#1 Ease of Use of Bottles and Jars for Users with Arthritis A study of ease of use issues and potential design solutions for designers and consumers. W. Bradley Fain, Ph.D. Keith A. Kline, M.S. May 2009 Preface This monograph documents the methods and results of research conducted in the Accessibility Evaluation Facility (AEF) of the Georgia Tech Research Institute. The AEF has performed a series of ease of use evaluations for the Arthritis Foundation, the Arthritis Society of Canada, and industry customers. Although information about the outcome of specific evaluations has been withheld, the data and recommendations presented in this monograph are based upon general outcomes and lessons learned from research and product evaluations conducted at the Georgia Tech Research Institute. For additional information about this monograph please contact: Dr. Brad Fain Georgia Tech Research Institute ELSYS/HSID/HSEB Mail Code 0837 Atlanta, GA 30332-0837 Voice (404) 407-7261 Fax (404) 407-9261 brad.fain@gtri.gatech.edu ii Table of Contents Preface................................................................................................................................. ii Table of Contents ............................................................................................................... iii List of Tables ...................................................................................................................... v List of Figures .................................................................................................................... vi Introduction ......................................................................................................................... 1 Impact of Container Design on People with Arthritis .................................................... 1 Tasks Associated with Container Usage ......................................................................... 2 Container Components and Variations ........................................................................... 4 Container Body ........................................................................................................... 5 Cap .............................................................................................................................. 5 Outer Safety Seal ........................................................................................................ 6 Inner Safety Seal ......................................................................................................... 7 Instructions and Labels ............................................................................................... 8 User Characteristics .......................................................................................................... 10 Types of Arthritis .......................................................................................................... 11 Osteoarthritis ............................................................................................................. 11 Rheumatoid Arthritis ................................................................................................ 12 Evaluation Methodologies ................................................................................................ 13 Ease of Use Issues and Potential Solutions....................................................................... 16 What are the common issues associated with the body of the container? .................... 17 The container may be too large to be gripped comfortably with adequate force. .... 17 The container may slip in the user’s hand. ............................................................... 21 What are the common issues associated with removing a twist-off cap? ..................... 23 Removing a factory sealed cap may require too much force. ................................... 23 Removing a cap may be difficult after it has been tightened by a user. ................... 25 The cap may slip in the user’s hand as he or she attempts to twist it. ...................... 26 Caps with a large diameter prevent a strong grasp. .................................................. 29 Short caps prevent a strong grasp. ............................................................................ 30 The amount of angular rotation required to remove the cap may be too great. ........ 31 What are the issues associated with opening a pop-open cap? ..................................... 32 The amount of force required to pop open the cap is too great. ............................... 32 The surface of the push tab is too small or too sharp................................................ 34 What are the issues associated with removing the outer safety seal or packaging? ..... 35 Removal of some outer safety seals requires the use of a tool. ................................ 35 The outer safety seal is intended to be broken as the product is initially opened, but the force requirement may be too great. ................................................................... 38 The packaging box does not have a flap or tab for the user to pull. ......................... 40 What are the issues associated with removing the inner safety seal? ........................... 42 The user cannot peel the seal from the container. ..................................................... 42 The user cannot puncture the seal with a finger. ...................................................... 44 What are the issues associated with instructions and labeling? .................................... 45 The text or graphics are difficult to see. ................................................................... 45 The text is difficult to find. ....................................................................................... 46 The expiration date is difficult to find, read, or interpret. ......................................... 47 iii Design Guidelines ............................................................................................................. 49 References ......................................................................................................................... 55 iv List of Tables Table 1: Tasks associated with container usage. ................................................................ 2 Table 2: Hand anthropometry of non-disabled individuals (Sources: [11, 13, 23]). ........ 10 Table 3: Maximum grip diameters of individuals with and without dexterity disabilities (Source: [11]). ................................................................................................................... 11 Table 4: Maximum grip diameters of individuals with and without dexterity disabilities (Source: [11]). ................................................................................................................... 19 Table 5: Relationships between maximum grip diameter and cylinder diameter for maximum grip force. ......................................................................................................... 19 Table 6: Ease of use guidelines for container design. ....................................................... 49 v List of Figures Figure 1: An assortment of containers. ............................................................................... 1 Figure 2: Container components. ........................................................................................ 5 Figure 3: A cylindrical plastic container wrapped in a paper label. ................................... 5 Figure 4: An assortment of caps. ........................................................................................ 6 Figure 5: Outer safety seals include (a) packaging boxes, (b) plastic wrappings on the cap, and (c) rings that bind the cap to the bottle. ................................................................ 7 Figure 6: Outer safety seal design featuring a thin strip of plastic connecting the cap to the lower ring. ..................................................................................................................... 7 Figure 7: Inner safety seals. ................................................................................................ 8 Figure 8: Example of an expiration date that is difficult to read. ....................................... 9 Figure 9: Joints of the hand ............................................................................................... 12 Figure 10: Rheumatoid arthritis can cause deformation of the joints, resulting in stiffness and restricted range of motion. ......................................................................................... 13 Figure 11: A user's grip strength (left) and pinch strength (right) are measured. ............. 15 Figure 12: The Wong-Baker FACES Pain Rating Scale. ................................................. 15 Figure 13: Indentions in a container allow a smaller grip diameter. ................................ 18 Figure 14: Indentions in the side of a large container provide good grasping points. ...... 18 Figure 15: A non-cylindrical container is easier for users to grasp. ................................. 21 Figure 16: Containers with shallow threading (left) and steep threading (right). ............. 25 Figure 17: A rubber coating on the cap increases surface friction and decreases required grip force. .......................................................................................................................... 26 Figure 18: A smooth knob (left) and knurled knob (right) (Source: [10])........................ 26 Figure 19: Average torque generated on round and knurled caps by individuals with arthritis. ............................................................................................................................. 27 Figure 20: Smoothly contoured knurls. ............................................................................ 27 Figure 21: Widely spaced, smooth knurls......................................................................... 28 Figure 22: Three styles of pop-open caps: the entire cap pops open (left), part of the cap pops open (center), and a button causes part of the cap to pop open (right). ................... 32 Figure 23: A push tab that is too small and has a sharp edge. .......................................... 34 Figure 24: The indentation on this flip cap is large and smooth. ...................................... 34 Figure 25: The perforations on this outer seal are clearly visible. .................................... 36 Figure 26: The outer seal is broken when the user first twists the cap. ............................ 38 Figure 27: A box with a perforated strip. .......................................................................... 40 Figure 28: A box that provides a large tab under which the user can insert a finger. ...... 40 Figure 29: The inner seal is easy to remove because of the large tab on the edge. .......... 42 Figure 30: An expiration date that is difficult to read. ...................................................... 47 Figure 31: An expiration date that is easy to read. ........................................................... 