The CLOQS trial protocol: a cluster-randomized trial evaluating a simple, low-cost intervention to reduce treatment times in acute stroke.

RATIONALE: In acute stroke, time is brain: faster tissue plasminogen activator treatment improves patient outcomes. Published guidelines for door-to-scanner time are <25 minutes, and for door-to-needle time <60 minutes. These benchmarks are rarely met. Paradoxically, the earlier a stroke patient arrives to hospital, the longer treatment takes. There is an urgent need to shift focus away from the 4.5 hour time window, towards treatment times <60 minutes. AIMS: The objective of the Countdown Lights to Optimize Quality in acute Stroke (CLOQS) trial is to determine whether a simple, low-cost organizational behavior intervention, a large, red stopwatch timer attached to the stretcher upon arrival, will decrease door-to-scanner and door-to-needle treatment times for tissue plasminogen activator-treated patients. DESIGN: A multicenter, time-clustered randomized control trial. The stopwatch timers will be used in Emergency Departments for all acute stroke patients across the University of Toronto Stroke Program. The order of intervention (ON) and control (OFF) blocks will be randomly assigned in a 1:1 ratio over an 18 month period. Blocks will be weighted in a 2:1 ratio of ON/OFF using a permuted block design (ON blocks last two weeks; OFF blocks last one week). STUDY OUTCOMES: The primary end-point is percentage of patients achieving best-practice guidelines (door-to-needle treatment time <60 minutes). Secondary end-points are median time intervals for 1) door-to-scanner and 2) door-to-needle times during ON versus OFF blocks. Tertiary end-points are in-hospital mortality and time series analysis to determine change in treatment times from prior to study onset through study completion.

Development of a South African integrated syndromic respiratory disease guideline for primary care.

AIMS: The Practical Approach to Lung Health in South Africa (PALSA) initiative aimed to develop an integrated symptom- and sign-based (syndromic) respiratory disease guideline for nurse care practitioners working in primary care in a developing country. METHODS: A multidisciplinary team developed the guideline after reviewing local barriers to respiratory health care provision, relevant health care policies, existing respiratory guidelines, and literature. Guideline drafts were evaluated by means of focus group discussions. Existing evidence-based guideline development methodologies were tailored for development of the guideline. RESULTS: A locally-applicable guideline based on syndromic diagnostic algorithms was developed for the management of patients 15 years and older who presented to primary care facilities with cough or difficulty breathing. CONCLUSIONS: PALSA has developed a guideline that integrates and presents diagnostic and management recommendations for priority respiratory diseases in adults using a symptom- and sign-based algorithmic guideline for nurses in developing countries.

Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol.

BACKGROUND: A major barrier to accessing free government-provided antiretroviral treatment (ART) in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. METHODS/DESIGN: This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART) for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a) 7400 registering with the programme with CD4 counts of

Effectiveness of antiretroviral treatment in a South African program: a cohort study.

BACKGROUND: The effectiveness of the South African government's expanding antiretroviral treatment program is unknown. Observational studies of treatment effectiveness are prone to selection bias, rarely compare patients receiving antiretroviral treatment with similar patients not receiving antiretroviral treatment, and underestimate mortality rates unless patients are actively followed up. METHODS: We followed up 14 267 patients in the Public Sector Anti-Retroviral Treatment project in Free State, South Africa, for up to 20 months after enrollment. A total of 3619 patients received highly active triple antiretroviral treatment (HAART) for up to 19 months (median, 6 months; interquartile range, 3-9 months) after enrollment. Patients' clinical data were linked with the national mortality register. Marginal structural regression models adjusted for baseline and time-varying covariates. RESULTS: Of 4570 patients followed up for at least 1 year, 53.2% died. Eighty-seven percent of patients who died had not received HAART. HAART was associated with lower mortality (hazard ratio, 0.14; 95% confidence interval [CI], 0.11-0.18) and with the presence of tuberculosis (hazard ratio, 0.61; 95% CI, 0.46-0.81) after adjusting for age, sex, weight, clinic, district, CD4 cell count, cotrimoxazole therapy, tuberculosis at baseline, and previous antiretroviral therapy. Cotrimoxazole therapy was associated with lower mortality (hazard ratio, 0.37; 95% CI, 0.32-0.42). Each month of HAART was associated with an increase in CD4 cell count of 15.1 cells/microL (95% CI, 14.7-15.5 cells/microL) and with an increase in body weight of 602 g (95% CI, 548-658 g). CONCLUSIONS: HAART provided through these South African government health services seems as effective as that provided in high-income countries. Delays starting HAART contributed to high mortality rates. Faster expansion and timely commencement of HAART are needed.

