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Randomised controlled trial assessing the impact of a nurse delivered, flow monitored protocol for optimisation of circulatory status after cardiac surgery.

OBJECTIVE: To assess whether a nurse led, flow monitored protocol for optimising circulatory status in patients after cardiac surgery reduces complications and shortens stay in intensive care and hospital. DESIGN: Randomised controlled trial. SETTING: Intensive care unit and cardiothoracic unit of a university teaching hospital. PARTICIPANTS: 174 patients who underwent cardiac surgery between April 2000 and January 2003. INTERVENTIONS: Patients were allocated to conventional haemodynamic management or to an algorithm guided by oesophageal Doppler flowmetry to maintain a stroke index above 35 ml/m2. RESULTS: 26 control patients had postoperative complications (two deaths) compared with 17 (four deaths) protocol patients (P = 0.08). Duration of hospital stay in the protocol group was significantly reduced from a median of nine (interquartile range 7-12) days to seven (7-10) days (P = 0.02). The mean duration of hospital stay was reduced from 13.9 to 11.4 days, a saving in hospital bed days of 18% (95% confidence interval -12% to 47%). Usage of intensive care beds was reduced by 23% (-8% to 59%). CONCLUSION: A nurse delivered protocol for optimising circulatory status in the early postoperative period after cardiac surgery may significantly shorten hospital stay.

Aged↗

Pilot study of a paediatric emergency department oral rehydration protocol.

OBJECTIVE: To ascertain if the use of a paediatric oral rehydration protocol in the emergency department changed rates of admission, total time spent in hospital, total time spent in the emergency department, or number of unscheduled returns to the emergency department. METHODS: A two month time period was analysed before and then after the adoption of an oral rehydration protocol for children presenting to the emergency department with symptoms suggestive of gastroenteritis. The rates of admission, total time spent in hospital, total time spent in the emergency department, and the rate of unscheduled returns were analysed using Fisher's exact and Wilcoxon testing for non-parametric data. RESULTS: The adoption of a paediatric rehydration protocol was associated with a significant reduction in admission rates (before = 22.5%, after 5.1%; p = 0.048) and mean total hospital time (before = 7 hours 54 minutes, after = 2 hours 17 minutes; p = 0.017). There was no significant difference in time spent in the emergency department (before = 1 hour 25 minutes, after 1 hour 35 minutes, p = 0.3). The number of unscheduled returns did not change significantly (p = 0.3). CONCLUSION: Adoption of a paediatric rehydration protocol significantly reduces admission rates and total time spent in hospital for children presenting to the emergency department with symptoms of gastroenteritis. The mean time spent in the actual emergency department does not significantly increase. The rate of unscheduled returns does not change.

Adolescent↗

Does the use of a syncope diagnostic protocol improve the investigation and management of syncope?

OBJECTIVES: To assess the efficacy of a protocol designed to improve the diagnosis and management of syncope. DESIGN: Prospective outcome analysis of all patients presenting with syncope for the 12 month period from 1 November 2000 to 31 October 2001, compared with a retrospective study of all patients presenting with syncope during the calendar year 1998. Use of the protocol commenced in September 2000. SETTING: Eastbourne District General Hospital, serving a population of approximately 250 000; 25% are older than 65 years. SUBJECTS: 421 consecutive patients presenting with syncope, investigated prospectively in January 2000 and compared with 660 patients retrospectively analysed for the calendar year 1998. RESULTS: In 1998, 71% of patients with syncope received a diagnostic classification. In January 2000 there was an appropriate diagnostic hypothesis for every patient. Ultimately a diagnosis was made for 78% of patients according to accepted criteria (p = 0.003). Use of tests with the highest diagnostic effectiveness, such as tilt tests, increased in 2001 and many tests were used more appropriately (such as echocardiography). However, non-diagnostic tests were still frequently used (such as chest radiography, electroencephalography, and carotid Doppler studies). Costs of investigation and hospital stay rose from pound 611 to pound 1384 (euro;874 to euro;1980) per patient (p < 0.001), with cost per diagnosis increasing from pound 870 (euro;1245) in 1998 to pound 1949 (euro;2790) (p < 0.001). CONCLUSION: The syncope protocol improved diagnosis and the use of appropriate investigations. However, significant inappropriate investigation and hospital admission still occurred. The protocol allowed reliable triage of syncopal patients into high and low risk groups.

Aged↗

Assessment of the Cardiff nephrectomy cut-up protocol with total blocking of the renal sinus: effect on tumour staging and practical issues.

