Patients' Perspectives on the Usability of a Mobile App for Self-Management following Spinal Cord Injury.

With decreasing inpatient lengths of stay following spinal cord injury (SCI), newly injured patients may be discharged into the community without the self-management skills needed to prevent secondary conditions. A mobile app was developed to facilitate self-management skills following SCI in the inpatient rehabilitation and early community settings. The objective of this study was to explore patients' perspectives on the usability of this self-management app. A mixed-methods study design was implemented. The app was trialed at a local rehabilitation centre with 20 inpatient participants who experienced a SCI. They received mobile app training sessions throughout their inpatient rehabilitation. A thematic analysis was performed on qualitative data from post-discharge exit questionnaires and researchers' field notes. Quantitative data (in the form of participants' tool usage data and self-reported system usability scale scores) were collected at discharge and 3 months post-discharge. Three main themes emerged from the qualitative analysis: (1) being accessible to users (i.e., being easy to adopt and compatible with assistive technologies), (2) being intuitive to navigate (i.e., incorporating a simple app layout and a system of alert notifications), and (3) offering users flexibility (i.e., providing users with control over their data). The mobile app received above average mean system usability scale scores, both at discharge (78.1/100) and 3 months post-discharge (71.6/100). Given that participants found the app acceptable for use in inpatient rehabilitation and following discharge into the community, further testing is warranted to explore its efficacy in preventing secondary complications.

Development of a Self-Management App for People with Spinal Cord Injury.

With decreasing inpatient rehabilitation lengths of stay, there may be a greater risk of spinal cord injury (SCI) populations being discharged into the community without the self-management skills needed to prevent secondary complications. Recent advancements in mobile health has made mobile apps a feasible method of delivering population-based, self-management interventions to address SCI-specific secondary complications. The objective of this study is to describe stakeholder perspectives on the development of a functional mobile app to facilitate self-management skills needed to prevent secondary complications following recent SCI during inpatient rehabilitation. A user-centered design approach was used that involved an evolving mobile app and the collection of prospective qualitative data. Stakeholders from three groups were enrolled in the study: individuals admitted for rehabilitation following SCI (n = 20) and informal (n = 7) and formal (n = 48) caregivers. Iterative feedback was gathered from rehabilitation inpatients during ongoing interactions and via post-discharge exit questionnaires, from informal caregivers via one-on-one interviews, and from formal caregivers via series of focus groups at various phases throughout the design process. Three main themes emerged from the analysis: (1) being individualized and user friendly (i.e., developing an app that is simple and easy to use to facilitate universal uptake), (2) targeting goals to promote self-management (i.e., adopting self-management skills relative to personal goals and confidence), and (3) increasing participation and support-seeking to facilitate lifestyle change (i.e., encouraging leisure activities to facilitate community integration). Key stakeholder perspectives contributed to the development of a self-management mobile app that will be evaluated in future research.

A Randomized Controlled Effectiveness Trial for PSA Screening Decision Support Interventions in Two Primary Care Settings.

BACKGROUND: Decision support interventions (DESIs) provide a mechanism to translate comparative effectiveness research results into clinical care so that patients are able to make informed decisions. Patient decision support interventions for prostate-specific antigen (PSA) have been shown to promote informed decision making and reduce PSA testing in efficacy trials, but their impact in real world settings is not clear. OBJECTIVE: We performed an effectiveness trial of PSA decision support interventions in primary care. DESIGN: A randomized controlled trial of three distribution strategies was compared to a control. PARTICIPANTS: Participants included 2,550 men eligible for PSA testing (76.6 % of the eligible population) and 2001 survey respondents (60.1 % survey response rate). INTERVENTIONS: The intervention groups were: 1) mailed the DESI in DVD format, 2) offered a shared medical appointment (SMA) to view the DESI with other men and discuss, and 3) both options. MAIN MEASURES: We measured PSA testing identified via electronic medical record at 12 months and DESI use by self-report 4 months after the intervention mailing. KEY RESULTS: We found no differences in PSA testing across the three distribution strategies over a year-long follow-up period: 21 %, 24 %, 22 % in the DESI, SMA, and combined group respectively, compared to 21 % in the control group (p = 0.51). Self-reported DESI use was low across all strategies at 4 months: 16 % in the mailed DESI group, 6 % in the SMA group, and 15 % in the combined group (p = < 0.0001). CONCLUSIONS: Mailing PSA decision support interventions or inviting men to shared medical appointments unrelated to a primary care office visit do not appear to promote informed decision making, or change PSA testing behavior.

