title: Informed consent in rhinoplasty: prospective randomized study of risk recall in patients who are given written disclosure of risks versus traditional oral discussion groups. Forewarned is forearmed--benefits of preparatory information on video cassette for patients receiving chemotherapy or radiotherapy--a randomised controlled trial. Randomised controlled trial of the effect of standard and detailed risk disclosure prior to bronchoscopy on peri-procedure anxiety and satisfaction Patient education and informed consent in head and neck surgery. Assisting informed decision making for labour analgesia: a randomised controlled trial of a decision aid for labour analgesia versus a pamphlet Improvement of the Educational Process by Computer-based Visualization of Procedures: Randomized Controlled Trial Informed Choice Assistance for Women Making Uterine Fibroid Treatment Decisions: A Practical Clinical Trial The influence of written information during the consenting process on patients’ recall of operative risks. A prospective randomised study A chairside aid for shared decision making in dentistry: a randomized controlled trial. Video informed consent improves knee arthroscopy patient comprehension. Effects of video information on precolonoscopy anxiety and knowledge: a randomised trial Combined written and oral information prior to gastrointestinal endoscopy compared with oral information alone: a randomized trial Effects of decision aids for menorrhagia on treatment choices, health outcomes, and costs: a randomized controlled trial. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy Patients' perceptions of written consent: questionnaire study Take-home informed consent for intravenous contrast media: do patients learn more? A randomised controlled trial of the effects of a web-based PSA decision aid, Prosdex. Protocol Informed consent: are we doing enough? Randomised controlled trial comparing effectiveness of touch screen system with leaflet for providing women with information on prenatal tests. Helping patients make informed choices: a randomized trial of a decision aid for adjuvant chemotherapy in lymph node-negative breast cancer. Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease Informed consent in facial plastic surgery: effectiveness of a simple educational intervention. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Use of evidence based leaflets to promote informed choice in maternity care: randomised controlled trial in everyday practice Informed consent: the assessment of two structured interview approaches compared to the current approach. A randomized trial using videotape to present consent information for colonoscopy. The use of video information in obtaining consent for female sterilisation: a randomised study Parental Desire for Perioperative Information and Informed Consent: A Two-Phase Study Educational intervention for women undergoing image-guided breast biopsy: results of a randomized clinical trial. Anaesthesia Information—What Patients Want to Know [Different information patterns and their influence on patient anxiety prior to dental local anesthesia]. Informed consent and patient participation in the medical encounter: a list of questions for an informed choice about the type of anaesthesia. Applying decision analysis to facilitate informed decision making about prenatal diagnosis for Down syndrome: a randomised controlled trial. Extended preoperative patient education using a multimedia DVD—impact on patients receiving a laparoscopic cholecystectomy: a randomised controlled trial Patient-physician communication: informed consent for imaging-guided spinal injections. How do doctors explain randomised clinical trials to their patients? An evaluation of informed consent prior to epidural analgesia for labor and delivery. How much now to tell? Patients' attitudes to an information sheet prior to angiography and angioplasty. The use of an information leaflet for patients undergoing wisdom tooth removal. Effect of evidence based risk information on “informed choice” in colorectal cancer screening: randomised controlled trial Patient comprehension of an interactive, computer-based information program for cardiac catheterization: a comparison with standard information. Involving Patients in Clinical Decisions: Impact of an Interactive Video Program on Use of Back Surgery Influence of supplemental written information on adolescent anxiety, motivation and compliance in early orthodontic treatment. Making choices for childbirth: a randomized controlled trial of a decision-aid for informed birth after cesarean. [3-dimensional computer animation--a new medium for supporting patient education before surgery. Acceptance and assessment of patients based on a prospective randomized study--picture versus text]. Development of a patient decision aid for choice of surgical treatment for breast cancer. Enhancement of Surgical Informed Consent by Addition of Repeat Back: A Multicenter, Randomized Controlled Clinical Trial Randomized Trial of a Patient Decision Aid for Choice of Surgical Treatment for Breast Cancer Impact of risk information in a patient education leaflet. Recall of informed consent after endoscopic procedures Effect of informed consent for intravascular contrast material on the level of anxiety: how much information should be given? A randomized controlled trial to assess the effect of audiotaped consultations on the quality of informed consent in cardiac surgery. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers. THE EFFECTIVENESS OF PATIENT VERBALIZATION ON INFORMED CONSENT Use of videotapes for viewing at home to inform choice in Down syndrome screening: a randomised controlled trial. A randomised study of three different informational AIDS prior to coronary angiography, measuring patient recall, satisfaction and anxiety. [Structure and quality of German-language gastroscopy information forms from the patients' viewpoint]. Interactive method of informing patients of the risks of intravenous contrast media. Informed consent in pediatric surgery: Do parents understand the risks? Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients? Informed Consent for Ankle Fracture Surgery: Patient Comprehension of Verbal and Videotaped Information Use of a Low-Literacy Informed Consent Form to Improve Women's Understanding of Tubal Sterilization: A Randomized Controlled Trial A randomised trial of conventional versus BAUS procedure-specific consent forms for transurethral resection of prostate. Factors affecting quality of informed consent. Recall of the Risks of Forefoot Surgery After Informed Consent Information seeking and interactive videodisc preparation for third molar extraction. Recall from informed consent counselling for cataract surgery. Informed consent: how much information is enough? Improving informed consent to chemotherapy: a randomized controlled trial of written information versus an interactive multimedia CD-ROM. Improving Informed Consent of Surgical Patients Using a Multimedia-Based Program?: Results of a Prospective Randomized Multicenter Study of Patients Before Cholecystectomy Informed consent: using a structured interview changes patients' attitudes towards informed consent. The effect of information level and coping style on pain and anxiety in needle liver biopsy. Spanish and English video-assisted informed consent for intravenous contrast administration in the emergency department: a randomized controlled trial. Informed consent in otologic surgery: prospective randomized study comparing risk recall with an illustrated handout and a nonillustrated handout. Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial. Challenges in evaluating surgical innovation Interactive Digital Education Aid in Breast Reconstruction   The Benefits of an Interactive, Individualized Online Patient Pathway for Patients Undergoing Minimally Invasive Radioguided Parathyroidectomy: A Prospective, Double-Blinded, Randomized Clinical Trial
abstract: OBJECTIVE To determine the effectiveness of providing written information in enhancing patient underst and ing and retention . DESIGN A multicentre prospect i ve r and omized study was conducted in university-affiliated ambulatory surgical centres . One hundred consecutive patients seen for rhinoplasty consultation were included . Patients were r and omly assigned to ( 1 ) those receiving traditional oral dialogue of the surgical risks or ( 2 ) those receiving an oral discussion and a written pamphlet outlining the risks of the procedure . Fourteen to 18 days after the consultation , each patient was contacted for an assessment of risk recall . RESULTS Overall risk recall was higher in the group that received written information ( 2.3 vs 1.3 of 5 risks ; p < .008 ) . As well , in the group that received a pamphlet , patients with university and postgraduate levels of education had a better rate of recall ( p < .05 ) . Female patients in both groups reported higher risk recall ( p < .01 ) . CONCLUSION Patient risk recall of rhinoplasty is improved with the addition of written information during the informed consent process . As the process of informed consent plays a very decisive role in facial plastic surgery , enhanced postoperative satisfaction may result from the use of supplemental educational material A series of UK and European audits have revealed that a high proportion of patients remain dissatisfied with the information they received following a diagnosis of cancer . Additional educational aids are often required to facilitate the consent process , and our previous work showed a high level of acceptability for video-directed information for this purpose . In this study a multidisciplinary team of health professionals worked with patients , a documentary film company and experienced television personalities to produce an information film . The aim of this study was to assess the benefits of receiving a cassette to take home following the first consultation and this was evaluated in a r and omised multicentre controlled study among 220 patients receiving chemotherapy or radiotherapy over a 6-month period . There was a significant correlation between satisfaction and reduced treatment-related anxiety overall . In the video group , the mean Hospital Anxiety and Depression ( HAD ) anxiety score was significantly lower during treatment compared with the non-video group ( 4.6+/-3.7 ( range : 0 - 18 ) versus 7.4+/-5.2 ( range : 0 - 20 ) , Chi square test P=0.001 ) . Likewise , the mean HAD depression scores were also significantly lower in the patients prepared for the side-effects of treatment with the video ( 2.9+/-2.9 ( range : 0 - 13 ) versus 5.3+/-4.7 ( range : 0 - 21 ) Chi square test P=0.001 ) . 81 % felt the video was helpful , only 5 % of patients felt this extra information was worrying . Well design ed video cassettes should be regarded as a useful additional information strategy , within routine oncology practice Background : Deciding what risks to disclose before a procedure is often challenging for clinicians . Consecutive patients undergoing elective fibreoptic bronchoscopy  were r and omised to receive simple or more detailed written information about the risks of the procedure and the effects on anxiety and satisfaction levels were compared . Methods : A 100 mm anxiety visual analogue scale ( VAS ) and a modified Amsterdam preoperative anxiety ( scored 4–20 ) scale ( APAIS ) were completed before and after reading the design ated information leaflet . Following bronchoscopy , subjects completed a satisfaction question naire . Results : Of 142 consecutive patients , 122 ( 86 % ) ( mean age 57.8 years , 53 % male ) completed the study . Baseline demographic , clinical and anxiety measures were similar in the two groups . Those who received more detailed risk information had significantly greater increase in anxiety levels than those who received simple information on both the VAS ( mean 14.0 ( 95 % CI 10.1 to 17.9 ) vs 2.5 ( 95 % CI −1.4 to 6.4 ) , p<0.001 ) and the APAIS ( 1.73 ( 95 % CI 1.19 to 2.26 ) vs 0.57 ( 95 % CI 0.05 to 1.10 ) , p<0.001 ) . Almost twice as many of those receiving detailed risk information reported that they felt they had received too much information about complications or that the information they had received about bronchoscopy had been worrying . Conclusions : Provision of more detailed risk information before bronchoscopy may come at the cost of a small but significant increase in anxiety OBJECTIVE To examine the effects of an educational intervention , in the form of printed material , on  patient knowledge and recall of possible risks from  parotidectomy or thyroidectomy .  DESIGN Prospect i ve , r and omized , controlled study conducted during a 9-month period . SETTING Head and neck surgery clinic of an academic tertiary care hospital . PATIENTS One hundred twenty-five consecutive patients older than 16 years who were undergoing thyroidectomy or parotidectomy at the head and neck surgery clinic were recruited . Four patients were excluded from analysis because their follow-up interview was not within the required limits . INTERVENTION At the preoperative visit during the routine consent process , both groups received a verbally delivered checklist of risks specific for the surgery to be performed . The intervention group was also given a pamphlet with written information accompanied by illustrations . MAIN OUTCOME MEASURES The effectiveness of the educational intervention  was determined by comparing the average rate of risk recall between the intervention and control groups . The effects of age , sex , level of education , and time between the consent and recall interviews on recall rate were also assessed . RESULTS The overall risk recall rate for both procedures was 39.1 % . The recall rate of the intervention group was 50.3 % compared with 29.5 % for the control group ( P<.001 ) . CONCLUSIONS The intervention consistently improved risk recall for all patients regardless of age , sex , and level of education . Patients ' ability to recall potential risks was significantly increased by an educational intervention ; all patients would benefit from this intervention Background Most women use some method of pain relief during labour . There is extensive research evidence available of pharmacological pain relief during labour ; however this evidence is not readily available to pregnant women . Decision aids are tools that present evidence based information and allow preference elicitation . Methods We developed a labour analgesia decision aid . Using a RCT design women either received a decision aid or a pamphlet .  