Electronic Health Record-Based Nudge Intervention and Axillary Surgery in Older Women With Breast Cancer: A Nonrandomized Controlled Trial.

Importance: Choosing Wisely recommendations advocate against routine use of axillary staging in older women with early-stage, clinically node-negative (cN0), hormone receptor-positive (HR+), and HER2-negative breast cancer. However, rates of sentinel lymph node biopsy (SLNB) in this population remain persistently high. Objective: To evaluate whether an electronic health record (EHR)-based nudge intervention targeting surgeons in their first outpatient visit with patients meeting Choosing Wisely criteria decreases rates of SLNB. Design, Setting, and Participants: This nonrandomized controlled trial was a hybrid type 1 effectiveness-implementation study with subsequent postintervention semistructured interviews and lasted from October 2021 to October 2023. Data came from EHRs at 8 outpatient clinics within an integrated health care system; participants included 7 breast surgical oncologists. Data were collected for female patients meeting Choosing Wisely criteria for omission of SLNB (aged ≥70 years with cT1 and cT2, cN0, HR+/HER2- breast cancer). The study included a 12-month preintervention control period; baseline surveys assessing perceived acceptability, appropriateness, and feasibility of the designed intervention; and a 12-month intervention period. Intervention: A column nudge was embedded into the surgeon's schedule in the EHR identifying patients meeting Choosing Wisely criteria for potential SLNB omission. Main Outcomes and Measures: The primary outcome was rate of SLNB following nudge deployment into the EHR. Results: Similar baseline demographic and tumor characteristics were observed before (control period, n = 194) and after (intervention period, n = 193) nudge deployment. Patients in both the control and intervention period had a median (IQR) age of 75 (72-79) years. Compared with the control period, unadjusted rates of SLNB decreased by 23.1 percentage points (46.9% SLNB rate prenudge to 23.8% after; 95% CI, -32.9 to -13.8) in the intervention period. An interrupted time series model showed a reduction in the rate of SLNB following nudge deployment (adjusted odds ratio, 0.26; 95% CI, 0.07 to 0.90; P = .03). The participating surgeons scored the intervention highly on acceptability, appropriateness, and feasibility. Dominant themes from semistructured interviews indicated that the intervention helped remind the surgeons of potential Choosing Wisely applicability without the need for additional clicks or actions on the day of the patient visit, which facilitated use. Conclusions and Relevance: This study showed that a nudge intervention in the EHR significantly decreased low-value axillary surgery in older women with early-stage, cN0, HR+/HER2- breast cancer. This user-friendly and easily implementable EHR-based intervention could be a beneficial approach for decreasing low-value care in other practice settings or patient populations. Trial Registration: ClinicalTrials.gov Identifier: NCT06006910.

Is the Number or Proximity of Margins Less than 2 mm Associated with an Increased Mastectomy Rate in Patients Attempting Breast Conservation Therapy for Ductal Carcinoma In Situ?

BACKGROUND: Consensus guidelines recommend ≥ 2 mm margins in patients undergoing partial mastectomy (PM) for ductal carcinoma in situ (DCIS). It is unknown whether the number or proximity of margins less than 2 mm is associated with an increased mastectomy rate in patients attempting breast conservation therapy (BCT) for DCIS. The aim of this study is to examine this relationship. PATIENTS AND METHODS: An institutional database review identified 208 patients with DCIS who underwent PM at a tertiary referral center and community hospitals from July 2020 to June 2023. Patients with a history of breast cancer, previous surgery for breast cancer, ipsilateral invasive carcinoma, papillary carcinoma, Paget's disease, more lobular carcinoma in situ (LCIS) than DCIS present, initial mastectomy, no DCIS present, routine shave margins (of all vectors), and ≥ 2 mm margins of all six vectors were excluded. Selective intraoperative margin re-excisions were included. RESULTS: A total of 208 patients who met inclusion criteria were retrospectively reviewed. 122 (25%) had one close/positive (< 2 mm) margin and 86 (18%) had two or more close/positive margins. Of the patients with one close/positive margin, 7% (9/122) eventually underwent mastectomy. Of the patients with two or more close/positive margins, 20% (17/86) eventually underwent mastectomy. Overall, no patients with opposing margins underwent mastectomy. CONCLUSIONS: Patients undergoing PM for DCIS have a mastectomy rate that is increased threefold, with two or more close/positive margins at initial PM, when compared with those with only one close/positive margin. The presence of opposing close/positive margins at initial PM did not increase the mastectomy rate and most were cleared with re-excision.

