Role of orthoses in ligament injuries of the knee]

OBJECTIVE: To review the literature for the benefits of the three different knee braces (prophylactic, rehabilitation, functional) that can be used to treat ligament injuries of the knee. What is their influence on stability? Do they have adverse effects? Is their use justified? METHODS: We searched the Medline and Embase databases with use of the keywords knee, orthoses, brace, proprioception, stability, rehabilitation, physical therapy, and anterior cruciate ligament for reports published between 1980 and 2003 and selected 93 articles, expert reports or literature reviews. RESULTS: Anterior tibial displacement can be controlled with mechanical strains (150 N), which are lower than physiological restraints? (400 N). The control of joint position is improved by increasing proprioception. Soft tissue stiffness influences the control of anterior tibial displacement. The beneficial effects observed are mainly subjective. Our analysis of the literature showed limitations and variations in study methodologies. CONCLUSION: We did not find any justification for use of either prophylactic or rehabilitation braces. Functional braces can improve stability, as reported by the patient, and may be used in some situations.     

Systematic review: general notions

Systematic review is a useful methodology in health, as it makes it possible to identify the best evidence and sumamrize them so as to found proposals for changes in the areas of prevention, diagnosis, treatment and rehabilitation. The purpose of this article is to provide support for planning systematic reviews by answering the following questions: What is evidence-based practice? What is systematic review? Should systematic reviews be anchored on qualitative or quantitative research? What are the pertinent information sources to identify the evidence? What is evidence? What are the procedures to validate a systematic review? How can the quality of evidence be evaluated? What methodology is used to summarize the evidence? How should a systematic review be planned?     

Benefits, barriers, sources of influence, and prostate cancer screening among rural men

ABSTRACT Objective: The objective of this study was to explore 3 research questions: (1) What are the perceived benefits of screening for prostate cancer (PC)? (2) What are the perceived barriers to screening for PC? and (3) Is there an association with perceived benefits or perceived barriers and participants' reported source of influence related to prostate cancer screening (PCS) decisions? Design and Sample: A nonexperimental exploratory design was used for the study. Sample included 94 rural‐dwelling male participants aged 40 and older. Measures: The instruments used included an adapted version of Champion's (1999) revised Health Belief Model scale and a researcher‐developed demographic and PCS patterns form. Results: Both benefits and barriers were significantly associated with PCS and sources of influence. Health care providers and family were highly reported, at 81.8% and 59.5%, respectively, as sources of influence regarding PCS decisions. Conclusions: In this primarily African American sample, significant barriers to PCS among rural men were indentifed. PC health education may need to include family, whom study participants highly reported as a source of influence regarding their PCS decisions.     

True or false: all genes are rhythmic

Multiple microarray studies have documented the importance of circadian regulation of gene expression in different species under many experimental conditions. However, these reports often differ with respect to the identity and total number of oscillating genes. This review explores the interrelated questions of: How many genes are oscillating within individual tissues or systems? What are the forces that drive these oscillations? What are the methodological sources contributing to the discrepancy between estimates of gene oscillation? And finally, what are the physiological and systemic implications of oscillatory gene expression with respect to circadian molecular biology? Since this remains an evolving area of investigation, this hypothetical and speculative review also highlights the potential limitations faced by the current data in the literature relating to the novel paradigm(s) proposed.     

Reflective Action—Strategies for Solving Client-Nurse Partnerships in Primary Care

In this grounded theory study, which addressed the research question, ‘What strategies do nurses use to form client-nurse partnerships,’ a variety of data sources were used. The first data set consisted of participant observation, and reports of focus groups formed as part of the ‘First International Conference on Nursing Theory and Primary Health Care’ at Massey University, New Zealand which was attended by an international group of 80 nurses in 1990. As an adjunct to the formal presentations, members of the focus groups addressed four questions: a) Is a nurse-client partnership viable in primary care? b) What do you plan to do to promote this partnership? c) What do you think others should do? and d) What is the next step? Reports from these focus groups, pooled with questionnaires (n = 17) and informal interviews completed this data set. The central process that described participants' perceptions of the viability of nurse-client partnerships was named reflective action. Ethical questions arose and were placed along a continuum of viability. A second data set consisted of interviews with, and selected literature by, Canadian nurses on partnerships in primary care. The perceptions of this international study group are seen as adding to our knowledge of barriers to nurse-client partnerships in primary care, and strategies for transcending these barriers.     