Eligible women were primiparous , ≥ 37 weeks , planning a vaginal birth of a single infant and had sufficient English to complete the trial material s. We used a combination of affective ( anxiety , satisfaction and participation in decision-making ) and behavioural outcomes ( intention and analgesia use ) to assess the impact of the decision aid , which were assessed before labour . Results 596 women were r and omised ( 395 decision aid group , 201 pamphlet group ) . There were significant differences in knowledge scores between the decision aid group and the pamphlet group ( mean difference 8.6 , 95 % CI 3.70 , 13.40 ) . There were no differences between decisional conflict scores ( mean difference -0.99 ( 95 % CI -3.07 , 1.07 ) , or anxiety ( mean difference 0.3 , 95 % CI -2.15 , 1.50 ) . The decision aid group were significantly more likely to consider their care providers opinion ( RR 1.28 95%CI 0.64 , 0.95 ) . There were no differences in analgesia use and poor follow through between antenatal analgesia intentions and use . Conclusions This decision aid improves women 's labour analgesia knowledge without increasing anxiety . Significantly , the decision aid group were more informed of labour analgesia options , and considered the opinion of their care providers more often when making their analgesia decisions , thus improving informed decision making . Trial Registration Trial registration no : IS RCT Background Before any invasive procedure , physicians have a legal obligation to inform patients . Traditionally , this involves a discussion with a physician , supplemented by written leaflet information directed at the specific procedure . Objective Comparison of the use and effectiveness of computer-based visualization opposed to st and ardized conversation for providing patients with information of forthcoming procedures ( coronary catheters or endoscopy procedures ) . Methods Prospect i ve , r and omized trial with 56 participants allocated in two different groups : Visualization Group ( st and ardized information supported by a tool for displaying two-dimensional pictures to explain medical facts as well as informative leaflet ) or Control Group ( st and ardized information and informative leaflet only ) . Detailed information was given about the indication , the probable complications and the details of the forthcoming procedures ( coronary catheters or endoscopy procedures ) . All participants had to reach a Karnofsky Score of 70 points and be able to underst and German or English . Main outcome measures were patient 's satisfaction with physician-patient conversation , patient 's acquired knowledge and duration of the intervention as described above . Results Patients of the Visualization Group were more satisfied with the conversation and had higher knowledge scores after the conversation . A Mann-Whitney-U-Test between the two groups showed that these differences in satisfaction ( P<0.001 ) and knowledge ( P=<0.006 ) were statistically significant . Length of time needed for the conversation was slightly higher in the Visualization Group , but this difference was not statistically significant ( 25 versus 23 min ; P= 0.441 ) . No differences could be found due to differing age or educational level in the results of the Visualization and the Control Group . Conclusions Using computerized visualization increased the satisfaction and knowledge of the patients . The presentation of the visualized information in the Visualization Group did not dem and significantly more time than the st and ard conversation in the Control Group Background . There is limited evidence about how to ensure that patients are helped to make informed medical care decisions . Objective . To test a decision support intervention for uterine fibroid treatments . Design and Setting . Practical clinical trial to test informed choice assistance in 4 r and omly assigned gynecology clinics compared to 5 others providing a pamphlet . Patients . Three hundred women facing a treatment decision for fibroids over a 13-month period . Intervention . Mailed DVD and brochure about fibroid treatments plus the Ottawa decision guide and an offer of counseling soon after an index visit . Measurements . Mailed survey 6 to 8 weeks later asking about knowledge , preferences , and satisfaction with decision support . Results . In total , 244 surveys were completed for an adjusted response rate of 85.4 % . On a 5-point scale , intervention subjects reported more treatment options being mentioned ( 3.0 v. 2.4 ) , had a higher knowledge score ( 3.3 v. 2.8 ) , and were more likely to report being adequately informed ( 4.4 v. 4.0 ) , and their decision was both more satisfactory ( 4.3 v. 4.0 ) and more consistent with their personal values ( 4.5 v. 4.2 ) . Neither knowledge nor use of the intervention was associated with greater concordance between preferences and decisions . Limitations . Implementation of intervention may not have been well timed to the decision for some patients , limiting their use of the material s and counseling . Conclusion . It is difficult to integrate structured decision support consistently into practice . Decision support for benign uterine conditions showed effects on knowledge and satisfaction but not on concordance In a recent article , Leigh ( J Bone Joint Surg [ Br ] 88-B:16–18 , 2006 ) notes that patients do not lay down memory when being counselled as to the risks involved in prospect i ve surgery . In our article we focused on the patients ’ recall of risk factors involved in elective spinal surgery . We assessed the influence of written information provided to the patients during the consenting process on their recall of operative risks . The study was a prospect i ve r and omised study . All patients having elective spinal surgery were included in our study from February 2006 to November 2006 as a consecutive series . Patients were r and omised into two groups , one of which received routine consent with verbal explanations ( group 1 ) , the other received the same information supplemented by a written sheet explaining the risks of the surgery ( group 2 ) . Two weeks later we assessed patients ’ recall of the risk involved in the surgery with a question naire and compared both groups with a Student t-test .  Fifty-three patients ( twenty in group 1 and twenty three in group 2 ) were involved . We noted a significant difference between the two groups in terms of mean number of risks recalled and number of patients recalling each risk ( p < 0.001 and p < 0.005 , respectively ) . The addition of a written sheet given to patients during the consenting process makes a significant difference in terms of their recall of the surgical risks in elective lumbar spine surgery . We advocate the routine use of written booklets during the consenting process . RésuméRappel : dans un article récent , Leigh montre que les patients ne se souviennent pas très bien des indicationsqui leur ont été données en ce qui concerne l’information sur les risques avant une intervention chirurgicale . Nous avons souhaité , dans notre étude mettre l’accent sur les risques pouvant survenir dans la chirurgie rachidienne . Nous avons essayé d’évaluer l ’ importance de l’information écrite lors de la mise en place du consentement éclairé de ces patients . Méthode : cette étude est une étude prospect i ve r and omisée . Tous les patients devant bénéficier d’une chirurgie rachidienne ont été inclus dans notre étude sur une période s’étalant de février 2006 à novembre 2006 . Tous les patients consécutifs ont été r and omisés en deux groupes . Le premier groupe n’ayant que des explications par voie orale , ( groupe 1 ) et le deuxième groupe avec un complément d’informations écrites , ( groupe 2 ) . Deux semaines après , ces patients ont été évalués avec un question naire et les deux groupes ont été comparés . Résultats : 53 patients dans le groupe 1 et 23 dans le groupe 2 ont été pris en compte dans cette étude . Nous avons noté une différence significative entre les deux groupes soit sur le nombre d’informations retenues par le patient ou le nombre de patients ayant pris en compte ces informations . En conclusion : outre l’information orale , une information écrite remise au patient durant le processus de consentement éclairé en chirurgie du rachis lombaire , est nécessaire avec une différence significative entre les deux groupes . Nous recomm and ons cette information écrite de façon routinière The concept of shared decision making ( SDM ) is an important emerging trend in clinical medicine but has received little or no attention in the dental literature . Decision aids can play a useful role in SDM by helping patients and clinicians choose among reasonable alternative treatment options . The purpose of this study was to develop and test an Endodontic Decision Board ( EndoDB ) for chairside use to help clarify treatment alternatives , benefits , risks , prognosis , and costs when root canal therapy or extraction of a tooth was indicated . The hypothesis was that the use of the EndoDB would lead to improved patient knowledge , greater satisfaction with the decision-making process , and no difference in anxiety when compared to the st and ard discussion and informed consent process ( usual care ) . The EndoDB was tested in a r and omized controlled trial in a postgraduate endodontics clinic . After treatment discussion , a brief question naire was completed by the patient to measure knowledge , satisfaction , and anxiety .  Patients in the EndoDB group ( n=32 ) demonstrated a small , but statistically significant , increase in knowledge ( t-test ; difference=+0.37 ; p=0.03 ) compared to the  usual care group ( n=35 ) . There was no difference between groups in the measures of satisfaction or anxiety ( Mann-Whitney U-test ; p>0.05 ) . Decision aids may emerge as a useful tool to facilitate SDM and evidence -based clinical practice PURPOSE The purpose of this study was to test the hypothesis that video informed consent improves knee arthroscopy patient comprehension and satisfaction compared with traditional verbal informed consent . TYPE OF STUDY Prospect i ve , r and omized controlled trial . METHODS Consecutive patients having informed consent in preparation for knee arthroscopy by a single surgeon were stratified by educational level < or = 12th grade or greater than 12th grade , then r and omized to video or traditional verbal informed consent groups . Immediately after the informed consent process , patients completed an outcome question naire evaluating comprehension and satisfaction . RESULTS Patients in the video group showed significantly higher comprehension ( 78.5 % ) than patients in the verbal group ( 65.4 % ) ( P = .00001 ) . In the subgroup with < or = 12th grade education level , the video patients scored 73.1 % comprehension and the verbal patients only 54.2 % ( P = .0011 ) . In the subgroup with greater than 12th grade education level , the video patients scored 82.3 % and the verbal patients scored 72.2 % ( P = .0002 ) . There was no significant difference in subjective self- assessment of satisfaction between groups . CONCLUSIONS Video informed consent improves knee arthroscopy patient comprehension compared with traditional verbal informed consent . LEVEL OF EVIDENCE Level BACKGROUND The provision of information before medical or surgical procedures should improve knowledge and allay anxiety about the pending procedure . This trial aim ed to assess the value of an information video in this process . METHODS Patients scheduled to undergo colonoscopy were approached about 1 week before the procedure . All patients were given an information leaflet about colonoscopy , and completed a  Spielberger state anxiety inventory ( STAI ) question naire to assess baseline anxiety . The patients were then r and omly assigned to watch or not watch the information video . Immediately before colonoscopy , all patients completed a second anxiety question naire and a knowledge question naire . FINDINGS 198 patients were screened . 31 declined to participate and 17 were unable to complete the forms . Of the remaining 150 patients , 72 were assigned the video , and 78 no video . The groups were similar with regard to age , sex , educational attainment , and initial anxiety score . Female patients had higher baseline anxiety than male patients ( mean STAI 46.3 [ 95 % CI 44.9 - 47.7 ] vs 36.9 [ 35.5 - 38.3 ] ; difference 9.4 [ 7.8 - 12.2 ] , p=0.0008 ) . Patients who had not had a previous colonoscopy had higher baseline anxiety scores than those who had prior experience of the procedure ( 46.9 [ 45.4 - 48.5 ] vs 36.3 [ 34.7 - 37.9 ] ; difference 10.6 [ 7.5 - 13.8 ] , p=0.0008 ) . Patients who watched the video were significantly less anxious before colonoscopy than those who did not . The former also scored more highly in the knowledge question naire than the latter with regard to the purpose of the procedure , procedural details , and potential complications of colonoscopy . INTERPRETATION An information video increases knowledge and decreases anxiety in patients preparing for colonoscopy Background Little is known about how to most effectively deliver relevant information to patients scheduled for endoscopy . Methods To assess the effects of combined written and oral information , compared with oral information alone on the quality of information before endoscopy and the level of anxiety . We design ed a prospect i ve study in two Swiss teaching hospitals which enrolled consecutive patients scheduled for endoscopy over a three-month period . Patients were r and omized either to receiving , along with the appointment notice , an explanatory leaflet about the upcoming examination , or to  oral information delivered by each patient 's doctor .  Evaluation of quality of information was rated on scales between 0 ( none received ) and 5 ( excellent ) . The analysis of outcome variables was performed on the basis of intention to treat- analysis . Multivariate analysis of predictors of information scores was performed by linear regression analysis . Results Of 718 eligible patients 577 ( 80 % ) returned their question naire . Patients who received written leaflets ( N = 278 ) rated the quality of information they received higher than those informed verbally ( N = 299 ) , for all 8 quality -of-information items . Differences were significant regarding information about the risks of the procedure ( 3.24 versus 2.26 , p < 0.001 ) , how to prepare for the procedure ( 3.56 versus 3.23 , p = 0.036 ) , what to expect after the procedure ( 2.99 versus 2.59 , p < 0.001 ) , and the 8 quality -of-information items ( 3.35 versus 3.02 , p = 0.002 ) . The two groups reported similar levels of anxiety before procedure ( p = 0.66 ) , pain during procedure ( p = 0.20 ) , tolerability throughout the procedure ( p = 0.76 ) , problems after the procedure ( p = 0.22 ) , and overall rating of the procedure between poor and excellent ( p = 0.82 ) . Conclusion Written information led to more favourable assessment s of the quality of information and had no impact on patient anxiety nor on the overall assessment of the endoscopy . Because structured and comprehensive written information is perceived as beneficial by patients , gastroenterologists should clearly explain to their patients the risks , benefits and alternatives of endoscopic procedures . Trial registration : Current Controlled trial number : IS RCT N34382782 CONTEXT Decision aids can increase patient involvement in treatment decision making . However , questions remain regarding their effects and cost implication s. OBJECTIVE To evaluate the effects of information , with and without a structured preference elicitation interview , on treatment choices , health outcomes , and costs . DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial with 2 years of follow-up . Between October 1996 and February 1998 , 894 women with uncomplicated menorrhagia were recruited from 6 hospitals in southwest Engl and . Women were r and omized to the control group , information alone group ( information ) , or information plus interview group ( interview ) . INTERVENTIONS Women in both intervention groups were sent an information pack ( a booklet and complementary videotape ) 6 weeks before their specialist consultation . Immediately before their consultation , women in the interview group underwent structured interview , to clarify and elicit their preferences . MAIN OUTCOME MEASURES Self-reported health status was the main outcome ; secondary outcomes included treatments received and costs . Cost analyses adopted a UK health service ( payer ) perspective , and were based on patient-reported re source use data and are reported in 1999 - 2000 US dollars . RESULTS The interventions had no consistent effect on health status . Hysterectomy rates were lower for women in the interview group ( 38 % ) ( adjusted odds ratio [ OR ] , 0.60 ; 95 % confidence interval [ CI ] , 0.38 - 0.96 ) than in the control group ( 48 % ) and women who received the information alone ( 48 % ) ( adjusted OR , 0.52 ; 95 % CI , 0.33 - 0.82 ) . The interview group had lower mean costs ( $ 1566 ) than the control group ( $ 2751 ) ( mean difference , $ 1184 ; 95 % CI , $ 684-$2110 ) and the information group $ 2026 ( mean difference , $ 461 ; 95 % CI , $ 236-$696 ) . CONCLUSIONS Neither intervention had an effect on health status . Providing women with information alone did not affect treatment choices ; however , the addition of an interview to clarify values and elicit preferences had a significant effect on women 's management and result ed in reduced costs Objectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy . Methods The Consent-20 instrument was developed and piloted on 47 subjects . Subsequently , parents of 101 children undergoing first-time , diagnostic upper endoscopy performed under moderate IV sedation were prospect ively and consecutively , blinded , r and omised and enrolled into two groups that received either st and ard form-based informed consent or st and ard form-based informed consent plus a commercial ( Emmi Solutions , Inc , Chicago , Il ) , sixth grade level , interactive learning module ( electronic assisted consent ) . Anonymously and electronically , the subjects ' anxiety ( State Trait Anxiety Inventory ) , satisfaction ( Modified Group Health Association of America ) , number of questions asked , and attainment of informed consent were assessed ( Consent-20 ) . Statistics were calculated using t test , paired t test , and Mann Whitney tests . Results The ability to achieve informed consent , as measured by the new instrument , was 10 % in the control form-based consent group and 33 % in the electronic assisted consent group ( p<0.0001 ) . Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction , anxiety or number of questions asked in a paediatric endoscopy unit . Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy . It also shows that even when necessary information was repeated electronically in a comprehensive and st and ardised video , informed consent as measured by our instrument was incompletely achieved . The supplemental information did , however , significantly improve underst and ing in a manner that did not negatively impact workflow , subject anxiety or subject satisfaction . Additional study of informed consent is required . Clinical trial registration number Clinical Trials.gov Identifier NCT00899392 Abstract Objective To examine patients ' underst and ing of the status , function , and remit of written consent to surgery . Design Prospect i ve question naire study . Question naires were sent to patients within one month of surgery . Responses were analysed with frequencies and single variable analyses . Setting Large teaching hospital . Participants 732 patients who had undergone surgery in obstetrics and gynaecology over a six month period . Main outcome measures Patients ' awareness of the legal implication s of written consent and their views on the function and remit of the consent form .  Results Patients had limited underst and ing of the legal st and ing of written consent . Nearly half ( 46 % , 95 % confidence interval 43 % to 50 % ) of patients believed the primary function of consent forms  was to protect hospitals and 68 % ( 65 % to 71 % ) thought consent forms allowed doctors to assume control . Only 41 % ( 37 % to 44 % ) of patients believed consent forms made their wishes known . Conclusions Many patients seem to have limited awareness of the legal implication s of signing or not signing consent forms , and they do not recognise written consent as primarily serving their interests . Current consent procedures seem inadequate as a means for the expression of autonomous choice , and their ethical st and ing and credibility can be called into question RATIONALE AND OBJECTIVES In 1978 , Morrow et al published the results of a simple technique for raising radiation oncology patients ' levels of awareness about medical options . They reported that providing written information at least 24 hours in advance was an effective tool for increasing the baseline knowledge in this patient group . However , Morrow 's cohort consisted exclusively of cancer patients receiving radiation therapy .  The authors of this article are concerned with whether the encouraging results reported by Morrow are reproducible when applied to patients awaiting invasive radiologic procedures . METHODS One hundred sixty consecutive out patients awaiting contrast were block r and omized into one of eight groups based on age , sex , and previous contrast exposure . For each group , half were given their consent form at least 24 hours prior , and the other half at the time of their procedure . All patients were tested at the time of their procedure to evaluate knowledge retention . RESULTS Comparison between the two study groups showed no overall statistically significant differences either in knowledge ( experimental group 4.7 + /- 1.32 versus 4.38 + /- 1.30 control group ) or level of satisfaction . Additionally , individuals experienced with contrast failed to outperform those who had never previously been given contrast . There is no significant difference in the performance between the two sexes regardless of group . CONCLUSIONS The providing of information 24 to 72 hours in advance of an invasive procedure does not have a beneficial effect over just providing the same information at the time of the study Background Informed decision making is the theoretical basis in the UK for men 's decisions about Prostate Specific Antigen ( PSA ) testing for prostate cancer testing . The aim of this study is to evaluate the effect of a web-based PSA decision-aid , Prosdex , on informed decision making in men . The objective is to assess the effect of Prosdex on six specific outcomes : ( i ) knowledge of PSA and prostate cancer-related issues – the principal outcome of the study ; ( ii ) attitudes to testing ; ( iii ) decision conflict ; ( iv ) anxiety ; ( v ) intention to undergo PSA testing ; ( vi ) uptake of PSA testing . In addition , a mathematical simulation model of the effects of Prosdex will be developed . Methods A r and omised controlled trial with four groups : two intervention groups , one viewing Prosdex and the other receiving a paper version of the site ; two control groups , the second controlling for the potential Hawthorn effect of the question naire used with the first control group . Men between the ages of 50 and 75 , who have not previously had a PSA test , will be recruited from General Practitioners ( GPs ) in Wales , UK . The principal outcome , knowledge , and four other outcome measures – attitudes to testing , decision conflict , anxiety and intention to undergo testing – will be measured with an online question naire , used by men in three of the study groups . Six months later , PSA test uptake will be ascertained from GP records ; the online question naire will then be repeated . These outcomes , and particularly PSA test uptake , will be used to develop a mathematical simulation model , specifically to consider the impact on health service re sources .Trial registration Current Controlled Trial : IS RCT N48473735 We report our findings in a prospect i ve , r and omised study of  patient recall of verbal versus written preoperative warnings . There were 132 patients in the verbal group and 137 in the written group , with a similar age and sex distribution in both groups . Four of the seven preoperative warnings were remembered significantly better by the group receiving the written warnings ( P < 0.001 - 0.05 ) . However , the mean number of warnings recalled was fewer than 3 in the verbal group , and fewer than 4 ( P = 0.0057 ) in the written group ( Mann-Whitney U-test ) . Patients given verbal warnings were less able to recall them than those receiving written warnings . The inference is that they entered into surgery less well informed Abstract Objective : To compare the effectiveness of touch screen system with information leaflet for providing women with information on prenatal tests . Design : R and omised controlled trial ; participants allocated to intervention group ( given access to touch screen and leaflet information ) or control group ( leaflet information only ) . Setting : Antenatal clinic in university teaching hospital . Subjects : 875 women booking antenatal care . Interventions : All participants received a leaflet providing information on prenatal tests . Women in the intervention arm also had access to touch screen information system in antenatal clinic . Main outcome measures : Women 's informed decision making on prenatal testing as measured by their uptake of and underst and ing of the purpose of specific tests ; their satisfaction with information provided ; and their levels of anxiety . Results : All women in the trial had a good baseline knowledge of prenatal tests . Women in the intervention group did not show any greater underst and ing of the purpose of the tests than control women . However , uptake of detailed anomaly scans was significantly higher in intervention group than the control group ( 94 % ( 351/375 ) v 87 % ( 310/358 ) , P=0.0014 ) . Levels of anxiety among nulliparous women in intervention group declined significantly over time ( P<0.001 ) . Conclusions : The touch screen seemed to convey no benefit over well prepared leaflets in improving underst and ing of prenatal tests among the pregnant women . It did , however , seem to reduce levels of anxiety and may be most effective for providing information to selected women who have a relevant adverse history or abnormal results from tests in their current pregnancy BACKGROUND In recent years , patients have indicated a desire for more information about their disease and to be involved in making decisions about their care . We developed an aid called the " Decision Board " to help clinicians inform patients with lymph node-negative breast cancer of the risks and benefits of adjuvant chemotherapy . We determined whether adding the Decision Board to the medical consultation improved patient knowledge and satisfaction compared with the medical consultation alone . METHODS Between October 1995 and March 2000 , 176 women with lymph node-negative breast cancer who were c and i date s for adjuvant chemotherapy were r and omly assigned to receive the Decision Board plus the medical consultation ( 83 patients ) or the medical consultation alone ( 93 patients ) . One week after the consultation , patients completed a question naire assessing their knowledge about breast cancer and chemotherapy .  Satisfaction with decision making was assessed 1 week and 3 , 6 , and 12 months after r and omization , and differences between groups were analyzed by a repeated measures analysis of variance . All statistical tests were two-sided . RESULTS Patients in the Decision Board arm were better informed about breast cancer and adjuvant chemotherapy than patients in the control arm ( mean knowledge score = 80.2 [ on a scale of 0 - 100 ] , 95 % confidence interval [ CI ] = 77.1 to 83.3 , and 71.7 , 95 % CI = 69.0 to 74.4 , respectively ; P<.001 ) . Over the entire study period , satisfaction with decision making was higher for patients in the Decision Board arm than for patients in the control arm ( P = .032 ) . There was no statistically significant difference between the two groups in the number of patients who chose adjuvant chemotherapy ( 77 % and 70 % for patients in the Decision Board arm and those in the control arm , respectively ; P = .303 ) . CONCLUSION When making decisions regarding adjuvant chemotherapy , patients with early breast cancer who had been exposed to the Decision Board had better knowledge of the disease and treatment options and greater satisfaction with their decision making than those who received the st and ard consultation OBJECTIVE : To determine the effect of the Ischemic Heart Disease Shared Decision-Making Program ( IHD SDP ) an interactive videodisc design ed to assist patients in the decision-making process involving treatment choices for ischemic heart disease , on patient decision-making . DESIGN : R and omized , controlled trial . SETTING : The Toronto Hospital , University of Toronto , Toronto , Ontario , Canada . PARTICIPANTS : Two hundred forty ambulatory patients with ischemic heart disease amenable to elective revascularization and ongoing medical therapy . MEASUREMENTS AND MAIN RESULTS : The primary outcome was patient satisfaction with the decision-making process . This was measured using the 12-item Decision-Making Process Question naire that was developed and vali date d in a r and omized trial of the benign prostatic hyperplasia SDP . Secondary outcomes included patient knowledge ( measured using 20 questions about knowledge deemed necessary for an informed treatment decision ) , treatment decision , patient-angiographer agreement on decision , and general health scores . Outcomes were measured at the time of treatment decision and /or at 6 months follow-up . Shared decision-making program scores were similar for the intervention and control group ( 71 % and 70 % , respectively ; 95 % confidence interval [ CI ] for 1 % difference , −3 % to 7 % ) . The intervention group had higher knowledge scores ( 75 % vs 62 % ; 95 % CI for 13 % difference , 8 % to 18 % ) . The intervention group chose to pursue revascularization less often ( 58 % vs 75 % for the controls ; 95 % CI for 17 % difference , 4 % to 31 % ) . At 6 months , 52 % of the intervention group and 66 % of the controls had undergone revascularization ( 95 % CI for 14 % difference , 0 % to 28 % ) . General health and angina scores were not different between the groups at 6 months . Exposure to the IHD SDP result ed in more patient-angiographer disagreement about treatment decisions . CONCLUSIONS : There was no significant difference in satisfaction with decision-making process scores between the IHD SDP and usual practice groups . The IHD SDP  patients were more knowledgeable , underwent less revascularization ( interventional therapies ) , and demonstrated increased patient decision-making autonomy without apparent impact on quality of life OBJECTIVE To evaluate the effectiveness of oral communication about the risks of facial cosmetic procedures compared with oral and written communication . DESIGN A prospect i ve r and omized study conducted in an ambulatory surgery center . One hundred twenty consecutive patients were included ; they presented for consultation for rhinoplasty , rhytidectomy , or laser resurfacing . Patients were r and omly assigned to 1 of 2 groups : ( 1 ) those receiving oral discussion of the risks of the procedure and ( 2 ) those receiving oral and written communication about the risks . Two weeks after the initial consultation , patients were surveyed for recall of the risks . RESULTS The group that received a pamphlet had a better risk recall than the group that did not ( 2.5 vs1.5 of 5 risks ; P<.001 ) . The recall rate in the following groups that received a pamphlet was also better : ( 1 ) university-educated patients ( P = .02 ) , ( 2 ) patients who underwent rhinoplasty ( P<.001 ) , ( 3 ) patients who underwent laser resurfacing ( P = .02 ) , and ( 4 ) female patients ( P<.001 ) . CONCLUSIONS Written disclosure of the risks of cosmetic procedures enables patients to retain and underst and more clearly those potential risks . They are , therefore , able to give an informed consent to the proposed procedure . This study also identifies patient groups who may require more intensive presurgical teaching . The medicolegal implication s are apparent BACKGROUND Provision of preoperative information can alleviate patients ' anxiety . However , the ideal method of delivering this information is unknown . Video information has been shown to reduce patients ' anxiety , although little is known regarding the effect of preoperative multimedia information on anxiety in patients undergoing regional anaesthesia . METHODS We r and omized 110 patients undergoing upper or lower limb surgery under regional anaesthesia into the study and control groups . The study group watched a short film ( created by the authors ) depicting the patient 's in-hospital journey including either a spinal anaesthetic or a brachial plexus block . Patients ' anxiety was assessed before and after the film and 1 h before and within 8 h after their operation , using the Spielberger state trait anxiety inventory and a visual analogue scale . RESULTS There was no difference in state and trait anxiety between the two groups at enrollment . Women had higher baseline state and trait anxiety than men ( P=0.02 ) . Patients in the control group experienced an increase in state anxiety immediately before surgery ( P<0.001 ) , and patients in the film group were less anxious before operation than those in the control group ( P=0.04 ) . After operation , there was a decrease in state anxiety from baseline in both groups , but patients in the film group were less anxious than the control group ( P=0.005 ) . CONCLUSIONS Preoperative multimedia information reduces the anxiety of patients undergoing surgery under regional anaesthesia . This type of information is easily delivered and can benefit many patients Abstract Objective : To assess the effect of leaflets on promoting informed choice in women using maternity services . Design : Cluster trial , with maternity units r and omised to use  leaflets  ( intervention units ) or offer usual care ( control units ) . Data collected through postal question naires . Setting : 13 maternity units in Wales . Participants : Four separate sample s of women using maternity services . Antenatal sample s : women reaching 28 weeks ' gestation before ( n=1386 ) and after ( n=1778 ) the intervention . Postnatal sample s : women at eight weeks after delivery before ( n=1741 ) and after ( n=1547 ) the intervention . Intervention : Provision of 10 pairs of Informed Choice leaflets for service users and midwives and a training session for staff in their use . Main outcome measures : Change in the proportion of women who reported exercising informed choice . Secondary outcomes : changes in women 's knowledge ; satisfaction with information , choice , and discussion ; and possible consequences of informed choice . Results : There was no change in the proportion of women who reported that they exercised informed choice in the intervention units compared with the control units for either antenatal or postnatal women . There was a small increase in satisfaction with information in the antenatal sample s in the intervention units compared with the control units ( odds ratio 1.40 , 95 % confidence interval 1.05 to 1.88 ) . Only three quarters of women in the intervention units reported being given at least one of the leaflets , indicating problems with the implementation of the intervention . Conclusion : In everyday practice , evidence based leaflets were not effective in promoting informed choice in women using maternity services We prospect ively studied 190 patients undergoing tonsillectomy or nasal surgery  to assess the value of two structured interview techniques . There were four groups : Group A did not have a consent interview during the study period . Group B had an informal interview . Group C had a structured interview and Group D had a structured interview and were given an information sheet .  