Reporting quality of acupuncture overviews: A methodological investigation based on the PRIOR statement.

OBJECTIVE: Acupuncture overviews are increasing rapidly; however, their reporting quality is yet unclear. We aimed to investigate the reporting quality of relevant overviews according to the preferred reporting items for overviews of reviews (PRIOR) statement. METHODS: We systematically searched PubMed from inception to August 16, 2022 for overviews on acupuncture therapies. Reporting quality of included overviews was evaluated using the PRIOR statement, and the results were cross-checked. Multiple linear regression analysis was used to assess the predictors of the reporting completeness. GraphPad 9.4 was utilized to generate an evidence map, Excel 2019 was used to extract and manage data, and R 4.2.3 was used for data analysis. RESULTS: A total of 49 overviews published from 2006 to 2022 were included, of which China ranked first with 38 overviews. The most frequently searched database was PubMed/ Medline (n = 48, 98%), and commonly used methodological quality assessment tool was AMSTAR-2 (n = 14, 29%). The overarching themes centered on acupuncture for obstetrics, gynecology, reproductive diseases, as well as depression, anxiety, and insomnia. Reporting quality needs to be improved involving the definition of systematic reviews (SRs), overlap of primary studies and SRs, methods for managing discrepant data across SRs, risk of bias in primary studies, heterogeneity, and sensitivity analysis of synthesized results, reporting bias assessment, and registration and protocol. Moreover, publication in recent years and receiving funding support were significantly associated with higher overall reporting quality score (P < 0.05). CONCLUSION: Based on the PRIOR statement, this methodological study indicates that the reporting quality of the included acupuncture overviews is poor. In the future, authors of overviews are encouraged to use the PRIOR statement for standardized reporting. Furthermore, it is recommended that journal editors mandate the inclusion of this statement in authors' reports and require a complete PRIOR checklist.

Biofield therapies: Guidelines for reporting clinical trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Time points of outcome are often neglected in acupuncture meta-analyses: a methodological survey.

OBJECTIVES: To systematically understand the transparency of outcome measurement time point reporting in meta-analyses of acupuncture. STUDY DESIGN AND SETTING: We searched for meta-analyses of acupuncture published between 2013 and 2022 in PubMed, Embase, and Cochrane Library. A team of method-trained investigators screened studies for eligibility and collected data using pilot-tested standardized questionnaires. We documented in detail the reporting of outcome measurement time points in acupuncture meta-analyses. RESULTS: A total of 224 acupuncture meta-analyses were included. Of these, 98 (43.8%) studies did not specify the time points of primary outcome. Among 126 (56.3%) meta-analyses which reported the time points of primary outcome, only 22 (17.5%) meta-analyses specified time points in corresponding protocol. Among 48 (38.1%) meta-analyses that estimated treatment effects of multiple time points, 11 (22.9%) meta-analyses used inappropriate meta-analysis method (subgroup analysis) to pool effect size, and none of the meta-analyses used advanced methods for pooling effect sizes at different time points. CONCLUSION: Transparency in reporting outcome time points for acupuncture meta-analyses and appropriate methods to pool the effect size of multiple time points were lacking. For future systematic reviews, the transparency of outcome measurement time points should be emphasized in the protocols and final reports. Furthermore, advanced methods should be considered for pooling effect sizes at multiple time points.

Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa.

A clinical trial is any research on human subjects that involves an investigational medicinal product or device. Investigational medicinal products include unlicensed drugs or drugs used outside the product license (e.g. for a new indication) (ICH-GCP). As per the internationally accepted ICH-GCP guidelines, clinical trials should be conducted strictly per the approved protocol. However, during the lifecycle of a trial, protocol deviations may occur. Under ICH efficacy guidelines, protocol deviations are divided into non-important (minor) or important (major), and the latter can jeopardise the participant's rights, safety or the quality of data generated by the study. Existing guidelines on protocol deviation management do not detail or standardise actions to be taken for participants, investigational products, data or samples as part of a holistic management of important protocol deviations. Herein, we propose guidelines to address the current literature gap and promote the standardisation of actions to address important protocol deviations in clinical trials. The advised actions should complement the existing local institutional review board and national regulatory authority requirements.

