Opioid prescription and postoperative outcomes in pediatric patients.

OBJECTIVES/HYPOTHESIS: To determine if the amount of opioid prescribed and postoperative outcomes after adenotonsillectomy changed following implementation of mandated opioid consent forms. STUDY DESIGN: Retrospective cohort study. METHODS: Patients undergoing adenotonsillectomy 6 months before and after implementation of mandated opioid consent forms at a tertiary-care pediatric hospital were studied. Demographics, operative data, weight-based opioid dosage, and postoperative outcome measures, including nursing calls, emergency department (ED) visits, hospital readmission, and bleed rates, were collected and analyzed. RESULTS: Of 300 patients, opioid prescription was provided for 211 patients (70.3%), 112 preconsent (74.7%) and 99 postconsent (66.0%). Mean (standard deviation) total opioid prescribed (milligrams/kilogram) was significantly higher preconsent 4.8 (5.6) than postconsent 3.2 (4.7), (P = .003). There were no differences between number of nursing calls (P = .134) or ED visits (P = .083). Interestingly, preconsent patients had more hospital readmission for pain/dehydration (odds ratio OR: 368, P = .016) and bleeding concerns (OR: 244, P = .003). CONCLUSIONS: A mandated consent form prior to opioid prescription was associated with decreased overall opioid prescription without resultant increase in postoperative complications in pediatric patients. These data provide support for minimizing opioid prescription on a systems-based level. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:1477-1481, 2019.

Improving consent in patients undergoing surgery for fractured neck of femur.

Background Neck of femur fractures and their subsequent operative fixation are associated with high rates of perioperative morbidity and mortality. Consenting in this setting is suboptimal with the Montgomery court ruling changing the perspective of consent. This quality improvement project assessed the adequacy of consenting against British Orthopaedic Association-endorsed guidance and implemented a series of changes to improve the documentation of risks associated with surgery for fractured neck of femur. Methods Seventy consecutive patients who underwent any operative fixation of a neck of femur fracture were included over a 6-month period at a single centre. Patients unable to consent or without electronic notes were excluded. Consent forms were analysed and the documented potential risks or complications associated with surgery were compared to British Orthopaedic Association-endorsed guidance. A series of changes (using the plan, do study, act (PDSA) approach) was implemented to improve the adequacy of consent. Results Documentation of four out of 12 potential risks or complications was recorded in <50% of cases for patients with intracapsular fractures (n=35), and documentation of seven out of 12 potential risks or complications was recorded in <50% of cases for patients with extracapsular fractures (n=35). Re-audit following raising awareness and attaching consent guidance showed 100% documentation of potential risks or complications in patients with intracapsular and extracapsular fractures (n=70). A neck of femur fracture-specific consent form has been implemented which will hopefully lead to sustained improvement. Conclusions Consenting patients with fractured neck of femur for surgery in the authors' unit was suboptimal when compared to British Orthopaedic Association-endorsed consent guidance. This project has shown that ensuring such guidance is readily available has improved the adequacy of consent. The authors hope that introduction of a neck of femur fracture-specific consent form within their unit will lead to sustained adequate documentation of risks associated with surgery.

Improving the Consent Process in Foot and Ankle Surgery With the Use of Personalized Patient Literature.

A patient-specific letter was introduced to the consent process to observe the effect, if any, on information recall and satisfaction for patients undergoing elective foot and ankle surgery. The patients attending the clinic were written a personalized letter-this was a simple personalized letter that outlined their treatment options, the proposed management plan, likely treatment course, and the benefits, risks, and likely period required for recovery. The personalized letter system was compared with the 2 existing methods of consent process: signing for consent at their outpatient encounter at which they were scheduled for surgery and a separate consent clinic without the personalized letter. A total of 111 patients (87 females, 24 males) undergoing elective foot and ankle surgery were assessed on the day of surgery for recall of the procedure, risks, postoperative course, and satisfaction with the consent process. Patients receiving a personalized letter recalled more than those who had attended a routine preoperative consent clinic visit and significantly more than those who had provided consent at their last clinic visit. Patient satisfaction with the consent process was also greater in the personalized group. Our results suggest that the consent process is improved using routine preoperative consent clinics and, most notably, with patient-specific information to improve patient recall and satisfaction.

An updated assessment of postpartum sterilization fulfillment after vaginal delivery.

