When there is an opportunity to gain a positive reputation, individuals are more willing to sacrifice their immediate self-interest. Partner choice creates opportunities for competitive altruism, i.e. individuals compete to be regarded as more generous and to be chosen for future partnerships. Tests of the competitive altruism hypothesis have focused so far on reputation based on direct observation, whereas the role of gossip has not been theoretically and empirically addressed. Partner choice can create an incentive to cooperate and to send truthful messages, but it can also work in the opposite direction. In order to understand the consequences of partner choice on cooperation and gossip, we designed an experimental study in which participants played a sequence of Public Goods games and gossip rounds. In our two treatments, we observed that cooperation increased when there was an opportunity to be selected, but also that cooperators sent more honest messages than defectors, and that this strategy was prevalent in the treatment in which inter-group competition was implemented. We also found evidence that participants detached themselves from the information more often when lying. Taken together, our study fills a theoretical and empirical gap by showing that partner choice increases both cooperation and honesty of gossip.This article is part of the theme issue ‘The language of cooperation: reputation and honest signalling’. It isIn a ‘market for cooperators’ , i.e. whReputation-based partner choice ,23 is baet al. [Gossip is the cornerstone of reputation in humans, and the choice between honest and truthful information about others or lying creates the ‘gossiper’s dilemma’ ,27. Becaet al.  suggest This view of gossip as being inherently unreliable has been recently questioned by empirical evidence indicating that the manipulative potential of gossip is less detrimental to cooperation than expected . This hoThis study contributes to the literature on cooperation and, more specifically, on the debate about the reliability of gossip by extending competitive altruism theory and suggesting that partner choice could ensure both material and informational cooperation. If cooperation is a costly signal, then reputations need to be effective in discriminating between cooperators and defectors. We hypothesize that cooperators have an incentive to be honest in order to preserve the signalling value of reputations and benefit from their previous material investment. Cooperation would go hand in hand with honest gossip because only truthful and honest information about cooperators and defectors will allow cooperators to benefit from partner choice. In a complementary manner, defectors would have an incentive to spoil the reputation system, actively contributing to its unreliability. If most of the gossip is dishonest it also becomes useless, therefore benefiting those who did not contribute because it becomes impossible to identify who the cheaters are.et al. [In addition to lying about content, gossip can also entail a misrepresentation of the source. Previous studies on false gossip mostly focused on content manipulation, without considering how important it can be to change the source when reporting information about an absent third party. Qualifying one’s endorsement or presenting information as originating with someone else, like ‘people say’ or ‘rumour has it’, distances the speakers from the information, thereby reducing their responsibility for what is told ,34. Peteet al.  show thaet al. [In order to test the relationship between competitive altruism, cooperation and the reliability of gossip we designed an experiment in which two blocks of PGG are played by groups of four participants . Each blet al. . Table 1. 2 (a)Participants were recruited from the University of Valencia Experimental Economics Laboratory’s (LINEEX) subjects pool. One hundred and sixty students from different faculties of the University of Valencia, excluding Economics students ( (b)Each experimental session involved a group of 16 participants playing three phases. In order to ensure anonymity, participants were identified by pseudonyms, i.e. 16 moons of the solar system, that remained unchanged during the entire session. Communication between participants was not allowed and they were not informed about others’ pseudonyms. No participants were excluded from the analysis and all of the 160 registered participants completed the experiment. Two experimental treatments called Competitive (COMP) and Non-Competitive (NCOMP) were carried out. COMP and NCOMP treatments were identical except for phase 3. Participants were informed about all treatment details at the beginning of the session when reading the experimental instructions.  (i)Dione to Proteo: ‘I know that Temisto cooperates’.Adrastea to Rea: ‘Someone told me that Febe does not cooperate’.Each participant was randomly assigned to a group of four members that remained the same during the entire PGG stage. Each group completed 10 rounds of a standard PGG with a value of 1.5 as multiplication factor and a round endowment of 50 points. Participants were informed about others’ contributions and their own payoffs at the end of each round. After the PGG stage, the first gossip stage started (in the experiment we used the term ‘information exchange’ and not gossip). In this stage, participants were assigned to four gossip groups formed of four members each, selected in order to have: two members from one previous PGG group and two members from another PGG group. During this stage, participants were given the opportunity to send multiple messages to one, two, or all other members of their gossip group. Messages were displayed as a chat text through a computer interface and participants could only communicate through predefined texts. The sender, i.e. the participant who is the source of the message, can begin the message with only two predefined sentences: ‘I know that…’ or ‘Someone told me that…’, and can choose the target and the recipient of the message among the other 15 participants of the session. Then, the sender selects the content of the message between ‘cooperates’ and ‘does not cooperate’. Here follows two message examples:There was no limit on the number of exchanged messages but the information exchange stage was set to be 5 min long. (ii)Each participant was assigned to a new group of four members who remained unchanged during this PGG stage (again 10 rounds). Groups were formed in order to have combinations of two participants who had interacted before and two strangers, therefore we could control for the reliability of the content and the source. Then, another stage of information exchange played in four other different groups followed. The information exchange stage lasted 5 min, exactly like the previous one. (iii)In the last stage, two new groups were formed through partner selection by two randomly selected group leaders. Group leaders alternatively chose seven other group members, with whom they completed a one-shot PGG with a value of 3 as multiplication factor and an endowment of 50 points. In the COMP treatment only the group contributing the most was paid for this phase, while in the NCOMP treatment both groups were rewarded according to their contributions. Group leader selection and a higher multiplication factor were designed to make partner selection salient to the participants.. 3 (a)We classified each gossip message according to the scheme in ‘Someone told me that…’ messages are classified as fake origin messages if the sender did not receive any message about the target . In a similar manner, messages are then classified as false or truthful depending on whether the sender modifies the content of the last received message about the target.χ2-test: χ = 8.6374, d.f. = 1, **p = 0.0033) and ‘I know that…’ truthful positive message frequencies , having more fake acquaintance messages in the NCOMP treatment .We report in χ2-test: χ = 12.813, d.f. = 1, ***p = 0.0003). This result means that truthful messages are generated more often from a direct source when considering both treatments. On the other hand, this difference is more visible and statistically significant in the COMP treatment  than in the NCOMP treatment .Furthermore, when a participant sends a ‘I know that…’ message, its content is truthful more than half of the time , as well as the other type of messages ‘Someone told me that…’ , with a significant difference in favour of the former type of messages , as well as for the COMP treatment  and the NCOMP treatment .Finally, to confirm our H3, ‘Someone told me that…’ messages are classified as false more frequently than direct source messages when looking at both treatments W = 4109, **p = 0.0019; phase 3, W = 5235.5, ***p < 0.001; MW test by group averages: phase 3, W = 100, ***p < 0.001).In W = 3834, *p = 0.0306; phase 2, W = 4068, **p = 0.0031).As predicted by the competitive altruism hypothesis, no remarkable end-of-game effect on contributions is present in the COMP treatment. In fact, participants were even more generous in the last rounds of COMP phase 2 with respect to NCOMP, when the pressure to be chosen as partners was higher and generosity could increase one’s chance of being selected during phase 3. In line with our H1b, differences on individual average contributions by phase are enhanced and statistically significant the closer participants are to the end of the experiment  and in a non-competitive  setting. Our research shows that competition to be chosen increases cooperation and, more importantly, that cooperators and defectors adopted different gossip strategies. Cooperators were more likely to report true information about other players, as opposed to defectors, and we observed a positive correlation between contributions in the game and the reliability of gossip for cooperators but not for defectors, and only in the competitive treatment.This study contributes to the literature on reputation-based cooperation in multiple ways. First, it provides further evidence in favour of the competitive altruism hypothesis . In an eSecond, to the best of our knowledge, this is the first study in which specific hypotheses about gossip strategies are derived from the theory of competitive altruism and tested. If cooperation has signalling value, then investing in it is beneficial only if the gossip about cooperators is honest, and they can be reliably identified and selected for future partnerships. In a complementary way, our results show that defectors actively try to undermine the reliability of gossip by spreading false information. This difference in gossip strategies adds to the ongoing debate about the honesty of gossip ,39,42,43Finally, this work contributes to the understanding of source manipulation as part of reputation management strategies. According to previous theoretical and experimental work on source manipulation ,37, usinFuture work on linguistic markers of gossip and on its consequences would allow the characterization of reliability not only in terms of what is told, i.e. its content, but also of the way in which the source is identified.Theories of reputation-based partner choice that do not explain the use of gossip are incomplete because reputations emerge from people talking about others ,49, and


