Reporting Quality of Endoscopic Colorectal Cancer Screening Randomized Controlled Trials: Adherence to Recommendations and Interventions.

Background and Aims: In 2013, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) steering group published recommendations to standardize reporting quality in randomized controlled trials (RCTs). We aim to assess adherence to SPIRIT reporting guidelines in RCTs on endoscopic colorectal cancer (CRC) screening and participants' adherence to trial protocols. Methods: We searched databases for RCTs evaluating flexible sigmoidoscopy or colonoscopy for CRC screening published in English language through September 2023. Each eligible study was evaluated using the 8 core SPIRIT statement areas, totaling 51 points. Each item received 1 point if it met the criteria and 0 points if it did not. Adherence to SPIRIT items was calculated, and participant adherence to RCT protocols was assessed as the proportion of participants screened compared to those invited. Results: Five RCTs, including 4 on flexible sigmoidoscopy and 1 on colonoscopy, were analyzed. Adherence to SPIRIT guidance ranged from 82.4% to 92.2%. The most missed recommendation was item 2b (trial registrations), scored 0 across all studies. Additionally, item 32 (informed consent materials) scored 20%, and items 17a & b (blinding) scored 40% each. In total, 587,572 participants were randomized across the 5 RCTs. Of these, 37% (200,610) underwent CRC screening, with 69.8% (139,983/200,610) adhering to the protocol. The Nordic-European Initiative on Colorectal Cancer (NordICC) trial, employing a unique invitation method, had a lower adherence rate of 42%. Excluding this trial would raise the adherence rate to 74.3% (128,050/172,390). Conclusion: The published CRC screening trials have acceptable adherence to the SPIRIT reporting guidelines. However, reporting appended consent form materials and disclosing all WHO trial registration data can be improved.

Assessing the reporting quality of pediatric neuro-oncology protocols, abstracts, and trials: Adherence to the SPIRIT and CONSORT statements.

Background: It is of vital importance to comprehensively and transparently report clinical trial activity. The SPIRIT 2013 and CONSORT 2010 statements exist to define items to be reported in clinical trial protocols and randomized controlled trials, respectively. The aim of this methodological review was to assess the reporting quality of pediatric neuro-oncology trial protocols and trial result articles. Methods: Published trial protocols and phase II/III trial result articles relating to pediatric brain tumors (published after the introduction of the SPIRIT 2013 statement), were identified through searches of 4 electronic bibliographic databases. The reporting quality of included trial protocols and result articles was assessed against the aforementioned statements. In addition, the CONSORT-A checklist was used to assess the abstracts of trial result articles. Percentage adherence was calculated for each article. Results: Nine trial protocols, 68 phase II trials, and 8 phase III trial result articles were included. Mean adherence of trial protocols to the SPIRIT statement was 76.8% (SD: 0.09). Mean adherence of trial abstracts to CONSORT-A was 67.4% (SD: 0.13) for phase II abstracts and 47.5% (SD: 0.09) for phase III abstracts. Adherence of trial result articles to CONSORT was 71.3% (SD: 0.10) for phase II trials and 70.3% (SD: 0.13) for phase III trials. Conclusions: The reporting quality of pediatric neuro-oncology trial protocols and trial result articles requires improvement, particularly in the areas of randomization and blinding. This is consistent with our previously published findings following similar assessment of reporting quality for adult neuro-oncology trial protocols and result articles.

Amina: Shaking Boundaries of a Woman Inhabited by the Spirits (Senegal).

In this article, I present the individual ethnography of Amina, a Senegalese woman possessed by the spirits of her lineage. Amina's story shows the lacerations of a person who simultaneously inhabits two worlds: the traditional Lebou culture and the Western one. When her spirits manifest themselves, she is forced to choose between two different interpretations of her suffering: the traditional persecutory and the Western psychopathological. She chooses the former but refuses the healers imposed by the tradition and turns to a priest of her choice, who proves to be sensitive to her need to personally own the healing journey. Amina strategically manipulates the plasticity of the traditional belief system without abandoning it; she bends it to shake the boundaries of herself, and her group and lineage. She uses the disruptive potential of possession and the irruption of the invisible world in the visible to renegotiate her role and acquire a new status in her group. She uses the performative dispositive of possession to renegotiate and expand her spaces of agency and affirm her tenacious subjectivity of a permanently liminal person, one who inhabits, shakes and redraws the boundaries between different worlds of meaning.

