scholarly journals Quality of informed consent documents among US. hospitals: a cross-sectional study

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e033299
Author(s):  
Erica S Spatz ◽  
Haikun Bao ◽  
Jeph Herrin ◽  
Vrunda Desai ◽  
Sriram Ramanan ◽  
...  

ObjectiveTo determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents.DesignRetrospective observational study of informed consent documents.Setting25 US hospitals, diverse in size and geographical region.CohortAmong Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital.Primary outcomeThe outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0–20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback.ResultsAmong 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality.ConclusionAll hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital’s informed consent documents can serve as a first step in driving attention to gaps in quality.

2013 ◽  
Vol 2 (1) ◽  
pp. 10 ◽  
Author(s):  
Marta Nobile ◽  
Elena Garavelli ◽  
Barbara Gagliardi ◽  
Silvia Giovanelli ◽  
Paolo Rebulla ◽  
...  

<em>Background</em>. The Center for Transfusion Medicine, Cell Therapy and Cryobiology, Milan, Northern Italy, is the headquarter of the POLI-MI biobank. It co-ordinates the biobank activities of the Fondazione Ca’ Granda Ospedale Maggiore Policlinico of Milan. Such activities require specific safeguarding of donors’ rights and protection of sensitive and genetic data. The Fondazione Ca’ Granda Ospedale Maggiore Policlinico has set up a project on informed consent with the aim of developing awareness and understanding of this issue. Within this project, it has been decided to evaluate how consent for biobanking material is expressed. <em>Design and methods.</em> The aim of the study was to evaluate the quality and completeness of consent to biobanking in the POLI-MI biobank. This was a retrospective study carried out in 2012 on samples of consent declarations collected by biobank units in 2011. Some units used a single, standard consent model available from a previous POLI-MI biobank workgroup. Other units used models which had been previouly formulated. Evaluation was made using a form that indicated the essential elements of consent. <em>Results</em>. A total of 48 consent declarations were collected using the single, standard model and 84 were collected using other models. The consent declarations that used the single, standard model were found to be the most complete and were filled in better than other models. <em>Conclusions</em>. Progressive adoption of a simple, standard consent model is expected to improve the quality of consent acquisition. Regular audit of the compliance of consent practices with ethical and legal requirements is mandatory to improve the quality of research biobanking.


2020 ◽  
Vol 30 (5) ◽  
Author(s):  
Balkew Asegidew Tegegn ◽  
Betregiorgis Zegeye Hailu ◽  
Birhanu Damtew Tsegaye ◽  
Gashaw Garedew Woldeamanuel ◽  
Wassie Negash

BACKGROUND: Inappropriate Tuberculosis (TB) diagnosis and treatment contributes to unfavorable health outcome among TB patients. Improving quality of healthcare service helps to avert TB related morbidity. Despite these facts, the level of quality of service is not known in the hospitals. Hence, the present study was conducted to assess the quality of care delivered to TB patients among publichospitals.METHODS: A facility-based cross-sectional study was conducted from March 15 to April 30, 2019 in North Shewa Zone, Amhara region, Ethiopia. All TB patients who had follow-up in the hospitals were included. This resulted in the involvement of 82 TB patients. Data was collected by trained data collectors using facility audit, clinical observation checklists, structured questionnaire and in-depth interview. Data was analyzed using SPSS version 20. Binary logistic regression analysis was done to identify the predictors of patients’ satisfaction.RESULTS: In this study, 82 respondents with a mean age of 36.48 (±13.27) years were participated. The mean quality score for structural dimension was 59.5%, and 53.7% of participants were found to be satisfied in outcome dimension. The mean score for process dimension of quality of service were 67.9%. Having TB symptoms were significantly associated with the level of patientsatisfaction towards TB care [AOR = 0.217, p = 0.015].CONCLUSION:Quality of TB services from structural and outcome dimension were low and higher in process dimension. Thus, careful attention on the quality of services will help to reduce the burden of TB.


