Practice Gap

Biopsies, excisions, and other invasive cutaneous procedures are performed regularly in dermatology clinics and require placement of a bandage after the procedure. Postprocedural bandaging varies by the type of procedure performed, anatomic site, and the physician’s preference of materials. Dermatologists can be left with an overwhelming choice of supplies and little practical education, as bandaging methods are not routinely addressed in residency curricula. To address this concern, we provide a succinct list of basic materials that are versatile and easily adapted to encompass all bandaging needs for dermatology procedures (Table).

With these few components, one can create an array of distinct bandages to cover wounds as small as a shave biopsy to linear closures and basic flaps or grafts. Even traditionally difficult-to-bandage areas are easily addressed. Simple modifications of the basic materials are required for each bandage adaptation, as outlined below.

The Techniques

Shave and Punch Biopsy Sites—Layer (from bottom to top) the emollient of choice, a cut 4×4-inch gauze pad, and flexible polyester tape cut to the appropriate size (Figure 1). This simple bandage conforms well to any anatomic site and can replace an adhesive bandage, if desired.

Cutaneous Surgery Sites—Pressure bandages are recommended on cutaneous surgery sites. One of the most common closures performed in dermatology is the layered closure with dissolvable subcutaneous sutures and nondissolvable cutaneous sutures. When this closure is performed on the trunk and proximal extremities, undermining often is required to adequately approximate skin. This technique eliminates tension on the wound but can increase the risk for hematoma.¹ A pressure bandage left in place and kept dry for 48 hours after surgery helps eliminate the risk for postoperative bleeding.

To make a pressure bandage, layer (from bottom to top) the emollient of choice, a nonstick pad cut to size, folded 4×4-inch gauze pads, and flexible polyester tape (Figure 2). Our practice routinely utilizes the tape fanning technique² to impart equal and firm pressure over the wound.

Complex Sites—When making a pressure bandage for an anatomically complex site—the ear, nose, or lip—nonstick pads and 4×4-inch gauze pads can be cut and folded or rolled to match the size and shape of the wound. Flexible polyester tape then conforms to these custom bandage shapes, allowing maintenance of targeted wound pressure (Figure 3).

Dental rolls can be of assistance on these sites. For example, a dental roll placed in the postauricular sulcus prior to bandaging an ear maintains comfortable anatomic positioning. Rolls can be placed in the nose, maintaining its architecture while the wound heals and providing counterpressure for added hemostasis of wounds on the lateral nasal sidewall and ala. We recommend coating dental rolls in petrolatum prior to placement in the nares for ease of removal and patient comfort.

Distal Arms and Legs—Another layer of compression is added to pressure bandages on the distal upper and lower extremities using a fabric and elastic wrap (Figure 4). The extra layer keeps the bandage in place on the upper extremities while the patient continues their daily activities. It also helps prevent edema and pain in the lower extremities.

The degree of postoperative lower extremity swelling varies by patient and procedure performed but largely is inevitable with surgery on the leg, given the potential for superficial lymphatic disruption and the dependent position of the leg when standing. Elevation is always advised, but a well-wrapped, long-stretch elastic bandage provides extra support, especially if the patient has baseline venous insufficiency or needs to be on their feet during the day. The wrap is applied from the distal to the proximal leg with graded compression, overlapping by half with each rotation. The wrap is tightest near the ankle, with gradual and subtle easing of tension as it is placed superiorly.

Healing by Secondary Intention, Full-Thickness and Split-Thickness Skin Grafts, and Partial Wound Closure—These postoperative scenarios require bandages with appropriate pressure; however, dressings need to remain moist against the patient’s skin for comfortable removal, which can be accomplished with petrolatum-impregnated gauze with or without antibacterial properties. The gauze is folded to the appropriate size and placed directly on the wound or sutured in place (Figure 5). A pressure bandage is then applied on top of the gauze.

Practice Implications

The universal bandage kit and instructions for its adaptation to accommodate multiple clinical needs can serve as a helpful resource for dermatologists and their staff.

Practice Gap

Biopsies, excisions, and other invasive cutaneous procedures are performed regularly in dermatology clinics and require placement of a bandage after the procedure. Postprocedural bandaging varies by the type of procedure performed, anatomic site, and the physician’s preference of materials. Dermatologists can be left with an overwhelming choice of supplies and little practical education, as bandaging methods are not routinely addressed in residency curricula. To address this concern, we provide a succinct list of basic materials that are versatile and easily adapted to encompass all bandaging needs for dermatology procedures (Table).

With these few components, one can create an array of distinct bandages to cover wounds as small as a shave biopsy to linear closures and basic flaps or grafts. Even traditionally difficult-to-bandage areas are easily addressed. Simple modifications of the basic materials are required for each bandage adaptation, as outlined below.

The Techniques

Shave and Punch Biopsy Sites—Layer (from bottom to top) the emollient of choice, a cut 4×4-inch gauze pad, and flexible polyester tape cut to the appropriate size (Figure 1). This simple bandage conforms well to any anatomic site and can replace an adhesive bandage, if desired.

Cutaneous Surgery Sites—Pressure bandages are recommended on cutaneous surgery sites. One of the most common closures performed in dermatology is the layered closure with dissolvable subcutaneous sutures and nondissolvable cutaneous sutures. When this closure is performed on the trunk and proximal extremities, undermining often is required to adequately approximate skin. This technique eliminates tension on the wound but can increase the risk for hematoma.¹ A pressure bandage left in place and kept dry for 48 hours after surgery helps eliminate the risk for postoperative bleeding.

To make a pressure bandage, layer (from bottom to top) the emollient of choice, a nonstick pad cut to size, folded 4×4-inch gauze pads, and flexible polyester tape (Figure 2). Our practice routinely utilizes the tape fanning technique² to impart equal and firm pressure over the wound.

Complex Sites—When making a pressure bandage for an anatomically complex site—the ear, nose, or lip—nonstick pads and 4×4-inch gauze pads can be cut and folded or rolled to match the size and shape of the wound. Flexible polyester tape then conforms to these custom bandage shapes, allowing maintenance of targeted wound pressure (Figure 3).

Dental rolls can be of assistance on these sites. For example, a dental roll placed in the postauricular sulcus prior to bandaging an ear maintains comfortable anatomic positioning. Rolls can be placed in the nose, maintaining its architecture while the wound heals and providing counterpressure for added hemostasis of wounds on the lateral nasal sidewall and ala. We recommend coating dental rolls in petrolatum prior to placement in the nares for ease of removal and patient comfort.

Distal Arms and Legs—Another layer of compression is added to pressure bandages on the distal upper and lower extremities using a fabric and elastic wrap (Figure 4). The extra layer keeps the bandage in place on the upper extremities while the patient continues their daily activities. It also helps prevent edema and pain in the lower extremities.

The degree of postoperative lower extremity swelling varies by patient and procedure performed but largely is inevitable with surgery on the leg, given the potential for superficial lymphatic disruption and the dependent position of the leg when standing. Elevation is always advised, but a well-wrapped, long-stretch elastic bandage provides extra support, especially if the patient has baseline venous insufficiency or needs to be on their feet during the day. The wrap is applied from the distal to the proximal leg with graded compression, overlapping by half with each rotation. The wrap is tightest near the ankle, with gradual and subtle easing of tension as it is placed superiorly.

Healing by Secondary Intention, Full-Thickness and Split-Thickness Skin Grafts, and Partial Wound Closure—These postoperative scenarios require bandages with appropriate pressure; however, dressings need to remain moist against the patient’s skin for comfortable removal, which can be accomplished with petrolatum-impregnated gauze with or without antibacterial properties. The gauze is folded to the appropriate size and placed directly on the wound or sutured in place (Figure 5). A pressure bandage is then applied on top of the gauze.

Practice Implications

The universal bandage kit and instructions for its adaptation to accommodate multiple clinical needs can serve as a helpful resource for dermatologists and their staff.

Practice Gap

Biopsies, excisions, and other invasive cutaneous procedures are performed regularly in dermatology clinics and require placement of a bandage after the procedure. Postprocedural bandaging varies by the type of procedure performed, anatomic site, and the physician’s preference of materials. Dermatologists can be left with an overwhelming choice of supplies and little practical education, as bandaging methods are not routinely addressed in residency curricula. To address this concern, we provide a succinct list of basic materials that are versatile and easily adapted to encompass all bandaging needs for dermatology procedures (Table).

With these few components, one can create an array of distinct bandages to cover wounds as small as a shave biopsy to linear closures and basic flaps or grafts. Even traditionally difficult-to-bandage areas are easily addressed. Simple modifications of the basic materials are required for each bandage adaptation, as outlined below.

The Techniques

Shave and Punch Biopsy Sites—Layer (from bottom to top) the emollient of choice, a cut 4×4-inch gauze pad, and flexible polyester tape cut to the appropriate size (Figure 1). This simple bandage conforms well to any anatomic site and can replace an adhesive bandage, if desired.

Cutaneous Surgery Sites—Pressure bandages are recommended on cutaneous surgery sites. One of the most common closures performed in dermatology is the layered closure with dissolvable subcutaneous sutures and nondissolvable cutaneous sutures. When this closure is performed on the trunk and proximal extremities, undermining often is required to adequately approximate skin. This technique eliminates tension on the wound but can increase the risk for hematoma.¹ A pressure bandage left in place and kept dry for 48 hours after surgery helps eliminate the risk for postoperative bleeding.

To make a pressure bandage, layer (from bottom to top) the emollient of choice, a nonstick pad cut to size, folded 4×4-inch gauze pads, and flexible polyester tape (Figure 2). Our practice routinely utilizes the tape fanning technique² to impart equal and firm pressure over the wound.

Complex Sites—When making a pressure bandage for an anatomically complex site—the ear, nose, or lip—nonstick pads and 4×4-inch gauze pads can be cut and folded or rolled to match the size and shape of the wound. Flexible polyester tape then conforms to these custom bandage shapes, allowing maintenance of targeted wound pressure (Figure 3).

Dental rolls can be of assistance on these sites. For example, a dental roll placed in the postauricular sulcus prior to bandaging an ear maintains comfortable anatomic positioning. Rolls can be placed in the nose, maintaining its architecture while the wound heals and providing counterpressure for added hemostasis of wounds on the lateral nasal sidewall and ala. We recommend coating dental rolls in petrolatum prior to placement in the nares for ease of removal and patient comfort.

Distal Arms and Legs—Another layer of compression is added to pressure bandages on the distal upper and lower extremities using a fabric and elastic wrap (Figure 4). The extra layer keeps the bandage in place on the upper extremities while the patient continues their daily activities. It also helps prevent edema and pain in the lower extremities.

The degree of postoperative lower extremity swelling varies by patient and procedure performed but largely is inevitable with surgery on the leg, given the potential for superficial lymphatic disruption and the dependent position of the leg when standing. Elevation is always advised, but a well-wrapped, long-stretch elastic bandage provides extra support, especially if the patient has baseline venous insufficiency or needs to be on their feet during the day. The wrap is applied from the distal to the proximal leg with graded compression, overlapping by half with each rotation. The wrap is tightest near the ankle, with gradual and subtle easing of tension as it is placed superiorly.

Healing by Secondary Intention, Full-Thickness and Split-Thickness Skin Grafts, and Partial Wound Closure—These postoperative scenarios require bandages with appropriate pressure; however, dressings need to remain moist against the patient’s skin for comfortable removal, which can be accomplished with petrolatum-impregnated gauze with or without antibacterial properties. The gauze is folded to the appropriate size and placed directly on the wound or sutured in place (Figure 5). A pressure bandage is then applied on top of the gauze.

Practice Implications

The universal bandage kit and instructions for its adaptation to accommodate multiple clinical needs can serve as a helpful resource for dermatologists and their staff.

Pseudofolliculitis barbae (PFB)(also known as razor bumps or shaving bumps)¹ is a skin condition that consists of papules resulting from ingrown hairs.² In more severe cases, papules become pustules, then abscesses, which can cause scarring.^1,2 The condition can be distressing for patients, with considerable negative impact on their daily lives.³ The condition also is associated with shaving-related stinging, burning, pruritus, and cuts on the skin.⁴

Pseudofolliculitis barbae is most common in men of African descent due to the curved nature of the hair follicle,^2,5,6 with an estimated prevalence in this population of 45% to 83%,^1,6 but it can affect men of other ethnicities.⁷ A genetic polymorphism in a gene encoding a keratin specific to the hair follicle also has been found to predispose some individuals to PFB.⁵ When hair from a curved or destabilized hair follicle is cut to form a sharp tip, it is susceptible to extrafollicular and/or transfollicular penetration,^5,6,8 as illustrated in Figure 1.

With extrafollicular or transfollicular penetration, the hair shaft re-enters or retracts into the dermis, triggering an inflammatory response that may be exacerbated by subsequent shaving.² Few studies have been published that aim to identify potential shaving solutions for individuals with PFB who elect to or need to continue shaving.

A new razor technology comprising 2 blades separated by a bridge feature has been designed specifically for men with razor bumps (SkinGuard [Procter & Gamble]). The SkinGuard razor redistributes shaving pressure so that there is less force from the blades on the skin and inflamed lesions than without the bridge, as seen in Figure 2. The razor has been designed to protect the skin from the blades, thereby minimizing the occurrence of new lesions and allowing existing lesions to heal.

The primary purpose of this study was to assess the appearance of males with razor bumps and shaving irritation when using the new razor technology in a regular shaving routine. The secondary objective was to measure satisfaction of the shaving experience when using the new razor by means of assessing itching, burning, and stinging using the participant global severity assessment (PGSA) and the impact on quality of life (QOL) measures.

Methods

Participants—Eligible participants were male, aged 20 to 60 years, and had clinically diagnosed PFB as well as symptoms of skin irritation from shaving. Participants were recruited from a dermatology clinic and via institutional review board–approved advertising.

Those eligible for inclusion in the study had a shaving routine that comprised shaving at least 3 times a week using a wet-shave, blade-razor technique accompanied by only a shave gel or foam. In addition, eligible participants had mild to moderate symptoms of skin irritation (a minimum of 10 razor bumps) from shaving based on investigator global severity assessment (IGSA) rating scales and were willing to shave at least 5 times a week during the study period. Participants could continue certain topical and systemic interventions for their skin.

Participants were excluded from the study if they had an underlying inflammatory disease that could manifest with a skin rash or were using any of these medications: topical benzoyl peroxide, topical clindamycin, topical retinoids, or oral antibiotics.

Study Design—A prospective, open-label study was conducted over a period of 12 weeks at a single site in the United States. Investigators instructed participants to shave 5 or more times per week with the test razor and to keep a daily shaving journal to track the number of shaves and compliance.

Participants were evaluated at the baseline screening visit, then at 4, 8, and 12 weeks. Evaluations included an investigator lesion count, the IGSA, and the PGSA. The PGSA was used to evaluate subjective clinical measurements (ie, indicate how much postshave burning/itching/stinging the participant was experiencing). The impact of shaving on daily life was evaluated at the baseline screening visit and at 12 weeks with the Participant Quality of Life Questionnaire comprised of 22 QOL statements. eTable 1 summarizes the investigator assessments used in the study, and eTable 2 summarizes the participant self-assessments. Both tables include the scale details and results interpretation for each assessment.

The study was approved by the local institutional review board, and all participants provided written informed consent in accordance with Title 21 of the Code of Federal Regulations, Part 50.

Study Visits—At the baseline screening visit, participants provided written informed consent and completed a prestudy shave questionnaire concerning shaving preparations, techniques, and opinions. Participants also provided a medical history, including prior and concomitant medications, and were evaluated using the inclusion/exclusion criteria. Investigators explained adverse event reporting to the participants. Participants were provided with an adequate supply of test razors for the 12-week period.

Data Analysis—Means and SDs were calculated for the study measures assessed at each visit. Analyses were performed evaluating change from baseline in repeated-measures analysis of variance models. These models were adjusted for baseline levels of the outcome measure and visit number. The magnitude of change from baseline was evaluated against a null hypothesis of 0% change. This longitudinal model adjusted for any potential differing baseline levels among participants. Statistical significance was defined as P<.05. SAS version 9.4 (SAS Institute Inc) was used for all analyses.

Results

In total, 21 individuals were enrolled, and 20 completed the study. Participants who completed the study were non-Hispanic Black (n=10); non-Hispanic White (n=8); Asian (n=1); or White, American Indian (n=1). All participants adhered to the protocol and reported shaving at least 5 times a week for 12 weeks using the test razor. One participant was removed after he was found to have a history of sarcoidosis, making him ineligible for the study. No study-related adverse events were reported.

