ABSTRACT
Background Sense of Coherence (SOC) relates to an individual's overall life orientation, and stronger SOC is associated with better health, quality of life, and coping strategies. When our research group used the SOC-13 questionnaire for the first time in Nepal, we identified difficulties in response patterns. The findings necessitated further evaluation of the Nepali version of the SOC-13 questionnaire. Objective To qualitatively evaluate the SOC-13 questionnaire in Nepali for cross-cultural adaptation. Method Nineteen nurses were interviewed. We used the methodological approach of "think aloud" to obtain a deeper understanding of the interferences of the scales. Transcribed materials were analyzed using a deductive approach through qualitative content analysis. The original translated version of the SOC-13 questionnaire in Nepali was modified by replacing words that were easier to understand. Result Participants found the questionnaire content general and non-specific but easy to complete. The nurses experienced that the meanings and sentences in some of the items and response alternatives were difficult to understand. However, the overall comprehensiveness of most items and response alternatives was perceived as good. Nurses' interpretation of the SOC-items in the translated version of the SOC-13 questionnaire in Nepali matched the original English version. Items that were experienced as difficult in the Nepali language were modified to increase their comprehensiveness. Modified items and response alternatives had the same content as before, but some words and meanings were substituted with easier language. Conclusion The current revised version of SOC-13 in Nepali is valid and useful to explore individuals' overall life orientation and their abilities to deal and cope with various life events in the Nepalese context.
Subject(s)
Quality of Life , Sense of Coherence , Humans , Cross-Cultural Comparison , Reproducibility of Results , Language , Surveys and QuestionnairesABSTRACT
Introduction: People with intellectual and developmental disabilities under the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD) have the right to access sexual health services including information, education, and support. Little is known about the capacity of sexual health professionals to provide these services. Methods: Using an observational research design, this study utilised a descriptive survey tool (PASH-Ext) that also encompassed a standardised measure, with a cross-sectional purposive sample of 52 Australian sexual health professionals. Data was collected in 2020. Results: Just over half of the participants reported having received training in their preservice education to work with people with intellectual and developmental disabilities, of these 60% held the view that people with intellectual and developmental disabilities would not feel embarrassed receiving sexual health information and support. Conclusion: The study found that training is both important to the professionals' preparedness to work with people with intellectual and developmental disabilities, and that these professionals advocate for the continuation of this training in pre-service courses and additional training in post service education for sexual health workers. Policy Implications: To progressively realise Article 25 of the UNCRPD signatory, countries need to ensure sexual health services are accessible to people with intellectual and developmental disabilities. This study recommends that sexual health policy addresses equity of access for people with intellectual and developmental disability by ensuring all staff are prepared and supported to provide these services.
ABSTRACT
Background Sense of coherence (SOC) is a core concept of salutogenesis which relates to individuals' overall life orientation. Stronger SOC associates with better coping strategies, better health, and better quality of life. Although the SOC-questionnaire is validated in many cultures and languages, it has not, to date, been applied in Nepal. Objective To determine and evaluate women's SOC before and after a health education intervention. Method This study was conducted as a part of the Heart-health Associated Research, Dissemination, and Intervention in the Community in the semi-urban JhaukhelDuwakot Health Demographic Surveillance Site in Nepal. Jhaukhel and Duwakot were selected as the control and intervention areas, respectively. Participants were women with children aged 1-7 years. Eight hundred and fifty-seven women before and 1,268 women after the health education intervention participated in the study. The statistical analysis was carried out with chi-square tests and one-way uni-variate ANOVA. Result Women's total SOC mean values at baseline were 51.1-57.4 and at follow up 54.4-54.9 in the intervention and control area, respectively. At baseline, SOC was significantly weaker in the intervention area compared to the control area (p < 0.001). At followup three months later, SOC was significantly stronger in the intervention area than in the control area (p < 0.001). Conclusion Nepalese women had weaker SOC than women in high-income countries, but comparable to neighboring country India with similar cultural features. Empowerment of women through community participation and health education strengthened SOC. The SOC-13-questionnaire in its Nepali version is recommended to be further evaluated.
