Traditional Chinese medicine for insomnia: Recommendation mapping of the global clinical guidelines.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese Medicine (TCM) represents a rich repository of empirically-developed traditional medicines. The findings call for more rigorous study into the efficacy, safety, and mechanisms of action of TCM remedies to strengthen the evidence base. AIM OF THE STUDY: To systematically review the quality of insomnia clinical practice guidelines that involve TCM recommendations and to summarize the certainty of evidence supporting the recommendations, strength, and consistency of recommendations, providing valuable research references for the development of future insomnia guidelines. MATERIALS AND METHODS: We systematically searched PubMed, Web of Science, Embase, CNKI, Wanfang, Chinese Biomedical Literature Database, Chinese Medical Association, Chinese Sleep Research Society, Medsci, Medlive, British National Institute of Health and Clinical Excellence (NICE), and the International Guidelines Collaboration Network (GIN) for clinical practice guidelines on insomnia from inception to March 5, 2023. Four evaluators conducted independent assessments of the quality of the guidelines by employing the AGREE II tool. Subsequently, the guideline recommendations were consolidated and presented as evidence maps. RESULTS: Thirteen clinical practice guidelines addressing insomnia, encompassing 211 recommendations (consisting of 127 evidence-based and 84 expert consensus recommendations), were deemed eligible for inclusion in our analysis. The evaluation results revealed an overall suboptimal quality, with the "scope and purpose" domain achieving the highest score (58.1%), while the "applicability" domain garnered the lowest score (13.0%). Specifically, it was observed that 74.8% (n = 95) of the evidence-based recommendations were supported by evidence of either very low or low certainty, in contrast to the expert consensus recommendations, which accounted for 61.9% (n = 52). We subsequently synthesized 44 recommendations into four evidence maps, focusing on proprietary Chinese medicines, Chinese medicine prescriptions, acupuncture, and massage, respectively. Notably, Chinese herbal remedies and acupuncture exhibited robust support, substantiated by high-certainty evidence, exemplified by interventions such as Xuefu Zhuyu decoction, spleen decoction, body acupuncture, and ear acupuncture, resulting in solid recommendations. Conversely, proprietary Chinese medicines needed more high-certainty evidence, predominantly yielding weak recommendations. As for other therapies, the level of certainty was predominantly categorized as low or very low. Recommendations about magnetic therapy, bathing, and fumigation relied primarily on expert consensus, needing more substantive clinical research evidence, consequently forming weak recommendations. Hot ironing and acupoint injection recommendations were weakly endorsed, primarily based on observational studies. Furthermore, interventions like qigong, gua sha, and moxibustion displayed a relatively limited number of clinical studies, necessitating further exploration to ascertain their efficacy. CONCLUSIONS: Our analysis revealed a need for substantial improvement in the quality of all the included guidelines related to insomnia. Notably, recommendations for Traditional Chinese Medicine (TCM) treatments predominantly rely on low-certainty evidence. This study represents a pioneering effort in the utilization of recommendation mapping to both present and identify existing gaps in the evidence landscape within TCM therapies, thus setting the stage for future research initiatives. The evidence supporting TCM therapy recommendations must be fortified to achieve a more substantial level of recommendation and higher certainty. Consequently, there exists a critical and pressing demand for high-quality clinical investigations dedicated to TCM, with a specific focus on ascertaining its long-term efficacy, safety, and potential side effects in the context of insomnia treatment. These endeavors are poised to establish a robust scientific foundation to inform the development of TCM therapy recommendations within the insomnia guidelines.

Clinical practice guidelines on nutrition management in head and neck cancer: a systematic quality appraisal using the Appraisal of Guidelines for Research and Evaluation 2nd edition instrument.

OBJECTIVE: Several guidelines have been produced for the management of nutrition in patients with head and neck cancer. However, no systematic evaluation of the quality of these guidelines has been performed to date. METHOD: A comprehensive search was conducted up to August 2020. The quality of guidelines was assessed by four independent reviewers using the Appraisal of Guidelines for Research and Evaluation, 2nd edition. RESULTS: Nine guidelines were assessed for critical evaluation. Only two guidelines were classified as 'high quality'. The 'scope and purpose' domain achieved the highest mean score (75.5 ± 17.0 per cent), and the lowest domain mean score was 'applicability' (37.6 ± 23.0 per cent). CONCLUSION: These findings highlight the variability in the methodological quality of guidelines for the management of nutrition in head and neck cancer. These results may help to improve the reporting of future guidelines and guide the selection for use in clinical practice.