Papules and Pustules—Over the course of the 12-week study, the papule count decreased significantly from baseline. Results from the investigator lesion count (see eTable 1 for key) indicated that by week 12—adjusted for number of papules at baseline—the mean percentage reduction was estimated to be 59.6% (P<.0001). A significant decrease in papule count also was observed between the baseline visit and week 8 (57.2%; P<.0001). A nonsignificant decrease was observed at week 4 (18.9%; P=.17). Only 3 participants presented with pustules at baseline, and the pustule count remained low over the course of the study. No significant change was noted at week 12 vs baseline (P=.98). Notably, there was no increase in pustule count at the end of the study compared with baseline (Table 1).

Skin Appearance—An improvement in the skin’s appearance over the course of the study from baseline was consistent with an improvement in the IGSA. The IGSA score significantly improved from a mean (SD) measurement of 2.5 (0.6) (indicating mild to moderate inflammation) at baseline to 1.4 (0.8) at week 8 (P<.0001) and 1.2 (1.1) (indicating mild inflammation to almost clear) at week 12 (P<.0001). The observed decrease in severity of skin condition and skin inflammation is shown in Figure 3.

Significant improvements were observed in every category of the PGSA at week 12 vs baseline (P≤.0007)(Table 2). At week 12, there was a significant (P≤.05) increase from baseline in participant agreement for all 22 QOL metrics describing positive shave experience, achieving results, skin feel, self-confidence, and social interactions (Figure 4), which supports the positive impact of adopting a shaving regimen with the test razor. Notably, after using the test razor for 12 weeks, men reported that they were more likely to agree with the statements “my skin felt smooth,” “my skin felt good to touch,” and “I was able to achieve a consistently good shave.” Other meaningful increases occurred in “shaving was something I looked forward to doing,” “others thought I looked clean cut,” “I looked my best for my family/others/work,” and “I felt comfortable/confident getting closer to others.” All QOL statements are shown in Figure 4.

Improvement With Novel Razor Technology—For the first time, frequent use of a novel razor technology designed specifically for men with PFB was found to significantly improve skin appearance, shave satisfaction, and QOL after 12 weeks vs baseline in participants clinically diagnosed with PFB. In men with shave-related skin irritation and razor bumps who typically wet-shaved with a razor at least 3 times a week, use of the test razor with their regular shaving preparation product 5 or more times per week for 12 weeks was associated with significant improvements from baseline in investigator lesion count, IGSA, PGSA, and Participant Quality of Life Questionnaire measurements.

Study strengths included the quantification of the change in the number of lesions and the degree of severity by a trained investigator in a prospective clinical study along with an assessment of the impact on participant QOL. A lack of a control arm could be considered a limitation of the study; however, study end points were evaluated compared with baseline, with each participant serving as their own control. Spontaneous resolution of the condition with their standard routine was considered highly unlikely in these participants; therefore, in the absence of any other changes, improvements were attributed to regular use of the test product over the course of the study. The results presented here provide strong support for the effectiveness of the new razor technology in improving the appearance of men with razor bumps and shaving irritation.

Hair Removal Tools for the Management of PFB—Although various tools and techniques have been proposed in the past for men with PFB, the current test razor technology provided unique benefits, including improvements in appearance and severity of the condition as well as a positive impact on QOL. In 1979, Conte and Lawrence⁹ evaluated the effect of using an electric hair clipper and twice-daily use of a skin-cleansing pad on the occurrence of PFB. Participants (n=96) allowed their beards to grow out for 1 month, after which they started shaving with an electric clipper with a triple O head. The authors reported a favorable response in 95% (91/96) of cases. However, the electric clippers left 1 mm of beard at the skin level,⁹ which may not be acceptable for those who prefer a clean-shaven appearance.⁶

A prospective survey of 22 men of African descent with PFB found use of a safety razor was preferred over an electric razor.¹⁰ The single-arm study evaluated use of a foil-guarded shaver (single-razor blade) in the management of PFB based on investigator lesion counts and a participant questionnaire. Participants were asked to shave at least every other day and use a specially designed preshave brush. A mean reduction in lesion counts was observed at 2 weeks (29.6%), 4 weeks (38.1%), and 6 weeks (47.1%); statistical significance was not reported. At 6 weeks, 77.3% (17/22) of participants judged the foil-guarded shaver to be superior to other shaving devices in controlling their razor bumps, and 90.9% (20/22) indicated they would recommend the shaver to others with PFB. The authors hypothesized that the guard buffered the skin from the blade, which might otherwise facilitate the penetration of ingrowing hairs and cause trauma to existing lesions.

The mean reduction in lesion count from baseline observed at week 4 was greater in the study with the foil-guarded shaver and preshave brush (38% reduction)¹⁰ than in our study (19% reduction in papule count). Different methodologies, use of a preshave brush in the earlier study, and a difference in lesion severity at baseline may have contributed to this difference. The study with the foil-guarded shaver concluded after 6 weeks, and there was a 47.1% reduction in lesion counts vs baseline.¹⁰ In contrast, the current study continued for 12 weeks, and a 59.6% reduction in lesion counts was reported. Participants from both studies reported an improved shaving experience compared with their usual practice,¹⁰ though only the current study explored the positive impact of the new razor technology on participant QOL.

Preventing Hairs From Being Cut Too Close—The closeness of the shave is believed to be a contributory factor in the development and persistence of PFB^6,8,11 based on a tendency for the distal portion of tightly curled hair shafts to re-enter the skin after shaving via transfollicular penetration.¹² Inclusion of a buffer in the razor between the sharp blades and the skin has been proposed to prevent hairs from being cut too close and causing transfollicular penetration.¹²

In the test razor used in the current study, the bridge technology acted as the buffer to prevent hairs from being cut too close to the skin and to reduce blade contact with the skin (Figure 2). Having only 2 blades also reduced the closeness of the shave compared with 5-bladed technologies,¹³ as each hair can only be pulled and cut up to a maximum of 2 times per shaving stroke. Notably, this did not impact the participants’ QOL scores related to achieving a close shave or skin feeling smooth; both attributes were significantly improved at 12 weeks vs baseline (Figure 4).

By reducing blade contact with the skin, the bridge technology in the test razor was designed to prevent excessive force from being applied to the skin through the blades. Reduced blade loading minimizes contact with and impact on sensitive skin.¹⁴ Additional design features of the test razor to minimize the impact of shaving on the skin include treatment of the 2 blades with low-friction coatings, which allows the blades to cut through the beard hair with minimal force, helping to reduce the tug-and-pull effect that may otherwise result in irritation and inflammation.^13,15 Lubrication strips before and after the blades in the test razor reduce friction between the blades and the skin to further protect the skin from the blades.¹⁵

Shaving With Multiblade Razors Does Not Exacerbate PFB—In a 1-week, split-faced, randomized study of 45 Black men, shaving with a manual 3-bladed razor was compared with use of 3 different chemical depilatory formulations.¹⁶ Shaving every other day for 1 week with the manual razor resulted in more papule formation but less irritation than use of the depilatories. The authors concluded that a study with longer duration was needed to explore the impact of shaving on papule formation in participants with a history of PFB.¹⁶

In 2013, an investigator-blinded study of 90 African American men with PFB compared the impact of different shaving regimens on the signs and symptoms of PFB over a 12-week period.⁴ Participants were randomized to 1 of 3 arms: (1) shaving 2 to 3 times per week with a triple-blade razor and standard products (control group); (2) shaving daily with a 5-bladed razor and standard products; and (3) shaving daily with a 5-bladed razor and “advanced” specific pre- and postshave products. The researchers found that the mean papule measurement significantly decreased from baseline in the advanced (P=.01) and control (P=.016) groups. Between-group comparison revealed no significant differences for papule or pustule count among each arm. For the investigator-graded severity, the change from baseline was significant for all 3 groups (P≤.04); however, the differences among groups were not significant. Importantly, these data demonstrated that PFB was not exacerbated by multiblade razors used as part of a daily shaving regimen.⁴

The findings of the current study were consistent with those of Daniel et al⁴ in that there was no exacerbation of the signs and symptoms of PFB associated with daily shaving. However, rather than requiring participants to change their entire shaving regimen, the present study only required a change of razor type. Moreover, the use of the new razor technology significantly decreased papule counts at week 12 vs the baseline measurement (P<.0001) and was associated with an improvement in subjective skin severity measurements. The participants in the present study reported significantly less burning, stinging, and itching after using the test product for 12 weeks (P<.0001).

Impact of Treatment on QOL—The current study further expanded on prior findings by combining these clinical end points with the QOL results to assess the test razor’s impact on participants’ lives. Results showed that over the course of 12 weeks, the new razor technology significantly improved the participants’ QOL in all questions related to shaving experience, achieving results, skin feel, self-confidence, and social interactions. The significant improvement in QOL included statements such as “shaving was a pleasant experience,” “I was able to achieve a consistently good shave,” and “my skin felt smooth.” Participants also reported improvements in meaningful categories such as “my shave made me feel attractive” and “I felt comfortable/confident getting closer to others.” As the current study showed, a shave regimen has the potential to change participants’ overall assessment of their QOL, a variable that must not be overlooked.

Conclusion

In men with clinically diagnosed PFB, regular shaving with a razor designed to protect the skin was found to significantly decrease lesion counts, increase shave satisfaction, and improve QOL after 12 weeks compared with their usual shaving practice (baseline measures). This razor technology provides another option to help manage PFB for men who wish to or need to continue shaving.

Acknowledgments—The clinical study was funded by the Procter & Gamble Company. Editorial writing assistance, supported financially by the Procter & Gamble Company, was provided by Gill McFeat, PhD, of McFeat Science Ltd (Devon, United Kingdom).

Pseudofolliculitis barbae (PFB)(also known as razor bumps or shaving bumps)¹ is a skin condition that consists of papules resulting from ingrown hairs.² In more severe cases, papules become pustules, then abscesses, which can cause scarring.^1,2 The condition can be distressing for patients, with considerable negative impact on their daily lives.³ The condition also is associated with shaving-related stinging, burning, pruritus, and cuts on the skin.⁴

Pseudofolliculitis barbae is most common in men of African descent due to the curved nature of the hair follicle,^2,5,6 with an estimated prevalence in this population of 45% to 83%,^1,6 but it can affect men of other ethnicities.⁷ A genetic polymorphism in a gene encoding a keratin specific to the hair follicle also has been found to predispose some individuals to PFB.⁵ When hair from a curved or destabilized hair follicle is cut to form a sharp tip, it is susceptible to extrafollicular and/or transfollicular penetration,^5,6,8 as illustrated in Figure 1.

With extrafollicular or transfollicular penetration, the hair shaft re-enters or retracts into the dermis, triggering an inflammatory response that may be exacerbated by subsequent shaving.² Few studies have been published that aim to identify potential shaving solutions for individuals with PFB who elect to or need to continue shaving.

A new razor technology comprising 2 blades separated by a bridge feature has been designed specifically for men with razor bumps (SkinGuard [Procter & Gamble]). The SkinGuard razor redistributes shaving pressure so that there is less force from the blades on the skin and inflamed lesions than without the bridge, as seen in Figure 2. The razor has been designed to protect the skin from the blades, thereby minimizing the occurrence of new lesions and allowing existing lesions to heal.

The primary purpose of this study was to assess the appearance of males with razor bumps and shaving irritation when using the new razor technology in a regular shaving routine. The secondary objective was to measure satisfaction of the shaving experience when using the new razor by means of assessing itching, burning, and stinging using the participant global severity assessment (PGSA) and the impact on quality of life (QOL) measures.

Methods

Participants—Eligible participants were male, aged 20 to 60 years, and had clinically diagnosed PFB as well as symptoms of skin irritation from shaving. Participants were recruited from a dermatology clinic and via institutional review board–approved advertising.

Those eligible for inclusion in the study had a shaving routine that comprised shaving at least 3 times a week using a wet-shave, blade-razor technique accompanied by only a shave gel or foam. In addition, eligible participants had mild to moderate symptoms of skin irritation (a minimum of 10 razor bumps) from shaving based on investigator global severity assessment (IGSA) rating scales and were willing to shave at least 5 times a week during the study period. Participants could continue certain topical and systemic interventions for their skin.

Participants were excluded from the study if they had an underlying inflammatory disease that could manifest with a skin rash or were using any of these medications: topical benzoyl peroxide, topical clindamycin, topical retinoids, or oral antibiotics.

Study Design—A prospective, open-label study was conducted over a period of 12 weeks at a single site in the United States. Investigators instructed participants to shave 5 or more times per week with the test razor and to keep a daily shaving journal to track the number of shaves and compliance.

Participants were evaluated at the baseline screening visit, then at 4, 8, and 12 weeks. Evaluations included an investigator lesion count, the IGSA, and the PGSA. The PGSA was used to evaluate subjective clinical measurements (ie, indicate how much postshave burning/itching/stinging the participant was experiencing). The impact of shaving on daily life was evaluated at the baseline screening visit and at 12 weeks with the Participant Quality of Life Questionnaire comprised of 22 QOL statements. eTable 1 summarizes the investigator assessments used in the study, and eTable 2 summarizes the participant self-assessments. Both tables include the scale details and results interpretation for each assessment.

The study was approved by the local institutional review board, and all participants provided written informed consent in accordance with Title 21 of the Code of Federal Regulations, Part 50.

Study Visits—At the baseline screening visit, participants provided written informed consent and completed a prestudy shave questionnaire concerning shaving preparations, techniques, and opinions. Participants also provided a medical history, including prior and concomitant medications, and were evaluated using the inclusion/exclusion criteria. Investigators explained adverse event reporting to the participants. Participants were provided with an adequate supply of test razors for the 12-week period.

Data Analysis—Means and SDs were calculated for the study measures assessed at each visit. Analyses were performed evaluating change from baseline in repeated-measures analysis of variance models. These models were adjusted for baseline levels of the outcome measure and visit number. The magnitude of change from baseline was evaluated against a null hypothesis of 0% change. This longitudinal model adjusted for any potential differing baseline levels among participants. Statistical significance was defined as P<.05. SAS version 9.4 (SAS Institute Inc) was used for all analyses.

Results

In total, 21 individuals were enrolled, and 20 completed the study. Participants who completed the study were non-Hispanic Black (n=10); non-Hispanic White (n=8); Asian (n=1); or White, American Indian (n=1). All participants adhered to the protocol and reported shaving at least 5 times a week for 12 weeks using the test razor. One participant was removed after he was found to have a history of sarcoidosis, making him ineligible for the study. No study-related adverse events were reported.

Papules and Pustules—Over the course of the 12-week study, the papule count decreased significantly from baseline. Results from the investigator lesion count (see eTable 1 for key) indicated that by week 12—adjusted for number of papules at baseline—the mean percentage reduction was estimated to be 59.6% (P<.0001). A significant decrease in papule count also was observed between the baseline visit and week 8 (57.2%; P<.0001). A nonsignificant decrease was observed at week 4 (18.9%; P=.17). Only 3 participants presented with pustules at baseline, and the pustule count remained low over the course of the study. No significant change was noted at week 12 vs baseline (P=.98). Notably, there was no increase in pustule count at the end of the study compared with baseline (Table 1).

Skin Appearance—An improvement in the skin’s appearance over the course of the study from baseline was consistent with an improvement in the IGSA. The IGSA score significantly improved from a mean (SD) measurement of 2.5 (0.6) (indicating mild to moderate inflammation) at baseline to 1.4 (0.8) at week 8 (P<.0001) and 1.2 (1.1) (indicating mild inflammation to almost clear) at week 12 (P<.0001). The observed decrease in severity of skin condition and skin inflammation is shown in Figure 3.

Significant improvements were observed in every category of the PGSA at week 12 vs baseline (P≤.0007)(Table 2). At week 12, there was a significant (P≤.05) increase from baseline in participant agreement for all 22 QOL metrics describing positive shave experience, achieving results, skin feel, self-confidence, and social interactions (Figure 4), which supports the positive impact of adopting a shaving regimen with the test razor. Notably, after using the test razor for 12 weeks, men reported that they were more likely to agree with the statements “my skin felt smooth,” “my skin felt good to touch,” and “I was able to achieve a consistently good shave.” Other meaningful increases occurred in “shaving was something I looked forward to doing,” “others thought I looked clean cut,” “I looked my best for my family/others/work,” and “I felt comfortable/confident getting closer to others.” All QOL statements are shown in Figure 4.

Improvement With Novel Razor Technology—For the first time, frequent use of a novel razor technology designed specifically for men with PFB was found to significantly improve skin appearance, shave satisfaction, and QOL after 12 weeks vs baseline in participants clinically diagnosed with PFB. In men with shave-related skin irritation and razor bumps who typically wet-shaved with a razor at least 3 times a week, use of the test razor with their regular shaving preparation product 5 or more times per week for 12 weeks was associated with significant improvements from baseline in investigator lesion count, IGSA, PGSA, and Participant Quality of Life Questionnaire measurements.

