Guideline Development Process Research Articles

Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology.

To update the 2016 American Academy of Neurology (AAN) practice advisory for patients with stroke and patent foramen ovale (PFO). The guideline panel followed the AAN 2017 guideline development process to systematically review studies published through December 2017 and formulate recommendations. In patients being considered for PFO closure, clinicians should ensure that an appropriately thorough evaluation has been performed to rule out alternative mechanisms of stroke (level B). In patients with a higher risk alternative mechanism of stroke identified, clinicians should not routinely recommend PFO closure (level B). Clinicians should counsel patients that having a PFO is common; that it occurs in about 1 in 4 adults in the general population; that it is difficult to determine with certainty whether their PFO caused their stroke; and that PFO closure probably reduces recurrent stroke risk in select patients (level B). In patients younger than 60 years with a PFO and embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (absolute recurrent stroke risk reduction of 3.4% at 5 years) and risks (periprocedural complication rate of 3.9% and increased absolute rate of non-periprocedural atrial fibrillation of 0.33% per year) (level C). In patients who opt to receive medical therapy alone without PFO closure, clinicians may recommend an antiplatelet medication such as aspirin or anticoagulation (level C).

The methodology for developing nursing clinical practice guidelines over recent decades in China: A critical appraisal using AGREE II.

To appraise the quality of current nursing clinical practice guidelines (N-CPGs) in China and explore the methodology for N-CPGs development. Implementation of quality improvement projects based on N-CPGs has becoming an hot topic for nursing with proliferation in the number of N-CPGs in China in recent years. The methodology for developing N-CPGs is worthy of exploration. A systematic literature search was performed using PubMed, CINAHL, Web of Science, CNKI, Wanfang, VIP and CBM and relevant representative guidelines repositories from inception to July 31, 2019. Two authors independently selected eligible guidelines and performed data extraction. Four appraisers independently assessed the quality of the N-CPGs using the AGREE II tool. 20 N-CPGs were eventually included in this review. After AGREE II appraisal, the final domain scores ranged between 0.00 and 83.33%. When comparing the total domain scores, "Scope and purpose" and "Clarity of presentation" scored highest with a total of 63.89 (59.37-69.79) (%, median, interquartile range (IQR)), and 63.89 (58.33-75.70) (%), respectively. "Editorial independence" obtained the lowest ranking with a total score of 0 (0-81.25) (%). The total scores of "Stakeholder involvement", "Rigour of development", "applicability" and "editorial independence" were lower than 50%. The quality of N-CPGs in China is not very high and the process of guideline development still needs to improve. N-CPGs are important documents used to guide nursing quality improvement. High quality N-CPGs are beneficial for nursing management.

Strengthening prehospital clinical practice guideline implementation in South Africa: a qualitative case study

BackgroundMethods on developing new (de novo) clinical practice guidelines (CPGs) have received substantial attention. However, research into alternative methods of CPG development using existing CPG documents (CPG adaptation) — a specific issue for guideline development groups in low- and middle-income countries — is sparse. There are only a few examples showcasing the pragmatic application of such alternative approaches in settings with time and budget constraints, especially in the prehospital setting. This paper aims to describe and strengthen the methods of developing prehospital CPGs using alternative guideline development methods through a case study design.MethodsWe qualitatively explored a CPG development project conducted in 2016 for prehospital providers in South Africa as a case study. Key stakeholders, involved in various processes of the guideline project, were purposefully sampled. Data were collected from one focus group and six in-depth interviews and analysed using thematic analysis. Overarching themes and sub-themes were inductively developed and categorised as challenges and recommendations and further transformed into action points.ResultsKey challenges revolved around guideline implementation as opposed to development. These included the unavoidable effect of interest and beliefs on implementing recommendations, the local evidence void, a shifting implementation context, and opposing end-user needs. Guideline development and implementation strengthening priority actions included: i) developing a national end-user document; ii) aligning recommendations with local practice; iii) communicating a clear and consistent message; iv) addressing controversial recommendations; v) managing the impact of interests, beliefs and intellectual conflicts; and vi) transparently reporting implementation decisions.ConclusionThe cornerstone of a successful guideline development process is the translation and implementation of CPG recommendations into clinical practice. We highlight key priority actions for prehospital guideline development teams with limited resources to strengthen guideline development, dissemination, and implementation by drawing from lessons learnt from a prehospital guideline project conducted in South Africa.

British Thoracic Society guideline for the use of long-term macrolides in adults with respiratory disease

The full British Thoracic Society (BTS) guideline for the use of long-term macrolides in adults with respiratory disease is published in Thorax. The following is a summary of the recommendations...

