BackgroundPatients and families are important contributors to the diagnostic team, but their perspectives are not reflected in current diagnostic measures. Patients/families can identify some breakdowns in the diagnostic process beyond the clinician’s view. We aimed to develop a framework with patients/families to help organisations identify and categorise patient-reported diagnostic process-related breakdowns (PRDBs) to inform organisational learning.MethodA multi-stakeholder advisory group including patients, families, clinicians, and experts in diagnostic error, patient engagement and safety, and user-centred design, co-developed a framework for PRDBs in ambulatory care. We tested the framework using standard qualitative analysis methods with two physicians and one patient coder, analysing 2165 patient-reported ambulatory errors in two large surveys representing 25 425 US respondents. We tested intercoder reliability of breakdown categorisation using the Gwet’s AC1 and Cohen’s kappa statistic. We considered agreement coefficients 0.61–0.8=good agreement and 0.81–1.00=excellent agreement.ResultsThe framework describes 7 patient-reported breakdown categories (with 40 subcategories), 19 patient-identified contributing factors and 11 potential patient-reported impacts. Patients identified breakdowns in each step of the diagnostic process, including missing or inaccurate main concerns and symptoms; missing/outdated test results; and communication breakdowns such as not feeling heard or misalignment between patient and provider about symptoms, events, or their significance. The frequency of PRDBs was 6.4% in one dataset and 6.9% in the other. Intercoder reliability showed good-to-excellent reliability in each dataset: AC1 0.89 (95% CI 0.89 to 0.90) to 0.96 (95% CI 0.95 to 0.97); kappa 0.64 (95% CI 0.62, to 0.66) to 0.85 (95% CI 0.83 to 0.88).ConclusionsThe PRDB framework, developed in partnership with patients/families, can help organisations identify and reliably categorise PRDBs, including some that are invisible to clinicians; guide interventions to engage patients and families as diagnostic partners; and inform whole organisational learning.
The investigators examined whether elders who have been taught pain management communication skills and pain management information obtain greater postoperative pain relief than elders not taught this information. Thirty-one elders were randomly assigned preoperatively to a control or communication group in this posttest-only experiment with repeated measures. Communication group participants were taught pain management, pain communication skills, and the use of two pain-intensity scales. Control group participants were taught to use the two pain-intensity scales. Pain was measured with the McGill Pain Questionnaire Short Form. The communication group elders reported less postoperative pain over the course of their hospital stay. Pain management knowledge alone may have enabled the elders to obtain greater pain relief. Nurses may want to incorporate similar pain management information and pain communication skills when teaching elders how to obtain greater postoperative pain relief.
An intervention assisting older adults to communicate their pain was tested in a posttest-only experiment. Thirty-eight preoperative older adults were randomly assigned to a communication group watching a videotape about communicating and managing postoperative pain or a comparison group watching a videotape about managing postoperative pain only. Pain was measured on Postoperative Days 1 and 2, and 1 and 7 days after hospital discharge by a data collector blind to the condition. The communication group reported greater pain relief and less pain interference on Postoperative Day 1. The comparison group reported greater pain relief on Postoperative Day 2 after attaining a pain interference level similar to the pain communication group. The pain communication intervention had modest effects for reducing pain interference with activities on Postoperative Day 1. Greater pain relief might be achieved when older adults and their health care providers are more knowledgeable about both pain communication and pain management.
Background: Factors influencing participation in clinical trials have been reported, but few studies analyze the combination of issues which affect overall patient accrual. When designing clinical trials, investigators are aware that some potential subjects may not be candidates for research participation and other subjects will decline. Total sample size is further affected by protocol-defined eligibility. BABY HUG (NCT00006400) is a randomized, double-blind, placebo-controlled Phase III clinical trial of hydroxyurea (HU), which had an enrollment goal of 200 infants, age 9–17 mo, with Hb SS or Sβ0-thalassemia. A number of screening tests (spleen scan, 99mTc-DTPA renal clearance, abdominal sonogram, transcranial Doppler ultrasound, neuropsychological testing, blood analyses) were required prior to study entry and at exit, with at least monthly follow-up visits during the 2-year study period. To enhance recruitment, an anonymized registry of potential subjects was created to identify factors affecting enrollment. Methods: BABY HUG study coordinators considered all infants with an FS/SS diagnosis on newborn screening who were less than age 17 mo. The coordinators developed an IRB-approved spreadsheet to record the number of potentially eligible subjects; whether parents were approached and, if not, why not; and reasons of those approached for participating or declining. Most of these reasons could be categorized into one of several common themes. Results: Of 1107 potential participants (23–132/center) identified between October 2003 and June 2007, 239 (22%) entered the screening process and 193 (17%) were randomized. More than 25% were not approached for various reasons, including poor adherence to standard clinical care or failing to meet eligibility criteria. Factors influencing enrollment decisions are shown in the figure. The willingness to contribute to medical knowledge, the hope of being randomized to receive the investigational drug (HU), and the desire for closer clinical care were the most common reasons for participating in BABY HUG. Conversely, fear of research, transportation problems, parental work schedules and the demanding nature of the study (with frequent blood samples and clinic visits) were the primary reasons for parents declining. Disease severity had less impact on decision-making, perhaps reflecting the often asymptomatic history of potential subjects. Conclusion: The time and effort required by multiple screening tests and frequent visits impact the willingness of eligible subjects to participate in a study. Similar trials may require a larger pool of potential participants than expected to meet accrual goals. Factors that influence subject availability and the decision-making process of participating families must be considered for successful recruitment. Figure Figure
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