Adverse reactions of the copper intrauterine device and related consequences: experiences described in discussion boards

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Recently, agencies have seen an increase in spontaneous reports of adverse reactions, and analysis of messages in discussion boards may lead to new insights. The aim was to explore experiences of adverse reactions related to the copper intrauterine device described by posters in Swedish public discussion boards. Methods Messages containing descriptions of client experiences were collected via Swedish public discussion boards about sexual and reproductive health, identified through searches in Google. Posters with experience of adverse reactions were included (n = 145 unique posters) and their messages were inductively analyzed with qualitative manifest content analysis. Results Four categories were derived from the data; physical reactions, psychological reactions, intensity of adverse reactions, and consequences of adverse reactions. Adverse reactions were identified as physical reactions (15 sub-categories illustrating the different types of reactions) and psychological reactions (5 sub-categories illustrating the different types of reactions). Posters expressed significant intensity of adverse reactions, such as the reaction being awful, extreme, and traumatic. Some had such a negative experience of adverse reactions that they would never again consider a copper intrauterine device and that they would never had it inserted if they knew about the experienced adverse reactions. While some decided to accept adverse reactions and keep the device, others did not and removed it. Adverse reactions had negative effects on sexual health, partner relationship, and fears and worries, including fear to seek gynecologic care because of a traumatic and painful insertion. Conclusions Descriptions of both expected and unexpected adverse reactions of the copper intrauterine device can be found in discussion boards, some which can feel like being of high intensity and have burdensome consequences in the lives of clients. Midwives, nurses and physicians working in contraceptive counseling need to ensure that clients are sufficiently informed about possible adverse reactions and followed-up accordingly. More research is needed that further investigates adverse reactions of the copper intrauterine device and the impact such reactions may have for clients. Women's studies Health Economics & Outcomes Research Contraceptive Devices Drug-Related Side Effects and Adverse Reactions Intrauterine Devices Copper Long-Acting Reversible Contraception Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction The copper intrauterine device (Cu-IUD) is a long-acting reversible contraception (LARC) that prevents unintended pregnancy through contraceptive mechanisms that lasts for several years and can be removed when desired. The LARC’s do not require user compliance and are associated with high contraceptive effectiveness. They also lead to high user satisfaction among clients, in regard to how satisfied they are of having chosen LARC as their contraceptive method [ 1 ]. Many leading organizations and experts now recommend LARC as suitable alternatives for those who desire effective contraception [ 2 – 5 ]. Research show that clients choose the Cu-IUD because of its high efficacy and lack of hormonal mechanism [ 6 ]. However, the overall use of LARC is still limited worldwide, with regional differences across different contexts [ 7 – 9 ]. Client’s expectations of possible adverse reactions are inversely associated with them deciding to use long-acting methods [ 10 ], and potential adverse reactions have a considerable impact on which contraceptive method that is ultimately chosen by clients [ 11 ]. This calls attention to the importance that clients place in potential adverse reactions of contraception. According to the literature, the most expected adverse reactions of Cu-IUD are localized in the uterus and are not considered medically serious [ 12 , 13 ]. However, elevated levels of copper in the blood have been observed when the Cu-IUD is used [ 14 ], raising questions concerning potential systemic effects. The Cu-IUD is often categorized as a medical device, meaning that it is not subjected to similar regulation and adverse reactions are not studied in the same manner as other medical products, such as the hormonal intrauterine system. The Swedish Medical Products Agency recently received an increase of spontaneous reports about adverse reactions of the Cu-IUD, which they relate to increased activity in social media [ 15 ]. Posts in online discussion boards contain information that may be relevant to explore patient experiences related to adverse reactions [ 16 ] and a growing number of Internet users participate in discussions that take place in virtual discussion boards [ 17 ]. Such communication allows laypersons to discuss sensitive subjects in a setting in which they can be anonymous and feel comfortable enough to disclose information about their health [ 18 ]. Using material collected from online discussion boards presents an opportunity for researchers to explore unobtrusive data that can complement other methods used for data collection [ 19 ]. The aim of this exploratory study was to explore experiences of adverse reactions related to the copper intrauterine device, as described in Swedish public discussion boards. Material And Methods Data collection Swedish public discussion boards about sexual and reproductive health were identified via Google, the most used search engine on the Web [ 20 ]. Two large Swedish virtual communities about reproduction, pregnancy and parenthood were identified. In these communities, searches were performed using combinations of search terms related to the study aim. The specific search terms will not be published in order to protect the identities of the posters included in the sample. Threads in which the first post was written by a poster that described own experiences related to adverse reactions of Cu-IUD were included. In total, 51 threads were identified and included in the sample. In these threads, a total of 144 unique posters (that had written a total of 369 posts in the included threads) described experiences of adverse reactions related to Cu-IUD. The mean number of messages per unique poster was 2.5 (range = 1–77), and 14 posters wrote in more than one thread. Data analysis The material was inductively analyzed with qualitative content analysis, inspired by the outline presented by Graneheim and Lundman [ 21 ]. All included threads were read repeatedly to gain an overall understanding of the content. Meaning units related to the aim were then identified, defined as words, sentences or paragraphs that contain aspects related to each other through their content and context. Meaning units were labeled with a code, and collated into categories and sub-categories, i.e., the obvious and observable content identified with as little interpretation as possible. Table 1 presents examples of the analytic process. The first and last authors were responsible for the primary analysis. The first author, a female registered nurse-midwife, identified meaning units and performed an initial categorization for eight of the threads (n = 51 posters). The last author aided in this process, who is a male specialist nurse, registered midwife and researcher with formal training and experience of content analyses. In addition, he separately identified meaning units and performed initial categorization for the remaining 43 threads (n = 93 posters). The second author (registered nurse-midwife) scrutinized the analysis to check if the meaning units, categorization, and results represented the raw data. The third author (registered specialist nurse-midwife and professor) aided in the identification of categories. Table 1 Examples of the analytic process Modified data excerpt Meaning units Code Sub-category Category I bled for ten days each menstruation with days of heavy bleeding and also some blood during ovulation. I also had pain during menstruation I bled for ten days each menstruation with days of heavy bleeding Menorrhagia Menstrual cycle and uterine bleeding Physical reactions Some blood during ovulation Metrorrhagia Menstrual cycle and uterine bleeding Physical reactions I also had pain during menstruation Dysmenorrhea Menstrual cycle and uterine bleeding Physical reactions Little bleedings came in between periods during ovulation. I became depressed and the hemoglobin was low. It also was painful. Little bleedings came in between periods during ovulation Metrorrhagia Menstrual cycle and uterine bleeding Physical reactions The hemoglobin was low Anemia Blood system Physical reactions It also was painful Unspecified pain General reactions Physical reactions I became depressed Depression and depressive mood Negative alterations in mood and Psychological reactions I want to kill myself sometimes. I have panic attacks. I feel indifference and apathy. The stress is killing me, even