9. Risk of bias for cosmetic evaluation.
| Study | Control | Confounding | Selection | Classification of intervention | Deviations from intended intervention | Missing data | Measurement of outcomes | Selection of reported results | Overall |
| Acosta‐Marin 2014 | S‐BCS | Serious | Serious | Low | Low | Serious | Serious | Moderate | Serious |
| Some clinicopathological variables demonstrated balance (age, BMI) and some significantly different (preoperative bra size, tumour size), most missing | Selection may be related to the outcome (mastectomy eventually) | Classification of interventions clear and determined at the start of intervention. Operative details given clearly | All patients received the surgical intervention described in the methods | Analysis unlikely to have removed risk of bias from missing data ‐ missed women with complications in short term. If major may have had to have mastectomy and therefore excluded | Validated reporting tool but vulnerable bias from subjective knowledge of intervention | No indication of selected reporting | |||
| Gicalone 2007 (2) | S‐BCS | Serious | Serious | Low | Low | Low | Critical | Moderate | Critical |
| Important clinicopathological factors demonstrated balance (BMI, tumour size, tumour location), some missing | Women chose their operation after being told the potential risks and benefits. Bias in assignment | Classification of interventions clear and determined at the start of intervention, operative details given clearly | All patients received the surgical intervention described in the methods. All operations done by 2 experienced surgeons. | All patients included followed up | 2 person panel of experts, bias likely to influence outcome | No indication of selected reporting | |||
| Hilli‐Betz 2014 | S‐BCS | Serious | Serious | Low | Low | Low | Moderate | Moderate | Serious |
| Some clinicopathological variables demonstrated balance (axillary node status) and some different (tumour size, pre‐operative bra size), some missing. Axillary management demonstrated balance, most co‐interventions missing | Women were invited to return, not all of them did | Classification of interventions clear and determined at the start of intervention | All patients received the surgical intervention described in the methods | All patients included followed up | Objective software/panel assessment | No indication of selected reporting | |||
| Jiang 2015 | S‐BCS | Moderate | Serious | Low | Low | Low | Critical | Moderate | Critical |
| Important clinicopathological factors balanced (age, weight, histology type,tumour size, grade, stage, tumour location) | 60 women were picked, study says randomised but not clear how therefore classified as cohort. Risk of selection | Classification of interventions clear and determined at the start of intervention | All patients received the surgical intervention described in the methods | All patients included followed up | 3 person panel of experts, bias likely to influence outcome | No indication of selected reporting | |||
| Keleman 2019 | S‐BCS | Moderate | Serious | Low | Low | Low | Critical | Serious | Critical |
| Some variables demonstrated balance (age, smoking status, diabetes, BMI, type of cancer, tumour size, grade, stage, immunohistochemical receptor) some different (preoperative bra size, axillary node status) but unlikely to affect outcome. Important co‐intervention of adjuvant RT demonstrated balance, some significantly different (neoadjuvant CT, adjuvant CT, adjuvant ET, axillary management) but less of an impact on outcome | Not all patients responded | Classification of interventions clear and determined at the start of intervention. The types of intervention were: Therapeutic mammaplasty (superior, central, inferior pedicle Wise‐pattern), Dermoglandular rotation (medial, lateral mammoplasty), Periareolar (round block, omega) or standard BSC | All patients received the surgical intervention described in the methods. Operations done by experienced breast surgeons. | Patients missed due to loss to follow up and did not respond to outcome, equal numbers in both groups so impact may be similar across groups | 3 person panel of experts, bias likely to influence outcome | Details not given | |||
| Lansu 2014 | S‐BCS | Moderate | Moderate | Low | Low | Low | Moderate | Moderate | Moderate |
| Important clinicopathological factors balance (age, tumour size, tumour location), some missing. Important co‐interventions demonstrated balance, some significantly different | Patients had to be disease free and alive at the time of inclusion | Classification of interventions clear and determined at the start of intervention | All patients received the surgical intervention described | Most patients responded and followed up | Objective BCCT.core score | No indication of selected reporting | |||
| Santos 2015 | S‐BCS | Serious | Serious | Low | Low | Low | Moderate | Moderate | Serious |