Physical health problems after single trauma exposure: when stress takes root in the body

Research has established that chronic stress, including traumatic events, leads to adverse health outcomes. The literature has primarily used two approaches: examining the effect of acute stress in a laboratory setting and examining the link between chronic stress and negative health outcomes. However, the potential health impact of a single or acute traumatic event is less clear. The goal of this literature review is to extend the literature linking both chronic trauma exposure and posttraumatic stress disorder to adverse health outcomes by examining current literature suggesting that a single trauma may also have negative consequences for physical health. The authors review studies on health, including cardiovascular, immune, gastrointestinal, neurohormonal, and musculoskeletal outcomes; describe potential pathways through which single, acute trauma exposure could adversely affect health; and consider research and clinical implications.     

Adverse drug events and the Freedom of Information Act: an apple in Eden.

OBJECTIVE: To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. DATA SOURCE: Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports. DATA SYNTHESIS: The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions. CONCLUSIONS: The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.     

Quadrivalent human papillomavirus (HPV) vaccine: a review of safety, efficacy, and pharmacoeconomics

What is known and background: The introduction of vaccines has lead to a significant reduction in morbidity and mortality from diseases such as measles, rubella and poliomyelitis, as well as the eradication of smallpox (Ertl HC, Xiang Z (1996) The Journal of Immunology, 156 , 3579–3582). A recent vaccine approved by the Food and Drug Administration (FDA) is the recombinant quadrivalent human papillomavirus (HPV) vaccine (Merck, Gardasil®). Concerns raised with this preventive measure include safety and efficacy issues as well as the financial implications. Furthermore, the use of the vaccine in women outside the currently approved age ranges and in adolescent boys and men has also been a source of debate. Objective: A review of two licensed HPV vaccines (Gardasil, Merck and Cervarix, GalxoSmithKline) in the light of these issues. Methods: Literature searches were conducted using the MEDLINE (1966 – December 2008) and PubMed databases in addition to the Centers for Disease Control and Prevention website. Bibliographies of selected references were also evaluated for relevant articles. Published guidelines and press releases were utilized as were the manufacturer’s package inserts. The collection of information for this review was limited to the most recently available human data. Results and discussion: The HPV quadrivalent vaccine has been effective in the management of HPV by preventing vaccine subtype‐related persistent infection and precancerous lesions as evidenced by numerous clinical trials. It is also regarded as a generally safe and well‐tolerated vaccine, based on an assessment of reported adverse events submitted through governmental databases and analyzed by independent researchers. The majority of adverse events were non‐serious and the vaccine has not been conclusively implicated with serious events. The FDA continues to focus on routine post‐marketing surveillance monitoring of reported adverse events. The bivalent vaccine has also been shown to be effective in reported trials. Its adverse effect profile also appears acceptable. What is new and conclusion: The HPV vaccines appear safe and effective. Additional clinical research on the vaccines on women outside the currently approved age ranges and in males is necessary. Studies on longer‐term outcomes, including cervical cancer and the emergence of new viral genotypes are also necessary.     

Preliminary tests of an ecological model of Hispanic farmworker health

ABSTRACT Objective: The purpose of this study was to propose and test an ecological model to structure research and practice concerning farmworker health in the United States. The research question was, “What is the relationship of selected social, cultural, and economic indicators to the health of adult Hispanic migrant farmworkers?” Design: A model of biogenetic, social, cultural, economic, individual response, and access factors affecting health was derived from the literature and nursing practice. Data from the 1998 National Agricultural Workers Survey (NAWS), conducted by the U.S. Department of Labor, were used in a secondary analysis to perform preliminary tests of the relationships proposed in the model. Sample: The NAWS conducts interviews with a nationally representative sample of farmworkers employed in the United States. Because of the importance of theorized cultural factors, the sample for this study was limited to farmworkers who identified themselves as Hispanic, resulting in 1,864 subjects. Measurements: Variables were used directly from the data or constructed from the available data, and proposed relationships were tested statistically. Results: Analysis of the data supported the relationships proposed in the model. Conclusions: The proposed model is a useful tool for organizing variables and giving direction to farmworker health research. Suggestions for future research are made.     

Do medical inpatients who report poor service quality experience more adverse events and medical errors?

