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There are wide variations in the practices of patient involvement in health technology assessment (HTA) in Europe. The field is lacking a consensus on good practices, leading to divergent processes, methods, and evaluation of patient involvement. To identify potential good practice approaches and current gaps, a structured online survey was conducted among HTA stakeholders, including HTA practitioners, patient stakeholders, industry representatives, and others who had experienced patient involvement in HTA.
Methods
The questionnaire was co-created by HTA experts, patient stakeholders, and industry representatives and disseminated between 29 April and 14 September 2022.
Results
Responses (n = 168) were submitted from thirty-two European countries by HTA practitioners (n = 33), patient stakeholders (n = 75), industry stakeholders (n = 42), providers (n = 5), academics (n = 7), and others (n = 6). The responses indicated that “allowing access to treatments that have demonstrated value”is the principle rationale for conducting HTA. In terms of the importance of patient involvement, there was consensus across stakeholder groups that “patients have insights and information [that] no other stakeholder has” and that patient involvement is important “to inform HTA which evidence is most patient-relevant”. Shortcomings were identified in the lack of systematic and transparent processes, an unsatisfactory level of information and guidance, and minimal communication and collaboration.
Conclusions
The diverse stakeholders who responded highlighted the need for improving specific aspects of patient involvement practices, including better guidance and information, a more consistent flow of communication between the HTA body and participating patient stakeholders, and the need to develop and implement a consensus on good practices.
This study provides researchers, practitioners, and policy makers with a profile of older adults’ travel behaviour and the older adult population that reports unmet travel needs. In addition, we quantified associations between reporting an unmet travel need and measures of health and social connectedness. Data came from the second follow-up survey of the Canadian Longitudinal Study on Aging, collected from 2018 to 2021 (n = 14,167). Nine in ten (90.2%) older adults aged 65 years and older indicated that driving is the main way they get around. Older adults with an unmet travel need were more likely to be women, have lower household incomes and education levels, and have a mobility limitation. People with an unmet travel need had 2.7 times the odds of reporting fair or poor general health (OR = 2.66, 95% CI: 2.19, 3.22) and 3.1 times the odds of feeling socially isolated (OR = 3.10, 95% CI: 2.57, 3.72) compared to those without an unmet need.
The aim of this study is to evaluate the validity and reliability of the Perceived Nutrition Environment Measures Survey (NEMS-P) translated and adapted for use in Brazil.
Design:
Validation of the NEMS-P questionnaire. The questionnaires were applied to assess validity and reliability, based on exploratory factor analysis, Cronbach’s α coefficient and intra-class correlation, with a significance level of 95 %.
Setting:
Brazil.
Participants:
Adults over 20 years of age diagnosed with hypertension were included in the internal validity and reliability test (n 176) and intra-rater reliability (subsample n 35).
Results:
Factor analysis obtained satisfactory results. Internal consistency was acceptable for most items, with Cronbach’s α ranging from 0·6 to 0·9. The intra-rater reliability of the subsample was also valid, with intra-class correlation coefficient values ranging from 0·5 to 0·9.
Conclusion:
This work reveals the usefulness of the instrument to assess the perceived food environment in the Brazilian context, being able to measure what is proposed according to its theoretical model, and reproduces the values when applied to a sample different from its original validation. However, refinement of some questions is suggested. Finally, it demonstrates the possibility of using the entire instrument or each section independently, according to the food environments to be investigated.
The Harmonized Cognitive Assessment Protocol (HCAP) describes an assessment battery and a family of population-representative studies measuring neuropsychological performance. We describe the factorial structure of the HCAP battery in the US Health and Retirement Study (HRS).
Method:
The HCAP battery was compiled from existing measures by a cross-disciplinary and international panel of researchers. The HCAP battery was used in the 2016 wave of the HRS. We used factor analysis methods to assess and refine a theoretically driven single and multiple domain factor structure for tests included in the HCAP battery among 3,347 participants with evaluable performance data.