47 vi Introduction According to the CDC’s Morbidity and Mortality Weekly Report, over 46 million American adults have been diagnosed with arthritis by a doctor [5]. Of these, 19 million Americans report that arthritis limits their daily activities in some way [6], and nearly 9 million Americans are disabled as a result of arthritis making it the most common cause of disability in the United States [4]. By 2030, it is expected that arthritis will affect an estimated 67 million American adults [5]. Many individuals with arthritis experience difficulty performing a variety of everyday tasks, such as opening and using product containers. The products under consideration in this monograph include jars, beverage bottles, and non-child resistant pill bottles, which are collectively referred to as “containers” (see Figure 1). These products vary in size, weight, shape, texture, safety seal design, and operating force requirements. Each of these design components affects a user’s experience with the product, especially users who suffer from the symptoms of arthritis. As a result, users with arthritis may be unable to use certain products, or may experience considerable pain and difficulty during use. This monograph discusses aspects of container design that affect ease of use for individuals with arthritis. Figure 1: An assortment of containers. There are two primary reasons why a company may choose to design products that are considered arthritis-friendly. First, a considerable portion of the market share is composed of individuals with arthritis, which is the most common cause of functional physical limitations in the United States. For users with arthritis, ease of use can become a key market discriminator in a group of similar, competing products. Second, products that are easy to use for individuals with arthritis will also be easy to use for most of the general population. Impact of Container Design on People with Arthritis Users with arthritis may frequently experience difficulty and pain when attempting to perform routine tasks such as opening containers. Beyond difficulty and pain, users may 1 also feel a sense of helplessness and a loss of independence. These negative feelings are likely to be directly associated with the product, and may reduce the chance that the product will be purchased again. Instead, the user may seek a competing product that appears to be easier to use. A tarnished product image may be extended to all products of the same brand. That is, a user might assume that all products of a given brand are equally difficult to use. Whereas those products that are difficult to use may generate avoidance, products that are easy to use may generate loyalty to the product and brand. Such products may stand out in the user’s mind as notable exceptions to the daily frustrations of living with arthritis and may help to restore a sense of independence. Tasks Associated with Container Usage To assess ease of use, the interaction between the user and the product should not be thought of as a single operation. Instead, the interaction should be decomposed into distinct operations. In this manner, the ease or difficulty of each operation can be assessed individually, and specific recommendations for improvement can be provided. Tasks are identified in a structured analysis of all the users’ actions associated with product usage. This may be accomplished by observing individuals as they use the product in a naturalistic setting. It is often beneficial to observe more than one user, because some users might skip operations or perform them differently than other users. For example, some users might neglect a container’s instructions for opening. Task analysis results for container usage are shown in Table 1. Table 1: Tasks associated with container usage. 1. Grasp and lift the container 2. Review product labeling and instructions 3. Remove the outer safety seal, or open the outer packaging 4. Open the cap 5. Remove the inner seal 6. Dispense contents of the container (extract a pill, pour or drink from the bottle, or scoop contents from the jar) 7. Close the container Each of the tasks in Table 1 may present difficulty for users with arthritis. In order to make a product that is truly easy to use, it is not sufficient to make most tasks easy, while neglecting one or more tasks. A single, difficult task can represent a significant barrier to overall ease of use. Hence, designers should carefully consider the ease of all tasks, rather than focusing on a single task that may seem more salient than others. Below is a 2 description of each task and a brief introduction of the associated container characteristics that impact task performance. Grasp and lift the container. For usage and transportation, a container must be grasped and lifted. In most cases this is a single handed operation, and the other hand is free to open the container or execute other related tasks. Grasping and lifting a container may be difficult if the container is heavy, large, or does not provide a good gripping surface. Individuals with arthritis may experience difficulty due to limited strength, dexterity, and range of motion. They may also experience pain as they attempt to extend inflamed joints beyond comfortable positions. As a result, some individuals with arthritis may be unable to use the product as intended by the manufacturer, or they may risk dropping the container. Review product labeling and instructions. In order to safely and effectively use many products, users must be able to read safety information, expiration dates, and dosage instructions. This critical information must be noticeable and readable for all users. Older adults, many of whom have age-related arthritis symptoms, typically have decreased visual acuity. Therefore, older adults may have difficulty reading product labeling and instructions that are printed in small font or with poor contrast. Although this difficulty is not directly related to arthritis, it is an important consideration for a product’s overall ease of use. Failure to read instructions and labels might have notable consequences. For example, a user might misread an expiration date that is printed in small font, and then proceed to consume a product that is no longer safe, efficacious, or fresh. This could obviously lead to a tarnished brand image, or worse. Remove the outer safety seal, or open the outer packaging. Outer packaging typically consists of a box that encloses the container, or a tamper-evident plastic wrapping on the cap of the container. Users can open a box by tearing it, peeling it open at a flap, or tearing away a serrated strip. These actions may be difficult for individuals with arthritis if excessive force is required and if the gripping surface is not adequate. The outer plastic wrapping on a container can sometimes be removed by tearing or by twisting the cap to break the plastic. Again, the forces required for these actions influence ease of use. If the outer seal consists of a non-serrated plastic sheet, most individuals with arthritis can be expected to experience difficulty. Although these tasks are only performed once for each product, they can represent significant barriers to overall ease of use. They also might establish a poor first impression of the product. A user might be unlikely to purchase the product in the future if the experience is difficult or painful, or if he or she must resort to using a tool (e.g., scissors). Open the cap. Traditional cap design requires the user to tightly grasp the cap while twisting it. Individuals with arthritis often have difficulty performing simultaneous actions like grasping and twisting. This is particularly true if either one of the actions requires substantial strength. Factory sealed caps may require more torque than some individuals with arthritis can exert. A poor gripping surface on the cap or bottle can compound the problem by forcing the user to exert excessive gripping force. Certain containers may simply be impossible to open for some individuals with arthritis. 3 Remove the inner seal. Many containers, such as pill bottles, feature an inner safety seal beneath the cap. The user must remove or puncture the seal in order to access the container’s contents. Users might attempt to remove most or all of the seal from the opening by either peeling the seal away from the opening or puncturing and tearing it. The act of peeling may be difficult for individuals with arthritis if the seal does not provide a sufficient gripping surface, or if the seal is bound too tightly to the opening. The act of puncturing a seal may difficult if the required force exceeds that which the user can exert with a fingertip. Users might resort to using a tool to puncture the seal, which would not be considered easy usage. Dispense contents of the container. The act of dispensing a container’s contents might consist of extracting a pill, pouring or drinking from a bottle, scooping contents from a jar, or some similar action. The potential difficulties associated with these actions are similar to those associated with grasping and lifting a container. Individuals with arthritis may encounter difficulties if the container is too large or heavy, or if the gripping surface is poor. In addition, difficulty might be encountered if dexterous movements are required (e.g., scooping contents from a small opening). An inability to correctly perform these actions may result in spills. Close the container. After using a product, the consumer must screw the cap onto the bottle or snap the cap closed. The act of screwing a cap onto a container sometimes requires a bit of dexterity in order to align the cap threading with the bottle threading. Due to dexterity limitations, this action might be difficult for some individuals with arthritis if the cap is short and has a small diameter. Container Components and Variations Most containers consist of five principal components (see Figure 2). These include the container body, cap, labeling, outer safety seal, and inner safety seal. Each of these may impede easy usage by individuals with arthritis. The following sections describe the components and their common design variations. 4 Figure 2: Container components. Container Body Containers differ from each other by virtue of their material composition, shape, surface texture, size, and weight. The material composition may be of a hard plastic, glass, metal, or of a malleable plastic that conforms slightly to the hand. The shape of most containers is cylindrical, but some are rectangular or elliptical. Some bottles have vertical indentations that are indented to facilitate grip, or horizontal indentations that allow a narrower grip. Finally, the container may be wrapped with a plastic or paper label (see Figure 3). Figure 3: A cylindrical plastic container wrapped in a paper label. Cap Caps (see Figure 4) vary by diameter, height, shape, surface texture, material, operating force requirements, and opening mechanism. Twist-off caps simply unscrew from the 5 container; these vary with respect to the extent of rotation that is needed to remove the cap from the container. Flip-top caps are hinged and can be pulled or lifted up, allowing the product to be dispensed without fully removing the cap. Pop-off caps are those that can be completely removed from the bottle by pulling or lifting without twisting. Some caps are hybrids of the aforementioned types. One example is a twist-off cap with a tab that pops open, so that the container’s contents can be accessed by either fully unscrewing the cap or by popping open the tab. Figure 4: An assortment of caps. Caps can be composed of plastic, metal, or rubber; the composition partially determines malleability and grip. More malleable materials may yield more readily to certain operations, such as popping open. More malleable materials may also conform slightly to the hand, thereby distributing the force and enhancing grip. However, note that if a cap flexes too much as a user squeezes it then friction will be generated between the cap and the bottle, making rotation more difficult. Surface texture is another important factor that affects the ease with which users can grip caps. Knurled and serrated surfaces generally provide better grip. However, extreme knurling or sharp serrations can cause discomfort in the joints and skin, respectively. This is especially true for users with arthritis who may have inflamed finger joints. Caps may also feature a safety mechanism that prevents tampering or accidental opening. For example, some pop-off caps, such as gallon milk containers, are bound to the bottle by a plastic ring that must be peeled away before usage. Some twist-off caps incorporate a ring that is attached to the lower rim of the cap (e.g., a soft drink bottle). Upon first opening, the ring breaks away from the cap. The amount of force required to break the seal varies dramatically between