OBJECTIVE: To describe sterilization completion rates after vaginal delivery and indications for unfulfilled procedures. STUDY DESIGN: We used labor and delivery operating room and delivery logs to identify all women over 20years of age with a completed live vaginal birth beyond 24weeks gestation over a 33-month period (March 1, 2012 to November 30, 2014). We reviewed the electronic medical records of all of these patients and identified those who requested a sterilization procedure as indicated in a physician's admission note or antenatal record. RESULTS: We identified 3514 live vaginal births beyond 24weeks gestation during the study period of which 219 requested postpartum sterilization. Sterilization occurred in 114 (52%). The most common reason for unfulfilled procedures was lack of valid federally mandated consent (n=46 [44%]). Fifty-nine percent (27 of 46) of these women had little or no prenatal care. Only one (0.5%) woman had documented completion of consent with the required time elapsed prior to delivery and no consent form available. Of the women with valid consent documentation, the most common indication for an unfulfilled procedure was patient refusal (n=30 [51%]). Body mass index was an independent predictor of an unfulfilled procedure (p<.001) among women with adequate consent. CONCLUSIONS: Inability to complete federally mandated consent is a principal cause of unfulfilled postpartum sterilization and primarily affects women desiring sterilization who lack sufficient prenatal care. Of women who meet consent criteria, the primary reason women eligible for sterilization did not undergo the procedure was due to withdrawing their request. IMPLICATIONS: Because women commonly do not undergo a requested sterilization after vaginal deliveries, antepartum counseling should include alternate contraception choices. Documented consent that fulfills all federally mandated criteria remains the most common barrier to requested sterilization after vaginal delivery; providers and policymakers should work together to help unburden women from this mandate.

Assessment of Breast Cancer Patients' Knowledge and Decisional Conflict Regarding Tamoxifen Use.

Breast cancer is the most common type of female cancer. Tamoxifen, a selective estrogen receptor modulator, is widely used to decrease breast cancer recurrence and mortality among patients. However, it also increases the risk of endometrial cancer. This study aimed to assess knowledge and decisional conflict regarding tamoxifen use. Between June and October 2014, breast cancer patients using tamoxifen were consecutively screened and requested to complete a survey including the EQ-5D, Satisfaction with Decision Scale (SWD), Decisional Conflict Scale (DCS), and a self-developed, 15-item questionnaire measuring tamoxifen-related knowledge. The study sample comprised 299 patients. The mean total knowledge score was 63.4 of a possible 100.0 (range, 13.3-93.3). While 73.9% of the participants knew that tamoxifen reduces the risk of breast cancer recurrence, only 57.9% knew that the drug increases endometrial cancer risk. A higher education level (≥ college) was associated with a higher, total knowledge score (ß = 4.291; P = 0.017). A higher knowledge score was associated with a decreased DCS score (ß = -0.366; P < 0.001). A higher SWD score was also associated with decreased decisional conflict (ß = -0.178; P < 0.001). In conclusion, the breast cancer patients with higher levels of tamoxifen-related knowledge showed lower levels of decisional conflict regarding tamoxifen use. Clinicians should provide the exact information about tamoxifen treatment to patients, based on knowledge assessment results, so as to aid patients' decision-making with minimal conflict.

Performance analysis of efforts towards promotion of corneal donation at a tertiary care trauma center in India.

PURPOSE: To identify the number of potential donors from trauma-related deaths and examine the extent of loss of opportunity at different levels for eye donation. METHODS: A retrospective review of the death records from the mortuary of Jai Prakash Narayan Apex Trauma Centre and National Eye Bank at All India Institute of Medical Sciences was conducted for the period between January 2008 and August 2009. All cases with trauma-related deaths were included in the study. Cases with known contraindications to eye donation were excluded from the study. The main outcome measure was "lost opportunity cases" where the families of eligible donors were not approached. The secondary outcome measure was successful procurement rate. RESULTS: The total number of trauma-related deaths noted during the study period was 1584. One hundred cases were excluded from the study because the records were either incomplete or not readily available. A total of 1066 cases were identified as medically suitable potential eye donors. The death-autopsy interval was 12 hours or less in 425 cases and >12 hours in 641 cases. Among eligible donors, there were 831 (78%) lost opportunity cases. Among 235 families approached, only 20 (8.5%) agreed to eye donation. Overall, successful eye donation was possible in only 20 (1.9%) of the eligible trauma-related deaths. CONCLUSIONS: Trauma-related deaths form a major pool for potential tissue donors. Only about one fifth of the medically eligible cases could be approached for counseling. A potentially large donor pool of trauma-related deaths is compromised by the lost opportunity cases and the low donation rate. Efforts are needed to augment existing administrative and manpower resources to increase the corneal procurement rate in the Indian population.

