Background Despite the heightened risk of serious influenza during infancy, vaccination is not recommended in infants younger than 6 months. We aimed to assess the safety, immunogenicity, and efficacy of maternal immunisation with trivalent inactivated influenza vaccine for protection of infants against a first episode of laboratory-confirmed influenza. Methods We did this prospective, active-controlled, observer-blind, randomised phase 4 trial at six referral centres and community health centres in Bamako, Mali. Third-trimester pregnant women (≥28 weeks' gestation) were randomly assigned (1:1), via a computer-generated, centre-specific list with alternate block sizes of six or 12, to receive either trivalent inactivated influenza vaccine or quadrivalent meningococcal vaccine. Study personnel administering vaccines were not masked to treatment allocation, but allocation was concealed from clinicians, laboratory personnel, and participants. Infants were visited weekly until age 6 months to detect influenza-like illness; laboratory-confirmed influenza diagnosed with RT-PCR. We assessed two coprimary objectives: vaccine efficacy against laboratory-confirmed influenza in infants born to women immunised any time prepartum (intention-to-treat population), and vaccine efficacy in infants born to women immunised at least 14 days prepartum (per-protocol population). The primary outcome was the occurrence of a first case of laboratory-confirmed influenza by age 6 months. This trial is registered with ClinicalTrials.gov, number NCT01430689. Findings We did this trial from Sept 12, 2011, to Jan 28, 2014. Between Sept 12, 2011, and April 18, 2013, we randomly assigned 4193 women to receive trivalent inactivated influenza vaccine (n=2108) or quadrivalent meningococcal vaccine (n=2085). There were 4105 livebirths; 1797 (87%) of 2064 infants in the trivalent inactivated influenza vaccine group and 1793 (88%) of 2041 infants in the quadrivalent meningococcal vaccine group were followed up until age 6 months. We recorded 5279 influenza-like illness episodes in 2789 (68%) infants, of which 131 (2%) episodes were laboratory-confirmed influenza. 129 (98%) cases of laboratory-confirmed influenza were first episodes (n=77 in the quadrivalent meningococcal vaccine group vs n=52 in the trivalent inactivated influenza vaccine group). In the intention-to-treat population, overall infant vaccine efficacy was 33·1% (95% CI 3·7–53·9); in the per-protocol population, vaccine efficacy was 37·3% (7·6–57·8). Vaccine efficacy remained robust during the first 4 months of follow-up (67·9% [95% CI 35·1–85·3] by intention to treat and 70·2% [35·7–87·6] by per protocol), before diminishing during the fifth month (57·3% [30·6–74·4] and 60·7 [33·8–77·5], respectively). Adverse event rates in women and infants were similar among groups. Pain at the injection site was more common in women given quadrivalent meningococcal vaccine than in those given trivalent inactivated influenza vaccine (n=253 vs n=132; p<0·0001), although 354 [92%] reactions were mild. Obstetrical and non-obstetrical serious adverse events were reported in 60 (3%) women in the quadrivalent meningococcal vaccine group and 61 (3%) women in the trivalent inactivated influenza vaccine group. Presumed neonatal infection was more common in infants in the trivalent inactivated influenza vaccine group than in those in the quadrivalent meningococcal vaccine group (n=60 vs n=37; p=0·02). No serious adverse events were related to vaccination. Interpretation Vaccination of pregnant women with trivalent inactivated influenza vaccine in Mali—a poorly resourced country with high infant mortality—was technically and logistically feasible and protected infants from laboratory-confirmed influenza for 4 months. With adequate financing to procure the vaccine, implementation will parallel the access to antenatal care and immunisation coverage of pregnant women with tetanus toxoid. Funding Bill & Melinda Gates Foundation.

