Is our public research money well spent? Publication of research outputs from Health Research Council of New Zealand-funded studies: a cross-sectional study.

OBJECTIVE: To evaluate the reporting of results from the projects and programmes funded by the Health Research Council (HRC) New Zealand. DESIGN: A cross-sectional analysis. SETTING: Research projects and programmes funded by the HRC New Zealand from 2006 to 2014. PARTICIPANTS: Publicly available data provided by the HRC. MAIN OUTCOME MEASURES: The number and proportion with evidence of publication and dissemination of a research output from HRC grants and the time taken to disseminate the results. RESULTS: Of the 374 HRC grants from 2006 to 2014, there was no evidence of publication or reporting of any research output for 48 studies (13%). Of the 326 (87%) grants with research outputs, there was a mean dissemination time of 4.73 years (SD 2.37). The total funding provided by the HRC was NZ$471 663 336, while the 48 grants with no evidence of dissemination represented NZ$47 095 727 (10%). CONCLUSIONS: Thirteen per cent of the HRC projects and programmes from 2006 to 2014 have not contributed to the healthcare evidence as their results remain unknown.

Pharmaceutical industry payments and assisted reproduction in Australia: a retrospective observational study.

OBJECTIVES: To investigate the extent and nature of pharmaceutical industry payments related to fertility and assisted reproduction in Australia. DESIGN AND SETTING: This retrospective observational study employed four databases compiled from publicly available pharmaceutical industry transparency reports on educational event sponsorship (October 2011-April 2018), payments to healthcare professionals (October 2015-April 2018) and patient group support (January 2013-December 2017). Analyses were restricted to fertility-related payments by two major manufacturers of fertility medicines in Australia: Merck Serono and Merck, Sharp and Dohme (MSD). PRIMARY AND SECONDARY OUTCOME MEASURES: Descriptive statistics on fertility-related payments and other transfers of value (counts, total and median costs in Australian dollars) for educational events and to healthcare professionals and patient groups. RESULTS: Between October 2011 and April 2018, Merck Serono and MSD spent $A4 522 263 on 970 fertility-related events for healthcare professionals, including doctors, nurses and fertility scientists. 56.8% (551/970) events were held by fertility clinics and 29.3% (284/970) by professional medical associations. Between October 2015 and April 2018, Merck Serono spent $A403 800 across 177 payments to 118 fertility healthcare professionals, predominantly for educational event attendance. Recipients included obstetricians and gynaecologists (76.3% of payments, 135/177), nurses (11.3%, 20/177) and embryologists/fertility scientists (9.6%, 17/117). The highest paid healthcare professionals held leadership positions in major fertility clinics. Merck Serono provided $A662 850 to fertility-related patient groups for advocacy and education (January 2013-December 2017). CONCLUSIONS: The pharmaceutical industry sponsored a broad range of fertility clinicians and organisations, including doctors, nurses, embryologists, professional medical organisations, fertility clinics and patient groups. This sponsorship may contribute to the overuse of fertility services.

Introduction: Add-ons for assisted reproductive technology: can we be honest here?

Adjuncts, more often known as add-ons, are now part of the landscape of an in vitro fertilization cycle. Since the early days of in vitro fertilization, fertility services have rightly been seeking improved success rates. At present there are a multitude of choices for patients who are usually presented with a menu of add-ons to choose from. This is driven by the desire to give patients the best chances of becoming parents. This Views and Reviews series discusses all aspects of add-ons. It is not exhaustive as even as we are finishing the preparation of the series, there is a new study about the use of cytokines as an add-on. The overall conclusion from this series of articles is that despite considerable efforts to establish benefits with add-ons that there is a paucity of data when we consider the outcome of live birth.

Effectiveness of social egg freezing: protocol for systematic review and meta-analyses.

INTRODUCTION: Social egg freezing is storing egg for the purpose of preserving fertility and delayed childbearing. Currently, little is known about the utilisation and effectiveness of this approach. This review aims to determine (1) the proportion of women who used their stored eggs, and (2) the egg survival rate through vitrification, and the clinical pregnancy rate and live birth rate per 100 women partaking in the procedure, and among women who stored their eggs for medical reasons. METHODS AND ANALYSES: This systematic review will be done according to the items listed in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. PubMed, Embase, Scopus, The Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Cochrane Library and Health Technology Assessment databases will be searched to identify eligible studies published since 2012. Two reviewers will independently appraise the eligibility and quality of the studies based on preset checklists and extract the data using a data extraction template. Outcomes of interest are proportion of women who used their stored eggs, egg survival rate, pregnancy rate and live birth rates. We will determine the presence heterogeneity among studies using the Cochrane's Q test. The percentage of total variation across studies, which is due to statistical heterogeneity, will be calculated using the I2 statistics. Outcomes of interest will be pooled together using metaprop programme STATA V.14. ETHICS AND DISSEMINATION: For this review, ethical committee approval is not required. We will use publically available data from previously published studies. The final report of the review will be disseminated through publication on national or international journal, and it will be presented on different scientific conferences. PROSPERO REGISTRATION NUMBER: CRD42018114254.

