured while he produced a force of 50 grams and 500 grams against a finger force transducer. Unlike previous studies of HPNS tremor, special attention was given to amplitude rather than frequency analysis. All subjects displayed a marked increase in tremor that interfered with fine motor performance at depths greater than 1000 fsw. A statistically significant increase in signal frequency was also observed.

Calibration↗

Poisoning hospitalizations among Texas adolescents: age and gender differences in intentional and unintentional injury.

Using 1999 Hospital Discharge Data, this study examines age and gender differences in the pattern of poisoning hospitalizations of Texas youngsters (N = 1246) aged 10 through 17 years and investigates self-inflicted poisoning as a function of age and gender. Nearly three quarters of poisoning admissions are girls and two thirds of admissions are older children (aged 15 through 17 years). Analgesics and psychotropic drugs are the two most common agents used. Nearly 1 in 3 admissions among younger children aged 10 through 14 years and 1 in 2 among older children are due to analgesics, with a higher proportion of female admissions. One quarter of admissions among both age groups are due to psychotropic drugs, with nearly equal proportions of boys and girls. Intentional poisoning admissions are significantly higher among girls in both age groups. Older children are 1 1/2 times more likely than younger children, and girls are 2 times more likely than boys to be at risk for self-inflicted poisoning admissions. Fifty-three percent of female and 39% of male self-inflicted poisoning admissions are due to analgesics. Psychotropic drugs caused 29% of male and 21% of female self-inflicted admissions. Accidental and intentional poisoning is a public health concern requiring intervention. Residents in family practice and pediatrics need increased training to become proactive in educating adolescents and their parents about the dangers of drug overdosing.

Accidents↗

Intent to become pregnant as a predictor of exposures during pregnancy: is there a relation?

OBJECTIVE: To evaluate the relationship between intent to be pregnant and selected maternal exposures during pregnancy. STUDY DESIGN: In 1982-1983, 3,029 women who gave birth to infants without birth defects from 1968-1980 (the control mothers from a large case-control study of birth defects) completed a detailed telephone interview. This analysis examined behaviors reported in the third month of pregnancy because most women would be aware of their pregnancies by the end of the first trimester, and our primary interest was assessing exposures that occurred after pregnancy recognition. RESULTS: Women who reported unintended pregnancies tended to be younger, nonwhite and less educated, and tended to have higher gravidity than women who reported intended pregnancies. After adjustingfor maternal age, education, race and previous adverse pregnancy outcome, women who reported unintended pregnancies were more likely to report smoking (odds ratio [OR] = 1.4, 95% confidence interval [CI] 1.2, 1.7), illicit drug use (OR=3.4, 95% CI 1.9, 6.4), not taking vitamins (OR = 1.4, 95% CI 1.2, 1.7), and alcohol use (OR=1.2, 95% CI 0.99, 1.4) than women who had intended pregnancies. No association was observed between pregnancy intention and medication use. CONCLUSION: These results suggest that women who report having unintended pregnancies are more likely to have some exposures that may result in adverse pregnancy outcomes.

Adult↗