Improving knowledge and decision readiness to participate in cancer clinical trials: Effects of a plain language decision aid for minority cancer survivors

ObjectiveTo evaluate the impact of a web-based, plain language decision aid (CHOICES DA) on minority cancer survivors’ knowledge of cancer clinical trials (CCTs), readiness for making decisions about clinical trial participation, and willingness to participate in a clinical trial.MethodsParticipants were 64 Black and Hispanic cancer survivors from Miami, Florida. In a single arm intervention study, participants completed self-report assessments of CCT knowledge, decision readiness regarding clinical trial participation, and willingness to participate at three time points.ResultsBlack and Hispanic participants did not differ on demographic characteristics. Post-test and follow-up measures of CCT knowledge and decision readiness were significantly greater than pre-test measures for the sample overall, and for Black and Hispanic participants separately. Few significant differences were observed between Black and Hispanic participant outcomes at each survey time point, and willingness to participate did not change overall and for either group independently.ConclusionsReviewing the CHOICES DA was associated with significantly improved knowledge and decision readiness to participate in a CCT immediately and at 2-week follow-up.Practical ImplicationsThese findings suggest that CHOICES DA may support informed decision making about CCT participation within an acute, yet clinically relevant window of time for minority cancer patients who are substantially under-represented in cancer research.     

The impact of a patient web communication intervention on reaching treatment suggested guidelines for chronic diseases: A randomized controlled trial

ObjectiveExamine the impact of a PACE (Prepare, Ask, Check, Express) inspired web-based communication intervention alone or combined with a workshop on reaching treatment goals for patients suffering from chronic diseases (CDs), compared to usual care.MethodsThree arm single-blind RCT in community primary care (PC) practices. PC practitioners (n = 18) had a CD patient caseload, and practicing >5 years. Patients >40 years old, English speaking, computer literate, not reaching treatment goals for hypertension, type II diabetes, and/or dyslipidemia.Interventions(1) web-intervention and (2) web intervention and nurse facilitated workshop and (3) usual care.OutcomeProportion of patients meeting all treatment suggested guidelines for the diagnoses they were enrolled for.ResultsPatients (n = 322) were randomized, and of these 221 returned for follow up. Patients in the web group were 1.42 times more likely to meet targets compared to usual care [95% CI: 1.00–2.00], a statistical difference not seen in the combined group. Sensitivity analyses were performed to mitigate bias due to loss to follow up.ConclusionsTraining patients in communication skills using a website positively affects reaching treatment goals for hypertensive, diabetic and dyslipidemic patients.Practice implicationsWeb communication interventions are an effective tool that can be used in primary care.     

Effectiveness of the Genomics ADvISER decision aid for the selection of secondary findings from genomic sequencing: a randomized clinical trial

PurposeTo evaluate the effectiveness of the Genomics ADvISER (www.genomicsadviser.com) decision aid (DA) for selection of secondary findings (SF), compared with genetic counseling alone.MethodsA randomized controlled trial (RCT) was conducted to evaluate whether the Genomics ADvISER is superior to genetic counseling when hypothetically selecting SF. Participants were randomized to use the DA followed by discussion with a genetic counselor, or to genetic counseling alone. Surveys were administered at baseline and post-intervention. Primary outcome was decisional conflict. Secondary outcomes were knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session.ResultsParticipants (n = 133) were predominantly White/European (74%), female (90%), and ≥50 years old (60%). Decisional conflict (mean difference 0.05; P = 0.60), preparation for decision-making (0.17; P = 0.95), satisfaction with decision (–2.18; P = 0.06), anxiety (0.72; P = 0.56), and knowledge of sequencing limitations (0.14; P = 0.70) did not significantly differ between groups. However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)ConclusionsThe Genomics ADvISER did not decrease decisional conflict but reduced counseling time and improved knowledge. This decision aid could serve as an educational tool, reducing in-clinic time and potentially health care costs.     

