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1.  A Randomized Trial of Planned Cesarean or Vaginal Delivery for Twin Pregnancy 
The New England journal of medicine  2013;369(14):1295-1305.
BACKGROUND
Twin birth is associated with a higher risk of adverse perinatal outcomes than singleton birth. It is unclear whether planned cesarean section results in a lower risk of adverse outcomes than planned vaginal delivery in twin pregnancy.
METHODS
We randomly assigned women between 32 weeks 0 days and 38 weeks 6 days of gestation with twin pregnancy and with the first twin in the cephalic presentation to planned cesarean section or planned vaginal delivery with cesarean only if indicated. Elective delivery was planned between 37 weeks 5 days and 38 weeks 6 days of gestation. The primary outcome was a composite of fetal or neonatal death or serious neonatal morbidity, with the fetus or infant as the unit of analysis for the statistical comparison.
RESULTS
A total of 1398 women (2795 fetuses) were randomly assigned to planned cesarean delivery and 1406 women (2812 fetuses) to planned vaginal delivery. The rate of cesarean delivery was 90.7% in the planned-cesarean-delivery group and 43.8% in the planned-vaginal-delivery group. Women in the planned-cesarean-delivery group delivered earlier than did those in the planned-vaginal-delivery group (mean number of days from randomization to delivery, 12.4 vs. 13.3; P = 0.04). There was no significant difference in the composite primary outcome between the planned-cesarean-delivery group and the planned-vaginal-delivery group (2.2% and 1.9%, respectively; odds ratio with planned cesarean delivery, 1.16; 95% confidence interval, 0.77 to 1.74; P = 0.49).
CONCLUSIONS
In twin pregnancy between 32 weeks 0 days and 38 weeks 6 days of gestation, with the first twin in the cephalic presentation, planned cesarean delivery did not significantly decrease or increase the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00187369; Current Controlled Trials number, ISRCTN74420086.)
doi:10.1056/NEJMoa1214939
PMCID: PMC3954096  PMID: 24088091 CAMSID: cams3905
2.  Core Competencies for Shared Decision Making Training Programs: Insights From an International, Interdisciplinary Working Group 
Shared decision making is now making inroads in health care professionals’ continuing education curriculum, but there is no consensus on what core competencies are required by clinicians for effectively involving patients in health-related decisions. Ready-made programs for training clinicians in shared decision making are in high demand, but existing programs vary widely in their theoretical foundations, length, and content. An international, interdisciplinary group of 25 individuals met in 2012 to discuss theoretical approaches to making health-related decisions, compare notes on existing programs, take stock of stakeholders concerns, and deliberate on core competencies. This article summarizes the results of those discussions. Some participants believed that existing models already provide a sufficient conceptual basis for developing and implementing shared decision making competency-based training programs on a wide scale. Others argued that this would be premature as there is still no consensus on the definition of shared decision making or sufficient evidence to recommend specific competencies for implementing shared decision making. However, all participants agreed that there were 2 broad types of competencies that clinicians need for implementing shared decision making: relational competencies and risk communication competencies. Further multidisciplinary research could broaden and deepen our understanding of core competencies for shared decision making training.
doi:10.1002/chp.21197
PMCID: PMC3911960  PMID: 24347105 CAMSID: cams3819
shared decision making; education; patient-centered care; implementation science; theory; risk communication
3.  Quantitative sputum cell counts to monitor bronchitis: A qualitative study of physician and patient perspectives 
Many common diseases affecting the airways are characterized by airway inflammation. The measurement of this inflammation has a significant role in the management of these diseases. Quantitative sputum cell counts provide a measurement of the type and severity of inflammation present. Sputum cell counts are used in routine clinical practice in some centres but their use is not widespread. The present study used a standardized questionnaire to determine both patients’ and physicians’ attitudes toward the use of sputum cell counts. The use of sputum cell counts was well accepted by patients and physicians. Ninety per cent of patients were satisfied with the test. Sixty per cent of family physicians were satisfied with the test and 80% were in favour of it being funded by the government. The authors recommend more widespread use of sputum cell counts to guide the management of airway diseases.
PMCID: PMC3628647  PMID: 23457675
Asthma; Bronchitis; Patient satisfaction; Sputum cell counts; Willingness to pay
4.  The development of a decision aid to elicit treatment preferences for displaced femoral neck fractures 
Indian Journal of Orthopaedics  2012;46(1):22-28.
Background:
Decision aids help physicians convey information to patients and enable patients to be involved in the decision-making process. There is a lack of use of decision aids in the orthopedic literature. The purpose of this study was to develop a decision board to elicit preferences for treatment of displaced femoral neck fractures in patients over 60 years old.
Materials and Methods:
We developed a decision board presenting descriptions and potential outcomes and complications of two treatment options, hemiarthroplasty (HA) and internal fixation (IF), for displaced femoral neck fractures. Five orthopedic surgeons evaluated the face and content validity of the decision board and 10 volunteers completed “scope tests” to determine the comprehensibility. We then presented the decision board to 108 study participants faced with the scenario of sustaining a displaced femoral neck fracture. Participants stated their preference for operative procedure and described the reasons for their choices.