Anxiety assessment s were made and patients ' recall of the operation name , details of the operation and its complications was assessed . Patients had higher than normal anxiety levels when admitted , but several hours after the interview anxiety was normal for Groups B , C and D. Group A maintained a higher anxiety level . Only 37 per cent correctly recalled the operation name , where as 87 per cent of all groups recalled the explanation of the operation . However , Groups C and D recalled a higher mean number of complications per patient . A structured interview when obtaining informed consent increases the number of complications recalled without increasing pre-operative anxiety A r and omized controlled trial was conducted to determine if a videotaped presentation by a physician conveys information more effectively than an in-person discussion by the same physician using the identical script . Two hundred one patients undergoing colonoscopy were enrolled in the study . Patients were r and omly assigned to one of three groups : video plus discussion , video alone , and discussion alone . A vali date d , 13-item knowledge test and the State-Trait Anxiety Inventory were administered to all patients . Mean number of correct test answers for video plus discussion was 11.04 ; for video alone , 10.70 ; and for discussion alone , 9.61 . ANOVA with planned orthogonal comparisons showed that the patients in the two video groups had significantly better scores ( p < 0.001 ) than those in the discussion -only group . No difference was noted between the two video groups ( p = 0.32 ) . Anxiety did not increase with increased underst and ing of the risks and benefits of colonoscopy . This approach may work as well for other invasive medical procedures and could save physician time while laying a foundation for a more personalized discussion Hypothesis Providing additional information by video in addition to the st and ard consultation in women requesting sterilisation increases patients ' knowledge about the procedure with no change in anxiety levels The purpose of this investigation was to identify the perioperative anesthetic information parents want from the anesthesiologist , and to determine whether the provision of detailed anesthetic risk information is associated with increased  parental anxiety . The investigation consisted of a cross-sectional study followed by a r and omized controlled trial . In Phase 1 , baseline and situational anxiety , coping strategy , and temperament were obtained from parents of children undergoing surgery ( n = 334 ) . A question naire examining the desire for perioperative information was administered to all parents . In Phase 2 , 47 parents were r and omly assigned to receive either routine anesthetic risk information ( control ) or detailed anesthetic risk information ( intervention ) . The effect of the intervention on parental anxiety was assessed over four time points : prior to the intervention , immediately after the intervention , day of surgery in the holding area , and at separation to the operating room . For Phase 1 , the majority of parents ( > 95 % ) preferred to have comprehensive information concerning their child 's perioperative period , including information about all possible complications . For selected items , increased parental educational level was associated with increased desire for information ( P < 0.05 ) . For Phase 2 , when the intervention group was compared with the control group , there were no significant differences in parental anxiety over the four time points [ F(1,45 ) = 0.6 , P = 0.4 ] . Also , the interaction between time and group assignment was not significant [ F(3,135 ) = 1.66 , P = 0.18 ] . We conclude that parents of children undergoing surgery desire comprehensive perioperative information . Moreover , when provided with highly detailed anesthetic risk information , the parental anxiety level did not increase . ( Anesth Analg 1997;84:299 - 306 BACKGROUND The process of informed consent has been examined for patients undergoing various procedures but not breast biopsy . Our study was a r and omized trial that examined the effect of an educational flip chart as part of the informed consent . METHODS A total of 122 patients referred for stereotactic or ultrasound-guided core breast biopsy  were r and omly assigned to receive an informed consent discussion with or without an illustrated flip chart . The chart included information about breast anatomy , pathology , and diagnostic procedures . Outcome measures included objective knowledge , subjective knowledge , anxiety , and satisfaction . RESULTS Analysis showed few significant main effects of the intervention . However , results showed interactions between experimental condition and race/ethnicity , indicating that the intervention was effective in enhancing objective and subjective knowledge for African American but not Caucasian patients . Anxiety after consultation was higher among patients assigned to the flip chart condition , possibly because they were better informed about the risks of the procedure . Patients who underwent biopsy sooner after learning they needed one were more satisfied with their care . CONCLUSIONS The usual care consent process is effective for many but not all patients . Informed consent that employs visual aids may help overcome characteristics of the consent process that are ineffective for some patients We developed and introduced into clinical practice a leaflet to improve the delivery of information to patients before obtaining their consent to anaesthesia . The amount of information needs to be what a “ reasonable ” patient thinks appropriate ; therefore we tested patients ’ responses to three levels of information : “ full ” disclosure , “ st and ard ” disclosure ( as contained in our leaflet ) and “ minimal ” disclosure .  Forty-five patients scheduled to undergo cardiac surgery were enrolled in the study . None of the information sheets caused a significant change in state anxiety score and only the “ full ” disclosure significantly increased knowledge about anaesthesia ( P=0.016 ) . All leaflets were easy to underst and . When only one leaflet was provided 64–73 % of patients thought the content was “ just right ” , whereas when all three leaflets were viewed together , 63 % of patients thought the “ minimal ” leaflet withheld too much information In 240 patients the correlation between different patterns of pretreatment verbal information on  local anesthesia  and perioperative patient anxiety was studied . Emphasis has been placed on the importance of " local anesthesia " itself as an anxiety factor as compared with other dental treatment measures and on legal aspects . The 240 patients were r and omized into 3 groups of 80 patients each receiving minimum , basic , or extended information on local anesthesia .  Anxiety was measured using the STAI test before and after the delivery of information , after local anesthesia , and finally after dental treatment . The significance of different anxiety factors was assessed with a question naire . Local anesthesia , pain sensation , and drilling were found to be the main anxiety factors . Higher STAI scores were observed in women and prior to surgical treatment , and the scores increased after minimum and extended information . Anxiety decreased after basic information , and significantly so in patients with high preoperative STAI scores . Disregarding the forensic aspects , our results suggest that basic information prior to dental treatment could be a useful method for reducing anxiety and improving the patients ' confidence in the dentist or surgeon The present study was undertaken to evaluate the impact of a new procedure for eliciting informed consent by patients undergoing minor surgical procedures , in which the choice between general anaesthesia ( GA ) and regional anaesthesia ( RA ) was possible . In this prospect i ve study , two r and omly selected groups of patients were compared : study group ( SG ) , 52 patients , received from the  nurse  before the preoperative interview , a list of seven questions , which they were invited to ask the anaesthetist ; while the control group ( CG ) , 73 patients , did not receive any suggested questions . There were two end points : the proportion that chose RA and the number of questions actually addressed to the doctor at the preanaesthetic interview . Psychological aspects were taken into account by collecting the Hospital Anxiety and Depression ( HAD ) scale before the preanaesthetic interview . Satisfaction with the interview was recorded using a telephone question naire 2 weeks after the operation . The results from the two groups were compared by calculating the odds ratio according to Mantel-Haenszel and by logistic analysis . Altogether , 71.2 % of the patients chose RA without any difference between the groups . The average number of questions asked by each SG patient was higher than for the CG ( 1.67 vs. 0.96 ) . The satisfaction level was similar in the two groups . Our list of questions was design ed to facilitate patient autonomy . It offered an aid to those requesting more information and assisted communication . The method did not change the proportion who chose a specific kind of anaesthesia , but does seem to improve patient participation in the decision-making process OBJECTIVE To evaluate decision analysis as a technique to facilitate women 's decision-making about prenatal diagnosis for Down syndrome using measures of effective decision-making . DESIGN R and omised controlled trial in a UK hospital 's prenatal diagnosis clinic . INTERVENTION Routine versus routine consultation structured by decision analysis . PARTICIPANTS 117/132 women receiving a screen-positive maternal serum screening result participated ( 58 routine , 59 decision analysis ) . METHODS Consultations were audio tape-recorded , transcribed and coded ; question naires were completed after the consultation and one month later after receipt of a diagnostic test and /or the 19-week scan result . MAIN MEASURES Test decision , subjective expected utilities , knowledge , informed decision-making , risk perception , decisional conflict , anxiety , perceived usefulness and directiveness of consultation information . RESULTS 48/59 in the decision-aided group and 47/58 in the routine group underwent prenatal diagnosis . Informed decision-making was higher , perceived risk more realistic and decisional conflict over time lower in the decision analysis group . Decision analysis had no impact on knowledge or SEU scores , and was no more or no less directive , useful or anxiety provoking than the routine care . Consultations were six minutes longer . CONCLUSIONS Decision analysis consultations enable women to make more informed prenatal diagnosis decisions . Professionals will need training to use this technique effectively Purpose The informed consent is a legal requirement prior to surgery and should be based on an extensive preoperative interview . Multimedia productions can therefore be utilised as supporting tool . In a prospect i ve r and omised trial , we evaluated the impact of an extended education on patients undergoing cholecystectomy . Material s and methods For extended patient information , a professionally built DVD was used . After r and omisation to either the DVD or the control group , patients were informed with or without additional presentation of the DVD . The quality of education was evaluated using a purpose -built question naire . Results One hundred fourteen patients were included in the DVD and 98 in the control group .  Patient characteristics did not differ significantly despite a higher educational level in the DVD group . The score of correctly answered questions was higher in the DVD group ( 19.88 vs. 17.58 points , p < 0.001 ) . As subgroup analysis revealed , particular patient characteristics additionally impacted on results . Conclusion Patients should be informed the most extensively prior to any surgical procedure . Multimedia productions therefore offer a suitable instrument . In the presented study , we could prove the positive impact of an information DVD on patients knowledge . Nevertheless , multimedia tools can not replace personal interaction and should only be used to support daily work PURPOSE Historically , informed-consent forms have been developed for the purpose of educating patients . However , informed-consent forms can be very difficult to underst and . The hypothesis of this study was that a method using diagrams would improve patient-physician communication without increasing the time required to obtain informed consent over the teach-the-teacher method , as well as over current st and ard informed-consent protocol . METHODS Ninety-nine of 109 patients undergoing spinal injections agreed to participate and completed this prospect i ve , r and omized , controlled study . The patients were r and omly assigned to the control group ( informed consent obtained in the customary manner at the investigators ' institution , with 12 key points of consent and home care discussed conversationally ) , the teach-the-teacher group ( patients had to repeat the 12 key points to the physicians before informed consent was complete ) , and the diagram group ( patients viewed a set of diagrams illustrating the 12 key points before signing the informed-consent form ) . After the procedure , the patients completed a survey to test knowledge recall , anxiety , and pain during the procedure . RESULTS Statistically significant results included a lower survey score for the control group , longer time required for the teach-the-teacher group than the control group , and a negative correlation between age and survey score in the teach-the-teacher group . CONCLUSIONS The diagram method required less time than the teach-the-teacher method , had no negative correlation in survey score results with age , and had improved patient-physician communication over the control group As part of a larger study design ed to improve doctor-patient communication in r and omised clinical trials ( RCT ) , we audiotaped the discussion s between doctor and patient in which consent was being obtained for a RCT . This paper reports on 82 discussion s conducted by 5 clinical oncologists in both District General and University Hospital outpatient departments . When introducing the subject of trials , uncertainty about treatment decisions was expressed by the doctors in the majority of cases ( 79 , 96.3 % ) . This was most often stated in a general sense ( 78 , 95.1 % ) , but some mentioned personal uncertainty ( 12 , 14.6 % ) , an approach which helps to maintain a trusting doctor-patient relationship . The word r and omization was mentioned in 51 ( 62.2 % ) consultations , although the process itself was usually described implicitly ( 78 , 95.1 % ) , e.g. by telling the patient that they would be allocated either one or other treatment . Analogies were used in 28 ( 34.1 % ) cases to describe the r and omisation process . In addition , although treatments and side-effects were described frequently , ( 68 , 82.9 % ) and ( 72 , 87.8 % ) respectively , information leaflets about the trials were not given to 23 ( 28 % ) patients . The study shows that U.K. clinicians adopt individual methods when providing information and eliciting consent to trials This investigation was performed to determine the ability of a parturient to recall the pre-anesthesia discussion with her anesthesiologist and to determine if written consent added to this discussion improves recall . Eighty-two women presenting in labor were r and omized to ' verbal ' and ' verbal plus written ' consent for epidural labor analgesia and were contacted 5 to 7 months after a pre-anesthetic interview . Ten objective questions were posed at this time that addressed issues that were ' true risks ' , ' false risks ' , and ' situational ' issues related to the consent process . These responses were scored on a point scale so that a maximal objective recall score of 100 points was possible . Median recall score was 80 ( 70 - 90 ) in the ' verbal ' group and 90 ( 80 - 100 ) in the ' verbal plus written ' group . This difference was statistically significant ( P < 0.01 ) . In addition , three subjective questions were asked of all women at this time . All but six women ( one ' verbal plus written ' and five ' verbal ' group patients ) expressed that written consent would help them ' remember and appreciate the different anesthetic options , risks , and procedures ' . Four of these same women ( one ' verbal plus written ' and three ' verbal ' group patients ) thought a written consent process was ' alarming ' . Two of these same women ( both ' verbal ' group patients ) reported that they felt unable to give informed consent A prospect ively controlled pilot study of 100 patients undergoing an invasive radiological procedure was undertaken to test patients ' acceptance of risk disclosure and whether this increases anxiety and rate of procedure cancellation . Two sheets with differing amounts of information on adverse outcome were r and omly allocated and patients provided a grade d response to statements following the procedure . Eighty-one completed question naires were received ( brief sheet n = 40 ; long sheet n = 41 ) . There were 19 non-compliers with main causes either due to lack of interest or problems such as language difficulties , visual impairment and dementia .  