Subject(s)
Sense of Coherence , Adaptation, Psychological , Child , Female , Humans , Nepal , Quality of Life , Surveys and QuestionnairesABSTRACT
The Certified Nursing Assistant (CNA) is an important part of the workforce in hospitals and nursing homes, whose work includes heavy and repetitive work tasks including patient manual handling. The Structured Multidisciplinary work Evaluation Tool (SMET) questionnaire is an Occupational Health Service method for evaluation of the work environment. The aim of this study is to compare the SMET questionnaire with technical measurements of physical workload in CNAs in a medical ward setting. 16 CNA's participated voluntarily to 8 h of measurements during one workday. Physical workload was measured with surface electromyography and inclinometers, and the work environment was evaluated with the SMET questionnaire during the same working day. Spearman's rho was used in the statistical correlation analysis between measurements. This study shows strong, statistically significant correlations between the items in the SMET questionnaire and measured physical workload, n CNAs.
Subject(s)
Nursing Assistants , Workload , Hospitals , Humans , Nursing Homes , Surveys and QuestionnairesABSTRACT
BACKGROUND: Occupational health services (OHS) are rarely involved in preventive issues and systematic work environment management. The Structured Multidisciplinary Work Evaluation Tool (SMET) questionnaire was created to address the lack of multidisciplinary/multifactorial OHS tools with the aim to be used in preventive issues and systematic work environment management. OBJECTIVES: The aim of this study was to evaluate trustworthiness of the inter-rater reliability in the qualitative analysis of the open-ended items and intra-rater reliability of the self-estimated items in the SMET questionnaire. METHODS: A qualitative comparison of the inter-rater reliability in the qualitative analysis of the open-ended items was performed to evaluate trustworthiness. The intra-rater reliability of the self-estimated items in the SMET questionnaire were analysed with Elisabet Svensson method. RESULTS: Qualitative analysis of the open-ended items showed good trustworthiness. The self-estimated items showed a high percent agreement (PA), 0.98-0.99 in the physically, 0.99 in the environmentally and 0.98-1.0 in the psychosocially demanding items. A low degree of systematic errors and individual variability were found. CONCLUSIONS: The SMET questionnaire shows good trustworthiness and intra-rater reliability and can be used to follow up and evaluate work environmental interventions.
Subject(s)
Psychometrics/standards , Workplace/standards , Adult , Female , Humans , Male , Middle Aged , Psychometrics/instrumentation , Psychometrics/methods , Qualitative Research , Reproducibility of Results , Surveys and Questionnaires , Workplace/psychologyABSTRACT
BACKGROUND: Important success factors for the Occupational Health Service (OHS) include services being based on active participation and risk identification from a multidisciplinary/multifactorial perspective. Despite an extensive search, no questionnaire with this approach was found so a new questionnaire was developed at the OHS. The aim of this study was to develop and validate the new questionnaire named Structured Multidisciplinary work Evaluation Tool (SMET) through action research. METHOD: Communicative and pragmatic validity were tested through the development of the questionnaire using action theory and presented in a descriptive portrayal. The Content Validity Index (CVI) was used to test content validity for each item as well as for the questionnaire as a whole. RESULT: Communicative and pragmatic validity were developed and tested over time in four different periods between 2008 and 2014, in 24 clinics (with a total of approximately 1000 employees) in Region Jönköping County.The content validity of the SMET questionnaire as a whole was close to excellent and the validity of the questions regarding physically and psychosocially demanding work factors were found to be excellent. The questions regarding environmentally demanding work factors were found to have a lower, but still good, validity. CONCLUSION: The SMET questionnaire has very good content validity. The pervasive work with the SMET questionnaire also shows good pragmatic and communicative validity.