PURPOSE: Service quality deficiencies are common in health care. However, little is known about the relationship between service quality and the occurrence of adverse events and medical errors. We hypothesized that patients who reported poor service quality were at increased risk of experiencing adverse events and medical errors. SUBJECTS AND METHODS: Patients were interviewed during and after their admissions regarding problems experienced during the hospitalizations. We used this information to identify service quality deficiencies. We then performed a blinded, retrospective chart review to independently identify adverse events and errors. We used multivariable methods to analyze whether patients who reported service quality deficiencies (obtained by patient report) experienced any adverse event, close call, or low risk error (ascertained by chart review). RESULTS: The 228 participants (mean age 63 years, 37% male) reported 183 service quality deficiencies. Of the 52 incidents identified on chart review, patients experienced 34 adverse events, 11 close calls, and 7 low risk errors. The presence of any service quality deficiency more than doubled the odds of any adverse event, close call, or low risk error (adjusted odds ratio = 2.5; 95% confidence interval = 1.2-5.4). Service quality deficiencies involving poor coordination of care (adjusted odds ratio = 4.4; 95% confidence interval = 1.4-14.0) were associated with the occurrence of adverse events and medical errors. CONCLUSIONS: Patient-reported service quality deficiencies were associated with adverse events and medical errors. Patients who report service quality incidents may help to identify patient safety hazards.     

Music therapy assessment in school settings: a preliminary investigation

The present investigation was undertaken in response to music therapists working in school settings for information relating to the availability of music therapy assessments and the feasibility of standardizing an assessment instrument for music therapists to use in school settings. Five research questions were identified, and the music therapy literature was surveyed to compile responses to those questions. Three different online data bases (ERIC, PsycINFO, and Article 1st) were used, covering articles published between 1980 and 1997. Individual hand searches were done of the Arts in Psychotherapy, Journal of Music Therapy, Journal of Research in Music Education, Journal of the International Association of Music for the Handicapped, Music Therapy and Music Therapy Perspectives. The questions and responses were as follows: 1. Which music-based assessment tools are being used with children with disabilities? Little commonality in assessment tools being used by music therapists and researchers was discovered. Of the total 41 studies, 20 (49%) reported using a "named" or "titled" assessment tool, and in the remaining 51% of studies, the authors reported using an untitled, and usually experimenter-designed, original assessment tool. 2. Have certain assessments been used in more than one study? Very limited replication of existing assessments was found. Of the 16 "named" assessments, only 3 were found to be used in more than one research study. 3. Are the actual assessments published along with the articles describing their use? Only 3 of the 20 studies using named assessments were published along with the journal article. Of the remaining 21 studies using original, experimenter-designed assessment tools, only 6 (28%) had the assessment instrument published with the article. 4. What is the primary purpose for using the assessment? Six primary purposes emerged from the review of the literature: to compare with data obtained from other assessment measures or from other populations (39%), as a baseline or pretest measure (29%), to determine eligibility for services or the receipt of treatment (12%), to determine the psychometric properties of the assessment (7%), suitability of the instrument for the given population (7%), and the identification of musical preferences (5%). 5. What are the musical or nonmusic elements being assessed? Musical elements were: music perception (37%), musical aptitude (29%), musical preferences (12%), and attention to/enjoyment of music (2%). Nonmusical behaviors/responses were: self-expression (10%), motor responses (10%), behavioral responses (7%), cognitive development (2%), and acts of communication (2%). 6. What subject populations are being assessed? Subject populations were: children with developmental disabilities/mental retardation (44%), children with autism (10%), children with hearing impairments (17%), "psychiatric" clients or emotionally disturbed (22%), individuals described as "handicapped" (5%), individuals with physical disabilities (2%), and a student with a speech impairment (2%). Nondisabled individuals were also included in 12 of the aforementioned studies.     

Interpretation of drug risk and benefit: individual and population perspectives

OBJECTIVE: To provide pharmacists with the necessary nomenclature and tools to interpret the medical literature on drug risks and benefits. DATA SOURCES: Primary articles were identified by MEDLINE search (1990-December 2003) and through secondary sources. STUDY SELECTION AND DATA EXTRACTION: All of the articles identified from the data sources were evaluated, and all information from secondary sources deemed relevant was included. DATA SYNTHESIS: Articles in the primary and secondary literature were reviewed. The articles show that measurement of drug risks and benefits is consistently reported with similar terminology. However, the interpretation and subsequent balancing of risks and benefits can be difficult. CONCLUSIONS: All drugs have concomitant risks and benefits. The medical literature documents those risks and benefits and it is this medical evidence that is typically used to make drug therapy decisions. Pharmacists who either manage individual patients or populations of patients (pharmacy benefit managers) may interpret this medical evidence more clearly by understanding the implications of various statistical methods used in studies.     

