ABSTRACT
The purpose of this study was to establish what is important to pre-school children as service users of a children's centre. This research was conducted as part of a range of service users' perspectives in one inner city children's centre. This study shows that young children as service users are capable of contributing their views. The participants enjoyed private spaces. Nature and the environment were important to these children, as was watching their friends playing happily A mosaic approach was used in this qualitative study of five children aged three to four years. The mosaic approach uses observation and interviewing with participatory use of cameras by the children. It is a strengths-based approach, which extends to all children irrespective of ability and background. If adults are to understand children they need to look for opportunities for their voices to be heard.
Subject(s)
Child Health Services/organization & administration , Patient Participation/psychology , Patient Satisfaction/statistics & numerical data , Play and Playthings/psychology , Quality of Health Care/organization & administration , State Medicine/organization & administration , Adult , Child, Preschool , Female , Humans , Male , Qualitative Research , United KingdomABSTRACT
BACKGROUND: Only recently has a standard chemotherapy regimen, gemcitabine plus cisplatin, been established for advanced biliary tract cancers (BTCs) based on a phase III randomized study. The aim of this phase II single-institution trial was to assess the efficacy and safety of gemcitabine combined with carboplatin in the first-line treatment of patients with advanced BTCs. METHODS: Patients with histologically proven BTCs, including cholangiocarcinoma or gallbladder and ampullary carcinomas, were treated with a maximum of nine cycles of intravenous (i.v.) gemcitabine at 1000 mg/m(2) over 30 min on days 1 and 8 with i.v. carboplatin dosed at an area-under-the-curve (AUC) of 5 over 60 min on day 1 of a 21-day cycle. RESULTS: A total of 48 patients with advanced BTCs (35 cholangiocarcinoma, 12 gallbladder and 1 ampullary cancer) were enrolled. A median of four cycles were administered (range: 1-9). The overall response rate for evaluable patients was 31.1%. Median progression-free survival, overall survival and 6-month survival rates are 7.8 months, 10.6 months and 85.4%, respectively. The most common grade 3-4 toxicities include neutropenia and thrombocytopenia. Grade 3 or 4 non-haematological toxicities were rare. CONCLUSIONS: Gemcitabine combined with carboplatin has activity against advanced BTCs. Our results are comparable to other gemcitabine-platinum or gemcitabine-fluoropyrimidine combinations in advanced BTCs.
Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biliary Tract Neoplasms/drug therapy , Adenocarcinoma/mortality , Adenocarcinoma/pathology , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Biliary Tract Neoplasms/mortality , Biliary Tract Neoplasms/pathology , Carboplatin/administration & dosage , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Disease-Free Survival , Drug Administration Schedule , Female , Humans , Infusions, Intravenous , Kaplan-Meier Estimate , Male , Middle Aged , Missouri , Survival Rate , Time Factors , Treatment Outcome , GemcitabineABSTRACT
BACKGROUND AND OBJECTIVES: The objective of this research was to obtain and describe medical students' perspectives about continuity of care while they are participating in a preclinical practice-based preceptorship. METHODS: Within the context of a preclinical preceptorship, students completed directed readings, conducted patient and physician interviews, and wrote reflections about continuity of care. Two coders independently analyzed a randomly selected subset of de-identified reflections (78 of 170) to describe predominant themes. RESULTS: During preceptorship, students interacted with patients affected by wide-ranging diseases, from diabetes to multiple sclerosis, within primary care and specialty clinical settings located in geographically diverse regions. Drawing on personal experience and interviews with patients and physicians, students reported benefits of continuity of care for patients and physicians concordant with claims from the literature, including improved medical management, better interpersonal communication, increased patient compliance, and higher levels of trust. Students also offered perspectives regarding challenges of and impediments to providing continuity of care, including managed care and work hour constraints, lack of comprehensive coordinated services, and specialty-driven care. CONCLUSIONS: Preclinical medical students are able to identify both benefits and barriers to continuity of care. These topics can provide a foundation for a future curriculum and may need to be explicitly addressed as students choose careers in medicine.
