Creation of a risk of harms informed consent form for dry needling: A nominal group technique.

BACKGROUND: When consenting patients to dry needling treatment, it is necessary to inform patients of potential risks of harms. OBJECTIVES: The aim of this study was to identify elements and framework for an Informed Consent (IC) risk of harm statement to improve patient decision-making. DESIGN: A virtual Nominal Group Technique (vNGT) methodology was used to achieve consensus among participants to identify what needs to be on a consent form, how it should be framed, and what it should state so patients understand the true risks. METHODS: Eligible participants were identified as one of four groups: legal expert, policy expert, dry needling expert, or patient. The vNGT session consisted of 5 rounds of idea generation and final consensus voting which lasted for 2 h. RESULTS: Five individuals consented to participate. Of the 27 original ideas, 22 reached consensus including ones specifically related to a risk of harms statement: identifying risks and discomforts, identify different sensations, and using a classification to order risks by severity. Consensus was achieved with percent agreement of ≥ 80%. The constructed risk of harm statement had a reading level of grade 7 and provided a list of stratified risks associated with dry needling. CONCLUSION: The generated risk of harm statement can be incorporated on IC forms that require disclosure of risks in both the clinical and research setting. Additionally, further elements were identified by panel participants about defining the framework for an IC form outside of the risk of harm statement. GOV REGISTRATION: NCT05560100 (29/09/22).

The use of consent forms in a "call from class" model of dental care for Australian Indigenous children.

ISSUES ADDRESSED: Dental caries is one of the most prevalent non-communicable diseases in children. Indigenous children reported a disproportionately higher prevalence of dental disease compared to their age-matched counterparts. To improve access to dental care a community-controlled service provides culturally appropriate dental services on the site of an Indigenous primary and secondary school. The dental clinic utilises a "call from class" model of care. Consent forms seeking permission to undertake a dental examination without a parent/guardian present during school hours are sent home. When the forms are returned, the student is located in class and a dental examination is undertaken. METHODS: A retrospective audit of dental records from 2019 and 2020 were undertaken. The number of consent forms sent and returned were recorded. RESULTS: In 2019, 87% (n = 220) of the school population were sent consent forms. Of the forms issued, 70% (n = 154) were returned. Almost all students required further treatment (90%, n = 137) and were sent a treatment consent form. Of the total student population, 67% (n = 171) were not seen or had outstanding treatment from unreturned forms. Proportions of incomplete treatment and unseen students were similar in 2020 (64%, n = 173). In this model, barriers are lessened by providing a free dental service on the school site. CONCLUSIONS: Consent is an ethical and legal necessity to undertake dental examination and treatment. Using physical forms were effective for gaining consent for most children. However, less than half of the school population's dental treatment was completed. Future studies should be conducted to explore the acceptability of using consent forms by parents/guardians and different models to gain consent for children from complex social circumstances.

Bloodless Management of the Anemic Patient in the Emergency Department.

Anemia is a commonly encountered condition in emergency medicine; transfusion of packed red blood cells is commonly performed for anemic patients in the emergency department (ED), but some patients are unable to accept transfusion of blood products due to medical or religious concerns. The unique, acute, and time-sensitive nature of emergency medicine practice requires that physicians maintain an enhanced awareness of bloodless medicine treatment modalities. Identification of bloodless medicine patient preferences in the ED can help guide physicians in the recommendation of acceptable methods of treating anemia in this patient population. A focus on early hemostasis and resuscitation, instead of attempts to convince the patient to accept blood transfusion, can be lifesaving in patients with acute bleeding. Treatment strategies including the use of methods to reduce unnecessary blood loss, enhance red blood cell production, and increase the oxygen-carrying capacity of blood should also be considered early in patient presentation. Timely involvement of the Hospital Liaison Committee can help facilitate successful interpersonal communication and shared decisionmaking between emergency physicians and bloodless medicine patients. By embracing an understanding of bloodless medicine patient needs as well as available treatment strategies, ED physicians can contribute to optimal overall outcomes for anemic bloodless medicine patients.

