Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials.

BACKGROUND: Demographic diversity among clinical trials is required for representing the real-world populations intended for treatment and disease prevention. Moreover, genetic and environmental differences between ethnic and racial groups necessitate appropriately powered trials for relevant subgroups. We investigate the racial and ethnic demographic diversity of US-based participants in GSK-sponsored interventional trials. We also assess the evaluation of demographic diversity against US Census and epidemiologic data. METHODS: GSK-sponsored interventional phase I-IV clinical trials conducted from 2002 to 2019 across three areas were analyzed: pharmaceutical (includes therapeutic medicines except for vaccines and human immunodeficiency virus (HIV)), vaccine (includes prophylactic and therapeutic vaccines), and ViiV (includes HIV therapies). A total of 1005 global trials encompassing 460,707 global participants were identified, of which 495 had US-based sites with a total of 108,261 (23.5% of global) US participants (pharmaceutical, n = 357 trials; vaccine, n = 45 trials; and ViiV, n = 93 trials). We evaluated how GSK US-based trial recruitment compares with US Census (in line with previously published studies from other groups) and with epidemiologic data. RESULTS: GSK participant data for race and ethnicity combined across areas were generally similar to US Census levels (e.g. GSK versus census: White, 76.5% versus 76.3%; Black or African American, 15.1% versus 13.4%; Asian, 1.8% versus 5.9%; Hispanic or Latino, 14.0% versus 18.5%; Non-Hispanic White, 63.5% versus 60.1%). However, this was not the case for the individual pharmaceutical, vaccine, and ViiV data sets; least represented groups were Asian individuals for pharmaceutical and ViiV trials and American Indian or Alaskan Native individuals for vaccine trials (6.2%, 11.8%, and 11.1% of trials met/exceeded census level representation, respectively). The percentage of trials reaching/exceeding census levels also varied per trial phase for race and ethnicity. Furthermore, disparities in the percentage of trials reaching/exceeding census levels versus epidemiology-based prevalence levels have revealed opportunities to improve industry success metrics; in HIV trials, the proportion of Black or African American individuals (35.1%) exceeded census (13.4%) but not epidemiologic levels (55.3%). CONCLUSION: Further work is required to achieve demographic diversity across clinical trials. We conclude that US Census data are an inappropriate universal benchmark. A shift to epidemiology benchmarking will enable the consideration of global participants into US analyses for highly intrinsic (i.e. influenced by ancestry) diseases and more firm requirements for US-based participants into US analyses for extrinsic (i.e. influenced by location or culture) diseases. Benchmarking in line with epidemiologic data will allow us to set better trial enrollment goals, with the aim of conducting more demographically balanced, diverse, and representative clinical trials and enabling a better understanding of drug safety and efficacy per demographic group.

Routine group and save screening prior to emergency laparoscopic surgery.

INTRODUCTION: Two group and save (G&S) samples are routinely collected from patients undergoing diagnostic laparoscopy and/or emergency appendicectomy. We aimed to identify the necessity of this practice by looking at the perioperative transfusion rates. METHODS: Data were obtained from our electronic theatre system for all patients who underwent emergency laparoscopic surgery (specifically diagnostic laparoscopy and/or laparoscopic appendicectomy) between January 2017 and December 2018. Records were reviewed for the number of G&S samples sent and perioperative transfusion rates. RESULTS: A total of 451 patients were included in the study. The numbers of procedures performed in 2017 and 2018 were 202 (44.8%) and 249 (55.2%), respectively. The total number of samples sent was 930. Only 786 (84.5%) samples were processed and the rest were rejected for various reasons. Of the 451 patients included in the study, 308 (68.3%) had two G&S samples sent, whereas 41 patients (9.1%) had only one G&S sample sent. Fifty-six (12.4%) and 20 (4.4%) patients had three and four G&S samples sent, respectively. Only two patients required transfusion perioperatively (0.4%), and the indication in both was irrelevant to the primary operation. CONCLUSIONS: These results demonstrate a near-zero transfusion rate in this patient cohort. Omitting G&S is safe and potentially saves time and resources.

Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality.

BACKGROUND: Haemorrhoidal disease (HD) is a common colorectal condition that often requires surgical treatment. Less invasive procedures are usually more acceptable to patients. The aim of this study was to report the outcome of a novel and minimally invasive technique employing a radiofrequency ablation (RFA) energy (Rafaelo®) to treat HD. METHODS: A total number of 27 patients who had RFA for the treatment of HD were recruited to this study. The procedure was performed under deep sedation and local anaesthesia. Patients' demographics; haemorrhoid severity score (HSS); quality of life; pain and satisfaction scores; and recurrence rate were recorded. RESULTS: The mean age of the patients was 46 (SD 14) years, 18 (67%) males and 9 (33%) females. The mean body mass index was 25 (SD 4) kg/m2. The predominant symptom of all patients was per-rectal bleeding. HSS improved from 7.2 (SD 1.9) before the procedure to 1.6 (SD 1) after the procedure (p < 0.0001). Postoperative pain scores on a scale of 0-10 were 0, 2 (SD 2), 1 (SD 2), and 0 on immediate, day-1, day-3, and 2-month follow-up questionnaire. The mean satisfacion score was 9 (SD 1.5) out of 10 on 2-month follow-up. Mean time until patients returned to normal daily activity was 3 (SD 1) days following the procedure. Quality-of-life assessments including: visual analogue scale scores (before: mean 70, SD 23; after: mean 82, SD 16; p < 0.001) and EQ-5D-5L (before: mean 0.84, SD 0.15; after: mean 0.94, SD 0.13; p < 0.05) were significantly improved. The mean length of follow-up for recurrence of symptoms was 20 months (range 12-32 months). One patient (4%) reported the recurrence of rectal bleeding 12 months after the procedure. CONCLUSIONS: RFA for the treatment of HD is safe and effective in achieving symptomatic relief. It is associated with minimal postoperative pain and low incidence of recurrence.

Specialty choices of medical students and house officers in Karachi, Pakistan.

Unerstanding patterns of career choices inmedicine is importnat for educators and policy-makers to plan the supply of specialists. This study analysed the career choices made by medical students and house officers in 2 private and 2 public medical schools in Karachi, Pakistan. An anonymous, self-administered and gynaecology were the 4 highest ranked specialties, with internal medicine ranked top as both the 1st and 2nd choice. Internal medicine was the 1st choice for significantly more students in public than private medical colleges (22.2% versus 1l4.9%). Students from private medical institutions chose a wider range of specialties than those from publicly-funded colleges. A high proportion of medical students and graduates in Karachi favour the same medical specialties, which may lead to saturation in those areas of specialization.

Specialty choices of medical students and house officers in Karachi, Pakistan

Understanding patterns of career choices in medicine is important for educators and policy-makers to plan the supply of specialists. This study analysed the career choices made by medical students and house officers in 2 private and 2 public medical schools in Karachi, Pakistan. An anonymous, self-administered questionnaire was completed by 850 students. Internal medicine, paediatrics, general surgery and obstetrics and gynaecology were the 4 highest ranked specialties, with internal medicine ranked top as both the 1st and 2nd choice. Internal medicine was the 1st choice for significantly more students in public than private medical colleges [22.2% versus 14.9%]. Students from private medical institutions chose a wider range of specialties than those from publicly-funded colleges. A high proportion of medical students and graduates in Karachi favour the same medical specialties, which may lead to saturation in those areas of specialization