Challenges to the validity of using medicine labels to categorize clinical behavior: An empirical and normative critique of “off‐label” prescribing

This study aimed to determine whether the label status of a medicine penetrates into the clinical reasoning of Australian medical practitioners and to explore the possible reasons for our findings using semistructured interviews with 14 Australian physicians. The interviews revealed 3 broad catalysts for off‐label prescribing. The first of these was lack of awareness or understanding of the regulatory process in general and labels more specifically. The second was the perception that labels are not meaningful guides for clinical practice. The third was the recognition of alternative mechanisms for ensuring safe, rational, and evidence‐based prescribing occurs. This research suggests that Australian physicians do not consider whether a medicine is off‐label to be a reliable measure of the appropriateness of their prescribing practices. Rather, the legitimacy of prescribing practices is determined by the abilities, skills, and knowledge base of particular prescribers by a culture that encourages and supports evidence‐based practice, and safe prescribing. Although labels are of minimal clinical significance, there are real conceptual, practical, and moral problems associated with conflating “good” or “better” practice with “on‐label” practice, and “bad” or “worse” practice with off‐label prescribing as often occurs. To ascribe greater meaning to the term “off‐label” than is warranted can have the unintended consequence of casting suspicion on and making it more difficult for physicians to provide appropriate clinical care. We conclude that labeling can, in some cases, provide assurances to both clinicians and patients that their medications have been demonstrated to be safe and effective, but that clinicians should be able to continue to prescribe responsibly off‐label without having any stigma attached to their practice.     

12. Pain Originating from the Lumbar Facet Joints

Although the existence of a “facet syndrome” had long been questioned, it is now generally accepted as a clinical entity. Depending on the diagnostic criteria, the zygapophysial joints account for between 5% and 15% of cases of chronic, axial low back pain. Most commonly, facetogenic pain is the result of repetitive stress and/or cumulative low‐level trauma, leading to inflammation and stretching of the joint capsule. The most frequent complaint is axial low back pain with referred pain perceived in the flank, hip, and thigh. No physical examination findings are pathognomonic for diagnosis. The strongest indicator for lumbar facet pain is pain reduction after anesthetic blocks of the rami mediales (medial branches) of the rami dorsales that innervate the facet joints. Because false‐positive and, possibly, false‐negative results may occur, results must be interpreted carefully. In patients with injection‐confirmed zygapophysial joint pain, procedural interventions can be undertaken in the context of a multidisciplinary, multimodal treatment regimen that includes pharmacotherapy, physical therapy and regular exercise, and, if indicated, psychotherapy. Currently, the “gold standard” for treating facetogenic pain is radiofrequency treatment (1 B+). The evidence supporting intra‐articular corticosteroids is limited; hence, this should be reserved for those individuals who do not respond to radiofrequency treatment (2 B±).     

Psychosocial functioning and self‐rated health in Japanese school‐aged children: A cross‐sectional study

Emotional and behavioral disorders in children are school‐health concerns; however, Japanese screening tools for such disorders are not yet available. We examined the association between psychosocial functioning as measured by the Pediatric Symptom Checklist (PSC) and self‐rated health within school settings. A cross‐sectional study was conducted for 2513 fifth and eighth graders from all of the primary and secondary schools in Shunan City, Japan. The Japanese PSC had high internal consistency (Cronbach's α = 0.90) and a factor structure similar to that of the English PSC. When the cut‐off values were set to ≥ 28 and ≥ 17, 4–9% and 20–39% of our respondents, respectively, reported high PSC scores. A multiple ordinal logistic regression analysis showed that the odds ratio of a positive PSC score (≥ 28) for poorer self‐rated health among ratings of “very good,” “good,” “fair,” and “poor” was 3.5 (95% confidence interval = 2.6–4.8). There was a clear association between psychosocial dysfunction identified by a PSC score ≥ 28 and poor self‐rated health. We offer directions for further research on appropriate PSC cut‐off values with Japanese samples.     

