This Isn’t Just a Phantom, Menopause, But You Can Vent Your Feelings - Qualitative Evaluation of Evidence Based Health Information (EBHI) Material

For years the availability of independent information regarding the efficacy, lack of efficacy and possible harm of medical interventions in order to enable the consumer to reach an informed decision regarding the treatment options in question has been demanded by patients and consumers. In Germany, following the health reformation of 2004 the development of generally comprehendible information regarding quality and efficiency as well as diagnostic and therapy of diseases with a substantial epidemiological meaning for all citizens was set up in paragraph 139b, SGB V by law as one of the assignments given to the Institute of Quality and Economy in Healthcare (IQWiG). This task is fulfilled by the IQWiG by producing information material which is freely accessible on their website (www.gesundheitsinformation.de). For the development of patient and consumer information the institute is guided by a previously unique objective: it is not to offer recommendations for treatment but rather to „increase critical health literacy of citizens in a sense of increasing cognitive and social competencies which destine the motivations and talents of an individual and aid to create access to information, to understand such information and to act accordingly in a way which improves and sustains health“¹. Furthermore, the institute adds to this objective one further dimension of empowerment which according to the definition by the WHO can be defined as “social, cultural and political processes by which individuals get to express their desires and needs, to present their issues, to define strategies for common decision-making processes and undertake political, social or cultural actions in order to meet those needs.” ¹.

As an example of one of the central research areas we remind the reader of the movement of emancipated women years ago demanding access to information in regard to efficacy, lack of efficacy and risks of hormone therapy during menopause. Women felt misinformed. By insisting on independent information a long-term, critical, social debate was initiated which then led to the now largest randomized controlled study carrying out an investigation of an efficacy/risk-assessment of hormone therapy. Due to the negative results regarding the relationship of the costs-risks-ratio this then led to a drastic decrease of hormone prescriptions. Similarly, the women’s health movement repeatedly drew attention to the strong influence of pharmaceutical interest in regard to the medicalization of the whole concept of menopause and the thus following importance of information independent from that of pharmaceutical companies ².

The decrease of hormone prescriptions up to 2004 was significant, however, stagnated on that annual level in 2004 and later slightly increased again which leads to believe that the development of a guideline for informed decision-making still is necessary ^{3, 4}.

In 2006 an information package addressing the topic menopause was published on the internet pages of the IQWiG which consisted of five different modules (extensive review, leaflet, decision-aid manual, vignettes, video). The evaluation was carried out by the Bremen working group ⁵ and is focused on the printed information given on those internet pages (excluding the video).

This qualitative study is assessing the extent to which information needs of potential users of the information material provided by IQWiG have been met and the extent to which the IQWiG was successful in supporting the participating women to make an informed decision based on the provided evidence-based information material. An initial publication merely deals in more depth with the decision-aid as part of an instrument used by IQWiG  ⁶.

The sample consisted of women with children (n=31) or without children (n=8), in a partnership / married (n=27), or without a steady partner (n=12), women with higher education or university degree (n=21), women with a completed vocational training (n=17) and women without a completed education (n=1). Furthermore, women included in this study either reported to be suffering from severe symptoms (n=21) or reported to experience hardly any symptoms at all (n=18). They either worked full-time (n=14), part-time (n=15), were unemployed (n=7) or housewives (n=3). The age of included participants ranged between 40-63 years (Table 1).

Based on the material provided by the available data we could identify the following six categories: The first five of them are related to the perception of the material: (1) Information were perceived as independent and deemed trustworthy. (2) Scientific study results were unknown, but welcomed. (3) Decision aids are useful but need further communicative support. (4) Women missed information dealing with biographical aspects of the menopause and requested suggestions for empowerment and self-help. (5) Some women are better accessible through emotional aspects of experiences. Category (6) contains attitudes preventing the understanding or the use of the offered material, so that woman could not be reached: They are either looking for easy solutions, or regard menopause as developmental stage in their life time, or insist on a helpless attitude.

Evidence-based patient information including information about pros and cons of intervention are valued. The overall verdict regarding the information package „Menopause“ indicated a positive result from users. The wish to inform appropriately about pros and cons of hormone therapy was recognized. The material was judged by the women as professional, honest and trustworthy. From the interviewed women’s point of view the following aspects contribute to being able to appraise the information as credible: the relinquishment of a clear instruction for action or rather recommendations in this regard, the reporting of advantages and disadvantages of the treatment options, statements regarding limited efficacy, application of numbers and study results, tables, referencing of sources and the confession to the limits of science (Table 2: number 1-3).

