Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information.

Effects of patient medication requests on physician prescribing behavior: results of a factorial experiment.

BACKGROUND: Because of internet searches, advice from friends, and pharmaceutical advertising, especially direct-to-consumer advertising, patients are increasingly activated to request medications during a physician encounter. OBJECTIVES: To estimate the effect of patient requests for medications on physician-prescribing behavior, unconfounded by patient, physician, and practice-setting factors. RESEARCH DESIGN: Two experiments were conducted among 192 primary care physicians, each using different video-based scenarios: an undiagnosed "patient" with symptoms strongly suggesting sciatica, and a "patient" with already diagnosed chronic knee osteoarthritis. Half of patients with sciatica symptoms requested oxycodone, whereas the other half requested something to help with pain. Similarly, half of knee osteoarthritis patients specifically requested celebrex and half requested something to help with pain. SUBJECTS: To increase generalizability and ensure sufficient numbers were available, we recruited 192 primary care physicians from 6 US states. MEASURES: The primary outcome was whether physicians would accede to a patient's request for a medication. Alternative pain medications prescribed were secondary outcomes. RESULTS: 19.8% of sciatica patients requesting oxycodone would receive a prescription for oxycodone, compared with 1% of those making no specific request (P = 0.001). Fifty-three percent of knee osteoarthritis patients requesting celebrex would receive it, compared with 24% of patients making no request (P = 0.001). Patients requesting oxycodone were more likely to receive a strong narcotic (P = 0.001) and less likely to receive a weak narcotic (P = 0.01). Patients requesting celebrex were much less likely to receive a nonselective nonsteroidal anti-inflammatory drugs (P = 0.008). No patient attributes, physician, or organizational factors influenced a physician's willingness to accede to a patient's medication request. CONCLUSIONS: In both scenarios, activated patient requests for a medication substantially affected physician-prescribing decisions, despite the drawbacks of the requested medications.

It's about time: physicians' perceptions of time constraints in primary care medical practice in three national healthcare systems.

BACKGROUND: As physicians are pressured to deliver an increasing number of preventive services, follow guidelines, engage in evidence-based practice, and deliver patient-centered care in managerially driven organizations, they struggle with how much control they have over their time. METHODS: A secondary analysis was conducted with data from 3 parallel studies of clinical decision making in Germany, the United Kingdom, and the United States with 128 physicians per country. Physicians reported how much time they were allocated and how much time they needed for high-quality care for new patient appointments, routine consultations, and complete physicals. They also reported how much control they had over their time in the office and spending adequate time with patients. RESULTS: German, British, and American physicians were allocated (on average) 16/11/32 minutes for a new patient appointment, 6/10/18 minutes for a routine visit, and 12/20/36 minutes for a complete physical, but felt that they needed more time. Over half of German and American physicians felt that they always or usually had control over the hours they were required to be in their office or spending sufficient time with their patients while less than half of British physicians felt this way. CONCLUSION: German physicians had the least time allocated and needed for most types of appointment. American physicians had the most time allocated and needed for each type of appointment. However, British physicians felt they had the least control over time in their office and spending sufficient time with patients.

Do pain patients at high risk for substance misuse experience more pain? A longitudinal outcomes study.

OBJECTIVES: The Screener and Opioid Assessment of Pain Patients (SOAPP v.1) has been shown to be a reliable measure of risk potential for substance misuse and to correlate with a history of substance abuse, legal problems, craving, smoking, and mood disorders among chronic pain patients. The aim of this study was to examine differences over time on a number of measures among chronic pain patients who were classified as high or low risk for opioid misuse based on scores on the SOAPP. METHODS: From an initial sample of one hundred thirty-four participants (N = 134), one hundred and ten (N = 110) completed the SOAPP and were grouped as high or low risk for misuse of medication based on SOAPP scores of > or =7. All subjects were asked to complete baseline measures and in-clinic monthly diaries of their pain, mood, activity interference, medication, and side effects over a 10-month study period. RESULTS: The results showed that although those who were classified as high-risk for opioid misuse reported significantly higher levels of pain intensity, activity interference, pain catastrophizing, disability, and depressed mood at baseline (P < 0.05), only pain intensity ratings were found to differentiate groups over time (P < 0.01). These results were unrelated to perceived helpfulness of pain treatment. CONCLUSIONS: Differences in subjective pain intensity were found between those who are high risk for opioid misuse compared with those at low risk for medication misuse, implying that higher-risk patients may experience more subjective pain. Consequently, these patients may be more challenging to treat.

