Urinary incontinence is widely accepted to be among the most important issues in the global health system. However, only a limited number of women are referred for treatment because different factors complicate help-seeking behaviors. The aim of this study was to explain the factors affecting help-seeking behaviors in women suffering from urinary incontinence.This study was a qualitative study using the conventional content analysis approach. The study was conducted from December 2018 and August 2019 in Tehran, Iran. The participants were 34 women with urinary incontinence selected using a purposive sampling method. The content analysis approach was based on the Graneheim and Lundman method, and qualitative data management software was used for analysis.Data analysis illustrates two themes; “ facilitator “ and “ inhibitor “; the categories “not perceiving disease”, “shame”, “ negative support of important others”, and “non-optimal health care system” were among the inhibitors and the categories “ reduced quality of life “ and “ positive support of important others” were found to be facilitators of help-seeking behaviors.The findings of the present study highlight the need for understanding the underlying facilitators and inhibitors of help-seeking behaviors in women with urinary incontinence. We suggest that healthcare providers consider an open dialogue with patients and consider their subjective beliefs and life context during routine visits to facilitate early diagnosis of the disease and ultimately lead to an improvement in the woman’s quality of life. According to the International Continence Society, any complaint of involuntary leakage of urine is called urinary incontinence  of teaching hospitals of Shahid Beheshti University of Medical Sciences, and also, public places  (for access convenient to women not seeking help) or in other parts of the city on interviewee request. Purposeful sampling was performed. The participants of the study included women with urinary incontinence who met the inclusion criteria as follows: they were willing to be interviewed, were not pregnant, were suffering from urinary incontinence . The minimum and maximum duration of urinary incontinence in the participants were 1 year and 25 years; also, the lowest and highest number of childbirths were zero (0) and 11 times, respectively.Supplementary file 1: Study questionnaire (Bradley’s questionnaire)). The interviews were conducted individually and recorded using a digital voice recorder with the permission of the participants. All interviews were conducted in person by the same interviewer (researcher). The interviews began with an open-ended question  and continued with the probing questions (Please explain more. What do you mean? etc.) or clarification statements  were used during the interviews. Because of the maximum diversity , data saturation did not occur until interview 34, in other words, no new information was obtained in interview 34. The duration of the interviews was determined by the participants and their willingness to continue the interview, but the sessions took on average 30–60 min. At the end of each interview, the researcher listened to the recorded interviews several times and then verbatim transcribed them into a Microsoft Word file.Data collection methods included in-depth interviews with women with UI from December 2018 to August 2019. The samples were taken in the research context, after the evaluation the inclusion criteria, and approval of the diagnosis of UI by Bradley’s Questionnaire for Urinary Incontinence Diagnosis (QUID). The questionnaire has previously been published elsewhere  , which included the implementation of each interview after it ended, reading the entire text to fully understand its contents, determining meaning units and initial codes, classifying similar initial codes into more comprehensive classes, and determining the main theme (latent content) (Table Lincoln and Guba’s (1985) trustworthiness criteria, which include credibility, dependability, conformability, and transferability, were used to increase the rigor of the collected data . CredibiThe research protocol and sampling has been approved by the ethics committee at Shahid Beheshti University of Medical Sciences (the code: IR.SBMU.PHNM. 1397.33) in the Tehran (Iran). Written informed consent was obtained from each woman included in the study.After reviewing the participants’ perspectives on the factors affecting their help-seeking behaviors, two themes were obtained. In the process of analyzing and comparing data after categorizing codes and eliminating similar codes, 60 codes, 36 sub-sub-categories,17 sub-categories, 6 main categories, and 2 themes (facilitator and inhibitor) were extracted .Not accepting incontinence as a disease was related to its attribution to natural processes, as well as the absence of warning signs. In this regard, one participant said, “Anyway, we have given birth many times; eventually, incontinence is related to many pregnancies and deliveries … “ .““I have urinary incontinence, but I don’t have any pain or bleeding at all … “ .I follow a diet of fruits, vegetables, and herbs” .Some participants controlled the disease by adapting to its symptoms and changing their eating habits. One participant said, “I try not to drink water or tea” .“Where I worked, I used well water; it was near a gas station, and people said the gasoline was leaking into the well. When we used water, it had a bad smell, and after that, I developed this urinary problem” .Unawareness of the nature of the disease (as the cause of disease genesis) and unawareness of its treatment prevents people from making the right decision in dealing with it. As one participant stated:“ Women with the disease don’t pursue treatment because it has no treatment. I don’t know if there is a cure” .“Fear and worry about the consequences of the disease, as well as fear of invasive treatments, also affected referral rates.I think women are afraid to go to a physician for their disease because of being diagnosed with a dangerous disease” .“If a doctor tells me to have surgery, I won’t do it; why should I put myself at the mercy of the surgeon’s knife?” .“In some participants, the shame of having UI led to hiding the disease and not telling the problem to healthcare professionals.I didn’t tell anyone about my problem; it’s not a matter to be talked about ...” .“I’m embarrassed .... it’s so hard .... to go to the doctor and say I’m incontinent; that I can’t hold it … “ .“Another part of the shame was the embarrassment of exposing the genital area. Participants were ashamed of being examined by their caregivers and even talking about it. This embarrassment became more apparent in relation to male healthcare specialists, so they preferred same-sex caregiver.“I told myself that if I went to the doctor, he might want to examine me; he would look down there , which I wouldn’t allow “ .I didn’t go to see the doctor; I took medicine myself; I’m embarrassed to talk about a problem in the genital area …” .“I came here to be examined by a female doctor, but the men examined me; her students were male; they’re the ones examining the patients” .After realizing the presence of male students in the doctor’s room, one participant said, “Diagnostic and therapeutic costs were important in the use of medical services because many people are unable to afford them.The medicine is expensive; my husband told me to, tell the doctor to prescribe medicine that was covered by insurance. I said, ‘What can I do? “ .“I heard that this hospital is free, so I came here ... I have health insurance. I just paid for the commute” .“I just came for a check-up, but they did a lot of tests, an ultrasound; they exhausted me …. I paid a lot of money” .“Inaccessibility to services in some areas, unavailability , lack of patient referral because of the defective referral system, and inappropriate behavior  of caregivers were some of the poor quality of services that participants complained about. One participant said:.... They [care providers] said that I should do the urodynamic test whose device is not available here; they told me to go to … [Province center]” .If I didn’t have the necessary time, I would go to private centers; now that I have the time, I came here . You have to wait a long time for your turn” .“One says do surgery, another one says no, the other one says go to that clinic, another one says go to this doctor; they give addresses, this is better, that’s better; I don’t know where to go, what to do” .“Excuse me, but some people insult us; for example, my belly is big, one of them said ‘What a big belly,’ and ‘Why is your belly so big?’ They insulted me repeatedly, for this reason. I didn’t like that hospital ...; that’s why I didn’t go to that hospital anymore” .One of the patients, complaining of the disrespectful treatment said, “I’m a patient of Dr...., but her students always examine me. She is there too, but she doesn’t answer me; she doesn’t pay attention to the patient at all” .“Important others had a dual effect (negative and positive) on the patients’ lives. In the inhibitor theme, negative support of important others by incorrect information about the disease and dissuade the patient from visiting had a negative effect on a person’s decision to seek help. Furthermore, the expression of reverse therapeutic experiences and ineffective treatment can cause doubt about the consequences of treatment and therefore, prevent help- seeking.My sister-in-law has been suffering from urinary incontinence for almost 6 years. She says, it’s because of the cesarean, and that I will get better; she tells me not to go to the clinic, I’ll get better, it’s a complication of surgery” .“My friends say we have the same problem, one of my friends had surgery and says she still has the problem; she tells me not to do it and that it’s useless” .“One of my daughters said that her mother-in-law had this problem, so she had surgery; the doctor pierced her bladder during the operation, and now, instead of a few drops, she has become completely incontinent”... .“In the inhibitor theme, the role of the family and spouse in referring for treatment was considerable. On the one hand, misconceptions in the family affected help-seeking behaviors, and on the other hand, the various expectations and responsibilities of the woman in the family prevented her from paying attention to her own problem. Moreover, her husband’s lack of perception about the problem, as well as his lack of support, delayed seeking help. The women said:My children, my daughter-in-law, and my son-in-law shouldn’t know about my incontinence problem. If they find out, they think I’m loose. It’s ugly for me. If I want to see a doctor, I have to lie” .“My family thinks that I’m lax” .“Look, I did the urodynamic test two years ago. I haven’t been able to show it to a doctor yet. I have a handicapped child at home and a lot of work to do; I’m so busy” .“My husband says ‘Can’t you go to the bathroom sooner?’ I’m under a lot of pressure involuntarily, I can’t hold myself; I can’t control it” .“At least I don’t have financial problems, but what about other women?!! They’re financially dependent on their husbands, so they do not have the authority to see a doctor whenever they wanted “ .“In the facilitator theme, others encouraged patients to see a doctor, as well as suggesting places to get treatment, that had a positive effect on the decision to seek help. Another way others facilitated help-seeking behaviors was by providing positive treatment experiences. Therefore, speaking about signs of recovery after receiving treatment, as well as transferring the experience of non-invasive treatments pursued patients to use treatment. The supports were also a stimulus for help-seeking. Participants said:My gynecologist told me to follow-up for the urinary problems, and my sister confirmed it, she said go visit a doctor, follow-up your problem “ .“My mother also has this problem, she went to see a doctor; the doctor prescribed pills for her; she says she’s better … I said to myself, why did I bother myself when I could get better with one pill!! “ .“My husband isn’t like some men who don’t pay attention to their wives. If I have surgery, I’m not worried because he does everything for me” .“Reduced quality of life was one of the factors that were extracted as a facilitator for help-seeking from the participants’ views. As the symptoms worsened, the limitations, and exhaustion from the disease, increased the chances of seeking help.It wasn’t so bad before; it’s gotten worse for the past couple of months. When I get out of bed to go to the bathroom in our bedroom before I take three steps, I lose control of my urine” .““I go to the bathroom a lot, that’s why I get wet all the time; my body is constantly burning”..“I couldn’t go out much; I didn’t go to parties, If that was not possible, I stayed there for just two or three hours, I was tired” .I was obsessed with the bathroom, I was tired, I was looking for it everywhere I went … “ .“In the present study, the main factors affecting help-seeking behaviors in women with UI were studied using a qualitative approach for the first time in Iran. Our findings indicated that there were different facilitating and deterring factors influencing the help-seeking behaviors and successful treatment.The emergence of non-alarming nature of UI as a reason for not seeking help and also attributing incontinence to natural processes in the findings indicates a lack of proper perception about the nature of UI. As a result of the unrealistic perception about the nature of this disease, they did not have a correct perception of treatment either, and they assumed UI to be incurable, and with this assumption, some participants chose self-care strategies. Some patients did not go to see a doctor because of the fear and worry caused by the probable outcomes of further investigation of the disease or the fear of invasive treatments, which resulted from the lack of awareness. These results are consistent with other results reported on help-seeking behaviors in patients with UI, in which adaptation mechanisms, belief in the naturalness of incontinence, and unawareness of the treatment options were mentioned as the reasons for avoiding treatment , 26. In Shame was another main category of inhibitor theme in the study. In general, shame is mostly considered a cultural issue. As it only 3% of cases barrier to referral to treatment accounted in the United States, and it did not play a significant role in the help-seeking in the Netherlands , 29. HowMoreover, the main categories of the non-optimal health care system included cost and quality of care. Most participants mentioned the very high costs of diagnostic and therapeutic procedures as one of the factors delaying their pursuit of treatment, as a result of the lack of basic health insurance or insufficient coverage of diagnostic and treatment costs by the insurance companies. Therefore, they preferred not to refer for treatment or to postpone it as much as possible. Because, affordability is effective in receiving treatment . Some paThe undeniable role of the important others, such as relatives, friends, and spouse, was another finding of the present study; these people played both a deterring and facilitating role in the interviews. In one study, the relatives’ influence was one of the factors related to referral for UI . This inMoreover, the husband could have both a deterring and a facilitating role. Therefore, the spouse could be a deterring factor by not understanding the woman’s problem and not supporting her due to lack of intimacy. On the other hand, the husband’s sincere support for his wife played a facilitating role in some patients’ help-seeking behaviors. However, the spouse’s deterring role was more prominent, which could be attributed to the financial dependence of women, however, it is more likely to be related to men’s authority in this society.Another major facilitating category of this study was the reduced quality of life. The exacerbation of the disease and its pervasiveness fell in this category, i.e. as the symptoms of disease worsened and invaded more dimensions of the patient’s life, the likelihood of help-seeking behavior increased. In other words, the reduced quality of life is accompanied by an increase in help-seeking. It should be noted that the patients’ quality of life changed from the onset of the disease, but they seek treatment only when these changes were tangible and intolerable. Various studies have reported the effect of UI on quality of life , 11, 18.In general, the extracted factors in this study, including; shame, not perceiving disease, reduced quality of life, were almost similar to the results of other studies, but factors non-optimal health care system and supportive effects of important others were different from previous findings.The manifestation of the non-optimal health care system category in this study could be related to the inefficient implementation of the family physician plan in cities in this community. The improper implementation of the family physician plan and, as a result, the weakness of the referral system increases the number of referrals to specialized medical centers, imposes high costs, increase waiting time, and ignorance of respect and dignity. Finally, all of the above reasons lead to the creation of the non-optimal health care system as a category.The negative support and positive support of important others categories in this study may be related to the family structure in this community. In this society, there are still a lot of family relations, so the mutual influence on individuals, both in a negative and a positive way, is undeniable.One of the strengths and innovations of the study was the co-extraction of the factors affecting help-seeking for the treatment in both forms of facilitating and deterring factors. In addition, sampling was not limited only to those help-seeking or those who had not help-seeking behaviors or only to a specific age group; therefore, the results would be useful to healthcare providers because it can be generalized to a larger population.Moreover, this study investigated the views of women with UI regarding the factors affecting their help-seeking behaviors for the first time in this society.As in other qualitative studies, generalizability, which is typically higher in quantitative research, was one of the limitations of this study. However, we strived for maximum diversity in recruiting the participants, and various strategies were used to increase the study acceptability and objectivity. Hence, our findings seem to have acceptable reliability.This study determined the factors affecting help-seeking behaviors for the treatment utilization in women with UI in the form of two inhibitor and facilitator themes. Diagnosis and screening would be accelerated by introducing the effective factors extracted in this study to healthcare providers so that they may be considered in dealing with and treatment of women who refer to clinics or healthcare centers. For example, since UI is a private issue and care providers are aware of the women’s shame to express it, they can be the pioneers to examine the symptoms and perform the initial screening by respecting and maintaining one’s dignity with simple diagnostic methods (such as questionnaires), which do not require them to examine the patients. Furthermore, education the factors affecting help-seeking to healthcare providers, in particular, at the first level of the referral system, at in-service training and regular retraining programs, with an emphasis on maintaining patients’ dignity, could have a fundamental and significant effect on the changes in the attitudes and awareness, modify misconceptions and the health literacy level of society. The care providers should consider the support of relatives, in particular, the family, in designing therapeutic interventions to reduce both the negative burden of the disease and enable women to adjust their roles and more easily follow-up on the treatment of UI with the comprehensive support.The final result, it is better to pay attention to people’s subjective beliefs and life context in routine care in an open dialogue with patients for early diagnosis disease.


Procalcitonin is an inflammatory biomarker that is sensitive for bacterial infections and a promising clinical decision aid in antimicrobial stewardship programs. However, there are few studies of physicians’ experiences concerning the use of PCT. The objective of this study was to investigate whether hospital physicians’ experience with procalcitonin after 18 months of use can inform the PCT implementation in antimicrobial stewardship programs.We deployed a qualitative approach using semi-structured interviews with 14 hospital physicians who had experience with procalcitonin in clinical practice. Interviews were audio-taped, transcribed verbatim and analysed using thematic analysis.Physicians reported a knowledge gap, which made them uncertain about the appropriate procalcitonin use, interpretation, and trustworthiness. Simultaneously, the physicians experienced procalcitonin as a useful clinical decision aid but emphasised that their clinical evaluation of the patient was the most important factor when deciding on antibiotic treatment.Procalcitonin was regarded a helpful clinical tool, but the physicians called for more knowledge about its appropriate uses. Active implementation of unambiguous procalcitonin algorithms and physician education may enhance the utility of the test as an antimicrobial stewardship adjunct. Antimicrobial resistance (AMR) is a global health threat . As one By 2017, most Norwegian hospitals had started to implement ASPs , and PCTThis qualitative study, using semi-structured interviews, was conducted at Østfold Hospital Trust, a 380-bed acute care hospital in south-eastern Norway. As PCT was introduced in the hospital in April 2017, an antibiotic stewardship team had recently