Study strengths included the quantification of the change in the number of lesions and the degree of severity by a trained investigator in a prospective clinical study along with an assessment of the impact on participant QOL. A lack of a control arm could be considered a limitation of the study; however, study end points were evaluated compared with baseline, with each participant serving as their own control. Spontaneous resolution of the condition with their standard routine was considered highly unlikely in these participants; therefore, in the absence of any other changes, improvements were attributed to regular use of the test product over the course of the study. The results presented here provide strong support for the effectiveness of the new razor technology in improving the appearance of men with razor bumps and shaving irritation.

Hair Removal Tools for the Management of PFB—Although various tools and techniques have been proposed in the past for men with PFB, the current test razor technology provided unique benefits, including improvements in appearance and severity of the condition as well as a positive impact on QOL. In 1979, Conte and Lawrence⁹ evaluated the effect of using an electric hair clipper and twice-daily use of a skin-cleansing pad on the occurrence of PFB. Participants (n=96) allowed their beards to grow out for 1 month, after which they started shaving with an electric clipper with a triple O head. The authors reported a favorable response in 95% (91/96) of cases. However, the electric clippers left 1 mm of beard at the skin level,⁹ which may not be acceptable for those who prefer a clean-shaven appearance.⁶

A prospective survey of 22 men of African descent with PFB found use of a safety razor was preferred over an electric razor.¹⁰ The single-arm study evaluated use of a foil-guarded shaver (single-razor blade) in the management of PFB based on investigator lesion counts and a participant questionnaire. Participants were asked to shave at least every other day and use a specially designed preshave brush. A mean reduction in lesion counts was observed at 2 weeks (29.6%), 4 weeks (38.1%), and 6 weeks (47.1%); statistical significance was not reported. At 6 weeks, 77.3% (17/22) of participants judged the foil-guarded shaver to be superior to other shaving devices in controlling their razor bumps, and 90.9% (20/22) indicated they would recommend the shaver to others with PFB. The authors hypothesized that the guard buffered the skin from the blade, which might otherwise facilitate the penetration of ingrowing hairs and cause trauma to existing lesions.

The mean reduction in lesion count from baseline observed at week 4 was greater in the study with the foil-guarded shaver and preshave brush (38% reduction)¹⁰ than in our study (19% reduction in papule count). Different methodologies, use of a preshave brush in the earlier study, and a difference in lesion severity at baseline may have contributed to this difference. The study with the foil-guarded shaver concluded after 6 weeks, and there was a 47.1% reduction in lesion counts vs baseline.¹⁰ In contrast, the current study continued for 12 weeks, and a 59.6% reduction in lesion counts was reported. Participants from both studies reported an improved shaving experience compared with their usual practice,¹⁰ though only the current study explored the positive impact of the new razor technology on participant QOL.

Preventing Hairs From Being Cut Too Close—The closeness of the shave is believed to be a contributory factor in the development and persistence of PFB^6,8,11 based on a tendency for the distal portion of tightly curled hair shafts to re-enter the skin after shaving via transfollicular penetration.¹² Inclusion of a buffer in the razor between the sharp blades and the skin has been proposed to prevent hairs from being cut too close and causing transfollicular penetration.¹²

In the test razor used in the current study, the bridge technology acted as the buffer to prevent hairs from being cut too close to the skin and to reduce blade contact with the skin (Figure 2). Having only 2 blades also reduced the closeness of the shave compared with 5-bladed technologies,¹³ as each hair can only be pulled and cut up to a maximum of 2 times per shaving stroke. Notably, this did not impact the participants’ QOL scores related to achieving a close shave or skin feeling smooth; both attributes were significantly improved at 12 weeks vs baseline (Figure 4).

By reducing blade contact with the skin, the bridge technology in the test razor was designed to prevent excessive force from being applied to the skin through the blades. Reduced blade loading minimizes contact with and impact on sensitive skin.¹⁴ Additional design features of the test razor to minimize the impact of shaving on the skin include treatment of the 2 blades with low-friction coatings, which allows the blades to cut through the beard hair with minimal force, helping to reduce the tug-and-pull effect that may otherwise result in irritation and inflammation.^13,15 Lubrication strips before and after the blades in the test razor reduce friction between the blades and the skin to further protect the skin from the blades.¹⁵

Shaving With Multiblade Razors Does Not Exacerbate PFB—In a 1-week, split-faced, randomized study of 45 Black men, shaving with a manual 3-bladed razor was compared with use of 3 different chemical depilatory formulations.¹⁶ Shaving every other day for 1 week with the manual razor resulted in more papule formation but less irritation than use of the depilatories. The authors concluded that a study with longer duration was needed to explore the impact of shaving on papule formation in participants with a history of PFB.¹⁶

In 2013, an investigator-blinded study of 90 African American men with PFB compared the impact of different shaving regimens on the signs and symptoms of PFB over a 12-week period.⁴ Participants were randomized to 1 of 3 arms: (1) shaving 2 to 3 times per week with a triple-blade razor and standard products (control group); (2) shaving daily with a 5-bladed razor and standard products; and (3) shaving daily with a 5-bladed razor and “advanced” specific pre- and postshave products. The researchers found that the mean papule measurement significantly decreased from baseline in the advanced (P=.01) and control (P=.016) groups. Between-group comparison revealed no significant differences for papule or pustule count among each arm. For the investigator-graded severity, the change from baseline was significant for all 3 groups (P≤.04); however, the differences among groups were not significant. Importantly, these data demonstrated that PFB was not exacerbated by multiblade razors used as part of a daily shaving regimen.⁴

The findings of the current study were consistent with those of Daniel et al⁴ in that there was no exacerbation of the signs and symptoms of PFB associated with daily shaving. However, rather than requiring participants to change their entire shaving regimen, the present study only required a change of razor type. Moreover, the use of the new razor technology significantly decreased papule counts at week 12 vs the baseline measurement (P<.0001) and was associated with an improvement in subjective skin severity measurements. The participants in the present study reported significantly less burning, stinging, and itching after using the test product for 12 weeks (P<.0001).

Impact of Treatment on QOL—The current study further expanded on prior findings by combining these clinical end points with the QOL results to assess the test razor’s impact on participants’ lives. Results showed that over the course of 12 weeks, the new razor technology significantly improved the participants’ QOL in all questions related to shaving experience, achieving results, skin feel, self-confidence, and social interactions. The significant improvement in QOL included statements such as “shaving was a pleasant experience,” “I was able to achieve a consistently good shave,” and “my skin felt smooth.” Participants also reported improvements in meaningful categories such as “my shave made me feel attractive” and “I felt comfortable/confident getting closer to others.” As the current study showed, a shave regimen has the potential to change participants’ overall assessment of their QOL, a variable that must not be overlooked.

Conclusion

In men with clinically diagnosed PFB, regular shaving with a razor designed to protect the skin was found to significantly decrease lesion counts, increase shave satisfaction, and improve QOL after 12 weeks compared with their usual shaving practice (baseline measures). This razor technology provides another option to help manage PFB for men who wish to or need to continue shaving.

Acknowledgments—The clinical study was funded by the Procter & Gamble Company. Editorial writing assistance, supported financially by the Procter & Gamble Company, was provided by Gill McFeat, PhD, of McFeat Science Ltd (Devon, United Kingdom).

Pseudofolliculitis barbae (PFB)(also known as razor bumps or shaving bumps)¹ is a skin condition that consists of papules resulting from ingrown hairs.² In more severe cases, papules become pustules, then abscesses, which can cause scarring.^1,2 The condition can be distressing for patients, with considerable negative impact on their daily lives.³ The condition also is associated with shaving-related stinging, burning, pruritus, and cuts on the skin.⁴

Pseudofolliculitis barbae is most common in men of African descent due to the curved nature of the hair follicle,^2,5,6 with an estimated prevalence in this population of 45% to 83%,^1,6 but it can affect men of other ethnicities.⁷ A genetic polymorphism in a gene encoding a keratin specific to the hair follicle also has been found to predispose some individuals to PFB.⁵ When hair from a curved or destabilized hair follicle is cut to form a sharp tip, it is susceptible to extrafollicular and/or transfollicular penetration,^5,6,8 as illustrated in Figure 1.

With extrafollicular or transfollicular penetration, the hair shaft re-enters or retracts into the dermis, triggering an inflammatory response that may be exacerbated by subsequent shaving.² Few studies have been published that aim to identify potential shaving solutions for individuals with PFB who elect to or need to continue shaving.

A new razor technology comprising 2 blades separated by a bridge feature has been designed specifically for men with razor bumps (SkinGuard [Procter & Gamble]). The SkinGuard razor redistributes shaving pressure so that there is less force from the blades on the skin and inflamed lesions than without the bridge, as seen in Figure 2. The razor has been designed to protect the skin from the blades, thereby minimizing the occurrence of new lesions and allowing existing lesions to heal.

The primary purpose of this study was to assess the appearance of males with razor bumps and shaving irritation when using the new razor technology in a regular shaving routine. The secondary objective was to measure satisfaction of the shaving experience when using the new razor by means of assessing itching, burning, and stinging using the participant global severity assessment (PGSA) and the impact on quality of life (QOL) measures.

Methods

Participants—Eligible participants were male, aged 20 to 60 years, and had clinically diagnosed PFB as well as symptoms of skin irritation from shaving. Participants were recruited from a dermatology clinic and via institutional review board–approved advertising.

Those eligible for inclusion in the study had a shaving routine that comprised shaving at least 3 times a week using a wet-shave, blade-razor technique accompanied by only a shave gel or foam. In addition, eligible participants had mild to moderate symptoms of skin irritation (a minimum of 10 razor bumps) from shaving based on investigator global severity assessment (IGSA) rating scales and were willing to shave at least 5 times a week during the study period. Participants could continue certain topical and systemic interventions for their skin.

Participants were excluded from the study if they had an underlying inflammatory disease that could manifest with a skin rash or were using any of these medications: topical benzoyl peroxide, topical clindamycin, topical retinoids, or oral antibiotics.

Study Design—A prospective, open-label study was conducted over a period of 12 weeks at a single site in the United States. Investigators instructed participants to shave 5 or more times per week with the test razor and to keep a daily shaving journal to track the number of shaves and compliance.

Participants were evaluated at the baseline screening visit, then at 4, 8, and 12 weeks. Evaluations included an investigator lesion count, the IGSA, and the PGSA. The PGSA was used to evaluate subjective clinical measurements (ie, indicate how much postshave burning/itching/stinging the participant was experiencing). The impact of shaving on daily life was evaluated at the baseline screening visit and at 12 weeks with the Participant Quality of Life Questionnaire comprised of 22 QOL statements. eTable 1 summarizes the investigator assessments used in the study, and eTable 2 summarizes the participant self-assessments. Both tables include the scale details and results interpretation for each assessment.

The study was approved by the local institutional review board, and all participants provided written informed consent in accordance with Title 21 of the Code of Federal Regulations, Part 50.

Study Visits—At the baseline screening visit, participants provided written informed consent and completed a prestudy shave questionnaire concerning shaving preparations, techniques, and opinions. Participants also provided a medical history, including prior and concomitant medications, and were evaluated using the inclusion/exclusion criteria. Investigators explained adverse event reporting to the participants. Participants were provided with an adequate supply of test razors for the 12-week period.

Data Analysis—Means and SDs were calculated for the study measures assessed at each visit. Analyses were performed evaluating change from baseline in repeated-measures analysis of variance models. These models were adjusted for baseline levels of the outcome measure and visit number. The magnitude of change from baseline was evaluated against a null hypothesis of 0% change. This longitudinal model adjusted for any potential differing baseline levels among participants. Statistical significance was defined as P<.05. SAS version 9.4 (SAS Institute Inc) was used for all analyses.

Results

In total, 21 individuals were enrolled, and 20 completed the study. Participants who completed the study were non-Hispanic Black (n=10); non-Hispanic White (n=8); Asian (n=1); or White, American Indian (n=1). All participants adhered to the protocol and reported shaving at least 5 times a week for 12 weeks using the test razor. One participant was removed after he was found to have a history of sarcoidosis, making him ineligible for the study. No study-related adverse events were reported.

Papules and Pustules—Over the course of the 12-week study, the papule count decreased significantly from baseline. Results from the investigator lesion count (see eTable 1 for key) indicated that by week 12—adjusted for number of papules at baseline—the mean percentage reduction was estimated to be 59.6% (P<.0001). A significant decrease in papule count also was observed between the baseline visit and week 8 (57.2%; P<.0001). A nonsignificant decrease was observed at week 4 (18.9%; P=.17). Only 3 participants presented with pustules at baseline, and the pustule count remained low over the course of the study. No significant change was noted at week 12 vs baseline (P=.98). Notably, there was no increase in pustule count at the end of the study compared with baseline (Table 1).

Skin Appearance—An improvement in the skin’s appearance over the course of the study from baseline was consistent with an improvement in the IGSA. The IGSA score significantly improved from a mean (SD) measurement of 2.5 (0.6) (indicating mild to moderate inflammation) at baseline to 1.4 (0.8) at week 8 (P<.0001) and 1.2 (1.1) (indicating mild inflammation to almost clear) at week 12 (P<.0001). The observed decrease in severity of skin condition and skin inflammation is shown in Figure 3.

Significant improvements were observed in every category of the PGSA at week 12 vs baseline (P≤.0007)(Table 2). At week 12, there was a significant (P≤.05) increase from baseline in participant agreement for all 22 QOL metrics describing positive shave experience, achieving results, skin feel, self-confidence, and social interactions (Figure 4), which supports the positive impact of adopting a shaving regimen with the test razor. Notably, after using the test razor for 12 weeks, men reported that they were more likely to agree with the statements “my skin felt smooth,” “my skin felt good to touch,” and “I was able to achieve a consistently good shave.” Other meaningful increases occurred in “shaving was something I looked forward to doing,” “others thought I looked clean cut,” “I looked my best for my family/others/work,” and “I felt comfortable/confident getting closer to others.” All QOL statements are shown in Figure 4.

Improvement With Novel Razor Technology—For the first time, frequent use of a novel razor technology designed specifically for men with PFB was found to significantly improve skin appearance, shave satisfaction, and QOL after 12 weeks vs baseline in participants clinically diagnosed with PFB. In men with shave-related skin irritation and razor bumps who typically wet-shaved with a razor at least 3 times a week, use of the test razor with their regular shaving preparation product 5 or more times per week for 12 weeks was associated with significant improvements from baseline in investigator lesion count, IGSA, PGSA, and Participant Quality of Life Questionnaire measurements.

Study strengths included the quantification of the change in the number of lesions and the degree of severity by a trained investigator in a prospective clinical study along with an assessment of the impact on participant QOL. A lack of a control arm could be considered a limitation of the study; however, study end points were evaluated compared with baseline, with each participant serving as their own control. Spontaneous resolution of the condition with their standard routine was considered highly unlikely in these participants; therefore, in the absence of any other changes, improvements were attributed to regular use of the test product over the course of the study. The results presented here provide strong support for the effectiveness of the new razor technology in improving the appearance of men with razor bumps and shaving irritation.

Hair Removal Tools for the Management of PFB—Although various tools and techniques have been proposed in the past for men with PFB, the current test razor technology provided unique benefits, including improvements in appearance and severity of the condition as well as a positive impact on QOL. In 1979, Conte and Lawrence⁹ evaluated the effect of using an electric hair clipper and twice-daily use of a skin-cleansing pad on the occurrence of PFB. Participants (n=96) allowed their beards to grow out for 1 month, after which they started shaving with an electric clipper with a triple O head. The authors reported a favorable response in 95% (91/96) of cases. However, the electric clippers left 1 mm of beard at the skin level,⁹ which may not be acceptable for those who prefer a clean-shaven appearance.⁶

A prospective survey of 22 men of African descent with PFB found use of a safety razor was preferred over an electric razor.¹⁰ The single-arm study evaluated use of a foil-guarded shaver (single-razor blade) in the management of PFB based on investigator lesion counts and a participant questionnaire. Participants were asked to shave at least every other day and use a specially designed preshave brush. A mean reduction in lesion counts was observed at 2 weeks (29.6%), 4 weeks (38.1%), and 6 weeks (47.1%); statistical significance was not reported. At 6 weeks, 77.3% (17/22) of participants judged the foil-guarded shaver to be superior to other shaving devices in controlling their razor bumps, and 90.9% (20/22) indicated they would recommend the shaver to others with PFB. The authors hypothesized that the guard buffered the skin from the blade, which might otherwise facilitate the penetration of ingrowing hairs and cause trauma to existing lesions.

The mean reduction in lesion count from baseline observed at week 4 was greater in the study with the foil-guarded shaver and preshave brush (38% reduction)¹⁰ than in our study (19% reduction in papule count). Different methodologies, use of a preshave brush in the earlier study, and a difference in lesion severity at baseline may have contributed to this difference. The study with the foil-guarded shaver concluded after 6 weeks, and there was a 47.1% reduction in lesion counts vs baseline.¹⁰ In contrast, the current study continued for 12 weeks, and a 59.6% reduction in lesion counts was reported. Participants from both studies reported an improved shaving experience compared with their usual practice,¹⁰ though only the current study explored the positive impact of the new razor technology on participant QOL.