| Some variables matched and demonstrated balance, stage significantly different: BMI, histological type, axillary node status. Intervention and control from different locations. Axillary management balanced, important co‐interventions missing: medical cancer treatment | Patients selected based on those that responded to questionnaire, not clear if/why all patients in the time period not selected | Classification of interventions clear and determined at the start of intervention: 'first group underwent level 2 O‐BCS techniques (bilateral surgeries with mammaplasty techniques', 'second group underwent lumpectomy with incisions over the tumour, without removing skin (except in cases where the tumours where close to skin)' | All patients received the surgical intervention described in methods | All patients included followed up | Objective BCCT.core score. Cosmesis also evaluated by two independent plastic surgeons and two breast surgeons using Garbay's criteria | No indication of selected reporting | |||
| Scheter 2019 | S‐BCS | Serious | Serious | Low | Low | Low | Serious | Serious | Serious |
| Important clinicopathological factors statistically adjusted for or demonstrated balance. Some significantly different: age, smoking status, tumour size. Some missing: axillary node status, grade, stage. Important co‐interventions demonstrated balance (medical cancer treatment and axillary management) | Patients were excluded if they proceeded to have a mastectomy after the intervention: "Patients who had subsequently proceeded to total mastectomy were excluded from the study." | Classification of interventions clear and determined at the start of intervention. Technique clearly described in methods: 'Patients with centrally located tumours who required NAC re‐ section and had medium‐ or large‐sized ptotic breasts were offered immediate OBR using a breast reduction pattern technique. Patients in the control group underwent primary closure of the NAC area in a horizontal or oblique scar and no oncoplastic reconstruction.' | All patients received the surgical intervention described in methods | All patients included followed up | 13 person panel of experts, bias likely to influence outcome | Selective reporting of certain domains | |||
| Viega 2011 | S‐BCS | Moderate | Serious | Low | Low | Moderate | Serious | Moderate | Serious |
| Important clinicopathological factors demonstrated balance (age, BMI, tumour size, tumour location) and "matched for demographic and oncologic aspects". Important co‐interventions demonstrated balance (adjuvant RT, adjuvant CT, axillary management), says some demographic and oncological aspects matched for | Unclear why these 45 patients were selected | Classification of interventions clear and determined at the start of intervention: "All patients underwent quadrantectomy and in most of them sentinel lymph node biopsy was performed. Breast reconstruction procedures included local flaps or breast reduction techniques. Neither distant flaps nor prosthesis were used." | All patients received the surgical intervention described in methods | Some patients were lost to follow‐up at 12 months: PParticipation rates at the follow‐up assessments of oncoplastic group were 100% at the 6th month and 88.9% at the 12th month follow‐up." | 4 person panel of experts, bias likely to influence outcome but tried to limit by standardisation and blinding of methods: "The aesthetic results of control group and oncoplastic group at 6 and 12 months postoperatively were evaluated through photographs of pre and postoperative, by a panel of four independent raters, according to the criteria shown on Table 4, modified from Garbay et al" | No indication of selected reporting | |||
| Gendy 2003 | Mx | Moderate | Serious | Low | Low | Low | Serious | Moderate | Serious |
| Important clinicopathological factors balanced (age, grade, axillary node status), some significantly different (histological type, tumour size), some missing. Important co‐interventions different across intervention group | All contactable participants | Classification of interventions clear and determined at the start of intervention, operative details given clearly | All patients received the surgical intervention described in the methods. All surgeries done by an experienced surgeon/under their supervision | All patients included followed up | 5 person panel of experts, bias likely to influence outcome | No indication of selected reporting | |||
| Ozmen 2020 | Mx +R | Serious | Serious | Low | Low | Low | Serious | Moderate | Serious |
| Important clinicopathological factors balance, some different (age, menopausal status, BMI, tumour size, grade, axillary node status, immunohistochemical receptor status (ER), multifocality), some missing. Important co‐interventions significantly different (adjuvant RT and axillary management), some missing (neoadjuvant RT + CT, adjuvant CT + ET) | Women chose their operation after being told the potential risks and benefits. Bias in assignment: "Both two procedures were explained to patients, and their choices were recorded." | Classification of interventions clear and determined at the start of intervention | All patient received the surgical intervention described in methods. All operations done by a single surgeon with more than 30 years of experience in breast surgery. | Most patients included: "Median follow‐up time was 56 (14‐116) months." | Cosmetic evaluation reporting tool validated but vulnerable to bias from subjective knowledge of intervention. Carried out by a single surgeon: "The cosmetic evaluation was conducted by a plastic surgeon who was not part of the surgical team." | No indication of selected reporting |
BMI: body mass index CT: chemotherapy ER: oestrogen receptor ET: endocrine therapy Mx: mastectomy PR: progesterone receptor R: reconstruction RT: radiotherapy
NAC: neoadjuvant chemotherapy