Standardizing Cranioplasty Outcomes Following Stroke or Traumatic Brain Injury: Protocol for the Development of a Core Outcome Set.

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 IDENTIFIER (IRRID): DERR1-10.2196/37442.

Seizures in palliative medicine: brivaracetam.

Seizures occur in around 13% of patients with cancer and can be distressing for family members to witness. In those unable to manage regular antiepileptic medications, midazolam can be administered subcutaneously using a syringe driver, but this may cause sedation. Brivaracetam is a newer drug licensed as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation and for restricted use in those with refractory epilepsy. It is associated with fewer behavioural or psychiatric side effects than levetiracetam, has a very low incidence of drug interactions and the maximal dose can be accommodated in a single syringe driver. We present three cases from 2019 to 2020 where subcutaneous brivaracetam has been successfully used in a Specialist Inpatient Palliative Care setting to manage seizures. Brivaracetam dosing is 1:1 conversion from oral:subcutaneous, with syringe driver doses ranging from 150 mg to 300 mg/24 hours being successfully used, with no adverse effects observed.

Comparison of postal and non-postal post-vasectomy semen sample submission strategies on compliance and failures: an 11-year analysis of the audit database of the Association of Surgeons in Primary Care of the UK.

BACKGROUND: Vasectomy 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. METHODS: We 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). RESULTS: Among 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. CONCLUSIONS: Postal 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.

Neurologic music therapy in multidisciplinary acute stroke rehabilitation: Could it be feasible and helpful?

Background: There is increasing evidence for music-based interventions in neurorehabilitation, improving mood and functional outcomes. In response, there is growing interest from health-care 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. Objectives: To assess the feasibility and acceptability of a two-day per-week NMT service over 24 months. 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. Results: Of 201 patients referred, 177 received treatment and 675 sessions were delivered. Twenty-four patients were discharged before sessions were scheduled and 28 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 = .007, CI = 2.1, 12.9) and an increase in 'Happy' (+ 6.2, p = .013, CI = -11.0, -1.4). Conclusions: Data suggest the service was feasible and helpful, particularly for patient mood, possibly improving engagement in rehabilitation. Research to determine generalizability in different stroke environments and treatment effects within them is warranted.

Dietary supplement labeling and advertising claims: are clinical studies on the full product required?

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.