Baseline anatomical assessment of the uterus and ovaries in infertile women: a systematic review of the evidence on which assessment methods are the safest and most effective in terms of improving fertility outcomes.

BACKGROUND: This review focuses on the initial presentation of women who suspect that they are infertile, and how best to assess the anatomy of their uterus and ovaries in order to investigate the cause of their infertility, and potentially improve desired fertility outcomes. This review was undertaken as part of a World Health Organization initiative to assess the evidence available to address guidance for the diagnosis and treatment of infertility within a global context. Providing access to care for infertile women will help to ease the psycho-social burdens, such as ostracization, intimate partner violence and other negative consequences of being involuntarily childless or unable to become pregnant despite desiring a biological child or children. OBJECTIVE AND RATIONALE: The aim of this paper was to present an evidence base for the diagnostic and prognostic value of various investigations used for detecting uterine and/or ovarian pathology in women presenting at fertility clinics for their initial assessment. SEARCH METHODS: We performed a comprehensive search of relevant studies on 28 August and 10 September 2014. A further search was performed on 6 June 2016 to ensure all possible studies were captured. These strategies were not limited by date or language. The search returned 3968 publications in total; 63 full text articles were retrieved and 10 additional studies were found through hand-searching. After excluding 54, a total of 19 studies were analysed. We extracted and tabulated data on the characteristics, quality and results of each eligible study and combined the findings in a narrative synthesis. Risk of bias was assessed according to article type using tools such as assessment of the methodological quality of systematic reviews, Newcastle Ottawa Scale, Cochrane risk of bias tool, quality assessment tool for diagnostic accuracy studies and quality in prognostic studies. Nineteen studies were selected as being the best evidence available. A narrative synthesis of the data was undertaken. Discussion of the data, and resultant consensus for best practice were accomplished in a consensus expert consultation in Geneva, October 2015. An independent expert review process concerning this work and outcomes was conducted during 2016. OUTCOMES: The draft recommendations presented here apply to infertile women whether or not they are undergoing fertility treatment. Transvaginal ultrasound (TVUS) should be offered to all infertile women with symptoms or signs of anatomic pelvic pathology. TVUS should not be offered routinely to women without symptoms of pelvic pathology. Hysteroscopy should be offered if intrauterine pathology is suspected by TVUS. Hysteroscopy should not be routinely offered to infertile women who have normal TVUS findings. In women who have normal TVUS findings and are undergoing IVF, hysteroscopy does not improve the outcome. Good practice points recommend that providers of fertility care should confirm that all infertile women have a recent pelvic examination, recent cervical screening and well-woman screening in line with local guidelines. Additionally, hystero-contrast salpingography in infertile women does not improve clinical pregnancy rates with expectant management in heterosexual couples and should not be offered as a therapeutic procedure. Most of the findings of this review on diagnosis are based on a low, or very low, quality of evidence, according to GRADE Working Group (grading of recommendations, assessment, development and evaluation) criteria. A low quality grading indicates that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate, while a very low grade indicates that any estimate of effect is very uncertain. WIDER IMPLICATIONS: This review provides the most reliable evidence available to guide clinicians worldwide in the initial, evidence-based investigation of women with fertility problems in order to undertake the most useful investigation and avoid the burden of unnecessary tests.

Cleavage-stage or blastocyst transfer: what are the benefits and harms?

