Evaluation of long-term outcome following therapeutic mammaplasty: the effect of wound complication on initiation of adjuvant therapy and subsequent oncological outcome.

INTRODUCTION: Therapeutic mammaplasty (TM) facilitates large tumour resection while maintaining optimal aesthetic outcome. It carries higher wound complication risks, which may delay adjuvant therapy initiation. Whether this delay affects oncological outcome requires evaluation. METHODS: Data were collected for consecutive patients receiving TM at the Leeds breast unit (2009-2017). A prospectively maintained database was used to determine tumour characteristics, wound complication rates, receipt of adjuvant therapy and breast cancer recurrence or death. RESULTS: In total 112 patients (median age of 54 years) underwent 114 TM procedures. The most common histological subtypes were invasive ductal carcinoma (61.4%), invasive lobular carcinoma (13.2%) and ductal carcinoma in situ (13.2%). Of the patients, 88.2% had oestrogen receptor-positive cancer and 14% had human epidermal growth factor receptor-positive cancer; 26.3% had multifocal cancer. The median tumour size was 30mm. The median Nottingham Prognostic Index was 4.2. The local recurrence rate was 3.5% (median follow-up of 8.6 years). The 5- and 10-year disease-free survival (DFS) was 88.5% and 83.5%, and the equivalent overall survival (OS) rates were 94% and 83.5%. Wound complication rate was 23.6% (n=27), the commonest being wound infection (11.4%; n=13) and T-junction wound breakdown (10.5%; n=12). The median time to adjuvant therapy was 72 days (interquartile range [IQR] 56-90) for patients with wound complications, and 51 days (IQR 42-58) for those without. However, this delay did not affect DFS or OS (log-rank test; p=0.58 and p=0.94, respectively). This was confirmed on Cox regression analysis. CONCLUSION: Our study finding demonstrates that although wound complications after TM leads to a modest delay to adjuvant therapy, the long-term oncological outcomes were comparable with those in patients without wound complications.

Development of comparable algorithms to measure primary care indicators using administrative health data across three Canadian provinces.

INTRODUCTION: Performance measurement has been recognized as key to transforming primary care (PC). Yet, performance reporting in PC lags behind even though high-performing PC is foundational to an effective and efficient health care system. OBJECTIVES: We used administrative data from three Canadian provinces, British Columbia, Ontario and Nova Scotia, to: 1) identify and develop a core set of PC performance indicators using administrative data and 2) examine their ability to capture PC performance. METHODS: Administrative data used included Physician Billings, Discharge Abstract Database, the National Ambulatory Care and Reporting System database, Census and Vital Statistics. Indicators were compiled based on a literature review of PC indicators previously developed with administrative data available in Canada (n=158). We engaged in iterative discussions to assess data conformity, completeness, and plausibility of results in all jurisdictions. Challenges to creating comparable algorithms were examined through content analysis and research team discussions, which included clinicians, analysts, and health services researchers familiar with PC. RESULTS: Our final list included 21 PC performance indicators pertaining to 1) technical care (n=4), 2) continuity of care (n=6), and 3) health services utilization (n=11). Establishing comparable algorithms across provinces was possible though time intensive. A major challenge was inconsistent data elements. Ease of data access, and a deep understanding of the data and practice context, was essential for selecting the most appropriate data elements. CONCLUSIONS: This project is unique in creating algorithms to measure PC performance across provinces. It was essential to balance internal validity of the indicators within a province and external validity across provinces. The intuitive desire of having the exact same coding across provinces was infeasible due to lack of standardized PC data. Rather, a context-tailored definition was developed for each jurisdiction. This work serves as an example for developing comparable PC performance indicators across different provincial/territorial jurisdictions.

Osteonecrosis of the jaw in patients transitioning from bisphosphonates to denosumab treatment for osteoporosis.