Scientific study results were unknown to the participating women but appreciated. So far precise information regarding efficacy, lack of efficacy and possible harm of medical and complementary therapies based on scientific results are unfamiliar. As an example for the communication of study results interviewed participants were questioned about their understanding of a depicted graphic of the efficacy of hormone therapy in regard to the endpoint “hot flashes” (Figure 1). Such a type of communication is unusual. However, part of the users thought the precise preparation of scientific studies was a pleasant, sensible alternative to package inserts and requested such a presentation for all types of pharmaceuticals. Other comments show that the representation is not fully understood or not to the extend that was intended by the authors. The fact that for many women medications prescribed by the doctor are not effective because symptoms simply dissipate by themselves or even that despite application of medication will not result in a benefit but instead could possibly result in harm, may possibly be confusing. Thus, there are some readers who even doubt the statements provided in the information packet (Table 2: 4-6).

Figure 1.Graphic and annotated text quoted from decision aid „Menopause“. Observations out of 10 women experiencing hot flashes which either require an estrogen-preparation or an estrogen-gestagen-combined-preparation the following after 3-6 months: * about 5 out of 10 women do not make use of any treatment, menopausal symptoms disappear “by themselves” (50%) * about 3 women no longer experience hot flashes (30%) as a result of the treatment about 2 women still experience hot flashes (20%) despite hormonal treatment.

The positive reactions to decision-aids illustrate the willingness of women to make decisions independently and in order to do that to make use of such kind of instruments. The decision-aids were perceived as a support to take time for these types of decisions. Decision-aids are interpreted as a sensible possibility for supplementing a conversation with the doctor which is often perceived as too short. Women expressed the wish to have available this type of decision-aids for other interventions in the healthcare system (Table 2: 7-8). Other women do not seem to think the decision-aid instrument is the right method for decision-making. They evaluate the decision-aid as confusing or incomprehensible and insufficient as a sole source of information. Furthermore, the decision-aid was able to convey risks of hormone treatment but was not able to overturn the conflict between advantages and disadvantages of hormones (Table 2: 9-10).

An especially important function of the decision-aid is the invitation of users to actively contribute by developing their own rating for the respective advantages and risks of interventions; to weigh the advantages of the treatment options against the disadvantages against their own preferences. This invitation is being assessed differently by users. The instructions for weighting is felt to be helpful and practical since such a thorough preoccupation with the advantages and disadvantages of the interventions is demanded. Additionally, the wish was expressed to make it more clear that for decision making not only scientific study results but also subjective aspects (values, favors and dislikes) should influence the decision-making. Others felt the weighting was inappropriate for the risks to be discussed or expressed a further need for clarification or counseling (Table 2: 11).

Numerous questions of interview partners for menopause in regard to efficacy and risks of hormones are resolved, on the other hand some topic areas and questions cannot be answered satisfactory. The information is more focused on the medical terminology of menopause after sufficient scientific evidence exists for the ability to influence the occurrence of hot flashes with hormones. Less accounted for are the subjective symptomatic complaints of the readers. Due to the focused information based on scientific evidence they feel less recognized in their world of experience. The necessity for support and encouragement for an independent dealing with changes caused by or associated with the menopause (of physiological and psychological nature) is not sufficiently covered for all users given the information provided. Especially, the overcoming of emotional symptoms is not being addressed adequately. For other women the menopause is represented as a challenging biographical upheaval which needs to be processed and structured. Suggestions of this nature are being appreciated or their absence are also regretted. The representation of alternative possibilities of dealing with menopause were welcomed; also the accounting for risks. The nature of communication of the current situation regarding scientific data for complementary medical methods was perceived as degrading and non-encouraging and thus was criticized as such. It was clear that for many women the use of alternative methods was not primarily about the reduction of hot flashes but much more about a general wellbeing and the feeling of being able to help oneself. A variety of positive experiences in this area were associated with diet, body therapies, exercise or even herbal and homeopathic therapies (Table 2: 12-15)

Some users only read the personal experiences from other women and perceive them as helpful because partly they replace missing communicative exchange, produce a feeling of solidarity, address emotional aspects and moods or address attitudes. The conveying of messages through others produces the feeling that they are not alone with their experiences. Due to the heterogeneity of the presented personal experiences, their own mental state can be relativized. The stories of other women encourage and produce a feeling of solidarity: one is one of many others who feel the same or who feel similar in the same situation. The reports of personal experiences offer opportunities for identification (Table 2: 16-19).