Development of a Critical Appraisal Tool (AIMRDA) for the Peer-Review of Studies Assessing the Anticancer Activity of Natural Products: A Step towards Reproducibility.

The journal of APJCP (Asian Pacific Journal of Cancer Prevention) focuses to gather relevant and up-to-date novel information's related to cancer sciences. The research methodologies and approaches adopted by the researcher are prone to variation which may be desirable in the context of novel scientific findings however, the reproducibility for these studies needs to be unified and assured. The reproducibility issues are highly concerned when preclinical studies are reported in cancer, for natural products in particular. The natural products and medicinal plants are prone to a wide variation in terms of phytochemistry and phyto-pharmacology, ultimately affecting the end results for cancer studies. Hence the need for specific guidelines to adopt a best-practice in cancer research are utmost essential. The current AIMRDA guidelines aims to develop a consensus-based tool in order to enhance the quality and assure the reproducibility of studies reporting natural products in cancer prevention. A core working committee of the experts developed an initial draft for the guidelines where more focus was kept for the inclusion of specific items not covered in previous published tools. The initial draft was peer-reviewed, experts-views provided, and improved by a scientific committee comprising of field research experts, editorial experts of different journals, and academics working in different organization worldwide. The feedback from continuous online meetings, mail communications, and webinars resulted a final draft in the shape of a checklist tool, covering the best practices related to the field of natural products research in cancer prevention and treatment. It is mandatory for the authors to read and follow the AIMRDA tool, and be aware of the good-practices to be followed in cancer research prior to any submission to APJCP. Though the tool is developed based on experts in the field, it needs to be further updated and validated in practice via implementation in the field.

A Scoping Review of Cross-Sectional Studies on Traditional Chinese Medicine.

Cross-sectional studies on traditional Chinese medicine (TCM-CSs) have become the most published type of TCM observational study; however, the research scope of current TCM-CSs is unknown. A scoping review of the literature was performed. A descriptive approach to summarize the core study characteristics was prepared, along with structured tables and figures to identify salient points of similarities and differences noted across studies. The reporting quality of TCM-CSs was assessed according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) cross-sectional checklist. Eight databases (Embase, CENTRAL, MEDLINE, AMED, CBM, CNKI, WanFang, and VIP) were systematically searched for TCM-CSs published up until 20 January 2020. The literature screening and evaluating were independently conducted by two researchers. When there was disagreement, a third-party senior researcher made the judgment. A total of 198 TCM-CSs published between 1997 and 2019 were included, 160 English studies and 38 Chinese studies, respectively. More TCM-CSs were published in each successive year. The journal Evidence-Based Complementary and Alternative Medicine published more TCM-CSs (24) than any other journal. Most TCM-CSs were conducted in mainland China (81, 40.9%), followed by Taiwan, China (44, 22.2%) and HKSAR, China (19, 9.6%). The most commonly used sampling method was purposive sampling (94, 47.5%), following by convenience sampling (60, 30.3%). The research topics can be summarized in four major categories as follows: constitution-related research (11.1%), TCM pattern-related research (18.7%), TCM intervention-related research (55.1%), and others (15.6%). The average sufficient reporting rate of included TCM-CSs according to the STROBE cross-sectional checklist was 45.6%. Papers written in English reported 9 items (items 2, 4, 14a, 16a, 18, 19, 20, 21, and 22) more frequently than papers written in Chinese. The number of TCM-CSs is increasing. Research topics are diverse; however, the reporting quality is unsatisfactory. In particular, TCM-CSs need greater transparency and standardization.

Tools to Assess the Risk of Bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation.