products. Some pop-off caps, such as those used on certain pain reliever bottles, feature a safety locking mechanism that prevents the cap from opening unless markings are aligned on the cap and cap. Outer Safety Seal Broadly defined, the outer safety seal may be either a box in which the bottle is packaged, a tamper-evident wrapping on the bottle or cap, or a ring that binds the cap to the bottle (see Figure 5). Rings that bind the cap to the bottle are discussed in the section on caps. 6 Figure 5: Outer safety seals include (a) packaging boxes, (b) plastic wrappings on the cap, and (c) rings that bind the cap to the bottle. A common type of outer safety seal consists of a thin plastic or paper wrapping that encircles the cap and a portion of the bottle (see Figure 5b). Some plastic seals are perforated, and may peel away or break loose when the cap is twisted. Others must be cut or torn before removing the cap. The properties of paper seals are similar to those of plastic seals. The thickness of the material and the presence of perforations will determine whether users can easily break the seal by turning the cap, or whether they must first remove the seal. A different safety seal design is used on some bottles with flip-top caps. A thin strip of plastic bridges the gap between the cap and the ring that attaches the cap to the bottle (see Figure 6). When the strip of plastic is peeled away, the cap is free to flip up. Figure 6: Outer safety seal design featuring a thin strip of plastic connecting the cap to the lower ring. Inner Safety Seal Many containers feature an inner safety seal that protects product safety and freshness. This type of seal usually features a tab that a user can grasp and pull either from the edge of the seal or from a tab that flips up from the center of the seal (see Figure 7). 7 Figure 7: Inner safety seals. The sizes and operating forces of tabs vary among products. Other seals do not provide a tab and must be punctured and torn from the closure. The amount of force required to puncture the seal varies among products. Instructions and Labels Instructions and labels may be required for safe and proper usage of a product. Instructions include opening instructions, dosage information, and instructions for consumption (e.g., “take with food”). Labels include warnings, such as drug interaction precautions, and expiration dates. Instructions for opening the cap are often placed directly on the cap, and are either engraved or printed. Engraved text and graphics yield poor contrast with the background surface, and may therefore be difficult to read, particularly in unfavorable lighting conditions. Dosage information and instructions for consumption are particularly important for proper and safe usage of a product. Recommended doses can be displayed in either paragraph or table format. Typically this information is made easier to find by using a prominent title and by placing it apart from other text on the container. Expiration dates are also important for safe and proper usage of a product. A user who fails to notice an expiration date on an expired product may proceed to consume a product that no longer meets the manufacturer’s standards, or may even be unsafe for consumption. Expiration dates are often placed in obscure locations where users are unlikely to see them, even if actively searching. Moreover, the text is often small, blurred, and printed with poor contrast to the background. The format of the date may also be important for identification and comprehension – for example, the meaning of “12 2010” is quite unclear in comparison with “Dec 2010.” The date can be preceded by the words “use by” or “best before” or “expiration.” Notice that a date without such a prefix might be interpreted as a “sell by” date. 8 Figure 8: Example of an expiration date that is difficult to read. Finally, warning labels alert users of the dangers associated with a product. Similar to dosage information, warnings can be set apart by spacing and prominent titles in order to make the information easier to find. Common to all instructions and labels, the issues of font size and contrast are important. Small font and poor contrast can make it difficult for users to find and read information. A common example is an expiration date printed in black letters on the body of a dark bottle. 9 User Characteristics The design of products that are intended for individuals with arthritis should be guided by anthropometric data and by an understanding of the functional limitations associated with arthritis. Arthritis is a term used to describe painful inflammation of the joint or joints. The disability has many causes, and there are over 100 types of arthritis. Inflammation causes a reduction in tactile sensation and range of movement with a corresponding loss of dexterity and mobility. Arthritis is the greatest contributor to mobility and dexterity limitations, the largest category of functional limitations. As noted by TIA Access (1996) [27], “Individuals have difficulty reaching things and doing complex or compound manipulations such as pushing while turning or pressing several buttons simultaneously. Twisting motions may be especially difficult. For individuals with arthritis, controls that require pinching or rotating are difficult to operate. In addition, individuals who are functionally limited are unable to exert as much force on controls as individuals without functional limitations. Individuals with poor muscle control may find it difficult to make fine motor movements with their fingers and may be restricted to gross movements with their hand(s).” Anthropometric data might provide useful guidance for the design of containers for users with arthritis. There exists only a limited amount of anthropometric data on individuals with arthritis. However, hand dimensions may not differ significantly between individuals with and without arthritis [15], except for instances in which arthritis causes deformation of the bones and joints (e.g., rheumatoid arthritis). These deformities may prevent a user’s hand from fully encircling a cap or bottle. Table 2 shows anthropometric data for individuals without arthritis. The data were compiled from several sources [10, 13, 24]. These include measurements from British adults aged 19-65 years [13], and from British adults of unspecified age [10, 24]. Table 2: Hand anthropometry of non-disabled individuals (Sources: [10, 13, 24]). Dimension Gender 5th percentile (mm) 50th percentile (mm) 95th percentile (mm) Male 173-175 178-189 205-209 Hand length Female 159-160 167-174 189-191 Male 98 107 116 Palm length Female 89 97 105 Male 44 51 58 Thumb length Female 40 47 53 Male 11-12 23 26-27 Thumb breadth Female 10-14 20-21 24 Male 64 72 79 Index finger length Female 60 67 74 Male 78 87 95 Hand breadth Female 69 76 83-85 10 Table 3 shows maximum grip diameters for individuals with and without dexterity disabilities [10]. Maximum grip diameter is defined as the maximum diameter of a cylinder that a person can grasp with contact between the thumb and middle finger. Table 3: Maximum grip diameters of individuals with and without dexterity disabilities (Source: [10]). Gender 5th percentile (mm) 50th percentile (mm) 95th percentile (mm) Male 45 52 59 Non-disabled Female 43 48 53 Male 34 40 47 Dexterity-disabled Female 34 40 48 Maximum grip diameter is of particular importance for usage of containers. Users with arthritis may experience considerable pain when forcibly grasping an object with a wide grip, in great excess of their maximum grip diameter. Hand breadth should also be taken into consideration when designing the height of a container. If the container spans the entire breadth of the hand (or more), then the user can distribute gripping force across the whole palm and all four fingers. Types of Arthritis The term “arthritis” is used to refer to over 100 different diseases that affect the joints of the body and the areas surrounding the joints. The most common types of arthritis are osteoarthritis and rheumatoid arthritis. Osteoarthritis is typically associated with the wear and tear of affected joints and is most prevalent in older adults. Rheumatoid arthritis can affect younger adults and even children, and is associated with inflammation of the lining of the joints. Other types of arthritis include fibromyalgia, gout, ankylosing spondylitis, and scleroderma. Osteoarthritis Osteoarthritis (OA) is characterized by the deterioration of cartilage in the joints. Healthy cartilage cushions adjacent bones and allows for easy joint movement. Thus, the deterioration of cartilage causes bones to rub against each other, leading to stiffness, swelling, pain, and restricted range of motion. In the final stages of OA, bits of bone may float freely within the joint, and the lining of the joint (synovium) becomes inflamed [1]. Symptoms of osteoarthritis are more common in some joints than others. The base of the thumb and the distal finger joints (see Figure 9) are most commonly affected [1]. These joints are used in many interactions with containers. Distal finger joints are heavily involved in certain pinch grips, such as that used to pinch a tab on a container’s safety seal. They may also be used when puncturing an inner seal with the tip of the finger, or when grasping a large container or cap. The thumb is involved with all grip types, and nearly all manual interactions with containers. When gripping large containers or caps, users may experience pain in the base of the thumb as they adopt a wide grip. However, pain may also be experienced with smaller grips, such as those used to pinch a safety seal or to twist a small cap. 11 Figure 9: Joints of the hand Symptoms are less common in the proximal interphalangeal joints (middle joint; approximately 35% of individuals with OA), and even less common in the metacarpophalangeal joints (base of the fingers; approximately 15%) [1]. These joints are involved in pinching tabs and gripping containers and caps. Wrists, which are affected in 20% of men with OA and only 5% of women [1], are involved in lifting and twisting actions. Symptoms are typically symmetric, meaning that symptoms in one hand are often accompanied by symptoms in the other hand [8]. Thus, many users may not be able to avoid pain by simply switching hands. A particularly problematic action for individuals with arthritis in the wrists is the act of twisting open a tightly secured cap. This can be painful for some users and simply impossible for others. Rheumatoid Arthritis Rheumatoid arthritis (RA) is characterized by inflammation and swelling of the joints, accompanied by pain and restricted range of motion [2]. More advanced RA causes deformation of the joints, which can prevent natural movements such as straightening the fingers (see Figure 10). Stiffness and restricted range of motion may cause individuals to adopt different strategies when using a product. For example, restricted wrist movement may force users to use many repeated small movements to twist open a cap rather than one or two large movements. Also, deformation of the finger joints may force users to adopt different grips (e.g., a lateral “key” pinch rather than a finger tip pinch). 