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1.
J Clin Med ; 12(23)2023 Nov 24.
Article in English | MEDLINE | ID: mdl-38068337

ABSTRACT

(1) Background: Most controlled trials of cognitive behavior therapy (CBT) in people living with chronic obstructive pulmonary disease (COPD) have targeted anxiety and depression. (2) Methods: This pragmatic randomized controlled trial explored whether a comprehensive pulmonary rehabilitation program (CPRP) with CBT for breathlessness or social group control (CPRP + SC) significantly improved health outcomes. (3) Results: People with moderate-to-severe COPD were block randomized (CPRP + CBT n = 52 or CPRP + SC n = 49). Primary outcomes (Hospital Anxiety and Depression scale (HADs), six-minute walk distance (6MWD)) and secondary outcomes (breathlessness, quality of life and habitual physical activity) were assessed before and 1, 6 and 12 months post intervention. Between-group differences were calculated with mixed models for each time point to baseline (intention to treat (ITT)). Participants (n = 101, mean ± SD age 70 ± 8.5 years, 54 (53%) males, FEV1% pred 47.7 ± 16.3) were similar between groups. Post intervention, primary outcomes did not differ significantly between groups at 1 (6MWD mean difference -7.5 [95% CI -34.3 to 19.4], HADs-A -0.3 [-1.4 to 0.9], HADs-D 0.2 [-0.8 to 1.3]), 6 (6MWD -11.5 [-38.1 to 15.1], HADs-A 1.1 [0.0 to 2.2], HADs-D 0.2 [-0.9 to 1.3]), or 12 months (6MWD -3.8 [-27.2 to 19.6], HADS-A -0.4 [-1.5 to 0.6], HADs-D -0.7 [-1.7 to 0.4]). (4) Conclusions: In this cohort, combining CBT with a CPRP did not provide additional health benefits beyond those achieved by a standard CPRP.

2.
Curr Opin Support Palliat Care ; 17(4): 255-262, 2023 12 01.
Article in English | MEDLINE | ID: mdl-37812384

ABSTRACT

PURPOSE OF THE REVIEW: Effective education enables people to modify the distress and impact of breathlessness by integrating evidence-informed breathlessness-related behaviours (knowledge, skill, attitude) into everyday life. This review considers recent studies of educational approaches focussed on chronic breathlessness as a modifiable, noxious and debilitating multidimensional experience. RECENT FINDINGS: Systematic assessments of text-based patient education materials and mobile phone applications specific to breathlessness indicate that while these resources are readily available, issues continue to persist with quality, readability, usefulness and availability of non-English language versions. Various forms of educational interventions for breathlessness have proven feasible and valued by people living with breathlessness and their significant others (uptake/completion, personal benefit, ripple effect on health professionals). Health professional knowledge about the impact of chronic breathlessness and effective management can be altered through structured, educational interventions. SUMMARY: Empiric studies of patient education for breathlessness are scarce despite persistent calls for better breathlessness education for people living with or providing care for someone living with this noxious symptom. In clinical practice, it is highly likely that there are effective and ineffective educational practices, both of which, if publicly disseminated, would inform future educational strategies to advance breathlessness self-management.


Subject(s)
Health Personnel , Patient Education as Topic , Humans , Health Personnel/education , Palliative Care , Dyspnea/therapy
3.
Healthcare (Basel) ; 11(12)2023 Jun 08.
Article in English | MEDLINE | ID: mdl-37372804

ABSTRACT

Chronic breathlessness is a multidimensional, unpleasant symptom common to many health conditions. The Common-Sense Model of Self-Regulation (CSM) was developed to help understand how individuals make sense of their illness. This model has been underused in the study of breathlessness, especially in considering how information sources are integrated within an individual's cognitive and emotional representations of breathlessness. This descriptive qualitative study explored breathlessness beliefs, expectations, and language preferences of people experiencing chronic breathlessness using the CSM. Twenty-one community-dwelling individuals living with varying levels of breathlessness-related impairment were purposively recruited. Semi-structured interviews were conducted with questions reflecting components of the CSM. Interview transcripts were synthesized using deductive and inductive content analysis. Nineteen analytical categories emerged describing a range of cognitive and emotional breathlessness representations. Representations were developed through participants' personal experience and information from external sources including health professionals and the internet. Specific words and phrases about breathlessness with helpful or nonhelpful connotations were identified as contributors to breathlessness representations. The CSM aligns with current multidimensional models of breathlessness and provides health professionals with a robust theoretical framework for exploring breathlessness beliefs and expectations.

