Objective: In 1981 McKinlay described "Seven Stages in the Career of a Medical Innovation". We wi... more Objective: In 1981 McKinlay described "Seven Stages in the Career of a Medical Innovation". We wished to examine whether the model fits a modern device life cycle, and to comment on device manufacturers' influence on the life cycle. We chose to study the complete life cycle of TVT Secur, a mesh kit for surgical treatment of stress urinary incontinence in women, from its marketing in 2006 to device discontinuation for commercial reasons in March 2013. Methods: A PubMed review was undertaken to identify all published literature related to TVT Secur from 2006 to November 2014. Each publication was classified according to McKinlay's seven stages.
Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstétrique et gynécologie du Canada : JOGC, 2014
Anecdotal reports in the Calgary area indicate a lack of integration of midwives into the mainstr... more Anecdotal reports in the Calgary area indicate a lack of integration of midwives into the mainstream obstetrical community and strained relationships between obstetrical care providers. Finding ways to cultivate positive working relationships is essential for ensuring excellent patient care standards. In this study we sought to identify barriers to an effective working relationship between physicians (both obstetricians and family physicians) and midwives, and to find ways to improve the quality of professional interactions and promote team-based pregnancy care. We conducted a mail survey within the former Calgary Health Region that included questions about professional interaction, philosophy regarding childbirth, and relationships between obstetrical practitioners. Participants included family physicians (FPs), midwives (MWs), and obstetricians (OBs) who were identified from publicly available lists. The overall response rate was 80% (144/180). Eligible responses were received fro...
This study was a 1-year follow-up of a cohort of 52 women who underwent trans-obturator tape (TOT... more This study was a 1-year follow-up of a cohort of 52 women who underwent trans-obturator tape (TOT) procedures using Obtape. Follow-up information was available for 45/52 (87%) women. The rate of erosions was 8/52 (15%). Among 34 women examined, 26% experienced tenderness on palpation of operative site, and 72% were objectively cured on pad test. Forty women completed questionnaires (median Incontinence Impact Questionnaire-7, 0; median Urogenital Distress Inventory-6, 17) and of those, 93% would recommend TOT to a friend. We found a high rate of erosions among our cohort. Our high rate of erosions may be a result of our review of the majority of the cohort, and it is likely related to the specific device used (Obtape). The majority of women were satisfied with the outcome. Before introducing new procedures into widespread clinical practice, it is important to rigorously investigate their outcomes.
This systematic review examined the use of incontinence-specific QOL measures in clinical trials ... more This systematic review examined the use of incontinence-specific QOL measures in clinical trials of female incontinence treatments, and systematically evaluated their quality using a standard checklist.
This study aimed to evaluate the exposure of obstetrics and gynecology residents to urogynecologi... more This study aimed to evaluate the exposure of obstetrics and gynecology residents to urogynecologic training and to compare this to the program directors' expectations. A cross-sectional questionnaire study was performed surveying the 60 final-year residents and their program directors at all 16 Canadian residency programs. Questions covered areas of knowledge and skills in basic and advanced urogynecology. Thirty-two (53%) residents and nine (56%) program directors responded. Twenty-six (81%) residents had a formal urogynecology rotation with training in incontinence, prolapse, pessaryfitting, and urodynamics. Residents performed a median of: 50 vaginal hysterectomies, 30 anterior repairs, 30 posterior repairs, 35 retropubic urethropexies, and 15 cystoscopies. All other procedures had a median of 6 or less. Responses of residents and program directors correlated well. Although residents in Canada have adequate exposure to simple urogynecologic procedures, they perform few complex cases. Such procedures should be performed by physicians with additional urogynecology fellowship training.
Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstétrique et gynécologie du Canada : JOGC, 2008
Surgical devices are often marketed before there is good evidence of their safety and effectivene... more Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surge...
To compare the effectiveness of transobturator tape with tension-free vaginal tape (TVT) in terms... more To compare the effectiveness of transobturator tape with tension-free vaginal tape (TVT) in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively.
To estimate the incidence of stress urinary incontinence (SUI) following vaginal repair of pelvic... more To estimate the incidence of stress urinary incontinence (SUI) following vaginal repair of pelvic organ prolapse (POP) in preoperatively continent women and to evaluate the impact of the problem. Women were eligible if they had undergone vaginal repairs for any degree or type of POP with no anti-incontinence procedure between July 1, 2004 and June 30, 2006, and had been continent preoperatively, as defined by a negative cough stress test with or without reduction of prolapse. Demographic, preoperative, operative, and postoperative data were retrieved from hospital charts. The incidence of postoperative SUI (POSUI) and its quality of life (QoL) impact were assessed by mailed questionnaire. The POSUI endpoint was defined by the report of SUI symptoms on the mailed questionnaire and/or affirmation of postoperative treatment for SUI. Forty-two out of 100 respondents reported POSUI within the 2-year average follow-up period. Twelve of 37 symptomatic women (32%) were moderately or greatly bothered by their symptoms. The QoL impact score was generally low but was statistically greater in women with POSUI compared to those with no POSUI (13 vs. 3, P=0.0006). The risk of POSUI following vaginal repairs of POP may be higher than previously reported and approximately one-third of women are bothered by these symptoms. These findings deserve further investigation.
