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BackgroundVasectomy occlusive success is defined by the recommendation of ‘clearance’ to stop other contraception, and is elicited by post-vasectomy semen analysis (PVSA). We evaluated how the choice of either a postal or non-postal PVSA submission strategy was associated with compliance to PVSA and effectiveness of vasectomy.MethodsWe studied vasectomies performed in the UK from 2008 to 2019, reported in annual audits by Association of Surgeons in Primary Care members. We calculated the difference between the two strategies for compliance with PVSA, and early and late vasectomy failure. We determined compliance by adding the numbers of men with early failure and those given clearance. We performed stratified analyses by the number of test guidance for clearance (one-test/two-test) and the study period (2008–2013/2014–2019).ResultsAmong 58 900 vasectomised men, 32 708 (56%) and 26 192 (44%) were advised submission by postal and non-postal strategies, respectively. Compliance with postal (79.5%) was significantly greater than with non-postal strategy (59.1%), the difference being 20.4% (95% CI 19.7% to 21.2%). In compliant patients, overall early failure detection was lower with postal (0.73%) than with non-postal (0.94%) strategy (−0.22%, 95% CI −0.41% to −0.04%), but this difference was neither clinically nor statistically significant with one-test guidance in 2014–2019. There was no difference in late failure rates.ConclusionsPostal strategy significantly increased compliance to PVSA with similar failure detection rates. This resulted in more individuals receiving clearance or early failure because of the greater percentage of postal samples submitted. Postal strategy warrants inclusion in any future guidelines as a reliable and convenient option.

BACKGROUND Core outcome sets (COSs) are important and necessary as they help standardize reporting in research studies. Cranioplasty following traumatic brain injury (TBI) or stroke is becoming increasingly common, leading to an ever-growing clinical and research interest, especially regarding the optimal material, cost-effectiveness, and timing of cranioplasty concerning neurological recovery and complications. Consequently, heterogeneous reporting of outcomes from such diverse studies has led to limited meta-analysis ability and an ongoing risk of outcome reporting bias. This study aims to define a standardized COS for reporting in all future TBI and stroke cranioplasty studies. OBJECTIVE This study has four aims: (1) undertake a systematic review to collate the most current outcome measures used within the cranioplasty literature; (2) undertake a qualitative study to understand better the views of clinicians, patients' relatives, and allied health professionals regarding clinical outcomes following cranioplasty; (3) undertake a Delphi survey as part of the process of gaining consensus for the COS; and (4) finalize consensus through a consensus meeting resulting in the COS. METHODS An international steering committee has been formed to guide the development of the COS. In addition, recommendations from other clinical initiatives such as COMET (Core Outcomes and Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) have been adhered to. Phase 1 is data collection through a systematic review and qualitative study. Phase 2 is the COS development through a Delphi survey and consensus meetings with consensus definitions decided and agreed upon before the Delphi survey begins to avoid bias. RESULTS Phase 1 started at the end of 2019, following ethical approval in December 2019, and the project completion date is planned for the end of 2022 or beginning of 2023. CONCLUSIONS This study should result in a consensus on a COS for cranioplasty, following TBI or stroke, to help standardize outcome reporting for future studies, which can be applied to future research and clinical services, help align future studies, build an increased understanding of cranioplasty and its impact on a patient’s function and recovery, and help standardize the evidence base. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/37442

Background: There is increasing evidence for music-based interventions in neurorehabilitation, improving mood and functional outcomes. In response, there is growing interest from healthcare providers in setting up Neurologic Music Therapy (NMT) services. This paper presents some preliminary data on the feasibility and acceptability of NMT in the acute stroke, multidisciplinary team setting, about which little is known.\ud Objectives: To assess the feasibility and acceptability of a two-day per-week NMT service over 24 months.\ud Methods: Data were collected on the number of referrals received, sessions attended, sessions declined and reasons why. Staff completed questionnaires, and collected them from patients and their relatives, rating interventions: 1. Not helpful, 2. Quite helpful, 3. Helpful, 4. Very helpful. Patients completed the Visual Analogue Mood Scale (VAMS) pre-/post- a single session.\ud Results: Of 201 patients referred, 177 received treatment and 675 sessions were delivered. Twenty-four patients were discharged before sessions were scheduled and twenty-eight sessions were declined, predominantly due to fatigue. Mean scores (SD) from questionnaire data were: patients (n = 99) 3.34 (0.825), relatives (n = 13) 3.83 (0.372), staff (n = 27) 3.85 (0.388). Mean, post-session VAMS data (n = 52) showed a non-significant reduction in ‘Sad’ (7.5, p = 0.007, CI = 2.1, 12.9) and an increase in ‘Happy’ (+ 6.2, p = 0.013, CI = -11.0, -1.4). \ud Conclusions: Data suggest the service was feasible and helpful, particularly for patient mood, possibly improving engagement in rehabilitation. Research to determine generalisability in different stroke environments and treatment effects within them is warranted.

In the United States, the Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) are two of the primary federal agencies that regulate nutraceutical products. Although there is some overlap between the two, the FDA's regulations are generally concerned with ensuring that the product and its ingredients are safe for human consumption and are appropriately manufactured. The FTC, on the other hand, has established many of the standards for advertising and monitors companies to ensure their advertising claims are truthful and accurate. In addition to governmental regulators, private actors—including consumers and competitors—may challenge advertising as deceptive either in court under state and federal laws or before self-regulatory bodies. In developing a new product, companies will reduce risk by being aware of the standards applicable to product formulation, claim language, and substantiation. In this chapter, we provide an overview of the basics of the FDA's regulations governing premarket safety assessments for products and ingredients, as well as the FTC's advertising laws and other actors that monitor potentially deceptive advertising. We also provide brief summaries of requirements applicable to specific types of claims that are common in the health food and dietary supplement industries.

Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients--rather than the actual product--has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law--when assessed together--indicate that the law allows and even protects "key ingredient claims" (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing). This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC's and FDA's guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.'s (NAD's) approach to evaluating key ingredient claims for dietary supplements. This article concludes that key ingredient claims--provided they are presented in a truthful and non-deceptive manner--are permissible, and should be upheld in litigation and cases subject to industry self-regulation. This article further concludes that the NAD's approach to key ingredient claims provides practical guidance for crafting and substantiating dietary supplement key ingredient claims.

Core Outcome sets (COS) are important and necessary as they help standardize reporting in research studies. Cranioplasty following traumatic brain injury or stroke is becoming increasingly common leading to an ever growing clinical and research interest especially regarding the optimal material, cost-effectiveness, and timing of cranioplasty concerning neurological recovery and complications. Consequently, heterogeneous reporting of outcomes from such diverse studies has led to a limited meta-analysis ability, with the ongoing risk of outcome reporting bias.To define a standardized COS for reporting in all future TBI and stroke cranioplasty studies.An international steering committee has been formed to guide the development of the COS. In addition, recommendations from other clinical initiatives such as COMET (Core Outcomes and Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) have been adhered to. The first phase of the project is data-collection through a systematic review and qualitative study. The second phase will be the COS-formation through a Delphi survey and consensus meeting. A definition of consensus will be decided and agreed upon before the Delphi survey begins to avoid bias, which is planned for the end of 2021.The development of a cranioplasty COS that can be applied in future research, helping to align future studies, building an increased understanding of cranioplasty and its impact on a patients function and recovery.This study should result in consensus on a COS for cranioplasty following TBI or stroke.The study has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) database for COS development.