Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021.

INTRODUCTION: Non-consented care, a form of obstetric violence involving the lack of informed consent for procedures, is a common but little-understood phenomenon in the global public health arena. The aim of this secondary analysis was to measure the prevalence and assess change over time of non-consented care during childbirth in Mexico in 2016 and 2021, as well as to examine the association of sociodemographic, pregnancy-, and childbirth-factors with this type of violence. METHODS: We measured the prevalence of non-consented care and three of its variations, forced sterilization or contraception, forced cesarean section, and forced consent on paperwork, during childbirth in Mexico for 2016 (N = 24,036) and 2021 (N = 19,322) using data from Mexico's cross-sectional National Survey on the Dynamics of Household Relationships (ENDIREH). Weighted data were stratified by geographical regions. We performed adjusted logistic regression analyses to explore associations. RESULTS: The national prevalence of non-consented care and one of its variations, pressure to get a contraceptive method, increased from 2016 to 2021. A decrease in the prevalence was observed for forced contraception or sterilization without knowledge, forcing women to sign paperwork, and non-consented cesarean sections nationally and in most regions. Women between the ages of 26 and 35 years, married, cohabiting with partner, living in urban settings, who do not identify as Indigenous, and who received prenatal services or gave birth at the Mexican Institute of Social Security (IMSS) facilities experienced a higher prevalence of non-consented care. Being 26 years of age and older, living in a rural setting, experiencing stillbirths in the last five years, having a vaginal delivery, receiving prenatal services at IMSS, or delivering at a private facility were significantly associated with higher odds of reporting non-consented care. CONCLUSION: While a decrease in most of the variations of non-consented care was found, the overall prevalence of non-consented care and, in one of its variations, pressure to get contraceptives, increased at a national and regional level. Our findings suggest the need to enforce current laws and strengthen health systems, paying special attention to the geographical regions and populations that have experienced higher reported cases of this structural problem.

Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study.

BACKGROUND: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals. OBJECTIVE: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure. METHODS: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses. RESULTS: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group. CONCLUSIONS: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.

From informed consent to adherence: factors influencing involvement in mass drug administration with ivermectin for malaria elimination in The Gambia.

BACKGROUND: The World Health Organization (WHO) recommends consideration of mass drug administration (MDA) for malaria control in low-endemic settings approaching elimination. However, MDA remains a controversial strategy, as multiple individual, social, and operational factors have shown to affect its acceptability at local levels. This is further complicated by inconsistent definitions of key indicators derived from individual and community involvement-coverage, adherence, and compliance-that cast doubts about the actual and potential epidemiological impact of MDA on disease control and elimination. This study aimed to identify limitations and enabling factors impacting involvement at different stages of a large cluster-randomized trial assessing the effect of combining dihydroartemisinin-piperaquine (DP) and ivermectin (IVM) in malaria transmission in The Gambia. METHODS: This social science study used a mixed-methods approach. Qualitative data were collected in intervention and control villages through ethnographic methods, including in-depth interviews (IDIs), focus group discussions (FGDs), and participant observation conducted with trial participants and decliners, community leaders, and field staff. A cross-sectional survey was conducted in the intervention villages after the first year of MDA. Both strands of the study explored malaria knowledge and opinions, social dynamics influencing decision-making, as well as perceived risks, burdens, and benefits associated with this MDA. RESULTS: 157 IDIs and 11 FGDs were conducted, and 864 respondents were included in the survey. Barriers and enabling factors to involvement were differentially influential at the various stages of the MDA. Issues of social influence, concerns regarding secondary effects of the medication, costs associated with malaria, and acceptability of the implementing organization, among other factors, differently affected the decision-making processes throughout the trial. Rather than a linear trajectory, involvement in this MDA trial was subjected to multiple revaluations from enrolment and consent to medicine intake and adherence to treatment. CONCLUSIONS: This study went beyond the individual factors often associated with coverage and adherence, and found that nuanced social dynamics greatly influence the decision-making process at all phases of the trial. These issues need to be consider for MDA implementation strategies and inform discussions about more accurate ways of reporting on critical effectiveness indicators.

Patient Reported Experience on Consenting for Surgery - Elective Versus Emergency Patients.

