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.

Barriers and facilitators to utilizing digital health technologies by healthcare professionals.

Digital technologies change the healthcare environment, with several studies suggesting barriers and facilitators to using digital interventions by healthcare professionals (HPs). We consolidated the evidence from existing systematic reviews mentioning barriers and facilitators for the use of digital health technologies by HP. Electronic searches were performed in five databases (Cochrane Database of Systematic Reviews, Embase®, Epistemonikos, MEDLINE®, and Scopus) from inception to March 2023. We included reviews that reported barriers or facilitators factors to use technology solutions among HP. We performed data abstraction, methodological assessment, and certainty of the evidence appraisal by at least two authors. Overall, we included 108 reviews involving physicians, pharmacists, and nurses were included. High-quality evidence suggested that infrastructure and technical barriers (Relative Frequency Occurrence [RFO] 6.4% [95% CI 2.9-14.1]), psychological and personal issues (RFO 5.3% [95% CI 2.2-12.7]), and concerns of increasing working hours or workload (RFO 3.9% [95% CI 1.5-10.1]) were common concerns reported by HPs. Likewise, high-quality evidence supports that training/educational programs, multisector incentives, and the perception of technology effectiveness facilitate the adoption of digital technologies by HPs (RFO 3.8% [95% CI 1.8-7.9]). Our findings showed that infrastructure and technical issues, psychological barriers, and workload-related concerns are relevant barriers to comprehensively and holistically adopting digital health technologies by HPs. Conversely, deploying training, evaluating HP's perception of usefulness and willingness to use, and multi-stakeholders incentives are vital enablers to enhance the HP adoption of digital interventions.

The global effect of digital health technologies on health workers' competencies and health workplace: an umbrella review of systematic reviews and lexical-based and sentence-based meta-analysis.

Systematic reviews have quantified the effectiveness, feasibility, acceptability, and cost-effectiveness of digital health technologies (DHTs) used by health-care workers. We aimed to collate available evidence on technologies' effect on health-care workers' competencies and performance. We searched the Cochrane Database of Systematic Reviews, Embase, MEDLINE, Epistemonikos, and Scopus for reviews published from database inception to March 1, 2023. Studies assessing the effects of DHTs on the organisational, socioeconomic, clinical, and epidemiological levels within the workplace, and on health-care workers' performance parameters, were included. Data were extracted and clustered into 25 domains using vote counting based on the direction of effect. The relative frequency of occurrence (RFO) of each domain was estimated using R software. AMSTAR-2 tool was used to appraise the quality of reporting, and the Confidence in the Evidence from Reviews of Qualitative research approach developed by Grading of Recommendations Assessment, Development and Evaluation was used to analyse the certainty of evidence among included studies. The 12 794 screened reviews generated 132 eligible records for assessment. Top-ranked RFO identifiers showed associations of DHT with the enhancement of health-care workers' performance (10·9% [95% CI 5·3-22·5]), improvement of clinical practice and management (9·8% [3·9-24·2]), and improvement of care delivery and access to care (9·2% [4·1-20·9]). Our overview found that DHTs positively influence the daily practice of health-care workers in various medical specialties. However, poor reporting in crucial domains is widely prevalent in reviews of DHT, hindering our findings' generalisability and interpretation. Likewise, most of the included reviews reported substantially more data from high-income countries. Improving the reporting of future studies and focusing on low-income and middle-income countries might elucidate and answer current knowledge gaps.

A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010.

OBJECTIVES: To identify, summarize, and analyse comments on the core reporting guidelines for protocols of randomized trials (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] 2013) and for completed trials (Consolidated Standards of Reporting Trials [CONSORT] 2010), with special emphasis on suggestions for guideline modifications. METHODS: We included documents written in English and published after 2010 that explicitly commented on SPIRIT 2013 or CONSORT 2010. We searched four bibliographic databases (Embase and MEDLINE to June 2022; Web of Science and Google Scholar to April 2022) and other sources (e.g., the EQUATOR Network website, the BMC Blog Network, and the BMJ rapid response section). Two authors independently assessed documents for eligibility and extracted data on basic characteristics and the wording of the main comments. We categorized comments as 'suggestion for modification to the wording of an existing guideline item,' 'suggestion for a new item,' or 'reflections on challenges or strengths.' We provided a summary and examples of the proposed suggestions and categorized comments into those that were directly linked to empirical investigations, were continuations of previous methodological discussions, or reflected new methodological developments. RESULTS: We assessed full text of 2,320 potentially eligible documents and included 93 documents with 114 comments. In total, 37 comments suggested modifications to existing guideline items. The participant flow section of CONSORT 2010 received the most comments (eight comments made different suggestions, e.g., one comment suggested to add numbers on nonrandomized screened participants). There were 46 comments suggesting new items. Multiple suggestions were related to trial interventions (eight comments made different suggestions, e.g., one comment suggested to add content on cointerventions), blinding (six comments suggested to add content on risk of unblinding), statistical methods (five comments made different suggestions, e.g., one comment suggested to add content on blinding of statisticians), and participant flow (seven comments made different suggestions, e.g., three comments suggested to add content on missing data). Half (53%) of the suggestions were directly linked to empirical investigations. Six (7%) suggestions were continuations of previous methodological discussions and five (6%) suggestions reflected new methodological developments related to conflicts of interest and funding, data sharing, and patient and public involvement. CONCLUSION: The issues raised provide context to authors, peer reviewers, editors, and readers of trials using SPIRIT 2013 and CONSORT 2010 and inform the planned updates of the core guidelines.

