Randomized,Single‐Blind,Parallel Study of the Effectiveness and Safety of Solifenacin versus Propiverine in the Treatment of Overactive Bladder

Objectives: To compare the effectiveness and safety of solifenacin versus propiverine in the treatment of overactive bladder (OAB), in a single‐blind, randomized parallel study. Methods: Sixty‐six patients with OAB (14 men and 52 women) were randomly assigned to groups: solifenacin (5 mg/day) or propiverine (20 mg/day) and treated for 8 weeks. The primary outcome variable was mean change from baseline to end of treatment in urgency of the OAB symptom score (OABSS). Secondary outcomes were bladder diary variables: change over 24 h in the mean number of voids (daytime and nighttime), episodes of micturition urgency and incontinence, and mean volume voided. Patients also completed total OABSS and the King's Health questionnaires. Results: Group backgrounds were comparable except for the male to female proportion; 11:22 for solifenacin (n = 33) versus 3:30 for propiverine (n = 33). Adverse events were 6 of 29 (21%) for solifenacin versus 14 of 26 (54%) for propiverine (P = 0.017). Three patients were withdrawn for voiding difficulty (one in solifenacin and two in propiverine) and one patient for dry mouth (propiverine group). Change in OABSS urgency score was ?2.3 ± 1.4 for solifenacin (n = 28) versus ?1.3 ± 1.7 for propiverine (n = 23), (P = 0.0169). Total OABSS and other individual scores, and voiding diary parameters for both drugs showed improvements; however, between‐group difference was not established. Conclusion: Although both solifenacin 5 mg and propiverine 20 mg were effective in the treatment of OAB, solifenacin appeared to be more effective and tolerable.     

Efficacy and Safety of Propiverine and Solifenacin for the Treatment of Female Patients with Overactive Bladder: A Crossover Study

Objectives: To evaluate the clinical efficacy and tolerability of propiverine and solifenacin in female patients with overactive bladder (OAB). Methods: A prospective nonrandomized crossover study of propiverine 20 mg and solifenacin 5 mg was conducted. Female OAB patients were assigned alternately to treatment with propiverine for 8 weeks then solifenacin for 8 weeks (Group P‐S) or solifenacin for 8 weeks then propiverine for 8 weeks (Group S‐P). At baseline, 8th week and 16th week, symptoms were assessed using overactive bladder symptom score (OABSS). Results: A total of 121 patients were enrolled. Overall, 38 patients (31.4%) discontinued or dropped out and 83 patients were available for analysis (39 in Group P‐S and 44 in Group S‐P). In both groups, the total score and each score of OABSS were significantly improved after 8 weeks compared with baseline. In only Group P‐S (changing over from propiverine to solifenacin), urgency score in the 16th week was further improved significantly compared with the 8th week. The most bothersome symptom at baseline was urgency incontinence (50.6%), followed by urgency (37.3%). Even after symptom improvement, more than half of the patients were bothered by urgency or urgency incontinence. The incidence of adverse events of moderate and severe grade was higher during propiverine treatment than solifenacin (11.1% vs 2.9%, P = 0.039). Conclusion: Propiverine 20 mg and solifenacin 5 mg were effective for treating female OAB patients. Urgency was further improved after switching from propiverine to solifenacin, but not after switching from solifenacin to propiverine. Solifenacin was better tolerated than propiverine.     

Efficacy of Propiverine in Improving Symptoms and Quality of Life in Female Patients with Wet Overactive Bladder