OBJECTIVES: (1) To determine whether new tools and items have been developed to evaluate the risk of bias (RoB) and reporting of randomized controlled trials (RCTs) in rehabilitation; (2) to determine which items are included in the existing reporting guidelines, and to create a matrix of items to report and conduct trials in rehabilitation as the first step for a starting a rigorous validation process. DATA SOURCES: Searches were conducted in MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health databases. STUDY SELECTION: Studies should describe a newly developed tool to evaluate the RoB or quality of reporting for RCTs in the area of rehabilitation. DATA EXTRACTION: (1) First, we extracted items from new tools identified by the electronic search strategies and then (2) we looked at the items provided by the Consolidated Standards of Reporting Trials statement and its relevant extensions. We determined whether these items were already included in our matrix of items. Items were classified based on methodological domains they accomplish, biases they were able to target, and whether they guide reporting or conduct. DATA SYNTHESIS: Among the 1596 citations found, 23 articles were potentially relevant. From these, only 3 new scales (National Institute for Complementary Medicine Acupuncture Network, Quality of reports on spa and balneotherapy [SPAC], Assessment of Study Quality and Reporting in Exercise) were found. In addition, the newly updated Cochrane RoB tool (RoB 2.0) was included. Our matrix contained 122 unique items for any rehabilitation area, 46 items (37.7%) were related to conduct, and 58 (47.5%) were related to the reporting; 18 (14.8%) were related to both. Overall, 76 new items were added among all domains. CONCLUSIONS: Many individual and diverse items have been used to guide the reporting and conduct of rehabilitation trials. This indicates a great variability in number of items and an apparent lack of consensus on a core set of items to be used in rehabilitation. Future research should look into developing a core set of items for the rehabilitation field.

Epidemiology and reporting characteristics of preclinical systematic reviews.

In an effort to better utilize published evidence obtained from animal experiments, systematic reviews of preclinical studies are increasingly more common-along with the methods and tools to appraise them (e.g., SYstematic Review Center for Laboratory animal Experimentation [SYRCLE's] risk of bias tool). We performed a cross-sectional study of a sample of recent preclinical systematic reviews (2015-2018) and examined a range of epidemiological characteristics and used a 46-item checklist to assess reporting details. We identified 442 reviews published across 43 countries in 23 different disease domains that used 26 animal species. Reporting of key details to ensure transparency and reproducibility was inconsistent across reviews and within article sections. Items were most completely reported in the title, introduction, and results sections of the reviews, while least reported in the methods and discussion sections. Less than half of reviews reported that a risk of bias assessment for internal and external validity was undertaken, and none reported methods for evaluating construct validity. Our results demonstrate that a considerable number of preclinical systematic reviews investigating diverse topics have been conducted; however, their quality of reporting is inconsistent. Our study provides the justification and evidence to inform the development of guidelines for conducting and reporting preclinical systematic reviews.

Introduction to the EQIPD quality system.

While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union's Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use.

When is lack of scientific integrity a reason for retracting a paper? A case study.

OBJECTIVE: The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immmediate past editors expand on the journal's decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators. METHODS: The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case. RESULTS: In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper. CONCLUSION: Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.

Homeopathy Assessment-Contribution of the Human Sciences.

The recent questions about homeopathy raised by some sceptics have focused an awareness on this therapy and led different protagonists among the scientific community to seek a much-needed re-assessment. The inputs coming from external but benevolent experts will broaden the knowledge and the consciousness of the whole medical community, and more widely of the public, about the meaning and the value of homeopathy.Looking at this from the point of view of the human sciences gives a perspective on the universality of the philosophy that underlies homeopathic thinking, which is particularly visible in the methodological similarities between homeopathic provings and sociological or anthropological observations. It also explains how this view of health and care coincides with the expectations of the public, who no longer want a limited mechanical approach to the human body or more generally to the environment.The input to homeopathy of the human sciences, with their methodological tools and approaches, and highlighting the possibilities offered by mixed-methods research, could enable these notions to be heard and shared in the wider scientific community.