been established. At the time, this team mainly conducted surveillance of antibiotic use, revised guidelines and offered education on antibiotic use. ASP team members educated the hospital’s physicians in internal meetings on how to use the PCT assay, and a clinical algorithm was presented  indication for PCT, ii) actions taken based on PCT results, and iii) their subjective view on the value of the test  had requested a mean of 20 PCT tests compared to a mean of four tests by the not-invited physicians (n = 219). An invitation to participate was not solely based on the number of PCT requests, but by a joint judgement by the authors IC and JBH of the candidates based on diversity in medical experience and speciality. The first author (IC) sent eligible physicians an email invitation to participate in the study which contained information about the aim and practical aspects of study participation, including the need to reserve 60–90 min of uninterrupted interview time.Potential informants were identified from the laboratory database of PCT requesters. Included physicians  and held in a quiet room at the hospital. The interview period lasted from November 2018 to February 2019. Following the 12th interview, no new themes were identified. To ensure saturation, we conducted two more interviews, resulting in a total of 14 interviews. The mean interview time was 52 min 23-74 min). Study participants included five from infectious diseases, three from oncology, one medical resident, and one from each of the following specialities: anaesthesiology, gastrointestinal surgery, gastroenterology, pulmonology, and haematology. Table -74 min. Interviews were audio-recorded, transcribed verbatim, and de-identified (IC). Thematic analysis following the recommendations of Braun and Clarke was performed by IC and last co-author (LPJJ) . IC scanTwo main themes were identified. Theme one, “knowledge gap”, consists of three subthemes: “unsure of use”, “unsure of interpretation”, and “trustworthiness”. Theme two, “diagnostic value”, consists of two subthemes: “supporting decisions” and “clinical evaluation most important.” Themes, subthemes, and representative quotes are presented in Table use of the test, an aspect that was reported both directly by the physicians and through their descriptions of clinical situations. In particular, uncertainty was expressed as to which indications it was appropriate to use PCT: “It (PCT) is not to be used for all diagnoses, I don’t quite remember ( …) I would like more experience; when is it indicated to use it?” . The physicians highlighted that uncertainty of use was a driver for not trusting and using the test more: “If we knew how to use it (PCT) correctly and had more competence on its use ( …) then it could be more helpful” . Moreover, the test was infrequently used, so obtaining information about the test from the scientific literature was not prioritised in a busy clinical practice. The physicians that had consulted the literature were still unsure due to diverse guidelines and lack of familiarity with the test, advocating the need for more experience: “I don’t have enough experience with it, to verify it; we sort of have to test it, so I think time will show” .Uncertainty was related to the actual how to interpret the test results. If clear-cut guidelines had been available, this could have facilitated faster and more targeted decisions: “If we had straightforward guidelines ( …) and knew that when a patient with PCT above this or that level most likely has sepsis, then it (PCT) would probably be pretty helpful” . When physicians encountered PCT levels referred to as “median,” “in-between” or “borderline values”, they fell short in interpreting the results: “I don’t quite have a sense of it yet; what is actually really high, what is low, and what is in between ?” . In fact, when left with “borderline values,” i.e. values which the physicians were unsure of, they usually chose to give antibiotic treatment “just in case.”Another area of uncertainty was on We recently had a patient where PCT increased to very high levels, but we did not have any other indicators for infection ( …); therefore, we used the result to observe that PCT is not the answer to everything” . Some reported frightening experiences;” it was a close call that the patient survived; negative PCT and pneumococcus in the aorta, but there was no sepsis (…). THAT one scared us; it was completely negative PCT” . Such experiences led to a lack of confidence in the test and, in some cases, physicians had stopped using it. The majority of physicians, however, had continued to use the test but applied it more cautiously.Several physicians reported experiences where the PCT results had “scared,” “failed,” or “disappointed” them, which led to uncertainty about the tests’ trustworthiness. E.g., when the PCT result was surprisingly deviant from their expectations based on the clinical picture: ““brave enough to stop antibiotics”, while others highlighted that it provided “legal support” , or “put more flesh on the bones” . They especially appreciated when the test supported their premade decision: “The clinical findings may not be convincing with regard to infection, so we order a PCT; if it is negative, we kind of get more support to quit antibiotics” . Several of the physicians had experienced PCT as an additional tool to traditional infection markers, such as C-reactive protein (CRP) and leukocytes.Physicians found PCT supportive for clinical decision-making involving infections, in particular when they referred to the results as either “very high” or “low,” as opposed to the “middle values.” Physicians framed this support in various ways, for instance informant 4 (25y) emphasised that PCT made him “Increased CRP – it does not necessarily mean an infection in cancer patients; in these cases, PCT is a good tool to obtain an overall picture ( …)” .The physicians viewed PCT as particularly useful in cancer patients. In these cases, clinical decisions were often perceived as challenging since fever, impaired general condition or increased CRP could relate to cancer itself or an infection: “In one patient, we were in some doubt about a possible rheumatic condition ( …); then, we requested a PCT which turned out to be 17, which led us to look more thoroughly for an infection” .An unexpected PCT value also guided the physicians to think more broadly and sometimes accelerated the diagnostic process. For example, looking for rheumatologically or malignant disorders when the result was lower than expected, or for infection when the result was higher than expected: I do not feel PCT is the answer to everything, we have to look at the CLINICAL APPEARANCE; you know, and what kind of disease is it? Where is the infection? Therefore, I do not base all my decisions on it” . One informant, however, reported on an episode in which a high PCT overruled the clinical picture and led to the prolonged use of antibiotics: “We expected the PCT to be low based on the clinical picture, but it was high, so we continued with antibiotics, even though the clinical picture was not convincing of infection” .Although PCT was viewed as a contribution to the diagnostic toolbox, it was not a standalone test. Some had felt great enthusiasm when it was introduced, but as they gained experience, they realised that PCT could not replace clinical judgement. The patient’s clinical appearance remained the most important basis for decisions: “This study has shown that physicians experience a knowledge gap related to the use of PCT, which acts as an important barrier to optimal use. The physicians, however, perceived PCT to be a helpful tool in clinical decision making, but the most crucial factor for antibiotic prescription remained their clinical assessment of the patient.A lack of clear guidelines on how to use PCT and the relatively short-term experience with PCT were factors the physicians pointed out to, a least partly, explain the knowledge gap. This gap barricaded for optimal use as it resulted in the use of PCT in clinical issues in which it had not been validated. For instance, the physicians questioned the trustworthiness of PCT when they used the test for focal infections, although such use is not recommended in the literature . Moreoveincreased days of antibiotics in the patients whom the physicians had used PCT [decreased antibiotic days of therapy [Another explanatory factor of the knowledge gap, and thus the suboptimal PCT use, is that there was no ongoing PCT implementation at the time of this study. Recent real-world studies have shown diverging results that underline the role of active implementation. One study, in which there had been no PCT implementation, found used PCT . On the  therapy , 27. TheOur finding of perceived usefulness of PCT for other indications than recommended in guidelines underscores a need for education on the current evidence, but also the need for further studies into the potential role of PCT in other diagnoses, such as cancer .Systematic reviews on the determinants of antibiotic prescription commonly report that physicians prescribe excess antibiotics due to anxiety about overlooking severe infections –30. In oAdherence to PCT algorithms is commonly low, but explanatory factors remain relatively unknown , 31. GivWhile the qualitative design of our study has enabled us to pinpoint areas that need more focus and potentially can optimise ASP practices, the study also has some limitations. First, we did our research at a single centre, and other perspectives might have been identified in different settings, e.g. in hospitals having used PCT for a prolonged period or with physicians more thoroughly trained in PCT use than ours. However, for many hospitals where PCT is a new diagnostic commodity, we think the present study is relevant. At least in a Norwegian context, our findings are expected to make a difference as judged by an aforementioned national survey of PCT use in hospitals. Although many Norwegian centres use PCT, an evaluation of its clinical usefulness was seldom performed. Also, in most hospitals, utilisation of PCT for clinical diagnostic indications seems to be far more prevalent than for antibiotic stewardship purposes. We assume that a similar situation may exist even in other countries.Secondly, the primary investigators (ICs) familiarity with some of the informants may have affected their responses. However, a deliberate process of reflexivity was deployed to limit the influence of IC’s position.The physicians valued PCT as a decision aid in antibiotic prescribing. Still, uncertainty about the test acted as a barrier for optimal use, which may be remedied by straight forward PCT guidelines and rigorous education and support of the physicians in future antimicrobial stewardship efforts.Additional file 1. Additional file 1_Point_of_care_questionnaire_PCT_use: Point of care questionnaire of the uses and consequences of PCT use.Additional file 2.Additional file 2_Interview_guide: Interview guide.