Is certainty more important than diagnosis for understanding race and gender disparities?: an experiment using coronary heart disease and depression case vignettes.

OBJECTIVES: To (1) examine the influence of patient and provider attributes on physicians' diagnostic certainty and (2) assess the effect of diagnostic certainty on clinical therapeutic actions. METHODS: Factorial experiment of 128 generalist physicians using identical clinically authentic videotaped vignettes depicting patients with coronary heart disease (CHD) or depression. RESULTS: For CHD, physicians were least certain for Black patients (p=.003) and for younger female patients (p=.013). For depression, average certainty was higher than for the CHD presentation (74.0 vs. 57.9 on of scale of 0-100, p<.001) and there were no main effects of patient or provider characteristics. Increasing diagnostic certainty was a significant predictor of subsequent clinical actions, and these varied according to physician and patient characteristics across both conditions. CONCLUSIONS: Physicians were least certain of their CHD diagnoses for Black patients and for younger women, but patient characteristics alone did not affect physician certainty of depression diagnoses. Physicians responded differentially to diagnostic certainty in terms of their clinical therapeutic actions such as test ordering and writing prescriptions. Physician responses to certainty may be as important as their responses to patient characteristics for understanding variation in clinical decision-making.

Evaluating the Film If Not for Me: Children and Clinical Studies.

Support for research involving children has a complicated history. Pediatricians and families have a unique opportunity to share perspectives about the relevance of pediatric clinical research. A national broadcast film on pediatric clinical research was developed to improve knowledge about and willingness to consider a clinical study. The film was delivered to a public audience employing a pre-post design comparing knowledge about clinical research before and after watching If Not for Me: Children and Clinical Studies. Change was measured by the difference in number of questions answered correctly prior to and after viewing the film. Engagement was measured by survey and a live feedback qualitative component. Adults viewing the program demonstrated a significant (P < .0001) difference in knowledge about pediatric clinical research across all domains. This format appears to be a viable approach for improving public education and as a support tool for pediatricians and pediatric researchers about this topic.

How are patient characteristics relevant for physicians' clinical decision making in diabetes? An analysis of qualitative results from a cross-national factorial experiment.

Variations in medical practice have been widely documented and are a linchpin in explanations of health disparities. Evidence shows that clinical decision making varies according to patient, provider and health system characteristics. However, less is known about the processes underlying these aggregate associations and how physicians interpret various patient attributes. Verbal protocol analysis (otherwise known as 'think-aloud') techniques were used to analyze open-ended data from 244 physicians to examine which patient characteristics physicians identify as relevant for their decision making. Data are from a vignette-based factorial experiment measuring the effects of: (a) patient attributes (age, gender, race and socioeconomic status); (b) physician characteristics (gender and years of clinical experience); and (c) features of the healthcare system in two countries (USA, United Kingdom) on clinical decision making for diabetes. We find that physicians used patients' demographic characteristics only as a starting point in their assessments, and proceeded to make detailed assessments about cognitive ability, motivation, social support and other factors they consider predictive of adherence with medical recommendations and therefore relevant to treatment decisions. These non-medical characteristics of patients were mentioned with much greater consistency than traditional biophysiologic markers of risk such as race, gender, and age. Types of explanations identified varied somewhat according to patient characteristics and to the country in which the interview took place. Results show that basic demographic characteristics are inadequate to the task of capturing information physicians draw from doctor-patient encounters, and that in order to fully understand differential clinical decision making there is a need to move beyond documentation of aggregate associations and further explore the mental and social processes at work.