though I have no real reason to feel stressed. I want to kill myself sometimes. Suicidal ideation Self-injurious behaviors Psychological reactions I have panic attacks Panic reactions Anxiety Psychological reactions The stress is killing me, even though I have no real reason to feel stressed. Stress reactions Anxiety Psychological reactions I feel indifference and apathy Apathy Negative alterations in mood and depression Psychological reactions Ethical Considerations The sample consists of messages in public discussion boards accessible without any password requirements. According to current guidelines for Web-based research, and in line with recommendations from the Codex rules and guidelines for research in Sweden [ 22 ], texts that are published on the Web without password requirements may be regarded as public and involve an implied consent for use in research [ 23 – 26 ]. In order to protect the identity of the included posters, we translated and modified the quotes, while still making sure that the meaning of the quotes was retained, and changed the user names of the posters to fictitious pseudonyms. The details regarding identification of threads will not be made public, in order to protect the identity of the included posters. Results Four categories were derived from the data: physical reactions , psychological reactions , intensity of adverse reactions , and consequences of adverse reactions . Figure 1 presents an overview of the categories and sub-categories. Nine posters described positive dechallenge, meaning that the adverse reactions ceased when the Cu-IUD was removed. Two posters described positive rechallenge, meaning that the adverse reactions recurred when a new Cu-IUD was inserted after a positive dechallenge. Category 1: Physical adverse reactions The sub-categories in physical reactions included blood system , cardiovascular system , device-related reactions , ears , eyes , excretory system , gastrointestinal and metabolic system , general reactions , integumentary system , menstrual cycle and uterine bleeding , muscoskeletal and connective tissue , nervous system , reproductive tract infections and inflammations , uterus , vulvovagina , and sexual health (Fig. 1 and Additional File 1). The most common adverse reactions mentioned by the posters were menorrhagia (n = 68 posters), dysmenorrhea (n = 17 posters), and metrorrhagia (n = 18 posters), please see Additional File 1 for more information. Category 2: Psychological adverse reactions The sub-categories in psychological reactions included anxiety , cognitive impairment , general psychological health , negative alterations in cognitions and mood , and self-injurious behaviors (Fig. 1 and Additional File 1). Category 3: Intensity of adverse reactions Negative expressions illustrating intensity (sub-category 1): 34 codes of expressions illustrating intensity were identified (Table 2 ). The expressions portray a significant intensity of the adverse reactions, such as the reaction being “ awful ”, “ extreme ”, “ indescribable ”, and “ traumatic ”. Several described the intensity of increased menstruations as an adverse reaction, including the amount of blood feeling like “ a flood ”, “ a river ”, “ a downpour ”, and “ gigantic ”. Posters also described bleeding “ like a pig ” and “ like crazy ”. Some took tranexamic acid or naturopathic drugs to counteract the increased menstruation. Posters described that they needed to change their tampons very often and that heavy menstruation had such intensity that it had a considerable impact on their daily life. Additional File 2 presents an expanded overview of the identified expressions. Table 2 Expressions and quotes in the sub-category intensity of the identified adverse reactions. Expression Illustrative quote (respondent number) Awful I’ve never experienced anything more awful. (82) Came crashing down All reactions came crashing down over me (19) Can’t live like this I can’t stand waiting if this will pass, I can’t live like this. (39) Can’t move or stand straight So much pain that I can hardly move or stand straight (74) Can’t stand it I have anxiety during ovulation and anxiety before menstruation. I can’t stand it. (109) Don’t know what to do I don’t know what to do, the tests are negative and the IUD is correctly in place (81) Enormous I had enormous pain during and right before menstruation (9) Extreme I feel really strange, I am dizzy, extremely fatigued (98) Feel really ill Felt really ill for several years because of it (82) Feels like dying You think that you are about to go insane or about to die! (1) Hell I didn’t understand what it was until almost a year and it had been a year of hell (14) Horrible The Cu-IUD was horrible for me! (82) How much do I need to withstand How much do you have to withstand (as a woman)? (80) Immense I bled immensely (9) Indescribable I was prepared that it would hurt but the pain was completely indescribable (77) Insane It’s insane that you bleed so much (70) It only got worse It only got worse for me. (132) In fetal position, cringing and turning in pain I’m laying on the couch and turning in pain (80) Like the plague The period is really like the plague, long and profuse (95) Lost hope I’m loosing hope in myself and become so scared when the panic comes (27) Misery It is alright all days except two, when it’s misery with the Cu-IUD. (84) Never felt this ill before Never felt this ill before! (60) Not for me The Cu-IUD was absolutely not for me! (76) Not fun at all Then I got this infection, which was not fun at all. (54) Nothing positive I can’t say a single positive thing about the copper IUD. (82) Sick and tired I have the Cu-IUD and I am so bloody sick and tired of it (16) Suffering I suffered for two years because of my copper IUD. (68) Tough The bleeding was really tough (11) Traumatic It was such a traumatic experience for me to have the IUD inserted (32) Uncomfortable Sometimes I feel a pinch somewhere in the genital area. It feels so uncomfortable (46) Without equal The worry was without equal... (1) Worse than giving birth I have given birth before but I can say that it was worse to have it inserted (54) Worst experience This is the worst thing I have experienced (1) Wouldn’t wish it on my worst enemy I wouldn’t wish it on my worst enemy... (1) Temporal aspects (sub-category 2): adverse reactions were described as constant (described for anemia, dysgeusia, dysmennorhea, metrorrhagia, nausea, unspecific pain, and vertigo), accelerating over time (described for abdominal distention, alopecia, altered mood, chest pain, depression and depressive mood, excessive worries and fears, fatigue, general anxiety, mental fatigue, nervousness, palpitations, panic reactions, paresthesia, and vertigo), having a fast onset (described for altered mood, depression and depressive mood, and premenstrual syndrome), and recurrent (described for menorrhagia and metrorrhagia). One poster had reactions that prolonged over several years, and another described having sought care several times to get help with the reactions. Retrospective thoughts (sub-category 3): eleven posters wrote that they would never again consider a Cu-IUD and one poster wrote that she would never had have the Cu-IUD inserted if she had known beforehand about the adverse reactions she experienced. Category 4: Consequences of adverse reactions Deciding to keep the Cu-IUD despite adverse reactions (sub-category 1): some decided to accept adverse reactions related to changes in menstrual bleeding. Reasons why these decided to accept the reactions and keep their Cu-IUD were that they regarded that the benefits associated with the contraception outweighed the adverse reactions, preferred using a contraceptive method without hormonal components, and considered the Cu-IUD as the more environmentally friendly alternative in comparison with hormonal contraception. Posters expressed that it was negative that there are so few methods for effective contraception that do not involve hormonal treatment, other than the Cu-IUD. “I’ve had a copper IUD before, and had spotting before menstruation. But I still feel that the advantages clearly overweigh the disadvantages. It’s nice that it’s without hormones, both for the environment and myself. But I’m so tired of the fact that there isn’t any contraception that is just great.” (Poster 15) Removing the Cu-IUD due to adverse reactions (sub-category 2): 31 posters articulated that they did not accept the adverse reactions and decided to remove the Cu-IUD. Adverse reactions that led to removal included menorrhagia, metrorrhagia, depression and depressive mood, dysmenorrhea, ovulation pain, fatigue, arthralgia, inability to lose weight, altered mood, headaches, unspecified uterine infection, anemia, vaginal discharge, ocular hyperemia, ocular pruritus, pruritus, nausea, paresthesia, eczema, and somnolence. “I bled most days of the year when I had the copper IUD. Finally, I couldn’t bear it anymore and decided to take it out.” (Poster 10) Consequences on sexual health and relationships (sub-category 3): posters