Making Sense of Home Pregnancy Test Instructions

Wallace, Lorraine S.; Zite, Nikki B.; Homewood, Virginia J

doi:10.1089/jwh.2008.0985

Cited by 22 publications

(12 citation statements)

References 25 publications

(32 reference statements)

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“…Fonts of open letter types and interline spacing equal or larger than 2 are better readable compared to fonts of closed letter types and interline spacing smaller than 2, especially at larger text columns. For patient education materials and health instructions, font sizes of 12 or larger are recommended [25,26]. …”

Section: Methodsmentioning

confidence: 99%

Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

Gillet

Maltha

Hermans

et al. 2011

Malar J

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BackgroundThe present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information.MethodsCriteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed.ResultsForty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n = 40) and (ii) ambiguous labelling of the reading window (n = 6). Buffer vial labels were lacking essential information (n = 24) or were of poor quality (n = 16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1 - 12.9) and user-unfriendly typography (median font size 8, range 5 - 10). Inadequacies included (i) no referral to biosafety (n = 18), (ii) critical differences between depicted and real devices (n = 8), (iii) figures with unrealistic colours (n = 4), (iv) incomplete information about RDT line interpretations (n = 31) and no data on test characteristics (n = 8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n = 4), (ii) not stating the identity of the pan-species antigen (n = 2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups.ConclusionOverall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information.

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Section: Methodsmentioning

confidence: 99%

Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

Gillet

Maltha

Hermans

et al. 2011

Malar J

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show abstract

“…Implementation of the FDA-approved athome pregnancy test provides an instructive example. Although these tests have been sold for over 40 years, and clinical trials research suggested at-home pregnancy tests could be implemented with high fidelity, subsequent studies provide convincing evidence that various population segments continue to have significant challenges with implementing at-home pregnancy tests [43][44][45][46]. Both SITs and at-home pregnancy testing require that program features fit the diverse populations that may use them, and those at highest risk may have characteristics (low income, poor education) that require different instructional strategies.…”

Section: Overviewmentioning

confidence: 99%

Bridging barriers to clinic-based HIV testing with new technology: translating self-implemented testing for African American youth

Catania

Dolcini

Harper

et al. 2015

Behav. Med. Pract. Policy Res.

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“…Font size was measured in Cicero as the ‘kp’ distance. For health instructions in general, font sizes >12 are recommended, interline spacing ≥2 and fonts of open letter types [16]. The readability level was expressed as Flesh Kincaid grade level.…”

Section: Methodsmentioning

confidence: 99%

“…The readability level was expressed as Flesh Kincaid grade level. There are no criteria of readability levels for IFUs but for patient education files, a level ≤6 th grade is recommended [16].…”

Section: Methodsmentioning

confidence: 99%

Self-Diagnosis of Malaria by Travelers and Expatriates: Assessment of Malaria Rapid Diagnostic Tests Available on the Internet

et al. 2013

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IntroductionIn the past malaria rapid diagnostic tests (RDTs) for self-diagnosis by travelers were considered suboptimal due to poor performance. Nowadays RDTs for self-diagnosis are marketed and available through the internet. The present study assessed RDT products marketed for self-diagnosis for diagnostic accuracy and quality of labeling, content and instructions for use (IFU).MethodsDiagnostic accuracy of eight RDT products was assessed with a panel of stored whole blood samples comprising the four Plasmodium species (n = 90) as well as Plasmodium negative samples (n = 10). IFUs were assessed for quality of description of procedure and interpretation and for lay-out and readability level. Errors in packaging and content were recorded.ResultsTwo products gave false-positive test lines in 70% and 80% of Plasmodium negative samples, precluding their use. Of the remaining products, 4/6 had good to excellent sensitivity for the diagnosis of Plasmodium falciparum (98.2%–100.0%) and Plasmodium vivax (93.3%–100.0%). Sensitivity for Plasmodium ovale and Plasmodium malariae diagnosis was poor (6.7%–80.0%). All but one product yielded false-positive test lines after reading beyond the recommended reading time. Problems with labeling (not specifying target antigens (n = 3), and content (desiccant with no humidity indicator (n = 6)) were observed. IFUs had major shortcomings in description of test procedure and interpretation, poor readability and lay-out and user-unfriendly typography. Strategic issues (e.g. the need for repeat testing and reasons for false-negative tests) were not addressed in any of the IFUs.ConclusionDiagnostic accuracy of RDTs for self-diagnosis was variable, with only 4/8 RDT products being reliable for the diagnosis of P. falciparum and P. vivax, and none for P. ovale and P. malariae. RDTs for self-diagnosis need improvements in IFUs (content and user-friendliness), labeling and content before they can be considered for self-diagnosis by the traveler.

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Making Sense of Home Pregnancy Test Instructions

Cited by 22 publications

References 25 publications

Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

Bridging barriers to clinic-based HIV testing with new technology: translating self-implemented testing for African American youth

Self-Diagnosis of Malaria by Travelers and Expatriates: Assessment of Malaria Rapid Diagnostic Tests Available on the Internet

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