The UK’s National Institute for Health and Care Excellence (NICE) is responsible for conducting health technology assessment (HTA) on behalf of the National Health Service (NHS). In seeking to justify its recommendations to the NHS about which technologies to fund, NICE claims to adopt two complementary ethical frameworks, one procedural—accountability for reasonableness (AfR)—and one substantive—an ‘ethics of opportunity costs’ (EOC) that rests primarily on the notion of allocative efficiency. This study is the first to empirically examine normative changes to NICE’s approach and to analyse whether these enhance or diminish the fairness of its decision-making, as judged against these frameworks. It finds that increasing formalisation of NICE’s approach and a weakening of the burden of proof laid on technologies undergoing HTA have together undermined its commitment to EOC. This implies a loss of allocative efficiency and a shift in the balance of how the interests of different NHS users are served, in favour of those who benefit directly from NICE’s recommendations. These changes also weaken NICE’s commitment to AfR by diminishing the publicity of its decision-making and by encouraging the adoption of rationales that cannot easily be shown to meet the relevance condition. This signals a need for either substantial reform of NICE’s approach, or more accurate communication of the ethical reasoning on which it is based. The study also highlights the need for further empirical work to explore the impact of these policy changes on NICE’s practice of HTA and to better understand how and why they have come about. In any healthcare system operating with finite resources, decisions must be made about how those resources are allocated. This inevitably creates both ‘winners’ and ‘losers’, as some groups find their needs prioritised while others are prevented from accessing potentially beneficial technologies. Healthcare priority-setting is thus an essential but often contentious activity, which must be subject to robust justification if its outcomes are to be considered ethically, socially and politically acceptable.The heated debate that often surrounds priority-setting is reflected in the experiences of the UK’s National Institute for Health and Care Excellence (NICE). Tasked by the UK government in 1999 with advising the National Health Service (NHS) on its adoption of new and existing health technologies, NICE is no stranger to controversy and has regularly had to justify both its decisions and its reasoning to politicians, patients and the public , 74, 76.The first of these, “accountability for reasonableness” (AfR), seeks to secure fairness through the pursuit of a fair process . This isAlthough this approach seems ethically sound , the conThe study adopted a mixed-methods design, comprising thematic analysis of NICE HTA policy documents and semi-structured qualitative interviews.NICE currently operates several HTA workstreams, including the ‘core’ technology appraisal (TA) programme, established in 1999, and a dedicated Highly Specialised Technologies (HST) programme, established in 2013. This study focused on these programmes because: (1) TA is the largest and most long-established of NICE’s HTA workstreams, (2) both TA and HST are used primarily to evaluate pharmaceuticals rather than other technology types, and (3) they are unique across NICE’s workstreams in carrying a funding mandate—that is, NHS England is obliged to make funds available for the technologies that they recommend.Thematic analysis covered 32 documents published between 1999 and 2018, including each edition of the core technical manuals relating to TA and HST.  NICE HTA. Their purpose was to contextualise, scrutinise, validate and challenge empirical findings and their preliminary interpretation by the researcher. Each interview lasted between one and 2 hours. Interviewees were selected purposively and were intended to represent a variety of perspectives. They included an appraisal committee Chair, a NICE Board member, two senior members of NICE staff, two technical advisors, an industry representative and an academic commentator.Two main themes emerged from the study: (1) the formalisation of NICE’s approach to HTA, and (2) increased leniency in its evidential requirements and handling of evidence.assessment, in which evidence relating to a technology is collated and evaluated in order to establish an estimated ICER, and appraisal, in which an independent committee balances this information against other potentially relevant considerations before making a recommendation, has consistently formed the backbone of NICE HTA. Nevertheless, aspects of NICE’s approach have undergone significant change over time, with important normative implications.Before considering these themes, it should be acknowledged that the analysis also revealed a high degree of continuity in NICE’s approach and a long-standing commitment to the AfR and EOC frameworks. NICE’s use of ICERs, quality-adjusted life-years (QALYs) and the cost-effectiveness threshold as its preferred tools for decision-making, with some allowance for relevant social and ethical values, has been consistent since the institute’s inception. Linked to this, the distinction between Since the TA programme was established in 1999, NICE’s documented approach has become increasingly standardised, specified and detailed: that is, it has become more formalised .This trend can be crudely illustrated by comparing the length of each edition of the TA technical manuals Fig. . UnsurprThis increase in the volume of guidance relates to both the methods used to conduct HTA and the processes followed in applying those methods. It also spans two distinct phases of activity: assessment and appraisal.NICE defines assessment as the systematic evaluation of evidence relating to a technology’s clinical- and cost-effectiveness . It is cThe trend towards formalisation of assessment has been underway since 1999 but is punctuated by the introduction of the so-called ‘reference case’ in 2004: a ‘blueprint’ standardising the calculation of a technology’s ICER by limiting variation across several technical domains.Another normative judgement that has become increasingly formalised is the scope of effects that can be included in the calculation of a technology’s ICER. The 1999 edition of the manual was both non-specific and inclusive: calculations could take account of a technology’s “direct and indirect costs” to the NHS, as well as unspecified “wider costs […] and benefits”, which could be presented to, and considered by, an appraisal committee . Over tiFormalisation has also occurred across appraisal: the process through which an independent committee balances the information contained within the assessment report against a range of other considerations in judging whether a particular technology should be adopted by the NHS . This evSocial value judgements: principles for the development of NICE guidance (SVJ), a formal policy document issued by NICE’s Board of Directors and intended for use by both internal and external stakeholders.In the early years of NICE’s existence, appraisal committees were guided in their decision-making by a set of high-level ethical principles formulated with the aid of public participation. In 2002, recognising the importance of normative judgements and acknowledging that NICE and its committees “have no particular legitimacy to determine the social values of those served by the NHS”, NICE established its Citizens Council (CC) , 65. SelThe first edition of SVJ contained 13 principles that endorsed or discouraged various value judgements, while acknowledging that “there will be circumstances when—for valid reasons—departures from these general principles are appropriate” . The secUntil the late 2000s, SVJ—informed by the deliberations of the CC—provided the basis for NICE’s normative approach. However, in recent years the importance of both SVJ and the CC has waned. Unlike the regularly reviewed technical manuals, SVJ has not been updated since 2008 and several interviewees suggested that it is no longer regularly consulted by appraisal committees.The first decision-rule to emerge was the use of an explicit cost-effectiveness threshold, together with the specification of several value-based factors for justifying committees’ violation of this basic rule.Under EOC, NICE’s foremost distributive concern is to support “an NHS objective of maximising health gain from limited resources” by basing its recommendations primarily on allocative efficiency: that is, cost-effectiveness . Prior tSince 2004, the £20,000–£30,000/QALY threshold range has remained unchanged. However, the factors used to justify breaching it have undergone substantial revision, with a trend towards greater specification Table . In partFollowing NICE’s high-profile rejection of several late-stage cancer drugs in 2008—and the public and political protest that ensued , 76—NICEA further example of formal prioritisation of a particular patient group relates to the HST programme, dedicated to drugs for very rare, usually serious conditions.Given the small commercial market and high price often demanded for highly specialised technologies , the likOne effect of weighting QALYs based on lifetime therapeutic improvement is to favour young patients suffering from severe or life-shortening diseases, who can potentially accrue large benefits over a long time-period. This group has also been formally prioritised through a change to NICE’s policy on discounting; the custom of valuing effects that are experienced today more highly than those that are experienced in the future , 12, 26.Prior to 2011, NICE’s policy was to discount both the costs and benefits associated with a technology’s adoption at a rate of 3.5%, as recommended by the UK Treasury . The norThe second major theme emerging from this study relates to NICE’s approach to the use and handling of evidence.The study identified three key examples of policy developments that have led to a weakening of the evidential requirements for recommending individual technologies.When assessing a technology’s impact, NICE has historically advocated the ‘hierarchy of evidence’ first promulgated by the evidence-based medicine movement in the early 1990s , 69. ThiAn increased tolerance of uncertainty is also apparent in NICE’s changing approach to the use of subgroups.The consideration of how ICERs might vary across different groups of patients—for example, based on disease stage, or risk factors—has always featured in NICE’s approach. However, early editions of the manual stipulated stringent criteria for the use of subgroup analysis because of the loss of statistical power that comes from dividing a trial population into smaller subsets, and the potential for bias to be introduced through ‘data dredging’ (i.e. searching for patterns in data that have arisen from chance) , 70, 79.The most explicit change to NICE’s evidential requirements concerns technologies eligible for consideration under NICE’s EOL rules; that is, cancer drugs.Since 2004, the methods manual has advised committees to take uncertainty into account when evaluating technologies with high ICERs, with committees discouraged from recommending adoption of technologies that appear to be both poorly cost-effective and subject to considerable uncertainty. Specifically, above ICERs of £20,000/QALY “the committee will be more cautious about recommending a technology when they are less certain about the ICERs presented” , 46. Thiplausible potential for satisfying criteria for routine use” [emphasis added] . Thus, over time NICE’s formal policy concerning high-ICER drugs has shifted from one that suggests increased exercise of caution in cases of uncertainty, to one that actively encourages their recommendation despite such uncertainty, as long as they are indicated for cancer.Following review and revision of the EOL rules in 2016, the level of uncertainty deemed acceptable was further increased through a caveat stating that technologies assessed under the rules must merely have “the prospect of” offering a 3-month extension to life , 50.9 FoAlongside changes to evidentiary requirements have been changes to the ways in which evidence is amassed and handled prior to use by an appraisal committee. This has occurred primarily through the introduction of new process variations which seek to increase the speed and efficiency of NICE HTA and reduce costs by making assessment ‘lighter touch’ and transferring workload from independent academic groups, commissioned by NICE, to industry. Table .Table 2KPrior to 2006, all technologies assessed within NICE’s TA programme underwent multiple technology appraisal (MTA). Under MTA, responsibility for assessment rests with an independent academic group known as the “assessment group” (AG), which is responsible for preparing a comprehensive report on the clinical- and cost-effectiveness of one or more technologies (or indications) for use by the appraisal committee. Although drawing on evidence submitted directly by the manufacturer, the assessment report “provides a systematic review of the literature” and is therefore “an independent synthesis” of all of the available evidence . NotablyIn 2006 a new process of single technology appraisal (STA) was introduced. Under STA, responsibility for assessment continues to rest with an independent academic group, but the remit of the renamed “evidence review group” (ERG) is limited to performing “a technical review of the manufacturer/sponsor’s evidence submission” . AlthougInterviewees suggested that the introduction of STA—and now FTA—reflects a shift in NICE’s onus