Results:
The decision board achieved good face and content validity. All participants in the scope tests appropriately switched their preference to the other modality when probabilities were altered. Most participants found the decision board easy to understand and helpful in making an informed decision. Also, most participants were satisfied with the amount of information presented and with the use of the decision board as a decision making tool. Sixty-one participants (56%) chose IF as their operative procedure of choice quoting less blood loss, shorter operative time, and less invasiveness as the top factors that contributed to this choice. Participants who preferred HA (44%) did so primarily due to the lower re-operation rate.
Conclusions:
The decision board is a useful and reliable tool to inform patients about the treatment options for displaced femoral neck fractures. They should be utilized by surgeons to incorporate patients’ preferences into the decision-making process.
doi:10.4103/0019-5413.91631
PMCID: PMC3270601  PMID: 22345803
Decision aid; decision board; femoral neck fracture; hemiarthroplasty; internal fixation
5.  Hip fracture prevention strategies in long-term care 
Canadian Family Physician  2010;56(11):e392-e397.
OBJECTIVE
To garner Canadian physicians’ opinions on strategies to reduce hip fractures in long-term care (LTC) facilities, focusing on secondary prevention.
DESIGN
A cross-sectional survey using a mailed, self-administered, written questionnaire.
SETTING
Canada.
PARTICIPANTS
Family physician members of the Ontario Long-Term Care Association (n = 165) and all actively practising geriatricians registered in the Canadian Medical Directory (n = 81).
MAIN OUTCOME MEASURES
The strength of recommendations for fracture-reduction strategies in LTC and barriers to implementing these strategies.
RESULTS
Of the 246 physicians sent the questionnaire, 25 declined study materials and were excluded. Of the 221 remaining, 120 responded for a response rate of 54%. About two-thirds of respondents were family physicians (78 of 120) and the rest were mostly geriatricians. Most respondents strongly recommended the following secondary prevention strategies for use in LTC after hip fracture: calcium, vitamin D, oral aminobisphosphonates, physical therapy, and environmental modification (such as handrails). Most respondents either did not recommend or recommended limited use of etidronate, intravenous bisphosphonates, calcitonin, raloxifene, testosterone (for hypogonadal men), and teriparatide. Postmenopausal hormone therapy was discouraged or not recommended by most respondents. Support was mixed for the use of hip protectors, B vitamins, and folate. Barriers to implementation identified by most respondents included a lack of strong evidence of hip fracture reduction (for B vitamins and folate, cyclic etidronate, and testosterone), side effects (for postmenopausal hormone therapy), poor compliance (for hip protectors), and expense (for intravenous bisphosphonates and teriparatide). Some respondents cited side effects or poor compliance as barriers to using calcium and potent oral bisphosphonates.
CONCLUSION
Canadian physicians favour the use of calcium, vitamin D, potent oral bisphosphonates, physical therapy, and evironmental modifications for LTC residents after hip fracture. Further study at the clinical and administrative levels is required to find ways to overcome the specific barriers to implementation and effectiveness of these interventions.
PMCID: PMC2980445  PMID: 21075980
6.  Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery 
BMC Medical Ethics  2010;11:14.
Background
Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.
Methods/Design
Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:
Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.
Ethics - beneficence, non-maleficence, autonomy, justice.
Economics - scarcity of resources, choices, opportunity costs.
For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.
Discussion
The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.
doi:10.1186/1472-6939-11-14
PMCID: PMC2936433  PMID: 20738887
7.  Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer - a randomized controlled trial 
Trials  2010;11:81.
Background
Patients with early stage papillary thyroid carcinoma (PTC), are faced with the decision to either to accept or reject adjuvant radioactive iodine (RAI) treatment after thryroidectomy. This decision is often difficult because of conflicting reports of RAI treatment benefit and medical evidence uncertainty due to the lack of long-term randomized controlled trials.
Methods
We report the protocol for a parallel, 2-arm, randomized trial comparing an intervention group exposed to a computerized decision aid (DA) relative to a control group receiving usual care. The DA explains the options of adjuvant radioactive iodine or no adjuvant radioactive iodine, as well as associated potential benefits, risks, and follow-up implications. Potentially eligible adult PTC patient participants will include: English-speaking individuals who have had recent thyroidectomy, and whose primary tumor was 1 to 4 cm in diameter, with no known metastases to lymph nodes or distant sites, with no other worrisome features, and who have not received RAI treatment for thyroid cancer. We will measure the effect of the DA on the following patient outcomes: a) knowledge about PTC and RAI treatment, b) decisional conflict, c) decisional regret, d) client satisfaction with information received about RAI treatment, and e) the final decision to accept or reject adjuvant RAI treatment and rationale.
