Category: Nevin Manimala

BMJ Open. 2021 Aug 9;11(8):e045618. doi: 10.1136/bmjopen-2020-045618.

ABSTRACT

BACKGROUND: Patient and public involvement (PPI) in research is well-established in the UK. However, it can be challenging to introduce PPI to research communities where there is limited prior knowledge, experience or appreciation of PPI. We aimed to explore current PPI practices, experiences and ethical and operational challenges with PPI within our own research community in Austria, to inform strategies for supporting PPI in Austria going forward.

METHODS: We surveyed scientists at 21 research institutes of the Ludwig Boltzmann Gesellschaft (LBG) and representatives of 32 medical and university research ethics committees in Austria using online questionnaires. We analysed quantitative data using descriptive statistics, and we collated textual responses to open questions. We combined survey data with anecdotal evidence from our personal experience to summarise current challenges around implementing PPI in Austria.

RESULTS: Nineteen scientists from nine research institutes indicated generally positive attitudes towards PPI. However, the majority reported they rarely or never involved patients and members of the public in roles of consultation, collaboration or control in research. Six of eight ethics committees were unfamiliar with PPI. We discern five current challenges to implementing PPI in Austria: lack of knowledge and skills for PPI among scientists, scepticism about the usefulness of PPI, conflation of PPI with qualitative research, uncertainty about ethical requirements for PPI and uncertainty about publishing PPI activities.

DISCUSSION: We suggest that the provision of guidance about ethical requirements of PPI is a strategic priority. To address this, and following on from a recently introduced PPI training and grant scheme by the LBG, our surveys have initiated a dialogue with ethics committees and have informed the development of a checklist for ethical aspects of PPI.

CONCLUSION: Our experiences may provide useful examples to others who seek to introduce or strengthen PPI practices within their own research communities.

PMID:34373295 | DOI:10.1136/bmjopen-2020-045618

BMJ Open. 2021 Aug 9;11(8):e044983. doi: 10.1136/bmjopen-2020-044983.

ABSTRACT

INTRODUCTION: India is home to 20% of the world’s children and yet, little is known on the magnitude and trends of child maltreatment nationwide. The aims of this review are to provide a prevalence of child maltreatment in India with considerations for any effects of gender; urbanisation (eg, urban vs rural) and legislation (Protection of Children from Sexual Offences (POCSO) Act 2012).

METHODS AND ANALYSIS: A rapid review will be undertaken of all quantitative peer-reviewed studies on child maltreatment in India between 2005 and 2020. Four electronic databases will be systematically searched: PubMed, EMBASE, Cochrane and PsychInfo. The primary outcomes will include all aspects of child maltreatment: physical abuse, sexual abuse, emotional abuse, emotional neglect and physical neglect. Study participants will be between 0 and 18 years and will have reported maltreatment experiences using validated, reliable tools such as the Adverse Childhood Experiences Questionnaire as well as child self-reports and clinician reports. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the methodological appraisal of the studies will be assessed by the Newcastle-Ottawa Quality assessment scale. A narrative synthesis will be conducted for all included studies. Also, if sufficient data are available, a meta-analysis will be conducted. Effect sizes will be determined from random-effects models stratified by gender, urbanisation and the pre-2012 and post-2012 POCSO Act cut-off. I² statistics will be used to assess heterogeneity and identify their potential sources and τ² statistics will indicate any between-study variance.

ETHICS AND DISSEMINATION: As this is a rapid review, minimal ethical risks are expected. The protocol and level 1 self-audit checklist were submitted and approved by the Usher Research Ethics Group panel in the Usher Institute (School of Medicine and Veterinary Sciences) at the University of Edinburgh (Reference B126255). Findings from this review will be disseminated widely through peer-reviewed publications and in various media, for example, conferences, congresses or symposia.

PROSPERO REGISTRATION NUMBER: CRD42019150403.

PMID:34373291 | DOI:10.1136/bmjopen-2020-044983

J Sex Med. 2021 Aug 6:S1743-6095(21)00578-6. doi: 10.1016/j.jsxm.2021.06.020. Online ahead of print.

ABSTRACT

BACKGROUND: No validated English language patient-reported outcome (PRO) currently exists that assesses satisfaction with inflatable penile prosthesis (IPP). Satisfaction data have been largely based primarily on surgeon assessment of patients or using questionnaires that have not been designed for this purpose.