The Effect of Lumpectomy and Cavity Shave Margin Status on Recurrence and Survival in Breast-Conserving Surgery.

BACKGROUND/OBJECTIVE: Cavity shave margins (CSMs) decrease rate of positive margins and need for re-excision. Recurrence data following breast-conserving surgery (BCS) are not always available in large cancer registries. We sought to define our recurrence and survival data in BCS with routine excision of CSMs. METHODS: A single institution, 10-year retrospective review of breast cancer patients who underwent BCS with routine CSMs was conducted. Cavity shave margin technique was standard. Cox proportional hazard analyses and the Kaplan-Meier method were used to estimate recurrence and survival. RESULTS: Breast-conserving surgery with CSM was performed in 839 patients. Re-excision rate to achieve negative margins was 8.5%. Fifty-two patients (75%) underwent margin re-excision vs 18 patients (25%) underwent salvage mastectomy. Positive margin rate stratified by tumor histology was highest for invasive lobular carcinoma followed by mixed invasive ductal carcinoma (IDC) and ductal carcinoma in situ (DCIS), followed by pure DCIS and lowest for IDC. Length of follow-up was (4.7 ± 2.6, years). Overall recurrence rate (locoregional and systemic) was 4.3%: highest in patients with negative lumpectomy margin but positive CSM (L-S+ = 15%) followed by positive lumpectomy and CSMs (L+S+ = 14%), followed by patients with positive lumpectomy margin but negative CSMs (L+S- = 13%) and lowest for negative lumpectomy and CSM (L-S- = 5%), (P = .0008). There was no difference in 5-year breast cancer-specific survival between the 4 subgroups: 96% for L-S-, 86.7% L-S+, 94.7% L+S+ and 90% L+S- (P = .094). CONCLUSIONS: Recurrence following BCS with CSMs can be stratified based on both lumpectomy and cavity shave margin positivity. Routine excision of CSMs allows identification of these patient subsets.

Intraoperative Radiation Therapy Versus Whole Breast Radiation for Early-Stage Breast Cancer Treatment in Rural Appalachia.

BACKGROUND: Intraoperative radiation therapy (IORT) is an alternate accelerated form of radiation following breast-conserving surgery (BCS). Lack of data regarding long-term outcomes has limited adoption. We report our experience with IORT in patients undergoing BCS versus whole breast radiation therapy (WBRT). METHODS: Retrospective review of patients undergoing BCS with IORT versus WBRT (2012-2017). Inclusion: low grade, T1-2N0M0, estrogen receptor/progesterone receptor positive, and Her2-negative infiltrating ductal carcinomas. IORT was delivered as a single fraction of radiation (20 Gy) intraoperatively. Outcomes were compared using Fisher's test for discrete variables or Wilcoxon signed-rank test for continuous variables. Kaplan-Meier method was used to estimate disease-free survival (DFS). RESULTS: Fifty-one patients (44%) received IORT, and 66 (56%) received WBRT. There was no difference in age, tumor size, receptor status, or in-breast recurrence (1.9% vs 0%, all P > .05). Length of follow-up was longer in the WBRT group due to time to inception of IORT (mean ± SD: 44 ± 8.1 vs 73 ± 13 months, P < .001). There was no difference in DFS between the 2 groups (HR 2.5; P = .44). IORT patients experienced delay to BCS (mean ± SD: 38 ± 12.7 vs 27 ± 12.2 days, P < .001) likely due to coordination of care. Analysis demonstrated IORT patients would have traveled a mean distance of 20 miles to the closest WBRT center (range 1-70, miles) for a mean travel time of 31 minutes (range 4-90, minutes) per WBRT treatment. DISCUSSION: IORT produces noninferior oncologic outcomes and decreased skin toxicity compared with WBRT. It can be convenient for patients in rural regions with limited health care access.

A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis.