Efficacy and adverse events of subcutaneous, oral, and intranasal sumatriptan used for migraine treatment: a systematic review based on number needed to treat

Objectives : To evaluate the efficacy, speed of onset, and adverse events of 6 mg subcutaneous, 100 mg oral, and 20 mg intranasal sumatriptan in the treatment of migraine attacks. Design : Systematic review of placebo-controlled randomized clinical trials. Data sources : Thirty trials up to April 1997 retrieved from a systematic literature search (Medline, review papers, handsearching of journals, congress proceedings, manufacturer's database); no restriction on language. Outcome parameters : Numbers needed to treat (NNT) were calculated for relief of headache and for adverse events (when data were available). Therapeutic gain was used to evaluate speed of onset of action. Results : Subcutaneous sumatriptan was more efficacious, combined number needed to treat 2.0 at 1 h, than oral (3.0 at 2 h) and intranasal sumatriptan (3.1 at 2 h). For adverse events, the NNT was 3.0 for subcutaneous and 8.3 for oral sumatriptan. Only limited data on adverse events for intranasal sumatriptan were available. Therapeutic gain analysis during the first 2 h showed that subcutaneous sumatriptan was the fastest-acting form of administration. Conclusions : Subcutaneous sumatriptan in a dose of 6 mg is significantly more efficacious than 100 mg of oral sumatriptan, but causes more adverse events than oral sumatriptan. Subcutaneous sumatriptan is the form with the quickest onset of action. Intranasal sumatriptan has the same efficacy as oral sumatriptan and a quicker onset of action than the oral form, but with a limited therapeutic effect for the first 30 min after administration.     

Adverse events induced by ceftriaxone: a 10-year review of reported cases to Iranian Pharmacovigilance Centre

What is known and Objectives: Ceftriaxone, a third‐generation cephalosporin antibiotic, is used for a vast variety of infectious diseases. Different types of adverse reactions are reported to be induced by ceftriaxone; however, there is limited published information on spontaneous adverse reactions collected by a national pharmacovigilance centre. This study was conducted to evaluate ceftriaxone‐induced adverse drug events, registered in the Iranian pharmacovigilance database during a 10‐year period, and to identify preventive measures for reducing ceftriaxone‐induced adverse events. Method: All adverse events registered in the Iranian pharmacovigilance database from 1998 through 2009 were screened for ceftriaxone‐related adverse events. The extracted data were categorized based on patients’ demographics and previous history of allergic reactions to antibiotics. Assessment of system–organ classes, seriousness and causality of reactions was performed according to World Health Organization scale. The preventability was analysed based on Schumock questionnaire. Results and Discussion: Ceftriaxone was responsible for the highest number of deaths in our database (49 cases). Of 20 877 reports, 1205 (5·8%) were related to ceftriaxone; 357 reports (30%) are categorized as serious including cardiac arrest, anaphylactic and anaphylactoid reactions. The high number of serious cases makes it necessary to develop preventive measures for reducing those adverse events. Unlabelled use of the drug (2·9%) is identified as one of the risk factors for adverse events. Evaluation of the 1030 intravenous injections of the drug shows that rapid intravenous injection of ceftriaxone is another risk factor. One hundred and sixteen patients (9·6%) had a previous history of allergic reaction to ceftriaxone, penicillin or both. We recommend an alternative antibiotic, if possible, in the case of a positive history of allergic reaction to cephalosporins, penicillins and/or other beta‐lactam antibiotics. What is new and Conclusion: Severe and life‐threatening adverse reactions induced by ceftriaxone are of great concern. Rapid intravenous injection, unlabelled use and previous patient history of allergic reactions to cephalosporins or penicillins are risk factors that should be guarded against.     

A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002

This study updates a previous analysis of trends in medical use and abuse of opioid analgesics, and provides data from 1997 through 2002. Two research questions were evaluated: 1) What are the trends in the medical use and abuse of frequently prescribed opioid analgesics used to treat severe pain, including fentanyl, hydromorphone, meperidine, morphine, and oxycodone? 2) What is the abuse trend for opioid analgesics as a class compared to trends in the abuse of other drug classes? Results demonstrated marked increases in medical use and abuse of four of the five studied opioid analgesics. In 2002, opioid analgesics accounted for 9.85% of all drug abuse, up from 5.75% in 1997. Increase in medical use of opioids is a general indicator of progress in providing pain relief. Increases in abuse of opioids is a growing public health problem and should be addressed by identifying the causes and sources of diversion, without interfering with legitimate medical practice and patient care.     