Effectiveness of question prompt lists in patients with breast cancer: A randomized controlled trial

ObjectivesTo evaluate the effectiveness of a question prompt list (QPL) in decision self-efficacy, decision-making participation, patient–physician communication, decisional conflict or regret, and health status in patients with breast cancer.MethodsA total of 240 patients with breast cancer were randomly assigned to a QPL group or control group (n = 120 each). The intervention and control groups received an additional educational QPL booklet and routine care, respectively.ResultsThe intervention group exhibited significant improvements in decision self-efficacy, perceived patient–physician interactions, and patient–physician communication compared with the control group. Multilevel modeling analyses revealed significant group–time interaction effects on decision self-efficacy (β = 9.99, P < 0.01), perceived patient–physician interactions (β = 8.10, P < 0.01), patient–physician communication (β = 5.02, P < 0.01), and anxiety status (β = ?3.78, P < 0.05). The QPL intervention exerted more favorable effects than routine care, with repeated measurements of the same patients and the data of patients under the care of the same surgeons accounted for.ConclusionsThe QPL intervention exerted multidimensional effects on decision-making outcomes among patients with breast cancer.Practical implicationsClinicians can integrate a QPL into routine care for patients with breast cancer.     

Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: A randomized controlled trial

ObjectiveTo evaluate the efficacy of shared decision-making (SDM) intervention among patients with lumbar degenerative diseases (LDDs) in terms of decision self-efficacy, control preferences, SDM process, decision satisfaction, and conflict.MethodsA total of 130 outpatients with LDDs recruited from orthopedic or rehabilitation clinics were randomly assigned to the SDM intervention (n = 67) or comparison (n = 63) groups. Patients in the intervention group received decision aids (DAs) with decision coaching and those in controlled group received standard educational materials from a health educator. The primary outcome was decision self-efficacy, and secondary outcomes were control preference, SDM process, conflict, and satisfaction.ResultsThe SDM intervention significantly improved decision self-efficacy (mean difference [MD] = 7.1, 95% confidence interval [CI]: 1.7–12.5, partial η² = 0.05) and reduced conflict (MD = −7.0, 95% CI: −12.2 to −1.9, partial η² = 0.06), especially in patients without family involvement, compared with the health education group. However, no significant between-group differences were observed in other outcomes.ConclusionSDM intervention improved SDM self-efficacy and reduced conflict in patients with LDDs.Practice ImplicationsClinicians can integrate DAs and decision coaching in SDM conversations. SDM intervention seems to engage patients in decision-making, especially those without family involvement.     

Patient preferences on general health and colorectal cancer screening decision-making: Results from a national survey

ObjectiveWe examined patient preferences regarding colorectal cancer (CRC) screening decision-making and factors associated with these preferences among screening-eligible US adults.MethodsThrough a national survey of 1595 US adults ages 40–75 (response rate: 31.3%), we measured general medical decision-making and CRC screening decision-making preferences (0–100, 100 = highest desire for involvement) and preferred control level over three CRC screening decisions (whether to screen, what method to use, and when to screen). Analyses focused on respondents aged 45–75 at average CRC risk (N = 1062).ResultsRespondents expressed strong desire for involvement in general medical decision-making and CRC screening decision-making (Mean = 68.1, 64.4). Over half of respondents reported preferring having equal control as their providers over whether to screen, what method to use, and when to screen. Women and people with higher education expressed higher desire for involvement in general medical decision-making. For CRC screening decision-making, variations exist in preferred level of involvement and control by race/ethnicity, educational attainment, insurance status, and recency of routine checkup.ConclusionMost respondents preferred a collaborative process of CRC screening decision-making, while variations existed across subgroups.Practice implicationsProviders should assess patients’ values and preferences and involve them in CRC screening decision-making at a level they are comfortable with.     

Evaluation of a mammography decision aid for women 75 and older at risk for lower health literacy in a pretest-posttest trial

ObjectiveThe evaluation of the effect of a mammography decision aid (DA) designed for older women at risk for lower health literacy (LHL) on their knowledge of mammography’s benefits and harms and decisional conflict.MethodsUsing a pretest-posttest design, women > 75 years at risk for LHL reviewing a mammography DA before and after their [B] primary care provider visit. Women were recruited from an academic medical center and community health centers and clinics.ResultsOf 147 eligible women approached, 43 participated. Receipt of the DA significantly affected knowledge of mammography’s benefits and harms [B] (pre-test (M = 3.75, SD = 1.05) to post-test (M = 4.42, SD = 1.19), p = .03). Receipt of the DA did not significantly affect decisional conflict (pre-test (M = 3.10, SD = .97) to post-test (M = 3.23, SD = 1.02), p = .71, higher scores = lower decisional conflict). The majority of the women (97%) indicated that the DA was helpful.ConclusionsWomen found a mammography screening DA helpful and its use was associated with these women having increased knowledge of mammography’s benefits and harms.Practice ImplicationsWith the shift toward shared decision-making for women > 75 years, there is a need to engage women of all literacy levels to participate in these decisions and have tools such as the one tested in this study.     

