Knowledge and Attitude Toward Informed Consent Among Private Dental Practitioners in Bathinda City,Punjab, India

Objectives

A study was conducted with the purpose to assess the knowledge and attitude towards informed consent among private dental practitioners in Bathinda City, Punjab, India.

Methods

A cross-sectional survey was conducted among all private dental practitioners in Bathinda City. A self-administered structured questionnaire consisting of 14 items was used to assess their knowledge and attitude regarding informed consent. The response format was based on a 3-point Likert scale. One-way analysis of variance, independent sample t test, and stepwise multiple linear regression analysis were utilized for statistical analysis. Confidence level and level of significance were set at 95% and 5%, respectively.

Results

The mean scores for knowledge and attitude were 19.37 ± 31.82 and 9.40 ± 1.72, respectively. Analysis revealed that qualification and years of experience was statistically significant among both dependent variables (p ≤ 0.05).

Conclusion

An unbalanced knowledge of informed consent among the current dentists has suggested the need for awareness programs to fill the knowledge gaps and instill positive attitudes.     

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

Background

Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals.

Methods

Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively.

Results

Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates.

Conclusions

A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research.Key words: informed consent, cohort study, ethics, genetics, randomization     

Peer Reviewed: Achieving a High Response Rate With a Health Care Provider Survey,Washington State, 2006

Background

Growing evidence of deficiencies in patient safety, health outcomes, cost, and overall quality of care in the United States has led to proposed initiatives and conceptual frameworks for improvement. A means for feasible, valid, and ongoing measurement of health care quality is necessary for planning and evaluating such initiatives.

Community Context

We sought to assess and improve health care quality for the management of chronic diseases in Washington State. We used the Chronic Care Model to develop a survey for health care providers and systems that measured quality of care and monitored improvement for multiple chronic conditions.

Methods

We surveyed a random sample of primary care providers and their clinic managers. We used 2 complementary tools: a provider questionnaire (administered by mail) and a clinic manager questionnaire (administered by telephone) to measure intermediate indicators of health care quality.

Outcome

We achieved high response rates (78% for physicians, 82% for physician assistants, and 71% for clinic managers).

Interpretation

Our survey administration methods, or modified versions of these methods, may be effective for obtaining high response rates as part of ongoing monitoring of health care quality.     

Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery

Objective

In Britain, consent for surgery is documented using a Department of Health form signed by the surgeon and the patient. In contrast, anaesthetic procedures have no formalised consent process. Evidence on the process of consent for regional anaesthesia, and patient perceptions of this, is scarce outside obstetric practice. We aimed to determine patient recall and perceptions of consent for interscalene brachial plexus block and compared this to surgical consent for shoulder arthroplasty.

Design

Prospective observational survey.

Setting

A specialist musculoskeletal centre, UK.

Participants

Forty-six patients (female:male 30:16, mean age 61 years) undergoing shoulder arthroplasty with interscalene brachial plexus block.

Main outcome measures

Recall and understanding of consent for regional anaesthesia and surgery was examined using a semi-structured questionnaire 1–2 days after arthroplasty. Surgical consent forms and discussions recorded by the anaesthetist were examined in participants’ medical notes to compare against the level of recall. Analysis to determine statistical significance was conducted using McNemar’s test.

Results

Recall of surgical risks was overall significantly better than recall of brachial plexus block risks. Compared to their recollections of surgical risk, patients remembered fewer specific risks for brachial plexus block (p < 0.001). There were more patients unable to recall any risks when questioned about brachial plexus block than about their surgery (p < 0.05). One-third of patients did not regard the consent discussion about regional anaesthesia as important as consent for surgery and over one-quarter had not recognised the preoperative discussion about the brachial plexus block as a consent process similar to that conducted for surgery.

Conclusions

Fundamental misunderstandings about the consent process are prevalent. Future work in this area should seek to investigate how documentation of the consent process and patients’ understanding of consent for regional anaesthesia can be improved.     

Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis

Objective

To estimate the proportion of participants in clinical trials who understand different components of informed consent.

Methods

Relevant studies were identified by a systematic review of PubMed, Scopus and Google Scholar and by manually reviewing reference lists for publications up to October 2013. A meta-analysis of study results was performed using a random-effects model to take account of heterogeneity.