12 Figure 10: Rheumatoid arthritis can cause deformation of the joints, resulting in stiffness and restricted range of motion. Symptoms of rheumatoid arthritis commonly appear first in the smaller joints of the body [2]. RA often affects the wrist joints and the finger joints closest to the hand (the metacarpophalangeal joints). Pain and swelling in these joints interferes with the ability to grip and twist objects, especially those that are large. Like OA, symptoms of RA are often symmetric, affecting the same joints on both sides of the body [2, 20]. Thus, many users may not be able to simply switch hands to avoid pain. Evaluation Methodologies There are two basic methods of acquiring information about human performance: direct measurement and derived assessment. If the goal is to evaluate the ability of a specific individual to use a product, then he or she is given a series of tasks to complete, and an evaluator observes performance. The tasks that are given to the user should be representative of the tasks associated with use of the product, as intended by the manufacturer, and the set of tasks should be comprehensive. A list of tasks may be generated by a task analysis, which may involve observing several users as they interact with the product. By observing several users, rather than just one, the observer is more likely to capture all tasks associated with the product. Direct Measurement. The direct measurement approach allows the collection of detailed data about the ability of a single individual to interact with a given product, although the findings may not generalize to a larger population. More robust direct measurement studies adopt effective population sampling strategies. By testing a diverse and representative group of users, the evaluator can generalize findings to a larger population segment with much better accuracy. Effective sampling for ease of use evaluations for people with arthritis can be very challenging. The variety of functional abilities and limitations within the population of individuals with arthritis must be considered. For example, some users may have limited strength, but normal dexterity. Others may have normal strength, but may experience considerable pain when exerting force. Still others may have limited reaching and grasping capabilities. A user’s level of 13 experience with the type of product being evaluated may also have a significant impact on the outcome of the evaluation. For example, experience with difficult inner safety seals may lead a user to puncture the seal with a fingernail, rather than attempt to grasp the edge of the seal and peel it off. Therefore, it is necessary to obtain a reasonably large and diverse sample of the population to which the evaluator wishes to generalize. Derived Assessment. Derived assessment methods, such as functional assessments, checklist evaluations, or expert inspections, do not seek to measure human performance directly. Instead, such techniques are used to determine the extent to which a product meets formal or informal guidelines that have been associated with desired usability objectives. A checklist evaluation, also known as a heuristic evaluation, is employed where a considerable body of knowledge exists about a specific domain of human performance relative to the product of interest [21]. For example, a significant amount of data has been collected on the grip and torque strengths of individuals with arthritis. These data can be used to determine whether a product’s force requirements are likely to exceed the capabilities of the population of interest. However, given the number of factors that affect the usability of a container (e.g., size and texture) and the wide variations of each factor, it may not be feasible to assess a product solely by its adherence to guidelines. Therefore, it is advisable to combine direct measurements with derived assessments. Given the challenges of sampling from a diverse population and the somewhat limited knowledge of designing for people with arthritis, it is necessary to combine data from both direct measurement and derived assessment evaluation techniques to obtain the desired degree of confidence in the evaluation results. Gaps in the knowledge regarding designing for people with arthritis can be addressed by performing user testing. Similarly, the sampling issues associated with human performance testing for accessibility can be addressed by using the derived assessment results to eliminate the need to test some populations and focus the assessment on others. A variety of evaluation techniques and methodologies are available to the evaluator interested in measuring ease of use for individuals with arthritis. For best results, a combination of objective and subjective measures should be used. The first stage of the evaluation may be accomplished without user participation. The evaluator first performs a task analysis in order to identify the actions that are involved in using the product. Next, the evaluator measures the force required for each of the physical actions identified in the task analysis. For example, the evaluator may measure the torque required to break the factory-tightened cap, and the linear force required to puncture a safety seal. Finally, the evaluator determines whether the product meets a prespecified set of design guidelines that are based on prior research. The second stage of the evaluation involves user participation. The evaluator should obtain measurements of the relevant functional capabilities of each user, such as grip and pinch strengths (see Figure 11). 14 Figure 11: A user's grip strength (left) and pinch strength (right) are measured. The evaluator may then objectively measure the forces that each user is able to generate upon the container. This requires instrumentation of the container by, for example, affixing a torque meter to the base of the container and a connecting rod to the cap. Objective force measurements for each user may be compared against the forces that are required to use the product, as measured during the first stage of the evaluation. If a number of participants are unable to generate the required forces upon the instrumented container, then a significant portion of the population with arthritis may experience difficulty with the product. Next, the user is given an unopened, unmodified product, and is asked to perform the set of tasks identified in the task analysis. During each task, the evaluator observes performance and records any difficulty or problems that arise. After each task, the user may provide subjective feedback about the experience in a free response format, and in the form of an ease-of-use rating scale. Users may also be asked to report any pain experienced and rate the severity of their pain, using an instrument such as the WongBaker FACES Pain Rating Scale (see Figure 12). The evaluator should record all such data, allowing the users to focus their attention on the product. After all tasks are completed, the users may be asked to rate their agreement with a series of statements about the product (e.g., “I can use this product without overexerting myself.”). Finally, the results of the evaluation should be documented in order to affirm or deny the product’s ease of use, and to provide recommendations to the manufacturer. Figure 12: The Wong-Baker FACES Pain Rating Scale. 15 Ease of Use Issues and Potential Solutions Containers have a number of ease of use issues related to the following components: Container body Twist-off cap Pop-open cap Outer safety seal Inner seal Instructions and labeling The following sections contain detailed information about common ease of use issues for each of these components. Potential solutions to each issue are proposed, and relevant design guidelines are presented. 16 What are the common issues associated with the body of the container? The body of a container is grasped and lifted during regular use of a container. The following tasks entail grasping and often lifting the body of a container: Transporting the product Removing the outer safety seal Opening and closing the cap Opening or removing the inner seal Reading instructions and labels Dispensing contents A number of factors influence the ease with which an individual with arthritis can grasp and lift a container. These are discussed in the sections below. The container may be too large to be gripped comfortably with adequate force. Detailed Description: Gripping a large container requires a wide grip. Because individuals with arthritis often experience limited range of motion in affected joints, they may be simply unable to open their hands wide enough to grasp a large container. Furthermore, strength declines as grip widens past moderate flexion. This means that even if a user is able to stretch his or her hand to fit the container, he or she may be unable to grasp the container tightly enough to perform other operations. The hand is most powerful when it is flexed moderately [25]. When the hand grips a smaller object, grip force is decreased due to inadequate contact with the object and due to shortening of the muscles. When the hand grips a larger object, the change in geometry results in a decrease in the amount of grip force that can be applied. Also, a larger grip places the thumb and fingers in opposition to each other, rather than in opposition to the palm. Potential Solutions: Provide grasp points that are narrower than the main body of the container. If the body of the container is too large to be comfortably grasped with adequate force, an indention can provide a more narrow grasping point (see Figure 13). It may not be practical to provide an indentation wide enough to accommodate the entire hand, but at least the thumb and two fingers should fit into the indention. 17 Figure 13: Indentions in a container allow a smaller grip diameter. On very large containers, it may not be feasible to incorporate an indention that encircles the entire container. In such cases, it may be sufficient to place a pair of cutouts on one side of the container (see Figure 14). Figure 14: Indentions in the side of a large container provide good grasping points. Laboratory testing at GTRI has indicated that the separation between indentations such as those shown in Figure 14 should not exceed 3 inches (75 mm). Individuals with arthritis found that a container with a 3.35 inch (85 mm) grip span was considerably more difficult to hold and lift than a product with a 3 inch (75 mm) grip span. Steinfeld and Mullick (1990) recommend that a grip span of no more than 2.8 inches (71 mm) be required [26]. Reduce the diameter of the container. Another solution is to simply decrease the diameter of the container, or to offer containers of several different sizes from which users can choose. Individuals with arthritis who struggle with wide grips can choose to purchase the smaller version of the product. Alternatively, container volume could be held constant by reducing its diameter and increasing its height. 18 For maximum grip power, what is the optimal container diameter? The answer depends in part on the user’s hand size and maximum grip diameter, because wider grips are associated with decreased strength. Maximum grip diameter is defined as the maximum diameter of a cylinder that a person can grasp while maintaining contact between the thumb and middle finger. For non-disabled adults, maximum grip power can be exerted on cylinders with diameters approximately 10 mm (0.4 inches) smaller than the maximum grip diameter. Specifically, the average non-disabled adult can exert maximum grip power on a cylinder with a diameter of 40 mm (1.6 inches) [25], which is approximately 10 mm less than their median maximum grip diameter ([10]; see Table 4). This diameter allows the thumb and middle finger to slightly overlap and directly oppose the palm. Table 4: Maximum grip diameters of individuals with and without dexterity disabilities (Source: [10]). Gender 5th percentile (mm) 50th percentile (mm) 95th percentile (mm) Non-disabled Dexterity-disabled Male 45 52 59 Female 43 48 53 Male 34 40 47 Female 34 40 48 Note that the relationship between maximum grip diameter and optimal diameter for grip force is somewhat speculative, because the data on these two parameters were derived from two separate studies [10, 25]. A single, systematic study is needed to confirm this relationship. Assuming that such a relation exists, however, we can infer the diameter of a container that should yield maximum grip power for dexterity-disabled adults, including those with arthritis. The median maximum grip diameter of dexterity-disabled adults is 40 mm (1.6 inches) (see Table 4). Therefore, they might be expected to exert maximum gripping force on 30 mm (1.2 inches) cylinders, in comparison to 40 mm cylinders for non-disabled adults (see Table 5). Although it might not be feasible to design containers with diameters of only 30 mm, these data highlight the importance of maintaining a small diameter at the location intended for grasping. Table 5: Relationships between maximum grip diameter and cylinder diameter for maximum grip force. Median Maximum Grip Diameter for Maximum Diameter (male & female) Grip Force (mm) (mm) Non-disabled 50 A 40 B Dexterity-disabled 40 A 30 C A: Source [10]; B: Source [25]; C: Inferred. 