Background
Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process.

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A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions

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 understand 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.

Search methods.
We searched the following databases using keywords and medical subject headings: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 5, 2012), MEDLINE (OvidSP) (1950 to July 2011), EMBASE (OvidSP) (1980 to July 2011) and PsycINFO (OvidSP) (1806 to July 2011). We applied no language or date restrictions within the search. We also searched reference lists of included studies.

Selection criteria.
Randomised controlled trials and cluster randomised trials of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. We considered an intervention to be intended to promote informed consent when information delivery about the procedure was enhanced (either by providing more information or through, for example, using new written materials), or if more opportunity to consider or deliberate on the information was provided.

Data collection and analysis.
Two authors assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of outcomes where there were sufficient data.

Main results.
We included 65 randomised controlled trials from 12 countries involving patients undergoing a variety of procedures in hospitals. Nine thousand and twenty one patients were randomised and entered into these studies. Interventions used various designs and formats but the main data for results were from studies using written materials, audio-visual materials and decision aids. Some interventions were delivered before admission to hospital for the procedure while others were delivered on admission.

Only one study attempted to measure the primary outcome, which was informed consent as a unified concept, but this study was at high risk of bias. More commonly, studies measured secondary outcomes which were individual components of informed consent such as knowledge, anxiety, and satisfaction with the consent process. Important but less commonly-measured outcomes were deliberation, decisional conflict, uptake of procedures and length of consultation.

Meta-analyses showed statistically-significant improvements in knowledge when measured immediately after interventions (SMD 0.53 (95% CI 0.37 to 0.69) I2 73%), shortly afterwards (between 24 hours and 14 days) (SMD 0.68 (95% CI 0.42 to 0.93) I2 85%) and at a later date (15 days or more) (SMD 0.78 (95% CI 0.50 to 1.06) I2 82%). Satisfaction with decision making was also increased (SMD 2.25 (95% CI 1.36 to 3.15) I2 99%) and decisional conflict was reduced (SMD -1.80 (95% CI -3.46 to -0.14) I2 99%). No statistically-significant differences were found for generalised anxiety (SMD -0.11 (95% CI -0.35 to 0.13) I2 82%), anxiety with the consent process (SMD 0.01 (95% CI -0.21 to 0.23) I2 70%) and satisfaction with the consent process (SMD 0.12 (95% CI -0.09 to 0.32) I2 76%). Consultation length was increased in those studies with continuous data (mean increase 1.66 minutes (95% CI 0.82 to 2.50) I2 0%) and in the one study with non-parametric data (control 8.0 minutes versus intervention 11.9 minutes, interquartile range (IQR) of 4 to 11.9 and 7.2 to 15.0 respectively). There were limited data for other outcomes.

In general, sensitivity analyses removing studies at high risk of bias made little difference to the overall results. 

Authors' conclusions.
Informed consent is an important ethical and practical part of patient care. We have identified efforts by researchers 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. Only one study attempted to measure informed consent as a unified concept.

Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures

Several major diseases, such as cancer and cardiovascular abnormalities, may be linked to pathological deposition of minerals or organic compounds in various tissues. Thus, the detection of such minerals or compounds and understanding the physicochemical processes associated with their formation are essential. As underlined by Schmidt et al., in Europe and the U.S., breast cancer will occur in 1 in 10 women. If clustered calcifications are one of the mammographic signs of early breast cancer, their chemical nature must be determined. More precisely, calcium phosphates (CaPs) are frequently associated with malignancy, but calcium oxalates are present in benign lesions. From a medical viewpoint, pathological calcifications refer to at least three very different families of biominerals: concretions, metastatic calcifications and dystrophic calcifications. Concretions are found in hollow organs or ducts of the body. For example, kidney stones are solid concretions of dissolved minerals in urine found in the kidney. In contrast, metastatic and dystrophic calcifications, which can be considered ectopic calcifications, are defined as unexpected biomineralization occurring in soft tissues. In the absence of a systemic mineral imbalance, dystrophic calcification is often associated with tissue alteration or necrosis. In contrast, metastatic calcifications resulting from mineral imbalance are more systemic and affect various tissues (e.g., vessels, lungs, kidneys). A fourth family can be considered physiological calcification (bone), which becomes pathological with diseases such as arthrosis or osteoporosis.

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Characterization and Some Physicochemical Aspects of Pathological Microcalcifications

Background:Frontal sinus fracture treatment strategies lack statistical power The authors propose statistically valid treatment protocols for frontal sinus fracture based on injury pattern, nasofrontal outflow tract injury, and complication(s)Methods:An institutional review board–approved retrospe

Twenty-six-year experience treating frontal sinus fractures: a novel algorithm based on anatomical fracture pattern and failure of conventional techniques.

