The notion of ‘evidence’ circulates in two realms of current maternity care: biomedical ‘evidence-based’ obstetrics and efforts to reform conventional obstetric practices. I observed that in California's childbearing culture, ‘evidence’ is a boundary object that allows diverse actors to engage in related conversations despite fundamentally different assumptions about what evidence is or does. Sometimes these actors form productive hybrids and other times they talk past one another. This article uses recent work from the history and philosophy of science to distinguish the biomedical use of evidence, which is based on controlled experiments to prove cause and effect, from reformists' use of evidence, which foregrounds patient outcomes. Using Stengers's classification of doctors, charlatans, and curers, I discuss the role of rationality and experience in producing authoritative knowledge. Reformists' use of evidence, in effect, challenges medical power dynamics on what they perceive to be the terms of medical authority itself; in doing so, it has the potential to fundamentally alter who is the primary beneficiary of medical protocols. The challenge is continuing to use evidence in a way that doesn't simply ossify a new set of norms, but becomes increasingly capacious, flexible, specific, and patient centered. The crowd isn’t large, maybe thirty or forty people. But energy is high. Hand-drawn rainbow prayer flags wave above us, including one I drew myself, at the BirthKeepers conference the day before. The woman speaking is standing on a platform, a sparkling turquoise cape draped around her shoulders. I had just learned the day before that turquoise is the color of the birth revolution. We are gathered outside the annual conference of the American College of Obstetricians and Gynecologists (ACOG), in San Francisco, in May of 2015.‘We demand evidence-based care!’ she says. ‘Don’t induce for large babies, low amniotic fluid, or anything before forty-two weeks — acknowledge forty to forty-four weeks as the norm! Ask before you do something, episiotomies, putting your hands inside. This is my body, I get to decide!’ The speaker proudly proclaims that she is ‘just a mom’; she is also the founder of the Just a Mom League, which advocates for changes in maternity care from outside the medical profession. She later tells me the organization is for ‘everyone who’s willing to support moms as the primary decision maker regarding their body’.The politics of medical decision making might seem self-evidently related to the use of evidence — good care is evidence based, while practices not based on evidence may be harmful or unnecessary, indicative of authoritative traditions rather than what is optimal for the patient. ‘Evidence-based medicine’ (often abbreviated as ‘EBM’) has become a dominant organizing paradigm for health care and medicine in the Western world over the past two decades, yet the activists in this brief vignette used evidence as a rallying point to challenge the medical community about what is optimal and who gets to decide. Evidence is not as straightforward as it seems.In 2008, Canadian obstetrician-anthropologist Wendland published a critical medical anthropology article about evidence-based obstetrics, arguing that it undermined beneficial care for birthing women by bypassing their experience, and that of the clinician, in favor of aggregated, trial-based data that reproduced ideological biases and justified increases in cesarean section. By contrast, in my recent fieldwork on childbearing in California, ‘evidence’ was commonly marshaled to oppose obstetric conventions around medicalized birth, such as those Wendland criticizes. The idea of evidence-based medicine can be appropriated to different ends and with different relationships to the power dynamics in maternity care.Being poorly defined yet taken for granted makes evidence both confusing and powerful. In this sense, it is a boundary object , meaningTo be clear, there is a robust discussion among medical researchers about the different kinds and qualities of evidence , for which I trained and served as a doula  and actively participated in classes, community events, and professional meetings aimed at doulas, midwives, nurses, doctors, childbirth educators, and childbearing people. I also conducted interviews with various people from these groups and followed articles in the popular press about maternity care. As I describe elsewhere , the BayBeing a practicing doula and anthropological researcher required juggling the practical and ideological commitments associated with each role. Since doulas tend to participate in what I call ‘reformist’ circles and efforts, I am more familiar with this perspective, though I endeavored to balance things out by, for example, regularly writing for a university medical blog and attending conferences aimed at nurses and doctors. In any case, from my feminist position as both anthropologist and doula, ‘neutrality’ was never a goal. In the Bay Area, birth reformists are a professionally heterogeneous group with varying ideological commitments and degrees of investment, and include actors as diverse as parents, doulas, midwives, obstetricians, nurses, scientists, and activists . These reformists marshal claims about evidence-based practice to push back against hospital interventions from surgery to pharmaceuticals, arguing that existing medical practice is based on litigation, profit, and outdated social conventions, not science see .Although ‘evidence’ is on the surface an epistemological term, reformists deploy it in a political way to contest broader power dynamics, sometimes with the tone of activist underdogs challenging a patriarchal establishment. Reformists’ dissatisfaction with the politics of medical practice and knowledge production includes critiques of litigation, liability, and the ‘pharmaco-insurance-research industrial complex’. Science studies scholar Sociologists There are two ways that evidence can be a boundary object, lacking consensus yet enabling cooperation. The first concerns the kind of evidence that is being used and its relative quality. In EBM this is typically illustrated as a pyramid: randomized controlled trials (RCTs) are the ‘gold standard’ of evidence in contemporary biomedical systems, with systematic reviews of RCTs at the very top . BeneathMy argument takes place on a different level that is concerned with underlying epistemological paradigms. These go unarticulated even as reformist and biomedical use of evidence blends and blurs. Evidence as a concept is naturalized as self-evident and ahistorical in both orientations. Its general association with science lends it moral and epistemological potency; among those concerned with maternity care, it was implicitly understood that no one could be ‘against evidence’. Yet significant practical and political differences stemmed from how evidence was understood. In what follows, I first describe how I saw ‘evidence’ being used by reformists to shift paradigms of knowledge and practice. Then I work closely with Stengers’s ideas to trace how contemporary understandings of evidence came into being through social processes of consolidating authority; dominant understandings consider evidence as offering proof of cause, whereas marginalized understandings point to empirical outcomes. Finally, I consider the contemporary interactions between the different concepts of evidence, referencing Stengers’s concept of ‘curers’ to consider what further ‘evidential diversity’ might look like. Given the ubiquity and centrality of evidence not only in obstetrics but in medicine generally, what ‘counts’ is a high-stakes issue, consequential for everything from everyday doctor visits to whether insurance will cover potentially life-saving treatments labeled ‘experimental’. Being more explicit about epistemological underpinnings and their genealogies can, I suggest, improve maternity care, and potentially have even broader impact.‘Midwifery is the only intervention ever proven to reduce prematurity!’ exclaimed Missy Cheyney, the medical anthropologist and home-birth midwife speaking at the 2012 Midwives Alliance of North America (MANA) conference. MANA is the most inclusive professional midwifery organization, comprising hospital-based, home-birth, certified, licensed, and traditional midwives; Cheyney was speaking about the MANA Statistics Project, which collects data about births attended by midwives, primarily occurring in homes or birth centers. Her small stature belied her larger-than-life presence, as she urged the audience of mostly midwives to enroll in the MANA Stats Project, an online birth registry that collects de-identified birth data from clients who consent to participate. MANA’s Division of Research began collecting data through an online system in 2004 and the total sample size numbered more than one hundred thousand cases by 2016 (MANA n.d.-b). This registry would enable researchers who applied for access to the data set to study and make claims about safety and risk in midwife-led births at home and in birth centers, as well as to supplement and critique the obstetric canon offered by the biomedical research industry. Existing databases do not accurately capture planned home and birth center births in most states, which also makes funding such research challenging.This dynamic speaker enumerated many of the findings that were emerging from the studies underway and the resulting claims: more than 70 percent of women delivered not laying on their backs , and 50 percent had little to no perineal damage, suggesting a possible connection between delivery position and perineal tearing. She reported the rate of cesarean section for women who went into labor intending a home or birth center birth (5 percent) and described very high rates of exclusive breastfeeding at the six-week visit (98 percent). She elaborated a careful discussion of how to represent transfers to the hospital in the statistics. In her opinion, the data showed ‘What we’re doing right’, and that ‘Midwifery works!’ She lamented the spread of dominant US models of obstetric care to other countries — ‘low resource nations are attempting to emulate our broken system’ — and mentioned partner initiatives such as the Home Birth Consensus Summit, letting audience members know where they could get a PDF pamphlet of abstracts of all known research on home birth.Beginning with that MANA conference, which was the first I attended during my preliminary fieldwork, I noticed the phrase ‘evidence based’ used ubiquitously by those concerned with maternity care, including pregnant people and parents, obstetricians, researchers, midwives, doulas, childbirth educators, and community activists, both those I met in person and those whose writings I found online. In my fieldwork encounters, the ideas of evidence and evidence-based practice were used to reassure, persuade, advertise, lend legitimacy, and consolidate surety among those inclined to agree. They were used to challenge (or justify) protocols and to justify  controversial decisions, which could potentially include all decisions in the fraught cultural landscape of childbearing! It was only later that I learned about the term’s particular usage in contemporary medicine, which led me to consider the longer history of evidence and its role in legitimating scientific knowledge. Below, I give a few illustrations to set the stage for the genealogical claims that follow.EvidenceBasedBirth.com, to which I was referred frequently. For prospective parents, it offers a newsletter and free access to reports describing key studies or summarizing research on a particular topic, suggesting that parents ‘print them and bring them to your appointment to talk with your provider’ (Dekker n.d. -b). For professionals, the site runs an ‘academy’ offering training, certification, and continuing education credits. It also includes a blog and shop with branded goods. The website was founded by Rebecca Dekker, PhD, a nurse who cites her own negative birthing experience as catalyzing her realization that standard American maternity care is not based on research and, in fact, is shown by research to be harmful to healthy birthing women (Dekker n.d.-a). She aims to ‘[put] the evidence back in the hands of the people who need it the most: birthing people and their families’, instead of having it be ‘locked away in medical journals’ (Dekker n.d.-a). The reports she synthesizes often reinterpret data around hot-topic issues, such as induction and ‘overdue’ babies (One of the most obvious examples is the website ’ babies . Dekker Arguably the first evidence-focused reformist effort was the Mother Friendly Childbirth Initiative (MFCI), drafted in 1996 and updated in 2015, a consensus document MANA calls ‘ahead of its time’ (MANA n.d.-a). The MFCI has five principles — normalcy of the birth process, empowerment and autonomy [for the birthing person], doing no harm, and taking responsibility [for the practitioner] — and ten steps to implement them (Improving Birth n.d.). Regional, state, and national organizations support the initiative, notably the Coalition for Improving Maternity Services. A key facet in reformists’ use of evidence is the idea that much existing hospital birth protocol is not standardized or based on empirical evidence about patient outcomes. Many common hospital practices are critiqued for not being evidence-based — often by citing research suggesting that they are, in fact, detrimental to patient experience and outcomes — including episiotomies , continuous fetal monitoring, routine use of pitocin (a contraction-stimulating drug), inducing labor for babies that are ‘overdue’ or ‘getting too big’, directed pushing in which the birthing person is told when to ‘bear down’, routine use of the lithotomy position (lying on one’s back), and removing newborns to the nursery.A recent initiative aligned with the MFCI principles is the California Maternal Quality Care Collaborative (CMQCC), founded in 2006 at Stanford University School of Medicine together with the State of California in response to rising maternal mortality and morbidity rates and racial disparities . CMQCC hLocally, Natural Resources is a prominent brick-and-mortar resource center and store in San Francisco that offers classes, trainings, and support groups. One of its emails explains that:When prenatal education and maternity care are not patient-centered , it is possible that the risks of labor and birth interventions may not be fully disclosed. In many hospital environments, inductions and cesarean births occur more frequently than statistically medically-necessary. The hospital prenatal courses are educating you from the hospital model of labor, birth, and perinatal care which is actually sometimes based on ‘the way it’s always been done’ rather than the most current and valid research about what supports normal and healthy labor and birth. (email dated 24 March 2016)Natural Resources describes its own classes as ‘committed to patient-centered, evidence-based, empowered, fully-informed, and individualized education and labor/birth planning’ (email dated 24 March 2016). The collapsing together of these qualities is typical of the way I saw reformists refer to evidence, as though evidence were necessarily centered around patient experience or promoting empowerment, as opposed to an implicit doctor- or institution-centric, disempowering norm. Many critical histories and social studies point out how hospital practices evolved to suit doctors’ convenience and support a power structure in which they wield authority  is precisely the work of contemporary charlatans, who do not belong in the experiment-oriented medical profession because they make claims about ‘what happened’ without attempting to prove why. Medicine has been ill-suited to applying science’s explanatory powers. The epistemic culture of obstetrics would do well to move beyond differentiating its knowledge from ‘mere’ midwifery, as it has done historically. The hybridity and dialog between midwifery and obstetrics that has begun over the past few decades due to the efforts of reformists is, I argue, just such a process. Reformist agitation to link clinical practice and outcomes-based research does focus on curing, and it seems to me that one could generally substitute ‘outcomes based’ for ‘evidence based’ in reformist discourse. The evidence-based obstetrics The Skeptical OB, falls in line with this prediction. Such defensiveness will be especially an issue, Reformists’ appeals to evidence are claims to rationality, as opposed to superstition, intuition, magic, emotional intelligence, faith/belief, or other kinds of nonauthoritative knowing often associated with midwifery, especially historically . A ratioThe invocation of rationality via evidence parallels the professionalization of American midwives in the late 1990s, during which the formulation of professional credentials, licensure, and accreditation legitimated midwives’ inclusion as medical practitioners. Since then, they have effected significant change from within the medical profession. It was this projected ability to change the establishment, and thereby improve things for the majority of women, that tipped the debate in favor of those who wanted to professionalize, against those who were concerned with whether professionalization would hamper midwives’ independence and devalue the spirit and artistry of midwifery. While American midwifery and obstetrics are not nearly as integrated as they are in many other Western countries, the inclusion of midwifery in hospital settings and its increasing professional legitimation has reshaped American maternity care. The recent hospital proliferation of family birth centers and birthing suites, expanding beyond labor and delivery wards, and of baby-friendly hospitals in which the newborn is not removed to a nursery, is at least partially in response to pressure from consumers attracted to the more ‘personal care’ a midwife offers.This ‘personal care’ reflects an orientation around the birthing person’s perspective, which is the fundamental difference between curing and proving. What would happen if cure and care, which are necessarily centered on the patient, were integrated with RCTs and experimental practice, which are shaped by an epistemic history in which care is irrelevant to producing knowledge? Perhaps it would raise the question of whether outcomes can ever be objective or neutral. In much EBM, patients are only conceived of as having preferences that might be factored into clinicians’ decision making, not as experiencing care or being in a position to comment on its effectiveness, much less decide what the problem is that needs attention . ‘Outcomes’ are often referenced statistically, such as lowered rates of maternal death or cesarean section, which — while certainly not against the interests of birthing people — are also not patient-centric in the more qualitative sense in which power dynamics are altered.  Shifting attention from knowledge production to outcomes could highlight the experience of childbearing people, but it doesn’t necessarily do so, and there is reason to value experimental knowledge production for its own sake. Disaggregating the two genealogies of evidence — cure and proof — could allow for more specificity in how power and knowledge interact in birth.and partial contributor to medical knowledge can the imagined neutrality of medical research be confronted effectively, allowing other suppressed evidence to be brought to light’ (emphasis added). She also notes an obstacle to doing so: in the medical literature, writing on birth at present is too easily polarized between a stubbornly naive ‘birth works’ model, on the one hand, and the fearful and technocratic ‘a chance to cut is a chance to cure’, on the other. … These discourses are at cross-purposes. Appearing in different journals, they preach only to the converted, although both are also marketed to the pregnant consumer of health care. Neither group creates a world the other recognizes as real. , 227I propose that consolidating an authoritative understanding of evidence is not in the interest of optimizing maternity care for the benefit of childbearing people. Rather, in making the concept of evidence more capacious — articulating its diverse forms, expanding the types of evidence that are considered valid, and thinking through the kinds of benefits and situations to which each is applicable — maternity care might not merely allow for these differences but draw strength from them see . WendlanWhile in some ways the ‘evidence wars’ I have described reproduce these silos, in other ways evidence, boundary object that it is, creates a bridge between worlds. Articulating the multiplicity within the bridge is a step towards maternity care that benefits a greater diversity of birthing people. In As a next step, what if evidentiary practice were expanded to include the nonrational? Interestingly enough, some EBM assertions of the importance of clinician expertise sound similar, as they advocate for the role of ‘intuitive and experiential thinking, which characterize expert judgment’ , 420. Th