Public health physician perspectives on developing and deploying clinical practice guidelines during the 2009 H1N1 pandemic.

During the H1N1 outbreak of 2009, local public health units engaged in consultations with various levels of government to develop clinical practice guidelines. These guidelines provide specific clinical considerations around prevention, management, and treatment associated with the particular pathogen involved and are used by frontline healthcare professionals across many healthcare settings. In this article, we report on the lessons learned by Medical Officers of Health from across Canada on the guideline development and deployment processes and provide suggestions to improve guidelines development and deployment during future pandemic situations.

Quality evaluation recommendation list and interpretation of traditional Chinese medicine clinical practice guidelines

Based on the idea of establishing a complete guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believes that a complete guideline evaluation system of traditional Chinese medicine clinical practice should be divided into three parts: quality evaluation, clinical applicability evaluation and clinical application investigation. According to the different purposes, different evaluators, different evaluation methods and different evaluation time points in the guideline evaluation, the quality evaluation recommendation list, the clinical applicability evaluation recommendation list and the clinical application questionnaire were formed. Among them, the purpose of quality evaluation is to evaluate the methodological quality in the guideline development process, in order to measure whether the entire guideline development process is scientifically rigorous. The evaluators must be the methodologists with an evidence-based medicine background. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. By referring to the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM by considering the characteristics of TCM field. In this paper, the author introduces the whole list of quality evaluation recommendations, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation.

The 2020 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation is intended to assist health care professionals worldwide who evaluate and manage potential candidates for deceased or living donor kidney transplantation. This guideline addresses general candidacy issues such as access to transplantation, patient demographic and health status factors, and immunological and psychosocial assessment. The roles of various risk factors and comorbid conditions governing an individual's suitability for transplantation such as adherence, tobacco use, diabetes, obesity, perioperative issues, causes of kidney failure, infections, malignancy, pulmonary disease, cardiac and peripheral arterial disease, neurologic disease, gastrointestinal and liver disease, hematologic disease, and bone and mineral disorder are also addressed. This guideline provides recommendations for evaluation of individual aspects of a candidate's profile such that each risk factor and comorbidity are considered separately. The goal is to assist the clinical team to assimilate all data relevant to an individual, consider this within their local health context, and make an overall judgment on candidacy for transplantation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. Guideline recommendations are primarily based on systematic reviews of relevant studies and our assessment of the quality of that evidence, and the strengths of recommendations are provided. Limitations of the evidence are discussed with differences from previous guidelines noted and suggestions for future research are also provided.

British Thoracic Society guideline for the use of long-term macrolides in adults with respiratory disease

The full British Thoracic Society (BTS) guideline for the use of long-term macrolides in adults with respiratory disease is published in Thorax. The following is a summary of the recommendations...

Summary of the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation.

The 2020 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation is intended to assist health care professionals worldwide who evaluate and manage potential candidates for deceased or living donor kidney transplantation. This guideline addresses general candidacy issues such as access to transplantation, patient demographic and health status factors, immunological and psychosocial assessment. The roles of various risk factors and comorbid conditions governing an individual’s suitability for transplantation such as adherence, tobacco use, diabetes, obesity, perioperative issues, causes of kidney failure, infections, malignancy, pulmonary disease, cardiac and peripheral arterial disease, neurologic disease, gastrointestinal and liver disease, hematologic disease, and bone and mineral disorder are also addressed. This guideline provides recommendations for evaluation of individual aspects of a candidate’s profile such that each risk factor and comorbidity are considered separately. The goal is to assist the clinical team to assimilate all data relevant to an individual, consider this within their local health context, and make an overall judgment on candidacy for transplantation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. Guideline recommendations are primarily based on systematic reviews of relevant studies and our assessment of the quality of that evidence. The strengths of recommendations are provided in the full report. Limitations of the evidence are discussed with differences from previous guidelines noted and suggestions for future research are also provided.