Results:
For the eight domains of cognitive functioning identified (orientation, memory [immediate, delayed, and recognition], set shifting, attention/speed, language/fluency, and visuospatial), all single factor models fit reasonably well, although four of these domains had either 2 or 3 indicators where fit must be perfect and is not informative. Multidimensional models suggested the eight-domain model was overly complex. A five-domain model (orientation, memory delayed and recognition, executive functioning, language/fluency, visuospatial) was identified as a reasonable model for summarizing performance in this sample (standardized root mean square residual = 0.05, root mean square error of approximation = 0.05, confirmatory fit index = 0.94).
Conclusions:
The HCAP battery conforms adequately to a multidimensional structure of neuropsychological performance. The derived measurement models can be used to operationalize notions of neurocognitive impairment, and as a starting point for prioritizing pre-statistical harmonization and evaluating configural invariance in cross-national research.
The purpose of the study was to design, develop, and validate a newer tool on radiation emergency preparedness responses (RadEM-PREM IPE tool) to measure communication, knowledge, performance skills in multidisciplinary health science learners.
Methods:
The study design is a prospective, single centric, pilot study. Five subject experts designed, analyzed, and selected items of the instrument for relevant content and domain. Psychometrics that the tool assessed were content validity, internal consistency, test-retest reliability, and intraclass correlation coefficient. Twenty-eight participants completed test-retest reliability for validation of 21 sorted out items calculated percentage of agreement >70% I-CVI/UA (item content validity index with universal acceptability) and S-CVI/UA (scale content validity index with universal agreement method).
Results:
Items with percentage agreement >70% and I-CVI over 0.80 were kept, ranged from 0.70 to 0.78 were revised, and below 0.70 were rejected. Items with kappa values ranging from 0.04 to 0.59 were revised and ≥0.74 were retained. Internal consistency assessed using Cronbach’s alpha was 0.449. Positive correlation between attitude and communication (r = 0.448), between performance and communication (r = 0.443) were statistically significant at 0.01 level. Overall, intraclass correlation coefficient for all the measures is 0.646, which is statistically significant at 0.05 level (P < 0.05).
Conclusions:
Study concludes that the RadEM-PREM IPE tool would be a new measuring tool to assess knowledge, performance, and communication skills of interprofessional radiation emergency response team learner’s evaluation.
The objective was to characterize the progression of sleep complaints in 115 dystrophy type 1 (DM1) patients who filled out a sleep questionnaire twice at a 9-year interval. Daytime napping (22.1% vs. 34.5%, p < 0.05), early awakenings (11.4% vs 21.1%, p < 0.05), nonrestorative sleep (39.5% vs 51.8%, p < 0.05), stimulant use (7.0% vs 19.3%, p < 0.01), breathing cessation (10.7% vs 23.2%, p < 0.01), and nighttime urination (42.5% vs 54.9%, p < 0.05) increased between Time 1 and Time 2. Sleep-related complaints are prominent and augment rapidly in DM1 patients. Physicians need to better identify and treat them to help alleviate the burden they impose on patients and their caregivers.
To assess hearing rehabilitation in patients with congenital aural atresia using an active middle-ear implant (Vibrant Soundbridge).
Methods
Of a cohort of 70 microtia and atresia patients, 10 underwent Vibrant Soundbridge implantation between 2008 and 2021. Two of the 10 patients had binaural implantation, resulting in 12 ears for analysis. Pre- and post-operative audiometry data were analysed, and patient satisfaction was evaluated. Surgical issues regarding coupling sites and outcomes were analysed.