Preventing Hairs From Being Cut Too Close—The closeness of the shave is believed to be a contributory factor in the development and persistence of PFB^6,8,11 based on a tendency for the distal portion of tightly curled hair shafts to re-enter the skin after shaving via transfollicular penetration.¹² Inclusion of a buffer in the razor between the sharp blades and the skin has been proposed to prevent hairs from being cut too close and causing transfollicular penetration.¹²

In the test razor used in the current study, the bridge technology acted as the buffer to prevent hairs from being cut too close to the skin and to reduce blade contact with the skin (Figure 2). Having only 2 blades also reduced the closeness of the shave compared with 5-bladed technologies,¹³ as each hair can only be pulled and cut up to a maximum of 2 times per shaving stroke. Notably, this did not impact the participants’ QOL scores related to achieving a close shave or skin feeling smooth; both attributes were significantly improved at 12 weeks vs baseline (Figure 4).

By reducing blade contact with the skin, the bridge technology in the test razor was designed to prevent excessive force from being applied to the skin through the blades. Reduced blade loading minimizes contact with and impact on sensitive skin.¹⁴ Additional design features of the test razor to minimize the impact of shaving on the skin include treatment of the 2 blades with low-friction coatings, which allows the blades to cut through the beard hair with minimal force, helping to reduce the tug-and-pull effect that may otherwise result in irritation and inflammation.^13,15 Lubrication strips before and after the blades in the test razor reduce friction between the blades and the skin to further protect the skin from the blades.¹⁵

Shaving With Multiblade Razors Does Not Exacerbate PFB—In a 1-week, split-faced, randomized study of 45 Black men, shaving with a manual 3-bladed razor was compared with use of 3 different chemical depilatory formulations.¹⁶ Shaving every other day for 1 week with the manual razor resulted in more papule formation but less irritation than use of the depilatories. The authors concluded that a study with longer duration was needed to explore the impact of shaving on papule formation in participants with a history of PFB.¹⁶

In 2013, an investigator-blinded study of 90 African American men with PFB compared the impact of different shaving regimens on the signs and symptoms of PFB over a 12-week period.⁴ Participants were randomized to 1 of 3 arms: (1) shaving 2 to 3 times per week with a triple-blade razor and standard products (control group); (2) shaving daily with a 5-bladed razor and standard products; and (3) shaving daily with a 5-bladed razor and “advanced” specific pre- and postshave products. The researchers found that the mean papule measurement significantly decreased from baseline in the advanced (P=.01) and control (P=.016) groups. Between-group comparison revealed no significant differences for papule or pustule count among each arm. For the investigator-graded severity, the change from baseline was significant for all 3 groups (P≤.04); however, the differences among groups were not significant. Importantly, these data demonstrated that PFB was not exacerbated by multiblade razors used as part of a daily shaving regimen.⁴

The findings of the current study were consistent with those of Daniel et al⁴ in that there was no exacerbation of the signs and symptoms of PFB associated with daily shaving. However, rather than requiring participants to change their entire shaving regimen, the present study only required a change of razor type. Moreover, the use of the new razor technology significantly decreased papule counts at week 12 vs the baseline measurement (P<.0001) and was associated with an improvement in subjective skin severity measurements. The participants in the present study reported significantly less burning, stinging, and itching after using the test product for 12 weeks (P<.0001).

Impact of Treatment on QOL—The current study further expanded on prior findings by combining these clinical end points with the QOL results to assess the test razor’s impact on participants’ lives. Results showed that over the course of 12 weeks, the new razor technology significantly improved the participants’ QOL in all questions related to shaving experience, achieving results, skin feel, self-confidence, and social interactions. The significant improvement in QOL included statements such as “shaving was a pleasant experience,” “I was able to achieve a consistently good shave,” and “my skin felt smooth.” Participants also reported improvements in meaningful categories such as “my shave made me feel attractive” and “I felt comfortable/confident getting closer to others.” As the current study showed, a shave regimen has the potential to change participants’ overall assessment of their QOL, a variable that must not be overlooked.

Conclusion

In men with clinically diagnosed PFB, regular shaving with a razor designed to protect the skin was found to significantly decrease lesion counts, increase shave satisfaction, and improve QOL after 12 weeks compared with their usual shaving practice (baseline measures). This razor technology provides another option to help manage PFB for men who wish to or need to continue shaving.

Acknowledgments—The clinical study was funded by the Procter & Gamble Company. Editorial writing assistance, supported financially by the Procter & Gamble Company, was provided by Gill McFeat, PhD, of McFeat Science Ltd (Devon, United Kingdom).

Nearly half of patients discharged from a hospital had inappropriate proton pump inhibitor (PPI) prescriptions, suggests a retrospective analysis of an Israeli health care database that showed no improvements in prescribing patterns over time.

The research was published online in the journal Digestive and Liver Disease.

First author Orly Sneh-Arbib, MD, division of gastroenterology and liver disease, Clalit Health Services, Talpiot, Jerusalem, said in an interview that she and her co-authors were “very surprised” that the rates of inappropriate prescribing remained so high, especially as they had discussed the adverse effects of the drugs numerous times during departmental meetings.

She believes that, for many clinicians, handing out a prescription for PPIs has become a habit, with the thought being: “Just take this; it’s like a vitamin.”

In the paper, the researchers write, “Undoubtedly, more action is needed to raise physicians’ knowledge and attention to the subject while providing automated and standardized technology-based tools to reduce inappropriate PPI use using an acceptable algorithm.”

For the study, Dr. Sneh-Arbib and her colleagues developed an algorithm to assess inappropriate PPI prescribing in almost 4,000 internal medicine patients. To try to limit future overprescribing, their algorithm is now included in the clinical records system.

Consequently, every time a clinician tries to prescribe a PPI, they have to confirm that there is a valid indication for doing so, with the aim of adding an “extra step in the process,” Dr. Sneh-Arbib said.
 

Clear but complex PPI indications

There are a small, well-defined number of indications for long-term PPI use, the authors write. The indications include prior upper gastrointestinal bleeding, maintenance treatment after healing of erosive esophagitis, Barrett’s esophagus, the use of nonsteroidal anti-inflammatory drugs or antiplatelet agents in patients with increased bleeding risk, and maintenance therapy for symptom control in patients with gastroesophageal reflux disease.

The authors also note that the “appropriateness of PPIs is complex,” with multiple factors to consider for long-term PPI use, including complex drug combinations and medical history.

But having seen patients in their 30s prescribed PPIs “just because of taking steroids or aspirin,” Dr. Sneh-Arbib said she wanted to investigate further.

To examine the rate of inappropriate long-term PPI prescription on discharge from internal medicine departments, the team conducted a retrospective analysis of adults admitted to their institution for the first 6 months of 2014 and the first 6 months of 2017.

They included all patients prescribed PPIs on discharge with a recommendation for long-term use and excluded those who were transferred between departments or who had a hospital stay longer than 3 months.

Information on age, gender, ethnicity, socioeconomic status, current and past diagnoses including all relevant gastrointestinal diagnoses, Charlson comorbidity index, and medications on admission and discharge were recorded.
 

Guidelines for use of PPIs

To assess inappropriate PPI prescribing, the team searched for published recommendations on long-term use, Dr. Sneh-Arbib said. They developed an algorithm based on the U.K. National Institute for Health and Care Excellence (NICE) clinical guideline, “Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management.”

The guideline is “not perfect,” Dr. Sneh-Arbib said, but it was suitable. The team then randomly chose 100 patients from their records to validate the resulting algorithm, finding an accuracy of 96%.

The full analysis included 3,982 patients, of whom 74% were aged 65 years or older, and 50.8% were women. PPIs were first prescribed before hospital admission in 92.4% of cases.

The researchers found that the overall rate of inappropriate PPI prescriptions was 44.3%, a figure that was stable between the two the study periods. In 2014, the rate of inappropriate use was 43.2%, and it was 45.6% in 2017, a nonsignificant difference.

Inappropriate PPIs were higher (68.1%) in patients younger than 65 years, compared with those aged 65 years and older (36%).

The researchers analyzed factors associated with inappropriate PPIs, first excluding 448 patients with clear gastrointestinal indications.

In the majority of cases, the inappropriate PPI prescriptions occurred in patients who were not taking dual antiplatelet treatment (89.4%), in younger patients who were taking aspirin only (8.6%), and in patients receiving a single antiplatelet agent other than aspirin (1.9%), according to multivariate analysis.

Overall, 42.4% of patients classified as inappropriate PPI use were not using aspirin, nonsteroidal anti-inflammatory drugs, antiplatelets, antiaggregants, anticoagulants, or steroids, the researchers found.

They also note that most patients in the study (92.3%) had received PPIs before admission, prescribed by their general practitioner or during a previous hospitalization. This raises concerns about unneeded continuation of the drugs and lack of review by clinicians, they write.
 

PPI deprescribing

Approached for comment, Adrienna Jirik, MD, a gastroenterologist at the Cleveland Clinic, told this news organization that “PPI overprescription is a common problem worldwide, with the United States being no exception.”

They are “one of the most prescribed medications in the world, with several formulations readily available as an over-the-counter medication,” she added.

Dr. Jirik, who was not involved with the study, said that the algorithm used is “on par with the United States clinical practice guidelines for PPI use” and a “great start to initiate an encounter with a patient on PPIs in the outpatient setting to review the indications and to de-escalate and deprescribe therapy.”

Indeed, the American Gastroenterological Association recently published a clinical practice update on deprescribing PPIs.

“It may be useful to incorporate a version of this algorithm as a ‘hard stop’ on some outpatient EMR [electronic medical record] templates to remind providers to address this issue prior to closing an encounter,” Dr. Jirik added.

She noted, however, that tackling any medication reconciliation is a very important but difficult and time-consuming task.

“Education is definitely key for both primary and subspecialty providers,” Dr. Jirik said. “If patients have been on a long-term PPI, the inpatient provider can suggest a plan for de-escalation based on practice guidelines and arrange proper outpatient follow-up for eventual deprescribing.”

No funding was declared. The authors and Dr. Jirik report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of patients discharged from a hospital had inappropriate proton pump inhibitor (PPI) prescriptions, suggests a retrospective analysis of an Israeli health care database that showed no improvements in prescribing patterns over time.

The research was published online in the journal Digestive and Liver Disease.

First author Orly Sneh-Arbib, MD, division of gastroenterology and liver disease, Clalit Health Services, Talpiot, Jerusalem, said in an interview that she and her co-authors were “very surprised” that the rates of inappropriate prescribing remained so high, especially as they had discussed the adverse effects of the drugs numerous times during departmental meetings.

She believes that, for many clinicians, handing out a prescription for PPIs has become a habit, with the thought being: “Just take this; it’s like a vitamin.”

In the paper, the researchers write, “Undoubtedly, more action is needed to raise physicians’ knowledge and attention to the subject while providing automated and standardized technology-based tools to reduce inappropriate PPI use using an acceptable algorithm.”

For the study, Dr. Sneh-Arbib and her colleagues developed an algorithm to assess inappropriate PPI prescribing in almost 4,000 internal medicine patients. To try to limit future overprescribing, their algorithm is now included in the clinical records system.

Consequently, every time a clinician tries to prescribe a PPI, they have to confirm that there is a valid indication for doing so, with the aim of adding an “extra step in the process,” Dr. Sneh-Arbib said.
 

Clear but complex PPI indications

There are a small, well-defined number of indications for long-term PPI use, the authors write. The indications include prior upper gastrointestinal bleeding, maintenance treatment after healing of erosive esophagitis, Barrett’s esophagus, the use of nonsteroidal anti-inflammatory drugs or antiplatelet agents in patients with increased bleeding risk, and maintenance therapy for symptom control in patients with gastroesophageal reflux disease.

The authors also note that the “appropriateness of PPIs is complex,” with multiple factors to consider for long-term PPI use, including complex drug combinations and medical history.

But having seen patients in their 30s prescribed PPIs “just because of taking steroids or aspirin,” Dr. Sneh-Arbib said she wanted to investigate further.

To examine the rate of inappropriate long-term PPI prescription on discharge from internal medicine departments, the team conducted a retrospective analysis of adults admitted to their institution for the first 6 months of 2014 and the first 6 months of 2017.

They included all patients prescribed PPIs on discharge with a recommendation for long-term use and excluded those who were transferred between departments or who had a hospital stay longer than 3 months.

Information on age, gender, ethnicity, socioeconomic status, current and past diagnoses including all relevant gastrointestinal diagnoses, Charlson comorbidity index, and medications on admission and discharge were recorded.
 

Guidelines for use of PPIs

To assess inappropriate PPI prescribing, the team searched for published recommendations on long-term use, Dr. Sneh-Arbib said. They developed an algorithm based on the U.K. National Institute for Health and Care Excellence (NICE) clinical guideline, “Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management.”

The guideline is “not perfect,” Dr. Sneh-Arbib said, but it was suitable. The team then randomly chose 100 patients from their records to validate the resulting algorithm, finding an accuracy of 96%.

The full analysis included 3,982 patients, of whom 74% were aged 65 years or older, and 50.8% were women. PPIs were first prescribed before hospital admission in 92.4% of cases.

The researchers found that the overall rate of inappropriate PPI prescriptions was 44.3%, a figure that was stable between the two the study periods. In 2014, the rate of inappropriate use was 43.2%, and it was 45.6% in 2017, a nonsignificant difference.

Inappropriate PPIs were higher (68.1%) in patients younger than 65 years, compared with those aged 65 years and older (36%).

The researchers analyzed factors associated with inappropriate PPIs, first excluding 448 patients with clear gastrointestinal indications.

In the majority of cases, the inappropriate PPI prescriptions occurred in patients who were not taking dual antiplatelet treatment (89.4%), in younger patients who were taking aspirin only (8.6%), and in patients receiving a single antiplatelet agent other than aspirin (1.9%), according to multivariate analysis.

Overall, 42.4% of patients classified as inappropriate PPI use were not using aspirin, nonsteroidal anti-inflammatory drugs, antiplatelets, antiaggregants, anticoagulants, or steroids, the researchers found.

They also note that most patients in the study (92.3%) had received PPIs before admission, prescribed by their general practitioner or during a previous hospitalization. This raises concerns about unneeded continuation of the drugs and lack of review by clinicians, they write.
 

PPI deprescribing

Approached for comment, Adrienna Jirik, MD, a gastroenterologist at the Cleveland Clinic, told this news organization that “PPI overprescription is a common problem worldwide, with the United States being no exception.”

They are “one of the most prescribed medications in the world, with several formulations readily available as an over-the-counter medication,” she added.

Dr. Jirik, who was not involved with the study, said that the algorithm used is “on par with the United States clinical practice guidelines for PPI use” and a “great start to initiate an encounter with a patient on PPIs in the outpatient setting to review the indications and to de-escalate and deprescribe therapy.”

Indeed, the American Gastroenterological Association recently published a clinical practice update on deprescribing PPIs.

“It may be useful to incorporate a version of this algorithm as a ‘hard stop’ on some outpatient EMR [electronic medical record] templates to remind providers to address this issue prior to closing an encounter,” Dr. Jirik added.

She noted, however, that tackling any medication reconciliation is a very important but difficult and time-consuming task.

“Education is definitely key for both primary and subspecialty providers,” Dr. Jirik said. “If patients have been on a long-term PPI, the inpatient provider can suggest a plan for de-escalation based on practice guidelines and arrange proper outpatient follow-up for eventual deprescribing.”

No funding was declared. The authors and Dr. Jirik report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of patients discharged from a hospital had inappropriate proton pump inhibitor (PPI) prescriptions, suggests a retrospective analysis of an Israeli health care database that showed no improvements in prescribing patterns over time.

The research was published online in the journal Digestive and Liver Disease.

First author Orly Sneh-Arbib, MD, division of gastroenterology and liver disease, Clalit Health Services, Talpiot, Jerusalem, said in an interview that she and her co-authors were “very surprised” that the rates of inappropriate prescribing remained so high, especially as they had discussed the adverse effects of the drugs numerous times during departmental meetings.

She believes that, for many clinicians, handing out a prescription for PPIs has become a habit, with the thought being: “Just take this; it’s like a vitamin.”

In the paper, the researchers write, “Undoubtedly, more action is needed to raise physicians’ knowledge and attention to the subject while providing automated and standardized technology-based tools to reduce inappropriate PPI use using an acceptable algorithm.”

For the study, Dr. Sneh-Arbib and her colleagues developed an algorithm to assess inappropriate PPI prescribing in almost 4,000 internal medicine patients. To try to limit future overprescribing, their algorithm is now included in the clinical records system.

Consequently, every time a clinician tries to prescribe a PPI, they have to confirm that there is a valid indication for doing so, with the aim of adding an “extra step in the process,” Dr. Sneh-Arbib said.
 