4.
Br J Gen Pract ; 73(731): e468-e477, 2023 06.
Article in English | MEDLINE | ID: mdl-37068966

ABSTRACT

BACKGROUND: Evidence about the delays to diagnosis for patients presenting with breathlessness is lacking. AIM: To explore current care of patients with breathlessness through the experiences of adults presenting with chronic breathlessness who are awaiting a diagnosis and the experiences of primary care clinicians. DESIGN AND SETTING: Qualitative study with adults presenting with chronic breathlessness and clinicians across 10 general practices. METHOD: Semi-structured interviews were conducted with patients and clinicians. Participants were recruited from a feasibility cluster randomised controlled trial investigating a structured diagnostic pathway for breathlessness. An interview guide explored experiences of help seeking for breathlessness, the diagnostic process, and associated health care. Transcripts were analysed using thematic analysis supported by NVivo software. RESULTS: Interviews were conducted with 34 patients (mean age 68 years, standard deviation [SD] 10.8, of whom 20 were female [59%]) and 10 clinicians (mean 17 years of experience, SD 6.3, of whom five were female [50%]). Five themes were identified: recognising and validating symptoms of breathlessness is an important first step; clinical decision making for breathlessness is complex; difficult conversations arise when a disease-related diagnosis is not confirmed; disease management rather than symptom management is prioritised by clinicians; and patient experience is influenced by clinician communication style. CONCLUSION: The findings indicate potential explanations for delays to diagnosis for patients with chronic breathlessness. Interventions are needed to enhance symptom recognition, include alternative approaches to incremental investigation, and expand the concept of diagnosis beyond a disease label to improve communication, with the ultimate aim of earlier diagnosis and management to improve patient outcomes.


Subject(s)
Delayed Diagnosis , Dyspnea , Adult , Humans , Female , Aged , Male , Dyspnea/diagnosis , Dyspnea/etiology , Dyspnea/therapy , Qualitative Research , Communication , Primary Health Care
5.
Chron Respir Dis ; 19: 14799731221105518, 2022.
Article in English | MEDLINE | ID: mdl-35698999

ABSTRACT

BACKGROUND: Dyspnoea and pain are symptoms of chronic obstructive pulmonary disease (COPD). This review focused upon pain and dyspnoea during hospital admissions for acute exacerbations of COPD (AECOPD), with the aim of examining prevalence, assessment, clinical associations, and researcher-reported implications of these symptoms. METHODS: Four electronic databases were searched from inception to 31 May 2021. Full text versions of studies were assessed for methodological quality and data were extracted independently by two reviewers. Where data permitted, pooled prevalence of pain and dyspnoea were calculated by meta-analysis. RESULTS: Four studies were included. The pooled prevalence of pain and dyspnoea was 44% (95% confidence interval (CI) 35%-52%) and 91% (95% CI 87%-94%) respectively. An array of instruments with varying focal periods were reported (pain: six tools, dyspnoea: four tools). Associations and clinical implications between the two symptoms at the time of hospital admission were rarely reported. CONCLUSIONS: Few studies reported prevalence of pain and dyspnoea during an AECOPD. A greater understanding into the prevalence, intensity and associations of these symptoms during AECOPD could be furthered by use of standardised assessment tools with clearly defined focal periods.


Subject(s)
Pulmonary Disease, Chronic Obstructive , Quality of Life , Disease Progression , Dyspnea/epidemiology , Dyspnea/etiology , Humans , Pain , Pain Measurement , Prevalence , Pulmonary Disease, Chronic Obstructive/complications , Pulmonary Disease, Chronic Obstructive/epidemiology
6.
J Pain Symptom Manage ; 63(1): e75-e87, 2022 01.
Article in English | MEDLINE | ID: mdl-34273524

ABSTRACT

CONTEXT: The Dyspnoea-12 (D-12) and Multidimensional Dyspnea Profile (MDP) were specifically developed for assessment of multiple sensations of breathlessness. OBJECTIVES: This systematic review aimed to identify the use and measurement properties of the D-12 and MDP across populations, settings and languages. METHODS: Electronic databases were searched for primary studies (2008-2020) reporting use of the D-12 or MDP in adults. Two independent reviewers completed screening and data extraction. Study and participant characteristics, instrument use, reported scores and minimal clinical important differences (MCID) were evaluated. Data on internal consistency (Cronbach's α) and test-retest reliability (intraclass correlation coefficient, ICC) were pooled using random effects models between settings and languages. RESULTS: A total 75 publications reported use of D-12 (n = 35), MDP (n = 37) or both (n = 3), reflecting 16 chronic conditions. Synthesis confirmed two factor structure, internal consistency (Cronbach's α mean, 95% CI: D-12 Total = 0.93, 0.91-0.94; MDP Immediate Perception [IP] = 0.88, 0.85-0.90; MDP Emotional Response [ER] = 0.86, 0.82-0.89) and 14 day test-rest reliability (ICC: D-12 Total = 0.91, 0.88-0.94; MDP IP = 0.85, 0.70-0.93; MDP ER = 0.84, 0.73-0.90) across settings and languages. MCID estimates for clinical interventions ranged between -3 and -6 points (D-12 Total) with small variability in scores over 2 weeks (D-12 Total 2.8 (95% CI: 2.0 to 3.7), MDP-A1 0.8 (0.6 to 1.1) and six months (D-12 Total 2.9 (2.0 to 3.7), MDP-A1 0.8 (0.6 to 1.1)). CONCLUSION: D-12 and MDP are widely used, reliable, valid and responsive across various chronic conditions, settings and languages, and could be considered standard instruments for measuring dimensions of breathlessness in international trials.


