Purpose: Back pain is the leading cause of global years lived with disability. This cross-sectional study assessed if a greater exposure to smoking cigarettes was associated with a greater prevalence of back pain.
Methods: This study examined data from 34,525 United States adults from the 2012 National Health Interview Survey. Analyses assessed the difference in back pain prevalence among current smokers, former smokers, and never smokers and the number of cigarettes smoked between current smokers with and without back pain.
Results: Back pain prevalence was 28%. There was a significant association between back pain and smoking, X2 (2, 599, n = 34, 241) = 546.3, p < .001. Back pain increased with increased smoking exposure; back pain was present in 23.5% of never-smokers, 33.1% of former smokers, and 36.9% of current smokers. The number of cigarettes smoked per day for current daily smokers was higher for those with back pain (Md = 13) than those without back pain (Md = 10), U = 2701065, z = -3.70, p < .001, r = .05.
Conclusions: Our findings suggest that there may be a biological gradient associated with exposure to smoking cigarettes and back pain in adult Americans.
smoking; back pain; prevalence
State newborn screening (NBS) programs routinely screen nearly all of the 4 million newborns in the United States each year for ~30 primary conditions and a number of secondary conditions. NBS could be on the cusp of an unprecedented expansion as a result of advances in whole-genome sequencing (WGS). As WGS becomes cheaper and easier and as our knowledge and understanding of human genetics expand, the question of whether WGS has a role to play in state NBS programs becomes increasingly relevant and complex. As geneticists and state public health officials begin to contemplate the technical and procedural details of whether WGS could benefit existing NBS programs, this is an opportune time to revisit the legal framework of state NBS programs. In this article, we examine the constitutional underpinnings of state-mandated NBS and explore the range of current state statutes and regulations that govern the programs. We consider the legal refinements that will be needed to keep state NBS programs within constitutional bounds, focusing on 2 areas of concern: consent procedures and the criteria used to select new conditions for NBS panels. We conclude by providing options for states to consider when contemplating the use of WGS for NBS.
Maximizing the quality and benefits of newly established chiropractic services represents an important policy and practice goal for the US Department of Veterans Affairs' healthcare system. Understanding the implementation process and characteristics of new chiropractic clinics and the determinants and consequences of these processes and characteristics is a critical first step in guiding quality improvement. This paper reports insights and lessons learned regarding the successful application of mixed methods research approaches—insights derived from a study of chiropractic clinic implementation and characteristics, Variations in the Implementation and Characteristics of Chiropractic Services in VA (VICCS). Challenges and solutions are presented in areas ranging from selection and recruitment of sites and participants to the collection and analysis of varied data sources. The VICCS study illustrates the importance of several factors in successful mixed-methods approaches, including (1) the importance of a formal, fully developed logic model to identify and link data sources, variables, and outcomes of interest to the study's analysis plan and its data collection instruments and codebook and (2) ensuring that data collection methods, including mixed-methods, match study aims. Overall, successful application of a mixed-methods approach requires careful planning, frequent trade-offs, and complex coding and analysis.
TRPC6-dependent Ca2+ flux in endothelial cells after TLR4-induced diacylglycerol production mediates lung endothelial barrier disruption and inflammation induced by LPS.
Lung vascular endothelial barrier disruption and the accompanying inflammation are primary pathogenic features of acute lung injury (ALI); however, the basis for the development of both remains unclear. Studies have shown that activation of transient receptor potential canonical (TRPC) channels induces Ca2+ entry, which is essential for increased endothelial permeability. Here, we addressed the role of Toll-like receptor 4 (TLR4) intersection with TRPC6-dependent Ca2+ signaling in endothelial cells (ECs) in mediating lung vascular leakage and inflammation. We find that the endotoxin (lipopolysaccharide; LPS) induces Ca2+ entry in ECs in a TLR4-dependent manner. Moreover, deletion of TRPC6 renders mice resistant to endotoxin-induced barrier dysfunction and inflammation, and protects against sepsis-induced lethality. TRPC6 induces Ca2+ entry in ECs, which is secondary to the generation of diacylglycerol (DAG) induced by LPS. Ca2+ entry mediated by TRPC6, in turn, activates the nonmuscle myosin light chain kinase (MYLK), which not only increases lung vascular permeability but also serves as a scaffold to promote the interaction of myeloid differentiation factor 88 and IL-1R–associated kinase 4, which are required for NF-κB activation and lung inflammation. Our findings suggest that TRPC6-dependent Ca2+ entry into ECs, secondary to TLR4-induced DAG generation, participates in mediating both lung vascular barrier disruption and inflammation induced by endotoxin.