on conducting “the most detailed, independent academic assessment that could be done” to completing appraisals quickly and efficiently, in part by relying more heavily on industry involvement. In the words of one interviewee, the introduction of STA “was the start of a slippery slope and we’ve just gone further and further down that route”.This study, the first systematic examination of how NICE HTA has developed normatively over time, has identified two key themes: (1) formalisation of NICE’s approach across both assessment and appraisal, and (2) increased leniency in its evidential requirements and handling of evidence. Overall, the effect of these trends has been to undermine NICE’s commitment to both the AfR and EOC frameworks and thus the fairness of its decision-making as defined by these frameworks. The wider political, social, organisational and economic implications of these developments are beyond the scope of this paper.unlike in normatively relevant respects be treated as unlike. This sensitivity is secured under EOC by requiring that potentially relevant differences between cases be given due consideration by an appraisal committee before a decision is reached. Formalisation makes this less likely if it restricts committees in their ability to take context into account and exercise judgement on a case-by-case basis. Thus, in seeking to secure fairness through formalisation, the benefits of consistency must be balanced against the harms of insensitivity.A key principle of justice—implicit in both the AfR and EOC frameworks—is that of formal equality: the notion that cases that are alike in normatively relevant respects should be treated as like , 24. AfRThese benefits and harms differ across the assessment and appraisal processes. While appraisal is clearly heavily value-laden, assessment can be viewed as a more technical activity in which sensitivity to normative concerns is comparatively less important. Increased consistency through formalisation therefore may have greater potential to enhance fairness when applied to assessment than to appraisal. As one interviewee explained, NICE’s “more prescriptive” approach to assessment has led to manufacturers preparing “more standardised, better quality submissions”, making it easier for committees to compare technologies consistently, and reducing the likelihood of them misunderstanding key findings or being deliberately misled by complex technical strategies intended to flatter the technology being appraised. Of course, this is not to claim that assessment is value-free or that the formalisation of value judgements within it is unproblematic; increased consistency still comes at a price. One might argue, for example, that individual economic productivity is a relevant consideration in some contexts but not in others and that consistently ignoring it allows unlike cases to be treated as like. However, NICE could reasonably argue that this is a point on which fair-minded people disagree, meaning that the grounds for this decision remain relevant, and that any loss of sensitivity is justified by the benefits of increased consistency.Formalising some relatively uncontentious value judgements through assessment, then, may be a sensible strategy for providing appraisal committees with a consistent starting point from which to weigh a technology’s ICER against other value-based considerations. However, formalisation of appraisal raises more significant concerns, particularly when this takes the form of highly specified decision-rules which limit committees’ potential to exercise judgement.The oldest and most fundamental of these rules is the £20,000–£30,000/QALY threshold, which provides the touchstone for defining cost-effectiveness under EOC. If applied strictly, the existence of an explicit threshold reduces sensitivity to normative concerns substantially. However, as NICE makes clear, the threshold is deliberately stated as a range so as to provide committees with space to exercise judgement, and it is also formally defeasible: that is, it can be revised or overridden in appropriate circumstances . Thus, wOver time, however, NICE’s policy concerning the threshold has become more restrictive. The manuals’ increasing specification of those circumstances in which exceptions can be made, together with the introduction of the three decision-rules highlighted above, significantly restricts committees’ freedom to exercise judgement by defining and limiting both the relevant ways in which cases can differ and the appropriate response to these differences. The EOL rules, for example, reduce a complex normative judgement concerning prioritisation of the terminally ill to positive questions about whether or not particular substantive criteria have been satisfied and a precise maximum threshold of £50,000/QALY. They are insensitive to potentially relevant differences within these criteria—for instance, a technology that offers a 3-month extension to life is treated the same as one that extends life by 5 years—and they limit committees’ freedom to consider other potentially relevant factors, such as the age of those concerned. The relevance of some of these formal criteria can also be questioned, with population studies and deliberations of NICE’s CC suggesting that fair-minded people might not support some of the values on which these rules are based , 56, 72.While committees are not explicitly prevented from exercising judgement in interpreting and applying these more specified rules, it is arguably naïve to consider them defeasible in any meaningful sense. In the politically charged, high-profile environment in which committees operate, the establishment of formal norms creates strong expectations that are difficult to disappoint, particularly when this would mean saying ‘no’ to a technology that might otherwise be recommended. Indeed, doing so might leave committees’ decisions open to appeal or even judicial review.These rules also redefine what can be considered cost-effective by increasing the threshold against which technologies are judged. Assuming that the ‘true’ opportunity cost to the NHS does lie somewhere between £20,000/QALY and £30,000/QALY, such ‘threshold creep’ implies a significant loss of efficiency, reducing the total amount of health the NHS can deliver. This could be justified under both AfR and EOC if the value judgements precipitating it could be shown to be relevant and arrived at through case-by-case deliberation. However, as described above, this cannot be demonstrated. As such, the formalisation of appraisal through the introduction of decision-rules that seek to define normatively relevant considerations and guide committees’ response to them can be shown to undermine both AfR and EOC.Formalisation also poses a challenge to AfR’s publicity condition. This requires that the rationales on which decisions are based are publicly available, but value judgements that are embedded in the assessment process cannot be considered truly ‘public’. The policy to consistently exclude economic productivity from the calculation of a technology’s ICER, for example, is currently made 45-pages into a 95-page technical manual and is characterised as a technical requirement rather than a value judgement . It alsoA further challenge to both the relevance and publicity conditions stems from the arbitrariness of the criteria on which these decision-rules are based, none of which have been publicly justified on either empirical or theoretical grounds. While rigorous academic arguments would not necessarily be expected from a policy body such as NICE, failure to provide any justification for such criteria makes NICE vulnerable to accusations that they are based on political expediency rather than morally relevant considerations. For example, several interviewees suggested that the £50,000/QALY threshold implied by the EOL rules was initially based on the political need to approve a particular cancer drug whose ICER was close to this figure, and that the change in discounting policy was similarly precipitated by the desire to recommend a particular drug , 61, 63.This study also demonstrates several ways in which NICE’s changing approach to the use and handling of evidence has led to a weakening of the burden of proof for recommending a technology’s adoption. This has important implications for NICE’s commitment to AfR and, in particular, the allocative efficiency so highy valued through EOC.The study has highlighted three ways in which NICE’s use of evidence has changed over time: through (1) an increased willingness to rely on non-randomised and indirect study designs; (2) more frequent and generalised use of subgroup analysis, and 3) the lowering of evidential requirements in relation to cancer drugs. In the case of both (1) and (2), the implications for NICE’s tolerance of uncertainty is, in principle, mixed. The traditional hierarchy of evidence of which RCTs are the pinnacle has been subject to much criticism  the lowe, 80, 81 no prospect of offering the required extension to life, and no plausible potential for achieving the required ICER. This shifts the burden of proof from the manufacturer, who was previously responsible for demonstrating that their drug likely met the criteria for cost-effectiveness, towards the appraisal committee, which in order to reject such a drug now needs to demonstrate that it likely does not. Thus, the likelihood that technologies will be recommended on the basis of over-optimistic estimates of cost-effectiveness is increased.In the case of cancer drugs, recent changes weaken this burden of proof to the point that it is arguably reversed. Under the revised EOL rules, cancer drugs need only demonstrate “the prospect of” offering a 3-month extension to life to warrant recommendation up to the £50,000/QALY limit, or the “plausible potential” for achieving cost-effectiveness (according to this limit) for inclusion in England’s Cancer Drugs Fund  would impose costs on others”. This shift has occurred gradually, without any public disclosure of the underlying rationale for this pattern of change, undermining NICE’s commitment to AfR’s publicity condition, and is based on formalised value judgements that are themselves open to question. If the tangible result of these changes is to reduce the efficiency of the NHS—as seems likely—then they considerably weaken the EOC framework, further undermining NICE’s commitment to publicity by contributing to an inaccurate representation of NICE’s substantive approach. As such, while certain elements of NICE’s evolving approach to HTA have the potential to enhance fairness, the overall effect of these changes has been to undermine it through a weakening of NICE’s commitment to both AfR and EOC.This empirical exploration of normative changes to NICE’s HTA approach has highlighted two concerning trends, which together appear to increase the likelihood that poorly cost-effective technologies will be recommended for adoption by the NHS. Further research is needed to understand why these changes have come about, but we might reasonably speculate that political pressures have played a part. Although legally a non-departmental (or “arms’ length”) public body and operationally independent of the Department of Health, NICE remains financially reliant on the government and has therefore had to robustly justify its continued existence during a period of significant change for the health service and the adoption of numerous austerity measures . Given tvolte-face—either to NICE’s methods or to the ethical frameworks on which it claims these are based—may be required if coherence is to be restored to its approach. Such widescale change may prove unfeasible in the short-term. But if NICE is to remain credible in the eyes of the public in whose interests it claims to act, there is a need for it to more accurately communicate the normative judgements on which its decisions are based, either through an update to SVJ or through an entirely new attempt to explicate its ethical approach.Speculative as these hypotheses may be, this paper has demonstrated a policy trend that appears to undermine NICE’s proclaimed commitment to procedural and distributive justice as conceptualised through AfR and EOC. Further empirical work is required to explore the impact of these changes to policy on practice. However, it seems likely that the overall effect has been to undermine the fairness of NICE’s decision-making and reduce NHS efficiency in a manner that cannot easily be justified. A substantial