There were no significant differences between the two groups with respect to subjective anxiety caused by the information or risk of procedure cancellation . This preliminary work has shown that information sheets are well accepted and provide a simple , st and ardized format for risk disclosure Attempts to inform the patient about surgical procedures have increased for the purpose s of ensuring informed consent and improving satisfaction with the service provided . Leaflets are being used as an additional aid in general practice and in hospital units . However , such written information is seldom evaluated . This study was conducted to assess the influence of using an information leaflet for patients attending oral surgery clinics at a local dental hospital . Sixty-six patients were included in the study and invited to complete a question naire to assess knowledge of wisdom tooth removal at the time of examination and just prior to surgery . The validity of the knowledge measure had been previously tested . At 1 month follow-up a patient satisfaction question naire was completed by the sample . Patients were r and omised at the examination appointment into four groups . The first group was provided with the leaflet and prompted to read it by the dentist ( WTL + Prompt ) . The second group was given the leaflet but not prompted ( WTL only ) . The two other groups acted as controls . The third group was provided with a dental health education leaflet with no prompting ( Control 1 ) . The fourth and final group was given no additional written material ( Control 2 ) but provided with verbal information and routine warnings in a similar way to all other groups participating in the study . The WTL + Prompt Group showed increased knowledge on retest ( P < 0.001 ) . The WTL Group showed a trend to greater knowledge ( P < 0.06 ) however the control groups showed no improvement ( P > 0.5 ) . Patient satisfaction , although greatest in the group given a leaflet without prompting , was not simply related to leaflet provision Objective To compare the effect of evidence based information on risk with that of st and ard information on informed choice in screening for colorectal cancer . Design R and omised controlled trial with 6 months ’ follow-up . Setting German statutory health insurance scheme . Participants 1577 insured people who were members of the target group for colorectal cancer screening ( age 50 - 75 , no history of colorectal cancer ) .  Interventions Brochure with evidence based risk information on colorectal cancer screening and two optional interactive internet modules on risk and diagnostic tests ; official information leaflet of the German colorectal cancer screening programme ( control ) . Main outcome measure The primary end point was “ informed choice , ” comprising “ knowledge , ” “ attitude , ” and “ combination of actual and planned uptake . ” Secondary outcomes were “ knowledge ” and “ combination of actual and planned uptake . ” Knowledge and attitude were assessed after 6 weeks and combination of actual and planned uptake of screening after 6 months . Results The response rate for return of both question naires was 92.4 % ( n=1457 ) . 345/785 ( 44.0 % ) participants in the intervention group made an informed choice , compared with 101/792 ( 12.8 % ) in the control group ( difference 31.2 % , 99 % confidence interval 25.7 % to 36.7 % ; P<0.001 ) . More intervention group participants had “ good knowledge ” ( 59.6 % ( n=468 ) v 16.2 % ( 128 ) ; difference 43.5 % , 37.8 % to 49.1 % ; P<0.001 ) . A “ positive attitude ” towards colorectal screening prevailed in both groups but was significantly lower in the intervention group ( 93.4 % ( 733 ) v 96.5 % ( 764 ) ; difference −3.1 % , −5.9 % to −0.3 % ; P<0.01 ) . The intervention had no effect on the combination of actual and planned uptake ( 72.4 % ( 568 ) v 72.9 % ( 577 ) ; P=0.87 ) . Conclusions Evidence based risk information on colorectal cancer screening increased informed choices and improved knowledge , with little change in attitudes . The intervention did not affect the combination of actual and planned uptake of screening . Trial registration Current Controlled Trials IS RCT N47105521 BACKGROUND Several studies suggest that st and ard verbal and written consent information for treatment is often poorly understood by patients and their families . The present study examines the effect of an interactive computer-based information program on patients ' underst and ing of cardiac catheterization .  METHODS Adult patients scheduled to undergo diagnostic cardiac catheterization ( n = 135 ) were r and omized to receive details about the procedure using either st and ard institutional verbal and written information ( SI ) or interactive computerized information ( ICI ) preloaded on a laptop computer .  Underst and ing was measured using semistructured interviews at baseline ( ie , before information was given ) , immediately following cardiac catheterization ( early underst and ing ) , and 2 weeks after the procedure ( late underst and ing ) . The primary study outcome was the change from baseline to early underst and ing between groups . RESULTS Subjects r and omized to the ICI intervention had significantly greater improvement in underst and ing compared with those who received the SI ( net change , 0.81 ; 95 % confidence interval , 0.01 - 1.6 ) . Significantly more subjects in the ICI group had complete underst and ing of the risks of cardiac catheterization ( 53.6 % vs 23.1 % ) ( P = .001 ) and options for treatment ( 63.2 % vs 46.2 % ) ( P = .048 ) compared with the SI group . Several predictors of improved underst and ing were identified , including baseline knowledge ( P < .001 ) , younger age ( P = .002 ) , and use of the ICI ( P = .003 ) . CONCLUSIONS Results suggest that an interactive computer-based information program for cardiac catheterization may be more effective in improving patient underst and ing than conventional written consent information . This technology , therefore , holds promise as a means of presenting underst and able detailed information regarding a variety of medical treatments and procedures Background .Back surgery rates are rapidly rising in the United States . This surgery is usually elective , so patient preferences are important in the treatment decision . Objectives .The objective of this study was to determine the impact on outcomes and surgical choices of an interactive , diagnosis-specific videodisk program for informing patients about treatment choices . Research Design .This was a r and omized , controlled trial at 2 sites comparing the interactive video plus a booklet with the booklet alone . Subjects . Elective surgery c and i date s ( n = 393 ) included 171 patients with herniated disks , 110 with spinal stenosis , and 112 with other diagnoses . Measures .Mailed question naires were used to assess outcomes and satisfaction ; surgery rates were determined by question naires and automated records . Results .Symptom and functional outcomes at 3 months and 1 year were similar between study groups . The overall surgery rate was 22 % lower in the videodisk group ( 26 % versus 33 % , P = 0.08 ) . Among patients with herniated disks , those in the video group underwent significantly less surgery ( 32 % versus 47 % , P = 0.05 by Kaplan-Meier test ) . Among patients with spinal stenosis , surgery rates in the video group were higher ( 39 % for the video group , 29 % for the booklet group;P = 0.4 ) . There was little effect on patient satisfaction , but patients in the video group felt better informed . Conclusions .The program appears to facilitate decision making and may help to ensure informed consent . For patients with herniated disks , it reduced the surgery rate without diminishing patient outcomes . Its impact on costs of care depends on the proportion of patients with various diagnoses and on local surgery rates OBJECTIVES To test the null hypotheses that supplementation of verbal information with written information when obtaining consent to orthodontic treatment has no effect on ( 1 ) anxiety , motivation and apprehension related to treatment and ( 2 ) compliance in the early stages of fixed appliance therapy . MATERIAL S AND METHODS Seventy-six adolescents who were due to start fixed appliance therapy were r and omly allocated to receive verbal information only or verbal and written information before orthodontic treatment . Participants ' anxiety , motivation , and apprehension were assessed using a question naire that was completed prior to meeting the orthodontic clinician ( T1 ) , following consent to treatment ( T2 ) , and after 12 weeks of treatment ( T3 ) . Appointment attendance , appliance breakages , and periodontal scores were used as measures of patient compliance . RESULTS Sixty participants completed the study . At T2 there was no change in anxiety scores for either group ( P = .412 ) ; however , increased motivation was detected in the group that had been given both written and verbal information ( P = .049 ) . At T3 both groups demonstrated similar reductions in anxiety ( P = .311 ) and apprehension ( P = .790 ) and similar levels of motivation ( P = .756 ) . A reduction in periodontal scores ( P = .065 ) , better appointment attendance ( P = .732 ) , and fewer breakages ( P = .525 ) were reported in the group that was given additional information , although these changes were not statistically significant . CONCLUSIONS Supplementation of verbal information with written information result ed in improved motivation for orthodontic treatment but had no statistically significant effect on anxiety , apprehension , or patient compliance BACKGROUND Decision-making about mode of birth after a cesarean delivery presents challenges to women and their caregivers and requires a balance of risks and benefits according to individual circumstances . The study objective was to determine whether a decision-aid for women who have experienced previous cesarean birth facilitates informed decision-making about birth options during a subsequent pregnancy . METHOD A prospect i ve multicenter r and omized controlled trial of 227 pregnant women was conducted within 3 prenatal clinics and 3 private obstetric practice s in New South Wales , Australia . Women with 1 previous cesarean section and medically eligible for trial of vaginal birth were recruited at 12 to 18 weeks ' gestation ; 115 were r and omized to the intervention group and 112 to the control group . A decision-aid booklet describing risks and benefits of elective repeat cesarean section and trial of labor was given to intervention group women at 28 weeks ' gestation . Main outcome measures included level of knowledge , decisional conflict score , women 's preference for mode of birth , and recorded mode of birth . RESULTS Women who received the decision-aid demonstrated a significantly greater increase in mean knowledge scores than the control group ( increasing by 2.17 vs 0.42 points on a 15-point scale ) ( p < 0.001 , 95 % CI for difference = 1.15 - 2.35 ) . The intervention group demonstrated a reduction in decisional conflict score ( p < 0.05 ) . The decision-aid did not significantly affect the rate of uptake of trial of labor or elective repeat cesarean section . Preferences expressed at 36 weeks were not consistent with actual birth outcomes for many women . CONCLUSION A decision-aid for women facing choices about birth after cesarean section is effective in improving knowledge and reducing decisional conflict . However , little evidence suggested that this process led to an informed choice . Strategies are required to better equip organizations and practitioners to empower women so that they can translate informed preferences into practice . Further work needs to examine ways to enhance women 's power in decision-making within the doctor-patient relationship INTRODUCTION The rigorous implementation of clear preoperative information is m and atory for the patient 's underst and ing , acceptance and written informed consent to all diagnostic and surgical procedures . In the present study , I evaluated whether new media are suitable for conveying basic information to patients ; I analysed the merits of computerized animation to illustrate a difficult treatment process , i.e. , the progressive steps of a thyroid operation , in comparison to the use of conventional flyers . METHODS 3D animation software was employed to illustrate the basic anatomy of the thyroid and the larnyx ; the principle of thyroidectomy was explained by visualizing the surgical procedure step by step . Finally , the possible complications that may result from the intraoperative manipulations were also visually explained . Eighty patients entered a prospect i ve r and omisation : on the day before surgery , group 1 watched the computer animation , whereas group 2 was given the identical information in a written text (= st and ard flyer ) . The evaluation included a question naire with scores of 1 - 5 , rating the patients ' underst and ing , subjective and objective knowledge , emotional factors like anxiety and trust , and the willingness to undergo an operation . RESULT Underst and ing of and subjective knowledge about the surgical procedure and possible complications , the degree of trust in professional treatment , the reduction in anxiety and readiness for the operation were significantly better after watching the computer animation than after reading the text . However , active knowledge did not improve significantly . The interest in the preoperative information was high in both groups . The benefit of  computer animation  was enhanced in a second inquiry ; patients who had only read the text had a significant improvement in parameters after an additional exposure to the video animation . CONCLUSION Preoperative surgical information can be optimized by presenting the operative procedure via computer animation . Nowadays , several types of new media such as the world wide web , CD , DVD , and digital TV are readily available and --as shown here -- suitable for effective visual explanation . Most patients are familiar with acquiring new information by one of these means . An appropriately design ed 3D repre-sentation is met with a high level of acceptance , as the present study clearly shows . Modern patient-based information systems are necessary . They can no longer be the sole responsibility of the medical profession , but must be on the agenda of hospital managements and of medical care systems as well PURPOSE : A patient decision aid for the surgical treatment of early stage breast cancer was developed and evaluated . The rationale for its development was the knowledge that breast conserving therapy ( lumpectomy followed by breast radiation ) and mastectomy produce equivalent outcomes , and the current general agreement that the decision for the type of surgery should rest with the patient . METHODS : A decision aid was developed and evaluated in sequential pilot studies of 18 and 10 women with newly diagnosed breast cancer who were facing a decision for breast conserving therapy or mastectomy .  