BACKGROUND: Breast cancer-related lymphedema (BCRL) represents a major source of morbidity among breast cancer survivors. Increasing data support early detection of subclinical BCRL followed by early intervention. A randomized controlled trial is being conducted comparing lymphedema progression rates using volume measurements calculated from the circumference using a tape measure (TM) or bioimpedance spectroscopy (BIS). METHODS: Patients were enrolled and randomized to either TM or BIS surveillance. Patients requiring early intervention were prescribed a compression sleeve and gauntlet for 4 weeks and then re-evaluated. The primary endpoint of the trial was the rate of progression to clinical lymphedema requiring complex decongestive physiotherapy (CDP), with progression defined as a TM volume change in the at-risk arm ≥ 10% above the presurgical baseline. This prespecified interim analysis was performed when at least 500 trial participants had ≥ 12 months of follow-up. RESULTS: A total of 508 patients were included in this analysis, with 109 (21.9%) patients triggering prethreshold interventions. Compared with TM, BIS had a lower rate of trigger (15.8% vs. 28.5%, p < 0.001) and longer times to trigger (9.5 vs. 2.8 months, p = 0.002). Twelve triggering patients progressed to CDP (10 in the TM group [14.7%] and 2 in the BIS group [4.9%]), representing a 67% relative reduction and a 9.8% absolute reduction (p = 0.130). CONCLUSIONS: Interim results demonstrated that post-treatment surveillance with BIS reduced the absolute rates of progression of BCRL requiring CDP by approximately 10%, a clinically meaningful improvement. These results support the concept of post-treatment surveillance with BIS to detect subclinical BCRL and initiate early intervention.

A Prospective Study of L-Dex Values in Breast Cancer Patients Pretreatment and Through 12 Months Postoperatively.

BACKGROUND: Data regarding pretreatment, bioimpedance spectroscopy (BIS) L-Dex® values for patients newly diagnosed with breast cancer, and longitudinal data 12 months postoperatively are lacking. This study describes L-Dex values at the time of breast cancer diagnosis and maximum L-Dex change within 12 months of surgery. METHODS AND RESULTS: Patients were enrolled in a parent, clinical trial that compares the effectiveness of BIS for early detection of breast cancer-related lymphedema to tape measurement. A total of 280 women with a pretreatment and at least one postoperative L-Dex measurement (within 12 months of surgery) were included. Pretreatment L-Dex readings were compared with population norms and maximum L-Dex changes within 12 months were examined. An L-Dex U400 device was used to obtain BIS measurements. The documented normative mean value using this device is 0.00, which is at the 49th percentile for this sample. Approximately 6% of patients had a pretreatment L-Dex value of ≥7.0; 1.8% had an L-Dex value ≥10.0. For 12 months, 17.1% (n = 48) of patients had a maximum change in L-Dex value from pretreatment of ≥7.0 L-Dex units, suggestive of clinical lymphedema. CONCLUSIONS: At the time of breast cancer diagnosis, L-Dex values are similar to normative values. Identified maximum changes in L-Dex values 12 months postoperatively suggest that frequent L-Dex measurements during that time frame are of potential clinical benefit. Our findings are consistent with research supporting an L-Dex value of ≥7 as indicative of clinical lymphedema with subclinical lymphedema logically occurring at somewhat lower likely, near ≥6.5.

Short-Term Follow-Up Mammography in Breast Conservation Therapy Likely Leads to Unnecessary Downstream Workup: A Longitudinal Study.

PURPOSE: To analyze the effect of post-radiation therapy (XRT) mammographic timing and radiation technique in relation to additional downstream workup for 569 breast conservation therapy patients treated with adjuvant XRT after their initial surveillance mammogram (MMG). METHODS AND MATERIALS: From January 2011 to December 2014, 569 breast cancer patients treated with breast conservation surgery and adjuvant XRT with a follow-up MMG were reviewed. Patients were stratified by the time interval until their first post-XRT MMG, and by XRT technique-whole breast (472), accelerated partial breast (96), conventional fractionation (373), hypofractionation (94), surgical cavity boosts (407), or no boost (66). The primary endpoint was further imaging after the initial MMG. RESULTS: Additional workup for those receiving an MMG within 3 months of completing XRT was 51% (73 of 143), compared with 40% (84 of 210) with MMG between 3 and 6 months and 34.5% (75 of 216) with MMG after 6 months (P=.04). Radiation boost to the postoperative bed was associated with further downstream imaging, whereas accelerated partial-breast irradiation and hypofractionated treatment were not. CONCLUSIONS: Breast conservation therapy patients who underwent screening MMG before 6 months after completion of XRT were more likely to undergo downstream workup, including additional biopsies. Accelerated and hypofractionated radiation techniques were not associated with supplementary workup. Further study is needed to assess appropriate selection of high-risk patients and possible negative implications of earlier post-XRT screening MMG.

Local failure and acute radiodermatological toxicity in patients undergoing radiation therapy with and without postmastectomy chest wall bolus: Is bolus ever necessary?

