2 BJS Open, 2021, zrab006 DOI: 10.1093/bjsopen/zrab006 Systematic Review A systematic review of outcome reporting in incisional hernia surgery 1, D. Harji *, C. Thomas 1,S. A. Antoniou2, H. Chandraratan3, B. Griffiths4, B. T. Henniford5, L. Horgan6, F. Köckerling7, M. López-Cano8, L. Massey2, M. Miserez 9 , A. Montgomery10, F. Muysoms 11 , B. K. Poulose12, W. Reinpold13 and N. Smart2; NoSTRA HarMoNY 1 Northern Surgical Trainees Research Association (NoSTRA), Northern Deanery, Newcastle Upon Tyne, UK 2 Department of Surgery, Royal Devon & Exeter NHS Foundation Trust, Exeter, UK 3 Notre Dame University, General Surgery, Murdoch, Western Australia, Australia 4 Newcastle Surgical Education, Newcastle Upon Tyne, UK 5 Division of Gastrointestinal and Minimally Invasive Surgery Carolinas Medical Center, Charlotte, North Carolina, USA 6 Upper Gastrointestinal Surgical Department, Northumbria Healthcare NHSFT, North Shields, UK 7 Department of Surgery and Centre for Minimally Invasive Surgery, Academic Teaching Hospital of Charité Medical School, Vivantes Hospital, Berlin, Germany 8 Abdominal Wall Surgery Unit, Hospital Universitario Vall d’Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain 9 Department of Abdominal Surgery, University Hospital Gasthuisberg, KU Leuven, Leuven, Belgium 10 Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden 11 Department of Surgery, Maria Middelares, Ghent, Belgium 12 Division of General and Gastrointestinal Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA 13 Department of Surgery and Reference Hernia Centre, Gross Sand Hospital Hamburg, Hamburg, Germany *Correspondence to: Northern Surgical Trainees Research Association (NoSTRA), Northern Deanery, Waterfront 4, Goldcrest Way, Newburn Riverside, Newcastle Upon Tyne, NE15 8NY, UK (e-mail: Deena_harji@hotmail.com) Abstract Background: The incidence of incisional hernia is up to 20 per cent after abdominal surgery. The management of patients with incisional hernia can be complex with an array of techniques and meshes available. Ensuring consistency in reporting outcomes across studies on incisional hernia is important and will enable appropriate interpretation, comparison and data synthesis across a range of clinical and operative treatment strategies. Methods: Literature searches were performed in MEDLINE and EMBASE (from 1 January 2010 to 31 December 2019) and the Cochrane Central Register of Controlled Trials. All studies documenting clinical and patient-reported outcomes for incisional hernia were included. Results: In total, 1340 studies were screened, of which 92 were included, reporting outcomes on 12 292 patients undergoing incisional hernia repair. Eight broad-based outcome domains were identified, including patient and clinical demographics, hernia- related symptoms, hernia morphology, recurrent incisional hernia, operative variables, postoperative variables, follow-up and patient-reported outcomes. Clinical outcomes such as hernia recurrence rates were reported in 80 studies (87 per cent). A total of nine different definitions for detecting hernia recurrence were identified. Patient-reported outcomes were reported in 31 studies (34 per cent), with 18 different assessment measures used. Conclusions: This review demonstrates the significant heterogeneity in outcome reporting in incisional hernia studies, with significant variation in outcome assessment and definitions. This is coupled with significant under-reporting of patient- reported outcomes. Introduction The current evidence base in incisional hernia surgery Incisional hernia is a common complication with a documented consists of a large number of retrospective cohort studies with a incidence of 2–20 per cent after open abdominal surgery1. The paucity of well designed RCTs2. In addition to this, outcome presence of an incisional hernia is associated with significant reporting in hernia surgery research is variable. Two systematic morbidity and has a considerable impact on patients’ overall reviews examining outcome reporting in inguinal hernia3 and quality of life1. The management of incisional hernia is complex ventral hernia4 both reported significant heterogeneity between due to a combination of factors including patient co-morbidity, RCTs in defining and reporting clinical outcomes and patient- hernia morphology and the vast array of available surgical reported outcomes (PROs). options. Consequently, generating a robust evidence base in this The European Hernia Society (EHS) has previously issued a cohort of patients is difficult. series of recommendations regarding outcome reporting in Received: September 04, 2020. Revised: December 20, 2020. Accepted: January 13, 2021 C The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. V This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. 