Assessment of Quality of Life and Safety in Postmenopausal Breast Cancer Patients Receiving Letrozole as an Early Adjuvant Treatment / 한국유방암학회지

PURPOSE: There are few reports from Asian countries about the long-term results of aromatase inhibitor adjuvant treatment for breast cancer. This observational study aimed to evaluate the long-term effects of letrozole in postmenopausal Korean women with operable breast cancer. METHODS: Self-reported quality of life (QoL) scores were serially assessed for 3 years during adjuvant letrozole treatment using the Korean version of the Functional Assessment of Cancer Therapy-Breast questionnaires (version 3). Changes in bone mineral density (BMD) and serum cholesterol levels were also examined. RESULTS: All 897 patients received the documented informed consent form and completed a baseline questionnaire before treatment. Adjuvant chemotherapy was administered to 684 (76.3%) subjects, and 410 (45.7%) and 396 (44.1%) patients had stage I and II breast cancer, respectively. Each patient completed questionnaires at 3, 6, 12, 18, 24, 30, and 36 months after enrollment. Of 897 patients, 749 (83.5%) completed the study. The dropout rate was 16.5%. The serial trial outcome index, the sum of the physical and functional well-being subscales, increased gradually and significantly from baseline during letrozole treatment (p<0.001). The mean serum cholesterol level increased significantly from 199 to 205 after 36 months (p=0.042). The mean BMD significantly decreased from −0.39 at baseline to −0.87 after 36 months (p<0.001). CONCLUSION: QoL gradually improved during letrozole treatment. BMD and serum cholesterol level changes were similar to those in Western countries, indicating that adjuvant letrozole treatment is well tolerated in Korean women, with minimal ethnic variation.

Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND).

BACKGROUND: Clinical trials require cost-effective methods for identifying, randomising, and following large numbers of people in order to generate reliable evidence. ASCEND (A Study of Cardiovascular Events iN Diabetes) is a randomised '2 × 2 factorial design' study of aspirin and omega-3 fatty acid supplements for the primary prevention of cardiovascular events in people with diabetes; this study used central disease registers and a mail-based approach to identify, randomise, and follow 15,000 people. In collaboration with UK consultants and general practitioners (GPs), researchers identified potentially eligible people with diabetes from centrally held registers (e.g. for retinopathy screening) and GP-held disease registers. Permission was obtained under section 251 of the National Health Service Act 2006 (previously section 60 of the NHS act 2001) to allow invitation letters to be generated centrally in the name of the holder of the register. In addition, with the collaboration of the National Institutes for Health Research (NIHR) Diabetes and Primary Care Research Networks (DRN and PCRN), general practices sent pre-assembled invitation packs to people with a diagnosis of diabetes. Invitation packs included a cover letter, screening questionnaire (with consent form), information leaflet, and a Freepost envelope. Eligible patients entered a 2-month, pre-randomisation, run-in phase on placebo tablets and were only randomised if they completed a randomisation form and remained willing and eligible at the end of the run-in. Follow-up is ongoing, using mail-based approaches that are being supplemented by central registry data. RESULTS: Information on approximately 600,000 people listed on 58 centrally held diabetes registers was obtained, and 300,188 potentially eligible patients were invited to join the study. In addition, 785 GP practices mailed invitations to 120,875 patients. A further 2,340 potential study participants were identified via other routes. In total, 423,403 people with diabetes were invited to take part; 26,462 entered the 2-month, pre-randomisation, run-in phase; and 15,480 were randomised. CONCLUSION: If sufficient numbers of potentially eligible patients can be identified centrally and the trial treatments do not require participants to attend clinics, the recruitment and follow-up of patients by mail is feasible and cost-effective. Wider use of these methods could allow more, large, randomised trials to be undertaken successfully and cost-effectively. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN60635500 , registered on 14 July 2005.

Diagnostic, therapeutic and healthcare management protocols in parathyroid surgery: II Consensus Conference of the Italian Association of Endocrine Surgery Units (U.E.C. CLUB).

AIM: To update the Diagnostic-Therapeutic-Healthcare Protocol (Protocollo Diagnostico-Terapeutico-Assistenziale, PDTA) created by the U.E.C. CLUB (Association of the Italian Endocrine Surgery Units) during the I Consensus Conference in 2008. METHODS: In the preliminary phase, the II Consensus involved a selected group of experts; the elaboration phase was conducted via e-mail among all members; the conclusion phase took place during the X National Congress of the U.E.C. CLUB. The following were examined: diagnostic pathway and clinical evaluation; mode of admission and waiting time; therapeutic pathway (patient preparation for surgery, surgical treatment, postoperative management, management of major complications); hospital discharge and patient information; outpatient care and follow-up. CONCLUSIONS: The PDTA for parathyroid surgery approved by the II Consensus Conference (June 2013) is the official PDTA of the U.E.C. CLUB.