Results
Pure tone average (0.5, 1, 2 and 4 kHz) improved from a pre-operative mean (standard deviation) of 65.3 (8.7) dB HL to a post-operative mean of 26.8 (4.9) dB HL. This resulted in a mean pure tone average gain of 38.5 dB HL. The results indicate no obvious difference between stapes (n = 8) and incus (n = 4) coupling. The mean effective gain for 0.5, 1, 2 and 4 kHz was −17.8 dB HL (standard deviation = 4.3). Concerning effective gain, Vibrant Soundbridge performed best at 2 kHz. Patients reported high overall satisfaction, good sound quality and strongly improved directional hearing.
Conclusion
An active middle-ear implant (Vibrant Soundbridge) allows hearing rehabilitation in selected atretic ears, and provides long-term hearing stability in children and adults.
Measurement-based care (i.e., the systematic use of rating scales to guide clinical decision-making) has shown great promise in the treatment of major depression in clinical trials. Unfortunately, measurement-based care has not yet gained ground in clinical practice, possibly because clinician-rated scales are time-consuming and limited by the availability of trained raters. Hence, brief and valid self-rated scales (questionnaires) may serve as an alternative or supplement to clinician-rated scales. The self-rated 6-item Hamilton Depression Rating Scale (HAM-D6-SR) has shown some promise in this regard, but its validity among inpatients remains unclear.
Objectives
The objective of this study is to evaluate the criterion validity and responsiveness (sensitivity to change) of the HAM-D6-SR among inpatients using the clinician-rated 17-item Hamilton Rating Scale for Depression (HAM-D17) as gold standard reference.
Methods
Inpatients with depression will complete the HAM-D6-SR twice during admission (at least one week between the two self-ratings). At both occasions, the patients will subsequently be rated on the HAM-D17 by trained raters, who are blind to the HAM-D6-SR ratings. The agreement between the HAM-D6-SR and the HAM-D6 extracted from the HAM-D17 will be evaluated using intra-class correlation.
Results
A total of 100 inpatients will be recruited for the study. Data collection is ongoing, and the results of the study will be presented at the 2022 EPA meeting.
Conclusions
If the agreement between the HAM-D6-SR and the HAM-D6 extracted from the HAM-D17 is satisfactory, the HAM-D6-SR could inform decision-making in the treatment of depression.
Disclosure
The presenting author, PK, declares no conflict of interests. Co-author, SDØ, has received the 2020 Lundbeck Foundation Young Investigator Prize. Furthermore, SDØ owns units of mutual funds with stock tickers DKIGI, DKIDKIX, MAJGRO, NBIDE, SPVILRKL and WE
The operating theatre, as the primary learning environment for surgeons, needs to be conducive to achieve successful training. A validated 27-item questionnaire aimed at evaluating the training experience of higher surgical trainees in the operating theatre was developed.
Methods
The initial questionnaire was developed using a literature review and a focus group. Items were validated with content validity index (CVI) and Cronbach's alpha.
Results
The initial version of 33 questions was modified in the focus group into a 29-item 4-point Likert scale questionnaire covering 3 areas. Of these 29 items, 27 reached the threshold CVI of 0.87, and they achieved a Cronbach's alpha of 0.89 from 17 responses.
Conclusion
The quantitative validations in the instrument are comparable to other existing medical education evaluation tools. Aspects of non-technical skills and human factors were featured heavily and perceived to be important for learning in the operating theatre.
This study aimed to determine the implications of including tympanometry in the Rapid Assessment of Hearing Loss survey protocol. A comparative study design was employed, with findings from otoscopy compared with the results of tympanometry.
Method
A population-based survey of the prevalence and causes of hearing loss among adults aged over 35 years in The Gambia was conducted. Clinical assessments included air conduction audiometry, otoscopy and clinical history. Otoscopy outcome was recorded and for those with hearing loss, a probable cause was assigned. Following otoscopy, tympanometry was completed. Otoscopy outcome was not changed as a result of tympanometry. Clinician assigned cause was compared to the results of tympanometry. The proportion of causes potentially misclassified by excluding tympanometry was determined.