Quantity and quality of complementary and alternative medicine recommendations in clinical practice guidelines for type 2 diabetes mellitus: A systematic review.

AIMS: Approximately 70% of Americans with diabetes have used complementary and alternative medicine (CAM) in the past year. Healthcare providers often receive minimal training on these therapies and subsequently rely on clinical practice guidelines (CPGs) to supplement their knowledge about the safe and effective use of CAM for the treatment/management of type 2 diabetes mellitus (T2DM). The purpose of this systematic review is to determine the quantity and assess the quality of CAM recommendations in CPGs for the treatment and/or management of T2DM. DATA SYNTHESIS: MEDLINE, EMBASE, and CINAHL were systematically searched from 2009 to 2020, in addition to the Guidelines International Network and the National Center for Complementary and Integrative Health websites. CPGs containing treatment and/or management recommendations for T2DM were eligible; those with CAM recommendations were quality-assessed with the AGREE II instrument twice, once for the overall CPG and once for the CAM sections. Twenty-seven CPGs were deemed eligible, of which 7 made CAM recommendations. Mean scaled domain percentages were (overall, CAM): scope and purpose (89.7%, 79.8%), clarity of presentation (85.7%, 48.4%), stakeholder involvement (67.9%, 28.2%), applicability (54.8%, 20.2%), rigour of development (49.7%, 35.7%), and editorial independence (44.1%, 44.1%). CONCLUSIONS: Quality varied within and across CPGs; domain scores across CAM sections generally scored lower than the overall CPG. Given that CAM therapies for T2DM are only represented in one-quarter of eligible CPGs and are of lower quality, a knowledge gap exists for healthcare providers who seek evidence-based information on this topic in order to effectively counsel inquiring patients.

Headache and migraine clinical practice guidelines: a systematic review and assessment of complementary and alternative medicine recommendations.

BACKGROUND: Globally, 3 billion people suffer from either migraine or tension-type headache disorder over their lifetime. Approximately 50% of American adults suffering from headache or migraine have used complementary and alternative medicine (CAM), however, the quality and quantity of recommendations associated with such therapies across clinical practice guidelines (CPGs) for the treatment and/or management of these conditions are unknown. The purpose of this study was to identify the quantity and assess the quality of such CAM recommendations. METHODS: MEDLINE, EMBASE and CINAHL were systematically searched from 2009 to April 2020; the Guidelines International Network and the National Center for Complementary and Integrative Health websites were also searched for eligible CPGs. CPGs were included if they provided any therapy recommendations. Eligible CPGs included those written for adult patients with headache and migraine; CPGs containing CAM recommendations were assessed twice for quality using the AGREE II instrument, once for the overall CPG and once for the CAM sections. RESULTS: Of 486 unique search results, 21 CPGs were eligible and quality assessed; fifteen CPGs mentioned CAM, of which 13 CPGs made CAM recommendations. The overall CPG assessment yielded higher scaled domain percentages than the CAM section across all domains. The results from highest to lowest were as follows (overall, CAM): clarity of presentation (66.7% vs. 50.0%), scope and purpose (63.9% vs. 61.1%), stakeholder involvement (22.2% vs. 13.9%), rigour of development (13.5% vs. 9.4%), applicability (6.3% vs. 0.0%), and editorial independence (0.0% vs. 0.0%). CONCLUSIONS: Of the eligible CPGs, the CAM sections were of lower quality compared to the overall recommendations across all domains of the AGREE II instrument. CPGs that scored well could serve as a framework for discussion between patients and healthcare professionals regarding use of CAM therapies in the context of headache and migraine.

Assessment of the Methods Used to Develop Vitamin D and Calcium Recommendations-A Systematic Review of Bone Health Guidelines.