2021 ◽  
Vol 15 (3) ◽  
Author(s):  
Supriya Patil ◽  
Yamini Patil ◽  
Sanjay Kumar Patil

Diabetes is a chronic metabolic disorder that disturbs the quality of life (QOL) of patients. Therefore, evaluation of diabetes- related QOL could be a key outcome measure for its management. This study assessed the QOL in type 2 diabetes mellitus (T2DM) patients using the World Health Organization (WHO) quality of life (QOL)˗BREF questionnaire and disease-specific appraisal of diabetes scale (ADS). In this cross-sectional study, 520 T2DM patients were included. Patients’ demographic data, clinical information was collected through interviews, and the WHOQOL-BREF instrument and ADS were used for the QOL of patients. Statistical analysis was performed by using R software (Version 3.6.0). The mean ADS scores were lower in controlled diabetic subjects (18.50±3.08) and higher in uncontrolled diabetic subjects (19.29±2.73) (P<0.05). For WHOQOL-BREF, the mean scores for all the domains (overall general health, physical, psychological, social, and environmental) were significantly higher in controlled diabetic subjects (P<0.001). In addition, the age, duration of diabetes, associated comorbidities, treatment, and HbA1c level of patients showed a highly significant correlation with WHOQOL-BREF (P<0.001). Diabetic patients had poor-to-average QOL. Therefore, public health measures and education of diabetic patients are essential to create more awareness for improving the QOL of T2DM.


2021 ◽  
pp. 1-6
Author(s):  
Shivani Saini ◽  
◽  
Agarwal Shail ◽  
Jain Manish ◽  
Yadav Devendra ◽  
...  

Background: Dermatophytosis is a common fungal infection affecting 20-25% of the world population. Aims: Our study was aimed to assess its impact on health-related quality of life(QoL), mental health, and various variables. Materials and Methods: A cross-sectional study was done from April 2019 to September 2019 on 174 patients of dermatophytosis of aged more than 16 years with their informed consent. The impact of infection on the quality of life was assessed by using the Dermatology life quality index questionnaire and General health questionnaire-12 was used to assess psychological impact. A visual analogue scale was used to assess the severity of pruritus. Appropriate statistical tests were applied. Results: Males to females ratio was 1.4:1. The age group of 21-30 was having the highest number of patients with the mean age of 27.8±9.97. Most patients had BSA under 10%. The mean value of DLQI and GHQ-12 were found 15.989±7.407 and 2.8563±2.8964, respectively. We found that dermatophytosis had a very large effect on the quality of life as the maximum number of patients(39%) were within this category. The “work and school” part in the questionnaire gained maximum importance(52.8%). The mean VAS score was 6±2.733 with most patients(32.7%) had moderate itching. We found a positive correlation between VAS and DLQI, VAS and GHQ-12, DLQI, and GHQ-12 with the statistical significance. Conclusion: In our study dermatophytosis affected the quality of life as well as the psychological health of patients. Therefore proper treatment of superficial dermatophtytosis is essential to prevent it from further complications


2019 ◽  
Vol 13 ◽  
Author(s):  
Nipaporn Butsing ◽  
Mathuros Tipayamongkholgul ◽  
Disya Ratanakorn ◽  
Nawarat Suwannapong ◽  
Kanitta Bundhamcharoen

AbstractSophisticated medical technologies can prolong a stroke patient’s life but not always their quality of life (QoL) due to poor functional outcomes. Social support can theoretically assist a patient’s adaptation to life after stroke and improve their QoL, but existing findings are inconclusive. This inconclusiveness is especially found in large cities where family and social bonding can be scarce. We conducted a hospital-based, cross-sectional study among 358 stroke patients to identify the effects of social support and functional outcome on QoL and its domains. The study took place in Bangkok, Thailand between July and December 2016. Data were collected by personal interview using a structured questionnaire that included the Short-Form WHO Quality of Life Instrument (WHOQOL-BREF) and by review of medical records. A hierarchical linear regression method was used to analyze data. The mean age of stroke respondents was 66.0 years (SD 13.5 years), and half were male. The mean total QoL score for patients was 68.6 (SD 15.2). Hierarchical multiple regression analysis found emotional support significantly impacted QoL in every domain (ps < .05) when all included variables were controlled for. To improve the quality of life among stroke survivors, health personnel and family members should provide not only physical assistance but also psychological support.