Subject(s)
Dyspnea , Emotions , Adult , Dyspnea/diagnosis , Dyspnea/psychology , Humans , Language , Psychometrics/methods , Reproducibility of Results , Surveys and Questionnaires
7.
Chron Respir Dis ; 18: 14799731211056092, 2021.
Article in English | MEDLINE | ID: mdl-34823382

ABSTRACT

OBJECTIVE: This descriptive qualitative study explored perspectives of people with chronic obstructive pulmonary disease (COPD) and health professionals concerning blood flow restricted exercise (BFRE) training. METHODS: People living with COPD and health professionals (exercise physiologists, physiotherapists, and hospital-based respiratory nurses and doctors) participated in interviews or focus groups, which included information about BFRE training and a facilitated discussion of positive aspects, barriers and concerns about BFRE training as a possible exercise-based intervention. Sessions were audio-recorded, and transcript data analysed using inductive content analysis. RESULTS: Thirty-one people participated (people with COPD n = 6; health professionals n = 25). All participant groups expressed positive perceptions of BFRE as a potential alternative low-intensity exercise mode where health benefits might be achieved. Areas of overlap in perceived barriers and concerns included the need to address the risk of potential adverse events, suitability of training sites and identifying processes to appropriately screen potential candidates. DISCUSSION: While potential benefits were identified, concerns about determining who is safe and suitable to participate, delivery processes, health professional training and effects on a variety of health-related outcomes need to be addressed before implementation of BFRE training for people with COPD.


Subject(s)
Exercise , Pulmonary Disease, Chronic Obstructive , Humans , Pulmonary Disease, Chronic Obstructive/therapy , Qualitative Research
8.
Physiotherapy ; 113: 188-198, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34579950

ABSTRACT

OBJECTIVES: Dry needling is widely used in physiotherapy. Lack of blinding in clinical trials means that dry needling effects and mechanisms remain unclear, with blinding issues accepted as an unavoidable barrier to better evidence. The authors aimed to overcome this barrier by designing a protocol to double-blind dry needling trials. DESIGN: A prospectively registered randomised experiment tested a novel blinding protocol for blinding effectiveness. SETTING: University physiotherapy clinic. PARTICIPANTS: Therapists (n=15) and asymptomatic volunteers ('recipients') (n=45) were randomly allocated to real and/or sham interventions. INTERVENTIONS: The protocol involved custom-made needles and cognitive and multisensory blinding techniques. MAIN OUTCOME MEASURES: The primary outcome was guesses about allocation. The a priori criterion for successful blinding was ≤50% correct guesses (random chance). Secondary analyses explored blinding patterns using blinding indices. RESULTS: Correct guesses were not different from 50% for therapists [41% (95%CI 30 to 50), n=120 guesses] or recipients [49% (95%CI 38 to 60), n=90 guesses]. Blinding indices supported the primary result but revealed that recipients were better at detecting real dry needling than sham. CONCLUSION: Both therapists and recipients were successfully blinded, which contrasts with the widely held assumption that double-blinding is impossible for needling interventions. The authors recommend that any future trials can, and therefore should, blind therapists. However, secondary analyses revealed that recipients receiving real dry needling were less blinded than sham recipients, which may still create bias in clinical trials and suggests further work is needed to improve recipient blinding. Nonetheless, the current findings offer an opportunity to gain better evidence concerning the effects and mechanisms of dry needling. STUDY REGISTRATION: https://osf.io/rkzeb/.


Subject(s)
Dry Needling , Humans , Needles , Physical Therapy Modalities , Randomized Controlled Trials as Topic
9.
Physiotherapy ; 113: 177-187, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34563384