As technology is advancing, so are the possibilities for new data collection methods in research, potentially improving data quality and validity of the results. In Sweden, a system using frequent repeated data collection using text messages, SMS Track, has been used in clinical research for more than a decade. In this paper, compliance with repeated text message questions was examined across five different studies, i.e. if compliance was1: associated with study-specific factors  and/or.2: associated with the methodology itself .Descriptive comparisons were done across five studies. Three studies were collecting weekly responses over at least 52 weeks (“Weekly studies”) and were used to investigate the effect of age, sex and pain severity on compliance, the effect of early compliance for late compliance, and finally the early occurrence of two successive weeks with non-compliance.Compliance was excellent across all five studies, and only influenced somewhat by age, sex and pain-level. The factor “study” remained significant in the final model thus the observed differences may be a result of the conditions studied but does not seem to be attributable to severity or development of these conditions. Number and frequency of questions did not influence compliance, nor did study duration.Compliance was excellent in the included studies and was not affected by population factors. However, differences in compliance were observed that cannot be easily explained and warrant further investigation. In particular, the nature of the variables or the management of the study are potential areas for further investigations. Data in prospective studies have traditionally been collected using interviews and questionnaires, and have often been restricted to before/after measurements, i.e. how the patient was doing at baseline (before the intervention) compared to some time later (after the intervention or the passing of time), often at 3, 6 or 12 months. Previously, the administrative burden of collecting data with these methods, as well as the challenge of get responders to comply, made frequent data collection unfeasible. A recent study concluded that this method of selecting rather arbitrary time points may render the results unreliable [Recent technological advances have permitted frequently repeated measures, using mobile phones and the internet. As people worldwide are becoming more IT literate, these methods are appealing in terms of availability, user-friendliness, costs and ultimately, data quality.In Western societies, IT penetration is close to 100%. In Sweden, nearly 100% of the population own their own mobile phone and have access to and use the internet daily . The lowA system whereby a participant receives automated text messages, SMS, at frequent intervals, and reports their status in a reply SMS requires a minimal effort from the respondent. People carry the phone with them at all times, and the tendency is that of being constantly on-line. This means that questions via SMS can be answered in real time, with a minimum of recall bias, and in real life circumstances, known as ecological momentary assessment . This teA system called SMS-Track®, specifically developed for research, has been used for about 10 years in the Scandinavian countries . It has In all data collection, scrutiny is warranted before relying on the data and hence, on the conclusions drawn from the study. In the case of collecting data with SMS, compliance, i.e. the response rate, is of the utmost importance if data imputation should be kept to a minimum. Specifically: it is important to assess if compliance is dependent on subject-related factors or on the method itself. Concerning text messages as a data collection tool; if there are certain individuals (who for some reason cannot manage the technology) or types of questions where this technology is not suitable. In addition, it will be important to know if measuring frequency, time of measurement (i.e. during holidays) or number of questions influence the compliance, or if the “severity” of the condition does, e.g. if individuals who are severely affected by a condition comply differently than individuals who are less affected regarding condition-specific outcomes. Finally, it will be a concern if subjects comply differently when recovering from their condition compared with experiencing a “steady state”.Data from five studies using the SMS Track system allowed these questions to be explored. Working with the system over the years, one hypothesis was that early compliance is “key” to long-term compliance.associated with study-specific factors  and/orassociated with the methodology itself .Specifically, this paper aimed to investigate if compliance with frequent SMS questions wasOn how many days during the past week were you bothered by your LBP (i.e.  affected in your daily activities or routines)?”The Maintenance Care “MC” Chiro study : Axén) . This wa“Have you fallen the previous two weeks? (yes or no)”. If the response was “yes”, the research team would call the individual for details in order to explore the incident further.The Spinal Cord Injury Prevention “SCIP” Falls study  , 15. Thi1) “Last week, how many days were you on sick leave?” 2) Last week, to what extent did your neck/back problems impair your work performance?” and 3) Last week, to what degree did your neck/back problems hinder you in carrying out daily routines in family life and leisure?”The Work-Up study (PI: Grahn) . This wa: 1) “How many circuit-training sessions did you do the past week”? and 2) “Besides the circuit training, how many additional days of the past week did you perform at least moderate-intensity physical activity for at least 30 minutes?”The Physical Activity program for people with Rheumatoid Arthritis, “PARA” study (PI: Opava) . This wa: “Stress means a state in which a person feels tense, restless, nervous or anxious or is unable to sleep at night because his/her mind is troubled all the time. Do you feel this kind of stress these days?”.The Stress Prevention At work “SPA” study (PI: Jensen) . This waThis paper utilized data from 5 prospective studies, all conducted in Sweden from 2011 through 2017 and all using SMS-Track as a data collection tool. The investigators in each of the included studies were trained by the same coordinator regarding response management and reminding, as previously tested and described . In shorAll the studies had individual ethical permission from their local ethic committees; MC Chiro: 2007/1458–31/4, SCIP Falls: 2012/830–31/2, 2013/391–32, 2014/364–32, Work-Up: 2012/497, 2012/648, 2012/833, PARA: 2010/1232–31/1 and SPA: 2012/2200–31/5.In addition, ethical approval for this specific merge and analysis of data was granted by the Swedish Ethical Review Authority (2017/961–31/5) for the Swedish data and by the Regional Committees for Medical and Health Research Ethics in Norway (2012/531) for the Norwegian data.The data for the five studies were rearranged to get a similar structure with respect to compliance over the available weeks. Three studies  covered a time span of (at least) 52 weeks with weekly SMS replies. Due to this similarity, data from these three studies, hereafter called the “Weekly studies” were used for comprehensive analysis. The remaining two studies did not cover 52 weeks (SPA) or weekly messaging  and they were therefore included only in the descriptive comparisons.Pain was investigated at baseline in four studies, all except SPA. In MC Chiro, the Numeric Rating Scale with categories 0–10 were used, and in SCIP Falls, Work-Up and PARA, the Visual Analog Scale (VAS) was used, where the respondent is asked to rate their pain on a horizontal line from 0 to 100. In our analysis, the VAS-score was treated like a categorical variable, in order to aggregate data from the Weekly studies . FurtherTime was represented with two different settings. The first setting, used in most of the descriptions and analysis in this paper, is the study week. This refers to the consecutive weeks the subjects obtained a SMS. For subjects in the Weekly studies, this number spans from 1 to 52. The second time setting in this paper, used to study compliance in relation to holidays, was the calendar week that corresponded to the subject’s study week.The dependent variable in this paper was “compliance”, i.e. if the subjects answered the SMS question. The variable was therefore dichotomous, 0 = no answer and 1 = answer.For descriptive purposes, compliance was presented in figures as percentage of missing answers; for all studies for 52 study weeks and in relation to calendar week. One study (PARA) collected data for 2 years, but for comparative purposes, the responses for the second year were omitted. Then, using data from the Weekly studies, figures of compliance stratified for sex, age and for pain severity categories were presented in this paper. A lowess method calculated a smoothed curve over the analyzed time period, in this case the 52 weeks. Lowess is described by Cleveland  as a robp-value for a test of RR = 1.0, that is, no effect on compliance. Factors that were assumed to effect compliance were “study” (with MC Chiro serving as the reference), age (with age below 50 years as the reference category), sex  and baseline pain in three categories (mild pain as reference). We also introduced a combined variable with age (below and above 50 years) crossed with sex, using the category males < 50 years as the reference category. The Poisson regression belongs to the family of generalized linear models with a distribution according to the Poisson distribution and a logarithmic link function.Early and late compliance in this paper was defined as the initial and last 8 weeks of the study, respectively. A Poisson regression with the outcome “number of missing SMS during 8-week periods” at the start and at the end of the 52 weeks study schedule were used for the Weekly studies. Thus, the outcome was a number in the interval 0 to 8 (i.e. the number of missing SMS). The outcome parameter was the Relative Risk (RR) for missing SMS, or non-compliance. The RR was shown with a 95% confidence interval (CI), and Finally, a time-to-event analysis was performed for the Weekly studies, where the event in this paper was the first occurrence of two consecutive weeks without answering SMS, as this was the suggested point of making contact with the respondent to ensure that they had understood the importance of answering every week. The analysis was based on a Cox proportional hazards model with “study”, age, sex and Painclass as the included variables. Results were presented with a curve equivalent to a survival curve, where the equivalence to death was the event described above. The Cox model also gives estimates of the Hazard Ratio (HR). The proportional hazards assumption of the Cox model was tested using Schoenfield residuals.p < 0.05.The statistical softwares STATA (version 15) and SPSS (version 25) were used for all analyses. Statistical significance was set to Some of the baseline characteristics of the individuals in the included studies are presented in Table There are clearly some differences in the study populations. Overall, most of the subjects were in their 40’s, but the subjects in PARA were older. In SCIP Falls, only a fifth were female, whereas in PARA, four fifths were. In Work-Up, a fifth had a university education, and in SPA, two thirds did. Concerning the health status of these individuals, the MC Chiro subjects were rating their health as good, compared to the poorest health that were found among the SCIP Falls and PARA participants. Comparing the Weekly studies, PARA is different from the other two concerning sex , age (older), and pain (milder).Overall compliance was slightly different between studies, see Table Overall, the compliance in all five studies started excellently (few missing SMS), and gradually lost responses over time , Moderate (Pain levels 6–7) and Severe (Pain levels 8–10), for the Weekly studies combined, is also presented in Table There was a tendency in PARA that those with severe pain had less compliance at the end of the study period but this observation was based on only 14 subjects and not found for the other studies.The Poisson regression analysis for the Weekly studies, investigated first whether early and late compliance was affected by age, sex, Painclass and “study”. Further, if early compliance was predictive of late compliance, i.e. if answering the SMS the first 8 weeks was predictive of answering the last 8 weeks of the study. This model was also adjusted for “study”, age, sex and baseline pain intensity, as shown in Table age seems to be associated with poorer compliance the first 8 weeks of the study  but does not influence late compliance. Women seem to be good compliers initially but late compliance has no association with sex. Pain intensity at baseline did not significantly influence early or late compliance, except for MC Chiro, where low pain was associated with better compliance at both times. The most important factor affecting compliance, however, was “study”. Thus, the available baseline characteristics explained far less of the compliance than the study itself. The initial early compliance was found to be a predictor for late compliance.Older The percentage of subjects in the Weekly studies that had no early missing SMS was plotted against the study week Fig. . There wp < 0.001).The results of the Cox proportional hazard model are shown in Table We explored compliance in five studies that had used frequent SMS to collect data over a fairly long time. Overall compliance was somewhat different between the studies, ranging from 98.2% (MC Chiro) to 88.1% (PARA). However, in the great scheme of clinical research, an overall compliance of around 90% is quite remarkable. Further, a compliance around 70% at the end of a study period of 52 weeks (the lowest compliance of the Weekly studies) is in line with previous studies using SMS to collect data , 23.The included populations were intentionally different, in order to get a variety of factors where compliance with the SMS methodology could be explored. Four studies with working populations were included: MC Chiro, SCIP Falls, Work-Up and SPA, and two populations consisted of patients with chronic conditions, SCIP Falls and PARA. Therefore, not surprisingly, the subjects in MC Chiro, although clearly in pain when consulting for care, consisted of healthy subjects without much sick-leave. The subjects in SCIP Falls, who all lived with spinal cord injuries, reported the poorest quality of life according to the EuroQol 5 dimensions (EQ-5D) index.Some gender differences between the populations were observed, some of which could be explained by the nature of the inclusion: PARA had the highest proportion of females, as RA is a condition affecting more females . In SPA, the population was also largely female, as the study was set among health care workers, traditionally female-dominated professions. In SCIP Falls, however, the participants were largely male . This isWe found that compliance was influenced to some degree by individual factors, but the factor that remained significant in the final model was “study”, i.e. the individual factors did not explain the difference in compliance as much as the study itself. We therefore need to look at the specifics of the studies to answer the questions of this paper.age and gender did influence compliance  but did not find differences in compliance between those who improved, stayed the same or deteriorated (data not shown).It is also possible that the us study . This waThe “study effect” may be a result of the condition but does not seem to be attributable to severity or development of this condition, nor other available population factors. It may be due to other unmeasured differences in these populations, as we could only make comparisons across common variables.Question 2: Is compliance associated with the SMS- methodology itself? In total 8 different questions  were asked across the studies, all to some extent “sensitive”. However, in PARA, the SMS questions were about compliance with the intervention, i.e. physical activity. These questions were related to a socially desired behavior that was supposed to increase during the study period, while the other studies mainly measured disease-related symptoms. Failure in behavior change might certainly have been the case for lower compliance in PARA, while there is no expected failure related to the reporting of symptoms as in MC Chiro, SCIP Falls, Work-Up and SPA.Questions have been raised concerning the influence of the technology itself on the outcome, i.e. does frequent questions about pain lead to more pain , 26, or Three studies were using weekly questions, one study was using questions every 2 weeks  and one (SPA) used a regimen of collecting data for 13 weeks, pausing for 12 weeks and then collecting data again for 26 weeks. If frequent questions were perceived as a burden, SCIP Falls and possibly SPA should show the highest compliance, which was not the case. It was, however, clear that holidays rendered somewhat lower compliance, as this was observed even in MC Chiro. The longest study (PARA) admittedly had the lowest compliance, but examining only the first year of PARA, compliance was lower already. Thus, the number and frequency of questions asked, as well as the study duration, did not explain differences in compliance between the studies.In these five studies, all PI’s were given the same instructions how to oversee the data collection, send reminders and call non-compliers. It is possible that compliance with the rigorous execution of these management procedures was explaining the “study effect”, that it was a “management effect”. Indeed, early compliance was found to influence “stamina”, i.e. compliance throughout the study. As found in a previous scrutiny of the SMS method, it is important to motivate the non-responders early on . In SCIPCompliance with frequent SMS questions was high across these studies. Individual factors, number and frequency of questions or duration of the study only marginally affected compliance and only partly explained the differences in compliance between the included studies. The “study effect” found in our analysis could however be due to the nature of the variables measured  or the management of the study. Future studies should aim to follow up on non-responders early to ensure good compliance throughout, and avoid questions relating to socially desirable behavior.


In recent decades, the cost of higher education has exceeded the pace of inflation while wages have stagnated or declined. As such, young adult children may increasingly look to their parents and other family members, including grandparents, to help them pay for college. We use data from the National Longitudinal Survey of Youth 1979 to determine who financially contributes to a young adult child’s college education, restricting our sample to mid-life parents with at least one biological child who attended a 2-year or 4-year college and completed the college expenditures module in 2014 . For each college-going child, parents reported who paid for the student’s tuition – student, parents, grandparents, other family members, or a combination of these. Using multinomial logistic regression, we will estimate who paid for college as a function of parents’ social and economic characteristics when the child was 16 and the child’s gender and birth order.


Sessile microorganisms were described as early as the seventeenth century. However, the term biofilm arose only in the 1960s in wastewater treatment research and was adopted later in marine fouling and in medical and dental microbiology. The sessile mode of microbial life was gradually recognized to be predominant on Earth, and the term biofilm became established for the growth of microorganisms in aggregates, frequently associated with interfaces, although many, if not the majority, of them not being continuous “films” in the strict sense. In this sessile form of life, microorganisms live in close proximity in a matrix of extracellular polymeric substances (EPS). They share emerging properties, clearly distinct from solitary free floating planktonic microbial cells. Common characteristics include the formation of synergistic microconsortia, using the EPS matrix as an external digestion system, the formation of gradients and high biodiversity over microscopically small distances, resource capture and retention, facilitated gene exchange as well as intercellular communication, and enhanced tolerance to antimicrobials. Thus, biofilms belong to the class of collective systems in biology, like forests, beehives, or coral reefs, although the term film addresses only one form of the various manifestations of microbial aggregates. The uncertainty of this term is discussed, and it is acknowledged that it will not likely be replaced soon, but it is recommended to understand these communities in the broader sense of microbial aggregates. We recognize that there have been many previous discussions on the definition of the term “biofilm” but there has not been a review discussing the etymology of the term “biofilm”. By necessity we touch on both definitions and the historical development of biofilm microbiology which is establishing itself as a distinct discipline. Biofilm research is fundamental in nature revealing ever more complexities in these biological systems but is also highly applied, since biofilms impact many aspects of human life. Since the intended and perceived meanings of scientific terms may change as the discipline evolves we believe it is important to provide context behind the use of the term “biofilm”, how it was originally interpreted and how it is interpreted today. We believe that this is not only an academic exercise of historical interest but is important in helping to identify common ground for the exchange of ideas and techniques between biofilm researchers and others studying microbial communities, who might refer to their communities using different terminology. Arguably, the inherent interdisciplinary nature of biofilm research provides a centralized hub for those studying microbial communities from seemingly disparate fields ranging from industrial fouling to soil and sediment microbial ecology to wastewater engineering to chronic infections.1. The more widespread access to microscopes in the years to come made it possible for naturalists to study such microbial communities either in the field or in samples taken back to the lab. The objects of observation were usually plankton-containing aqueous samples, but also organisms colonizing surfaces such as the submersed leaves of plants or inert materials, e.g., rocks and sediments. The organisms examined and described were mostly animals, algae, and protists. The much smaller bacteria were hardly ever mentioned; only in communities with exceptionally