Feasibility, Acceptability, and Effectiveness of a Decision Aid versus an Informational Website to Promote Clinical Trial Decision-Making among Cancer Patients: A Pilot Randomized Controlled Trial

Abstract Background: Postoperative pain is a common disorder that interferes with the quality of sleep after nasal endoscopic surgery and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied through a randomized controlled trial. Method/Design: A pilotrandomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of electroacupuncturein managing postoperative pain following nasal endoscopic surgery of sinusitis with nasal polyps. There will be 30participants randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 hours before operation, immediately after the operation upon arrival to the recovery ward, and once daily for 3 days. The primary outcome of the Pain Numerical Rating Scale (NRS) will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include Heart Rate (HR) and Blood Pressure (BP) after operation, the sleep quality during the hospital stay (Actigragh),Quality of Recovery-15 (QoR-15), and the MOS item short form health survey (SF-36). ITT analysis will be used in this RCT. Discussion: This pilot randomized controlled trial will explore the feasibility of further clinical application for the management of postoperative pain using electroacupuncture treatment, and it will inform the design of a further full-scale trial. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024183, Date: 2019-06-29. URL: http://www.chictr.org.cn/showproj.aspx?proj=40573 Keywords: Electroacupuncture; postoperative pain;nasal endoscopic surgery; RCT; randomized controlled trial; clinical trial

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Comparing the use of Arabic decision aid to usual care. A multicenter randomized controlled trial for Arabic speaking metastatic colorectal cancer patients in Saudi Arabia

Saudi Medical Journal ◽

10.15537/smj.2020.5.25064 ◽

2020 ◽

Vol 41 (5) ◽

pp. 499-507

Author(s):

Aeshah AlSagheir ◽

Norah Alrowais ◽

Basema Kh. Alkhudhair ◽

Nada AlYousefi ◽

Ahmed Al Sagheir ◽

...

Keyword(s):

Colorectal Cancer ◽

Randomized Controlled Trial ◽

Saudi Arabia ◽

Cancer Patients ◽

Decision Aid ◽

Controlled Trial ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Colorectal Cancer Patients ◽

Arabic Speaking

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The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial

The Breast ◽

10.1016/j.breast.2019.12.012 ◽

2020 ◽

Vol 49 ◽

pp. 210-218 ◽

Cited By ~ 1

Author(s):

Maria Charalampopoulou ◽

Flora Bacopoulou ◽

Konstantinos N. Syrigos ◽

Evaggelos Filopoulos ◽

George P. Chrousos ◽

...

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trial ◽

Adjuvant Therapy ◽

Cancer Patients ◽

Controlled Trial ◽

Self Awareness ◽

Breast Cancer Patients ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

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Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial

Chiropractic & Manual Therapies ◽

10.1186/s12998-020-00348-z ◽

2020 ◽

Vol 28 (1) ◽

Author(s):

Claire Lagoutaris ◽

Justin Sullivan ◽

Michelle Hancock ◽

Andrew M. Leaver

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Cervical Spine ◽

Neck Pain ◽

Controlled Trial ◽

Trial Registration ◽

Single Treatment ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

Abstract Study design Pilot randomized controlled trial. Background Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization. Methods Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization. Results Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants. Conclusions Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial. Trial registration Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true

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A randomized controlled trial of a self-administered, online decision-aid (“Navya Patient Preference Tool”) to reduce decisional conflict in women with early breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.7033 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 7033-7033

Author(s):

Shalaka P Joshi ◽

Lakshmi Ramarajan ◽

Ojas Deshpande ◽

Elizabeth Fernandes ◽

Vaibhav Vanmali ◽

...