AIM: To develop an English-language validated PRO that assesses patient satisfaction after IPP surgery.

METHODS: Initially, a literature review and discussions with experts defined domains important to IPP satisfaction (pain, appearance, function, overall satisfaction). The initial 35-item Satisfaction Survey for Inflatable Penile Implant (SSIPI) was developed. Cognitive interviews were then performed with IPP patients (n = 12) to gain feedback on the SSIPI domains and items. These data were used to modify SSIPI with the addition of 2 questions for a final item number of 37. Patients from 4 centers, who were between 6 months and 5 years after IPP, were administered the questionnaire through RedCap. Reliability statistics and content analysis were used to winnow questions to yield the final 16-item version of the SSIPI. Internal consistency was assessed via Cronbach’s alpha and item-total correlation. Test-retest reliability was assessed via intraclass correlation coefficients using baseline and 2-week data. For convergent validity, the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship (SEAR) questionnaire were used. For discriminant validity, the International Prostate Symptom Score (IPSS) was used. Confirmatory factor analysis was used to assess the factor structure of the SSIPI.

OUTCOMES: Internal consistency, test-retest reliability, convergent and discriminant validity, and confirmatory factor analysis were assessed.

RESULTS: 118 men were surveyed. Mean age was 66.8 ± 9.5 years. The 16-item SSIPI showed high internal consistency with an overall Cronbach’s Alpha of 0.97 (domains 0.85-0.89). Item-total correlations for individual items to subscales ranged from 0.60 to 0.91. The overall test-retest reliability was 0.94 (domains 0.87-0.93). Erectile Dysfunction Inventory of Treatment Satisfaction and Self-Esteem and Relationship had correlations of 0.84 overall (domains 0.57-0.79) and 0.47 overall (domains 0.34-0.44), respectively. International Prostate Symptom Score (discriminant validity) had correlations of -0.29 overall (domains -0.17 to -0.31).

CLINICAL IMPLICATIONS: SSIPI is the first English-language validated IPP satisfaction PRO. This will enable clinicians to collect satisfaction data in a standardized way.

STRENGTHS AND LIMITATIONS: As strengths we have used a rigorous psychometric process and have no industry sponsorship. Limitations include small numbers of specific subpopulations.

CONCLUSION: The SSIPI has demonstrated robust psychometric properties. Salter CA, Bach PV, Jenkins L, et al. Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI). J Sex Med 2021;XX:XXX-XXX.

PMID:34373212 | DOI:10.1016/j.jsxm.2021.06.020

Ann Rheum Dis. 2021 Aug 9:annrheumdis-2021-220709. doi: 10.1136/annrheumdis-2021-220709. Online ahead of print.

ABSTRACT

OBJECTIVES: The impact of inflammatory arthritis (IA) on male fertility remains unexplored. Our objective was to evaluate the impact of IA on several male fertility outcomes; fertility rate (number of biological children per man), family planning, childlessness and fertility problems.

METHODS: We performed a multicentre cross-sectional study (iFAME-Fertility). Men with IA 40 years or older who indicated that their family size was complete were invited to participate. Participants completed a questionnaire that included demographic, medical and fertility-related questions. To analyse the impact of IA on fertility rate, patients were divided into groups according to the age at the time of their diagnosis: ≤30 years (before the peak of reproductive age), between 31 and 40 years (during the peak) and ≥41 years (after the peak).

RESULTS: In total 628 participants diagnosed with IA were included. Men diagnosed ≤30 years had a lower mean number of children (1.32 (SD 1.14)) than men diagnosed between 31 and 40 years (1.60 (SD 1.35)) and men diagnosed ≥41 years (1.88 (SD 1.14)).This was statistically significant (p=0.0004).The percentages of men diagnosed ≤30 and 31-40 years who were involuntary childless (12.03% vs 10.34% vs 3.98%, p=0.001) and who reported having received medical evaluations for fertility problems (20.61%, 20.69% and 11.36%, p=0.027) were statistically significant higher than men diagnosed ≥41 years.

CONCLUSIONS: This is the first study that shows that IA can impair male fertility. Men diagnosed with IA before and during the peak of reproductive age had a lower fertility rate, higher childlessness rate and more fertility problems. Increased awareness and more research into the causes behind this association are urgently needed.

PMID:34373257 | DOI:10.1136/annrheumdis-2021-220709

Z Med Phys. 2021 Aug 6:S0939-3889(21)00061-1. doi: 10.1016/j.zemedi.2021.06.003. Online ahead of print.

