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1.
JAMA Netw Open ; 7(6): e2418383, 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38913372

ABSTRACT

Importance: There is significant concern regarding increasing long-term antidepressant treatment for depression beyond an evidence-based duration. Objective: To determine whether adding internet and telephone support to a family practitioner review to consider discontinuing long-term antidepressant treatment is safe and more effective than a practitioner review alone. Design, Setting, and Participants: In this cluster randomized clinical trial, 131 UK family practices were randomized between December 1, 2018, and March 31, 2022, with remote computerized allocation and 12 months of follow-up. Participants and researchers were aware of allocation, but analysis was blind. Participants were adults who were receiving antidepressants for more than 1 year for a first episode of depression or more than 2 years for recurrent depression who were currently well enough to consider discontinuation and wished to do so and who were at low risk of relapse. Of 6725 patients mailed invitations, 330 (4.9%) were eligible and consented. Interventions: Internet and telephone self-management support, codesigned and coproduced with patients and practitioners. Main Outcomes and Measures: The primary (safety) outcome was depression at 6 months (prespecified complete-case analysis), testing for noninferiority of the intervention to under 2 points on the 9-item Patient Health Questionnaire (PHQ-9). Secondary outcomes (testing for superiority) were antidepressant discontinuation, anxiety, quality of life, antidepressant withdrawal symptoms, mental well-being, enablement, satisfaction, use of health care services, and adverse events. Analyses for the main outcomes were performed on a complete-case basis, and multiple imputation sensitivity analysis was performed on an intention-to-treat basis. Results: Of 330 participants recruited (325 eligible for inclusion; 178 in intervention practices and 147 in control practices; mean [SD] age at baseline, 54.0 [14.9] years; 223 women [68.6%]), 276 (83.6%) were followed up at 6 months, and 240 (72.7%) at 12 months. The intervention proved noninferior; mean (SD) PHQ-9 scores at 6 months were slightly lower in the intervention arm than in the control arm in the complete-case analysis (4.0 [4.3] vs 5.0 [4.7]; adjusted difference, -1.1; 95% CI, -2.1 to -0.1; P = .03) but not significantly different in an intention-to-treat multiple imputation sensitivity analysis (adjusted difference, -0.9 (95% CI, -1.9 to 0.1; P = .08). By 6 months, antidepressants had been discontinued by 66 of 145 intervention arm participants (45.5%) who provided discontinuation data and 54 of 129 control arm participants (41.9%) (adjusted odds ratio, 1.02; 95% CI, 0.52-1.99; P = .96). In the intervention arm, antidepressant withdrawal symptoms were less severe, and mental well-being was better compared with the control arm; differences were small but significant. There were no significant differences in the other outcomes; 28 of 179 intervention arm participants (15.6%) and 22 of 151 control arm participants (14.6%) experienced adverse events. Conclusions and Relevance: In this cluster randomized clinical trial of adding internet and telephone support to a practitioner review for possible antidepressant discontinuation, depression was slightly better with support, but the rate of discontinuation of antidepressants did not significantly increase. Improvements in antidepressant withdrawal symptoms and mental well-being were also small. There were no significant harms. Family practitioner review for possible discontinuation of antidepressants appeared safe and effective for more than 40% of patients willing and well enough to discontinue. Trial Registration: ISRCTN registry Identifiers: ISRCTN15036829 (internal pilot trial) and ISRCTN12417565 (main trial).


Subject(s)
Antidepressive Agents , Internet , Telephone , Humans , Female , Male , Antidepressive Agents/therapeutic use , Middle Aged , Adult , Depression/drug therapy , United Kingdom
2.
J Clin Med ; 10(19)2021 Sep 28.
Article in English | MEDLINE | ID: mdl-34640467