INTRODUCTION: Informed consent for surgery is a medical and legal requirement, but completing these does not necessarily translate to high patient satisfaction. This patient-reported experience study aimed to examine the surgical consent process, comparing the patients' experience in elective and emergency settings. METHODS: Over a 6-mo period, postoperative patients at The Alfred Hospital Breast and Endocrine Surgical Unit were invited to participate in a survey on the surgical consent process - including perceived priorities, information provided and overall experience. Standard statistical techniques were used, with a significant P-value of < 0.05. RESULTS: A total of 412 patients were invited, with 130 (32%) responses. More patients underwent elective surgery (N= 90, 69%) than emergency surgery (N = 40, 31%). Emergency patients were more likely to sign the consent form regardless of its contents (93% versus 39%, P < 0.001) and more likely to be influenced by external pressures (63% versus 1%, P < 0.001). Elective patients were more likely to want to discuss their surgery with a senior surgeon (74% versus 23%, P < 0.001) and more likely to seek advice from external sources (83% versus 10%, P < 0.001). Both groups highly valued the opportunity to ask questions (67% versus 63%, P = 0.65). CONCLUSION: This study shows patients have a range of different priorities in preparation for surgery. Therefore, each consent process should be patient-specific, and focus on providing the patient with quality resources that inform decision-making.

Outcome measures in solid organ donor management research: a systematic review.

AIM: We systematically reviewed published outcome measures across randomised controlled trials (RCTs) of donor management interventions. METHODS: The systematic review was conducted in accordance with recommendations by the Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. We searched MEDLINE, Embase, CENTRAL, Web of Science, and trial databases from 1980 to February 2021 for RCTs of donor management interventions. RESULTS: Twenty-two RCTs (n=3432 donors) were included in our analysis. Fourteen RCTs (63.6%) reported a primary outcome relating to a single organ only. Eight RCTs primarily focused on aspects of donor optimisation in critical care. Thyroid hormones and methylprednisolone were the most commonly evaluated interventions (five and four studies, respectively). Only two studies, focusing on single organs (e.g. kidney), evaluated outcomes relating to other organs. The majority of studies evaluated physiological or biomarker-related outcomes. No study evaluated recipient health-related quality of life. Only one study sought consent from potential organ recipients. CONCLUSIONS: The majority of RCTs evaluating donor management interventions only assessed single-organ outcomes or effects on donor stability in critical care. There is a need for an evaluation of patient-centred recipient outcomes and standardisation and reporting of outcome measures for future donor management RCTs.

Validation of the factors influencing family consent for organ donation in the UK.

Between 2013 and 2019, there was an increase in the consent rate for organ donation in the UK from 61% to 67%, but this remains lower than many European countries. Data on all family approaches (16,896) for donation in UK intensive care units or emergency departments between April 2014 and March 2019 were extracted from the referral records and the national potential donor audit held by NHS Blood and Transplant. Complete data were available for 15,465 approaches. Consent for donation after brain death was significantly higher than for donation after circulatory death, 70% (4260/6060) vs. 60% (5645/9405), (OR 1.58, 95%CI 1.47-1.69). Patient ethnicity, religious beliefs, sex and socio-economic status, and knowledge of a patient's donation decision were strongly associated with consent (p < 0.001). These factors should be addressed by medium- to long-term strategies to increase community interventions, encouraging family discussions regarding donation decisions and increasing registration on the organ donor register. The most readily modifiable factor was the involvement of an organ donation specialist nurse at all stages leading up to the approach and the approach itself. If no organ donation specialist nurse was present, the consent rates were significantly lower for donation after brain death (OR 0.31, 95%CI 0.23-0.42) and donation after cardiac death (OR 0.26, 95%CI 0.22-0.31) compared with if a collaborative approach was employed. Other modifiable factors that significantly improved consent rates included less than six relatives present during the formal approach; the time from intensive care unit admission to the approach (less for donation after brain death, more for donation after cardiac death); family not witnessing neurological death tests; and the relationship of the primary consenter to the patient. These modifiable factors should be taken into consideration when planning the best bespoke approach to an individual family to discuss the option of organ donation as an end-of-life care choice for the patient.

Donor Factors Associated with Familial Consent for Organ Donation among Trauma Casualties: a 10-Year Retrospective Study.