No personalization without participation: on the active contribution of psychiatric patients to the development of a mobile application for mental health.

BACKGROUND: Despite the increasing pervasiveness of mobile computational technologies, knowledge about psychiatric patients' preferences regarding the design and utility of mobile applications is very poor. This paper reports on a pilot-study that involved 120 psychiatric patients in the development of a mobile application (app) that is being used for data entry into the Signature Project data bank at the Institut universitaire en santé mentale de Montréal (IUSMM), Canada. Participants were invited to comment on the 'look and feel' of the Signature App. Their input also extended the procedures for data collection. These suggestions may contribute to increased mental health literacy and empowerment of persons with mental illness receiving services at the IUSMM. METHODS: Participants were recruited to fill out a questionnaire on a tablet computer while waiting at the Emergency Room (ER, n = 40), Psychotic Disorders outpatient clinic (n = 40) or Anxiety and Mood Disorders outpatient clinic (n = 40) of IUSMM. Nine patients from each of these sub-groups participated in a focus group to review the results and to discuss how the design and use of the Signature App could be improved to better meet the needs of patients. RESULTS: This study (n = 120) indicated that psychiatric patients are clearly capable of using a tablet computer to fill out questionnaires for quantitative data entry, and that they enjoyed this experience. Results from the focus groups (n = 27) highlight that the app could also be used by patients to communicate some personal and contextual qualitative information. This would support a holistic and person-centered approach, especially at the ER where people acutely need to describe their recent history and receive emotional support. CONCLUSIONS: This pilot-study has confirmed the necessity of involving patients not only in the testing of a new mobile application, but also as active contributors in the entire research and development process of a person-centered information and communication technology infrastructure. The input of participants was essential in designing the Signature Project computational procedure and making use of the app a positive and empowering experience. Participants also gave critical feedback remarks that went beyond the initial scope of the pilot-study, for example they suggested the addition of a client-clinician component.

Shared decision making through informed consent in chiropractic management of low back pain.

OBJECTIVE: The purpose of this study was to propose questions that may be helpful to educate patients considering treatment approaches to manage low back pain (LBP) and to determine if the information currently presented in informed consent (IC) documents at chiropractic colleges is sufficient to help a patient considering chiropractic management of LBP make a fully informed decision. METHODS: Questions to inform decision making for a patient contemplating any intervention for LBP were developed by the authors based on their clinical and research experience. Answers to the questions were suggested based on findings from recent clinical practice guidelines and systematic reviews. Institutions that are members of the Association of Chiropractic Colleges (ACC) were surveyed and asked to provide a copy of the IC documents currently used in their outpatient educational clinics. The IC documents were analyzed to determine if they stated (or implied) information that may be helpful in addressing each of the proposed questions. RESULTS: The list of 20 questions included 4 questions on each of the following 5 topics: condition, proposed treatment, potential benefits, potential harms, and possible alternatives. A total of 21 ACC institutions were contacted, of which 20 responded. The number of questions that could potentially be answered with information provided in the IC documents ranged from 2 to 13, with a mean of 6.5, including a mean of 3.6 stated answers and 2.9 implied answers. CONCLUSIONS: Some information to help patients consider chiropractic management of LBP is currently included in the IC documents used in clinics of ACC institutions. However, many of the questions that could help achieve shared decision making are not included. Modifying IC documents may help patients understand the nature, benefits, harms, costs, and alternatives to LBP care.

Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form.

BACKGROUND: To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture. METHODS: The prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed. RESULTS: A total of 229,230 patients received on average 10.2 +/- 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor's statement, and Consent. CONCLUSION: Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent.

A randomised trial of conventional versus BAUS procedure-specific consent forms for transurethral resection of prostate.

