Treatment Outcome Expectations Research Articles

Expectation of treatment outcomes in complete denture wearers.

Edentulism is a condition associated with age, and the outcome of prosthodontic treatment depends on a number of dental and nondental factors. In complete denture therapy, patient satisfaction is a key objective and various other variables affect this parameter. The ability to foresee its preferences may assist dentists in making informed treatment selections. The study purpose is to assess the expectations of treatment outcomes in complete denture users. For the study, all cases referred for total denture therapy during September 2020 and February 2021 were included. Both new and old denture users completed questionnaires on factors such as retention, mastication, phonetics, esthetics, and comfort. Excel was used to compile the data, which was then imported into SPSS for statistical analysis. The study's statistical significance level was established at P < 0.05. Male patients over the age of 60 years wearing dentures were very common. Denture wearers were highly prevalent in the age group of >60 years among male patients. Retention, esthetics, and phonetics are highly satisfied in existing denture wearers and mastication is highly satisfied in new denture wearers. The comfort factor is commonly satisfied in both the denture wearers. The results were statistically significant with a P = 0.05. Clinician can plan their treatments more effectively if they are aware of the treatment's expectations.

Federated Electronic Health Record Database via a Public-Private Partnership to Enhance Health Care Equity by Disparity Discovery and Equitable Clinical Trial Recruitment.

Despite increasingly stringent requirements from regulatory agencies, clinical trials often fail to recruit study populations representative of real-world demographics and disease prevalence and are often skewed away from racial/ethnic minorities. Consequently, data produced by such trials can result in treatment guidelines and outcome expectations that do not apply to racial/ethnic minorities, further widening health disparities. In this study, we describe a new tool, the TriNetX Diversity Lens ("Diversity Lens"), which augments the existing electronic health record querying functionality of TriNetX and allows clinical trial sponsors to rapidly evaluate the potential impact of inclusion and exclusion criteria on the eligibility rates of different racial and ethnic groups. We describe the development of Diversity Lens in collaboration with public and private stakeholders. Additionally, we feature examples of how Diversity Lens can bring to the surface insights into existing health disparities and prospectively explore the impact of study criteria on the eligibility of racial/ethnic minorities.

Preoperative flow analysis of arteriovenous malformations and obliteration response after stereotactic radiosurgery.

Morphological and angioarchitectural features of cerebral arteriovenous malformations (AVMs) have been widely described and associated with outcomes; however, few studies have conducted a quantitative analysis of AVM flow. The authors examined brain AVM flow and transit time on angiograms using direct visual analysis and a computer-based method and correlated these factors with the obliteration response after Gamma Knife radiosurgery. A retrospective analysis was conducted at a single institution using a prospective registry of patients managed from January 2013 to December 2019: 71 patients were analyzed using a visual method of flow determination and 38 were analyzed using a computer-based method. After comparison and validation of the two methods, obliteration response was correlated to flow analysis, demographic, angioarchitectural, and dosimetric data. The mean AVM volume was 3.84 cm3 (range 0.64-19.8 cm3), 32 AVMs (45%) were in critical functional locations, and the mean margin radiosurgical dose was 18.8 Gy (range 16-22 Gy). Twenty-seven AVMs (38%) were classified as high flow, 37 (52%) as moderate flow, and 7 (10%) as low flow. Complete obliteration was achieved in 44 patients (62%) at the time of the study; the mean time to obliteration was 28 months for low-flow, 34 months for moderate-flow, and 47 months for high-flow AVMs. Univariate and multivariate analyses of factors predicting obliteration included AVM nidus volume, age, and flow. Adverse radiation effects were identified in 5 patients (7%), and 67 patients (94%) remained free of any functional deterioration during follow-up. AVM flow analysis and categorization in terms of transit time are useful predictors of the probability of and the time to obliteration. The authors believe that a more quantitative understanding of flow can help to guide stereotactic radiosurgery treatment and set accurate outcome expectations.