Clear but complex PPI indications

There are a small, well-defined number of indications for long-term PPI use, the authors write. The indications include prior upper gastrointestinal bleeding, maintenance treatment after healing of erosive esophagitis, Barrett’s esophagus, the use of nonsteroidal anti-inflammatory drugs or antiplatelet agents in patients with increased bleeding risk, and maintenance therapy for symptom control in patients with gastroesophageal reflux disease.

The authors also note that the “appropriateness of PPIs is complex,” with multiple factors to consider for long-term PPI use, including complex drug combinations and medical history.

But having seen patients in their 30s prescribed PPIs “just because of taking steroids or aspirin,” Dr. Sneh-Arbib said she wanted to investigate further.

To examine the rate of inappropriate long-term PPI prescription on discharge from internal medicine departments, the team conducted a retrospective analysis of adults admitted to their institution for the first 6 months of 2014 and the first 6 months of 2017.

They included all patients prescribed PPIs on discharge with a recommendation for long-term use and excluded those who were transferred between departments or who had a hospital stay longer than 3 months.

Information on age, gender, ethnicity, socioeconomic status, current and past diagnoses including all relevant gastrointestinal diagnoses, Charlson comorbidity index, and medications on admission and discharge were recorded.
 

Guidelines for use of PPIs

To assess inappropriate PPI prescribing, the team searched for published recommendations on long-term use, Dr. Sneh-Arbib said. They developed an algorithm based on the U.K. National Institute for Health and Care Excellence (NICE) clinical guideline, “Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and management.”

The guideline is “not perfect,” Dr. Sneh-Arbib said, but it was suitable. The team then randomly chose 100 patients from their records to validate the resulting algorithm, finding an accuracy of 96%.

The full analysis included 3,982 patients, of whom 74% were aged 65 years or older, and 50.8% were women. PPIs were first prescribed before hospital admission in 92.4% of cases.

The researchers found that the overall rate of inappropriate PPI prescriptions was 44.3%, a figure that was stable between the two the study periods. In 2014, the rate of inappropriate use was 43.2%, and it was 45.6% in 2017, a nonsignificant difference.

Inappropriate PPIs were higher (68.1%) in patients younger than 65 years, compared with those aged 65 years and older (36%).

The researchers analyzed factors associated with inappropriate PPIs, first excluding 448 patients with clear gastrointestinal indications.

In the majority of cases, the inappropriate PPI prescriptions occurred in patients who were not taking dual antiplatelet treatment (89.4%), in younger patients who were taking aspirin only (8.6%), and in patients receiving a single antiplatelet agent other than aspirin (1.9%), according to multivariate analysis.

Overall, 42.4% of patients classified as inappropriate PPI use were not using aspirin, nonsteroidal anti-inflammatory drugs, antiplatelets, antiaggregants, anticoagulants, or steroids, the researchers found.

They also note that most patients in the study (92.3%) had received PPIs before admission, prescribed by their general practitioner or during a previous hospitalization. This raises concerns about unneeded continuation of the drugs and lack of review by clinicians, they write.
 

PPI deprescribing

Approached for comment, Adrienna Jirik, MD, a gastroenterologist at the Cleveland Clinic, told this news organization that “PPI overprescription is a common problem worldwide, with the United States being no exception.”

They are “one of the most prescribed medications in the world, with several formulations readily available as an over-the-counter medication,” she added.

Dr. Jirik, who was not involved with the study, said that the algorithm used is “on par with the United States clinical practice guidelines for PPI use” and a “great start to initiate an encounter with a patient on PPIs in the outpatient setting to review the indications and to de-escalate and deprescribe therapy.”

Indeed, the American Gastroenterological Association recently published a clinical practice update on deprescribing PPIs.

“It may be useful to incorporate a version of this algorithm as a ‘hard stop’ on some outpatient EMR [electronic medical record] templates to remind providers to address this issue prior to closing an encounter,” Dr. Jirik added.

She noted, however, that tackling any medication reconciliation is a very important but difficult and time-consuming task.

“Education is definitely key for both primary and subspecialty providers,” Dr. Jirik said. “If patients have been on a long-term PPI, the inpatient provider can suggest a plan for de-escalation based on practice guidelines and arrange proper outpatient follow-up for eventual deprescribing.”

No funding was declared. The authors and Dr. Jirik report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Being male, being older, and having a clear intent to die were among the key independent predictors of psychiatric hospital admission after self-harm, based on data from more than 1,800 individuals.

Clinicians who assess suicidal patients in the emergency department setting face the challenge of whether to admit the patient to inpatient or outpatient care, and data on predictors of compulsory admission are limited, wrote Laurent Michaud, MD, of the University of Lausanne, Switzerland, and colleagues.

To better identify predictors of hospitalization after self-harm, the researchers reviewed data from 1,832 patients aged 18 years and older admitted to four emergency departments in Switzerland between December 2016 and November 2019 .

Self-harm (SH) was defined in this study as “all nonfatal intentional acts of self-poisoning or self-injury, irrespective of degree of suicidal intent or other types of motivation,” the researchers noted. The study included 2,142 episodes of self-harm.

The researchers conducted two analyses. They compared episodes followed by any hospitalization and those with outpatient follow-up (1,083 episodes vs. 1,059 episodes) and episodes followed by compulsory hospitalization (357 episodes) with all other episodes followed by either outpatient care or voluntary hospitalization (1,785 episodes).

Overall, women were significantly more likely to be referred to outpatient follow-up compared with men (61.8% vs. 38.1%), and hospitalized patients were significantly older than outpatients (mean age of 41 years vs. 36 years, P < .001 for both).

“Not surprisingly, major psychopathological conditions such as depression, mania, dementia, and schizophrenia were predictive of hospitalization,” the researchers noted.

Other sociodemographic factors associated with hospitalization included living alone, no children, problematic socioeconomic status, and unemployment. Clinical factors associated with hospitalization included physical pain, more lethal suicide attempt method, and clear intent to die.

In a multivariate analysis, independent predictors of any hospitalization included male gender, older age, assessment in the Neuchatel location vs. Lausanne, depression vs. personality disorders, substance use, or anxiety disorder, difficult socioeconomic status, a clear vs. unclear intent to die, and a serious suicide attempt vs. less serious.

Differences in hospitalization based on hospital setting was a striking finding, the researchers wrote in their discussion. These differences may be largely explained by the organization of local mental health services and specific institutional cultures; the workload of staff and availability of beds also may have played a role in decisions to hospitalize, they said.

The findings were limited by several factors including the lack of data on the realization level of a self-harm episode and significant events such as a breakup, the researchers explained. Other limitations included missing data, multiple analyses that could increase the risk of false positives, the reliance on clinical diagnosis rather than formal instruments, and the cross-sectional study design, they said.

However, the results have clinical implications, as the clinical factors identified could be used to target subgroups of suicidal populations and refine treatment strategies, they concluded.

The study was supported by institutional funding and the Swiss Federal Office of Public Health. The researchers had no financial conflicts to disclose.

Being male, being older, and having a clear intent to die were among the key independent predictors of psychiatric hospital admission after self-harm, based on data from more than 1,800 individuals.

Clinicians who assess suicidal patients in the emergency department setting face the challenge of whether to admit the patient to inpatient or outpatient care, and data on predictors of compulsory admission are limited, wrote Laurent Michaud, MD, of the University of Lausanne, Switzerland, and colleagues.

To better identify predictors of hospitalization after self-harm, the researchers reviewed data from 1,832 patients aged 18 years and older admitted to four emergency departments in Switzerland between December 2016 and November 2019 .

Self-harm (SH) was defined in this study as “all nonfatal intentional acts of self-poisoning or self-injury, irrespective of degree of suicidal intent or other types of motivation,” the researchers noted. The study included 2,142 episodes of self-harm.

The researchers conducted two analyses. They compared episodes followed by any hospitalization and those with outpatient follow-up (1,083 episodes vs. 1,059 episodes) and episodes followed by compulsory hospitalization (357 episodes) with all other episodes followed by either outpatient care or voluntary hospitalization (1,785 episodes).

Overall, women were significantly more likely to be referred to outpatient follow-up compared with men (61.8% vs. 38.1%), and hospitalized patients were significantly older than outpatients (mean age of 41 years vs. 36 years, P < .001 for both).

“Not surprisingly, major psychopathological conditions such as depression, mania, dementia, and schizophrenia were predictive of hospitalization,” the researchers noted.

Other sociodemographic factors associated with hospitalization included living alone, no children, problematic socioeconomic status, and unemployment. Clinical factors associated with hospitalization included physical pain, more lethal suicide attempt method, and clear intent to die.

In a multivariate analysis, independent predictors of any hospitalization included male gender, older age, assessment in the Neuchatel location vs. Lausanne, depression vs. personality disorders, substance use, or anxiety disorder, difficult socioeconomic status, a clear vs. unclear intent to die, and a serious suicide attempt vs. less serious.

Differences in hospitalization based on hospital setting was a striking finding, the researchers wrote in their discussion. These differences may be largely explained by the organization of local mental health services and specific institutional cultures; the workload of staff and availability of beds also may have played a role in decisions to hospitalize, they said.

The findings were limited by several factors including the lack of data on the realization level of a self-harm episode and significant events such as a breakup, the researchers explained. Other limitations included missing data, multiple analyses that could increase the risk of false positives, the reliance on clinical diagnosis rather than formal instruments, and the cross-sectional study design, they said.

However, the results have clinical implications, as the clinical factors identified could be used to target subgroups of suicidal populations and refine treatment strategies, they concluded.

The study was supported by institutional funding and the Swiss Federal Office of Public Health. The researchers had no financial conflicts to disclose.

Being male, being older, and having a clear intent to die were among the key independent predictors of psychiatric hospital admission after self-harm, based on data from more than 1,800 individuals.

Clinicians who assess suicidal patients in the emergency department setting face the challenge of whether to admit the patient to inpatient or outpatient care, and data on predictors of compulsory admission are limited, wrote Laurent Michaud, MD, of the University of Lausanne, Switzerland, and colleagues.

To better identify predictors of hospitalization after self-harm, the researchers reviewed data from 1,832 patients aged 18 years and older admitted to four emergency departments in Switzerland between December 2016 and November 2019 .

Self-harm (SH) was defined in this study as “all nonfatal intentional acts of self-poisoning or self-injury, irrespective of degree of suicidal intent or other types of motivation,” the researchers noted. The study included 2,142 episodes of self-harm.

The researchers conducted two analyses. They compared episodes followed by any hospitalization and those with outpatient follow-up (1,083 episodes vs. 1,059 episodes) and episodes followed by compulsory hospitalization (357 episodes) with all other episodes followed by either outpatient care or voluntary hospitalization (1,785 episodes).

Overall, women were significantly more likely to be referred to outpatient follow-up compared with men (61.8% vs. 38.1%), and hospitalized patients were significantly older than outpatients (mean age of 41 years vs. 36 years, P < .001 for both).

“Not surprisingly, major psychopathological conditions such as depression, mania, dementia, and schizophrenia were predictive of hospitalization,” the researchers noted.

Other sociodemographic factors associated with hospitalization included living alone, no children, problematic socioeconomic status, and unemployment. Clinical factors associated with hospitalization included physical pain, more lethal suicide attempt method, and clear intent to die.

In a multivariate analysis, independent predictors of any hospitalization included male gender, older age, assessment in the Neuchatel location vs. Lausanne, depression vs. personality disorders, substance use, or anxiety disorder, difficult socioeconomic status, a clear vs. unclear intent to die, and a serious suicide attempt vs. less serious.

Differences in hospitalization based on hospital setting was a striking finding, the researchers wrote in their discussion. These differences may be largely explained by the organization of local mental health services and specific institutional cultures; the workload of staff and availability of beds also may have played a role in decisions to hospitalize, they said.

The findings were limited by several factors including the lack of data on the realization level of a self-harm episode and significant events such as a breakup, the researchers explained. Other limitations included missing data, multiple analyses that could increase the risk of false positives, the reliance on clinical diagnosis rather than formal instruments, and the cross-sectional study design, they said.

However, the results have clinical implications, as the clinical factors identified could be used to target subgroups of suicidal populations and refine treatment strategies, they concluded.

The study was supported by institutional funding and the Swiss Federal Office of Public Health. The researchers had no financial conflicts to disclose.

In 1993, managing patients with stroke had long remained an elusive and somewhat intimidating task for the neurological world. Previous efforts to treat the condition had produced more frustration than success, leaving clinicians and patients alike in despair for a solution. However, some successes in treating coronary thrombosis during that era rejuvenated researchers’ efforts to crack the code. An international team of researchers had studied a Streptococcus derivative (streptokinase) and others had begun to study a natural substance termed tissue plasminogen activator (tPA) as thrombolytic agents to lyse coronary clots and to treat pulmonary embolism. The adverse event of excessive bleeding found in Australian studies done on streptokinase intervention in patients with stroke prompted researchers to contemplate use of tPA in stroke management.

The combination of tPA and advanced imaging technology led researchers to take a unique approach that would forever revolutionize stroke management, beginning in the early 1990s.

A group of German, Japanese, and American investigators began to research thrombolysis in acute stroke patients during the mid-1980s.

“What was unique is that patients had a CT scan followed by a catheter angiogram,” said Louis Caplan, MD, a senior member of the division of cerebrovascular disease at Beth Israel Deaconess Medical Center, Boston, professor of neurology at Harvard Medical School, Boston, and founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center.

“If they had a blocked vessel, they got the drug, delivered either intravenously or intra-arterially.”

The process involved keeping the catheter open after drug administration to determine whether the vessel had opened or remained occluded. The researchers learned which blocked vessels opened when the drug was given intravenously and which required direct introduction of the drug into the clots.

A group of investigators in the United States funded by the National Institute of Neurological Disease and Stroke then performed a randomized therapeutic trial of intravenous tPA given within 90 minutes and 180 minutes after stroke symptom onset. The study was reported in the New England Journal of Medicine. Soon thereafter, in 1995, the Food and Drug Administration approved the use of tPA following the inclusion and exclusion rules used in the NINDS trial.

After the FDA approved tPA in 1995, stroke management was never the same.
 

tPA was just one factor in optimizing stroke management

Despite the major therapeutic breakthrough with tPA’s approval, it took the clinics, hospitals, and other acute care systems a while to catch up. “Neurologists and hospitals weren’t ready for acute stroke intervention and proper stroke management in the mid-90s,” Dr. Caplan recalled. “At the time, stroke wasn’t at the forefront of treatment, general neurologists weren’t trained, and there weren’t enough stroke neurologists.”

The preparation and training deficit was further exacerbated by low reimbursement for services. As a result, only about 5% of patients who were eligible for acute stroke management were treated with tPA.

According to Dr. Caplan, during the next 15-20 years, the accumulation of stroke data from MRI and CT vascular imaging clarified further which patients, with what extent of infarction, with which blocked vessels, would be good candidates for treatment.

More patients received interventional treatment using catheters directed into the area of clotting in attempt to remove the blockages. In addition, information regarding intervention at different periods (10-16 hours, up to 24 hours) and conditions (for example, patients with varying degrees of disability, infarct) were tested.

Eventually, hospitals became more attuned to emergency stroke treatment. More neurologists became trained, more stroke centers emerged, and clinicians enjoyed the benefit of technological advancements that allowed them to explore perfusion.
 

While decentralized care enhances outcomes in stroke management, more progress is needed

As of early 2023, stroke is one of the leading emergency diagnoses, and patients have access to primary and secondary stroke centers that are sprinkled throughout the United States. As impressive as the feat may seem, health care systems still have major strides to make to truly optimize therapy and outcomes in this patient population.

For example, location and access remain important issues. Secondary centers are typically located in large, metropolitan areas. While an urban location makes a primary center geographically more accessible to a larger patient population, traffic frequently hinders door-to-door access.

In the case of rural centers, distance can retard access, but they also face the challenges of how to route patients – especially patients who require more specialized care offered by secondary centers. Fortunately, primary centers have some ways to help better support their patients.

“One thing that happened is that primary centers made agreements with secondary centers via telemedicine to determine whether patients should be treated at the primary center or whether they should be routed to the higher-level center. These arrangements were termed ‘spoke and wheel,’ ” Dr. Caplan told this publication.

However, not all patients who are candidates for transport to a secondary center are able to be transported. In such cases, primary centers can use telemedicine to collaborate with secondary centers for support.

Logistics aside, perhaps today’s greatest challenge for clinicians is ensuring their patients and families receive education to increase their awareness of stroke centers as an important option for treatment and outcome optimization. Many patients and their loved ones do not realize that these centers exist or how to utilize them if and when the time comes.