伴尿微量白蛋白增高的2型糖尿病肾病患者的循证治疗（附2例报告）

目的 为两例尿微量白蛋白增高的2型糖尿病肾病患者制定治疗方案。方法 根据循证临床实践的方法，提出问题，检索证据，对所获证据进行评价，并结合患者意愿为患者制定治疗方案。结果 共纳入14个随机对照试验，2个系统评价，2个Meta分析和41个临床指南。证据结果表明：①尿白蛋白增高是糖尿病患者心血管事件的独立危险因素；②血管紧张素受体拮抗剂能降低2型糖尿病肾病患者尿白蛋白水平。③降糖降压治疗能使此类患者获益。结合患者情况，应用证据治疗1月后，2例患者血肌酐恢复正常，尿白蛋白转阴性。结论 以高质量证据，结合患者情况制定治疗方案，能明显保护肾脏及心脏，降低尿白蛋白，但远期预后尚需要更长时间的随访观察。     

13. Sacroiliac Joint Pain

The sacroiliac joint accounts for approximately 16% to 30% of cases of chronic mechanical low back pain. Pain originating in the sacroiliac joint is predominantly perceived in the gluteal region, although pain is often referred into the lower and upper lumbar region, groin, abdomen, and/ or lower limb(s). Because sacroiliac joint pain is difficult to distinguish from other forms of low back pain based on history, different provocative maneuvers have been advocated. Individually, they have weak predictive value, but combined batteries of tests can help ascertain a diagnosis. Radiological imaging is important to exclude “red flags” but contributes little in the diagnosis. Diagnostic blocks are the diagnostic gold standard but must be interpreted with caution, because false‐positive as well as false‐negative results occur frequently. Treatment of sacroiliac joint pain is best performed in the context of a multidisciplinary approach. Conservative treatments address the underlying causes (posture and gait disturbances) and consist of exercise therapy and manipulation. Intra‐articular sacroiliac joint infiltrations with local anesthetic and corticosteroids hold the highest evidence rating (1 B+). If the latter fail or produce only short‐term effects, cooled radiofrequency treatment of the lateral branches of S1 to S3 (S4) is recommended (2 B+) if available. When this procedure cannot be used, (pulsed) radiofrequency procedures targeted at L5 dorsal ramus and lateral branches of S1 to S3 may be considered (2 C+).     

Modern medicine and the one‐size‐fits‐all approach: A clinician's comment to Alexandra Pârvan's “Mind Electric” article

As a clinician, I can easily agree with the author that a person's own reality of being healthy is independent of physical evidence or clinical categories and that this perspective should be considered to improve clinical care. However, I cannot follow the assumptions about the nature and working of modern medicine and psychiatry as typically using “black box” and one‐size‐fits‐all treatments in daily practice. I outline several working contexts of doctors where this criticism does only marginally apply or not at all and wonder whether the author might wish, if possible at all from a philosophical viewpoint, to differentiate her concepts with regard to these different contexts. In addition, I think that ill health in the field of psychiatry might have to be dealt with differently than physical ill health.     

Development of Two Search Strategies for Literature in MEDLINE–PubMed: Nursing Diagnoses in the Context of Evidence‐Based Nursing

PURPOSE. To develop and validate search filters for MEDLINE via PubMed according to two categories of the NLINKS‐EBN matrix. METHODS. The search results of the search filters were compared to a gold standard. FINDINGS. The usage of nursing classification terms for the literature search in evidence‐based nursing (EBN) is still limited because taxonomies are neither widely used in nursing literature nor applied for indexing by MEDLINE. The proposed filters achieved a sensitivity of 96% and a specificity of 94% for “secondary data” and a sensitivity of 87% and a specificity of 73% for “diagnostic tests.” CONCLUSIONS. The usage of database‐specific search filters are a reliable and valid method to search for nursing classification terms in medical databases.     

Performance of age‐adjusted D‐dimer cut‐off to rule out pulmonary embolism

Summary: Background: Age‐adjusted D‐dimer cut‐off has recently been proposed to increase D‐dimer usefulness in older patients suspected of pulmonary embolism (PE). Objective: We externally validated this age‐adjusted D‐dimer cut‐off using different D‐dimer assays in a multicenter sample of emergency department patients. Methods: Secondary analysis of three prospectively collected databases (two European, one American) of patients suspected of having PE. D‐dimer performance for ruling out PE was assessed by calculating negative likelihood ratio (nLR) for D‐dimer with age‐adjusted D‐dimer cut‐off (< age × 10 in patients over 50 years) and with conventional cut‐off (< 500 μg dL^?1). Test efficiency was assessed by the number needed to test (NNT) to rule out PE in one patient. Results: Among 4537 patients included, overall PE prevalence was 10.1%. In the overall population, nLR was 0.06 (95% confidence interval, 0.03–0.09) with conventional cut‐off and 0.08 (0.05–0.12) with age‐adjusted cut‐off. Using age‐adjusted cut‐off, nLR was 0.08, 0.09 and 0.06 for Vidas^®, Liatest^® and MDA^® assays, respectively. Use of age‐adjusted cut‐off produced a favorable effect on NNT in the elderly; the greatest decrease was observed in patients > 75 years: NTT halved from 8.1 to 3.6. The proportion of patients over 75 years with normal D‐dimer was doubled (27.9% vs. 12.3%). Conclusions: Our study shows that age‐adjusted D‐dimer had low nLR, allowing its use as a rule‐out PE strategy in non‐high pretest clinical probability patients, as well as using Vidas^®, Liatest^® or MDA^® assays. This age‐adjusted cut‐off increased clinical usefulness of D‐dimer in older patients. A large prospective study is required to confirm these results.     