AIM: To evaluate the effects on detection of vascular invasion and workload of a new standard dissection protocol for examining nephrectomy specimens for renal cell carcinoma. METHODS: Using 192 consecutive renal cell carcinoma nephrectomy specimens, the incidence of vascular invasion and number of tissue blocks per tumour were compared before and after introduction of the new protocol. RESULTS: The Cardiff protocol increased the percentage of tumours staged as T3b (renal sinus or hilar vein invasion) from 37.7% to 55.7% cases (p<0.001), with an increase from 9.1% to 21.7% of those staged as T3b due to renal sinus vein invasion alone (p<0.01). A small, but significant, permanent increase in workload was observed from an average of 11.7 to 13.4 blocks per case (p<0.001). CONCLUSIONS: This protocol is suitable for use in routine practice to evaluate pathological prognostic determinants important for clinical management, while causing only a small increase in workload.

Carcinoma, Renal Cell↗

Computerised protocols for laboratory investigation and their effect on use of medical time and resources.

AIMS: To devise a computerised management system protocol which not only proposes the laboratory investigations to be performed on each patient but also performs related clinical functions. METHODS: The system was designed by senior members of staff. The protocols defined all laboratory investigations including haematology, biochemistry, immunology and cross-matching, and included static and dynamic rules. Patients can be changed to different or additional protocols, as required; likewise proposed tests can be deleted or added. The software is written in MUMPS and runs on a 386 PC running MSM MUMPS under MSDOS. RESULTS: The number of clinical chemistry tests requested per patient per day fell by 9.5% (p less than 0.01) for transplant recipients and by 28.8% (p less than 0.01) for non-transplant recipients. The average time spent by junior medical staff requesting laboratory investigations and enquiring about results fell from 10 minutes per patient per day to 4.1 minutes (p less than 0.001). CONCLUSIONS: The introduction of this system in no way abrogates clinicians' responsibility for the management of patients, because all proposed investigations must be confirmed or modified by the authorising doctor. The system allows for the audit of requesting patterns and subsequent improvement in protocols by recording any alterations made to the proposed investigations. Significant benefits in terms of better use of house officer time and medical resources were also achieved.

Clinical Laboratory Information Systems↗

Evaluation of a protocol for examining nephrectomy specimens with renal cell carcinoma.

AIMS: To evaluate the practicality of use and the effectiveness of a standard protocol for examining nephrectomy specimens for renal cell carcinoma (RCC), with emphasis on the identification of vascular invasion. METHODS: A standard protocol, devised to identify the major prognostic determinants, was used to examine 79 consecutive tumours submitted to four histopathology departments. The incidence of vascular invasion found was compared with the incidence in a historical series of tumours. RESULTS: The protocol proved easy to follow, and appeared to increase the incidence of observed vascular invasion (40 of 69 cases compared with 69 of 176 cases in the historical series; p = 0.059, Fishers exact test, one sided) CONCLUSIONS: If pathological prognostic determinants are to be used for clinical management, then it is important that they are identified and recorded consistently. The protocol described provides a method of examining nephrectomy specimens that can be used in routine practice and would probably reliably identify recognised prognostic variables.

Carcinoma, Renal Cell↗

Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol.

BACKGROUND: The conventional view that participants in randomised controlled trials sacrifice themselves for the good of future patients is challenged by increasing evidence to suggest that individual patients benefit from participation in trials. OBJECTIVE: To test the hypothesis that trial participants receive higher quality care and, as a consequence, have better outcomes than patients receiving guideline driven routine care. METHODS: Retrospective comparative study of 408 women with pre-eclampsia all managed according to a strict protocol. Trial participants were 86 women who participated in a multicentre randomised controlled trial of magnesium sulphate for the treatment of pre-eclampsia (Magpie Trial); 322 non-participants formed the control group. Indicators of the process of care and clinical outcomes were compared between the two groups. RESULTS: Trial participants were significantly more likely to have received daily blood tests (odds ratio (OR) 6.82, 95% CI 1.62 to 28.72) and had their respiration rate measured hourly (OR 3.42, 95% CI 1.69 to 6.92) than control patients. There were no significant differences in other markers of clinical process and no significant difference in clinical outcomes. CONCLUSION: This study shows minor differences in process markers and no difference in clinical outcomes between patients in a clinical trial and patients receiving protocol driven care. The benefits of improved clinical care that have previously been associated with being in a trial may be explained by the use of clear clinical protocols. In routine practice, patients may be well advised to insist on treatment as part of a protocol.

