Evaluation Of Clinical Guidelines Research Articles

Telemedicine applied to neuromuscular disorders: focus on the COVID-19 pandemic era.

Neuromuscular diseases are rare and usually chronic progressive disorders that require a multidisciplinary clinical evaluation and functional monitoring. The patient-physician relationship and therapies are also key elements to be provided. The COVID-19 pandemic dramatically changed the way patients' health was managed and national health care services underwent a radical reorganization. Telemedicine, with the use of Information and Communication Technology (ICT) by health professionals, became the main strategy to ensure the continuation of care. However, the experience regarding the use of Telemedicine in neuromuscular disorders is very limited and the scientific literature is extremely scarce. From the first experiences in the '50s, the development of Telemedicine has been supplemented and supported by the implementation of ICT to guarantee the secure and effective transmission of medical data. Italian national guidelines (2010-2020) describe the technical and professional guarantees necessary to provide Telemedicine services. Nevertheless, at the time the pandemic appeared, no guidelines for clinical evaluation or for the administration of functional scales remotely were available for neuromuscular diseases. This has been a critical point when clinical evaluations were mandatory also for the renewal of drug prescriptions. However, the common opinion that telemedicine basic services were important to overcome the change in medical practice due to COVID-19 in neuromuscular diseases, even in pediatric age, emerged. Moreover, alternative digital modalities to evaluate patients at home in a kind of virtual clinic were considered as a field of future development.

Comparison of adult defendants' forensic psychiatric evaluation in criminal courts between Mainland China and Taiwan China: From law to clinical practice

The defendant's mental capacity is often crucial in criminal procedure, and an expert witness may be requested to conduct a forensic psychiatric evaluation. This paper analyzes the law and clinical practice of adult defendants' forensic psychiatric evaluation in criminal courts between Mainland China and Taiwan China. Results indicated that the law in Taiwan China explicitly mentioned more mental illness and mental capacity than the law in Mainland China regarding forensic psychiatric evaluation. Concerning expert witnesses, Mainland China has established a registration and management system, but in Taiwan China, the judge decides the expert witness's admissibility. Furthermore, clinical evaluation guidelines have been promulgated in Mainland China, while none in Taiwan China. Implications of the findings were discussed.

Etiopathological and hematobiochemical profiles in goats with gastrointestinal disorders

Background and AimGastrointestinal (GI) disorders in small ruminants limit production efficiency and productivity growth in the livestock sector, thereby directly preventing farmers from augmenting their income. This study aimed to provide detailed insight into the etiology, hematobiochemical parameters, and epidemiological risk factors of GI disorders in goats and to determine the pathology associated with the disorders.Materials and MethodsOver the period of 2018-2019, 500 goats in and around Bhubaneswar, Odisha, India, were screened for GI disorders based on clinical signs. Blood samples from the control (n=10) and treatment (n=25) groups were collected for both hematological and serum biochemical alterations. Fecal examinations (n=220) were conducted for parasitic, bacterial, and virological assessments. Detailed necropsy and histopathological evaluations were conducted on 27 goats.ResultsThe GI disorder prevalence rate and mortality rate among the 500 goats analyzed were 44.4% and 12.27%, respectively. Chi-square analysis showed a significantly higher occurrence of GI disorders among the goats that were between 6 months and 1.5 years old (58.72%), were of the Ganjam breed (45.49%), had a poor body condition (71.11%), and were housed with an earthen floor (55.22%). The most common etiological risk factor observed was parasitic infection (65.45%), followed by bacterial (18.18%) and mixed infection (9.54%). Blood analysis showed neutrophilia and eosinophilia in infected goats, in addition to anemia; significant decreases in total protein, globulin, albumin, and glucose levels; and significant increases in aspartate transaminase and alanine aminotransferase levels. The major histopathological findings were infiltration of mononuclear cells and desquamation of the intestinal and ruminal mucosa.ConclusionStakeholders should focus not only on parasitic infections and other important etiological risk factors for GI disorders in goats but also on proper farming management practices to help enhance the income of farmers. The hematobiochemical alterations and pathomorphological changes reported in this study can be used by field veterinarians as guidelines for clinical evaluation and disease severity assessment.

Clinical features and outcomes for nonabscess cellulitis in hospitalized pediatric patients

To the Editor: Cellulitis is a skin infection that can present with purulence, defined by generation of pus often as drainage or pustules. Purulent cellulitis can further be distinguished by the formation of a cutaneous abscess, a walled accumulation of pus within the subcutaneous space that requires surgical management.1 Guidelines for clinical evaluation and management are limited especially for children.1-4 This study assesses the characteristics of inpatient pediatric cellulitis without abscess.