large bacteria of distinct morphology, e.g., (phototrophic) sulfur bacteria or some iron bacteria, were such microorganisms described and even named. The terms used for these surface colonizing communities varied, e.g., “Aufwuchs” (German for “surface growth” or “overgrowth”)2, or epiphyton3.The first report on microbial communities colonizing surfaces was published already in the seventeenth century where famously the aggregates of microbes in the “scurf” scraped from teeth and tongue were described4. On slides submerged in seawater “bacterial films” were identified and it was concluded that “bacteria and, to a lesser extent, other microorganisms are the primary film-formers on submerged glass slides” and that “such films favor the subsequent attachment of the larger and more inimical fouling organisms”, explaining the phenomenon of marine biofouling5. Subsequently, the sessile mode of microbial life was gradually recognized to be ubiquitous and predominant in natural as well as in engineered aquatic ecosystems as well as in commensal and pathogenic interactions with plants, animals, and humans8. From these observations the term “biofilm” became established as a general designation for sessile growth of microorganisms in diverse natural and built environments and industrial processes8.Some of the earliest references to what we now call “biofilm” originated in wastewater treatment, marine fouling and dental microbiology. In these varied fields, the word “film” was commonly used to describe the biological layer that formed on solid surfaces and which, from macroscopic inspection or physical touch, appeared to be a continuous layer over rather large surfaces, particularly in biological wastewater treatment and marine fouling. In early microscopic studies the term “film” was introduced to account for the frequent observation that bacteria, and occasionally algae and protists, attached and multiplied on glass slides submerged in freshwater and marine environments. Microorganisms on slides exposed to lake water were shown to develop “in a fairly uniform film”12 were recognized to be beneficial such as in wastewater treatment, by supporting bacteria capable of biotransformation of multiple contaminants, but also detrimental to the shipping or power industry, by causing increased drag, heat transfer resistance, and corrosion. In wastewater treatment it was important to understand and model reactions mediated by such films in “biological film reactors” to optimize efficiency of these systems12. Although the “film” was utilized to break down waste, the rate at which waste contaminants moved into, and the broken down products moved out of, the film slowed as it grew thicker. As early as 1967 it was recognized that this “mass transfer limitation” was not only a function of film thickness, but also depended on the structure and heterogeneity of the film. Atkinson et al.12. noted in a hand drawn sketch that such films were not necessarily uniformly flat layers, but were heterogeneous and composed of microscopic features now referred to as “streamers”, “columns”, “mushrooms”, “clusters”, “microcolonies” and, more recently, “aggregates”15. Atkinson et al.12 concluded after modeling experimental data that the system could be adequately described using a one-dimensional model, assuming that the film was a continuous homogeneous layer. In engineering, the concept of “film theory” in fluid dynamics is a useful construct for understanding how the “no-slip condition”  produces discrete boundary layers , which influence drag (the resistance of fluids to move past a solid surface or vice versa), heat and mass transfer between the bulk liquid in the main flow and the surface. Thus, it was a natural progression to make the simplifying assumption to incorporate the microbial layer as a continuous film into boundary layer film theory. The term “slime film” was later extended from biotransformation to fouling drag in industrial process and production plant pipelines16.From a technical point of view, “biological-”, “microbial-”, or “slime-films”17, as a natural extension of characterizing and predicting the effect of microbial fouling on heat transfer and drag. First, Characklis18, Marshall19, Geesey et al.20 and Costerton et al.6, all pioneers in the field, studied films at interfaces in a variety of environmental habitats. Several studies looked at controlling of such films with antimicrobials and made the discovery that microbes in biofilms were much more difficult to kill than single planktonic cells22.The first incidence of the migration from using the term “biological film” to “biofilm” that we are aware of occurred in 1975 in a paper describing processes in a “microbial film trickling filter” used for wastewater purification23. Non-attached cell aggregates of bacterial pathogens have been observed in chronic infections, where they are localized in the lumen of organs or within tissues, e.g., in the lungs of cystic fibrosis patients and in non-healing wounds. As these medically relevant aggregates show features resembling those of surface-attached biofilms such as EPS production, slow growth rate, and tolerance towards antibiotics and host immune cells, they have been included in the biofilm definition24. Many in the medical community now associate biofilms with a number of unique properties and the clinically relevant consequences in terms of prophylaxis and treatment strategies—and after several decades of growing awareness of their existence and an understanding of how these localized microbial communities may explain the natural history and recalcitrance to treatment of many chronic localized infections, the term is becoming widely accepted by practitioners25.This commonality of microbial surface attachment and their recalcitrance to chemical treatment unified evolving concepts to describe biofilms in industrial systems to extend to those causing medical infections. However, medically relevant biofilms were constrained by the scale of human anatomy to much smaller areas. Observation of clinical samples, first with scanning and transmission electron microscopy and later with confocal laser scanning microscopy, has revealed that in many cases such biofilms represent discrete aggregates of microbial cells rather than continuous films26 did not use the term biofilm, he was very much aware of the significance of interfaces for the development of microbial communities. Consequently, he included many references related to films, flocs, aggregates, and microlayers. Nevertheless, it took several years for the first books with the term “biofilm” in the title to be published28. Thereby, the topic slowly started to establish itself as a research field of its own. Currently, it is accepted that biofilms are manifestations of microbial life not only growing on surfaces but developing at any solid-liquid, liquid–liquid, liquid–gas, and solid–gas interface27.When discussing the terms film and/or biofilm, the surface to which the film/biofilm is attached to, or more broadly, the interface with which it is associated, immediately comes into focus. Although Marshall, in his pioneering work “Interfaces in Microbial Ecology”29, the penetrated water-channel mushroom-like biofilm model30, and the dense confluent biofilm model32. In the heterogeneous mosaic biofilm model based on the analysis of biofilms in oligotrophic drinking water systems the biofilm usually consists of a thin (≈5 µm) basal layer of microorganisms with tall stacks (up to 100 µm) of microcolonies rising from the surfaces. In the water-channel model, microcolonies form mushroom-like structures attached by stalks of EPS and microorganisms which may merge into each other and are penetrated by water channels30. This model was proposed on the basis of observations of laboratory biofilms of Pseudomonas aeruginosa grown in flow cells under relatively high nutrient conditions, as well as other strains or mixed cultures; however, these laboratory-grown biofilm structures are not representative for many environmental biofilms. The dense confluent biofilm model has been described for medically important biofilms such as oral biofilms 32 as well as for aquatic environments31. Observations of natural and laboratory-grown biofilms as well as computer modeling of biofilm growth suggested that biofilm structure may be largely determined by the prevailing substrate concentration33 and hydrodynamic conditions34. In natural and industrial ecosystem biofilms grazing by protozoa can also influence structure35. There may be a continuum between these types of biofilms as, for example, an increase in nutrient availability may cause a transition from sparsely colonized surfaces with heterogeneous biofilms to confluent and compact biofilms that correspond to the initial notion of biofilms as surface-covering biological layers.In the last few decades, the term biofilm has grown in usage while still remaining somewhat vague to non-specialists. It suggests the presence of a surface, on which a film of microorganisms is spread—with cells colonizing in patchy, thin, or multilayered patterns. Accordingly, a number of early conceptual and mathematical models were proposed for the diverse appearances of microbial biofilms on surfaces, for example, the heterogeneous mosaic biofilm model37. This matrix is self-secreted and protective, surrounding and immobilizing microbial cells within a biofilm so that they can establish those stable spatial interactions not possible in well-mixed planktonic populations. The EPS comprise polysaccharides, proteins, lipids, and nucleic acids—most of them highly hydrated, but also containing water-insoluble compounds such as cellulose or amyloids—all of which can form the scaffold of the matrix alone or through interactions of these polymers. The EPS also contain bacterial derived refractory compounds23 as well as molecules and particles sorbed from the local environment . Importantly, the EPS are responsible for capturing inorganic constituents whose deposition is clearly distinct from the pure inorganic chemical deposition of scaling. The matrix exists in a continuum of physical states ranging from dissolved to dense gels and sometimes biogeomineral precipitates, e.g., iron and manganese oxides and calcium carbonate39. One issue in recognizing these outwardly appearing inorganic fouling deposits as biofilms is that the biomass may be an extremely small fraction of the deposit, even though the associated bacteria may initiate or accelerate the inorganic deposition40. It is clear that the EPS largely determine the mechanical properties of biofilms, which can range from rigid solids, to viscoelastic permeable solids41 to highly viscous liquids42, depending on the type of biofilm and the manner in which the biofilm is mechanically stressed45. The matrix enhances biogeochemical gradients in the micrometer scale resulting from microbial activities46. The EPS are responsible for the “gluing” interactions between interfaces and cells as well as with dissolved and particulate compounds. The EPS provide balance between structural stability and a degree of compliance that allows the development of structured microbial communities with emergent properties that are clearly distinct from planktonic single cells15. Key to these properties is the close proximity of the cells over extended periods of time, facilitated by long retention times in juxtaposition within the EPS matrix. Some of the properties emerging from this situation are listed here23: These include:- Retention of extracellular enzymes which provides enzymatic products closely to the cells, representing an extracellular digestion system- Formation of localized gradients in pH, dissolved oxygen, redox potential, nutrient and metabolic product concentration and, as a consequence, microenvironments for habitat diversity.