Development of the Japanese version of the Woman Abuse Screening Tool‐Short

This study develops a Japanese version of the Woman Abuse Screening Tool, comprising two simple questions, to examine its accuracy and validity. A cohort study involving women in the third trimester of pregnancy and one month after childbirth was conducted in an antenatal clinic in a Tokyo suburb. The Japanese versions of the Index of Spouse Abuse and Hospital Anxiety and Depression Scale were used to examine the cut‐off point, accuracy, and validity of the Woman Abuse Screening Tool. Results showed that the tool demonstrated good accuracy (sensitivity 66.7–71.4%, specificity 89.7%), using an alternative cut‐off point (i.e. responses of “some tension” or “some difficulty” [2 points] for one item and “a lot of tension” or “great difficulty” [1 point] for the other), and good concurrent, convergent, and predictive validity. The results indicated that the Woman Abuse Screening Tool could be useful in Japanese perinatal health settings, as an initial screening tool to detect intimate partner violence efficiently and effectively during pregnancy.     

The Reliability and Validity of the Visual Analog Mood Scales in Non‐English‐Speaking Pain Patients

Objectives: This study assessed the validity and reliability of the Visual Analog Mood Scales (VAMS) when administered to a non‐English‐speaking, headache population. Methods: The VAMS and another frequently administered measure of mood, the Profile of Mood States (POMS), were administered to sixty patients at a headache clinic in Milan, Italy. The VAMS and POMS were both administered before and after a regularly scheduled appointment at the clinic. Multitrait–multimethod analyses were conducted to assess the validity of each subscale comprising the VAMS. Results: All subscales comprising the VAMS possessed high test–retest reliability, and the “confused,”“sad,”“angry,”“energetic,” and “tired” subscales of the VAMS were shown to be valid when administered to a non‐English‐speaking pain population. Further, compared to age‐matched controls (from available normative data), pain patients reported being significantly more confused, sad, and tense on the VAMS and significantly more tired, confused, depressed, and tense on the POMS. Discussion: Given the evidence of strong reliability and validity, the VAMS may be useful as a clinical diagnostic tool when administered to non‐English‐speaking pain populations.     

The Difficulty of Selecting the NANDA‐I Nursing Diagnosis (2015–2017) of “Death Anxiety” in Japan

PURPOSE

The purpose of our study was to clarify any difficulties or problems that exist in Japanese healthcare sites regarding the selection of death anxiety as a nursing diagnosis.

METHODS

This study was a qualitative, inductive research design. The semistructured interviews were conducted on the participants who were nurses and had 3 or more years of clinical experience in Japan.

RESULTS

Results showed four categories: “The Japanese have a culture of avoiding death,” “It is extremely difficult to match diagnostic indicators and related factors with specific patient cases,” “Other diagnoses exist that are effective and enable proactive intervention,” and “The definition of death anxiety and the meaning of its diagnostic indicators are unintelligible.”

DISCUSSION

It is thought that nursing diagnoses that reflect specific cultural backgrounds require definitions appropriate to each country and appropriate revisions to diagnostic indicators.     

