Insights from outside BJOG

Authors

  • Athol Kent,

  • Shona Kirtley


  • The Research Snippets are extracts from a monthly service called the Journal Article Summary Service. It is a service that summarises new articles in obstetrics and gynaecology published over the preceding month. If you would like to have information on how to subscribe, please email the editor Athol Kent at atholkent@mweb.co.za or visit the website www.getjass.com.
  • The remaining sections of Insights from outside BJOG are written by Shona Kirtley, Research Information Specialist, Centre for Statistics in Medicine, Botnar Research Centre, Oxford, UK.
  • This Insights from outside BJOG was edited by Aris Papageorghiou, Consultant in Fetal Medicine and Obstetrics, St George's Hospital, London, UK and BJOG Executive Scientific Editor.

Supplementation and ethics

Should healthy people take supplements? Or put another way—should people who have a balanced diet supplement their intake with vitamins and minerals?

The answer is: no. There is considerable evidence that these extra vitamins and minerals do not improve health, or prevent cardiovascular disease or protect against cancer or relieve chronic diseases or affect mortality.

There is overwhelming proof of no value—so much so that it would be futile to reinvestigate the topic further. Studies cost money, so it would be unethical to spend finite resources proving something that already has sufficient evidence for definitive conclusions to be drawn.

Vitamin D has been the topic of much debate recently, especially its place in the prevention or treatment of osteoporosis. Using systematic review and meta-analysis approaches, researchers from New Zealand have examined all the published data and conclude that its use in people without risk factors ‘seems to be inappropriate’ (Reid et al. Lancet 2014;383:146–55).

  • Two years ago the US Physicians Health Study monitored over 14 000 American doctors who took multivitamins or placebo for a decade and showed no difference in their cardiovascular disease risk, death rates or any other measure (Sesso et al. JAMA 2012;308:1751–60 and Lonn JAMA 2012;308:1802–3).
  • A study—this time consisting of 6000 healthy doctors with a mean age of 65 years—again taking multivitamins or placebo for more than a decade showed that active tablets made no difference to their cognitive abilities (Grodstein et al. Ann Intern Med 2013;159:806–14).
  • A group of 1700 people who had a myocardial infarction were given multivitamins or placebo for 5 years and again no advantage accrued one way or the other (Lamas et al. Ann Intern Med 2013;159:797–804).
  • Finally, a systematic review looking at trials of over 400 000 participants comparing supplements with placebo found no effect on all-cause mortality, cardiovascular disease risk or cancer (Fortmann et al. Ann Intern Med 2013;159:824–34).

Some supplements like β-carotene, vitamin E and possibly high doses of vitamin A increase mortality and their inclusion in multivitamin preparations should be viewed with more than circumspection (Guallar et al. Ann Intern Med 2013;159:850–1). Given that at best they are useless and at worst they are harmful, should the profession not be advising against their use?

In the USA more than half the adult population take some form of dietary supplement. The waste of money on this misguided effort is enormous—US$28 billion per year by the latest count. Imagine the benefit of that amount spent on exercise programmes.

Distracted driving

It may appear self-evident but car crashes are more likely to happen when the driver is distracted. A group of researchers in the USA fitted cameras and sensors to 150 cars and paid (compensated) the drivers to allow the technology to monitor their driving performance for a year and a half (Klauer et al. N Engl J Med 2014;370:54–9).

Unsurprisingly they found that drivers who had their licences for less than 2 years were more at risk than experienced drivers when distracted. Their data showed that the following functions increased the likelihood of novice drivers having accidents compared with the risk when not distracted (expressed as Odd Ratios)—using a cell phone (8.3 times), reaching for objects in the car (eight times), locating a cell phone (seven times), texting (four times), looking at roadside objects (four times) or eating (three times). These newly qualified drivers indulged in risky behaviour increasingly over the duration of observation.

Experienced drivers had at least twice the normal risk of an accident when using a cell phone but they did not carry out more of high-risk distractions over time. This is hardly counter-intuitive information but the facts were published in the world's most prestigious medical journal so hopefully the legislators will take note (Figure 1).

Figure 1.

Crash or near crash/distractions among novice (less than 2 years’ experience) drivers. Source: Klauer et al. N Eng J Med 2014;370:54–9.