The increased analgesic efficacy of cold therapy after an unsuccessful analgesic experience is associated with inferior parietal lobule activation

Prior experiences of successful and failed treatments are known to influence the efficacy of a newly applied treatment. However, whether that carry-over effect applies to non-pharmacological treatments is unknown. This study investigated how a failed treatment history with placebo analgesic cream affected the therapeutic outcomes of cold-pack treatment. The neural correlates underlying those effects were also explored using functional magnetic resonance imaging. The effect of the placebo analgesic cream was induced using placebo conditioning with small (44.5 °C to 43.7 °C, negative experience) and large (44.5 °C to 40.0 °C, positive experience) thermal stimuli changes. After the placebo conditioning, brain responses and self-reported evaluations of the effect of subsequent treatment with a cold-pack were contrasted between the two groups. The negative experience group reported less pain and lower anxiety scores in the cold-pack condition than the positive experience group and exhibited significantly greater activation in the right inferior parietal lobule (IPL), which is known to be involved in pain relief. These findings suggest that an unsatisfying experience with an initial pain-relief treatment could increase the expectations for the complementary treatment outcome and improve the analgesic effect of the subsequent treatment. The IPL could be associated with this expectation-induced pain relief process.

A qualitative exploration of cultural safety in nursing from the perspectives of Advanced Practice Nurses: meaning, barriers, and prospects

BackgroundCultural safety requires healthcare professionals and organisations to improve healthcare, facilitate patient access to healthcare, and achieve equity within the workforce.MethodsThis ethnomethodological study, which consisted of two phases, explored the concept of cultural safety from the perspective of Advanced Practice Nurses. Semi-structured interviews and the nominal group technique were used to prioritise challenges related to cultural safety, identify barriers to clinical practise and assess educational needs. The data collected was subjected to thematic analysis.ResultsNurses working in Austria, Germany and Switzerland were recruited (N = 29). Accordingly, the phenomenon of cultural safety in health care is not generally known and there is little prior knowledge about it. The most frequently discussed themes were communication difficulties, lack of knowledge, the treatment of people with insufficient language skills and expectations of treatment goals and outcomes, which can lead to conflicts and accusations of unequal treatment due to diverse cultural backgrounds.ConclusionDiverse cultures are encountered in German-speaking healthcare settings. Cultural safety is also about healthcare staff, as nurses with different socialisations encounter prejudice, discrimination and racism. Although the issue of power was not discussed, academic nurses were willing to make an effort to change. Only a minority were aware that lasting change requires challenging one’s own cultural structures and adapted behaviours, rather than pushing for the mere acquisition of cultural competence. Organisations were encouraged to introduce self-reflection sessions and provide better access to translation services to improve equity and support nurses.

What is success of treatment? Expected outcome scores in cervical radiculopathy patients were much higher than the previously reported cut-off values for success

PurposeTreatment success can be defined by asking a patient how they perceive their condition compared to prior to treatment, but it can also be defined by establishing success criteria in advance. We evaluated treatment outcome expectations in patients undergoing surgery or non-operative treatment for cervical radiculopathy.MethodsThe first 100 consecutive patients from an ongoing randomized controlled trial (NCT03674619) comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy were included. Patient-reported outcome measures and expected outcome and improvement were obtained before treatment. We compared these with previously published cut-off values for success. Arm pain, neck pain and headache were measured by a numeric rating scale. Neck disability index (NDI) was used to record pain-related disability. We applied Wilcoxon signed-rank test to compare the expected outcome scores for the two treatments.ResultsPatients reported mean NDI of 42.2 (95% CI 39.6–44.7) at baseline. The expected mean NDI one year after the treatment was 4 (95% CI 3.0–5.1). The expected mean reduction in NDI was 38.3 (95% CI 35.8–40.8). Calculated as a percentage change score, the patients expected a mean reduction of 91.2% (95% CI 89.2–93.2). Patient expectations were higher regarding surgical treatment for arm pain, neck pain and working ability, P < 0.001, but not for headache.ConclusionsThe expected improvement after treatment of cervical radiculopathy was much higher than the previously reported cut-off values for success. Patients with cervical radiculopathy had higher expectations to surgical treatment.