Digital audio recordings improve the outcomes of patient consultations: A randomised cluster trial

ObjectivesTo investigate the effects on patients’ outcome of the consultations when provided with: a Digital Audio Recording (DAR) of the consultation and a Question Prompt List (QPL).MethodsThis is a three-armed randomised controlled cluster trial. One group of patients received standard care, while the other two groups received either the QPL in combination with a recording of their consultation or only the recording. Patients from four outpatient clinics participated: Paediatric, Orthopaedic, Internal Medicine, and Urology. The effects were evaluated by patient-administered questionnaires.ResultsA total of 4349 patients participated in the study. DAR significantly increased the probability of fulfilling the participants’ self-perceived information needs by 4.1% to 6.3%, particularly with regard to test results (OR = 1.41, 95%CI: 1.14-1.74, p = 0.001) and treatment options (OR = 1.39, 95%CI: 1.13-1.71, p = 0.002). Additionally, the interventions positively influenced the participants’ satisfaction with the treatment, their relationship with the health professional, and their experience of being involved in the decision-making.ConclusionProviding outpatients with a QPL and DAR of their consultation positively influences the patients’ perception of having adequate information after the consultation.Practice implicationsThe implementation of a QPL and audio recording of consultations should be considered in routine practice.     

Peer support interventions on quality of life,depression, anxiety,and self-efficacy among patients with cancer: A systematic review and meta-analysis

ObjectivePeer support is a common form of social support that is provided by individuals with the same disease, which is cost-effective and has enhanced health outcomes for patients. This study aimed to determine the effectiveness of peer support interventions on quality of life (QOL), depression, anxiety, and self-efficacy among patients with cancer.MethodsA systematic search of seven databases were conducted from inception to January 2021. Studies were screened and assessed by two independent reviewers. Data synthesis was conducted using RevMan 5.3 software, and the standardized mean difference was used to calculate pooled effect sizes.ResultsSeventeen studies were included in current review. The meta-analysis indicated significant beneficial effects of peer support on QOL (SMD = 0.48, 95% CI 0.21–0.75; p < 0.001), depression (SMD = ?0.23, 95% CI ?0.39 to ?0.07; p = 0.005), anxiety (SMD = ?0.24, 95% CI ?0.45 to 0.03; p = 0.03), and self-efficacy (SMD = 0.22, 95% CI 0.03–0.42; p = 0.03) relative to controls. The subgroup analysis for QOL revealed that peer support delivered in the mixed mode contributed more than peer support delivered in the single mode (e.g., face-to-face or telephone).ConclusionPeer support has significant effects on improving QOL and self-efficacy as well as alleviating depression and anxiety among patients with cancer. Additional randomized controlled trials with rigorous design and larger sample sizes are warranted in the future.Practice implicationsPeer support programs might benefit patients with cancer and could be used as a complementary approach to traditional healthcare services during cancer rehabilitation.     

Development and pilot testing of an online screening decision aid for men with a family history of prostate cancer

Objective

This study aimed to develop and pilot test an online screening decision aid (DA) for men with a family history of prostate cancer.

Methods

Eligible men (with no previous prostate cancer diagnosis) were recruited through relatives attending a urology outpatient clinic. Men evaluated the DA in two stages. First, they appraised a paper-based version using a questionnaire (n = 22). Second, the same men were asked to reflect on an interactive web-based version via a semi-structured telephone interview (n = 20).

Results

Men evaluated both forms of the DA positively. Of the paper-based version, the majority of participants found the DA useful (91%), and that it contained enough information to make a screening decision (73%). All participants reported that the online DA was easy to use and navigate. Most participants reported that a website was their preferred mode of receiving prostate cancer screening information (70%).

Conclusion

The developed DA may represent the first online decision-making tool designed specifically for men with a family history prostate cancer that presents age and risk specific information to the user.

Practice implications

Comprehensive evaluations of the efficacy and impact of educational interventions such as this are crucial to improve services for individuals making informed screening decisions.     

