Table II. Methodological characteristics of Benchmarking Controlled Trials (BCTs) in 10 studies published between January 2010 and October 2014 in leading medical journals. Assessment is based solely on each particular paper; if information is not reported, the issue is assessed as unclear. Each characteristic is recorded as yes, partial, unclear, or no; yes indicates that the criterion has been met.
Study characteristics | Coleman et al., Lancet, 8 Jan 2011a | Pearse et al., Lancet, 22 Sep 2012 | Birkmeyer et al., NEJM, 10 Oct 2013 | Karthikesalinam et al., Lancet, 15 Mar 2014 | Chung et al., Lancet, 12 April 2014 | Finks et al., NEJM, 2 June 2011 | Song et al., NEJM, 9 Aug 2011 | Wallace et al., NEJM, 31 May 2012b | Sutton et al., NEJM, 8 Nov 2012a | Aiken et al., Lancet, 24 May 2014 |
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1. Research question and study design | To produce up-to-date survival estimates for selected cancers, to establish whether international differences (Australia, Canada, Denmark, Norway, Sweden, UK) in survival have changed, and to investigate the causes of survival deficits | Describe mortality rates and patterns of critical care resource use for patients undergoing non-cardiac surgery across several European nations | To assess the effect of surgical skill as a determinant for complication rates after bariatric surgery | To compare the in-hospital mortality of patients with rupture of an abdominal aortic aneurysm in England and USA | To compare crude and casemix-standardized 30-day mortality for acute myocardial infarction between UK and Sweden | To evaluate the extent to which decreases in mortality after esophagectomy, pancreatectomy, lung resection, cystectomy, and abdominal aortic aneurysm repair could be associated with a concentration of surgical care in high-volume hospitals | To assess the effect of the Alternative Quality Contract system on health care spending and on measures of the quality of ambulatory care in 2009 | To assess the relationship between night-time intensivist physician staffing and mortality among intensive care patients | To analyze the association of a hospital pay-for-performance program with patient mortality among patients with pneumonia, heart failure, or acute myocardial infarction | To assess whether differences in patient-to-nurse workloads and nurses’ educational qualifications in nine countries with similar patient discharge data are associated with variation in hospital mortality after common surgical procedures |
1.1. clinical or system comparison | Clinical | Clinical | Clinical | Clinical | Clinical | System comparison | System comparison | System comparison | System comparison | System comparison |
1.2. subcategory of comparison | Whole clinical pathway | Whole clinical pathway | Single intervention | Whole clinical pathway | Whole clinical pathway | Related to how and by whom the services are organized / provided | Related to the reimbursement and incentives | Related to how and by whom the services are organized / provided, and to the resources available for health care | Related to the reimbursement and incentives | Related to the resources available for health care |
1.3. conceptually pertinent and clear | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
1.4. natural experiment (allocation to study groups apparently by chance) | No | No | No | No | No | No | No | No | No | No |
1.5. operationalized according to the PICO principle (patient; treatment; comparison treatment; outcomes) | No | No | Yes | Yes | Yes | Yes | No | No | No | No |
2. Selection of patients/population to the study and measures to increase comparability (all studies have individual patient data) | ||||||||||
2.1. population-based cohort, administrative database, or clinical register | Population-based register | Clinical sample | Clinical register | Administrative databases | Clinical register | Administrative databases | Clinical register | Clinical register | Clinical register | Administrative databases |
2.2. prospective or retrospective design | Retrospective | Prospective | Prospective | Unclear | Retrospective | Retrospective | Unclear | Retrospective | Unclear | Retrospective |
2.3. level of health care provider (e.g. individual, health care center, hospital, district, country) | Country level | Country level | Individual provider | Country level | Country level | Hospital level | Provider organization | Hospital level | Hospital level | Hospital level |
2.4. description of patients’ clinical path before eligible for the study | No | No | NA | No | No | No | No | No | No | No |
2.5. description of patients’ clinical eligibility criteria | Yes | No | Yes | Yes | Partial | Yes | No | No | No | No |
2.6. comprehensive patient population of the catchment area | Yes | Yes | No | Yes | Unclear | Unclear | No | Unclear | Yes | Unclear |
2.7. restriction of patients to a particular group in order to increase homogeneity (e.g. first episode ever of ischemic stroke) | No | No | No | No | Partial | No | No | No | No | No |
2.8. use of instrumental variables to compensate for lack of randomization | No | No | No | No | No | No | No | No | No | No |