Background: Concern has been growing in the academic literature and popular media about the licen... more 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.
American Journal of Obstetrics and Gynecology, 2014
The primary objectives of this study were to explore the pain experience after gynecologic laparo... more The primary objectives of this study were to explore the pain experience after gynecologic laparoscopy that is performed for nonacute pain conditions and to determine whether preoperative psychologic tests and quantitative tests of sensitization can predict postoperative pain. Participants included 61 women who underwent laparoscopy for nonacute pain (n = 61). A second group of 16 women who had undergone tubal ligation was included to explore whether laparoscopy induced a painful postoperative response in women without preoperative pain. Subjective tests included numeric pain scale, pain catastrophizing scale, depression scale, global assessment of change, and the McGill Pain Questionnaire Short Form. Quantitative sensory testing included abdominal cutaneous allodynia, trigger points, and reduced pain thresholds. The nonacute pain sample had 80% power to detect a difference of 0.5 standard deviation in average pain levels. Analysis included parametric and nonparametric comparisons of groups and univariate and linear regression analysis of clinically relevant variables. In women who underwent tubal ligation, pain levels were low before and after the procedure. In women who underwent surgery for nonacute pain, pain levels at 6 months and all psychologic test scores were reduced significantly compared with baseline (P < .001 and P = .001, respectively). Among those women with positive results on the quantitative pain tests of sensitization at baseline, average postoperative pain was also significantly reduced (P < .001). Univariate analysis demonstrated only tests of sensitization that were correlated with change in average pain level (P = .01). Regression analysis suggested that baseline pain, catastrophizing, and the presence of cutaneous allodynia significantly predicted pain levels 6 months after surgery (P < .001). Pain after laparoscopic surgery for nonacute painful conditions can be predicted by baseline pain, catastrophizing, and the presence of allodynia, which is a simple swab test that indicates sensitization.
Using data from interviews with Health Technology Assessment (HTA) professionals in Canada, this ... more Using data from interviews with Health Technology Assessment (HTA) professionals in Canada, this paper shows their views of the appropriate role of, and evidence required for, HTA are associated with values and norms. Recognizing HTA as a moral economy helps to explain when and why HTA professionals’ views of what HTA should and can do are mutable, and may specifically help to explain why there is resistance among some HTA professionals to the inclusion of ethical issues and patients or the public in technology assessment. The moral economy framework furthermore sheds light on the nature of objectivity in contemporary HTA.
Objective: In 1981 McKinlay described "Seven Stages in the Career of a Medical Innovation". We wi... more Objective: In 1981 McKinlay described "Seven Stages in the Career of a Medical Innovation". We wished to examine whether the model fits a modern device life cycle, and to comment on device manufacturers' influence on the life cycle. We chose to study the complete life cycle of TVT Secur, a mesh kit for surgical treatment of stress urinary incontinence in women, from its marketing in 2006 to device discontinuation for commercial reasons in March 2013. Methods: A PubMed review was undertaken to identify all published literature related to TVT Secur from 2006 to November 2014. Each publication was classified according to McKinlay's seven stages.
Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstétrique et gynécologie du Canada : JOGC, 2014
Anecdotal reports in the Calgary area indicate a lack of integration of midwives into the mainstr... more Anecdotal reports in the Calgary area indicate a lack of integration of midwives into the mainstream obstetrical community and strained relationships between obstetrical care providers. Finding ways to cultivate positive working relationships is essential for ensuring excellent patient care standards. In this study we sought to identify barriers to an effective working relationship between physicians (both obstetricians and family physicians) and midwives, and to find ways to improve the quality of professional interactions and promote team-based pregnancy care. We conducted a mail survey within the former Calgary Health Region that included questions about professional interaction, philosophy regarding childbirth, and relationships between obstetrical practitioners. Participants included family physicians (FPs), midwives (MWs), and obstetricians (OBs) who were identified from publicly available lists. The overall response rate was 80% (144/180). Eligible responses were received fro...
This study was a 1-year follow-up of a cohort of 52 women who underwent trans-obturator tape (TOT... more This study was a 1-year follow-up of a cohort of 52 women who underwent trans-obturator tape (TOT) procedures using Obtape. Follow-up information was available for 45/52 (87%) women. The rate of erosions was 8/52 (15%). Among 34 women examined, 26% experienced tenderness on palpation of operative site, and 72% were objectively cured on pad test. Forty women completed questionnaires (median Incontinence Impact Questionnaire-7, 0; median Urogenital Distress Inventory-6, 17) and of those, 93% would recommend TOT to a friend. We found a high rate of erosions among our cohort. Our high rate of erosions may be a result of our review of the majority of the cohort, and it is likely related to the specific device used (Obtape). The majority of women were satisfied with the outcome. Before introducing new procedures into widespread clinical practice, it is important to rigorously investigate their outcomes.
This systematic review examined the use of incontinence-specific QOL measures in clinical trials ... more This systematic review examined the use of incontinence-specific QOL measures in clinical trials of female incontinence treatments, and systematically evaluated their quality using a standard checklist.