described that the experienced adverse reactions had negative effects on their sexual health, because of menorrhagia, vulvovaginal pain, vaginal discharge, and the partner feeling the cords of the Cu-IUD. These consequences were described to have negative effects on their quality of life. When psychological reactions were experienced, it had negative consequences on the poster’s relationships with their partners. Some described that they feared that their relationships would end because of the adverse reactions. Some described that their partner was negatively affected by the alterations in mood and psychological health they experienced. “I’ve had terrible premenstrual syndrome during these years that keeps getting worse. I cry, scream and have anxiety. I drive my partner crazy.” (Poster 25) Fears and worries because of adverse reactions and a traumatic insertion (sub-category 4): some described fears and worries related to the adverse reactions, particularly when they did not recognize the manifestations or could explain them. Posters who had experienced a painful and traumatic insertion expressed considerable fears of seeking care at a gynecologist or midwife. This consequence resulted in deciding not to remove the Cu-IUD, despite wanting to. Some required repeated visits to the midwife before they felt prepared and ready to remove the device. “I tried to have it removed for several months but could not go through with it because of the pain I experienced when it was inserted. It was the most painful situation I have ever experienced” (Poster 32) Discussion The aim was to explore experiences of adverse reactions related to the Cu-IUD. Public discussion boards were used to analyze from posters with experience of the Cu-IUD, revealing various physical and psychological adverse reactions. The reactions were described in powerful words illustrating an intense experience and burdensome consequences, including impacts on sexual health and relationships as well as fears and worries. The findings illustrate that patients place great importance in potential adverse reactions of Cu-IUD and base their decisions to continue or discontinue contraception partly on this aspect. While the desire to have contraception without hormonal effects is an acknowledged reason why clients decide to use a Cu-IUD, changed menstrual bleedings and pain are expected reasons for discontinuation [ 27 ]. In addition to the expected menorrhagia and dysmenorrhea [ 12 , 13 ], we also observed more unexpected physical and psychological reactions, including symptoms that could implicate serious conditions such as anemia, fatigue, depression and suicidal ideation. Posters in this study also described alterations in their cognition and mood, such as mental fatigue and increased irritability. Studies have observed a potential association between levels of free copper in blood and cognitive impairment [ 28 ]. Although inconclusive results have been reported [ 29 ], one study also suggests a relationship between elevated copper levels and depression [ 30 ]. The identified adverse reactions illustrate the importance of follow-up consultations with the aim to identify those who develop adverse reactions. However, research indicates variability with regard to how much attention that is given during contractive counseling to inform about possible adverse reactions, and further, that only a proportion who are prescribed contraception are offered a follow-up visit [ 31 ]. The adverse reactions resulted in burdensome consequences for included posters, including negative consequences on sexual health and relationship with partner. These findings are in line with previous research, illustrating the association between medical conditions and sexual health [ 32 ]. Another serious consequence was the articulated fear of gynecological care developed among posters with a traumatic experience of the insertion of the device. Pelvic examinations are an essential part of gynecologic care needed for many purposes, including establishing diagnoses, screening for cervical cancer, and for the insertion or removal of intrauterine devices. Consequently, fear of pelvic examinations could lead to serious consequences for women. Therefore, clinicians need to take active measures as to effectively prevent development of these fears [ 33 ]. Research acknowledges that a proportion of clients experience high pain during insertion of intrauterine devices [ 34 , 35 ] and that they find the pain more intense than expected [ 36 ]. Oral analgesia, local anesthesia and cervical priming have the potential to alleviate pain during insertion, but no firm conclusions have yet been drawn concerning implementation of routine clinical use [ 37 ]. We did not observe any descriptions whether or not the posters were given any pain relief before the insertion. Nevertheless, the findings illustrate the potential impact that painful insertion may have and portray the importance of an individualized approach in which clients who are at risk of high pain are identified and supported. Research indicates that few midwives and gynecologists use analgesia in clinical practice [ 38 ], calling attention to the need for further improvement in clinical management and more studies that investigates how to prevent insertion-related pain for patients who are at risk. Qualitative methodologies have the potential to offer insights into patient perspectives explored in an inductive approach within the field of drug utilization [ 39 ]. Using the Web to collect patient-generated data could lead to further insights regarding adverse reactions [ 40 ], which was the rationale behind the chosen methodology. This was a convenience sample consisting of persons who decide to write about their experiences on web-based discussion boards. Thus, the transferability of the findings is limited and we acknowledge the probability that those who write about adverse reactions could constitute a subgroup with especially challenging reactions and consequences. The fact that anyone can write in public discussion boards implicate that it would be possible to fabricate stories about adverse reactions. On the other hand, web-based communication involves an opportunity for patients to tell their stories in an anonymous setting and previous research indicates that people disclose more about themselves than they do during face-to-face interactions [ 41 ]. We did not observe anything during the analysis that would suggest fabrication. Moreover, while all posters did describe their adverse reactions as being caused by the Cu-IUD, we cannot make any certain claims about causality and adverse reactions among the general population. Thus, there is a need for more descriptive and exploratory studies in this field, particularly concerning the impact and consequences that adverse reactions may have for clients. Conclusion Posters who write in public discussion boards about adverse reactions of the copper intrauterine device describe both expected and more unexpected reactions. Some of these are serious events that need to be identified and treated in clinical praxis. When adverse reactions of the copper intrauterine device are experienced they can have burdensome consequences, including sexual health and relationships. Those who experience a traumatic insertion are at risk of developing fear of pelvic examinations, resulting in reluctance to seek care at a gynecologist or midwife. It is important that health professionals identify, prevent and treat pain during insertion. Health professionals need to ensure that clients who have a copper intrauterine device are followed-up accordingly, so that potential adverse reactions and its potential consequences are adequately assessed and supported. Abbreviations Cu-IUD Copper intrauterine device LARC Long-acting reversible contraception Declarations Ethics approval and consent to participate Not applicable. Consent for publication Not applicable. Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests. Funding No funding supported this work. Authors’ contributions MF designed the study, collected the data, analyzed the data, wrote an early Swedish draft of the manuscript, and critically reviewed the manuscript. MSM designed the study, aided in the analysis of the data and critically reviewed the manuscript. 