Main findings
We identified four decision aids and sixteen information leaflets for pregnant women. One of the decision aids [
39] was excluded as it was targeted at health care professionals, not lay people. Another decision aid [
40] was excluded, as it dealt with IOL, but did not explicitly cover the indications of late and post term pregnancies. Three information leaflets [
41-
43] were excluded, because their references to late and post-term pregnancies were confined to merely listing prolonged pregnancy as one possible indication for IOL without providing further related information.
The two decision aids and eleven information leaflets included into the assessment are listed in alphabetical order and numbered consecutively in Table
1.
Table 1
Analyzed decision aids and information leaflets
Decision aids
|
1. | | GB | When your baby is overdue for women (W12) | 2008 |
2. | | AU | Choosing how your labour will start in: The Having a Baby in Queensland Book, Your choices during pregnancy and birth, S. 81 - 95 | 2010 |
Leaflets
|
3. | | US | Post-term Pregnancy: What you should know | 2005 |
4. | | US | Pregnancy: What to expect when you’re past your due date | 2000, update: 2010 |
5. | | DE | Wenn das Baby auf sich warten lässt [When the baby keeps you waiting] | last update: 2011 |
6. | | DE | Merkblatt: Überschreitung des Geburtstermins: Wann wird eine Geburtseinleitung nötig? [Beyond the due date: When is labour induction required?] | 2008, update: 2012 |
7. | | D | Merkblatt: Wenn die Geburt des Babys auf sich warten lässt [When birth of the baby keeps you waiting] | 2008, update: 2012 |
8. | | US | Inducing labor: When to wait, when to induce | 2011 |
9. | | US | Overdue pregnancy: What to do when baby’s overdue | 2011 |
10 | | GB | Overdue: Over 40 weeks pregnant | last review: 2011 |
11 | | GB | Inducing Labor | last review: 2011 |
12 | | GB | Induction of labour | 2008 |
13 | | US | Patient information: Postterm pregnancy (Beyond the Basics) | 2012 |
The analysis of the decision aids and information leaflets on the basis of our checklist is displayed in Additional file
1. The reference numbers of the appraised decision aids and information leaflets quoted in brackets in the following text are consistent with the respective numeration in Table
1 and in Additional file
1.
All of the assessed decision aids and information leaflets are freely available on the respective providers’ websites except for the decision aid issued by “MIDIRS” [
44] (Nr. 1) (costs: £ 11,00 in print; £ 3,60 as a downloadable PDF version).
Decision aids
The two decision aids that we included into our assessment were from Australia, issued by the University of Queensland [
45] (Nr. 2), and from the United Kingdom, issued by MIDIRS (Midwives Information and Resource Service) [
44] (Nr. 1), an organization providing information resource to support the professional development of midwives. Both decision aids provide detailed information about the various options of care in cases of late and post term pregnancies. None of them gives an exact definition of a late term pregnancy, i.e. a pregnancy continuing beyond the EDD as opposed to a post term, post-date or prolonged pregnancy, i.e. a pregnancy continuing beyond 42 completed weeks. This may be owed to the fact that in Anglo-Saxon countries obstetricians – without any further implications - tend to define “term” as a period of time rather than on one particular date, as is usual in Germany.
While both decision aids explain the difficulties of the exact determination of gestational age, and describe the risks associated with late and post term pregnancies, only the British one discloses the uncertainties around the calculation of these risks.
Among the methods of stimulating labor before 42 completed weeks, the Australian decision aid only displays the membrane sweep, whereas the British one additionally describes natural (sexual intercourse, nipple stimulation) and alternative (castor oil, raspberry leaf tea, acupuncture) ways of labor stimulation.
In both publications the two basic options of “watchful waiting” and IOL are presented and the respective proceedings under each of these options are described. However, the description of the different ways of IOL in the British decision aid is comparatively short. In contrast to the Australian decision aid, the British one does not display probabilities for possible positive and negative outcomes of either option.
Whilst the British decision aid repeatedly refers to NHS guidance, the Australian decision aid refrains from any reference to guideline recommendations.
The display of the probabilities of clinical outcomes in the Australian decision aid fully complies with the IPDAS criteria. This applies in particular to the communication of risk probabilities by means of “100-person-diagrams”, which guarantee the continuity of reference parameters. For each risk probability reference is made to scientific evidence, and letters from A to C rates the quality of such evidence. In contrast, the British decision aid fully abstains from the display of risk probabilities. Contrary to the Australian publication, the British leaflet only insufficiently supports pregnant women in clarifying their personal values.
Whereas the Australian decision aid includes specific tools (structured work sheet, questionnaire) to help pregnant women clarify their preferences and discuss them with others, the British decision aid provides an empty sheet of scratch paper for this purpose. The Australian publication presents information in a balanced manner. Due to the shortness of information on pharmacological IOL as compared to alternative methods and due to the fact that the check-up methods applied under the option of “watchful waiting” and possible disadvantages of pharmacological IOL are the only text passages printed in bold, the British decision aid gives the impression of a certain bias against pharmacological IOL. Both decision aids name their authors and report their qualifications, but do not disclose whether and if so to which extent they have gone through a systematic development process including field tests with users.