2 | BJS Open, 2021, Vol. 00, No. 0 abdominal hernia repair5. Following a systematic review and a ‘AND’. The search strategy was limited to human studies pub- consultation exercise with international experts, 20 key reporting lished in English between 1 January 2010 and 31 December 2019. recommendations were made; 11 of these related to study design, This time frame was chosen to reflect current clinical guidelines two to hernia morphology, three to operative strategy and four to from the EHS and contemporary surgical practice, including min- clinical follow-up. This guideline represents a step towards im- imally invasive surgical techniques and enhanced recovery after proving outcome reporting in abdominal wall hernia. However, it surgery. Reference lists of included articles were hand-searched has a number of limitations, including the lack of definition to to identify any additional studies. All citations were collated R V underpin the reporting outcomes, the lack of diversity amongst within EndNote X7 (Phildelphia, USA) and duplicates were re- the expert members of the consultation exercise with no repre- moved. sentation of patient perspectives or views and the exclusion of PROs. Current clinical guidelines recommend that surgical repair Selection of studies for incisional hernia should be undertaken to improve patient All relevant titles and abstracts were screened by two reviewers symptoms and quality of life. Despite this, the majority of studies (D.H. and C.T.). Full papers of potentially eligible abstracts were fail adequately to capture or report patient-centred outcomes retrieved in full. Any conflicts were resolved through discussion such as quality of life and pain. Parker and colleagues reported with a senior author (B.G.). that four studies out of 31 employed a PRO as a primary endpoint in RCTs assessing ventral hernia repair6. To ensure outcome Data extraction reporting reflects the goals and aims of incisional hernia repair, it Data extraction was conducted by two reviewers and was verified is essential that PROs are appropriately defined, captured and by a third reviewer. Data were extracted under the broad catego- reported. ries of participant demographics, clinical details, treatment and The reporting of standardized definitions and outcomes im- surgery-related details, clinical outcomes and PROs reported. portant to all stakeholders, including clinicians and patients, has All reported outcomes were identified and recorded verbatim. been recognized to be of key importance in improving overall out- Outcomes were considered defined if text was provided to explain come reporting and in delivering high-quality clinical research by the outcome or a citation was provided to define the outcome. If the Core Outcome Measures in Effectiveness Trials (COMET) ini- no explanation or appropriate citation were provided, outcomes tiative. The COMET initiative has developed standard methodol- were classified as not defined. ogy to help formulate core outcome sets (COS) in a variety of clinical scenarios7. The aim of a COS is to develop a universally Study quality agreed minimum number of key outcomes which are important Methodological quality assessment of studies included in this re- to all stakeholders and should be reported for all studies in a par- view was undertaken using the Risk of Bias In Non-Randomised ticular clinical area. A COS in incisional hernia surgery has the Studies of Intervention (ROBINS-I) assessment tool11 for non- potential to overcome a number of the documented limitations randomized studies and the Cochrane risk of bias tool for RCTs. of outcome reporting in hernia surgery. The first step towards achieving a COS in incisional hernia repair is to identify the cur- Data analysis rent reported outcomes. The aim of this systematic review was to Individual reporting outcomes were extracted and the frequency identify variation in clinical outcomes and PROs currently that each outcome was reported was calculated. The definitions reported within the literature for incisional hernia. of reporting outcomes were identified and extracted. The consis- tency of reporting outcomes and the frequency of inconsistencies in definitions of reported outcomes were compared between Methods studies. Descriptive data were expressed using basic statistics in- This systematic review was conducted according to a pre-speci- cluding proportions and averages. All data were entered into R fied protocol based on guidance from the