ABSTRACT

PURPOSE: Robotic systems to assist needle placements for low-dose rate brachytherapy enable conformal dose planning only restricted to path planning around risk structures. We report a treatment planning system (TPS) combining multiple direction needle-path planning with inverse dose optimization algorithms.

METHODS: We investigated in a path planning algorithm to efficiently locate needle injection points reaching the target volume without puncturing risk structures. A candidate needle domain with all combinations of trajectories is used for the optimization process. We report a modular algorithm for inverse radiation plan optimization. The initial plan with V100>99% is generated by the “greedy optimizer”. The “remove-seed algorithm” reduces the number of seeds in the high dose regions. The “depth-optimizer” varies the insertion depth of the needles. The “coverage-optimizer” locates under-dosed areas in the target volume and supports them with an additional amount of seeds. The dose calculation algorithm is benchmarked on an image set of a phantom with a liver metastasis (prescription dose D_pr=100Gy) and is re-planned in a commercial CE-marked TPS to compare the calculated dose grids using a global gamma analysis. The inverse optimizer is benchmarked by calculating 10 plans on the same phantom to investigate the stability and statistical variability of the dose parameters.

RESULTS: The path planning algorithm efficiently removes 72.5% of all considered injection points. The candidate needle domain consists of combinations of 1971 tip points and 827 injection points. The global gamma analysis with gamma 1%=2.9Gy, 1mm showed a pass rate of 98.5%. The dose parameters were V100=99.1±0.3%, V150=76.4±2.5%, V200=44.5±5.5% and D90=125.9±3.6Gy and 10.7±1.3 needles with 34.0±0.8 seeds were used. The median of the TPS total running time was 4.4minutes.

CONCLUSIONS: The TPS generates treatment plans with acceptable dose coverage in a reasonable amount of time. The gamma analysis shows good accordance to the commercial TPS. The TPS allows taking full advantage of robotic navigation tools to enable a new precise and safe method of minimally invasive low-dose-rate brachytherapy.

PMID:34373188 | DOI:10.1016/j.zemedi.2021.06.003

Cont Lens Anterior Eye. 2021 Aug 6:101498. doi: 10.1016/j.clae.2021.101498. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate comfort, visual function, and in vivo wettability after the insertion of hydrogel and silicone hydrogel contact lenses for a better understanding of how long practitioners should wait for the initial evaluation of soft contact lenses.

METHODS: A short-term prospective, contralateral, randomized, and participant-masked study was carried out. Twenty healthy participants (25.4 ± 2.6 years) were evaluated after the insertion of two different soft contact lenses at different times (1, 5, 10, 20, 30 min). Ocufilcon D (hydrogel) and Somofilcon A (silicone hydrogel) contact lenses were randomly assigned to both eyes of the same participant. Comfort, visual function under photopic conditions in terms of high-contrast visual acuity, low-contrast visual acuity, contrast sensitivity, and in vivo wettability were measured.

RESULTS: There was an increase in comfort (p < 0.001), high-contrast visual acuity (p < 0.05), and contrast sensitivity (p < 0.001, only with silicone hydrogel) directly related to time after contact lens insertion. Besides, in vivo wettability suffered a statistically significant deterioration directly related to time with both contact lenses (p < 0.05). Except for comfort and contrast sensitivity, all the parameters stabilized their values 10 min after the insertion of both soft contact lenses. Additionally, in vivo wettability and visual acuity differences were found between hydrogel and silicone hydrogel contact lenses (p < 0.05).

CONCLUSIONS: It would be possible to properly evaluate high-contrast visual acuity, low-contrast visual acuity, and in vivo wettability 10 min after the insertion of both soft contact lenses.

PMID:34373201 | DOI:10.1016/j.clae.2021.101498

Ann Emerg Med. 2021 Aug 3:S0196-0644(21)00512-6. doi: 10.1016/j.annemergmed.2021.06.012. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: Heuristics, or rules of thumb, are hypothesized to influence the care physicians deliver. One such heuristic is the availability heuristic, under which assessments of an event’s likelihood are affected by how easily the event comes to mind. We examined whether the availability heuristic influences physician testing in a common, high-risk clinical scenario: assessing patients with shortness of breath for the risk of pulmonary embolism.