Development of an eHealth Program for Parents of Adolescents With Type 1 Diabetes.

Purpose The purpose of this study was to understand the experience of parenting an adolescent with type 1 diabetes (T1DM), to develop a prototype of an eHealth program for parents of adolescents with T1DM, and to evaluate the prototype content and acceptability from the perspective of parents and health care providers. Methods A multiphase method was used generating both qualitative and quantitative data at multiple time points. There were 27 parents of adolescents aged 12 to 18 years with T1DM and 16 health care providers who participated in semistructured interviews to identify parental challenges; 53 parents and 27 providers evaluated the prototype. Thematic content analysis was used to analyze interview transcripts, and descriptive statistics were used to summarize survey data. Results Challenges experienced by parents of adolescents with T1DM included understanding the developmental and hormonal changes of adolescence that affect diabetes care, feeling tension between adolescent independence and parent control, communicating without nagging or conflict, transferring diabetes care responsibility safely, dealing with feelings of stress and distress, and perceiving a lack of resources for T1DM care and insufficient personal time for self-care. In the prototype evaluation, both parents and providers found content to be relevant and provided feedback to guide the development of the full program. Conclusions Parents of adolescents with T1DM and providers expressed a need for parents to have more support in transitioning diabetes care from parent to adolescent. eHealth programs offer an ideal way to address these needs and ultimately can be linked to electronic medical records improving quality and efficiency of health care in this population.

Using focus groups to improve the validity of cross-national survey research: a study of physician decision making.

In this article, the authors demonstrate how qualitative methods can form a foundation for quantitative research by improving instrument validity, informing the data collection process, and improving cost-effectiveness in a study of physician decision making. To test terminology, applicability, and comprehension of a quantitative questionnaire for doctors in the United States and United Kingdom, each country's researchers conducted physician focus groups with questions organized around the experiment, including (a) validity of video vignettes of actor "patients," (b) population accessibility, (c) level of remuneration, (d) appropriate endorsement figure, and (e) question comprehension. Focus group data collected during instrument development and fieldwork planning streamlined processes and achieved cost efficiencies and effectiveness for the overall study. Beyond simply adding a post hoc qualitative component to an already free-standing quantitative methodology, focus groups were used in the study formulation, where the qualitative methodology was integrated into the process of developing a valid survey instrument.

Physician assessments of drug seeking behavior: A mixed methods study.

BACKGROUND: Pain complaints are common, but clinicians are increasingly concerned about overuse of opioid pain medications. This may lead patients with actual pain to be stigmatized as "drug-seeking," or attempting to obtain medications they do not require medically. We assessed whether patient requests for specific opioid pain medication would lead physicians to classify them as drug-seeking and change management decisions. METHODS AND FINDINGS: Mixed-methods analysis of interviews with 192 office-based primary care physicians after viewing video vignettes depicting patients presenting with back pain. For each presentation physicians were randomly assigned to see either an active request for a specific medication or a more general request for help with pain. The main outcome was assignment by the physician of "drug-seeking" as a potential diagnosis among patients presenting with back pain. Additional outcomes included other actions the physician would take and whether the physician would prescribe the medication requested. A potential diagnosis of drug-seeking behavior was included by 21% of physicians seeing a specific request for oxycodone vs. 3% for a general request for help with back pain(p<0.001). In multivariable models an active request was most strongly associated with a physician-assigned diagnosis of drug-seeking behavior(OR 8.10; 95% CI 2.11-31.15;p = 0.002); other major patient and physician characteristics, including gender and race, did not have strong associations with drug-seeking diagnosis. Physicians described short courses of opioid medications as a strategy for managing patients with pain while avoiding opioid overuse. CONCLUSIONS: When patients make a specific request for opioid pain medication, physicians are far more likely to suspect that they are drug-seeking. Physician suspicion of drug-seeking behavior did not vary by patient characteristics, including gender and race. The strategies used to assess patients further varied widely. These findings indicate a need for the development of better clinical tools to support the evaluation and management of patients presenting with pain.