Antiresorptive-related osteonecrosis of the jaw (ARONJ) is a rare but severe side effect of antiresorptive treatment with bisphosphonates or RANKL-antibody denosumab in patients with malignant diseases or osteoporosis. Whilst osteonecrosis of the jaw (ONJ) related to the administration of bisphosphonates (BPs) has been investigated for more than 1 decade now, only few data are available on denosumab-related ONJ, especially in patients with osteoporosis. From 2008 to 2016, 52 osteoporosis patients were treated with ARONJ in the Department of Oral and Maxillofacial Surgery, University Medical Center Freiburg, Germany. In all patients, a surgical regimen consisting of complete removal of necrotic bone, primary wound closure and perioperative i.v. antibiotic therapy was applied. Of the 52 patients, 38 developed ARONJ after BP monotherapy; in 11 patients, antiresorptive therapy had been transitioned from BPs to denosumab and 3 patients had received denosumab monotherapy. From July 2013, when the first patient with ONJ and transitioning therapy from BPs to denosumab presented to our department, to October 2016, we found recurrences in 17.6% of the patients with BP monotherapy and in 45.5% of the patients with transitioning therapy from BPs to denosumab. Transitioning antiresorptive therapy from BPs to denosumab may be an additional risk factor for developing ARONJ. In these patients, treatment of ARONJ-lesions seems to provoke more complications. An additional dental screening before transitioning should be initiated. Further studies are needed to evaluate if a first-line treatment with denosumab decreases the incidence of ARONJ in patients with osteoporosis and simplifies its treatment.

The influence of dexamethasone on postoperative swelling and neurosensory disturbances after orthognathic surgery: a randomized controlled clinical trial.

BACKGROUND: Orthognathic surgery is associated with considerable swelling and neurosensory disturbances. Serious swelling can lead to great physical and psychological strain. A randomized, prospective, controlled clinical trial was realized in order to evaluate the effect of a preoperative intravenous dexamethasone injection of 40 mg on postoperative swelling and neurosensory disturbances after orthognathic surgery. METHODS: Thirty-eight patients (27 male and 11 female) patients, all with the indication for an orthognathic surgery, were enrolled in this study (mean age: 27.63 years, range: 16-61 years) and randomly divided into two groups (study group/ control group). Both groups underwent either maxillary and/or mandibular osteotomies, resulting in three subgroups according to surgical technique (A: LeFort I osteotomy, B: bilateral sagittal split osteotomy (BSSO), C: bimaxillary osteotomy). The study group received a single preoperative intravenous injection of 40 mg dexamethasone. Facial edema was measured by 3D surface scans on the 1st, 2nd, 5th, 14th and 90th postoperative day. Furthermore, neurosensory disturbances on the 2nd, 5th, 14th and 90th postoperative day were investigated by thermal stimulation. RESULTS: Facial edema after LeFort I osteotomy, BSSO and bimaxillary osteotomy showed a significant decrease in the study group compared to the control group (P = 0.048, P = 0.045, P < 0.001). The influence of dexamethasone on neurosensory disturbances was not significant for the inferior alveolar nerve (P = 0.746) or the infraorbital nerve (P = 0.465). CONCLUSIONS: Patients undergoing orthognathic surgery should receive a preoperative injection of dexamethasone in order to control and reduce edema. However, there was no influence of dexamethasone on reduction of neurosensory disturbances. TRIAL REGISTRATION: DRKS00009033 .

Update MRONJ and perspectives of its treatment.

Antiresorptive agents are widely used in catabolic bone diseases. Not only bisphosphonates but also new drugs like Denosumab may induce osteonecrosis of the jaw as a side effect. The present review describes the current effect mechanisms of commonly used antiresorptives, pathogenetic theories for the development of antiresorptive-related osteonecrosis of the jaw (ARONJ), and potential risk factors. Furthermore, diagnostic modalities and treatment options as well as new and innovative strategies are discussed. The major key factor to avoid the occurrence of ARONJ still remains the implementation of throughout preventive measures.

Improving prevention in primary care: evaluating the effectiveness of outreach facilitation.

BACKGROUND: Out reach facilitation is designed to promote uptake of evidence-based guidelines. There is evidence indicating that outreach facilitation can be effective in improving implementation of preventive care in GPs' offices. In this trial, we test a modified version of an outreach facilitation intervention. OBJECTIVE: To evaluate whether a comprehensive preventive intervention program using outreach facilitators improves preventive care delivery. DESIGN: Match-paired, cluster-randomized controlled trial. SETTING: Fee-for-service primary care practices in Eastern Ontario, Canada, at a time of physician shortage. PARTICIPANTS: Volunteer sample of 54 primary care practices. MAIN OUTCOME MEASURES: Mean difference between trial arms in practices' delivery of preventive manoeuvres, measured by preventive performance indices estimated from chart reviews and patient survey data. RESULTS: No difference was detected between the trial's arms for the primary outcome's overall prevention index [2.0%; 95% confidence interval (CI) -3.2 to 7.3; P = 0.44]. A small significant difference between the arms was detected for the secondary outcome's overall prevention index (2.8%; 95% CI 0.7-4.8; P = 0.01). CONCLUSION: In contrast to similar facilitation trials, this outreach facilitation program did not produce improvements in the delivery of preventive care. This lack of effect may be due to differences in the intervention and context, or the practice's limited capacity to change. Our intervention simultaneously facilitated a high number of manoeuvres, blinded facilitators and physicians to the targeted tests and had a relatively short intervention period and large number of practices assigned per facilitator. Changes in the primary care service model in Ontario at the time of the trial could have also washed out the intervention effect.