What Are Realistic Expectations to Become Free of Overactive Bladder Symptoms? Experience from Non-interventional Studies with Propiverine.

IntroductionUnmet expectations are a major cause of perceived treatment failure and discontinuation of treatment. To enable evidence-based counselling of patients on realistic expectations, we determined the chance of patients with overactive bladder becoming free of a given symptom upon treatment with a muscarinic antagonist in a non-interventional setting.MethodsTwo non-interventional studies included 1335 and 745 patients, respectively, who received 30 or 45 mg q.d. propiverine ER for 12 weeks. They were monitored for becoming free of urgency, urinary incontinence, frequency, or nocturia. Analyses were also performed in subgroups defined by basal symptom severity, age, and gender. Categorical data are shown as a percentage of the respective population. Continuous data are expressed as means or as median depending on whether the variability was considered to exhibit a normal distribution.ResultsThe probability of becoming symptom-free was largest for incontinence and frequency (about 50%), but lesser for urgency (about 20%) and nocturia (about 10%). Greater basal severity of a symptom reduced the chance to become free of that symptom upon treatment, but the chance to become free of incontinence and frequency was still considerable. Age and gender had only minor if any effects on the chance of becoming symptom-free. These findings are in line with those of a limited number of randomized controlled trials.ConclusionThese data provide an evidence base for the counselling of patients with overactive bladder on realistic expectations of treatment outcomes. We propose that realistic expectations can lead to greater long-term adherence.

Real-world disease-modifying therapy usage in persons with relapsing-remitting multiple sclerosis: Cross-sectional data from the Swiss Multiple Sclerosis Registry

IntroductionSeveral disease-modifying therapies (DMTs), covering a broad spectrum of mechanisms of action, have been approved by regulatory agencies for the treatment of relapsing-remitting multiple sclerosis (RRMS). However, only little is known about the current real-world treatment situation in Switzerland. Based on data from a diverse population of 668 persons with RRMS from the Swiss Multiple Sclerosis Registry (SMSR), the present study aims to fill this gap with a descriptive, cross-sectional approach. MethodsData originated from the SMSR baseline questionnaire and follow-up surveys. Data on current health status and life situation in the last 6 months were extracted from the survey distributed throughout 2020 and 2021, while data on disease-modifying therapy (DMT) histories were included from preceding surveys. Initially, data was stratified into three DMT groups according to the current DMT status (NO (No DMT), CONTINUED (DMT started more than 6 months ago), and NEW (DMT started less than 6 months ago)). In a subsequent analysis, the sample was stratified into groups corresponding to the five most frequently prescribed DMTs. Self-reported outcomes including therapy discontinuation or interruption, relapses and side-effects in the last 6 months were analyzed per group. Life and health situation parameters were also determined and analyzed. ResultsThe study population consisted of 445 (66.6%) individuals belonging to the CONTINUED, 84 (12.6%) to the NEW, and 139 (20.8%) to the NO group. Within the NO group, 24 (17.3%) reported relapses. Furthermore, self-reported relapses (28 (33.3%)), side-effects (39 (46.4%)), and treatment discontinuations or interruptions (30 (35.7%)) occurred more frequently in the NEW compared to the CONTINUED group (37 (8.3%), 125 (28.1%), 8 (1.8%), respectively). The three groups also differed with respect to age, time since diagnosis, number of symptoms, DMT history, and health-related quality of life. The five most frequently prescribed DMTs included fingolimod (33.4%), dimethyl fumarate (25.0%), ocrelizumab (23.6%), natalizumab (10.6%) and teriflunomide (7.5%). The frequency of self-reported relapses ranged from 9.7% to 13.6%. Notable differences were found in the number of self-reported side-effects, ranging from 9.1% with natalizumab to 56.7% with dimethyl fumarate. DiscussionThis cross-sectional analysis suggested that the majority of individuals with RRMS in Switzerland continuously receive tolerable DMT. However, groups not receiving DMT or struggling with side-effects or continued disease worsening while on DMT still persist. It is conceivable that the number of self-reported symptoms indicates the need for more detailed clarification of the DMT characteristics and expectations of treatment outcomes. Injectable DMTs no longer play a major role in the treatment of RRMS in Switzerland and a trend toward an early use of potent drugs is emerging.