Legislative barriers to outpatient e-prescribing in a randomized trial.

Newer outpatient electronic prescribing software programs produce typewritten paper prescriptions with electronically created signatures. Current Canadian federal legislation forbids static (unchanging) signature images on prescriptions. We conducted a randomized trial of electronic prescribing in outpatients at a university-affiliated hospital. The application was a wireless Palm-based system that creates a prescription that is either printed and given to the patient or faxed to a pharmacy. Using the software, the physician creates a unique signature image for each prescription. We successfully overcame challenges related to wireless network reliability, local printer availability and physician training. However, to comply with federal legislation and provincial regulations, we were required to design workarounds to create acceptable prescribing processes. Our experience suggests that the legality of the electronic signature must be clearly defined to realize the full potential of standalone outpatient electronic prescribing systems and fully integrated hospital-wide electronic medical records.

A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting.

BACKGROUND: Medication errors, adverse drug events and potential adverse drug events are common and serious in terms of the harms and costs that they impose on the health system and those who use it. Errors resulting in preventable adverse drug events have been shown to occur most often at the stages of ordering and administration. This paper describes the protocol for a pragmatic trial of electronic prescribing to reduce prescription error. The trial was designed to overcome the limitations associated with traditional study design. DESIGN: This study was designed as a 65-week, cluster randomized, parallel study. METHODS: The trial was conducted within ambulatory outpatient clinics in an academic tertiary care centre in Ontario, Canada. The electronic prescribing software for the study is a Canadian electronic prescribing software package which provides physician prescription entry with decision support at the point of care. Using a handheld computer (PDA) the physician selects medications using an error minimising menu-based pick list from a comprehensive drug database, create specific prescription instructions and then transmit the prescription directly and electronically to a participating pharmacy via facsimile or to the physician's printer using local area wireless technology. The unit of allocation and randomization is by 'week', i.e. the system is "on" or "off" according to the randomization scheme and the unit of analysis is the prescription, with adjustment for clustering of patients within practitioners. DISCUSSION: This paper describes the protocol for a pragmatic cluster randomized trial of point-of-care electronic prescribing, which was specifically designed to overcome the limitations associated with traditional study design. TRIAL REGISTRATION: This trial has been registered with clinicaltrials.gov (ID: NCT00252395).

Diagnostic accuracy of an integrated respiratory guideline in identifying patients with respiratory symptoms requiring screening for pulmonary tuberculosis: a cross-sectional study.

BACKGROUND: To evaluate the diagnostic accuracy of the integrated Practical Approach to Lung Health in South Africa (PALSA) guideline in identifying patients requiring bacteriological screening for tuberculosis (TB), and to determine which clinical features best predict suspected and bacteriologically-confirmed tuberculosis among patients with respiratory symptoms. METHODS: A prospective, cross-sectional study in which 1392 adult patients with cough and/or difficult breathing, attending a primary care facility in Cape Town, South Africa, were evaluated by a nurse using the guideline. The accuracy of a nurse using the guideline to identify TB suspects was compared to that of primary care physicians' diagnoses of (1) suspected TB, and (2) proven TB supported by clinical information and chest radiographs. RESULTS: The nurse using the guideline identified 516 patients as TB suspects compared with 365 by the primary care physicians, representing a sensitivity of 76% (95% confidence interval (CI) 71%-79%), specificity of 77% (95% CI 74%-79%), positive predictive value of 53% (95% CI 49%-58%), negative predictive value of 90% (95% CI 88%-92%), and area under the receiver operating characteristic curve (ARUC) of 0.76 (95% CI 0.74-0.79). Sputum results were obtained in 320 of the 365 primary care physicians TB suspects (88%); 40 (13%) of these were positive for TB. Only 4 cases were not identified by the nurse using the guideline. The primary care physicians diagnostic accuracy in diagnosing bacteriologically-confirmed TB (n = 320) was as follows: sensitivity 90% (95% CI 76%-97%), specificity 65% (95% CI 63%-68%), negative predictive value 7% (95% CI 5%-10%), positive predictive value 99.5% (95% CI 98.8%-99.8%), and ARUC 0.78 (95% CI 0.73-0.82). Weight loss, pleuritic pain, and night sweats were independently associated with the diagnosis of bacteriologically-confirmed tuberculosis (positive likelihood ratio if all three present = 16.7, 95% CI 5.9-29.4). CONCLUSION: The PALSA guideline is an effective screening tool for identifying patients requiring bacteriological screening for pulmonary tuberculosis in this primary care setting. This supports the randomized trial finding that use of the guideline increased TB case detection.