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In: Elseviers M, Wettermark B, Almarsóttir AB, Andersen M, Benko R, Bennie M et al, editors. Drug Utilization Research: Methods and Applications. United Kingdom: John Wiley & Sons; 2016. pp. 280–96. White RW, Harpaz R, Shah NH, DuMouchel W, Horvitz E. Toward enhanced pharmacovigilance using patient-generated data on the internet. Clin Pharmacol Ther. 2014;96:239–46. Tidwell LC, Walther JB. Computer-Mediated Communication Effects on Disclosure, Impressions, and Interpersonal Evaluations: Getting to Know One Another a Bit at a Time. Hum Commun Res. 2002;28:317–48. Supplementary Files AdditionalFile1.pdf AdditionalFile2.pdf Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Hogskola","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Moa","middleName":"Sterner","lastName":"Molin","suffix":""},{"id":2512171,"identity":"f356bab4-cbe0-4258-9b85-922948218288","order_by":2,"name":"Susanne Georgsson","email":"","orcid":"","institution":"Karolinska Institutet","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Susanne","middleName":"","lastName":"Georgsson","suffix":""},{"id":2512172,"identity":"fe1bb7b6-2360-4771-999f-0c48e8762a27","order_by":3,"name":"Tommy Carlsson","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA60lEQVRIiWNgGAWjYFADdjBpY2AgQUAhD5zFDCbTSNdymLAWe/bu1M08DHby5s3sjz983HHe2Fy6gU2ah6FODqctPGe33eZhSDacc5jHTHLmmdtmlnMOgLQcNsapRSIXpOUA4wxmHjZm3rbbNgY3EkBaDiQ2ENBiP4OZ/fFn3rZzMC119YS0JM5gZjCQ5m07YAbVwpyA02Fnzm67OccgORnoMKBf2pKNLWckNlvOMThsiMsW9vbebTfeVNjZzmBvB4ZYm53hdonkg0CROnlctoAAE48BCp8RaL4BdqVwJT/wy4+CUTAKRsFIBwD2PkxgaQ0wyQAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0003-4141-8692","institution":"Uppsala Universitet","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Tommy","middleName":"","lastName":"Carlsson","suffix":""}],"badges":[],"createdAt":"2020-08-15 11:13:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-60156/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-60156/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":2514727,"identity":"0137bf83-27fe-4dd4-ae87-83a12ff5d77d","added_by":"auto","created_at":"2020-09-21 14:57:23","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":29860,"visible":true,"origin":"","legend":"Physical reactions described by posters.","description":"","filename":"Fig1.png","url":"https://assets-eu.researchsquare.com/files/rs-60156/v1/Fig1.png"},{"id":2514728,"identity":"39dc7554-0971-4371-8d2a-784378760c29","added_by":"auto","created_at":"2020-09-21 14:57:23","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":11226,"visible":true,"origin":"","legend":"Psychological reactions described by posters.","description":"","filename":"Fig2.png","url":"https://assets-eu.researchsquare.com/files/rs-60156/v1/Fig2.png"},{"id":2514729,"identity":"cc702522-7bec-48fb-afe6-e642031b816e","added_by":"auto","created_at":"2020-09-21 14:57:23","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":24015,"visible":true,"origin":"","legend":"Intensity of adverse reactions described by posters.","description":"","filename":"Fig3.png","url":"https://assets-eu.researchsquare.com/files/rs-60156/v1/Fig3.png"},{"id":2514730,"identity":"e3c9964e-8f9c-4186-b961-749e9fa6f245","added_by":"auto","created_at":"2020-09-21 14:57:24","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":27665,"visible":true,"origin":"","legend":"Consequences of adverse reactions described by posters.","description":"","filename":"Fig4.png","url":"https://assets-eu.researchsquare.com/files/rs-60156/v1/Fig4.png"},{"id":13594370,"identity":"86d69016-98c2-4283-a5cd-285deeb88047","added_by":"auto","created_at":"2021-09-17 05:20:06","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":886036,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-60156/v1/e369d71e-46a4-4275-a182-abe596d8ce3f.pdf"},{"id":2514732,"identity":"acd30571-ecbe-44b8-8e8a-0e22a891612a","added_by":"auto","created_at":"2020-09-21 14:57:24","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":130997,"visible":true,"origin":"","legend":"","description":"","filename":"AdditionalFile1.pdf","url":"https://assets-eu.researchsquare.com/files/rs-60156/v1/AdditionalFile1.pdf"},{"id":2514733,"identity":"ea3a1a5a-b133-4f7c-929f-fe051d8830e1","added_by":"auto","created_at":"2020-09-21 14:57:24","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":95846,"visible":true,"origin":"","legend":"","description":"","filename":"AdditionalFile2.pdf","url":"https://assets-eu.researchsquare.com/files/rs-60156/v1/AdditionalFile2.pdf"}],"financialInterests":"","formattedTitle":"Adverse reactions of the copper intrauterine device and related consequences: experiences described in discussion boards","fulltext":[{"header":"Introduction","content":" \u003cp\u003eThe copper intrauterine device (Cu-IUD) is a long-acting reversible contraception (LARC) that prevents unintended pregnancy through contraceptive mechanisms that lasts for several years and can be removed when desired. The LARC\u0026rsquo;s do not require user compliance and are associated with high contraceptive effectiveness. They also lead to high user satisfaction among clients, in regard to how satisfied they are of having chosen LARC as their contraceptive method [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Many leading organizations and experts now recommend LARC as suitable alternatives for those who desire effective contraception [\u003cspan additionalcitationids=\"CR3 CR4\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Research show that clients choose the Cu-IUD because of its high efficacy and lack of hormonal mechanism [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. However, the overall use of LARC is still limited worldwide, with regional differences across different contexts [\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Client\u0026rsquo;s expectations of possible adverse reactions are inversely associated with them deciding to use long-acting methods [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], and potential adverse reactions have a considerable impact on which contraceptive method that is ultimately chosen by clients [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. This calls attention to the importance that clients place in potential adverse reactions of contraception. According to the literature, the most expected adverse reactions of Cu-IUD are localized in the uterus and are not considered medically serious [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. However, elevated levels of copper in the blood have been observed when the Cu-IUD is used [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e], raising questions concerning potential systemic effects. The Cu-IUD is often categorized as a medical device, meaning that it is not subjected to similar regulation and adverse reactions are not studied in the same manner as other medical products, such as the hormonal intrauterine system. The Swedish Medical Products Agency recently received an increase of spontaneous reports about adverse reactions of the Cu-IUD, which they relate to increased activity in social media [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Posts in online discussion boards contain information that may be relevant to explore patient experiences related to adverse reactions [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] and a growing number of Internet users participate in discussions that take place in virtual discussion boards [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Such communication allows laypersons to discuss sensitive subjects in a setting in which they can be anonymous and feel comfortable enough to disclose information about their health [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Using material collected from online discussion boards presents an opportunity for researchers to explore unobtrusive data that can complement other methods used for data collection [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The aim of this exploratory study was to explore experiences of adverse reactions related to the copper intrauterine device, as described in Swedish public discussion boards.\u003c/p\u003e "},{"header":"Material And Methods","content":" \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eSwedish public discussion boards about sexual and reproductive health were identified via Google, the most used search engine on the Web [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Two large Swedish virtual communities about reproduction, pregnancy and parenthood were identified. In these communities, searches were performed using combinations of search terms related to the study aim. The specific search terms will not be published in order to protect the identities of the posters included in the sample. Threads in which the first post was written by a poster that described own experiences related to adverse reactions of Cu-IUD were included. In total, 51 threads were identified and included in the sample. In these threads, a total of 144 unique posters (that had written a total of 369 posts in the included threads) described experiences of adverse reactions related to Cu-IUD. The mean number of messages per unique poster was 2.5 (range\u0026thinsp;=\u0026thinsp;1\u0026ndash;77), and 14 posters wrote in more than one thread.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eThe material was inductively analyzed with qualitative content analysis, inspired by the outline presented by Graneheim and Lundman [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. All included threads were read repeatedly to gain an overall understanding of the content. Meaning units related to the aim were then identified, defined as words, sentences or paragraphs that contain aspects related to each other through their content and context. Meaning units were labeled with a code, and collated into categories and sub-categories, i.e., the obvious and observable content identified with as little interpretation as possible. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents examples of the analytic process. The first and last authors were responsible for the primary analysis. The first author, a female registered nurse-midwife, identified meaning units and performed an initial categorization for eight of the threads (n\u0026thinsp;=\u0026thinsp;51 posters). The last author aided in this process, who is a male specialist nurse, registered midwife and researcher with formal training and experience of content analyses. In addition, he separately identified meaning units and performed initial categorization for the remaining 43 threads (n\u0026thinsp;=\u0026thinsp;93 posters). The second author (registered nurse-midwife) scrutinized the analysis to check if the meaning units, categorization, and results represented the raw data. The third author (registered specialist nurse-midwife and professor) aided in the identification of categories.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eExamples of the analytic process\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModified data excerpt\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMeaning units\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCode\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSub-category\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCategory\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eI bled for ten days each menstruation with days of heavy bleeding and also some blood during ovulation. I also had pain during menstruation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eI bled for ten days each menstruation with days of heavy bleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMenorrhagia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMenstrual cycle and uterine bleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePhysical reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSome blood during ovulation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMetrorrhagia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMenstrual cycle and uterine bleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePhysical reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eI also had pain during menstruation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDysmenorrhea\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMenstrual cycle and uterine bleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePhysical reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eLittle bleedings came in between periods during ovulation. I became depressed and the hemoglobin was low. It also was painful.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLittle bleedings came in between periods during ovulation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMetrorrhagia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMenstrual cycle and uterine bleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePhysical reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eThe hemoglobin was low\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAnemia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBlood system\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePhysical reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIt also was painful\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eUnspecified pain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGeneral reactions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePhysical reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eI became depressed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDepression and depressive mood\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNegative alterations in mood and\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePsychological reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003eI want to kill myself sometimes. I have panic attacks. I feel indifference and apathy. The stress is killing me, even though I have no real reason to feel stressed.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eI want to kill myself sometimes.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSuicidal ideation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSelf-injurious behaviors\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePsychological reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eI have panic attacks\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePanic reactions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAnxiety\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePsychological reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eThe stress is killing me, even though I have no real reason to feel stressed.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eStress reactions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAnxiety\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePsychological reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eI feel indifference and apathy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eApathy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNegative alterations in mood and depression\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePsychological reactions\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003ch2\u003eEthical Considerations\u003c/h2\u003e \u003cp\u003eThe sample consists of messages in public discussion boards accessible without any password requirements. According to current guidelines for Web-based research, and in line with recommendations from the Codex rules and guidelines for research in Sweden [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e], texts that are published on the Web without password requirements may be regarded as public and involve an implied consent for use in research [\u003cspan additionalcitationids=\"CR24 CR25\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. In order to protect the identity of the included posters, we translated and modified the quotes, while still making sure that the meaning of the quotes was retained, and changed the user names of the posters to fictitious pseudonyms. The details regarding identification of threads will not be made public, in order to protect the identity of the included posters.\u003c/p\u003e "},{"header":"Results","content":" \u003cp\u003eFour categories were derived from the data: \u003cem\u003ephysical reactions\u003c/em\u003e, \u003cem\u003epsychological reactions\u003c/em\u003e, \u003cem\u003eintensity of adverse reactions\u003c/em\u003e, and \u003cem\u003econsequences of adverse reactions\u003c/em\u003e. Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents an overview of the categories and sub-categories. Nine posters described positive dechallenge, meaning that the adverse reactions ceased when the Cu-IUD was removed. Two posters described positive rechallenge, meaning that the adverse reactions recurred when a new Cu-IUD was inserted after a positive dechallenge.\u003c/p\u003e \u003cp\u003e \u003cspan type=\"ItalicUnderline\" class=\"ItalicUnderline\" name=\"Emphasis\"\u003eCategory 1: Physical adverse reactions\u003c/span\u003e \u003c/p\u003e \u003cp\u003eThe sub-categories in physical reactions included \u003cem\u003eblood system\u003c/em\u003e, \u003cem\u003ecardiovascular system\u003c/em\u003e, \u003cem\u003edevice-related reactions\u003c/em\u003e, \u003cem\u003eears\u003c/em\u003e, \u003cem\u003eeyes\u003c/em\u003e, \u003cem\u003eexcretory system\u003c/em\u003e, \u003cem\u003egastrointestinal and metabolic system\u003c/em\u003e, \u003cem\u003egeneral reactions\u003c/em\u003e, \u003cem\u003eintegumentary system\u003c/em\u003e, \u003cem\u003emenstrual cycle and uterine bleeding\u003c/em\u003e, \u003cem\u003emuscoskeletal and connective tissue\u003c/em\u003e, \u003cem\u003enervous system\u003c/em\u003e, \u003cem\u003ereproductive tract infections and inflammations\u003c/em\u003e, \u003cem\u003euterus\u003c/em\u003e, \u003cem\u003evulvovagina\u003c/em\u003e, and \u003cem\u003esexual health\u003c/em\u003e (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e and Additional File 1). The most common adverse reactions mentioned by the posters were menorrhagia (n\u0026thinsp;=\u0026thinsp;68 posters), dysmenorrhea (n\u0026thinsp;=\u0026thinsp;17 posters), and metrorrhagia (n\u0026thinsp;=\u0026thinsp;18 posters), please see Additional File 1 for more information.\u003c/p\u003e \u003cp\u003e \u003cspan type=\"ItalicUnderline\" class=\"ItalicUnderline\" name=\"Emphasis\"\u003eCategory 2: Psychological adverse reactions\u003c/span\u003e \u003c/p\u003e \u003cp\u003eThe sub-categories in psychological reactions included \u003cem\u003eanxiety\u003c/em\u003e, \u003cem\u003ecognitive impairment\u003c/em\u003e, \u003cem\u003egeneral psychological health\u003c/em\u003e, \u003cem\u003enegative alterations in cognitions and mood\u003c/em\u003e, and \u003cem\u003eself-injurious behaviors\u003c/em\u003e (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e and Additional File 1).