Both qualitative ( general reaction , self-reported anxiety , clarity , satisfaction ) and quantitative ( knowledge and decisional conflict ) measures were assessed . RESULTS : The decision aid consists of an audiotape and workbook and takes 36 min to complete . Based on qualitative comments and satisfaction ratings , 17 of 18 women reported a positive reaction to the decision aid , and all 18 reported that it helped clarify information given by the surgeon . Women did not report an increase in anxiety and 17 of 18 women were either satisfied or very satisfied with the decision aid . CONCLUSION : This pilot study supports the hypothesis that this decision aid may be a helpful adjunct in the decision for surgical management of early stage breast cancer . We are currently conducting a r and omized trial of the decision aid versus a simple educational pamphlet to evaluate its efficacy as measured by knowledge , decisional conflict , anxiety and post-decisional regret Objective : In this r and omized , controlled , unblinded trial , we sought to test Repeat Back 's ( RB ) effect on comprehension following informed consent discussion s. Summary Background Data : RB has been suggested as a method to improve patient comprehension when obtaining informed consent . In this technique , patients are asked to recount what they have been told in the informed consent discussion . Despite preliminary data , this practice has not been evaluated in any large scale study . Methods : This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent , the VA 's computer based platform . Patients scheduled for elective surgeries were r and omized to RB ( a module added to the iMedConsent package ) or st and ard iMedConsent ( no RB ) .  Comprehension was tested after the informed consent using procedure-specific question naires . Time stamps in the iMedConsent program estimated the time spent completing the informed consent process . Provider and patient satisfaction were measured using 5-point Likert scales . Statistical comparisons of groups were performed using t-tests and & khgr;2 tests . Results : A total of 575 patients were enrolled . In the RB group , providers spent 2.6 minutes longer ( P < 0.0001 ) obtaining informed consent . The mean comprehension score was significantly higher in the RB group ( 71.4 % ) versus the no RB group ( 68.2 % , P = 0.03 ) ; the effect was greatest in carotid endarterectomy patients ( RB = 73.4 % vs. no RB = 67.7 % , P = 0.02 ) . Quality of decision making was rated similarly . Providers were neutral to slightly favorable regarding RB . Conclusions : RB implemented within an electronic informed consent system improved patient comprehension . The additional time required was acceptable to providers . RB should be considered as an enhancement to surgical informed consent . This clinical trial was registered at http://www . clinical trials.gov ( Identifier NCT00288899 ) A decision aid for the surgical treatment of early breast cancer was evaluated in a r and omized controlled trial . The decision aid , a tape and workbook , includes explicit presentation of probabilities , photographs and graphics , and a values clarification exercise . Community surgeons were r and omized to use the decision aid or a control pamphlet .  Patients completed a question naire prior to using the decision aid , after review ing it but prior to surgery , and 6 months after enrollment . There was no difference in anxiety , knowledge , or decisional regret across the 2 groups . There was a nonsignificant trend toward lower decisional conflict in the decision aid group . A subgroup of women who were initially leaning toward mastectomy or were unsure had lower decisional conflict . Although the decision aid had minimal impact on the main study outcomes , a subgroup may have benefited . Such subgroups should be identified , and appropriate decision support interventions should be developed and evaluated Informed consent requires the communication of information about possible adverse effects of treatment . Health professionals have expressed concern that increased provision of risk information may make patients unduly anxious and change their decisions about treatment . This study compared two patient leaflets about laparoscopy , one containing detailed information about potential side effects . Forty one consenting participants attending an outpatient gynaecology clinic and scheduled for an elective laparoscopic procedure were studied . They were r and omly assigned to receive one of two leaflets after their consultation . Knowledge about laparoscopy , satisfaction with information provided , and anxiety were tested 2 days later , between the original consultation and their operation . Results showed that the leaflet containing detailed risk information was associated with greater knowledge about laparoscopy , higher satisfaction with information provision and no increase in anxiety . Provision of detailed information about possible adverse consequences of treatment can improve patients ' underst and ing and satisfaction without inducing increased anxiety PURPOSE : The aim of this study was to determine if recall of informed consent is affected by the timing of obtaining informed consent before endoscopic procedures . METHODS : Sixty patients scheduled for colonoscopy or esophagogastroduodenoscopy  were enrolled in this prospect i ve , r and omized study . Each patient received informed consent 24 to 72 hours or immediately before the procedure , and follow-up occurred one to three days postprocedure . RESULTS : There was no statistically significant difference in recall of informed consent or the individual elements of informed consent ( indication , risks , benefits , alternatives ) between the two groups . CONCLUSION : Recall of informed consent is similar whether consent is obtained immediately or several days before endoscopie procedures Purpose : To compare the effect of two different informed consent forms on patients ' anxiety level prior to intravenous contrast material ( IVCM ) injection . Material and Methods : Two different informed consent forms were r and omly given to 265 consecutive patients referred for either intravenous pyelography or computed tomography requiring IVCM injections . Form 1 had brief information , including only the common risks and risk factors associated with IVCM , while Form 2 had more comprehensive information . Before being presented with the two different informed consent forms , 191 of the 265 patients filled out two other forms evaluating : 1 : How they felt in that particular situation/moment ( STAI-T ) ; and 2 : How they felt independently of the situation or condition at that moment ( STAI-S ) . After the patients were informed , the STAI-T ( measuring how they felt in that particular situation ) was filled out once more to see if the anxiety level had changed . Results : The anxiety level for 88 patients receiving Form 1 decreased after they were given the informed consent ( P = 0.033 ) . However , among the 103 patients receiving Form 2 , the anxiety level showed a significant increase ( P = 0.001 ) compared to the values obtained before Form 2 was given . Conclusion : These results indicate that informed consent , including brief information about the risk factors and potential adverse reactions of IVCM , reduces anxiety level , while detailed information before the procedure increases the anxiety level OBJECTIVE To evaluate the effect of audiotaping outpatient consultations  on informed consent for cardiac surgery . DESIGN R and omized controlled trial . SETTING Tertiary health care center in Scotl and . PARTICIPANTS Eighty-four patients who had first-time coronary artery surgery conducted by 1 surgeon from February 10 , 2005 , through March 15 , 2006 , whose consultations before surgery were audiotaped . INTERVENTION R and omization to 3 trial arms . The control group ( n = 29 ) received no tape . The generic group ( n = 25 ) received a tape about coronary artery surgery , which we scripted to include information covering the domains described by the General Medical Council . The consultation group ( n = 30 ) received a tape of their consultation interview . On admission to the hospital , patients were interviewed with the Knowledge Question naire , the Multidimensional Health Locus of Control , and the Hospital Anxiety and Depression Scale . MAIN OUTCOME MEASURES The effect of audiotaping in improving the informed consent process for cardiac surgery . RESULTS The mean knowledge score of patients in the consultation group was much higher than that of the control individuals ( P < .001 ) . Patients in the consultation group reported a significantly greater sense of control with regard to their own health ( P < .001 ) and being less anxious and depressed overall . CONCLUSION Providing an audiotaped recording of the consultation before cardiac surgery appears to improve patients ' knowledge and perceptions of control of their health status and to reduce anxiety and depression . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N20081026 BACKGROUND Obtaining informed consent before performing invasive procedures and operations has become a st and ard practice at all medical institutions in the United States . All agree that patients should be both conscious of and in agreement with their medical care . Though patients routinely sign consent forms with numerous risks and complications detailed , there are only a limited amount of reports that study if these patients have a thorough underst and ing of those risks and complications . Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English . To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy  understood the complications associated with this procedure . METHODS We conducted a r and omized prospect i ve study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy . Fifty patients agreed to participate in our study . Participants were split into two groups . In the first group ( the control group ) surgical benefits , risks and complications were explained in the usual fashion . In the second group , after hearing the st and ard explanation of surgical risks , complications and benefits , patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy . Patients from both groups then took a ten question assessment based on the presentations that they encountered . Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment . The patients ' age , education level , income , and birth country were also studied . RESULTS Fifty-two percent of the patients in the study were born outside of the United States . All of the non-US born patients were Hispanic and their primary language was Spanish . The average age of the studied patients was 38 . Sixty-eight percent of the patients reported an education level no higher than high school . The majority of the studied patients noted an  income of less than $ 40,000 . Differences were seen between patient native to the US and those born outside the United States . US born patients had an 80 % correct response rate versus non-US born patients who had only a 63 % correct response . Differences were seen between US born patient and non-US born patients concerning the topics of the severity of a common bile duct injury , gastrointestinal changes after cholecystectomy and the safety concerning conversion from laparoscopic to open cholecystectomy . No difference was appreciated in the PowerPoint group versus the non-PowerPoint group . CONCLUSION The addition of a PowerPoint presentation did not increase underst and ing of the risks and benefits associated with a laparoscopic cholecystectomy . This study did however highlight the problem of obtaining consent from foreign born patients . Patients who were not US natives showed a decreased underst and ing of the surgical procedure and the severity of the complications in both the control group and the PowerPoint group . Better methods of educating foreign patients should be investigated to truly obtain informed consents from this patient population OBJECTIVE To determine if preoperative patient verbalization of the risks and benefits of  anterior cruciate ligament ( ACL ) reconstruction  enhances underst and ing of the risks and benefits of that procedure . DESIGN A r and omized clinical trial . SETTING A referral-based outpatient sport medicine clinic . SUBJECTS Twenty patients from the general population with clinical ly diagnosed ACL tears requiring elective reconstruction surgery were r and omly assigned to 2 groups . Twelve patients who made up a control group received a st and ard surgical consultation , consisting of knee models , diagrams , open dialogue and informed consent to surgery . Eight patients in the experimental group were exposed to the same surgical consultation and were required to accurately verbalize the associated risks and benefits before operation . One month after informed consent was obtained , patients answered 3 questions about the risks and benefits of ACL reconstruction . INTERVENTION ACL reconstruction . MAIN OUTCOME MEASURES A 3- question question naire , addressing 2 risks and 1 benefit of ACL reconstruction . MAIN RESULTS Patients in the experimental group were able to answer all 3 questions correctly . In the control group , 4 patients answered all 3 questions correctly , but 1 patient answered all 3 questions incorrectly , and 7 patients answered 1 question incorrectly . There was a statistically significant difference ( p = 0.03 ) between the control group and the experimental group . CONCLUSION Patients who verbalized the risks and benefits during their surgical consultation demonstrated a significantly greater underst and ing of the risks and benefits of an ACL reconstruction procedure A r and omised trial was carried out to assess the effect of a  Down syndrome screening video on test uptake , knowledge and psychological stress .  A total of 2000 women referred for antenatal care were allocated to two equal groups : one to be sent a video to their home , before their hospital booking visit , and a control group . All women also received screening information in the form of a leaflet before booking and from a midwife at booking . The video had no effect on the screening uptake rate : 638/993 ( 64.2 % ) and 652/1007 ( 64.7 % ) in the video and control groups , respectively . Women were requested to return the video for reuse in other pregnancies and 612 ( 62 % ) did so . A subset of 1200 women were selected to be posted at 17 - 19 weeks ' gestation a self-completed question naire to assess the psychological endpoints . Knowledge of screening was increased in the video group with a mean score of 7.3 compared with 6.7 in the controls , a statistically significant difference ( t=3.24 , p=0.0005 ) . There were no significant differences between the groups in specific worries about abnormalities in the baby , and general anxiety . We conclude that a video can increase knowledge without affecting the uptake of the test , or psychological stress BACKGROUND Informed consent is a basic st and ard of care for all patients undergoing medical procedures , but recall of information has been shown to be poor . We sought to compare verbal , written and animated audiovisual information delivery , during consent for coronary angiography , by measuring improvement in recall . METHOD A sample population of 99 cardiac patients at Flinders Medical Centre was r and omised ( 1:1:1 ) to receive one of three information delivery methods . The information content was st and ardised by a risk proforma , which explained the procedure and defined 12 specific risks . Recall , satisfaction and anxiety were assessed by a question naire administered at three different time points : post-consent , post-procedure and at 30 days . Effect of delivery method on satisfaction and anxiety was rated on a self-reported scale from 1 - 5 , with 5 representing very satisfied or very anxious . Groups were compared by non-parametric testing and a p-value of < 0.05 was considered statistically significant . RESULTS Patients were a median age of 64 ( i.q.r . 56 , 72 ) years . Information delivery method had no effect on recall of risks at any time-point ( p=0.2 , 0.7 , 0.5 , respectively ) and the average recall score across the population was 3 - 4 out of 12 . There was no significant effect on median satisfaction scores : verbal ; 5 ( i.q.r.4 , 5 ) versus written/audiovisual ; 4 ( i.q.r.4 , 5 ) ( p = ns ) , or on median anxiety scores : verbal ; 3 ( i.q.r.2 , 4 ) versus written/audiovisual ; 3 ( i.q.r.2 , 4 ) ( p = ns ) . CONCLUSION Despite careful design of an innovative audiovisual delivery technique aim ed at optimising comprehension and aiding memory , recall of information was poor and informational aids showed no improvement . Modes of information delivery are not the key to patient assimilation of complex medical information UNLABELLED Information about procedure and risks is prerequisite for obtaining informed consent for endoscopy . This prospect i ve and r and omized investigation evaluated ( i ) the extent of patients ' information needs and ( ii ) the formal quality ( language , ease of underst and ing , length , figures etc . ) of three information forms concerning upper CI-endoscopy issued in 1995 by DIOmed ( 1 ) , perimed compliance ( 2 ) , and PERIMED-spitta ( 3 ) as judged by the patients . ( iii ) Outcome quality was investigated as the influence of these forms on underst and ing why and how endoscopy was performed as well as the influence on feeling threatened . Furthermore patients ' anxiety was assessed by using Spielberger 's state-trait anxiety inventory ( STAI ) .  