Findings

The analysis included 103 studies evaluating 135 cohorts of participants. The pooled proportion of participants who understood components of informed consent was 75.8% for freedom to withdraw at any time, 74.7% for the nature of study, 74.7% for the voluntary nature of participation, 74.0% for potential benefits, 69.6% for the study’s purpose, 67.0% for potential risks and side-effects, 66.2% for confidentiality, 64.1% for the availability of alternative treatment if withdrawn, 62.9% for knowing that treatments were being compared, 53.3% for placebo and 52.1% for randomization. Most participants, 62.4%, had no therapeutic misconceptions and 54.9% could name at least one risk. Subgroup and meta-regression analyses identified covariates, such as age, educational level, critical illness, the study phase and location, that significantly affected understanding and indicated that the proportion of participants who understood informed consent had not increased over 30 years.

Conclusion

The proportion of participants in clinical trials who understood different components of informed consent varied from 52.1% to 75.8%. Investigators could do more to help participants achieve a complete understanding.     

Improvement in Likelihood to Donate Blood After Being Offered a Topical Anesthetic

Background

While there are many reasons people choose not to donate blood, pain sustained during the venipuncture portion of the blood donation process is likely one deterrent to volunteer donation. The purpose of this study was to survey the improvement in likelihood of donation if participants were given the option of a topical anesthetic cream prior to venipuncture.

Study Design and Methods

Over a three month period 316 adults (convenience sample) completed a one page survey consisting of twelve questions pertaining to blood donation. Participants were asked about their likelihood of donating blood in the near future (No Possibility, Possible, Likely, Certain). They were then informed of the possibility of using a topical anesthetic cream prior to donation. Subsequently, their likelihood of donating blood was reassessed.

Results

Fifty (16%) subjects reported an increased likelihood of donating blood if offered a topical anesthetic (p<0.0001). Of these respondents reporting an increase in donation likelihood, eleven improved by 2 or more likelihood categories. Amongst the 169 participants who never donated blood, 34 (20%) reported an increased likelihood of donation after being told about the topical anesthetic cream, compared to 16 (10%) of the 147 subjects who had previously donated blood (p=0.02).

Conclusion

The findings of this study suggest that providing a topical anesthetic had a positive effect on the study participants'' likelihood of donating blood. This improvement was greater amongst those who have never donated blood.     

Experience of nurses in the process of donation of organs and tissues for transplant

Objective

to investigate the meaning of the action of nurses in the donation process to maintain the viability of organs and tissues for transplantation.

Method

this qualitative study with a social phenomenological approach was conducted through individual interviews with ten nurses of three Organ and Tissue Procurement Services of the city of São Paulo.

Results

the experience of the nurses in the donation process was represented by the categories: obstacles experienced in the donation process, and interventions performed. The meaning of the action to maintain the viability of organs and tissues for transplantation was described by the categories: to change paradigms, to humanize the donation process, to expand the donation, and to save lives.

Final considerations

knowledge of the experience of the nurses in this process is important for healthcare professionals who work in different realities, indicating strategies to optimize the procurement of organs and tissues for transplantation.     

Comparison of Chewing Ability,Oral Health Related Quality of Life and Nutritional Status Before and After Insertion of Complete Denture amongst Edentulous Patients in a Dental College of Pune

Background

The relationship between tooth loss and nutritional intake is important. As people age, their diminished physical capacity and decreased income adversely affect their ability to maintain their teeth. The aim of the study was to assess and compare the chewing ability, oral health related quality of life and nutritional status before and after fabrication and insertion of complete denture amongst edentulous participants in a dental college.

Material and Methods

Non Randomized Intervention study. The study population consisted of 42 participants (16 females and 26 males), aged 50 years and above. Prior to commencement of the study, informed consent was obtained and validation and reliability test of the questionnaire were done. The data for chewing ability, GOHAI and nutritional status assessment was recorded at baseline, 3^rd, 6^th and 12^th month after denture fabrication and insertion. The statistical comparisons were performed by repeated measure ANOVA and Chi-square test. P value<0.05 was considered as statistically significant.

Results

Chewing ability, GOHAI, BMI (Body Mass Index) and data from Food-intake questionnaire showed statistically significant improvement from baseline to 6^th month but no statistically significant improvement was observed from 6^th month to 12^th month. Nutritive value of food (protein, energy and fat) showed no significant difference over a period of 12 months (p<0.05).

Conclusion

Thus, it was concluded that the intervention (denture insertion) was effective in increasing the chewing ability, body weight, food-intake, and oral health related quality of life.     

Random demographic household surveys in highly mobile pastoral communities in Chad

Problem

Reliable demographic data is a central requirement for health planning and management, and for the implementation of adequate interventions. This study addresses the lack of demographic data on mobile pastoral communities in the Sahel.