Introduction and methods of the evidence-based guidelines for the diagnosis and management of autism spectrum disorder by the Italian National Institute of Health

BackgroundAutism Spectrum Disorder (ASD) is a neuro-developmental disorder that affects communication and behavior with a prevalence of approximately 1% worldwide. Health outcomes of interventions for ASD are largely Participant Reported Outcomes (PROs). Specific guidelines can help support the best care for people with ASD to optimize these health outcomes but they have to adhere to standards for their development to be trustworthy.ObjectiveThe goal of this article is to describe the new methodological standards of the Italian National Institute of Health and novel aspects of this guideline development process. This article will serve as a reference standard for future guideline development in the Italian setting.MethodsWe applied the new standards of the Italian National Institute of Health to the two guidelines on diagnosis and management of children/adolescents and adults with ASD, with a focus on the scoping, panel composition, management of conflict of interest, generation and prioritization of research questions, early stakeholders’ involvement, and PROs. Recommendations are based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence-to-Decision frameworks.ResultsFollowing a public application process, the ISS established two multidisciplinary panels including people with ASD and/or their caregivers. Seventy-nine research questions were identified as potentially relevant for the guideline on children and adolescents with ASD and 31 for the one on adults with ASD. Questions deemed to have the highest priority were selected for inclusion in the guidelines. Other stakeholders valued their early involvement in the process which will largely focus on PROs. The panels then successfully piloted the development of recommendations using the methodological standards and process set by the ISS with a focus on PROs.ConclusionsIn this article, we describe the development of practice guidelines that focus on PROs for the diagnosis and management of ASD based on novel methods for question prioritization and stakeholder involvement. The recommendations allow for the adoption or adaptation to international settings.

Prioritising gender, equity, and human rights in a GRADE-based framework to inform future research on self care for sexual and reproductive health and rights

IntroductionIn January 2019, the WHO reviewed evidence to develop global recommendations on self-care interventions for sexual and reproductive health and rights (SRHR). Identification of research gaps is part of the...

Approval processes in evidence-based clinical practice guidelines sponsored by medical specialty societies.

ObjectiveTo determine the approval processes for evidence-based Clinical Practice Guidelines sponsored by medical specialty societies in the United States.Study design and settingCross-sectional analysis of published Clinical Practice Guidelines and Guideline procedure manuals, sponsored by the 43 members of the Council of Medical Specialty Societies in the United States. Approval processes were measured by written evidence in the specialty society’s guideline procedure manual or published guidelines, through May 2017.ResultsAmong the 36 (of 43) specialty societies that published evidence-based Clinical Practice Guidelines, 27 (75%) required approval by a committee representing the society as a whole. None specified the criteria used for approval decisions. Six specialty societies (17%) required approval but included procedures to maintain some editorial independence for the guideline development group, such as approval by a guideline committee not an executive committee or approval dependent on fidelity to established guideline methodology, not content. One society required Board review, but not approval. The approval process was not reported by 2 (6%) of the specialty societies.ConclusionsMost medical specialty societies in the U.S. require approval of guidelines by a board that represents the society as whole. Since medical specialty societies have loyalties to the patients they serve and to their physician members, and because the interests of those two groups may differ, such an approval process introduces a potential conflict of interest into the guideline development process.

Practice guideline: Treatment for insomnia and disrupted sleep behavior in children and adolescents with autism spectrum disorder: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology.

To review pharmacologic and nonpharmacologic strategies for treating sleep disturbances in children and adolescents with autism spectrum disorder (ASD) and to develop recommendations for addressing sleep disturbance in this population. The guideline panel followed the American Academy of Neurology 2011 guideline development process, as amended. The systematic review included studies through December 2017. Recommendations were based on evidence, related evidence, principles of care, and inferences. For children and adolescents with ASD and sleep disturbance, clinicians should assess for medications and coexisting conditions that could contribute to the sleep disturbance and should address identified issues. Clinicians should counsel parents regarding strategies for improved sleep habits with behavioral strategies as a first-line treatment approach for sleep disturbance either alone or in combination with pharmacologic or nutraceutical approaches. Clinicians should offer melatonin if behavioral strategies have not been helpful and contributing coexisting conditions and use of concomitant medications have been addressed, starting with a low dose. Clinicians should recommend using pharmaceutical-grade melatonin if available. Clinicians should counsel children, adolescents, and parents regarding potential adverse effects of melatonin use and the lack of long-term safety data. Clinicians should counsel that there is currently no evidence to support the routine use of weighted blankets or specialized mattress technology for improving disrupted sleep. If asked about weighted blankets, clinicians should counsel that the trial reported no serious adverse events with blanket use and that blankets could be a reasonable nonpharmacologic approach for some individuals.

Quality of chronic pain interventional treatment guidelines from pain societies: Assessment with the AGREE II instrument.