Expectations of a Health-Related Mobile Self-Management App Intervention Among Individuals With Spinal Cord Injury.

Background: Our research team developed a mobile application (app) to facilitate health-related self-management behaviors for secondary conditions among individuals with spinal cord injury (SCI). To facilitate mobile app adoption and ongoing use into the community, it is important to understand potential users' expectations and needs. Objectives: The primary objective of this study was to explore user expectations of a mobile app intervention designed to facilitate self-management behavior among individuals with SCI. Methods: Data were collected via one-on-one, semi-structured interviews with a subsample of 20 community-dwelling participants enrolled in a larger, clinical trial. Analysis of the transcripts was undertaken using a six-phase process of thematic analysis. Results: Our analysis identified three main themes for expectations of the mobile app intervention. The first theme, desiring better health outcomes, identified participants' expectation of being able to improve their psychological, behavioral, and physical health outcomes and reduce associated secondary conditions. The second theme, wanting to learn about the mobile app's potential, identified participants' interest in exploring the functionality of the app and its ability to promote new experiences in health management. The third theme, desiring greater personal autonomy and social participation, identified participants' desire to improve their understanding of their health and the expectation for the app to facilitate social engagement with others in the community. Conclusion: By exploring end-users' expectations, these findings may have short-term effects on improving continued mobile health app use among SCI populations and long-term effects on informing future development of mobile app interventions among chronic disease populations.

The Use and Effect of the Health Storylines mHealth App on Female Childhood Cancer Survivors' Self-efficacy, Health-Related Quality of Life and Perceived Illness.

BACKGROUND: mHealth apps have been not been well tested among childhood cancer survivors (CCSs) to track physical and psychosocial functioning for improved self-management of post-treatment needs. OBJECTIVES: This pilot study had 3 aims: (1) assess the usage of the Health Storylines mHealth app; (2) examine its effect in improving self-efficacy in managing survivorship healthcare needs, health-related quality of life, and perceived illness; and (3) determine if app usage moderated the effects on the above patient-reported outcome measures among female CCSs. METHODS: Study participants accessed the Health Storylines mHealth app on their own personal device. This single-group, pilot study included 3 measurement points: baseline and 3 and 6 months after initiation of using the app. RESULTS: Use of the mHealth app ranged from 0 times to 902 times. Every study participant who used the app (n = 26) also used the mental health app component of the Health Storylines app. Generalized estimating equations were fit to examine the effect of the mHealth app use on self-efficacy, perceived illness, and health-related quality of life, between baseline, 3-month follow-up, and 6-month follow-up. No statistically significant changes were evident, on average, from baseline to 3- or 6-month follow-up on any outcome. Subsequent testing of effect moderation showed differential trends for high versus low users. CONCLUSIONS: Studies are needed among this clinical population to determine who will benefit and who will perceive the app as a useful aspect of their survivorship care. IMPLICATIONS FOR PRACTICE: Sharing mental health functioning tracked on mhealth apps with healthcare providers may inform needed interventions for young adult female CCSs.

Implementing a self-management mobile app for spinal cord injury during inpatient rehabilitation and following community discharge: A feasibility study.

Objective: To determine the feasibility of implementing and evaluating a self-management mobile app for spinal cord injury (SCI) during inpatient rehabilitation and following community discharge. Design: Pilot feasibility study. Setting: Rehabilitation hospital and community. Participants: Inpatients from rehabilitation hospital following admission for their first SCI. Intervention: A mobile app was developed to facilitate self-management following SCI. The app consisted of 18 tools focusing on goal setting, tracking various health aspects, and identifying confidence regarding components of self-management. In-person training and follow-up sessions were conducted during inpatient rehabilitation and follow-up calls were provided after participants were discharged into the community. Main outcome measures: Participants completed outcome measures at baseline, community discharge, and 3-months post discharge. This study focused on feasibility indicators including recruitment, retention, respondent characteristics, adherence, and app usage. Additionally, participants' self-management confidence relating to SCI (e.g. medication, skin, bladder, pain) was evaluated over time. Results: Twenty participants (median age 39, IQR: 31 years, 85% male) enrolled in the study. Participants' Spinal Cord Injury Independence Measure (SCIM-III) median score was 23 and IQR was 33 (range: 7-84), which did not correlate with app usage. Retention from admission to discharge was 85% and 70% from discharge to 3-months post discharge. Individuals in the study who used the app entered data an average of 1.7x/day in rehabilitation (n = 17), and 0.5x/day in the community (n = 7). Participants' bowel self-management confidence improved between admission and discharge (P < 0.01). Conclusions: Feasibility indicators support a larger clinical trial during inpatient rehabilitation; however, there were challenges with retention and adherence following community discharge.