The Danish Spinal Cord Injury Shoulder (DanSCIS) cohort: methodology and primary results.

STUDY DESIGN: Cross-sectional study. OBJECTIVES: To describe the socio-demographics, injury characteristics, prevalence of shoulder and neck symptoms, weekly participation in leisure time physical activity (LTPA) and quality of life (QoL) of individuals with spinal cord injury in Denmark (SCI). SETTING: Nation-wide community survey, Denmark. METHODS: Individuals with SCI for >2 years were included from three SCI rehabilitation departments. Questionnaire data regarding socio-demographic details, SCI injury characteristics, medical history, shoulder and neck symptoms, LTPA and QoL were collected. RESULTS: Of 2454 potential participants, 1517 (62%) responded to the survey (mean age = 56.2, SD 16.1, 37% female, 42% tetraplegia, 23% complete SCI, mean time since injury = 16.9, SD 13.5). 75% used some form of assistive mobility device. Responders and non-responders showed no sex or injury type/severity differences. Shoulder and neck symptoms within the past 3 months were reported by 63 and 67% respectively, with 51% reporting shoulder symptoms within the past week. Among those with symptoms, 61% had experienced shoulder symptoms and 56% neck symptoms, for more than 30 days during the previous 3 months. Symptoms often prevented participants from performing their usual activities (due to shoulder symptoms 46%, neck symptoms 41%). CONCLUSIONS: A high prevalence of self-reported shoulder and neck symptoms was found, which may limit physical function and social activities. We succeeded in generating the Danish Spinal Cord Injury Shoulder (DanSCIS) dataset, which comprised a substantial proportion of Danish adults with SCI. Future studies using data from this cohort will investigate patterns and associations between shoulder/neck symptoms, use of assistive mobility devices, LTPA and QoL.

Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study.

OBJECTIVE: To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally. DESIGN: Qualitative interview study. PARTICIPANTS: Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed. SETTING: Interviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest. RESULTS: The interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage. CONCLUSION: This study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers' understanding of what conflicts of interest are and when they should be reported.

Systematic review finds that appraisal tools for medical research studies address conflicts of interest superficially.

OBJECTIVES: The objective of this study was to identify and summarize 1) appraisal tools and other guides which address conflicts of interest in medical research studies; and 2) top journals with policies on managing conflicts of interest in journal papers. STUDY DESIGN AND SETTING: We searched bibliographic databases, other sources, and websites of 30 top medical journals. Two authors selected documents and extracted data. RESULTS: We included 27 appraisal tools. None were designed specifically for addressing conflicts of interest and they included only 1-2 short items on conflicts of interest. We also included eight other types of guides. Of 27 appraisal tools, 23 addressed study funding, and 19 authors' conflicts of interest. Nine tools addressed availability of conflicts of interest information, 13 reported conflicts of interest, and five influence from conflicts of interest. Twelve of 30 top journals had conflicts of interest managing policies (beyond disclosure). One journal restricted nonresearch papers (e.g., editorials) to authors without financial conflicts of interest and ten only restricted under certain circumstances. CONCLUSION: Appraisal tools that address conflicts of interest typically do so superficially and rarely address how conflicts of interest may influence studies. Less than half of top medical journals have explicit policies on managing conflicts of interest.

Generalised joint hypermobility and knee joint hypermobility: prevalence, knee joint symptoms and health-related quality of life in a Danish adult population.

