The strength and conditioning practices and perspectives of soccer coaches and players

Strength and conditioning (S&C) is implemented across various sports and levels, but there is limited understanding of the personnel responsible for this, including their S&C practices and perspectives. Whereas recent evidence has shown that coaches and players are often tasked with the responsibility. Therefore, this study aimed to investigate: 1) the personnel responsible for delivering S&C across different levels of soccer, 2) the practices and perspectives of soccer coaches and players, and 3) to ascertain whether the practices employed align with contemporary evidence and guidelines. Forty-two soccer coaches and 30 soccer players completed an online survey with six sections: (a) informed consent, (b) background information, (c) education, qualifications, and prescription, (d) views on S&C, (e) exercise selection and preferences, and (f) issues and improvements. Frequency analysis was used to report responses to fixed-response questions and thematic analysis for open-ended questions. Most respondents reported S&C to be ‘important’ to ‘very important’ for all soccer, physical fitness, and injury parameters, with perspectives being predominantly aligned with S&C guidelines and research in soccer. Although S&C coaches were mostly responsible for delivering S&C sessions, over 60% of respondents disclosed S&C sessions were delivered independently or by support staff. This is problematic given only four coaches held S&C qualifications, and issues and improvements were mostly regarding a lack of S&C expertise and education. This study provides valuable information for S&C and soccer organizations. Particularly regarding the additional support required to ensure those responsible for delivering S&C in soccer have the appropriate knowledge and qualifications.

Harmonising the human biobanking consent process: an Irish experience

Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by the Participant Information Leaflets and Informed Consent Form (PI/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation and the related Irish Health Research Regulation presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, General Data Protection Regulation/Health Research Regulation-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the Health Research Data Protection Network.

New method of tibio-calcaneal-navicular arthrodesis after talectomy.

Purpose To develop and investigate the results of a new, simple and versatile method of tibia- calcaneal arthrodesis that reduces limb shortening. Materials and methods This prospective study was conducted in patients who voluntarily agreed to a new operation. Informed consent was obtained from all individual participants included in the study. For 17 years, we have observed 14 patients with various forms of osteomyelitis, fractures and septic necrosis of the talus, who underwent a new method of tibio-calcaneal-navicular arthrodesis (TCNA). The age of the patients ranged from 23 to 75 years, (42 years on average). 2 patients were female, 12 were male. The Ilizarov apparatus was used as a fixator. The average time of immobilization in the apparatus was 4.9 months (from 3.5 to 6 months). The operations were performed by one surgeon. Results In all patients the wounds healed by primary intention. The average limb shortening 1.9 ± 0.5 cm. AOFAS Ankle-Hindfoot score (n=14) in all patients came up to 77,9 ± 6,8 (min 68, max 86) SD 12,8. Patients wore ordinary footwear without arch supporter and heels till 2cm. Only two female patients over 70 years used a stick. 2 patients had minor pain during prolonged walking. Conclusion Excellent and good results were obtained in all patients. The new TCNA method allows restoring the support ability of a limb, reduces shortening and improves the quality of life for patients.

Evaluating and extending the Informed Consent Ontology for representing permissions from the clinical domain

The purpose of this study was to evaluate, revise, and extend the Informed Consent Ontology (ICO) for expressing clinical permissions, including reuse of residual clinical biospecimens and health data. This study followed a formative evaluation design and used a bottom-up modeling approach. Data were collected from the literature on US federal regulations and a study of clinical consent forms. Eleven federal regulations and fifteen permission-sentences from clinical consent forms were iteratively modeled to identify entities and their relationships, followed by community reflection and negotiation based on a series of predetermined evaluation questions. ICO included fifty-two classes and twelve object properties necessary when modeling, demonstrating appropriateness of extending ICO for the clinical domain. Twenty-six additional classes were imported into ICO from other ontologies, and twelve new classes were recommended for development. This work addresses a critical gap in formally representing permissions clinical permissions, including reuse of residual clinical biospecimens and health data. It makes missing content available to the OBO Foundry, enabling use alongside other widely-adopted biomedical ontologies. ICO serves as a machine-interpretable and interoperable tool for responsible reuse of residual clinical biospecimens and health data at scale.

Seeking Approval from Universities to Research the Views of Their Staff. Do Gatekeepers Provide a Barrier to Ethical Research?

A “gatekeeper” controls access to an organization; “gatekeeper approval” is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.

Struggling With Extensive Informed Consent Procedures for Cancer Trails – Is There Even a Benefit for the Patients?

PurposeInformed consent procedures in clinical trials often differ in length and complexity to those in clinical routine care. Little is known about the benefit of extensive procedures as intended in clinical trials compared to procedures in routine cancer treatment. MethodsIn two different clinical studies performed at a comprehensive cancer center, we compared patients’ comprehension and satisfaction of current informed consent procedures in routine clinical care with the level of comprehension and satisfaction of patients treated within clinical trials. Patients with a new cancer diagnosis and recent informed consent received a questionnaire about satisfaction, comprehension, time management and physician-patient relationship of the informed consent process. Patients in cohort 1 consented to cancer treatment within a clinical trial and were additionally interviewed in a structured way; patients in cohort 2 consented to “standard” chemotherapy and received a follow-up questionnaire after 6 months. ResultsIn cohort 1, 82 patients completed the questionnaire and had an additional structured interview. They were treated in 41 different trials, receiving up to 40 pages of educational material. In cohort 2, 89 patients completed the first and 52 completed the follow-up questionnaire after receiving a standard informed consent form of 6 pages. Subjective understanding and satisfaction with the information provided was equally very high. However, deficits in objective understanding were observed in both cohorts. ConclusionExtensive informed consent procedures for clinical cancer trials have not been associated with a higher level of satisfaction or measurable objective understanding, therefore the benefit seems to be limited.

Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan—a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial)

Background Maternal undernutrition is critical in the etiology of poor perinatal outcomes and accounts for 20% of small-for-gestational-age (SGA) births. High levels of food insecurity, antenatal undernourishment, and childhood undernutrition necessitate the supplementation of fortified balanced energy protein (BEP) during pregnancy in low-income settings especially with scarce literature available in this subject. Hence, this paper extensively covers the protocol of such a trial conducted in an urban slum of Karachi, Pakistan. Methods The trial is community-based, open-labelled, four-arm, and randomized controlled that will include parallel group assignments with a 1:1:1:1 allocation ratio in low-income squatter settlements in urban Karachi, Pakistan. All pregnant women (PW), if identified between > 8 and < 19 weeks of gestation based on ultrasound, will be offered routine antenatal care (ANC) counseling and voluntary participation in the trial after written informed consent. A total number of 1836 PW will be enrolled with informed consent and randomly allocated to one of the four arms receiving: (1) ANC counseling only (control group), (2) ANC counseling plus BEP supplement (intervention arm 1), (3) ANC counseling plus BEP supplement plus 2 doses azithromycin (intervention arm 2), or (4) ANC counseling plus BEP supplement plus daily single dose of nicotinamide and choline (intervention arm 3). Trial registration ClinicalTrials.govNCT04012177. Registered on July 9, 2019.