\u003c/p\u003e \u003cp\u003e \u003cspan type=\"ItalicUnderline\" class=\"ItalicUnderline\" name=\"Emphasis\"\u003eCategory 3: Intensity of adverse reactions\u003c/span\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eNegative expressions illustrating intensity\u003c/em\u003e (sub-category 1): 34 codes of expressions illustrating intensity were identified (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The expressions portray a significant intensity of the adverse reactions, such as the reaction being \u0026ldquo;\u003cem\u003eawful\u003c/em\u003e\u0026rdquo;, \u0026ldquo;\u003cem\u003eextreme\u003c/em\u003e\u0026rdquo;, \u0026ldquo;\u003cem\u003eindescribable\u003c/em\u003e\u0026rdquo;, and \u0026ldquo;\u003cem\u003etraumatic\u003c/em\u003e\u0026rdquo;. Several described the intensity of increased menstruations as an adverse reaction, including the amount of blood feeling like \u0026ldquo;\u003cem\u003ea flood\u003c/em\u003e\u0026rdquo;, \u0026ldquo;\u003cem\u003ea river\u003c/em\u003e\u0026rdquo;, \u0026ldquo;\u003cem\u003ea downpour\u003c/em\u003e\u0026rdquo;, and \u0026ldquo;\u003cem\u003egigantic\u003c/em\u003e\u0026rdquo;. Posters also described bleeding \u0026ldquo;\u003cem\u003elike a pig\u003c/em\u003e\u0026rdquo; and \u0026ldquo;\u003cem\u003elike crazy\u003c/em\u003e\u0026rdquo;. Some took tranexamic acid or naturopathic drugs to counteract the increased menstruation. Posters described that they needed to change their tampons very often and that heavy menstruation had such intensity that it had a considerable impact on their daily life. Additional File 2 presents an expanded overview of the identified expressions.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eExpressions and quotes in the sub-category intensity of the identified adverse reactions.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExpression\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIllustrative quote (respondent number)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAwful\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI\u0026rsquo;ve never experienced anything more awful.\u003c/em\u003e (82)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCame crashing down\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eAll reactions came crashing down over me\u003c/em\u003e (19)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCan\u0026rsquo;t live like this\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI can\u0026rsquo;t stand waiting if this will pass, I can\u0026rsquo;t live like this.\u003c/em\u003e (39)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCan\u0026rsquo;t move or stand straight\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eSo much pain that I can hardly move or stand straight\u003c/em\u003e (74)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCan\u0026rsquo;t stand it\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI have anxiety during ovulation and anxiety before menstruation. I can\u0026rsquo;t stand it.\u003c/em\u003e (109)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDon\u0026rsquo;t know what to do\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI don\u0026rsquo;t know what to do, the tests are negative and the IUD is correctly in place\u003c/em\u003e (81)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEnormous\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI had enormous pain during and right before menstruation\u003c/em\u003e (9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExtreme\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI feel really strange, I am dizzy, extremely fatigued\u003c/em\u003e (98)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFeel really ill\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eFelt really ill for several years because of it\u003c/em\u003e (82)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFeels like dying\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eYou think that you are about to go insane or about to die!\u003c/em\u003e (1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHell\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI didn\u0026rsquo;t understand what it was until almost a year and it had been a year of hell\u003c/em\u003e (14)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHorrible\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eThe Cu-IUD was horrible for me!\u003c/em\u003e (82)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHow much do I need to withstand\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eHow much do you have to withstand (as a woman)?\u003c/em\u003e (80)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImmense\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI bled immensely\u003c/em\u003e (9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndescribable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI was prepared that it would hurt but the pain was completely indescribable\u003c/em\u003e (77)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInsane\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eIt\u0026rsquo;s insane that you bleed so much\u003c/em\u003e (70)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIt only got worse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eIt only got worse for me.\u003c/em\u003e (132)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIn fetal position, cringing and turning in pain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI\u0026rsquo;m laying on the couch and turning in pain\u003c/em\u003e (80)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLike the plague\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eThe period is really like the plague, long and profuse\u003c/em\u003e (95)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLost hope\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI\u0026rsquo;m loosing hope in myself and become so scared when the panic comes\u003c/em\u003e (27)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMisery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eIt is alright all days except two, when it\u0026rsquo;s misery with the Cu-IUD.\u003c/em\u003e (84)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNever felt this ill before\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eNever felt this ill before!\u003c/em\u003e (60)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNot for me\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eThe Cu-IUD was absolutely not for me!\u003c/em\u003e (76)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNot fun at all\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eThen I got this infection, which was not fun at all.\u003c/em\u003e (54)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNothing positive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI can\u0026rsquo;t say a single positive thing about the copper IUD.\u003c/em\u003e (82)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSick and tired\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI have the Cu-IUD and I am so bloody sick and tired of it\u003c/em\u003e (16)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuffering\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI suffered for two years because of my copper IUD.\u003c/em\u003e (68)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTough\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eThe bleeding was really tough\u003c/em\u003e (11)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTraumatic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eIt was such a traumatic experience for me to have the IUD inserted\u003c/em\u003e (32)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUncomfortable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eSometimes I feel a pinch somewhere in the genital area. It feels so uncomfortable\u003c/em\u003e (46)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWithout equal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eThe worry was without equal...\u003c/em\u003e (1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorse than giving birth\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI have given birth before but I can say that it was worse to have it inserted\u003c/em\u003e (54)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorst experience\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eThis is the worst thing I have experienced\u003c/em\u003e (1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWouldn\u0026rsquo;t wish it on my worst enemy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eI wouldn\u0026rsquo;t wish it on my worst enemy...