Objectives: The present prospective study was conducted to assess the effects of propiverine hydrochloride in improving symptoms and quality of life (QoL) in female patients with wet OAB. Methods: Propiverine was administered orally for 8 weeks to 58 female patients who had urgency incontinence. Prior to administration, and at 4 and 8 weeks after administration, symptoms and QoL of the patients were assessed using a micturition diary, the International Consultation on Incontinence Questionnaire‐Short Form (ICIQ‐SF), and the King's Health Questionnaire (KHQ). In addition, the relationships between changes in frequency of urinary incontinence or amount of urine leakage following treatment and changes in each domain of the KHQ were investigated by multiple regression analysis. Results: After administration of propiverine, the mean numbers of daily micturitions, incontinence episodes, and urgency episodes assessed on the basis of the micturition diary significantly improved in comparison to the baseline: from 11.7 to 9.6 for daily micturitions, from 2.8 to 1.1 for incontinence episodes, and from 5.9 to 2.3 for urgency episodes in 8 weeks. The mean of the ICIQ‐SF total scores significantly decreased, from 8.4 to 4.6 points at 4 weeks and to 3.6 points at 8 weeks. The mean scores for three individual items in the ICIQ‐SF, namely, frequency of incontinence episodes, amount of leakage, and impact on everyday life also significantly improved. The KHQ scores significantly improved at both 4 and 8 weeks post‐administration in all domains except personal relationships. In the multiple regression analysis, improvement in frequency of incontinence was significantly related to the domain of severity measure of the KHQ, while improvement in amount of leakage was significantly related to the domains of general health perception and social limitations. Conclusion: Propiverine hydrochloride contributed to improvements not only in symptoms but also in QoL in female patients with wet OAB.     

Association of Medication Adherence with Workplace Productivity and Health-Related Quality of Life in Patients with Asthma

Objective. Examine the association of medication adherence with workplace productivity and health-related quality of life (HRQL) in asthma patients. Methods. Adult patients with asthma in a state health insurance program identified from medical claims (July 2001–June 2003) were mailed a three-part survey to measure HRQL (St. George's Respiratory Questionnaire), workplace productivity (Workplace Productivity Short Inventory), and self-reported medication adherence (Morisky Scale). Results. The symptoms domain had the worst HRQL scores, followed by the activity and impacts domains; 39% of the participants reported themselves as “high” adherent, whereas 19% were “medium,” and 42% were “low” adherent. Asthma resulted in productivity losses of $597 ± $1,024 (absenteeism) and $658 ± $1,808 (presenteeism) per enrollee per year. Conclusions. Asthma was associated with HRQL detriments and workplace productivity losses.     

Clinical Efficacy of α1‐Adrenargic Receptor Antagonist Naftopidil 75 mg/day in Patients with Benign Prostatic Hyperplasia

Objectives: The clinical efficacy and safety of 75 mg/day of naftopidil, an α1‐adrenargic receptor antagonist, was assessed in patients with benign prostatic hyperplasia (BPH). Methods: A total of 28 patients (mean age, 71.1 years; range, 46–86 years) with BPH were studied. Inclusion criteria were: (i) International Prostate Symptom Score (IPSS) ≥8; and (ii) quality of life (QOL) index ≥3. IPSS, QOL index, Overactive Bladder Symptom Score (OABSS), and bladder diary (urinary frequency in daytime and nighttime, frequency of urinary incontinence and urgency) were evaluated before and 4 weeks after treatment with naftopidil at 75 mg/day. Results: Total IPSS and QOL index were significantly decreased after treatment. Total OABSS tended to decrease after treatment, with significant improvements in the “urgency” parameter. From the bladder diary, urinary frequency in daytime and nighttime and frequency of urgency were significantly decreased after treatment. Total IPSS and QOL index in patients with previous treatment were significantly improved after treatment, with significant improvements in the “incomplete emptying,”“poor flow” and “nocturia” parameters of IPSS. One case with a mild adverse effect of dizziness was encountered. Conclusion: These results suggest that administration of naftopidil at 75 mg/day was safe and effective for patients with BPH, regardless of the presence of previous treatment. This study indicates the feasibility of naftopidil at 75 mg/day as a first‐line treatment for men with BPH, or a second‐line treatment in cases with symptoms of incomplete emptying, poor flow and nocturia.     

