Strong Evidence-based Medicine Research Articles

How does the role of complementary and alternative medicine in general practice differ between countries? Interviews with doctors who have worked both in Germany and elsewhere in Europe

BackgroundAvailable data suggest that general practitioners (GPs) in Germany use complementary and alternative medicine (CAM) modalities more frequently than GPs in many other countries. We investigated the country differences perceived by general practitioners who have worked in Germany and in one of four other European countries with regard to the role of complementary and alternative treatments in primary care.MethodsIn this qualitative study we conducted semi-structured interviews with 12 GPs who had worked both in Germany and Italy, the Netherlands, Norway or the United Kingdom (UK; n = 3 for each of the four countries). Participants were asked how they perceived and experienced country differences regarding health system, relevance of CAM modalities, the role of evidence-based medicine (EBM) and science, and how they handle so-called indeterminate situations. For the analysis, we followed a thematic analysis approach according to Braun and Clarke with focus on themes that cover CAM.ResultsParticipants unanimously reported that they perceived CAM to be more relevant in general practice in Germany compared to the other countries. We identified four overarching themes in relation to the perceived reasons for these differences. Firstly, physicians with experiences in countries with a strong EBM and science orientation (Netherlands, Norway and the UK) considered the deeply ingrained view in national healthcare systems and GP communities that CAM modalities are not evidence-based as the main reason for the lower use of CAM by GPs. Secondly, extensive training of communication skills was cited as a reason that reduced the need for CAM in the Netherlands, Norway and the UK. Thirdly, differences in patient expectations and demands were perceived as a factor contributing to greater utilisation of CAM by German GPs compared to the other countries. Finally, country-specific reimbursement mechanisms were considered as a factor influencing the role of CAM in general practice.ConclusionsThe study results point to major differences between countries with regard to the role of CAM in GP care. Differences in basic attitudes in the discipline of general practice, patient expectations and system conditions appear to play an important role here.

Evidence-Based Medicine Culture, Curriculum, and Program Outcomes: A CERA Study.

Limited faculty development is a barrier to advancing evidence-based medicine (EBM) education. This study sought to describe program director perception of EBM culture in family medicine residency training and to assess the association among structured faculty roles, EBM curricula, and specific resident outcomes including publications in EBM. Members of the Society of Teachers of Family Medicine EBM collaborative drafted survey questions based on a literature review. The questions were electronically distributed in May 2023 to all US family medicine residency program directors who had not previously opted out by the Council of Academic Family Medicine Educational Research Alliance within its study of family medicine program directors. We analyzed results using descriptive and comparative statistics. The overall response rate was 44.7% (309/691). We found that 260/281 (92%) of program directors reported an EBM curriculum of some kind, and 253/281 (90%) of program directors agreed/strongly agreed that EBM was accepted by residents. Of the respondents, 72/281 (25.6%) reported that no specific faculty member was responsible for their EBM curriculum. Most program directors reported that less than 50% of residents will leave their programs with the ability to detect an error in original research (23.8%; 67/281), detect an important omission in an UpToDate article (16%; 45/281), or author a narrative review for American Family Physician (10%; 28/281). Program directors reported strong acceptance of EBM among residents and a high prevalence of a formal curriculum. However, many lacked a specific faculty lead, and few reported that residents had strong EBM skills. This study identified gaps in residency training to support future EBM-skilled family physicians as well as concerns about pathways for the development of future EBM faculty.

Professional judgement in clinical practice (part 3): A better alternative to strong evidence-based medicine.