The end of the golden age of doctoring.

Eight interrelated reasons for the decline of the golden age of doctoring are discussed in this article. Major extrinsicfactors (generally outside the control of the profession) include (1) the changing nature of the state and loss of its partisan support for doctoring, (2) the bureaucratization (corporatization) of doctoring; (3) the emerging competitive threat from other health care workers; (4) the consequences of globalization and the information revolution; (5) the epidemiologic transition and changes in the public conception of the body; and (6) changes in the doctor-patient relationship and the erosion of patient trust. Major intrinsic factors are (7) the weakening of physicians' labor market position through oversupply; and (8) the fragmentation or weakening of the physicians, union (AMA). Despite the recent sociopolitical transformation of modern U.S. medicine, our thinking remains wedded to a now inadequate theoretical approach. A future sociology of the professions can no longer overlook now pervasive macrostructural influences on provider behavior (corporate dominance). Until these influences are appropriately recognized and incorporated in social analyses, most policies designed to restore the professional ideal have little chance of success.

Variations among primary care physicians in exercise advice, imaging, and analgesics for musculoskeletal pain: results from a factorial experiment.

OBJECTIVE: To examine whether medical decisions regarding evaluation and management of musculoskeletal pain conditions varied systematically by characteristics of the patient or provider. METHODS: We conducted a balanced factorial experiment among primary care physicians in the US. Physicians (n = 192) viewed 2 videos of different patients (actors) presenting with pain: undiagnosed sciatica symptoms or diagnosed knee osteoarthritis. Systematic variations in patient gender, socioeconomic status, and race and physician gender and experience (<20 versus ≥20 years in practice) permitted estimation of unconfounded effects. Analysis of variance was used to evaluate associations between patient or provider attributes and clinical decisions. Quality of decisions was defined based on the current recommendations of the American College of Rheumatology, American Pain Society, and clinical expert consensus. RESULTS: Despite current recommendations, less than one-third of physicians would provide exercise advice (30.2% for osteoarthritis and 32.8% for sciatica). Physicians with fewer years in practice were more likely to provide advice on lifestyle changes, particularly exercise (P ≤ 0.01), and to prescribe nonsteroidal antiinflammatory drugs for pain relief, both of which were appropriate and consistent with current recommendations for care. Newer physicians ordered fewer tests, particularly basic laboratory investigations or urinalysis. Test ordering decreased as organizational emphasis on business or profits increased. Patient factors and physician gender had no consistent effects on pain evaluation or treatment. CONCLUSION: Physician education on disease management recommendations regarding exercise and analgesics and implementation of quality measures may be useful, particularly for physicians with more years in practice.

From cottage industry to a dominant mode of primary care: stages in the diffusion of a health care innovation (retail clinics).

Primary health care is essential to population health and there is increasing need for it, especially with an aging population with multiple comorbidities. Primary health care in the U.S. is widely considered in an ever-deepening crisis. This paper presents a detailed case study of the recent rise of a "disruptive innovation" - retail clinics - which have the potential to transform the face of primary health care in the US. We describe six stages in the diffusion of retail clinics, from cottage industry to a dominant mode for the delivery of primary health care, and consider sociopolitical influences that facilitate and impede their emerging potential. Retail clinics may provide a strategic opportunity to re-engineer the primary health care system, although they may also produce worrisome unanticipated consequences. Discussion concerning the potential threats and opportunities posed by retail clinics occurs in the absence of sound evidence concerning their comparative effectiveness and quality-of-care. This case study identifies the sociopolitical influences and processes that determine whether health care innovations rise or fall, and highlights critically important points along the pathway to health system change.

Do doctors contribute to the social patterning of disease? The case of race/ethnic disparities in diabetes mellitus.