Subject(s)
Psychometrics/instrumentation , Reproducibility of Results , Surveys and Questionnaires/standards , Work Capacity Evaluation , Workplace/standards , Communication , Female , Humans , Male , Psychometrics/methods , SwedenABSTRACT
BACKGROUND: Hypertension is common and may lead to cerebrovascular and cardiovascular events and mortality. District nurses frequently encounter patients requiring blood pressure monitoring, lifestyle counsel and support. Empowerment as a method enables patients to both increase their control over their health and improve it. AIM: This study aims to describe the effects of the counsel and support from district nurses to patients with hypertension. METHODS: A randomized controlled intervention trial. Questionnaires were answered by patients with hypertension before and after the intervention comprising district nurses' counsel and support based upon empowerment. A specially developed card for blood pressure monitoring was also used. RESULTS: Blood pressure decreased in intervention and the control groups. The intervention group experienced significantly improved health, with better emotional and physical health, and reduced stress. Living habits did not change significantly in either group. Satisfaction with knowledge of hypertension increased significantly in both groups. The intervention group reported that their care was based upon their health needs. LIMITATIONS: Conducting large multi-centre studies with long follow-ups is complicated and results sometimes have a tendency to decline with time. A shorter follow-up might have shown a greater difference between the groups. CONCLUSION: Nursing interventions through district nurses' counsel and support with empowerment improved patients' health. More research is needed to evaluate nursing interventions' effect on hypertension. IMPLICATIONS FOR NURSING AND HEALTH POLICY: This study highlighted that district nurses' counsel and support increased patients' health and decreased stress by focusing on empowerment.
Subject(s)
Hypertension/nursing , Nurse-Patient Relations , Power, Psychological , Female , Health Status Indicators , Humans , Life Style , Male , Primary Health Care , Surveys and Questionnaires , SwedenABSTRACT
BACKGROUND: Low socio-economic status (SES), and a conflictive, cold and unsupportive family environment in childhood have been associated with early adulthood hostility. However, it is unknown whether this association changes in magnitude with age from childhood to adulthood. We investigated whether childhood family factors (SES and parental child-rearing style) predicted differential development of offspring hostility and anger from early to middle adulthood. METHOD: Between 2041 and 2316 participants (age range 3-18 years at baseline) were selected from the longitudinal Young Finns study. The participants were followed for 27 years between 1980 and 2007. Childhood SES and parent's self-reported child-rearing style were measured twice: at baseline and 3 years after baseline. Hostility and anger were assessed with self-report questionnaires at 12, 17, 21 and 27 years after baseline. RESULTS: Low parental SES and hostile child-rearing style at baseline predicted higher mean levels of offspring anger and hostility. Low parental SES and one of the hostile child-rearing style components (strict disciplinary style) became more strongly associated with offspring hostility with age, suggesting an accumulating effect. CONCLUSIONS: Childhood family factors predict the development of hostility and anger over 27 years and some of these family factors have a long-term accumulating effect on the development of hostility.
Subject(s)
Anger , Child Development , Child Rearing/psychology , Family , Hostility , Parent-Child Relations , Social Class , Adolescent , Adult , Child , Child, Preschool , Female , Humans , Longitudinal Studies , Male , Multilevel Analysis , Prospective Studies , Young AdultABSTRACT
AIM: To describe registered nurses' (RNs) ratings of their work-related health problems, sickness presence and sickness absence in community care of older people. To describe RNs' perceptions of time, competence and emotional pressure at work. To describe associations between time, knowledge and emotional pressure with RNs' perceptions of work-related health problems, sickness presence and sickness absence. BACKGROUND: There is a global nursing shortage. It is a challenge to provide working conditions that enable RNs to deliver quality nursing care. METHOD: A descriptive design and a structured questionnaire were used. 213 RNs in 60 care homes for older people participated, with a response rate of 62%. FINDINGS: RNs' reported work-related health problems, such as neck/back disorders, dry skin/dry mucous membranes, muscles/joints disorders, sleep disorders and headache. They had periods of fatigue/unhappiness/sadness because of their work (37%). Most of the RNs felt at times psychologically exhausted after work, with difficulties leaving their thoughts of work behind. RNs stated high sickness presence (68%) and high sickness absence (63%). They perceived high time pressure, adequate competence and emotional pressure at work. There was a weak to moderate correlation between RNs' health problems and time pressure. DISCUSSION: We cannot afford a greater shortage of RNs in community care of older people. Politicians and employers need to develop a coordinated package of policies that provide a long-term and sustainable solution with healthy workplaces. CONCLUSION: It is important to prevent RNs' work-related health problems and time pressure at work.