Political Man, Party Systems and Voter Alignment, and Some Social Requisites of Democracy, never entered the sociological canon. In contrast, Lipset’s work on democracy has gained a strong foothold in political science and his groundbreaking ‘cleavage theory’ is of continuing relevance to political scientists.Seymour M. Lipset was one of the leading scholars of his generation in political science and sociology. Empirically, this article highlights divergent receptions of Lipset in both disciplines: while Lipset experiences increasing visibility in political science, his visibility in sociology turns out to be rather transitory. To better understand these divergent legacies, this paper identifies major topics in Lipset’s oeuvre and reconstructs the ideas that received the most attention in both disciplines since the 1950s. It becomes apparent that the demise of Lipset in sociology can be explained through his decreasing impact on social stratification research and the fact that three major contributions,  Research Committee on Political Sociology.American Political Science Association (1979–1980) and the American Sociological Association (1992–1993). Lipset  was among the most important sociologists of his generation. His work mostly revolved around political topics. His main publications facilitated the establishment of the subfield ‘political sociology’ Janoski, ,1 and he. Lipset  himself Lipset’s citation impact has often been the source of much commentary. It has been, among other things, posited that ‘no living political scientist or sociologist is more frequently cited’  by counting citing articles in academic journals. By doing so, we detect the ‘multiple lives’ of Lipset in the literature  to study the Cooperative Commonwealth Federation (CCF) of Saskatchewan for his doctoral dissertation (1945–1946). He worked as a lecturer at the University of Toronto (1946–1948), defended his dissertation in spring 1948 and accepted an associate professorship position at UC Berkeley (1948–1950), which enabled him to access – together with Reinhard Bendix – massive job history data gathered by the Institute of Industrial Relations, which was based in Oakland, California. Merton invited Lipset back to Columbia with an associate professor position 1950–1956), which resulted in a period of intense cognitive interaction between the onetime-student turned professor, Lipset, and many talented students (including Martin Trow or James S. Coleman). From the 1950s, he travelled frequently to Europe and other parts of the world, becoming an intellectual known beyond the confines of the United States Velasco, , p. 588., which rHe continued his career as a full professor at UC Berkeley (1956–1965), where he renewed his cooperation with Bendix. In 1965, he moved to Harvard University (1965–1975) mostly to free himself from the time-consuming involvement in Berkeley academic politics Lipset, , p. 17.6and sociology . Thus, Lipset can be considered one of the true figureheads of the hybrid ‘political sociology’.Admittedly, this is a short exposition of Lipset’s remarkable academic career.A central characteristic of Lipset the academic is his outstanding life-long productivity. Agrarian Socialism , book contributions amount to approximately 3000 pages.As ‘Lipset wrote [literally] about everything’ Lakin, , p. 337,Thus, when asked to find the essentials in Lipset’s work, different scholars offer different classification grids. To clarify more precisely which topics dominate Lipset’s writings, we apply automatic text analysis to his oeuvre to empirically establish on which of these topics Lipset worked most and how and when his research interests changed over time. The simple assumption underlying this quantitative methodology for identifying distinct research domains is that an author uses different vocabulary when writing on only loosely related topics.N = 15) to be searched in texts are determined beforehand. Each topic is represented by a ‘dictionary’, that is a list of key words that were found to stand for certain topics. Dictionaries were ‘calibrated’ by extracting the most frequent ‘meaningful’ words from the most representative texts.The key advantage of computer-aided rather than hand-coded content analysis is that the rules are made explicit Weber, . In our MAXQDA, ignores different word endings and capitalisation. For example, the dictionary entry ‘jew’ suffices to count the frequencies of such different words as ‘Jew’, ‘Jewish’, ‘Jewry’ or ‘Jewishness’.Dictionaries contain, with one exception, between 20 and 30 words (see Online Appendix). The computer programme used, n-grams (n > 2) contained in each publication.To assign contributions to topics, we first delete 310 extremely common stop-words – that are of little value for our analysis – from all texts and then calculate the percentage ratio of dictionary-based keywords to total number of While we calculated the ‘fit’ between each publication and each ‘dictionary’, for the purposes of demonstration, we present here only the results for all books and Lipset’s academic memoir. To construct As It Didn’t Happen Here is even covered by four different dictionaries: class politics , democrOverall, To further explore Lipset’s research, we apply the same methodology to another 92 journal articles published by Lipset (see Online Appendix), which enables us to comprehensively capture the sheer quantity of research published in different research domains.The key point to take from weighted paged count. An alternative depiction based on a simple page count yields greater values for both research strands. In both approaches, however, it transpires equally that both research activities were, more or less, confined to certain career stages only.The fact that Lipset collaborated, closely with different co-authors (including Reinhard Bendix or Everett C. Ladd), especially in the fields of social stratification and politics of academics, results in smaller numbers in Taking a more dynamic view on the research agenda thus reveals that Lipset’s research focus was alternating between democracy research (1947–1965) and research on American exceptionalism (1966–2001). Overall, it can be concluded that apart from these two lifelong research themes, Lipset dedicated his time and energy to various research areas  but always for a limited time.ISI Web of Science is the standard and most widely used tool for generating citation data as indicators for the reception of a scholar’s work. ISI, the Institute for Scientific Information, was founded by the bibliometrician Eugene Garfield in 1960. In 1992, ISI was sold to the Thomson Reuters corporation (‘Thomson IS’). Today, the citation indexing service is maintained by Clarivate Analytics. Thomson Reuters had already made its citation databases accessible using the online platform called ‘Web of Science’ (previously known as ISI Web of Knowledge).In bibliometric research, the former number of articles published in SSCI journals citing Lipset at least once.We base our citations analysis on the Social Science Citation Index (SSCI-present) that is included in the WoS.The other research tool we use to study the reception of Lipset’s work is JSTOR data for research (DfR).To reconstruct the reception of Lipset in political science and sociology, we build on the previously conducted content analysis and take cues from scientometrics. Having assigned each book and journal article listed in the Online Appendix A1 to one or more topics, we can tell which research – and not only which specific publication – attracted the most attention by peers in two social sciences disciplines. The overall picture that emerges for each discipline overlaps to some degree. Even if the versatile scholar Lipset published in many different fields see , the bulOver time, the reception patterns diverge strikingly. In political science, Lipset garners a substantially growing number of citations for his work related to democracy and American exceptionalism. Looking at the results for sociology, we see little change, with one notable exception. Publications on social stratification started to garner a rather average number of citations.To bring more light to the divergent reception trends we disaggregate SSCI citation on the level of publication type and choose a more fine-grained temporal scale see . RegardiIf one disaggregates these citation counts (see Online Appendix) and looks at the citation trajectories of publications that contribute the most to the overall citation volume, one can easily identify the underlying reasons for the different reception histories identified.Political Man remains often-cited in political science but lost traction in sociology. Citations of the sociological classic Social Mobility in Industrial Society decreased. The book Party Systems and Voter Alignment, in which the editors, Lipset and Rokkan, outline the importance of social cleavages for the ‘freezing’ of party systems more than forty years ago, appears more relevant today to political scientists than ever. Finally, the 1959 journal article Some Social Requisites of Democracy, in which Lipset identified a nexus of causal factors leading from economic development to prospects for stable democracies, garners more citations every ten years in political science, while it remains rarely cited in sociology journals.The book To validate the ‘citation approach’, we use a second method that aims at identifying dominant topics covered in the reception of Lipset by analysing the full content of JSTOR-archived journal articles mentioning the word ‘Lipset’ at least once. JSTOR provides up to ten ‘Topic Cards’ derived for each article from a thesaurus, which are intended to provide background and content for the many subjects covered on JSTOR. To give an example, the article ‘Some Social Requisites of Democracy’ is assigned the following topics: democracy, political parties, dictatorship, economic development, countries, social democracy, urbanisation, communism, and Catholicism.It has become apparent that the case of Lipset confirms the more general observation that if an author has an afterlife in the literature, the majority of citations will typically refer to very few major works .Some Social Requisites of Democracy , Lipset posits a list of factors that constitute the conditions, though not necessarily the causes, for democracy (‘requisites of democracy’). There exist basically two interpretations of Lipset’s theory. The wide interpretation is that the interplay of many changing social conditions  foster a democratic culture (‘socioeconomic development’) that needs to be perceived as legitimate in order to stay firmly established (‘legitimacy’). The boiled-down version of Lipset’s argument is that there is a simple correlation between per capita income and democracy, and, indeed, Lipset argues in a central passage that ‘the more well-to-do a nation, the greater the chances that it will sustain democracy’  sociologists, the book never influenced the collective understanding of sociology as a discipline to the same extent. As Da Silva and Vieira . There is, however, one notable difference in reception between the two disciplines. Sociologists have paid significantly more attention to Lipset’s work on social stratification. Thus, the reality is more ‘messy’ than stylised models of reception would suggest, and neither scenario 1, political scientists and sociologists borrow the same ideas, nor scenario 2, political scientists and sociologists borrow different ideas, fully apply.Political Man, Some Social Requisites of Democracy or Party System and Voter Alignment, received constant or even increasing attention over the years in political science, while garnering an ever-decreasing number of citations in sociology. A major explanation of the puzzle identified is thus that a small number of Lipset’s major contributions experience an ‘episodic rebirth’ (Ollion & Abbott, Political Man remains a source of inspiration for political scientists. In the same vain, social-cleavage theories do not only remain associated with Lipset but experience various reformulations in political science, even more so after the publication of Party Systems and Voter Alignment.The central finding is that there are different citation trajectories in Lipset’s work. Key publications, such as Social Mobility in Industrial Society, is cited because of the so-called ‘Lipset and Zetterberg hypothesis’ only. The LZ-hypothesis might today still inspire some sociological research, but scholars do not try to resuscitate a ‘Lipsian perspective’ in analyzing the social world when citing this work. Additionally, it is evident that Lipset never gained a lasting canonical status in a key knowledge domain of sociology, namely, social stratification research – a claim that we confirmed by studying changing topics in a huge JSTOR text corpus.In contrast, a key contribution to Lipset’s reputation in sociology, namely Political Man, have not been included in the sociological canon to the same extent as, for example, Daniel Bell’s The Coming Crisis of Post-Industrial Society or Peter Blau’s and Otis D. Duncan’s The American Occupational Structure.Political Man never received much sociological commemoration, much suggests that – all protestations about the necessity for interdisciplinary understanding to the contrary – sociologists found the book too focused on political issues to become a sociological classic. This is not without a certain irony, given that Lipset wrote in the foreword to Political Man that ‘the study of man in society cannot fruitfully be compartmentalized according to substantive concerns’ (Lipset, One must additionally consider that Lipset’s best contributions, such as  Lipset, , p. IX.originality and timelessness of ideas. While Lipset’s early work on social mobility has proved to be outdated, his ideas on the social bases of political cleavages, for example, remain relevant. The second factor is the ever-changing trajectories of a discipline. Many observers of sociology, including Lipset (More generally, this case study highlights the interplay of two central factors that determine the reception of an author. The first factor is the g Lipset  , considg Lipset . Furtherg Lipset , p. 447.Moreover, democracy research has not been able to establish itself within sociology, while it has become a major research area within political science. Especially with the ‘third wave of democratisation’ and the rise of populist parties in many established democracies, Lipset’s groundbreaking ideas on democratic legitimacy or on the relevance of socio-economic cleavages for structuring party systems have experienced a revival within political science. Lipset, the democracy theorist, thus continues to inform the social sciences, albeit mostly within the confines of political science.