[Application of the holism of body-qi-spirit in needle knife treatment for cervical vertigo].

This paper introduces Professor WANG Haidong's approach to treat cervical vertigo with needle knife based on the holism of body-qi-spirit. Professor WANG Haidong, considering the etiology and pathogenesis of cervical vertigo, starting from the holism of body-qi-spirit, based on the anatomical structure, employs the "seven-neck points" technique to improve local blood supply and address the physical issue; guided by the Jingjin theory, he utilizes the "knot releasing technique" to disperse knots and relax sinews, thereby regulating qi. In addition, he uses the "bone puncturing technique at governor vessel" to uplift yang-qi and nourish the brain, thereby nurturing the spirit.

Performance of Adult's Death and Burial Among Ilaje People of Southwest Nigeria.

The meaning ascribed to death differs from one society to the other. This study adopts the descriptive method in unraveling the ritual of burial practices among the Ilaje people of Nigeria's Niger delta. Based on linguistic similarities, Ilaje people are part of the Yoruba ethnic group of Nigeria's Southwest area. Among the people, burial accorded to the dead is based on how the deceased died. The Ilaje groups death into five distinctive categories - death due to old-age, death caused by witchcraft or evil spirit, death through drowning by accident, death through curse, and death due to suicide. For the people, adult's death has two layers of meaning: sorrow and merriment. We conclude that physical death is viewed as part of the continuum of life's circle; it is the point when the dead pass to the realm of the ancestor who may be reborn into the family in the future.

Locus of Control and Mental Health: Human Variation Complicates a Well-Established Research Finding.

INTRODUCTION: Locus of control (LoC) refers to one's expectation that life outcomes and (mis)fortune are driven largely by one's own actions or abilities (internal LoC) or by external factors (e.g., powerful others, chance; external LoC). There is a large literature demonstrating an association between internal LoC and positive mental health outcomes. However, this research is conducted mostly in high-income, Global North settings, with limited consideration of cross-cultural variability. This short report explores how LoC relates to mental health when considered in a less-studied context: in a setting of stark structural violence and in relation to supernatural agents. METHODS: I conducted a community-based survey in rural Haiti (n = 322) that assessed sent spirit-related locus of control (LoC-S) and mental health. RESULTS: Among individuals experiencing higher levels of daily stressors, depressive and anxiety symptoms were high regardless of LoC-S. However, for individuals facing low-to-moderate daily stressors, external LoC-S (believing one does not have control in relation to sent spirits) was associated with lower depressive and anxiety symptoms, though this interaction did not hold for anxiety after controlling for covariates. Though initially a nonintuitive finding, I contextualize this outcome in relation to ethnographic work in Haiti, showing that the ability to explain misfortune via the supernatural world can serve as a form of blame displacement. CONCLUSION: In a context where extreme structural violence means that individuals realistically have little control over their lives, an external LoC better reflects lived experience, helping explain the association with better mental health outcomes.

Chemical exposure from the Hebei spirit oil spill accident and its long-term effects on mental health.