Use of second look nephroscopy in children undergoing percutaneous nephrolithotomy.

PURPOSE: We determined the rate of stone clearance in children following percutaneous nephrolithotomy, endoscopic assessment of residual stone and the judicious use of second look nephroscopy. MATERIALS AND METHODS: We retrospectively reviewed the charts of all children undergoing percutaneous nephrolithotomy from 1996 to 2007. Cases were reviewed for pertinent details including preoperative and postoperative imaging, specifics of the procedure and followup. On completion of percutaneous nephrolithotomy the collecting system was assessed via combined nephrostogram and direct nephroscopy. If the collecting system could not be completely visualized or all stone fragments could not be cleared, the patient was referred for second look nephroscopy. Any residual stone present on initial followup imaging constituted a treatment failure. RESULTS: A total of 24 patients underwent percutaneous nephrolithotomy for 30 separate renal calculi. Mean patient age was 9.6 years, and mean stone burden was 2.53 cm. The success rate for percutaneous nephrolithotomy (inclusive of second look nephroscopy) was 87%. Of 30 cases 16 were managed by second look nephroscopy, with findings of residual fragments in all 16. Treatment failure was noted in 1 patient without second look nephroscopy and in 3 patients with second look nephroscopy. Of the 4 patients with treatment failure all were eventually rendered stone-free. CONCLUSIONS: Second look nephroscopy based on endoscopic findings during initial percutaneous nephrolithotomy is a reliable method of detecting and clearing residual stone fragments. Using such a protocol we achieved a high success rate of stone clearance in a population of patients with a significant stone burden.

Long-term outcomes of Gamma Knife radiosurgery for classic trigeminal neuralgia: implications of treatment and critical review of the literature. Clinical article.

OBJECT: Few long-term studies of Gamma Knife surgery (GKS) for trigeminal neuralgia (TN) exist. The authors report their long-term experience with the use of GKS in a previously reported cohort of patients with TN that has now been followed since 1996. METHODS: One hundred twelve patients with TN were treated with GKS at the University of Maryland between June 1996 and July 2001. Of these, 67% had no invasive operations for TN prior to GKS, 13% had 1, 4% had 2, and 16% had >or= 3. The right side was affected in 56% of cases, predominantly involving V2 (26%), V3 (24%), or a combination of both (18%) branches. The median age at diagnosis was 56 years, and median age at GKS was 64 years. The median prescription dose of 75 Gy (range 70-80 Gy) was delivered to the involved trigeminal nerve root entry zone. The authors assessed the degree of pain before and after GKS by using the Barrow Neurological Institute (BNI) pain scale. RESULTS: In total, 102 patients took the survey at least once, for a response rate of 91%. Although not found to alter the conclusions of this study, 7 cases of atypical TN were found and these patients were removed, for a total of 95 cases herein analyzed. The median follow-up was 5.6 years (range 13-115 months). Before GKS, 88% of patients categorized their pain as BNI IV or V (inadequate control or severe pain on medication), whereas the remainder described their pain as BNI III (some pain, but controlled on medication). After GKS, 64% reported a BNI score of I (no pain, no medications), 5% had BNI II (no pain, still on medication), 12% had BNI III, and 19% reported a BNI score of IV or V. The median time to response was 2 weeks (range 0-12 weeks) and the median response duration was 32 months (range 0-112 months). Eighty-one percent reported initial pain relief, and actuarial rates of freedom from treatment failure at 1, 3, 5, and 7 years were 60, 41, 34, and 22%, respectively. Response duration was significantly better for those who had no prior invasive treatment versus those in whom a previous surgical intervention had failed (32 vs 21 months, p < 0.02). New bothersome facial numbness was reported in 6% of cases. CONCLUSIONS: This study represents one of the longest reported median follow-up periods and actuarial results for a cohort of patients with classic TN treated with GKS. Although GKS achieves excellent rates of initial pain relief, these results suggest a steady rate of late failure, particularly among patients who had undergone prior invasive surgical treatment. Despite a higher than expected recurrence rate, GKS remains a viable treatment option, particularly for patients who have had no prior invasive procedures. Patients with recurrences can still be offered salvage therapy with either repeat GKS, microvascular decompression, or rhizotomy.