19 Applicable Guidelines: Guideline: Ensure that the product is easy to grip and control. The shape of the product should be easy to hold, so that it fits the hand. There should also be a texture to the surface so that it can be gripped and held onto. Sources: Cushman and Rosenberg, 1991 [7]; Haigh, 1993 [16] Guideline: Allow for alternatives to a standard grip. Size the gripping area and clearances to allow alternatives to the standard grip, including knuckles, the side, back and heels of the hand, and two-handed “pinch” grips. Source: Steinfeld and Mullick, 1990 [26] Guideline: Require a grip span of no more than 2.8 inches (71 mm) for products that are intended to be grasped with one hand. If the size of the container exceeds the maximum grip span recommendations, then add design features such as handles or cutouts to facilitate a reduced grip span requirement. Source: Steinfeld and Mullick, 1990 [26] 20 The container may slip in the user’s hand. Detailed Description: Individuals with arthritis typically have weaker grips than those without arthritis. A weakened grip may allow a container to slip in the hand as the user attempts to lift or manipulate the container. Slippage can prevent the user from performing such actions as lifting the container, removing its cap, or removing its seal. The size of a container partially determines how tightly an individual can grasp it. For further discussion of container size, refer to the section entitled “The container may be too large to be gripped comfortably with adequate force.” In addition to container size, other important factors include container shape, surface texture, and material composition. Traditional smooth, cylindrical containers may be unsuitable for many users with arthritis because they provide little friction, no leverage, and are not contoured to the user’s hand. Potential Solutions: Maximize friction between the container and the hand. Friction can be increased by making the surface of the container rough or by using a “sticky” material such as rubber. Certain plastic and paper wrappings may provide more friction than others. Use a non-cylindrical shape for the container. Container slippage can be reduced by using a non-cylindrical container shape. The uniform contour of a cylinder allows it to slide easily in a weak grip. In contrast, elliptical and rectangular containers provide leverage points (see Figure 15). These surfaces can act as lever arms, and can reduce grip strength requirements during cap opening. Figure 15: A non-cylindrical container is easier for users to grasp. Applicable Guidelines: Guideline: Ensure that the product is easy to grip and control. The shape of the product should be easy to hold, so that it fits the hand. There should also be a texture to the surface so that it can be gripped and held onto. Sources: Cushman and Rosenberg, 1991 [7]; Haigh, 1993 [16] Guideline: Allow for alternatives to a standard grip. Size the gripping area and clearances to allow alternatives to the standard grip, including 21 knuckles, the side, back and heels of the hand, and two-handed “pinch” grips. Source: Steinfeld and Mullick, 1990 [26] Guideline: Require a grip span of no more than 2.8 inches (71 mm) for products that are intended to be grasped with one hand. If the size of the container exceeds the maximum grip span recommendations, then add design features such as handles or cutouts to facilitate a reduced grip span requirement. Source: Steinfeld and Mullick, 1990 [26] Guideline: Provide a high friction grip surface on cylindrical containers. Tight grasping of the container is required to provide a counter-rotational force when removing a twist off cap. Provide a high friction surface on a cylindrical container to facilitate tight grasping. Source: GTRI Guideline: Provide a non-cylindrical grip feature, such as grip indentions, or use a non-cylindrical container. Source: GTRI 22 What are the common issues associated with removing a twistoff cap? The act of removing a twist-off cap entails gripping the container in one hand while tightly gripping and applying rotational force to the cap with the other hand. For a discussion of issues related to grasping the container, refer to the section entitled “What are the common issues associated with grasping and lifting a container?” The simultaneous actions of grasping the cap and twisting may be especially difficult for some individuals with arthritis. In the sections below, issues related to the cap are discussed. Child safety mechanisms have not been addressed, and are reserved for future consideration. Removing a factory sealed cap may require too much force. Detailed Description: Many individuals with arthritis experience difficulty when exerting the force that is required to open some containers. The factory sealed caps that have been tested at the Accessibility Evaluation Facility at GTRI have required between just a few pound-inches (~0.2-0.3 N m) of torque to over 20 pound-inches (2.3 N m) to open. In laboratory tests at GTRI with various caps, users with arthritis have typically been able to exert approximately 5 to 30 poundinches (0.6-3.4 N m) of rotational force on the caps before experiencing pain. This wide range is the result of differences among individuals and among cap designs. When high torque is required, high grip force is also required. In order to prevent a cap from slipping in the hand, the user must apply sufficient grip force. Thus, users with arthritis may experience pain in the wrist as they apply rotational force and in the hand and fingers as they apply grip force. Potential Solution: Limit the amount of rotational force that is required to remove a factory sealed cap to 10 pound-inches (1.1 N m) or less. The key to reducing user difficulty is to reduce the amount of force that is required, although product safety and integrity must also be considered. To accommodate approximately 90% of users with arthritis, rotational force requirements should not exceed 10 pound-inches (1.1 N m). Reducing the amount of force required for rotation also reduces the amount of grip force that is required to prevent the cap from slipping in the hand. Applicable Guidelines: Guideline: Minimize rotational force required to remove the cap from the factory sealed position. Sources: Berns, 1981 [3]; Langley, Janson, Wearn, and Yoxall, 2005 [19]; Voorbij and Steenbekkers, 2002 [29] 23 Guideline: Provide at least one mode of operation that does not require fine motor control or simultaneous actions, and that is operable with limited reach and strength. Source: Section 508 1194.31(f) [13] 24 Removing a cap may be difficult after it has been tightened by a user. Detailed Description: After the initial opening, caps can be retightened with a variable amount of rotational force, and this may affect the ease of future openings. Hence, even if a factory sealed bottle is easy to open for a user with arthritis, it may be difficult on subsequent uses. A friend or family member might tighten the cap too much, or an individual with arthritis might tighten it too much on a day when he or she is not experiencing severe symptoms (symptoms can vary dramatically between days). Potential Solution: Use steep threading rather than shallow threading. The tendency for users to over tighten a cap might be reduced by using steep threading (causing the cap to rise more rapidly as it is unscrewed). Preliminary testing at GTRI with 6 different bottles suggests that caps with steep threading cannot be tightened onto the bottle as tightly as those with more shallow threads (see Figure 16). After tightening caps with 15 pound-inches (1.7 N m) of torque, those with steep threading (average incline 4.5°) required approximately 33% less force to open than those with shallow threading (average incline 1.8°). Figure 16: Containers with shallow threading (left) and steep threading (right). Applicable Guideline: Guideline: Provide at least one mode of operation is that does not require fine motor control or simultaneous actions, and that is operable with limited reach and strength. Source: Section 508 1194.31(f) [13] 25 The cap may slip in the user’s hand as he or she attempts to twist it. Detailed Description: If a cap is tightly secured to a container, users’ hands may slip on the cap as they attempt to twist it. To prevent slippage, users may need to exert considerable grip force. Potential Solutions: Reduce the required grip force by increasing the friction between the cap and the hand. A common method of increasing friction is to incorporate ridges or serrations into the cap’s surface. These should be large (deep and wide) enough to provide friction, but not so wide as to produce discomfort on the skin. Surface friction can also be introduced by using different types of materials other than plastic. For example, a rubber surface coating can provide excellent grip. Figure 17: A rubber coating on the cap increases surface friction and decreases required grip force. Reduce the required grip force by providing grip features on the cap. Knurled, square, and elliptical caps provide grip features that may reduce grip strength requirements. Individuals with and without arthritis are able to generate more torque on knurled objects than smooth objects ([9]; see Figure 18 and Figure 19). Figure 18: A smooth knob (left) and knurled knob (right) (Source: [9]). 26 Figure 19: Average torque generated on round and knurled caps by individuals with arthritis. Knurl contours should be smooth and gradual, because small or sharp points of contact can create uncomfortable pressure points. The knurls shown above in Figure 18 might produce pressure points. Rounder knurls, such as those shown in Figure 20, might be more suitable. Figure 20: Smoothly contoured knurls. In one case of laboratory testing at GTRI, some users preferred a traditional round cap over a knurled cap, because the later caused painful pressure points. The discomfort that some users experienced was most likely due to the abrupt edges in the knurling pattern, somewhat like those shown in Figure 18. To prevent painful pressure points, knurls should be rounded. Perhaps the best strategy is to use widely spaced, rounded knurls, such as those shown in Figure 21. The “valleys” in this knurling pattern can accommodate a large portion of the user’s fingers, and might therefore reduce pressure points. However, further laboratory testing is needed to determine the optimal knurling style. 