ABSTRACT

Few studies describe supportive care needs among young adults (YAs) with cancer ages 25 to 39 using validated questionnaires. Previous findings identified the need for psychological and information support and suggest that gender, age, psychological distress, and coping may be associated with greater need for this support. To substantiate these findings, this study aimed to (1) describe the supportive care needs of YAs in each domain of the Supportive Care Needs Survey and (2) explore the relationship between unmet supportive care needs and clinical and demographic factors, health-related quality of life, psychological distress, illness cognitions, and service needs using latent class analysis. Clinical teams from six hospitals in England invited eligible patients to a cross-sectional survey by post. A total of 317 participants completed the survey online or on paper. YAs expressed the most need in the psychological and sexuality domains. Using latent class analysis, we identified three classes of YAs based on level of supportive care need: no need (53.3%), low need (28.3%), and moderate need (18.4%). In each class, median domain scores in each domain were similar. Low and moderate need classes were associated with worse health-related quality of life and greater helplessness. Unmet service needs were associated with the moderate-need class only. Patients with unmet supportive care needs should be offered holistic care across supportive care domains.

3.
Colorectal Dis ; 23(12): 3234-3250, 2021 12.
Article in English | MEDLINE | ID: mdl-34679253

ABSTRACT

AIM: Depression experienced by people with colorectal cancer (CRC) is an important clinical problem affecting quality of life. Recognition of depression at key points in the pathway enables timely referral to support. This study aimed to examine depression before and 5 years after surgery to examine its prevalence and identify determinants. METHOD: The ColoREctal Wellbeing (CREW) study is a prospective UK cohort study involving 872 adults with nonmetastatic CRC recruited before surgery with curative intent. Questionnaires completed before surgery and 3, 9, 15, 24, 36, 48 and 60 months after surgery captured socio-demographics and assessed depression (Centre for Epidemiologic Studies Depression Scale, CES-D) and other psychosocial factors. Clinical details were also gathered. We present the prevalence of clinically significant depression (CES-D ≥ 20) over time and its predictors assessed before and 2 years after surgery. RESULTS: Before surgery, 21.0% of the cohort reported CES-D ≥ 20 reducing to 14.7% 5 years after surgery. Presurgery risk factors predicting subsequent depression were clinically significant depression and anxiety, previous mental health service use, low self-efficacy, poor health, having neoadjuvant treatment and low social support. Postsurgery risk factors at 2 years predicting subsequent depression were clinically significant depression, negative affect, cognitive dysfunction, accommodation type and poor health. CONCLUSION: Depression is highly pervasive in people with CRC, exceeding prevalence in the general population across follow-up. Our findings emphasize the need to screen and treat depression across the pathway. Our novel data highlight key risk factors of later depression at important and opportune time points: before surgery and at the end of routine surveillance. Early recognition and timely referral to appropriate support is vital to improve long-term psychological outcomes.


Subject(s)
Colorectal Neoplasms , Quality of Life , Adult , Anxiety , Cohort Studies , Colorectal Neoplasms/epidemiology , Colorectal Neoplasms/surgery , Depression/epidemiology , Depression/etiology , Humans , Prevalence , Prospective Studies
4.
Eur J Cancer Care (Engl) ; 30(5): e13458, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33942418

ABSTRACT

OBJECTIVE: Adolescents and young adults with cancer face unique psychosocial and practical issues. However, patients across this group encounter different life experiences, cancer diagnoses and treatment settings given the tailored services for patients ages 15 to 24. Here, we qualitatively explore the psychosocial experiences and practical challenges of young adults (YAs) with cancer diagnosed between ages 25 and 39 in the United Kingdom. METHODS: We invited YAs diagnosed with cancer in the 5 years prior to enrolment at participating sites to take part in semi-structured interviews or focus groups. Transcripts were analysed using inductive thematic analysis. Two YA patients reviewed the results to ensure robustness. RESULTS: Sixty-five YAs with varied diagnoses participated. Participants struggled to balance work, childcare and financial solvency with treatment. The halt in family and work life as well as changes in image and ability threatened participants' identity and perceived 'normality' as a YA, however, these also stimulated positive changes. YAs experienced social isolation from friends and family, including children. Many struggled to cope with uncertainty around treatment outcomes and disease recurrence. CONCLUSION: The disruption of family and work life can lead to age-specific issues in YAs diagnosed with cancer. Age-tailored psychological and practical services must be considered.