While evidence indicates that exposure to oil spill incidents can affect mental health, it is unclear whether the mental health effects result from the incident itself or from exposure to associated chemicals. Oil contains chemicals that can impact mental health and these chemicals may have long-term effects due to their persistence in the environment. To address the gap in current knowledge, we conducted cross-sectional and prospective analyses of data from adults who participated in the Health Effects of the Hebei Spirit Oil Spill study. To assess chemical exposure from oil spills, we used indirect exposure indicators such as distance from the contaminated oil band to residences and duration of clean-up work, along with direct exposure indicators such as urine metabolite concentrations of volatile organic compounds and polycyclic aromatic hydrocarbons. Mental health assessments covered posttraumatic stress disorder (PTSD), depression, state anxiety, and trait anxiety. In the cross-sectional analyses, all four mental health issues were found to be associated with proximity to the oil band (p-value<0.05) and showed a positive association with clean-up work duration (p-value<0.05). Cox regression analysis revealed that higher urinary t, t-muconic acid levels were associated with an increased risk of depression (Hazard Ratio [HR] = 1.55, 95 % Confidence Interval [CI] = 1.05-2.28), and elevated 1-hydroxypyrene levels increased the risk of PTSD (HR = 1.60, 95 % CI = 1.03-2.48). Additionally, higher urinary 2-naphthol levels were associated with increased state anxiety (HR = 1.39, 95 % CI = 1.00-1.93) and trait anxiety (HR = 1.64, 95 % CI = 1.15-2.32). These associations persisted even after controlling for distance and duration variables related to psychosocial exposure. Our findings suggest that environmental disaster response plans should prioritize minimizing chemical exposure while also considering the duration and nature of the mental health impacts.

[Effects of Shugan Tiaoshen intradermal needling intervention on attentional networks in subthreshold depression: a randomized controlled trial].

OBJECTIVE: To analyze the effects of Shugan Tiaoshen (regulating liver and harmonizing spirit) intradermal needling protocol on the attentional networks of patients with subthreshold depression using the attention network test (ANT). METHODS: Eighty patients with subthreshold depression were randomly divided into an intradermal needling group (40 cases) and a sham needling group (40 cases, 2 cases dropped out), with an additional 43 healthy subjects as a normal group. The intradermal needling group received intradermal needling treatment, while the sham needling group received sham intradermal needling, with the needle tip not penetrating the skin. The bilateral Xinshu (BL 15), Ganshu (BL 18), Shentang (BL 44) as well as auricular points Xin (CO15) and Gan (CO12) were selected alternately. Treatments were administered twice a week for a total of 6 weeks in the two groups. The patient health questionnaire-9 (PHQ-9) and generalized anxiety disorder (GAD-7) scores were observed before treatment, after 3 weeks of treatment, after treatment, and at 1 month after the end of treatment (follow-up), and the ANT of the two groups of patients with subthreshold depression before and after treatment as well as the normal group of healthy subjects was compared. RESULTS: The PHQ-9 and GAD-7 scores of the patients with subthreshold depression were decreased after 3 weeks of treatment, after treatment, and in follow-up in the two groups (P<0.05), the differences in PHQ-9 and GAD-7 scores before and after treatment were greater in the intradermal needling group than those in the sham needling group (P<0.01). Before treatment, the executive control network reaction time of the subthreshold depression group (the intradermal needling group and the sham needling group) was higher than that of the normal group (P<0.05). Compared before treatment, the executive control network reaction time of the patients in the intradermal needling group and the sham needling group was decreased after treatment (P<0.05), and the alerting network reaction time of the intradermal needling group was increased after treatment (P<0.05); the difference in alerting network reaction time before and after treatment was greater in the intradermal needling group than that of the sham needling group (P<0.01). CONCLUSION: Regulating liver and harmonizing spirit intradermal needling protocol could effectively improve depressive and anxious symptoms in patients with subthreshold depression, and enhance the efficiency of the alerting network.

Coercive Control in 2SLGBTQQIA+ Relationships: A Scoping Review.

