Table 1

The PICOTS format: study inclusion/exclusion criteria

Study elementsCriteria for inclusionCriteria for exclusion
Populations

  • Participants who were clinically diagnosed with HS with no restriction on age, sex, ethnicity or disease severity/Hurley stage, which addressed at least one of the outcomes of interest

  • Other subgroups or secondary analyses will be also included if studies provide data to calculate the effect estimates of the outcomes of interest

  • In vitro, in vivo or animal studies

  • Studies not pertaining to HS

  • Studies including less than 10 participants (to mitigate type II error)

Interventions

  • Pharmacological treatment with any type of administered treatments for HS

  • Studies regrading non-pharmacological, physical or surgical therapies

  • Studies regarding imaging modalities (ie, ultrasound)

  • Studies regarding disconnected node of treatments

Comparators

  • Placebo, active comparator or standard of care

  • Studies without control groups (single-arm studies)

Outcomes

  • Primary outcomes

  • Treatment response: change in HS symptoms score from baseline using validated measurement tools (ie, HiSCR, IHS4, MSS, HS-PGA, SAHS, AISI, SASH, HASI/HASI-R)

  • Treatment response: proportion of clinical responders (ie, ≥50% HiSCR or IHS4 reduction from baseline)

  • Unacceptability of treatment (all-cause discontinuation)

  • Secondary outcomes

  • Change in total abscess and abscess and inflammatory nodule counts from baseline

  • Percentage change in surface area of the HS surgical site from baseline

  • Time to new HS exacerbation

  • Proportion of participants who required no surgery as determined by the designed surgeon

  • Change in high-sensitivity C reactive protein from baseline

  • Occurrence of adverse event (participant with at least one reported adverse event)

  • Occurrence of SAE (participant with at least one reported SAE)

  • Patient-reported HRQOL, including general, dermatology-specific and HS-specific measures

  • Additional outcomes

  • Symptoms burden (ie, pain, fatigue, pruritus, malodour, sleep problems, sexual dysfunction)

  • Work impairment (ie, absenteeism, presenteeism, work productivity and/or school performance)

  • Psychosocial aspects (ie, depressive symptoms, anxiety, distress and well-being)

  • Treatment satisfaction

  • Healthcare utilisation (ie, emergency/unplanned visit during follow-up and costs of care)

  • Studies not providing data to calculate the effect estimates of the outcome of interest

  • Studies with a follow-up period of less than 2 weeks

Timing

  • An extensive search strategy from the inception of bibliographical databases forward to assure all published literature will be identified

  • No restrictions were imposed on timing of start date or language

Setting

  • Experimental study: RCTs (parallel or crossover trials)

  • Non-randomised studies (open-label, multiple-armed clinical trial, comparative effectiveness observational studies)

  • Case–control, cross-sectional studies, N-of-one, case series/case reports and pharmacokinetic/pharmacodynamics studies

  • Reports not involving primary data including narrative review, systematic review, meta-analysis, news items, consensus statement, guidelines and opinion/editorials

  • AISI, Acne Inversa Severity Index; HASI/HASI-R, Hidradenitis Suppurativa Area and Severity Index/Hidradenitis Suppurativa Area and Severity Index Revised; HiSCR, Hidradenitis Suppurativa Clinical Response; HRQOL, health-related quality of life; HS, hidradenitis suppurativa; HS-PGA, Hidradenitis Suppurativa-Physicians’ Global Assessment; IHS4, International Hidradenitis Suppurativa Severity Score System; MSS, Modified Sartorius Score; PICOTS, populations, interventions, comparators, outcomes, timing, setting; RCTs, randomised controlled trials; SAE, serious adverse event; SAHS, Severity Assessment of Hidradenitis Suppurativa; SASH, Severity and Area Score for Hidradenitis.