David D. Wirtschafter

The Kaiser Permanente prenatal smoking-cessation trial: when more isn't better, what is enough?

INTRODUCTION The effectiveness of low-cost smoking interventions targeted to pregnant women has been demonstrated, although few gains in absolute cessation rates have been reported in the past decade. Under conditions of typical clinical practice, this study examined whether outcomes achieved with brief counseling from prenatal care providers and a self-help booklet could be improved by adding more resource-intensive cognitive-behavioral programs. DESIGN Randomized Clinical Trial. SETTING A large-group-model managed care organization. PARTICIPANTS 390 English-speaking women 18 years of age or older who self-reported to be active smokers at their initial prenatal appointment. INTERVENTION Participants were randomized to one of three groups: (1) a self-help booklet tailored to smoking patterns, stage of change, and lifestyle of pregnant smokers; (2) the booklet plus access to a computerized telephone cessation program based on interactive voice response technology; or (3) the booklet plus proactive telephone counseling from nurse educators using motivational interviewing techniques and strategies. No attempt was made to change smoking-related usual care advice from prenatal providers. MAIN OUTCOME MEASURE Biochemically confirmed abstinence measured by level of cotinine in urine samples obtained during a routine prenatal visit at approximately the 34th week of pregnancy. RESULTS Twenty percent of participants were confirmed as abstinent with no significant differences found between intervention groups. Multivariate baseline predictors of cessation included number of cigarettes smoked per day, confidence in ability to quit, exposure to passive smoke, and educational level. No differential intervention effects were found within strata of these predictors or by baseline stage of readiness to change. Cessation rates among heavier smokers were strikingly low in all intervention groups. CONCLUSION Neither a computerized telephone cessation program nor systematic provision of motivational counseling improved cessation rates over a tailored self-help booklet delivered within the context of brief advice from prenatal providers. Innovative strategies need to be developed to increase the effectiveness of existing prenatal smoking interventions. Special attention should be paid to the needs of heavier smokers.

Prospective evaluation of postnatal steroid administration: a 1-year experience from the California Perinatal Quality Care Collaborative.

OBJECTIVE. Postnatal steroids (PNSs) are used frequently to prevent or treat chronic lung disease (CLD) in the very low birth weight (VLBW) infant, and their use continues despite concerns regarding an increased incidence of longer-term neurodevelopmental abnormalities in such infants. More recently, there has been a suggestion that corticosteroids may be a useful alternative therapy for hypotension in VLBW infants, but there have been no prospective reports of such use for a current cohort of VLBW infants. METHODS. The California Perinatal Quality Care Collaborative (CPQCC) requested members to supplement their routine Vermont Oxford Network data collection with additional information on any VLBW infant treated during their hospital course with PNS, for any indication. The indication, actual agent used, total initial daily dose, age at treatment, type of respiratory support, mean airway pressure, fraction of inspired oxygen, and duration of first dosing were recorded. RESULTS. From April 2002 to March 2003 in California, 22 of the 62 CPQCC hospitals reported supplemental data, if applicable, from a cohort of 1401 VLBW infants (expanded data group [EDG]), representing 33.2% of the VLBW infants registered with the CPQCC during the 12-month period. PNSs for CLD were administered to 8.2% of all VLBW infants in 2003, 8.6% of infants in the 42 hospitals that did not submit supplemental data (routine data-set group, compared with 7.6% in EDG hospitals). Of the 1401 VLBW infants in the EDG, 19.3% received PNSs; 3.6% received PNSs for only CLD, 11.8% for only non-CLD indications, and 4.0% for both indications. At all birth weight categories, non-CLD use was significantly greater than CLD use. The most common non-CLD indication was hypotension, followed by extubation stridor, for which 36 (16.3%) infants were treated. For hypotension, medications used were hydrocortisone followed by dexamethasone. Infants treated with PNSs exclusively for hypotension had a significantly higher incidence of intraventricular hemorrhage, periventricular leukomalacia, and death when compared with infants treated only for CLD or those who did not receive PNSs. CONCLUSIONS. The common early use of hydrocortisone for hypotension and the high morbidity and mortality in children receiving such treatment has not been recognized previously and prospective trials evaluating the short- and long-term risk/benefit of such treatment are urgently required.