Data from the Boston Area Community Health Survey show that both undiagnosed signs and symptoms and diagnosed type 2 diabetes mellitus (T2DM) are patterned by socioeconomic status (SES). Such patterning is corroborated by National Health and Nutrition Examination Survey data for diagnosed T2DM. Complementary data from an experiment concerning clinical decision making show T2DM is patterned by race/ethnicity, following diagnosis by a physician. Undiagnosed signs and symptoms of T2DM in the community are patterned by SES (rather than race/ethnicity), but following diagnosis by primary care physicians they are patterned more by race/ethnicity (rather than by SES). Race/ethnicity and SES in the United States are almost totally confounded, such that measuring one is essentially also measuring the other. Physician patterning of T2DM by race/ethnicity, however, motivates the search for genetic and biophysiologic explanations and distracts attention from the more important contribution of SES circumstances to the prevalence of diabetes mellitus.

Influences of organizational features of healthcare settings on clinical decision making: qualitative results from a cross-national factorial experiment.

A proliferating literature documents cross-national variation in medical practice and seeks to explain observed differences in terms of the presence of certain kinds of healthcare systems, economic, and cultural differences between countries. Less is known about how providers themselves understand these influences and perceive them as relevant to their clinical work. Using qualitative data from a cross-national factorial experiment in the United States and United Kingdom, we analyze 244 primary care physicians' explanations of how organizational features of their respective healthcare settings influence the treatment decisions they made for a vignette patient, including affordability of care; within-system quality deficits; and constraints due to patient behavior. While many differences are attributed to financial constraints deriving from two very differently structured healthcare systems, in other ways they are reflections of cultural and historical expectations regarding medical care, or interactions between the two. Implications, including possible challenges to the implementation of universal care in the USA, are discussed.

Electronic pain assessment in clinical practice.

SUMMARY The assessment and treatment of chronic pain remains an international challenge for healthcare providers among aging patients and rising healthcare costs. This article provides a brief overview of studies on the use of electronic pain diaries and innovative software programs for pain assessment and monitoring among providers and persons with chronic pain. The advent of software pain monitoring programs on smart phones, personal digital assistants and internet-based tracking allow for the collection of large datasets of momentary data to better assist in the management of chronic pain. Electronic tracking in the home and clinic can improve data quality and reduce the biases of recalled information compared with paper diaries and questionnaires. Furthermore, 3D pain mapping programs can enable patients to represent the location and intensity of their pain with greater accuracy. However, despite the benefits, there are a number of barriers to incorporating electronic pain assessment into daily clinical practice. Additional control trials and clinical investigations are needed to demonstrate the efficacy and benefit of electronic pain assessment over and above standard practices.

Differences between internists and family practitioners in the diagnosis and management of the same patient with coronary heart disease.

It has been suggested that internists and family practitioners have somewhat different "disease" perspectives, which may be generated by use of different explanatory models during medical training (pathophysiological vs. biopsychosocial, respectively). This article explores differences between internists and family practitioners in their suggested diagnoses, level of diagnostic certainty, test and prescription ordering, when encountering exactly the same "patient" with coronary heart disease (CHD). Internists were more certain of a CHD diagnosis than family practitioners and were more likely to act on this diagnosis. Family practitioners were more likely to diagnose (and were more certain of) a mental health condition. While many physicians simultaneously entertain several alternate diagnoses, diagnostic certainty has shown to have an important influence on subsequent clinical actions, such as stress testing and prescription of beta blockers. These results may inform future educational strategies designed to reduce diagnostic uncertainty in the face of life-threatening conditions, such as CHD.

Diagnosis and management of depression in 3 countries: results from a clinical vignette factorial experiment.