PURPOSE: Postmastectomy chest wall radiation therapy has historically used bolus to increase dose at the skin surface. Despite the theoretical benefits of bolus, the clinical implications of locoregional tumor control, cosmesis, and the incidence of radiodermatitis are less well characterized. We hypothesized that treatment in the presence or absence of bolus results in equivalent chest wall recurrence rates, but its presence results in more severe acute dermatologic toxicity. METHODS AND MATERIALS: Locally advanced breast cancer patients undergoing chest wall radiation therapy were retrospectively reviewed from 2005 to 2015 (n = 106; 53 with bolus, 53 without). Outcomes including local failure, acute skin toxicity, and treatment interruptions were recorded. Median age was 59 years (range, 28-91) and median follow-up was 34 months. Histology was invasive ductal carcinoma (73%), invasive lobular carcinoma (20%), inflammatory (6%), and neuroendocrine (1%). Fifty-nine percent were T3/T4 primary tumors and 29.2% had clinical/pathologic skin involvement. Node-positive patients accounted for 80.2%. Chemotherapy was administered in 84.0%. All patients had 3-dimensional conformal radiation therapy and received a median dose of 61Gy (range, 50-63 Gy). RESULTS: Local failure was 6.6% (n = 7) overall, with 4 failures in the bolus group and 3 in the no bolus group. No pathological factors were associated with local failure. Acute grade 2 and 3 skin toxicities (37 vs 22) and treatment interruptions (20 vs 3) were more common in the bolus group (P < .05). Mean treatment interruption (14.5 vs 5 days) was longer for patients receiving bolus. Patients undergoing treatment interruption were more likely to fail locally than patients not requiring a treatment interruption (17.4% vs 3.6%, P = .0322). CONCLUSIONS: Bolus omission in adjuvant chest wall radiation therapy may be a reasonable approach to avoid acute skin toxicity and treatment interruptions while preserving local control; however, further study will be needed to reach a definitive conclusion.

Tweeting the Meeting: Twitter Use at The American Society of Breast Surgeons Annual Meeting 2013-2016.

BACKGROUND: Twitter social media is being used to disseminate medical meeting information. Meeting attendees and other interested parties have the ability to follow and participate in conversations related to meeting content. We analyzed Twitter activity generated from the 2013-2016 American Society of Breast Surgeons Annual Meetings. METHODS: The Symplur Signals database was used to determine number of tweets, tweets per user, and impressions for each meeting. The number of unique physicians, patients/caregivers/advocates, and industry participants was determined. Physician tweeters were cross-referenced with membership and attendance rosters. Tweet transcripts were analyzed for content and tweets were categorized as either scientific, social, administrative, industry promotion, or irrelevant. RESULTS: From 2013 to 2016, the number of tweets increased by 600 %, the number of Twitter users increased by 450 %, and the number of physician tweeters increased by 457 %. The number of impressions (tweets × followers) increased from more than 3.5 million to almost 20.5 million, an increase of 469 %. The majority of tweets were informative (70-80 %); social tweets ranged from 13 to 23 %. A small percentage (3-6 %) of tweets were related to administrative matters. There were very few industry or irrelevant tweets. CONCLUSIONS: Twitter social media use at the American Society of Breast Surgeons annual meeting showed a substantial increase during the time period evaluated. The use of Twitter during professional meetings is a tremendous opportunity to share information. The authors feel that medical conference organizers should encourage Twitter participation and should be educating attendees on the proper use of Twitter.

Do Primary Care Physician Perform Clinical Breast Exams Prior to Ordering a Mammogram?

Both the American Cancer Society and National Comprehensive Cancer Network recommend annual clinical breast examination (CBE) along with screening mammogram (SM) for patients starting at 40 years of age. However, patients with a palpable breast mass should have a diagnostic mammogram (DM) during workup. Review at our institution demonstrated that 11% of patients with newly diagnosed breast cancer and self-identified breast mass had SM instead of DM. This led us to question whether primary care physicians (PCP) perform CBE prior to ordering mammography. As part of the routine preimaging screening, patients were asked if they had undergone breast examination by a medical provider prior to mammogram order. Data on mammogram type, ordering physician specialty, and presence of symptoms on day of mammogram were recorded. Of 6,109 mammograms, 4,823 were ordered by PCPs. CBE was performed prior to 67.2% SM and 64.8% DM (p = 0.12). OB/GYN performed statistically significantly higher CBE (81.6%) compared to internal (45.4%) and family (50.5%) medicine physicians (p < 0.001). Of patients with self-reported breast symptoms, 8.7% had SM ordered rather than DM. Despite recommendations, approximately 1/3 of women report not having CBE prior to mammogram. The chances of having a CBE varied significantly by PCP specialty. Lack of CBE can lead to incorrect type of mammogram, with possibly increased cost and delay in diagnosis. Further evaluation is needed to understand why CBE was not performed in some patients.