27 Figure 21: Widely spaced, smooth knurls. An alternative to knurls is to use two smooth, rounded protrusions separated by 180°. Such a design would be similar in shape and functionality to an elliptical cap. Another alternative is to use a square cap (with a rounded interior, of course). Although no such designs have been directly evaluated by users with arthritis at GTRI, the principles derived from other designs suggest that these might be successful. Applicable Guidelines: Guideline: Ensure that the product is easy to grip and control. The shape of the product should be easy to hold, so that it fits the hand. There should also be a texture to the surface so that it can be gripped and held onto. Sources: Cushman and Rosenberg, 1991 [7]; Haigh, 1993 [16] Guideline: Avoid sharp edges. Knurls on twist-off caps should be rounded. Source: GTRI Guideline: Allow for alternatives to a standard grip. Size the gripping area and clearances to allow alternatives to the standard grip, including knuckles, the side, back and heels of the hand, and two-handed “pinch” grips. Source: Steinfeld and Mullick, 1990 [26] 28 Caps with a large diameter prevent a strong grasp. Detailed Description: The size of a cap has a great effect on how tightly a user can grasp it. Very large diameter caps afford weak grips, because the fingers are weaker when they are near full extension [25]. Caps with very small diameters may also afford weak grips, due to muscle shortening. Potential Solution: Use a moderate diameter for caps. Because the hand is most powerful when it is flexed moderately [25], it may be best to design moderately sized caps. Maximum force can be generated by non-disabled individuals on caps with diameters between 1-3 inches (25-75 mm) [22]. This is a very wide range, the extremes of which may cause discomfort in the hands of users with arthritis. More moderate cap diameters (e.g., 1.6-2 inches (41-51 mm)) may be preferable. Applicable Guideline: Guideline: Require a grip span of no more than 2.8 inches (71 mm) for products that are intended to be grasped with one hand. If the size of the container exceeds the maximum grip span recommendations, then add design features such as handles or cutouts to facilitate a reduced grip span requirement. Source: Steinfeld and Mullick, 1990 [26] Discussion: This guideline applies to a standard power grip (like grasping a cylinder) and may not be directly applicable to the key pinch grip commonly used to grasp a cap. 29 Short caps prevent a strong grasp. Detailed Description: The height of the cap may affect the ease and strength with which it can be grasped. Short caps (e.g., 0.4 inches (10 mm)) may be difficult to grasp for users with arthritis, due to their decreased dexterity and inability to adopt certain hand positions. A short cap height limits the variety of hand positions that can be used to grasp the cap, whereas taller caps allow more flexibility. Potential Solution: Increase the height of the cap up to 1 inch (25 mm). In order to increase the ease of grasping and the surface contact between the fingers and the cap, caps should be made approximately 1 inch (25 mm) in height [17]. Applicable Guideline: Guideline: Allow for alternatives to a standard grip. Size the gripping area and clearances to allow alternatives to the standard grip, including knuckles, the side, back and heels of the hand, and two-handed “pinch” grips. Source: Steinfeld and Mullick, 1990 [26] 30 The amount of angular rotation required to remove the cap may be too great. Detailed Description: Some caps require a large rotation to open (e.g., 270°). Because many individuals with arthritis have limited ranges of motion in their hands and wrists, they must make many small movements rather than a few large movements to unscrew the cap. Each movement may be painful for some users. Potential Solution: Use a steep and short threading so that the cap can be removed with a limited amount of rotation. Ideally, the removal of a cap should require no more than ¼ turn. This may be accomplished by using a steep and short threading design which allows the cap to rise rapidly from the container as it is turned. Applicable Guidelines: Guideline: Screw top caps should fit in the hand. Their removal should require no more than ¼ turn for each angular movement, and no more than two angular movements should be required. Source: Haigh, 1993 [16] Guideline: Minimize user actions. Source: HFDS 2.6.8 [12] 31 What are the issues associated with opening a pop-open cap? Caps that pop open, rather than twisting open, can offer an easy-to-use solution for many users with arthritis. There are two basic styles of caps that pop open. The most common pop-open caps are attached to the bottle by a ring around the bottle neck. Another style of design features a portion of the cap that pops open; to fully expose the bottle opening, the user must unscrew the cap. A variant of this design features a push tab that causes an adjacent section to pop open. See Figure 22 for illustrations of these cap styles. Figure 22: Three styles of pop-open caps: the entire cap pops open (left), part of the cap pops open (center), and a button causes part of the cap to pop open (right). These pop-open mechanisms alleviate the concerns of gripping and twisting that are associated with twist-off caps, but they introduce new concerns. Some primary concerns are discussed in the following sections; a more in-depth discussion is reserved for future work. The amount of force required to pop open the cap is too great. Detailed Description: Users with limited strength may struggle to pop open a cap if too much force is required. This action is typically accomplished with only one finger or thumb, which greatly limits the amount of force the user can exert on the tab. Potential Solution: Minimize operating forces. If the amount of force necessary to open the cap is limited, most users with arthritis should be able to use the product with ease. Applicable Guidelines: Guideline: Require no more than 3.3 pounds (14.7 N) to push in a push tab. Source: Berns, 1981 [3] 32 Guideline: Minimize the forces required to open and close flip-top caps. The forces required to flip the cap open and closed should not exceed 5.0 pounds (22.2 N). Source: Section 508 1194.23(k)(2) [13] Discussion: Section 508 sets a broad guideline for maximum linear force requirements for all user actions. The guideline may not be directly applicable to removing opening a flip top cap. Further research will be needed to determine if the 5.0 pound recommendation should be modified for this application. 33 The surface of the push tab is too small or too sharp. Detailed Description: Pop-open caps typically have a tab or indention that provides the user with a surface against which to push the cap upwards. In some cases, this surface is very small, and may be painful to push against, especially if its edge is sharp (see Figure 23). Pressing against a small surface might also require a degree of dexterity that some users with arthritis do not possess. Figure 23: A push tab that is too small and has a sharp edge. Potential Solution: Provide a surface for the user to push against that is sufficiently large and that has a smooth edge. The force required to flip the cap open can be more easily applied when the area to which the force is applied is larger. The area where the force is applied (e.g., an overhanging cap and/or an indention below the edge of the cap) should be large enough to accommodate a number of methods for opening the cap (e.g., fingernail, one or more fingertips, tip or side of thumb, side of hand, etc.) (see Figure 24). Figure 24: The indentation on this flip cap is large and smooth. Applicable Guideline: Guideline: Provide a sufficient area for applying force to open the cap. Source: GTRI Discussion: Additional research is required to quantify what constitutes a “sufficient” area for applying force. 34 What are the issues associated with removing the outer safety seal or packaging? Outer safety seals are intended to protect product integrity and safety by providing evidence of tampering or damage. They must be removed prior to first usage of the product. In a broad sense, outer safety seals include the tamper-evident wrapping of the bottle and the box in which the bottle is packaged. Because outer safety seals and packaging are intended to protect the product and provide evidence of tampering, they can sometimes be difficult to remove. Users with arthritis, in particular, may often experience great difficulty when removing the outer safety seal or when opening the packaging. Although this action is only performed once for each item, it can represent a significant barrier to overall ease of use and may discourage users from future purchases. Removal of some outer safety seals requires the use of a tool. Detailed Description: Some outer plastic wrappings are not perforated or scored, and therefore cannot be easily torn by hand. Instead, a user must initiate a tear in the plastic with a tool, such as a knife or scissors. However, the use of tools can be problematic for two reasons. First, a tool may not be readily available, so the user may struggle to accomplish the task by hand before searching for a tool. Second, users with arthritis may experience pain in their fingers, hands, and wrists while using the tool. Pain may be caused by the narrow grip required to hold the tool, or by exerting force with the tool against the product. Potential Solution: Provide a clearly visible perforation or scoring in the seal to allow users to remove the seal by hand. Perforations or scoring in the plastic seal allow users to easily tear the plastic. The perforations or scoring in the plastic should be clearly evident by virtue of their placement and their visual contrast with the underlying material (see Figure 25). Note that perforations in clear plastic may be difficult to see, particularly when covering a light-colored container. Perforations and scoring can be made evident by using a dark plastic seal, or by placing markings on the seal. In addition to being clearly visible, the edge of the seal should be easy to grip. 35 Figure 25: The perforations on this outer seal are clearly visible. Applicable Guidelines: Guideline: Ensure that the product is easy to grip and control. The shape of the product should be easy to hold, so that it fits the hand. There should also be a texture to the surface so that it can be gripped and held onto. Sources: Cushman and Rosenberg, 1991 [7]; Haigh, 1993 [16] Guideline: Provide at least one mode of operation that does not require fine motor control or simultaneous actions, and that is operable with limited reach and strength. Source: Section 508 1194.31(f) [13] Guideline: Do not require the use of tools. Source: GTRI Guideline: Require a pinch force of no more than 3.0 pounds (13.3 N). Source: GTRI Discussion: Preliminary data collected during GTRI assessments of users with arthritis suggested that pinch force requirements should not exceed 3.0 pounds; however, further research is needed to validate this finding. Guideline: Ensure that the proper method of removing the outer safety seal is clearly evident, either because of the design of the safety seal or because of instructions printed prominently on the packaging. For example, if the seal is removed by twisting the cap to break the seal, instructions like “Twist cap to break seal” should be provided. If the seal is removed by pulling a perforated strip, the strip should be clearly visible. Source: Vanderheiden, 1997 [28] Discussion: The steps required to open some containers may be intuitively obvious to most users and therefore may not require printed instructions. 36 Guideline: If the outer safety seal is intended to be torn open, then provide a perforated strip or a starter slit. Source: GTRI Guideline: If the safety seal is removed in an independent action (e.g., by pulling a perforated strip), the force required to remove the safety seal should not exceed 5.0 pounds (22.2 N). Source: Section 508 1194.23(k)(2) [13] Discussion: Section 508 sets a broad guideline for maximum linear force requirements for all user actions. The guideline may not be directly applicable to removing a safety seal. Further research will be needed to determine if the 5.0 pound recommendation should be modified for this application. 37 The outer safety seal is intended to be broken as the product is initially opened, but the force requirement may be too great. Detailed Discussion: Some outer safety seals may break away from the cap and container upon initial opening. For example, a serrated strip may tear as the cap is twisted. This design has the benefit of reducing the number of user actions, but can be detrimental if too much force is required to simultaneously break the seal and open the container. If the perforated section of the seal is beneath the user’s hand, then the material may not break easily. Figure 26: The outer seal is broken when the user first twists the cap. Potential Solutions: Reduce the combined required forces required to break the safety seal and open the factory sealed cap. If the seal is intended to be broken as the cap is opened, then the total required operating forces should be minimized. Operating forces should be minimized to any extent possible, while maintaining the integrity of the safety seal. Place two or more perforated strips in the safety seal. At least two perforated strips can be placed in the outer safety seal, in order to reduce the chance that a user’s grasp will prevent the seal from breaking. Applicable Guidelines: Guideline: Ensure that the proper method of removing the outer safety seal is clearly evident, either because of the design of the safety seal or because of instructions printed prominently on the packaging. For example, if the seal is removed by twisting the cap to break the seal, instructions like “Twist cap to break seal” should be provided. If the seal is removed by pulling a perforated strip, the strip should be clearly visible. Source: Vanderheiden, 1997 [28] Discussion: The steps required to open some containers may be intuitively obvious to most users and therefore may not require printed instructions. 