Existing measures and theories of intimate partner coercive control largely evaluate men's coercion of women. The extent of knowledge pertaining to intimate relationships among other genders and sexual identities is unclear. Guided by a theoretical framework of intersectionality, we examined and synthesized original studies on coercive control by (perpetration) or against (victimization) Two Spirit, lesbian, gay, bisexual, trans, queer, questioning, intersex, and asexual individuals within intimate partner relationships. We searched eight academic databases for records from 2014 through 2022 and hand-searched review articles' reference lists, supplemented with gray literature and website searches. Using duplicate screening, we identified 1,774 unique documents; 526 met preliminary eligibility criteria and 277 were retained for data extraction in duplicate. Coercive control was more common among minority individuals and was related to mental health challenges. Few studies reported on gender- or sexual-identity specific forms of coercive control, and an intersectional focus was uncommon. This review revealed a lack of agreed definition of coercive control or accepted standard of measurement, and a gap in research with individuals who identify as gender diverse, gender fluid or intersex, or those identifying their sexuality as asexual, pansexual, or sexually diverse.

'Sometimes white doctors are not very friendly or inclusive': a Critical Race Theory analysis of racism within and beyond sexual health settings.

Many Two-Spirit, gay, bisexual, transgender, and other queer Black, Indigenous, people of colour in Canada encounter racism when testing for sexually transmitted and blood-borne infections. Our objective in this study was to understand how racism shapes testing experiences for these communities in Ontario, Canada. Four peer researchers conducted recruitment and data collection in consultation with a community advisory board. Focus groups and interviews took place with 21 participants and their narrative accounts were analysed using reflexive thematic analysis. Participants identified three interrelated issues when testing: (1) experiencing judgement and discomfort due to racism; (2) lack of community and cultural indicators in testing spaces; and (3) barriers to accessing testing centres and services. Systemic racism was linked to each of these barriers, including increased distance to testing centres due to racial segregation. Participant accounts signal the need for antiracist testing spaces and practices. Key implications include the need for antiracism training for health service providers and others working with Two-Spirit, gay, bisexual, transgender, and other queer Black, Indigenous, people of colour, and the organisations that serve them, in order to make testing spaces safer. Dismantling systemic racism is imperative to achieve health equity for members of these communities.

Reporting characteristics and quality of randomized controlled trial protocols in traditional Chinese medicine: a cross-sectional study.

Objectives: The impact of the Standard Protocol Items: Recommendations for Interventional Trials of Traditional Chinese Medicine (SPIRIT-TCM) Extension 2018 statement on the reporting quality of randomized controlled trial (RCT) protocols in traditional Chinese medicine (TCM) is not clear. This review aimed to assess the reporting characteristics and quality of RCT protocols involving interventions such as Chinese herbal medicine formulas (CHMF), acupuncture, and moxibustion published in the last 3 years. Methods: We conducted an extensive search among multiple databases, including All EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid MEDLINE(R), PubMed, Web of Science, Google Scholar, and ClinicalTrials.gov for publications in English from 1 January 2020 to 10 August 2023. Two reviewers independently assessed the eligibility of the publications, extracted predetermined information, and evaluated the reporting based on the SPIRIT-TCM Extension 2018 checklist. Results: Of the 420 eligible protocols (comprising 163 studies on CHMF, 239 on acupuncture, and 18 on moxibustion), the average reporting compliance rate was only 35.4%. Approximately half of the assessed items fell into the category of poorly reported, demonstrating a compliance rate below 65%. Notably, reporting compliance in acupuncture and moxibustion interventional studies exhibited higher scores than compliance in CHMF studies. Conclusion: Continued, concerted, and coordinated efforts are required by journals, editors, reviewers, and investigators to improve the application and promotion of the SPIRIT-TCM Extension 2018 reporting guideline.

Preliminary Investigation of Fruit Mash Inoculation with Pure Yeast Cultures: A Case of Volatile Profile of Industrial-Scale Plum Distillates.