Procedures to relieve pain are performed frequently but there are concerns about patient selection, appropriate image guidance, frequency and training for physicians. Patients, healthcare providers, policymakers and licensing bodies seek evidence-based recommendations to use these interventions judiciously. In this review we appraised the methodological quality of recent clinical practice guidelines (CPGs) for interventional pain procedures. A systematic search of the medical literature was performed. Three trained appraisers independently evaluated the methodological quality of the CPGs using a validated instrument, the Appraisal of Guidelines in Research and Evaluation II (AGREE II). Six domains were considered: 1) score and purpose; 2) stakeholder involvement; 3) rigour of development; 4) clarity of presentation; 5) applicability and 6) editorial independence. A total of 23 items were scored. CPGs were deemed 'high quality' if a mean scaled score above 60% for rigour of development and for two other domains was obtained. Mean scaled domain quality scores ranged from 61.72% to 69.99%. Despite being based on modest levels of evidence, two of the four included CPGs were considered to be of high methodological quality. The AGREE II scores across the four guidelines exhibited good inter-rater reliability. None of the guidelines involved key stakeholders such as patients, other healthcare providers, and payers. All four CPGs were limited by a weak execution of the guideline development process. There is a need to develop methodologically sound evidence-based guidelines for the use of interventional pain procedures using a rigorous process that involves all relevant stakeholders. This systematic review appraises the methodological quality of existing CPGs on interventional procedures using a validated epidemiological tool (AGREE II). The aims of this review were to identify methodological and knowledge gaps in existing CPGs. Findings of this study will help in development of a high-quality CPG that can assist healthcare providers and patients in making informed decisions while ensuring that the right intervention is performed for the right patient at the right time. The quality of the evidence provided by the CPGs provided in support of their recommendations was also evaluated.

Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children.

To develop evidence-based recommendations for clinicians caring for children (including infants, school-aged children, and adolescents) with septic shock and other sepsis-associated organ dysfunction. A panel of 49 international experts, representing 12 international organizations, as well as three methodologists and three public members was convened. Panel members assembled at key international meetings (for those panel members attending the conference), and a stand-alone meeting was held for all panel members in November 2018. A formal conflict-of-interest policy was developed at the onset of the process and enforced throughout. Teleconferences and electronic-based discussion among the chairs, co-chairs, methodologists, and group heads, as well as within subgroups, served as an integral part of the guideline development process. The panel consisted of six subgroups: recognition and management of infection, hemodynamics and resuscitation, ventilation, endocrine and metabolic therapies, adjunctive therapies, and research priorities. We conducted a systematic review for each Population, Intervention, Control, and Outcomes question to identify the best available evidence, statistically summarized the evidence, and then assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. We used the evidence-to-decision framework to formulate recommendations as strong or weak, or as a best practice statement. In addition, "in our practice" statements were included when evidence was inconclusive to issue a recommendation, but the panel felt that some guidance based on practice patterns may be appropriate. The panel provided 77 statements on the management and resuscitation of children with septic shock and other sepsis-associated organ dysfunction. Overall, six were strong recommendations, 52 were weak recommendations, and nine were best-practice statements. For 13 questions, no recommendations could be made; but, for 10 of these, "in our practice" statements were provided. In addition, 49 research priorities were identified. A large cohort of international experts was able to achieve consensus regarding many recommendations for the best care of children with sepsis, acknowledging that most aspects of care had relatively low quality of evidence resulting in the frequent issuance of weak recommendations. Despite this challenge, these recommendations regarding the management of children with septic shock and other sepsis-associated organ dysfunction provide a foundation for consistent care to improve outcomes and inform future research.

Considerations for Rice (Oryzasativa) Fortification with Essential Micronutrients in Public Health Intervention

Background and Rationale: Fortification of staple foods and commonly used condiments with vitamins and minerals has been considered one of the most cost-effective interventions to prevent and control micronutrient deficiencies. Because of its wide local consumption, acceptability, reach, and quantum of consumption, rice (Oryzasativa) far exceeds the requirements of a staple food vehicle that can be considered for fortification purposes at a population-level intervention. The World Health Organization (WHO) has the mandate to develop evidenceinformed guidelines for the fortification of staple foods as a public health intervention, including rice fortification with micronutrients. The WHO, in collaboration with the Global Alliance for Improved Nutrition (GAIN), convened a consultation on “Technical Considerations for Rice Fortification in Public Health” in Geneva, Switzerland in 2012 to provide technical inputs to the guideline development process, particularly with reference to feasibility and implementability.
 Conclusion: The industrial and regulatory technical considerations in rice fortification, as well as the considerations for implementing it as a public health strategy and assuring equitable access and universal coverage and priority research areas for the forthcoming years were reviewed in this article based on WHO consultation
 Bangladesh Journal of Medical Science Vol.19(2) 2020 p.189-193

Impact and use of reviews and ‘overviews of reviews’ to inform clinical practice guideline recommendations: protocol for a methods study

IntroductionGuidelines are systematically developed recommendations to assist practitioner and patient decisions about treatments for clinical conditions. High quality and comprehensive systematic reviews and ‘overviews of systematic reviews’ (overviews) represent the...