2017 ◽  
Vol 157 (4) ◽  
pp. 690-695 ◽  
Author(s):  
Onyinyechi C. Ukaegbe ◽  
Foster T. Orji ◽  
Basil C. Ezeanolue ◽  
James O. Akpeh ◽  
Ijeoma A. Okorafor

Objectives To evaluate the quality of life of patients with ongoing tinnitus. Study Design This was a cross-sectional study of patients with ongoing tinnitus. Setting The study was carried out in a tertiary hospital in southeastern Nigeria. Subjects and Methods Subjects are adults who presented to the otorhinolaryngology clinic with tinnitus as their primary complaint. Pure-tone audiometry, tinnitus pitch, and loudness matching were done. The Tinnitus Handicap Inventory (THI) questionnaire was used in assessing their quality of life. Results There were 63 participants within the age range of 16 to 74 years; 20 (31.7%) were male and 43 (68.3%) were female. The mean duration of tinnitus was 26.7 ± 38.1 months. Nineteen (30.2%) participants had bilateral tinnitus while 44 (69.8%) had unilateral tinnitus. The mean THI score was 36.6 ± 19.7. The most reported handicap was anxiety and difficulty with concentration followed by depression and irritability. There was no correlation between the disability shown by the THI score and the age, sex, duration of the tinnitus, the tinnitus pitch, tinnitus loudness, or the laterality of the tinnitus. There was a significant positive correlation between the grade of hearing loss and the level of disability reported in the THI ( P = .01). Conclusion Tinnitus sufferers appear to have poorer quality of life compared with nonsufferers. This quality-of-life affectation is likely to be worse in those with disabling hearing loss but does not appear to be related to their age, sex, symptom duration, or the loudness and pitch of their tinnitus.


2013 ◽  
Vol 53 (6) ◽  
pp. 350
Author(s):  
Naomi Riahta ◽  
Muhammad Ali ◽  
Bistok Saing ◽  
Yazid Dimyati ◽  
Johannes Saing

Background Headaches are common problems in adults,adolescents, and children. Headaches impact a child's life, theirfamily life, and even society. An assessment of quality of life inadolescents with primary headaches may help to determine actionsnecessary to improve the quality of life of these patients.Objective To assess the quality oflife of adolescents with primaryheadach es compared to healthy adolescents.Methods We conducted a cross-sectional study in December2009 on adolescents aged 13 to 18 years. The headache groupconsisted of children with primary headaches according to theInternational Classification of Headache Disarders and the controlgroup consisted of healthy adolescents. Subjects were selected byconsecutive sampling, with 75 subjects in each group. Subjectsfilled the Pediatric Quality of Life Inventary version 4.0 (PedsQL4.0) questionnaire.Results The mean PedsQL total score was significantly lowerin the headache group than in the contra 1 group [ l 7 5. 7 vs.392.2, respectively, (95%CI of differences -28.l to -219.3, P =0.001)]. However, out of23 items in the questionnaire, 9 werenot significantly different between the headache and controlgroups.Conclusions Primary headaches in adolescents is associatedwith lower quality of life. Most quality of life domains scoresare significantly lower in adolescents with primary headachescompared to those without primary headaches.


KnE Medicine ◽  
2017 ◽  
Vol 1 (1) ◽  
pp. 202
Author(s):  
Muhammad D. Priangga ◽  
Gita Pratama ◽  
Mila Maidarti ◽  
Achmad K. Harzif ◽  
Budi Wiweko