Right now, some cities have stroke ambulances staffed with physicians to treat patients in the field. This decentralized model helps address access burdens such as door-to-needle delays and transportation while improving survival and recovery. Dr. Caplan said these services are available in Munich, and in a few select U.S. cities such as Cleveland and Houston, which helped pioneer the concept.
 

Better access in the future?

Looking ahead, Dr. Caplan seems optimistic about how stroke management will continue to evolve. Many cities will have stroke ambulances to provide on-site care, while stroke institutions will improve their cross-collaborative efforts to support their patient populations.

At the crux of cross-collaboration lies enhanced communication between peripheral and urban hospitals.

“Peripheral and urban hospitals and state organizations will engage in smoother integration to figure out when to take patient to the bigger hospitals,” Dr. Caplan said. “I also believe we will see greater emphasis on rehabilitation and recovery.”

As promising as the future looks, only time will tell.
 

In 1993, managing patients with stroke had long remained an elusive and somewhat intimidating task for the neurological world. Previous efforts to treat the condition had produced more frustration than success, leaving clinicians and patients alike in despair for a solution. However, some successes in treating coronary thrombosis during that era rejuvenated researchers’ efforts to crack the code. An international team of researchers had studied a Streptococcus derivative (streptokinase) and others had begun to study a natural substance termed tissue plasminogen activator (tPA) as thrombolytic agents to lyse coronary clots and to treat pulmonary embolism. The adverse event of excessive bleeding found in Australian studies done on streptokinase intervention in patients with stroke prompted researchers to contemplate use of tPA in stroke management.

The combination of tPA and advanced imaging technology led researchers to take a unique approach that would forever revolutionize stroke management, beginning in the early 1990s.

A group of German, Japanese, and American investigators began to research thrombolysis in acute stroke patients during the mid-1980s.

“What was unique is that patients had a CT scan followed by a catheter angiogram,” said Louis Caplan, MD, a senior member of the division of cerebrovascular disease at Beth Israel Deaconess Medical Center, Boston, professor of neurology at Harvard Medical School, Boston, and founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center.

“If they had a blocked vessel, they got the drug, delivered either intravenously or intra-arterially.”

The process involved keeping the catheter open after drug administration to determine whether the vessel had opened or remained occluded. The researchers learned which blocked vessels opened when the drug was given intravenously and which required direct introduction of the drug into the clots.

A group of investigators in the United States funded by the National Institute of Neurological Disease and Stroke then performed a randomized therapeutic trial of intravenous tPA given within 90 minutes and 180 minutes after stroke symptom onset. The study was reported in the New England Journal of Medicine. Soon thereafter, in 1995, the Food and Drug Administration approved the use of tPA following the inclusion and exclusion rules used in the NINDS trial.

After the FDA approved tPA in 1995, stroke management was never the same.
 

tPA was just one factor in optimizing stroke management

Despite the major therapeutic breakthrough with tPA’s approval, it took the clinics, hospitals, and other acute care systems a while to catch up. “Neurologists and hospitals weren’t ready for acute stroke intervention and proper stroke management in the mid-90s,” Dr. Caplan recalled. “At the time, stroke wasn’t at the forefront of treatment, general neurologists weren’t trained, and there weren’t enough stroke neurologists.”

The preparation and training deficit was further exacerbated by low reimbursement for services. As a result, only about 5% of patients who were eligible for acute stroke management were treated with tPA.

According to Dr. Caplan, during the next 15-20 years, the accumulation of stroke data from MRI and CT vascular imaging clarified further which patients, with what extent of infarction, with which blocked vessels, would be good candidates for treatment.

More patients received interventional treatment using catheters directed into the area of clotting in attempt to remove the blockages. In addition, information regarding intervention at different periods (10-16 hours, up to 24 hours) and conditions (for example, patients with varying degrees of disability, infarct) were tested.

Eventually, hospitals became more attuned to emergency stroke treatment. More neurologists became trained, more stroke centers emerged, and clinicians enjoyed the benefit of technological advancements that allowed them to explore perfusion.
 

While decentralized care enhances outcomes in stroke management, more progress is needed

As of early 2023, stroke is one of the leading emergency diagnoses, and patients have access to primary and secondary stroke centers that are sprinkled throughout the United States. As impressive as the feat may seem, health care systems still have major strides to make to truly optimize therapy and outcomes in this patient population.

For example, location and access remain important issues. Secondary centers are typically located in large, metropolitan areas. While an urban location makes a primary center geographically more accessible to a larger patient population, traffic frequently hinders door-to-door access.

In the case of rural centers, distance can retard access, but they also face the challenges of how to route patients – especially patients who require more specialized care offered by secondary centers. Fortunately, primary centers have some ways to help better support their patients.

“One thing that happened is that primary centers made agreements with secondary centers via telemedicine to determine whether patients should be treated at the primary center or whether they should be routed to the higher-level center. These arrangements were termed ‘spoke and wheel,’ ” Dr. Caplan told this publication.

However, not all patients who are candidates for transport to a secondary center are able to be transported. In such cases, primary centers can use telemedicine to collaborate with secondary centers for support.

Logistics aside, perhaps today’s greatest challenge for clinicians is ensuring their patients and families receive education to increase their awareness of stroke centers as an important option for treatment and outcome optimization. Many patients and their loved ones do not realize that these centers exist or how to utilize them if and when the time comes.

Right now, some cities have stroke ambulances staffed with physicians to treat patients in the field. This decentralized model helps address access burdens such as door-to-needle delays and transportation while improving survival and recovery. Dr. Caplan said these services are available in Munich, and in a few select U.S. cities such as Cleveland and Houston, which helped pioneer the concept.
 

Better access in the future?

Looking ahead, Dr. Caplan seems optimistic about how stroke management will continue to evolve. Many cities will have stroke ambulances to provide on-site care, while stroke institutions will improve their cross-collaborative efforts to support their patient populations.

At the crux of cross-collaboration lies enhanced communication between peripheral and urban hospitals.

“Peripheral and urban hospitals and state organizations will engage in smoother integration to figure out when to take patient to the bigger hospitals,” Dr. Caplan said. “I also believe we will see greater emphasis on rehabilitation and recovery.”

As promising as the future looks, only time will tell.
 

In 1993, managing patients with stroke had long remained an elusive and somewhat intimidating task for the neurological world. Previous efforts to treat the condition had produced more frustration than success, leaving clinicians and patients alike in despair for a solution. However, some successes in treating coronary thrombosis during that era rejuvenated researchers’ efforts to crack the code. An international team of researchers had studied a Streptococcus derivative (streptokinase) and others had begun to study a natural substance termed tissue plasminogen activator (tPA) as thrombolytic agents to lyse coronary clots and to treat pulmonary embolism. The adverse event of excessive bleeding found in Australian studies done on streptokinase intervention in patients with stroke prompted researchers to contemplate use of tPA in stroke management.

The combination of tPA and advanced imaging technology led researchers to take a unique approach that would forever revolutionize stroke management, beginning in the early 1990s.

A group of German, Japanese, and American investigators began to research thrombolysis in acute stroke patients during the mid-1980s.

“What was unique is that patients had a CT scan followed by a catheter angiogram,” said Louis Caplan, MD, a senior member of the division of cerebrovascular disease at Beth Israel Deaconess Medical Center, Boston, professor of neurology at Harvard Medical School, Boston, and founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center.

“If they had a blocked vessel, they got the drug, delivered either intravenously or intra-arterially.”

The process involved keeping the catheter open after drug administration to determine whether the vessel had opened or remained occluded. The researchers learned which blocked vessels opened when the drug was given intravenously and which required direct introduction of the drug into the clots.

A group of investigators in the United States funded by the National Institute of Neurological Disease and Stroke then performed a randomized therapeutic trial of intravenous tPA given within 90 minutes and 180 minutes after stroke symptom onset. The study was reported in the New England Journal of Medicine. Soon thereafter, in 1995, the Food and Drug Administration approved the use of tPA following the inclusion and exclusion rules used in the NINDS trial.

After the FDA approved tPA in 1995, stroke management was never the same.
 

tPA was just one factor in optimizing stroke management

Despite the major therapeutic breakthrough with tPA’s approval, it took the clinics, hospitals, and other acute care systems a while to catch up. “Neurologists and hospitals weren’t ready for acute stroke intervention and proper stroke management in the mid-90s,” Dr. Caplan recalled. “At the time, stroke wasn’t at the forefront of treatment, general neurologists weren’t trained, and there weren’t enough stroke neurologists.”

The preparation and training deficit was further exacerbated by low reimbursement for services. As a result, only about 5% of patients who were eligible for acute stroke management were treated with tPA.

According to Dr. Caplan, during the next 15-20 years, the accumulation of stroke data from MRI and CT vascular imaging clarified further which patients, with what extent of infarction, with which blocked vessels, would be good candidates for treatment.

More patients received interventional treatment using catheters directed into the area of clotting in attempt to remove the blockages. In addition, information regarding intervention at different periods (10-16 hours, up to 24 hours) and conditions (for example, patients with varying degrees of disability, infarct) were tested.

Eventually, hospitals became more attuned to emergency stroke treatment. More neurologists became trained, more stroke centers emerged, and clinicians enjoyed the benefit of technological advancements that allowed them to explore perfusion.
 

While decentralized care enhances outcomes in stroke management, more progress is needed

As of early 2023, stroke is one of the leading emergency diagnoses, and patients have access to primary and secondary stroke centers that are sprinkled throughout the United States. As impressive as the feat may seem, health care systems still have major strides to make to truly optimize therapy and outcomes in this patient population.

For example, location and access remain important issues. Secondary centers are typically located in large, metropolitan areas. While an urban location makes a primary center geographically more accessible to a larger patient population, traffic frequently hinders door-to-door access.

In the case of rural centers, distance can retard access, but they also face the challenges of how to route patients – especially patients who require more specialized care offered by secondary centers. Fortunately, primary centers have some ways to help better support their patients.

“One thing that happened is that primary centers made agreements with secondary centers via telemedicine to determine whether patients should be treated at the primary center or whether they should be routed to the higher-level center. These arrangements were termed ‘spoke and wheel,’ ” Dr. Caplan told this publication.

However, not all patients who are candidates for transport to a secondary center are able to be transported. In such cases, primary centers can use telemedicine to collaborate with secondary centers for support.

Logistics aside, perhaps today’s greatest challenge for clinicians is ensuring their patients and families receive education to increase their awareness of stroke centers as an important option for treatment and outcome optimization. Many patients and their loved ones do not realize that these centers exist or how to utilize them if and when the time comes.

Right now, some cities have stroke ambulances staffed with physicians to treat patients in the field. This decentralized model helps address access burdens such as door-to-needle delays and transportation while improving survival and recovery. Dr. Caplan said these services are available in Munich, and in a few select U.S. cities such as Cleveland and Houston, which helped pioneer the concept.
 

Better access in the future?

Looking ahead, Dr. Caplan seems optimistic about how stroke management will continue to evolve. Many cities will have stroke ambulances to provide on-site care, while stroke institutions will improve their cross-collaborative efforts to support their patient populations.

At the crux of cross-collaboration lies enhanced communication between peripheral and urban hospitals.

“Peripheral and urban hospitals and state organizations will engage in smoother integration to figure out when to take patient to the bigger hospitals,” Dr. Caplan said. “I also believe we will see greater emphasis on rehabilitation and recovery.”

As promising as the future looks, only time will tell.
 

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

A version of this article first appeared on Medscape.com.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report is revised annually and is used widely throughout the world as a tool for implementing effective management.

Among the updates in the 2023 GOLD Report, the section on diagnostic criteria added a proposed new category “PRISm,” denoting “preserved ratio impaired spirometry,” encompassing individuals who present with structural lung lesions (for example, emphysema) and/or other physiological abnormalities such as low-normal forced expiratory volume in 1 second (FEV₁), gas trapping, hyperinflation, reduced lung diffusing capacity and/or rapid FEV₁ decline, but without airflow obstruction (FEV₁/FEV ≥ 0.7 post bronchodilation). Some of these “pre-COPD” (chronic obstructive pulmonary disease) individuals, who have a normal ratio but abnormal spirometry are at risk over time of developing airflow obstruction. The best treatment for them, beyond smoking cessation, needs to be determined through research, the report states.
 

Clinical updates

The GOLD 2023 Report also offers proposed clinical guidance, in the absence of high-quality clinical trial evidence, on initial pharmacologic management of COPD. The proposal is based on individual assessment of symptoms and exacerbation risk following use of the ABE Assessment Tool, a revised version of the ABCD Assessment Tool that recognizes the clinical relevance of exacerbations independent of symptom level.

These updates to information and figures pertaining to initial pharmacological treatment and follow-up pharmacological treatment revise the positioning of LABA (long-acting beta₂ agonists) plus LAMA (long-acting muscarinic agonists) and LABA/ICS (inhaled corticosteroids). Among GOLD group A patients with 0 or 1 moderate exacerbations that do not lead to hospital admission, a bronchodilator is recommended.

The recommendation for group B patients is LABA/LAMA with the caveat that single inhaler therapy may be more convenient and effective than multiple inhalers. For group E patients with two or more moderate exacerbations or one or more leading to hospitalization, LABA/LAMA is recommended (with the same inhaler therapy caveat). With blood eosinophil levels at 300 or higher, LABA/LAMA/ICS may be considered.

Commenting on the combination recommendations in a press release, Antonio Anzueto, MD, professor of medicine, pulmonary critical care, University of Texas Health, San Antonio, stated: “From a physician’s perspective, we are always grateful to receive well-vetted and informed recommendations on how we can best utilize available treatment options to provide the most benefit to our patients. The new 2023 GOLD recommendations represent a meaningful change for the treatment of COPD by prioritizing the utilization of a fixed LAMA/LABA combination.”
 

More interventions

In a section on therapeutic interventions to reduce COPD mortality, the report lists studies showing mortality benefits for fixed-dose inhaled triple combinations (LABA + LAMA + ICS) versus dual inhaled long-acting bronchodilations, and for smoking cessation and pulmonary rehabilitation.

Also new is a strong emphasis on inhaler choice, education, and technique training with assessment of inhaler technique and adherence urged as a prerequisite to judging whether current therapy as insufficient. The report summarizes principles guiding inhaler type selection.

The report also added a section on chronic bronchitis, defining it as a common but variable condition in COPD patients with cough and expectorated sputum on a regular basis over a defined period in the absence of other conditions plausibly causing symptoms.

The fact that chronic bronchitis is sometimes found in never-smokers suggests the involvement of other factors such as exposure to inhaled dusts, biomass fuels, chemical fumes, or domestic heating and cooking fuels, according to the report. Gastroesophageal reflux may also be associated with chronic bronchitis.

The report discusses various taxonomic terms for different types of COPD, such as COPD-G for genetically determined COPD, COPD-D for those with abnormal lung development, and COPD-C for COPD associated with cigarette smoking, etc.
 

Change in exacerbations

The report also revises the definition of a COPD exacerbation as “an event characterized by increased dyspnea and/or cough and sputum that worsens in less than 14 days which may be accompanied by tachypnea and/or tachycardia and is often associated with increased local and system inflammation caused by infection, pollution, or other insult to the airways.” To overcome limitations conferred by the current grading of COPD exacerbations, the 2023 report proposes a four-step point-of-contact diagnosis and assessment tool.

Telemedicine

Given the constraints brought on by COVID-19 on top of the generally sparse availability of programs and facilities for delivering well-proven pulmonary rehabilitation methods, tele-rehabilitation has been proposed as an alternative to traditional approaches. While the evidence base is still evolving and best practices have not yet been established, the GOLD Report calls for better understanding of barriers to tele-rehabilitation success.

Comorbidities update

The GOLD Report chapter on COPD and comorbidities was also updated, and lists cardiovascular disease, lung cancer, osteoporosis, depression/anxiety, and gastroesophageal reflux disease as common comorbid conditions which may affect prognosis and, in the case of cancer, mortality. The report urges simplicity of treatment to minimize polypharmacy. While annual low-dose CT is recommended for COPD caused by smoking, it is not recommended for COPD caused by smoking; data are insufficient to establish benefit over harm.

While the GOLD Report “COVID-19 and COPD” chapter summarizes current evidence stating that individuals with COPD do not seem to be at substantially greater risk of infection with SARS-CoV-2, it underscores that they are at higher risk of hospitalization for COVID-19 and may be at higher risk for developing severe disease and death.

Many other topics are included in the updated report, among them screening, imaging, vaccinations, adherence to therapy, and surgical and bronchoscopic interventions. In its closing section, the GOLD Report 2023 reiterates its mission, stating: “The GOLD initiative will continue to work with National Leaders and other interested health care professionals to bring COPD to the attention of governments, public health officials, health care workers, and the general public, to raise awareness of the burden of COPD and to develop programs for early detection, prevention and approaches to management.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report is revised annually and is used widely throughout the world as a tool for implementing effective management.