Subject(s)
Attitude of Health Personnel , Continuity of Patient Care , Curriculum , Students, Medical , Family Practice/education , Humans , Internal Medicine/education , Pediatrics/education , Preceptorship , United StatesABSTRACT
CONTEXT: Tamoxifen is approved for the reduction of breast cancer risk, and raloxifene has demonstrated a reduced risk of breast cancer in trials of older women with osteoporosis. OBJECTIVE: To compare the relative effects and safety of raloxifene and tamoxifen on the risk of developing invasive breast cancer and other disease outcomes. DESIGN, SETTING, AND PATIENTS: The National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial, a prospective, double-blind, randomized clinical trial conducted beginning July 1, 1999, in nearly 200 clinical centers throughout North America, with final analysis initiated after at least 327 incident invasive breast cancers were diagnosed. Patients were 19,747 postmenopausal women of mean age 58.5 years with increased 5-year breast cancer risk (mean risk, 4.03% [SD, 2.17%]). Data reported are based on a cutoff date of December 31, 2005. INTERVENTION: Oral tamoxifen (20 mg/d) or raloxifene (60 mg/d) over 5 years. MAIN OUTCOME MEASURES: Incidence of invasive breast cancer, uterine cancer, noninvasive breast cancer, bone fractures, thromboembolic events. RESULTS: There were 163 cases of invasive breast cancer in women assigned to tamoxifen and 168 in those assigned to raloxifene (incidence, 4.30 per 1000 vs 4.41 per 1000; risk ratio [RR], 1.02; 95% confidence interval [CI], 0.82-1.28). There were fewer cases of noninvasive breast cancer in the tamoxifen group (57 cases) than in the raloxifene group (80 cases) (incidence, 1.51 vs 2.11 per 1000; RR, 1.40; 95% CI, 0.98-2.00). There were 36 cases of uterine cancer with tamoxifen and 23 with raloxifene (RR, 0.62; 95% CI, 0.35-1.08). No differences were found for other invasive cancer sites, for ischemic heart disease events, or for stroke. Thromboembolic events occurred less often in the raloxifene group (RR, 0.70; 95% CI, 0.54-0.91). The number of osteoporotic fractures in the groups was similar. There were fewer cataracts (RR, 0.79; 95% CI, 0.68-0.92) and cataract surgeries (RR, 0.82; 95% CI, 0.68-0.99) in the women taking raloxifene. There was no difference in the total number of deaths (101 vs 96 for tamoxifen vs raloxifene) or in causes of death. CONCLUSIONS: Raloxifene is as effective as tamoxifen in reducing the risk of invasive breast cancer and has a lower risk of thromboembolic events and cataracts but a nonstatistically significant higher risk of noninvasive breast cancer. The risk of other cancers, fractures, ischemic heart disease, and stroke is similar for both drugs. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00003906.
Subject(s)
Breast Neoplasms/epidemiology , Breast Neoplasms/prevention & control , Raloxifene Hydrochloride/therapeutic use , Selective Estrogen Receptor Modulators/therapeutic use , Tamoxifen/therapeutic use , Adult , Aged , Cataract/epidemiology , Cause of Death , Double-Blind Method , Female , Fractures, Bone/epidemiology , Humans , Incidence , Middle Aged , Myocardial Ischemia/epidemiology , Risk , Thrombosis/epidemiology , Uterine Neoplasms/epidemiologyABSTRACT
BACKGROUND: Injury to the anterior cruciate ligament (ACL) can be detrimental to any athlete, having both short- and long-term health consequences. Examining preseason screening landing mechanics can indicate the likelihood of injury during the season. Furthermore, previous injury is also commonly referred as a predisposing factor for reinjury. HYPOTHESIS: Players with a history of lower extremity injury would have higher Landing Error Scoring System (LESS) scores than those with no previous injury, and healthy soccer athletes who sustained an injury during the 2014 season would have higher LESS scores than those who remained uninjured. STUDY DESIGN: Prospective cohort study. LEVEL OF EVIDENCE: Level 3. METHODS: Thirty-four Division I male and female soccer athletes (19 men, 15 women; mean age, 19.6 ± 1.2 years; mean height, 172.4 ± 8.7 cm; mean weight, 70.8 ± 9.1 kg). An a priori sample size estimation for a power of 0.80 (80%) and an alpha error of 0.05 with an estimated effect size of 0.6 for a sample of 30 participants was attained. Participants performed a drop-landing task and were scored on their landing mechanics using the LESS. Lower extremity injuries were tracked during the season. LESS scores between those with and without a history of injury and those who were injured and uninjured during the season were compared using 2 separate 1-way analyses of variance. RESULTS: No statistically significant differences (F(1,33) = 0.47, P = 0.50) existed between LESS scores in athletes who had a previous injury history compared with those with no injury history. No statistically significant differences (F(1,20) = 0.05, P = 0.83) existed between LESS scores in healthy athletes who were injured during the 2014 season compared with those healthy athletes who were uninjured. CONCLUSION: No differences were present between athletes with and without a history of lower extremity injury. The majority of healthy participants who were injured during the season had similar LESS scores to those who remained uninjured, suggesting that the LESS may not be able to identify atypical landing mechanics in this group of athletes.