\u003c/em\u003e (1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eTemporal aspects\u003c/em\u003e (sub-category 2): adverse reactions were described as \u003cem\u003econstant\u003c/em\u003e (described for anemia, dysgeusia, dysmennorhea, metrorrhagia, nausea, unspecific pain, and vertigo), \u003cem\u003eaccelerating over time\u003c/em\u003e (described for abdominal distention, alopecia, altered mood, chest pain, depression and depressive mood, excessive worries and fears, fatigue, general anxiety, mental fatigue, nervousness, palpitations, panic reactions, paresthesia, and vertigo), \u003cem\u003ehaving a fast onset\u003c/em\u003e (described for altered mood, depression and depressive mood, and premenstrual syndrome), and \u003cem\u003erecurrent\u003c/em\u003e (described for menorrhagia and metrorrhagia). One poster had reactions that prolonged over several years, and another described having sought care several times to get help with the reactions.\u003c/p\u003e \u003cp\u003e \u003cem\u003eRetrospective thoughts\u003c/em\u003e (sub-category 3): eleven posters wrote that they would never again consider a Cu-IUD and one poster wrote that she would never had have the Cu-IUD inserted if she had known beforehand about the adverse reactions she experienced.\u003c/p\u003e \u003cp\u003e \u003cspan type=\"ItalicUnderline\" class=\"ItalicUnderline\" name=\"Emphasis\"\u003eCategory 4: Consequences of adverse reactions\u003c/span\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003eDeciding to keep the Cu-IUD despite adverse reactions\u003c/em\u003e (sub-category 1): some decided to accept adverse reactions related to changes in menstrual bleeding. Reasons why these decided to accept the reactions and keep their Cu-IUD were that they regarded that the benefits associated with the contraception outweighed the adverse reactions, preferred using a contraceptive method without hormonal components, and considered the Cu-IUD as the more environmentally friendly alternative in comparison with hormonal contraception. Posters expressed that it was negative that there are so few methods for effective contraception that do not involve hormonal treatment, other than the Cu-IUD.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I\u0026rsquo;ve had a copper IUD before, and had spotting before menstruation. But I still feel that the advantages clearly overweigh the disadvantages. It\u0026rsquo;s nice that it\u0026rsquo;s without hormones, both for the environment and myself. But I\u0026rsquo;m so tired of the fact that there isn\u0026rsquo;t any contraception that is just great.\u0026rdquo;\u003c/em\u003e (Poster 15)\u003c/p\u003e \u003cp\u003e \u003cem\u003eRemoving the Cu-IUD due to adverse reactions\u003c/em\u003e (sub-category 2): 31 posters articulated that they did not accept the adverse reactions and decided to remove the Cu-IUD. Adverse reactions that led to removal included menorrhagia, metrorrhagia, depression and depressive mood, dysmenorrhea, ovulation pain, fatigue, arthralgia, inability to lose weight, altered mood, headaches, unspecified uterine infection, anemia, vaginal discharge, ocular hyperemia, ocular pruritus, pruritus, nausea, paresthesia, eczema, and somnolence.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I bled most days of the year when I had the copper IUD. Finally, I couldn\u0026rsquo;t bear it anymore and decided to take it out.\u0026rdquo;\u003c/em\u003e (Poster 10)\u003c/p\u003e \u003cp\u003e \u003cem\u003eConsequences on sexual health and relationships\u003c/em\u003e (sub-category 3): posters described that the experienced adverse reactions had negative effects on their sexual health, because of menorrhagia, vulvovaginal pain, vaginal discharge, and the partner feeling the cords of the Cu-IUD. These consequences were described to have negative effects on their quality of life. When psychological reactions were experienced, it had negative consequences on the poster\u0026rsquo;s relationships with their partners. Some described that they feared that their relationships would end because of the adverse reactions. Some described that their partner was negatively affected by the alterations in mood and psychological health they experienced.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I\u0026rsquo;ve had terrible premenstrual syndrome during these years that keeps getting worse. I cry, scream and have anxiety. I drive my partner crazy.\u0026rdquo;\u003c/em\u003e (Poster 25)\u003c/p\u003e \u003cp\u003e \u003cem\u003eFears and worries because of adverse reactions and a traumatic insertion\u003c/em\u003e (sub-category 4): some described fears and worries related to the adverse reactions, particularly when they did not recognize the manifestations or could explain them. Posters who had experienced a painful and traumatic insertion expressed considerable fears of seeking care at a gynecologist or midwife. This consequence resulted in deciding not to remove the Cu-IUD, despite wanting to. Some required repeated visits to the midwife before they felt prepared and ready to remove the device.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I tried to have it removed for several months but could not go through with it because of the pain I experienced when it was inserted. It was the most painful situation I have ever experienced\u0026rdquo;\u003c/em\u003e (Poster 32)\u003c/p\u003e "},{"header":"Discussion","content":" \u003cp\u003eThe aim was to explore experiences of adverse reactions related to the Cu-IUD. Public discussion boards were used to analyze from posters with experience of the Cu-IUD, revealing various physical and psychological adverse reactions. The reactions were described in powerful words illustrating an intense experience and burdensome consequences, including impacts on sexual health and relationships as well as fears and worries.\u003c/p\u003e \u003cp\u003eThe findings illustrate that patients place great importance in potential adverse reactions of Cu-IUD and base their decisions to continue or discontinue contraception partly on this aspect. While the desire to have contraception without hormonal effects is an acknowledged reason why clients decide to use a Cu-IUD, changed menstrual bleedings and pain are expected reasons for discontinuation [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. In addition to the expected menorrhagia and dysmenorrhea [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], we also observed more unexpected physical and psychological reactions, including symptoms that could implicate serious conditions such as anemia, fatigue, depression and suicidal ideation. Posters in this study also described alterations in their cognition and mood, such as mental fatigue and increased irritability. Studies have observed a potential association between levels of free copper in blood and cognitive impairment [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Although inconclusive results have been reported [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e], one study also suggests a relationship between elevated copper levels and depression [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. The identified adverse reactions illustrate the importance of follow-up consultations with the aim to identify those who develop adverse reactions. However, research indicates variability with regard to how much attention that is given during contractive counseling to inform about possible adverse reactions, and further, that only a proportion who are prescribed contraception are offered a follow-up visit [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe adverse reactions resulted in burdensome consequences for included posters, including negative consequences on sexual health and relationship with partner. These findings are in line with previous research, illustrating the association between medical conditions and sexual health [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. Another serious consequence was the articulated fear of gynecological care developed among posters with a traumatic experience of the insertion of the device. Pelvic examinations are an essential part of gynecologic care needed for many purposes, including establishing diagnoses, screening for cervical cancer, and for the insertion or removal of intrauterine devices. Consequently, fear of pelvic examinations could lead to serious consequences for women. Therefore, clinicians need to take active measures as to effectively prevent development of these fears [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Research acknowledges that a proportion of clients experience high pain during insertion of intrauterine devices [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e] and that they find the pain more intense than expected [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. Oral analgesia, local anesthesia and cervical priming have the potential to alleviate pain during insertion, but no firm conclusions have yet been drawn concerning implementation of routine clinical use [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. We did not observe any descriptions whether or not the posters were given any pain relief before the insertion. Nevertheless, the findings illustrate the potential impact that painful insertion may have and portray the importance of an individualized approach in which clients who are at risk of high pain are identified and supported. Research indicates that few midwives and gynecologists use analgesia in clinical practice [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e], calling attention to the need for further improvement in clinical management and more studies that investigates how to prevent insertion-related pain for patients who are at risk.