There is an apparent reluctance to engage ‘vulnerable’ participants in conversation about sensitive topics such as suicide and violence and this can often lead to a paucity of research in these areas. This study aimed to explore the experiences of male prisoners taking part in quantitative and qualitative research on suicide and violence.Participants at four male prisons completed a visual analogue scale of mood before and after data collection for both a cross-sectional study and also a qualitative interview. Participants were also asked to give three words to describe their experience of participation. A paired samples T-test was conducted to explore the difference in pre- and post-mood ratings, and content analysis was conducted to explore the positive and negative comments on participants’ experiences.p = 0.016), and there was no significant change in mood following participation in a related qualitative study . Participants primarily described their experiences as positive, stating that the process had been satisfying, calming, interesting, enlightening and beneficial. A smaller number of participants described their experiences as stressful, challenging, saddening, uncomfortable and bizarre.Overall, participants’ mood significantly improved after participating in a cross-sectional study about suicide and violence . At the beginning of the session people were asked to rate their mood from 0 to 10. Zero was the worst possible imaginable mood and 10 was the best possible imaginable mood. People were asked to do this again at the end of the session. People were also asked to give three words to describe their experience of the session. The people who took part in the questionnaire study had a significant improvement in mood after the session. The people who took part in the interview study had no difference in mood after the session. Most people gave positive words to describe the session. People said the session was satisfying, calming, interesting, enlightening and beneficial. A smaller number of people gave negative words. They described the session as stressful, challenging, saddening, uncomfortable and bizarre. This study therefore contrasts the idea that prisoners will become upset if they take part in research about suicide and violence. Therefore, we should continue to research this area.The online version contains supplementary material available at 10.1186/s40900-021-00303-z. The decubjects” . Furthertection” .Some researchers have come to consider specific topics of research and / or specific groups of participants as particularly open to the risk of harm from research participation. For instance, some have questioned the studying of topics such as suicide due to the psychological harms that may be associated with this. Indeed, researchers have reported concerns prior to embarking upon suicide research about the distress that may be caused to participants  with onereductions in levels of suicide ideation from pre-to post-assessment and participants exposed to suicide-related content were significantly less likely to report a suicide attempt than individuals who were not exposed to such content [Despite this, there is now a body of evidence to suggest that, not only does taking part in suicide research not cause harm, it may also have a beneficial effect for participants. For example, a recent meta-analysis found that exposure to suicide-related content did not result in significant changes in levels of distress from pre- to post-assessment, nor did it lead to higher levels of immediate or delayed distress in comparison to those not exposed to content on suicide . Further content . Further content . Partici content .A particular group of participants that may be considered as ‘vulnerable’ are prisoners. Indeed, ethics review boards are known to label prisoners as “high risk” or “vulnerable subjects”, which can make access for researchers difficult and may hinder scientific inquiry . PrisoneThe present study describes a research methods study nested within a larger study which has already been published elsewhere , 17. The“any act of self-poisoning or self-injury carried out by a person, irrespective of their motivation” [“Violence and aggression refer to a range of behaviours or actions that can result in harm, hurt or injury to another person, regardless of whether the violence or aggression is physically or verbally expressed, physical harm is sustained or the intention is clear.” [“persons displaying both harm to self and harm to others” [Alexithymia can be defined as an inability to identify or describe feelings and is also related to an externally oriented thinking style . Researcivation” . Violenc clear.” . Dual ha others” .The present study aimed to investigate male prisoners’ experiences of participating in both a qualitative enquiry and also a cross-sectional, questionnaire-based study that explored sensitive topics such as suicide, self-harm and violence.The present study describes a research methods study nested within a larger study which has already been published elsewhere , 17. A qData for this study were taken from participants who had been selected to take part in either, or both, a qualitative study  or a croData were collected from three host prison sites in the North West of England. These included a category ‘A’ prison (maximum security), a category B prison (establishments for those who do not require maximum security but for whom escape must be made difficult) and a category C prison (for prisoners who cannot be housed in open conditions but who are unlikely to try to escape). Data collection occurred in a private room within each of the prisons, with only the researcher and participant present.A patient and public involvement group was recruited to assist with all studies, in order to ensure data collection, analysis and dissemination included the views of individuals with lived experience of incarceration. The group inputted to the design, the data collection tools  and made important changes to the interview process which highlighted the need to recognise participant concerns and distress. A full outline of the extent of patient and public involvement is outlined elsewhere  and is a“If you could choose any three words to describe our session today, what would they be?”. Participants were encouraged to provide their own words, but for those who struggled or showed a reluctance to do so, a list of possible words . Following this, the words were sorted into ‘positive’, ‘neutral’ and ‘negative’ words by LH and PB. Words were categorised according to the word itself, as well as the accompanying free text which helped to give context to whether the word was used in a positive, neutral or negative manner. Only positive and negative words are reported upon in this paper. Within this framework, similar words were then grouped together to form themes, which were reviewed and revised following discussion between authors, including an individual with lived experience of incarceration. Where notes had been made about the context of each word, these were analysed using thematic analysis [First, a list of words used to describe data collection sessions was compiled across both the qualitative and cross-sectional studies, with frequencies of each word recorded. Word clouds were created to illustrate visually the frequency of words given, using a free online word cloud generator ).A total of 79 (out of 80) participants provided pre- and post-VAS scores when completing the cross-sectional data collection. The participants were male, predominantly White British (87%) and had a mean age of 34.7 years (SD = 9.02). The pre- and post-VAS data for cross-sectional participants were considered to be normally distributed. The mean score for mood at the beginning of cross-sectional data collection sessions was 4.8 (SD = 2.2) and the mean score for mood at the end of the session was 5.3 (SD = 2.0). A paired samples T-test revealed this to be a statistically significant improvement in mood ).A total of fourteen (out of fifteen) participants provided responses about their experiences of participating in the qualitative study. The participants were male, predominantly White British (86%) and had a mean age of 34.4 years (SD = 8.99). The assumption of normal distribution was considered to be met. There was no significant difference in pre-VAS scores  and post-VAS scores  for the qualitative study  and 77 participants provided responses about their experiences of participating in the cross-sectional study . Across all 91 participants, a total of 97 words were given, and these words were given a total of 323 times. A total of sixteen words (16%) were from the list of suggested words and these words were mentioned a total of 167 (52%) times. Figure Of the 97 words provided, a total of 58 (60%) words were coded as positive, and these were mentioned a total of 216 times (67%). A total of 43 participants used only positive words to describe the session, and a further 30 participants used both positive and negative words to describe the session. The most frequently used positive words were interesting (N = 39), good (N = 16), worthwhile and helpful (N = 14). Figure Someone listening. It helps. Normally it falls on deaf ears. (W45)Good. To. Talk. It’s nice to say how it is to somebody like you. (W46)People also described how they had enjoyed the session, had had fun, and found some of it funny even. This led to participants feeling content and happy and participants described their mood improving after completing the session.Some