- Resource capture and retention of cellular products and debris which can be used as a reservoir for biological transformations.- Water retention, protecting against dehydration.- Allowing for long-term development of synergistic consortia between different species.- Enhanced tolerance against antibiotics, biocides, and other chemical or physical antimicrobial agents.- Facilitated gene exchange and recycling of nucleic acids, representing a genetic pool for horizontal gene transfer.- Enhanced intercellular communication and collective behavior.- Continuous regeneration by competition in response to stressful and changing environmental conditions.- Habitat formation.Research on biofilms living at diverse types of interfaces reveals commonality in the way in which these microorganisms live, often embedded in a matrix of EPS47. These phenomena have been characterized by Moshynets and Spiers48 as a “continuum of aggregations”. In spite of their vast phenomenological diversity, they share common properties, unifying them in a class of complex collective ecosystems, such as forests, coral reefs, and social insect communities15. Similar to such communities, microbial biofilms act as “protective and internally homeostatic fortresses at a scale much larger than the living organisms who built them” and fit into the concept of “extended organisms”50.Biofilms as a characterization of microbial communities is not restricted to microbial films on surfaces but applies to multicellular microbial aggregates in general. They comprise a wide range of manifestations including endolithic microbial populations, flocs, pellicles, slimes, zooglea, microbial mats, microorganisms in soils, sediments and aerosols, bacterial neuston in the aquatic surface microlayer, marine and lake snow, biofilms on leaves and plant roots, activated and granular sludge, biofilters in drinking and wastewater purification, aggregates in biofouling and microbially influenced corrosion and weathering, and many more51 or others as “films”, since these terms are already well established in their respective disciplines. The term biofilm was uncommon in literature on soils, where the term “biofilm” traditionally did not appear until recently52, because researchers had failed to observe anything resembling films in these systems54. The latter authors preferred to refer instead to “groups of cells” located in specific microenvironments. In this discipline, as in others before, the push by some to adopt the “biofilm” terminology has led to occasionally heated discussions among “biofilm” researchers and those not happy questioning their field of research requiring a new label55.It is obvious that the term “film” does not fit every aggregate in this huge spectrum. Understandably, the respective scientific communities addressing sectors of this spectrum were hesitant about renaming accepted terms such “dental plaque”, “activated sludge”, “microbial mats”, “desert varnish”, “soil aggregates”48. Incorporation of the term “aggregate“ may be useful since it already appears in the IUPAC definition of biofilms14: “Biofilms are aggregates of microorganisms in which cells are frequently embedded in a self-produced matrix of extracellular polymeric substances (EPS) that are adherent to each other and/or an interface”. In this slightly amended definition, we have substituted the original word “surface” with “interface” to meet the expanded view of biofilm phenomena  the term is already used to describe collections of abiotic particulate matter, not involving microorganisms at all, so that using aggregates there might lead to confusion. An alternative to “biofilm” suggested by Neu and Lawrence56 is “biofilm system” which includes both “bio-films” and “bio-aggregates”. In the context of soils, use of the term “bio-cluster” was suggested, acknowledging that a key feature of the associations of cells and extracellular polymers found in terrestrial environments is that clay particles are very often adsorbed to them as a kind of sheath.The jury is still out on whether there can be an acceptable alternative to the term “biofilm” that would better describe all the manifestations of the “continuum of aggregations”57, soils58, wastewater59, or the human gut60, to name a few). Usually, the biofilm aspects in terms of interactions among the members of the communities are not considered.It is interesting to perceive that a large proportion of microbial community research is not directed to single, planktonic cells but to biofilms in the broad sense of our definition (e.g., in sediments47.Although it is unlikely that the term “biofilm” will be replaced any time soon, we hope that our perspective will encourage circumspection before adopting the term in fields where historically its use has not been routine, and where there are other options. As a broader take-home message, it is worth remembering that sensu stricto, the term biofilm can serve only a section of the wide spectrum of manifestations of cell–EPS aggregates on earth


Background and objectives: Limited evidence exists exploring perceptions of which aspects of a pain management program are perceived as valuable and impactful. The aim of this study was to explore patient beliefs about which aspects of a pain management program were valued and/or had perceived impact. Materials and Methods: One-on-one structured interviews were conducted with 11 adults three months after their completion of the Spark Pain Program at Westmead Hospital, Sydney, Australia. Concepts in the transcripts were inductively identified and explored, utilizing thematic analysis to better understand their relevance to the study aim. Results: Four themes emerged: (1) “The program overall was positive, but…”; (2) “I valued my improved knowledge and understanding of pain, but…”; (3) “I valued the stretching/relaxation/pacing/activity monitoring”; and (4) “I valued being part of a supportive and understanding group”. Participants reported that they liked being treated as an individual within the group. A lack of perceived personal relevance of key messages was identified in some participants; it appears that patients in pain programs must determine that changes in knowledge, beliefs, and attitudes are personally relevant in order for the changes to have a significant impact on them. Conclusions: This study provides new insights into aspects of a pain management program that were perceived as valuable and impactful, areas that “missed the mark”, and hypotheses to guide the implementation of service delivery and program redesign. Persistent pain creates an enormous biopsychosocial burden. The most frequent cause of years lived with disability globally is persistent low back pain, and other frequent causes include chronic neck pain, osteoarthritis, musculoskeletal disorders, migraine, and medication overuse headache . PersistTo address this burden, multidisciplinary pain management programs are the gold standard approach for the treatment of persistent pain, targeting changes in beliefs and behaviors, and encouraging acceptance, coping, and self-management. Current guidelines recommend non-pharmacological and non-invasive management, including patient education, exercise therapy, and advice to remain active . MultidiLimited evidence exists exploring perceptions of which aspects of a pain management program are valuable and impactful, which could guide the implementation of service delivery and program redesign. Qualitative studies, which can achieve this purpose, have previously concentrated on other aspects including, but not limited to: patient values in the years following a high-intensity program , the patThe study was approved by the Human Research Ethics Committee of Western Sydney Local Health District on 17 April 2019 (Ref: 2019/ETH00462).This qualitative study utilized one-on-one structured interviews, lasting approximately 10 to 20 min, of adults three months after their completion of a low-intensity multidisciplinary pain management program, as part of the departmental quality improvement program. The ‘Spark Pain Program’ runs for 2 h, once per week, for 6 consecutive weeks at Westmead Hospital Pain Management Centre in Sydney, Australia. This 12-h program containing 6–12 participants is jointly coordinated by a senior physiotherapist and clinical psychologist. Each week involves pain science education based on published target concepts  (20 min)The study population consisted of participants of the Spark Pain Program between October 2018 and June 2019. Patients are eligible for the Spark Pain Program if they are aged >18 years and have had pain for more than 3 months. Personalized emails and phone calls were used to invite consecutive participants to take part in a follow-up interview three months after their completion of the Spark Pain Program. Participants were interviewed until “information power” was established ,41. InteAn interview script was developed  to exploIndividual structured interviews were conducted by a research assistant (E.T.). The research assistant was a health professional who had no previous relationship with the participants. Interviews took place at a time chosen by the participant with no one else present. Interviews were, on average, 11 min (range = 6–18) and conducted via telephone. Interviews were audio-recorded, transcribed, and de-identified by the research assistant. Participants were invited to review the transcripts for accuracy before analysis. Data saturation was defined as when no additional new information was attained with additional interviews regarding the list of codes contributing to themes and subthemes. Data collection was stopped when all four researchers agreed that saturation had taken place.Audio recordings from interviews were transcribed verbatim by the research assistant (E.T.) and checked for accuracy by another researcher (J.W.P.). The data was then thematically analyzed and synthesized . Because three of the researchers  are also pain-related clinicians, it was impossible not to have preconceptions about patient perceptions. Therefore, contrary to the original formulations of theories such as grounded theory, we a priori had consulted relevant research. The constant comparison method of grounded theory  was usedn = 4), too busy for the interview (n = 2), and self-reported inadequate English language skills (n = 1). n = 5) and the number of pain sites reported ranged from two to 11 sites. Eight participants (73%) reported they were unemployed due to pain, and 3 (27%) were retired from work by choice. Two participants had a worker’s compensation claim. On average, participants had moderate pain severity and interference, severe depression, severe anxiety, moderate stress, high pain catastrophizing, and severe pain self-efficacy. No participants reported feeling upset or distressed during the in-depth interviews.All consecutive potential participants across the three programs in the study period, a total of 18 people, were contacted, and 11 participants consented to be interviewed. The reasons for non-participation were: no answer after three attempts to call “…It did help me, and it helped me mentally as well.”