"Extremely Painful, but Worth It": The Lived Experience of Receiving Collagenase as Treatment for Dupuytren Disease.

Collagenase injection is a relatively new, minimally invasive treatment option for Dupuytren disease. Most literature focusses on quantitative outcome measures, such as degree of residual contracture and recurrence. The patient experience of the treatment has rarely been explored. This study sought to explore patients' experiences of the treatment process, including their reasons for seeking and choosing the treatment. A qualitative descriptive design was used to explore patients' experiences. Seven patients (aged 57 to 81 years) who had received collagenase treatment for Dupuytren disease engaged in individual, semistructured interviews. Interviews were audio recorded, transcribed verbatim, and analyzed thematically. Thematic analysis revealed that Dupuytren disease was an obstacle to doing things, but not a barrier. Patients "went with the flow" of treatment, often taking a passive approach to their health care decisions. Patients found the collagenase injections to be extremely painful, but worth it. They had a varied knowledge of the disease and treatment. Patients were pleased with the results of the collagenase treatment, even if the finger was not completely straight or there was recurrence. The quick recovery and minimal complications were positive factors; however, the injections were extremely painful and could deter patients from future treatment. This research highlighted that a number of patients had low health literacy regarding their condition, and this affected their expectations of treatment outcomes and future treatment seeking. There are opportunities for health professionals to improve health literacy for people with Dupuytren disease, possibly in a group setting.

Expectations of treatment outcomes in patients with spinal metastases; what do we tell our patients? A qualitative study

BackgroundRealistic pre-treatment expectations are important and have been associated with post-treatment health related quality of life (HRQOL). Patient expectations are greatly influenced by physicians, as they are the primary resource for information. This study aimed to explore the communication practices of physicians regarding treatment outcomes for patients with spinal metastases, and physician experiences with patients’ pre-treatment expectations.MethodsAn international qualitative study using semi-structured interviews with physicians routinely involved in treating metastatic spine disease (spine surgeons, radiation and medical oncologists, and rehabilitation specialists) was conducted. Physicians were interviewed about the content and extent of information they provide to patients with spinal metastases regarding treatment options, risks and treatment outcomes. Interviews were transcribed verbatim and analyzed using a thematic coding network.ResultsAfter 22 interviews data saturation occurred. The majority of the physicians indicated that they currently do not establish patients’ pre-treatment expectations, despite acknowledging the importance of these expectations. Spine surgeons often believe that patient expectations are disproportionate. Physicians expressed they manage expectations by detailing the most common risks and providing a broad but nonspecific overview of treatment outcomes. While the palliative intent seems clear to the physicians, their perception is that the implications of a palliative treatment remains elusive to most patients.ConclusionThis study highlights the current gap in patient-physician communication regarding expectations of treatment outcomes of patients with spinal metastases. These results warrant further research to improve communication practices and determine the effect of patient expectations on patient reported outcomes in this population.

Influence of functional and esthetic expectations on orthodontic pain.