AIM: Several biomechanical factors, such as knee joint hypermobility (KJH), are suggested to play a role in the etiology of knee joint symptoms and knee osteoarthritis. Nevertheless, the prevalence or consequences of KJH solely or included in the classification of generalized joint hypermobility (GJHk) is unknown for a general population. Therefore, the objectives were to report the prevalence of self-reported GJHk and KJH, as well as the association of these conditions to knee joint symptoms, severity and duration of symptoms, and health-related quality of life (HRQoL) in a Danish adult population. METHOD: This study is a cross-sectional population-based survey of 2056 Danish adults. Respondents received online questionnaires of GJHk and KJH, knee joint symptoms, the severity and duration of these, as well as HRQoL. RESULTS: Total response rate was 49% (n = 1006). The prevalence of self-reported GJHk and KJH was 13% and 23%, mostly representing women. More than half of the respondents with GJHk and KJH had knee joint symptoms. The odds for reporting knee joint symptoms, severity of knee joint symptoms and duration of knee joint symptoms were twice as high for respondents with GJHk and KJH. Respondents with GJHk and KJH reported lower HRQoL. CONCLUSION: GJHk and KJH were frequently reported in the Danish adult population, mostly in women. Respondents with GJHk and KJH were two times more likely to report knee joint-related symptoms such as pain, reduced performance of usual activity and lower HRQoL. The impact of these conditions on HRQoL is comparable with knee osteoarthritis.

Generalised joint hypermobility and shoulder joint hypermobility, - risk of upper body musculoskeletal symptoms and reduced quality of life in the general population.

BACKGROUND: Generalised Joint Hypermobility (GJH) is a hereditary condition with an ability to exceed the joints beyond the normal range. The prevalence of GJH in the adult population and its impact on upper body musculoskeletal health and quality of life has mostly been studied in selected populations. The aims of this study were therefore, firstly to study the prevalence of GJH and GJH including shoulder hypermobility (GJHS), in the general Danish adult population; secondly to test the associations between GJH or GJHS and upper body musculoskeletal symptoms and health-related quality of life (HRQoL). METHODS: The study was cross-sectional where 2072 participants, aged 25-65, randomly extracted from the Danish Civil Registration System), were invited to answer a questionnaire battery (Five-Part Questionnaire for classification of GJH, Standardised Nordic Questionnaire for musculoskeletal symptoms, EuroQoL-5D for HRQoL). RESULTS: Totally 1006 (49%) participants responded. The prevalence of GJH and GJHS were 30% (n = 300) and 5% (n = 51), respectively. Compared with Non GJH (NGJH), participants with GJH and GJHS had Odds Ratio (OR) of 1.5-3.5 for upper body musculoskeletal symptoms within the last 12 months (mostly shoulders and hands/wrists). GJH and GJHS also had OR 1.6-4.4 for being prevented from usual activities, mostly due to shoulder and neck symptoms. Furthermore, GJH and GJHS had OR 2.2-3.1 for upper body musculoskeletal symptoms lasting for more than 90 days (neck, shoulders, hand/wrists), and 1.5-3.5 for reduced HRQoL (all dimensions, but anxiety/depression) compared with NGJH. Generally, most OR for GJHS were about twice as high as for those having GJH alone. CONCLUSIONS: GJH and GJHS are frequently self-reported musculoskeletal conditions in the Danish adult population. Compared with NGJH, GJH and especially GJHS, present with higher OR for upper body musculoskeletal symptoms, more severe symptoms and decreased HRQoL.

Trajectory of self-reported pain and function and knee extensor muscle strength in young patients undergoing arthroscopic surgery for meniscal tears: A systematic review and meta-analysis.

OBJECTIVES: To investigate the trajectory of patient reported pain and function and knee extensor muscle strength over time in young individuals undergoing arthroscopic meniscal surgery. DESIGN: Systematic review and meta-analysis METHODS: Six databases were searched up to October 13th, 2016. PATIENTS AND INTERVENTION: People aged 30 years or younger undergoing surgery for a meniscal tear. OUTCOMES: and comparator: (1) Self-reported pain and function in patients undergoing meniscal surgery compared to a non-operative control group (2). Knee extensor strength in the leg undergoing surgery compared to a healthy control group or the contra-lateral leg. Methodological quality was assessed using the SIGN 50 guidelines. RESULTS: No studies were found on patient reported pain and function. Six studies, including 137 patients were included in the analysis on knee extensor muscle strength. Knee extensor muscle strength was impaired in the injured leg prior to surgery and was still reduced compared with control data up to 12 months after surgery (SMD: -1.16) (95% CI: -1.83; -0.49). All included studies were assessed to have a high risk of bias. CONCLUSIONS: No studies were found comparing the trajectory of self-reported pain and function in patients undergoing arthroscopic surgery compared with non-operative treatments for young patients with meniscal tears. Knee extensor strength seemed to be impaired up to 12 months after surgery in young patients undergoing surgery for meniscal tears. The results of the present study should be interpreted with caution due to a limited number of available studies with high risk of bias including relatively few patients.