A manufacturer's perspective on selected palm-based products.

An overview from the perspective of one manufacturer is provided on products that utilise either palm oil or palm kernel oil. The manufacturer is Macphie of Glenbervie while the products are of a wide-ranging nature for use in bakery, food service and food-manufacturing. Much of the discussion concerns cream alternatives on the grounds that this product-category places great demand on the type of fat needed and, to Macphie of Glenbervie, is responsible for most of the oil from oil palm used. However, other products are also touched on. The overview considers key product attributes the function that fat has within these products, together with research requirements and future opportunity.

The effect of cluster randomization on sample size in prevention research.

BACKGROUND: This paper concerns the issue of cluster randomization in primary care practice intervention trials. We present information on the cluster effect of measuring the performance of various preventive maneuvers between groups of physicians based on a successful trial. We discuss the intracluster correlation coefficient of determining the required sample size and the implications for designing randomized controlled trials where groups of subjects (e.g., physicians in a group practice) are allocated at random. METHODS: We performed a cross-sectional study involving data from 46 participating practices with 106 physicians collected using self-administered questionnaires and a chart audit of 100 randomly selected charts per practice. The population was health service organizations (HSOs) located in Southern Ontario. We analyzed performance data for 13 preventive maneuvers determined by chart review and used analysis of variance to determine the intraclass correlation coefficient. An index of "up-to-datedness" was computed for each physician and practice as the number of a recommended preventive measure done divided by the number of eligible patients. An index called "inappropriateness" was computed in the same manner for the not-recommended measures. The intraclass correlation coefficients for 2 key study outcomes (up-to-datedness and inappropriateness) were also calculated and compared. RESULTS: The mean up-to-datedness score for the practices was 53.5% (95% confidence interval [CI], 51.0%-56.0%), and the mean inappropriateness score was 21.5% (95% CI, 18.1%-24.9%). The intraclass correlation for up-to-datedness was 0.0365 compared with inappropriateness at 0.1790. The intraclass correlation for preventive maneuvers ranged from 0.005 for blood pressure measurement to 0.66 for chest radiographs of smokers, and as a consequence required the sample size ranged from 20 to 42 physicians per group. CONCLUSIONS: Randomizing by practice clusters and analyzing at the level of the physician has important implications for sample size requirements. Larger intraclass correlations indicate interdependence among the physicians within a cluster; as a consequence, variability within clusters is reduced, and the required sample size increased. The key finding that many potential outcome measures perform differently in terms of the intracluster correlation reinforces the need for researchers to carefully consider the selection of outcome measures and adjust sample sizes accordingly when the unit of analysis and randomization are not the same.

Process evaluation of a tailored multifaceted approach to changing family physician practice patterns improving preventive care.

BACKGROUND: We conducted a process evaluation of a multifaceted outreach facilitation intervention to document the extent to which the intervention was implemented with fidelity. We also hoped to gain insight into how facilitation worked to improve preventive performance. METHODS: We used 5 data collection tools to evaluate the implementation of the intervention, and a combination of descriptive, quantitative, and qualitative analyses. Triangulation was used to attain a complete understanding of the quality of implementation. Twenty-two intervention practices with a total of 54 physicians participated in a randomized controlled trial that took place in Southwestern Ontario, Canada. The key measures of process were the frequency and time involved to deliver intervention components, the scope of the delivery and the utility of the components, and physician satisfaction with the intervention. RESULTS: Of the 7 components in the intervention model, prevention facilitators (PFs) visited the practice most often to deliver the audit and feedback, consensus building, and reminder system components. All the study practices received preventive performance audit and feedback, achieved consensus on a plan for improvement, and implemented a reminder system. Ninety percent of the practices implemented a customized flow sheet, and 10% used a computerized reminder system. Ninety-five percent of the intervention practices wanted critically appraised evidence for prevention, 82% participated in a workshop with opinion leaders in preventive care, and 100% received patient education materials in a binder. Content analysis of the physician interviews and bivariate analysis of physician self-reported changes between intervention and control group physicians revealed that the audit and feedback, consensus building, and development of reminder systems were the key intervention components. Ninety-five percent of the physicians were either satisfied or very satisfied with the intervention, and 90% would have been willing to have the PF continue working with their practice. CONCLUSIONS: Primary care practices in Ontario can implement significant changes in their practice environments that will improve preventive care activity with the assistance of a facilitator. The main components for creating change are audit and feedback of preventive performance, achieving consensus on a plan for improvement, and implementing a reminder system.