Evidence supports the implementation of task shifting to address health worker shortages that are common in resource-limited settings. However, there is need to learn from established programs to identify ways to achieve the strongest, most sustainable impact. This study examined the Botswana lay counselor cadre, a task shifting initiative, to explore effectiveness and contribution to the health workforce.
This evaluation used multiple methods, including a desk review, a national lay counselor survey (n = 385; response = 94%), in-depth interviews (n = 79), lay counselors focus group discussions (n = 7), lay counselors observations (n = 25), and client exit interviews (n = 47).
Interview and focus group data indicate that lay counselors contribute to essentially all HIV-related programs in Botswana and they conduct the majority of HIV tests and related counseling at public health facilities throughout the country. Interviews showed that the lay counselor cadre is making the workload of more skilled health workers more manageable and increasing HIV acceptance in communities. The average score on a work-related knowledge test was 74.5%. However for 3 questions, less than half answered correctly. During observations, lay counselors demonstrated average competence for most skills assessed and clients (97.9%) were satisfied with services received. From the survey, lay counselors generally reported being comfortable with their duties; however, some reported clinical duties that extended beyond their training and mandate. Multiple factors affecting the performance of the lay counselors were identified, including insufficient resources, such as private counseling space and HIV test kits; and technical, administrative, and supervisory support.
Lay counselors are fulfilling an important role in Botswana's healthcare system, serving as the entry point into HIV care, support, and treatment services.
For this and other similar task shifting initiatives, it is important that lay counselors' responsibilities are clear and that training and support are adequate to optimize their effectiveness.
The purposes of this study were to analyze data from the longitudinal Medical Expenditures Panel Survey (MEPS) to evaluate the impact of an aging population on secular trends in back pain and chronicity and to provide estimates of treatment costs for patients who used only ambulatory services.
Using the MEPS 2-year longitudinal data for years 2000 to 2007, we analyzed data from all adult respondents. Of the total number of MEPS respondent records analyzed (N = 71 838), we identified 12 104 respondents with back pain and further categorized 3842 as chronic cases and 8262 as nonchronic cases.
Secular trends from the MEPS data indicate that the prevalence of back pain has increased by 29%, whereas chronic back pain increased by 64%. The average age among all adults with back pain increased from 45.9 to 48.2 years; the average age among adults with chronic back pain increased from 48.5 to 52.2 years. Inflation-adjusted (to 2010 dollars) biennial expenditures on ambulatory services for chronic back pain increased by 129% over the same period, from $15.6 billion in 2000 to 2001 to $35.7 billion in 2006 to 2007.
The prevalence of back pain, especially chronic back pain, is increasing. To the extent that the growth in chronic back pain is caused, in part, by an aging population, the growth will likely continue or accelerate. With relatively high cost per adult with chronic back pain, total expenditures associated with back pain will correspondingly accelerate under existing treatment patterns. This carries implications for prioritizing health policy, clinical practice, and research efforts to improve care outcomes, costs, and cost-effectiveness and for health workforce planning.
Back pain; Costs and cost analysis; Aging; Spine; Economics; Chronic disease
Two recent studies that examined National Health Interview Survey data reported divergent findings regarding the propensity of adult chiropractic users to receive seasonal influenza immunization. Although one study found a statistically significant negative association between chiropractic use and influenza vaccination, another found that chiropractic users were significantly more likely to be vaccinated. The purpose of this study is to extend previous works by delving more deeply into recent data to identify adult chiropractic users at high risk and high priority for vaccination against influenza and pneumococcal disease.