Subject(s)
Neoplasms , Adaptation, Psychological , Adolescent , Adult , Child , Focus Groups , Humans , Neoplasms/therapy , Qualitative Research , Uncertainty , Young Adult
5.
PLoS One ; 15(4): e0231332, 2020.
Article in English | MEDLINE | ID: mdl-32271835

ABSTRACT

BACKGROUND: The ColoREctal Wellbeing (CREW) study is the first study to prospectively recruit colorectal cancer (CRC) patients, carry out the baseline assessment pre-treatment and follow patients up over five years to delineate the impact of treatment on health and wellbeing. METHODS: CRC patients received questionnaires at baseline (pre-surgery), 3, 9, 15, 24, 36, 48 and 60 months. The primary outcome was Quality of Life in Adult Cancer Survivors (QLACS); self-efficacy, mental health, social support, affect, socio-demographics, clinical and treatment characteristics were also assessed. Representativeness was evaluated. Predictors at baseline and at 24 months of subsequent worsened quality of life (QOL) were identified using multivariable regression models. RESULTS: A representative cohort of 1017 non-metastatic CRC patients were recruited from 29 UK cancer centres. Around one third did not return to pre-surgery levels of QOL five years after treatment. Baseline factors associated with worsened QOL included >2 comorbidities, neoadjuvant treatment, high negative affect and low levels of self-efficacy, social support and positive affect. Predictors at 24 months included older age, low positive affect, high negative affect, fatigue and poor cognitive functioning. CONCLUSIONS: Some risk factors for poor outcome up to five years following CRC surgery, such as self-efficacy, social support and comorbidity management, are amenable to change. Assessment of these factors from diagnosis to identify those most likely to need support in their recovery is warranted. Early intervention has the potential to improve outcomes.


Subject(s)
Colorectal Neoplasms/psychology , Quality of Life , Affect , Aged , Body Mass Index , Colorectal Neoplasms/pathology , Colorectal Neoplasms/surgery , Fatigue/etiology , Female , Humans , Logistic Models , Male , Mental Health , Middle Aged , Odds Ratio , Self Efficacy , Social Support , Surveys and Questionnaires
6.
Acupunct Med ; 37(2): 98-106, 2019 04.
Article in English | MEDLINE | ID: mdl-30896248

ABSTRACT

OBJECTIVES: To test whether a newly developed person-, theory- and evidence-based website about acupuncture helps patients make informed decisions about whether or not to use acupuncture for back pain. METHODS: A randomised online study compared a newly developed 'enhanced website' to a 'standard website'. The enhanced website provided evidence-based information in a person-based manner and targeted psychological constructs. The standard website was based on a widely used patient information leaflet. In total, 350 adults with recent self-reported back pain were recruited from general practices in South West England. The two primary outcomes were knowledge change and making an informed choice about using acupuncture. Secondary outcomes were beliefs about and willingness to have acupuncture. RESULTS: Participants who viewed the enhanced acupuncture website had a significantly greater increase in knowledge about acupuncture (M = 1.1, standard deviation (SD) = 1.7) than participants who viewed the standard website (M = 0.2, SD = 1.1; F(1, 315) = 37.93, p < 0.001, η2 = .107). Participants who viewed the enhanced acupuncture website were also 3.3 times more likely to make an informed choice about using acupuncture than those who viewed the standard website (χ2(1) = 23.46, p < 0.001). There were no significant effects on treatment beliefs or willingness to have acupuncture. CONCLUSION: The enhanced website improved patients' knowledge and ability to make an informed choice about acupuncture, but did not optimise treatment beliefs or change willingness to have acupuncture. The enhanced website could be used to support informed decision-making among primary care patients and members of the general public considering using acupuncture for back pain.