Subject(s)
Community Health Nursing , Geriatric Nursing , Occupational Diseases/epidemiology , Adult , Aged , Female , Humans , Middle Aged , Nurses/psychology , Stress, Psychological/diagnosis , Stress, Psychological/etiology , Surveys and Questionnaires , Sweden/epidemiology , Workload , Young AdultABSTRACT
BACKGROUND: Traumatic and musculoskeletal injury rates have been high in dairy farming compared to other industries. Previous work has shown that social marketing efforts can persuade farm managers to adopt practices that reduce injury hazards compared to traditional practices if the new practices maintain profits. METHODS: The intervention disseminated information to 4,300 Northeast Wisconsin dairy farm managers about three safer and more profitable production practices (barn lights, silage bags, and calf feed mixing sites) using information channels that these managers were known to rely on. We evaluated rolling, independent, community-based samples, at baseline and then again after each of four intervention years. We also evaluated samples from Maryland's 1,200 dairy farms after the second through the fourth year of the intervention. Maryland dairy managers read many of the same nationally distributed print mass media that we used in the intervention and so were a "partially exposed" comparison group. RESULTS: The intervention to disseminate information about the innovations was successful. In comparisons before and after the intervention, Wisconsin managers reported getting more information about calf sites from public events and equipment dealers, about silage bags from other farmers and equipment dealers, and about barn lights from public events, other farmers, equipment dealers, consultants, and electrical suppliers. Wisconsin managers also reported getting more information than Maryland managers from public events for barn lights and silage bags. During years three and four, the intervention managed to sustain, but not improve, earlier increases in adoption and awareness from the first 2 years. After adjusting for farm manager and operation variables, intervention years was associated with increased Wisconsin manager adoption of two of three practices in comparisons between the baseline and the fourth intervention year: barn lights (odds ratio = 5.58, 95% confidence interval = 3.39-9.17) and silage bags (OR = 2.94, CI = 1.84-4.70). There were similar results for awareness of barn lights and the calf feeding sites. Compared to Maryland managers, Wisconsin managers reported greater awareness of barn lights. CONCLUSIONS: Disseminating information to managers through information channels that they usually consulted was associated with increased reports of getting information and with greater adoption and awareness of safer, profit-enhancing work practices in a high hazard industry.
Subject(s)
Agriculture/statistics & numerical data , Health Promotion/methods , Musculoskeletal Diseases/prevention & control , Occupational Exposure/adverse effects , Occupational Health/statistics & numerical data , Program Evaluation , Animals , Cattle , Confidence Intervals , Dairy Products/statistics & numerical data , Health Education , Humans , Information Dissemination , Maryland/epidemiology , Musculoskeletal Diseases/epidemiology , Musculoskeletal Diseases/etiology , Odds Ratio , Program Development , Surveys and Questionnaires , Time Factors , Wisconsin/epidemiologyABSTRACT
OBJECTIVES: We conducted an intervention to increase adoption of three dairy farming practices shown to reduce certain traumatic and musculoskeletal injury hazards. METHODS: The intervention disseminated information to 4,300 Wisconsin dairy farm managers about three safer, more profitable production practices (barn lights, bag silos, and calf feed mixing sites) using information channels upon which these managers were known to rely. We evaluated rolling, independent, community-based samples at baseline and after each of two intervention years. We also evaluated a single sample after the intervention's second year from 1,200 Maryland dairy farm managers who were exposed only to the intervention's nationally distributed print publications, as a "partially exposed" comparison group. RESULTS: In before/after comparisons, Wisconsin managers reported getting more information from print media, public events, and resource people for barn lights and bag silos. Also, Wisconsin managers, in comparison with Maryland managers after the intervention's second year, reported getting more barn lights and bag silo information from public events and resource people, but not from print media. Analyses that adjusted for farm manager, farm operation, and herd variables associated the intervention with increased Wisconsin manager adoption of all three practices after the second intervention year: barn lights (odds ratio [OR] = 2.268, 95% confidence interval [CI] 1.476, 3.485), bag silos (OR = 3.561, 95% CI 2.684, 4.728), and calf feeding sites (OR = 2.433, 95% CI 1.059, 5.591). There were also increases in awareness of barn lights and calf feeding sites. CONCLUSION: Disseminating information to managers through well-known information channels was associated with increased reports of information gathering, adoption, and awareness of safer, profit-enhancing work practices in a high-hazard industry.