of the questions were fun and we had a laugh. (W48)I’d do it again. I feel better now that I’ve done it. (W60)Participants used a range of words to describe how the data collection sessions had been satisfying including good (N = 16), enjoyable (N = 10), happy (N = 5), pleasant, mood-lifting, okay (N = 2), awesome, fun, funny, content, joyful and satisfying (N = 1). Primarily participants described the session as ‘good’ due to the opportunity allowing them to discuss feelings, get things off their chest and have somebody listen to them.I felt relaxed for the whole thing even though some of the questions were a bit touchy, I tried to answer all of them honestly. (W61)As well as describing the sessions as satisfying, participants described the sessions as relaxing, calming (N = 7) and chilled (N = 1). Again, this was associated with an improvement in mood following data collection.The questions related to me. I’m interested in how you’ve come about those questions. I felt it was directed to me. (W28)Participants described the sessions as interesting (N = 39), intriguing (N = 5), exciting, relatable and even mind-blowing (N = 1). Participants tended to be interested in the types of questions being asked of them, interested to find out more about themselves through the process of data collection and also interested by how relatable the questions felt to them.Making me think about what sort of person I am and what I need to be when I go through the gates. (W53)Learning something about myself and understanding my own thoughts and feelings. (W41)Emotional improvement – I don’t tend to understand emotions, but now I understand them a little bit more. (W55)Participants spoke about data collection sessions being enlightening and used a range of words to describe this; insightful (N = 12), thought-provoking (N = 8), informative (N = 4), educational (N = 3), productive, articulate, reflective, awareness, improvement, knowledge, realisation, brain teaser and eye-opening (N = 1). Primarily, people spoke about the data collection session inviting them to think about things they hadn’t previously considered or reported that they saw things in a different light to what they had previously.It makes me think more. Although I was told there will be no direct benefit for taking part, I feel that I am getting something out of it just by doing it. (M08)In addition, participants stressed that they were glad to have taken part due to it being helpful to others, including the researcher and also others in the future who may find themselves in a similar situation to the participant.I feel it’s helping someone else down the line. (W15)Because it will help the researcher to obtain PhD and help others in the future who are feeling suicidal. (M04)Participants described the sessions as being beneficial both to themselves and to others in a range of ways. Participants used the following words to describe these benefits: helpful, worthwhile (N = 14), useful (N = 11), therapeutic (N = 8), comfortable (N = 3), meaningful (N = 2), important, inspiring, appreciative, glad, grateful, re-usable and supported (N = 1). People spoke about the benefits of participating for themselves being mainly that the session had been cathartic or therapeutic for them, that they had gained knowledge from taking part or that their mood had improved as a result of taking part.Not something I do every day, or every week, or every month. It was a good difference because it got me out of my cell. (W30)Participants spoke about taking part in research as being a new experience which was viewed as a welcome break from the monotony of prison life. Participants used words to describe this such as different (N = 3), experience (N = 2), timeout and eventful (N = 1).Researcher was patient and smiley. (W35)Participants described the research process as in-depth/deep (N = 2), easy, fair, quick and reasonable (N = 1). Again, these were all viewed favourably by participants:I enjoyed going as in-depth with questions. It’s different to anything I’ve done before. (W40)You get all the options to the answers and the questions seem reasonable. (W36)Participants described the researcher as friendly (N = 1), open (N = 1) and understanding (N = 1). Participants viewed these traits positively.Of the 97 words given in total, participants used a total of 30 (31%) negative words to describe the sessions with a total frequency of 98 (30%). Ten participants gave negative words only to describe the sessions, and a further 30 participants gave a combination of positive and negative words to describe the sessions. The most frequently used negative words were anxiety-provoking (N = 13), uncomfortable (N = 10), stressful, embarrassing, and upsetting (N = 8). Figure Sometimes answering the questions truthfully was anxiety provoking. (W11)Once the questions started, I wasn’t anxious. But at the start some questions made me feel uncomfortable. (W25)At times distressing due to some of the more intense questions, e.g. about suicide. (W08)Some participants described data collection sessions as anxiety-provoking (N = 13), stressful (N = 8), worrying (N = 3), scary and distressing (N = 1). People spoke about being worried due to not knowing what to expect and finding answering the questions anxiety-provoking. It is worth noting that several participants identified this as due to having existing anxiety problems, and others mentioned that the anxiety dissipated as the session went on.I had to think about things, but I enjoyed the challenge. (G01)As a result of this emotional demand, some participants described the session as tiring (N = 5) and draining (N = 1).Participants spoke about finding participating emotionally challenging using words such as difficult, challenging (N = 5), testing, tough and probing (N = 1) to describe the process. This was typically related to questions reminding participants of past difficult times, and it being difficult for participants to re-experience this.It’s made me feel a bit sad. (W39)In contrast to participants describing the session as satisfying (3.2.1.1), some participants spoke about sessions being upsetting (N = 8), saddening (N = 4), emotional (N = 3) and depressing (N = 1). People particularly felt that questions about suicide and self-harm could be upsetting.Getting started was quite uncomfortable because they’re quite personal questions. Once we got started I felt comfortable. (W60)Despite participants reporting feeling comfortable with the sessions, some reported feeling uncomfortable (N = 10), embarrassed (N = 8), awkward and vulnerable (N = 1). Participants largely cited reasons for this discomfort as being due to the personal nature of the questions, and also cited specific reasons such as being embarrassed by a lack of literacy and being asked about sexual appetite and their offence.Lost interest because it took too long. (M09)Some participants described the session as long (N = 3), repetitive (N = 2) and boring (N = 1). Particularly in relation to the cross-sectional study, participants felt that they were often asked the same questions in different ways, and this led to them becoming disinterested in the process.You’re new to me, so it’s hard to try and answer the questions you’ve asked me. (W56)Not knowing what was going to be asked. (W19)A very small number of participants described sessions as weird (N = 2), silly, unexpected and unusual (N = 1). This was mainly in relation to participants feeling ‘weird’ about opening up to a relative stranger, and also was about unknown aspects of the assessment.A lot of questions and lots of different answers. It’s not straightforward, but it’s manageable. (W59)In direct contrast to those participants who described the session as easy and fair, others described it as confusing (N = 4), complex and baffling (N = 1). This was typically in relation to being asked questions they hadn’t previously considered, and due to the diversity and breadth of questions asked.This study has found that overall, participating in a research study about sensitive topics including suicide and violence had positive benefits. Although there were some negative impacts, these were less frequent than positive, and overall, mood improved following participation. Whilst there was no significant change in mood following participation in a qualitative study, it is important to note that the T-test included only fourteen participants, so it is likely that there was not enough power to detect a significant change in mood. The findings of this study echo previous findings of a meta-analysis which found that participating in suicide research did not lead to a statistically significant increase in distress . PertineThe words chosen to describe experiences of participation were predominantly positive with participants describing their participation as satisfying, calming, interesting, enlightening and beneficial. Participants also described the research process and the researcher positively and acknowledged that participating had given them an opportunity to experience something new. Previous studies have found that ‘vulnerable’ participants have described participating in the research process as beneficial both to themselves and to others , 29, 30.Despite the overwhelmingly positive experiences of participation, it is important to acknowledge that some participants described their experiences negatively. Namely, participants found the experience to be stressful, challenging, saddening, uncomfortable, bizarre and complicated. It is important to note, however, that participants who gave negative words did so most frequently in combination with positive words, indicating that very few participants found the process to be entirely negative. In addition to this, many of the responses accompanying the negative words given outlined that although there may have been negative aspects of participation, these were deemed to be acceptable by participants. Previous studies have echoed findings that participants may experience initial apprehension or nerves prior to participation , 30, 32.As aforementioned, an individual with lived experience of incarceration was invited to contribute to this paper at a number of different stages. In this section, PB outlines his reflections on this experience, providing an overview of how the findings of this study resonate with his own lived experience of incarceration.My comments are based on my lived experience as