“…Overall, I’m ecstatic about how the program went.”The program was described as logical and credible, life-changing, something to be recommended, and exceeding initial expectations.“Everything made sense…”“I can walk without pain. It’s a miracle that program.”“I’ve spoken about the program to quite a lot of people & I would recommend it hands-down.”“I was surprised. I didn’t expect it to be as good as it was.”For one participant, the program provided hope and optimism.“But with their help, I was able to see that there is a future providing I’m in the right mindset”Despite this overall positivity, some participants expressed negativity about their persistent pain.“…It just didn’t really work for me. I was like, I was always in pain.”“My body is more flexible than before. But pain is not gone away...”It was also apparent that the beliefs of some participants in relation to the pathoanatomical basis of their pain were difficult to shift or that the overall program was not personally applicable to them. Other participants mentioned how information from their specialists conflicted with the overall program messages.“The specialist even said that nothing can be done…”“I went to my neurosurgeon and he said that ‘you’ve got a bulging disc’. He said, ‘I’ll see you back for another op’ and as soon as you hear that you get scared…”Theme 2.I valued my improved knowledge and understanding of pain, but…Participants valued their improved knowledge and understanding in relation to the key messages of the program, however, the extent to which the key educational messages were accepted varied. Participants described the messages as logical and credible, and value was attached to being more knowledgeable and better informed about pain in general. In some cases, the messages appeared to be wholly embraced.“It was good for me being a person who likes the information, to have that as background knowledge to understanding why I’m in pain and how to go about managing it. It really helped me.”For some participants, the messages were only partially or conditionally accepted, and in other cases, participants highlighted the value of key educational messages but rejected their relevance to their own specific situations.“My pain was completely different to other people’s pain and what I suffered was something different and that other people had different pain. But I could share and understand other people’s views. We shared a lot of things in common.”“I can understand where they’re coming from, … but that hasn’t proven to be true in my case. I’ve had to have more medical intervention.”Theme 3.I valued the stretching/relaxation/pacing/activity monitoringSeveral participants singled out individual aspects of the program they believed to be of particular benefit. These were typically the simple action-oriented components of the program, including the daily stretching exercise routine, relaxation training, and monitoring of self-pacing.“There were a couple of things I found really, really helpful & that was the easily adapted stretching & exercise regime each day.”“I have a routine that helps me sleep at night, involving an hour of stretching that I adapted from the stretching part of the program. I do it every night before bed...”“The meditation, separated from the context of some sort of religious spirituality, but just in terms of calming the nerves, is extremely important.”“Start doing a little bit and increase more and more and more… You get a little bit of pain but don’t get put off, just keep going…”“I could really see from the paperwork that we were filling out, how in black & white, I was progressing.”Participants highlighted how they tracked their progress on paper handouts, thereby demonstrating progress with these tasks. Some participants reported that they had adopted these routines into their daily lives and appeared to value the sense of achievement in doing so. Others who had not fully adhered with the recommendations about exercise, relaxation and pacing noted that they knew that they should have and believed that these factors were important in pain management.Theme 4.I valued being part of a supportive and understanding groupParticipants appeared to value the dynamics of a group-based program. Participants noted the support that they felt from the staff and peers within the group and noted the importance of being accepted and having their pain experience validated.“I thought J and T were both great. I thought J was inspirational. His energy and his passion and his belief in the program resonated not just with me, but everyone in our group.”“It became possible to relate to the other individuals participating in the program. The small number of people, I got to know them almost every single one, personally.”“[Outside of the group] Because we don’t look physically unwell, we haven’t got a broken leg with a cast on it, we’re not showing it & we’re not being believed.”The group setting also provided an opportunity for benchmarking progress with peers.“… Some of them obviously had more injuries than others… You can see by the end of that program how much they had progressed.”Participants also noted that despite the group setting, they felt that they were treated as individuals.“The program is good in that you can make it custom made to yourself.”This study explored elements of the perceived value and impact of elements of a multidisciplinary group-based pain education program. Four themes emerged from these data. Firstly, while participants generally valued the program, there were elements of the program perceived to be negative, and there was a suggestion that some of the key messages may have missed their mark. Secondly, participants appeared to appreciate gaining new knowledge and education for its own sake, even when the knowledge was deemed not applicable to their situation and when the knowledge did not translate into changed beliefs, attitudes, or behaviors. Thirdly, participants singled out some of the simpler action-orientated components of the program as being highly valued, possibly because they involved clear and easy to implement recommendations. This contrasts with some of the more complex content involving changing beliefs, attitudes, and approaches. Finally, participants valued particular aspects of the group setting of the program particularly in relation to the overall mood and atmosphere. A unique finding from this study is the idea that clinicians can change a patient’s knowledge, beliefs, and attitudes regarding pain during pain programs, but it appears that patients must deem these changes to have personal relevance in order for the changes to have a significant impact on them.The overall impressions and general appraisal by participants in this study were very positive, suggesting that the components of the Spark Pain Program were generally both impactful and valuable. This aligns with the large qualitative evidence base regarding the healthcare experience of people challenged by persistent pain, which has concluded that treating a patient with a sense that they are worthy of care and hearing their story is not an adjunct to, but integral to their care . The mixOur results indicated that participants appreciated the group dynamics and aspects of the Spark Pain Program related to the mood and atmosphere rather than just content and delivery. Participants valued previously researched variables, such as the sense of validation and being believed , as wellThe other features of the Spark Pain Program that were perceived as valuable and impactful were the simple action-orientated tasks such as stretching, exercises, relaxation, and self-monitoring activities. Participant reports also suggested that in many cases, these components resulted in lasting behavioral change. It is possible that the relative ease of implementation of these strategies influences their acceptability and perceived value. It is, therefore, possible that delivery of some of the more abstract key messages of the pain management program that involve shifting strong and entrenched beliefs might be more effective with better designed, action-orientated educational resources. Our results have also identified some potential weaknesses in traditional approaches to group-based pain management education and highlighted areas where key educational messages are misunderstood or not fully accepted. One recurrent theme was the acceptance of the inherent logic of some of the key messages while deeming the message to be inapplicable to the participant’s personal circumstances. If a patient observes themselves not improving and they also observe others in the group improving, attending the group program may reinforce the perception that “it’s good but not for me”. This is consistent with the Health Belief Model  for healOur results suggest that the one particular key message that was not well accepted by all participants in this low-intensity program involved challenging the link between pathoanatomical findings and pain. Many participants, despite accepting other key messages such as “hurt versus harm”  and actiThis qualitative study has several strengths and limitations. A strength of this study was the large variations in pain experience among the participants in terms of pain duration, pain sites, work status, and compensation status, capturing individual variability in experiences of pain . A furthThese findings provide insights into aspects of the Spark Pain Program that are linked to patient values and impacts, in addition to a better understanding of aspects of the program that might be missing their mark. It appears that patients in pain programs must determine that changes in knowledge, beliefs, and attitudes, are personally relevant in order for the changes to have a significant impact on them. Perceived value and impact may relate closely to the perceived ease of implementation of different strategies and the action-oriented nature of educational resources. This new knowledge provides opportunities for quality improvement as well as opportunities for implementing innovations in educational design into group-based pain management programs.