A novel approach for evaluating acceptable intra-operative correction of lower limb alignment in femoral and tibial malunion using the deviation angle of the normal contralateral knee

BackgroundA simple and appropriate approach for evaluating an acceptable alignment of bone around the knee during operation has not yet been reported.MethodsThirty-five men and 35 women presenting with nonunion or malunion of the unilateral femoral shaft were included in the first study. Using the standing scanograph, the contralateral normal lower extremity was measured to determine the normal deviation angle (DA) of the medial malleolus when the medial aspect of the knee was placed in the midline of the body. In the second study, the normal DA from individual patients was used as a reference to evaluate knee alignment during operation in 40 other patients presenting with distal femoral or proximal tibial nonunion or malunion. The clinical and knee functional outcomes of these 40 patients were investigated.ResultsThe average normal DA was 4.2° in men and 6.0° in women (p < 0.001). Thirty-four of the 40 patients presenting with disorders around the knee were followed up for an average of 3.6 years (range, 1.1–6.5 years). Thirty fractures healed with a union rate of 88% and an average union period of 4.2 months (range, 2.5–6.5 months). Ideal knee alignment was maintained in all 30 patients with fracture union. Satisfactory function of the knee was achieved in 28 patients (82%, p < 0.001).ConclusionsUsing a normal DA as a reference may be a feasible and effective technique for evaluating an acceptable alignment of bone around the knee during operation.Levels of evidenceLevel IV, Case series.     

Efficacy of individualized homeopathic medicines in irritable bowel syndrome: A double-blind randomized,placebo-controlled trial

ContextGastrointestinal ailments are some of the common conditions treated in homeopathy; yet only a few trials have explored the effects of individualized homeopathic medicines (IHMs) for irritable bowel syndrome (IBS).ObjectiveTo explore the efficacy of IHMs in treatment of IBS.DesignDouble-blind, randomized, placebo-controlled trial.SettingOutpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, India.PatientsSixty patients suffering from IBS; randomized to receive either IHMs (n = 30) or identical-looking placebo (n = 30).InterventionsIHMs or placebo in the mutual context of concomitant care in terms of dietary advice, yoga, meditation and exercises.Main outcome measuresPrimary – IBS quality of life (IBS-QOL) questionnaire; secondary –IBS severity scoring system (IBS-SSS) and EQ-5D-5L scores; all measured at baseline and every month, up to 3 months.ResultsGroup differences and effect sizes (Cohen's d) were calculated on intention-to-treat (ITT) sample. Groups were comparable at baseline. Recruitment, retention and attrition rates were 64.5%, 91.7% and 8.3% respectively. Group differences in IBS-QOL total scores, IBS-SSS, EQ-5D-5L scores favored IHMs against placebo overall and at all the time points (all P < 0.001). Pulsatilla nigricans (n = 4, 6.7%) and Thuja occidentalis (n = 4, 6.7%) were the most frequently prescribed medicines. Barring some minor events unrelated to interventions, no harms or serious adverse events were recorded in either of the groups. Thus, IHMs acted significantly better than placebos in the treatment of IBS. Independent replications are warranted. [Trial registration: CTRI/2019/10/021632]     

Exploring variables related to medical surrogate decision-making accuracy during the COVID-19 pandemic

ObjectiveSurrogate medical decision making is common in the United States healthcare system. Variables that may influence surrogate decision making have been proposed. Little work has examined relations between these variables and outcomes of surrogate decision making. This study investigated whether surrogates’ characteristics, including their knowledge of treatment options, and interpersonal factors predicted surrogates’ accuracy and intervention selections. Specifically, predictor variables included: trust in the medical profession, trait-level anxiety, depression, anxiety about COVID-19, religiosity, perceived emotional support, understanding of treatment options, empathy, willingness to accept responsibility for medical decisions, reluctance to burden others, and perceived similarity between oneself and the patient.Methods154 pairs of patients and their surrogates completed an online survey. Patients indicated preferred treatments in hypothetical decision scenarios. Surrogates indicated the treatment that they thought the patient would prefer.ResultsWhen taken all together in a predictive model, the variables significantly predicted surrogates? accuracy, F (6) = 3.03, R² = .12, p = .008. Variables also predicted selection of intensive interventions, F (4) = 5.95, R² = .14, p = .00. Surrogates reporting greater anxiety about COVID-19 selected more intensive interventions.ConclusionsConsistent with prior research, this study found that surrogates’ characteristics influence the interventions they choose, with anxiety about COVID-19 having considerable bearing on their chosen interventions.Practice implicationsThese findings can inform development of decision-making interventions to improve surrogates’ accuracy. Providers may attend to variables highlighted by this study to support surrogates, particularly within the stressful context of COVID-19 and possible future pandemics.     

Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin 2 g for treatment of rectal and pharyngeal gonorrhoea: a randomized controlled trial

ObjectivesThe aim was to evaluate the efficacy and tolerability of gentamicin 240 mg plus azithromycin 2 g for treatment of uncomplicated rectal and pharyngeal gonorrhoea compared to ceftriaxone 500 mg plus azithromycin 2 g, the recommended European first-line gonorrhoea treatment.MethodsA non-inferiority, open-label, single-centre randomized controlled trial was conducted in Prague, Czech Republic. Patients, 18–75 years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) were randomized to treatment with gentamicin 240 mg intramuscularly plus azithromycin 2 g orally or ceftriaxone 500 g intramuscularly plus azithromycin 2 g orally. The primary outcome was negative culture and negative NAAT, i.e. 1 week and 3 weeks, respectively, after treatment.ResultsBoth clinical cure and microbiological clearance was achieved by 100% (95% CI 0.95–1.00) of patients in the gentamicin/azithromycin arm (n = 72; 40 rectal, 17 pharyngeal and 15 rectal+pharyngeal infections both localizations) and 100% (95% CI 0.95–1.00) in ceftriaxone/azithromycin arm (n = 71; 38 rectal, 14 pharyngeal and 19 rectal+pharyngeal infections). The absolute difference between the two arms was 0.0% (CI95% –5.1 to 5.1), thus less than the pre-specified margin of 7%. Administration of gentamicin was not more painful than ceftriaxone according to the visual analogue scale (1.8 vs. 3.4; p <0.001). Gastrointestinal adverse events were similar in the ceftriaxone arm (33/71, 46.5%) and the gentamicin arm (29/72, 40.3%), and overall in most (52/62, 83.9%) cases they were mild.ConclusionsGentamicin 240 mg plus azithromycin 2 g is an effective alternative for treatment of extragenital gonorrhoea.     

Epidemiology of Connectional Silence in specialist serious illness conversations

ContextHuman connection can reduce suffering and facilitate meaningful decision-making amid the often terrifying experience of hospitalization for advanced cancer. Some conversational pauses indicate human connection, but we know little about their prevalence, distribution or association with outcomes.PurposeTo describe the epidemiology of Connectional Silence during serious illness conversations in advanced cancer.MethodsWe audio-recorded 226 inpatient palliative care consultations at two academic centers. We identified pauses lasting 2+ seconds and distinguished Connectional Silences from other pauses, sub-categorized as either Invitational (ICS) or Emotional (ECS). We identified treatment decisional status pre-consultation from medical records and post-consultation via clinicians. Patients self-reported quality-of-life before and one day after consultation.ResultsAmong all 6769 two-second silences, we observed 328 (4.8%) ECS and 240 (3.5%) ICS. ECS prevalence was associated with decisions favoring fewer disease-focused treatments (OR_adj: 2.12; 95% CI: 1.12, 4.06). Earlier conversational ECS was associated with improved quality-of-life (p = 0.01). ICS prevalence was associated with clinicians' prognosis expectations.ConclusionsConnectional Silences during specialist serious illness conversations are associated with decision-making and improved patient quality-of-life. Further work is necessary to evaluate potential causal relationships.Practice implicationsPauses offer important opportunities to advance the science of human connection in serious illness decision-making.     

Decision making about anti-TNF therapy: A pilot trial of a shared decision-making intervention

ObjectiveWe conducted a pre-post pilot trial to determine the feasibility and acceptability of a multi-component intervention (pre-clinic letter, shared decision making cards and follow-up phone call) designed to facilitate SDM in pediatric inflammatory bowel disease (IBD).MethodsWe recruited physicians (n = 11) caring for IBD patients and families (n = 36) expected to discuss anti-tumor necrosis treatment. We measured feasibility and acceptability of the intervention, observed SDM, perceived SDM, decision conflict, and regret. Medical records were used to assess clinical outcomes, time to decision and adherence. We compared all outcomes between the usual care and intervention study arms.ResultsTwo out of three intervention components were feasible. Visit length increased significantly in the intervention arm. Parents and patients rated the intervention as acceptable, as did most physicians. The intervention was associated with a higher-level of observed SDM. There was no difference perceived SDM, decision conflict, regret or quality of life outcomes between arms. Physician global assessment improved over time in the intervention arm.ConclusionsThis pilot trial provides important guidance for developing a larger scale trial of a modified intervention.Practice implicationsOverall, our intervention shows promise in supporting SDM and engaging both parents and patients in pediatric IBD decisions.