an ex-prisoner. The findings reflect my experiences of prison life and of others I came into contact with. I can relate to the comments made, for example that being involved in the study breaks up the monotony of prison life. But more than that, it offers an opportunity to engage with something perhaps new to the participant such as the field of research and education. It may offer an introduction to a topic they may never have considered or knew existed, but they may notice a connection to how they view the world and themselves .The findings appeared to be that participants felt valued and felt that their participation gave them back some self-worth which may have been eroded. Prison can sometimes feel like a zoo. The researcher can be seen as the one doing a field study of animals (prisoners) that they may never have encountered face to face other than on TV, such as the more exotic animals (violent prisoners). This is therefore often outside of the researcher’s realm of experience and is like a field study. The zookeeper (prison staff) may tell the researcher to watch out, be careful, they’re dangerous animals, don’t turn your back for a second and pay attention to the safety briefing. However, participants in this study described feeling like they were being asked for their help, and not being studied like an ‘exhibit’. They may have felt useful being able to contribute to research which may help others in the future. People like to feel needed, and these participants might have been instrumental in bringing about positive change. Comments about wanting to help the researcher with their PhD suggested that they felt needed by someone else rather than them having to seek someone else's approval or needing something themselves and having to submit to authority.to them as opposed to with them and this felt less of a disempowering experience.The language used by participants felt participatory and inclusive. Participants acknowledged that it had been outlined to them that there were no direct benefits to taking part, but still they felt they had benefited from the fact they had been asked to take part. They had been consulted. This outlines to me that the participants may have been used to having things done Participants used very positive language throughout about their experiences, but this could be due to the artificial environment of being contained and them feeling obligated, or even conditioned, to give positive favourable responses, and not to rock the boat. They may have been conscious of appearing to be cooperating to look good on their record of being a good participant, and to avoid disappointing the researcher. Alternatively, they may have felt peer pressure or pressure from staff for example. They may have little contact with the outside world or no visitors and having interaction with someone may have therefore increased feelings of well-being.The results showed that taking part did not lead to a decrease in mood, although this finding was not statistically significant for those who participated in the qualitative study. I think the qualitative interviews were more challenging as these can potentially lead to participants feeling they have opened up a can of worms by discussing sensitive topics such as violence/suicide. This may lead to participants reflecting upon the pertinence of the questions asked and puzzling over themes that appear outside of their realms of experience. Hence why they commented they found aspects 'bizarre'.There can be triggering words, phrases and scenarios which can be more hard hitting than when rating mood using scales. Also, any harms associated with participating may not be obvious to the researcher, or the participant, until later. For instance, participation in the study may not be instantly recognisable as a trigger for something and could lead to a decline in mood that the participant is not aware of.I think the results demonstrate the need for an advisory group to be involved in planning of any future research from the outset to mitigate these factors. However, it’s important to be mindful of the training issues such as issues around prior knowledge, education, power imbalances around research/ academia and issues of class, race, poverty and disadvantage amongst other factors. Also access needs such as documents in large print and a glossary of terms used which may be unfamiliar to participants, should be considered when working with advisory group members.This study makes a unique contribution to the literature in its exploration of male prisoners’ experiences of taking part in research on sensitive topics such as suicide and violence. The study has benefitted from exploring in some detail individuals’ experiences whilst adopting a relatively brief methodology, which avoided placing undue burden on participants or engaging in an arduous process. The study also benefits from its inclusion of an individual with lived experience of incarceration, which helped to contextualise the words given by participants and to provide a different perspective on the findings. A final strength of this study lays in its diversity of host prisons, spanning several different categories and functions, meaning that these prisons therefore represent prisons typical of the UK.Despite this, the study is not without limitations. The comments given by participants were verbal, and notes were written by the researcher. This may have led to inaccuracies for example in comparison to having recorded conversations and transcribing them verbatim; interpretation or meaning may have been altered between the participants’ comments and the researcher’s recording of these. Moreover, this brief methodology inhibits the opportunity to explore in-depth individual’s experiences of participating in sensitive research, since data is limited to short excerpts only. Related to this, this sample represents a particularly challenging sample to conduct this nature of research with; indeed, several participants had high scores on a measure of alexithymia indicating difficulties with describing feelings. Thus, whilst it may have been necessary to provide a predetermined list of words to choose from, this somewhat inhibits the ability for participants to describe their feelings, and may have introduced bias. It is also possible that participants may have been reluctant to give honest opinions about the research experience, given that the same researcher completed the data collection with them and then asked about their experiences of this. Despite concerted efforts to recruit a diverse range of participants, this sample was predominantly White British, and it is important to note that other populations may respond differently to these sensitive topics for instance females, LGBTQIA+ and BIPOC. Finally, the data were collected immediately after the data collection session ceased; it is therefore not possible to draw conclusions about the long-term consequences of participation or whether the positive and negative impacts described here were lasting.Future research should aim to explore in greater detail male prisoners’ experiences of participating in sensitive research. Specifically, future research should utilise more open qualitative methodologies , and responses should be audio recorded and transcribed verbatim. Future researchers should also consider appointing a third party, possibly a researcher with lived experience, to independently conduct the research to minimise the potential impact of social desirability. Future researchers should also consider exploring similar topics in a more diverse range of prison populations, for instance youth offenders, female prisoners and prisoners from BIPOC communities.The findings of this study also have important implications for those researching sensitive topics with ‘vulnerable’ populations. This study has shown that conducting research with male prisoners on sensitive topics did not impact negatively on mood, and in fact improved participants’ moods, on average. Future researchers and ethics review boards should therefore consider this evidence when reviewing research topics and methodologies and use the evidence to make a balanced assessment about the likelihood of participants experiencing harm as a result of participating in such studies.Others have noted the difficulties that researching in prisons can bring –35, and Lastly, the results of this study can also be used to improve both recruitment rates to studies as well as to improve the experiences of participants who agree to take part. For instance, it may be appropriate to include material in participant information sheets which outlines some of the possible benefits of participating in research such as feeling calm and happy after participating, having an opportunity to experience something new (particularly relevant to prisoner populations) and the possible benefits both to the individual and to others. Moreover, the findings reveal some practical points which should be considered in the research process, for instance ensuring that researchers are open, friendly and understanding, and ensuring that research processes are fair, easy, quick and reasonable. Working with a patient and public involvement group may be of use with this latter point, to ensure that all questions being asked of participants are deemed appropriate and not too complicated. Furthermore, it would also seem appropriate to communicate to potential participants the possibility of negative consequences such as finding the experience stressful, challenging, saddening and uncomfortable. It would be worth explaining to participants that the majority of people find these effects to be transient and manageable  and do nThis study has found that male prisoners participating in a study about suicide and violence did not experience a significant negative impact on their mood. Moreover, participants generally described the experience of participating in a positive manner, with negative comments given mainly in tandem with positive comments. This study therefore suggests a need for researchers to reassess their views of prisoners as a ‘sensitive’ population, and also to reassess topics such as suicide and violence as ‘sensitive’ or ‘risky’. This is important, given the paucity of research in these populations on such topics.Additional file 1. Visual Analogue Scale of mood.Additional file 2. List of suggested words.Additional file 3. GRIPP2-SF.