Parts 1 and 2 in this series of three articles have shown that and how strong evidence-based medicine has neither a coherent theoretical foundation nor creditable application to clinical practice. Because of its core commitment to the discredited positivist tradition it holds both a false concept of scientific knowledge and misunderstandings concerning clinical decision-making. Strong EBM continues attempts to use flawed adjustments to recover from the unsalvageable base view. Paper three argues that a promising solution is at hand if we can manage several modes of inclusion. A modified original, moderate version of EBM continues though usually overshadowed. As definitively laid out by Sackett in the 1990s, clinical decision making is intended to be person-centered, recognizing and integrating multiple modes of evidence and knowledge that have been marginalized: professional experience, illness narratives, and individual patients' values and preferences. Complementary resources are at hand: interpretative understanding and practice, such as philosophical anthropology, hermeneutical phenomenology, complexity theory, and phronetic practices respond to the major problems and open new possibilities. Phronesis is especially important in regard to public decision making. Within part 3 an additional tone necessarily occurs. While most of papers 1, 2, and 3 are written in the classical mode of contrasting the theoretical-logical and empirical evidence offered by contending positions bearing on the decision making and judgement in clinical practice, a shift occurs when considerations move beyond what is possible for clinical practitioners to accomplish. A different, discontinuous level of power operates in the trans-personal realm of instrumental policy, insurance, and hospital management practices. In this social-economic-political-ethical realm what happens in clinical practice today increasingly becomes a matter of what is "done unto" clinical practitioners, of what hampers their professional action and thus care of individual patients and clients.

Professional judgement in clinical practice (part 2): knowledge into practice.

Though strong evidence-based medicine is assertive in its claims, an insufficient theoretical basis and patchwork of arguments provide a good case that rather than introducing a new paradigm, EBM is resisting a shift to actually revolutionary complexity theory and other emergent approaches. This refusal to pass beyond discredited positivism is manifest in strong EBM's unsuccessful attempts to continually modify its already inadequate previous modifications, as did the defenders of the Ptolemaic astronomical model who increased the number of circular epicycles until the entire epicycle-deferent system proved untenable. Narrative Review. The analysis in Part 1 of this three part series showed epistemological confusion as strong EBM plays the discredited positivistic tradition out to the end, thus repeating in a medical sphere and vocabulary the major assumptions and inadequacies that have appeared in the trajectory of modern science. Paper 2 in this series examines application, attending to strong EBM's claim of direct transferability of EBM research findings to clinical settings and its assertion of epistemological normativity. EBM's contention that it provides the "only valid" approach to knowledge and action is questioned by analyzing the troubled story of proposed hierarchies of the quality of research findings (especially of RCTs, with other factors marginalized), which falsely identifies evaluating findings with operationally utilizing them in clinical recommendations and decision-making. Further, its claim of carrying over its normative guidelines to cover the ethical responsibilities of researchers and clinicians is questioned.

Reference Intervals of the Ratio of Urine Iodine to Creatinine in Pregnant Women in an Iodine-Replete Area of China.

The assessment method of iodine nutrition for pregnant women lacks strong evidence-based medicine. The prevalence of iodine deficiency in pregnant women may be overestimated using urinary iodine concentration (UIC). The reference intervals of UIC-to-urinary creatinine concentration ratio (UIC/UCr) were established using a self-sequential longitudinal study of pregnant women with singleton gestation who were recruited using the criteria of the National Academy of Clinical Biochemistry in Dandong City, which is a long-term iodine-replete area. Nine thousand one hundred sixty-four pregnant women in the first trimester from Dalian City, Dandong City, and Shenyang City were included to verify our proposed reference intervals. UIC and concentrations of urinary creatinine, serum iodine, TSH, FT4, TPOAb, and TgAb were measured. The reference intervals of UIC/UCr were 38.63-489.46μg/g for the first trimester, 58.48-644.03μg/g for the second trimester, and 56.27-644.93μg/g for the third trimester. The prevalence of iodine deficiency was 49.50% using UIC as the indicator (< 150μg/L), while the prevalence was 3.28% using UIC/UCr (< 38.63μg/g). The prevalence of iodine excess was 3.21% using UIC as the indicator (> 500μg/L) while the prevalence was 1.45% using UIC/UCr (> 489.46μg/g). The highest prevalence of overt hypothyroidism and positive thyroid antibodies was in the group with UIC/UCr < 38.63μg/g. In contrast to the place of residence and age, BMI was an influencing factor for UIC/UCr. The reference intervals of UIC/UCr were established. UIC/UCr may eliminate the effect of urine volume and reflect the actual prevalence of iodine deficiency in pregnant women.

Outcomes after bariatric surgery according to large databases: a systematic review.