BACKGROUND: Consent rates for organ donation remain one of the most important factors determining the number of organs available for transplantation. Trauma casualties constitute a substantial part of the deceased organ donor pool and have unique characteristics that distinguish them from the general donor population. However, this group has not been extensively studied. OBJECTIVES: To identify donor factors associated with positive familial consent for solid organ donation among trauma casualties. METHODS: This retrospective study included all trauma casualties who were admitted to the Rabin Medical Center, Beilinson hospital, during the period from January 2008 to December 2017, who were potential organ donors. Data collected included demographic features, the nature of the injury, surgical interventions, and which organs were donated. Data was collected from the Rabin Medical Center Trauma Registry. RESULTS: During the study period 24,504 trauma patients were admitted and 556 died over their hospital course. Of these 76 were potential donors, of whom 32 became actual donors and donated their organs. Two factors showed a statistically significant correlation to donation, namely female gender (P = 0.018) and Jewish religion of the deceased (P = 0.032). CONCLUSIONS: Only a small group of in hospital trauma deaths were potential solid organ donors (13.7%) and less than half of these became actual donors. Consent rates were higher when the deceased was female or Jewish.

Common Reasons for Malpractice Lawsuits Involving Pulmonary Embolism and Deep Vein Thrombosis.

BACKGROUND: Pulmonary embolism and deep vein thrombosis are common clinical entities, and the related malpractice suits affect all medical subspecialties. Claims from malpractice litigation were analyzed to understand the demographics of these lawsuits and the common reasons for pursuing litigation. METHODS: Cases entered into the Westlaw database from March 5, 1987, to May 31, 2018, were reviewed. Search terms included "pulmonary embolism" and "deep vein thrombosis." RESULTS: A total of 277 cases were identified. The most frequently identified defendant was an internist (including family practitioner; 33%), followed by an emergency physician (18%), an orthopedic surgeon (16%), and an obstetrician/gynecologist (9%). The most common etiology for pulmonary embolism was prior surgery (41%). The most common allegation was "failure to diagnose and treat" in 62%. Other negligence included the failure to administer prophylactic anticoagulation while in the hospital (18%), failure to prescribe anticoagulation on discharge (8%), failure to administer anticoagulation after diagnosis (8%), and premature discontinuation of anticoagulation (2%). The most frequently claimed injury was death in 222 cases (80%). Verdicts were found for the defendant in 57% of cases and for the plaintiff in 27% and settled in 16%. CONCLUSIONS: The most frequently cited negligent act was the failure to give prophylactic anticoagulation, even after discharge. The trends noted in this study may potentially be addressed and therefore prevented by systems-based practice changes. The most common allegation, "failure to diagnose and treat," suggests that first-contact doctors such as emergency physicians and primary care practitioners must maintain a high index of suspicion for deep vein thrombosis/pulmonary embolism.

Who decides? Shared decision-making among colorectal cancer surgery patients in China.

PURPOSE: Patient-centered care (PCC) and shared decision-making (SDM) is advised within the English medical literature for its positive impact. The benefits of such approaches are said to foster increased trust, patient decision satisfaction, and even better outcomes. Looking at a Chinese cancer hospital, this research sought to understand how surgical decision-making was made among colorectal cancer patients. METHODS: Observations (n = 36) and semi-structured interviews (n = 24) were conducted with patients and family members. RESULTS: In the observations, 69.4% of the participating families made the decision to undergo surgery at the end of the consultation. In the interviews, three main themes emerged in regard to the characteristics in the family decision-making model, and they included three structural elements: the patient's sick role, family functional structure, and control of information. CONCLUSION: This study showed that the Chinese decision-making model is different from the western SDM model. In the Chinese context, family members dominated the decision-making process which raised concerns around informed consent. This may benefit patients insofar as receiving timely treatment in the short term but at the same time may be at the expense of limiting patient's autonomy. The promotion of a new model or a model encompassing family-centered care values may be more appropriate in clinical practice in China that can address the issues around informed consent.

Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials.