This study aimed to evaluate the exposure of obstetrics and gynecology residents to urogynecologi... more This study aimed to evaluate the exposure of obstetrics and gynecology residents to urogynecologic training and to compare this to the program directors' expectations. A cross-sectional questionnaire study was performed surveying the 60 final-year residents and their program directors at all 16 Canadian residency programs. Questions covered areas of knowledge and skills in basic and advanced urogynecology. Thirty-two (53%) residents and nine (56%) program directors responded. Twenty-six (81%) residents had a formal urogynecology rotation with training in incontinence, prolapse, pessaryfitting, and urodynamics. Residents performed a median of: 50 vaginal hysterectomies, 30 anterior repairs, 30 posterior repairs, 35 retropubic urethropexies, and 15 cystoscopies. All other procedures had a median of 6 or less. Responses of residents and program directors correlated well. Although residents in Canada have adequate exposure to simple urogynecologic procedures, they perform few complex cases. Such procedures should be performed by physicians with additional urogynecology fellowship training.
Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstétrique et gynécologie du Canada : JOGC, 2008
Surgical devices are often marketed before there is good evidence of their safety and effectivene... more Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surge...
To compare the effectiveness of transobturator tape with tension-free vaginal tape (TVT) in terms... more To compare the effectiveness of transobturator tape with tension-free vaginal tape (TVT) in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively.
To estimate the incidence of stress urinary incontinence (SUI) following vaginal repair of pelvic... more To estimate the incidence of stress urinary incontinence (SUI) following vaginal repair of pelvic organ prolapse (POP) in preoperatively continent women and to evaluate the impact of the problem. Women were eligible if they had undergone vaginal repairs for any degree or type of POP with no anti-incontinence procedure between July 1, 2004 and June 30, 2006, and had been continent preoperatively, as defined by a negative cough stress test with or without reduction of prolapse. Demographic, preoperative, operative, and postoperative data were retrieved from hospital charts. The incidence of postoperative SUI (POSUI) and its quality of life (QoL) impact were assessed by mailed questionnaire. The POSUI endpoint was defined by the report of SUI symptoms on the mailed questionnaire and/or affirmation of postoperative treatment for SUI. Forty-two out of 100 respondents reported POSUI within the 2-year average follow-up period. Twelve of 37 symptomatic women (32%) were moderately or greatly bothered by their symptoms. The QoL impact score was generally low but was statistically greater in women with POSUI compared to those with no POSUI (13 vs. 3, P=0.0006). The risk of POSUI following vaginal repairs of POP may be higher than previously reported and approximately one-third of women are bothered by these symptoms. These findings deserve further investigation.
Background: Concern has been growing in the academic literature and popular media about the licen... more 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.
American Journal of Obstetrics and Gynecology, 2014
The primary objectives of this study were to explore the pain experience after gynecologic laparo... more The primary objectives of this study were to explore the pain experience after gynecologic laparoscopy that is performed for nonacute pain conditions and to determine whether preoperative psychologic tests and quantitative tests of sensitization can predict postoperative pain. Participants included 61 women who underwent laparoscopy for nonacute pain (n = 61). A second group of 16 women who had undergone tubal ligation was included to explore whether laparoscopy induced a painful postoperative response in women without preoperative pain. Subjective tests included numeric pain scale, pain catastrophizing scale, depression scale, global assessment of change, and the McGill Pain Questionnaire Short Form. Quantitative sensory testing included abdominal cutaneous allodynia, trigger points, and reduced pain thresholds. The nonacute pain sample had 80% power to detect a difference of 0.5 standard deviation in average pain levels. Analysis included parametric and nonparametric comparisons of groups and univariate and linear regression analysis of clinically relevant variables. In women who underwent tubal ligation, pain levels were low before and after the procedure. In women who underwent surgery for nonacute pain, pain levels at 6 months and all psychologic test scores were reduced significantly compared with baseline (P < .001 and P = .001, respectively). Among those women with positive results on the quantitative pain tests of sensitization at baseline, average postoperative pain was also significantly reduced (P < .001). Univariate analysis demonstrated only tests of sensitization that were correlated with change in average pain level (P = .01). Regression analysis suggested that baseline pain, catastrophizing, and the presence of cutaneous allodynia significantly predicted pain levels 6 months after surgery (P < .001). Pain after laparoscopic surgery for nonacute painful conditions can be predicted by baseline pain, catastrophizing, and the presence of allodynia, which is a simple swab test that indicates sensitization.
Using data from interviews with Health Technology Assessment (HTA) professionals in Canada, this ... more Using data from interviews with Health Technology Assessment (HTA) professionals in Canada, this paper shows their views of the appropriate role of, and evidence required for, HTA are associated with values and norms. Recognizing HTA as a moral economy helps to explain when and why HTA professionals’ views of what HTA should and can do are mutable, and may specifically help to explain why there is resistance among some HTA professionals to the inclusion of ethical issues and patients or the public in technology assessment. The moral economy framework furthermore sheds light on the nature of objectivity in contemporary HTA.
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Papers by Sue Ross