BACKGROUND: There are numerous guidelines developed for bone health. Yet, it is unclear whether the differences in guideline development methods explain the variability in the recommendations for vitamin D and calcium intake. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess the methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. METHODS: We searched MEDLINE, EMBASE, CINAHL, and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxyvitamin D [25(OH)D] level, and sunlight exposure; assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) handbook for guideline development; and, identified types identified types of evidence underpinning the recommendations. RESULTS: we included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200~600-4000 IU/day) and 70% provided calcium (600-1200 mg/day) recommendations, 96% and 88% recommended vitamin D and calcium supplements, respectively, and 70% recommended a specific 25(OH)D concentration. On average, each guideline met 10 (95% CI: 9-12) of the total of 25 methodological criteria for guideline development recommended by the WHO Handbook. There was uncertainty in the association between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, including previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, and perspectives/editorials were used to underpin the recommendations. CONCLUSIONS: There is considerable variability in vitamin D and calcium recommendations and in guideline development methods in bone health guidelines. Effort is required to strengthen the methodological rigor of guideline development and utilize the best available evidence to underpin nutrition recommendations in evidence-based guidelines on bone health.

A Systematic Review and Quality Assessment of Breast Cancer Clinical Practice Guidelines Providing Complementary and Alternative Medicine Recommendations.

PURPOSE OF REVIEW: Up to 80% of patients with breast cancer are reported to use complementary and alternative medicine (CAM). Despite this high prevalence, many healthcare providers have little knowledge and education surrounding this topic and may be inadequately prepared to discuss such therapies with their patients. Given this knowledge gap, the purpose of this study was to systematically identify the quantity and assess the quality of CAM recommendations in clinical practice guidelines (CPGs) for the treatment and/or management of breast cancer. RECENT FINDINGS: Thirty-four CPGs were deemed eligible, 5 of which mentioned CAM, and 4 of which made CAM recommendations. Eligible CPGs containing CAM recommendations were assessed with the AGREE II instrument. Scaled domain percentages from highest to lowest were (% overall, % CAM) as follows: scope and purpose (100.0%, 100.0%), editorial independence (100.0%, 100.0%), clarity of presentation (97.2%, 80.6%), rigour of development (80.2%, 80.2%), stakeholder involvement (88.9%, 77.8%), and applicability (58.3%, 58.3%). CPGs with favourable scores may provide practitioners with guidance on safe and effective use of CAM therapies. A need exists to improve the quality of CAM recommendations in CPGs.

Level of Scientific Evidence Underlying the National Comprehensive Cancer Network Clinical Practice Guidelines for Hematologic Malignancies: Are We Moving Forward?

Background: The level of scientific evidence in National Comprehensive Cancer Network (NCCN) guidelines for malignant hematological conditions haven't been recently investigated. We describe the distribution of categories of evidence and consensus (EC) among the 10 most common hematologic malignancies with regard to recommendations for staging, initial and salvage therapy, and surveillance. Methods: We reviewed the level of evidence for the 10 most common hematological malignancies by incidence in the United States as of 2020. The NCCN definitions for EC are: category 1, high level of evidence, such as randomized controlled trials, with uniform consensus; category 2A, lower level of evidence with uniform consensus; category 2B, lower level of evidence without a uniform consensus but with no major disagreement; and category 3, any level of evidence but with major disagreement. We compared our results with previously published results from 2011. Results: Of 1353 recommendations, 5%, 91%, 4%, and 1% fell into EC categories 1, 2A, 2B, and 3, respectively, while in 2011 the comparable percentages were 3%, 93%, 4%, and 0%, respectively. Recommendations with category 1 EC were found in all guidelines, except for Burkitt lymphoma. Of all therapeutic recommendations, 6.3% were category 1 EC, with the majority of these (56.4%) pertaining to initial therapy. Guidelines with highest proportions of therapeutic recommendations with category 1 EC were multiple myeloma (12.4%), chronic lymphocytic leukemia/small lymphocytic lymphoma (6.9%), and acute myeloid leukemia (5.6%). Conclusions: Recommendations in the 2020 NCCN guidelines are largely developed from lower levels of evidence but with uniform expert opinion, underscoring the urgent need and available opportunities to expand the current evidence base in malignant hematological disorders.