Approach

A total of 1081 Arab, Fulani and Gorane women and 2541 children (1336 boys and 1205 girls) were interviewed and registered by a biometric fingerprint scanner in five repeated random transect demographic and health surveys conducted from March 2007 to January 2008 in the Lake Chad region in Chad.

Local setting

Important determinants for the planning and implementation of household surveys among mobile pastoral communities include: environmental factors; availability of women for interviews; difficulties in defining “own” children; the need for information-education-communication campaigns; and informed consent of husbands in typically patriarchal societies.

Relevant changes

Due to their high mobility, only 5% (56/1081) of registered women were encountered twice. Therefore, it was not possible to establish a demographic and health cohort.

Lessons learnt

Prospective demographic and health cohorts are the most accurate method to assess child mortality and other demographic indices. However, their feasibility in a highly mobile pastoral setting remains to be shown. Future interdisciplinary scientific efforts need to target innovative methods, tools and approaches to include marginalized communities in operational health and demographic surveillance systems.     

Ethical Issues in Measuring Biomarkers in Children’s Environmental Health

Background

Studying the impact of environmental exposures is important in children because they are more vulnerable to adverse effects on growth, development, and health. Assessing exposure in children is difficult, and measuring biomarkers is potentially useful. Research measuring biomarkers in children raises a number of ethical issues, some of which relate to children as research subjects and some of which are specific to biomarker research.

Objective

As an international group with experience in pediatric research, biomarkers, and the ethics of research in children, we highlight the ethical issues of undertaking biomarker research in children in these environments.

Discussion

Significant issues include undertaking research in vulnerable communities, especially in developing countries; managing community expectations; obtaining appropriate consent to conduct the research; the potential conflicts of obtaining permission from an ethics review board in an economically developed country to perform research in a community that may have different cultural values; returning research results to participants and communities when the researchers are uncertain of how to interpret the results; and the conflicting ethical obligations of maintaining participant confidentiality when information about harm or illegal activities mandate reporting to authorities.

Conclusion

None of these challenges are insurmountable and all deserve discussion. Pediatric biomarker research is necessary for advancing child health.     

Effects of Written Informed Consent Requirements on HIV Testing Rates: Evidence From a Natural Experiment

Objectives. I evaluated the effects of written informed consent requirements on HIV testing rates in New York State to determine whether such consent creates barriers that discourage HIV testing.Methods. New York streamlined its HIV testing consent procedures on June 1, 2005. If written informed consent creates barriers to HIV testing, then New York''s streamlining exercise should have reduced such barriers and increased HIV testing rates. I used logistic regression to estimate the effects of New York''s policy change.Results. New York''s streamlined consent procedures led to a 31.4% (95% confidence interval [CI] = 20.9%, 41.9%) increase in the state''s HIV testing rate. In absolute terms, 7% of the state''s population had been tested for HIV in the preceding 6 months under the streamlined procedures, whereas only 5.3% would have been tested under the original procedures. These estimates imply that the streamlined consent procedures accounted for approximately 328 000 additional HIV tests in the 6 months after the policy change.Conclusions. Written informed consent requirements are a substantial barrier to HIV testing in the United States.There may be a trade-off between efforts to increase HIV testing rates and efforts to improve patient awareness.In 2006, the Centers for Disease Control and Prevention (CDC) endorsed a shift from targeted HIV testing of high-risk groups to broad-based screening of the general population.¹ The CDC called for opt-out HIV screening of all patients in health care settings and argued that written informed consent procedures that are separate and distinct from general consent to medical treatment procedures should not be required for HIV testing.¹ The CDC recommendations reflect concerns that HIV testing rates are too low in the United States because a large number of people do not learn about their infection until it is too late for treatment to be effective.Opt-out screening has increased testing rates in other settings, including genitourinary clinics in the United Kingdom, and there is little doubt that it would increase HIV testing in the general population.^2,3 The effect of informed consent regulations on HIV testing rates is less clear. The CDC claims that such regulations create administrative and social barriers that discourage HIV testing.¹ There is also some evidence that written informed consent regulations represent a legal impediment to the implementation of opt-out testing.⁴ Such concerns might also explain the CDC''s advocacy of informed consent repeal.Critics of the recommendations argue that separate informed consent promotes important ethical and clinical objectives in public health policy and that removing informed consent regulations could lead to a more coercive HIV testing environment.^5–8 In summarizing the controversy, Bayer and Fairchild argued that the CDC''s informed consent recommendations signal an end to the practice of HIV exceptionalism, which leads the medical establishment to approach HIV/AIDS issues differently than it approaches other health conditions.⁹It is difficult to estimate the effects of informed consent regulations on HIV testing rates because variations in state consent requirements may be correlated with state-level characteristics that themselves predict testing rates; that is, state populations are not randomly assigned to different informed consent policies. Zetola et al. reported the best evidence to date. They found that monthly testing rates increased from 13.5 to 17.9 HIV tests per 1000 patients in a set of institutions in San Francisco after that city''s department of public health eliminated written informed consent requirements.⁵ However, the Zetola et al. study lacked a comparison group, which would have alleviated concerns that the increases observed were associated with underlying trends and changes in HIV testing that occurred in the same time frame as the San Francisco policy change.In addition, Zetola et al. relied on administrative data, for which observations were conditional on patients'' visits to particular institutions. It is possible that HIV testing rates among patients who visited these institutions were different than testing rates in the general population. As a result of such problems, it is difficult to generalize the effects of the San Francisco policy change on HIV testing rates in particular institutions to testing rates in the general population.A careful decision on whether to repeal or maintain written informed consent requirements in HIV testing depends on estimates of the effects of the regulations in terms of both testing rates and the physical and psychological risks to patient well-being. It also requires normative judgments regarding the relative importance of these effects in terms of public welfare.¹⁰ In this study, I investigated the CDC''s claim that informed consent regulations lead to reductions in HIV testing rates. I used data from the Behavioral Risk Factor Surveillance System (BRFSS) to examine HIV testing rates in New York State and a set of comparison states before and after the introduction of streamlined HIV test consent procedures in New York. The policy change in New York generated a natural experiment that helps address many of the challenges associated with evaluating the effects of consent procedures on testing rates.     