ET is a critical step in an assisted reproduction cycle. Over the past decade there has been an increasing trend to extending culture from cleavage-stage to blastocyst transfer. There has also been a trend to single ET and reporting the success of an assisted reproductive cycle as a cumulative live-birth rate after using both fresh and frozen embryos. There is low evidence that fresh blastocyst transfer is associated with improved live-birth rates compared with fresh cleavage-stage embryos. However, in the few studies that report cumulative pregnancy rates after fresh and frozen transfers, no significant difference was found. Cleavage-stage transfer is associated with greater numbers of embryos available for freezing, and blastocyst transfer is associated with increased number of cycles with no embryos to transfer. Further well-designed studies are warranted to evaluate the outcomes for blastocyst transfer including cumulative live-birth rate after fresh and frozen transfers, time to live birth, costs of the different transfer strategies, and perinatal mortality and severe perinatal morbidity.

Gynaecologic cancer patients' needs and experiences of supportive health services in New Zealand.

BACKGROUND AND OBJECTIVES: Psychosocial care across the cancer continuum is a core component of quality gynaecologic cancer services. The purpose of this qualitative study was to identify needs for supportive care in a sample of New Zealand women and to understand to what extent they feel their needs are being met by health services. METHODS: Purposive sampling was used to recruit women (n=28) diagnosed with a gynaecologic cancer. Unstructured interviews were conducted and a thematic analysis was performed. RESULTS: Interviews revealed a range of shared and unique needs and support experiences. Three themes emerged reflecting participants' sense of control, need for validation of the cancer experience and organisation of their care. Findings suggest issues of continuity and coordination of care result in unmet support needs across the continuum of care, but primarily after treatment finishes. CONCLUSION: While broadly consistent with previous results, findings highlight the need for a patient-focused, comprehensive, integrated approach to supportive cancer care encompassing diagnosis, treatment and long-term recovery.

A pilot survey of the impact of menstrual cycles on adolescent health.

BACKGROUND: The experience of menstruation and reproductive health by adolescent girls has been poorly studied in New Zealand. AIMS: To develop and pilot a Web-based survey of 16-year-olds' experience of menstruation and reproductive health with the eventual objective of conducting a larger population-based survey. A secondary aim was to report on the experience of menstrual and reproductive health in a group of 16-year-old girls in an urban setting. METHODS: A Web-based survey was developed and tested in 2006 with assistance of a multidisciplinary advisory group. The final version of the questionnaire had 146 questions in 11 sections and the topics were menstrual history, general health including use of medications, access to medical care or health information, sexual health, family history and personal information including smoking, height, weight, ethnicity, paid employment of parents, drug and alcohol use and exercise patterns. RESULTS: Seventy-five 16-year-old students completed the survey. Twenty-five per cent considered that their periods were quite a bit or a lot of trouble and 10% avoided certain activities during their menstrual periods, nearly 50% of girls always experienced some pain with every period, and 30% had seen a health professional about their period pains. Thirty-three stated that menstruation was moderately to severely painful and that daily activity was affected. Fifty per cent of girls were sexually active and of these 80% described it as painful. CONCLUSIONS: The Web-based survey was a successful approach to collecting information and could be used in a larger study.

An economic evaluation of laparoscopic ovarian diathermy versus gonadotrophin therapy for women with clomiphene citrate-resistant polycystic ovarian syndrome.

PURPOSE OF REVIEW: Women with polycystic ovarian syndrome are typically anovulatory and require ovulation induction. Ovarian wedge resection was the first treatment for anovulation but was eventually abandoned because of the increased risk of postsurgical adhesions and as medical ovulation induction with clomiphene and gonadotrophins was introduced. However, with the advent of laparoscopy, there has been a return to surgical approaches. The potential advantages of laparoscopic surgery include avoidance of hyperstimulation and the lowered costs make ovarian surgery an attractive alternative to gonadotrophins. RECENT FINDINGS: Clinical trials in New Zealand and the Netherlands have compared costs of laparoscopic ovarian drilling with gonadotrophins. The total cost of treatment in the Netherlands study for the ovarian drilling group was euro 4664 and for the gonadotrophins group was euro 5418. Without the cost of monitoring and the diagnostic laparoscopy then the difference was euro 2110 in favour of ovarian drilling. It was estimated that the cost per term pregnancy would be euro 14,489 for gonadotrophin and euro 11,301 for ovarian drilling (22% lower). The higher rates of multiple pregnancy in the gonadotrophin group were considered to be responsible for the increased costs. In the New Zealand trial the costs of a live birth were one-third lower in the group that underwent laparoscopic ovarian diathermy compared with those women who received gonadotrophins (NZ$19,640 and 29,836, respectively). SUMMARY: Treating women with clomiphene-resistant polycystic ovarian syndrome with laparoscopic ovarian diathermy results in reduced direct and indirect costs. The reduction in multiple pregnancies makes the alternative of surgery particularly attractive.