Salivary Gland Hypofunction and/or Xerostomia Induced by Nonsurgical Cancer Therapies: ISOO/MASCC/ASCO Guideline.

PURPOSE: To provide evidence-based recommendations for prevention and management of salivary gland hypofunction and xerostomia induced by nonsurgical cancer therapies. METHODS: Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) and ASCO convened a multidisciplinary Expert Panel to evaluate the evidence and formulate recommendations. PubMed, EMBASE, and Cochrane Library were searched for randomized controlled trials published between January 2009 and June 2020. The guideline also incorporated two previous systematic reviews conducted by MASCC/ISOO, which included studies published from 1990 through 2008. RESULTS: A total of 58 publications were identified: 46 addressed preventive interventions and 12 addressed therapeutic interventions. A majority of the evidence focused on the setting of radiation therapy for head and neck cancer. For the prevention of salivary gland hypofunction and/or xerostomia in patients with head and neck cancer, there is high-quality evidence for tissue-sparing radiation modalities. Evidence is weaker or insufficient for other interventions. For the management of salivary gland hypofunction and/or xerostomia, intermediate-quality evidence supports the use of topical mucosal lubricants, saliva substitutes, and agents that stimulate the salivary reflex. RECOMMENDATIONS: For patients who receive radiation therapy for head and neck cancer, tissue-sparing radiation modalities should be used when possible to reduce the risk of salivary gland hypofunction and xerostomia. Other risk-reducing interventions that may be offered during radiation therapy for head and neck cancer include bethanechol and acupuncture. For patients who develop salivary gland hypofunction and/or xerostomia, interventions include topical mucosal lubricants, saliva substitutes, and sugar-free lozenges or chewing gum. For patients with head and neck cancer, oral pilocarpine and oral cevimeline, acupuncture, or transcutaneous electrostimulation may be offered after radiation therapy.Additional information can be found at www.asco.org/supportive-care-guidelines.

Practice Implications from the WCET® International Ostomy Guideline 2020.

GENERAL PURPOSE: To introduce the 15 recommendations of the International Ostomy Guideline (IOG) 2020, covering the four key arenas of education, holistic aspects, and pre- and postoperative care; and to summarize key concepts for clinicians to customize for translation into their practice. TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant will:1. Analyze supporting evidence for the education recommendations in the IOG 2020.2. Identify a benefit of the International Charter of Ostomate Rights.3. Distinguish concepts related to pre- and postoperative ostomy-related care.4. Select a potential barrier to IOG 2020 guideline implementation.

The second edition of the WCET ® International Ostomy Guideline (IOG) was launched in December 2020 as an update to the original guideline published in 2014. The purpose of this article is to introduce the 15 recommendations covering four key arenas (education, holistic aspects, and pre- and postoperative care) and summarize key concepts for clinicians to customize for translation into their practice. The article also includes information about the impact of the novel coronavirus 2019 on ostomy care.

AGREEing on Nutritional Management of Patients with CKD-A Quality Appraisal of the Available Guidelines.

Chronic kidney disease (CKD) is an important public health issue with increasing prevalence worldwide. Several clinical practice guidelines have been recently published regarding the nutritional management of CKD patients. The purpose of the present study is to evaluate the quality of the published guidelines and provide recommendation for future updates. PubMed, Scopus and Google Scholar were searched for relevant guidelines and 11 clinical practice guidelines were finally included. Guidelines developed by the American Society for Parenteral and Enteral nutrition (ASPEN), the Dietitians Association of Australia (DAA), the German Society for Nutritional Medicine (DGEM), the European Best Practice Guidelines (EBPG), the European Dialysis and Transplantation Nurses Association-European Renal Care Association (EDTNA-ERCA), the European Society for Clinical Nutrition and Metabolism (ESPEN), the Andalusian Group for Nutrition Reflection and Investigation (GARIN) group, the National Kidney foundation-Kidney Disease Outcomes Quality Initiative (KDOQI), the Italian Society of Nephrology-Association of Dieticians-Italian Association of Hemodialysis, Dialysis and Transplant (SIN-ANDID-ANED), and the Renal Association were assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. Guidelines by KDOQI, ESPEN, and DAA were of moderate quality and the rest of them were low-quality guidelines. Our study demonstrates gaps related to the development of guidelines and therefore greater emphasis on methodological approaches is recommended. AGREE II tool can be useful to improve quality of guidelines.