Experiencing organ donation: feelings of relatives after consent

Objective:

to identify experiences and feelings on the organ donation process, from the perspective of a relative of an organ donor in a transplant unit.

Method:

this was exploratory research using a qualitative approach, performed with seven family members of different organ donors, selected by a lottery. Sociodemographic data and the experiences regarding the donation process were collected through semi-structured interviews. The language material was transcribed and submitted to content analysis.

Results:

poor sensitivity of the medical staff communicating the relative''s brain death - the potential donor - and the lack of socio-emotional support prior to the situation experienced by the family was highlighted by participants.

Conclusions:

the study identified the need to provide social-emotional support for families facing the experience of the organ donation process. From these findings, other care and management practices in health must be discussed to impact the strengthening of the family ties, post-donation, as well as the organ procurement indexes.     

Awareness and Perception Regarding Eye Donation in Students of a Nursing College in Bangalore

Context:

Corneal diseases constitute a significant cause of visual impairment and blindness in the developing world. The number of corneal transplants done is far less than the actual requirement in India. This is largely due to the inadequate number of corneas collected. Well-informed nursing students could be expected to influence eye donation rates.

Aims:

To assess the awareness and perception of 188 first- and second-year nursing students towards eye donation in Bangalore.

Settings and Design:

Cross-sectional study design.

Materials and Methods:

A pretested, semi-structured questionnaire.

Statistical Analysis Used:

Data were analyzed using the Epi-Info software package, Version 6.04.

Results:

The majority (96.8%) of students knew that eyes can be donated after death but only 38.2% knew that the ideal time of donation was within 6 hours of death. Most participants (85.1%) were either willing or had already donated their eyes. Nobility in the act of eye donation was the main motivational force for eye donation according to 85.6% of students. Perceived reasons for not pledging eyes by the students were: the unacceptable idea of separating the eyes from the body (67.9%), lack of awareness (42.8%), objection by family members (28.5%), and unsuitability to donate because of health problem (10.7%).

Conclusion:

This study revealed that nursing students were well aware of eye donations and most of them were inclined to sign-up for eye donation. The perceived reasons for not donating eyes need to be considered while creating awareness about eye donation in the community. The nursing students could be actively involved as volunteers in eye donation campaigns and they can act as counsellors for eye donors. They can also contribute by participating in creating awareness and motivating people to become eye donors.     

A behavior model for blood donors and marketing strategies to retain and attract them

Objective

analyze and propose a theoretical model that describes blood donor decisions to help staff working in blood banks (nurses and others) in their efforts to capture and retain donors.

Methods

analysis of several studies on the motivations to give blood in Spain over the last six years, as well as past literature on the topic, the authors'' experiences in the last 25 years in over 15 Non Governmental Organizations with different levels of responsibilities, their experiences as blood donors and the informal interviews developed during those 25 years.