Twitter Social Media is an Effective Tool for Breast Cancer Patient Education and Support: Patient-Reported Outcomes by Survey.

BACKGROUND: Despite reported benefits, many women do not attend breast cancer support groups. Abundant online resources for support exist, but information regarding the effectiveness of participation is lacking. We report the results of a Twitter breast cancer support community participant survey. OBJECTIVE: The aim was to determine the effectiveness of social media as a tool for breast cancer patient education and decreasing anxiety. METHODS: The Breast Cancer Social Media Twitter support community (#BCSM) began in July 2011. Institutional review board approval with a waiver of informed consent was obtained for a deidentified survey that was posted for 2 weeks on Twitter and on the #BCSM blog and Facebook page. RESULTS: There were 206 respondents to the survey. In all, 92.7% (191/206) were female. Respondents reported increased knowledge about breast cancer in the following domains: overall knowledge (80.9%, 153/189), survivorship (85.7%, 162/189), metastatic breast cancer (79.4%, 150/189), cancer types and biology (70.9%, 134/189), clinical trials and research (66.1%, 125/189), treatment options (55.6%, 105/189), breast imaging (56.6%, 107/189), genetic testing and risk assessment (53.9%, 102/189), and radiotherapy (43.4%, 82/189). Participation led 31.2% (59/189) to seek a second opinion or bring additional information to the attention of their treatment team and 71.9% (136/189) reported plans to increase their outreach and advocacy efforts as a result of participation. Levels of reported anxiety before and after participation were analyzed: 29 of 43 (67%) patients who initially reported "high or extreme" anxiety reported "low or no" anxiety after participation (P<.001). Also, no patients initially reporting low or no anxiety before participation reported an increase to high or extreme anxiety after participation. CONCLUSIONS: This study demonstrates that breast cancer patients' perceived knowledge increases and their anxiety decreases by participation in a Twitter social media support group.

Conservative axillary surgery in breast cancer patients undergoing mastectomy: long-term results.

BACKGROUND: Recently, the American College of Surgeons Oncology Group Z0011 trial demonstrated that axillary lymph node dissection (ALND) could be safely avoided in selected breast cancer patients with limited nodal disease and having breast conservation therapy. However, for node positive (N+) mastectomy patients, full ALND remains the standard of care. Hypothesizing that omission of complete ALND is safe in many N+ breast cancer patients, a hybrid procedure called conservative axillary regional excision (CARE) was developed, consisting of removal of sentinel nodes and other palpable nodes (without intraoperative frozen section or reoperation for N+). STUDY DESIGN: A retrospective review of patients undergoing mastectomy with CARE between 2002 and 2010 was performed. Data collected included demographics; staging; number of lymph nodes removed; adjuvant, antihormonal, and radiation therapies; recurrence; lymphedema; and survival data. Recurrence-free survival was estimated using the Kaplan-Meier method and compared using Cox proportional hazards. RESULTS: Five hundred and eighty-seven patients underwent mastectomy with CARE. Mean follow-up was 5.1 years. A median of 8 nodes were removed. There were 7 patients with local recurrence, of which 3 were axillary recurrences. Lymphedema developed in 20 (3.4%) patients, 75% of which had neoadjuvant chemotherapy. Lymphedema development was associated with the number of lymph nodes removed (p = 0.05) and radiation therapy (p = 0.004). CONCLUSIONS: Conservative axillary regional excision is an excellent model for understanding the role of limited axillary surgery in mastectomy patients. The locoregional recurrence rate among N1 patients having CARE is low (3.4%). Conservative axillary regional excision is also associated with low rates of lymphedema. These data support the use of limited ALND in selected N+ mastectomy patients.

Optimizing clinical management of surgical margins in breast-conserving therapy for breast cancer.