[Quality assessment of global breast cancer screening guidelines].

Objective: To evaluate the quality of the published breast cancer screening guidelines to provide a reference for domestic studies in the future. Methods: PubMed, Embase, Cochrane Library, Web of Science, SinoMed, China National Knowledge Infrastructure, VIP, and Wanfang Data were searched to identify breast cancer screening guidelines on until August 2020. Two reviewers screened literature and extracted data independently. The Appraisal of Guidelines for Research & Evaluation Ⅱ(AGREEⅡ) and Reporting Items for Practice Guidelines in Healthcare(RIGHT) tools were used to evaluate the quality of the included guidelines. Results: A total of 15 breast cancer screening guidelines were included, of which seven were published in the United States, with publication years focusing on 2015 to 2019, and 11 guidelines had updated versions. "Rigour of development" (47.0%±22.1%) and "Applicability" (44.0%±15.1%) of AGREEⅡ scored lower than other domains. "Review and quality assurance" (46.7%±39.9%) and "Funding, declaration, and management of interests" (41.7%±24.4%) of RIGHT were reported poorer than others. There were six guidelines recommended and another nine recommended with modifications based on the overall AGREEⅡ score. There were four guidelines with a good level, and another 11 were with a moderate level of RIGHT. The National Comprehensive Cancer Network published the best overall quality guidelines in 2018 (AGREEⅡ: 83.3%, RIGHT: 80.0%) and by the American Cancer Society in 2015 (AGREEⅡ: 83.3%, RIGHT: 85.7%). Conclusion: The quality of breast cancer screening guidelines was predominantly of moderate quality, and greater attention should be paid to the guideline development process and quality control of the guidelines.

Quality assessment of traditional and conventional medicine clinical practice guidelines for osteoporosis.

ABSTRACT: Numerous studies have reported the variable quality of clinical practice guidelines (CPGs) across various domains. The aim of this study was to systematically assess the quality, methodology, and consistency of recently developed traditional and conventional medicine CPGs that focus on the management of osteoporosis and provide helpful recommendations for patients with osteoporosis.From June 2020 to July 2020, CPGs with osteoporosis targeting any age were systematically retrieved. All CPGs of traditional and conventional medicine related to the assessment and diagnosis, management, and clinical therapeutic and pharmacological recommendations with osteoporosis were eligible for inclusion in this study. The excluded documents included guidelines without recommendations, secondary publications derived from CPGs, consensus statements, or consensus conferences based on the opinion of panelists, systematic reviews, editorials, clinical trials, and single-author documents. The quality of CPGs was independently examined by three assessors using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument. AGREE II consists of 6 domains; scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence. Consequently, selected CPGs were graded as recommended (A), recommended with modifications (B), or not recommended (C), and the specific treatments and preventive recommendations in the CPGs were summarized.The quality of the 15 CPGs assessed varied across the AGREE II domains. The overall quality ranged from 3.0 to 6.0 out of 7. The domain that had the highest scores were "clarity of presentation," with a mean value of 69.0% (range 46%-83%); "editorial independence" had the lowest score of 30.2% (range 0%-75%). The conventional CPGs focused on pharmacological treatments, calcium and vitamin D intake, and prevention, while the traditional CPGs consistently emphasized on herbal medicine and non-pharmaceutical treatment and management.Further development of CPGs will require improvement in domains where low item scores have been obtained in the quality assessment in this present study. Further research is needed on alternative modalities for osteoporosis, especially complementary approaches, and higher quality CPGs are needed to facilitate evidence-based clinical practice.

Toward the Development of a Comprehensive Clinically Oriented Patient Profile: A Systematic Review of the Purpose, Characteristic, and Methodological Quality of Classification Systems of Adult Spinal Deformity.