To the Editor,Since the first report on the outbreak of a novel coronavirus disease COVID‐19 in Wuhan, Hubei, China, in December, 2019,Although asymptomatic patients with SARS were uncommon, they were documented in a retrospective study in the minor 2004 SARS outbreak after reopening of the wildlife market in Guangzhou.In both cases, asymptomatic carriers were diagnosed by screening after other family members developed symptoms. We presume there would be many other asymptomatic carriers who were never tested. Even if those carriers were in the hospital, perhaps for another reason, would the doctor think of doing a viral nucleic acid test for COVID‐19 in time? If it is not possible to screen these asymptomatic carriers from truly healthy populations, they will be a source of COVID‐19 infection back into the community, which will also pose a huge challenge for COVID‐19 prevention and control.On February 25, the case of COVID‐19 transmission occurring in a prison in Rencheng district, Jining city, Shandong province has sounded an alarm for us. On February 9, a man was released from prison and returned home. But he was informed to isolate himself because a prison officer was confirmed to have COVID‐19 infection on February 14. In order to avoid isolation and observation, the man absconded from his home. Later, it was confirmed that this man was an asymptomatic carrier, and his brother who had close contact with him became infected with COVID‐19. This case is an example of asymptomatic transmission. One study has reported that the viral load that was detected in the asymptomatic patients was similar to that in the symptomatic patients, which also theoretically suggests the potential transmission of asymptomatic patients.In Conclusion, we considered that asymptomatic COVID‐19 infection is possible, and person‐to‐person transmission can occur from asymptomatic COVID‐19 carriers to the community. Therefore, vigilant control measures are warranted at this stage of the COVID‐19 epidemic to avoid a resurgence in cases.We declare no competing interests.Xingxia Yu: Conceptualization ; Data curation ; Formal analysis ; Investigation ; Methodology ; Project administration ; Resources ; Software ; Supervision ; Validation ; Visualization ; Writing‐original draft ; Writing‐review & editing . Rongrong Yang: Conceptualization ; Data curation ; Formal analysis ; Investigation ; Methodology ; Project administration ; Resources ; Software ; Supervision ; Validation ; Visualization ; Writing‐original draft ; Writing‐review & editing .


Previous physical activity interventions have failed to create population change and an alternative approach is needed to support a World Health Organization target of a 15% reduction in global levels of inactivity by 2030. There is growing evidence that gamification-based interventions can reach substantial portions of the community. However, to date, these studies have been predominantly quantitative and as such there is a paucity of research in the area on motivations and barriers to engagement with these programs. Four focus groups conducted with N = 26 players who participated in a gamification-based intervention ‘Beat the Street’ revealed several varied motives to engagement, including collective reward; social influence; game reinvention; exploration; accessibility and awareness. However, several barriers specific to the Beat the Street intervention and outdoor gamification interventions more generally were also identified. This study provides novel insight into the motives which engage individuals into physical activity interventions and the design principles which need to be considered when implementing interventions of this nature. Despite significant investment in physical activity interventions over the past 20 years, a recent study concluded that 27.5% of adults were insufficiently active, globally, and that levels of inactivity in high-income western countries had increased by over 5% between 2001 and 2016.  In EnglaPrevious attempts to reduce physical inactivity have focussed on individualistic approaches, such as exercise referral/on prescription programs, clinical populations and community groups and whilst some have shown improvement for specific population groups, they have made little impact at community-wide level. –11 In 20Interventions which incorporate game elements and technology have been successful at engaging substantial portions of the population. These approaches apply game principles  to encourage people to walk, cycle and generally be more active. Pokémon Go is one example which demonstrates the mass-appeal of these technology supported, gamified approaches. At its peak Pokémon Go had an estimated 45million daily participants worldwide. Whilst this game was never designed to be a public health, or physical activity intervention, it did result in encouraging users to walk, run and explore their environment, as a biproduct of gameplay. Due to both the novelty of mass scale gamification-based approaches and their very recent application, the evidence-base is, to date, sparse. According to Corepal et al. they conclude that gamification interventions have rarely been developed using theoretical frameworks and furthermore, little is known about the perspectives of those that take part. Whilst the Corepal et al., paper was published in 2018, research in this area is still, to date, sparse. Recent qualitative efforts have attempted to unravel the motivational constructs underpinning the mass-appeal of these approaches. In one study, Shameli et al. found competition incentivised users of a smart-phone walking challenge to increase their activity, however group dynamics  had both positive and negative effects on engagement.  ElsewherAt a general level, there is a paucity of research investigating engagement with these novel approaches that specifically tackle levels of inactivity. Further, there is an even greater lack of evidence regarding the study of the lived experience of participants from a qualitative perspective. As a response to the gap in the current literature, this study aimed to identify why participants engaged with the intervention, and the barriers to participation they encountered during a community-wide gamification-based physical activity intervention, ‘Beat the Street’.An exploratory qualitative research design was used to explore the motivations underpinning engagement with the intervention. Focus groups and thematic analysis were used to collect and analysis the data for the study.Beat the Street is a community-wide, gamification-based physical activity intervention. The intervention aims to change levels of physical activity by turning a local area into a game where participants register their walking and cycling journeys by tapping a Radio-frequency identification (RFID) card on RFID readers called ‘Beat Boxes’. Beat Boxes are placed on lampposts throughout the locality, in greenspaces and in places of local interest  at half-mile intervals. Points are accrued by distance travelled whereby each time two boxes are touched in under 1 hour a player receives 10-points for themselves and their team. At the end of the game period, highest scoring schools, community groups, and individuals are rewarded with prizes, such as vouchers for sports equipment, craft or book vouchers, or cash prizes. An online portal is used to engage with each participant. This platform allows players to register to take part, select a team they wish to be a part of, provide data on their health and wellbeing, monitor their progress, compare themselves with others and receive up-to-date communications about the game. It has previously been assumed that children and adults compete to see which schools, community groups and individuals can achieve the greatest number of points throughout the 7-week game period, however little is known about the precise motivating components, nor indeed barriers to particpation. ,21 The iBeat the Street ran between March 15 and May 13 2017 in Wolverhampton, England. Adult participants who took part in the intervention were encouraged to register their RFID card via an online portal which allowed them to select a team to join, such as their child’s school, their workplace or a local charity. During registration participants were asked to complete a range of sociodemographic questions and a validated physical activity questionnaire.  ImmediatFour focus groups were undertaken with participants  and were organised by gender to ensure participants felt comfortable when discussing their motivations and barriers to activity. Each focus group lasted for approximately 2 hours with participants spending 1.5 hours in their discrete groups before coming together into two larger, mixed gender, groups for a 30-minute reflection and sharing session. The data collection period was completed within 3 weeks of the intervention concluding. Informed consent to be contacted following the game period was obtained electronically via the online portal and written consent was obtained prior to each focus group. Ethical approval was granted by Cardiff Metropolitan University, Psychology Research Ethics Committee (Ref 8405). Participation in the intervention was entirely voluntary and participants could choose to partake in the intervention without being contacted in future, providing data at baseline and/or follow-up and taking part in a focus group post-intervention.Each focus group was guided by an identical discussion guide. The discussion guide was developed following extensive consultation between the researchers, intervention deliverers  and a review of past literature exploring the motivations to engagement with gamification-based interventions. The focus groups were split into 5 sections. First, participants were asked to introduce themselves and discuss their hobbies, what they like to do to relax and the words they associate with sport, exercise and activity. Second, participants were asked their general drivers and barriers to physical activity and specifically what makes a good experience and what makes a bad experience. Third, participants were asked to discuss their direct experience of Beat the Street, their reasons for taking part, the initial prompt, how they found out about it, what made them sign-up and if they got what they hoped to achieve out of the game. Fourth, the groups were asked to discuss any impact Beat the Street had on their attitudes and behaviours, if they felt it had led to change and if any change will continue. Finally, once the four groups were combined into 2 groups with mixed genders, they were asked to share what they had discussed previously with each other and to visualise and discuss what a future intervention would look like in an ideal word.Beat the Street was delivered as a pilot intervention on behalf of Sport England, a national non-departmental public body, and City of Wolverhampton Council. Wolverhampton was chosen as an important location for this pilot due the area possessing high levels of inactivity and multiple deprivation. The intervention engaged a total N = 25,790 people. None of those participants, nor in fact in any of the previous intervention participants to date, had been invited to participate in a qualitative investigation into understanding motivations for engagement. Therefore, a selection were invited to take part, of which N = 26 players were recruited to take part in the study. Participants that took part in the focus groups had a mean age of 44, which ranged from 25 to 60, and there was an even distribution of males and females (50:50). Of all adults who took part in the intervention  80% were aged between 19 and 49 and 71% were female. As such, the focus groups had strong representation of intervention participants more broadly.The focus groups were audio recorded and transcribed following the completion of the data collection period. Data were analysed using thematic analysis and followed the six stage principles outlined by Braun and Clarke. ,24 In stThrough the process of thematic analysis,  seven thUnsurprisingly, given the nature and design of the intervention, extrinsic motivations were a key incentive underpinning engagement with the program. These rewards, however, were predominantly social and altruistic in nature with participants wanting to ‘win’ for others, such as a community group or school.For instance, Andrew: “My wife wanted to win the money for her walking group. We got everyone to sign up for it” and Rebecca: “I used to feel sorry