Review article: Leaving the emergency department without being seen

Patients who leave the ED without being seen (LWBS) are unlikely to be satisfied with the quality of the service provided and might be at risk from conditions that have not been assessed or treated. We therefore examined the available research literature to inform the following questions: (i) In patients who attend for ED care, what factors are associated with the decision to LWBS? (ii) In patients who attend for ED care, are there adverse health outcomes associated with the decision to LWBS? (iii) Which interventions have been used to try to reduce the number of patients who attend for ED care and LWBS? From the available literature, there was insufficient evidence to draw firm conclusions; however, the literature does suggest that patients who LWBS have conditions of lower urgency and lower acuity, are more likely to be male and younger, and are likely to identify prolonged waiting times as a central concern. LWBS patients generally have very low rates of subsequent admission, and reports of serious adverse events are rare. Many LWBS patients go on to seek alternative medical attention, and they might have higher rates of ongoing symptoms at follow‐up. Further research is recommended to include comprehensive cohort or well‐designed case–control studies. These studies should assess a wide range of related factors, including patient, hospital and other relevant factors. They should compare outcomes for groups of LWBS patients with those who wait and should include cross‐sectoral data mapping to truly detect re‐attendance and admission rates.     

Identifying and aligning expectations in a mentoring relationship

The mentoring relationship between a scholar and their primary mentor is a core feature of research training. Anecdotal evidence suggests this relationship is adversely affected when scholar and mentor expectations are not aligned. We examined three questions: (1) What is the value in assuring that the expectations of scholars and mentors are mutually identified and aligned? (2) What types of programmatic interventions facilitate this process? (3) What types of expectations are important to identify and align? We addressed these questions through a systematic literature review, focus group interviews of mentors and scholars, a survey of Clinical and Translational Science Award (CTSA) KL2 program directors, and review of formal programmatic mechanisms used by KL2 programs. We found broad support for the importance of identifying and aligning the expectations of scholars and mentors and evidence that mentoring contracts, agreements, and training programs facilitate this process. These tools focus on aligning expectations with respect to the scholar's research, education, professional development and career advancement as well as support, communication, and personal conduct and interpersonal relations. Research is needed to assess test the efficacy of formal alignment activities.     

Safety Considerations for Cerebellar Theta Burst Stimulation

PurposeThe cerebellum is an intricate neural structure that orchestrates various cognitive and behavioral functions. In recent years, there has been an increasing interest in neuromodulation of the cerebellum with transcranial magnetic stimulation (TMS) for therapeutic and basic science applications. Theta burst stimulation (TBS) is an efficient and powerful TMS protocol that is able to induce longer-lasting effects with shorter stimulation times compared with traditional TMS. Parameters for cerebellar TBS are traditionally framed in the bounds of TBS to the cerebral cortex, even when the 2 have distinct histologic, anatomical, and functional characteristics. Tolerability limits have not been systematically explored in the literature for this specific application. Therefore, we aimed to determine the stimulation parameters that have been used for cerebellar.TBS to date and evaluate adverse events and adverse effects related to stimulation parameters.MethodsWe used PubMed to perform a critical review of the literature based on a systematic review of original research studies published between September 2008 and November 2019 that reported on cerebellar TBS. We recovered information from these publications and communication with authors about the stimulation parameters used and the occurrence of adverse events.FindingsWe identified 61 research articles on interventions of TBS to the cerebellum. These articles described 3176 active sessions of cerebellar TBS in 1203 individuals, including healthy participants and patients with various neurologic conditions, including brain injuries. Some studies used substantial doses (eg, pulse intensity and number of pulses) in short periods. No serious adverse events were reported. The specific number of patients who experienced adverse events was established for 48 studies. The risk of an adverse event in this population (n = 885) was 4.1%. Adverse events consisted mostly of discomfort attributable to involuntary muscle contractions. Authors used a variety of methods for calculating stimulation dosages, ranging from the long-established reference of electromyography of a hand muscle to techniques that atone for some of the differences between cerebrum and cerebellum.ImplicationsNo serious adverse events have been reported for cerebellar TBS. There is no substantial evidence of a tolerable maximal-efficacy stimulation dose in humans. There is no assurance of equivalence in the translation of cortical excitability and stimulation intensities from the cerebral cortex to cerebellar regions. Further research for the stimulation dose in cerebellar TBS is warranted, along with consistent report of adverse events. © 2020 Elsevier HS Journals, Inc.