To investigate the effect of orthodontic treatment outcome (OTO) expectations on the level of pain intensity experienced after orthodontic elastomeric separation (OES). Atotal of 100 orthodontic patients (74female and 26male, age 14years and above) from the Faculty of Dentistry, Mahidol University were enrolled. Before OES, questionnaires were administered to obtain patients' expectations regarding various aspects of OTO as well as OES pain expectations. Real-time self-reported pain intensity from OES at the maxillary and mandibular first permanent molars was obtained before and immediately after separator placement and at 6 h, 24 h, and then every day until day 7after OES. Data were analyzed for the relationship between OTO expectations and OES pain intensity. The level of significance was set at 0.05. The maximum OES pain intensity occurred on day 2after OES and gradually decreased to the pretreatment level on day7. The degree of facial, tooth alignment, masticatory function improvement expectations, and ahigh level of OES pain expectations were significantly associated with the severity of OES pain after separator placement. Esthetic and functional expectations of OTO were significantly associated with OES pain intensity. Thus, knowledge about esthetic and functional expectations may help to predict patient's pain response to orthodontic treatment.

Effect of Briefing on Acupuncture Treatment Outcome Expectations, Pain, and Adverse Side Effects Among Patients With Chronic Low Back Pain

In observational studies, patients' treatment outcome expectations have been associated with better outcomes (ie, a placebo response), whereas concerns about adverse side effects have been associated with an in increase in the negative effects of treatments (ie, a nocebo response). Some randomized trials have suggested that communication from clinicians could affect the treatment outcomes by changing patients' expectations. To investigate whether treatment outcome expectations and reported adverse side effects could be affected by different briefing contents before a minimal acupuncture treatment in patients with chronic low back pain (CLBP). This randomized single-blinded clinical trial was conducted among patients with CLBP at 1 outpatient clinic in Switzerland who had a pain intensity of at least 4 on a numeric rating scale from 0 to 10. Different recruitment channels were used to enroll patients. Data were collected from May 2016 to December 2017 and were analyzed from June to November 2018. Patients were randomized to receive either a regular expectation briefing or a high expectation briefing (effectiveness) and either a regular adverse side effect briefing or an intense adverse side effect briefing (adverse side effect) in a 2 × 2 factorial design. The intervention (briefing sessions and written materials) was standardized and delivered before the acupuncture treatment, with additional booster informative emails provided during the 4-week, 8-session acupuncture course. The primary end point was the patients' expectations regarding the effectiveness of the acupuncture treatment (Expectation for Treatment Scale [ETS]) after the briefing and the subsequent pain intensity (numeric rating scale). The primary end point for the adverse side effect briefing was the adverse side effect score at the end of the acupuncture treatment, derived from session-by-session assessments of adverse side effects. A total of 152 patients with CLBP (mean [SD] age, 39.54 [12.52] years; 100 [65.8%] women) were included. The estimated group difference (regular vs high) for the ETS was -0.16 (95% CI -0.81 to 0.50, P = .64), indicating no evidence for a difference between intervention groups. There was also no evidence for a difference in pain intensity at the end of the acupuncture treatment between the groups with different expectation briefings. The adverse side effects score in the group with the intense adverse side effect briefing were estimated to be 1.31 times higher (95% CI, 0.94 to 1.82; P = .11) than after a regular adverse side effect briefing, but the finding was not statistically significant. In this study, suggestions regarding treatment benefits (placebo) and adverse side effects (nocebo) did not affect treatment expectations or adverse side effects. Information regarding adverse side effects might require more research to understand nocebo responses. German Clinical Trials Register Identifier: DRKS00010191.

Patient and Physician Perspectives of Depressive Symptoms and Expectations for Treatment Outcome: Results from a Web-Based Survey.