Discussion
This trial will provide evidence of feasibility and efficacy of the use of a computerized DA in explaining complex issues relating to decision making about adjuvant RAI treatment in early stage PTC.
Trial registration
Clinical Trials.gov Identifier: NCT01083550
doi:10.1186/1745-6215-11-81
PMCID: PMC2917435  PMID: 20659341
8.  A Scoping Review of Strategies for the Prevention of Hip Fracture in Elderly Nursing Home Residents 
PLoS ONE  2010;5(3):e9515.
Background
Elderly nursing home residents are at increased risk of hip fracture; however, the efficacy of fracture prevention strategies in this population is unclear.
Objective
We performed a scoping review of randomized controlled trials of interventions tested in the long-term care (LTC) setting, examining hip fracture outcomes.
Methods
We searched for citations in 6 respective electronic searches, supplemented by hand searches. Two reviewers independently reviewed all citations and full-text papers; consensus was achieved on final inclusion. Data was abstracted in duplicate.
Findings
We reviewed 22,349 abstracts or citations and 949 full-text papers. Data from 20 trials were included: 7 - vitamin D (n = 12,875 participants), 2 - sunlight exposure (n = 522), 1 - alendronate (n = 327), 1 - fluoride (n = 460), 4 – exercise or multimodal interventions (n = 8,165), and 5 - hip protectors (n = 2,594). Vitamin D, particularly vitamin D3 ≥800 IU orally daily, reduced hip fracture risk. Hip protectors reduced hip fractures in included studies, although a recent large study not meeting inclusion criteria was negative. Fluoride and sunlight exposure did not significantly reduce hip fractures. Falls were reduced in three studies of exercise or multimodal interventions, with one study suggesting reduced hip fractures in a secondary analysis. A staff education and risk assessment strategy did not significantly reduce falls or hip fractures. In a study underpowered for fracture outcomes, alendronate did not significantly reduce hip fractures in LTC.
Conclusions
The intervention with the strongest evidence for reduction of hip fractures in LTC is Vitamin D supplementation; more research on other interventions is needed.
doi:10.1371/journal.pone.0009515
PMCID: PMC2831075  PMID: 20209088
9.  Developing and pre-testing a decision board to facilitate informed choice about delivery approach in uncomplicated pregnancy 
Background
The rate of caesarean sections is increasing worldwide, yet medical literature informing women with uncomplicated pregnancies about relative risks and benefits of elective caesarean section (CS) compared with vaginal delivery (VD) remains scarce. A decision board may address this gap, providing systematic evidence-based information so that patients can more fully understand their treatment options. The objective of our study was to design and pre-test a decision board to guide clinical discussions and enhance informed decision-making related to delivery approach (CS or VD) in uncomplicated pregnancy.
Methods
Development of the decision board involved two preliminary studies to determine women's preferred mode of risk presentation and a systematic literature review for the most comprehensive presentation of medical risks at the time (VD and CS). Forty women were recruited to pre-test the tool. Eligible subjects were of childbearing age (18-40 years) but were not pregnant in order to avoid raising the expectation among pregnant women that CS was a universally available birth option. Women selected their preferred delivery approach and completed the Decisional Conflict Scale to measure decisional uncertainty before and after reviewing the decision board. They also answered open-ended questions reflecting what they had learned, whether or not the information had helped them to choose between birth methods, and additional information that should be included. Descriptive statistics were used to analyse sample characteristics and women's choice of delivery approach pre/post decision board. Change in decisional conflict was measured using Wilcoxon's sign rank test for each of the three subscales.
Results
The majority of women reported that they had learned something new (n = 37, 92%) and that the tool had helped them make a hypothetical choice between delivery approaches (n = 34, 85%). Women wanted more information about neonatal risks and personal experiences. Decisional uncertainty decreased (p < 0.001) and perceived effectiveness of decisions increased (p < 0.001) post-intervention.
Conclusion
Non-pregnant women of childbearing age were positive about the decision board and stated their hypothetical delivery choices were informed by risk presentation, but wanted additional information about benefits and experiences. This study represents a preliminary but integral step towards ensuring women considering delivery approaches in uncomplicated pregnancies are fully informed.
doi:10.1186/1471-2393-9-50
PMCID: PMC2774286  PMID: 19874628
10.  Family Physician attitudes about prescribing using a drug formulary 
BMC Family Practice  2009;10:69.
Background
Drug formularies have been created by third party payers to control prescription drug usage and manage costs. Physicians try to provide the best care for their patients. This research examines family physicians' attitudes regarding prescription reimbursement criteria, prescribing and advocacy for patients experiencing reimbursement barriers.
Methods
Focus groups were used to collect qualitative data on family physicians' prescribing decisions related to drug reimbursement guidelines. Forty-eight family physicians from four Ontario cities participated. Ethics approval for this study was received from the Hamilton Health Sciences/Faculty of Health Sciences Research Ethics Board at McMaster University. Four clinical scenarios were used to situate and initiate focus group discussions about prescribing decisions. Open-ended questions were used to probe physicians' experiences and attitudes and responses were audio recorded. NVivo software was used to assist in data analysis.