BACKGROUND: Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens the need for informed consent. We reviewed a random sample of published cluster randomized trials involving only individual-level health care interventions to determine (a) the prevalence of reporting a rationale for the choice of cluster randomization; (b) the types of explicit, or if absent, apparent rationales for the use of cluster randomization; (c) the prevalence of reporting patient informed consent for study interventions; and (d) the types of justifications provided for waivers of consent. We considered cluster randomized trials for evaluating exclusively the individual-level health care interventions to focus on clinical trials where individual randomization is only theoretically possible and where there is a general expectation of informed consent. METHODS: A random sample of 40 cluster randomized trials were identified by implementing a validated electronic search filter in two electronic databases (Ovid MEDLINE and Embase), with two reviewers independently extracting information from each trial. Inclusion criteria were the following: primary report of a cluster randomized trial, evaluating exclusively an individual-level health care intervention, published between 2007 and 2016, and conducted in Canada, the United States, European Union, Australia, or low- and middle-income country settings. RESULTS: Twenty-five trials (62.5%, 95% confidence interval = 47.5%-77.5%) reported an explicit rationale for the use of cluster randomization. The most commonly reported rationales were those with logistical or administrative convenience (15 trials, 60%) and those that need to avoid contamination (13 trials, 52%); five trials (20%) were cited rationales related to the push for more pragmatic trials. Twenty-one trials (52.5%, 95% confidence interval = 37%-68%) reported written informed consent for the intervention, two (5%) reported verbal consent, and eight (20%) reported waivers of consent, while in nine trials (22.5%) consent was unclear or not mentioned. Reported justifications for waivers of consent included that study interventions were already used in clinical practice, patients were not randomized individually, and the need to facilitate the pragmatic nature of the trial. Only one trial reported an explicit and appropriate justification for waiver of consent based on minimum criteria in international research ethics guidelines, namely, infeasibility and minimal risk. CONCLUSION: Rationales for adopting cluster over individual randomization and for adopting consent waivers are emerging, related to the need to facilitate pragmatic trials. Greater attention to clear reporting of study design rationales, informed consent procedures, as well as justification for waivers is needed to ensure that such trials meet appropriate ethical standards.

A nationwide survey on clinical practice patterns and bleeding complications of percutaneous native kidney biopsy in Japan.

BACKGROUND: Practice patterns and bleeding complications of percutaneous native kidney biopsy (PNKB) have not recently been investigated and the Japanese Society of Nephrology performed a nationwide questionnaire survey in 2018. METHODS: The survey consisted of nine sections about PNKB: (1) general indications; (2) indications for high-risk patients; (3) informed consent; (4) pre-biopsy evaluation; (5) procedures; (6) sedation; (7) post-biopsy hemostasis, bed rest, and examinations; (8) bleeding complications; and (9) specimen processing. A supplementary survey examined bleeding requiring transcatheter arterial embolization (TAE). RESULTS: Overall, 220 directors of facilities (nephrology facility [NF], 168; pediatric nephrology facility [PF], 52) completed the survey. Indications, procedures, and monitoring protocols varied across facilities. Median lengths of hospital stay were 5 days in NFs and 6 days in PFs. Gauge 14, 16, 18 needles were used in 5%, 56%, 33% in NFs and 0%, 63%, 64% in PFs. Mean limits of needle passes were 5 in NFs and 4 in PFs. The bed rest period was 16-24 h in 60% of NFs and 65% of PFs. Based on 17,342 PNKBs, incidence rates of macroscopic hematuria, erythrocyte transfusion, and TAE were 3.1% (NF, 2.8%; PF, 6.2%), 0.7% (NF, 0.8%; PF, 0%), and 0.2% (NF, 0.2%; PF, 0.06%), respectively. Forty-six percent of facilities processed specimens all for light microscopy, immunofluorescence, and electron microscopy, and 21% processed for light microscopy only. Timing of bleeding requiring TAE varied among PNKB cases. CONCLUSION: Wide variations in practice patterns of PNKB existed among facilities, while PNKBs were performed as safely as previously reported.

The potential for organ donation in Iceland: A nationwide study of deaths in intensive care units.

BACKGROUND: The deceased organ donation rate in Iceland has been low compared with other Western countries. The aim of this study was to explore the potential for organ donation after brain death in Iceland. METHODS: Observational cohort study of patients with catastrophic brain injury who died in intensive care units (ICUs) at hospitals in Iceland in 2003-2016. Medical records were retrospectively reviewed to identify potential donors (PDs), using the WHO Critical Pathway for Deceased Donation. Trends in annual incidence of PDs, conversion to actual donors, and family refusals were assessed. RESULTS: Among 1537 patients who died in the ICU, 125 (8.1%) were identified as PDs. Of 103 PDs who were declared brain dead, consent for organ donation was pursued in 84 cases and granted in 63. Fifty-six became actual donors. The annual donation rate averaged 13 per million population (pmp), but rose abruptly in the final 2 years to 36 and 27 pmp, respectively. This was paralleled by an increase in annual incidence of PDs from an average of 28 pmp to 54 and 42 pmp, respectively. The donor conversion rate increased during the study period (P = .026). Twenty-three PDs (18%) were not pursued without an apparent reason. CONCLUSIONS: The donation rate increased markedly in the last 2 years of the study period after remaining low for more than a decade. This change can largely be explained by a high incidence of PDs and a low family refusal rate. Missed donation opportunities suggest a potential to maintain a high donation rate in the future.