Clinical Protocols↗

The reliability of a structured examination protocol and self administered vaginal swabs: a pilot study of gynaecological outpatients in Goa, India.

OBJECTIVES: Low participation rates for gynaecological examination and low reliability of clinical reporting of gynaecological examination findings are problems in community studies of gynaecological morbidity in India. This pilot study aimed to describe the reliability of a new examination protocol for recording the findings of gynaecological examination and the reliability and acceptability of the use of self administered vaginal swabs for the diagnosis of reproductive tract infections. METHOD: 75 women attending a gynaecology outpatient clinic were purposively sampled. Each woman was examined by two gynaecologists independently who recorded findings on the new examination protocol. Two swabs were collected from each woman, one by the gynaecologist and one by the woman. Swabs were smeared on separate slides which were stained and read for bacterial vaginosis and candidiasis by laboratory technicians blind to the mode of collection of the slides. RESULTS: The study showed a high inter-rater reliability for most of the items of the examination protocol. The interslide agreement for the diagnosis of the two RTIs was high. One third of women preferred the self administered swab. CONCLUSIONS: The examination protocol is a reliable method of recording gynaecological examination findings, and self administered swabs a useful way of obtaining vaginal specimens from women who did not wish to undergo gynaecological examinations in studies in the Indian setting.

Adolescent↗

Influence of race on death and ischemic complications in patients with non-ST-elevation acute coronary syndromes despite modern, protocol-guided treatment.

BACKGROUND: In the setting of acute coronary syndromes (ACS), nonwhite patients are less likely to undergo invasive cardiac procedures and may have worse clinical outcomes than white patients. Whether the disparate outcomes exist independently of potential biases in treatment patterns remains unclear. METHODS AND RESULTS: We examined the association between race and outcome in the Treat Angina with Aggrastat and Determine Cost of Therapy With an Invasive or Conservative Strategy-Thrombolysis in Myocardial Infarction 18 study (TACTICS-TIMI 18), a randomized trial of invasive versus conservative treatment strategy in patients with non-ST-elevation ACS. There were 1722 white and 461 nonwhite patients. After adjustment for differences in medical characteristics, nonwhite patients were at significantly increased risk for death, MI, or rehospitalization for ACS (hazard ratio [HR], 1.54; P=0.003). Rates of protocol-guided angiography and revascularization were similar in both groups. For non-protocol-guided care, however, we found significant disparities, with nonwhite patients less likely to be taking their cardiac medications at follow-up (odds ratio [OR], 0.59; P=0.0002), to undergo non-protocol-mandated angiography (OR, 0.40; P=0.03), to receive a stent if undergoing percutaneous coronary intervention (OR, 0.55; P=0.045), and to have less procedural success after percutaneous coronary intervention (acute gain, 1.40+/-0.83 versus 1.81+/-0.92 mm; P=0.004). Nonetheless, an invasive strategy was similarly efficacious in white (HR, 0.66; 95% CI, 0.50 to 0.88) and nonwhite (HR, 0.85; 95% CI, 0.52 to 1.39) patients (P(interaction)=0.52), especially in those with troponin elevation or ST deviation. CONCLUSIONS: After adjustment for baseline characteristics, nonwhite patients had a significantly worse prognosis than white patients, regardless of treatment approach. In the absence of protocol guidance, important disparities emerged between the care given the 2 groups. An early invasive strategy is beneficial in and should be considered for all patients, regardless of race.

Black or African American↗

Protocol for bedside laparotomy in trauma and emergency general surgery: a low return to the operating room.

Bedside laparotomy (BSL) was introduced as a heroic procedure in trauma patients too unstable for safe transport to the operating room (OR). We hypothesize a BSL protocol would maintain patient safety while reducing OR use. Patients were prospectively entered into a BSL protocol from July 2002 to June 2003 and retrospectively reviewed. Protocol indications for BSL were abdominal compartment syndrome, decompensation due to hemorrhage, washout/closure, and sepsis in a patient too unstable for safe transport to the OR. Primary outcomes were mortality, emergent return to OR, and primary fascial closure (PFC). Trauma operating room charges and OR time were analyzed. One hundred thirty-three BSL were performed on 60 patients with an overall mortality of 23.3 per cent (14/60). There was an average of 2.2 BSL per patient (range 1-8). Indications for BSL were 1) explore/washout (n = 100, 75.2%), 2) decompression (n = 14, 10.5%), 3) infection/abscess (n = 12, 9.0%), 4) hemorrhage (n = 7, 5.3%). Five of 133 BSL (5.8%) were emergently returned to the OR because of perforation or compromised bowel. Trauma OR charges were dollar 5,300 per cases with 2.12 hours per cases. The protocol standardized the conduct of BSL procedure to allow for a low return to OR rate of 5.8 per cent and had an overall in-hospital mortality rate of 23.3 per cent. Primary fascial closure of the abdomen had a significantly reduced hospital stay. BSL allowed trauma OR charges of dollar 5,300 per cases with 2.12 hours per cases savings.