Background: Pain is the most common and bothersome symptom experienced by people with hidradenitis suppurativa (HS) and has been prioritized as an outcome domain by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC). Objectives: To perform a scoping review of pain measurement in randomized control trials (RCTs) of painful skin conditions (PSCs) and use of the pain numerical rating scale (NRS) and visual analogue scale (VAS) in rheumatoid arthritis RCTs, to inform the efforts of HISTORIC to reach consensus on how to measure pain intensity in HS trials. Methods: A search was conducted on several publication databases. Inclusion criteria were RCTs with a minimum of 10 participants that measured pain intensity. Results: Pain NRS and VAS were used in 68% of PSC trials. Respectively, 77% and 87% of PSC and rheumatoid arthritis RCTs did not specify the recall window. The commonest recall window in PSCs when specified was 24 h. In total, 33% of PSC trials assessed maximum pain intensity and 3% average pain intensity, while 87% of rheumatoid arthritis trials did not provide details. Pain data were reported as mean difference by 76% of PSC trials and 75% of rheumatoid arthritis trials. Respectively, 10% and 11% of PSC and rheumatoid arthritis studies reported pain as the percentage of patients reaching a desirable state and only 1% and 2% reported number needed to treat. Conclusions: While pain NRS and VAS are standard methods to measure pain intensity in PSCs, key details such as the recall window are often omitted and there is no consensus on how to report pain NRS data. What is already known about this topic? Pain is the most burdensome symptom experienced by patients with hidradenitis suppurativa and has been prioritized as an outcome domain by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC). What does this study add? Our review shows substantial variation in how pain numerical rating scale (NRS) and visual analogue scale are utilized in clinical trials. This variation restricts meta-analysis of pain intensity results. There is a need for consensus regarding the recall window for pain NRS and maximum vs. average pain, and whether current pain should be measured.

Background: Patients with hidradenitis suppurativa (HS) experience high physical and emotional symptom burden and may benefit from palliative care interventions, though no studies have explored the unmet palliative care needs in this population. Objective: This case series aimed to qualitatively evaluate unmet needs and palliative care interventions among patients with HS who were referred to palliative care. Methods: We reviewed medical records of patients with HS who were referred from an HS specialty clinic and seen in an interprofessional palliative care ambulatory clinic. Palliative care notes were qualitatively analyzed inductively and deductively to identify themes characterizing unmet needs and palliative care interventions. Results: Thirteen patients with HS (median [IQR] age, 38 [31-45] years; 11 [85%] women; 11 [85%] Black) were referred and seen in a palliative care specialty clinic. Topics discussed included uncontrolled HS pain, housing insecurity, and emotional distress. Palliative care interventions included a thorough assessment of pain, multimodal pain management approaches, social worker weekly check-ins, and management of psychotropic medications. Limitations: Small study at a single tertiary center. Conclusions: Care models integrating palliative care approaches with multidisciplinary support services may reduce disease burden in a subset of patients with HS.

Fewer work relative value units (wRVU) may be generated from encounters with female, racial minority, and younger patients because these populations require fewer procedures such as biopsies and cryotherapy.1,2 How medical complexity and encounter length influence wRVU differences by patient sex, race, and age is unknown.2 If encounter length accounted for more wRVU differences than discrepancies in procedures, then differences may not reflect disparities. We aimed to evaluate if differences in wRVU by patient sex, race, and age persist after encounters are grouped into 4-hour clinic half days (HD) to control for time.