Centre for Reviews and MicrosoftV Excel (Microsoft, Redmond, Washington, USA) for Dissemination8 and the Cochrane Handbook9 and is reported in analysis. line with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement10. The protocol was registered with the international, prospective register of system- Results atic reviews, PROSPERO (CRD42018090084). The search strategy identified a total of 1760 manuscripts, of which 456 duplicate references were identified and 1304 studies Eligibility criteria were screened. Some 171 manuscripts were examined in full, of All studies reporting clinical outcomes and/or PROs in adults which 92 studies were eligible for inclusion12–103 (Fig. 1). Fifteen (over 18 years old) undergoing incisional hernia repair between RCTs (16 per cent), 25 prospective cohort studies (27 per cent), of 2010 and 2019 were included. Studies were excluded if clinical which 2 (2 per cent) were sub-analyses from RCTs, and 52 retro- outcomes and PROs were reported for other types of hernias (um- spective cohort studies (57 per cent) were identified (Table 1). bilical, epigastric, port-site). In addition, case reports, systematic Eleven multicentre (14 per cent) and 69 single-centre (86 per cent) reviews and letters were excluded. studies were included. The primary outcome was defined in 39 studies (42 per cent). Clinical primary endpoints were reported in Search strategy 30 studies (32.6 per cent), which included complications, hernia The OPID SP versions of MEDLINE (1950 to present), EMBASE recurrence, mesh-related complications (infection or protrusion), (1980 to present) and the Cochrane Central Register of Controlled structural mesh changes, length of stay, biomechanics and trun- Trials were searched using the following search terms ‘incisional cal flexion. Patient-reported primary endpoints were assessed in hernia’, ‘abdominal wall reconstruction’, ‘patient-reported out- nine studies (10 per cent) which included the SF36 question- comes’ and ‘quality of life’ separated by the Boolean operator naire95, the bodily pain subscale of the SF-36 questionnaire53, the Harji et al. | 3 Abstracts identified Identification n = 1760 Total after removal of duplicates n = 1304 Screening Records excluded n = 1025 Full-text studies assessed for eligibility n = 171 Full-text studies excluded n = 79 Enable to extract outcomes for Eligibility incisional hernia alone n = 39 Conference abstract n = 13 Wrong study design n = 8 No clinical or patient-reported outcome reported n = 5 No full-text of paper available n = 3 No English translation available n = 3 Paediatric population n = 2 Fewer than 5 patients included n = 1 Included Studies included n = 92 Fig. 1 PRISMA diagram showing search strategy physical health subscale of the SF36 at 21 days after surgery103, clinical demographics relating to BMI, ASA classification and co- postoperative pain29, postoperative pain scores at 3 weeks54,104, morbidity were less well reported (Table 2). Patient co-morbidity Americas Hernia Society Quality Collaborative (AHSQC) pain was reported in 48 studies (52 per cent), of which chronic obstruc- questionnaire14 and HerQLes14. Two studies (2.1 per cent) tive pulmonary disease was the commonest co-morbidity employed a composite primary endpoint of pain and recur- reported. Co-morbidities were often reported in an ad hoc man- rence.40,47 ner, with only one study employing a systematic approach by using the APACHE system65. Important clinical demographic details regarding steroid use and smoking status were poorly Outcome reporting reported, with 17 (18 per cent) and 33 (36 per cent) studies report- A total of 2215 outcomes were reported, these outcomes were ing these outcomes respectively. Smoking status was defined in mapped to eight broad-based domains (Fig. 2), including patient 12 studies (13 per cent), with significant variation in the definition and clinical demographics, hernia-related symptoms, hernia employed (Table 3). morphology, recurrent incisional hernia, operative variables, postoperative variables, follow-up and PROs. Hernia-related symptoms Study bias Symptomatic indications for surgical intervention were reported The risk of bias associated with the RCTs is outlined in Fig. 3 and in 12 studies (13 per cent): six prospective cohort studies, one with observational studies is outlined in Fig. 4. The risk of bias RCT and five retrospective cohort studies (Table 4). A number of was high in six RCTs, with the majority of bias being attributed to composite symptoms were often reported, with studies failing the lack of blinding of outcome assessors and selective outcome to discriminate between different