The rapid development of technological tools to record data allows storage of enormous datasets, often termed "big data". In the USA, three large databases have been developed to store data regarding surgical outcomes: the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), the Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample (NIS) and the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). We aimed to evaluate the clinical impact of studies found in these databases concerning outcomes of bariatric surgery. We performed a systematic review using the Meta-analysis of Observational Studies in Epidemiology guidelines. Research carried out using the PubMed database identified 362 papers. All outcomes related to bariatric surgery were analysed. Fifty-four studies, published between 2005 and February 2017, were included. These articles were divided into (1) outcomes related to surgical techniques (12 articles), (2) morbidity and mortality (12), (3) 30-day hospital readmission (10), (4) outcomes related to specific diseases (11), (5) training (2) and (6) socio-economic and ethnic observations in bariatric surgery (7). Forty-two papers were based on data from ACS-NSQIP, nine on data from NIS and three on data from MBSAQIP. This review provides an overview of surgical management and outcomes of bariatric surgery in the USA. Large databases offer useful complementary information that could be considered external validation when strong evidence-based medicine data are lacking. They also allow us to evaluate infrequent situations for which randomized control trials are not feasible and add specific information that can complement the quality of surgical knowledge.

Cerebral small vessel disease and Alzheimer's disease.

Cerebral small vessel disease (CSVD) is a group of pathological processes with multifarious etiology and pathogenesis that are involved into the small arteries, arterioles, venules, and capillaries of the brain. CSVD mainly contains lacunar infarct or lacunar stroke, leukoaraiosis, Binswanger’s disease, and cerebral microbleeds. CSVD is an important cerebral microvascular pathogenesis as it is the cause of 20% of strokes worldwide and the most common cause of cognitive impairment and dementia, including vascular dementia and Alzheimer’s disease (AD). It has been well identified that CSVD contributes to the occurrence of AD. It seems that the treatment and prevention for cerebrovascular diseases with statins have such a role in the same function for AD. So far, there is no strong evidence-based medicine to support the idea, although increasing basic studies supported the fact that the treatment and prevention for cerebrovascular diseases will benefit AD. Furthermore, there is still lack of evidence in clinical application involved in specific drugs to benefit both AD and CSVD.

Controversies in Pediatric Perioperative Airways.

Pediatric airway management is a challenge in routine anesthesia practice. Any airway-related complication due to improper procedure can have catastrophic consequences in pediatric patients. The authors reviewed the current relevant literature using the following data bases: Google Scholar, PubMed, Medline (OVID SP), and Dynamed, and the following keywords: Airway/s, Children, Pediatric, Difficult Airways, and Controversies. From a summary of the data, we identified several controversies: difficult airway prediction, difficult airway management, cuffed versus uncuffed endotracheal tubes for securing pediatric airways, rapid sequence induction (RSI), laryngeal mask versus endotracheal tube, and extubation timing. The data show that pediatric anesthesia practice in perioperative airway management is currently lacking the strong evidence-based medicine (EBM) data that is available for adult subpopulations. A number of procedural steps in airway management are derived only from adult populations. However, the objective is the same irrespective of patient age: proper securing of the airway and oxygenation of the patient.

Sublingual Immunotherapy for Respiratory Allergy

Sublingual allergen immunotherapy (SLIT) is a new alternative for the treatment of respiratory allergy. Strong evidence-based medicine data on clinical efficacy and safety about SLIT support the new standardised products register in Europe and the US. SLIT-tablets significantly reduce nasal and ocular symptoms scores, reduce the use of relief medication and improves quality of life in both adults and children with pollen respiratory allergy. New data support its efficacy and safety for house dust mites (HDM) respiratory allergy.