The role of ovarian surgery in polycystic ovary syndrome.

Problems in inducing ovulation in women with polycystic ovary syndrome (PCOS) and anovulation are well recognized. In 1935, Stein and Leventhal first described surgical treatment by ovarian wedge resection at laparotomy for women with anovulation and PCOS. Ovarian wedge resection was eventually abandoned because of the significant risk of postsurgical adhesion formation, which resulted in tubal adhesions, and because of the advent of medical ovulation induction with clomiphene and gonadotrophins. However, since the arrival of minimally invasive surgical techniques, laparoscopic ovarian surgery has become feasible. The potential advantages of laparoscopic ovarian surgery include repeated single ovulations and less adhesion formation. Lowered costs make ovarian surgery an attractive alternative to gonadotrophins. However, although many case series have suggested that ovarian surgery is an effective strategy, few randomized, controlled trials have been undertaken comparing the success rates of surgery with gonadotrophins. The long-term concerns with surgery include adhesion formation and premature ovarian failure.

An economic evaluation of laparoscopic ovarian diathermy versus gonadotrophin therapy for women with clomiphene citrate resistant polycystic ovary syndrome.

BACKGROUND: Laparoscopic ovarian diathermy and gonadotrophin ovulation induction for women with clomiphene citrate resistant polycystic ovary syndrome have been shown to result in similar pregnancy rates, but their relative cost-effectiveness has not been evaluated. METHODS: A cost-minimization study was undertaken alongside a randomized controlled trial in women with anovulatory infertility secondary to clomiphene resistant polycystic ovary syndrome. Inclusion criteria were age less than 39 years, body mass index less than 35 kg/m(2), failure to ovulate with 150 mg of clomiphene citrate for 5 days in the early follicular phase, more than 12 months of infertility and no other causes of infertility. Laparoscopic ovarian diathermy was compared with three cycles of urinary or recombinant gonadotrophins. Direct and indirect costs were based on the results of a randomized trial. RESULTS: The cost of a live birth was one third lower in the group that underwent laparoscopic ovarian diathermy compared to those women who received gonadotrophins (19 640 New Zealand dollars and 29 836 New Zealand dollars, respectively). CONCLUSIONS: This economic evaluation shows that treating women with clomiphene-resistant polycystic ovarian syndrome with laparoscopic ovarian diathermy results in a significant reduction in both direct and indirect costs.

Cost effectiveness of pre-operative gonadotrophin releasing analogues for women with uterine fibroids undergoing hysterectomy or myomectomy.

OBJECTIVE: To conduct a cost effectiveness analysis of pre-operative gonadotrophin releasing hormone agonists (GnRHa) in women with uterine fibroids undergoing hysterectomy or myomectomy. DESIGN: A cost effectiveness analysis using the effectiveness data from a systematic review of GnRHa. SETTING: Secondary care. SAMPLE: Women with uterine fibroids undergoing hysterectomy or myomectomy and women volunteers. METHODS: Effectiveness data were used from a systematic review to construct a model and to calculate the cost per surgical outcome avoided. In order to evaluate the value women place on the outcome, a willingness to pay analysis of women volunteers was undertaken. MAIN OUTCOME MEASURES: (a) The cost of avoiding abdominal hysterectomy and the cost of avoiding a vertical incision at either hysterectomy or myomectomy; (b) The value that women place on avoiding abdominal hysterectomy and on avoiding a vertical incision at either hysterectomy or myomectomy. All costs are in NZ dollars. RESULTS: For hysterectomy, the additional cost of treatment with GnRHa was NZ$1190 per case. The cost of avoiding one abdominal procedure was NZ$4577 per case and the cost of avoiding one vertical incision was NZ$6263. For a myomectomy, the additional cost of treatment with GnRHa was NZ$1535 per case. The cost of avoiding one vertical incision was NZ$4651 per case. These costs exceeded the benefit women placed on the outcomes. CONCLUSION: Although the pre-operative use of GnRHa results in benefits which include less frequent abdominal incisions in the case of hysterectomy and less frequent vertical incisions in the case of myomectomy, the benefits do not justify the costs. This study highlights the importance of considering both the benefits and costs in health care decisions.

The impact of endometrial ablation on hysterectomy rates in women with benign uterine conditions in the United States.