Living With Neuroendocrine Tumors: Assessment of Quality of Life Through a Mobile Application.

PURPOSE: To understand the quality of life (QoL) for patients with neuroendocrine tumors (NETs) through comparison of QoL questionnaires and symptom tracking as well as journaling via the Carcinoid NETs Health Storylines mobile application (app). PATIENTS AND METHODS: This was a 12-week prospective, observational study of US patients with NET who were taking long-acting somatostatin analogs. National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) and European Organisation for Research and Treatment of Cancer (EORTC) questionnaires were administered three times. Patients also monitored symptoms, mood, bowel movements, food, activity, and sleep, and they journaled in their app, which was coded by theme and sentiment for qualitative analysis. RESULTS: Of the 120 patients with NET, 78% were women (mean age, 57 years); 76% had gastroenteropancreatic NETs, and 88% had metastases. Lanreotide depot and octreotide long-acting release (LAR) were used by 41% and 59%, respectively. The most common symptoms at baseline were fatigue (76.7%), diarrhea (62.5%), abdominal discomfort (64.1%), and trouble sleeping (57.5%). The majority completed five of six survey assessments (median, 5; mean, 5.1) and tracked four symptoms in the app (median, 4; mean, 5.5); the average frequency was 41.6 days for each symptom (median, 43; mean, 41.6; range, 1 to 84 days [12 weeks]). Without treatment change, most EORTC-assessed physical symptoms decreased from baseline to midpoint (eg, 59.3% at baseline v 33% at midpoint reported "quite a bit" or "very much" diarrhea; P = .002). App-based symptom tracking revealed large day-to-day variation, but weekly averages correlated well with survey scores. Journal entries showed that more patients made predominantly negative unsolicited entries about their injection experience with octreotide LAR compared with lanreotide (13 of 17 v two of 13; P < .001). CONCLUSION: Patients with NET experience a large symptom burden that varies daily. A decrease in physical symptoms on QoL surveys suggests an effect from daily app-based monitoring or journaling, which may reduce recall bias and benefit the patient's experience of symptoms.

Preferences of older and younger adults with serious mental illness for involvement in decision-making in medical and psychiatric settings.

OBJECTIVES: There is a growing call for greater consumer participation in health care encounters. Prior research suggests that older age is associated with a greater preference for a more passive role in clinical decision-making, yet little is known about preferences for persons with mental illness. This pilot study compared preferences for involvement in decision-making between older and younger adults with serious mental illness. DESIGN: Cross-sectional observational survey. PARTICIPANTS: The authors surveyed 33 older adults (>or=50 years) and 32 younger adults (<50 years) with serious mental illness from two mental health center clinics and one residential facility for their preferences on decision-making with their psychiatrists and primary care providers. MEASUREMENTS: Measures included the Control Preferences Scale, the Autonomy Preference Index, and the Decision Self-Efficacy Scale. RESULTS: Contrary to our primary hypothesis, older adults reported a stronger desire for involvement in decision-making compared with younger adults. However, both age groups were similar in their desire for information to aid in decision-making. The majority in both age groups also preferred a collaborative role with a psychiatrist for medication decisions, an autonomous role for decisions related to psychosocial interventions, and a passive role with their primary care provider. Older and younger adults expressed similar decision self-efficacy. CONCLUSION: Our study suggests that older persons with serious mental illness have a stronger desire for involvement in decision-making than younger consumers. Additionally, role preference for involvement in decision-making varies across different clinical decisions and for psychopharmacological versus psychosocial interventions.

Improving Self-Management Skills Among People With Spinal Cord Injury: Protocol for a Mixed-Methods Study.