Subject(s)
Acupuncture Therapy , Back Pain/psychology , Back Pain/therapy , Adult , Aged , England , Female , Health Knowledge, Attitudes, Practice , Humans , Informed Consent , Internet , Male , Middle Aged
7.
J Med Internet Res ; 21(1): e9955, 2019 01 17.
Article in English | MEDLINE | ID: mdl-30664462

ABSTRACT

BACKGROUND: Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing information leaflets often fail to describe the potential benefits and adverse effects associated with placebo allocation. This study tested the effects of a new website designed to inform patients about placebo effects (The Power of Placebos, PoP). PoP was designed using qualitative methods in combination with theory- and evidence-based approaches to ensure it was engaging, informative, and addressed patients' concerns. OBJECTIVE: This study aimed to test the effects of PoP, compared with a control website, on people's knowledge about placebo and the ability to make an informed choice about taking part in a placebo-controlled trial. METHODS: A total of 350 adults with back pain recruited from 26 general practices in Southern England participated in this Web-based study. Participants were randomly assigned to PoP (which presented scientifically accurate information about placebo effects in an engaging way) or a control website (based on existing information leaflets from UK trials). Participants self-completed Web-based pre- and postintervention questionnaire measures of knowledge about placebo effects and preintervention questionnaire measures of attitudes toward and intentions to participate in a placebo-controlled trial. The 2 primary outcomes were (1) knowledge and (2) informed choice to take part in a placebo-controlled trial (computed from knowledge, attitudes, and intentions). RESULTS: After viewing PoP, participants had significantly greater knowledge about placebos (mean 8.28 [SD 1.76]; n=158) than participants who viewed the control (mean 5.60 [SD 2.24]; n=174; F1,329=173.821; P<.001; η2=.346). Participants who viewed PoP were 3.16 times more likely than those who viewed the control to make an informed choice about placebos (χ21=36.5; P<.001). CONCLUSIONS: In a sample of adults with back pain, PoP increased knowledge and rates of informed choice about placebos compared with a control website. PoP could be used to improve knowledge about placebo effects in back pain. After essential further development and testing in clinical trial settings, it could support informed consent in placebo-controlled trials.


Subject(s)
Back Pain/psychology , Back Pain/therapy , Health Knowledge, Attitudes, Practice , Informed Consent/psychology , Placebo Effect , Female , Humans , Internet , Male , Surveys and Questionnaires
8.
Eur J Cancer Care (Engl) ; 27(6): e12980, 2018 11.
Article in English | MEDLINE | ID: mdl-30485601

ABSTRACT

OBJECTIVE: Health-related quality of life (HRQoL) concerns of adolescents and young adults (AYAs) aged 14-25 years were compared with those of older adults (26-60 years) with cancer. METHODS: AYAs and older adults receiving curative intent treatment or supportive palliative care for cancer were recruited from eight research centres across Europe. Participants used a rating scale to score the relevance and importance of a list of 77 issues covering 10 areas of HRQoL concern: symptoms; activity restrictions; social; emotional; body image; self-appraisals; outlook on life; lifestyle; treatment-related and life beyond treatment. RESULTS: HRQoL issues were reviewed by 33 AYAs and 25 older adults. Several issues were recognised as relevant and important across all age groups: symptoms, emotional impact, outlook on life, lifestyle and treatment-related. A number of issues were more relevant or important to AYAs including interrupted education, greater motivation to achieve academic goals, increased maturity, boredom, fertility and change in living situation. CONCLUSION: While there is overlap in several of the HRQoL concerns across the age span, it is important that HRQoL measures used with AYAs capture the diverse and unique psychosocial aspects of this developmental stage.


Subject(s)
Health Status , Neoplasms/psychology , Quality of Life/psychology , Activities of Daily Living , Adolescent , Adult , Age Factors , Attitude , Body Image , Emotions , Female , Humans , Life Style , Male , Middle Aged , Neoplasms/physiopathology , Neoplasms/therapy , Self Concept , Social Participation , Young Adult
9.
Psychooncology ; 27(10): 2427-2435, 2018 10.
Article in English | MEDLINE | ID: mdl-30070052