Evaluación de la calidad de estructura y contenido de los formatos de consentimiento médico informado de los hospitales de la Región Lambayeque: marzo-junio 2010 / An assessment of structure and contents quality of informed consent forms in Lambayeque Region: March-June 2010

Objetivo: Determinar la calidad de estructura y de contenido de los formatos de consentimiento médico informado utilizados en los diferentes hospitales de la región Lambayeque. Material y método: Estudio descriptivo, transversal y observacional. Obtenidos los formatos de CMI de los hospitales de la región de Lambayeque; se evaluó su calidad de estructura y de contenido constatándola con los Comités de Ética. Se establecieron dos categorías: Cumple (si figuraba de manera completa y detallada); o, No Cumple (por omisión o tergiversación). Para el análisis, los formatos fueron divididos por número de requisitos cumplidos: más del 75 (cumple 19-24 requisitos); entre el 50-75 (de 12 a18) y menos del 50 (de 0 a 11). Resultados: De los 8 formatos estudiados de los Hospitales de la Región de Lambayeque se encontró que en ningún (0) hospital cumplían con los requisitos del modelo al no lograr más del 75 (19-24 requisitos); 1 (12,5) hospitales se halló entre el 50 y 75 (12-18 requisitos) y en 7 hospitales (75) cumplían menos del 50 (0-11 requisitos). Conclusiones: La calidad de los formatos de CMI de los hospitales de la Región Lambayeque en cuanto a su estructura y contenido: Deficiente.

Objective: To determine the quality of informed medical consent forms (ICFs) used in different hospitals in Lambayeque region with respect to their structure and contents Material and method: This was a descriptive, cross-sectional and observational study. ICFs used in Lambayeque hospitals were assessed with respect to their quality of structure and contents with the participation of Ethics Committees. Two categories were established: complied (if the forms were complete and detailed); or non-compliant (because of omission or confounding). Forms were divided according to the number of requisites complied with: more than 75 (complying with 19-24 requisites); between 50 to 75 (12 to 18 requisites) and less than 50 (0 to 11 requisites). Results: Of the eight forms studied in the Hospitals of the Region Lambayeque found in no (0) were eligible hospital of failing to model more than 75 (19-24 requirements), 1 (12.5) hospitals was found between 50 and 75 (12-18 requirements) and in six hospitals (75) had less than 50 (0-11 requirements). Conclusions: The quality of ICFs in Lambayeque region in terms of their structure and contents is poor.

Adequacy of informed consent for lumbar puncture in a pediatric emergency department.

OBJECTIVE: To determine whether informed consent is adequately obtained by documentation of appropriate risks, benefits, alternatives, and procedure explanation for children who had a lumbar puncture (LP) in a pediatric emergency department (PED). METHODS: Authors agreed on the criteria for appropriate informed consent for LP, including risks and benefits of the procedure, alternatives to doing the procedure, explanation of the procedure including the purpose of the LP, and a signature of a witness. A retrospective chart review was done for all children who had LP during a 1-year period in a PED. Information documented on a general procedure consent form was analyzed. RESULTS: There were 336 patients who had LP in the PED during a 1-year period. Mean (SD) age of patients was 37.8 (61.9) months (median age, 1.6 months), and 56.5% were boys. Consent was obtained by attending physicians (18.9%), pediatric emergency medicine fellows (7.1%), residents (73.6%), and medical students (0.3%). Documented risks of the LP included back pain (19.3%), infection (88.2%), bleeding (86.5%), apnea for infants 1 year or younger (9.5%), and post-LP headache for children 10 years and older (44.9%). Benefits of the procedure were documented for 36.1%, alternatives for 12.5%, explanation of the procedure for 45.9%, purpose for 94.3%. There was no statistically significant difference for training level of person obtaining consent and risks documented. However, pediatric emergency medicine fellows documented benefits more frequently (P = 0.005), residents documented alternatives more frequently (P = 0.006), and attending physicians documented explanation of the procedure more frequently (P = 0.005). CONCLUSIONS: Risks, benefits, alternatives, and explanation of the LP procedure are not adequately documented on consent forms in the PED. Although the actual discussion with guardians is unknown, these data imply that informed consent may not have been properly obtained before the LP was performed. In the event of a complication and subsequent malpractice lawsuit, clinicians may be unable to demonstrate they adequately informed a guardian about the LP.

Active parent consent for health surveys with urban middle school students: processes and outcomes.

BACKGROUND: To achieve high participation rates and a representative sample, active parent consent procedures require a significant investment of study resources. The purpose of this article is to describe processes and outcomes of utilizing active parent consent procedures with sixth-grade students from urban, ethnically diverse, economically disadvantaged K-8 public schools involved in an evaluation of a middle school service-learning program. METHODS: As part of the evaluation of the Lead Peace-Plus service-learning program, active parent consent was obtained for participation in school-based health surveys conducted with sixth graders in 3 schools. To achieve acceptable rates of parent permission, we employed multiple procedures including regular communication with school staff, incentives for involved schools and teachers, a multipronged approach for reaching parents, and direct encouragement of students to return forms through repeated classroom visits, individual and classroom incentives. We used Fisher's exact tests to compare selected characteristics among students whose parents weren't reached, those whose parents refused, and those whose parents consented to survey participation. RESULTS: We achieved a parent response rate of 94.6% among sixth-grade students. No significant differences in student gender, race/ethnicity, school, or free/reduced lunch status were identified across parent consent status groups. Rates of absenteeism were significantly higher (p = .03) among students whose parents weren't reached compared to other groups. CONCLUSIONS: Employing a multifaceted active parent consent campaign can result in high rates of parental response with limited sampling bias among an urban, ethnically diverse and economically disadvantaged group of middle school students.