The research aim was to evaluate the rationale of undergraduate final-year student nurses to undertake paid clinical placements during COVID-19 (Wave 1). The nursing profession reacted innovatively to meet demands placed on the National Health Service during COVID-19. Temporary changes to professional regulation enabled final-year United Kingdom nursing students to voluntarily undertake paid placements in the National Health Service. Neither full-time employees nor full-time students, volunteers undertook a unique hybrid role bolstering the front-line health workforce. Using reflective qualitative inquiry, 17 volunteers evaluated reasoning for entering practice in acute hospitals. Online surveys based around the UK Nursing and Midwifery Council Competency Framework (NMC 2012) were completed weekly for 6 weeks. Data were thematically analysed. Six themes were identified, including sense of duty, and opting-in or out. These highlighted the importance of collaboration and the tripartite relationship between University, host and student during placement, and the influence of these on the learning experience. Several significant insights emerged for nurse education and curricula during pandemics related to patient safety, safety climate and governance. The insights were used to develop a “Student Nurses Placement Framework” with recommendations for Pre-During-Post placement, offering a guide for future nursing workforce recruitment and retention. This paper presents findings from a United Kingdom (UK) service evaluation adopting a reflective qualitative inquiry approach to highlight third-year student nurses’ preparedness to enter practice early during the Covid-19 pandemic. Using an online survey, the overarching service evaluation question was: “How effective has Higher Education been in preparing undergraduate pre-registration third-year final student nurses to respond to an emergency situation–COVID-19?”The survey was designed around the NMC  competenWhat led your decision to opt into a voluntary paid clinical placement during this emergency period arising from the COVID-19 pandemic?What impact has the removal of supernumerary status had on your supervision and support in practice?A reflective qualitative appreciative inquiry approach was considered ideal because it enabled the collection of real-time data during Wave 1, using a simple, logical phased approach to explore the following questions:The paper outlines a background to the pandemic, describing the UK’s nursing response and incorporating a review of the relevant literature at the time. Four emergent themes were evident from the literature: “international concern and response”, “policy and guidance”, “student and staff experience” and “clinical practice and learning environment”; these are used to frame the discussion of the survey findings.At the time of writing, COVID-19 has reached over 220 countries and regions, infecting 190,770,507 individuals, contributing to 4,095,924 confirmed deaths as at 20 July 2021  campus in the city centre. This is believed to be the only such facility in the north west to assist in preparing nurses and other frontline health and social care staff for the outbreak at a time of exceptional demand” .This enabled students to make an informed choice to opt-in to undertake a paid placement. The University focused on evaluating student nurses’ response to the call for volunteers, and the level of preparedness of final-year students to undertake this unique role. “Preparedness” or “the state of being ready for something to happen” , in thisA literature review was conducted using the search strategy outlined in Mitigating virus spread by introducing social distancing, PPE and infection prevention control measures;Initiating institutional responses in education delivery, e.g., the move towards e-learning, information technology equipment and support;Online learning to enhance digital literacy;Use of simulation to improve student nurses’ non-technical learning  and aid The international impact of COVID-19 on undergraduate pre-registration nursing according to Carolan et al.  and Belt“Challenging” because students needed to adapt to new ways of working away from campuses, adjusting to online delivery by embracing the shift to e-learning and associated flexibility ; for somCOVID-19 placed global pressure on governments, care regulators and professional bodies to respond to ease demand on health and care systems and staff. UK NMC  emergencExperiences of working during the pandemic are emerging; four student focused articles ,16,17,18Safety and protection of student nurses and staff emerged as a priority, and maintaining a safe and effective clinical practice and/or learning environment was critical . A soundReflective qualitative inquiry see  offered The service evaluation focused on “process” and “impact” to capture reflections of adult student nurses’ preparedness moving into practice.Process evaluation included how interrelated processes within a project and programme were implemented, who was involved, resources used, and success and problems experienced by the participants. Various aspects of the programme, modules and placements which impacted students’ experience and management of working in clinical practice were explored.Impact evaluation comprised the difference a programme made, including improving workforce deficit, patient safety, quality of care and services. How much was attributed to finishing the programme and joining clinical practice earlier? A service improvement framework was adopted, applying the four phases of the plan, do, study, act (PDSA) cycle :Plan the change to be tested or implemented,Do, carry out the change,Study, based on measurable outcomes, collect data and reflect on the impact of change,Act, change cycle or full implementation of the PDSA cycle.To dovetail the PDSA with reflective qualitative inquiry, an additional DO phase was applied, which:Focused directly on organisational strengths, rather than weaknesses,Explored underlying values, beliefs, assumptions of people and existing rituals, ceremonies of the teams, wards, and organisation,Mirrored the qualitative inquiry phases, through “discovery”, what is working well?, “envision”, what would they like to see happening more of the time?, “co-create”, how to achieve the vison?Online surveys captured student nurses’ responses across a range of acute settings, within the region. This allowed participants to complete entries at a time and place convenient to them, which was beneficial for participants working different shift patterns and/or with restrictive time constraints. Participants were recruited from the University Adult Nursing BSc (Hons) programme. All third-year students enrolled in the 2017 cohort of the undergraduate pre-registration nursing course and who opted into practice early, were offered the opportunity to participate. Invitations were emailed to 165 nursing students with the inclusion criteria; they were entering practice in an acute setting, were from the 2017 nursing cohort, and participating in a third-year paid placement. Seventeen third year nursing students volunteered to participate in the evaluation. Given this was a self-selected sample reasons for non-participation were not collected.Approval as a service evaluation was granted by the University ethics board. All invited students were emailed a participant information sheet, and if they opted to take part, participants were asked to give consent at the beginning of every survey, being unable to complete the remainder of the questions without doing so. Anonymity was maintained throughout and no student was identifiable.Thematic analysis “encompasses a broad range of approaches which are focused on gathering, analysing and presenting stories, texts or personal accounts with the purpose of establishing a rich description of the meaning of an individual experience” , p. 120.Following participant validation, all detailed reflective accounts and summaries were read and analysed individually by the research team to identify emergent and recurrent themes. Subsequently, four members of the research team met to review and consolidate the themes and subthemes, discussing any discrepancies to come to an agreement on the themes. The emergent themes were validated throughout the analytical and thematic development processes identified by Burnard . Data saThe majority of participants were female in the 20–25 years age group (58.8%), reflecting the demographic of the third-year undergraduate adult nursing programme at the University. Fifteen participants identified as British, and one each African and Caribbean, see Most participants entered paid practice in acute medicine, see Of the 17 participants, 11 entered practice in April, 3 in May and 3 in June 2020. Commonly, it took between 1–4 weeks from the time participants agreed to go into practice and for the placement to become available. A number of participants were in post less than one week after agreeing to go into practice (17.6%), however one indicated the process had taken approximately 2 months.Participants were asked how they had decided which placement to accept see . Six parThirteen participants noted they would like to work in the same area as their paid placement in the future, and only four would not. Of the eight participants with prior experience, seven agreed they would like to continue working in the same area and one did not. For those without prior experience in the area, six agreed they would like to continue in the same role and three did not.These findings drawn from analysis of the two introductory questions, applying Burnard’s framework , identifThe six emergent and five sub-themes are explored below.The majority of participants (P1–P17) expressed an overwhelming sense of “duty” and “desire” to help the NHS, patients and colleagues to provide “care” during the pandemic. Five students reported it was part of their role and responsibility as a student nurse to volunteer, e.g., “work during coronavirus to do my [their] part and help during the crisis” (P1). Participants opting-in demonstrated their commitment to duty, care, the nursing profession and NHS, as exemplified by the following:I believe I have come into nursing to help individuals at risk and who are sick. I don’t believe it would be right to opt out now when the NHS’ need is so high, and I could help”.