Importance: Low- and middle-income countries have a high burden of respiratory syncytial virus lower respiratory tract infections. A monoclonal antibody administered monthly is licensed to prevent these infections, but it is cost-prohibitive for most low- and middle-income countries. Long-acting monoclonal antibodies and maternal vaccines against respiratory syncytial virus are under development. Objective: We estimated the likelihood of respiratory syncytial virus preventive interventions (current monoclonal antibody, long-acting monoclonal antibody, and maternal vaccine) being cost-effective in Mali. Design: We modeled age-specific and season-specific risks of respiratory syncytial virus lower respiratory tract infections within monthly cohorts of infants from birth to six months. We parameterized with respiratory syncytial virus data from Malian cohort studies, as well as product efficacy from clinical trials. Integrating parameter uncertainty, we simulated health and economic outcomes for status quo without prevention, intra-seasonal monthly administration of licensed monoclonal antibody, pre-seasonal birth dose administration of a long-acting monoclonal antibody, and maternal vaccination. We then calculated the incremental cost-effectiveness ratio of each intervention compared to status quo from the perspectives of the government, donor, and society. Results: At a price of $3 per dose and from the societal perspective, current monoclonal antibody, long-acting monoclonal antibody, and maternal vaccine would have incremental cost-effectiveness ratios of $4280 (95% CI $1892 to $122,434), $1656 (95% CI $734 to $9091), and $8020 (95% CI $3501 to $47,047) per disability-adjusted life-year averted, respectively. Conclusions and Relevance: In Mali, long-acting monoclonal antibody is likely to be cost-effective from both the government and donor perspectives at $3 per dose. Maternal vaccine would need higher efficacy over that measured by a recent trial in order to be considered cost-effective.

Pain contributes substantially to reduced quality of life in individuals living with hidradenitis suppurativa (HS). Although improved understanding of HS pathogenesis and treatment has resulted in improved evidence-based HS management guidelines, comprehensive pain management guidelines have yet to be developed. Few HS-specific data exist to guide pharmacologic analgesia; however, recognizing HS pain as either acute or chronic and predominantly nociceptive (aching and gnawing pain due to tissue damage) versus neuropathic (burning-type pain due to somatosensory nervous system dysfunction) provides a conceptual framework for applying outside pain management practices to HS management. This article incorporates the best available evidence from the HS and pain literature to propose an HS pain algorithm that integrates psychological, pharmacologic, and complementary and alternative treatment modalities.

Background: Hidradenitis suppurativa (HS) is a chronic painful skin disease that severely impairs patients' quality of life. While high-quality trials of HS therapies remain limited, medical knowledge of best treatment practices is rapidly evolving, leading to the recent publication of multiple international treatment guidelines for HS. Summary: This review compares international HS treatment guidelines, describes evidence for effectiveness of common and emerging HS therapies, and provides guidance for integrating evidence-based HS care into practice. Although over 50 medical and procedural treatments are mentioned across international HS guidelines, only adalimumab and infliximab have grade B/weak recommendation or higher across all major guidelines. This review describes the appropriate patient selection and effectiveness of the most commonly used medical and procedural treatments for HS. It also includes recommendations for counseling, dosing, and duration of medical therapies as well as procedure videos for the practicing dermatologist.

Background: Hidradenitis suppurativa (HS) is associated with comorbidities that contribute to poor health, impaired life quality, and mortality risk. Objective: To provide evidence-based screening recommendations for comorbidities linked to HS. Methods: Systematic reviews were performed to summarize evidence on the prevalence and incidence of 30 comorbidities in patients with HS relative to the general population. The screening recommendation for each comorbidity was informed by the consistency and quality of existing studies, disease prevalence, and magnitude of association, as well as benefits, harms, and feasibility of screening. The level of evidence and strength of corresponding screening recommendation were graded by using the Strength of Recommendation Taxonomy (SORT) criteria. Results: Screening is recommended for the following comorbidities: acne, dissecting cellulitis of the scalp, pilonidal disease, pyoderma gangrenosum, depression, generalized anxiety disorder, suicide, smoking, substance use disorder, polycystic ovary syndrome, obesity, dyslipidemia, diabetes mellitus, metabolic syndrome, hypertension, cardiovascular disease, inflammatory bowel disease, spondyloarthritis, and sexual dysfunction. It is also recommended to screen patients with Down syndrome for HS. The decision to screen for specific comorbidities may vary with patient risk factors. The role of the dermatologist in screening varies according to comorbidity. Limitations: Screening recommendations represent one component of a comprehensive care strategy. Conclusions: Dermatologists should support screening efforts to identify comorbid conditions in HS.