Subject(s)
Lower Extremity/injuries , Plyometric Exercise , Soccer/injuries , Soccer/physiology , Anterior Cruciate Ligament Injuries/physiopathology , Female , Humans , Lower Extremity/physiopathology , Male , Prospective Studies , Risk Factors , Young AdultABSTRACT
The selective estrogen-receptor modulator (SERM) tamoxifen became the first U.S. Food and Drug Administration (FDA)-approved agent for reducing breast cancer risk but did not gain wide acceptance for prevention, largely because it increased endometrial cancer and thromboembolic events. The FDA approved the SERM raloxifene for breast cancer risk reduction following its demonstrated effectiveness in preventing invasive breast cancer in the Study of Tamoxifen and Raloxifene (STAR). Raloxifene caused less toxicity (versus tamoxifen), including reduced thromboembolic events and endometrial cancer. In this report, we present an updated analysis with an 81-month median follow-up. STAR women were randomly assigned to receive either tamoxifen (20 mg/d) or raloxifene (60 mg/d) for 5 years. The risk ratio (RR; raloxifene:tamoxifen) for invasive breast cancer was 1.24 (95% confidence interval [CI], 1.05-1.47) and for noninvasive disease, 1.22 (95% CI, 0.95-1.59). Compared with initial results, the RRs widened for invasive and narrowed for noninvasive breast cancer. Toxicity RRs (raloxifene:tamoxifen) were 0.55 (95% CI, 0.36-0.83; P = 0.003) for endometrial cancer (this difference was not significant in the initial results), 0.19 (95% CI, 0.12-0.29) for uterine hyperplasia, and 0.75 (95% CI, 0.60-0.93) for thromboembolic events. There were no significant mortality differences. Long-term raloxifene retained 76% of the effectiveness of tamoxifen in preventing invasive disease and grew closer over time to tamoxifen in preventing noninvasive disease, with far less toxicity (e.g., highly significantly less endometrial cancer). These results have important public health implications and clarify that both raloxifene and tamoxifen are good preventive choices for postmenopausal women with elevated risk for breast cancer.
Subject(s)
Adenocarcinoma/prevention & control , Breast Neoplasms/prevention & control , Estrogens , Neoplasms, Hormone-Dependent/prevention & control , Raloxifene Hydrochloride/therapeutic use , Selective Estrogen Receptor Modulators/therapeutic use , Tamoxifen/therapeutic use , Adenocarcinoma/epidemiology , Adenocarcinoma/pathology , Adult , Aged , Aged, 80 and over , Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Cataract/chemically induced , Cataract/epidemiology , Double-Blind Method , Drug Utilization , Endometrial Neoplasms/chemically induced , Endometrial Neoplasms/epidemiology , Female , Follow-Up Studies , Fractures, Spontaneous/epidemiology , Fractures, Spontaneous/etiology , Fractures, Spontaneous/prevention & control , Humans , Incidence , Middle Aged , Myocardial Ischemia/epidemiology , Myocardial Ischemia/prevention & control , Neoplasm Invasiveness , Neoplasms, Hormone-Dependent/epidemiology , Neoplasms, Hormone-Dependent/pathology , Osteoporosis, Postmenopausal/complications , Osteoporosis, Postmenopausal/prevention & control , Raloxifene Hydrochloride/adverse effects , Raloxifene Hydrochloride/pharmacology , Risk , Selective Estrogen Receptor Modulators/adverse effects , Selective Estrogen Receptor Modulators/pharmacology , Tamoxifen/adverse effects , Tamoxifen/pharmacology , Thromboembolism/chemically induced , Thromboembolism/epidemiology , Uterus/pathologyABSTRACT
BACKGROUND: Initial findings from the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial (P-1) demonstrated that tamoxifen reduced the risk of estrogen receptor-positive tumors and osteoporotic fractures in women at increased risk for breast cancer. Side effects of varying clinical significance were observed. The trial was unblinded because of the positive results, and follow-up continued. This report updates our initial findings. METHODS: Women (n = 13,388) were randomly assigned to receive placebo or tamoxifen for 5 years. Rates of breast cancer and other events were compared by the use of risk ratios (RRs) and 95% confidence intervals (CIs). Estimates of the net benefit from 5 years of tamoxifen therapy were compared by age, race, and categories of predicted breast cancer risk. Statistical tests were two-sided. RESULTS: After 7 years of follow-up, the cumulative rate of invasive breast cancer was reduced from 42.5 per 1000 women in the placebo group to 24.8 per 1000 women in the