for them (children) in the morning outside school, they’d tap their machine before they went into school. They weren’t getting the points. You have to tap a machine and then tap another one. My motivation was getting points for those children who couldn’t get them”. Stacey shared a personal story about how the collective charity prize was a key driver to her participation, explaining “It was about Wolverhampton benefiting from the total. Compton Hospice would get a donation. Work did say about friendly competition but for me it was more personal, health and Compton.”The social nature of Beat the Street was the overarching catalyst for participation. Whether family, friends, colleagues, or the Compton Hospice charity, participants wanted to take part in an activity with other people, and for other people.Gareth and Alan: “Family was a big one for me. Engaging in any task on your own, you can do it, but you feel separated. When we did it together it was more motivating. It kept us all going. We all have to stay connected to get something done.” and “It’s for me and my son. I like boxing but I have arthritis. This Beat the Street made me get up and now I do all sorts with my son. I enjoy it. I’m a van driver so I’m sat down all day, but this got me doing something different. Now I do more things.” respectively. However, the social coercion (often referred to as ‘pester power’) ,23,25 byThe scheme had a very simple underlying concept where participation merely involved tapping a card on a physical box. This simplicity allowed individuals to invent their own concept of participation. For some, particularly children, they could incorporate a fantasy, role-play element to the ‘collection’ of boxes. Whereas others used the program to track their activity, set targets and compete with friends.Rhys: “I used Beat the Street with the guys I work with in therapy as a benefit for mental health. They’re adults and they love it. They want to carry on doing it even though it’s finished. It really helps them.” and Suzanne: “Rather than eating lunch in the office, a couple of friends and I made an effort to go out and walk. It meant we could go out and have a chat. We all have Fitbits so we were competing.” This was in contrast to Maggie who expressed how the children where influential in shaping the game with their imaginations, “For the kids it’s like a mini adventure or a treasure hunt. My daughter found adventure in the whole thing. I got excited about it was well. It wasn’t dull. For such a simple thing, it became an adventure. It was really good.”The participants articulated a strong sense of satisfaction from exploring their local area, whether that be areas of blue or greenspace, local markets or neighbouring streets. Participants were shocked to discover new features of the environment they thought they were previously familiar with. The game appeared to give them the license, or purpose, to explore the areas where they lived and worked, and indeed new areas in their local environment.For Stacey there was a passion for discovering different areas, rather than collecting the Beat Boxes, “Getting to discover places I didn’t know. We did Cupcake Lane and the abandoned station is a teashop. One day I thought, “Let’s try going a little further.” I hadn’t realised there was a massive park at the back of Newbridge. I walked all around there and found the Wolves training ground.” Although for Jennine and Rob there was a sense of achievement in ‘collecting’ the boxes over the course of the game period, they explained, “My little boy was looking at the map, marking it off and circling where he’d been.” (Jennie) and “Being involved in a successful day, it becomes habit. You come home thinking you’ve had a good day. So that’s an addictive feeling. Once we knew we could map up which ones we were going to, then we could do that one on the way to other places.” (Rob).The simplistic and inclusive nature of the intervention seemed to appeal broadly. Participants felt they could play in any way they wanted, whether completing a circuit close to their house or travelling further afield to tap boxes in the wider vicinity of the game area. They felt they didn’t need specialist equipment or clothing and that participant didn’t carry a financial burden.Ed and Rob, respectively, explained how the game could be incorporated into daily routine without any cost, mentioning “You’ve got family and work commitments. You can play the game on your doorstep” and “There's nothing more accessible than walking around. Clubs usually have a membership or some kind of cost involved. This is accessible for anyone.” Supporting these arguments, Maggie revealed how Beat the Street had altered her regular travel behaviour for shopping: “If I go to Asda  in Wolverhampton I walk down there and catch the bus back. With Beat the Street, there was the incentive to carry my shopping and walk back.”The game aimed to promote health by stealth where the health benefits of physical activity weren’t promoted. However, taking part in the program made individuals self-aware of the benefits the program, which facilitated walking, cycling and communication between residents, was having on their physical and emotional wellbeing. This process of self-discovery motivated participants to take other steps to maintain or further these benefits, such as joining a traditional gym or spending more time outdoors.Lucy and Katherine both talked to the group about the influence it had had on their physical activity: “Yes, it encouraged me to do more of that [cycling]. I can see the benefit of what I’ve done, and I don’t want to stop doing it. I want to do it more.” (Lucy) and “I went back to the gym. It prompted me to think about how important it was. We live too far from the school to walk the whole way. With Beat the Street we started walking partway. I felt healthier, more toned and it reminded me how I used to feel. I never used to care about people looking at me and I’d started to care so I wanted to get back to how I used to feel.” (Katherine). For Sarah, however, the behaviour change came from an awareness of nature, rather than physical activity solely “I’m still walking a lot. I spend more time outdoors because of Beat the Street. I think there’s more awareness of the benefits of being out in the fresh air.”There were several varied motivations for engaging with the intervention, however, there were also number of potential barriers to both engagement during the game period and sustained participation in physical activity, post-game. These potential barriers were mostly reported by participants who engaged with Beat the Street through their child(ren), who often cited practical barriers such as safety or the game set-up, i.e. proximity of beat boxes to each other. For instance, Noel: “This year [it was the second year of the game in this area] they were outside the park and across the road. So that’s dangerous to take them [the children] across the road” and Alan: “To be more kid friendly, there would need to be more [beat boxes] that were closer together. If they’ve got to walk half a mile to get two, they won’t”. Those, who were engaged directly in the intervention also provided recommendations for improving the programme, which might help with engagement. For instance, Chris: “The boxes were the same colour as the lamppost, and you'd go past it. Put fluorescent tape on it.” and Jennie: “Sometimes the little ones would fight to tap my card. Sometimes they didn’t all work. Some of the boxes didn’t work.”The current study indicated several varied motivations for participation in the intervention which may have been activated by distinct game mechanisms. Key motivating factors for engagement with the intervention were:Collective reward, acquiring points for collective gain (i.e. a charity or school).Social influence, taking part in an activity with shared common goals with family, friends and/or colleagues.Exploration, discovering the local area, finding new routes and greenspaces, and orienteering to ‘collect’ ‘Beat Boxes’.Game reinvention, for instance, using the game as motivation for activity as part of a patient’s treatment plan or using it as motivation for lunchtime activity in the workplace.Accessibility, awareness of the ease by which participation could be incorporated into daily life and regular routine.Awareness, where participant’s involvement triggered engagement in other sustainable physical activity, such as going back to the gym, and changing dietary behaviours which stemmed from an increased awareness of their importance, from engagement in the game.Findings also revealed several barriers to participation which need to be addressed to maximise future engagement. These barriers were mostly expressed by parents who had concerns about child safety, a finding consistent with other outdoor gamification-based interventions.  However,There are several game mechanisms which may have engaged participants via the varied motivations presented above. Firstly, the game used a points-based system centred on collective reward. Previous research has shown collective rather than individual extrinsic rewards are more powerful motivations for changing behaviour. ,28 SeconThere are several important practical implications from this qualitative research. Whilst the current findings cannot be generalised to the 25,790 participants that took part in the intervention, combined with other recent qualitative inquiries of gamification-based programmes, they suggest that the mass appeal of these initiatives could stem from the many, and varied, motivations which they are able to cater for. Firstly, this research implies that interventions, both individualistic and community-wide, need to be simple to engage with, social in nature and facilitate social interaction, co-operation, encourage outdoor activity, and provide a degree of healthy competition, where possible. This argument is supported by a recent systematic review of physical activity messaging which suggests messages should be framed positively and highlight short-term outcomes, specifically relating to social and mental health. Second, programs should be as inclusive as possible, where individuals of different abilities can compete, or participate with no or minimal cost and without the requirement of specialist clothing or equipment. Again, using Parkrun as an example, its the growing success highlights how making activities easy, financially accessible and inclusive to individuals of all backgrounds may be crucial to generating mass participation in regular physical activity. Third, intervention providers could benefit from recognising the allure of approaches which tap into the so called biophilic instinct to be outdoors. Other approaches, such as incentives to collect or accumulate achievements could also be capitalised on for initial engagement techniques to such activity. This research raises the question whether there is a need to reframe the messaging used to publicise and promote the benefits of physical activity or risks of inactivity. This research suggests that allowing individuals the time, autonomy and opportunity to discover the benefits for themselves may produce more salient results than traditional health messaging has achieved. Finally, this research suggests there is a need to engage the public, through proper and legitimate co-production, in the design of interventions, where possible, to limit the avoidable barriers to participation identified above.The findings from this exploratory qualitative study, combined with other similar investigations of gamification approaches, demonstrate how gamification can tap into several distinct motivations likely to be responsible for the engagement of substantial portions of the population. ,19 What These findings provide insight not previously captured in research to date, into the experiences of participants following engagement with a gamification-based community-wide physical activity intervention. Gamification-based approaches can engage individuals through several varied motivations which is likely to be a key underlying factor enabling these interventions to engage substantial numbers of people. However, there is a pertinent need for large-scale controlled trials to reveal the extent of behaviour change achieved through gamification based public health interventions such as Beat the Street. There is also a need for such interventions to be part of a wider whole systems approach to addressing physical inactivity