"It's Not Smooth Sailing": Bridging the Gap Between Methods and Content Expertise in Public Health Guideline Development.

Background: The development of reliable, high quality health-related guidelines depends on explicit and transparent processes, methods aimed at minimising risks of bias and the inclusion of all relevant expertise and perspectives. While the methodological aspects of guidelines have been a focus to improve their quality, less is known about the social processes involved, for example, how guideline group members interact and communicate with one another, and how the evidence is considered in informing recommendations. With this in in mind, we aimed to empirically examine the perspectives and experiences of the key participants involved in developing public health guidelines for the Australian National Health and Medical Research Council (NHMRC). Design: This study was conducted using constructivist grounded theory as described by Charmaz, which informed our sampling, data collection, coding and analysis of interviews with key participants involved in developing public health guidelines. Setting: Australian public health guidelines commissioned by the NHMRC. Participants: Twenty experts that were involved in Australian NHMRC public health guideline development, including working committee members with content topic expertise (n=16) and members of evidence review groups responsible for evaluating the evidence (n=4). Results: Public health guideline development in Australia is a divided process. The division is driven by 3 related factors: the divergent disciplinary background and expertise that each group brings to the process; the methodological limitations of the framework, inherited from clinical medicine, that is used to assess the evidence; and barriers to communication between content experts and evidence reviewers around respective roles and methodological limitations. Conclusion: Our findings suggest several improvements for a more functional and unified guideline development process: greater education of the working committee on the methodological process employed to evaluate evidence, improved communication on the role of the evidence review groups and better facilitation of the process so that the evidence review groups feel their contribution is valued.

Практические советы для медсестер по реализации клинических сестринских руководств - Оценка риска и профилактика сердечно-сосудистых заболеваний

The aim of the study: The evidence-based nursing clinical guidelines transform the best research evidence into recommendations for clinical practice. Majority of patients can be managed according to nursing clinical guidelines. In nursing clinical guideline implementation the nurse uses his/her own knowledge base and jurisdiction in the care of the patient. The nurse makes observations of the status of the patient and chooses the best nursing intervention included in the nursing clinical guideline to promote the condition of the patient. Methods. In the Republic of Kazakhstan, adaptation was chosen as a method how to develop nursing clinical guidelines. The Kazakhstani nursing clinical guideline “Risk estimation and prevention of cardiovascular diseases” contains recommendations for nursing professionals involved in screening risk factors and caring for patients with cardiovascular diseases. The guideline was originally developed by the Scottish Intercollegiate Guidelines Network. Results. Nurses need to make decisions concerning the care of cardiovascular patients: advice on treatment, patient information and education. The article contains evidence-based information of cardiovascular nursing care and recommendations for nursing professionals involved in screening risk factors and caring for patients with cardiovascular diseases. The main nursing intervention is motivational interview technique to establish a trustworthy relationship with the patient and trough controversial dialogue to support the patient towards healthier lifestyle and commitment to planned care. Conclusion. In addition, the article covers a short overview of nursing clinical guideline development process in the Republic of Kazakhstan, to ensure the common understanding of nursing clinical guideline development process and the role of nursing clinical guidelines in everyday nursing practice.

Development of an evidence-based clinical imaging diagnostic guideline for implant planning: Joint recommendations of the Korean Academy of Oral and Maxillofacial Radiology and National Evidence-based Healthcare Collaborating Agency.

PurposeThis study was conducted to develop an evidence-based clinical imaging diagnostic guideline for implant planning, taking into account efficacy, benefits, and risks.Materials and MethodsThe guideline development process employed the adaptation methodology used for Korean clinical imaging guidelines(K-CIG). Core databases(Ovid-Medline, Ovid-Embase, National Guideline Clearinghouse, Guideline International Network) and domestic databases (KoreaMed, KMbase, and KoMGI) were searched for guidelines. The retrieved articles were analyzed by 2 reviewers, and articles were selected using well-established inclusion criteria.ResultsThe search identified 294 articles, of which 3 were selected as relevant guidelines. Based on those 3 guidelines, 3 recommendations for implant planning were derived.ConclusionWe recommend radiography or cone-beam computed tomography (CBCT) scanning for individual patients judged to require a cross-sectional image after reading of a panoramic X-ray image and a conventional intraoral radiological image. Various steps should be taken to raise awareness of these recommendations among clinicians and the public, and K-CIG should be regularly reviewed and revised.