Taking the Leap Toward Cost-Conscious Education in Obstetrics and Gynaecology: A Preliminary Randomized Controlled Trial.

OBJECTIVE: Residents have a professional obligation with respect to the stewardship of health care resources, yet there is a paucity of research on how to improve residents' cost-awareness. Rising health care expenditures highlight a critical need to improve education related to this competency. This study aimed to test if an educational module can teach residents to make cost-conscious decisions and reduce health care spending. METHODS: All Canadian obstetrics and gynaecology residents in 2017 were eligible to participate in this randomized controlled trial. The study was administered online via REDCap. Interested residents were enrolled, stratified by level of training, and block randomized. Residents completed a survey to determine their management of 4 obstetrical scenarios. The intervention group reviewed an educational module on cost-effective ordering prior to completing the survey; the control group was given the option to review the module afterward. The primary outcome was mean total expenditures, compared between the 2 groups using the t test. RESULTS: Eighty-five residents were enrolled between August and November 2017, and 63 residents from 13 Canadian residency programs completed the study requirements (33 control and 30 intervention). Mean total expenditure was CAD$291.03 (95% CI 259.38-322.68) versus CAD$192.98 (95% CI 170.67-215.29) for the control and intervention groups, respectively. These figures corresponded to a 33.69% or CAD$98.05 reduction in total expenditures (P = 0.0001). CONCLUSION: This educational module decreased expenditures by Canadian obstetrics and gynaecology residents managing hypothetical obstetrical cases. This introduces a potential curriculum innovation to improve resident education in judicious use of health care resources.

Can a simple 'cost-awareness' campaign for laparoscopic hysterectomy change the use and costs of disposable surgical supplies? Pre-post non-controlled study.

OBJECTIVES: Does a cost-awareness campaign for gynaecologists lead to a change in use and costs of disposable surgical supplies for laparoscopic hysterectomy (LH) without increasing hospital utilisation measures (operating room (OR) time or hospital length of stay (LOS))? DESIGN: Pre-post non-controlled study. The OR database was used to identify relevant cases before and after the cost-awareness intervention, and provided information on quantity of each supply item, operative details and LOS. SETTING: Lois Hole Hospital for Women, Edmonton, Alberta, Canada. PARTICIPANTS: 12 laparoscopic trained gynaecologists (7 female, 5 male) participated in both phases of the study. Eligible surgical cases were all LH cases for any indication for women aged ≥18 years. 201 cases were undertaken before the intervention (2011-2013) and 229 cases after the intervention (2016-2017). INTERVENTION: The cost-awareness intervention for gynaecologists included site meetings and rounds providing information on costs of disposable and reusable instruments, a full day skills lab, OR posters about cost and effectiveness of disposable and reusable surgical supplies and demonstrations of reusable equipment (2015-2016). PRIMARY OUTCOME MEASURE: Disposable supplies costs per case (standardised for 2016 unit costs). RESULTS: There was a significant (p<0.05) reduction (unadjusted) in disposable supplies cost per case for LH between cases before and after the intervention: from $C1073, SD 281, to $C943 SD 209. Regression analysis found that the adjusted cost per case after the intervention was $C116 lower than before the intervention (95% CI -160 to -71). Neither OR time nor hospital LOS differed significantly between cohorts. CONCLUSIONS: Our study suggests that cost-awareness campaigns may be associated with reduction in the cost of surgery for LH. However, many other factors may have contributed to this cost reduction, possibly including other local initiatives to reduce costs and emerging evidence indicating lack of effectiveness of some surgical practices.

Does Cost Influence the Choice of Disposable Versus Reusable Instruments? Mailed Survey of Obstetrician/Gynaecologists.

OBJECTIVE: A "cost-awareness" campaign was undertaken at a tertiary hospital from 2015 to 2016 to raise awareness about costs of disposable versus reusable instruments in laparoscopic procedures. We undertook a before and after survey of obstetrician/gynecologists (Ob/Gyns) to find out if the campaign had affected their attitudes about choosing disposable versus less expensive reusable instruments. METHODS: In 2015 (before the cost-awareness campaign) and 2017 (after the cost-awareness campaign), all full-time university-associated Ob/Gyns were mailed a cover letter, questionnaire, and coffee card ($5) with a postage-paid return envelope. Responses (with unique identification) from Ob/Gyns who perform laparoscopic procedures were entered into a password-protected REDCap database on a secure server. All statistical analyses were performed using SAS software version 9.4 (SAS Institute Inc, Cary, NC) (Canadian Task Force Classification II-3). RESULTS: A total of 35 of 42 eligible Ob/Gyns (85%) with a median 10 years in practice completed questionnaires before and after the intervention. The majority had undertaken minimally invasive surgery training, mainly during residency (80%) and conferences (71%). Before the intervention, the three most important qualities influencing their decision to use a particular instrument were safety (66%), effectiveness (57%), and personal experience (49%). After the intervention, the three most important qualities were effectiveness (57%), safety (57%), and ease of use (46%). Device cost was ranked sixth (26%) before and seventh (17%) after the intervention. The majority (57%) of participants did not change their choice of disposable or reusable instruments, or they would make the choice according to the specific procedure. CONCLUSION: Given the current economy, operative costs are constantly under review. Knowledge about Ob/Gyns' attitudes provides information to design more effective awareness campaigns to encourage use of less costly instruments. To change practice, a campaign increasing Ob/Gyns' exposure to less expensive but safe and effective instruments may help to increase uptake and potentially lead to cost reduction. Cost awareness alone is unlikely to change practice.

