The review included nine controlled studies (12 articles) and an unspecified number of uncontrolled studies (60 articles). The controlled studies comprised two RCTs (79 intervention group providers and 78 control providers), one interrupted time series (one provider) and six controlled before-and-after studies (115 intervention group providers, 208 control providers).
In the update, an additional controlled before-and-after study was included (95 intervention group providers and 125 control providers). A further seven uncontrolled studies were retrieved, but it was not possible to carry out an effectiveness evaluation.
Most of the nine controlled studies had major methodological flaws. These included possible differences in baseline measurement (six studies), limited information about control sites, no clear indication that blinding was used and possible contamination. This applied also to the additional study in the update, although baseline measurement was comparable and follow-up was 100%. The uncontrolled studies did not contain adequate information about data collection or analysis and measures were not objective and commonly consisted of self-report measures by participating providers. Almost all of the uncontrolled studies were methodologically weak and probably biased towards positive findings.
Among the controlled studies there were marked differences between the interventions. Four studies contained elements of the chronic care programme in the intervention; two others included ongoing support beyond the time-frame of the quality improvement collaboration. Therefore, it was not possible to determine to the extent to which any effects were related to the quality improvement collaboration.
Breakthrough Series (three studies and one additional study in the update):
Two studies reported positive findings associated with the intervention. One before-and-after study set in nursing homes reported a statistically significant reduction in the proportion of patients with pain (7.2% versus 11.2%, p<0.05). Another study (an interrupted time series of infant mortality in the community) reported a statistically significant increase in mean length of time between deaths (55 days versus 114 days, p<0.05) after a five-year quality programme during which a one-year Breakthrough Series project was conducted. One before-and-after study set in HIV clinics reported no statistically significant effect for any outcome; this included measures of screening, prophylaxis and access to care.
In the updated review, a study that measured conversion rate for organ donation (eligible donors who became actual donors) showed a pre-post period change of 8% (95% confidence interval 2% to 13%) in favour of the collaborative intervention. However, the authors acknowledged that causality was unclear.
Breakthrough Series plus chronic care model (four studies):
A RCT among children with asthma reported no statistically significant effect associated with the intervention on any key processes or intermediate outcomes. Three before-and-after studies reported mixed effects, with statistically significant improvements for some measures. One of these studies focused on management of diabetes in primary care and found statistically significant benefits associated with the intervention in measures of end-organ surveillance, glycaemic control and control of hypertension (p<0.05). A before-and-after study of asthma in children showed statistically significant improvements (p<0.05) in measures of self-management (such as peak flow monitoring) and education (such as use of metered inhalers), but no significant improvement in satisfaction with care or in functional measures. A before-and-after study of patients with chronic heart failure found statistically significant improvements (p<0.05) in measures of counselling, education and communication (for example, related to medications, diet, exercise and goal setting), but performance rates remained low (<50%) for most educational indicators and there was no significant improvement in outcomes such as diagnostic indicators or heart failure symptoms. The process measures that improved the most were those with the lowest initial performance rates.
Vermont Oxford Network (two studies):
Two studies of pre-term infants reported mixed effects. One cluster RCT found a statistically significant increase in rates of oxygen supplementation and a statistically significant decrease in infection rates in the intervention group (both p<0.05), but there was no evidence of a significant improvement in death rates or pneumothorax. A before-and-after study reported a statistically significant improvement associated with the intervention in several measures; these included decreased infection rates in six neonatal units (12.3% versus 16.5%, p<0.05) and in the rate of supplemental oxygen use in four units (34% versus 38.7%). There was no significant improvement in other measures, such as rates of death and pneumothorax.
Findings of uncontrolled studies:
Most of the accounts of uncontrolled studies (88%) reported improvements in patient care and organisational performance, in some cases of 30% to 80%. However, given methodological limitations of these studies, no conclusions on effectiveness could be drawn. Details of these studies were not reported in the review but could be obtained from the authors on request.