This process is summarised in the PRISMA [21] flow diagram in Fig. Furthermore, note was made of funding sources and any potential conflicts of interest. These categories were reviewed and refined using a constant comparison method. volume21, Articlenumber:58 (2020) People discussed the process of consent in five different findings extracted from four studies [24,25,26, 30]. This study makes it clear that the cultural and societal norms surrounding consent differed from the western view of consent. Patients discussed feelings of not wanting their behaviour to be seen out of character by questioning the doctor, that the consent form was simply signed as a matter of process with little thought and that some patients had agreed to treatment despite not understanding what they had agreed to. Privacy Sandelowski M, Docherty S, Emden C. Focus on qualitative methods qualitative Metasynthesis: issues and techniques. Chapter 20: Qualitative research and Cochrane reviews. Check with your insurance company on what you should do. LJC is funded by a clinical research fellowship from the South Eastern Health and Social Care Trust, Northern Ireland. This document gives the name of the person who will make decisions for you if you are no longer able to make them. Included studies were published between 1996 and 2016. 2017;18(1):29. Indian J Med Ethics. Some studies reported that poor levels of knowledge hampered patients ability to participate in the process while others claimed that they did not wish to have large volumes of information. However, some reports (n=6) also included patients treated in an emergency setting [23,24,25, 27, 30, 36]. This includes why you are having it, any risks the surgery has, and what you can expect afterward. Studies examining ways in which doctors and patients believe the informed consent process could be improved or re-imagined were also included. It is envisaged that the development of a core outcome set (COS) would encourage standardised reporting of outcomes to address the issues highlighted by the Cochrane review. This review is not without some limitations. Informed consent for clinical procedures is a complex process involving the exchange of information from clinicians to patients, in which patients process information before making a decision that is free from coercion. However, there is no internationally recognised singular method to combine the findings of qualitative studies, as illustrated by the numerous methodologies available for this purpose. Some states might specify the time frame in which consent remains valid; others require that consent be obtained no more than 30 days from the procedure.
Informed consent: Know rules and exceptions, when they apply - Relias Media Nine findings from seven primary studies were included in this category [22, 25,26,27,28, 31, 36]. Spector D, Mayer DK, Knafl K, Pusic A. . However, because no two studies have assessed the effects of their intervention in the same way, it has been impossible to make direct comparisons between studies or to synthesise the data with any meaning. Patients described knowledge in terms of their understanding their condition, the treatment options available to them and what they ought to expect from their chosen option. 2006;62:274253. All abstracts for clearly relevant and potentially relevant studies were then screened in a similar way. They listened carefully to the professional advice and were ready to accept the recommended option, convinced that the best option was pointed out to them. Findings from a study in South India. PubMedGoogle Scholar. But an "emancipated" or "mature" adolescent may consent to his or her own medical care. A central part of the informed consent process is the . Furthermore, this phenomenon is being investigated elsewhere [19]. Montgomery v. Lanarkshire Health Board. 2000;120:2649. The search strategy was developed among the authors with the assistance of a senior medical librarian. Make a list of questions to ask yourhealthcare provider or surgeon about the type of surgery you are to have. While no non-English studies were identified through our searches, it may be the case that if the search strategy had been written in other languages it would have yielded relevant studies that were not forthcoming because of the indexing problems previously discussed. 1997;20:36571. 2016;19:75161. All authors read and approved the final manuscript. It may be the case that researchers believe that trust is too difficult a concept to measure in a trial setting. You should read through the consent carefully before signing it. The aim of this qualitative synthesis is to determine which domains determine the quality of informed consent for surgery as viewed by patients and clinicians. If anything did go wrong you know, you were, you were signing to say youve accepted the risks that were involved The consent form as a ritual - All I remember is that it being shoved under my nose and saying youve got to go down to surgery, sign and that was it The consent forma as control and power -"Its only when the consent form comes that you have got the choice to turn around and say you dont want it [24]. Patients were not adequately informed prior to making the decision (U), I dont know how they did itthe not knowing whats going on is kind of difficult to handle [33]. Jensen LA, Allen MN. Shortcomings in this process can lead to a breakdown in the clinician-patient relationship and occasionally litigation. Informed consent for inguinal herniorrhaphy and cholecystectomy: describing how patients make decisions to have surgery. Manson NC, ONeill O. Estabrooks CA, Field PA, Morse JM. Core information sets for informed consent to surgical interventions: baseline information of importance to patients and clinicians.