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

INTRODUCTION: Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants. METHODS: A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted. MEDLINE, EMBASE, CINAHL, Cochrane Library and Biotechnology & BioEngineering Abstracts were searched from 2005 to 2014, plus journal tables of contents and 32 HTA web sites. Patients were aged 18 and older who underwent primary TKA or UKA assessed in cohort or randomized controlled studies. Summary statistics were used to report study characteristics. RESULTS: A total of 265 eligible primary studies published between 1986 and 2014 involving 59,217 patients were identified in 10 HTAs (2 low, 7 moderate, 1 high risk of bias). Most evaluated TKA (198, 74.5%). The quality of evidence in primary studies was limited. Most studies were industry-funded (23.8%) or offered no declaration of funding or conflict of interest (44.9%); based on uncontrolled single cohorts (58.5%), enrolled fewer than 100 patients (66.4%), and followed patients for 2 years or less (UKA: single cohort 29.8%, comparative cohort 16.7%, randomized trial 25.0%; TKA: single cohort 25.0%, comparative cohort 31.4%, randomized trial 48.6%). Furthermore, most devices were evaluated in only one study (55.3% TKA implants, 61.1% UKA implants). CONCLUSIONS: Patients, physicians, hospitals and payers rely on poor-quality evidence to support decisions about knee implants. Further research is needed to explore how decisions about the use of devices are currently made, and how the evidence base for device safety and effectiveness can be strengthened.

Plasma 3-Epi-25-Hydroxycholecalciferol Can Alter the Assessment of Vitamin D Status Using the Current Reference Ranges for Pregnant Women and Their Newborns.

BACKGROUND: Vitamin D is critical for healthy pregnancies and normal fetal development. It is important to accurately ascertain vitamin D status in mothers and their newborns to establish the optimal vitamin D concentration during pregnancy. There are many different metabolites and epimers of vitamin D in peripheral blood and controversy as to the importance of epimers in estimating vitamin D status in maternal and infant health. OBJECTIVES: We undertook this study to measure 25-hydroxyvitamin D metabolites and epimers and their relations in maternal and cord blood and to evaluate the impact of the inclusion of epimers on assessing vitamin D status. METHODS: We performed a substudy in a longitudinal cohort of pregnant women and their infants in Alberta, Canada [APrON (Alberta Pregnancy Outcomes and Nutrition) Study]. Maternal and cord blood plasma collected at the time of newborn delivery was stored at -70°C until testing and assayed for 25-hydroxyergocalciferol [25(OH)D2], 25-hydroxycholecalciferol [25(OH)D3], and 3-epi-25-hydroxycholecalciferol [3-epi-25(OH)D3] by using LC-tandem mass spectrometry. The effect of 3-epi-25(OH)D3 on estimates of vitamin D adequacy was explored by using McNemar's chi-square test at both recommended thresholds of 50 and 75 nmol/L. RESULTS: Ninety-two pairs of maternal and cord blood samples were obtained. 3-Epi-25(OH)D3 was detected in all samples, comprising 6.0% and 7.8% of 25(OH)D3 in maternal and cord blood, respectively. Positive correlations were found between 25(OH)D3 and 3-epi-25(OH)D3 for both maternal and cord blood (maternal blood: r = 0.34, P = 0.01; cord blood: r = 0.44, P = 0.01). In addition, regression analysis showed a significant association between vitamin D supplementation and 3-epi-25(OH)D3 in maternal and cord blood (ß: 0.423; 95% CI: 0.173, 0.672). When 3-epi-25(OH)D3 was not included in plasma vitamin D estimations, 38% of women and 80% of neonates were classified as having an insufficient concentration (<75 nmol/L); however, with 3-epi-25(OH)D3 included, the estimates of insufficiency were significantly lower: 33% and 73% for women and neonates, respectively. CONCLUSIONS: Using LC-MS/MS we showed the presence of 3-epi-25(OH)D3 in all samples of pregnant women and their cord blood, and when the 3-epimer was included in the estimation of status the prevalence of vitamin D insufficiency (<75 nmol/L) was significantly lower. Our data suggest that the high use of dietary supplements in this group of women contributes to 3-epi-25(OH)D3 concentrations in both maternal and cord blood. Further research on the role of the epimers in characterizing vitamin D status in pregnancy and infancy is imperative.

Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research.

BACKGROUND: Non-drug technologies offer many benefits, but have been associated with adverse events, prompting calls for improved postmarket surveillance. There is little empirical research to guide the development of such a system. The purpose of this study was to identify optimal postmarket surveillance strategies for medical and surgical devices. METHODS: Qualitative methods were used for sampling, data collection and analysis. Stakeholders from Canada and the USA representing different roles and perspectives were first interviewed to identify examples and characteristics of different surveillance strategies. These stakeholders and others they recommended were then assembled at a 1-day nominal group meeting to discuss and prioritise the components of a postmarket device surveillance system, and research needed to achieve such a system. RESULTS: Consultations were held with 37 participants, and 47 participants attended the 1-day meeting. They recommended a multicomponent system including reporting by facilities, clinicians and patients, supported with some external surveillance for validation and real-time trials for high-risk devices. Many considerations were identified that constitute desirable characteristics of, and means by which to implement such a system. An overarching network was envisioned to broker linkages, establish a shared minimum dataset, and support communication and decision making. Numerous research questions were identified, which could be pursued in tandem with phased implementation of the system. DISCUSSION: These findings provide unique guidance for establishing a device safety network that is based on existing initiatives, and could be expanded and evaluated in a prospective, phased fashion as it was developed.

Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial.

BACKGROUND: We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial. METHODS/DESIGN: All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature. DISCUSSION: This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is less effective, will have a significant impact on individual quality of life, and societal and health care costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT00234754. Registered October 2005.

Assessing image quality of low-cost laparoscopic box trainers: options for residents training at home.

INTRODUCTION: Low-cost laparoscopic box trainers built using home computers and webcams may provide residents with a useful tool for practice at home. This study set out to evaluate the image quality of low-cost laparoscopic box trainers compared with a commercially available model. METHODS: Five low-cost laparoscopic box trainers including the components listed were compared in random order to one commercially available box trainer: A (high-definition USB 2.0 webcam, PC laptop), B (Firewire webcam, Mac laptop), C (high-definition USB 2.0 webcam, Mac laptop), D (standard USB webcam, PC desktop), E (Firewire webcam, PC desktop), and F (the TRLCD03 3-DMEd Standard Minimally Invasive Training System). Participants observed still image quality and performed a peg transfer task using each box trainer. Participants rated still image quality, image quality with motion, and whether the box trainer had sufficient image quality to be useful for training. RESULTS: Sixteen residents in obstetrics and gynecology took part in the study. The box trainers showing no statistically significant difference from the commercially available model were A, B, C, D, and E for still image quality; A for image quality with motion; and A and B for usefulness of the simulator based on image quality. The cost of the box trainers A-E is approximately $100 to $160 each, not including a computer or laparoscopic instruments. CONCLUSIONS: Laparoscopic box trainers built from a high-definition USB 2.0 webcam with a PC (box trainer A) or from a Firewire webcam with a Mac (box trainer B) provide image quality comparable with a commercial standard.

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery.

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.

An illustration of the "inverse care law": A commentary on giving birth in Canada: providers of maternity and infant care.

The recent Canadian Institute for Health Information (CIHI) report Giving Birth in Canada: Providers of Maternity and Infant Care highlights the limited availability of obstetrical resources. The efficient allocation of these resources is likely to disadvantage the rural and remote areas of Canada, where individual need may be greatest. This situation is a contemporary illustration of the "inverse care law" described by Julian Tudor Hart in 1971.

Modelling consultation rates in infancy: influence of maternal and infant characteristics, feeding type and consultation history.

BACKGROUND: Severity of illness, sociodemographic factors, and breastfeeding have been identified as predictors of consultation rates in infants, and prescriptions for antibiotics have been found to increase future consultation rates in older children. The Baby Check trial (1996-1998) provided detailed information about consultations for 935 babies during their first 6 months. AIMS: To investigate potential predictors of consultation rates in babies. DESIGN OF STUDY: A 6-month cohort study of newborn babies originally enrolled into a randomised controlled trial. Maternal and infant characteristics were collected from hospital discharge records. Primary care consultation data for each baby were collected by case note review. SETTING: Thirteen general practices in Glasgow. METHOD: Multilevel models were used to analyse the number of consultations for each baby during its first 26 weeks, dependent upon the baby's age, the calendar month, maternal and infant characteristics, and previous consultations. RESULTS: The strongest predictors of consultation rates were previous consultations, particularly during the preceding week. Breastfed babies and those with older mothers consulted less often. A multilevel model was better than a fixed effects model, with considerable variation in consultation rates between babies. CONCLUSION: Infants' consultation rates over time can be analysed using multilevel models, if details of primary care consultations are available. These models can incorporate the effects of fixed variables and those that change during the follow-up period. Our findings add to previous research linking breastfeeding with reduced morbidity in infancy, and for that reason breastfeeding should continue to be promoted in primary care.