hernia-related symptoms, reporting. For observational studies, 17 studies were identified as treatment strategy and outcomes. Two studies used validated being seriously or critically biased, with the domains associated quality-of-life measures to assess hernia-related symptoms14,16. with the highest risk of bias being participant selection, measure- The majority of studies reported hernia-related symptoms in ment of outcomes and selection of reported outcomes. the elective setting, with only one study reporting symptomatic indications in the emergency setting25. Patient and clinical demographics Outcomes were reported in 12 292 patients undergoing incisional hernia repair. Patient demographics were well reported, however, 4 | BJS Open, 2021, Vol. 00, No. 0 Table 1 Study characteristics 11 studies. Loss of domain was reported by six studies. A total of 12 studies reported on grade of incisional hernia, with three Variable Number of studies prospective studies and five retrospective studies employing the (n 5 92) Ventral Hernia Working group classification. Study type RCT 15 (16) Prospective cohort study 25 (27) Retrospective cohort study 52 (57) Recurrent incisional hernia Multicentre 11 (14) Single centre 69 (86) Recurrent incisional hernia outcomes were reported by 37 stud- Year of publication ies: 11 prospective cohort studies, three RCTs and 23 retrospec- 2010 8 (9) tive cohort studies. The number of previous incisional hernia 2011 5 (5) repairs were documented by 12 studies alone, with detail on 2012 5 (5) 2013 12 (13) mesh use provided in 16 studies and mesh placement in 12 stud- 2014 11 (12) ies. Use of previous component separation was reported in five 2015 16 (17) studies. Use of adjunctive measures, such as botox or preopera- 2016 12 (13) tive pneumoperitoneum, was reported in four studies. 2017 11 (12) 2018 5 (5) 2019 7 (8) Country Austria 1 (1) Operative variables Brazil 3 (3) Operative variables were reported in the majority of studies, with China 3 (3) Croatia 1 (1) mode and timing of surgery reported in 83 (90 per cent) and Denmark 1 (1) 42 (46 per cent) studies respectively (Table 6). The majority of Egypt 1 (1) studies (21 per cent) reported outcomes on open incisional hernia France 3 (3) repair (57 studies, 62 per cent), 19 studies reported outcomes on Finland 1 (1) Germany 5 (5) laparoscopic incisional hernia repair, 15 (16 per cent) reported on India 2 (2) both open and laparoscopic repair and one (1 per cent) reported Italy 10 (11) on a hybrid procedure. Elective hernia repair was reported in Japan 1 (1) 25 studies (27 per cent), emergency repair in three (3 per cent) Lithuania 1 (1) and a combination of elective and emergency in six (7 per cent). Nigeria 1 (1) Norway 2 (2) Operative technique, including mesh use, mesh placement and Pakistan 4 (4) fixation, were reported by the majority of studies. Outcomes Poland 3 (3) pertaining to use of specialist techniques, including component Romania 6 (7) separation (24 studies, 26 per cent), use of adjuncts (8 studies, Serbia 1 (1) Spain 4 (4) 9 per cent) and intra-abdominal pressure monitoring (2 studies, Sweden 5 (5) 2 per cent), were poorly reported. The Netherlands 6 (7) Turkey 8 (9) UK 6 (7) USA 12 (13) Postoperative outcomes Values in parentheses are percentages. Postoperative morbidity was reported by 82 studies (89 per cent) (Table 7), with this outcome defined as 30-day morbidity in 17 studies (18 per cent). Generic postoperative complications, Hernia morphology including respiratory, cardiovascular, thromboembolic and gastrointestinal, were reported by a third of studies. Specific post- Significant variation exists in the reporting and assessment of operative complications were more widely reported, with wound hernia morphology (Table 5). The site of the hernia was reported infection (68 studies, 74 per cent) and seroma formation (60 stud- in 25 studies: six prospective cohort studies, three RCTs and ies, 65 per cent) being the most commonly reported. Skin necrosis 16 retrospective cohort studies. Recommended EHS guidelines for and mesh infection were significantly under-reported, with the classification of incisional hernia were only used in seven only 12 (13 per cent) and eight (9 per cent) studies respectively, studies. A total of 15 prospective cohort studies, 10 RCTs and reporting these outcomes. 