218 patients completed the investigation ( n = 73 ; 70 ; 75 , respectively ) . 60 % cl aim ed the need for a detailed explanation of the planned endoscopy and 48 % said they wanted exhaustive informations about potential complications and risks . The three forms ( length 819 , 771 , 1,245 words ) were entirely read by 87 % , 89 % and 82 % of the patients . Positive language , adequate length ( 69 % , 69 % , 71 % ) and adequate layout were evenly attributed to the three forms . A high impact of the figures for underst and ing was found more frequently ( 48 % , 46 % , 35 % ) with ( 1 ) and ( 2 ) and language war regarded easy by 57 % , 54 % and 44 % , respectively . Flesh 's reading ease score , however , proved a sophisticated niveau of language with all three forms . The indication for endoscopy ( 37 % , 49 % , 56 % ) and explanation of performance ( 43 % , 43 % , 63 % ) was superior with ( 3 ) . This form also reduced anxiety as judged by STAI-means , overall STAI-changes , and relevant changes ( > or = 5 points ) . Form ( 2 ) increased patients ' anxiety . CONCLUSION While the formal quality of all information forms is appreciated by patients both their reading ease score and figures should be improved . A significant reduction of anxiety can be achieved by appropriate selection of the information material PURPOSE To evaluate interactive computer-based informed consent  for use of contrast material versus the same information in a written format . MATERIAL S AND METHODS Patients ( n = 160 ) referred for radiologic examination with intravenous contrast material were block r and omized ( sex , age , and previous exposure to contrast material ) into two groups and were provided either written or computer-based ( video ) informed consent . RESULTS The female patients in the video group scored better on the test than those in the group with the written consent form . Male patients attained equivalent scores with both types of consent . The video took an average of 1.6 minutes longer to complete , probably because the majority of patients chose to be informed of every risk of intravenous contrast material . CONCLUSION This project demonstrates that a video format for informed consent before use of intravenous contrast material offers a good alternative to the written consent form OBJECTIVE To investigate parent underst and ing of the risks of pediatric ear , nose , and throat surgery after counseling with and without the use of informational aids . DESIGN Prospect i ve , r and omized trial . SETTING Academic tertiary care center . PARTICIPANTS Parents of children undergoing ear , nose , and throat surgery . INTERVENTIONS  Parents  were  r and omized  to receive st and ard informed consent with or without detailed informational aids . MAIN OUTCOME MEASURES Parents completed identical question naires testing their general procedure knowledge and their recall of 9 specific surgical risks both immediately after counseling and on the day of surgery . RESULTS Thirty-four parents enrolled in and completed the study ( 18 in the control group and 16 in the test group ) . The mean time from informed consent to surgery was 6.3 days ( range , 1 - 22 days ) . Parents in the test group scored significantly higher on identifying the 9 risks on both the preoperative question naire ( mean score , 6.00 vs 4.44 ; P = .007 , 2-tailed t test ) and the postoperative question naire ( 6.25 vs 4.17 ; P < .001 ) . There was a negative correlation ( inverse relationship ) between parent education score and risk recall , with parents with lower education levels scoring higher on both the preoperative ( Pearson r = -0.36 ; P = .04 ) and the postoperative ( r = -0.35 ; P = .04 ) surveys . The maternal parent recalled risks significantly better than the paternal parent , with surgical risk recall scores of 5.46 out of 9 vs 3.67 out of 9 ( P = .02 , 2-tailed t test ) . CONCLUSIONS Parents of children undergoing ear , nose , and throat surgery recall far less than 100 % of counseled risks . The use of detailed surgical risk counseling improves measured parental underst and ing of surgical risk . Parental educational level and maternal vs paternal parent may affect risk counseling recall OBJECTIVE To ascertain whether a written information sheet is acceptable to patients and improves recall of the consent interview . DESIGN Prospect i ve r and omised controlled study using question naires , comparing a group of patients given information in a written sheet with appropriate explanation to a group given verbal information alone . SETTING A specialist orthopaedic surgery unit . PATIENTS The test group was 126 patients undergoing revision or primary total hip arthroplasty ; 65 patients were given information verbally , 61 patients were given written information .  OUTCOME MEASURE Patients ' recall of information given , tested with a question naire completed on admission ( mean of 18 days later ) . RESULTS The patients receiving written information scored significantly higher ( 48 % correct answers ) than the patients receiving verbal information ( 38 % correct answers ) . CONCLUSIONS Written information sheets contribute to the process of informed consent . As patients ' recall of information is generally poor , the sheets may also be useful medicolegally , as a permanent record of what was discussed Background : The purpose of our study was to evaluate the effectiveness of using a videotape to give patients information about the risks , benefits , alternatives , and treatment of a common orthopaedic procedure before they sign consent forms . Methods : During a 9-month period , 48 patients with isolated closed ankle fractures requiring surgical intervention were r and omized into two groups that received either videotaped or conventional verbal information regarding consent for surgery . The study group watched a videotape containing information about the risks , benefits , and treatment alternatives , while the control group obtained this information verbally . To determine comprehension and retention , all patients completed a multiple-choice question naire immediately after receiving the information , and 37 patients ( 77 % ) were available to complete a question naire at an average of 10 weeks later . Results : The videotape group outperformed the verbal consent group by 40.1 % on the initial question naire ( p = .0002 ) and by 27.2 % on the followup question naire ( p = 0.0139 ) . Patients with educational levels of less than or equal to the 12th grade performed 67.8 % better on the initial question naire after watching the video than after receiving the information verbally . ( p = .0001 ) . Conclusion : Patients who received information about their surgery on a videotape before giving their consent demonstrated a significant increase in comprehension compared to patients who received this information verbally . The benefit was even greater for patients with lower education levels OBJECTIVE : To estimate whether the Medicaid-Title XIX Sterilization Consent Form ( SCF ) format—“st and ard ” compared with “ low-literacy”—is associated with women 's underst and ing of tubal sterilization . METHODS : This study was a r and omized trial that took place in an obstetrics and gynecology residency clinic in the southeastern United States . Women , aged 21 to 45 years , were r and omly allocated to receive a copy of either the st and ard or the low-literacy Medicaid-Title XIX SCF . A research assistant assessed women 's sociodemographic characteristics , health-literacy skills , and underst and ing of sterilization using items from the Postpartum Tubal Sterilization Knowledge question naire . Women were also queried regarding their preferences for either version of the Medicaid-Title XIX SCF . RESULTS : We included 201 women in the study . Compared with women in the st and ard group ( n=99 ) , women in the low-literacy group ( n=102 ) with no additional counseling better understood the length of time required between signing the form and undergoing sterilization ( 23.6 % difference between groups , P<.01 ) , the time interval until the form expired ( 33.7 % difference between groups , P<.01 ) , permanence of sterilization ( 15.7 % difference between groups , P=.01 ) , and that nonpermanent contraceptive options as effective as sterilization are available ( 8.2 % difference between groups , P=.02 ) . When given the choice to select either Medicaid-Title XIX SCF , 189 ( 94 % ) preferred the low-literacy version . CONCLUSION : Our results support replacing the st and ard Medicaid-Title XIX SCF with the low-literacy version to foster increased underst and ing of sterilization . LEVEL OF EVIDENCE : 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 ' underst and ing of the risks and benefits of TURP after the consenting process with either conventional documentation or PSCF . PATIENTS AND METHODS One hundred patients were r and omised to be consented with either a conventional or PSCF .  After 3 h , their underst and ing was assessed with a question naire 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 r and omised to each group . There was no significant difference in mean age , grade of doctor obtaining consent or time interval from consent to question naire . 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 retro grade 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 OBJECTIVE --To examine the factors influencing quality of informed consent .  DESIGN -- Prospect i ve study comprising interviews with patients and patients ' completing st and ard question naires . SETTING --Academic surgical unit of large teaching hospital . PATIENTS --265 patients undergoing intrathoracic , intraperitoneal , and vascular surgical procedures .  Of these patients , 192 have been followed up for six months . MAIN OUTCOME MEASURES -- Patients ' recall of information at various points in the study ; this score was compared by age , provision of written information , cognitive function , intelligence quotient ( IQ ) , mood state and personality traits , and health locus of control . RESULTS --The patients were best informed immediately after signing the consent form and from then on recall of information deteriorated . A total of 172/250 ( 69 % ) patients admitted to not reading the consent form before signing it . Old age adversely affected recall of information at all assessment points . Impaired cognitive function reduced information recall only during the stay in hospital . Patients with above average IQs h and led information better than those with a lower IQ except immediately after the signing of consent forms . Patients with an internal locus of health control ( that is , those who believed their health to be in their own control ) were better informed than those with an external locus of health control . Operation information cards improved recall only on the day of discharge . CONCLUSION --Elderly patients and patients with below average IQ , impaired cognitive functions , and an external locus of control have poor information recall . Written information may be more useful if given before admission to hospital Purpose : To determine the number of risks a patient can recall from the informed consent process prior to surgery and if recall can be improved with a visual aid and to assess patient satisfaction with the informed consent process utilized . Methods : R and omly selected patients , from all patients requiring forefoot surgery , were r and omly assigned into two groups from August 2001 through October 2001 . All patients were asked to recall the risks of surgery and to rate their satisfaction with the informed consent process  at their final routine postoperative visit . Results : There were 19 patients in each group . All patients uniformly expressed their satisfaction with the preoperative informed consent discussion at their final visit . The mean number of the 11 risks recalled per patient was 1.0 for group A ( range , 0–3 ) and 0.94 for group B ( range , 0–4 ) . Conclusion : At the final routine postoperative visit , patients in both groups had poor or no recall of the risks of surgery . The visual aid had no effect on improving recall Patient response to interactive videodisc preparation for third molar extraction surgery was examined as a function of self-reported information-seeking style . Amount learned was compared among patients informed via an interactive videodisc , noninteractive videotape of the same material , or surgeon only .  Anxiety levels and satisfaction with preparation were compared between the videodisc and videotape groups . At consultation , patients ( n = 35 ) were r and omly assigned to either the disc- or the tape-viewing group . First , subjects completed a demographic survey , state anxiety scale , quiz on knowledge about third molars and surgery risks and complications , and information-seeking scales . Immediately after viewing the video , subjects completed another anxiety scale and a multiple-choice quiz covering the material presented . Subsequently , another 25 patients undergoing the routine ( surgeon-only ) consultation procedure were given the same multiple-choice quiz following consultation . Quiz scores differed significantly among the groups ; mean percent correct for the tape-viewing subjects was 85 ; for disc-viewing subjects 72.6 ; for surgeon-only subjects , 40 . Self-rated information seeking was unrelated to amount of video viewed by disc subjects ( on average , 64 % of the videodisc was viewed ) , and disc subjects who rated themselves higher in information-seeking achieved the lowest postpreparation quiz scores . Subjects in the disc group were significantly more satisfied with the amount of preparation than the tape group . Although disc group subjects were significantly less knowledgeable following consultation than were tape group subjects , interactive videodisc preparation for third molar extraction appears to have some advantages over more traditional approaches . Further research is needed to determine whether this approach to preparing patients is suitable for widespread clinical use The authors investigated the effect of giving written material on information recall from informed consent counselling for cataract surgery . Fifty English-speaking patients who underwent non-urgent cataract extraction at Flinders Medical Centre , South Australia , were prospect ively enrolled .  