METHODS: We performed an event study from 2011 to 2018 of emergency physicians caring for patients presenting with shortness of breath to 104 Veterans Affairs (VA) hospitals. Our measures were physician rates of pulmonary embolism testing (D-dimer and/or computed tomography scan) for subsequent patients after having a patient visit with a pulmonary embolism discharge diagnosis, hypothesizing that physician rates of pulmonary embolism testing would increase after having a recent patient visit with a pulmonary embolism diagnosis due to the availability heuristic.

RESULTS: The sample included 7,370 emergency physicians who had 416,720 patient visits for shortness of breath. The mean rate of pulmonary embolism testing was 9.0%. For physicians who had a recent patient visit with a pulmonary embolism diagnosis, their rate of pulmonary embolism testing for subsequent patients increased by 1.4 percentage points (95% confidence interval 0.42 to 2.34) in the 10 days after, which is approximately 15% relative to the mean rate of pulmonary embolism testing. We failed to find statistically significant changes in rates of pulmonary embolism testing in the subsequent 50 days following these first 10 days.

CONCLUSION: After having a recent patient visit with a pulmonary embolism diagnosis, physicians increase their rates of pulmonary embolism testing for subsequent patients, but this increase does not persist. These results provide large-scale evidence that the availability heuristic may play a role in complex testing decisions.

PMID:34373141 | DOI:10.1016/j.annemergmed.2021.06.012

Am J Orthod Dentofacial Orthop. 2021 Aug 6:S0889-5406(21)00448-0. doi: 10.1016/j.ajodo.2021.03.014. Online ahead of print.

ABSTRACT

INTRODUCTION: This cross-sectional study sought to assess clinical features and 3-dimensional distribution of unilateral impacted maxillary central incisors and identify factors associated with the root morphology.

METHODS: Cone-beam computed tomography (CBCT) images from 94 subjects exhibiting unilateral impacted maxillary incisors were selected and evaluated. Original CBCT data were reconstructed using Mimics software (version 17.0; Materialise, Belgium). Clinical features and 3-dimensional distribution of impacted maxillary central incisors and factors associated with the root morphology were observed and analyzed by 2 orthodontists.

RESULTS: This patient cohort included 52 male patients and 42 female patients. Thirty-three incisors (35.11%) with dilacerated roots, 17 incisors (18.09%) with retained deciduous teeth, 15 incisors (15.96%) with supernumerary teeth, and 15 incisors (15.96%) with a history of trauma were identified in the study. Of the 94 impacted incisors, the most common were labially impacted (n = 65; 69.15%), followed by vertically impacted (n = 17; 18.09%) and palatally impacted (n = 12; 12.77%). Chi-square tests revealed that differences in subjects with supernumerary teeth, buccolingual position, sagittal position, and axial position in the upright and dilacerated root groups were statistically significant (P <0.05). Logistic regression analysis indicated that the incidence of dilacerations was higher in the inverted position than in the inclined position and horizontal position (P <0.05).

CONCLUSIONS: Labially impacted maxillary incisors were more common than vertically or palatally incisors. Dilaceration was most commonly observed in patients with inverted incisors. In clinical practice, CBCT is a valuable tool for diagnosing impacted maxillary central incisors and for making appropriate treatment plans for patients.

PMID:34373151 | DOI:10.1016/j.ajodo.2021.03.014

J Prosthet Dent. 2021 Aug 6:S0022-3913(21)00365-6. doi: 10.1016/j.prosdent.2021.06.047. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: Studies that have analyzed the bond strength of resilient denture liners to milled denture bases are sparse, and the authors are unaware of research that has investigated the tensile bond strength of denture relining materials to 3D-printed denture bases.

PURPOSE: The purpose of this in vitro study was to evaluate the tensile bond strength of both hard and soft denture reline materials on denture bases fabricated by 3D printing and computer-aided design and computer-aided manufacture (CAD-CAM) milling technology.

MATERIAL AND METHODS: Injected, milled, and printed denture base specimens were fabricated (n=30) and bonded to 5 different denture reline materials: soft chairside reline (Coe Soft and PermaSoft), hard chairside reline (Tokuyama Rebase ii and Kooliner), and hard laboratory reline (ProBase Cold). Specimens of each reline material were divided into 5 groups (n=10) and were placed in distilled water for 24 hours before tensile testing. Maximum tensile stress values before failure were recorded, and the failure mode was also determined. The type of failure was analyzed by a scanning electron microscope. Statistics were analyzed with 2-way ANOVA and multiple comparison tests (α=.05).