ABSTRACT

OBJECTIVE: Complex physical interventions are widely used in physiotherapy, despite doubts over the validity of clinical trial results due to lack of credible shams. Credible shams are critically needed, so too, therefore, is a process by which they can be developed. The authors used a novel methodology to develop and test blinding protocols for dry needling, a complex physical intervention for which blinding is particularly difficult. DESIGN: The research design was a practical three-day workshop influenced by Participatory Action Research, which uses iteration and reflection to solve a problem. PARTICIPANTS: Five multidisciplinary experts (researchers, clinicians, technician, magician) were invited. Healthy volunteers ('recipients', n=17) and accredited physiotherapists (n=6) were recruited to enable testing of blinding strategies. MAIN OUTCOME MEASURES: Primary outcomes were expert opinion on the potential to blind recipients/therapists for (1) individual blinding strategies, and (2) entire blinding protocols. Secondary outcomes included recipient/therapist blinding effectiveness and acceptability. RESULTS: Experts iteratively developed 11 blinding protocols involving 22 blinding strategies. Experts rated 18 of the blinding strategies to 'definitely have potential' and identified four categories: knowledge of the sham, clinical interaction, disinformation, and sensation. Recipient and therapist blinding became more successful as the protocols evolved. CONCLUSIONS: Credible shams capable of simultaneous recipient and therapist blinding have been regarded to be impossible in dry needling. The preliminary success of the devised protocols suggest that our novel approach may be a crucial step in sham development. Improvements in expert rankings and blinding effectiveness as the protocols progressed support the value of this workshop approach.


Subject(s)
Dry Needling , Humans , Physical Therapy Modalities
10.
PeerJ ; 9: e11554, 2021.
Article in English | MEDLINE | ID: mdl-34277146

ABSTRACT

BACKGROUND: Blood flow restricted exercise (BFRE) improves physical fitness, with theorized positive effects on vascular function. This systematic review and meta-analysis aimed to report (1) the effects of BFRE on vascular function in adults with or without chronic health conditions, and (2) adverse events and adherence reported for BFRE. METHODOLOGY: Five electronic databases were searched by two researchers independently to identify studies reporting vascular outcomes following BFRE in adults with and without chronic conditions. When sufficient data were provided, meta-analysis and exploratory meta-regression were performed. RESULTS: Twenty-six studies were included in the review (total participants n = 472; n = 41 older adults with chronic conditions). Meta-analysis (k = 9 studies) indicated that compared to exercise without blood flow restriction, resistance training with blood flow restriction resulted in significantly greater effects on endothelial function (SMD 0.76; 95% CI [0.36-1.14]). No significant differences were estimated for changes in vascular structure (SMD -0.24; 95% CI [-1.08 to 0.59]). In exploratory meta-regression analyses, several experimental protocol factors (design, exercise modality, exercised limbs, intervention length and number of sets per exercise) were significantly associated with the effect size for endothelial function outcomes. Adverse events in BFRE studies were rarely reported. CONCLUSION: There is limited evidence, predominantly available in healthy young adults, on the effect of BFRE on vascular function. Signals pointing to effect of specific dynamic resistance exercise protocols with blood flow restriction (≥4 weeks with exercises for the upper and lower limbs) on endothelial function warrant further investigation.

11.
J Med Internet Res ; 23(3): e17023, 2021 03 03.
Article in English | MEDLINE | ID: mdl-33656451

ABSTRACT

BACKGROUND: Mobile ecological momentary assessment (mEMA) permits real-time capture of self-reported participant behaviors and perceptual experiences. Reporting of mEMA protocols and compliance has been identified as problematic within systematic reviews of children, youth, and specific clinical populations of adults. OBJECTIVE: This study aimed to describe the use of mEMA for self-reported behaviors and psychological constructs, mEMA protocol and compliance reporting, and associations between key components of mEMA protocols and compliance in studies of nonclinical and clinical samples of adults. METHODS: In total, 9 electronic databases were searched (2006-2016) for observational studies reporting compliance to mEMA for health-related data from adults (>18 years) in nonclinical and clinical settings. Screening and data extraction were undertaken by independent reviewers, with discrepancies resolved by consensus. Narrative synthesis described participants, mEMA target, protocol, and compliance. Random effects meta-analysis explored factors associated with cohort compliance (monitoring duration, daily prompt frequency or schedule, device type, training, incentives, and burden score). Random effects analysis of variance (P≤.05) assessed differences between nonclinical and clinical data sets. RESULTS: Of the 168 eligible studies, 97/105 (57.7%) reported compliance in unique data sets (nonclinical=64/105 [61%], clinical=41/105 [39%]). The most common self-reported mEMA target was affect (primary target: 31/105, 29.5% data sets; secondary target: 50/105, 47.6% data sets). The median duration of the mEMA protocol was 7 days (nonclinical=7, clinical=12). Most protocols used a single time-based (random or interval) prompt type (69/105, 65.7%); median prompt frequency was 5 per day. The median number of items per prompt was similar for nonclinical (8) and clinical data sets (10). More than half of the data sets reported mEMA training (84/105, 80%) and provision of participant incentives (66/105, 62.9%). Less than half of the data sets reported number of prompts delivered (22/105, 21%), answered (43/105, 41%), criterion for valid mEMA data (37/105, 35.2%), or response latency (38/105, 36.2%). Meta-analysis (nonclinical=41, clinical=27) estimated an overall compliance of 81.9% (95% CI 79.1-84.4), with no significant difference between nonclinical and clinical data sets or estimates before or after data exclusions. Compliance was associated with prompts per day and items per prompt for nonclinical data sets. Although widespread heterogeneity existed across analysis (I2>90%), no compelling relationship was identified between key features of mEMA protocols representing burden and mEMA compliance. CONCLUSIONS: In this 10-year sample of studies using the mEMA of self-reported health-related behaviors and psychological constructs in adult nonclinical and clinical populations, mEMA was applied across contexts and health conditions and to collect a range of health-related data. There was inconsistent reporting of compliance and key features within protocols, which limited the ability to confidently identify components of mEMA schedules likely to have a specific impact on compliance.