Subject(s)
Accidents, Occupational/prevention & control , Dairying/methods , Health Promotion/methods , Safety Management/methods , Animals , Cattle , Dairying/economics , Dairying/standards , Female , Humans , Information Dissemination/methods , Male , Middle Aged , Program Evaluation , Safety Management/economicsABSTRACT
Little research is available about the specifics of child or adolescent work on dairy farm operations. The objective of this study was to investigate work performed by children and adolescents on these operations. The authors administered mail questionnaires to a community-based, age- and operation size-stratified sample of individuals aged 6 to 18 (n = 240) who worked on dairy operations in Wisconsin. Data were collected in 1999. The 197 children and adolescents reported averaging 567 hours of dairy farm work in the last year (10.9 hours/week) and completed over 1/3 of all calf feeding, 1/5 of the milking, 1/5 of cow feeding, and 1/10 of tractor operation hours on their farm during the weeks they worked. Some of these young workers reported accomplishing duties also judged by some experts as hazardous work, including nearly half of the 9- to 11-year-olds driving tractors. Six nonfatal injuries were reported that required stopping work (14.6 per 100 full time equivalents per year), including those that required medical attention. Musculoskeletal discomfort and disability reports were unremarkable compared to existing studies of general and working populations. Wisconsin dairy farm youth appeared to be working no more hours per week than their peers in other studies of agricultural populations. Adolescents and some children largely performed the same range of tasks and often the same scope of work as adults, including some performing hazardous work. There is a need for further investigations with larger samples of dairy youth to confirm these findings. The exposures of very young workers to hazardous tractor driving and tower silo tasks suggest that there is an urgent need for improved and validated interventions to reduce these exposures.
Subject(s)
Accidents, Occupational/statistics & numerical data , Agricultural Workers' Diseases/epidemiology , Dairying , Musculoskeletal Diseases/epidemiology , Occupational Exposure/adverse effects , Adolescent , Agricultural Workers' Diseases/etiology , Child , Dairying/methods , Dairying/statistics & numerical data , Female , Humans , Male , Musculoskeletal Diseases/etiology , Surveys and Questionnaires , Time Factors , Wisconsin/epidemiology , Workload/statistics & numerical dataABSTRACT
OBJECTIVES: Dairy farming injury rates are high. Previous agricultural research has shown that better information flow can speed adoption of more profitable practices. We conducted and evaluated an intervention to increase voluntary adoption of three production practices that were safer and more profitable than typical practices: barn lights, bag silos, and a mixing site for calf feed. METHODS: Print mass media, public events, university Extension, and dairy farmers already using the practices were all enlisted to disseminate information to 4,300 northeast district Wisconsin dairy farmers. Evaluation questionnaires were mailed to independent samples of farm managers before (n = 582) and after (n = 572) the 12 month long intervention. RESULTS: After the intervention, more managers reported getting information about barn lights from public events (12% vs. 23%) and private consultants (8% vs. 17%) and about silo bags from print media (79% vs. 87%) and private consultants (9% vs. 14%). More managers were aware of barn lights (48% vs. 72%) and the calf feed mixing site (44% vs. 56%). There was a nonsignificant tendency for more managers to report adopting barn lights (12% vs. 23%). CONCLUSIONS: Improving information flow to operation managers about safer, more profitable production practices may be a relatively easy way to supplement conventional injury control efforts in high-hazard industries.