Acute Effect of Inhaled Budesonide on Bronchial Inflammation in Asthmatic Rats

The aim of this study was to determine the level of asthma control and the concordance between physicians' and patients' opinions and the real patients' situation. A total of 777 subjects (55% female) with asthma were recruited. The study comprised a 4-week follow-up period, during which subjects completed a diary recording peak expiratory flow (PEF), symptoms, and use of rescue medication. At the end, both physicians and patients rated asthma control status. The level of control was evaluated using a composite measure. Agreement among subjective assessments of asthma control by patients and physicians and objective evaluation with the composite measure was assessed through kappa scores. A total of 518 (67%) patients had “not well-controlled asthma,” being the remaining “totally controlled” (8%) or “well-controlled” (25%). “Not well-controlled asthma” was more frequent in smokers (82%) than in ex-smokers (70%) or in non-smokers (62%; p = 0.0002). Kappa scores between patients' and physicians' opinions and the real patients' status were 0.02 (95% CI, 0.01–0.05) and 0.07 (95% CI, 0.03–0.09), respectively. In conclusion, current level of asthma control is suboptimal for a majority (67%) of patients in Spain. Besides, asthma control is worse in smokers. Neither patients' nor physicians' opinions agree with patients' real situation. Both patients and physicians accept as normal a suboptimal status of their disease.     

Modulation of Bladder Afferent Activity by Propiverine and its Active Metabolites (M‐1 and M‐2) in Rats

Objectives: To evaluate the effects of propiverine and its active metabolites (M‐1 and M‐2) on bladder function through modulation of afferent activity in rats. Methods: Cystometry was performed in urethane anesthetized female rats. We examined the effects of intravesical administration of propiverine, M‐1 and M‐2 on bladder overactivity induced by oxotremorine‐M (Oxo‐M; non‐selective mAChR agonist). Results: Intravesical administration of Oxo‐M (200 µM) elicited bladder overactivity as evidenced by decreased intercontraction interval (ICI) and pressure threshold (PT) without changing maximum voiding pressure or baseline pressure. These effects were blocked by intravesical administration of propiverine (30 µM) or M‐2 (300 µM). Intravesical administration of M‐1 (30 µM) alone increased ICI and PT, but did not prevent Oxo‐M‐induced decreases in ICI and PT. Conclusion: These results suggest that propiverine and M‐2 have anticholinergic effects on bladder afferent activity and that M‐1 has an inhibitory effect through the mechanism other than muscarinic receptor modulation. Thus, clinical benefits of propiverine in patients with overactive bladder could be mediated by multiple actions of propiverine and its active metabolites.     

Improved quality of life following direct‐acting antiviral treatment for chronic hepatitis C infection in Rwanda: Results from a clinical trial in sub‐Saharan Africa (the SHARED study)

Around 71 million people are living with chronic hepatitis C virus (HCV) infection, with approximately 14% residing in sub‐Saharan Africa. Direct‐acting antiviral (DAA) therapies offer clear benefits for liver‐related morbidity and mortality, and data from high‐income settings suggest that DAA treatments also provide significant benefits in terms of health‐related quality of life (HRQL). In this study, we assessed the effect of DAA treatment on HRQL for individuals treated for HCV in a clinical trial in Rwanda. We assessed the HRQL of participants using an 83‐question composite survey at Day 0 (‘baseline’) and Week 24 (‘endpoint’). Data were analysed in R. A total of 296 participants were included in this analysis. Their ages ranged from 19 to 90, and 184 (62.2%) were female. There were significant improvements from baseline to endpoint median scores for all physical and mental quality of life sub‐scales. Additionally, a reduction—before and after treatment—in the proportion of those classified as depressed and needing social support was statistically significant (both P < .001). Economic productivity increased after treatment (P < .001), and households classified as food secure increased from baseline to endpoint (P < .001). These results demonstrate that Rwandans with chronic HCV infection experience both clinical and HRQL benefits, including household‐level benefits like substantial gains in workforce stability, economic productivity, and poverty alleviation, from DAA treatment. A stronger demonstration of accurate and broader household‐level benefits achieved through treatment of HCV with DAAs will help financing and investment for HCV in resource‐constrained settings become an urgent priority.     