We used data from the 2007 National Health Interview Survey in an attempt to replicate previous methodologies and further examine vaccination among adult chiropractic users (age ≥18 years) who, according to the Center for Disease Control and Prevention guidelines, should receive influenza and/or pneumococcal vaccination. We used complex survey design methods to make national estimates and used logistic regression to determine if having used chiropractic care predicted vaccination.
We found major methodological differences between the prior studies. In our analyses, we found that chiropractic users were significantly less likely than nonusers to have received the pneumococcal vaccine, and we found no significant difference between chiropractic users and nonusers relative to having received the seasonal flu vaccine.
Methodological differences in previous studies that investigated the association between chiropractic care and adult vaccination likely explain divergent findings reported in the literature. Future studies should consider these differences.
Chiropractic; Vaccination; Health Surveys; Preventive Health Services
Previous studies suggest a possible association between using chiropractic care and lower influenza vaccination rates. We examined adult influenza vaccination rates for chiropractic patients to determine if they are different than those for users of other complementary and alternative medicine(CAM).
We used the 2007 National Health Interview Survey to examine influenza vaccination rates among adult respondents who were considered high priority for the influenza vaccine(n=12,164). We separated respondents into clinically meaningful categories according to age and whether or not they had recently used chiropractic care, some other type of CAM, or neither. We used adjusted logistic regression to determine whether user status predicted influenza vaccination.
Only 33% of younger and 64% of older high priority Chiropractic Users were vaccinated in 2007; these rates approximated those of Non-CAM Users. However, younger Non-Chiropractic CAM Users were more likely than Non-CAM Users to have been vaccinated (p-value=0.05). In adjusted logistic regressions, we found statistically insignificant differences when comparing Chiropractic Users to Non-CAM Users for younger adults (OR=0.93(95% CI:0.76–1.13), or for older adults OR=0.90(95% CI:0.64–1.20).
Chiropractic Users appear no less likely to be vaccinated for influenza; whereas, younger Non-chiropractic CAM Users are more likely than Non-CAM Users to be vaccinated.
The purpose of this study was to explore the extent to which individuals with back pain or other health conditions, and individuals with no health problems, report having a usual source of care (USC) for their health care needs.
This study evaluated longitudinal Medical Expenditures Panel Survey data (MEPS data pooled for survey calendar years 2000-through-2006). Comparisons were made between adult MEPS respondents identified as having a back pain condition (n=10,194) compared to those without back pain but with other health condition (n=45,541), and those with no back pain and no other condition (n=5,497).
Compared to individuals with no health problems, those with back pain were almost 8 times more likely (OR=7.8, p<.001) to report having a USC; and those with other health problems besides back pain were 5 times more likely (OR=5.4, p<.001). For those with a USC, individuals with back pain, and those with other problems but not back pain, were both about one and a half times more likely than those without any health problems to report a specific provider type as their USC (p<.001).
Study findings suggest that relatively healthy adults without back pain are less likely to have a USC than those with back pain or other health problems.
Back Pain; Spine; Chiropractic
The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS) was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potential adverse drug events in their chiropractic patients, and by bringing suspected adverse drug events to the attention of the prescribing clinicians.
Mail survey of US chiropractors about their detection of potential adverse drug events in their chiropractic patients.
Over half of responding chiropractors (62%) reported having identified a suspected adverse drug event occurring in one of their chiropractic patients. The severity of suspected drug-related events detected ranged from mild to severe.
Chiropractors or other nonprescribing clinicians may be in a position to detect potential adverse drug events in the community. These detection and reporting mechanisms should be standardized and policies related to clinical case management of suspected adverse drug events occurring in their patients should be developed.