Subject(s)
Accidents, Occupational/prevention & control , Agriculture , Preventive Health Services/standards , Animals , Cattle , Dairying , Female , Humans , Information Dissemination , Male , Middle Aged , Program Evaluation , Surveys and Questionnaires , WisconsinABSTRACT
Nursing home patients with dementia were videotaped in three previous studies. Sixty sequences of nine patients exhibiting agitated behaviors were examined to identify the most probable antecedents to agitation. Probable reasons were interpreted and applied to the Progressively Lowered Stress Threshold model, which suggests that agitation is stress related. Analysis suggests that agitation often serves as a form of communication. Two underlying reasons seem to be that the patient had loss of control over the situation and deficient autonomy. The most common causes for expressed agitation were interpreted as discomfort, a wish to be served immediately, conflict between patients or with nursing staff, reactions to environmental noises or sound, and invasion of personal space. It is recommended that nursing staff promote autonomy and independency for this group of patients whenever possible. By evaluating probable reasons for expressed agitation, the nursing staff can take steps to prevent or alleviate agitation.
Subject(s)
Dementia/complications , Psychomotor Agitation/etiology , Psychomotor Agitation/psychology , Stress, Psychological/etiology , Stress, Psychological/psychology , Aged , Aged, 80 and over , Conflict, Psychological , Female , Health Facility Environment , Humans , Internal-External Control , Male , Noise/adverse effects , Nurse-Patient Relations , Nursing Homes , Nursing Methodology Research , Patient Participation , Personal Space , Psychomotor Agitation/nursing , Risk Factors , Stress, Psychological/nursing , Videotape RecordingABSTRACT
The antiemetic effect of prednisolone on nausea/vomiting was investigated in 67 patients with advanced prostatic cancer and a performance status of < or = 2. The study was a double-blind, placebo-controlled, randomized trial with a parallel group design. The objective was to compare the incidence and severity of nausea/vomiting between the two groups. Prednisolone or placebo was given twice daily for 3 weeks with the dose decreased during the third week from 15 mg/day to 10 mg for 3 days and finally to 5 mg/day during the last 4 days. EMP was given as two 140 mg capsules daily for 3 days at the beginning, then as four capsules for 4 days followed by six capsules for 21 days. Areas under curves (AUCs) for nausea and for nausea/vomiting scores were calculated based on the patient's diary notes: nausea (0-3), vomiting (0-6), nausea/vomiting (0-9). Control of emesis in terms of complete, moderate or poor control was registered. Pretreatment characteristics were evenly balanced. The results indicated that no statistical differences between the two groups of patients were present in AUCs for weeks 1-3 or weeks 1-4. We conclude that it was not possible to demonstrate a significant antiemetic efficacy of prednisolone. However, in all but one case the patients in the prednisolone group could be treated for at least 3 weeks without any major incidents of nausea/vomiting.
Subject(s)
Antiemetics/therapeutic use , Estramustine/adverse effects , Nausea/prevention & control , Prednisolone/therapeutic use , Prostatic Neoplasms/drug therapy , Vomiting/prevention & control , Aged , Antineoplastic Agents, Alkylating/adverse effects , Antineoplastic Agents, Alkylating/therapeutic use , Area Under Curve , Double-Blind Method , Estramustine/therapeutic use , Humans , Male , Treatment OutcomeABSTRACT
From October 1993 through May 1994, 38 consecutive morbidly obese patients underwent a laparoscopic vertical banded gastroplasty (VBG). During the operation a gastric window was made by a 25-mm circular stapler; and the vertical staple line, establishing the gastric pouch, was constructed by using a 60-mm, four-row linear stapler. The outflow stoma was reinforced by a Gore-Tex band and calibrated to have an internal diameter of 9 mm. Three patients had to be converted to open surgery during the initial laparoscopic procedure because of insufficient operative access. Another three patients had to be reoperated during subsequent postoperative courses, one laparoscopically to reinforce a vertical staple line defect caused by a transected nasogastric tube, another because of an open reoperation during the first postoperative day for a rupture in the vertical staple line, and, finally, a patient was reexplored because of the present of postoperative fever with a left-sided pleuropneumonia and subphrenic accumulation of fluid. However, during the operation no leakage or any other local complications were detected. The subsequent postoperative courses were uneventful in all these patients. Compared with the reference group comprising the latest consecutive 17 obese patients operated with open VBG before the introduction of the laparoscopic technique, the laparoscopy group had less postoperative pain and had mobilization sooner. In the latter group, we recorded an improved respiratory status during the early postoperative period, as reflected by increased oxygen saturation and peak exspiratory flow rates as well as a lower body temperature. In conclusion, laparoscopic VBG is technically feasible and can be safely performed. Our early postoperative experiences suggest that these patients have a shorter and less cumbersome postoperative recovery period compared with conventionally operated obese patients. The long-term follow-up of these patients will determine whether these initial advantages of the laparoscopic approach are corroborated by comparable effects on weight control.