Abdominal Injuries↗

Prevention of transfusion-associated HIV transmission with the use of a transfusion protocol for under 5s.

Recently there has been an increasing realization that for the prevention of transfusion-associated HIV infection, HIV screening alone is insufficient. In 1988, a treatment protocol for children under 5 years with severe anaemia, was introduced in Ekwendeni Hospital. Initial results showed that it was possible to reduce the number of blood transfusions without increasing the mortality rate. By January 1992 the protocol was being widely disregarded by ward staff, and transfusion rates had increased. Strict enforcement of the transfusion protocol from the 16 January produced a sharp drop in the percentage transfused from 44% to 11%. Mortality rates remained similar throughout the period of the study. Thus, it would appear to be possible, with the use of the transfusion protocol, to reduce the number of blood transfusions carried out, without affecting mortality rates, and hence to reduce the risk of transfusion-associated HIV.

Anemia↗

Protocol for outpatient screening and initiation of continuous subcutaneous insulin infusion therapy: impact on cost and quality.

PURPOSE: The purpose of this study was to determine the effectiveness of a screening protocol in identifying subjects who would initiate continuous subcutaneous insulin infusion (CSII) and continue the therapy for at least 2 1/2 years. METHODS: One hundred four subjects were recruited to participate in a screening protocol involving a mock trial of insulin pump use. Participants who initiated CSII were followed for 2 1/2 years; those deemed ill suited for CSII used multiple insulin injections. Discontinuation rates, quality of life, and costs were evaluated for subjects using CSII. Baseline and quarterly hemoglobin A1C (A1C) were measured and compared. RESULTS: The screening protocol identified 37 subjects (35.6%) who were unsuited for CSII. Subjects who initiated CSII reported enhanced quality of life and exhibited a low discontinuation rate (3.3%). No safety issues were encountered. Screening, CSII initiation, and follow-up were accomplished at lower costs per subject ($2431.50) than those reported in the Diabetes Control and Complications Trial (DCCT) ($8265.00). A1C was significantly lower over time for subjects receiving CSII compared with those receiving multiple injections. CONCLUSIONS: A structured screening protocol with trial pump use was effective in identifying individuals who would initiate CSII and continue the therapy for at least 2 1/2 years.

Activities of Daily Living↗

Evaluation of pressure ulcer prevalence rates for hospice patients post-implementation of pressure ulcer protocols.

Hospice patients may be particularly at risk for pressure ulcer development due to several factors. Identifying populations at risk for pressure ulcer development, such as hospice patients, and providing prevention and risk protocols for these populations can substantially reduce the prevalence and incidence of pressure ulcers. However, are hospice patients prone for skin breakdown despite prevention and treatment efforts? This study examines the prevalence of pressure ulcers in hospice patients following the implementation of pressure ulcer prevention and treatment protocols. Levine's theory of conservation of structural integrity formed the theoretical framework for this descriptive study. A midwestern hospital-based hospice agency was the site for this study. All patients 18 years of age and older were included in the study. Pressure ulcer prevalence audits were done at four, eight, 12, and 18 months after protocols were outlined by the hospice staff. Results of the audits revealed prevalence rates of 14.8 percent, 8.5 percent, 13.6 percent, and 23.8 percent, at each of the aforementioned audits. 10 of 15 patients who were pressure ulcer positive were males; the sacral location was most common (seven of 19 ulcers occurred sacrally) with the ischial location being the next common (six of 19 ulcers were ischially located). No ulcers occurred above the waist or in patients below 51 years of age. Recommendations from this study urge that particular prevention attention be given to protocols which address "sitting," due to the predominance of ulcers located in the sacral and ischial regions. In addition, the author concludes that perhaps, pressure ulcers may occur in this population despite the best of efforts to prevent them.

Aged↗

Magnetic resonance imaging protocols for cervical disc disease: what is your neighbor up to?