Do information systems improve the quality of clinical research? Results of a randomized trial in a cooperative multi-institutional cancer group☆

Abstract A facsimile communications network was established to serve eight randomly selected medical centers belonging to the Southeastern Cancer Study Group (SEG) to test whether clinical algorithms could augment protocol compliance and patient safety. An SEG protocol (75HD0103) for testing alternative chemotherapy regimens in Advanced Hodgkins Disease was rewritten as a clinical algorithm. The algorithm generates treatment advice rules, emulating how the clinical researcher would accurately and appropriately apply the general protocol to an individual patients specific visit, considering his prior response to therapy. The visit-specific advice rules were typed onto general encounter forms and sent to the oncologists over the facsimile equipment prior to each therapy visit. A facsimile of the completed form was transmitted back. Protocol compliance, as judged by explicit criteria on a visit-by-visit basis, was 94% in the algorithm user group and 64% in the nonuser group (p

Cesarean delivery rates and Neonatal morbidity in a low-risk population

OBJECTIVE: To estimate the relationship between case-mix adjusted cesarean delivery rates and neonatal morbidity and mortality in infants born to low-risk mothers. METHODS: This retrospective cohort study used vital and administrative data for 748,604 California singletons born without congenital abnormalities in 1998–2000. A total of 282 institutions was classified as average-, low-, or high-cesarean delivery hospitals based on their cesarean delivery rate for mothers without a previous cesarean delivery, in labor at term, with no evidence of maternal, fetal, or placental complications. Neonatal mortality, diagnoses, and therapeutic interventions determined by International Classification of Diseases, 9th Revision, Clinical Modification codes, and neonatal length of stay were compared across these hospital groupings. RESULTS: Compared with average-cesarean delivery-rate hospitals, infants born to low-risk mothers at low-cesarean delivery hospitals had increased fetal hemorrhage, birth asphyxia, meconium aspiration syndrome, feeding problems, and electrolyte abnormalities (P < .02). Infused medication, pressors, transfusion for shock, mechanical ventilation, and length of stay were also increased (P < .001). This suggests that some infants born in low-cesarean delivery hospitals might have benefited from cesarean delivery. Infants delivered at high-cesarean delivery hospitals demonstrated increased fetal hemorrhage, asphyxia, birth trauma, electrolyte abnormalities, and use of mechanical ventilation (P < .001), suggesting that high cesarean delivery rates themselves are not protective. CONCLUSION: Neonatal morbidity is increased in infants born to low-risk women who deliver at both low- and high-cesarean delivery-rate hospitals. The quality of perinatal care should be assessed in these outlier hospitals. LEVEL OF EVIDENCE: III

A Consultant-Extender System for Breast Cancer Adjuvant Chemotherapy

We have implemented a consultant-extender system that enables community physicians, in cooperation with regional specialists, to deliver adjuvant chemotherapy to patients with node-positive breast cancer. The system employs computer-generated care protocol forms that indicate the data to be collected and the drug dose(s), with the appropriate rules for their administration. This continuous process of monitoring and modifying therapy assures protocol compliance and facilitates quality of care assessment. Seventy-three physicians throughout Alabama delivered appropriate chemotherapy at nearly 97% of 2612 visits by 195 patients. Disease-free intervals of 149 of those patients treated in a prospective clinical trial are indistinguishable from those of comparable patients treated largely within academic centers. This system provides a mechanism for decentralizing speciality care, incorporating community physicians into clinical trials, and improving continuing medical education techniques.