Robotic fiddle

If you have qualms about the financial aspects of robotic surgery, be prepared to have your misgivings reinforced. A personal view article in the BMJ (Trehan and Dunn 2013;347:f7470) sets out how the monopoly has been cornered by the makers of the da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) who have carefully manipulated things to their advantage by buying out competitors, ensuring the limit of the re-usability of their instruments and through annual maintenance fees.

In a free market economy this is seen as competitive and they are merely maximising their expertise and strategic market position but there must be careful thought given by any prospective purchasers to the real advantages of robotic surgery over manual laparoscopic operations and the moral use of finite resources. Medicine and exorbitant profits make for very uncomfortable bed-fellows.

American legislation against women

Contraception and termination of pregnancy are legislative footballs in the USA. The law and the medical profession are frequently at loggerheads over many aspects of women's rights and in a litigious society this is fuel for ongoing law suits.

The Affordable Care Act in the USA mandates that women should have access to the Food and Drug Administration's approved panel of contraception methods. Some companies that do not believe in contraception for religious reasons are contesting their obligations to provide such family planning on the grounds that this is not a compelling public health need or that the company's right to religious freedom is being infringed (The Editors N Engl J Med 2014;370:77–8). Two cases are due to be heard in the courts in the next few months.

Catholic faith-based hospitals are also challenging their accountability, saying that contraception is not true primary prevention, and that it would be against their ethical tenets to provide these services whereas others believe that withholding legislated provision of designated aspects of health care is a ‘sectarian incursion into private health care decisions’ (Zimmer et al. JAMA 2013;309:1999–2000 and Gossett et al. JAMA 2013;309:1997–8).

Termination of pregnancy is a field in which US legislators have much to say. For two decades right-wing politicians have been pushing for laws to make the procurement of termination of pregnancy more complex and have involved themselves in attempts to close clinics and harass women and their doctors to the point where women seeking a termination of pregnancy are increasingly abandoned by their physicians.

Charo (N Engl J Med 2014;370:193–5) gives many examples where biased consent procedures are required to be completed by physicians, inaccurate information has to be conveyed and courts enact measures where laws interfere in the ethical relationship between the doctor and his or her patient. Intrusions on medical practice should be resisted by the profession and the American Congress of Obstetricians and Gynecologists has reached the point where it has felt the need to release statements against unwarranted legal intrusions.

The policy on sterilisation used by Medicaid is archaic and can inhibit access to this form of contraception in just those women who need it most, namely the poor and the disadvantaged (Borrero et al. N Engl J Med 2014;370:102–4). It is one of life's ironies that those most in need often have the most barriers to accessing the services they desire.

Smoking and the profession

Smoking is a form of slow suicide. Gro Harlem Brundtland famously said, ‘A cigarette is the only consumer product that when used as directed kills its consumer’. Half of all smokers will die a premature death from smoking and all will have their health and finances made poorer by their addiction to cigarettes.

In 1950 Doll and Hill (BMJ 1950;2:739–48) published their seminal paper showing the link between smoking and lung cancer while in 1964 the Surgeon General's Report in the USA changed the smoking landscape forever. Smoking was virtually unheard of a century ago but the habit caught on and became popular within communities, stoked by evocative advertising until these landmark publications showed the dangers. These revelations astonished educated society in which 45% of people surveyed smoked. It is difficult to believe but in the 1950s, 60% of UK male doctors admitted to smoking (Doll and Hill BMJ 1954;1:1451–5). This is the same percentage as Chinese doctors today (Lancet 2014;383:100).

Smoking and risks to women

Not only do women ‘who smoke like men, die like men’, they are more susceptible than men to lung cancer and some cardiovascular pathologies. They also suffer more from premature aging and gender-specific cancers like breast, endometrial and cervical if they smoke. This is in addition to increased risks of lung, digestive tract, cardiovascular system, stroke, cerebral, musculo-skeletal and skin pathologies compared with nonsmokers.

About 30% of the gains in longevity that have been made in the last half century have been made through reduced smoking rates. Women who smoke forfeit on average 10 years of their life expectancy (Holford et al. JAMA 2014;311:164–71).

Women are being specifically targeted in e-cigarette advertisements in an attempt to make the habit appear fashionable, glamorous or portray e-cigarettes as a flashy accessory.