We investigated the effect of two commonly studied surfactants, sodium dodecyl sulfate (SDS) and dodecyl trimethylammonium bromide (C12TAB), on skin barrier properties. Using skin conductivity, FT-IR of stratum corneum samples, and penetration of radiolabelled SDS, we determined that addition of C12TAB lowers the ability of SDS to perturb skin’s barrier properties. Ultrafiltration experiments revealed that addition of C12TAB serves to decrease the concentration of monomers and sub-micellar aggregates. None of the measured skin properties including enhancement of skin conductivity, perturbation of lipid structure and skin concentration of SDS correlated with the total SDS concentration in the donor compartment (i.e., the total SDS concentration). However, all these parameters correlated well against the concentration of monomers and sub-micellar aggregates. These findings provide the evidence of the importance of monomer and sub-micellar components in altering skin barrier properties.
Transdermal; Surfactant; Mixture; Synergy; Mechanism
The purpose of this study was to provide new information that describes chiropractors' professional identity relative to their perceived clinical role as specialist or generalist.
A pragmatic, descriptive, cross-sectional survey was performed of randomly sampled state-board licensed chiropractors in the United States during the period 2002–2003 to assess the chiropractors' perceptions of how their chiropractic patients see them, and how they see themselves, as specialist or generalist. For this exploratory study, we anchored the terms “back pain specialist,” “musculoskeletal specialist,” and “primary care generalist” to brief generic reference definitions in our survey instrument.
Of our 2598 valid survey contacts, 1343 chiropractors returned their surveys either partially or fully completed, and a total of 720 chiropractor surveys were used in this study. Most of these chiropractors perceived that their new patients viewed them as “back pain specialists.” Chiropractors believed that their established patients (80%), more so than their new patients (58%), were likely to view them as a primary care generalist. Chiropractors described themselves as both specialist and generalist, and they expressed a greater capability to diagnose, rather than to treat, health disorders that were not musculoskeletal.
Chiropractic physician perceptions as reported in this study suggest that the nature of certain chiropractor-patient relationships may evolve profoundly over time, particularly as patients transition from new to established patients within the chiropractic practice. Understanding the complex nature of chiropractic health care provision may carry implications for advancing evidence-based chiropractic practice and clinical training, enhancing successful and comprehensive management of the complex health concerns of chiropractic patients, fostering beneficial sustained partnerships between chiropractors and their patients, and improving overall delivery of optimal integrative health care.
Chiropractic; Health occupations; Back pain; Specialization
This commentary discusses the evolving sociocultural roles and sociocultural authority of chiropractic.
The complex interconnectivity of the biological, psychological, and social aspects of our individual and collective well-being has occupied centuries of “nature versus nurture” philosophical debate, creative art, and scientific work. What has emerged is a better understanding of how our human development is affected by the circumstances of what we are born with (ie, nature) and how we are shaped by the circumstances that we are born into (ie, nurture).
In the new millennium, a cumulative challenge to the emerging integrative biopsychosocial health care disciplines is one of reconciling “circumstance versus choice”; that is, advancing individually and collectively the fullest actualization of human potential through the philosophy, art, and science of autonomy and empowerment.
Chiropractic; Health care provider; Professional role
Curcumin, a compound found in the spice turmeric, has been shown to possess a number of beneficial biological activities exerted through a variety of different mechanisms. Some curcumin effects have been reported to involve activation of the nuclear transcription factor peroxisome proliferator-activated receptor-γ (PPAR-γ), but the concept that curcumin might be a PPAR-γ ligand remains controversial. Results reported here demonstrate that, in contrast to the PPAR-γ ligands ciglitazone and rosiglitazone, curcumin is inactive in five different reporter or DNA-binding assays, does not displace [3H]rosiglitazone from the PPAR-γ ligand-binding site, and does not induce PPAR-γ–dependent differentiation of preadipocytes, while its ability to inhibit fibroblast-to-myofibroblast differentiation is not affected by any of four PPAR-γ antagonists. These multiple lines of evidence conclusively demonstrate that curcumin is not a PPAR-γ ligand and indicate the need for further investigation of the mechanisms through which the compound acts.