“(P13)A contributory factor in “sense of duty” was the recognition of a significant acute demand with potential to overwhelm capacity arising from shortages in staffing and skills. Participants considered the “NHS was already short of staff and skills mix” (P9) and they had “skills which could be utilised in a practice area freeing up more skilled members of staff to take a more active role in the pandemic” (P16). This was to “try and help the NHS cope with the change of cases and influx of people” (P5). The majority of students felt it would be even harder on the service to cope during the pandemic, and in training to join the NHS they were “able to offer skills that help provide care to patients at a difficult time” (P12). The decision-making process to opt-in was difficult for some participants due to limited availability of information. However, despite this student’s commitment to help and support the NHS superseded this limitation. “The decision process was quite difficult given the level of information available in which I could make an informed decision. With this being said I lent on the opt-in side as I wanted to help out” (P16).Given the seriousness of the situation it is interesting that the majority of respondents adopted a pragmatic and opportunistic approach. They identified the situation as a way of helping out the NHS, but also an opportunity to gain invaluable “experience of working on a ward” (P12), to “improve confidence and competence” (P4) and to “assist my learning” (P11). Furthermore, “it is a good learning opportunity for how the healthcare system operates during a crisis” (P16). An urgency to complete required placement hours on time in order to qualify in September 2020 was evident: “I did not want to fall behind on my last placement hours” (P11) and “I knew that if I didn’t it may be difficult to arrange other placements as areas had been shut and services cancelled” (P15). Resolve to finish the placement, programme and degree was palpable, as illustrated: “I wanted to continue with my degree so I could be qualified by September” (P2), and it was an “opportunity to complete my degree in the expected time” (P10).Participants felt that they had worked hard to complete their degree: “I had worked too hard to be a nurse and I felt it was the right thing to do” (P9). Becoming a qualified nurse for several participants was the primary reason to opt-in: “I wanted to complete my degree this year and I felt that one of the main reasons I wanted to become a nurse was to help people” (P14). The prestige of becoming a nurse was evident in the positivity of this simple response: “I will soon be qualified” (P12).Only a small number of participants highlighted the financial incentives (to be paid as a band 4 nurse for 6 months) for opting-in: “getting paid was really helpful as our cohort does not receive anything for placement normally”. (P8).The dichotomy of being a healthcare and/or student nurse was clearly evident. Participants referred to needing role clarification due to confusion around role expectations; the position of “healthcare” could be a healthcare assistant, healthcare worker or healthcare support worker. This included, in some situations, student nurses being substituted as a healthcare assistant and in others the healthcare role being taken away from student nurses: “some days I have been used as a healthcare in the numbers and not been allowed to uphold my student status” (P1). This inconsistency contributed to role confusion: “I think it is a bit difficult to understand the role, as I can often be counted as a healthcare now but thankfully, I still get to be involved in nursing skills such as medication rounds” (P2). Tension around workforce and skill mix contributed to questioning from other team members, and student nurses: “[I was] made to feel guilty for my position as ‘healthcares’ were taken away’ due to students being counted in the numbers” (P1). Equally, “there have been times when I have had more of a health care assistant role, as students being included on the numbers mean that health care assistants can be moved to other areas” (P13). Supernumerary status was viewed, depending on the context, as either a positive or negative experience and in some situations, both. For the following participants, the removal of supernumerary status proved problematic: it “made me worried to commence placement as I was unsure of what support I would receive” (P1), and “I am not getting as much support as if I was supernumerary” (P11). Additionally, a cause of confusion insofar as it “has been difficult to find that balance of being a student nurse observing and participating in nursing jobs and the role of an HCA” (P3). Similarly, it “has been a challenge at times, some days a student will be considered a health care assistant and other days they will be promoting their learning to become a nurse by shadowing mentors and observing nursing qualities” (P4).However, student nurses recognised positives from the removal of supernumerary status as it facilitated opportunities to “help build my patient management skills” (P2), and “put us in a position to be able to become more confident and take more initiative” (P4). Preconceived concerns surrounding levels of support were addressed in placements for some participants; “I have been working with a trained nurse each shift” (P1), and “I have…been supported and adequately supervised during this placement” (P7).Participants identified the value of learning opportunities from working in Trusts during the pandemic, particularly relating to the removal of supernumerary status. Acquiring invaluable experience was a factor in volunteering for a placement; improving confidence and competence: “it would help me gain the experience I needed to become competent” (P8), “invaluable experience” (P9) and “I have had to learn to think on my feet” (P12). Equally, placements provided opportunities to work alongside trained nursing staff to deliver care: “I…get to be involved in nursing skills such as medication” (P2), and “I always have a member of staff with me during medication rounds, cannulation, etc.” (P12). Linked to a “sense of duty” and wanting to “help out”, participants felt it was a nurse’s role to care: “to help the NHS cope…with the influx of people” (P5), and “so with a pandemic I knew it would be harder on the service” (P9).In keeping with a reflective qualitative inquiry approach, as advocated by McSherry et al.  and DewaThe international response across healthcare systems to safeguard and protect nurses, doctors and allied health professionals and the public was unprecedented. This was mirrored within the higher education undergraduate pre-registration nursing response to protect and safeguard the student nurse ,11. InnoThis theme recognised the importance of developing policies and guidance to safeguard and protect student nurses during the pandemic. A plethora of responses by nursing boards, authorities and regulators ,12,14,15This was by far the most challenging theme to conceptualise, as it was founded on students’ and staff’s personal experiences of joining the workforce as part of paid employment ,20. SeveIn contrast to Jimenez-Rodrıguez et al.  and HuanThe authors acknowledge several possible limitations to this study with reference to sample size and potential bias of self-selecting participants. The sample size was small and as participants opted in to the study we were unable to control the demographics of the study. In relation to bias, we did not ascertain the reasons potential participants declined to take part in the study.With regard to ensuring patient and staff safety, and creating a safety culture, several recommendations relating to governance emerged. These focused primarily on nurse leaders, managers, academics and clinicians , helping to inform future nursing strategy, curriculum development and actions for clinical practice. An emerging Pre-During-Post Student Nurses Placement Framework has been developed around the recommendations to enhance safety, quality and practice see .“Pre-placement” is associated with universities in partnership with local trusts, hospitals, clinical settings and other care providers preparing both the student and clinical learning environments to accommodate the student nurses. This must involve role clarification and what to expect from the role. Promoting confidence through providing reassurance of adequate support in clinical practice, and formalising supernumerary status over paid work/employment (they should either be included in the nursing numbers or not) is essential. The students’ overriding sense of duty should not be used to coerce them into choosing to opt into practice placement during a crisis.“During-placement” is aligned to the student nurses’ host organisations in partnership with the university. It is concerned with having robust systems and processes of mentorship, preceptorship and supervision. These must focus on enhancing the student nurses’ learning experience and improving the quality of the clinical learning environment. Induction and orientation programmes, along with key learning objectives and outcomes, should form an integral part of the placement. It is imperative also that the student nurse and organisation are clear as to whether the role is “student nurse as a mentee”, or “employed worker as a preceptee”.“Post-placement” is about developing and implementing formal systems between the University, host organisations and the student nurses. This tripartite relationship is essential to establish and facilitate the cycle of ongoing learning and reflection throughout the placement. Furthermore, it is imperative in capturing feedback from all parties involved in the relationship. This should be in the form of debriefing, periodic review of placements, and real time review of competencies and achievements during the placement to inform future programmes and curriculum developments.The Pre-During-Post Student Nurses Placement Framework has highlighted the significance of having robust patient safety, quality and governance systems and processes in place to facilitate student nurses’ learning. In parallel, it illuminates the importance of ensuring patient and staff safety and facilitates the provision of outstanding patient care. In future pandemics it is recommended this tripartite relationship is fostered and maintained to bring about the best possible experience for student nurses, staff and patients.The COVID-19 pandemic exposed real time challenges and opportunities to address workforce and skill mix shortages, and safeguard and protect patients and staff. The UK NMC emergency standards enabled undergraduate pre-registration third-year nursing students to complete their training by opting into the workforce on a paid placement.Student nurses displayed an overriding sense of duty, desire and commitment to opt-in, underpinned by a sense of moral obligation to support the NHS during this crisis. There was also a strong desire to complete the training programme and become a professionally registered nurse. It is evident that student nurses’ action released capacity for other more experienced members of staff, ensuring the right skills were deployed in the right place at the right time when demand threatened to overwhelm the healthcare system.The importance of role clarification and provision of sufficient support for student nurses voluntarily opting in to take up a paid placement is imperative. This is essential for good clinical practice, and creating the right environment for nurses to feel confident, competent and capable of giving appropriate care and services. It is important to differentiate between being used as a healthcare and/or student nurse, and also to establish whether the individual is supernumerary and/or included in the workforce numbers. Aligned to this is the importance of providing the appropriate clinical supervision, mentorship and preceptorship, without which there is a risk that student nurse placements are not managed as sound learning experiences.By responding to the “call to arms”, the significance of the tripartite relationship between University, host and student nurse has demonstrated how an integrated whole system approach is essential, playing a pivotal role in ensuring excellence in practice for all partners and patients. The Pre-During-Post Student Nurses Placement Framework could be seen as a platform for the management of nurse education programmes and curricula moving forward.