ABSTRACT

OBJECTIVE: More people are living with the consequences of cancer and comorbidity. We describe frequencies of comorbidities in a colorectal cancer cohort and associations with health and well-being outcomes up to 5 years following surgery. METHODS: Prospective cohort study of 872 colorectal cancer patients recruited 2010 to 2012 from 29 UK centres, awaiting curative intent surgery. Questionnaires administered at baseline (pre-surgery), 3, 9, 15, 24 months, and annually up to 5 years. Comorbidities (and whether they limit activities) were self-reported by participants from 3 months. The EORTC QLQ-C30 and QLQ-CR29 assessed global health/quality of life (QoL), symptoms, and functioning. Longitudinal analyses investigated associations between comorbidities and health and well-being outcomes. RESULTS: At baseline, the mean age of participants was 68 years, with 60% male and 65% colon cancer. Thirty-two per cent had 1 and 40% had ≥2 comorbidities. The most common comorbidities were high blood pressure (43%), arthritis/rheumatism (32%), and anxiety/depression (18%). Of those with comorbidities, 37% reported at least 1 that limited their daily activities. Reporting any limiting comorbidities was associated with poorer global health/QoL, worse symptoms, and poorer functioning on all domains over 5-year follow-up. Controlling for the most common individual comorbidities, depression/anxiety had the greatest deleterious effect on outcomes. CONCLUSIONS: Clinical assessment should prioritise patient-reported comorbidities and whether these comorbidities limit daily activities, as important determinants of recovery of QoL, symptoms, and functioning following colorectal cancer. Targeted interventions and support services, including multiprofessional management and tailored assessment and follow-up, may aid recovery of health and well-being in these individuals.


Subject(s)
Cancer Survivors/psychology , Colorectal Neoplasms/psychology , Depression/psychology , Quality of Life/psychology , Aged , Cohort Studies , Colorectal Neoplasms/complications , Colorectal Neoplasms/surgery , Comorbidity , Depression/etiology , Female , Humans , Male , Middle Aged , Prospective Studies , Social Support , Socioeconomic Factors , Surveys and Questionnaires , Time Factors
10.
J Rehabil Assist Technol Eng ; 5: 2055668318765406, 2018.
Article in English | MEDLINE | ID: mdl-31191932

ABSTRACT

PURPOSE: Reliability of motor-evoked potential threshold and amplitude measurement of upper limb muscles is important when detecting changes in cortical excitability. The objective of this study was to investigate intra-rater, test-retest reliability and minimal detectable change of resting motor threshold and amplitude of a proximal and distal upper limb muscles, anterior deltoid and distal extensor digitorum communis in healthy adults. METHOD: To measure motor-evoked potential responses, transcranial magnetic stimulation was interfaced with electromyography and neuronavigation equipment. Two measurements were conducted on day 1 and a third measurement three days later. Reliability was analysed using intraclass correlation coefficients. RESULTS: Twenty participants completed the study. Excellent intra-rater (intraclass correlation coefficient = 0.91 (extensor digitorum), 0.94 (anterior deltoid)) and good to excellent test-retest reliability (intraclass correlation coefficient = 0.69 (anterior deltoid), 0.84 (extensor digitorum)) was found for resting motor threshold. Minimal detectable change for resting motor threshold was found at 10.95% (extensor digitorum) and 16.35% (anterior deltoid) between first and third measurements. Motor-evoked potential amplitude of extensor digitorum communis had fair to good intra-rater (intraclass correlation coefficient = 0.50) and test-retest reliability (intraclass correlation coefficient = 0.65). CONCLUSIONS: Our results suggest that resting motor threshold is a reliable neurophysiological measure even for proximal shoulder muscles. Future research should further explore the reliability of motor-evoked potential amplitude before integration into neurological rehabilitation.

11.
Psychooncology ; 26(12): 2276-2284, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29094430

ABSTRACT

OBJECTIVE: Social support is acknowledged as important in cancer survivorship, but little is known about change in support after cancer diagnosis and factors associated with this, particularly in colorectal cancer. The CREW cohort study investigated social support up to 2 years following curative intent surgery for colorectal cancer. METHODS: A total of 871 adults recruited pre-treatment from 29 UK centres 2010 to 2012 consented to follow-up. Questionnaires at baseline, 3, 9, 15, and 24 months post-surgery included assessments of social support (Medical Outcomes Study-Social Support Survey, MOS-SSS) and health-related quality of life (HRQoL). Socio-demographic, clinical and treatment details were collected. Longitudinal analyses assessed social support over follow-up, associations with participant characteristics, and HRQoL. RESULTS: Around 20% were living alone and 30% without a partner. Perceived social support declined in around 29% of participants, with 8% of these reporting very low levels overall from baseline to 2 years (mean MOS-SSS overall score < 40 on a scale from 0 to 100). Older age, female gender, greater neighbourhood deprivation, presence of co-morbidities, and rectal cancer site were significantly associated with reductions in perceived support. Poorer HRQoL outcomes (generic health/QoL, reduced wellbeing, anxiety, and depression) were significantly associated with lower levels of social support. CONCLUSIONS: Levels of social support decline following colorectal cancer diagnosis and treatment in nearly a third of patients and are an important risk factor for recovery of HRQoL. Assessment of support early on and throughout follow-up would enable targeted interventions to improve recovery, particularly in the more vulnerable patient groups at risk of poorer social support.