Pregnant women who smoke place their fetus at risk of miscarriage, low birthweight, preterm delivery and placental abruption. The latest data from the USA (Varner et al. Obstet Gynecol 2014;123:113–25) indicate that smoking is associated with stillbirth in a dose-dependent fashion. Mothers whose babies had evidence of marijuana or cigarette use in their cord blood had raised odds ratios for stillbirth—odds ratio 2.34 (95% confidence interval 1.13–4.81).

As professionals we can do a woman more good by persuading her to give up smoking than through all the screening tests we can offer her. As such, should it not be our most important task of preventive medicine?

Virgin births

Pregnancy and the delivery of a baby without ever having had sexual intercourse is called a virgin birth. It could happen through the use of reproductive technology but this would be called a ‘long shot’ in a teenager—even in the USA where the following data have been collected (Herring et al. BMJ 2013;347:f7102).

The National Longitudinal Study of Adolescent Health (AddHealth) surveyed over 7500 teenagers serially over 12 years during which time 0.5% of the women interviewed had given birth but had yet to initiate intercourse. The term virgin birth appeared somewhat open to interpretation and was associated with chastity pledges, which could be signed-up to by those intending to remain chaste until marriage as well as by nonvirgins who pledge to abstain from further intercourse till married—sort of born-again or serial virgins.

Virgin births were also more common in women who indicated that they had lower levels of communication with their parents about sexual matters and those to whom religion had great importance. These findings beg the point about the accuracy of self-reported data, especially in the face of living proof to the contrary.

New reports and guidelines

Conducting and evaluating national civil society advocacy for reproductive, maternal and child health

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This report, published by the World Health Organization (WHO), discusses strategies, tactics and approaches to conducting and evaluating national civil society advocacy for reproductive, maternal and child health. The report builds upon a WHO technical consultation on ‘Civil Society Advocacy for Reproductive, Maternal and Child Health’, held in Glion, Switzerland, on 14–16 May 2012. There are four main themes: working to influence health sector policy and programmes at national and local levels; working to influence national policy, parliamentarians and the legislative process; supporting national and subnational civil society advocacy; and assessing advocacy impact and monitoring performance. Each theme is introduced and summaries are provided of individual country experiences (including from South Africa, Zambia, India and the Philippines). Emerging lessons analysed include: understanding that context is crucial to any advocacy evaluation; that not all advocacy is visible, especially within a specific time period; and that evaluation of the advocacy process is as important as the policy change. Four future directions for action are proposed: using both linear and nonlinear models to evaluate and monitor advocacy; establishing an advocacy plan to define the advocacy process clearly; maintaining a long-term perspective; and considering the evaluator. The report draws a number of conclusions including: that advocacy requires clearly articulated demands, with a strategic focus and compelling evidence; the importance of considering all levels within a country, due to increasing decentralisation; that capacity building is a continuous learning process, which should be localised; promoting greater accessibility of funds for small civil society organisations (CSOs); forming partnerships between CSOs as a movement. Table 1 outlines a useful framework on determinants of political priority for global health initiatives.

Available online at www.who.int

Family planning and immunisation integration toolkit

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This toolkit, developed by K4Health, provides access to a range of evidence-based resources to support the integration of family planning and immunisation services.

The toolkit is arranged around six key topic areas: essential knowledge; evidence-based advocacy; service delivery implementation tools; social and behavioural change in communication; monitoring and evaluation research tools; country experiences. Each topic area provides an overview and a list of key online resources including for example reports, guidelines, job aids, patient information, briefing documents, case studies and systematic reviews, which are available in a range of different languages. Detailed individual country experiences (from Liberia, Rwanda, Mali, Zambia, Kenya, Nigeria, Ghana, Uganda, the Philippines, Senegal and India) regarding integrating family planning and immunisation services are provided detailing strategies used, challenges encountered and lessons learned. It is hoped that the development of this toolkit will also highlight gaps in existing information provision and prompt new resources addressing these evidence gaps to be developed. A map and list of countries that currently implement integrated family planning and immunisation services is available on the USAID Family Planning High Impact Practices website (www.fphighimpactpractices.org/hips/map).