One of the largest spontaneous adverse events reporting databases in the world is the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Unfortunately, researchers face many obstacles in analyzing data from the FAERS database. One of the major obstacles is the unstructured entry of drug names into the FAERS, as reporters might use generic names or trade names with different naming structures from all over the world and, in some cases, with typographical errors. Moreover, report duplication is a known problem in spontaneous adverse event-reporting systems, including the FAERS database. Hence, thorough text processing for database entries, especially drug name entries, coupled with a practical case-deduplication logic, is a prerequisite to analyze the database, which is a time- and resource-consuming procedure. In this study, we provide a clean, deduplicated, and ready-to-import dataset into any relational database management software of the FAERS database up to September 2021. Drug names are standardized to the RxNorm vocabulary and normalized to the single active ingredient level. Moreover, a pre-calculated disproportionate analysis is provided, which includes the reporting odds ratio (ROR), proportional reporting ratio (PRR), Chi-squared analysis with Yates correction ( Drug post-marketing surveillance programs aim to minimize the risk of drug harm in clinical and pharmacy practices. It basically relies on spontaneous adverse event reporting systems. The information obtained during the drug development phase is commonly incomplete because clinical trials are limited by the short duration of drug exposure and the limited size and diversity of the population being tested. Hence, some rare adverse drug reactions cannot be linked to the drugs being tested in clinical trials, as only a few thousand volunteers are being recruited and only the more common side effects will be detected. An essential tool of post-marketing monitoring is the spontaneous adverse event reporting systems ,2,3,4, wIt is common practice in each country to have a designated official entity responsible for supervising drug post-marketing surveillance activities . In the Unfortunately, there are many known obstacles in using the FAERS/ Legacy AERS (LAERS) database, the most important being the unstructured entry of drug names and the uncontrolled case duplication in the database ,10. DrugCase report duplication is a known issue in spontaneous adverse event reporting databases , includiIf not properly handled and mitigated to the minimum, all these issues would affect the quality and reliability of the data analysis to be performed on the database. So, a multi-step and time-consuming raw data processing should be performed first, which would require skilled people to query the database to finally obtain a clean, normalized, and standardized dataset ready to be used by any researcher. However, previous publications have addressed these issues. Poluzzi et al. introduced a method for mapping drug names and handling missing entries and case duplication for the FAERS database . Banda eFAERS is a database for the spontaneous reporting of adverse events and medication errors involving human drugs and therapeutic biological products . Currenthttps://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html (Accessed on 12 December 2021)The quarterly data extracts for FAERS/LAERS were downloaded for the period from the first quarter of 2004 (2004Q1) to the third quarter of 2021 (2021Q3), from the FDA’s website: ASCII files were used as the data sources for the FAERS/LAERS database. All data files were loaded into SQL server 2019, where all data manipulations were performed, except for the manual drug mapping, for which Microsoft Access 2019 was used.Each quarterly data extract contains seven files, comprising the database, as illustrated in The DEMO file contains the basic demographic information for the patients, where each record in this table represents a single report in the database. The DRUG file contains drug information, with the most important field being the “DrugName” as it contains the trade names or the active constituents of the reported drugs. As of the third quarter of 2014 (14Q3), a separate active ingredient or “prod_ai” field was added to the DRUG file, in addition to the “DrugName” field.The REAC file provides the adverse drug reactions, where it includes the “P.T.” field or the “Preferred Term” level terminology from the Medical Dictionary for Regulatory Activities (MedDRA) , as it iSince only a few differences exist between the FAERS and LAERS datasets, all the data of the same file types of the two datasets were merged into one combined table, making a unified dataset.The ISR and “primaryid” fields were consolidated into one common field, “primaryid”, as both fields are the primary link field for data files in LAERS and FAERS, respectively.The “PERIOD” field was also introduced, which allows the user to track any report back to its original year and quarter.As recommended by the FDA, a deduplication step was performed to retain the most recent report for each case with the same case identifier.Moreover, a second deduplication process is performed, focusing on the case reports duplicated as a result of reporting the same case report from multiple sources. These reports have different case identifiers; hence, a deduplication logic was applied based on comparing and matching specific fields of all case reports.Poluzzi et al.  and BandOf all the FAERS/LAERS database cases, about 11% of the gender entries are null or not specified, and 54% are females. So, around 54% of the cases already matched in terms of the gender criteria, compromising the gender criterion’s ability to detect duplicate entries. The same concept also applies to the reporting country criterion, in which about 7% of the cases are missing the reporting country entry, and about 65% of the cases are from the United States of America, making 65% of the cases already matched in terms of the reporting country criterion. Missing data also impair the ability of the field “event_dt” (event date) as a deduplication criterion, as about 46% of reports have missing “event_dt”. The age is also affected by the missing entries, as about 40% of the cases are missing the age entries.To improve the quality of the matching criteria and case deduplication, two more criteria were added to the previous ones, the therapy “start_dt” (start date) and the drug indication fields. However, the therapy “start_dt” was considered to be missing if no “start_dt” is found in the “THER_ combined” file as per distinct “primaryid” selection. This was found to be about 42%. The overlapping missing dates of either the therapy “start_dt” or the “event_dt” is approximately 32% across all case reports, making at least one date is present in the matching criteria in approximately 68% of cases.Due to the enormous diversity of the administered drugs and the resulting adverse events, and the practical absence of missing data in these two fields (except for a few data entry errors), these two criteria can be considered the most important matching criteria in this deduplication step.Moreover, the inclusion of the drug indication field in the deduplication logic would also enhance the deduplication efficiency due to the diversity of drug indication and also due to the low missing percentage in this field, as it is about 12%.Differently than Poluzzi et al. and Banda et al., the authors considered two cases to be the same if they had a complete match of the eight criteria which are gender, age, reporting country, event date, start date, drug indications, drugs administered, and adverse reactions. Two records were also considered duplicated if they mismatch in only one of the gender, age, reporting country, event date, start date, or drug indications fields, but not the drug or adverse event fields.The authors acknowledge that the deduplication logic, like all other deduplication logics, might have some possible mistakes, but hopefully kept it at a minimum.Finally, starting from the first quarter of 2019, each quarterly data extract included a deleted case file, which was also used to delete the available cases in the dataset.The count of the unique cases after the deduplication process was 11,631,635 case reports.A graphical representation of all the steps involved in creating this dataset is illustrated in A comprehensive drug vocabulary to normalize and standardize all the drug names in the dataset to the single active ingredient level is needed, so that all the same