PPAR-γ; TGF-β; rosiglitazone; ciglitazone; PPRE; preadipocyte; fibroblast; turmeric; peroxisome; curcumin
Changes in the subject’s breathing rate or depth, such as a breath-hold challenge, can cause significant MRI signal changes. However, the response function that best models breath-holding induced signal changes, as well as those resulting from a wider range of breathing variations including those occurring during rest, has not yet been determined. Respiration related signal changes appear to be slower than neuronally-induced BOLD signal changes and are not modeled accurately using the typical hemodynamic response functions used in fMRI. In this study, we derive a new response function to model the average MRI signal changes induced by variations in the respiration volume (breath-to-breath changes in the respiration depth and rate). This was done by averaging the response to a series of single deep breaths performed once every 40s amongst otherwise constant breathing. The new “respiration response function” consists of an early overshoot followed by a later undershoot (peaking at approximately 16s), and accurately models the MRI signal changes resulting from breath holding as well as cued depth and rate changes.
While glucocorticoids are currently the most effective therapy for asthma, associated side effects limit enthusiasm for their use. Peroxisome proliferator-activated receptor-γ (PPAR-γ) activators include the synthetic thiazolidinediones (TZDs) which exhibit anti-inflammatory effects that suggest usefulness in diseases such as asthma. How the ability of TZDs to modulate the asthmatic response compares to that of glucocorticoids remains unclear, however, because these two nuclear receptor agonists have never been studied concurrently. Additionally, effects of PPAR-γ agonists have never been examined in a model involving an allergen commonly associated with human asthma.
We compared the effectiveness of the PPAR-γ agonist pioglitazone (PIO) to the established effectiveness of a glucocorticoid receptor agonist, dexamethasone (DEX), in a murine model of asthma induced by cockroach allergen (CRA). After sensitization to CRA and airway localization by intranasal instillation of the allergen, Balb/c mice were challenged twice at 48-h intervals with intratracheal CRA. Either PIO (25 mg/kg/d), DEX (1 mg/kg/d), or vehicle was administered throughout the period of airway CRA exposure.
PIO and DEX demonstrated similar abilities to reduce airway hyperresponsiveness, pulmonary recruitment of inflammatory cells, serum IgE, and lung levels of IL-4, IL-5, TNF-α, TGF-β, RANTES, eotaxin, MIP3-α, Gob-5, and Muc5-ac. Likewise, intratracheal administration of an adenovirus containing a constitutively active PPAR-γ expression construct blocked CRA induction of Gob-5 and Muc5-ac.
Given the potent effectiveness shown by PIO, we conclude that PPAR-γ agonists deserve investigation as potential therapies for human asthma.
PPARs, most notably PPAR-γ, play a crucial role in regulating the activation of alveolar macrophages, which in turn occupy a pivotal place in the immune response to pathogens and particulates drawn in with inspired air. In this review, we describe the dual role of the alveolar macrophage as both a first-line defender through its phagocytotic activity and a regulator of the immune response. Depending on its state of activation, the alveolar macrophage may either enhance or suppress different aspects of immune function in the lung. We then review the role of PPAR-γ and its ligands in deactivating alveolar macrophages—thus limiting the inflammatory response that, if unchecked, could threaten the essential respiratory function of the alveolus—while upregulating the cell's phagocytotic activity. Finally, we examine the role that inadequate or inappropriate PPAR-γ responses play in specific lung diseases.
With the increasing popularity of chiropractic care in the United States, inter-professional relationships between conventional trained physicians (MDs and DOs) and chiropractors (DCs) will have an expanding impact on patient care. The objectives of this study are to describe the intra-professional referral patterns amongst DCs, describe the inter-professional referral patterns between DCs and conventional trained medical primary care physicians (MDPCPs), and to identify provider characteristics that may affect these referral behaviors.