There has been, and continues to be, significant controversy over the definition of an "optimal" surgical margin in breast-conserving therapy (BCT). The historic basis of this controversy stems from the original trials documenting the safety of BCT and many conflicting retrospective studies that have sought to define the association between surgical margin width and outcomes over the last 20 years. It is important to understand that margin assessment is an inexact science, and current laboratory approaches to surgical-margin assessment represent only a sampling of the surgical margin. Currently available evidence suggests that decisions regarding surgical margins in BCT should be made in the context of what is known about the biology of breast cancer, as well the interactions of tumor biology, adjuvant treatment for breast cancer, and outcomes. Achieving consensus on management of surgical margins in BCT should be a clinical priority as it offers the opportunity to reduce the burden of breast cancer treatment on patients without compromising cancer-related outcomes.

Colectomy for fulminant Clostridium difficile colitis: predictors of mortality.

The purpose of this study was to define clinical and radiographic variables associated with postoperative mortality after urgent colectomy for fulminant Clostridium difficile colitis. Data were obtained regarding patients undergoing colectomy for fulminant C. difficile colitis at two institutions (1997-2005). Univariate analysis of factors predicting 30-day mortality was performed using chi2 and Student's t tests. Multivariable logistic regression was done to include all variables whose P value was < 0.20. Clinical variables analyzed included: age, gender, recent operation, comorbidities, preoperative multisystem organ failure, vasopressors, symptom duration, time to surgery, serum albumin, change in serum albumin, serum creatinine, white blood cell count, and extent of colectomy. Computed tomography variables included: ascites, megacolon, and extent of colitis. Thirty-five patients (mean age 70 years, 46% male) underwent urgent colectomy for C. difficile colitis. The 30-day mortality rate was 45.7 per cent (16/35). The only clinical variable associated with mortality was preoperative multisystem organ failure (nonsurvivors 9/16 vs survivors: 4/19; P = 0.037). None of the three patients undergoing partial colectomy survived, although the difference in survival versus those undergoing subtotal colectomy was not significant. Patients with fulminant C. difficile colitis undergoing colectomy have a high mortality rate. Preoperative presence of multisystem organ failure was independently predictive of mortality.

Correlation of the use of axillary ultrasound and lymph node needle biopsy with surgical lymph node pathology in patients with invasive breast cancer.

BACKGROUND: Results vary regarding the utility of perioperative axillary ultrasound (AUS) and biopsy for detecting axillary metastases. METHODS: Patients diagnosed with invasive breast cancer from 2004 through 2005 who underwent preoperative AUS with or without biopsy, and their surgical pathologic findings were reviewed. RESULTS: Of 152 patients who underwent preoperative AUS, 38% had abnormal AUS findings. Sixty-two percent of biopsy specimens were positive. The sensitivity of AUS both with and without biopsy was 54%, and specificity was 96%. The positive predictive value was 91%, and the negative predictive value was 71%. CONCLUSIONS: Our results correlate favorably with published reports of preoperative AUS. Standardization of AUS report descriptors is needed. Preoperative AUS should be included in the preoperative workup of clinically node-negative patients. A positive biopsy specimen decreases the need for a sentinel lymph node biopsy specimen; however, a negative AUS result or biopsy specimen does not replace the need to obtain a sentinel lymph node biopsy specimen.

Physician activities during time out of the examination room.

PURPOSE: Comprehensive medical care requires direct physician-patient contact, other office-based medical activities, and medical care outside of the office. This study was a systematic investigation of family physician office-based activities outside of the examination room. METHODS: In the summer of 2000, 6 medical students directly observed and recorded the office-based activities of 27 northeastern Ohio community-based family physicians during 1 practice day. A checklist was used to record physician activity every 20 seconds outside of the examination room. Observation excluded medical care provided at other sites. Physicians were also asked to estimate how they spent their time on average and on the observed day. RESULTS: The average office day was 8 hours 8 minutes. On average, 20.1 patients were seen and physicians spent 17.5 minutes per patient in direct contact time. Office-based time outside of the examination room averaged 3 hours 8 minutes or 39% of the office practice day; 61% of that time was spent in activities related to medical care. Charting (32.9 minutes per day) and dictating (23.4 minutes per day) were the most common medical activities. Physicians overestimated the time they spent in direct patient care and medical activities. None of the participating practices had electronic medical records. CONCLUSIONS: If office-based, medically related activities were averaged over the number of patients seen in the office that day, the average office visit time per patient would increase by 7 minutes (40%). Care delivery extends beyond direct patient contact. Models of health care delivery need to recognize this component of care.