drug entities but with different formats should be collapsed into only one from.RxNorm is a standard clinical drug vocabulary that includes other source vocabularies, in addition to the RxNorm source vocabulary . RxNorm Moreover, RxNorm is open to the public after proper user registration. All these factors make RxNorm the best choice for performing this task.https://www.fda.gov/drugs/drug-approvals-and-databases/about-drugsfda (Accessed on 1 December 2021).All “DRUG” files from the FAERS/LAERS database were merged into a “DRUG_combined” table. Then, the provided New Drug Application (NDA) number in the “DRUG_combined” table was used to map drug names to FDA-approved drugs database (Drugs@FDA), which was already mapped to RxNorm. Drugs@FDA can be downloaded from: The next step was performing string matching for the remaining drug names in the “DRUG_combined” table with RxNorm, combined with minimal string cleaning and the removal of leading and trailing spaces and unexplained symbols that might be present in some drug names.After the previous two steps, only 8% of drug names remained unidentified, which included trade names that are not registered in the United States of America and drugs with different naming conventions  than the standard RxNorm vocabulary. They also include misspelled drug names, devices, non-specific drug names or drug categories, and in some cases, unidentified texts. Examples of these remaining drug names are shown in The International Drug Dictionary (IDD)  was usedManual drug mapping for drug names counted >200.Extensive text cleansing of the remaining unidentified drug names, followed by a second time string matching with RxNorm, then with the IDD.To identify as much as possible from the unidentified drug names, the following steps were performed in order:RxNorm also provides relationships between drug names, which would help normalize drug names to the set target, the single active ingredient level. Unlike Banda et al.’s dataset, where the multi-ingredient drugs are kept as one entity, the authors have separated the multi-drug entities into single active ingredients in the dataset. This approach creates more accurate counts, and subsequently, more accurate signal detection, of drug-adverse event pairs. An active ingredient in a multi-ingredient dosage form within the dataset will not be readily accessible for inclusion in the total count of the same active ingredient originating from the other single and multi-ingredient forms within the dataset. The background counts in the contingency table for the “all other drugs” will also be affected.The multi-ingredient drugs are still traceable in the dataset, through the “Drug_id” serial numbers which were given to all drug entries in the “DRUG_combined” table. In cases in which a multi-ingredient form is separated into single ingredients, the newly separated entities have the same parent multi-ingredient “Drug_id” number.The mapping logic in the previous step was primarily targeting RxNorm as the primary source vocabulary. If there is no match with RxNorm, then it will try to match other source vocabularies. However, even those mapped to RxNorm source vocabulary are not all at the active ingredient level. Therefore, all drugs that were not mapped to the source vocabulary RxNorm in the single active ingredient level need to be remapped to the RxNorm source vocabulary as single drug entities at the ingredient level. The RxNorm relationships was used to do the remapping to the single active ingredient level.Finally, the authors performed a manual remapping step to maximize the number of normalized drugs to the ingredient level in RxNorm.When other source vocabularies express the active components more precisely (in terms of granularity) than the RxNorm, then the other vocabulary name is adapted.All vaccines are kept in their best string matching the RxNorm, regardless of whether they match RxNorm source vocabulary or other source vocabularies, and also might contain combined vaccines.Active ingredients that are not included in the RxNorm source vocabulary but are maintained in other source vocabularies are mapped to those other vocabularies.A few exceptions were made for some drugs, which included:However, all drug names in the dataset are mapped to a unique identification number for each entity called the Atom Unique Identifier (RXAUI) from RxNorm, representing about 97.1% of all drug names in the FAERS/LAERS database.A drug-adverse reaction contingency table was created, based on the concept of To further make it easier for researchers who are not familiar with large databases, a “ready to use” proportional analysis table was made for each drug-adverse event pair in the dataset. The reporting odds ratio (ROR) , proportx2) ,29 and tFirst, the method of importing the data files was validated by checking the counts of records of 10 imported tables and found them to be consistent with the counts stated with the relevant raw files. Additionally, the first and the last ten records in these ten tables were verified manually and found to be consistent with the relevant records in the original raw data files.Demographic files have been linked correctly to the drugs, indications, reactions, and therapy start date for each case report;There is no case duplication for the data that have been selected.Second, manual auditing was performed for 20 randomly selected case records from the final deduplicated dataset to confirm that:The deduplication matching criteria for these case reports have been fulfilled;These dropped cases are those that should be dropped based on the applied criteria.Third, another 20 randomly selected records were sampled from the dropped case records for being duplicated and verified that:Active ingredients have been retrieved correctly for each drug name;The RXAUI mapping to the source drug names was done correctly;Adverse reactions for each drug have been retrieved correctly in the drug-adverse reaction pairs table.Fourth, 50 records were randomly selected from the final standardized drug table and the following were manually verified: https://github.com/Mohammad-Ali-Khaleel/FAERS).The codes used to create the dataset are publicly available , with drug names being mapped to the single active ingredient level and standardized to RxNorm. A drug identification number “DRUG_ID” field was added to the raw data before processing the “DRUG_combined” file to ensure that combined drug active in the same dosage form will have the same “DRUG_ID” when they become separate entities in the final “DRUGS_STANDARDIZED” file, so that it will be easy to trace multi-ingredient drugs in the dataset if needed.ADVERSE_ REACTIONS: This file includes the adverse events associated with each case report in the dataset and created from combining “REAC” files.DRUG_ADVERSE_REACTIONS_PAIRS: This file is composed of all adverse drug reactions paired with the associated drug name.DRUG_ADVERSE_REACTIONS_COUNT: This file includes drugs associated with adverse reactions and frequency counts for each association.DRUG_INDICATIONS: This file includes the combined “INDI” files from FAERS/LAERS database. Entries with drug indication descriptions as “Product used for the unknown indication” and “Drug use for the unknown indication” have been considered as null values and thereby deleted.CASE_OUTCOMES: This file contains the patient outcome details. It was created from the combined “OUTC” files.THERAPY_DATES: Contains information about the start and end therapy dates and also the duration of the therapy. It was created from the “THER” files.REPORT_SOURCES: Contains information about the source of the reports. It was created from the “RPSR” files.CONTINGENCY_TABLE: This file contains the 2 X 2 table or contingency table for drugs and adverse drug reactions.PROPORTIONATE_ANALYSIS: This file contains the pre-calculated proportionate statistics, the ROR, PPR, and IC with upper and lower 95% confidence intervals. It also contains the Chi-squared analysis with Yates correction (These files are as follows:A detailed example of data retrieval from the dataset in illustrated in The verification steps and the intensive work carried out to create this dataset ensures the quality and consistency of the produced dataset to be valid for spontaneous adverse drug reactions data analysis.This dataset can be considered as a reliable and accurate source of pharmacovigilant data mining and hypothesis generation regarding drug post-marketing safety surveillance acquired from the FAERS/LAERS data files for the period from January 2004 to September 2021.