38 Guideline: Minimize safety seal removal force. If the safety seal is broken by simply opening the package (e.g., by twisting a cap), the total force required to break the seal and open the package should not exceed the maximum force specified for opening the package when the safety seal is not present. Source: GTRI Discussion: Additional research is required to determine appropriate maximum force requirements. 39 The packaging box does not have a flap or tab for the user to pull. Detailed Description: A box can be difficult to open if its opening flap does not have a tab for users to grasp. Flaps without sufficient gripping space must be picked at with a tool or a finger nail. This may be somewhat difficult for some users with arthritis, because it requires relatively fine movement control. A user might simply tear open the box by inserting a finger under the flap’s edge, but the force required to do this might cause pain for users with arthritis. Potential Solutions: Provide a perforated strip that peels away. A perforated strip can be peeled away easily, provided that the force required is not excessive (less than 5 lbs (22.2 N)). The end of the strip should have a sufficiently large tab for grasping (see Figure 27). Figure 27: A box with a perforated strip. Provide a large tab under which the user can insert a finger. If a tab is provided with no perforated strip, the tab should be large enough to accommodate most of the tip of the finger (see Figure 28). The force required to pull open the tab should not exceed 5 lbs (22.2 N). Figure 28: A box that provides a large tab under which the user can insert a finger. 40 Applicable Guidelines: Guideline: If the safety seal is removed in an independent action (e.g., by pulling a perforated strip), the force required to remove the safety seal should not exceed 5.0 pounds (22.2 N). Source: Section 508 1194.23(k)(2) [13] Discussion: Section 508 sets a broad guideline for maximum linear force requirements for all user actions. The guideline may not be directly applicable to removing a safety seal. Further research will be needed to determine if the 5.0 pound recommendation should be modified for this application. Guideline: If the outer safety seal is intended to be torn open, then provide a perforated strip or a starter slit. Source: GTRI Guideline: Require a pinch force of no more than 3.0 pounds (13.3 N). Source: GTRI Discussion: Preliminary data collected during GTRI assessments of users with arthritis suggested that pinch force requirements should not exceed 3.0 pounds (13.3 N); however, further research is needed to validate this finding. Guideline: Offer redundant modes of operation utilizing the next larger set of motor movements (finger to hand, hand to arm). Offer different ways to accomplish the same task using increasingly larger motor movements. For example, a tab on a seal should be large enough to grip between the thumb and knuckle, rather than between the tips of the finger. Source: Pirkl, 1995 [23] Discussion: By allowing redundant modes of operation, users might have the option to avoid using joints in which swelling and pain are most severe. Guideline: Provide at least one mode of operation that does not require fine motor control or simultaneous actions, and that is operable with limited reach and strength. Source: Section 508 1194.31(f) [13] 41 What are the issues associated with removing the inner safety seal? Inner safety seals are located directly beneath the cap. They maintain product freshness and provide additional tamper-evident protection. Like the outer seal, the inner seal is only removed once for each product, yet can represent a significant barrier to overall ease of use of the product. The user cannot peel the seal from the container. Detailed Description: Inner seals can be difficult to remove if no tab is provided for grasping, or if too much pull force is required to peel the seal from the container. Many inner seals provide little or no grasping surface. With such products, some users search in vain for a tab, and then attempt to pinch the tiny edge of the seal. This can be painful and frustrating for users with arthritis. If the seal cannot be peeled from the opening, then a user must puncture it and peel away the remnants. In this case, the user is forced to perform several physical actions, rather than a single, simple action of peeling the entire seal at once. Even if a tab is provided, the force required to pull it may exceed the capabilities of some users with arthritis. Small tabs may be difficult to grasp. Potential Solution: Provide a large tab on the edge of the seal, and require no more than 5 lbs (22.2 N) to peel the seal from the container. If a smooth, nontextured tab is provided, it should be at least 0.47 inches (12 mm) wide by 0.79 inches (20 mm) long so that users can grasp it between the thumb and lateral aspect of the index finger. Smaller tabs may be difficult to grasp and may slide from users’ fingers, especially if the tabs are not textured. One potential solution is to use a large tab that flips up from the center of the seal. However, this places the pull force on the center rather than the edge of the seal, and may require more force. The optimal pull tab would be large, located on the edge of the seal (see Figure 29), with a textured surface that reduces slippage (e.g., a foil tab with raised bumps). The amount of force required to peel the seal away from the container should not exceed 5 lbs (22.2 N). Figure 29: The inner seal is easy to remove because of the large tab on the edge. 42 Applicable Guidelines: Guideline: Minimize user actions. Source: HFDS 2.6.8 [12] Guideline: Do not require the use of tools. Source: GTRI Guideline: On smooth inner seal tabs, provide a sufficiently large grasping point. A tab that is at least 0.47 inches (12 mm) wide by 0.79 inches (20 mm) long is recommended. Source: Department of Trade and Industry, UK, 2003 [11] Discussion: The study was based on a smooth tab. The study only looked at one tab width and two tab lengths (0.47 and 0.79 inches). The tabs were rectangular. The test population included people with disabilities, but the sample was relatively small and included a variety of disabilities. Guideline: Provide texture on the grasp point that facilitates gripping the tab. The grasp point should be textured with a series of bumps or raised strips that are perpendicular to the peel direction. Source: Department of Trade and Industry, UK, 2003 [11] Guideline: On inner seals that are intended to be grasped and peeled from the container, place the grasp point in a location selected for the application of optimum force. The tab should be located along the edge of the seal if the seal is designed to be peeled from the edge. A tab located along the top centerline of the seal can also be used, provided the tab runs across the diameter of the seal. Source: GTRI Guideline: Do not glue the grasp point to the inner seal or other surface. Source: GTRI Guideline: Provide at least one mode of operation that does not require fine motor control or simultaneous actions, and that is operable with limited reach and strength. Source: Section 508 1194.31(f) [13] Guideline: Offer redundant modes of operation utilizing the next larger set of motor movements (finger to hand, hand to arm). Offer different ways to accomplish the same task using increasingly larger motor movements. For example, a tab on a seal should be large enough to grip between the thumb and knuckle, rather than between the tips of the finger. Source: Pirkl, 1995 [23] Discussion: By allowing redundant modes of operation, users might have the option to avoid using joints in which swelling and pain are most severe. 43 The user cannot puncture the seal with a finger. Detailed Description: If no tab is provided on the seal, then users must puncture and tear it. In general, manufacturers should provide a tab, because users may struggle to puncture the seal with their fingertip. They may have previous difficult experiences with other products that lacked tabs on the seal, and may therefore assume that all seals are difficult to puncture. Users may resort to using a tool, such as a knife or scissors. This can be problematic if a tool is not readily available, or if use of the tool causes pain in inflamed joints. Potential Solution: Limit the amount of force required to puncture the seal. The amount of force that is required to puncture the seal, as measured with a blunt object that simulates a fingertip, should not exceed 5 lbs (22.2 N) (but see Guideline Discussion below). Applicable Guidelines: Guideline: Do not require the use of tools. Source: GTRI Guideline: Minimize safety seal removal force. The force required to remove the safety seal (e.g., by puncturing the seal or by pulling to remove it) should not exceed 5.0 pounds (22.2 N). Sources: GTRI; Section 508 1194.23(k)(2) [13] Discussion: Section 508 sets a broad guideline for maximum linear force requirements for all user actions. The guideline may not be directly applicable to puncturing a safety seal. Further research will be needed to determine if the 5.0 pound recommendation should be modified for this application. 44 What are the issues associated with instructions and labeling? Instructions are defined as any textual or graphical information that tells the user how to operate or consume the product. This includes opening instructions, consumption instructions, and dosage information. Labels include warnings, product information, and expiration dates. The ease of use issues associated with instructions and labels are not unique to users with arthritis, but are common to all users. However, older adults, who comprise a large portion of the population with arthritis, often experience a decline in visual acuity. Therefore, the visual design of instructions and labeling are particularly important for many users with arthritis. The text or graphics are difficult to see. Detailed Description: Some users may have difficulty reading text due to its small size or poor contrast with the background. Textual or graphical instructions for opening a cap are often engraved into the cap, giving very poor visual contrast. Additionally, the readability of text may be poor due to small text size and low contrast. Inability to read instructions and labeling may lead to incorrect or unsafe usage of the product. Potential Solution: Enhance readability of all text by increasing font size and contrast. If instructions are engraved, poor contrast should be compensated for by increasing the font size. Ideally, all text should be printed with both high contrast and large font. Applicable Guideline: Guideline: Enhance readability and comprehension of labels, critical instructions, and expiration dates. Print critical text with large print in a sans-serif font with high contrast on a solid background. Source: GTRI 45 The text is difficult to find. Detailed Description: Instructions and labels may be difficult to find if they are not preceded by a prominent title, or if they are placed in an unexpected location. For example, dosage information may be difficult to find if it runs together with warnings and ingredients. Potential Solution: Provide clearly visible, prominent titles for each section (e.g., Warnings and Active Ingredients), and use white space or lines to separate sections of text. Visual cues, such as white space, lines, and prominent titles, can help users as they search for information. 