Patients' Expectations of Asthma Treatment

A multicomponent model has been developed to explain patients' unmet expectations of medical care. The model proposes that expectations are related to patients' personal experiences with illness, perceived vulnerability to disease, transmitted knowledge, and perceived severity of disease. The objective of this cross‐sectional study was to determine whether this model can be applied to patients' unrealistic expectations of treatment outcomes, specifically expecting to be cured of asthma. In total, 230 patients observed in a primary care practice in New York City were interviewed in person with open‐ended questions about their expectations of asthma treatment. Responses were analyzed with qualitative techniques to generate categories of expectations. Patients had a mean age of 41 ± 11 years, 21% were white, 30% African American, 42% Latino, and 7% other groups. Major categories of expectations were generated from patients' responses and included symptom relief (expected by 52%), cure (36%), improved physical function (21%), and improved psychological well‐being (15%). The category of expecting a cure was assessed with patients' responses to the following items representing components of the model: 1) resource utilization and medication requirements for asthma (representing severity of disease); 2) perceived quality of asthma care and satisfaction with care (representing past asthma experiences); 3) the Asthma Self‐Efficacy Scale (representing perceived vulnerability to exacerbations); and 4) experiences of social network contacts with asthma and the Check Your Asthma IQ survey (representing transmitted knowledge). In bivariate analysis, patients who expected a cure were more likely to be Latino or Native American or Asian (p = 0.02), to have never required oral corticosteroids (p = 0.004), to be dissatisfied with the status of their asthma (p = 0.008), to know others who were limited by asthma (p = 0.03), to have worse Asthma Self‐Efficacy Scale scores (p = 0.002), to have worse Check Your Asthma IQ scores (p = 0.04), and to currently be taking inhaled corticosteroids (p = 0.03). In multivariate analysis, worse asthma self‐efficacy (p = 0.008), never having required oral corticosteroids (p = 0.005), and currently taking inhaled corticosteroids (p = 0.05) remained associated with expecting a cure. As a result of this study, we found that patients have multiple expectations of asthma treatment, including realistic expectations such as symptom relief and improved function, as well as unrealistic expectations, specifically to be cured of asthma. A multicomponent model of patient and disease characteristics was associated with this unrealistic expectation. These findings indicate that clinicians can intervene in diverse areas to foster realistic expectations of treatment outcomes among asthma patients.     

Randomized Controlled Trial to Treat Benign Prostatic Hyperplasia with Overactive Bladder Using an Alpha‐blocker Combined with Anticholinergics

Objectives: TAABO was a randomized, controlled trial to evaluate the efficacy and safety of combination therapy of tamsulosin (TAM) with propiverine (PROP) in men with both benign prostatic hyperplasia and overactive bladder. Methods: It enrolled men 50 years or older who had an international prostate symptom score (IPSS) of 8 or higher, an urgency item score of 1 or higher, and a quality of life (QOL) score of 2 or higher. After 8 weeks of TAM 0.2 mg/day, patients who met the inclusion criteria (8 micturitions per 24 h and 1 urgency per 24 h, evaluated by bladder diary) and were eligible for 12‐weeks of continued Treatment II. Five hundred and fifteen patients were enrolled. Thereafter, 214 patients were assigned randomly to receive either TAM alone (n = 67), TAM plus PROP 10 mg (n = 72), or TAM plus PROP 20 mg (n = 75) in Treatment II. The primary efficacy end point was a change in micturitions per 24 h documented in the bladder diary. The change from baseline in urgency episodes per 24 h, IPSS, IPSS/QOL subscore, urinary flow rate and postvoid residual volume were assessed as secondary efficacy measures. Results: A total of 141 men (47 TAM, 49 TAM plus PROP 10 mg, and 45 TAM plus PROP 20 mg patients) were assessed by week 12. Compared with the TAM, TAM plus PROP 10 mg patients experienced significantly fewer micturitions (P = 0.0261), urgencies (P = 0.0093) per 24 h, lower IPSS storage (P = 0.0465), and IPSS urgency (P = 0.0252) subscores. Conclusions: These results suggest that combining TAM and 10 mg of PROP for 12 weeks provides added benefit for men with both benign prostatic hyperplasia and overactive bladder.     