Whereas the Australian decision aid comprises a detailed bibliography of scientific evidence, the British publication only refers to a corresponding publication for health care professionals [
39], which then on its part contains a reference list.
Conflicts of interest are addressed in the Australian, but not in the British decision aid. Both publications are written at a generally understandable language level. The Australian decision aid distinguishes itself by its appealing layout and by clear text-supporting illustrations. The British leaflet is less clearly arranged and does not regard layout aspects to the same extent.
Of the eleven information leaflets included into the assessment, three are from Germany (Nr. 5 [
46], 6 [
47], 7 [
48]), five from the US (Nr. 3 [
49], 4 [
50], 8 [
51], 9 [
52], 13 [
53] and three from the UK (Nr. 10 [
54], 11 [
55], 12 [
56]).
The German publications were issued by a government agency, the Bundeszentrale für gesundheitliche Aufklärung (BZgA) (Nr. 5), and by a professionally independent scientific institute under public law, the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWIG) (Nr. 6, 7). The UK publications have been developed by the National Health Service (NHS) (Nr. 10, 11) and the National Institute of Health and Clinical Excellence (NICE) (Nr. 12), which provides national guidance and advice to improve health and social care on behalf of the NHS [
52]. Of the five US publications, two have been issued by a physicians’ organization (Nr. 3, 4), two by a hospital (Nr. 8, 9) and one by a private information service for health care professionals and patients (Nr. 13).
None of the information leaflets fulfilled the IPDAS criteria for patient decision aids, which is unsurprising, as they are intended to provide mere information and are not directly targeted at involving pregnant women in the decision-making process.
Six of the eleven publications were too short and superficial to be of any substantial benefit for pregnant women, even considering the fact that they are mere information leaflets (AAFP (Nr. 3, 4, Mayo Clinic (Nr. 8, 9); NHS (Nr. 10, 11). Important features were missing in the 2–3 page publications. This concerned mainly graphs and tables on risks and probabilities, as well as detailed explanations on methods of induction. Three of the publications provided at least some important information on late and post term pregnancies (BZgA (Nr. 5), NICE (Nr. 12), UpToDate (Nr. 13) with one of them also describing CAM methods of labor stimulation (BZgA (Nr. 5). For the most part, however, the leaflets focused one-sidedly on medical and pharmacological IOL. As they were not immediately aimed at shared decision-making and did not perceive and address pregnant women in their role as decision-makers, they were not capable of facilitating a balanced choice for pregnant women based on their individual needs and values.
One of the information leaflets (IQWIG: “Überschreitung des Geburtstermins …” (“Beyond the due date …”) (Nr. 6) is confined to explaining in comprehensive language the results of a Cochrane review by Gülmezoglu et al. [
11], according to which after 42 completed weeks of gestation the benefits of IOL outbalance the risks. Due to its narrow subject matter this leaflet is unsuitable for supporting pregnant women’s informed choice.
Among the mere information leaflets only the IQWIG leaflet “Wenn die Geburt des Babys auf sich warten lässt” (“When birth of the baby keeps you waiting”) (Nr. 7) stands out. The question, at what point a pregnancy is to be considered “lasting too long” is discussed in detail.
The German equivalents of late (“Terminüberschreitung”) and post term or prolonged (“Übertragung”) pregnancy are precisely defined. The methods of determining gestational age are described at length and immanent uncertainties are emphasized. “Watchful waiting” with its various check-up methods is described, however, not as one of two possible options between which pregnant women may choose, but as the initially indicated approach for healthy pregnant women beyond their EDD. Likewise, IOL is not so much presented as one option among others, but rather as the appropriate intervention to reduce perinatal mortality at least beyond 42 completed weeks of gestation. CAM methods of labor stimulation are discussed with reference to the lack or insufficiency of evidence for some of them. The pharmacological methods of IOL are described in detail. A particular paragraph is dedicated to the problem of how it may feel for a pregnant woman to be medically induced.
Outcome probabilities are presented only selectively and not comprehensively or systematically, which is why the leaflet does not allow for a balanced choice based on outcome results.
Individual values of pregnant women are not addressed. The information sheet consists of text only, the layout is little appealing and there are no illustrations. Tools to facilitate decision- making like work sheets or questionnaires are not attached. The leaflet comprises a bibliography, to which, however, no reference is made in the text, which does not allow for the attribution of the evidence provided in the bibliography to specific text passages. Only one text passage refers to a hyperlink providing the results of a study.
In particular with regard to its itemization, the leaflet is capable of supporting pregnant women in the process of decision-making, even though it is not designed as a decision aid in the proper sense. Overall, it is an item of information of good quality.