OBJECTIVE: International differences in disease prevalence rates are often reported and thought to reflect different lifestyles, genetics, or cultural differences in care-seeking behavior. However, they may also be produced by differences among health care systems. We sought to investigate variation in the diagnosis and management of a "patient" with exactly the same symptoms indicative of depression in 3 different health care systems (Germany, the United Kingdom, and the United States). METHOD: A factorial experiment was conducted between 2001 and 2006 in which 384 randomly selected primary care physicians viewed a video vignette of a patient presenting with symptoms suggestive of depression. Under the supervision of experienced clinicians, professional actors were trained to realistically portray patients who presented with 7 symptoms of depression: sleep disturbance, decreased interest, guilt, diminished energy, impaired concentration, poor appetite, and psychomotor agitation or retardation. RESULTS: Most physicians listed depression as one of their diagnoses (89.6%), but German physicians were more likely to diagnose depression in women, while British and American physicians were more likely to diagnose depression in men (P = .0251). American physicians were almost twice as likely to prescribe an antidepressant as British physicians (P = .0241). German physicians were significantly more likely to refer the patient to a mental health professional than British or American physicians (P < .0001). German physicians wanted to see the patient in follow-up sooner than British or American physicians (P < .0001). CONCLUSIONS: Primary care physicians in different countries diagnose the exact same symptoms of depression differently depending on the patient's gender. There are also significant differences between countries in the management of a patient with symptoms suggestive of depression. International differences in prevalence rates for depression, and perhaps other diseases, may in part result from differences among health care systems in different countries.

What do physicians gain (and lose) with experience? Qualitative results from a cross-national study of diabetes.

An empirical puzzle has emerged over the last several decades of research on variation in clinical decision making involving mixed effects of physician experience. There is some evidence that physicians with greater experience may provide poorer quality care than their less experienced counterparts, as captured by various quality assurance measures. Physician experience is traditionally narrowly defined as years in practice or age, and there is a need for investigation into precisely what happens to physicians as they gain experience, including the reasoning and clinical skills acquired over time and the ways in which physicians consciously implement those skills into their work. In this study, we are concerned with 1) how physicians conceptualize and describe the meaning of their clinical experience, and 2) how they use their experience in clinical practice. To address these questions, we analyzed qualitative data drawn from in-depth interviews with physicians from the United States, United Kingdom, and Germany as a part of a larger factorial experiment of medical decision making for diabetes. Our results show that common measures of physician experience do not fully capture the skills physicians acquire over time or how they implement those skills in their clinical work. We found that what physicians actually gain over time is complex social, behavioral and intuitive wisdom as well as the ability to compare the present day patient against similar past patients. These active cognitive reasoning processes are essential components of a forward-looking research agenda in the area of physician experience and decision making. Guideline-based outcome measures, accompanied by underdeveloped age- and years-based definitions of experience, may prematurely conclude that more experienced physicians are providing deficient care while overlooking the ways in which they are providing more and better care than their less experienced counterparts.

In-clinic use of electronic pain diaries: barriers of implementation among pain physicians.

OBJECTIVES: The aim of this study was to examine barriers to the use of electronic diaries within the clinic setting and determine outcome differences between patients who used electronic diaries to monitor their progress with summary data feedback and patients who monitored their progress with paper diaries without summary data feedback. METHODS: One hundred thirty-four (n=134) chronic pain patients were asked to monitor their pain, mood, activity interference, medication use, and pain location on either a paper or electronic diary immediately before each monthly clinic visit for 10 months. Patients and their treating physicians in the electronic diary group (n=67) were able to observe changes in their ratings whereas patients using the paper diaries (n=67) had no feedback about their data entry. RESULTS: Most participants believed that completing pain diaries was beneficial; yet, only 23% of patients in the experimental condition felt that the data from the electronic diaries improved their care and less than 15% believed that their doctor made a change in their treatment based on the summary diary information. CONCLUSION: In general, treating physicians were positive about the use of electronic diaries, although they admitted that they did not regularly incorporate the summary data in their treatment decision making because either they forgot or they were too busy. Future studies in understanding barriers to physicians' and patients' use of diary data to impact treatment outcome are needed to improve care for persons with chronic pain.