Results
Among people with hearing loss, including tympanometry led to a higher proportion diagnosed with middle-ear conditions.
Conclusion
The value of adding tympanometry to population-based survey protocols is a higher estimated proportion of hearing loss being attributed to middle-ear disease rather than sensorineural causes. This can inform service needs as more people will be classified as needing medical or surgical services, and a slightly lower number will need rehabilitative services, such as hearing assistive devices. It is highly recommended that tympanometry is included in the protocol.
To assess parent or guardian satisfaction with a newly instituted day-case tonsillectomy programme at a tertiary paediatric institution.
Methods
After receiving ethical approval, an anonymous questionnaire was sent to the parent or guardian of every patient who underwent day-case tonsillectomy between July 2018 and December 2020.
Results
A total of 135 patients were included. The parent or guardian of each patient was sent a questionnaire to be filled in and returned. Ninety-two completed surveys were returned. There were high satisfaction levels, with 91.3 per cent of parents or guardians feeling comfortable bringing their child home, and 92.4 per cent of parents or guardians would recommend day-case tonsillectomy to another parent or guardian. Of the parents or guardians, 10.9 per cent needed to contact healthcare services in the 24 hours following surgery.
Conclusion
Day-case tonsillectomy has proven to be a safe, efficient service at our institution, with high satisfaction levels from patients and parents or guardians. Areas for improvement focused on communication at the time of discharge regarding follow up and analgesia.
A disproportionate number of people with mental ill-health experience social exclusion. Appropriate measurement tools are required to progress opportunities to improve social inclusion. We have developed a novel measure, the Filia Social Inclusion Measure (F-SIM). Here we aimed to present a more concise, easy-to-use form, while retaining its measurement integrity by (i) refining the F-SIM using traditional and contemporary item-reduction techniques; and (ii) testing the psychometric properties of the reduced measure.
Methods
Five hundred and six participants completed the F-SIM, younger and older groups of people with serious mental illness (including psychosis, mood, anxiety disorders) and same-aged community counterparts. The F-SIM was completed at baseline and 2-week follow-up, alongside other measures (including social inclusion, loneliness). The F-SIM was refined using multidimensional scaling network analysis, confirmatory factor analysis and item response theory. The psychometric evaluation included assessment of dimensionality, internal consistency, test–retest reliability, discriminant ability and construct validity.
Results
The F-SIM was reduced from 135-items to 16; with 4-items in each domain of housing and neighbourhood, finances, employment and education and social participation and relationships. Psychometric properties were sound, including strong internal consistency within domains (all α > 0.85) and excellent overall (α = 0.92). Test–retest reliability was also high (γ = 0.90). Differences between groups were observed; clinical subgroups consistently reported lower levels of social inclusion compared to community counterparts.
Conclusions
The F-SIM16 is a sound, reliable, brief self-report measure of social inclusion suitable for use in clinical and research settings. It has the potential to evaluate the effectiveness of interventions, and aid in fostering targeted and personalised needs-based care.
Subjective tinnitus is a common symptom, and there is often an underlying otological cause. This study investigated the degree of tinnitus-related annoyance in patients with chronic otitis media and analysed whether associations with tinnitus severity exist.
Method
The multinational collaborative Chronic Otitis Media Questionnaire-12 study collected prospective data on 478 adult patients suffering from chronic otitis media across 9 otology referral centres in 8 countries. Based on this dataset, we investigated tinnitus severity using participant responses to item 7 of a native version of the Chronic Otitis Media Questionnaire-12.
Results
With respect to tinnitus severity, 23.8 per cent, 17.4 per cent, 15.5 per cent, and 43.4 per cent of participants reported no, minor, moderate, and major inconvenience or greater, respectively. The absence of ear discharge, absence of cholesteatoma, and poorer disease-specific health-related quality-of-life were associated with increased tinnitus severity in patients with chronic otitis media, whereas age, hearing disability and geographical region showed no association.