Results
Most physicians reported that drug reimbursement guidelines complicated their prescribing process and can require lengthy interpretation and advocacy for patients who require medication that is subject to reimbursement restrictions.
Conclusion
Physicians do not generally see their role as being cost-containment monitors and observed that cumbersome reimbursement guidelines influence medication choice beyond the clinical needs of the patient, and produce unequal access to medication. They observed that frustration, discouragement, fatigue, and lack of appreciation can often contribute to family physicians' failure to advocate more for patients. Physicians argue cumbersome reimbursement regulations contribute to lower quality care and misuse of physicians' time increasing overall health care costs by adding unnecessary visits to family physicians, specialists, and emergency rooms.
doi:10.1186/1471-2296-10-69
PMCID: PMC2770461  PMID: 19835601
11.  Cost analysis of monitoring asthma treatment using sputum cell counts 
BACKGROUND:
In a four-centre trial, the use of sputum cell counts (sputum strategy [SS]) to guide treatment had resulted in fewer and less severe exacerbations without the need for a higher corticosteroid dose, compared with the use of symptoms and spirometry (clinical strategy [CS]).
OBJECTIVE:
To compare the cost of the SS with the CS in the treatment of patients with moderate to severe asthma.
METHODS:
In 39 patients (19 in the SS, 20 in the CS) from one of the centres, the cost (third-party payer) of the two treatment strategies was compared. Resource use data were collected using a structured questionnaire. Corresponding unit costs in 2006 Canadian dollars were obtained.
RESULTS:
The clinical characteristics of the patients were similar to the study population at the four centres. In the SS, the number of visits to a family physician for health disorders indirectly related to asthma (P=0.003) and the amount of inhaled long-acting beta-agonists (P=0.007) were less than that of the CS. While the total estimated median cost per patient for spirometry ($393; range $299 to $487) was less than that for sputum induction ($1,008; range $907 to $1,411), the total cost of the SS ($2,265; range $1,466 to $4,347) was less than that of the CS ($3369; range $2208 to $3927) (P=0.216). This cost difference was due to lower costs of physician and hospital visits and services (P=0.078), of inhaled short-acting bronchodilators (P=0.067), of long-acting beta-agonists (P=0.002) and of inhaled corticosteroids (P=0.064) in the SS.
CONCLUSION:
In patients with moderate to severe asthma, the use of sputum cell counts to guide treatment is more effective and is likely to be less costly than management using symptoms and spirometry.
PMCID: PMC2679573  PMID: 18949107
Asthma; Cost; Spirometry; Sputum cell counts; Symptoms
12.  The utilization of appropriate osteoporosis medications improves following a multifaceted educational intervention: the Canadian quality circle project (CQC) 
Background
Osteoporosis is a serious but treatable condition. However, appropriate therapy utilization of the disease remains suboptimal. Thus, the objective of the study was to change physicians' therapy administration behavior in accordance with the Osteoporosis Canada 2002 guidelines.
Methods
The Project was a two year cohort study that consisted of five Quality Circle (QC) phases that included: 1) Training & Baseline Data Collection, 2) First Educational Intervention & First Follow-Up Data Collection 3) First Strategy Implementation Session, 4) Final Educational Intervention & Final Follow-up Data Collection, and 5) Final Strategy Implementation Session. A total of 340 family physicians formed 34 QCs and participated in the study. Physicians evaluated a total of 8376, 7354 and 3673 randomly selected patient charts at baseline, follow-up #1 and the final follow-up, respectively. Patients were divided into three groups; the high-risk, low-risk, and low-risk without fracture groups. The generalized estimating equations technique was utilized to model the change over time of whether physicians
Results
The odds of appropriate therapy was 1.29 (95% CI: 1.13, 1.46), and 1.41 (95% CI: 1.20, 1.66) in the high risk group, 1.15 (95% CI: 0.97, 1.36), and 1.16 (95% CI: 0.93, 1.44) in the low risk group, and 1.20 (95% CI: 1.01, 1.43), and 1.23 (95% CI: 0.97, 1.55) in the low risk group without fractures at follow-up #1 and the final follow-up, respectively.
Conclusion
QCs methodology was successful in increasing physicians' appropriate use of osteoporosis medications in accordance with Osteoporosis Canada guidelines.
doi:10.1186/1472-6920-9-54
PMCID: PMC2731752  PMID: 19660103
13.  Discussing prognosis with patients and their families near the end of life: impact on satisfaction with end-of-life care 
Open Medicine  2009;3(2):e101-e110.
Background
Seriously ill patients and their physicians often avoid discussing prognosis, which may compromise optimal end-of-life (EOL) care planning. The relation between prognosis discussion and patient and family satisfaction with EOL care is unknown.