Guidelines for clinical evaluation of chronic kidney disease

Guidelines for clinical evaluation of chronic kidney disease

Development of Novel Pharmaceutical Agents for Alzheimer’s Disease: The Impact of Regulatory Initiatives in Japan and the United States

PurposeThe incidence of Alzheimer’s disease (AD) has been steadily increasing worldwide. AD is a serious disease that has both societal and economic impacts. The greatest risk factor for AD is aging. Thus, because of the rapidly aging population in Japan, the development of new, effective drugs for AD is urgently needed. The goal of the present article was to analyze the status, clarify the problems, and discuss the scientific and political challenges of disease-modifying drug development for AD. MethodsPublic data, official documents, literature, and news releases were surveyed and discussed. FindingsCompared with diabetes mellitus drugs, there is a lack of quantitative surrogate end points among AD drugs. Much AD drug development has focused on amyloid-β and its associated pathways; however, these drugs have not shown efficacy in Phase III clinical trials. Thus, the US Food and Drug Administration has appealed for a new draft industrial guidance for the development of AD drugs, including those for early-stage AD. In Japan, the Minister of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency have also taken action, including the publication of potential new guidelines for clinical evaluation and development of new AD therapeutics, including drugs. Moreover, scientific initiatives to develop novel AD drugs are ongoing. ImplicationsThe development of quantitative surrogate end points remains necessary to improve the development of AD drugs. Therefore, collaboration among industry, government, and academia should be encouraged. Following the principles of regulatory science, strategies to develop drugs for illnesses with unmet needs can be framed by investigating the effects of past, current, and future AD drug development initiatives.

Research methods for formal consensus development.

This paper reviews three research methods for developing consensus. Consensus statements and guidelines are increasingly used to clarify and standardise practice, and inform health policy, when relevant and rigorous evidence is lacking. Clinicians need to evaluate the quality of practice guidelines to determine whether to incorporate them into clinical practice or reject them. Formal methods of developing consensus provide a scientific method that uses expert panel members to evaluate current evidence and expert opinions to produce consensus statements for clinical problems. Online search for relevant literature was conducted in Medline and CINAHL. A literature review of consensus, consensus development and research methods papers published in English in peer-reviewed journals. The three methods of developing consensus discussed are the Delphi technique, nominal group technique and the consensus development conference. The techniques and their respective advantages are described, and examples from the literature are provided. The three methods are compared and a flowchart to assist researchers selecting an appropriate method is included. Online resources with information on the development and evaluation of clinical guidelines are reviewed. This paper will help researchers to select an appropriate research method for developing consensus statements and guidelines. When developing consensus guidelines for clinical practice, researchers should use a formal research method to ensure rigour and credibility.

Evaluation of Clinical Guidelines in Psychiatry

Evaluation of Clinical Guidelines in Psychiatry

Declining Rates of Osteoporosis Management Following Fragility Fractures in the U.S., 2000 Through 2009

Clinical practice recommendations state that patients with fragility fractures should be evaluated for osteoporosis and treated for the disease if it is present. The purpose of this study was to assess osteoporosis evaluation and treatment patterns for patients with fragility fractures and assess whether anti-osteoporosis pharmacotherapy initiated immediately following a fragility fracture is associated with improved adherence to the treatment protocol. This retrospective cohort study involved data from a large commercially insured population seen in the period from 2001 through 2009. Patients were community-dwelling individuals aged fifty years or older who had a new low-energy fracture at the hip, vertebra, wrist, or humerus with no evidence of a fragility fracture, osteoporosis treatment, malignant disease, or Paget disease for twelve months preceding the fracture. Rates of diagnostic testing and pharmacotherapy for osteoporosis within twelve months post-fracture were evaluated. Patients treated with oral bisphosphonates were evaluated to determine whether twelve-month adherence to the treatment protocol differed between those who had initiated therapy sooner (at zero to ninety days) and those who initiated it later (at ninety-one to 365 days) following the fracture. The 88,571 women and 41,984 men had an average age of 72.3 years and 70.5 years, respectively. Nineteen percent (16,464) of the women and 10% (4014) of the men initiated osteoporosis pharmacotherapy, and 30% (26,481) of the women and 15% (6427) of the men underwent diagnostic testing and/or pharmacotherapy following fracture. Treatment rates were highest following vertebral fracture and lowest following wrist or humeral fracture. Treatment rates significantly decreased over time (from 2001 through 2009). The average twelve-month adherence (medication possession ratio) was 56% and 61% among women and men, respectively. Adherence was similar between patients who had initiated treatment sooner after the fracture and those who had initiated it later after the fracture. Clinical guidelines for evaluation and treatment following fragility fracture were met for less than one-third of women and less than one-sixth of men. While primary fracture prevention remains the ideal, secondary prevention is critical and there is a need to reverse the downward trend in adherence to post-fracture guidelines.