A survey instrument to assess the attitudes and patterns of referral and consultation between MD primary care physicians (MDPCPs) and DCs was developed and sent to all DCs in the state of Iowa. Multivariable logistic regression models were built to assess the impact of provider characteristics on intra-professional and inter-professional referral patterns.
Of all DCs contacted, 452 (40.7%) participated in the study. Close to 8% of DCs reported that they never send a case report when referring a patient to another DC, while 13% never send a case report to a MDPCP. About 10% of DCs never send follow-up clinical information to referring doctors. DCs that perform differential diagnosis were significantly more likely to have engaged in inter-professional referral than DCs who did not perform differential diagnosis.
The tendency toward informality, in both referral practices and sharing of clinical documentation for referred patients between MDPCPs and DCs, is an explicit marker of concerns that need to be addressed in order to improve coordination and continuity of care for patients shared between these provider types.
Despite the increasing usage and popularity of chiropractic care, there has been limited research conducted to examine the professional relationships between conventional trained primary care physicians (PCPs) and chiropractors (DCs). The objectives of our study were to contrast the intra-professional referral patterns among PCPs with referral patterns to DCs, and to identify predictors of PCP referral to DCs.
We mailed a survey instrument to all practicing PCPs in the state of Iowa. Descriptive statistics were used to summarize their responses. Multivariable logistic regression analyses were conducted to identify demographic factors associated with inter-professional referral behaviors.
A total of 517 PCPs (33%) participated in the study. PCPs enjoyed strong intra-professional referral relationships with other PCPs. Although patients exhibited a great deal of interest in chiropractic care, PCPs were unlikely themselves to make formal referral relationships with DCs. PCPs in a private practice arrangement were more likely to exhibit positive referral attitudes towards DCs (p = 0.01).
PCPs enjoy very good professional relationships with other PCPs. However, the lack of direct formalized referral relationships between PCPs and chiropractors has implications for efficiency, continuity, quality, and patient safety in the health care delivery system. Future research must focus on identifying facilitators and barriers for developing positive relationships between PCPs and chiropractors.
We report on a multidisciplinary focus group project related to the appropriate care of chiropractic patients who present with chest pain. The prevalence and clinical management, both diagnosis and treatment, of musculoskeletal chest pain in ambulatory medical settings, was explored as the second dimension of the focus group project reported here.
This project collected observational data from a multidisciplinary focus group composed of both chiropractic and medical professionals. The goals of the focus group were to explore the attitudes and experiences of medical and chiropractic clinicians regarding their patients with chest pain who receive care from both medical and chiropractic providers, to identify important clinical or research questions that may inform the development of 'best practices' for coordinating or managing care of chest pain patients between medical and chiropractic providers, to identify important clinical or research questions regarding the diagnosis and treatment of chest pain of musculoskeletal origin, to explore various methods that might be used to answer those questions, and to discuss the feasibility of conducting or coordinating a multidisciplinary research effort along this line of inquiry. The convenience-sample of five focus group participants included two chiropractors, two medical cardiologists, and one dual-degreed chiropractor/medical physician. The focus group was audiotaped and transcripts were prepared of the focus group interaction. Content analysis of the focus group transcripts were performed to identify key themes and concepts, using categories of narratives.
Six key themes emerged from the analysis of the focus group interaction, including issues surrounding (1) Diagnosis; (2) Treatment and prognosis; (3) Chest pain as a chronic, multifactorial, or comorbid condition; (4) Inter-professional coordination of care; (5) Best practices and standardization of care; and (6) Training and education.
This study carries implications for chiropractic clinical training relative to enhancing diagnostic competencies in chest pain, as well as the need to ascertain and improve those skills, competencies, and standards for referrals and sharing of clinical information that may improve cross-disciplinary coordination of care for chest pain patients.