Subject(s)
Ecological Momentary Assessment , Health Behavior , Adolescent , Adult , Child , Humans , Self Report
12.
Article in English | MEDLINE | ID: mdl-32425516

ABSTRACT

Cognitive behavioral therapy (CBT) is increasingly recommended in the management of people living with chronic obstructive pulmonary disease (COPD). This rapid review presents the evidence base for CBT for people with COPD and describes 1) the nature of CBT interventions and comparators in controlled trials (high or low resource intensity); and 2) factors influencing intervention effects on health outcomes (anxiety, depression, breathlessness, quality of life and exercise capacity). Primary studies reporting CBT interventions in adults with COPD were identified with data extracted by a single reviewer (20% of studies checked for data accuracy). Studies were synthesized descriptively with meta-analyses (random effects models) of controlled trials undertaken to report mean standardized effect sizes (95% CI) for health outcomes. Random effects meta-regression models explored whether CBT target, intervention dosage, intensity, facilitator profession, delivery mode, clinically significant anxiety/depression, trial design/quality and sample size predicted effect size. The search identified 33 primary studies published between 1996 and 2019 (controlled trials n=24, single group cohort n=6, case exemplars n=2, phenomenological n=1). Controlled trials frequently compared high-intensity CBT interventions against enhanced/usual care (n=12) or high-intensity CBT interventions against high-intensity comparators (n=11). When all controlled studies were included, small, significant improvements favoring CBT were evident across all health outcomes (SMD ranged from -0.27 to 0.35, p<0.05). When intensity dyads were considered, significant improvements were evident only when high-intensity CBT interventions were compared to enhanced usual care/usual care (SMDs ranged from -0.45 to 0.54, p <0.05). No other variable consistently predicted intervention effect sizes across all health outcomes. Overall, the evidence base supports the use of CBT for a range of health outcomes in people with COPD. Consistent benefits were evident when high-resource-intensive CBT interventions were compared to usual care. Low-resource-intensity CBT warrants further investigation in settings where cost of comprehensive care is prohibitive.


Subject(s)
Cognitive Behavioral Therapy , Pulmonary Disease, Chronic Obstructive , Adult , Anxiety , Anxiety Disorders , Humans , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/therapy , Quality of Life
13.
BMC Med Educ ; 20(1): 90, 2020 Mar 30.
Article in English | MEDLINE | ID: mdl-32228544

ABSTRACT

BACKGROUND: Clinicians and people living with chronic breathlessness have expressed a need to better understand and manage this symptom. The aim of this study was to evaluate a 3-day health professional training workshop on the practical management of chronic breathlessness. METHODS: Workshop design and delivery were based on current understandings and clinical models of chronic breathlessness management, principles of transformative learning, and included sessions co-designed with people living with breathlessness. Registrants were invited to complete pre and post-workshop surveys. Pre and 1-week post-workshop online questionnaires assessed familiarity and confidence about workshop objectives (0[lowest]-10[highest] visual analogue scale), attitudes and practices regarding chronic breathlessness (agreement with statements on 5-point Likert scales). Post-workshop, participants were asked to describe implementation plans and anticipated barriers. Baseline familiarity and confidence were reported as mean (SD) and change examined with paired t-tests. Pre-post attitudes and practices were summarised by frequency/percentages and change examined non-parametrically (5-point Likert scale responses) or using a McNemar test of change (binary responses). RESULTS: Forty-seven of 55 registrants joined the study; 39 completed both pre and post-workshop questionnaires (35 female; 87% clinicians; median 8 years working with people with chronic breathlessness). Post-workshop, greatest gains in confidence were demonstrated for describing biopsychosocial concepts unpinning chronic breathlessness (mean change confidence = 3.2 points; 95% CI 2.7 to 4.0, p < 0.001). Respondents significantly changed their belief toward agreement that people are able to rate their breathlessness intensity on a scale (60 to 81% agreement) although only a minority strongly agreed with this statement at both time points (pre 11%, post 22%). The largest shift in attitude was toward agreement (z statistic 3.74, p < 0.001, effect size r = 0.6) that a person's experience of breathlessness should be used to guide treatment decisions (from 43 to 73% strong agreement). Participants' belief that cognitive behavioural strategies are effective for relief of breathlessness changed further toward agreement after the workshop (81 to 100%, McNemar test chi- square = 5.14, p = 0.02). CONCLUSION: The focus of this training on biopsychosocial understandings of chronic breathlessness and involvement of people living with this symptom were valued. These features were identified as facilitators of change in fundamental attitudes and preparedness for practice.


