External inspection of compliance with standards for improved healthcare outcomes

Gerd Flodgren, Daniela C Gonçalves-Bradley, Marie-Pascale Pomey

Inspection systems are used in healthcare to promote quality improvements (i.e. to achieve changes in organisational structures or processes, healthcare provider behaviour and patient outcomes). These systems are based on the assumption that externally promoted adherence to evidence-based standards (through inspection/assessment) will result in higher quality of healthcare. However, the benefits of external inspection in terms of organisational-, provider- and patient-level outcomes are not clear. This is the first update of the original Cochrane review, published in 2011. To evaluate the effectiveness of external inspection of compliance with standards in improving healthcare organisation behaviour, healthcare professional behaviour and patient outcomes. We searched the following electronic databases for studies up to 1 June 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Database of Abstracts of Reviews of Effectiveness, HMIC, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. There was no language restriction and we included studies regardless of publication status. We also searched the reference lists of included studies and contacted authors of relevant papers, accreditation bodies and the International Organization for Standardization (ISO), regarding any further published or unpublished work. We also searched an online database of systematic reviews (PDQ-evidence.org). We included randomised controlled trials (RCTs), non-randomised trials (NRCTs), interrupted time series (ITSs) and controlled before-after studies (CBAs) evaluating the effect of external inspection against external standards on healthcare organisation change, healthcare professional behaviour or patient outcomes in hospitals, primary healthcare organisations and other community-based healthcare organisations. Two review authors independently applied eligibility criteria, extracted data and assessed the risk of bias of each included study. Since meta-analysis was not possible, we produced a narrative results summary. We used the GRADE tool to assess the certainty of the evidence. We did not identify any new eligible studies in this update. One cluster RCT involving 20 South African public hospitals and one ITS involving all acute hospital trusts in England, met the inclusion criteria. A trust is a National Health Service hospital which has opted to withdraw from local authority control and be managed by a trust instead.The cluster RCT reported mixed effects of external inspection on compliance with COHSASA (Council for Health Services Accreditation for South Africa) accreditation standards and eight indicators of hospital quality. Improved total compliance score with COHSASA accreditation standards was reported for 21/28 service elements: mean intervention effect was 30% (95% confidence interval (CI) 23% to 37%) (P < 0.001). The score increased from 48% to 78% in intervention hospitals, while remaining the same in control hospitals (43%). The median intervention effect for the indicators of hospital quality of care was 2.4% (range -1.9% to +11.8%).The ITS study evaluated compliance with policies to address healthcare-acquired infections and reported a mean reduction in MRSA (methicillin-resistant Staphylococcus aureus) infection rates of 100 cases per quarter (95% CI -221.0 to 21.5, P = 0.096) at three months' follow-up and an increase of 70 cases per quarter (95% CI -250.5 to 391.0; P = 0.632) at 24 months' follow-up. Regression analysis showed similar MRSA rates before and after the external inspection (difference in slope 24.27, 95% CI -10.4 to 58.9; P = 0.147).Neither included study reported data on unanticipated/adverse consequences or economic outcomes. The cluster RCT reported mainly outcomes related to healthcare organisation change, and no patient reported outcomes other than patient satisfaction.The certainty of the included evidence from both studies was very low. It is uncertain whether external inspection accreditation programmes lead to improved compliance with accreditation standards. It is also uncertain if external inspection infection programmes lead to improved compliance with standards, and if this in turn influences healthcare-acquired MRSA infection rates. The review highlights the paucity of high-quality controlled evaluations of the effectiveness and the cost-effectiveness of external inspection systems. If policy makers wish to understand the effectiveness of this type of intervention better, there needs to be further studies across a range of settings and contexts and studies reporting outcomes important to patients.