Prioritization of Evidence-Based Indications for Intravenous Immunoglobulin

Prioritization of Evidence-Based Indications for Intravenous Immunoglobulin

Recurrent miscarriage and thrombophilia

Acquired and inherited thrombophilia is an important research avenue in the recurrent miscarriage field. The optimum treatment for patients with recurrent miscarriage and a confirmed thrombophilia remains a contentious issue. We aim to appraise and explore the latest research in the field of thrombophilia and recurrent miscarriage in this review. Antiphospholipid syndrome (APS) is the only proven thrombophilia that is associated with adverse pregnancy outcomes. Research involving inherited thrombophilia and recurrent miscarriage is limited to small observational studies with small and heterogeneous populations. Aspirin and heparin therapy are frequently prescribed for APS, yet there is no robust evidence for the most efficacious regime. The combination of inherited hypercoagulability and environmental factors in association with recurrent miscarriage has recently been explored as an aid to identify high-risk individuals. The cause of recurrent miscarriage is multifactorial and appropriate treatment continues to be a challenge. Laboratory tests need to be standardized and well designed multicentre research trials are essential to expand on the current knowledge base with the aim to produce strong evidence-based medicine.

Critical analysis of the laryngopharyngeal reflux literature

We read with interest the article by Kotby et al. [1] which highlights some of the weaknesses of the laryngopharyngeal reXux (LPR) literature. I am referring to their comment on posterior commissure and in particular that “there is no posterior commissure”. The existence of the posterior commissure of the human larynx has been disputed since the 1980s as shown in the work of Hirano et al. [2]. More recently though, Tucker et al. [3] in their embryo-anatomical study concluded that “the posterior end of the glottis is a wall, the cricoid cartilage; the posterior median cricoid cartilage is also the developmental anatomical site of union of the cricoid cartilage and the posterior commissure. It is a relevant, deWnitive, anatomical site, as is the anterior commissure and does not vary with vocal fold mobility”. We agree with the rest of the comments, especially on empiric antacid trials. “Empiric”—from the greek word “empeiriki”—means “from experience”. The evaluation of any medical outcome that relies on empiric treatment and not on accurate diagnostic methods is bound to be Xawed and is—if we want to adhere to evidence based medicine (EBM) terminology—one of the lowest forms of evidence. For years gastroenterologists were talking about the silent manifestations of gastroesophageal reXux (GORD) and in the last 15 years the laryngologists have literally “taken over” the literature writing about LPR and its implication in head and neck symptoms that cannot be otherwise explained. Pepsin has been found in the middle ear and in the larynx and even sinusitis has been linked to reXux [4]. Some classic animal studies have proven with robust methodology the link between acid injury and laryngeal pathology [5]. Nevertheless, physicians have spent years trying to Wnd an ideal test for diagnosing “upper neck” reXux and the norm for interpretation of pH in the proximal oesophagus has never been universally agreed upon. The acid throat family has always included multifactorial symptoms and anything that responds to antacids may equally respond to other treatments. A typical example of empiric treatment based on poor evidence and a well-established worldwide practice over the last 30 years was the attempts to treat globus pharyngeus patients—a classic component of many well-accepted and widely used reXux indexes—with expensive and potent antacids [6]. Globus was never proven to be an “acid phenomenon” [7] and yet the vast majority of family physicians and specialists would often prescribe antacids. If one looks at the literature, there are numerous randomised trials and even more uncontrolled studies on antacids for LPR. Level I evidence though is lacking and those few positive studies are based either on poor methods or on diagnostic criteria that use empiric treatment and symptom/sign questionnaires as main methods for LPR diagnosis. One cannot aVord to be critical of course, as dual probe prolonged pH metry—once thought a gold standard test—is far from a ideal diagnostic tool. In the last few years and following two systematic reviews [8, 9] and a Cochrane metaanalysis [10] of randomised controlled trials (RCTs), it was evident that something is not “right” in the empiric treatment of reXux. Is it the dose, the length of treatment, the sometimes non-acidic nature of reXux or perhaps the timing of PPI dosage? Are we even using the right drugs? No one knows for sure. Comparing placebo to a drug is strong EBM only if you have an equally strong, highly speciWc and sensitive diagnostic tool for the condition you are testing. And at the moment we not only lack this, but also many of the laryngologists do not agree on how to interpret a laryngeal picture of “reXux laryngitis”; even experienced laryngologists often score diVerently “an angry looking larynx”. P. D. Karkos (&) Royal Liverpool University Hospital, 36 Hopkinsons Court, Walls Avenue, Chester CH1 4LN, UK e-mail: pkarkos@aol.com