Systematic counselling for cataract surgery was provided , with a written copy of the content given to a r and omly selected group of patients ( n = 24 ) . All subjects completed a question naire after counselling and again at two weeks after surgery to test their satisfaction with , and recall of , information provided . Patients were found to be satisfied with the amount of information they received and most were able to recall details about the cataract surgery procedure . However , many could not recall success rates or complication rates and only a minority could list any complication . The provision of written information did not significantly alter recall ( p>0.05 ) . Recall was significantly better immediately after counselling than two weeks after surgery ( p<0.05 ) . Younger patients also had significantly better recall ( p<0.05 ) . Patients were happy with the information they had been given but did not remember enough from the informed consent process to satisfy legal requirements BACKGROUND Recent judicial decisions involving informed consent have led to some medical practitioners altering the way they obtain consent . The aim of this study was to determine the degree to which patients understood the risks associated with a surgical procedure after giving routine consent and whether providing additional detailed verbal and /or written information improved their underst and ing . It was further determined whether the provision of more extensive information altered patients ' anxiety levels . METHODS Patients undergoing femoral popliteal bypass or carotid surgery were r and omized to obtain either routine consent only or routine consent with verbal or written or verbal and written consent . Patients undertook a pre-operative risk and complication question naire , a pre- and postoperative anxiety and depression evaluation and a follow-up question naire 6 weeks after discharge . RESULTS Thirty-two patients were included in the trial . The comprehension question naire result ed in a correct percentage response of 48 % for the routine information only , 59 % with added verbal information , 59 % with added written information and 55 % with added written and verbal information . Twenty-five per cent of patients stated that they had a poor underst and ing of the risks and complications of the procedure . CONCLUSIONS Additional written or verbal information did not improve a patient 's underst and ing of risks and complications of the procedure . It also did not improve patients ' perceived underst and ing of the operation or its complications . Patients ' anxiety levels were unaltered by the increase in the information they were given . The information provided to patients should be simple , easy to underst and and list any possible major complications to enable the patient to determine whether to undergo or decline a procedure OBJECTIVE This r and omized controlled trial aim ed to determine whether an interactive CD-ROM improved cancer patients ' recall of chemotherapy treatment information over st and ard written information , and whether demographic , cognitive , and psychological factors better predicted recall than this format of delivery . METHODS One-hundred- and -one new patients about to commence chemotherapy were r and omized to receive written information or a CD-ROM containing treatment information before giving informed consent . Patients ' recall , concentration , short-term memory , reading comprehension , anxiety , depression , and coping styles were assessed with st and ardized measures pre-treatment . Seventy-seven patients completed tests for recall of treatment information before their second chemotherapy session . RESULTS Intention-to-treat analyses indicated no significant differences between the written information and CD-ROM groups across recall questions about number of drugs received ( p=.43 ) , treatment length ( p=.23 ) , and treatment goal ( p=.69 ) . Binary logistic regressions indicated that for groups combined different variables predicted each of the recall questions . CONCLUSION An interactive CD-ROM did not improve cancer patients '  recall of treatment information enough to warrant changes in consent procedures . PRACTICE IMPLICATION S Different variables predicted recall of different treatment aspects highlighting the complex nature of attempting to improve patient recall . Attending to the effect of depression on patient knowledge and underst and ing appears paramount Objective : The term “ informed consent ” explains the process by which a patient , before treatment , is provided comprehensive and impartial information regarding a planned operative procedure so that he/she underst and s the implication s of the procedure before consenting . The goal of the current study was to investigate whether st and ard methods of consenting can be improved using a multimedia-based information program ( MM-IP ) . Patients and Methods : In a prospect i ve multicenter study , 80 patients undergoing laparoscopic cholecystectomy went through the st and ard informed consent process . One group of patients was also given access to a MM-IP . Question naires were completed before surgery . These evaluated how patients perceived their own underst and ing of important aspects of their illness ( ie , disease , therapeutic alternatives , operation , risks ) and satisfaction with the consenting process . Patients ’ anxiety levels were also assessed . These question naires were used to evaluate the effectiveness of the MM-IP for improving the consent process . Results : Seventy-six patients ( 47 women , 29 men , median age 54 years ) were included . There was no significant age or gender variation between the groups ( st and ard n = 41 and MM-IP n = 35 ) . Eighty-two percent of all respondents were satisfied with the st and ard informed consent process . However , perceived underst and ing of the material was significantly improved in the MM-IP group ( P < 0.001 ) . Patients with less formal education profited particularly from the MM-IP .  Preoperative anxiety did not vary between the groups . Conclusion : Use of the multimedia-based program was positively evaluated by patients , and significantly improved patients ’ perceived underst and ing of their disease and its treatment . It is , therefore , valuable in the informed consent process Patients want to know more about their condition and its proposed treatment . Gaining patients ' confidence before treatment reduces the changes of their seeking legal redress for an unexpected outcome . As part of a prospect i ve study of informed consent for surgery we have assessed the attitudes of patients towards informed consent  when different types of consent interview are used . We found that most patients are happy to do as their doctor advises but think the informal consent interview is important because it gives them information ; they also want to know about most , but not all , complications of the procedure . One quarter worried about the anaesthetic , about one eighth worried about ' not waking up ' and similar proportions worried about complications and other things such as pain and nausea . Most patients think that the consent form is a legal document . In addition patients who had an informal interview felt obliged to sign the consent form and thought it had medicolegal implication s. In contrast those who had a structured interview felt less obliged to sign the consent form and more involved in the decision to operate Biopsy of the liver is an important diagnostic procedure . The procedure is invasive and may be painful for patients . Sedative drugs are not used because the associated drop in blood pressure mimics hemorrhage , a major complication of the procedure . Cognitive and behavioural techniques have been used to decrease stress in patients undergoing other medical procedures . In the present study , it is postulated that providing procedural and sensory information may reduce patient anxiety levels . Patient coping styles were evaluated and anxiety and pain levels were assessed by using a visual analogue scale .  Subjects were r and omly assigned to one of two groups . The control group received basic information about the procedure . The experimental group received the same basic information followed by more detailed educational information . Subjects also filled out the Krantz Health Opinion Survey  , a short question naire used to classify coping styles as either information-seeking or information-avoiding . Seventy-five subjects ( 38 control and 37 experimental ) with similar demographics were included in the present study . No significant differences were found in anxiety levels or pain levels 30 min and 6 h post-biopsy . There was also no significant difference between groups once coping style was added into the analysis . The study failed to show any advantage in providing additional information to subjects before liver biopsy , regardless of coping style STUDY OBJECTIVE This study determined whether Spanish and English educational videos are superior to routine discussion for informing emergency department ( ED ) patients about risks , benefits , and alternatives to receiving intravenous contrast for computed tomography ( CT ) . METHODS A prospect i ve r and omized controlled trial was performed on a convenience sample of adult ED patients scheduled to receive intravenous contrast for CT . Patients r and omized to the intervention group watched a video in Spanish or English explaining the procedure and its risks , benefits , and alternatives . The control group underwent routine discussion , receiving intravenous contrast information from their emergency physician . After their educational sessions , all participants completed a 10- question intravenous contrast knowledge measure and 1 question rating satisfaction with the informed consent process . Mean scores were compared to assess whether the videos were superior to routine discussion for educating patients about intravenous contrast . Secondary outcomes included the proportion of satisfied patients and refusals to sign consent . RESULTS Of the 112 patients enrolled , 56 were r and omized to the video group and 56 to routine discussion . Five patients withdrew from the study , leaving 107 for analysis ( video N=53 ; control N=54 ) . Mean knowledge scores were higher in the video group ( 68.1 % ) compared to routine discussion ( 47.8 % ) ( 95 % confidence interval [ CI ] for the difference 12.6 % to 28.1 % ) . Video-group patients exhibited greater satisfaction than routine- discussion patients ( 86.8 % [ 95 % CI 74.6 % to 94.5 % ] versus 77.4 % [ 95 % CI 63.8 % to 87.7 % ] ) . All patients signed consent to receive intravenous contrast . CONCLUSION Using Spanish and English educational videos yielded higher intravenous contrast knowledge scores compared with routine informed consent procedures OBJECTIVE Following consent , do pictures in a h and out improve  patients ' recall of otologic surgical risks ? STUDY DESIGN Prospect i ve , r and omized trial in a tertiary care centre . METHODS Patients undergoing otologic surgery were consented with a st and ardized checklist of risks by two surgeons . They were r and omized ( stratified by educational level ) to receive either a pure text or a text and pictures h and out outlining the risks of surgery . A telephone interview tested recall at a mean of 19 days . Twenty-six patients were re sample d at 1 year . MAIN OUTCOME MEASURES Recall was analyzed with respect to type of h and out , age , sex , and level of education . A subset of 31 patients was analyzed for the effects of which surgeon consented , previous otologic surgery , and actually reading the h and out . RESULTS Fifty-one patients completed the study . The overall risk recall was 43 % , with 45 % in the pictorial group and 42 % in the pure text group ( p = .84 ) . The illustrated h and out did not improve the recall of any individual surgical risk either . Higher education improved risk recall from 36 to 54 % ( p = .009 ) . Age , consenting surgeon , previous otologic surgery , and even reading the h and out did not improve risk recall . A subgroup of 26 patients was followed up 1 year later , and their recall fell from 41 to 35 % . The illustrated h and out did not improve long-term recall ( p = .674 ) . CONCLUSION Pictorial cues do not improve recall of surgical risks , but education level does BACKGROUND AND PURPOSE To evaluate the effects of an evidence -based patient decision aid ( DA ) on  multiple sclerosis ( MS ) immunotherapy . METHODS Two hundred and ninety-seven MS patients who were considering or reconsidering immunotherapy participated in a r and omized community-based controlled trial in Germany . An intervention group ( IG ) received the DA and a control group ( CG ) received st and ard information . Primary outcome measure was the match between the patient 's preferred and actual roles during consultation with the physician . Secondary end-point was treatment choice . The course of the decision-making process and patients ; evaluation of the decision were also evaluated . Data were collected at baseline , after receiving the information , after consultation with the physician and 6 months after baseline . RESULTS The percentage of preference matches did not differ between groups ( IG 49 % , CG 51 % , P = 0.71 ) . There were no differences in immunotherapy choices between groups . IG patients temporarily became more critical of immunotherapy and rated the information as significantly more helpful . CONCLUSIONS Although the intervention led to intensified processing of the information it affected neither the roles adopted in physician-patient encounters nor the immunotherapy choices made . Providing patients with balanced information may not be sufficient to alter the decision-making process Research on surgical interventions is associated with several method ological and practical challenges of which few , if any , apply only to surgery . However ,  surgical evaluation  is especially dem and ing because many of these challenges coincide . In this report , the second of three on surgical innovation and evaluation , we discuss obstacles related to the study design of r and omised controlled trials and non-r and omised studies assessing surgical interventions . We also describe the issues related to the nature of surgical procedures -for example , their complexity , surgeon-related factors , and the range of outcomes . Although difficult , surgical evaluation is achievable and necessary . Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential Background : An interactive digital education aid for breast reconstruction patients was developed because of a perceived need to provide patients with more education regarding the treatment so that they can make better informed treatment decisions . A prospect i ve r and omized study was conducted to assess its effectiveness . Methods : Breast cancer patients who were c and i date s for breast reconstruction were recruited and r and omized into a control group and a study group . Both groups received routine assessment and education in the plastic surgery clinic , but the study group also watched the interactive digital education aid .  Question naires assessing knowledge , anxiety , and satisfaction were administered ( 1 ) before the initial plastic surgery consultation , ( 2 ) immediately before surgery , and ( 3 ) 1 month after surgery . Results : A total of 133 women participated , 66 in the control group and 67 in the study group . Women in both groups showed decreased anxiety , increased knowledge , and enhanced satisfaction with their decision-making ability associated with preoperative instructions about reconstructive surgery . However , the study group was significantly more satisfied than the control group with the method of receiving information and showed a less steep learning curve regarding the different techniques of breast reconstruction . They also tended to have a reduced mean level of anxiety and increased satisfaction with the treatment choice compared with the control group . Conclusions : An interactive digital education aid is a beneficial educational adjunct for patients contemplating breast reconstruction . Patients who use an interactive digital education aid demonstrate greater factual knowledge , reduced anxiety , and increased postoperative satisfaction compared with patients given preoperative instructions using st and ard methods alone . The benefit of an interactive digital education aid is expected to be higher in a broad-based practice setting outside of a comprehensive cancer center Aim . This study determined the usefulness of an interactive , individualized online patient pathway to patients undergoing elective operation for nonmalignant disease . Methods . An exploratory double-blind , prospect i ve r and omized controlled trial was established involving consecutive patients undergoing minimally invasive radioguided parathyroidectomy ( MIRP ) .  A total of 64 patients were r and omly assigned to either a st and ard or an enhanced Web site ( interactive with detailed , personalized timeline ) . Each patient completed vali date d Hospital Anxiety and Depression Scale question naires preoperatively and pain assessment s and question naires concerning Web site usefulness postoperatively . Results . All patients found their Web site useful , although patient satisfaction was significantly higher with the enhanced Web site in regard to overall impression as well as ease , organization , usefulness , and specificity of information . There were no significant differences in mean anxiety or pain scores , in analgesia requirements , or adequacy of informed consent . Conclusion . Providing education and information through a tailored Web server is viewed positively by patients
target: We have identified efforts by research ers to investigate interventions which seek to improve information delivery and consideration of information to enhance  informed consent .
  The interventions used consistently improve patient knowledge , an important prerequisite for informed consent .
  This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable .
  Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions .
background: BACKGROUND Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken .
  However , it is a complex process which requires patients be provided with information which they can underst and and retain , opportunity to consider their options , and to be able to express their opinions and ask questions .
  There is evidence that at present some patients undergo procedures without informed consent being achieved .
  OBJECTIVES To assess the effects on patients , clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures .
  AUTHORS ' CONCLUSIONS Informed consent is an important ethical and practical part of patient care .