BACKGROUND: Most people with spinal cord injury will develop secondary complications with potentially devastating consequences. Self-management is a key prevention strategy for averting the development of secondary complications and their recurrence. Several studies have shown that self-management programs improve self-management behaviors and health outcomes in individuals living with chronic conditions such as asthma, diabetes, hypertension, and arthritis. Given the burgeoning health care costs related to secondary complications, we developed an alternative electronic health-based implementation to facilitate the development of self-management skills among people with spinal cord injury. OBJECTIVE: This study aims to evaluate the efficacy of a self-management app in spinal cord injury populations. The primary outcome is attainment of self-selected, self-management goals. Secondary outcomes include increases in general and self-management self-efficacy and reductions in self-reported health events, health care utilization, and secondary complications related to spinal cord injury. This study also aims to explore how the intervention was implemented and how the app was experienced by end users. METHODS: This study will employ a mix of qualitative and quantitative methods. The quantitative portion of our study will involve a rater-blinded, randomized controlled trial with a stepped wedge design (ie, delayed intervention control group). The primary outcome is successful goal attainment, and secondary outcomes include increases in self-efficacy and reductions in self-reported health events, health care utilization, and secondary conditions related to spinal cord injury. The qualitative portion will consist of semistructured interviews with a subsample of the participants. RESULTS: We expect that the mobile self-management app will help people with spinal cord injury to attain their self-management goals, improve their self-efficacy, reduce secondary complications, and decrease health care utilization. CONCLUSIONS: If the results are positive, this study will produce credible new knowledge describing multiple outcomes that people with spinal cord injury realize from an app-based self-management intervention and support its implementation in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03140501; http://clinicaltrials.gov/ct2/show/NCT03140501 (Archived by WebCite at http://www.webcitation.org/73Gw0ZlWZ). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/11069.

Shared decision-making preferences of people with severe mental illness.

OBJECTIVE: Perceived roles and preferences were explored for shared decision making among persons with severe mental illnesses. METHODS: In this pilot study, 30 adult clients with severe mental illness in a community mental health center were surveyed about decision making regarding psychiatric medications, rehabilitation, and general medical care. RESULTS: Clients generally expressed a desire for greater participation in decisions about psychiatric care than they currently experienced. Regarding use of new psychiatric medications, 23 persons (77%) preferred autonomous or shared roles, but only 11 (37%) rated their current roles as more than passive (z=-2.83, p=.005). Clients were less likely to prefer a passive role in medication decisions about psychiatric care than about general medical care (seven persons, or 23%, versus 23 persons, or 77%; z=-3.01, p=.003). CONCLUSIONS: Most clients with severe mental illnesses prefer shared decision making, particularly in relation to their mental health care.

Characterizing Smartphone Engagement for Schizophrenia: Results of a Naturalist Mobile Health Study.

INTRODUCTION: Despite growing interest in smartphone apps for schizophrenia, little is known about how these apps are utilized in the real world. Understanding how app users are engaging with these tools outside of the confines of traditional clinical studies offers an important information on who is most likely to use apps and what type of data they are willing to share. METHODS: The Schizophrenia and Related Disorders Alliance of America, in partnership with Self Care Catalyst, has created a smartphone app for schizophrenia that is free and publically available on both Apple iTunes and Google Android Play stores. We analyzed user engagement data from this app across its medication tracking, mood tracking, and symptom tracking features from August 16th 2015 to January 1st 2017 using the R programming language. We included all registered app users in our analysis with reported ages less than 100. RESULTS: We analyzed a total of 43,451 mood, medication and symptom entries from 622 registered users, and excluded a single patient with a reported age of 114. Seventy one percent of the 622 users tried the mood-tracking feature at least once, 49% the symptom tracking feature, and 36% the medication-tracking feature. The mean number of uses of the mood feature was two, the symptom feature 10, and the medication feature 14. However, a small subset of users were very engaged with the app and the top 10 users for each feature accounted for 35% or greater of all entries for that feature. We find that user engagement follows a power law distribution for each feature, and this fit was largely invariant when stratifying for age or gender. DISCUSSION: Engagement with this app for schizophrenia was overall low, but similar to prior naturalistic studies for mental health app use in other diseases. The low rate of engagement in naturalistic settings, compared to higher rates of use in clinical studies, suggests the importance of clinical involvement as one factor in driving engagement for mental health apps. Power law relationships suggest strongly skewed user engagement, with a small subset of users accounting for the majority of substantial engagements. There is a need for further research on app engagement in schizophrenia.

Cost-effectiveness considerations in the treatment of essential thrombocythemia.