INTRODUCTION: Conventional consent forms often contain incomplete information regarding risks associated with invasive procedures. BAUS has introduced procedure-specific consent forms (PSCF) documenting the risks associated with urological procedures. We compared patients' understanding of the risks and benefits of TURP after the consenting process with either conventional documentation or PSCF. PATIENTS AND METHODS: One hundred patients were randomised to be consented with either a conventional or PSCF. After 3 h, their understanding was assessed with a questionnaire asking patients to document the indication and likelihood of symptomatic improvement, estimate frequency of complications and the risk of future re-operation. Data were compared by Mann-Whitney test. RESULTS: Fifty patients were randomised to each group. There was no significant difference in mean age, grade of doctor obtaining consent or time interval from consent to questionnaire. Both groups accurately predicted the chance of improved symptoms (median, 80%). There was no significant difference in patients' median estimation of risk of complications such as incontinence, erectile dysfunction, or retrograde ejaculation. Patients consented with the PSCF predicted the risk of re-operation more accurately (median answer, 10% versus 30%; P = 0.007, Mann-Whitney test). CONCLUSIONS: Recall of data was sub-optimal in both groups. For most data points there was no significant difference in estimation of risks between groups. Those consented with a procedure-specific consent form predicted risk of re-operation at 10 years more accurately. Procedure-specific consent forms offer an advantage over conventional consent in this study. We feel that the provision of a written structured framework allows better informed consent for TURP.

Informed consent in Ghana: what do participants really understand?

OBJECTIVES: To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15-45 years perceive the trial and whether they know that not all trial capsules are the same, and to identify factors associated with this knowledge. METHODS: 60 semistructured interviews and 12 focus groups were conducted to explore subjects' perceptions of the trial. Steps were taken to address areas of low comprehension, including retraining fieldworkers. 1971 trial subjects were randomly selected for a survey measuring their knowledge that not all trial capsules are the same. The subjects' fieldworkers were also interviewed about their characteristics and trial knowledge. Factors associated with knowledge were explored using multi-level modeling. RESULTS: Although subjects knew they were taking part in research, most thought they were receiving an active and beneficial medication. Variables associated with knowledge were education and district of residence. Radio broadcasts benefited those with some schooling. Fieldworkers' characteristics were not associated with subjects' knowledge. CONCLUSIONS: Research and debate on new or improved consent procedures are urgently required, particularly for subjects with little education.

Consent: its practices and implications in United kingdom and United States chiropractic practice.

OBJECTIVE: This study explores the implementation of consent procedures in a sample of chiropractors in the United Kingdom (UK) and the United States (US) and how well they satisfy the core ethical principles of autonomy, veracity, justice, nonmaleficence, and beneficence. METHODS: A precoded questionnaire was sent to 500 geographically stratified, randomly selected chiropractors in the UK and 500 similarly selected chiropractors within 10 states (50 from each) across the US. Questionnaires were dispatched 100 per month over a 5-month period. Nonresponders were followed up twice. Quantitative data were analyzed descriptively. Qualitative data were charted and examined for emergent themes. RESULTS: The overall response rate was 35% (346 of 1000), equating to 23% (n = 117) of the US and 46% (n = 231) of the UK cohort. Results suggest chiropractors view consent as an event rather than a process and revealed important omissions in key areas. Reasons specified for the nondisclosure of risk have important negative implications on the principles of autonomy, veracity, and justice, whereas paternalistic tendencies are indicative of tension between beneficence and paternalism. CONCLUSION: Results from this survey suggest a patient's autonomy and right to self-determination may be compromised when seeking chiropractic care. Difficulties and omissions in the implementation of valid consent processes appear common, particularly in relation to risk. Practitioners felt that a serious adverse event occurred so infrequently that this, coupled with a lack of convincing evidence regarding the risk associated with certain treatment, rendered the routine discussion of major risk unnecessary.

La protección de datos en la práctica privada / Data protection in private practice

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Breaking through the silence: illegality of performing resuscitation procedures on the "newly-dead".

Israeli author Daniel Sperling brings to a light a disturbing practice that is taking place in some teaching hospitals throughout the world--the practice of resuscitation procedures on newly dead patients without the consent of the next-of-kin. Mr. Sperling examines some of the policies and procedures in place to prevent such practice and also looks at the ethical principles that should guide such procedures. The paper also reviews the general issue of consent in the context of medical decision-making and discusses potential legal claims that might be available to persons who have not been consulted or informed before such procedures are performed. The evolving jurisprudence surrounding the treatment of the newly dead is analyzed and Mr. Sperling concludes by suggesting ways to improve upon the procedures currently in place at some teaching facilities.