Evidence to action: a tailored multifaceted approach to changing family physician practice patterns and improving preventive care.

BACKGROUND: Although there is much room for improvement in the performance of recommended preventive manoeuvres, many inappropriate preventive interventions are being done. We evaluated a multifaceted intervention, delivered by nurses trained in prevention facilitation, to improve prevention in primary care. METHODS: Forty-six health service organizations (HSOs) were recruited from 100 sites in Ontario. After baseline data were collected, we randomly assigned the practices to either an 18-month (July 1997 to December 1998) multifaceted intervention delivered by 1 of 3 nurse facilitators (23 practices) or no intervention (23 practices). The unit of intervention and analysis was the medical practice. The outcome measure was an overall index of preventive performance, which was calculated as the proportion of eligible patients who received 8 recommended preventive manoeuvres less the proportion of eligible patients who received 5 inappropriate preventive manoeuvres. RESULTS: One HSO, in the intervention group, was lost to follow-up. Before the intervention, the index of preventive performance was similar for the intervention and control groups (31.9% [95% confidence interval (CI) 27.3%-36.5%] and 32.1% [95% CI 27.2%-37.0%] respectively). At follow-up the corresponding values were 43.2% (95% CI 38.4%-48.0%) and 31.9% (95% CI 26.8%-37.0%), for an absolute improvement in the intervention group of 11.5% (p < 0.001). The mean proportion of eligible patients who received the recommended manoeuvres was 62.3% (95% CI 58.2%-66.4%) in the intervention group, as compared with 57.4% (95% CI 54.1%-60.7%) in the control group, for an absolute improvement of 7.2% (p = 0.008). The corresponding values for the inappropriate manoeuvres were 19.1% (95% CI 15.6%-22.6%) and 25.5% (95% CI 20.0%-31.0%), for an absolute improvement of 4.4% (p = 0.019). INTERPRETATION: The tailored multifaceted intervention delivered by nurse facilitators was effective in modifying physician practice patterns and significantly improved preventive care performance.

Peer consultation reflection exercise.

OBJECTIVE: To explore participants' overall perception of the value of the Peer Consultation Reflection Exercise (PCRE); of barriers and facilitators to participation and learning during a PCRE; and of the transferability of the experience to participants' own settings. DESIGN: This study used the qualitative techniques of key informant interviews and a focus group. SETTING: Focus group and key informant interviews at the 1996 Annual Meeting of the College of Family Physicians of Canada's Section of Teachers. PARTICIPANTS: Family medicine teachers attending a PCRE. METHOD: Five key informant interviews and one focus group composed of five participants were conducted to explore participants' experience of participating and learning during a PCRE. MAIN FINDINGS: Participants viewed the PCRE as a valuable opportunity to interact and learn from colleagues a were especially impressed with the opportunity to listen. Confidentiality and the important role of the facilitator were identified as key components. The greatest perceived barrier was the formal structure of the PCRE. CONCLUSIONS: The PCRE is an innovative strategy for personal and professional development. It could be used in other settings.

Randomized controlled study of customized preventive medicine reminder letters in a community practice.

OBJECTIVE: To test the effectiveness of customized, family-oriented reminder letters in activating patients to seek appropriate preventive services. DESIGN: Randomized clinical trial. One group received computer-generated, customized letters explaining recommended preventive procedures for each family member. A second group received a form letter listing recommendations for all preventive procedures for all age and sex groups. A third group (control group) received no letters. SETTING: A private medical centre, without university affiliation, in rural Quebec. PARTICIPANTS: From 8770 patients who met study criteria, 719 families were randomly selected. Data were available for 1971 of 1998 patients in these families. MAIN OUTCOME MEASURES: The Family Received Index is the proportion of all procedures for which a family was overdue that they received. The Family End-of-study Up-to-date Index is the proportion of procedures for which the family was eligible and for which they were up-to-date at the end of the study. RESULTS: The Family Received Index for families mailed customized letters was more than double the index for patients not mailed letters (Kruskal-Wallis P = .0139). Comparison of the Family End-of-study Up-to-date indices also demonstrated that families of patients sent customized letters were more likely to be up-to-date than families not sent letters (Kruskal-Wallis P = .0054). No statistically significant difference appeared between the number of preventive measures received by the control group and the form-letter group. CONCLUSIONS: This study demonstrates a clinically small but statistically significant value to customizing reminder letters.