46 The expiration date is difficult to find, read, or interpret. Detailed Description: Expiration dates may be difficult to find if they are placed in obscure, atypical locations. For example, if the date is printed on the side of the bottle, the user must rotate the bottle and search across its entire surface. Once the date is found, it may be difficult to read if it is printed in small lettering with poor contrast. Expiration dates are often printed directly on containers that do not provide enough contrast with the text (Figure 30). Finally, the date may be misinterpreted or unrecognized if its format is ambiguous. For example, “12 07 11” might mean December 7, 2011 or July 12, 2011, or it might simply be a product code. Figure 30: An expiration date that is difficult to read. Potential Solution: Print expiration dates in a standard location, using an unambiguous format, large font, and good contrast. The location of the expiration date should be standardized across products. Users may typically expect to find them on the bottom of containers. To enhance contrast, the container should be opaque, or its contents should provide sufficient contrast with the text (Figure 31). Note that lettering printed on the upper portion of a transparent container may become difficult to read after some of the contents have been dispensed. Figure 31: An expiration date that is easy to read. 47 Applicable Guideline: Guideline: Enhance readability and comprehension of labels, critical instructions, and expiration dates. Print critical text with large print in a sans-serif font with high contrast on a solid background. Sources: GTRI 48 Design Guidelines The design and evaluation of bottles can be informed by guidelines that have been suggested by researchers. The number of published studies that address human performance in handling and opening consumer product containers is limited. The quality of existing research may be questionable if a small subject sample was used or if the researchers employed flawed experimental designs. Therefore, it is important to document the sources for the guidance offered in this report. Careful review of the sources may lead to an understanding of how to allocate future research resources and make better usage of the guidelines. The container design guidelines used in this report are shown in Table 6. Table 6: Ease of use guidelines for container design. Guideline Guideline Source(s) Discussion Packages should be designed to minimize hand and eye movements, thus maximizing efficiency. Applicable Components Minimize user actions. HFDS 2.6.8 [12] All components Ensure that the product is easy to grip and control. The shape of the product should be easy to hold, so that it fits the hand. There should also be a texture to the surface so that it can be gripped and held onto. Cushman and Rosenberg, 1991 [7]; Haigh, 1993 [16] - Container body - Cap - Outer safety seal - Inner seal Allow for alternatives to a standard grip. Size the gripping area and clearances to allow alternatives to the standard grip, including knuckles, the side, back and heels of the hand, and two-handed “pinch” grips. Steinfeld and Mullick, 1990 [26] - Container body - Cap - Outer safety seal - Inner seal Require a grip span of no more than 2.8 inches for products that are intended to be grasped with one hand. If the size of the container exceeds the maximum grip span recommendations, then add design features such as handles or cutouts to facilitate a reduced grip span requirement. Steinfeld and Mullick, 1990 [26] This includes, but is not limited to, products that must be grasped with one hand while opening the cap with the other hand. This guideline is especially important for heavy containers and for those whose surface provides little friction with the hand. - Container body Provide a high friction grip surface on cylindrical containers. GTRI Tight grasping of the container is required to provide a counter-rotational force when removing a twist off cap. Provide a high friction surface on a cylindrical container to facilitate tight grasping. - Container body 49 Guideline Guideline Source(s) Discussion Non-cylindrical grip features can enhance grip while removing a cap. Applicable Components Provide a non-cylindrical grip feature, such as grip indentions, or use a non-cylindrical container. GTRI - Container body Provide at least one mode of operation that does not require fine motor control or simultaneous actions, and that is operable with limited reach and strength. Section 508 1194.31(f) [13] Whenever possible, do not require simultaneous actions such as pulling and rotating. Kanis, 1993 [18] In some cases, it may not be possible to avoid simultaneous actions. For example, users must simultaneously grip and rotate a cap to remove it. In such cases, the required forces for each action should be minimized. - Cap - Outer safety seal - Inner seal Offer redundant modes of operation utilizing the next larger set of motor movements (finger to hand, hand to arm). Offer different ways to accomplish the same task using increasingly larger motor movements. For example, a tab on a seal should be large enough to grip between the thumb and knuckle, rather than between the tips of the finger. Pirkl, 1995 [23] By allowing redundant modes of operation, users might have the option to avoid using joints in which swelling and pain are most severe. - Cap - Outer safety seal - Inner seal Do not require the use of tools. GTRI Require no more than 3.3 pounds to push in a push tab. Berns, 1981 [3] The study included people from the general population as well as people with a variety of disability types including arthritis, multiple sclerosis, Parkinson’s disease, cerebral palsy, hemiplegics, and amputees. - Cap - Inner seal Verify that the requirement for constant, uninterrupted actions is minimized by investigating the required actions for each component of the container. Vanderheiden, 1997 [28] This might apply to hinged flip-top caps that should remain open on their own, rather than being held open by the user. - Cap Verify presence of definitive feedback cues (e.g., latches should “snap” into position). Pirkl, 1995 [23] - Cap - Outer safety seal - Inner seal - Cap - Outer safety seal - Inner seal - Cap 50 Guideline Guideline Source(s) Discussion Applicable Components Verify that operation of the product does not violate standard conventions (clockwise for “close,” counterclockwise for “open”). Pirkl, 1995 [23] - Cap Screw top caps should fit in the hand. Their removal should require no more than ¼ turn for each angular movement, and no more than two angular movements should be required. Haigh, 1993 [16] This study did not address replacing the cap. - Cap Avoid sharp edges. GTRI The push point of the flip top cap should be beveled and devoid of sharp edges. Knurls and serrations on twist-off caps should be rounded. - Cap Minimize rotational force required to remove the cap from the factory sealed position. Berns, 1981 [3]; Langley, Janson, Wearn, and Yoxall, 2005 [19]; Voorbij and Steenbekkers, 2002 [29] The research available on this topic is very limited. The amount of rotational force that a user can apply to a twist off cap is dependent on the following factors: cap diameter, cap height, cap coefficient of friction, container shape, container coefficient of friction, skin moisture, and grasp type. - Cap Minimize the forces required to open and close flip-top caps. The forces required to flip the cap open and closed should not exceed 5.0 pounds. Section 508 1194.23(k)(2) [13] Section 508 sets a broad guideline for maximum linear force requirements for all user actions. The guideline may not be directly applicable to removing opening a flip top cap. Further research will be needed to determine if the 5.0 pound recommendation should be modified for this application. - Cap (flip-top and pop-off) 51 Guideline Guideline Source(s) Discussion Applicable Components Provide a sufficient area for applying force to open the cap. GTRI The force required to flip the cap open can be applied more easily when the area where the force is applied is larger. The area where the force is applied (e.g., an overhanging cap and/or an indention below the edge of the cap) should be large enough to accommodate a number of methods for opening the cap (e.g., fingernail, one or more fingertips, tip or side of thumb, side of hand, etc.). - Cap (flip-top and pop-off) When using knurls to enhance the grip on a cap, consider that tightly spaced knurls may not provide sufficient texture for gripping, and widely spaced knurls may cause painful pressure points on the user’s joints. GTRI Additional research is required to determine appropriate range of knurl spacing. - Cap Use steep rather than gradual threading to prevent over tightening of the cap. GTRI Steep threading can also reduce the extent of rotation that is necessary to remove the cap from the container. - Cap Require a pinch force of no more than 3.0 pounds. GTRI Preliminary data collected during GTRI assessments of users with arthritis suggested that pinch force requirements should not exceed 3.0 pounds; however, further research is needed to validate this finding. - Outer safety seal - Inner seal Ensure that the proper method of removing the outer safety seal is clearly evident, either because of the design of the safety seal or because of instructions printed prominently on the packaging. For example, if the seal is removed by twisting the cap to break the seal, instructions like “Twist cap to break seal” should be provided. If the seal is removed by pulling a perforated strip, the strip should be clearly visible. Vanderheiden, 1997 [28] The steps required to open some containers may be intuitively obvious to most users and therefore may not require printed instructions. - Outer safety seal If the outer safety seal is intended to be torn open, then provide a perforated strip or a starter slit. GTRI - Outer safety seal 52 Guideline Guideline Source(s) Discussion Applicable Components Minimize safety seal removal force. The force required to remove the safety seal (e.g., by puncturing the seal or by pulling to remove it) should not exceed 5.0 pounds (22.2 N). GTRI; Section 508 1194.23(k)(2) [13] Section 508 sets a broad guideline for maximum linear force requirements for all user actions. The guideline may not be directly applicable to removing a safety seal. Further research will be needed to determine if the 5.0 pound recommendation should be modified for this application. - Outer safety seal On smooth inner seal tabs, provide a sufficiently large grasping point. A tab that is at least 0.47 inches wide by 0.79 inches long is recommended. Department of Trade and Industry, UK, 2003 [11] The study was based on a smooth tab. The study only looked at one tab width and two tab lengths. Only two pull tab sizes were studied: 0.47 inches and 0.79 inches. The tabs were rectangular. - Inner seal The test population included people with disabilities but the sample was relatively small and included a variety of disabilities. Provide texture on the grasp point that facilitates gripping the tab. The grasp point should be textured with a series of bumps or raised strips perpendicular to the peel direction. Department of Trade and Industry, UK, 2003 [11] - Inner seal On inner seals that are intended to be grasped and peeled from the container, place the grasp point in a location selected for the application of optimum force. The tab should be located along the edge of the seal if the seal is designed to be peeled from the edge. A tab located along the top centerline of the seal can also be used, provided the tab runs across the diameter of the seal. GTRI - Inner seal Do not glue the grasp point to the inner seal or other surface. 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