PurposeA previous international study suggested that perceptions of depression symptoms, social function, and treatment expectations are different between patients/physicians. We aimed to examine whether such differences exist in Japan.MethodsA web-based survey was conducted with patients who reported that they had been diagnosed with depression, and physicians who reported that they had treated patients with depression, in Japan. Questionnaires were designed to quantify patients’ perceptions of symptoms, social function, and treatment expectations. Patients were categorized into three stages of disorder based on their reported current symptoms: severe symptomatic, mild symptomatic, and remission. Physicians were assigned up to three patients, were provided with patient information from the questionnaire completed by those patients, and finally the completed questionnaire forms for each patient. Agreement between the perceptions of the patients and physicians was examined for each stage.ResultsOf the 2618 eligible patients, 828 were assigned to 326 eligible physicians. Overall, we found small differences in the perceptions of depression treatment between patients/physicians. Slightly fewer physicians than patients reported physical symptoms (85% vs 91%; p=0.018) in the mild symptomatic stage. Fewer physicians than patients reported cognitive symptoms in the severe (82% vs 87%; p=0.029) and mild (54% vs 66%; p=0.003) symptomatic stages. Social function was deemed to be lower by physicians than by patients, across all stages of disorder (p<0.001). Regarding treatment expectations, more physicians than patients reported “return to a normal life” in the mild symptomatic (51% vs 35%, p<0.001) and remission stages (57% vs 36%, p<0.001), and more patients than physicians reported “reduction of side effects” in the severe (10% vs 4%, p=0.004) and mild (12% vs 5%, p<0.001) symptomatic disorder stages.ConclusionThese results suggest small differences in patient/physician perceptions of depression treatment in Japan. Discrepancies between patients’/physicians’ perceptions may vary depending on the medical environment.

Associations between positive treatment outcome expectations, illness understanding, and outcomes: a cohort study on non-operative treatment of first carpometacarpal osteoarthritis

Purpose More positive outcome expectations and illness perceptions are associated with better outcomes for patients with several osteoarthritic orthopedic conditions. However, it is unknown whether these factors also influence outcomes of non-operative treatment for first carpometacarpal osteoarthritis (CMC-1 OA). Therefore, we assess the role of pre-treatment outcome expectations and illness perceptions in reports of pain and hand function 3 months after non-operative treatment for CMC-1 OA. Materials and methods We conducted a cohort study with 219 patients treated non-operatively for CMC-1 OA between September 2017 and October 2018. Patients were included in the study if they completed measures of pain and hand function, illness perceptions (scale: 0–10), and expectations (scale: 3–27) as part of routine outcome measurements. Pain and hand function were measured before treatment and 3 months after starting treatment using the Dutch version of the Michigan Hand Outcomes Questionnaire. Multivariable linear regression analysis was used to assess the influence of outcome expectations and illness perceptions on pain and hand function. Results Both positive outcome expectations (B = 0.64; 95% CI [0.1–1.2]) and a better illness understanding (an illness perception subdomain; B = 1.53; 95% CI [0.2–2.9]) at baseline were associated with less pain at 3 months. For hand function, similar estimates were found. Conclusions We found that positive outcome expectations and a better illness understanding, were associated with a better outcome of non-operative treatment for CMC-1 OA. IMPLICATIONS FOR REHABILITATION Non-operative treatment can often be successful for patients with arthritis of the thumb. Outcome expectations and illness perceptions are associated with pain and hand function 3 months after non-operative treatment for thumb base osteoarthritis. Improving the outcome expectations and illness perceptions of patients through better education could improve the outcome of non-operative treatment.

Best Clinical Practices with ATX-101 for Submental Fat Reduction: Patient-related Factors and Physician Considerations.

Background:Submental fat can be reduced with ATX-101 (deoxycholic acid injection), a customizable and minimally invasive alternative to liposuction. In the years since its approval, the treatment patterns of ATX-101 have evolved.Methods:A panel of experienced physicians from the United States gathered to generate best practices for the use of ATX-101 in submental contouring.Results:The expert panel provided their insights on appropriate patient selection, managing patient expectations of ATX-101 treatment outcomes, and adverse events, and guidance on ATX-101 administration for optimal outcomes are presented here.Conclusion:These best clinical practices on the use of ATX-101 for the reduction of submental fat should enable physicians to enhance the patient treatment experience and outcomes.

Effectiveness of Presurgical Nasoalveolar Molding Appliance in Infants With Complete Unilateral Cleft Lip and Palate.