Hydrometeorological aspects of flood hazards in Canada

Floods are major disasters in Canada and worldwide. Although technology has reduced the flood hazard in many areas, the world death toll from floods in recent decades still has averaged 4680 per year. During the summer of 1993, flooding in the U.S.A. caused an estimated $12 billion damage. These statistics confirm that floods are a major natural disaster. This paper reviews the hydrometereological aspects of the hazard associated with rainstorm, urban, ice-jam, and snowmelt floods. The hazard element is highest for floods with rapid onsets such as rainstorm, urban, and ice-jam floods. Although snowmelth floods are common throughout Canada, their slower onset times reduce their risk potential. To reduce the risk of the flood hazard, society must have access to statistical information for adequate planning and design, and forecasts for issuing warnings and implementing evacuation strategies. Flood design statistics and forecast models are discussed relative to each major flood type. The paper also describes historical flood frequency trends and discusses the implications of climatic warning for future floods. The paper concludes with a brief discussion of some knowledge gaps and research needs.(AU)

Effect of location on family medicine residents' training.

A survey of family medicine residents trained at community-based or hospital-based centres suggested differences in experience and in career plans. Community-based residents saw more patients in the same family, believed they knew the community better, made more housecalls, expected to use allied health professionals more frequently, and were more likely to choose a small community practice.

Incorporating the family into a computerized office registration system.

BACKGROUND AND OBJECTIVES: New office computer systems provide physicians with the opportunity to link together the medical records of all members of a family. The purpose of this report is to describe our experience with a computerized family grouping system in a practice of 12,000 patients. METHODS: Using a computerized patient registration system, we developed a six-digit numbering scheme that signified how various members of a household were related to one another. When first instituting the system, we initially linked individuals who shared the same phone number. Subsequently, information was updated and corrected by patients when they came to the office. RESULTS: Costs for the system included the cost of an 80386 computer with a 200 megabyte hard disk and software. In addition, initial entry of patient data cost approximately $0.36 per patient. Costs were lower ($.08 per patient) once the system was established. Several problems were noted in instituting the system, including staff difficulty in adjusting to new routines and errors in data entry and reports. CONCLUSIONS: Computerized patient registration systems permit linkage of medical records and registration information of all individuals in a family or household. Integrating such systems into medical offices requires acceptance of new routines by staff.

Rural obstetrics: a 5-year prospective study of the outcomes of all pregnancies in a remote northern community.

OBJECTIVE: To determine whether a small, isolated hospital that has no facilities to perform cesarean section and handles fewer than 50 deliveries annually can provide acceptably safe obstetric and perinatal care. DESIGN: Cohort study. SETTING: Southern region of the Queen Charlotte Islands, BC, served by a 21-bed hospital and medical clinic in Queen Charlotte City. The hospital and clinic are staffed by five family practitioners without local obstetric, pediatric, anesthetic or surgical support. PATIENTS: All women beyond 20 weeks' gestation who gave birth from Jan. 1, 1984, to Dec. 31, 1988; 33% were primiparous and 20% native. Of the 286 women 192 (67%) delivered locally, 33 (12%) were transferred after admission because of antepartum or intrapartum complications, and 61 (21%) delivered elsewhere by choice or on their physician's recommendation. OUTCOME MEASURES: Perinatal mortality rate and adverse perinatal outcome (death, birth weight of less than 2500 g, neonatal transfer or Apgar score of less than 7 at 5 minutes). MAIN RESULTS: There were six perinatal deaths, for a perinatal mortality rate of 20.8 (95% confidence interval [CI] 4.4 to 37.2). The hospital-based rate of adverse perinatal outcome was 6.2% (12 of 193 newborns) (95% CI 2.8% to 9.6%). CONCLUSIONS: The perinatal mortality rate is not a meaningful way to assess small populations; about 85 years of data would be required to decrease the 95% CIs from within 16 to within 4. The rate of adverse perinatal outcome in our study was consistent with the rate in other studies. Collaboration of small, rural hospitals is required to increase cohort size so that the correlation between the currently accepted standard, the perinatal mortality rate, and other outcome measures can be determined.