This study investigates the effect of pure yeast culture fermentation versus spontaneous fermentation on the volatile compound profile of industrially produced plum brandy. Using traditional distillation methods, the evolution of key volatile compounds is monitored at seven different moments during the distillation process. By integrating advanced analytical techniques such as GC-MS and sensory evaluation, significant differences in the composition of the distillates are highlighted, particularly in terms of ethyl esters and higher alcohols which are key to the sensory properties of the final product. Distillates produced with the addition of pure cultures gave higher concentrations of esters than those obtained by wild fermentation. The results of our industrial research show that the most critical step is to limit the storage of the input raw material, thereby reducing the subsequent risk of producing higher concentrations of 1-propanol. Furthermore, our results indicate that the heart of the distillate can only be removed up to an ethanol content of approximately 450 g/L and that the removal of additional ethanol results in only a 10% increase in the total volume of the distillate, which in turn results in an increase in boiler heating costs of approximately 30%.

[Clinical experience of Shao's nu-needle manipulation method for post-stroke depression].

The clinical experience of Shao's needling technique for post-stroke depression is introduced. Professor SHAO Jingming proposes that the main pathogenesis of this condition lies in the "imbalance of body and spirit," with its onset closely related to the heart, liver, spleen, and kidney. In clinical practice, based on the principle of "treating both the body and spirit", "three acupoints for treating the spirit" including Dazhui (GV 14), Fengchi (GB 20), and Baihui (GV 20) are selected, combined with back-shu points such as Xinshu (BL 15), Ganshu (BL 18), Pishu (BL 20), and Shenshu (BL 23). The nu-needle manipulation method is applied. The treatment focuses on both physical and mental aspects, achieving remarkable therapeutic effects.

Religion would be a missing link in the case formulation of adolescents with conduct problems: an eclectic approach.

Psychiatry is concerned with mental health. Cognition is one of the key mental functions and manifests itself primarily as behavior. A behavior exhibited in response to a stimulus is influenced by biological (inherited), psychological (individual), and social (environmental) factors. During consolidation of an exhibited behavior, the factors affecting the individual's cognitive structure and personality play crucial roles. Underlying factors for a problematic behavior, and their weakness/strength levels are determined via the Biopsychosocial model. Empirically effective current practices to intervene the problematic behaviors do not always result in success. One of the reasons may be other elements that were omitted during the case formulation process. This article aims to stress the idea that whatever the underlying factor of a problematic behavior is, the most crucial determinant and/or pre-emptive factor in developing or maintaining that behavior might actually be the religion as a governing and directive philosophy on how to conduct oneself. In this instance, the key is in the hands of the parents or caregivers.

Alkali-assisted extraction, characterization and encapsulation functionality of enzymatic hydrolysis-resistant prolamin from distilled spirit spent grain.

Curcumin is a natural lipophilic polyphenol that exhibits significant various biological properties such as antioxidant and anti-inflammatory properties following oral administration. However, its uses have shown limitations concerning aqueous solubility, bioavailability and biodegradability that could be improved by prolamin-based nanoparticle. In this study, curcumin was encapsulated into prolamin from sorghum (SOP) and wheat (WHP) and distilled spirit spent grain (DSSGP), which was obtained after microbial proteolysis of the former two cereal grains. All the three prolamins showed clear variation of protein profiles and microstructure as confirmed by electrophoresis analysis, disulfide bond determination and Fourier-transform infrared spectroscopy (FTIR). For curcumin-loaded nanospheres (NPs) fabrication, three prolamin-based NPs shared features of spherical shape, uniform particle size, and smooth surface. The average size ranged from 122 to 193 nm depending on the prolamin variety and curcumin loading. In the experiments in vitro, curcumin showed significantly improved UV/thermal stability. Furthermore, DSSGP was more resistant to enzymatic digestion in vitro, hence achieving the controlled release of curcumin in gastrointestinal tract. Collectively, the results indicated the improved bioavailability and biodegradability of curcumin encapsulated by DSSGP, which would be an innovative potential encapsulant for effective protection and targeted delivery of hydrophobic compounds.

Perspectives on digital testing services for sexually transmitted and blood-borne infections from Two-Spirit, gay, bisexual, transgender, and other queer Black, Indigenous, people of colour living in Ontario, Canada.