Subject(s)
Gastroplasty/methods , Laparoscopy , Obesity, Morbid/surgery , Adult , Female , Humans , Male , Middle Aged , Obesity, Morbid/physiopathology , Postoperative Complications , Reoperation , Respiratory Mechanics , Surgical Stapling , Treatment OutcomeABSTRACT
From November 1978 to July 1984, 285 men with previously untreated, localized prostate cancer were consecutively randomized in an open multicenter study. The main objective was to determine if early endocrine treatment prolongs the interval to metastasis and/or cancer related or overall survival. Patients were randomized to receive either 80 mg. polyestradiol phosphate by intramuscular injection every 4 weeks plus 50 micrograms ethinylestradiol 3 times daily or 280 mg. estramustine phosphate 2 times daily, or for surveillance only but with deferred endocrine treatment at progression to metastatic disease. From 1983 further inclusion into the polyestradiol phosphate plus ethinylestradiol group was closed because of a high frequency of cardiovascular complications and thereafter 13 patients were instead randomized to a new treatment group with 80 mg. polyestradiol phosphate only by intramuscular injection every 4 weeks. Mean age was 70 years for 228 evaluable patients: 66 in the polyestradiol phosphate plus ethinylestradiol group, 74 in the estramustine phosphate group and 88 in the deferred treatment group, respectively. Mean followup for 100 patients alive on August 31, 1993 was 144 months (range 111 to 180). During the observation period 51 patients had metastasis. There was no difference in interval to metastasis (p = 0.07) among the 3 groups, although there was a tendency for a higher probability of metastases in the deferred treatment group. A total of 128 patients (56%) died during the observation period and prostatic cancer was considered to be the cause of death in 46 (20%). There was a significant difference (p = 0.03) among the 3 groups in the probability of dying of prostatic cancer, with the highest risk in the surveillance group but we found no significant difference in overall survival. The relevance of different prognostic factors and their interaction with treatment was also evaluated. These analyses were applied to the entire patient group as well as to the different subgroups. We found that patients with moderately well differentiated cancer (stage greater than T0a) who received early treatment with estramustine phosphate had the lowest risk of metastases or death from prostatic cancer, while those with well differentiated cancer (stage greater than T0a) did best on early polyestradiol phosphate plus ethinylestradiol treatment.
Subject(s)
Adenocarcinoma/drug therapy , Estradiol Congeners/therapeutic use , Estradiol/analogs & derivatives , Estramustine/therapeutic use , Ethinyl Estradiol/therapeutic use , Prostatic Neoplasms/drug therapy , Adenocarcinoma/mortality , Aged , Disease-Free Survival , Drug Administration Schedule , Drug Therapy, Combination , Estradiol/therapeutic use , Follow-Up Studies , Humans , Male , Middle Aged , Prostatic Neoplasms/mortality , Risk Factors , Time Factors , Treatment FailureABSTRACT
In this double-blind multicentre study, using the intention-to-treat approach, a total of 293 patients with fever (> or = 38.5 degrees C), symptoms of sepsis and signs of pneumonia or pyelonephritis were randomly assigned to treatment with ampicillin and mecillinam (A+M) or cefotaxime followed by cefadroxil. In the febrile phase, treatment was given intravenously twice daily, either with 1,200 mg ampicillin together with 600 mg mecillinam or with 2 g cefotaxime alone. When the patients stayed afebrile, the intravenous administration was replaced by oral treatment twice daily for 14 days, either with 500 mg pivampicillin and 400 mg pivmecillinam or 1 g cefadroxil. In the A+M group, 33% (48/144) of the patients did not complete the full course of treatment as compared with 32% (47/149) in the cephalosporin group, the reasons being treatment failure in 27 and 29, respectively, or adverse effects (n = 16 in both groups). The median duration of fever was 47 h in the A + M group and 50 h in the cephalosporin group. Of 135 patients with pneumonia, 68% were completely cured in the A + M group, and 65% in the cephalosporin group, the main reasons for treatment failure being Mycoplasma pneumonia or ornithosis. Of 136 patients with pyelonephritis, 63% were cured in each group. The main reason for failure was bacteriological relapse. Side-effects were reported by 32 patients (22%) of the A+M group, as compared with 41 (28%) of the cephalosporin group. Epigastric complaints were equally frequent in both groups, but there was a tendency for a higher frequency of exanthema in the A+M group, and for antibiotic-associated diarrhoea and fungal superinfections in the cephalosporin group.