Methods
Using a 5-domain questionnaire, we surveyed inpatients with cancer or end-stage medical disease and their families on their satisfaction with specific aspects of EOL care and their overall satisfaction with EOL care. Scores were standardized to 0–100 points. We compared the results based on whether or not a physician had discussed the patient’s prognosis with them, as well as on whether the patient and family member agreed on whether the patient was nearing the end of life. Supplementary questions were also asked (e.g., preferred location of death, willingness to discuss cardiopulmonary resuscitation).
Results
Of 569 eligible patients and 176 eligible family members, 440 (77%) patients and 160 (91%) family members participated in the study. Overall, 18% of patients and 30.1% of families recalled a prognosis discussion with a physician. Patients who recalled such a discussion were more satisfied with overall care (76.1 v. 73.1 points, difference 3.0, 95% confidence interval [CI] 0.40 to 5.67, p = 0.02) and with communication and decision-making aspects of care (77.9 v. 72.4 points, difference 5.5, 95% CI 1.43 to 9.52, p = 0.008), and were more willing to discuss cardiopulmonary resuscitation status (69.6% v. 55.3%, difference 14.3, 95% CI 2.15 to 26.45, p = 0.03), than those who did not. Patients who were in accord with their family member as to whether they were nearing the end of life also showed significant satisfaction in these 3 areas. Family members’ overall satisfaction was also higher among those who recalled a prognosis discussion (75.3 v. 70.4 points, difference 4.9, 95% CI 0.53 to 9.24, p = 0.03). Multivariate analyses confirmed the significance of the relation between the prognosis discussion and overall satisfaction with care for both patients and family members.
Conclusion
Although discussions about prognosis occur infrequently for patients who have advanced terminal disease, such discussions with patients and their families may facilitate advance care planning and improve satisfaction with EOL care. Encouraging discussion regarding EOL status between the patient and family members may also lead to greater satisfaction with EOL care for patients.
PMCID: PMC2765767  PMID: 19946391
14.  The Impact of Thyroid Cancer and Post-Surgical Radioactive Iodine Treatment on the Lives of Thyroid Cancer Survivors: A Qualitative Study 
PLoS ONE  2009;4(1):e4191.
Background
Adjuvant treatment with radioactive iodine (RAI) is often considered in the treatment of well-differentiated thyroid carcinoma (WDTC). We explored the recollections of thyroid cancer survivors on the diagnosis of WDTC, adjuvant radioactive iodine (RAI) treatment, and decision-making related to RAI treatment. Participants provided recommendations for healthcare providers on counseling future patients on adjuvant RAI treatment.
Methods
We conducted three focus group sessions, including WDTC survivors recruited from two Canadian academic hospitals. Participants had a prior history of WDTC that was completely resected at primary surgery and had been offered adjuvant RAI treatment. Open-ended questions were used to generate discussion in the groups. Saturation of major themes was achieved among the groups.
Findings
There were 16 participants in the study, twelve of whom were women (75%). All but one participant had received RAI treatment (94%). Participants reported that a thyroid cancer diagnosis was life-changing, resulting in feelings of fear and uncertainty. Some participants felt dismissed as not having a serious disease. Some participants reported receiving conflicting messages from healthcare providers on the appropriateness of adjuvant RAI treatment or insufficient information. If RAI-related side effects occurred, their presence was not legitimized by some healthcare providers.
Conclusions
The diagnosis and treatment of thyroid cancer significantly impacts the lives of survivors. Fear and uncertainty related to a cancer diagnosis, feelings of the diagnosis being dismissed as not serious, conflicting messages about adjuvant RAI treatment, and treatment-related side effects, have been raised as important concerns by thyroid cancer survivors.
doi:10.1371/journal.pone.0004191
PMCID: PMC2615133  PMID: 19142227
15.  Improvement in health-related quality of life in osteoporosis patients treated with teriparatide 
Background
Individuals with osteoporosis and recent vertebral fractures suffer from pain and impaired health-related quality of life (HRQL). To determine whether patients with osteoporosis treated with teriparatide experienced improvement in HRQL and pain symptoms after several months of therapy.
Methods
We retrospectively studied a sample of osteoporosis patients treated with teriparatide in a Canadian rheumatology practice. We included patients that received teriparatide therapy with baseline and follow-up Mini-Osteoporosis Quality of Life Questionnaire (OQLQ) data. Follow-up data was measured at three or six months. We used a paired Student's t-test to compare baseline and follow-up measurements for each of the questionnaire's ten questions (five domains). Statistical analysis was also repeated to only include patients who suffered a prior vertebral fracture.