Subject(s)
Attitude of Health Personnel , Clinical Competence , Dyspnea/therapy , Health Personnel/education , Self Efficacy , Adult , Female , Humans , Male , Middle Aged , Program Evaluation , Surveys and Questionnaires
14.
Clin Trials ; 17(3): 295-305, 2020 06.
Article in English | MEDLINE | ID: mdl-32153205

ABSTRACT

BACKGROUND/AIMS: In clinical trials of physical interventions, participant blinding is often poorly addressed and therapist blinding routinely omitted. This situation presents a substantial barrier to moving the field forward. Improving the success of blinding will be a vital step towards determining the true mechanisms of physical interventions. We used a Delphi approach to identify important elements of shams for physical interventions to maximise the likelihood of participant and therapist blinding in clinical trials. METHODS: Two expert groups were recruited: (1) experts in research methodology and (2) experts in deceptive and/or hypnotic techniques including magic. Magicians were included because they were considered a potentially rich source of innovation for developing credible shams due to their unique skills in altering perceptions and beliefs. Three rounds of survey were conducted, commencing with an open-ended question. Responses were converted to single 'items', which participants rated in the following two rounds using a 9-point Likert scale, categorised as 'Not important' (0-3), 'Depends' (4-6) and 'Essential' (7-9). Consensus was pre-defined as ≥80% agreement within a 3-point category. RESULTS: Thirty-eight experts agreed to participate (research methodology: n = 22; deceptive and/or hypnotic techniques: n = 16), and 30 experts responded to at least one round (research methodology: n = 19; deceptive and/or hypnotic techniques: n = 11). Of 79 items, five reached consensus in the 'Essential' category in both groups, which related to beliefs of participants (n = 3 items), interactions with researchers (n = 1 item) and standardisation of clinical assessments (n = 1 item). Thirteen additional items reached consensus in the 'Essential' category in one group. Experts in research methodology had one additional item reach consensus, related to authentic delivery of study information. The remaining 12 additional items that reached consensus in the deceptive and/or hypnotic techniques group related mainly to therapist attitude and behaviour and the clinical interaction. CONCLUSION: Experts agreed that, for shams to be believable, consideration of cognitive influences is essential. Contrary to the focus of previous shams for physical interventions, replicating the tactile sensation of the active treatment was not considered an essential part of sham development. Therefore, when designing sham-controlled clinical trials, researchers should carefully consider the cognitive credibility of the entire intervention experience, and not just the indistinguishability of the sham intervention itself. The findings provide new guidance to researchers on important contributors to blinding in physical intervention trials.


Subject(s)
Clinical Trials as Topic/methods , Physical Therapy Modalities , Placebos , Research Design , Adult , Consensus , Delphi Technique , Female , Humans , Hypnosis/methods , Male , Middle Aged , Single-Blind Method , Surveys and Questionnaires
15.
ERJ Open Res ; 6(1)2020 Jan.
Article in English | MEDLINE | ID: mdl-32154293

ABSTRACT

Few studies have examined the contribution of life-course factors in explaining familial aggregation of chronic lung conditions. Using data from the 1958 British Birth Cohort, a life-course approach was used to examine whether, and how, exposure to risk factors through one's life explained the association between parental respiratory disease history and symptomatic airflow obstruction (AO). Cohort participants (n=6212) were characterised in terms of parental respiratory disease history and symptomatic AO at 45 years. Life-course factors (e.g. smoking, asthma and early-life factors) were operationalised as life period-specific and cumulative measures. Logistic regression and path analytic models predicting symptomatic AO adjusted for parental respiratory disease history were used to test different life-course models (critical period, accumulation- and chain-of-risks models). While some life-course factors (e.g. childhood passive smoking and occupational exposure) were individually associated with parental respiratory disease history and symptomatic AO, asthma (OR 6.44, 95% CI 5.01-8.27) and persistent smoking in adulthood (OR 5.42, 95% CI 4.19-7.01) had greater impact on the association between parental respiratory disease history and symptomatic AO. A critical period model provided a better model fit compared with an accumulation-of-risk model and explained 57% of the effect of parental respiratory disease history on symptomatic AO. Adulthood asthma and smoking status explained around half of the effect of parental respiratory disease history on chronic obstructive pulmonary disease. Beyond smoking history, the combination of parental respiratory disease history and adulthood asthma may provide an opportunity for early diagnosis and intervention.

