The microINR portable coagulometer: analytical quality and user-friendliness of a PT (INR) point-of-care instrument

Regular measurement of prothrombin time as an international normalized ratio PT (INR) is mandatory for optimal and safe use of warfarin. Scandinavian evaluation of laboratory equipment for primary health care (SKUP) evaluated the microINR portable coagulometer (microINR^®) (iLine Microsystems S.L., Spain) for measurement of PT (INR). Analytical quality and user-friendliness were evaluated under optimal conditions at an accredited hospital laboratory and at two primary health care centres (PHCCs). Patients were recruited at the outpatient clinic of the Laboratory of Medical Biochemistry, St Olav’s University Hospital, Trondheim, Norway (n?=?98) and from two PHCCs (n?=?88). Venous blood samples were analyzed under optimal conditions on the STA-R^®Evolution with STA-SPA?+?reagent (Stago, France) (Owren method), and the results were compared to capillary measurements on the microINR^®. The imprecision of the microINR^® was 6% (90% CI: 5.3–7.0%) and 6.3% (90% CI: 5.1–8.3) in the outpatient clinic and PHCC2, respectively for INR ≥2.5. The microINR^® did not meet the SKUP quality requirement for imprecision ≤5.0%. For INR <2.5 at PHCC2 and at both levels in PHCC1, CV% was ≤5.0. The accuracy fulfilled the SKUP quality goal in both outpatient clinic and PHCCs. User-friendliness of the operation manual was rated as intermediate, defined by SKUP as neutral ratings assessed as neither good nor bad. Operation facilities was rated unsatisfactory, and time factors satisfactory. In conclusion, quality requirements for imprecision were not met. The SKUP criteria for accuracy was fulfilled both at the hospital and at the PHCCs. The user-friendliness was rated intermediate.     

Ultrasonic resonator technology as a new quality control method evaluating gelatin nanoparticles

Nanomedicine is a quickly evolving field where more and more possible applications become evident and start entering clinical trials or even the market. However, the analytic methods are not always able to keep pace with the new formulations’ demands. One example of a promising medical implementation is oligodeoxynucleotide (ODN) delivery by gelatin nanoparticles (GNPs). Currently, quality control is dependent on either some time consuming or destructive spectrometric, chromatographic or electrophoretic methods. A possible enlargement of the portfolio by Ultrasonic Resonator Technology (URT) is investigated here by subjecting plain GNPs in various sizes and concentrations as well as ODN-loaded GNPs to URT analysis. If calibrated by photon correlation spectroscopy (PCS) and other spectroscopy methods for each single nanoparticle system parameter, URT is an efficient and non-destructive technique and serves as a broad characterization method. URT is emphasized to play a possible future part in the size, concentration and ODN loading monitoring, e.g. of gelatin nanoparticles in the course of formulation development.     

Impact of disease severity on work productivity and activity impairment in Japanese patients with atopic dermatitis

Atopic dermatitis (AD) is a common inflammatory skin disease that is characterized by chronic and persisting pruritic and eczematous lesions. There has been no study of work productivity and activity in AD patients in relation to disease severity. The purpose of this study was to examine the impact of disease severity on work productivity and activity impairment (WPAI) in adult AD patients using the Japanese version of the questionnaire. Data were collected from 112 AD patients who visited the Jikei University Hospital. Outcomes as measured by the questionnaire included employment status, total work productivity impairment (TWPI) and total activity impairment (TAI). We investigated the correlation between TWPI or TAI scores and severity scoring of AD (SCORAD) for disease severity and dermatology life quality index (DLQI) for quality of life impairment. Both TWPI and TAI scores were significantly correlated with the SCORAD and DLQI scores (P < 0.001), indicating disease severity is significantly associated with WPAI in Japanese adult AD patients. Further studies are necessary to evaluate the effects of treatments on WPAI for severe AD patients.     

Quality of life,effort and disturbance perceived in noise: A comparison between employees with aided hearing impairment and normal hearing

Abstract

Objectives: The aims were to compare health-related quality of life (HRQOL) and hearing handicap between two groups of employees with normal hearing and aided hearing impairment (HI). HRQOL was also compared to a normative population. The second aim was to compare perceived effort (PE) and disturbance after completing a task in office noise between the two study groups. Design: A Swedish version of the short form-36 (SF-36) and the hearing handicap inventory for adults (HHIA) was used to determine HRQOL and hearing handicap. The Borg-CR 10 scale was used to measure PE and disturbance. Study sample: Hearing impaired (n = 20) and normally hearing (n = 20) participants. The normative sample comprised of 597 matched respondents. Results: Hearing-impaired employees report relatively good HRQOL in relation to the normative population, but significantly lower physical functioning and higher PE than their normally-hearing peers in noise. Results from the HHIA showed mild self-perceived hearing handicap. Conclusions: The current results demonstrate that physical health status can be negatively affected even at a mild-moderate severity of HI, and that a higher PE is reported from this group when performing a task in noise, despite the regular use of hearing aids.     