OBJECTIVE: To assess the impact of endometrial ablation on the utilization of hysterectomy in U.S. women with benign uterine conditions. METHODS: Data are from the State Inpatient and Ambulatory Surgery Databases of the Healthcare Cost and Utilization Project for six states, 1990-97. Women who underwent hysterectomy (ICD-9-CM codes 68.3, 68.4, 68.5, 68.51, 68.59, 68.9) and endometrial ablation (68.23, 69.29) and had benign uterine conditions (ICD-9-CM code 218.0 and CCS groupings 47, 171, 173, 175, 176, 215) were extracted. Comparative rates, length of stay, total charges, age, payer, hospital, and teaching status of the hospital are reported. RESULTS: The rates of hysterectomy decreased in three states: Colorado (37% decrease; 33 per 10,000 women in 1990 to 21 per 10,000 in 1997), Maryland (18% decrease; 17/10,000 in 1990 to 14/10,000 in 1997), and New Jersey (11% decrease; 9/10,000 to 8/10,000); were static in two states (Connecticut and New York) and increased in one state, Wisconsin (11% increase; 19/10,000 in 1994 to 21/10,000 in 1997). The rates for endometrial ablation increased in all states. The ratio of hysterectomy rates to endometrial ablation rates fell in each state across the 7 years. In two states (New York and New Jersey) the rate of endometrial ablation was equivalent to the rate of hysterectomies by 1997. The total combined rate for hysterectomy and endometrial ablation for women with benign uterine conditions for each state increased by more than 10%, with the exception of Maryland, which had an increase of only 5%, and Colorado, which had a decline of 23%. CONCLUSIONS: In the six states studied, the diffusion of endometrial ablation has had a varying impact on hysterectomy rates among women with benign uterine conditions. However, endometrial ablation is used as an additive medical technology rather than a substitute.

Translating research into practice: the future ahead.

OBJECTIVE: To summarize and analyze the focus and methodologies of the Translating Research into Practice (TRIP) projects funded in 1999-2000 by the US Agency for Healthcare Research and Quality (AHRQ). DATA SOURCES AND STUDY DESIGN: An analysis of the successful applications for the TRIP I and II requests for applications in 1999 and 2000 was produced from the data collected. DATA COLLECTION: The following items were abstracted from each of the successful applications: provider focus, patient population, vulnerable populations, methodologies, interventions for change, outcomes measured, and conceptual framework used. PRINCIPAL FINDINGS: AHRQ funded 27 TRIP grants in 1999 and 2000. A wide variety of health care providers, settings, and patients were the target of the grants. The most common study design was a randomized controlled trial. The most common TRIP interventions were educational and the most common frameworks were either adult learning theory or organizational theory. More than half of the projects planned to use information technology and half the projects had a focus on reducing errors. CONCLUSIONS: The TRIP projects encompass a broad range of providers, environments, patients, and interventions. The field of applied research and quality improvements should be considerably enhanced by these research projects.

Hysterectomy rates in the United States 1990-1997.

OBJECTIVE: To assess hysterectomy rates, type of hysterectomy, and other factors associated within the United States from 1990-1997. METHODS: A descriptive statistical analysis of national discharge data was undertaken. Data from the nationwide Inpatient Sample of the Healthcare Cost and Utilization Project (from which national estimates are generated based on a 20% stratified sample of US community hospitals) were used for the years 1990-1997. All women who underwent hysterectomy were identified using International Classification of Diseases, 9th Revision, Clinical Modification, procedure codes. Outcome measures included rate, type of hysterectomy, age of patients, length of stay, total hospital charges, and diagnostic categories. RESULTS: Rates of hysterectomy have not changed significantly over the years from 1990-1997. Rates for hysterectomy in 1990 were 5.5 per 1000 women and increased slightly by 1997 to 5.6 per 1000 women. The type of hysterectomy has changed, with laparoscopic hysterectomy accounting for 9.9% of cases by 1997, with a concomitant decline in abdominal hysterectomy but no substantial change in vaginal hysterectomy rates. Length of stay decreased and total charges increased for all types of hysterectomy. Vaginal hysterectomy and laparoscopic hysterectomy are associated with shorter length of stay than abdominal hysterectomy. Abdominal hysterectomy is the most common procedure (63.0% in 1997). CONCLUSION: The majority of hysterectomies are abdominal, and the most common indication is uterine fibroids. The introduction of alternative techniques for controlling abnormal uterine bleeding such as endometrial ablation has not had an impact on hysterectomy rates, and there has only been a limited uptake of laparoscopic approaches.