Results
57 patients were included in the study, including 47 women. The mean age was 63.8 years (standard deviation 12.1 years). About sixty five percent (37/57) had previously sustained one or more osteoporotic fractures and about 38.6% (22/57) had suffered a prior vertebral fracture. About 44% (25/57) of individuals were taking one or more types of pain medications regularly prior to starting therapy. At follow-up, significant improvements were observed in the OQLQ domains of pain symptoms. This was seen when all patients on teriparatide were included, and also when only patients with prior vertebral fractures were included. There was also an improvement in emotional functioning, relating to fear of falling at 3 months follow-up (p = 0.019). Respondents also reported improvement in the domain of activities of daily living, relating to vacuuming at 6 months follow-up (p = 0.036), and an improvement in the leisure domain, relating to ease of traveling in the prior vertebral fracture population at 3 months follow-up (p = 0.012). However, there was no significant improvement observed in the domains of physical functioning. Participants also reported a decrease in need for pain medications, with 26% (15/57) requiring analgesics at the time of follow-up.
Conclusion
Teriparatide use may be associated with improvements in HRQL in osteoporosis patients, in particular alleviation of pain symptoms. These results were especially evident in patients with a history of vertebral fractures. These findings should be confirmed in larger prospective studies with a suitable control group.
doi:10.1186/1471-2474-9-151
PMCID: PMC2588585  PMID: 18990249
16.  Is There a Tension between Clinical Practice and Reimbursement Policy? The Case of Osteoarthritis Prescribing Practices in Ontario 
Healthcare Policy  2007;3(2):e128-e144.
Background:
Reimbursement policies, such as those used to manage the public drug program for senior citizens in Ontario, focus on providing access to cost-effective drug therapies. These policies may create a dilemma for physicians who want to prescribe a particular drug to a patient, but must factor reimbursement restrictions affecting patient-level access into the prescribing decision.
Methods:
Information was collected from 102 physicians about prescriptions given to osteoarthritis patients (n=2,147) aged 65 years or older. Patients' access to prescribed drugs was determined from their insurance coverage and the reimbursement criteria set out in the formulary of the public Ontario Drug Benefit Program (ODBP). Starting from the assumption that physicians would follow published consensus guidelines respecting gastroprotection when prescribing NSAIDs in these at-risk elderly patients, three groups of physicians were identified from the record of their actual prescriptions. Group A physicians (n=14) prescribed non-selective NSAIDs alone to >60% of their patients. Group B physicians (n=26) prescribed an NSAID + gastroprotective agent or a Cox-2 selective NSAID to >70% of their patients. Group C physicians (n=62) were those that fit into neither category. An open-ended question was included in the study questionnaire to elicit physicians' own interpretation of what impact drug coverage had on their prescribing behaviour.
Results:
No significant differences were found across groups with respect to years or type of practice, or to patient characteristics (LR=3.00, p>.2). Group C physicians were most likely to change their treatment choice in favour of restricted (limited use) drugs when patients met the criteria for reimbursement or had private insurance and therefore did not have to bear the additional cost out-of-pocket (LR=58.5; p<.0001).
Interpretation:
Most elderly at-risk patients are prescribed NSAIDs according to the prevailing guidelines. We found, however, that 40% of physicians have prescribing behaviour that favours non–evidence-based (Group A) or evidence-based (Group B) prescribing in this clinical setting irrespective of drug coverage. The remaining 60% of physicians appeared to be more responsive in their prescribing behaviour to financial constraints on patients' access to drugs. They also self-identified as most likely to change treatment if drug coverage had been different. These results have important implications for equity and quality of patient care. They also confirm that physicians' knowledge, values and self-efficacy are key determinants of prescribing behaviour and require further study to better understand how medical education and third-party policies and programs that govern pharmaceutical care are integrated into physicans' decision-making.
PMCID: PMC2645175  PMID: 19305773
17.  Optimizing care in osteoporosis: The Canadian quality circle project 
Background
While the Osteoporosis Canada 2002 Canadian guidelines provided evidence based strategies in preventing, diagnosing, and managing this condition, publication and distribution of guidelines have not, in and of themselves, been shown to alter physicians clinical approaches. We hypothesize that primary care physicians enrolled in the Quality Circle project would change their patient management of osteoporosis in terms of awareness of osteoporosis risk factors and bone mineral density testing in accordance with the guidelines.
Methods
The project consisted of five Quality Circle phases that included: 1) Training & Baseline Data Collection, 2) First Educational Intervention & First Follow-Up Data Collection 3) First Strategy Implementation Session, 4) Final Educational Intervention & Final Follow-up Data Collection, and 5) Final Strategy Implementation Session. A total of 340 circle members formed 34 quality circles and participated in the study. The generalized estimating equations approach was used to model physician awareness of risk factors for osteoporosis and appropriate utilization of bone mineral density testing pre and post educational intervention (first year of the study). Odds ratios (OR) and 95% confidence intervals (95% CI) were calculated.
Results
After the 1st year of the study, physicians' certainty of their patients' risk factor status increased. Certainty varied from an OR of 1.4 (95% CI: 1.1, 1.8) for prior vertebral fracture status to 6.3 (95% CI: 2.3, 17.9) for prior hip fracture status. Furthermore, bone mineral density testing increased in high risk as compared with low risk patients (OR: 1.4; 95% CI: 1.2, 1.7).