Among the updates in the 2023 GOLD Report, the section on diagnostic criteria added a proposed new category “PRISm,” denoting “preserved ratio impaired spirometry,” encompassing individuals who present with structural lung lesions (for example, emphysema) and/or other physiological abnormalities such as low-normal forced expiratory volume in 1 second (FEV₁), gas trapping, hyperinflation, reduced lung diffusing capacity and/or rapid FEV₁ decline, but without airflow obstruction (FEV₁/FEV ≥ 0.7 post bronchodilation). Some of these “pre-COPD” (chronic obstructive pulmonary disease) individuals, who have a normal ratio but abnormal spirometry are at risk over time of developing airflow obstruction. The best treatment for them, beyond smoking cessation, needs to be determined through research, the report states.
 

Clinical updates

The GOLD 2023 Report also offers proposed clinical guidance, in the absence of high-quality clinical trial evidence, on initial pharmacologic management of COPD. The proposal is based on individual assessment of symptoms and exacerbation risk following use of the ABE Assessment Tool, a revised version of the ABCD Assessment Tool that recognizes the clinical relevance of exacerbations independent of symptom level.

These updates to information and figures pertaining to initial pharmacological treatment and follow-up pharmacological treatment revise the positioning of LABA (long-acting beta₂ agonists) plus LAMA (long-acting muscarinic agonists) and LABA/ICS (inhaled corticosteroids). Among GOLD group A patients with 0 or 1 moderate exacerbations that do not lead to hospital admission, a bronchodilator is recommended.

The recommendation for group B patients is LABA/LAMA with the caveat that single inhaler therapy may be more convenient and effective than multiple inhalers. For group E patients with two or more moderate exacerbations or one or more leading to hospitalization, LABA/LAMA is recommended (with the same inhaler therapy caveat). With blood eosinophil levels at 300 or higher, LABA/LAMA/ICS may be considered.

Commenting on the combination recommendations in a press release, Antonio Anzueto, MD, professor of medicine, pulmonary critical care, University of Texas Health, San Antonio, stated: “From a physician’s perspective, we are always grateful to receive well-vetted and informed recommendations on how we can best utilize available treatment options to provide the most benefit to our patients. The new 2023 GOLD recommendations represent a meaningful change for the treatment of COPD by prioritizing the utilization of a fixed LAMA/LABA combination.”
 

More interventions

In a section on therapeutic interventions to reduce COPD mortality, the report lists studies showing mortality benefits for fixed-dose inhaled triple combinations (LABA + LAMA + ICS) versus dual inhaled long-acting bronchodilations, and for smoking cessation and pulmonary rehabilitation.

Also new is a strong emphasis on inhaler choice, education, and technique training with assessment of inhaler technique and adherence urged as a prerequisite to judging whether current therapy as insufficient. The report summarizes principles guiding inhaler type selection.

The report also added a section on chronic bronchitis, defining it as a common but variable condition in COPD patients with cough and expectorated sputum on a regular basis over a defined period in the absence of other conditions plausibly causing symptoms.

The fact that chronic bronchitis is sometimes found in never-smokers suggests the involvement of other factors such as exposure to inhaled dusts, biomass fuels, chemical fumes, or domestic heating and cooking fuels, according to the report. Gastroesophageal reflux may also be associated with chronic bronchitis.

The report discusses various taxonomic terms for different types of COPD, such as COPD-G for genetically determined COPD, COPD-D for those with abnormal lung development, and COPD-C for COPD associated with cigarette smoking, etc.
 

Change in exacerbations

The report also revises the definition of a COPD exacerbation as “an event characterized by increased dyspnea and/or cough and sputum that worsens in less than 14 days which may be accompanied by tachypnea and/or tachycardia and is often associated with increased local and system inflammation caused by infection, pollution, or other insult to the airways.” To overcome limitations conferred by the current grading of COPD exacerbations, the 2023 report proposes a four-step point-of-contact diagnosis and assessment tool.

Telemedicine

Given the constraints brought on by COVID-19 on top of the generally sparse availability of programs and facilities for delivering well-proven pulmonary rehabilitation methods, tele-rehabilitation has been proposed as an alternative to traditional approaches. While the evidence base is still evolving and best practices have not yet been established, the GOLD Report calls for better understanding of barriers to tele-rehabilitation success.

Comorbidities update

The GOLD Report chapter on COPD and comorbidities was also updated, and lists cardiovascular disease, lung cancer, osteoporosis, depression/anxiety, and gastroesophageal reflux disease as common comorbid conditions which may affect prognosis and, in the case of cancer, mortality. The report urges simplicity of treatment to minimize polypharmacy. While annual low-dose CT is recommended for COPD caused by smoking, it is not recommended for COPD caused by smoking; data are insufficient to establish benefit over harm.

While the GOLD Report “COVID-19 and COPD” chapter summarizes current evidence stating that individuals with COPD do not seem to be at substantially greater risk of infection with SARS-CoV-2, it underscores that they are at higher risk of hospitalization for COVID-19 and may be at higher risk for developing severe disease and death.

Many other topics are included in the updated report, among them screening, imaging, vaccinations, adherence to therapy, and surgical and bronchoscopic interventions. In its closing section, the GOLD Report 2023 reiterates its mission, stating: “The GOLD initiative will continue to work with National Leaders and other interested health care professionals to bring COPD to the attention of governments, public health officials, health care workers, and the general public, to raise awareness of the burden of COPD and to develop programs for early detection, prevention and approaches to management.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report is revised annually and is used widely throughout the world as a tool for implementing effective management.

Among the updates in the 2023 GOLD Report, the section on diagnostic criteria added a proposed new category “PRISm,” denoting “preserved ratio impaired spirometry,” encompassing individuals who present with structural lung lesions (for example, emphysema) and/or other physiological abnormalities such as low-normal forced expiratory volume in 1 second (FEV₁), gas trapping, hyperinflation, reduced lung diffusing capacity and/or rapid FEV₁ decline, but without airflow obstruction (FEV₁/FEV ≥ 0.7 post bronchodilation). Some of these “pre-COPD” (chronic obstructive pulmonary disease) individuals, who have a normal ratio but abnormal spirometry are at risk over time of developing airflow obstruction. The best treatment for them, beyond smoking cessation, needs to be determined through research, the report states.
 

Clinical updates

The GOLD 2023 Report also offers proposed clinical guidance, in the absence of high-quality clinical trial evidence, on initial pharmacologic management of COPD. The proposal is based on individual assessment of symptoms and exacerbation risk following use of the ABE Assessment Tool, a revised version of the ABCD Assessment Tool that recognizes the clinical relevance of exacerbations independent of symptom level.

These updates to information and figures pertaining to initial pharmacological treatment and follow-up pharmacological treatment revise the positioning of LABA (long-acting beta₂ agonists) plus LAMA (long-acting muscarinic agonists) and LABA/ICS (inhaled corticosteroids). Among GOLD group A patients with 0 or 1 moderate exacerbations that do not lead to hospital admission, a bronchodilator is recommended.

The recommendation for group B patients is LABA/LAMA with the caveat that single inhaler therapy may be more convenient and effective than multiple inhalers. For group E patients with two or more moderate exacerbations or one or more leading to hospitalization, LABA/LAMA is recommended (with the same inhaler therapy caveat). With blood eosinophil levels at 300 or higher, LABA/LAMA/ICS may be considered.

Commenting on the combination recommendations in a press release, Antonio Anzueto, MD, professor of medicine, pulmonary critical care, University of Texas Health, San Antonio, stated: “From a physician’s perspective, we are always grateful to receive well-vetted and informed recommendations on how we can best utilize available treatment options to provide the most benefit to our patients. The new 2023 GOLD recommendations represent a meaningful change for the treatment of COPD by prioritizing the utilization of a fixed LAMA/LABA combination.”
 

More interventions

In a section on therapeutic interventions to reduce COPD mortality, the report lists studies showing mortality benefits for fixed-dose inhaled triple combinations (LABA + LAMA + ICS) versus dual inhaled long-acting bronchodilations, and for smoking cessation and pulmonary rehabilitation.

Also new is a strong emphasis on inhaler choice, education, and technique training with assessment of inhaler technique and adherence urged as a prerequisite to judging whether current therapy as insufficient. The report summarizes principles guiding inhaler type selection.

The report also added a section on chronic bronchitis, defining it as a common but variable condition in COPD patients with cough and expectorated sputum on a regular basis over a defined period in the absence of other conditions plausibly causing symptoms.

The fact that chronic bronchitis is sometimes found in never-smokers suggests the involvement of other factors such as exposure to inhaled dusts, biomass fuels, chemical fumes, or domestic heating and cooking fuels, according to the report. Gastroesophageal reflux may also be associated with chronic bronchitis.

The report discusses various taxonomic terms for different types of COPD, such as COPD-G for genetically determined COPD, COPD-D for those with abnormal lung development, and COPD-C for COPD associated with cigarette smoking, etc.
 

Change in exacerbations

The report also revises the definition of a COPD exacerbation as “an event characterized by increased dyspnea and/or cough and sputum that worsens in less than 14 days which may be accompanied by tachypnea and/or tachycardia and is often associated with increased local and system inflammation caused by infection, pollution, or other insult to the airways.” To overcome limitations conferred by the current grading of COPD exacerbations, the 2023 report proposes a four-step point-of-contact diagnosis and assessment tool.

Telemedicine

Given the constraints brought on by COVID-19 on top of the generally sparse availability of programs and facilities for delivering well-proven pulmonary rehabilitation methods, tele-rehabilitation has been proposed as an alternative to traditional approaches. While the evidence base is still evolving and best practices have not yet been established, the GOLD Report calls for better understanding of barriers to tele-rehabilitation success.

Comorbidities update

The GOLD Report chapter on COPD and comorbidities was also updated, and lists cardiovascular disease, lung cancer, osteoporosis, depression/anxiety, and gastroesophageal reflux disease as common comorbid conditions which may affect prognosis and, in the case of cancer, mortality. The report urges simplicity of treatment to minimize polypharmacy. While annual low-dose CT is recommended for COPD caused by smoking, it is not recommended for COPD caused by smoking; data are insufficient to establish benefit over harm.

While the GOLD Report “COVID-19 and COPD” chapter summarizes current evidence stating that individuals with COPD do not seem to be at substantially greater risk of infection with SARS-CoV-2, it underscores that they are at higher risk of hospitalization for COVID-19 and may be at higher risk for developing severe disease and death.

Many other topics are included in the updated report, among them screening, imaging, vaccinations, adherence to therapy, and surgical and bronchoscopic interventions. In its closing section, the GOLD Report 2023 reiterates its mission, stating: “The GOLD initiative will continue to work with National Leaders and other interested health care professionals to bring COPD to the attention of governments, public health officials, health care workers, and the general public, to raise awareness of the burden of COPD and to develop programs for early detection, prevention and approaches to management.

“Do you smoke?” I asked the patient.

“Yes, and I got what I deserved,” he answered, clearly upset.

I ignored his reaction and continued with the exam, but in retrospect, I should have explained why doctors ask patients this question.

It was not my intention to be rude or blame the patient for his lung cancer diagnosis. Doctors ask patients if they smoke because a smoking history can change the type of treatment and it can be associated with other conditions that may interfere with treatment. It can also determine whether smoking cessation assistance should be offered to the patient. It is crucial that we as doctors know a patient’s medical history, but how we approach sensitive issues may determine if we even get the information we need. In this case, I didn’t explain why I asked the patient if he smoked. Had I taken the time to explain why I needed to know if and how long he smoked and that I was not blaming him for his lung cancer diagnosis, we may have had a more mutually respectful and beneficial relationship.

Almost all of my patients with lung cancer have been asked at one time or another – by a health care provider, friends, or acquaintances – “Do you smoke?” Whether or not they smoked, patients with lung cancer feel the weight of moral judgment being cast upon them by society.

It is common for people who smoke and who go on to develop lung cancer to be weighed down by guilt associated with their diagnosis. Patients with lung cancer face stigma-associated hurdles based on the “I did it to myself” mindset. This societal stigma is not without harm as it can result in emotional responses of guilt and self-blame. This internalized stigma may lead to psychosocial distress and decreased interactions with family, friends, and health care providers. The guilt may drive a patient to forgo lung cancer screening, minimize symptoms, delay seeking treatment, and not advocate for themselves with their physician. Some patients even decide to forgo all treatment.

What about patients who never smoked? They too feel tinged with blame. Many of these patients feel called upon to defend themselves by proclaiming loudly that they have never smoked.

Blame and shame also divides the lung cancer community, resulting in less advocacy. It may also impact research dollars for lung cancer. According to the Lung Cancer Research Foundation, “Despite being the leading cause of cancer mortality, lung cancer receives far less research funding than any other cancer.” By comparison, women with breast cancer are showered with far more resources, supportive services, fundraising events, and certainly more lobbying.

By making unintentional hurtful statements and using judgmental or denigrating language, the lung cancer community may unconsciously be playing a role in perpetuating stigmas associated with lung cancer. That kind of language can come across as blame.

The International Association for the Study of Lung Cancer has developed a language guide to help reduce stigma associated with lung cancer. The aim is to reduce and replace traditional medical language during our patient interactions, presentations, and publications with language that is more empathic and nonjudgmental.

For example, replace the term “cancer patient” with the term “the patient with cancer.” The patient is a person who happens to have been diagnosed with lung cancer, they are not “cancer.” Patients can be very sensitive to language and may misinterpret language that doctors commonly use. Language such as “the patient failed treatment” may be interpreted by patients as a personal failure. In reality, the treatment failed the patient, instead of the other way around. Instead, shift the blame from the patient to the cancer. Adopt terms like “the tumor did not respond to treatment.” Or, “the cancer progressed” instead of “the patient progressed.”

Language around smoking is particularly stigmatizing because it categorizes a person by a behavior. As health care providers, we should consider removing the term “smoker” from our interactions with patients and instead, use “patient who smokes” or ”patient with a smoking history.” Other ways health care providers can reduce stigma triggered by assessing smoking status include using supportive communication skills, providing a rationale for asking smoking related questions, offering help and tobacco cessation and other resources, and displaying empathic behavior, such as maintaining eye contact and a nonjudgmental body position orientated toward the patient.

Many of these common medical phrases were developed to enable efficient communication among health care professionals. Times have changed and patients should not be defined by an illness. They are people first. In addition to improving patient interactions in clinic, using nonjudgmental language whenever possible in presentations and publications is also extremely important, as patients are living longer and getting more involved in research and advocacy.

“Words have energy and power with the ability to help, to heal, to hinder, to hurt, to harm, to humiliate, and to humble,” says Yehuda Berg, author and codirector of the Kabbalah Centre International in Los Angeles.
 

Dr. Schiller is a medical oncologist and founding member of Oncologists United for Climate and Health. She is a former board member of the International Association for the Study of Lung Cancer and a current board member of the Lung Cancer Research Foundation.

“Do you smoke?” I asked the patient.

“Yes, and I got what I deserved,” he answered, clearly upset.

I ignored his reaction and continued with the exam, but in retrospect, I should have explained why doctors ask patients this question.

It was not my intention to be rude or blame the patient for his lung cancer diagnosis. Doctors ask patients if they smoke because a smoking history can change the type of treatment and it can be associated with other conditions that may interfere with treatment. It can also determine whether smoking cessation assistance should be offered to the patient. It is crucial that we as doctors know a patient’s medical history, but how we approach sensitive issues may determine if we even get the information we need. In this case, I didn’t explain why I asked the patient if he smoked. Had I taken the time to explain why I needed to know if and how long he smoked and that I was not blaming him for his lung cancer diagnosis, we may have had a more mutually respectful and beneficial relationship.

Almost all of my patients with lung cancer have been asked at one time or another – by a health care provider, friends, or acquaintances – “Do you smoke?” Whether or not they smoked, patients with lung cancer feel the weight of moral judgment being cast upon them by society.

It is common for people who smoke and who go on to develop lung cancer to be weighed down by guilt associated with their diagnosis. Patients with lung cancer face stigma-associated hurdles based on the “I did it to myself” mindset. This societal stigma is not without harm as it can result in emotional responses of guilt and self-blame. This internalized stigma may lead to psychosocial distress and decreased interactions with family, friends, and health care providers. The guilt may drive a patient to forgo lung cancer screening, minimize symptoms, delay seeking treatment, and not advocate for themselves with their physician. Some patients even decide to forgo all treatment.

What about patients who never smoked? They too feel tinged with blame. Many of these patients feel called upon to defend themselves by proclaiming loudly that they have never smoked.

Blame and shame also divides the lung cancer community, resulting in less advocacy. It may also impact research dollars for lung cancer. According to the Lung Cancer Research Foundation, “Despite being the leading cause of cancer mortality, lung cancer receives far less research funding than any other cancer.” By comparison, women with breast cancer are showered with far more resources, supportive services, fundraising events, and certainly more lobbying.