<p><strong>Introduction</strong></p><p>Infertility in Indonesia has an estimated prevalence as high as 22.3%, with the nature of the problem and its treatment could be devastating, it could affect quality of life and vice versa influence successful of the treatment. The Fertility Quality of Life (FertiQol) Questionnaire was specifically designed for infertility couples and has been demonstrated to have good properties. Studies in several countries has showed consistency in validity and reliability of the questionnaire. Precedently there has been no published study about Fertiqol in Indonesia, this preliminary study is to measure validity and reliability of FertiQol questionnaire among Indonesian infertility women.</p><p><br /> <strong>Material &amp; Methods</strong></p><p>This is a cross-sectional study, a written Fertiqol Questionnaire Indonesian version (www.Fertiqol.org) were distribute to Infertility clinic in Cipto Mangunkusumo General Hospital, total of 129 women completed the questionnaire. Statistical analysis used SPSS version 23.0. The questionnaire were tested for validity with Pearson’s correlation with two tailed and Cronbach α coefficient for reliability.<br /> <strong></strong></p><p><strong>Results</strong></p><p>FertiQol were completed by 129 women with infertility problem. The mean of total FertiQol score was 70.49±11.44, score for emotional, mind/body, relational, environment and tolerability was respectively 63.79±18.86; 66.05±18.22; 75.19.±15.11; 68.99±18.63; 75.64±16.55; 66.23±19.17. Reliability of Fertiqol was high (Cronbach a &gt; 0.70) with every item of questionnaires was valid ( r&gt; 0.1729).<br /> <strong></strong></p><p><strong>Conclusion</strong></p><p>This study showed that FertiQol Indonesian version are valid and reliable in measured quality of life among infertility women in Indonesia.</p>


2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Hassan Joulaei ◽  
Seyed Ghaleb Mousavi ◽  
Zohre Foroozanfar ◽  
Tayebeh Rakhshani

Health-related quality of life (HRQoL) is one of the most important indicators in assessing the health and well-being of HIV-positive patients. The present study investigated the HRQoL of HIV patients referred to Abadan’s Voluntary Counseling and Testing (VCT) center in 2019. In this cross-sectional study, a total of 134 HIV+ patients referred to Abadan’s VCT center were selected through convenience sampling. Demographic information was collected through a researcher-made checklist; the patients’ status and health information were collected through electronic medical records of HIV+ patients and their records at the VCT center. The HRQoL index was assessed using the World Health Organization (WHOQOL-BREF) questionnaire. Data analysis was carried out using simple and multiple linear regression as well as a t -test in SPSS software. A P value < 0.05 was considered as the significance level in all tests. The mean of the HRQoL in all the participating patients was 56.42 ± 22.66 . The highest and lowest mean scores of HRQoL domains were related to social relationships ( 57.53 ± 24.73 ) and environmental health ( 53.68 ± 19.07 ). There was a positive significant relationship between the marital status, residency, years of education, duration of infection, transmission route, and antiretroviral (ARV) therapy with the score of the HRQoL. The results showed a moderate score for the mean HRQoL and its domains. The present study revealed the necessity of improving HIV+ patients’ living conditions, employment status, health education, and mental health care.


Author(s):  
Luis Pardo-Galán ◽  
Raquel Pastor-Cisneros ◽  
Daniel Collado-Mateo ◽  
José Adsuar ◽  
Miguel García-Gordillo ◽  
...  

The anthropometric reference data used to examine the growth pattern of children in Spain are obtained from studies carried out several years ago. In the region of Extremadura, the tables obtained by the Faustino Obergozo Foundation, which date back to 2004, are used. The first objective of this work is to develop growth tables and graphs that accurately reflect the somatometric variables of children in Extremadura. Secondly, the averages of these variables by sex will be compared to determine if there are significant differences between them. A database provided by the General Directorate of Planning, Training, and Health and Social Quality of the Regional Government of Extremadura was used, which contains the measurements of height, weight, and body mass index (BMI) of boys and girls in Extremadura between the years 2006–2016. The database was analyzed using the Statistical Package for the Social Sciences (SPSS) version 23 and the R software version 3.5.1, considering a cross-sectional study. As a result, the tables and growth graphs of Extremadura’s population base for weight and height are presented, from birth to 10 years, as well as comparisons of the average values of the analyzed variables between boys and girls. We found that there are significant differences in the mean values, according to sex, of the height and weight. On the other hand, BMI progressed normally when comparing the results of the Extremadura population with those reflected by the World Health Organization (WHO). Differences were found when comparing the results with those obtained by the Faustino Orbegozo Foundation.


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