35 retrospective cohort studies reported hernia defect size, using Significant variation was demonstrated in defining postopera- a variety of definitions. The most common definition used was tive complications. Wound infection was defined in 10 studies, defect surface area, with 11 studies reporting this metric. Surface with a total of eight different definitions employed (Table 8). area was calculated using the length and width dimensions of Four different definitions for seroma formation were identified the hernia, with these measurements assessed during the opera- (Table 9). Of the five studies reporting mesh infection, only two tion in two studies, clinically in the supine position in two studies studies provided a comprehensive definition. Complications were and using preoperative CT imaging in two studies. Twenty-five graded in 17 studies, with 12 studies providing detail on classifi- studies reported the mode of assessment of hernia defect size cation/grading systems. Postoperative mortality was reported in with preoperative clinical assessment reported by four studies, 23 studies (29 per cent), with two studies documenting the time CT in 10 studies, with one study reserving CT for use in hernia de- frame in which this outcome was measured. Re-operation fect size greater than 10 cm, CT or ultrasound scan (USS) in and re-intervention rate were reported in 31 (33 per cent) and two studies, USS in two studies and intraoperative assessment in 25 (28 per cent) studies respectively. Harji et al. | 5 Duration of critical care Previous hernia stay repair Duration of stay Number of previous repairs Recurrent incisional hernia Seroma Use of previous mesh Wound infection Placement of previous mesh Postoperative variables Skin necrosis Mode of surgery Respiratory Complications Cardiovascular Timing of surgery Mesh use Gastrointestinal Mesh placement Thromboembolic Mesh fixation Mesh infection Component separation Age Operative variables Basic demographics Use of adjuncts Incisional Hernia Outcome Reporting Gender Intra-abdominal pressure monitoring ASA Intraoperative Patient demographics BMI complications Clinical demographics Smoking status Duration of operation Steroid use Blood loss Comorbidity Hernia recurrence rate Follow up Hernia-related Symptoms Time to follow up symptoms Site of hernia Assessment Quality of life Timing Metrics used Patient- Patient reported Hernial defect outcomes reported outcomes Hernia morphology Assessment method Assessment Pain Loss of domain Timing Grade of hernia Fig. 2 Outcomes extracted Follow-up were used to assess pain scores. Only one study used a disease- specific assessment measure to assess pain-related outcomes14. Time to follow-up was reported in 81 studies (88 per cent), with a Twenty-three studies were designed as longitudinal studies, with variety of time points reported for follow-up ranging from 15 studies providing baseline data and two studies providing 14 days to 137 months. Hernia recurrence was the only long-term long-term data at 5 years. outcome reported in the majority of studies, with recurrence rate reported in 80 studies (87 per cent) (). A total of nine different def- initions for detecting hernia recurrence were identified, of which four were based on clinical examination, one on patient or physi- Discussion cian reporting, two on combined clinical and radiological exami- Incisional hernia surgery is a complex surgical entity, which nation and two on radiological examination alone (Table 10). requires comprehensive assessment and planning prior to select- ing the correct operative strategy to improve patient symptoms and quality of life whilst limiting morbidity and reducing the risk Patient-reported outcomes of recurrence. Study reporting pertaining to incisional hernia PROs were evaluated in 31 studies (34 per cent): 11 prospective should reflect all component parts of this process of clinical deci- cohort studies, nine RCTs and 11 retrospective cohort studies. A sion making and management. At present reporting standards variety of patient-reported outcome measures (PROMs) were for incisional hernia do not appropriately reflect this complexity. used, including ten ad hoc measures, two disease-specific meas- There is a huge emphasis on reporting clinical outcomes, with ures and eight generic measures (Table 11). Fourteen studies were the most commonly reported outcomes being mesh use and designed as cross-sectional studies assessing PROs as a one-off placement, hernia recurrence and postoperative complications, assessment ranging from 3–49 months after surgery. Sixteen with significant under-reporting of patient selection criteria, her- studies were designed as longitudinal studies. Thirteen studies nia morphology and PROs. Coupled with this there is significant provided baseline data and only three studies provided long-term heterogeneity in the manner in which they are defined, with mul- data beyond 3 years. tiple differing definitions