Evaluation of clinical guidelines for contracted (frozen) shoulder 12–18 months after publication

Background/aim: To obtain an early indication of the dissemination of evidence-based physiotherapy guidelines for contracted (frozen) shoulder and to explore how the guidelines’ recommendations correspond with practice. Methods: The authors monitored downloads of the guidelines for the 18 months after publication. This study also used a self-administered, anonymous online questionnaire survey, which targeted UK-based physiotherapists who had accessed the guidelines by 12–18 months after publication. The survey's questions required ‘yes’ or ‘no’ responses and ‘yes’ responses activated questions asking whether practice had changed. With ethics clearance, and following piloting, the survey was advertised electronically. Analysis was by frequency counts. Results: There were 6 185 de-replicated UK downloads of the guidelines, most via the Chartered Society of Physiotherapy website. There were 366 survey responses. The median correspondence between the guidelines’ recommendations and practice was 66%, mostly reflecting validation of practice, but some change of practice. Notably among the diagnosis and assessment recommendations, passive external rotation was widely used as a pathognomonic test (75%). The proposed pain-predominant/stiffness-predominant classification was widely adopted (66%), and 88% of those who asked their patients said those patients found this terminology meaningful. Only 34% of responders reported using validated outcome measures. Correspondence of practice with the guidelines’ treatment recommendations was high for out-patient physiotherapy and injection but low for shortwave diathermy. Conclusion: The wide distribution and survey results suggest that the guidelines’ development was worthwhile. There were some areas of poor implementation of the guidelines’ recommendations, explicable by known obstacles; however, the findings provide a timely indication of where supplementary efforts should be targeted, e.g. using validated outcome measures.

Current Issues Regarding ASCO Guideline Implementation

Current Issues Regarding ASCO Guideline Implementation

A quantitative assessment of a methodology for collaborative specification and evaluation of clinical guidelines

We introduce a three-phase, nine-step methodology for specification of clinical guidelines (GLs) by expert physicians, clinical editors, and knowledge engineers and for quantitative evaluation of the specification’s quality. We applied this methodology to a particular framework for incremental GL structuring (mark-up) and to GLs in three clinical domains. A gold-standard mark-up was created, including 196 plans and subplans, and 326 instances of ontological knowledge roles (KRs). A completeness measure of the acquired knowledge revealed that 97% of the plans and 91% of the KR instances of the GLs were recreated by the clinical editors. A correctness measure often revealed high variability within clinical editor pairs structuring each GL, but for all GLs and clinical editors the specification quality was significantly higher than random ( p < 0.01). Procedural KRs were more difficult to mark-up than declarative KRs. We conclude that given an ontology-specific consensus, clinical editors with mark-up training can structure GL knowledge with high completeness, whereas the main demand for correct structuring is training in the ontology’s semantics.

Functional Gallbladder and Sphincter of Oddi Disorders

The functional disorder of the gallbladder (GB) is a motility disorder caused initially either by metabolic abnormalities or by a primary motility alteration. The functional disorders of the sphincter of Oddi (SO) encompass motor abnormalities of either the biliary or the pancreatic SO. Dysfunction of the GB and/or biliary SO produce similar patterns of pain. The pain caused by a dysfunction of the pancreatic SO can be similar to that of acute pancreatitis. The symptom-based diagnostic criteria of motility dysfunction of the GB and biliary SO are episodes of moderate to severe steady pain located in the epigastrium and right upper abdominal quadrant that last at least 30 minutes. GB motility disorder is suspected after gallstones and other structural abnormalities have been excluded. This diagnosis should then be confirmed by a decreased GB ejection fraction induced by cholecystokinin at cholescintigraphy and after disappearance of the recurrent biliary pain after cholecystectomy. Symptoms of biliary SO dysfunction may be accompanied by features of transient biliary obstruction, and those of pancreatic SO dysfunction are associated with elevation of pancreatic enzymes and even pancreatitis. Biliary-type SO dysfunction is more frequently recognized in postcholecystectomy patients. SO manometry is valuable to select patients with sphincter dysfunction; however, because of the high incidence of complications, these patients should be referred to an expert unit for such assessment. Thus invasive tests should be performed only in the presence of compelling clinical evidence and after noninvasive testing has yielded negative findings. The committee recommends that division of the biliary or pancreatic sphincters only be considered when the patient has severe symptoms, meets the required criteria, and other diagnoses are excluded.

Choice of control group in efficacy-showing clinical trials in Japan: does the ICH-E10 guideline change conventions?

Clinical trials that aim to establish efficacy in the target population need to have an adequate control group. Although scientific principles for efficacy evaluation apply universally, actual choices of control in each region seem to be unique, reflecting differences in regional guidelines for clinical evaluation, preferences of the population, and constraints in study environments.

Goiter and nodular thyroid disease: clinical guidelines for diagnosis and treatment. (Waiting? Hormone therapy? Surgery? radioiodine?)