An advance directive redesigned to meet the literacy level of most adults: a randomized trial.

OBJECTIVE: To determine whether an advance directive redesigned to meet most adults' literacy needs (fifth grade reading level with graphics) was more useful for advance care planning than a standard form (>12th grade level). METHODS: We enrolled 205 English and Spanish-speaking patients, aged >/=50 years from an urban, general medicine clinic. We randomized participants to review either form. Main outcomes included acceptability and usefulness in advance care planning. Participants then reviewed the alternate form; we assessed form preference and six-month completion rates. RESULTS: Forty percent of enrolled participants had limited literacy. Compared to the standard form, the redesigned form was rated higher for acceptability and usefulness in care planning, P

Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding.

BACKGROUND: Despite widespread agreement on the importance of informed consent in clinical research, uncertainty remains about the adequacy of current consent procedures and documentation. METHODS: The objective of the study was to compare an informed consent document developed by a consumer group of potential study participants to one developed by the study investigators. The study was a cluster randomized, controlled study embedded in a 'parent' randomized controlled trial of 1092 participants with Gulf War veterans' illnesses recruited in 1999-2000 at 20 US medical centers. Centers were randomized to the investigator-developed or participant-developed consent document. The primary outcome measure was an Informed Consent Questionnaire-4 (ICQ-4), a validated four-item scale measuring self-reported participant understanding scored from 0 to 1. Secondary outcomes included the Client Satisfaction Questionnaire-8 and measures of study refusal and adherence to the parent trial protocol. RESULTS: There were no significant differences between consent documents on the ICQ-4 score overall or at any of the time points. Mean (95% CI) treatment differences ranged from +0.020 (-0.015, 0.055) (better understanding) at entry to -0.021 (-0.054, 0.012) (worse understanding) at three-months for the participant versus the investigator document group. There were also no significant differences in satisfaction, adherence to the protocol, or in the proportion of patients who refused to participate in the trial. LIMITATIONS: The consumer group may not have been representative of the study participants and they did not suggest dramatic changes to the consent document. The outcome assessment questionnaire was not validated prior to the trial's initiation. CONCLUSIONS: Consumer modification of the consent document did not lead to either benefit or harm in understanding, satisfaction, or study refusal and adherence rates. This study did demonstrate, however, that embedding consent studies in a clinical trial is feasible and can address important questions about informed consent without disrupting the primary study.

Reuse of samples: ethical issues encountered by two institutional ethics review committees in Kenya.

There is growing concern about the reuse and exploitation of biological materials (human tissues) for use in research worldwide. Most discussions about samples have taken place in developed countries, where genetic manipulation techniques have greatly advanced in recent years. There is very little discussion in developing countries, although collaborative research with institutions from developed countries is on the increase. The study sought to identify and describe ethical issues arising in the storage, reuse and exportation of samples in a developing country. Research protocols presented to two Ethics Review Committees in Kenya during a period of two years were reviewed. A record was made of the protocol title, sample collected, request for storage, reuse or exportation and whether or not subject consent was sought. The findings indicated that about 25% out of the 388 protocols sought permission for reuse and only half of those actually informed subjects of the contemplated re-use. Less than 20% requested storage and again, about half of them sought consent from subjects. There is an indication that investigators do not see the need to seek consent for storage, reuse and exportation of samples. It is proposed that these issues should be addressed through policy interventions at both the national and global levels.

Do written consent forms provide medicolegal protection from litigation in radiotherapy?

Two methods were used in an attempt to determine whether written consent forms serve a useful medicolegal purpose in Australian radiotherapy departments. First a survey was posted to all practising radiation oncologists to ask about their use of written consent forms and whether they had ever been useful in any claims made against them. Second, the largest medical defence organization in Australia was contacted for de-identified details about every claim ever made against a radiation oncologist. The survey yielded a response rate of 50.3%. Only one respondent indicated that any consent form had ever played a role in any claim and was not prepared to discuss it. Many radiation oncologists did not routinely use a consent form and its use could not be considered standard practice. The submitted consent forms generally did not contain warnings to the patient about specific risks of treatment. The details of the previous claims provided by the medical defence organization indicated that more often claims arose from circumstances in which a written consent form could not provide any useful protection such as radiation dose calculation errors. The medicolegal value of written consent forms in radiotherapy seems low, although further research may be necessary before dispensing with them completely.