16.
Physiotherapy ; 106: 12-23, 2020 03.
Article in English | MEDLINE | ID: mdl-32026842

ABSTRACT

OBJECTIVES: Sham-controlled trials of dry needling, a popular treatment for pain, use a range of methods and theoretical frameworks and most have high risk of bias. Critically, patient blinding is often unsuccessful and therapist blinding has not been attempted. The specific effects of dry needling on pain therefore remain unclear. Our objectives were to identify (1) important elements of active dry needling; (2) important elements of shams for dry needling. DESIGN AND PARTICIPANTS: Two Delphi surveys (to quantify levels of consensus) were undertaken with three expert groups: experts in (1) dry needling, (2) research methodology, and (3) deceptive/hypnotic techniques including magic. Experts in dry needling participated in Delphi 1 and all three groups participated in Delphi 2. Each survey commenced with an open-ended question. Responses were converted to single 'items' suitable for rating on 9-point Likert scales [categorised as 'Not important' (0-3), Depends (4-6), and Essential (7-9)], which participants rated in the following two rounds. Consensus was pre-defined as ≥80% agreement within a 3-point category. RESULTS: In Delphi 1 (n=20 experts), of 80 items, 35 reached consensus in the 'Essential' category, which related to explanations, therapist knowledge/skills, intervention rationale, the setting, and safety. In Delphi 2 (n=53 experts), of 97 items, 15 items reached consensus in the 'Essential' category in all three groups, which related to standardisation/indistinguishability, therapist attributes, expectations/beliefs, vision, protocol, and environment. CONCLUSIONS: Experts placed high importance on the entire intervention experience for active and sham protocols. Cognitive influences that extend beyond mimicking of tactile sensations should be used to create a believable simulation of active dry needling.


Subject(s)
Delphi Technique , Dry Needling , Placebos , Research Design , Adult , Female , Humans , Male , Middle Aged
17.
J Ren Care ; 46(3): 137-150, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32052590

ABSTRACT

BACKGROUND: Dyspnoea is a common, disabling symptom of people living with end-stage kidney disease (ESKD), which may persist despite optimal management. Dyspnoea assessments can be grouped according to the instruments that assess domains related to: sensory-perception (intensity, sensory quality), affective distress (unpleasantness) and impact/burden (function, quality of life). OBJECTIVES: To describe dyspnoea assessment in adults with ESKD receiving renal replacement therapy (RRT). DESIGN: Systematic review. METHODS: Five databases were searched. Primary studies reporting an assessment of dyspnoea in adults with ESKD receiving RRT were included. Studies were excluded where participants with ESKD had received palliative/conservative treatment (no dialysis) or renal transplant. Conference abstracts, protocols, commentaries and/or images were excluded. Two independent reviewers screened and extracted the data. Descriptive analysis summarised the (1) number and type of instruments used to assess dyspnoea; (2) which dyspnoea domains to be assessed and (3) rationale and context for dyspnoea assessment. RESULTS: From 2,234 records screened, 28 studies were eligible for inclusion (observational n = 22 and experimental n = 6). Across studies, 12 different instruments were identified (dyspnoea-specific n = 3, subscale of a comprehensive instrument n = 9). Most instruments (n = 11, 92%) assessed a single domain (intensity n = 6, unpleasantness n = 6 and impact/burden n = 5). Studies reported a rationale for measuring dyspnoea (n = 26) as either a characteristic of the participant cohort (n = 14) or as an outcome (n = 14). CONCLUSIONS: Surprisingly, a few primary studies reported assessment of dyspnoea in people with ESKD receiving RRT. When assessed, there was a predominance of unidimensional instruments. As dyspnoea is associated with adverse clinical outcomes, routine dyspnoea assessment may improve management and relieve suffering.


Subject(s)
Dyspnea/classification , Kidney Failure, Chronic/complications , Symptom Assessment/methods , Dyspnea/complications , Dyspnea/physiopathology , Humans , Kidney Failure, Chronic/psychology , Physical Examination/methods , Symptom Assessment/trends
18.
J Pain Symptom Manage ; 59(2): 310-319.e12, 2020 02.
Article in English | MEDLINE | ID: mdl-31655188