Nasal Continuous Positive Airway Pressure

Continuous positive airway pressure (CPAP) was employed using nasal prongs in 30 neonates with hyaline membrane disease (HMD). There was a significant improvement in mean Pa02 (from 47 to 80 mmHg; p

The Kaiser Permanente prenatal smoking-cessation trial 1

INTRODUCTION The effectiveness of low-cost smoking interventions targeted to pregnant women has been demonstrated, although few gains in absolute cessation rates have been reported in the past decade. Under conditions of typical clinical practice, this study examined whether outcomes achieved with brief counseling from prenatal care providers and a self-help booklet could be improved by adding more resource-intensive cognitive-behavioral programs. DESIGN Randomized Clinical Trial. SETTING A large-group-model managed care organization. PARTICIPANTS 390 English-speaking women 18 years of age or older who self-reported to be active smokers at their initial prenatal appointment. INTERVENTION Participants were randomized to one of three groups: (1) a self-help booklet tailored to smoking patterns, stage of change, and lifestyle of pregnant smokers; (2) the booklet plus access to a computerized telephone cessation program based on interactive voice response technology; or (3) the booklet plus proactive telephone counseling from nurse educators using motivational interviewing techniques and strategies. No attempt was made to change smoking-related usual care advice from prenatal providers. MAIN OUTCOME MEASURE Biochemically confirmed abstinence measured by level of cotinine in urine samples obtained during a routine prenatal visit at approximately the 34th week of pregnancy. RESULTS Twenty percent of participants were confirmed as abstinent with no significant differences found between intervention groups. Multivariate baseline predictors of cessation included number of cigarettes smoked per day, confidence in ability to quit, exposure to passive smoke, and educational level. No differential intervention effects were found within strata of these predictors or by baseline stage of readiness to change. Cessation rates among heavier smokers were strikingly low in all intervention groups. CONCLUSION Neither a computerized telephone cessation program nor systematic provision of motivational counseling improved cessation rates over a tailored self-help booklet delivered within the context of brief advice from prenatal providers. Innovative strategies need to be developed to increase the effectiveness of existing prenatal smoking interventions. Special attention should be paid to the needs of heavier smokers.

A Strategy for Redesigning the Medical Record for Quality Assurance

The medical record should be viewed as an instrument to facilitate and demonstrate the achievement of explicit health care goals. Current systems do not accomplish this. Our examination of the traditional record suggests that modifications of the record should be based on the principles of information system design theory. Necessary modifications include changes which prompt the monitoring of the outcome parameters of a patients illness, encourage the analysis of the patients outcome, and facilitate adaptive (corrective) actions. We have termed those data elements which describe the achievement of patientspecific, problem-specific objectives as the “minimum care assurance data set.” To designers of computerized medical information systems, this approach provides a rationale for selecting which data to place in computer storage from the myriad of detail in the traditional paper record.

Automation of a Patient Medical Profile from Insurance Claims Data: A Possible First Step in Automating Ambulatory Medical Records on a National Scale

This report describes how a detailed patient medical profile can be produced by the systematic collection and linkage of claims data in a state-wide Medicaid program. Extension of this system nationally could provide automated medical profiles for more than 20,000,000 people at a small increment in cost. The possibility that this cost could be offset by reduction of duplicated services currently provided deserves serious consideration by health care planners and administrators. The ability of the profile to portray a patients clinical status accurately hinges on both the determination of health care administrators to adopt sensitive and precise diagnostic codes and on the adoption of improved data acquisition techniques. The deficiencies of the database are described, and methods of overcoming these problems are suggested.

Automating ambulatory medical records: A claims-based medical profile

Abstract Whether we continue to have a fee-for-service medical system or federally sponsored universal health insurance, physicians and other providers will be required to submit billing documents or encounter forms to insurance carriers. Because modern payment systems convert billing data into machine-processable form, data from all providers can be linked to generate a summary of medical care. A medical profile derived from insurance data resembles those produced by operational computerized medical record systems (1, 2, 3). It too provides a clear snapshot listing the patients past medical problems, the medications currently and previously dispensed, the laboratory and radiological examinations performed, and the previous hospitalizations and operations. Profiles are currently used to enhance communication among physicians in group practice and even to replace the traditional record for most patient visits (3). Since the claims-based profile contains information from all providers of care, communication among separate practices would be enhanced and unnecessary duplication of services could be reduced were it widely adopted.