Decision‐making process of patients with gynecological cancer regarding their cancer treatment choices using the analytic hierarchy process

Aim: In order to support patients' decision‐making regarding cancer treatments, it is important to clarify which criteria that cancer patients use to set priorities in their treatment choices. Using the analytic hierarchy process (AHP), a mathematical decision‐making method, this article investigates the criteria and the priorities of patients with gynecological cancer. Methods: In the AHP, multiple and hierarchical criteria in the decision‐making process were organized by a repeated pairwise judgment of the participants so as to serialize the alternatives along with the rational order of the priorities. For the alternatives “to receive treatment” and “to not receive treatment,” the following five criteria were set: “anxiety about relapse and metastasis”, “distress about side‐effects”, “advice of family”, “advice of medical staff”, and “economic burden”. The participants determined a pairwise priority scale, as well as a priority scale between the alternatives for every criterion. The logical consistency of their answers was checked by a consistency index (CI). The participants were 31 patients with ovarian or endometrial cancer who were being followed up after undergoing surgery and adjuvant chemotherapy. Results: Of the participants who answered the questionnaire, 17 satisfied the logical consistency. Of the five criteria for the treatment choices, “anxiety about relapse and metastasis” and “advice of medical staff” were found to be the important factors for treatment choice; however, the weight attached to the priority criteria differed much among the patients. Conclusion: The AHP made it possible to support patients' decision‐making in order to clarify their priority criteria and to quantitatively present their decision‐making process.     

Suffering without a medical diagnosis. A critical view on the biomedical attitudes towards persons suffering from burnout and the implications for medical care

The search for causal explanations in medically unexplained syndromes such as burnout has not been resolved by evidence‐based medicine. A biomedical model encourages a reductionist diagnostic practice and a dualist split between physical and psychological symptoms. Therefore, diagnosing and treating these syndromes remains a challenge. Depression is a common aspect in burnout and, as a result, clinicians often diagnose burnout patients as depressed. The Norwegian government expects medical efficiency to reduce sick leaves. Medically treating depression has a documented effect. This practice may pose threats to the increasing number of individuals experiencing burnout. The clinical guidelines in evidence‐based medicine mirror what counts as knowledge in medical inquiry, which in turn shapes attitudes towards individual patients. The aim of this article is 2‐fold: firstly, to assess how the values that accompany the biomedical paradigm affect clinical care, and secondly, to replace the biomedical model with a genuine person‐centred approach. In the study described, an existential phenomenological method was applied. Eight individuals, who experienced burnout, were included. They had been on long‐term sick leave (>1 year) due to symptoms of fatigue and pain and fulfilled the criteria for Exhaustion Disorder (ICD‐10, F43.8A). Their symptoms were not medically explained, and almost all the participants were labelled as depressed. Four themes emerged that described how they experienced living with burnout: “unhomelike being in the world,” “the limit of diagnosis,” “naked in the eyes of the public,” and “a path to hopelessness.” I identify 2 main problems; firstly, the mismatch between the patient's experience of his or her illness and the doctor's interpretation of the condition can lead to ineffective treatment. Secondly, the interviewees struggled to be recognized as ill. Thus, the inherent values in the biomedical paradigm might have serious implications for the medical care of patients with burnout.     

Changes in life style for young adults with profound handicaps following discharge from hospital care into a “second generation” housing project

During 1986 five young adults left hospital to live in a bungalow in Exeter. This move has been described as a “second generation” project. In other words it was not one of the first such ventures in the area. It followed earlier, trail-blazing projects and had to compete for administrative and specialist support with a number of other projects being commissioned at the same time. No net change in staff/client ratio occurred and 70 per cent of the new staff team were staff who had previously worked with the young people whilst they were in hospital. A number of findings consistent with the view that the quality of life of the young people had been improved as a result of leaving hospital were recorded: they went out more, and to more varied places; they spent more time engaged in interaction with other people; less behaviour judged to be “inappropriate” was recorded; and staff considered the group as a whole to be “better off”. On the other hand little evidence of integration being achieved within the local community was recorded; and there was little or no evidence of individuals being supported in ways that increased their competence, particularly in relation to participating at a simple level in routine domestic tasks. The implications of these findings for others engaged in the large-scale commissioning of such housing projects are discussed.     

Terminology Matters: Patient Understanding of “Opioids” and “Narcotics”

Background: The terms “opioid” and “narcotic” are often used interchangeably by healthcare providers. The purpose of this study was to compare understanding “narcotics” vs. “opioids.” Methods: A convenience sample of English‐speaking women (n = 188), aged 21–45 years, seeking care at a primary care clinic were asked (1) “What is an opioid/narcotic?” (2) “Give an example of an opioid/narcotic?” (3) “Why does someone take an opioid/narcotic?” and (4) “What happens when someone takes an opioid/narcotic for a long time?” Responses were recorded verbatim by a research assistant and then coded independently by two investigators. Results: More than half of respondents (55.9%) responded “don’t know” to all 4 opioid questions, while just 3.2% responded “don’t know” to all 4 narcotic questions (P < 0.01). Most women were unfamiliar with the term opioid (76.3%) and did not know why someone would take an opioid (68.8%). About two‐thirds of respondents were able to give an example of a narcotic (64.2%) and knew the consequences of long‐term narcotic use (63.2%). Conclusions: While more women were more familiar with narcotic, many identified negative connotations with this term. Future research should explore how to improve patient understanding and attitudes regarding both the terms opioids and narcotics.     