OBJECTIVES: Increased sexually transmitted and blood-borne infections (STBBI) testing can reduce the burden of disease among Two-Spirit, gay, bisexual, transgender, and other queer Black, Indigenous, people of colour (2SGBTQ+ BIPOC). However, this population encounters barriers, such as discrimination, when accessing in-person STBBI testing services. Digital STBBI testing, such as self-testing/collection kits ordered online and digital requisitions, may address some of these barriers. Our aim was to understand acceptability of free digital STBBI testing among 2SGBTQ+ BIPOC living in Ontario, Canada. DESIGN: We approached this analysis using Implementation Science and Critical Race Theory. We conducted interviews and focus groups with 21 2SGBTQ + BIPOC individuals from 2020-2021. Participants were asked about their perceptions of the benefits and drawbacks of digital STBBI testing, populations that would benefit from using these services, and recommendations for how these services may be implemented in Ontario. Interviews and focus groups were transcribed verbatim and analyzed using reflexive thematic analysis. RESULTS: Six themes emerged. Digital STBBI testing services: (1) May reduce oppression experienced by 2SGBTQ + BIPOC when testing in-person; (2) Should address the unique needs that 2SGBTQ + BIPOC experience due to other intersecting identities they possess; (3) Should adapt their services to suit the varying cultural contexts and living circumstances of 2SGBTQ + BIPOC; (4) Should be accessible to 2SGBTQ + BIPOC who hold diverse or no documentation; (5) Should be offered in multiple languages; (6) May be inaccessible to those without Internet access or devices. CONCLUSION: Digital STBBI testing is one strategy that may reduce discrimination experienced by 2SGBTQ + BIPOC when getting tested in-person. However, digital STBBI testing services may not address all the needs of 2SGBTQ + BIPOC. Racism and other forms of oppression embedded into in-person and digital testing services will need to be addressed to meet the needs of this diverse population.

A Novel Approach for Correcting Limb Length Discrepancy in Total Hip Arthroplasty.

INTRODUCTION: This study aimed to evaluate the accuracy of the suture technique, along with the utilization of a spirit-level device which is an instrument designed to indicate whether a surface is horizontal or vertical, in comparison to the conventional supraacetabular pin method and caliper measurement for correcting leg length discrepancy (LLD) during total hip arthroplasty (THA). Materials and methods: Consecutive patients who underwent unilateral primary THA between January 2021 and March 2023 were included in the study. The exclusion criteria were severe flexion and adduction contracture that could affect the accuracy of measurements, a history of lower extremity surgery, the presence of lower extremity deformity, and the absence of postoperative full-length radiographs. Patients were allocated into two groups based on the technique employed for correcting LLD during THA. Group 1 (n=62) consisted of patients evaluated using the suture technique with a spirit-level device, while group 2 (n=75) comprised patients who underwent the supraacetabular pin method with caliper measurement. The distance between the inter-teardrop line and the tip of the lesser trochanter was measured for both hips to assess LLD. RESULTS: The mean preoperative LLD was similar between groups, which was 11.6 ± 9.1 mm in group 1 and 9.5 ± 9.8 mm in group 2 (p=0.191). Postoperatively, group 1 had a significantly lower LLD compared to group 2 (p<0.001). CONCLUSION: According to the results obtained from this study, the use of a suture technique in conjunction with a spirit-level device to achieve a consistent leg position is an effective method for correcting LLD during THA.

Traditional health practitioners' understanding of spirit possession in Gauteng province, South Africa.