Available online at www.k4health.org/toolkits/family-planning-immunization-integration

Reproductive health and access to services among rural-to-urban migrants in China

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In 2009 around 230 million people living in rural China moved to urban areas; such mass population movement has important implications for the provision of effective health services. This working paper, is part of a series of outputs from the research project on Migration and Health in China, which is a joint project implemented by the Sun Yat-sen Center for Migrant Health Policy and the United Nations Research Institute for Social Development UNRISD and funded by the China Medical Board (Grant No. 10-009). It assesses reproductive health knowledge, status, service use and health interventions among Chinese migrants who have settled in urban areas and in particular focuses upon self-reported reproductive health, maternal health and use of health services by migrant women and contraceptive use by migrant men. The review is based on three surveys: a two-part survey undertaken in Beijing in 2005 and 2011; a cross-sectional survey of migrant women workers in Guangzhou in 2008 and a cross-sectional survey of migrant men in Beijing in 2004. The paper concludes that rural-to-urban migrants in China were less likely to have access to and to seek healthcare services for some reproductive health issues such as reproductive tract infection or early antenatal care, and that migrants had limited access to services generally and had less knowledge of and access to information about reproductive healthcare issues. The paper highlights that a limitation of currently available data means that it is not possible to assess the effect of policy change or the contribution of improvement programmes.

Available online at www.unrisd.org

Medical Aid Films: cervical cancer

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Medical Aid Films have recently released three new, freely available films about cervical cancer. The first film, which is aimed at community health workers and communities, focuses on understanding the prevention, screening and treatment of cervical cancer and explains how cervical cancer develops and what women can do to protect themselves. Two additional films have been developed specifically for training health workers about screening, early detection, prevention and treatment of cervical cancer and how to perform two visual inspection screening tests: visual inspection with acetic acid and visual inspection with Lugol's iodine. Each film consists of six chapters, which can be downloaded if bandwidth is a problem or for use as e-learning modules. The films have been developed in accordance with WHO protocols (2006, 2012), and were written and produced in collaboration with advisors from organisations such as PATH Uganda and Grounds for Health. Currently the films are only available in English but French, Swahili and Somali versions are in production.

Available online at http://medicalaidfilms.org

Clinical guidelines updates

American Congress of Obstetricians and Gynecologists (ACOG)

The following guidelines are now available online at www.acog.org

Management of women with dense breasts diagnosed with mammography. (committee opinion) no. 593, April 2014

Royal College of Obstetricians and Gynaecologists (RCOG)

The following guidance is now available online at www.rcog.org.uk

Non-invasive prenatal testing for chromosomal abnormality using maternal plasma DNA. Scientific Impact Paper No. 15

The Society of Obstetricians and Gynaecologists of Canada (SOGC)

The following guidelines are now available online at www.sogc.org.

Best practices to minimize risk of infection with intrauterine device insertion, no. 105, March 2014

Innovations and patents

Patent applications

The following patents can be found online at http://worldwide.espacenet.com

AU2012273879 (A1) Phosphodiesterase inhibitors applied via the transvaginal route for the treatment of infertility. This patent application discusses the transvaginal administration of a phosphodiesterase inhibitor to treat couples affected by infertility. The inventors state that treatment with phosphodiesterase inhibitors provides an alternative to invasive assisted reproductive techniques.

Pardina PMC, Vaz-Romero UMA. 6 February 2014.

US2014046182 (A1) Methods and devices for determining lumen occlusion. This patent application outlines methods for determining the occlusion of body lumens. Specifically, this invention relates to confirming, using contrast-enhanced ultrasonography (also known as stimulated acoustic emission hysterosalpingo-contrast sonography), whether the fallopian tubes have been successfully occluded by the placement of an intrafallopian contraceptive device.

This application claims the benefit of US provisional patent application Ser. No. 60/692,497, filed 20 June 2005.

Connor V, Swann B, Sinclair E. 13 February 2014.

US2014037686 (A1) Lactobacillus paracasei NCC2461 (ST11) for the use by perinatal maternal administration in the reduction and prevention of allergies in progeny. This patent application outlines the use of a probiotic, Lactobacillus paracasei NCC2461 (specifically ST11), by pregnant and/or lactating women to reduce and prevent the development of immune responses in infants to allergens. The inventors state that ST11 should be administered daily to pregnant women for at least 2 weeks before delivery. Postdelivery, a daily dose of ST11 is administered either to the breastfeeding mother or directly to the newborn infant for at least 2 months.