Informed consent for clinical treatment - PMC - National Center for Cochrane Handbook for Systematic Reviews of Interventions. However, it appears that these additional information sources reinforced the message patients had heard from their clinicians and increased their confidence in the decision making process. UK: Department of Health; 2012. While many studies employed qualitative methods of data collection, they actually did not perform any qualitative analysis and simply reported quantitative measures of how often participants responded with a particular answer (n=4). Kumar S, Mohanraj R, Rose A, Paul MJ, Thomas G. How informed is informed consent? Hall DE, Morrison P, Nikolajski C, Fine M, Arnold R, Zickmund SL. Informed Consent Information Sheet . Using the ten-point Joanna Briggs Institute qualitative appraisal checklist, all studies had evidence of congruity between the research methodology and the method of data collection, congruity between methodology and the interpretation of the results and the conclusions of each study flowed from the analysis of the data. Studies using qualitative methods of data collection and analysis were eligible for inclusion. statement and In evaluating the qualitative literature in this field in a systematic way, we believe we can construct a picture of the factors which are important to both patients and their doctors during the informed consent process. Consent is your agreement for a healthcare professional to provide you with medical treatment and care. Qual Health Res. (U), There is no choice: you either have the surgery or you have this for the rest of your life I knew right away that I had to, you know, I had to have the surgery [34]. This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Hospitals must assure that the practitioner(s) responsible for the surgery obtain informed consent from patients in a manner consistent with the hospital's policies governing the informed Rethinking informed consent in bioethics. The report of the public inquiry into childrens heart surgery at the Bristol Royal Infirmary 1984-1995: Learning from Bristol. 1998;47:21321. Doctors discussed time pressure was a significant barrier in their ability to impart as much information as they would like resulting in the patient agreeing to treatment despite not being optimally informed. Blackhall LJ, Frank G, Murphy S, Michel V. Bioethics in a Different Tongue: The Case of Truth-Telling; 2001. In half of the studies in this review, patients and doctors discussed the importance of trust in the doctor-patient relationship, the patient and the institution and the patient and medicine in general. Patients and doctors involved in the consent process described the transfer of knowledge as an important element of the consent process. Arrange for any home care or equipment you will need at home after the surgery. BMJ Qual Saf Heal Care. This information may reveal some potential outcome measures that have not yet been reported elsewhere for prioritisation in the development of a COS. What are the experiences, concerns and needs of patients and clinicians during the informed consent process for surgery or other invasive healthcare procedures? The full search strategy for each database is available in AdditionalFile1. If a patient cannot consent, their legal guardian or appointed representative can do so on their behalf. Part of
Informed Consent Process in Ambulatory Surgery - ASC Focus Schedule any labs tests you need to have before the surgery. Anxiety has been commonly investigated as an outcome when trialling interventions to improve informed consent [6]. Citations and reasons for exclusion for these studies are included in AdditionalFile2. Development of the trust in physician scale: a measure to assess interpersonal trust in patient-physician relationships. In 2015, a significant development in UK case law, known as the Montgomery decision, led to a surge in claims against healthcare professionals related to the consent process. This may appear to be a formality, but, in fact, this process should be taken very seriously. Three findings from two studies reported that factors such as pain, fear, anxiety and medications all had a significant impact on the patients ability to fully engage in the informed consent and decision-making processes [23, 31]. Noyes J, Popay J, Pearson A, Hannes K, Booth A. The medical staff will carefully explain the surgery to you before you have it. No reference was made to recall of specific consent related details as being personally important to patients in the included studies. Patients and clinicians acknowledged that there was a certain amount of process and box ticking involved in the consent process and while many viewed this as bothersome, they believed it was unavoidable. Patients and doctors discussed the importance of clear communication within the consent process. Trusting the doctors proficiency - Most patients in the study expressed a fundamental confidence in the doctors, their competence and their intentions. In some cases, patients and clinicians believed that initial anxieties could be in some way allayed or reduced through an effective consent process. Healthcare without informed consent is only allowed under specific exceptions, which requires a record in the patient charts. 