Reverse engineering techniques applied to a human skull,for CAD 3D reconstruction and physical replication by rapid prototyping

The production of a copy of an existing object of complex shape is one of the typical applications of the integration between two modern computer-based technologies, reverse engineering (RE) and rapid prototyping (RP). The method is extremely versatile and can be used in various applicative domains (e.g. replacement of anatomical parts with artificial prostheses, replication of skeletal remains). Two different acquisition techniques of images of a skull, by laser and by CT scan, were compared to ascertain which enabled more accurate reproduction of the original specimen. The skull was chosen due to it being the body part most often used in medico-legal investigations (for personal identification, skull-photo superimposition techniques, forensic art, etc). Comparison between the copy and the original yielded satisfactory results for both techniques. However, CT scanning demonstrated some advantages over the laser technique, as it provided a cleaner point cloud, enabling shorter pre-reproduction processing times, as well as data on the internal parts, which resulted in the reproduction of a more faithful copy.     

Self-Administered and Interviewer-Administered Instruments for Dementia Research

ABSTRACT

Objective: To compare data produced with instruments used to obtain information from caregivers of demented older adults, when the instruments are self-administered at home or administered by an interviewer.

Design: The functional status of patients with Alzheimer's disease was determined at baseline and six months later with three instruments using the patients' caregivers as informants. The instruments were both self-administered and administered by trained interviewers. Three other instruments were administered by interviewers only.

Setting: A geriatric clinic in an urban university teaching hospital and residences of the patients.

Participants: Thirty-four Alzheimer's patients and their caregivers completed the study.

Measurements: Three instruments were compared: an activities of daily living instrument, a sleep problem instrument, and a dysfunctional behavior instrument. Validity was determined by Pearson correlations and agreement with intraclass correlations (ICC) on base-line assessments. Instrument responsiveness was detcrmined by t-test comparisons of pre-post change scores.

Results: Correlations between instruments were consistent with predictions, and agreement between versions of the instruments as determined by ICC ranged from 0.71 to 0.89. The instrument used for the measurement of activities of daily living was more responsive to change over the six months when self-administered compared to interviewer-administered (p = 0.007). A reduction in sample size requirements was obtained as a result of the increased responsiveness of the self-administered version of the Lawton.

Conclusion: The results suggest that these self-administered instruments when completed at home by caregivers are valid, in agreement with and may be more responsive than interviewer-administered instruments.     

Compliance to the CONSORT statement of randomized controlled trials in solid organ transplantation: a 3‐year overview

The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting quality of randomized controlled trials (RCTs). Our primary aim was to assess to what extent reports of RCTs in solid organ transplantation adhere to the 2010 CONSORT statement. Secondly, we investigated the relationship between CONSORT adherence, methodological quality and some other factors. We included 290 RCTs that were published between 2007 and 2009. We examined to what extent trial reports complied with 30 items of the CONSORT statement. Methodological quality was evaluated using the Jadad scale plus allocation concealment and whether data analysis was by randomized group (intention to treat). On average, trial reports addressed 47% of the CONSORT items. Forty‐three per cent of RCTs was considered to be of good quality according to Jadad scale, and the items allocation concealment and data analysis were satisfied in approximately one‐third of trials. Good quality RCTs reported on more CONSORT items than poor quality trials. The methodological quality and adherence to the CONSORT statement of RCTs published in journals that endorse the CONSORT statement was superior to those in journals without CONSORT endorsement. Overall compliance with the CONSORT statement and the methodological quality of RCTs in organ transplantation remains unsatisfactory.     

A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms

Abstract

This paper proposes the development of a drug product Manufacturing Classification System (MCS) based on processing route. It summarizes conclusions from a dedicated APS conference and subsequent discussion within APS focus groups and the MCS working party. The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the API and the needs of the formulation. It has many applications in pharmaceutical development, in particular, it will provide a common understanding of risk by defining what the “right particles” are, enable the selection of the best process, and aid subsequent transfer to manufacturing. The ultimate aim is one of prediction of product developability and processability based upon previous experience.

This paper is intended to stimulate contribution from a broad range of stakeholders to develop the MCS concept further and apply it to practice. In particular, opinions are sought on what API properties are important when selecting or modifying materials to enable an efficient and robust pharmaceutical manufacturing process. Feedback can be given by replying to our dedicated e-mail address (mcs@apsgb.org); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.     

A structural equation model relating oral condition,denture quality,chewing ability,satisfaction, and oral health-related quality of life in complete denture wearers

ObjectivesTo investigate the relationship between mandibular ridge form, stability and retention of mandibular complete denture, accuracy of jaw relation recording, patients’ perception of chewing ability, satisfaction with dentures and oral health-related quality of life (OHRQoL) in complete denture wearers.MethodsA total of 183 edentulous patients, who visited the Dental Hospital of Tokyo Medical and Dental University for new complete dentures, were recruited. Oral examination was performed. Cawood and Howell's method was used to grade the mandibular ridge form. The stability and retention of the mandibular complete denture were assessed using Kapur method. Accuracy of jaw relation recording was evaluated using a newly developed jaw relation index. Patients’ perception of chewing ability was rated using a food intake questionnaire. Patients’ satisfaction with complete dentures was assessed on a 100-mm visual analogue scale. OHRQoL was measured using the Japanese version of the Oral Health Impact Profile for edentulous subjects. A structural equation model was constructed based on the hypothesis that oral condition and denture quality would be related to chewing ability, satisfaction and OHRQoL.ResultsSignificant relationships were found between mandibular ridge form, stability of mandibular complete denture, accuracy of jaw relation recording, perceived chewing ability, satisfaction and OHRQoL. Various fit indices were within acceptable limits.ConclusionsOral condition and denture quality were related to patients’ perception of chewing ability, satisfaction with dentures and OHRQoL in complete denture wearers.Clinical significanceA favourable oral condition and denture quality are important for successful complete denture therapy.