Effect of ferulic acid and Angelica archangelica extract on behavioral and psychological symptoms of dementia in frontotemporal lobar degeneration and dementia with Lewy bodies

Aim: The behavioral and psychological symptoms of dementia place a heavy burden on caregivers. Antipsychotic drugs, though used to reduce the symptoms, frequently decrease patients' activities of daily living and reduce their quality of life. Recently, it was suggested that ferulic acid is an effective treatment for behavioral and psychological symptoms. We have also reported several patients with dementia with Lewy bodies showing good responses to ferulic acid and Angelica archangelica extract (Feru‐guard). The present study investigated the efficacy of Feru‐guard in the treatment of behavioral and psychological symptoms in frontotemporal lobar degeneration and dementia with Lewy bodies. Methods: We designed a prospective, open‐label trial of daily Feru‐guard (3.0 g/day) lasting 4 weeks in 20 patients with frontotemporal lobar degeneration or dementia with Lewy bodies. Behavioral and psychological symptoms of dementia were assessed at baseline and 4 weeks after the start of treatment, using the Neuropsychiatric Inventory. The Neuropsychiatric Inventory scores were analyzed using the Wilcoxon rank sum test. Results: Treatment with Feru‐guard led to decreased scores on the Neuropsychiatric Inventory in 19 of 20 patients and significantly decreased the score overall. The treatment also led to significantly reduced subscale scores on the Neuropsychiatric Inventory (“delusions”, “hallucinations”, “agitation/aggression”, “anxiety”, “apathy/indifference”, “irritability/lability” and “aberrant behavior”). There were no adverse effects or significant changes in physical findings or laboratory data. Conclusion: Feru‐guard may be effective and valuable for treating the behavioral and psychological symptoms of dementia in frontotemporal lobar degeneration and dementia with Lewy bodies. Geriatr Gerontol Int 2011; 11: 309–314.     

Quality of life in adolescents with hepatitis C treated with sofosbuvir and ribavirin

Chronic HCV infection has been associated with impairment of HRQL in both adults and paediatric patients. Our aim was to assess the HRQL of HCV‐positive children treated with SOF + RBV. The data for this post hoc analysis were collected in a phase 2 open‐label multinational study that evaluated safety and efficacy of SOF (400 mg/day) plus RBV (weight‐based up to 1400 mg/day) for 12 or 24 weeks in adolescents with chronic HCV (GS‐US‐334‐1112). Patients and their parents/guardians completed the PedsQL‐4.0‐SF‐15 questionnaire at baseline, at the end of treatment and in post‐treatment follow‐up. We included 50 adolescents with HCV genotype 2 and 3 without cirrhosis (14.8 ± 1.9 years; male: 58%; treatment‐naïve: 82%; vertically transmitted HCV: 70%). After treatment, 100% of patients with HCV genotype 2 and 95% with genotype 3 achieved SVR‐12. During treatment with SOF + RBV, there were no significant decrements in any of patients’ self‐reported or parent‐proxy‐reported PRO scores regardless of treatment duration (all P > .05). After treatment cessation, we recorded a statistically significant improvement in patients’ self‐reported Social Functioning score by post‐treatment week 12: on average, +4.8 points on a 0‐100 scale (P = .02). By post‐treatment week 24, parent‐proxy‐reported School Functioning score increased by, on average, +13.0 points (P = .0065). In multivariate analysis, history of abdominal pain and psychiatric disorders were predictive of impaired HRQL in adolescents with HCV (P < .05). Adolescents with HCV do not seem to experience any HRQL decrement during treatment with SOF + RBV and experience some improvement of their HRQL scores after achieving SVR.     

Asthma Severity: The Patient's Perspective

Background: Although asthma is a common condition, limited epidemiological data exists on the distribution or course of asthma severity. We know even less about how patients or parents rate the severity of their or their child's asthma or what factors they associate with more severe asthma. A large nationally diverse sample of asthma patients' self‐assessment of severity is available but has not been analyzed to look at asthma severity from the patients' perspective. Method: Data from the “household” and “event” files from the 1999 Medical Expenditure Panel Survey were combined to obtain a distribution of patient‐reported asthma severity and the health care utilization, medication usage, and personal characteristics associated with different levels of self‐reported severity for that subgroup that answered the chronic disease portion of the survey. Results: Almost two thirds of patients (63% of adults) or parents (65% of children) described their or their child's asthma as very or somewhat serious. Among both children and adults, more severe asthma was associated with greater numbers of missed school and workdays, and lower overall health status. The associated differences in health utilization varied by age. Models of severity based on available NAEPP criteria explained less than 10% of the participant's variation in self‐reported asthma severity. Conclusion: Parents and patients with asthma appear to use different metrics than physicians and researchers to define the more severe categories of asthma. This disparity suggests the need for an asthma measure that is more widely understood, and accepted by patients and clinicians to serve as a tool to improve asthma‐related communications and the achievement of mutually determined therapy goals.     