The Influence of Long-Chain Omega-3 Fatty Acids on Eccentric Exercise-Induced Delayed Muscle Soreness: Reported Outcomes Are Compromised by Study Design Issues.

Delayed onset muscle soreness (DOMS) following eccentric exercise is associated with increased inflammation which can be debilitating. Incorporation of long-chain omega-3 polyunsaturated fatty acids (LC n-3 PUFA), eicosapentaenoic acid, and docosahexaenoic acid into membrane phospholipids provides anti-inflammatory, proresolving, and analgesic effects. This systematic review aims to examine both the quality of studies and the evidence for LC n-3 PUFA in the attenuation of DOMS and inflammation following eccentric exercise, both which of course are empirically linked. The Scopus, Embase, and Web of Science electronic databases were searched to identify studies that supplemented fish oil for a duration of ≥7 days, which included DOMS outcomes following an eccentric exercise protocol. Fifteen (n = 15) studies met inclusion criteria. Eccentric exercise protocols varied from single to multijoint activities. Risk of bias, assessed using either the Cochrane Collaboration tool or the Risk of Bias in Nonrandomized Studies of Interventions tool, was judged as "unclear" or "medium," respectively, for the majority of outcomes. Furthermore, a custom 5-point quality assessment scale demonstrated that only one (n = 1) study satisfied current recommendations for investigating LC n-3 PUFA. In combination, this highlights widespread inappropriate design protocols among studies investigating the role of LC n-3 PUFA in eccentric exercise. Notwithstanding these issues, LC n-3 PUFA supplementation appears to have favorable effects on eccentric exercise-induced DOMS and inflammatory markers. However, the optimal LC n-3 PUFA supplemental dose, duration, and fatty acid composition will only become clear when study design issues are rectified and underpinned by appropriate hypotheses.

Near-infrared light spectroscopy and stimulation in cognitive neuroscience: the need for an integrative view?

Near-infrared spectroscopy (NIRS) has been largely used in neuroscience as an alternative non-invasive neuroimaging technique, primarily to measure the oxygenation levels of cerebral haemoglobin. Its portability and relative robustness against motion artefacts made it an ideal method to measure cerebral blood changes during physical activity. Usually referred to as 'functional' NIRS (fNIRS) when used to monitor brain changes during motor or cognitive tasks, this technique often involves the montage the probes on the forehead of the participants to gauge the neurophysiological underpinning of executive functioning. Other applications of NIRS include other aspects of cerebral hemodynamics such as cerebral pulsatility. However, there is an important aspect that fNIRS studies do not seem to have taken into account so far, which relates to the capacity of near-infrared light to modulate cognitive and psychological processes according to what is known as photobiomodulation (PBM). Hence, drawing on a selection of NIRS and PBM experiments, we argue in favour of an integrative view for NIR-based neuroimaging studies, which should embrace a control for the possible effects of light stimulation, especially when fNIRS is considered to test the effect of an intervention.

Sample size, study length, and inadequate controls were the most common self-acknowledged limitations in manual therapy trials: A methodological review.

OBJECTIVES: The aim of this study was to quantify and analyze the presence and type of self-acknowledged limitations (SALs) in a sample of manual therapy (MT) randomized controlled trials. STUDY DESIGN AND SETTING: We randomly selected 120 MT trials. We extracted data related to SALs from the original reports and classified them into 12 categories. After data extraction, specific limitations within each category were identified. A descriptive analysis was performed using frequencies and percentages for qualitative variables. RESULTS: The number of SALs per trial article ranged from 0 to 8, and more than two-thirds of trials acknowledged at least two different limitations. Despite its small proportion, 9% of trials did not report SALs. The most common limitation declared, in almost half of our sample, related to sample size (47.5%) followed by limitations related to study length and follow-up (33.3%) and inadequate controls (32.5%). CONCLUSION: Our results indicate that at least two different limitations are consistently acknowledged in MT trial reports, the most common being those related to sample size, study length, follow-up, and inadequate controls. Analysis of the reasons behind the SALs gives some insights about the main difficulties in conducting research in this field and may help develop strategies to improve future research.