To assess the effectiveness of the presurgical nasoalveolar molding appliance among infants with unilateral cleft lip and palate. In this prospective study, 95 pairs of casts of infants with unilateral cleft lip and palate treated by presurgical nasoalveolar molding were selected at the Children's Hospital 1 at Ho Chi Minh City, Vietnam. The average time of treatment was 3 months. All casts were scanned and measured using 3-dimensional technology before and after treatment. Paired t tests were applied for comparisons. There was a statistically significant increase in the nostril height in cleft side (P < .001), decrease in the nostril width and columella angle (P < .001), and decrease in cleft width and midline deviation (P < .001) after treatment with presurgical nasoalveolar molding appliance. Nasoalveolar molding appliance is effective in improving the morphology of nostril and maxillary alveolar. Understanding this helps orthodontists and surgeons in treatment outcome expectations.

Optimising clinical trial design to manage placebo response in randomised controlled trials of irritable bowel syndrome

Irritable bowel syndrome (IBS) is the most common gastroenterology referral and is defined by abdominal pain associated with altered bowel habits. In the absence of objective biomarkers, patient perception of symptoms means everything. Evaluating IBS treatment response in practice relies on the physician to ask their patient if they feel better. A simple question, yet one that is greatly influenced by preconceived expectations of treatment outcomes, frequency of care received, and even side-effects of treatment, which can predispose a patient toward perceiving that a treatment is working. 1 Kaptchuk TJ Kelley JM Conboy LA et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008; 336: 999-1003 Crossref PubMed Scopus (814) Google Scholar , 2 Ballou S Beath A Kaptchuk TJ et al. Factors associated with response to placebo in patients with irritable bowel syndrome and constipation. Clin Gastroenterol Hepatol. 2018; 16: 1738-1744.e1 Summary Full Text Full Text PDF PubMed Scopus (18) Google Scholar , 3 Shah E Triantafyllou K Hana AA Pimentel M Adverse events appear to unblind clinical trials in irritable bowel syndrome. Neurogastroenterol Motil. 2014; 26: 482-488 Crossref PubMed Scopus (18) Google Scholar As recently as 10 years ago, the basic question of whether a patient achieved adequate or global relief of symptoms was the most common (and most sensible) endpoint for clinical trials. Yet this endpoint yielded placebo response rates reaching around 40%. Taken even further, active placebo (with informed consent) has even shown promise as an IBS treatment. 4 Kaptchuk TJ Friedlander E Kelley JM et al. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010; 5e15591 Crossref PubMed Scopus (532) Google Scholar These realities allude to the challenges in evaluating investigational IBS treatments in randomised, placebo-controlled trials. The placebo response rate in pharmacological trials in patients with irritable bowel syndrome: a systematic review and meta-analysisMore than a quarter of patients with irritable bowel syndrome had a placebo response in terms of global improvement, with multiple associated moderators. We recommend future trials apply a run-in period of at least 2 weeks and dose once or twice a day to minimise the placebo response rate. Full-Text PDF

Patients With Higher Treatment Outcome Expectations Are More Satisfied With the Results of Nonoperative Treatment for Thumb Base Osteoarthritis: A Cohort Study