for a number of key outcomes. Pain was evaluated in 39 studies (42 per cent): 17 prospective Hernia recurrence was a primary endpoint in 14 studies and cohort studies, nine RCTs and 16 retrospective cohort studies. was reported overall in 80 studies (87 per cent). Despite this out- Pain was assessed at variable time points using a variety of mea- come being widely reported, the majority of studies failed to de- surement tools. The majority of studies assessing pain employed fine how recurrence was defined; of the 32 studies (35 per cent) a pain scale, however a total of seven different types of pain scale that defined hernia recurrence, a total of nine definitions were 6 | BJS Open, 2021, Vol. 00, No. 0 Reporting bias Selective reporting Attrition bias Low risk Incomplete outcome Data High risk Unclear Detection bias Blinding of outcome assessment Performance bias Blinding of participants Allocation concealment Selection bias Random sequence generation 0 2 4 6 8 10 12 14 16 Number of RCTs (n = 15) Fig. 3 Study bias according to the Cochrane risk of bias tool for RCTs Overall bias Low Selection of reported result Moderate Serious Measurement of outcomes Critical Not reported Missing data Deviations from intended interventions Classification of interventions Participant selection Confounding 0 10 20 30 40 50 60 70 80 Number of observational studies (n = 77) Fig. 4 Study bias according to the ROBINS-I risk of bias domain for observational studies identified. Only one of these nine definitions relied on patient- radiological evaluation to determine recurrence. Postoperative and/or professional-led reporting of recurrence. The remaining complications were also widely reported, with 82 studies (87 per studies used a mixture of differing clinical assessment and cent) reporting this outcome, however, the time frame in which Harji et al. | 7 Table 2 Patient and clinical characteristics Table 5 Reporting of hernia morphology Patient and clinical Frequency reported Hernia morphology variable Frequency reported characteristics (n 5 92) (n 5 92) Age 86 (93) Site of previous incision 20 (22) Gender 87 (95) Site of hernia 25 (27) BMI 64 (70) Hernial defect 60 (65) ASA 34 (37) Modality of hernia detection Smoking status 33 (36) Clinical 4 (4) Steroid use 17 (18) CT 10 (11) Co-morbidity 48 (52) CT/USS 2 (2) USS 2 (2) Values in parentheses are percentages. Intraoperative 11 (12) Loss of domain 6 (7) Grade of hernia 12 (13) Table 3 Definitions of smoking status Values in parentheses are percentages. USS, ultrasound scan. Definition of smoking status Frequency reported Table 6 Reporting of operative variables >5 pack years 1 (1) Operative variable Frequency reported Active smoker 3 (3) (n 5 92) Chronic smoker 1 (1) Nicotine use prior to 6 weeks before hernia repair 1 (1) Mode of surgery 83 (90) Patient self-reported 3 (3) Timing of surgery 42 (46) Tobacco use 1 (1) Mesh use 88 (96) Current smoker and ex-smoker 2 (2) Mesh placement 84 (91) Values in parentheses are percentages of the total number of studies (n ¼ 92). Mesh fixation 69 (75) Use of component separation 24 (26) Use of adjuncts 8 (9) Use of intra-abdominal pressure monitoring 2 (2) Table 4 Reporting of hernia related symptoms Intraoperative complications 12 (13) Duration of operation 45 (49) Author Hernia symptoms Blood loss 6 (7) 51 Poelman et al. Complaint of bowel obstruction Values in parentheses are percentages. (patients felt pain or had difficulties passing stool) or aesthetically unpleasing Rogmark et al.53 Cosmesis, pain, movement restrictions, Table 7 Reporting of postoperative outcomes bowel symptoms, episodes of incar- ceration Postoperative variable Frequency reported Lauscher et al.105 Discomfort, occasional sensation of (n 5 92) pressure, continuous pain and pain on pressure Duration of critical care stay 2 (2) Akinci et al.25 Incarceration was defined as irreducibil- Duration of stay 62 (67) ity of an external hernia and strangu- Postoperative complications 82 (89) lation as irreducibility with objective Seroma formation 60 (65) signs of ischaemia or gangrene at op- Wound infection 68 (74) eration procedure Skin necrosis 12 (13) Schoenmaeckers et al.106 Pain Respiratory complications 23 (25) Ah-kee et al.24 Pain, discomfort, cosmetic complaints Cardiovascular complications 10 (11) and functional disability Gastrointestinal complications 31 (34) Saeede et al.107 Pain and swelling Thromboembolic complications 16 (1) Aliotta et al.14 Americas Hernia Society Quality Mesh infection 8 (9) Collaborative pain questionnaire and Grade of postoperative complications 17 (18) HerQLes questionnaire Postoperative mortality 27 (29) Feng et al.16 