Uncomplicated urinary tract infection (uUTI) is very common among women in primary care. The risk of developing pyelonephritis remains low after uUTI, nonetheless, empiric antibiotic therapy is frequently prescribed for symptomatic purposes. This may lead to adverse effects and antibiotic resistance. Furthermore, patients may express the will to limit the use of antibiotics. Some European countries recommend discussing a delayed prescription with the patient and developing a shared decision. The aim of this study is to create a patient decision aid (PtDA) used in primary care settings to make a shared decision between practitioners and women about whether or not to treat uUTI with antibiotics.We followed the steps recommended by the International Patient Decision Aids Standards, with a scoping phase, a design phase (including focus groups and literature review), and an alpha-testing phase. A steering group, made of patients and physicians, met throughout the study to develop a prototype PtDA.The information included in the PtDA is the definition of uUTI, information on the options, their benefits, risks, and consequences, based on a review of the literature. The results of the focus group made possible to determine the patient’s values and preferences to consider in decision-making, including: the discomfort felt, the impact on daily life, patients’ perceptions of antibiotics, and the position relative to the risk of adverse effect. The choices in presentation, organisation and design are the result of the work of the steering group, improved by feedback from alpha testing. We confirmed the need for shared decision-making and the equipoise in this situation.We developed a PtDA to be used in primary care for sharing decision on the use of antibiotic in uUTI. It needs to be validated in a beta-testing phase, with complementary advice from peers, and then tested in a clinical study comparing its use with the systematic prescription approach. Uncomplicated urinary tract infection (uUTI), or cystitis, is among the leading reasons for infectious disease consultation in primary care . Nearly There is no standard definition of uUTI internationally accepted. In France, uUTI in women is defined as an acute urinary tract infection in adult under 75 years-old, without signs of pyelonephritis or risk factor for more severe disease .Acute cystitis affects several facets of women’s life: social and intimate relationships, self-esteem, and ability to work. Depending on the situation, the impact can vary from a woman to another: from small discomfort to severe disability impacting personal and/or professional life , 4. NoneCurrently, the systematic and immediate prescription of empiric antibiotic treatment is often recommended to reduce symptoms , even thSociété de Pathologie Infectieuse de Langue Française) recommends fosfomycin  [40 [4010] .“It restricts social life, because you always have to be near a bathroom (laughter)” (P3.2), “You don’t dare to have sex anymore” (P4.4).Participants spoke of their personal or reported experiences with cystitis and their impact on their social and sexual lives: “It’s a feeling of guilt, actually. Well, in a way it is, because we feel that our intimacy as women is being attacked” (P3.4).This experience touched on intimacy and could be perceived as taboo: “If there’s blood in my urine it means that the kidneys must be affected” (P3.2), “It’s going to make an infection maybe a bit generalized in that area, maybe causing problems to have children...” (P1.2).They feared that cystitis could be complicated by renal, gynaecological, or fertility problems: “I told my mother about it and she said: don’t worry, drink lots of water, it will pass, this antibiotic works well; because she often had it” (P2.2).Their knowledge about the risk factors and treatment of cystitis was part of a lay knowledge shared amongst women: “The doctor or the ones I saw, made me feel like it was my fault because I didn’t wash (myself) well. Afterwards, we are told once we hold it back! We don’t have to be told every time” (P3.2).Some participants described a feeling of infantilization and guilt during the consultation with the physician: “What is important with cystitis, I learned from the doctor who took the time to explain it to me. [...] We are not in a normal state when we are sick. So he really needs to listen to us” (P2.5).They wanted a personalized exchange, where they could express their experiences: “And in rather simple terms, so that everyone can understand it... Not in doctor’s language” (P1.3). They suggested a pictorial presentation: “The more graphic, the more people are affected” (P1.3), accompanied by the doctor: “The diagram is nice, but if the doctor doesn’t explain it to you, [...] she won’t understand anything” (P3.3).The participants wished to clearly define cystitis and its risk factors, with a vocabulary accessible to all, without medical jargon: “Isn’t there something more effective and long-lasting, [...] rather than just immediately stopping the pain?” (P1.2).Their expectations of treatment could be the rapid relief of symptoms, or the prevention of recurrence in the longer term: “Do you have something to offer me that is not antibiotics? I have time now, I can stay at home, if it’s really not going well we’ll switch to antibiotics, but why don’t we test something else? Maybe there should be a second option” (P4.4).Some patients have expressed an interest in being involved in the decision related to the antibiotic: “This antibiotic was really a miracle” (P6.1), “Every antibiotic [...] that we swallow, we know that there are side-effects” (P1.1).The action of the antibiotic was seen as magical, but could lead to side effects and resistance: “Having the choice between a chemical molecule and something a bit more natural, something less harsh, I’ll take what is less harsh” (P2.3).The participants considered alternative treatments, described as natural, such as cranberry or hydration: The draft version of the prototype Fig.  includedThe title explicitly described the decision of whether to take an antibiotic or not. The elements of the PtDA were then arranged according to these two choices.The common symptoms and etiology of uUTI were briefly described and illustrated with a diagram of the bladder.The treatment options that were presented included antibiotic treatment, hydration, and cranberry. The practical modality of a single-dose antibiotic therapy was specified.The average duration of symptoms, the risks of recurrence, resistance and complications were detailed according to whether the antibiotic was taken or not.Coloured pictograms numerically represented the evolution of symptoms after three days according to the choice of treatment and the incidence of adverse effects.The patient values to report were physical discomfort, the impact on their daily life , their general opinion on antibiotics and their adverse effects. A free space allowed for the collection of additional value.Deliberation was facilitated by sliders polarized according to the two options, for each expressed value. A final slider helped in the decision-making process.The chosen format of the PtDA was a double-sided A4 sheet of paper. It was intended to be used during a discussion with the physician during the consultation and not by the patient alone.The results of the alpha-testing phase and the second meeting of the steering group are presented in Table The literature review showed a need to increase patient’s involvement in the decision-making process for uUTI treatment. Patient’s feedbacks during focus groups confirmed this need  7]. The. The7]. Hence, we developed a prototype of PtDA to help physicians and patients to make a shared decision regarding antibiotic treatment for uUTI. This prototype aims to provide support during consultations, in addition to the information delivered orally by the physician .Of note, we recruited more patients face-to-face during medical consultations than through patient support and community groups. The ease of face-to-face recruitment was previously described in the literature . MoreoveThe medium-sized focus groups in our study allowed rich and varied exchanges, including those involving intimate topics, as already described in the literature, where a focus group of four to six participants has previously been documented to facilitates communication . The ageSome elements collected from the focus groups corresponded with the existing literature, such as representations of uUTI and its risk factors , represeSome of these representations correspond to known risk factors , however, the steering group decided not to mention risk factors because they were not directly involved in the decision-making process. Other representations were beliefs (risk of infertility) that were absent in the literature. Some patients wanted to be able to discuss them. This information could be added in a leaflet handed over to the patient.Most of the patients’ values expressed in the focus groups could be integrated into the PtDA, particularly in the slider. An empty slider allows the patient to express additional values, like her expectations regarding treatment .One concern expressed among the interviewed patients and doctors was the risk of pyelonephritis. There is little data on the natural course of uUTI without antibiotics, and the meta-analysis comparing antibiotics to placebo did not show a significant increase in the risk of pyelonephritis between the two . HoweverSome of the interviewed physicians were concerned that the use of the PtDA would lengthen the consultation. There is little evidence on the impact of shared-decision making on the length of consultations , but a sA noticeable limitation of this PtDA is the lack of medical perspectives exterior to the study. The number of interviews with physicians during the alpha-testing phase was low. As already reported in a Cochrane review, during PtDAs development, patients’ views were more often collected than those of physicians .The steering group chose to present the probability of symptoms after three days. This time frame made possible to present data in the PtDAs regarding the first-line antibiotic in France (fosfomycin) and placebo. This short delay is in line with the French guidelines which recommend another consultation after three days in case of treatment failure, but also with the British guidelines proposing a 48-h delay for the delayed prescription of antibiotics. Indeed, delayed prescribing could reduce antibiotic use . This opOur PtDA was created in line with international standards and will soon be beta-tested in a larger study . Helped The possibility to implement this approach in France will also be studied during the beta-test. Indeed, there may be some difficulties to implement the PtDA in clinical practice. The PtDA leads to a discussion with the patient about the choice of using antiobiotic or not, whereas actual French guidelines advise a systematic antibiotic prescription. Furthermore, systematic antibiotic prescription requires less investment from the practitioner. Nevertheless, practitioner investment can lead to better outcomes: if the practitioner is optimistic about diagnosis and prognosis, symptoms could resolve faster . Thus, iuUTI is no longer considered as a pathology for which the symptomatology is experienced similarly for all patients and for which a single treatment should be offered. The literature review suggests that uUTI is an equipoise situation, hence, shared-decision making seems to be the best way to broach this subject. Developing a tool to help for shared-decision making in primary care consultation is necessary to move forward and to assess its efficiency compared to a systematic antibiotic treatment approach. To do so, we developed one of the first PtDA for uUTI treatment in primary care, in line with international standards.The impact of our PtDA on patients’ satisfaction and antibiotic prescription remains to be evaluated, but its conception has already brought a lot of information on patients’ and practitioners’ perceptions of uUTI.