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.

Evaluation of quality of pharmacoeconomic studies involved in traditional Chinese medicine in China.

OBJECTIVES: The pharmacoeconomic studies of traditional Chinese medicine (TCM) are still in its infancy. Assessing the quality of pharmacoeconomic studies of TCM to improve the efficiency of health resource allocation and guide the rational use of medicine. METHODS: Four databases were searched from inception to January 2018. The Consolidated Health Economic Evaluation Reporting Standards statement (CHEERS) and the Quality of Health Economic Studies (QHES) were used to assess the reporting quality and methodological quality. STATA 12.0 and Meta analyst 3.13 were used to analyze the related data. RESULTS: A total of 178 studies were included. The methodological evaluation of the study found that the total score of QHES was 47.85 ± 8.09. The report quality evaluation results found that many studies did not report comprehensive information, such as lack of detailed reports on abstracts, study perspectives, time frames, discount rates, model selection, but the titles, study background and location, and health results, resource and cost estimates, analysis methods, and heterogeneity analysis are reported in more detail. Six of the ten stratification factors have statistically significant differences. CONCLUSION: The overall quality of pharmacoeconomic studies of TCM is low, and further standardization and improvement are needed to obtain reliable study results.

Toward Better Reproducibility in Experimental Research on New Agents for Pulmonary Hypertension. An Analysis of Data from Four Hundred Animal Studies.

PURPOSE: Pre-clinical data can provide a rationale for subsequent clinical trials and they are the first step in drug development; however, the therapeutic effect observed during animal studies does not necessarily translate to similar results in humans. METHODS: Taking the example of pulmonary hypertension, the present study explores whether the methodological aspects of preclinical experiments can determine the final result. RESULTS: The present paper describes a systematic analysis of 409 studies conducted on a variety of animal models to identify potential drug candidates for PH treatment; it explores the influence of various aspects of study design on the final outcome, e.g. type of animal model of PH, dosage schedules of tested agents, type of anesthesia, measurement of exercise intolerance or animal survival. CONCLUSIONS: The animal models of PH used for pre-clinical studies are diverse and there are several methodological items within the established protocols that can determine the obtained result. Graphical abstract.

The reporting quality and risk of bias of randomized controlled trials of acupuncture for migraine: Methodological study based on STRICTA and RoB 2.0.

OBJECTIVES: To investigate the reporting quality and risk of bias of randomized controlled trials (RCTs) of acupuncture for migraine, to facilitate and improve the quality of RCTs of acupuncture for migraine. METHODS: The Cochrane Library, PubMed and EMBASE were searched from inception to June 11, 2019 using a comprehensive search strategy. The reporting quality and risk of bias of included RCTs were independently evaluated by two investigators using STRICTA and RoB 2.0. Any disagreement was resolved by a third investigator. RESULTS: A total of 28 eligible RCTs were published in 24 academic journals from 1994 to 2018. Based on STRICTA, four sub-items including "details of other interventions'' (1/28, 4 %), "setting and context of treatment" (9/28, 32 %), "the extent to which treatment was varied" (11/28, 39 %), and "number of needle insertions per subject per session" (13/28, 46 %), showed low reporting quality. A total of 32 different outcomes were reported in 28 RCTs, and based on RoB 2.0, nine (9/28, 32 %) RCTs were judged to be high RoB, three of which were owing to deviations from intended interventions; 11(11/28, 39 %) RCTs elicited some concerns; and eight (8/28, 29 %) RCTs were low RoB for their outcomes. CONCLUSIONS: The reporting quality and risk of bias of RCTs of acupuncture for migraine remain suboptimal. Therefore, all stakeholders should make a contribution to improve the quality of RCTs of acupuncture for migraine using STRICTA and RoB 2.0, while not limiting this approach solely to studies on migraine, using STRICTA and RoB 2.0 tools.