3. Validity and completeness of baseline data + Comparability ensured between groups at baseline (e.g. Validity: Yes; Comparability: No → Yes/No) | ||||||||||
3.1. diagnostics | Yes/Unclear | No/Unclear | Yes/Unclear | Yes/Yes | Yes/Yes | No/Unclear | No/Unclear | No/Unclear | Yes/Yes | No/Unclear |
3.2. other clinically important data relevant to the particular disorder/disease (e.g. severity) | No/Unclear | No/Unclear | Yes/Unclear | Yes/Unclear | Yes/Yes | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear |
3.3. general health/risk status | No/Unclear | No/Unclear | No/Unclear | No/Unclear | Yes/Yes | No/Unclear | Yes/Yes | Yes/Yes | No/Unclear | No/Unclear |
3.4. co-morbid conditions | No/Unclear | No/Unclear | Yes/Unclear | Yes/Yes | Yes/Yes | Yes/Yes | No/Unclear | Yes/Yes | Yes/Yes | Yes/Yes |
3.5. behavioral factors (e.g. on health-related lifestyle) | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear |
3.6. environmental factors (e.g. work conditions) | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear |
3.7. potential inequality (e.g. socio-economic status) | No/Unclear | No/Unclear | No/Unclear | Yes/Yes | No/Unclear | Yes/Yes | No/Unclear | No/Unclear | No/Unclear | No/Unclear |
3.8. other potential predictors (e.g. genetic factors), confounders, and effect modifiers | No/Unclear | No/Unclear | No/Unclear | Unclear/Unclear | Yes/Yes | No/Unclear | No/Unclear | No/Unclear | No/Unclear | No/Unclear |
4. Validity and completeness of process data (also unrelated to the disorder in question) throughout the clinical pathway | ||||||||||
4.1. diagnostics | Yes | No | Yes | Yes | Yes | No | Yes | Yes | No | No |
4.2. treatment procedures | No | No | Yes | Yes | Yes | No | Yes | Yes | No | No |
4.3. rehabilitation | No | No | NA | NA | Yes | No | NA | NA | No | No |
4.4. hospitalizations and health care visits | No | No | Yes | Yes | NA | No | NA | NA | No | No |
4.5. individual behavior (e.g. lifestyle-related to health) | No | No | No | NA | No | No | NA | NA | No | No |
4.6. adherence to treatments | Yes | No | Yes | NA | No | No | NA | NA | No | No |
4.7. characteristics of the clinical pathway | No | No | NA | NA | No | No | NA | NA | No | No |
5. Validity and completeness of outcome data (related to the disorder in question) | ||||||||||
5.1. validity of the outcomes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
5.2. outcomes assessed also among disadvantaged patients | No | No | No | No | No | No | No | No | No | No |
5.3. comparability (similarity) of follow-up time points | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes |
5.4. percentage of dropouts during follow-up documented and acceptable (<e.g. 10%) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
5.5. data at each comparator arm free of suggestion of selective outcome reporting | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
6. Statistical and data issues | ||||||||||
6.1. description of power calculations and rationale on how the study size was arrived at or post-analysis power calculation | No | Yes | No | No | No | No | Yes | No | No | No |
6.2. documentation of how data were classified and coded (e.g. blinding, multiple raters, inter-rater reliability) | Unclear | Unclear | Yes | Unclear | Yes | Unclear | Unclear | Yes | Unclear | Unclear |
6.3. measures to increase reliability of data classification and coding (e.g. blinding, multiple raters, inter-rater reliability) | Yes | Unclear | Yes | Unclear | Partial | Unclear | Unclear | Yes | Unclear | Unclear |
6.4. description of all primary statistical methods, including those used to control for confounding | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
6.5. description and use of methods to examine subgroups and interactions | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
6.6. description and use of propensity score or other methods to improve comparability at baseline | No | No | No | No | Yes | No | Yes | No | No | No |
6.7. adjustment for the characteristic outcomes of each health care provider (e.g. differences in general life expectancy in each country) | Yes | No | NA | No | No | No | No | No | No | No |
6.8. incomplete outcome data adequately addressed. If no missing data or appropriate imputation: Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
6.9. use of multilevel modeling or survival modeling | Yes | Yes | Yes | Yes | Unclear | Yes | Yes | No | No | Yes |
In studies on health care system as determinant of outcome: | ||||||||||
6.10. diagnostic and treatment processes analyzed as the mediators of the effects | No | No | No | No | No | Yes | No | No | No | No |
Study having comparisons also with cohorts in time, i.e. changes in outcomes between follow-up years (each have patients of their own). For this design there are three additional methodological issues: | ||||||||||
7.1. Documentation of changes in patient characteristics over time | No | No | ||||||||
7.2. Documentation of changes in treatment practices over time | No | No | ||||||||
7.3. Documentation of changes in patient outcomes over time | Yes | Yes |
NA = not applicable.
aStudy having comparisons also with cohorts in time: study characteristics 7.1.–7.3.
bStudy assessing the effect of one factor related to the organization of the system (e.g. presence of night-time intensivist).