RESULTS: Overall, no statistically significant difference in tensile bond strength was found in the injected, milled, and printed denture groups. However, the printed denture base group demonstrated significantly lower values of tensile bond strength (P<.05) with PermaSoft, Tokuyama Rebase ii, and ProBase Cold groups than other denture base groups (milled and injected). The milled denture bases had the highest mean value of tensile bond strength with 4 of the 5 denture relining materials tested (Coe Soft, PermaSoft, Tokuyama Rebase ii, and Kooliner). No statistically significant difference (P>.05) was found among the injected, milled, and printed denture bases when relined with Kooliner. When comparing the denture reline type, the lowest values were seen with the soft chairside relining materials, and highest values with the hard laboratory reline material. Among the modes of failure, adhesive failures were observed predominantly with the printed denture base materials relined with soft chairside relining materials, while cohesive and mixed modes of failure were found in the milled and injected denture base groups.

CONCLUSIONS: The printed denture bases had significantly lower tensile bond strength values than the injection and milled denture bases with the PermaSoft, Tokuyama Rebase ii, and ProBase Cold denture relines, while milled denture bases demonstrated the highest values of tensile bond strength for all chairside relining groups. In addition, the soft chairside relining materials showed the lowest tensile bond strength values regardless of the denture processing method with respect to the denture base type (injected, printed, and milled) compared with the hard relining materials.

PMID:34373111 | DOI:10.1016/j.prosdent.2021.06.047

Eur Urol. 2021 Aug 6:S0302-2838(21)01917-5. doi: 10.1016/j.eururo.2021.07.014. Online ahead of print.

ABSTRACT

BACKGROUND: Most available prognostic nomograms in metastatic castration-resistant prostate cancer (mCRPC) are derived from datasets not representative of the current treatment landscape. A prognostic nomogram for first-line mCRPC treatment was developed from patients treated in the PREVAIL study.

OBJECTIVE: To validate the Armstrong model in the COU-AA-302 trial.

DESIGN, SETTING, AND PARTICIPANTS: A post hoc analysis of mCRPC patients treated in the COU-AA-302 trial was carried out (NCT00887198).

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The Armstrong prognostic model was applied to patients treated in COU-AA-302. A continuous risk score was derived from coefficients from the original model. Time-dependent area under the curve (tAUC) was used to evaluate the overall predictive ability of the model. Patients were categorized according to the number of risk factors present into those at a low (three or fewer risk factors), intermediate (four to six risk factors), and high (seven to ten risk factors) risk. The association with survival was assessed with Cox regression models. Interaction tests were used to assess the impact of treatment arm in each of the prognostic groups.

RESULTS AND LIMITATIONS: A total of 1088 patients were analyzed. The risk score was associated with overall survival (OS; tAUC 0.733). Most patients were at a low (49%) or intermediate (41%) risk. Risk category was significantly associated with OS (hazard ratio [HR]: 2.3; 95% confidence interval [CI]: 1.9-2.4; p < 0.001), radiographic progression-free survival (rPFS; HR: 1.7; 95% CI: 1.5-1.8; p < 0.001), and prostate-specific antigen progression-free survival (HR: 1.7; 95% CI: 1.5-1.9; p < 0.001). A significant interaction between risk group and OS (p = 0.007) and rPFS (p = 0.009) was observed. Survival was superior in low-risk patients (HR: 0.73; 95% CI: 0.59-0.89; p = 0.009), but similar in intermediate-risk (HR: 0.97; 95% CI: 0.79-1.21; p = 0.9) and high-risk (HR: 1.35; 95% CI: 0.80-2.28; p = 0.5) patients. Two-year OS rates in abiraterone versus placebo were 82% versus 74% in low-risk, 55% versus 52% in intermediate-risk, and 28% versus 31% in high-risk patients.

CONCLUSIONS: We validate the prognostic value of the Armstrong risk model in patients treated with first-line androgen receptor signaling inhibitors. Abiraterone provided a greater benefit in low-risk patients with less aggressive disease. Further research is needed to establish the role of Armstrong risk groups for treatment selection in mCRPC patients.

PATIENT SUMMARY: In this report, we validated the Armstrong nomogram in the COU-AA-302 trial population. We found a similar prognostic performance to that of the original model. Good-risk patients received the greatest benefit from abiraterone.

PMID:34373138 | DOI:10.1016/j.eururo.2021.07.014