The effect on consent rates for deceased organ donation in Wales after the introduction of an opt-out system.

Organ transplantation saves and transforms lives. Failure to secure consent for organ retrieval is widely regarded as the single most important obstacle to transplantation. A soft opt-out system of consent for deceased organ donation was introduced into Wales in December 2015, whilst England maintained the existing opt-in system. Cumulative data on consent rates in Wales were compared with those in England, using a two-sided sequential procedure that was powered to detect an absolute difference in consent rates between England and Wales of 10%. Supplementary risk-adjusted logistic regression analysis examined whether any difference in consent rates between the two nations could be attributed to variations in factors known to influence UK consent rates. Between 1 January 2016 and 31 December 2018, 8192 families of eligible donors in England and 474 in Wales were approached regarding organ donation, with overall consent rates of 65% and 68%, respectively. There was a steady upward trend in the proportion of families consenting to donation after brain death in Wales as compared with England and after 33 months, this reached statistical significance. No evidence of any change in the donation after circulatory death consent rate was observed. Risk-adjusted logistic regression analysis revealed that by the end of the study period the probability of consent to organ donation in Wales was higher than in England (OR [95%CI] 2.1 [1.26-3.41]). The introduction of a soft opt-out system of consent in Wales significantly increased organ donation consent though the impact was not immediate.

Nothing to lose: a grounded theory study of patients' and healthcare professionals' perspectives of being involved in the consent process for oncology trials with non-curative intent.

BACKGROUND: Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging. AIM: To gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved. METHODS: In-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process. RESULTS: 'Nothing to lose' was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the 'only hope in the room'. The decision regarding participation was taken within a 'trusting relationship' that was important to both patients and professionals. Both were united in their 'fight against cancer'. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model. CONCLUSION: This study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.

The patients have a story to tell: Informed consent for people who use illicit opiates.

BACKGROUND: There is a significant discourse in the literature that opines that people who use illicit opiates are unable to provide informed consent due to withdrawal symptoms and cognitive impairment as a result of opiate use. AIMS: This paper discusses the issues related to informed consent for this population. ETHICAL CONSIDERATIONS: Ethical approval was obtained from both the local REB and the university. Written informed consent was obtained from all participants. METHOD: This was a qualitative interpretive descriptive study. 22 participants were interviewed, including 18 nurses, 2 social workers and 2 clinic support workers. The findings were analyzed using thematic analysis, which is a way of systematically reducing the complexity of the information to arrive at generalized explanations. RESULTS: The staff at the clinic were overwhelming clear in their judgment that people who use opiates can and should be able to participate in research and that their drug use is not a barrier to informed consent. CONCLUSIONS: It is important to involve people who use opiates in research. Protectionist concerns about this population may be overstated. Such concerns do not promote the interests of research participants. People who use heroin need to be able to tell their story.

A Pot Ignored Boils On: Sustained Calls for Explicit Consent of Intimate Medical Exams.

Unconsented intimate exams (UIEs) on men and women are known to occur for training purposes and diagnostic reasons, mostly during gynecological surgeries but also during prostate examinations and abdominal surgeries. UIEs most often occur on anesthetized patients but have also been reported on conscious patients. Over the last 30 years, several parties-both within and external to medicine-have increasingly voiced opposition to these exams. Arguments from medical associations, legal scholars, ethicists, nurses, and some physicians have not compelled meaningful institutional change. Opposition is escalating in the form of legislative bans and whistleblower reports. Aspiring to professional and scientific detachment, institutional consent policies make no distinction between intimate exams and exams on any other body part, but patients do not think of their intimate regions in a detached or neutral way and believe intimate exams call for special protections. UIEs are found to contribute to moral erosion and moral distress of medical students and compromise the sacred trust between the medical community and the general public. This paper refutes the main arguments in favor of the status quo, identifies a series of harms related to continuing the current practice, and proposes an explicit consent policy for intimate exams along with specific changes to medical school curriculum and institutional culture. Because patients are the rights-holders of their bodies, consent practices should reflect and uphold patient values which call for explicit consent for intimate exams.

Did Inclusion of informed consent affect the observed hiv prevalence rate among injecting drug users during hiv sentinel surveillance 2017 in Delhi, Uttar Pradesh, Uttarakhand, and Jharkhand States of Central Zone of India?