Subject(s)
Drug Therapy, Combination/administration & dosage , Pneumonia, Bacterial/drug therapy , Pyelonephritis/drug therapy , Amdinocillin/administration & dosage , Ampicillin/administration & dosage , Cefadroxil/administration & dosage , Cefotaxime/administration & dosage , Cephalosporins/administration & dosage , Double-Blind Method , Escherichia coli Infections/drug therapy , Female , Fever/drug therapy , Humans , Male , Middle Aged , Penicillins/administration & dosageABSTRACT
A study was conducted to evaluate 2 prophylactic penicillin regimens in 18 patients undergoing orthognathic surgery. The effects on the oral microflora were also studied. All patients received 3 g benzyl-penicillin as infusion from the beginning of operation and then 3 g every 6th hour during 24 h. One group of 9 patients then received 1 g phenoxymethylpenicillin as oral suspension twice daily for 6 days postoperatively. The second group of 9 patients received no further penicillin. One infection occurred in this second group, but the patient was cured with metronidazole. 7 of the 9 patients who received penicillin for 1 week, showed pronounced decreases in the number of streptococci and micrococci. In the 9 other patients who received only benzylpenicillin for one day, much smaller changes in the aerobic microflora were observed. Colonization with different enterococci, enterobacteria or yeasts was greater in the group receiving 1-week treatment. No major differences between the 2 groups of patients, concerning the impact on the anaerobic microflora were observed. The results indicate that benzylpenicillin is still a suitable prophylactic antibiotic in maxillofacial surgery. Extension of the antibiotic coverage to 1 week is doubtful because of the increased ecological risks. The clinical significance of anaerobes was obvious, as one postoperative infection occurred caused by an anaerobic micro-organism.
Subject(s)
Bacteria/drug effects , Orthognathic Surgical Procedures , Penicillins/therapeutic use , Premedication , Saliva/microbiology , Adolescent , Adult , Ecology , Female , Humans , Male , Osteotomy , Penicillin G/therapeutic use , Penicillin V/therapeutic useABSTRACT
10 healthy volunteers received 200 mg norfloxacin orally every 12 h for 7 days. Saliva, throat and faecal specimens were collected days 0, 3, 5, 7, 14 and 21 to study the effect of norfloxacin on the normal microflora. The concentrations of norfloxacin in serum, urine, saliva and faeces were determined by a microbiological method and all samples except faeces were also assayed by high-pressure liquid chromatography (HPLC). The pharmacokinetics of norfloxacin were studied on day 3. The mean peak serum concentration (+/- SD) attained after 0.75-1.0 h was 0.75 +/- 0.15 mg/l measured by HPLC, and the mean terminal serum half-life was 4.2 +/- 0.6 h. The mean cumulative urinary elimination was 29% during 12 h after dosing. There was no significant difference between values obtained by microbiological assay and by HPLC. The saliva concentration was approximately 30% of the serum levels 1.0-1.5 h after administration. No accumulation in faeces was found during the administration period, and mean concentrations were 940 mg/kg. The changes in the oropharyngeal flora were minor and only branhamella were affected. In the colonic flora, the number of enterobacteria was strongly depressed while the anaerobic microflora was only slightly affected. Two weeks after the administration period, both the oropharyngeal and colonic microflora had returned to normal.