Subject(s)
Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/psychology , Depression/etiology , Quality of Life/psychology , Social Support , Adult , Aged , Anxiety , Cohort Studies , Colorectal Neoplasms/surgery , Depression/psychology , Female , Health Status , Humans , Male , Middle Aged , Prospective Studies , Risk Factors , Socioeconomic Factors , Surveys and Questionnaires , United Kingdom
12.
J Cancer Surviv ; 11(5): 634-642, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28822053

ABSTRACT

PURPOSE: There is a growing emphasis on self-management of cancer aftercare. Little is known about patient's self-efficacy (confidence) to manage illness-related problems and how this changes over time. This paper describes the patterns of self-efficacy for managing illness-related problems amongst colorectal cancer patients in the 2 years following diagnosis. METHODS: In this prospective cohort study, questionnaires were administered at baseline (pre-surgery), 3, 9, 15 and 24 months to 872 colorectal cancer patients. Self-efficacy (confidence to manage illness-related problems), anxiety, social support, affect, socio-demographics, physical symptoms and clinical and treatment characteristics were assessed. Group-based trajectory analysis identified trajectories of self-efficacy up to 24 months and predictors. RESULTS: Four trajectories of self-efficacy were identified: group 1 (very confident) 16.0% (95% confidence interval (CI) 10.7-21.3%), group 2 (confident) 45.6% (95% CI 40.3-51.0%), group 3 (moderately confident) 29.5% (95% CI 25.1-33.8%) and group 4 (low confidence) 8.9% (95% CI 6.4-11.4%). Greater deprivation, domestic status, more co-morbidities, worse fatigue and pain, lower positivity and greater negativity were significantly associated with lower self-efficacy. There was an increase in mean scores for self-efficacy over time for the whole sample, but this did not reach the cut-off for minimally important differences. At 2 years, the lowest level of confidence to manage was for symptoms or health problems. CONCLUSION: Around 40% of patients had suboptimal levels of confidence to manage illness-related problems with little change from the time of diagnosis across the four groups. IMPLICATIONS FOR CANCER SURVIVORS: Screening for self-efficacy at diagnosis would enable targeted, early intervention which could in turn enhance health-related quality of life.


Subject(s)
Colorectal Neoplasms/complications , Quality of Life/psychology , Aftercare , Colorectal Neoplasms/mortality , Colorectal Neoplasms/pathology , Female , Humans , Male , Middle Aged , Prospective Studies , Self Efficacy , Self-Management , Survivors , Time Factors
13.
Eur J Integr Med ; 8(4): 384-393, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27807469

ABSTRACT

INTRODUCTION: Potential acupuncture patients seek out information about acupuncture from various sources including websites, many of which are unreliable. We aimed to create an informative, scientifically accurate and engaging website to educate patients about acupuncture for back pain and modify their beliefs in a way that might enhance its clinical effects. METHODS: We used psychological theory and techniques to design an evidence-based website, incorporating multimedia elements. We conducted qualitative "think aloud" audio-recorded interviews to elicit user views of the website. A convenience sample of ten participants (4 male; aged 21-64 years from the local community) looked at the website in the presence of a researcher and spoke their thoughts out loud. Comments were categorised by topic. RESULTS: The website comprises 11 main pages and addresses key topics of interest to potential acupuncture patients, including beneficial and adverse effects, mechanisms of action, safety, practicalities, and patients' experiences of acupuncture. It provides information through text, evidence summaries and audio-clips of four patients' stories and two acupuncturists' descriptions of their practice, and three short films. Evidence from the think aloud study was used to identify opportunities to make the website more informative, engaging, and user-friendly. CONCLUSIONS: Using a combination of psychological theory and qualitative interviews enabled us to produce a user-friendly, evidence-based website that is likely to change patients' beliefs about acupuncture for back pain. Before using the website in clinical settings it is necessary to test its effects on key outcomes including patients' beliefs and capacity for making informed choices about acupuncture.