Nodular thyroid disease is a common problem. We present clinical guidelines for the management of patients with thyroid nodules, multinodular goiters and thyroid cysts for use by primary physicians. In the initial evaluation ultrasonography of the thyroid and fine-needle aspiration biopsy (FNAB) is recommended. FNAB has become the cornerstone in the evaluation of solitary thyroid nodules, cysts and dominant nodules within multinodular goiters. If the procedure is done properly, it should have a false-negative rate of less than 5% and a false-positive rate of not more than 1%. Thyroid radionuclide scans are less frequently used in the initial evaluation of a nodular goiter. Surgery is the primary therapy for patients with nodular thyroid disease. Other available treatment options are radioiodine and TSH-suppression with thyroxine. The main indications for surgery in euthyroid patients with thyroid nodule or with nontoxic multinodular goiter are recently documented or suspected malignancy, compression of the trachea and esophagus, significant growth of the nodule, recurrence of a cyst after aspiration, neck discomfort and cosmetic concern.

Assessing the impact of clinical guidelines: research lessons learned.

Clinical guidelines are proliferating. Here, a theoretical and practical perspective is presented on how to evaluate the effectiveness of guidelines and lessons learned from impact studies conducted. A nosology of guidelines is presented, along with the rationale for evaluating key dimensions, including degree of implementation, impact on process, outcomes, and cost of care, as well as provider and patient satisfaction. Key methodologic problems in evaluation and some possible ways to address them are addressed. Rapid and practical evaluation of clinical guidelines is a critical step that can both confirm their usefulness and direct their revision and improvement.

Use of clinical practice guidelines in managed care physician groups.

There is increasing interest in the use of clinical guidelines as a tool to improve the quality and cost-effectiveness of health care. Yet, relatively little data are available regarding the use of guidelines by health care provider organizations. We developed a written descriptive survey investigating the development, implementation, and evaluation of clinical guidelines that was administered to medical directors or their designees from physician medical groups and independent practice associations. Eighty-seven percent of physician organizations were reported to be developing or implementing clinical guidelines. The reasons most often cited for developing clinical guidelines were quality improvement and cost containment. Local expert opinion or judgment was rated as the most important influence in the development of clinical guidelines, followed by medical and scientific literature and externally developed guidelines. Feedback of information was the most popular method of increasing compliance with clinical guidelines, although 19% of physician organizations reported imposing sanctions on physicians who did not use guidelines. Most of the physician organizations surveyed have embraced clinical guidelines. Local development or adaptation of clinical guidelines may be common. There has been disproportionately little attention paid to guideline implementation and to evaluation of guideline effects relative to their development.

Effect of Clinical Guidelines on Medical Practice

Although interest in clinical guidelines has never been greater, uncertainty persists about whether they are effective. The debate has been hampered by the lack of a rigorous overview. We have identified 59 published evaluations of clinical guidelines that met defined criteria for scientific rigour; 24 investigated guidelines for specific clinical conditions, 27 studied preventive care, and 8 looked at guidelines for prescribing or for support services. All but 4 of these studies detected significant improvements in the process of care after the introduction of guidelines and all but 2 of the 11 studies that assessed the outcome of care reported significant improvements. We conclude that explicit guidelines do improve clinical practice, when introduced in the context of rigorous evaluations. However, the size of the improvements in performance varied considerably.

Scientific and methodological issues in quality assurance

SynopsisThe framework for this chapter stems from the proposal that the basic steps of the quality cycle should be combined with the practical stages of the scientific method to form an extended quality cycle comprising nine steps. The scientific and methodological implications of each step are considered in turn. The discussion of the three steps relating to the development, dissemination and implementation of clinical standards is based on a recent review of rigorous evaluations of clinical guidelines. The discussion of the three steps relating to the comparison of clinical performance with agreed standards is based on the existing principles of medical research. The final step is concerned with the management of change. The chapter ends by applying the steps of the extended quality cycle to the topic of thrombolytic therapy after acute myocardial infarction. The resulting hypothetical quality assurance exercise appears simple and potentially very effective. We conclude that, if quality assurance is pursued with a combination of scientific rigour, imagination and persistence, it has the potential to bring substantial benefits to patients and health professionals.

The Path to New FDA Guidelines for Clinical Evaluation of Anti-Infective Drugs

This article describes the current collaborative effort of the U.S. Food and Drug Administration and the Infectious Diseases Society of America to generate new general and disease/organism-specific guidelines for the evaluation of anti-infective agents. The description includes examples of proposed changes from draft documents. If approved and implemented, the envisioned changes should enable investigators and sponsors to improve the quality of clinical trials of anti-infective drugs. The ultimate goal is to provide physicians with the best information about new drugs and thus to enhance the care of patients with infectious diseases.