Background Little is known of the actual understanding that underlies patient choices with regard to their surgical treatment This review explores current knowledge of patient understanding and techniques that may be used to improve this understanding Methods MEDLINE and PubMed were searched using the terms “patient understanding,” “patient comprehension,” “consent,” “video,” “multimedia,” “patient information leaflet,” “internet,” “test-feedback,” “extended discussion,” “shared decision making,” and “decision aid” All retrieved peer-reviewed studies were included in the review Results Understanding in surgical patients is poor There is little evidence to support the use of information leaflets, although multimedia appears to be effective in improving patient understanding The internet is not used effectively as an aid to consent by health care providers Patients with lower educational levels may gain most from additional interventions Improving patient understanding does not impact on their satisfaction with the treatment they have received but may reduce periprocedural anxiety Conclusions There is a need for greater awareness of patients' information needs, and novel approaches that may enhance decision making through improved understanding are required

Beyond consent--improving understanding in surgical patients.

Open reduction and internal fixation of low subcondylar fractures of mandible through high cervical transmasseteric anteroparotid approach.

High Cervical Transmasseteric Anteroparotid Approach for Open Reduction and Internal Fixation of Condylar Fracture

Summary Purpose Frontal sinus fractures represent 2–12% of facial trauma. The purpose of this article is to discuss proper management of these fractures and to evaluate the indications for treatment, the complications and the morphologic results of surgery. Material & methods The records of 40 patients admitted to this department with a frontal sinus fracture were reviewed. Sex, age, the circumstances of injury, the imaging techniques, fracture patterns, associated injuries, length of hospital stay, surgical approaches and the complications were analysed. The operations included 3 main options: cranialization, obliteration or reconstruction of the frontal sinus. Results There were 32 men and 8 women (average 34 years). The most common cause of injury was motor vehicle accidents. Conventional radiography of the face was complemented by computed tomography and 3D reconstructions. Isolated anterior table fractures were found in 72.5% and combined anterior/posterior table fractures in 27.5% of the cases. The treatment was surgical for 70% of the patients; the average length of hospitalization was 1 week. Postoperative complications were: 1 brain abscess, 2 cases of frontal sinusitis and 2 cases of chronic headache. Conclusion Long-term complications in frontal sinus fractures are intracranial infection, sinusitis and forehead defects. To avoid these it was decided to treat all displaced fractures surgically in displaced anterior table fractures the sinus was obliterated with cancellous bone and in displaced posterior table fractures the sinus was cranialized.

The frontal sinus: a culprit or a victim? A review of 40 cases.

The position of mandibular foramen is variable at the medial aspect of mandibular ramus. Nevertheless its location is useful for the oral and maxillofacial surgeon in orthognatic surgery, especially in vertical ramus osteotomy (VRO) procedure. The aim of our study is to analyse the position of mandibular foramen in order to provide simple and reliable surgical landmarks. A radio-anatomical study was undertaken on normal mandibular panoramic X-ray examinations. Precise reproductions were outlined on tracing paper. Original orthonormal landmark was designed using posterior border of the ramus, mandibular incisure and anterior border of the ramus. All these elements are visible in the patient in VRO. Measurements of the position of mandibular foramen in horizontal and vertical dimensions were then performed with a ruler by two independent observers: l (width of mandibular branch), x (distance between posterior border of the ramus and mandibular foramen), h (height of mandibular branch) and y (distance between sigmoid notch and mandibular ramus). x/l and y/h ratios were calculated in order to minimise magnifications and image distortions due to the imaging process. Forty-six panoramic X-rays were analysed, including 24 male and 22 female specimens (sex-ratio 1.1/1) with the mean-age 21 years. In vertical dimension, y/h ratio was distributed on a gaussian mode with a peak around 0.30–0.35, mandibular foramen was located around the midpoint of the inferior two-thirds and the superior third of the ramus, preferentially under this point. In horizontal dimension, x/l ratio observed the same model with a peak around 0.35; mandibular foramen was located around the midpoint of the anterior two-thirds and the posterior third of the ramus, preferentially in front of this point. Mandibular foramen was situated in the ventral and inferior two-thirds of the ramus without difference according to the side, sex or age. Posterior and superior thirds of the ramus constitute a “safety zone” where mandibular foramen is unlikely to be found. This area can be used by the oral and maxillofacial surgeon in vertical ramus osteotomy of the mandible with low inferior alveolar nerve morbidity probability.

Gabriel Malka

Papers

Open reduction and internal fixation of low subcondylar fractures of mandible through high cervical transmasseteric anteroparotid approach.

High Cervical Transmasseteric Anteroparotid Approach for Open Reduction and Internal Fixation of Condylar Fracture

The frontal sinus: a culprit or a victim? A review of 40 cases.

A simple method to locate mandibular foramen: preliminary radiological study

Effects of an informational CD-ROM on anxiety and knowledge before aesthetic surgery: a randomised trial.