14.
JMIR Res Protoc ; 5(2): e106, 2016 Jun 10.
Article in English | MEDLINE | ID: mdl-27288271

ABSTRACT

BACKGROUND: According to established ethical principles and guidelines, patients in clinical trials should be fully informed about the interventions they might receive. However, information about placebo-controlled clinical trials typically focuses on the new intervention being tested and provides limited and at times misleading information about placebos. OBJECTIVE: We aimed to create an informative, scientifically accurate, and engaging website that could be used to improve understanding of placebo effects among patients who might be considering taking part in a placebo-controlled clinical trial. METHODS: Our approach drew on evidence-, theory-, and person-based intervention development. We used existing evidence and theory about placebo effects to develop content that was scientifically accurate. We used existing evidence and theory of health behavior to ensure our content would be communicated persuasively, to an audience who might currently be ignorant or misinformed about placebo effects. A qualitative 'think aloud' study was conducted in which 10 participants viewed prototypes of the website and spoke their thoughts out loud in the presence of a researcher. RESULTS: The website provides information about 10 key topics and uses text, evidence summaries, quizzes, audio clips of patients' stories, and a short film to convey key messages. Comments from participants in the think aloud study highlighted occasional misunderstandings and off-putting/confusing features. These were addressed by modifying elements of content, style, and navigation to improve participants' experiences of using the website. CONCLUSIONS: We have developed an evidence-based website that incorporates theory-based techniques to inform members of the public about placebos and placebo effects. Qualitative research ensured our website was engaging and convincing for our target audience who might not perceive a need to learn about placebo effects. Before using the website in clinical trials, it is necessary to test its effects on key outcomes including patients' knowledge and capacity for making informed choices about placebos.

15.
PLoS One ; 11(5): e0155434, 2016.
Article in English | MEDLINE | ID: mdl-27171174

ABSTRACT

PURPOSE: This paper identifies predictors of recovery trajectories of quality of life (QoL), health status and personal wellbeing in the two years following colorectal cancer surgery. METHODS: 872 adults receiving curative intent surgery during November 2010 to March 2012. Questionnaires at baseline, 3, 9, 15, 24 months post-surgery assessed QoL, health status, wellbeing, confidence to manage illness-related problems (self-efficacy), social support, co-morbidities, socio-demographic, clinical and treatment characteristics. Group-based trajectory analyses identified distinct trajectories and predictors for QoL, health status and wellbeing. RESULTS: Four recovery trajectories were identified for each outcome. Groups 1 and 2 fared consistently well (scores above/within normal range); 70.5% of participants for QoL, 33.3% health status, 77.6% wellbeing. Group 3 had some problems (24.2% QoL, 59.3% health, 18.2% wellbeing); Group 4 fared consistently poorly (5.3% QoL, 7.4% health, 4.2% wellbeing). Higher pre-surgery depression and lower self-efficacy were significantly associated with poorer trajectories for all three outcomes after adjusting for other important predictors including disease characteristics, stoma, anxiety and social support. CONCLUSIONS: Psychosocial factors including self-efficacy and depression before surgery predict recovery trajectories in QoL, health status and wellbeing following colorectal cancer treatment independent of treatment or disease characteristics. This has significant implications for colorectal cancer management as appropriate support may be improved by early intervention resulting in more positive recovery experiences.


Subject(s)
Adaptation, Psychological , Colorectal Neoplasms/psychology , Colorectal Neoplasms/surgery , Depression/psychology , Health Status , Aged , Aged, 80 and over , Cohort Studies , Female , Follow-Up Studies , Humans , Male , Middle Aged , Quality of Life/psychology , Regression Analysis , Surveys and Questionnaires
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