Chest Pain; Chiropractic; Medical Education; Coordination of Care
BACKGROUND: Ensuring appropriate prescribing is an important challenge for the health service, and the need for research that takes account of the reasons behind individual general practitioners' (GPs) prescribing decisions has been highlighted. AIM: To explore differences among GPs in their decisions to prescribe new drugs. DESIGN OF STUDY: Qualitative approach, using in-depth semistructured interviews. SETTING: Northern and Yorkshire Health Authority Region. METHOD: Participants were identified from a random sample of 520 GPs in a quantitative study of patterns of uptake of eight recently introduced drugs. Purposeful sampling ensured inclusion of GPs prescribing any of the eight drugs and working in a range of practice settings. Fifty-six GPs were interviewed, using a topic guide. Interviews were recorded on audiotape. Transcribed text was methodically coded and data were analysed by constantly comparing emerging themes. RESULTS: Both low and high prescribers shared a view of themselves as conservative in their prescribing behaviour. Low prescribers appeared to conform more strongly to group norms and identified a consensus among practice partners in prescribing and cost-consciousness. Conformism to group norms was represented by a commitment to practice formularies. High prescribers more often expressed themselves to be indifferent to drug costs and a shared practice ethos. CONCLUSIONS: A shift in the attitudes of some GPs is required before cost-effectiveness is routinely incorporated in drug prescribing. The promotion of rational prescribing is likely to be more successful if efforts are focused on GPs' appreciation of cost issues and attitudes towards shared decision-making and responsibility.
Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be “impossible.”
Controversial ProtecT (prostate testing for cancer and treatment) trial embedded within qualitative research.
Background and setting
Screening for prostate cancer is hotly debated, and evidence from trials about the effectiveness of treatments (surgery, radiotherapy, and monitoring) is lacking. Mounting a treatment trial is controversial because of past failures and concerns that differences in complications of treatment but not survival make randomisation unacceptable to patients and clinicians, particularly for a trial including monitoring.
Strategy for change
In-depth interviews explored interpretation of study information. Audiotape recordings of recruitment appointments enabled scrutiny of content and presentation of study information by recruiters. Initial qualitative findings showed that recruiters had difficulty discussing equipoise and presenting treatments equally; they unknowingly used terminology that was misinterpreted by participants. Findings were used to determine changes to content and presentation of information.
Effects of change
Changes to the order of presenting treatments encouraged emphasis on equivalence, misinterpreted terms were avoided, the non-radical arm was redefined, and randomisation and clinical equipoise were presented more convincingly. The randomisation rate increased from 40% to 70%, all treatments became acceptable, and the three arm trial became the preferred design.
Changes to information and presentation resulted in efficient recruitment acceptable to patients and clinicians. Embedding this controversial trial within qualitative research improved recruitment. Such methods probably have wider applicability and may enable even the most difficult evaluative questions to be tackled.
The addition of enhancements to a COSTAR system can involve a significant investment of effort. This paper describes recent experience in implementing two major COSTAR enhancements, namely a patient-specific encounter form and an order entry and dispatch subsystem. A number of points to be considered in regard to planning and implementing such enhancements are raised, and the relative success of these two enhancements at one particular site is discussed.
Over the past 20 years, cancer patient advocacy groups have demonstrated that patient engagement in cancer care is essential to improving patient quality of life and outcomes. Bladder cancer patient advocacy only began 10 years ago in the United States, but is now expanding around the globe with non-profit organizations established in Canada, the United Kingdom and Italy, and efforts underway in Australia. These organizations, at different levels of maturity, are raising awareness of bladder cancer and providing essential information and resources to bladder cancer patients and their families. The patient advocacy organizations are also helping to advance research efforts by funding research proposals and facilitating research collaborations. Strong partnerships between these patient advocates and the bladder cancer medical community are essential to ensuringsustainability for these advocacy organizations, increasing funding to support advances in bladder cancer treatment, and improving patient outcomes.
Bladder cancer; patient advocacy; patient advocate; public awareness; patient education; Bladder Cancer Advocacy Network (BCAN); Bladder Cancer Canada (BCC); Fight Bladder Cancer; Pazienti Liberi dale Neoplasie Uroteliali (PaLiNUro); Bladder Cancer Australia (BCA); improved outcomes; quality of life; partnership