Another ten stories in antiviral drug discovery (part C): “Old” and “new” antivirals,strategies, and perspectives

The ten stories told here deal with (i) ribavirin as an inhibitor of IMP dehydrogenase and (ii) ribavirin, in combination with pegylated interferon, as the present “standard of care” for hepatitis C; (iii) S‐adenosylhomocysteine hydrolase inhibitors as antiviral agents; (iv) new adamantadine derivatives for the treatment of influenza A virus infections; (v) 5‐substituted 2′‐deoxyuridines (i.e. IDU, TFT) for the treatment of herpes simplex virus (HSV) infections; (vi) acyclic guanosine analogues (e.g. acyclovir) for the treatment of HSV infections; (vii) OMP decarboxylase inhibitors (i.e. pyrazofurin) and CTP synthetase inhibitors (i.e. cyclopentenylcytosine) as possible antiviral agents; (viii) the future of cidofovir (and alkoxyalkyl esters thereof) and ST‐246 as potential antipoxvirus agents; (ix) the two decade journey from tivirapine to rilpivirine in the ultimate therapy of HIV infections; and (x) the extension of the therapeutic application of tenofovir disoproxil fumarate (Viread^®) to the treatment of hepatitis B virus infection, in addition to HIV infection. © 2009 Wiley Periodicals, Inc. Med Res Rev     

Critical thinking and contemporary mental health care: Michel Foucault's “history of the present”

In order to be able to provide informed, effective and responsive mental health care and to do so in an evidence‐based, collaborative and recovery‐focused way with those who use mental health services, there is a recognition of the need for mental health professionals to possess sophisticated critical thinking capabilities. This article will therefore propose that such capabilities can be productively situated within the context of the work of the French philosopher Michel Foucault, one of the most challenging, innovative and influential thinkers of the 20th century. However, rather than focusing exclusively upon the content of Foucault's work, it will be suggested that it is possible to discern a general methodological approach across that work, a methodological approach that he refers to as “the history of the present.” In doing so, Foucault's history of the present can be understood as a productive, albeit provisional, framework in which to orientate the purpose and process of critical thinking for mental health professionals by emphasizing the need to both historicize and politicize the theoretical perspectives and therapeutic practices that characterize contemporary mental health care.     

Therapeutic effects of angiotensin II inhibition or blockade on the progression of chronic renal disease

Experimental and clinical research has supported the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) in diabetic, hypertensive and proteinuric nephropathies. This review will evaluate the role of angiotensin II in the progression of renal damage in kidney diseases; the diagnostic value of microalbuminuria as an early clinical sign of renal damage and the possibility of preventing its further progression; the clinical results obtained with ACE inhibitors and/or ARBs in diabetic and non-diabetic nephropathies; and the therapeutic possibilities of ACE inhibitors and ARBs in renal transplantation. Based on available clinical data, ACE inhibitors can be considered to be the gold standard in reducing and/or preventing albuminuria, and thereby decreasing the percentage of patients who will progress to end-stage renal disease and death. Renal transplantation and chronic allograft nephropathy appear to be a promising field for the use of ACE inhibitors and ARBs.     

Nurses' Perspectives of Encouraging Clients' Care‐of‐Self in a Short‐Term Rehabilitation Unit Within a Long‐Term Care Facility

This article presents a study conducted on a short‐term rehabilitation unit in a long‐term care facility. The purpose of the study was to explore, through qualitative methods, nurses' perspectives of encouraging clients to care for themselves. Although the literature suggested that encouraging self‐care does not occur, the findings of this study showed that nurses have a broader view than what is currently known in nursing as “self‐care.” Potential impediments to nursing practice were overcome by the development of nurse‐client relationships through which the nurses encouraged clients in what is described throughout this study as “care‐of‐self” Rehabilitation nurses play an important role in helping clients to integrate and reclaim the care of their emerging new selves. Care‐of‐self may be critical to clients not only in reaching their outcome goals for discharge but also in maintaining outcomes beyond discharge.