Conclusion
This analysis provided novel insight into potential risk factors for tinnitus in patients with chronic otitis media.
This study aimed to provide an objective means of identifying patterns in academic publication among ENT trainees during their higher surgical training.
Method
A cross-sectional survey was distributed to ENT higher surgical trainees.
Results
A total of 153 ENT specialty trainees participated, giving a response rate of 46.5 per cent. Across all years of training, the mean number of first author publications was three and the mean number of non-first author publications was two. For trainees at specialty trainee year 8 level, these figures were nine and five, respectively. Participants with doctoral degrees and those in academic programmes published more papers but the mean difference was only significant for the doctoral subgroup (p < 0.0001). Those with additional undergraduate degrees and those in less than full-time training had an overall lower number of publications.
Conclusion
Participants in the current survey achieved a higher average number of academic publications than is presently required to successfully complete higher surgical training in ENT. It is hoped that these results act as a guide for trainees planning the research component of their training to ensure that they remain competitive at consultant interview.
To develop an international template to support patient submissions in Health Technology Assessments (HTAs). This was to be based on the experience and feedback from the implementation and use of the Scottish Medicines Consortium's (SMC) Summary Information for Patient Groups (SIP).
Methods
To gather feedback on the SMC experience, web-based surveys were conducted with pharmaceutical companies and patient groups familiar with the SMC SIP. Semistructured interviews with representatives from HTA bodies were undertaken, along with patient group discussions with those less familiar with the SIP, to explore issues around the approach. These qualitative data informed the development of an international SIP template.
Results
Survey data indicated that 82 percent (18 of 22 respondents) of pharmaceutical company representatives felt that the SIP was worthwhile; 88 percent (15/17) of patient group respondents found the SIP helpful. Both groups highlighted the need for additional support and guidance around plain language summaries. Further suggestions included provision of a glossary of terms and cost-effectiveness information. Patient group interviews supported the survey findings and led to the development of a new template. HTA bodies raised potential challenges around buy-in, timing, and bias connected to the SIP approach.
Conclusions
The international SIP template is another approach to support deliberative processes in HTA. Although challenges remain around writing summaries for lay audiences, along with feasibility considerations for HTA bodies, the SIP approach should support more meaningful patient involvement in HTAs.
Recent terror attacks led the Norwegian government to develop a procedure for emergency and law enforcement services cooperation during Active Violent Incidents (AVI, abbreviated PLIVO in Norwegian). To address further national initiatives to improve preparedness for mass casualty events and penetrating injuries among emergency medical services (EMS) in Norway, training and equipment status were mapped.
Methods:
All EMS regions in Norway were invited to participate in an electronic nation-wide survey about practical medical training in PLIVO scenario training and specific training in hemorrhage control and penetrating injuries.
Results:
Ninety percent (842/938) had attended at least 1 PLIVO training scenario. Of these, 76% (642/938) reported only evacuation training during the exercise, while only 20% (168/938) had practiced hemorrhage control. Eighty-one percent (760/938) respondents reported that they were equipped with tourniquets and 91% (853/938) were equipped with gauze to pack wounds. However, only 52% (487/938) and 48% (450/938) reported practical training in tourniquet application and wound packing, respectively, while 30% (280/938) reported that they had no training or only theoretical education in tourniquet application. Supervised practical training on penetrating thoracic injuries was reported by <20%, and <50% reported practical training in needle decompression of a tension pneumothorax.
Conclusions:
Enhanced focus on training in hemorrhage control and penetrating injuries is needed. This supports the recent decision from the Norwegian government to strengthen the training for EMS in AVI (PLIVO) exercises, by focusing on medical procedures in addition to evacuation training. Although the estimated response rate is 17%, we believe the large number of respondents still make the results valuable.
The audiological benefits of a bone conducting hearing implant are well documented; however, there is a paucity of literature comparing pre- and post-operative quality of life benefits. This study assessed the quality of life status before and after the device is implanted.