ABSTRACT

CONTEXT: Explanations provided by health professionals may underpin helpful or harmful symptom beliefs and expectations of people living with chronic breathlessness. OBJECTIVES: This study sought perspectives from health professionals with clinical/research expertise in chronic breathlessness on priority issues in chronic breathlessness explanations and research. METHODS: Authors (n = 74) of publications specific to chronic breathlessness were invited to a three-round Delphi survey. Responses to open-ended questions (Round 1 "What is important to: include/avoid when explaining chronic breathlessness; prioritize in research?") were transformed to Likert scale (1-9) items for rating in subsequent rounds. A priori consensus was defined as ≥70% of respondents rating an item as important (Likert rating 7-9) and interquartile range ≤2. RESULTS: Of the 31 Round 1 respondents (nine countries, five professional disciplines), 24 (77%) completed Rounds 2 and 3. Sixty-three items met consensus (include n = 28; avoid n = 9; research n = 26). Explanations of chronic breathlessness should use patient-centered communication; acknowledge the distress, variability, and importance of this sensation; emphasize current management principles; clarify maladaptive beliefs and expectations; and avoid moral culpability and inappropriate reassurance. Research priorities included the need 1) for a comprehensive understanding of breathlessness science; 2) to optimize, explore, and develop effective interventions, both pharmacological and nonpharmacological; and 3) determine effective models of care including strategies for education and training of health professionals and people caring for, or living with, chronic breathlessness. CONCLUSION: These consensus-based concepts for chronic breathlessness explanations and research provide a starting point for conversations between patients, carers, clinicians, and researchers within the chronic breathlessness community.


Subject(s)
Dyspnea , Research , Consensus , Delphi Technique , Dyspnea/therapy , Humans , Surveys and Questionnaires
19.
Phys Ther ; 99(11): 1461-1480, 2019 11 25.
Article in English | MEDLINE | ID: mdl-31373369

ABSTRACT

BACKGROUND: Blinding of participants and therapists in trials of physical interventions is a significant and ongoing challenge. There is no widely accepted sham protocol for dry needling. PURPOSE: The purpose of this review was to summarize the effectiveness and limitations of blinding strategies and types of shams that have been used in dry needling trials. DATA SOURCES: Twelve databases were searched from inception to February 2016. STUDY SELECTION: Trials that compared active dry needling with a sham that simulated dry needling were included. DATA EXTRACTION: The main domains of data extraction were participant/therapist details, intervention details, blinding strategies, blinding assessment outcomes, and key conclusions of authors. Reported blinding strategies and sham types were synthesized descriptively, with available blinding effectiveness data synthesized using a chance-corrected measurement of blinding (blinding index). DATA SYNTHESIS: The search identified 4894 individual publications with 27 trials eligible for inclusion. In 22 trials, risk of methodological bias was high or unclear. Across trials, blinding strategies and sham types were heterogeneous. Notably, no trials attempted therapist blinding. Sham protocols have focused on participant blinding using strategies related to group standardization and simulation of tactile sensations. There has been little attention given to the other senses or cognitive strategies to enhance intervention credibility. Nonpenetrating sham types may provide effective participant blinding. LIMITATIONS: Trials were clinically and methodologically diverse, which limited the comparability of blinding effectiveness across trials. Reported blinding evaluations had a high risk of chance findings with power clearly achieved in only 1 trial. CONCLUSIONS: Evidence-based consensus on a sham protocol for dry needling is required. Recommendations provided in this review may be used to develop sham protocols so that future protocols are more consistent and potentially more effective.


Subject(s)
Dry Needling , Research Design , Complementary Therapies , Humans
20.
Palliat Med ; 33(10): 1319-1324, 2019 12.
Article in English | MEDLINE | ID: mdl-31368843

ABSTRACT

BACKGROUND: To date, time-use studies in palliative care have been limited to exploration of time commitments of caregivers. Understanding time-use in people with a life-limiting illness might provide insight into disease progression, symptom management and quality of life. AIM: To determine the feasibility of a repeated-measures, time-use study in people with a life-limiting illness, and their primary caregivers, and to explore associations between time-use and perceived quality of life. DESIGN: An observational repeated-measures feasibility pilot study. A priori criteria were established for study uptake (70%), retention (80%) and study value/burden (⩾7 Numerical Rating Scale 0-10). Burden and value of the study, use of time (Multimedia Activity Recall for Children and Adults with adjunctive accelerometry) and quality of life data (EuroQol-5 Dimension-5-Level Health Questionnaire and Australia-modified Karnofsky Performance Status scale) were assessed at time-points across five consecutive months. SETTING/PARTICIPANTS: People living with a life-limiting illness and caregivers recruited from Southern Adelaide Palliative Services outpatient clinics. RESULTS: A total of 10 participants (2 caregivers and 8 people with a life-limiting illness) enrolled in the study. All but one of the criteria thresholds was met: 66% of participants who consented to be screened were enrolled in the study, 80% of enrolled participants (n = 8) completed all assessments (two participants died during the study) and mean Numerical Rating Scale scores for acceptable burden and value of the study exceeded the criteria thresholds at every time-point. CONCLUSION: A repeated-measures time-use study design is feasible and was not unduly burdensome for caregivers and people living with a life-limiting illness.


Subject(s)
Palliative Care/statistics & numerical data , Aged , Aged, 80 and over , Feasibility Studies , Female , Humans , Longitudinal Studies , Male , Middle Aged , Pilot Projects , Quality of Life , Terminal Care/statistics & numerical data , Time and Motion Studies
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