Various emotional dimensions of concern can be addressed through reports of personal experiences. The feeling of emotional resonance enables encouragement and the ability to act. However, this reception of personal experience reports does not mean by far that the cognitive information has been fully accounted for (Table 2: 20-22).

This study enables a deeper understanding regarding the different ways in which evidence-based health information (EBHI) is received. The study was carried out as a qualitative study, revealing the different dimensions of use of this information material we can find in the German public. In order to find out to which extent each of this dimension exist we have to choose quantitative study designs. Nevertheless, our study results could help to improve the Health information homepage from IQIWiG; it was relaunched in 2013 using plenty of evaluation results. However, these results could even be used for the development of further health information in general.

On one hand the enthusiasm in regard to trustworthy information attracts attention, on which basis an informed decision can only be made in the first place. This information package represents a further fundamental development since in earlier qualitative studies the lack of high-quality and structured decision making aids were deplored ⁸. It also shows that independent EBHI are namely an important foundation for the increase of critical health literacy competence. On the other hand EBHI are still quite unknown since they have not yet been implemented into healthcare structures. There is a demand which is increasingly expressed ⁹ and different training formats are being developed to train consumers and health care professionals to use, develop and understand EBHI ^{10, 11}.

Criteria which were put forward by our interview partners to be indicators for the trustworthiness of the information are internationally regarded as ethical standards for the production of patient information. Also, the representation of efficacy, lack of efficacy and harm of hormone therapy in graphical form as a representation of study results is regarded as a standard for evidence-based patient information ¹². It is surprising though that as opposed to the study by Glenton et al ¹³ who assessed the perception of evidence-based patient information by users regarding the topic back pain issues that as this study found, scientific institutions and statistical information do not necessarily have to produce mistrust but can even generate trust.

The study by Hirschberg et al ¹⁴ from 2013 under instruction of the IQWiG also analyzed a EBHI from the view of the users. Similarly, a variety of different types of receptions of the science-based information design was found here as well. Since narratives were not content of Hirschberg’s evaluation, users’ emotional needs as well as those perceived aspects that went beyond those of medical informative nature of the investigated issue went unnoticed. However, the authors specifically remarked on the lack of personal reference as a prerequisite for the better understanding and adaption of the EBHI.

A main remark from users perspective is, that they understood menopause not primarily as a medical problem but as a normal event in their life. They see it as a normal biographic episode with challenges to be mastered where medical support could be useful. Medical information should take into consideration the biographic perspective of life events like the menopause especially in times where personalized medicine plays a more and more important role ¹⁵.

The offered information materials are mainly based on cognitive information, which many women hoped for and welcomed. However, other women were mainly seeking an exchange of experiences and satisfy their needs by means of the personal experience reports. The actual reception of personal experiences does not mean by far that an argument with cognitive information took place. Reports of personal experiences do enable an emotional identification and thus play an important role in patient information but so far could not be entirely recommended for a cognitive dispute for their efficacy or lack of hormones ¹⁶.

On the other hand the very one-sided, objective pointing out of efficacy, lack of efficacy and possible harm of hormones without any emotional embedding could lead to unwanted reactions. This was previously shown in a study by Herber et al. where they investigated the reception of information in instruction leaflets of drugs ¹⁷. An appropriate connection of the narrative level in correspondence with the cognitive needs of users seems to be useful. An example for the narrative level be found at www.Krankheitserfahrungen.de (http://krankheitserfahrungen.de) which was developed in close resemblance to the database of patient experiences (DIPEX) ¹⁸. That way biographical dimensions of disease and the healing process could be made visible, which could appeal to patients on an emotional as well as cognitive level and the information access could be made easier.

The need for support and the dealing with subjective wellness dysfunctions and stimulation for self-help are also expressed by patients who were asked about their motives for seeking medical help from complementary therapists ¹⁹. Thus, this need seems to be of importance to different groups of people. The discussion of the latest scientific findings in regard to complementary and self-help supplies should be carried forward in a more neutral tone. A rather process-oriented processing of menopausal-dependent changes seems to be desired. Recommendations for group counseling or group training can be provided which enable the coping with psychosocial aspects, a reduction of menopausal symptoms and an increase of the knowledge and the options for action ²⁰.