HerQLes questionnaire Re-operation rate 31 (34) Gillion et al.15 Study-specific quality-of-life question- Re-intervention rate 25 (27) naire Readmission rate 7 (6) Values in parentheses are percentages. this outcome was assessed was reported by only two studies, and the severity of complications by 17 (18 per cent). There is signifi- standardized definition109. This consequently reduces the cant under-reporting of important postoperative complications, measurement properties of this outcome due to the variation in such as wound infection, seroma formation and mesh infection. definition across studies, thus leading to variable detection rates Furthermore, when these outcomes are reported, there is signifi- of the outcome. cant heterogeneity in the definitions employed to determine There is significant under-reporting of important preoperative their incidence. Wound infection was reported in 68 studies factors regarding optimal patient selection and indication for (74 per cent), of which nine studies defined this outcome measure surgical intervention. More than half of the identified studies using a total of eight different definitions. Wound infection has included in this review failed to report co-morbid status, BMI, previously been documented to be poorly reported in surgical ASA grade, smoking status and steroid use. These important trials, both as a primary and secondary endpoint, due to a lack of parameters are recognized risk factors for adverse events in 8 | BJS Open, 2021, Vol. 00, No. 0 Table 8 Reported definitions for wound infection Table 10 Reporting for hernia recurrence Author Definitions Modality of detection for hernia recurrence Frequency 50 reported Peres et al. Infectious cellulitis, treated with local (n 5 92) measures and changing antibiotics Bittner et al.108 Centers for Disease Control and Prevention Clinical 7 (8) Kaafarani et al.98 classification Clinical defined as any palpable or detected fascial 1 (1) Westphalen et al.101 defect located within 7 cm of the hernia repair Stra^mbu et al.57 Deep wound infection defined as purulent Clinical and CT 12 (13) suppuration Clinical – a recurrent hernia was diagnosed when 1 (1) 49 Pajtak et al. Redness or purulent wound secretion a fascial defect could be palpated when lifting Rogmark et al.53 Superficial SSI defined as clinical signs of the head from the examination table to raise cutaneous wound infection in need of the abdominal pressure antibiotic or bedside treatment; deep SSI Clinical/USS/CT 3 (3) as wound infection surgically drained in CT 4 (4) the operating ward Defined as a hernia discovered by clinical exami- 1 (1) Ion et al.65 Superficial infections occurred mainly dur- nation at 1 year ing the early postoperative period (the Patient/professional reported 1 (1) first 10–14 days); they generally evolved USS 3 (3) in the subcutaneous dead space associ- ated with a serohematic collection and Values in parentheses are percentages. USS, ultrasound scan. had a favourable evolution after the ap- plication of conservative measures. Deep juxtaprosthetic infections, with a signifi- cant local and general response, required wide opening of the prosthetic bed, re- hernia-related symptoms. Furthermore, a PRO was the primary peated antiseptic lavage in the focus, tar- endpoint in only nine studies. In contrast, a third of studies geted antibiotic therapy and exhibited a favourable slow progress over 3 to 8 reported a clinical outcome as the primary endpoint, thus weeks highlighting the greater emphasis on clinician-centric outcomes Mommers et al.38 Wound complications were reported as in this cohort of patients. Coupled with the under-reporting of surgical site occurrences, defined as any PROs, there are significant methodological drawbacks associated wound complication (haematoma, super- ficial and deep wound infection, abscess, with the design of the studies reporting these outcomes. These seroma, fistula and wound dehiscence). include the lack of use of validated, disease-specific measures for Infectious wound complications were hernia surgery combined with the lack of baseline and longitudi- reported separately as SSIs, defined as nal data and consistent assessment time points. The Carolinas abscess, infected seroma, superficial or Comfort Scale (CCS) and the HerQLes measures were the only deep wound infection Moreno-Egea et al.40 Wound infection was defined as redness, disease-specific measures identified to assess quality of life and discharge of pus from the wound or a were used in only five studies. The CCS is a well designed, vali- positive bacterial culture dated outcome measure for use in patients undergoing