Conversion to Silodosin in Men on Conventional α1‐Blockers for Symptomatic Benign Prostatic Hyperplasia

Objectives: α₁‐blockers have commonly been used as first‐line medical therapy for symptomatic benign prostatic hyperplasia (BPH). Recently, a highly selective α_1A‐adrenoceptor antagonist, silodosin, was developed in Japan. We examined the efficacy and safety of conversion from conventional α₁‐blockers to silodosin in men with BPH. Methods: Conversion to silodosin was proposed to consecutive patients on conventional α₁‐blockers for symptomatic BPH for at least 6 months. The effects of conversion were examined by the International Prostate Symptom Score, quality of life index, overactive bladder symptom score, peak flow rate, residual urine volume, and adverse events at 12 weeks. The efficacy of silodosin was also evaluated by patients' impression. Results: Eighty‐one men underwent conversion, for the most part because of dissatisfaction with the efficacy of their current treatment in improving nocturia or weak stream. The International Prostate Symptom Score total score significantly improved from 12.7 ± 5.9 at baseline to 10.6 ± 5.4 at 4 weeks (P < 0.001) and 10.9 ± 5.8 at 12 weeks (P < 0.01). The progress was mostly due to improvement in voiding symptoms, although reduction of storage symptoms was also significant. The quality of life index also significantly decreased with conversion to silodosin. Efficacy as judged by patients' impression was 76% (37/49) at 12 weeks of treatment. None of the overactive bladder symptom score, peak flow rate, and residual urine volume exhibited significant change. No serious adverse events were observed during the study period. Conclusion: Conversion to silodosin may be beneficial in men who are dissatisfied with conventional α₁‐blockers for BPH, and be particularly useful in improving voiding symptoms.     

Validation of the revised international prognostic score of thrombosis for essential thrombocythemia (IPSET‐thrombosis) in 585 Mayo clinic patients

The primary objective of treatment in essential thrombocythemia (ET) is to prevent thromboembolic complications. In this regard, advanced age and thrombosis history have long distinguished “low” from “high” risk patients. More recently, JAK2V617F and cardiovascular (CV) risk factors were identified as additional modifiers, leading to the development of a 3‐tiered International Prognostic Score of Thrombosis for ET (IPSET‐thrombosis): “low,” “intermediate,” and “high”. The international data set used to develop IPSET‐thrombosis was recently re‐analyzed in order to quantify the additional pro‐thrombotic effect of JAK2V617F and CV risk factors in specific risk subcategories. The revised IPSET‐thrombosis identified four risk categories based on three adverse variables (thrombosis history, age >60 years and JAK2V617F): very low (no adverse features), low (presence of JAK2V617F), intermediate (age >60 years) and high (presence of thrombosis history or presence of both advanced age and JAK2V617F). In this study of 585 patients with ET (median age 68 years; 61% female), we validated the revised IPSET‐thrombosis by confirming significant differences in thrombosis risk between “very low” and “low” (HR 2.4, 95% CI 1.1 ? 5.3) and between “intermediate” and “high” (HR 2.3, 95% CI 1.1 ? 5.2) risk patients. Furthermore, in multivariable analysis, only JAK2V617F (HR=1.8, CI= 1.07 ? 2.94) and history of thrombosis (HR=2.1, CI= 1.20 ? 3.58) were independently predictive of future thrombotic events. The revised IPSET‐thrombosis needs confirmation in prospective studies, especially in terms of risk‐adapted therapy that includes the need for aspirin therapy in very low risk, twice‐daily aspirin therapy for low risk and cytoreductive therapy for low or intermediate risk patients. Am. J. Hematol. 91:390–394, 2016. © 2016 Wiley Periodicals, Inc.     

Breast Cancer Treatment Decision-Making: Are We Asking Too Much of Patients?

OBJECTIVE

Physicians are mandated to offer treatment choices to patients, yet not all patients may want the responsibility that entails. We evaluated predisposing factors for, and long-term consequences of, too much and not enough perceived decision-making responsibility among breast cancer patients.