BACKGROUND: Existing adult spinal deformity (ASD) classification systems are based on radiological parameters but management of ASD patients requires a holistic approach. A comprehensive clinically oriented patient profile and classification of ASD that can guide decision-making and correlate with patient outcomes is lacking. OBJECTIVE: To perform a systematic review to determine the purpose, characteristic, and methodological quality of classification systems currently used in ASD. METHODS: A systematic literature search was conducted in MEDLINE, EMBASE, CINAHL, and Web of Science for literature published between January 2000 and October 2018. From the included studies, list of classification systems, their methodological measurement properties, and correlation with treatment outcomes were analyzed. RESULTS: Out of 4470 screened references, 163 were included, and 54 different classification systems for ASD were identified. The most commonly used was the Scoliosis Research Society-Schwab classification system. A total of 35 classifications were based on radiological parameters, and no correlation was found between any classification system levels with patient-related outcomes. Limited evidence of limited quality was available on methodological quality of the classification systems. For studies that reported the data, intraobserver and interobserver reliability were good (kappa = 0.8). CONCLUSION: This systematic literature search revealed that current classification systems in clinical use neither include a comprehensive set of dimensions relevant to decision-making nor did they correlate with outcomes. A classification system comprising a core set of patient-related, radiological, and etiological characteristics relevant to the management of ASD is needed.

Multidisciplinary tumor boards and their analyses: the yin and yang of outcome measures.

BACKGROUND: The standard to ensure utmost cancer treatment is a prerequisite in national cancer plans for comprehensive cancer centers (CCCs) and ensured through multidisciplinary tumor boards (MTBs). Despite these being compulsory for CCCs, various analyses on MTBs have been performed, since MTBs are resource-intensive. Outcome measures in these prior analyses had been survival (OS), MTB-adherence and -satisfaction, inclusion of patients into clinical trials and better cancer care. MAIN BODY: A publication from Freytag et al. performed an analysis in multiple tumor entities and assessed the effect of number of MTBs. By matched-pair analysis, they compared response and OS of patients, whose cases were discussed in MTBs vs. those that were not. The analysis included 454 patients and 66 different tumor types. Only patients with > 3 MTBs showed a significantly better OS than patients with no MTB meeting. Response to treatment, relapse free survival and time to progression were not found to be better, nor was there any difference for a specific tumor entity with vs. without MTB discussions. An in-depth discussion of these results, with respect to the literature (PubMed search: "MTBs AND cancer") and within the author group, including statisticians specialized in data analysis of cancer patients and questions addressed in MTBs, was performed to interpret these findings. We conclude that the results by Freytag et al. are deceiving due to an "immortal time bias" that requires more careful data interpretation. CONCLUSIONS: The result of Freytag et al. of a seemingly positive impact of higher number of MTBs needs to be interpreted cautiously: their presumed better OS in patients with > 3 MTB discussions is misleading, due to an immortal time bias. Here patients need to survive long enough to be discussed more often. Therefore, these results should not lead to the conclusion that more MTBs will "automatically" increase cancer patients' OS, rather than that the insightful discussion, at best in MTBs and with statisticians, will generate meaningful advice, that is important for cancer patients.

A systematic review and quality assessment of complementary and alternative medicine recommendations in insomnia clinical practice guidelines.

BACKGROUND: Sleep disorders encompass a wide range of conditions which affect the quality and quantity of sleep, with insomnia being a specific type of sleep disorder of focus in this review. Complementary and alternative medicine (CAM) is often utilized for various sleep disorders. Approximately 4.5% of individuals diagnosed with insomnia in the United States have used a CAM therapy to treat their condition. This systematic review identifies the quantity and assesses the quality of clinical practice guidelines (CPGs) which contain CAM recommendations for insomnia. METHODS: MEDLINE, EMBASE and CINAHL were systematically searched from 2009 to 2020, along with the Guidelines International Network, the National Center for Complementary and Integrative Health website, the National Institute for Health and Care Excellence, and the Emergency Care Research Institute. CPGs which focused on the treatment and/or management of insomnia in adults were assessed with the Appraisal of Guidelines, Research and Evaluation II (AGREE II) instrument. RESULTS: From 277 total results, 250 results were unique, 9 CPGs mentioned CAM for insomnia, and 6 out of the 9 made CAM recommendations relevant to insomnia. Scaled domain percentages from highest to lowest were scope and purpose, clarity of presentation, editorial independence, stakeholder involvement, rigour of development, and applicability. Quality varied within and across CPGs. CONCLUSIONS: The CPGs which contained CAM recommendations for insomnia and which scored well could be used by health care professionals and patients to discuss the use of CAM therapies for the treatment/management of insomnia, while CPGs which scored lower could be improved in future updates according to AGREE II.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines for Deep Brain Stimulations for Obsessive-Compulsive Disorder: Update of the 2014 Guidelines.