2012;204:61925. 2 and 3, respectively. The courts now expect doctors to advise their patients of all risks that an individual patient would determine to be of material importance to him or her, regardless of how unlikely that risk might be [4]. Informed consent Disclosure of information. 1985;8. It appears that most patients included in these studies valued the support of friends and family in assisting them with their decision making in relation to consent. However, the value of systematic reviews of qualitative evidence has been increasingly recognised as providing important context for quantitative data as well as answering some healthcare questions in their own right [9, 10]. BMC Med Ethics. Patients managed their anxieties relating to surgery by focusing on the positive reputation of the institution that they were being treated in. A further 3 studies were identified through hand searching reference lists of included studies or because of prior knowledge of a relevant study, resulting in a total of 16 eligible articles. When duplicate results were removed, 9692 titles remained for screening. Both doctors and patients recounted experiences whereby patients exhibited unwavering faith in surgery as a solution to their medical condition. Fear may inhibit patients desire for survival information (U), Ive got to ask the question because clearly those are the answers you want to know, you know. Of these, 16 studies met the inclusion criteria. Almost every primary study included a finding related to the importance of the transfer of knowledge in the consent process. Most side effects are minor and temporary, such as nausea, vomiting, chills, confusion for a few days, and a sore throat caused by a breathing tube. Accessed 11 Sep 2017, https://training.cochrane.org/handbook/chapter-20, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017077101, http://creativecommons.org/licenses/by/4.0/, http://creativecommons.org/publicdomain/zero/1.0/. Six of the included studies explored patients or doctors views of the consent process for major or life-threatening procedures or conditions [26, 28, 30, 31, 33, 37]. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Trust was a predominant theme present in almost half of included studies. Decision aids for people facing health treatment or screening decisions. Whilst the jostling on the crowded train or the melee in the supermarket at Christmas inevitably results in uninvited and potentially unwelcome touches from strangers, society dismisses these as inevitable irritants of modern life. Whats going on? Youre going to panic, arent you? It appears, from some of the included studies, that patient trust in the individual doctor had a greater bearing on their decision to consent to treatment than the communication of consent related knowledge had. 2016;16:258. LJC would like to acknowledge the help of Richard Fallis, medical librarian, Queens University Belfast in designing the search strategy. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The role of printed information in communication - patients expressed an interest in more written materials.
Informed consent for surgery: risk discussion and documentation BMJ. 2014;41:6673. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Responding to Trust: Surgeons Perspective on Informed Consent. It may also be the case that people believe that consent in current medical practice is obsolete and even dangerous. (U), Helen (P): Yes, no, you decide, I wont say anything. Luke (D): No, it is a difficult Helen (P): Its got to be the ones who understand it. () Luke (D): If I understand you properly, then you are willing to undergo surgery if we think its medically Helen (P): Yes. The following is a checklist to help you get ready for surgery. For example, patients and clinicians felt that patients consenting for a procedure related to a malignant diagnosis differed to patients receiving treatment for benign disease. These feelings were heightened where patients were using publicly funded and resource strapped healthcare. Informed consent is a person's decision, given voluntarily, to agree to a healthcare treatment, procedure or other intervention that is made: Following the provision of accurate and relevant information about the healthcare intervention and alternative options available; and
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