hernia re- SSI, surgical site infection. pair with mesh113. The HerQLes has been designed and validated for use in patients undergoing ventral hernia repair114. The Americas Hernia Society Quality Collaborative pain question- Table 9 Reported definitions for seroma formation naire was the only disease-specific measure used to assess pain in patients undergoing ventral hernia repair115. Disease-specific Author Definition measures have the ability to detect subtle differences between Rogmark et al.53 A fluid accumulation in need of aspiration/ patient and treatment groups, which generic measures may po- surgical intervention tentially miss116. The use of hernia-specific PROMs should be ad- Munegato et al.42 Morales–Conde classification vocated when reporting PROs in this cohort of patients. Designing Pajtak et al.49 Ultrasound scan proven Moreno-Egea et al.40 Seroma was defined as a fluid collection methodologically robust studies with appropriate PRO assess- detected by palpation on clinical exami- ment is key to better outcome reporting. Alongside this, high- nation when patients attended for rou- quality reporting of PROs is paramount to the clinical interpreta- tine follow-up clinic appointments tion and utility of these complex outcome measures. A number of clinical guidelines exist within the field of inci- sional hernia repair5,117,118. Unfortunately, there is poor pene- incisional hernia repair110–112 and help decision making and risk trance of these guidelines in clinical and academic practice; only stratification when considering the optimal operative strategy in seven studies (8 per cent) employed the EHS guidelines when incisional hernia repair. The lack of detail regarding patient classifying incisional hernias. Eight studies (9 per cent) employed physiology and co-morbid status fails to provide clear guidance the Ventral Hernia Working Group guidance to grade incisional on patient selection, thus limiting the clinical application of the hernias. These classification systems represent unidimensional obtained results, and further contributing to the heterogeneity aspects of incisional hernia surgery and are often based on expert observed in clinical practice. opinion and current published literature, which often reflect PROs are of particular relevance and importance in the benign clinical and surgical outcomes alone. The development of a mul- disease setting whereby the main goals of treatment are to im- tidimensional system, which reflects the opinions of all key prove quality of life and symptom control. This is not reflected in stakeholders, including surgeons, patients, radiologists and the current literature for incisional hernia surgery, with only a methodologists, is more likely to have better clinical and aca- third of studies reporting PROs, pain-related outcomes and demic utility. Harji et al. | 9 Table 11 Patient-reported outcomes in incisional hernia surgery methodology will help strengthen the evidence base in incisional hernia surgery and will aid the development and delivery of fu- Patient-reported outcome measure Frequency ture high-quality research. (n 5 92) The main limitations of the present study include the inclu- Ad hoc PROMs sion of literature limited to the English language; this may have Better quality of life after the procedure 1 (1) led to missing important outcomes relevant to an international Discomfort 1 (1) audience. The second key limitation is that assessment of the Discomfort, cosmesis, functional disability 1 (1) Fatigue and movement restriction 1 (1) current evidence was limited to published literature and did not Foreign body sensation and rigidity of the 1 (1) include grey literature, including published guidelines. This may abdominal wall have a potential impact on the outcomes identified in this sys- Satisfaction 3 (3) tematic review. Improvement on visual analogue scale 0–10 1 (1) Return to full activity 1 (1) Return to everyday activities (e.g., a walk, driving, 1 (1) making family visits, attending social meetings) Patient satisfaction – Swedish Hernia Register 1(1) Funding sources Not reported 3 (3) Disease-specific PROMs Funding was provided by the British Hernia Society and European Carolina Comfort Scale 3 (3) Hernia Society. HerQLes 2 (2) Generic PROMs FACT-G 1 (1) EuroQoL-5D 1 (1) References SF36 11 (12) Daily Activities Questionnaire 1 (1) 1. van Ramshorst GH, Eker HH, Hop WC, Jeekel J, Lange JF. WHO Quality of Life – BREF 1 (1) Impact of incisional hernia on health-related quality of life Quebec back pain disability scale 1 (1) and body image: a prospective cohort study. 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