BACKGROUND: In 2020, the Guidelines Task Force conducted another systematic review of the relevant literature on deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) to update the original 2014 guidelines to ensure timeliness and accuracy for clinical practice. OBJECTIVE: To conduct a systematic review of the literature and update the evidence-based guidelines on DBS for OCD. METHODS: The Guidelines Task Force conducted another systematic review of the relevant literature, using the same search terms and strategies as used to search PubMed and Embase for relevant literature. The updated search included studies published between 1966 and December 2019. The same inclusion/exclusion criteria as the original guideline were also applied. Abstracts were reviewed and relevant full-text articles were retrieved and graded. Of 864 articles, 10 were retrieved for full-text review and analysis. Recommendations were updated according to new evidence yielded by this update. RESULTS: Seven studies were included in the original guideline, reporting the use of bilateral DBS as more effective in improving OCD symptoms than sham treatment. An additional 10 studies were included in this update: 1 class II and 9 class III. CONCLUSION: Based on the data published in the literature, the following recommendations can be made: (1) It is recommended that clinicians utilize bilateral subthalamic nucleus DBS over best medical management for the treatment of patients with medically refractory OCD (level I). (2) Clinicians may use bilateral nucleus accumbens or bed nucleus of stria terminalis DBS for the treatment of patients with medically refractory OCD (level II). There is insufficient evidence to make a recommendation for the identification of the most effective target.The full guidelines can be accessed at https://www.cns.org/guidelines/browse-guidelines-detail/deep-brain-stimulation-obsessive-compulsive-disord.

Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments.

BACKGROUND: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. METHODS: We developed and distributed an anonymous survey assessing COVID-19-related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. RESULTS: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years' professional experience in clinical research, and 56% had personal experience with a COVID-19-related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years' professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). CONCLUSIONS: Clinical research professionals perceive that COVID-19-related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience-both specific to COVID-19-related changes and more generally-are more likely to recommend that these adjustments continue in the future.

Clinical Practice Guidelines for Bladder Cancer: A Systematic Review and Meta-Analysis Using the AGREE II Instrument.

CONTEXT: Numerous health care organizations have established guidelines on diagnosis and treatment of bladder cancer. However, the lack of a standardized guideline development approach results in considerable differences of the guidelines' methodological quality. OBJECTIVE: To assess the methodological quality of all relevant clinical practice guidelines (CPGs) for urinary bladder cancer and provide a reference for clinicians in choosing guidelines of high methodological quality. EVIDENCE ACQUISITION: A systematic literature search was conducted in Medline via PubMed, 4 CPG databases, and 7 databases of interdisciplinary organizations. CPGs for non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) with the topics screening, pathology, diagnosis, treatment, and aftercare published in English language between 2012 and 2018 were included. The CPG quality was analyzed using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. EVIDENCE SYNTHESIS: A total of 16 CPGs were included for the quality appraisal. Because of predefined criteria, 5 CPGs were "strongly recommended" (American Urological Association NMIBC, European Association of Urology [EAU] NMIBC, EAU MIBC, National Institute for Health and Care Excellence, and National Comprehensive Cancer Network), 4 CPGs were "weakly recommended" and 7 CPGs were "not recommended." CONCLUSIONS: The methodological quality of bladder cancer guidelines is diverse. Considering the rapid development of new therapies (e.g., immune checkpoint inhibitors), "living guidelines" of high methodological quality, such as the EAU NMIBC or MIBC guideline, will become more relevant in the future guideline's landscape.