\u003c/p\u003e \u003cp\u003eQualitative methodologies have the potential to offer insights into patient perspectives explored in an inductive approach within the field of drug utilization [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. Using the Web to collect patient-generated data could lead to further insights regarding adverse reactions [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e], which was the rationale behind the chosen methodology. This was a convenience sample consisting of persons who decide to write about their experiences on web-based discussion boards. Thus, the transferability of the findings is limited and we acknowledge the probability that those who write about adverse reactions could constitute a subgroup with especially challenging reactions and consequences. The fact that anyone can write in public discussion boards implicate that it would be possible to fabricate stories about adverse reactions. On the other hand, web-based communication involves an opportunity for patients to tell their stories in an anonymous setting and previous research indicates that people disclose more about themselves than they do during face-to-face interactions [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. We did not observe anything during the analysis that would suggest fabrication. Moreover, while all posters did describe their adverse reactions as being caused by the Cu-IUD, we cannot make any certain claims about causality and adverse reactions among the general population. Thus, there is a need for more descriptive and exploratory studies in this field, particularly concerning the impact and consequences that adverse reactions may have for clients.\u003c/p\u003e "},{"header":"Conclusion","content":" \u003cp\u003ePosters who write in public discussion boards about adverse reactions of the copper intrauterine device describe both expected and more unexpected reactions. Some of these are serious events that need to be identified and treated in clinical praxis. When adverse reactions of the copper intrauterine device are experienced they can have burdensome consequences, including sexual health and relationships. Those who experience a traumatic insertion are at risk of developing fear of pelvic examinations, resulting in reluctance to seek care at a gynecologist or midwife. It is important that health professionals identify, prevent and treat pain during insertion. Health professionals need to ensure that clients who have a copper intrauterine device are followed-up accordingly, so that potential adverse reactions and its potential consequences are adequately assessed and supported.\u003c/p\u003e "},{"header":"Abbreviations","content":" \u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCu-IUD\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCopper intrauterine device\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eLARC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eLong-acting reversible contraception\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e "},{"header":"Declarations","content":" \u003cp\u003e \u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e \u003cp\u003eNot applicable.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent for publication\u003c/strong\u003e \u003cp\u003eNot applicable.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e \u003cp\u003eThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCompeting interests\u003c/strong\u003e \u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e \u003c/p\u003e \u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eNo funding supported this work.\u003c/p\u003e \u003ch2\u003eAuthors\u0026rsquo; contributions\u003c/h2\u003e \u003cp\u003eMF designed the study, collected the data, analyzed the data, wrote an early Swedish draft of the manuscript, and critically reviewed the manuscript. MSM designed the study, aided in the analysis of the data and critically reviewed the manuscript. SG aided in the identification of categories and critically reviewed the manuscript. TC conceived and designed the study, collected the data, analyzed the data and drafted the English version of the final manuscript. All authors approved the final version of the manuscript.\u003c/p\u003e \u003ch2\u003eAcknowledgements\u003c/h2\u003e \u003cp\u003eNot applicable.\u003c/p\u003e "},{"header":"References","content":"\u003col\u003e\u003cli\u003e \u003cspan\u003eKopp Kallner H. Benefits of reversible contraception. F1000Research. 2018;7.\u003c/span\u003e \u003c/li\u003e \u003cli\u003e \u003cspan\u003eCommittee on Practice Bulletins-Gynecology, Long-acting Reversible Contraception Work Group. Practice bulletin no. 186: long-acting reversible contraception: implants and intrauterine devices. 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Hum Commun Res. 2002;28:317\u0026ndash;48.\u003c/span\u003e \u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Contraceptive Devices, Drug-Related Side Effects and Adverse Reactions, Intrauterine Devices, Copper, Long-Acting Reversible Contraception","lastPublishedDoi":"10.21203/rs.3.rs-60156/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-60156/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eThe copper intrauterine device is a recommended and effective method for contraception. Recently, agencies have seen an increase in spontaneous reports of adverse reactions, and analysis of messages in discussion boards may lead to new insights. The aim was to explore experiences of adverse reactions related to the copper intrauterine device described by posters in Swedish public discussion boards.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eMessages containing descriptions of client experiences were collected via Swedish public discussion boards about sexual and reproductive health, identified through searches in Google. Posters with experience of adverse reactions were included (n\u0026thinsp;=\u0026thinsp;145 unique posters) and their messages were inductively analyzed with qualitative manifest content analysis.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eFour categories were derived from the data; physical reactions, psychological reactions, intensity of adverse reactions, and consequences of adverse reactions. Adverse reactions were identified as physical reactions (15 sub-categories illustrating the different types of reactions) and psychological reactions (5 sub-categories illustrating the different types of reactions). Posters expressed significant intensity of adverse reactions, such as the reaction being awful, extreme, and traumatic. Some had such a negative experience of adverse reactions that they would never again consider a copper intrauterine device and that they would never had it inserted if they knew about the experienced adverse reactions. While some decided to accept adverse reactions and keep the device, others did not and removed it. Adverse reactions had negative effects on sexual health, partner relationship, and fears and worries, including fear to seek gynecologic care because of a traumatic and painful insertion.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eDescriptions of both expected and unexpected adverse reactions of the copper intrauterine device can be found in discussion boards, some which can feel like being of high intensity and have burdensome consequences in the lives of clients. Midwives, nurses and physicians working in contraceptive counseling need to ensure that clients are sufficiently informed about possible adverse reactions and followed-up accordingly. More research is needed that further investigates adverse reactions of the copper intrauterine device and the impact such reactions may have for clients.\u003c/p\u003e","manuscriptTitle":"Adverse reactions of the copper intrauterine device and related consequences: experiences described in discussion boards","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2020-09-21 14:55:34","doi":"10.21203/rs.3.rs-60156/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fad19b55-8f77-4b5e-8193-7d065ecd900e","owner":[],"postedDate":"September 21st, 2020","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":562151,"name":"Women's studies"},{"id":562152,"name":"Health Economics \u0026 Outcomes Research"}],"tags":[],"updatedAt":"2020-10-19T18:33:45+00:00","versionOfRecord":[],"versionCreatedAt":"2020-09-21 14:55:34","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-60156","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-60156","identity":"rs-60156","version":["v1"]},"buildId":"cBFmMYwuxLRRLfASyISRj","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}