Background: Traditional health practitioners (THPs) understand spirit possession as a cultural or religious spirit occupying a person, while the mental healthcare providers understand it as a mental illness. The different understanding is based on manifestations that mimic that of mental illness, such as seeing and hearing things that others cannot see or hear. Spirit possession holds different meanings in different cultures and religions that could be either beneficial or detrimental. Furthermore, spirit possession is understood as a channel of communication between the living and the dead or God or a supernatural phenomenon in which a spirit owns a person. Aim: This study explored and interpreted THPs' understanding of spirit possession in Gauteng province, South Africa. Method: Hermeneutic phenomenology study explored and interpreted the THPs' understanding of spirit possession in Gauteng province. In-depth individual interviews were conducted with 12 THPs who were selected through snowball sampling techniques. Data analysis followed Heidegger's and Gadamer's philosophies and Van Manen's six steps of the analytic approach. Results: The findings revealed that THPs understood spirit possession as spiritual illness, ancestral calling and demonic spirit or witchcraft. Conclusion: Traditional health practitioners' understanding of spirit possession could promote mental health and prevent mental illness by providing support to a spirit-possessed person and referral to mental healthcare services. Contribution: This study contributed that not all manifestations presented by persons with spirit possession are actual and clear-cut mental illness, but could be unwritten cultural and/ or religious illnesses that needs cultural and religious services also.

Justification for unequal allocation ratios in clinical trials: A scoping review.

OBJECTIVE: The objective of this review is to provide an overview of the justification reported for using unequal allocation ratios in randomized clinical trials (RCTs) testing a medical intervention. METHODS: Using the PICOS framework, we conducted a systematic search to find meta-studies within PubMed (a Medline database interface) that addressed the objective. RESULTS: The developed search strategy generated 525 results, of which, three studies met criteria for inclusion. These studies found that 22-43% of RCTs provided a justification for the use of unequal allocation based on publication alone, and between 38.7 and 66% after seeking input from trial authors. The most common reason given for this design was to gather increased safety data according to two reviews and to gain experience with an intervention according to the third review. CONCLUSION: Reporting of justification for RCTs designed with unequal allocation appears to occur less than half the time in the included studies. The reasons given for designing clinical trials with unequal participants encompass many domains, including ethical considerations. As such, this design feature should be implemented with intentionality to maximize the ethical features of clinical trials for participants. Coupling lack of justification with lack of adjusting for sample size estimations depicts an overall landscape in which there is significant room for improvement in methodological transparency within this area of RCTs.

Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements.

OBJECTIVES: To describe, and explain the rationale for, the methods used and decisions made during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines. METHODS: We developed SPIRIT 2024 and CONSORT 2024 together to facilitate harmonization of the two guidelines, and incorporated content from key extensions. We conducted a scoping review of comments suggesting changes to SPIRIT 2013 and CONSORT 2010, and compiled a list of other possible revisions based on existing SPIRIT and CONSORT extensions, other reporting guidelines, and personal communications. From this, we generated a list of potential modifications or additions to SPIRIT and CONSORT, which we presented to stakeholders for feedback in an international online Delphi survey. The Delphi survey results were discussed at an online expert consensus meeting attended by 30 invited international participants. We then drafted the updated SPIRIT and CONSORT checklists and revised them based on further feedback from meeting attendees. RESULTS: We compiled 83 suggestions for revisions or additions to SPIRIT and/or CONSORT from the scoping review and 85 from other sources, from which we generated 33 potential changes to SPIRIT (n = 5) or CONSORT (n = 28). Of 463 participants invited to take part in the Delphi survey, 317 (68%) responded to Round 1, 303 (65%) to Round 2 and 290 (63%) to Round 3. Two additional potential checklist changes were added to the Delphi survey based on Round 1 comments. Overall, 14/35 (SPIRIT n = 0; CONSORT n = 14) proposed changes reached the predefined consensus threshold (≥80% agreement), and participants provided 3580 free-text comments. The consensus meeting participants agreed with implementing 11/14 of the proposed changes that reached consensus in the Delphi and supported implementing a further 4/21 changes (SPIRIT n = 2; CONSORT n = 2) that had not reached the Delphi threshold. They also recommended further changes to refine key concepts and for clarity. CONCLUSION: The forthcoming SPIRIT 2024 and CONSORT 2024 Statements will provide updated, harmonized guidance for reporting randomized controlled trial protocols and results, respectively. The simultaneous development of the SPIRIT and CONSORT checklists has been informed by current empirical evidence and extensive input from stakeholders. We hope that this report of the methods used will be helpful for developers of future reporting guidelines.