Conclusion
Quality Circle methodology was successful in increasing both physicians' awareness of osteoporosis risk factors and appropriate bone mineral density testing in accordance with the 2002 Canadian guidelines.
doi:10.1186/1471-2474-9-130
PMCID: PMC2567974  PMID: 18828906
18.  Effect on birth outcomes of a formalised approach to care in hospital labour assessment units: international, randomised controlled trial 
Objective To determine if a complex nursing and midwifery intervention in hospital labour assessment units would increase the likelihood of spontaneous vaginal birth and improve other maternal and neonatal outcomes.
Design Multicentre, randomised controlled trial with prognostic stratification by hospital.
Setting 20 North American and UK hospitals.
Participants 5002 nulliparous women experiencing contractions but not in active labour; 2501 were allocated to structured care and 2501 to usual care.
Interventions Usual nursing or midwifery care or a minimum of one hour of care by a nurse or midwife trained in structured care, consisting of a formalised approach to assessment of and interventions for maternal emotional state, pain, and fetal position.
Main outcome measures Primary outcome was spontaneous vaginal birth. Other outcomes included intrapartum interventions, women’s views of their care, and indicators of maternal and fetal health during hospital stay and 6-8 weeks after discharge.
Results Outcome data were obtained for 4996 women. The rate of spontaneous vaginal birth was 64.0% (n=1597) in the structured care group and 61.3% (n=1533) in the usual care group (odds ratio 1.12, 95% confidence interval 0.96 to 1.27). Fewer women allocated to structured care (n=403, 19.5%) rated staff helpfulness as less than very helpful than those allocated to usual care (n=544, 26.4%); odds ratio 0.67, 98.75% confidence interval 0.50 to 0.85. Fewer women allocated to structured care (n=233, 11.3%) were disappointed with the amount of attention received from staff than those allocated to usual care (n=407, 19.7%); odds ratio 0.51, 98.75% confidence interval 0.32 to 0.70. None of the other results met prespecified levels of statistical significance.
Conclusion A structured approach to care in hospital labour assessment units increased satisfaction with care and was suggestive of a modest increase in the likelihood of spontaneous vaginal birth. Further study to strengthen the intervention is warranted.
Trial registration Current Controlled Trials ISRCTN16315180.
doi:10.1136/bmj.a1021
PMCID: PMC2526182  PMID: 18755762
19.  Competing interests in development of clinical practice guidelines for diabetes management: Report from a multidisciplinary workshop 
Objective
To explore the complex issue of competing interests (CIs) in development of clinical practice guidelines (CPGs) in diabetes with stakeholders.
Methods
A multidisciplinary panel of 26 health, methodological, legal, and bioethical experts, trainees, and lay people from across Canada participated in a workshop on CIs in CPGs. Mixed methods were used such that qualitative themes were extracted from the discussions and quantitative survey data were collected.
Results
In the discussions, participants acknowledged that potential competing interests were not uncommon among sponsoring organizations and authors of CPGs. Avoidance of all potential CIs in development of CPGs was emulated as ideal, but considered probably unrealistic, given the paucity of peer-reviewed funding opportunities for development of evidence-informed CPGs and the scarcity of knowledgeable authors without CIs. An optimal approach for management of CIs in CPGs could not be agreed upon by participants. Full disclosure of any financial CIs for authors and sponsoring organizations as well as discouragement of external financial contributors from writing involvement, were endorsed by participants in the workshop and a subsequent survey.
Conclusions
Complete disclosure of financial CIs of sponsoring organizations and authors of CPGs is essential, yet the optimal approach to management of potential CIs is currently undefined.
PMCID: PMC3004553  PMID: 21197330
conflicts of interest; clinical practice guidelines; diabetes; knowledge translation; bioethics
20.  Canadian Quality Circle pilot project in osteoporosis 
Canadian Family Physician  2007;53(10):1694-1700.
PROBLEM ADDRESSED
Family physicians are not adequately following the 2002 Osteoporosis Canada guidelines for providing optimal care to patients with osteoporosis.
OBJECTIVE OF PROGRAM
The Canadian Quality Circle (CQC) pilot project was developed to assess the feasibility of the CQC project design and to gather informationfor implementing a national study of quality circles (QCs). The national study would assess whether use ofQCs could improve family physicians’ adherence to the osteoporosis guidelines.
PROGRAM DESCRIPTION
The pilot project enrolled 52 family physicians and involved 7 QCs. The project had 3 phases: training and baseline data collection, educational intervention and follow-up data collection, and sessions on implementing strategies for care.
CONCLUSION
Findings from the pilot study showed that the CQC project was well designed and well received. Use of QCs appeared to be feasible for transferring knowledge and giving physicians an opportunity to analyze work-related problems and develop solutions to them.
PMCID: PMC2231434  PMID: 17934033
21.  Not safer and not cheaper? 
doi:10.1503/cmaj.1060146
PMCID: PMC1626493
22.  The costs of planned cesarean versus planned vaginal birth in the Term Breech Trial 
Background
The Term Breech Trial compared the safety of planned cesarean and planned vaginal birth for breech presentations at term. The combined outcome of perinatal or neonatal death and serious neonatal morbidity was found to be significantly lower among babies delivered by planned cesarean section. In this study we conducted a cost analysis of the 2 approaches to breech presentations at delivery.