BACKGROUND: In 2017, the sampling procedure for HIV sentinel surveillance (HSS) among all high-risk groups was changed from the consecutive sampling to random sampling along with the introduction of linked anonymous testing strategy with informed written consent. OBJECTIVE: The objective of this study was to assess whether the inclusion of informed consent affects the HIV positivity rate among the participants and nonparticipants injecting drug users (IDU) in HSS 2017 in four states of Central Zone of India. METHODS: This study was a cross-sectional study. All sentinel sites from Delhi, Uttar Pradesh, Jharkhand, and Uttarakhand located at targeted intervention facilities in 2017 were included in the study. Information about the participation and nonparticipation of each high-risk individual at the sentinel site was gathered from the master list, respective registers, and website portal of the National AIDS Control Organization. A total of 8639 individuals were included in the analysis. RESULTS: Overall, 16 sites in four states were included in the study. Overall, the nonparticipation rate of IDUs was 14.3%; highest being for Delhi (17.2%), followed by Uttar Pradesh (14.6%), Uttarakhand (10.9%), and Jharkhand (4.4%). Overall, the HIV-positivity rate among nonparticipants (9.6%) was significantly higher (P = 0.009) compared to the participants (6.7%). CONCLUSION: Change in methodology and seeking written informed consent might have an effect on the nonparticipation in all four states. This, in turn, could have led to the underestimation of HIV-positivity rates among IDU in the states.

National age-of-consent laws and adolescent HIV testing in sub-Saharan Africa: a propensity-score matched study.

OBJECTIVE: To estimate the association between legal age of consent and coverage of human immunodeficiency virus (HIV) testing among adolescents in countries with high HIV-burden. METHODS: We analysed data from adolescents aged 15-18 years, who participated in Demographic and Health Surveys or AIDS Indicator Surveys between 2011 and 2016, in 15 sub-Saharan African countries. To improve balance in the distribution of measured individual- and country-level characteristics, we used propensity score matching between adolescents in countries with more versus less restrictive age-of-consent laws (≤ 15 years versus ≥ 16 years). We estimated the percentage of individuals who self-reported that they have done an HIV test in the past 12 months and compared the differences in such testing rates among adolescents exposed to lower versus higher age-of-consent laws. We also investigated effect modifications by sex and age. FINDINGS: Legal age of consent below 16 years was associated with an 11.0 percentage points higher coverage of HIV testing (95% confidence interval, CI: 7.2 to 14.8), corresponding to a rate ratio of 1.74 (95% CI: 1.35 to 2.13). HIV testing rate had a stronger association with lower age of consent among females than males. The testing rates differences were 14.0 percentage points (95% CI: 8.6 to 19.4) for females and 6.9 percentage points (95% CI: 1.6 to 12.2) for males (P-value for homogeneity = 0.07). CONCLUSION: This study provides evidence to support the recent World Health Organization's recommendations that countries should examine current laws and address age-related barriers to uptake of sexual and reproductive health services.

Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia.

IntroductionDespite consistently high discontinuation rates due to withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and dropout is limited. A better understanding of these factors could help to improve trial design and completion rates. METHODS: Using data from 1,136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) dropout due to WOC and ITE and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses. RESULTS: ITE was associated with poor clinical improvement, poor investigator satisfaction with treatment, and poor patient insight into their own disease, whereas WOC only showed a meaningful association with poor patient satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association to satisfaction with treatment among investigators and patients, and neither did a patient's experienced psychopathology, nor their self-rating of functional impairment. CONCLUSIONS: Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient's decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with the treatment.

INFORMED CONSENT IN CROATIAN CLINICAL LABORATORY PRACTICE - CURRENT ISSUES AND FUTURE PERSPECTIVES.

This paper deliberates on the place and role of informed consent in everyday clinical laboratory practice. Taking into account international ethical guidelines such as the UNESCO Universal Declaration on Bioethics and Human Rights, the Declaration of Helsinki of the World Medical Association, and Croatian national laws and codes such as the Act on the Protection of Patients' Rights, the Act on Medical Biochemistry, the Code of Ethics of Medical Biochemists and Medical Deontology, the Act on Healthcare Services, and the Code of Ethics of the Croatian Chamber of Healthcare Workers, an overview is given on the actual implementation of the aforementioned recommendations and regulations. A distinction between consent to a medical procedure and consent to enrolment in a research protocol is strongly stressed out. Special emphasis is placed on the role of specialists in laboratory medicine and masters of medical biochemistry in the process of obtaining informed consent. The design of an 'informed consent interview' is to be taken into consideration. Additional deliberation is needed on the option of 'broad consent'. It is concluded that informed consent should represent an important and routine activity within Croatian clinical laboratories.