BACKGROUND AND PURPOSE: To summarize the prevalence of particular protocols used for routine magnetic resonance imaging of the cervical spine. METHODS: Centers nationwide were asked to submit routine protocols for degenerative disease. Cases with a history of demyelinating disease or suspected cord lesions were excluded. The pulse sequences and scanning planes were tabulated for 105 centers. For the last 53 centers studied, axial gradient recalled echo sequences were subdivided into 2-dimensional and 3-dimensional Fourier transform. RESULTS: There were 21 different combinations. A protocol consisting of sagittal T1+sagittal T2+axial gradient recalled echo T2 was used by 48% of centers. Two sagittal and 2 axial series in any combination was used in 30% (32/105 centers). One center used gradient recalled echo images exclusively, consisting of T1, proton density, and T2-weighted images, which included axial and sagittal planes. CONCLUSION: Sagittal T1+sagittal T2+axial gradient recalled echo T2 is by far the most prevalent protocol used for imaging the cervical spine.

Cervical Vertebrae↗

Pharmacy-enforced outpatient drug treatment protocols: a case study of Medi-Cal restrictions for cefaclor.

OBJECTIVE: To evaluate whether a pharmacy-enforced treatment protocol successfully limited the use of a high-cost medication to high-risk patients. DESIGN: A case study cost-effectiveness analysis was conducted to evaluate a treatment protocol for cefaclor. Episodes of care were defined, healthcare expenditures for all services were aggregated, and demographic data were retrieved from a five percent random sample of California Medicaid (Medi-Cal) recipients. Data were available for episodes occurring before cefaclor was made available under Medi-Cal. SETTING: Medi-Cal added cefaclor to its formulary, limiting its use to patients over 50 years of age with lower respiratory tract infections (LRTIs). The unit of analysis was an episode of outpatient antibiotic treatment. PATIENTS: Confirmed LRTI episodes and unconfirmed LRTI cefaclor episodes were analyzed, including multiple episodes of treatment for individual patients. A total of 7855 non-cefaclor LRTI episodes and 2556 cefaclor episodes were analyzed. MAIN OUTCOME MEASURES: The primary outcome measures were healthcare expenditures three months after the initiation of antibiotic therapy, differentiated by type of service. RESULTS: Physicians directed cefaclor toward higher-risk patients over age 50 years, even in unconfirmed LRTI episodes. Cefaclor use was estimated to reduce posttreatment costs by $388 per patient (p < 0.001), primarily because of reduced hospital expenditures of $366 (p < 0.001). CONCLUSIONS: Pharmacy-enforced outpatient drug treatment protocols may be a viable alternative to restrictive formularies and prior authorization. In the case of cefaclor, the Medi-Cal treatment protocol appeared to allow high-risk patients better access to a high-cost medication while reducing total posttreatment costs.

Aged↗

Emergency department staff responses to a protocol of care for abused women.

While there is increasing recognition by health care providers of the need to identify and intervene in cases of partner abuse, there has been little evaluation of the interventions that have been implemented. This article documents emergency department staff responses to a five-step protocol of care on partner abuse implemented in a public hospital. It draws on in-depth interviews with a range of emergency department staff members, undertaken as part of the project's process evaluation. Findings suggest protocol training provided staff members with an opportunity to gain a greater awareness and understanding of partner abuse. Protocol use improved and consolidated existing practices; however, staff members were concerned about screening all women for abuse and highlighted areas in which further support and resources are required. Taking these factors into account may assist the appropriate and effective introduction of such protocols in other health care settings.

Attitude of Health Personnel↗

Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649].

BACKGROUND: Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably. METHODS: In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity") and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation. DISCUSSION: No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.

Absenteeism↗

Clinical trial of a weaning protocol.

Krishnan and colleagues have conducted a prospective clinical trial of a weaning strategy previously demonstrated to enhance clinical outcomes of mechanically ventilated patients. They draw conclusions quite different from those drawn in an accompanying editorial. Krishnan and colleagues compared the outcomes of patients supported with mechanical ventilation for at least 24 hours. The outcome of those patients weaned from mechanical ventilation was compared with the outcome of those patients who received usual care. Although usual care was not defined, it was delivered in an unusual environment that included many systems improvement elements previously demonstrated to improve clinical outcomes. The investigators worked in a closed intensive care unit that employed large numbers of physicians (six residents, two postdoctoral fellows, and two attending physicians for a 14-bed unit), and used a structured standard checklist to make patient review during rounds more systematic. These features might reduce the difference in outcome between the protocol group and other patients in their unit. In addition, the experimental design allowed convergence of the method of care of protocol group patients with the method of care of other patients. Their results are compatible with either no effect of the protocol or with an inability to demonstrate the effect of the protocol because of the systems improvement elements in operation in their intensive care unit.

Clinical Protocols↗