Methods
A prospective study was conducted of all adult bone conducting hearing implants inserted in a teaching hospital between 2012 and 2017. All patients completed the Glasgow Health Status Inventory, a validated quality of life questionnaire, before and three to six months after implantation.
Results
Sixty-two patients received a unilateral bone conducting hearing implant. All scores except the social score improved post-operatively. The paired t-test showed that the differences in the means for the Glasgow Health Status Inventory total, general and physical scores were statistically significant at the 5 per cent level (p < 0.0001).
Conclusion
This study, one of the few to assess quality of life pre- and post-implantation, showed a vast improvement in patients’ perceived quality of life from the pre- to the post-operative phase.
Accounts of patient experiences are increasingly used in health technology assessment (HTA) processes. However, we know little about their impact on the decision-making process. This study aims to assess the level and the type of impact of patient input to highly specialised technologies (HSTs) and interventional procedures (IPs) guidance at the National Institute for Health and Care Excellence (NICE).
Methods
A questionnaire was developed to capture quantitative and qualitative data on the amount and type of impact of patient input into NICE HTAs. It was completed by committee members of the guidance-producing programs after a discussion of the considered topics. The data were analyzed by topic and overall, for each program, and compared across programs.
Results
Patient input was assessed on ten pieces of HST guidance published between January 2015 and November 2019, and on twenty-six pieces of IP guidance scoped between February 2016 and October 2018. A total of 96 responses were collected for HST and 440 for IP. The level of impact of patient input was higher for HST than for IP. For HST, no respondents stated that it had no impact, whereas in IP, 35 percent of respondents did. The most common types of impact found for HST and IP were that it helped interpret the other evidence and that it provided new evidence.
Conclusions
The impact of patient input is not necessarily explicit in changing recommendations, but it provides context, reassurance, and new information to the committee for the decision-making process in HTAs.
The ENT run through pilot was introduced in 2018 to improve early recruitment to the specialty. This study aimed to understand what makes a successful interview applicant and the experience of the run through trainees during the specialty trainee one and specialty trainee two years.
Method
A questionnaire survey was sent to all ENT run through trainees.
Results
Twenty-three trainees responded. Of the successful candidates, 74 per cent held additional degrees prior to application. The median core surgical interview rank was 27 (range: 3–174). Trainees felt that being on the run through pilot had increased ENT trainer engagement.
Conclusion
The ENT run through posts are highly competitive, and holding an additional degree may improve applicant success. The pilot programme has been successful by increasing trainer engagement at this critical stage of training. These results will enable development of the pilot programme and provide valuable information for those applying to an ENT run through post.
To investigate how individuals with a history of affective disorder use and perceive their use of social media and online dating.
Methods:
A questionnaire focusing on affective disorders and the use of social media and online dating was handed out to outpatients from unipolar depression and bipolar disorder clinics and general practice patients with or without a history of affective disorders (latter as controls). The association between affective disorders and use of social media and online dating was analysed using linear/logistic regression.
Results:
A total of 194 individuals with a history of unipolar depression, 124 individuals with a history of bipolar disorder and 196 controls were included in the analysis. Having a history of unipolar depression or bipolar disorder was not associated with the time spent on social media compared with controls. Using the controls as reference, having a history bipolar disorder was associated with use of online dating (adjusted odds ratio: 2.2 (95% CI: 1.3; 3.7)). The use of social media and online dating had a mood-congruent pattern with decreased and more passive use during depressive episodes, and increased and more active use during hypomanic/manic episodes. Among the respondents with a history of affective disorder, 51% reported that social media use had an aggravating effect on symptoms during mood episodes, while 10% reported a beneficial effect. For online dating, the equivalent proportions were 49% (aggravation) and 20% (benefit), respectively.
Conclusion:
The use of social media and online dating seems related to symptom deterioration among individuals with affective disorder.