Factors that influence the choice of anagrelide, hydroxyurea, or interferon-alfa (IFN-alpha) for treatment of essential thrombocythemia include efficacy, toxicity, and cost. Anagrelide has the US Food and Drug Administration's approval to be used for treating patients with thrombocythemia secondary to chronic myeloproliferative disorders. In contrast, the use of IFN-alpha and hydroxyurea are considered "off-label." We performed an incremental cost-effectiveness analysis to compare anagrelide, hydroxyurea, and IFN-alpha for treating essential thrombocythemia, in terms of estimated impact on life expectancy. The case used for this analysis was of a 40-year-old man with essential thrombocythemia. Clinical assumptions were based on information obtained from nonrandomized clinical trials, and the economic assumptions were derived from information abstracted from observational studies. Lifelong treatment use of anagrelide versus hydroxyurea would cost approximately $72,000 per additional year of life gained, while the use of IFN-alpha was found to be both more costly and less effective than anagrelide. The results were very sensitive to the risk of leukemia caused by hydroxyurea, with an incremental cost-effectiveness of anagrelide compared with hydroxyurea of $156,969 per additional year of life gained if the lifetime leukemia risk drops from a baseline of .08 to.05. Given that many commonly used medical interventions cost in the range of $50,000 to $100,000 per year of life gained, and the generally poor outcome associated with treatment-related leukemia that can result from hydroxyurea, anagrelide could be considered a therapeutic alternative that is clinically effective at an acceptable cost.

Use of erythropoietin in cancer patients: assessment of oncologists' practice patterns in the United States and other countries.

PURPOSE: To assess physician use of erythropoietin in cancer patients before publication of the American Society of Clinical Oncology/American Society of Hematology guidelines. METHODS: Questionnaires about erythropoietin use in practice and 12 hypothetical clinical scenarios involving patients with cancer were mailed to 2000 oncologists/hematologists in the United States and 19 other countries. Response rates were 30% in the United States and 25% internationally. Data on erythropoietin use for ovarian cancer were obtained from one clinical trial. Multivariate regression models assessed predictors of erythropoietin prescription. RESULTS: Most physicians selected a hemoglobin level < or =10 g/dL as an upper threshold for erythropoietin use (36% to 51% of U.S. physicians and 21% to 32% of foreign physicians). Frequent erythropoietin use (defined as use in at least 10% of cancer patients) was higher in the United States than elsewhere (adjusted odds ratio [OR] = 5.8; 95% confidence interval [CI]: 2.5 to 13.4). Among U.S. physicians, those who said they used erythropoietin frequently were more likely to be in fee-for-service than managed care settings (OR = 2.2; 95% CI: 1.3 to 3.7). Those who reported never using erythropoietin practiced in countries that had lower annual per capita health care expenditures, lower proportions of privately funded health care, and a national health service (P <0.05 for all comparisons). Of 235 ovarian cancer patients who received topotecan, 38% (45/118) of U.S. patients and 2% (2/117) of European patients who developed grade 1 anemia (hemoglobin level between 10 and 12 g/dL) were treated with erythropoietin (P <0.01). CONCLUSION: Financial considerations and a hemoglobin level <10 g/dL appear to influence erythropoietin use in the United States, whereas financial considerations alone determine erythropoietin use abroad.

Erythropoietin, uncertainty principle and cancer related anaemia.

BACKGROUND: This study was designed to evaluate if erythropoietin (EPO) is effective in the treatment of cancer related anemia, and if its effect remains unchanged when data are analyzed according to various clinical and methodological characteristics of the studies. We also wanted to demonstrate that cumulative meta-analysis (CMA) can be used to resolve uncertainty regarding clinical questions. METHODS: Systematic Review (SR) of the published literature on the role of EPO in cancer-related anemia. A cumulative meta-analysis (CMA) using a conservative approach was performed to determine the point in time when uncertainty about the effect of EPO on transfusion-related outcomes could be considered resolved. PARTICIPANTS: Patients included in randomized studies that compared EPO versus no therapy or placebo. MAIN OUTCOME MEASURES: Number of patients requiring transfusions. RESULTS: Nineteen trials were included. The pooled results indicated a significant effect of EPO in reducing the number of patients requiring transfusions [odds ratio (OR) = 0.41; 95%CI: 0.33 to 0.5; p < 0.00001;relative risk (RR) = 0.61; 95% CI: 0.54 to 0.68]. The results remain unchanged after the sensitivity analyses were performed according to the various clinical and methodological characteristics of the studies. The heterogeneity was less pronounced when OR was used instead of RR as the measure of the summary point estimate. Analysis according to OR was not heterogeneous, but the pooled RR was highly heterogeneous. A stepwise metaregression analysis did point to the possibility that treatment effect could have been exaggerated by inadequacy in allocation concealment and that larger treatment effects are seen at hb level > 11.5 g/dl. We identified 1995 as the point in time when a statistically significant effect of EPO was demonstrated and after which we considered that uncertainty about EPO efficacy was resolved. CONCLUSION: EPO is effective in the treatment of anemia in cancer patients. This could have already been known in 1995 if a CMA had been performed at that time.