DESIGN

Longitudinal assessment, with measurements collected just after surgical treatment (baseline) and 6-month follow-up.

PARTICIPANTS

Women with early-stage breast cancer treated surgically at eight NYC hospitals, recruited for a randomized controlled trial of patient assistance to improve receipt of adjuvant treatment.

MEASUREMENTS

Using logistic regression, we explored multivariable-adjusted associations between perceived treatment decision-making responsibility and a) baseline knowledge of treatment benefit and b) 6-month decision regret.

RESULTS

Of 368 women aged 28–89 years, 72 % reported a “reasonable amount”, 21 % “too much”, and 7 % “not enough” responsibility for treatment decision-making at baseline. Health literacy problems were most common among those with “not enough” (68 %) and “too much” responsibility (62 %). Only 29 % of women had knowledge of treatment benefits; 40 % experienced 6-month decision regret. In multivariable analysis, women reporting “too much” vs. “reasonable amount” of responsibility had less treatment knowledge ([OR] = 0.44, [95 % CI] = 0.20–0.99; model c?=?0.7343;p?<?0.01) and more decision regret ([OR] = 2.,91 [95 % CI] = 1.40–6.06; model c?=?0.7937;p?<?0.001). Findings were similar for women reporting “not enough” responsibility, though not statistically significant.

CONCLUSION

Too much perceived responsibility for breast cancer treatment decisions was associated with poor baseline treatment knowledge and 6-month decision regret. Health literacy problems were common, suggesting that health care professionals find alternative ways to communicate with low health literacy patients, enabling them to assume the desired amount of decision-making responsibility, thereby reducing decision regret.     

Quality of life after islet transplantation: data from the GRAGIL 1 and 2 trials

Background Rigorous assessment of health‐related quality of life (HRQL) is mandatory to establish the benefits of islet transplantation. Methods The 36‐Item Short Form Health Survey (SF‐36) and the Diabetes Quality of Life (DQOL) scales were completed by patients included in an Islet Transplantation Alone (ITA) trial (n = 10) and an Islet After Kidney (IAK) trial (n = 10). Results The two populations differed by HRQL scores at baseline, with poorer scores in ITA patients. SF‐36 scores for physical limitations, bodily pain, general health perception, social functioning, and health transition improved significantly in ITA patients 6 and 12 months post transplantation. The DQOL global score was significantly improved at 6 months and remained so at 12 months, because of a significant improvement in the dimensions of satisfaction and impact of diabetes. No improvement was observed in the IAK patients. Conclusion HRQL assessment may help in the selection of candidates with brittle diabetes for islet transplantation.     

What outcomes from pharmacologic treatments are important to people with rheumatoid arthritis? Creating the basis of a patient core set

Objective

Function, patient global assessment, and pain are routinely measured in rheumatoid arthritis (RA) clinical trials. However, other patient‐reported outcomes identified as important to patients in qualitative studies, such as fatigue and quality of life, are commonly not included, and modern treatment regimens may have changed patients' expectations of treatment outcomes. Our objective was to elicit patient priority treatment outcomes for pharmacologic interventions since the common use of anti–tumor necrosis factor (anti‐TNF) therapy, which will form the basis of a core set of patient priorities to complement existing professional core sets.

Methods

In‐depth interviews were conducted with 23 RA patients, purposively sampled for age, sex, medication (anti‐TNF or other disease‐modifying antirheumatic drugs), disease severity, and work status. Grounded theory guided iterative data collection and analysis. Coding of the data was peer reviewed. A patient research partner collaborated in the research design and analysis.

Results

Sixty‐three different outcomes important to patients were generated from the interviews. Four major categories of patient outcomes from pharmacologic treatments were developed: “RA under control,” “Doing things,” “Emotional health,” and “Coping with illness.” The core category (or overall theme) was “Minimizing the personal impact of RA.”

Conclusion

Although the routine outcomes of pain, function, and overall well‐being were raised by the patients, they also generated a further 60 important outcomes that they look for from treatment. This difference in perspective may potentially influence treatment decisions. The next step is therefore to use these data to develop a patient core set.