Methods
We used a third-party–payer (i.e., Ministry of Health) perspective. We included all costs for physician services and all hospital-related costs incurred by both the mother and the infant. We collected health care utilization and outcomes for all study participants during the trial. We used only the utilization data from countries with low national rates of perinatal death (≤ 20/1000). Seven hospitals across Canada (4 teaching and 3 community centres) were selected for unit cost calculations.
Results
The estimated mean cost of a planned cesarean was significantly lower than that of a planned vaginal birth ($7165 v. $8042 per mother and infant; mean difference –$877, 95% credible interval –$1286 to –$473). The estimated mean cost of a planned cesarean was lower than that of a planned vaginal birth for both women having a first birth ($7255 v. $8440) and women having had at least one prior birth ($7071 v. $7559). Although the treatment effect was largest in the subgroup of women having their first child, there was no statistically significant interaction between treatment and parity since the 95% credible intervals for difference in treatment effects between parity equalling zero and parity of one or greater all include zero.
Interpretation
Planned cesarean section was found to be less costly than planned vaginal birth for the singleton fetus in a breech presentation at term in the Term Breech Trial.
doi:10.1503/cmaj.050796
PMCID: PMC1421479  PMID: 16606959
23.  What matters most in end-of-life care: perceptions of seriously ill patients and their family members 
Background
Initiatives to improve end-of-life care are hampered by our nascent understanding of what quality care means to patients and their families. The primary purpose of this study was to describe what seriously ill patients in hospital and their family members consider to be the key elements of quality end-of-life care.
Methods
After deriving a list of 28 elements related to quality end-of-life care from existing literature, focus groups with experts and interviews with patients, we administered a face-to-face questionnaire to older patients with advanced cancer and chronic end-stage medical disease and their family members in 5 hospitals across Canada to assess their perspectives on the importance. We compared differences in ratings across various subgroups of patients and family members.
Results
Of 569 eligible patients and 176 family members, 440 patients (77%) and 160 relations (91%) agreed to participate. The elements rated as “extremely important” most frequently by the patients were “To have trust and confidence in the doctors looking after you” (55.8% of respondents), “Not to be kept alive on life support when there is little hope for a meaningful recovery” (55.7%), “That information about your disease be communicated to you by your doctor in an honest manner” (44.1%) and “To complete things and prepare for life's end — life review, resolving conflicts, saying goodbye” (43.9%). Significant differences in ratings of importance between patient groups and between patients and their family members were found for many elements of care.
Interpretation
Seriously ill patients and family members have defined the importance of various elements related to quality end-of-life care. The most important elements related to trust in the treating physician, avoidance of unwanted life support, effective communication, continuity of care and life completion. Variation in the perception of what matters the most indicates the need for customized or individualized approaches to providing end-of-life care.
doi:10.1503/cmaj.050626
PMCID: PMC1389825  PMID: 16505458
24.  Does Alendronate reduce the risk of fracture in men? A meta-analysis incorporating prior knowledge of anti-fracture efficacy in women 
Background
Alendronate has been found to reduce the risk of fractures in postmenopausal women as demonstrated in multiple randomized controlled trials enrolling thousands of women. Yet there is a paucity of such randomized controlled trials in osteoporotic men. Our objective was to systematically review the anti-fracture efficacy of alendronate in men with low bone mass or with a history of prevalent fracture(s) and incorporate prior knowledge of alendronate efficacy in women in the analysis.
Methods
We examined randomized controlled trials in men comparing the anti-fracture efficacy of alendronate to placebo or calcium or vitamin D, or any combination of these. Studies of men with secondary causes of osteoporosis other than hypogonadism were excluded. We searched the following electronic databases (without language restrictions) for potentially relevant citations: Medline, Medline in Process (1966-May 24/2004), and Embase (1996–2004). We also contacted the manufacturer of the drug in search of other relevant trials. Two reviewers independently identified two trials (including 375 men), which met all inclusion criteria. Data were abstracted by one reviewer and checked by another. Results of the male trials were pooled using Bayesian random effects models, incorporating prior information of anti-fracture efficacy from meta-analyses of women.
Results
The odds ratios of incident fractures in men (with 95% credibility intervals) with alendronate (10 mg daily) were: vertebral fractures, 0.44 (0.23, 0.83) and non-vertebral fractures, 0.60 (0.29, 1.44).
Conclusion
In conclusion, alendronate decreases the risk of vertebral fractures in men at risk. There is currently insufficient evidence of a statistically significant reduction of non-vertebral fractures, but the paucity of trials in men limit the statistical power to detect such an effect.
doi:10.1186/1471-2474-6-39
PMCID: PMC1182376  PMID: 16008835

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