Mercenier A, Zuercher A, Nutten S, Wiedermann U, Schabussova I. 6 February 2014.

Legal matters

India: state must act on contraception

Despite the existence of national health policies in India providing universal access to all forms of modern contraceptives, the government of Haryana is said to favour the use of sterilisation at the expense of all other methods of contraception. In November 2013 a petition, alleging that the government of Haryana's reproductive health policy was discriminating against women as a result of it limiting provision of information and access to a full choice of modern contraceptives, was sent to the High Court of Punjab and Haryana at Chandigarh. The Chief Justice has recently given the government of Haryana 1 month to respond to the allegations outlined in the petition.

Source: http://reproductiverights.org/en/feature/India-state-must-act-on-contraception

Canada: three parents listed on baby's birth certificate

Following the British Columbia Family Law Act passed in March 2013, a 12-week-old infant has become the first child to be registered with three legal parents listed on its birth certificate. The infant is the child of two lesbian parents who received a sperm donation from a friend who they wished to be involved in the upbringing of their child. Under the new law in British Columbia up to four parents can officially be registered on a birth certificate.

Source: www.bionews.org.uk/page_396795.asp?dinfo=qUSflJrqJ5EapBGJFP2isrvP&PPID=397105

Clinical trials

Clinicians keen to keep up-to-date regarding clinical studies that are currently recruiting may find the following informative.

Prediction of preterm deliveries by cervical length measurement with embryo transfer catheter in ICSI patients
Registration http://clinicaltrials.gov/ct2/show/NCT02059304
Description This study aims to assess whether cervical length (CL) measurement with embryo transfer catheter is useful in the prediction of spontaneous preterm deliveries in women receiving intracytoplasmic sperm injection (ICSI).
Outcome measures Primary: Delivery week.Secondary: Not specified.
Study site Kayseri, Turkey.Anticipated study end date: July 2014.
Use of dexamethasone in uterine artery embolization
Registration http://clinicaltrials.gov/ct2/show/NCT02056717
Description This randomised study aims to investigate the effects of dexamethasone on inflammatory response after uterine artery embolisation in women with uterine myoma or adenomyosis.
Outcome measures Primary: Inflammatory reactions.Secondary: Pain; nausea and vomiting.
Study site Seoul, Republic of Korea.Anticipated study end date: December 2014.
Dasatinib in treating patients with recurrent or persistent ovarian, fallopian tube, endometrial or peritoneal cancer
Registration http://clinicaltrials.gov/ct2/show/NCT02059265
Description This phase III trial aims to determine the effectiveness of DCTD-Sponsored Dasatinib (NSC #732517) in treating women with persistent ovarian, fallopian tube, endometrial or peritoneal cancer.
Outcome measures Primary: Proportion of women with objective tumour response rate.Secondary: Duration of progression-free survival; duration of overall survival; frequency and severity of adverse effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Study site Various locations, USA.Anticipated study end date: July 2016.
Severe pelvic organ prolapse and postobstructive diuresis (SOPPO) pilot study
Registration http://clinicaltrials.gov/ct2/show/NCT02060331
Description This observational study aims to investigate whether surgical correction (with colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension) of severe pelvic organ prolapse improves and/or resolves nocturia and postobstructive diuresis.
Outcome measures Primary: Impact of surgical treatment of apical pelvic organ prolapse on bothersome nocturia.Secondary: Impact of surgical treatment of apical pelvic organ prolapse on nocturnal polyuria; impact of surgical treatment of apical pelvic organ prolapse on urine osmolality parameters.
Study site Illinois, USA.Anticipated study end date: June 2015.
Vaginal vs laparoscopic hysterectomy
Registration http://clinicaltrials.gov/ct2/show/NCT02059954
Description This randomised controlled trial aims to compare a range of different outcomes in women who have undergone vaginal hysterectomy compared with total laparoscopic hysterectomy for benign indications. Outcomes to be assessed include: quality of life; postoperative recovery; operating time; sexual health.
Outcome measures Primary: Operating time.Secondary: Complications; anaesthesia; quality of life; sexual health; return to work.
Study site Various locations, Austria.Anticipated study end date: July 2015.

Ancillary