Results

a model is proposed with different internal and external factors that influence blood donation, as well as the different stages of the decision-making process.

Conclusion

the knowledge of the donation process permits the development of marketing strategies that help to increase donors and donations.     

Effect of vitamin?A supplementation on cause-specific mortality in women of reproductive age in Ghana: a secondary analysis from the ObaapaVitA trial

Objective

To determine the effect of weekly low-dose vitamin A supplementation on cause-specific mortality in women of reproductive age in Ghana.

Methods

A cluster-randomized, triple-blind, placebo-controlled trial was conducted in seven districts of the Brong Ahafo region of Ghana. Women aged 15–45 years who were capable of giving informed consent and intended to live in the trial area for at least 3 months were enrolled and randomly assigned, according to their cluster of residence, to receive oral vitamin A (7500 μg) or placebo once a week. Randomization was blocked, with two clusters in each fieldwork area allocated to vitamin A and two to placebo. Every 4 weeks, fieldworkers distributed capsules and collected data during home visits. Verbal autopsies were conducted by field supervisors and reviewed by physicians, who assigned a cause of death. Cause-specific mortality rates in both arms were compared by means of random-effects Poisson regression models to allow for the cluster randomization. Analysis was by intention-to-treat, based on cluster of residence, with women eligible for inclusion once they had consistently received the supplement or placebo capsules for 6 months.

Findings

The analysis was based on 581 870 woman–years and 2624 deaths. Cause-specific mortality rates were found to be similar in the two study arms.

Conclusion

Low-dose vitamin A supplements administered weekly are of no benefit in programmes to reduce mortality in women of childbearing age.     

The joint action MODE (Mutual Organ Donation and Transplantation Exchanges): a sound contribution to implementation of health policies in organ donation and transplantation

Background

The main objective of the joint action MODE is the transfer of best-practices in the field of organ donation and transplantation and the creation of positive synergies among participating European (EU) Member States (MS) apt to support authorities in possible decision-making and policy contexts.

Methods

The consortium has chosen to foster the exchange of best-practice through a series of exchange visits followed by the provision of a set of specialized trainings.Each participating MS has presented its strengths and weaknesses through a questionnaire based on the Organ Action Plan. Once the situation was clearer, countries with the strongest program organized and hosted the on-site visits and each country had the opportunity to perform five exchange visits on five selected topics.Specific courses for healthcare staff of organ coordinating and transplantation centres were organized. Based on evaluation of the results of the on-site visits and training needs indicated by the partners, the chosen topics were:• reporting on adverse events and reactions• quality assurance programme of the donation process in Spain• quality assurance of the transplantation process

Results and conclusions

The outcome is that within the EU, even among MS with well-developed services, the organ donation and transplantation activity has substantial differences so that all participating countries would benefit from investigating foreign donation and transplant systems. Collaboration at EU level can be beneficial for all systems and the joint action MODE indicated that in some countries the sharing of expertise across the EU Member States has already proved to be useful in starting a virtuous circle in organization and training that would allow to increase organ donor rates and improve overall performance.     

Will the introduction of non‐invasive prenatal testing for Down's syndrome undermine informed choice?

Objective

To investigate whether the introduction of non‐invasive pre‐natal testing for Down''s syndrome (DS) has the potential to undermine informed choice.

Participants

Three hundred and ninety‐three health professionals; 523 pregnant women.

Methods

A cross‐sectional questionnaire study across nine maternity units and three conferences in the UK designed to assess opinions regarding test delivery and how information should be communicated to women when offered Down''s syndrome screening (DSS) or diagnosis using invasive (IDT) or non‐invasive testing (NIPT).

Results

Both pregnant women and health professionals in the NIPT and DSS groups were less likely than the IDT group to consider that testing should take place at a return visit or that obtaining written consent was necessary, and more likely to think testing should be carried out routinely. Compared to health professionals, pregnant women expressed a stronger preference for testing to occur on the same day as pre‐test counselling (P = 0.000) and for invasive testing to be offered routinely (P = 0.000). They were also more likely to indicate written consent as necessary for DSS (P = 0.000) and NIPT (P < 0.05).

Conclusions

Health professionals and pregnant women view the consenting process differently across antenatal test types. These differences suggest that informed choice may be undermined with the introduction of NIPT for DS into clinical practice. To maintain high standards of care, effective professional training programmes and practice guidelines are needed which prioritize informed consent and take into account the views and needs of service users.