Keyword(s):

Breast Cancer ◽

Decision Making ◽

Randomized Controlled Trial ◽

Decision Aid ◽

Controlled Trial ◽

Decisional Conflict ◽

Shared Decision ◽

Breast Cancer Patients ◽

Medical Encounter ◽

Randomized Controlled

7033 Background: Shared decision making to confront choices with clinical equipoise, has been the privilege of those patients with access to time intensive consults with oncologists. We conducted a randomized controlled trial for breast cancer patients to use an online, self-administered, out-of-the-medical-encounter decision aid (DA) to choose between breast conserving surgery (BCS) and mastectomy. Methods: Navya Patient Preference Tool (Navya PPT) is a multilingual DA based on adaptive conjoint analysis of tradeoffs between cost, adverse effects of radiation, and breast conservation. Prior analysis established high internal reliability and external validity of the Navya PPT. Eligible cT1/2, cN0 breast cancer patients planned for surgery were block randomized, in 1:1:1 ratio, to receive the research questionnaire (RQ) to measure decisional conflict on choice of surgery (control, arm 1), Navya PPT followed by RQ (experimental, arm 2) or Navya PPT followed by RQ administered with key male family member (experimental, arm 3). Groups were stratified with respect to age, socio-economic status (SES) and educational level. The study was powered to detect a decrease in Decisional Conflict Index (DCI) by 0.25 (β-0.8, two sided α- 0.01). Results: Between June 2017 and December 2019, 247/255 patients were randomized to arm 1 (83), arm 2 (84), and arm 3 (80). Median age was 48 years (IQR 23-76), and median pT size was .5 cm (0.5-6 cm). 59% of patients were middle or lower SES and 46.2% had ≤ 12th grade education. DCI was significantly reduced in arm 2 as compared with arm 1 (1.34 vs. 1.65, Cohen’s d 0.49 (± 0.31) p<0.05) as well as in arm 3 as compared with arm 1 (1.30 vs. 1.65, Cohen’s d 0.54 (± 0.31) p<0.05). 80% (± 6%) of patients underwent surgery of choice as determined by Navya PPT. BCS rate was similar in all three arms (85.2, 88.9 and 86.5% respectively (p=0.779). Conclusions: Online, self-administered, adaptive DAs used out of the medical encounter can reduce decisional conflict and increase access to shared decision making for every patient; especially in practices with low doctor to patient ratios. Clinical trial information: IEC/0116/1619/001 .

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Lock to Live—An Interactive Web-Based Lethal Means Safety Decision Aid for Suicidal Adults: Pilot Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/16253 ◽

2020 ◽

Vol 22 (1) ◽

pp. e16253 ◽

Cited By ~ 2

Author(s):

Marian E Betz ◽

Christopher E Knoepke ◽

Scott Simpson ◽

Bonnie J Siry ◽

Ashley Clement ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Suicide Prevention ◽

Decision Aid ◽

Controlled Trial ◽

Community Dwelling ◽

Web Based ◽

Randomized Controlled ◽

Lethal Means ◽

Pilot Randomized Controlled Trial

Background Counseling to reduce access to lethal means such as firearms and medications is recommended for suicidal adults but does not routinely occur. We developed the Web-based Lock to Live (L2L) decision aid to help suicidal adults and their families choose options for safer home storage. Objective This study aimed to test the feasibility and acceptability of L2L among suicidal adults in emergency departments (EDs). Methods At 4 EDs, we enrolled participants (English-speaking, community-dwelling, suicidal adults) in a pilot randomized controlled trial. Participants were randomized in a 13:7 ratio to L2L or control (website with general suicide prevention information) groups and received a 1-week follow-up telephone call. Results Baseline characteristics were similar between the intervention (n=33) and control (n=16) groups. At baseline, many participants reported having access to firearms (33/49, 67%), medications (46/49, 94%), or both (29/49, 59%). Participants viewed L2L for a median of 6 min (IQR 4-10 min). L2L also had very high acceptability; almost all participants reported that they would recommend it to someone in the same situation, that the options felt realistic, and that L2L was respectful of values about firearms. In an exploratory analysis of this pilot trial, more participants in the L2L group reported reduced firearm access at follow-up, although the differences were not statistically significant. Conclusions The L2L decision aid appears feasible and acceptable for use among adults with suicide risk and may be a useful adjunct to lethal means counseling and other suicide prevention interventions. Future large-scale studies are needed to determine the effect on home access to lethal means. Trial Registration ClinicalTrials.gov NCT03478501; https://clinicaltrials.gov/ct2/show/NCT03478501

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