ObjectiveTo investigate how satisfaction with treatment outcome is associated with patient mindset and Michigan Hand Outcome Questionnaire (MHQ) scores at baseline and 3 months in patients receiving nonoperative treatment for first carpometacarpal joint (CMC-1) osteoarthritis (OA). DesignCohort study SettingA total of 20 outpatient locations of a clinic for hand surgery and hand therapy in the Netherlands. ParticipantsPatients (N=308) receiving nonoperative treatment for CMC-1 OA, including exercise therapy, an orthosis, or both, between September 2017 and February 2019. InterventionsNonoperative treatment (ie, exercise therapy, an orthosis, or both) Main Outcome MeasuresSatisfaction with treatment outcomes was measured after 3 months of treatment. We measured total MHQ score at baseline and at 3 months. As baseline mindset factors, patients completed questionnaires on treatment outcome expectations, illness perceptions, pain catastrophizing, and psychological distress. We used multivariable logistic regression analysis and mediation analysis to identify factors associated with satisfaction with treatment outcomes. ResultsMore positive pretreatment outcome expectations were associated with a higher probability of being satisfied with treatment outcomes at 3 months (odds ratio, 1.15; 95% confidence interval, 1.07-1.25). Only a relatively small part (33%) of this association was because of a higher total MHQ score at 3 months. None of the other mindset and hand function variables at baseline were associated with satisfaction with treatment outcomes. ConclusionsThis study demonstrates that patients with higher pretreatment outcome expectations are more likely to be satisfied with treatment outcomes after 3 months of nonoperative treatment for CMC-1 OA. This association could only partially be explained by a better functional outcome at 3 months for patients who were satisfied. Health care providers treating patients nonoperatively for CMC-1 OA should be aware of the importance of expectations and may take this into account in pretreatment counseling.

Patient Mindset and the Success of Carpal Tunnel Release.

Depression and pain catastrophizing are aspects of the patient's mindset that have been shown to be important in relation to the outcome of carpal tunnel release. However, other factors of the patient's mindset have been understudied, such as treatment expectations and illness perceptions. The aim of the present study was to investigate the influence of these mindset aspects on outcome of carpal tunnel release, in addition to psychological distress and pain catastrophizing. A total of 307 patients with carpal tunnel syndrome who visited outpatient hand surgery clinics and who completed online questionnaires regarding demographic and psychosocial characteristics and carpal tunnel syndrome severity were included. The patient mindset was measured with the Patient Health Questionnaire-4, the Pain Catastrophizing Scale, the Credibility Expectancy Questionnaire, and the Brief Illness Perception Questionnaire. Hierarchical linear regression models were used to examine the relation between self-reported severity 6 months after carpal tunnel release, as measured with the Boston Carpal Tunnel Questionnaire, and psychosocial aspects of mindset, adjusting for preoperative Boston Carpal Tunnel Questionnaire score, patient characteristics, and comorbidities. Independent associations with better self-reported outcome were found for higher treatment expectations (β = -0.202; p < 0.001) and illness comprehensibility (β = -0.223; p < 0.001). The additional explained variance in Boston Carpal Tunnel Questionnaire scores by the patient's mindset was 13.2 percent (psychological distress and pain catastrophizing together, 2.1 percent; treatment expectations and illness perceptions together, 11.1 percent). Treatment outcome expectations and comprehensibility of illness are both independently associated with the outcome of carpal tunnel release, showing the importance of these aspects of the patient's mindset for the outcome of carpal tunnel release. Risk, III.

Which drugs are best for overactive bladder? From patients' expectations to physicians' decisions.

AimIn order to help physicians determine which drugs are the best for treating overactive bladder (OAB) symptoms, this review considered three questions: what are the patient's expectations? What information is generated by the Multicriteria Decision Analysis (MCDA) model? What can physicians expect from medical treatments?MethodsA comprehensive literature search was undertaken on these three topics in order to assist physicians regarding the optimum treatment modality for OAB.ResultsPatients’ difficulties in reporting symptoms and their expectations of treatment outcomes interfere with the success of treatment. To assist physicians in meeting patients’ expectations and to choose the most appropriate treatment, a new approach, recognised by the European Medicines Agency, the MCDA model was used to compare the benefits and safety of OAB treatments.ConclusionThe MCDA model is useful for comparing the benefit‐safety profiles of OAB drugs in order to equip clinicians with information on the drug that might best meet their patient's needs. Flexibly dosed fesoterodine appeared to be most efficacious in resolving urgency and urgency incontinence compared with other drugs, and resolution of urinary urgency appears to be associated with a reduced number of reported adverse events.