tamoxifen group (RR = 0.57, 95% CI = 0.46 to 0.70) and the cumulative rate of noninvasive breast cancer was reduced from 15.8 per 1000 women in the placebo group to 10.2 per 1000 women in the tamoxifen group (RR = 0.63, 95% CI = 0.45 to 0.89). These reductions were similar to those seen in the initial report. Tamoxifen led to a 32% reduction in osteoporotic fractures (RR = 0.68, 95% CI = 0.51 to 0.92). Relative risks of stroke, deep-vein thrombosis, and cataracts (which increased with tamoxifen) and of ischemic heart disease and death (which were not changed with tamoxifen) were also similar to those initially reported. Risks of pulmonary embolism were approximately 11% lower than in the original report, and risks of endometrial cancer were about 29% higher, but these differences were not statistically significant. The net benefit achieved with tamoxifen varied according to age, race, and level of breast cancer risk. CONCLUSIONS: Despite the potential bias caused by the unblinding of the P-1 trial, the magnitudes of all beneficial and undesirable treatment effects of tamoxifen were similar to those initially reported, with notable reductions in breast cancer and increased risks of thromboembolic events and endometrial cancer. Readily identifiable subsets of individuals comprising 2.5 million women could derive a net benefit from the drug.
Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/prevention & control , Estrogen Receptor Modulators/therapeutic use , Receptors, Estrogen/analysis , Tamoxifen/therapeutic use , Adult , Aged , Antineoplastic Agents, Hormonal/adverse effects , Bias , Breast Neoplasms/chemistry , Confidence Intervals , Endometrial Neoplasms/chemically induced , Estrogen Receptor Modulators/adverse effects , Female , Follow-Up Studies , Fractures, Bone/etiology , Fractures, Bone/prevention & control , Humans , Incidence , Middle Aged , Odds Ratio , Osteoporosis/complications , Patient Selection , Research Design , Risk Assessment , Risk Factors , Stroke/etiology , Tamoxifen/adverse effects , Thromboembolism/chemically induced , Thromboembolism/complications , Time FactorsABSTRACT
BACKGROUND: Information about breast cancer treatment and prevention in African American women is scant, and recommendations for therapy from clinical trials for breast cancer are based primarily on data obtained from white women. METHODS: We compared the effects of tamoxifen on risk of contralateral breast cancer and thromboembolic events in African American women and white women with a history of primary breast cancer. Data from 13 National Surgical Adjuvant Breast and Bowel Project clinical trials were pooled for analyses of time to contralateral breast cancer as a first event (eight trials and 10,619 patients) and of time to any thromboembolic phenomenon as a first event (all 13 trials and 20,878 patients). Risk factors for contralateral breast cancer and thromboembolic events among all women were determined using univariate proportional hazards models. (For each racial group, the rate of events associated with tamoxifen use was calculated as the ratio of the incidence rate with tamoxifen to that without tamoxifen.) Proportional hazards regression models were used to calculate 95% confidence intervals (CIs) and risk ratios. All statistical tests were two-sided. RESULTS: Risk factors for contralateral breast cancer were body mass index (BMI) and lymph node positivity; those for thromboembolic events were BMI and age. In women of both ethnicities with estrogen receptor-positive breast cancer, those who took tamoxifen experienced a similar reduction in contralateral breast cancer (risk ratio for African American women = 0.74, 95% CI = 0.46 to 1.17, n = 690; risk ratio for white women = 0.76, 95% CI = 0.59 to 0.98, n = 9929; P = .92). Tamoxifen was also associated with an increase in thromboembolic events. The relative risk for thromboembolic events was higher in both African American and white women treated with tamoxifen and chemotherapy than in those who were treated with tamoxifen alone (risk ratio for African American women = 10.70, 95% CI = 5.94 to 19.28 versus 2.16, 95% CI = 1.26 to 3.71; n = 1842; risk ratio for white women = 15.49, 95% CI = 9.53 to 25.17 versus 3.13, 95% CI = 2.04 to 4.79, n = 19,036), and this effect was similar between the races (P = .10). CONCLUSIONS: African American and white women appear to have the same risks of contralateral breast cancer and thromboembolic events in response to tamoxifen treatment.