By making unintentional hurtful statements and using judgmental or denigrating language, the lung cancer community may unconsciously be playing a role in perpetuating stigmas associated with lung cancer. That kind of language can come across as blame.

The International Association for the Study of Lung Cancer has developed a language guide to help reduce stigma associated with lung cancer. The aim is to reduce and replace traditional medical language during our patient interactions, presentations, and publications with language that is more empathic and nonjudgmental.

For example, replace the term “cancer patient” with the term “the patient with cancer.” The patient is a person who happens to have been diagnosed with lung cancer, they are not “cancer.” Patients can be very sensitive to language and may misinterpret language that doctors commonly use. Language such as “the patient failed treatment” may be interpreted by patients as a personal failure. In reality, the treatment failed the patient, instead of the other way around. Instead, shift the blame from the patient to the cancer. Adopt terms like “the tumor did not respond to treatment.” Or, “the cancer progressed” instead of “the patient progressed.”

Language around smoking is particularly stigmatizing because it categorizes a person by a behavior. As health care providers, we should consider removing the term “smoker” from our interactions with patients and instead, use “patient who smokes” or ”patient with a smoking history.” Other ways health care providers can reduce stigma triggered by assessing smoking status include using supportive communication skills, providing a rationale for asking smoking related questions, offering help and tobacco cessation and other resources, and displaying empathic behavior, such as maintaining eye contact and a nonjudgmental body position orientated toward the patient.

Many of these common medical phrases were developed to enable efficient communication among health care professionals. Times have changed and patients should not be defined by an illness. They are people first. In addition to improving patient interactions in clinic, using nonjudgmental language whenever possible in presentations and publications is also extremely important, as patients are living longer and getting more involved in research and advocacy.

“Words have energy and power with the ability to help, to heal, to hinder, to hurt, to harm, to humiliate, and to humble,” says Yehuda Berg, author and codirector of the Kabbalah Centre International in Los Angeles.
 

Dr. Schiller is a medical oncologist and founding member of Oncologists United for Climate and Health. She is a former board member of the International Association for the Study of Lung Cancer and a current board member of the Lung Cancer Research Foundation.

“Do you smoke?” I asked the patient.

“Yes, and I got what I deserved,” he answered, clearly upset.

I ignored his reaction and continued with the exam, but in retrospect, I should have explained why doctors ask patients this question.

It was not my intention to be rude or blame the patient for his lung cancer diagnosis. Doctors ask patients if they smoke because a smoking history can change the type of treatment and it can be associated with other conditions that may interfere with treatment. It can also determine whether smoking cessation assistance should be offered to the patient. It is crucial that we as doctors know a patient’s medical history, but how we approach sensitive issues may determine if we even get the information we need. In this case, I didn’t explain why I asked the patient if he smoked. Had I taken the time to explain why I needed to know if and how long he smoked and that I was not blaming him for his lung cancer diagnosis, we may have had a more mutually respectful and beneficial relationship.

Almost all of my patients with lung cancer have been asked at one time or another – by a health care provider, friends, or acquaintances – “Do you smoke?” Whether or not they smoked, patients with lung cancer feel the weight of moral judgment being cast upon them by society.

It is common for people who smoke and who go on to develop lung cancer to be weighed down by guilt associated with their diagnosis. Patients with lung cancer face stigma-associated hurdles based on the “I did it to myself” mindset. This societal stigma is not without harm as it can result in emotional responses of guilt and self-blame. This internalized stigma may lead to psychosocial distress and decreased interactions with family, friends, and health care providers. The guilt may drive a patient to forgo lung cancer screening, minimize symptoms, delay seeking treatment, and not advocate for themselves with their physician. Some patients even decide to forgo all treatment.

What about patients who never smoked? They too feel tinged with blame. Many of these patients feel called upon to defend themselves by proclaiming loudly that they have never smoked.

Blame and shame also divides the lung cancer community, resulting in less advocacy. It may also impact research dollars for lung cancer. According to the Lung Cancer Research Foundation, “Despite being the leading cause of cancer mortality, lung cancer receives far less research funding than any other cancer.” By comparison, women with breast cancer are showered with far more resources, supportive services, fundraising events, and certainly more lobbying.

By making unintentional hurtful statements and using judgmental or denigrating language, the lung cancer community may unconsciously be playing a role in perpetuating stigmas associated with lung cancer. That kind of language can come across as blame.

The International Association for the Study of Lung Cancer has developed a language guide to help reduce stigma associated with lung cancer. The aim is to reduce and replace traditional medical language during our patient interactions, presentations, and publications with language that is more empathic and nonjudgmental.

For example, replace the term “cancer patient” with the term “the patient with cancer.” The patient is a person who happens to have been diagnosed with lung cancer, they are not “cancer.” Patients can be very sensitive to language and may misinterpret language that doctors commonly use. Language such as “the patient failed treatment” may be interpreted by patients as a personal failure. In reality, the treatment failed the patient, instead of the other way around. Instead, shift the blame from the patient to the cancer. Adopt terms like “the tumor did not respond to treatment.” Or, “the cancer progressed” instead of “the patient progressed.”

Language around smoking is particularly stigmatizing because it categorizes a person by a behavior. As health care providers, we should consider removing the term “smoker” from our interactions with patients and instead, use “patient who smokes” or ”patient with a smoking history.” Other ways health care providers can reduce stigma triggered by assessing smoking status include using supportive communication skills, providing a rationale for asking smoking related questions, offering help and tobacco cessation and other resources, and displaying empathic behavior, such as maintaining eye contact and a nonjudgmental body position orientated toward the patient.

Many of these common medical phrases were developed to enable efficient communication among health care professionals. Times have changed and patients should not be defined by an illness. They are people first. In addition to improving patient interactions in clinic, using nonjudgmental language whenever possible in presentations and publications is also extremely important, as patients are living longer and getting more involved in research and advocacy.

“Words have energy and power with the ability to help, to heal, to hinder, to hurt, to harm, to humiliate, and to humble,” says Yehuda Berg, author and codirector of the Kabbalah Centre International in Los Angeles.
 

Dr. Schiller is a medical oncologist and founding member of Oncologists United for Climate and Health. She is a former board member of the International Association for the Study of Lung Cancer and a current board member of the Lung Cancer Research Foundation.

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.

Asking knee osteoarthritis patients a simple question – do you have difficulty climbing stairs? – may predict the risk of future functional limitation, according to research presented at the annual meeting of the American College of Rheumatology. Finding out that the patient has difficulty also opens avenues for further evaluation and intervention, said Jason Jakiela, a PhD candidate at the University of Delaware, Newark, who led the study. “We like to view it as a kind of yellow flag,” Mr. Jakiela said in an interview.

Another expert agreed. “I think this is useful for clinical rheumatologists,” said C. Kent Kwoh, MD, professor of medicine and medical imaging at the University of Arizona, Tucson, and director of the University of Arizona Arthritis Center. He commented on the study findings but was not involved in the study. Another common question asked of OA patients, about pain, may not be as useful as asking about difficulty climbing stairs, he said. “Their pain level can go up and down and can be quite varied.”

decade3d/Thinkstock

Study details, results

Mr. Jakiela and his team, including Daniel White, PT, ScD, MSC, associate professor of physical therapy at the University of Delaware, Newark, used data from the Osteoarthritis Initiative (OAI). They assessed stair climbing difficulty at baseline with the question: Does your health now limit you in climbing several flights of stairs? Respondents could answer that they were limited a lot, a little, or not at all.

The researchers evaluated functional limitation using two measures: Walking speed and Western Ontario and McMaster Universities Osteoarthritis Index physical function (WOMAC-PF) scores. A walking speed of < 1.22 m/s over 20 meters, the speed needed to safely cross a timed intersection, represented poor function. A WOMAC-PF score of 28/68 or more was also used to define low functioning.

The analyses included only people free of functional limitations at baseline. Each measure was conducted at the start and then at 12, 24, 36, 48, 72, and 96 months’ follow-up visits.

While 2,952 participants (mean age 60.1, 54% female, mean body mass index 27.9) were in the walking speed sample, 3,983 participants (mean age 61.2, 57% female, mean BMI 28.2) were in the WOMAC-PF sample.

Starting the conversation

The question about stair climbing difficulty is a good “jumping-off point,” Mr. Jakiela said. “It opens up a line of questioning.” With knee OA, stair climbing difficulty is often the first reported limitation. That difficulty could capture a variety of issues, he said. Patients could be struggling with strength issues, cardiovascular problems, or balance deficits, for instance.

It signals there may be a trajectory of slow decline coming in this patient, Mr. Jakiela said.

“It’s a signal that something is not right,” Dr. White said in an interview. “We don’t know what is wrong.” While questions about stairs have routinely been asked of OA patients, the study findings suggest the answer to the question about having difficulty could help predict a patient’s future course, he said.

After patients reported a little or a lot of difficulty with stair climbing, the average time to reach functional limitation status was about 3 years, Mr. Jakiela said. That gives health care providers time to ask more questions about the patient’s condition and potentially intervene, depending on the details of the difficulty. If it’s a balance issue, physical therapy might help, for example.

While gait speed is a tried-and-true indication, collecting answers about stair climbing difficulty is easier and quicker for clinicians than assessing gait speed, which requires more time as well as office space, Mr. Jakiela said. It’s also intuitive for the patients to recall, the researchers said.
 

More practical takeaways

Finding out whether functional limitation is likely, based on the stair question, can help health care providers consider nonpharmacologic interventions, Dr. Kwoh agreed, such as physical therapy or braces. “It doesn’t have to be drugs. We have limited drugs for OA at the moment. We don’t have a so-called DMARD drug [for OA].”

NSAIDs have side effects, and people are very familiar with the issues of opioids, he said. It’s important, he added, for the health care provider, if referring to a physical therapist, to find the right one. To help those dealing with knee OA, a PT in sports medicine might be a good choice, he said.

Mr. Jakiela has no disclosures. Dr. Kwoh and Dr. White have no relevant disclosures.

We are in the golden age of atopic dermatitis (AD) drug development. We are fortunate to have numerous topicals, oral systemics, and biologics recently approved or in late-stage clinical development. Yet, we are still lacking effective strategies for primary prevention of incident AD and secondary prevention of AD exacerbations.

Kottner and colleagues published the results from the ADAPI study of 150 infants who were at an enhanced risk for AD. The children were randomly assigned to receive either a skincare regimen that was standardized or unstandardized skincare preferred by parents. They found that in the first year of life, the overall cumulative incidence rate of AD was similar between standardized skincare and skincare preferred by parents (P = .999).

Bradshaw and colleagues also published results from the BEEP study (a 5-year prospective study) of 1394 infants who were at high risk for AD. The children were randomly assigned to receive either emollient for the first year plus standard skincare or standard skincare alone. They found a similar proportion of children were clinically diagnosed with AD between 12 and 60 months in the emollient plus skincare group vs skincare alone group (31% vs 28%; adjusted relative risk 1.10; 95% CI 0.93-1.30). Unfortunately, the results from both studies are consistent with earlier results from BEEP, as well as other studies, and did not show that early application of emollients successfully prevent AD.

The use of applying emollients for primary prevention is unclear. However, proactive application of topical corticosteroids (TCS) and other topical nonsteroidal agents is well accepted in AD treatment guidelines for secondary prevention of AD exacerbations.¹  Although, a recent study from Kamiya and colleagues suggested that proactive application of topical corticosteroids may not work as well as we think. They conducted an open-label, active-controlled, parallel-group study of 49 pediatric patients with moderate to severe AD who achieved remission with potent TCS. The children were then randomly assigned to receive proactive therapy with or discontinuation of TCS. The authors found no significant decrease in relapse rates with proactive vs no proactive treatment groups (8.33% vs 20.0%; P = .0859). I don't think these results will change our guidelines. But I do think these results raise important questions about the myriad aspects of proactive therapy that require appropriate counseling, including frequency of application per week (1-3 times), choice of therapies (corticosteroid or nonsteroidal agent), additional emollient use, bathing practice, etc. I personally would strongly recommend use of proactive therapy in clinical practice, but these results highlight that it is not a magic bullet for all patients either.

Additional Reference

1. Boguniewicz M, Fonacier L, Guttman-Yassky E, et al. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120:10-22.e2. Doi: 10.1016/j.anai.2017.10.039

We are in the golden age of atopic dermatitis (AD) drug development. We are fortunate to have numerous topicals, oral systemics, and biologics recently approved or in late-stage clinical development. Yet, we are still lacking effective strategies for primary prevention of incident AD and secondary prevention of AD exacerbations.

Kottner and colleagues published the results from the ADAPI study of 150 infants who were at an enhanced risk for AD. The children were randomly assigned to receive either a skincare regimen that was standardized or unstandardized skincare preferred by parents. They found that in the first year of life, the overall cumulative incidence rate of AD was similar between standardized skincare and skincare preferred by parents (P = .999).

Bradshaw and colleagues also published results from the BEEP study (a 5-year prospective study) of 1394 infants who were at high risk for AD. The children were randomly assigned to receive either emollient for the first year plus standard skincare or standard skincare alone. They found a similar proportion of children were clinically diagnosed with AD between 12 and 60 months in the emollient plus skincare group vs skincare alone group (31% vs 28%; adjusted relative risk 1.10; 95% CI 0.93-1.30). Unfortunately, the results from both studies are consistent with earlier results from BEEP, as well as other studies, and did not show that early application of emollients successfully prevent AD.

The use of applying emollients for primary prevention is unclear. However, proactive application of topical corticosteroids (TCS) and other topical nonsteroidal agents is well accepted in AD treatment guidelines for secondary prevention of AD exacerbations.¹  Although, a recent study from Kamiya and colleagues suggested that proactive application of topical corticosteroids may not work as well as we think. They conducted an open-label, active-controlled, parallel-group study of 49 pediatric patients with moderate to severe AD who achieved remission with potent TCS. The children were then randomly assigned to receive proactive therapy with or discontinuation of TCS. The authors found no significant decrease in relapse rates with proactive vs no proactive treatment groups (8.33% vs 20.0%; P = .0859). I don't think these results will change our guidelines. But I do think these results raise important questions about the myriad aspects of proactive therapy that require appropriate counseling, including frequency of application per week (1-3 times), choice of therapies (corticosteroid or nonsteroidal agent), additional emollient use, bathing practice, etc. I personally would strongly recommend use of proactive therapy in clinical practice, but these results highlight that it is not a magic bullet for all patients either.

Additional Reference

1. Boguniewicz M, Fonacier L, Guttman-Yassky E, et al. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120:10-22.e2. Doi: 10.1016/j.anai.2017.10.039

We are in the golden age of atopic dermatitis (AD) drug development. We are fortunate to have numerous topicals, oral systemics, and biologics recently approved or in late-stage clinical development. Yet, we are still lacking effective strategies for primary prevention of incident AD and secondary prevention of AD exacerbations.

Kottner and colleagues published the results from the ADAPI study of 150 infants who were at an enhanced risk for AD. The children were randomly assigned to receive either a skincare regimen that was standardized or unstandardized skincare preferred by parents. They found that in the first year of life, the overall cumulative incidence rate of AD was similar between standardized skincare and skincare preferred by parents (P = .999).

Bradshaw and colleagues also published results from the BEEP study (a 5-year prospective study) of 1394 infants who were at high risk for AD. The children were randomly assigned to receive either emollient for the first year plus standard skincare or standard skincare alone. They found a similar proportion of children were clinically diagnosed with AD between 12 and 60 months in the emollient plus skincare group vs skincare alone group (31% vs 28%; adjusted relative risk 1.10; 95% CI 0.93-1.30). Unfortunately, the results from both studies are consistent with earlier results from BEEP, as well as other studies, and did not show that early application of emollients successfully prevent AD.

The use of applying emollients for primary prevention is unclear. However, proactive application of topical corticosteroids (TCS) and other topical nonsteroidal agents is well accepted in AD treatment guidelines for secondary prevention of AD exacerbations.¹  Although, a recent study from Kamiya and colleagues suggested that proactive application of topical corticosteroids may not work as well as we think. They conducted an open-label, active-controlled, parallel-group study of 49 pediatric patients with moderate to severe AD who achieved remission with potent TCS. The children were then randomly assigned to receive proactive therapy with or discontinuation of TCS. The authors found no significant decrease in relapse rates with proactive vs no proactive treatment groups (8.33% vs 20.0%; P = .0859). I don't think these results will change our guidelines. But I do think these results raise important questions about the myriad aspects of proactive therapy that require appropriate counseling, including frequency of application per week (1-3 times), choice of therapies (corticosteroid or nonsteroidal agent), additional emollient use, bathing practice, etc. I personally would strongly recommend use of proactive therapy in clinical practice, but these results highlight that it is not a magic bullet for all patients either.

Additional Reference

1. Boguniewicz M, Fonacier L, Guttman-Yassky E, et al. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120:10-22.e2. Doi: 10.1016/j.anai.2017.10.039