G-CSF as prophylaxis of febrile neutropenia in SCLC.

OBJECTIVES: In 1991, small cell lung cancer (SCLC) was reported as the first tumour type where colony stimulating factor (CSF) support was clinically effective. We reviewed 13 health services research studies that addressed CSF use as supportive care for SCLC. METHODS: Findings from American Society of Clinical Oncology (ASCO) membership surveys, patterns of care studies, ASCO evidence-based guidelines and cost-effectiveness studies for CSF use were reviewed. RESULTS: For primary prophylaxis for SCLC, ASCO CSF clinical guidelines clearly do not support granulocyte (G)-CSF use. Cost-effectiveness models indicate that CSF use in this setting is associated with as much as US$1900 incremental patient care costs per cycle given an 18% febrile neutropenia rate. ASCO membership surveys found that < 10% of respondents supported CSF as primary prophylaxis while a patterns-of-care study found 55% use. In the secondary prophylaxis setting, ASCO CSF guidelines in 1994, 1996 and 1997 were equally supportive of CSF use versus dose reduction but dose-reduction was considered the preferred option in 2000. Over half of the ASCO member respondents in 1994 and in 1997 supported G-CSF use; cost-effectiveness models indicated that CSF use incurred an additional US$144 and 277 per cycle and the patterns of care study found 27% use of CSF in the community practice setting. CONCLUSIONS: In 2002, the findings of a decade of health services studies have shifted towards not being supportive of CSF use for primary or secondary prophylaxis for SCLC patients.

Functional assessment of accommodating intraocular lenses versus monofocal intraocular lenses in cataract surgery: metaanalysis.

PURPOSE: To compare accommodating intraocular lens (IOLs) and monofocal IOLs in restoring accommodation in cataract surgery. SETTING: Dartmouth Medical School and Department of Ophthalmology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA. METHODS: In this metaanalysis, 2 researchers independently extracted data, assessed trial quality, and contacted authors for missing information. Because of measurement-scale variations, outcomes were pooled for distance-corrected near visual acuity (DCNVA) as standardized mean differences with 95% confidence intervals [CIs] and anterior displacement of the lens as weighted mean differences (95% CI). RESULTS: The metaanalysis comprised 12 randomized controlled studies of 727 eyes. Based on 10 studies that compared DCNVA, accommodating IOLs were favored but failed the test of heterogeneity (I(2) = 94%). Pooling the 6 homogeneous trials (I(2) = 43%) showed no difference (standardized mean difference, -0.16; 95% CI, -0.56 to 0.25). Heterogeneity could not be explained by any characteristic of the study population or methodology. Based on 4 studies that evaluated pilocarpine-induced IOL shift, there was a significant anterior compared with the control (weighted mean difference, 95% CI, -0.36 - 0.47 to -0.24]), although the studies were heterogeneous (I(2) = 58%). Three of 5 studies mentioning posterior capsule opacification (PCO) reported increased rates in the accommodating IOL group postoperatively. CONCLUSIONS: There was no clear evidence of near acuity improvement despite statistically significant pilocarpine-induced anterior lens displacement. Further randomized controlled studies with standardized methods evaluating adverse effects (eg, PCO) are needed to clarify the tradeoffs.

Shared decision-making and evidence-based practice.

Shared decision-making refers to a process of health care delivery in which practitioners and clients seeking help for problems or disorders collaborate to access relevant information and to enable client-centered selection of health care resources. Though nearly all clients express a desire for more information, preferences for participation in health care decisions vary by individual and by illness. Two common strategies to promote shared decision-making are communication training for clients and clinicians, and decision aids to provide targeted information and values clarification. Research in several areas of medicine shows that active client participation results in a variety of benefits, from increased satisfaction to decreased symptom burden. Many current mental health interventions promote client-centered care, client choice, and self-directed care, but research on shared decision-making in mental health for clients with severe and persistent mental illness is just beginning.