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1.
Pain Rep ; 9(3): e1161, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38655237

RESUMEN

The effectiveness of analgesics can be increased if synergistic behavioural, psychological, and pharmacological interventions are provided within a supportive environment.

2.
Pain ; 165(6): 1380-1390, 2024 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-38227560

RESUMEN

ABSTRACT: We define narrative bias as a tendency to interpret information as part of a larger story or pattern, regardless of whether the facts support the full narrative. Narrative bias in title and abstract means that results reported in the title and abstract of an article are done so in a way that could distort their interpretation and mislead readers who had not read the whole article. Narrative bias is often referred to as "spin." It is prevalent in abstracts of scientific papers and is impactful because abstracts are often the only part of an article read. We found no extant narrative bias instrument suitable for exploring both efficacy and safety statements in randomized trials and systematic reviews of pain. We constructed a 6-point instrument with clear instructions and tested it on randomised trials and systematic reviews of cannabinoids and cannabis-based medicines for pain, with updated searches to April 2021. The instrument detected moderate or severe narrative bias in the title and abstract of 24% (8 of 34) of randomised controlled trials and 17% (11 of 64) of systematic reviews; narrative bias for efficacy and safety occurred equally. There was no significant or meaningful association between narrative bias and study characteristics in correlation or cluster analyses. Bias was always in favour of the experimental cannabinoid or cannabis-based medicine. Put simply, reading title and abstract only could give an incorrect impression of efficacy or safety in about 1 in 5 papers reporting on these products.


Asunto(s)
Cannabinoides , Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Cannabinoides/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Dolor/tratamiento farmacológico , Revisiones Sistemáticas como Asunto , Sesgo , Narración , Manejo del Dolor/métodos
3.
J Pain ; 25(4): 833-842, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37863344

RESUMEN

Cannabidiol (CBD) attracts considerable attention for promoting good health and treating various conditions, predominantly pain, often in breach of advertising rules. Examination of available CBD products in North America and Europe demonstrates that CBD content can vary from none to much more than advertised and that potentially harmful other chemicals are often included. Serious harm is associated with chemicals found in CBD products and reported in children, adults, and the elderly. A 2021 International Association for the Study of Pain task force examined the evidence for cannabinoids and pain but found no trials of CBD. Sixteen CBD randomized trials using pharmaceutical-supplied CBD or making preparations from such a source and with pain as an outcome have been published subsequently. The trials were conducted in 12 different pain states, using 3 oral, topical, and buccal/sublingual administration, with CBD doses between 6 and 1,600 mg, and durations of treatment between a single dose and 12 weeks. Fifteen of the 16 showed no benefit of CBD over placebo. Small clinical trials using verified CBD suggest the drug to be largely benign; while large-scale evidence of safety is lacking, there is growing evidence linking CBD to increased rates of serious adverse events and hepatotoxicity. In January 2023, the Food and Drug Administration (FDA) announced that a new regulatory pathway for CBD was needed. Consumers and health care providers should rely on evidence-based sources of information on CBD, not just advertisements. Current evidence is that CBD for pain is expensive, ineffective, and possibly harmful. PERSPECTIVE: There is no good reason for thinking that CBD relieves pain, but there are good reasons for doubting the contents of CBD products in terms of CBD content and purity.


Asunto(s)
Cannabidiol , Cannabinoides , Adulto , Niño , Humanos , Anciano , Cannabidiol/efectos adversos , Dolor/tratamiento farmacológico , Dolor/inducido químicamente , Europa (Continente)
4.
Pain ; 165(5): 1086-1100, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38112633

RESUMEN

ABSTRACT: Many gaps remain in finding effective, safe, and equitable treatments for children and adolescents with chronic pain and in accessing treatments in different settings. A major goal of the field is to improve assessment of pain and related experience. Valid and reliable patient-reported outcome measures are critical for advancing knowledge of clinical interventions for pediatric chronic pain. Building on the work of the Ped-IMMPACT group, we previously updated a core outcome set (COS) for pediatric chronic pain clinical trials using stakeholder feedback from providers, youth, and parents. The new COS includes 3 mandatory domains: pain severity, pain-related interference with daily living, and adverse events and 4 optional domains: overall well-being, emotional functioning, physical functioning, and sleep quality. The aim of this study was to use a multiphased approach to recommend specific measures for each of the 7 domains identified in our new COS for pediatric chronic pain. We synthesized evidence through conducting the following: (1) a Delphi study of experts to identify candidate measures for the new COS domains, (2) a review phase to gather evidence for measurement properties for candidate measures, and (3) an expert consensus conference to reach agreement on measurement recommendations. Final recommendations included 9 patient-reported measures. Important contextual considerations are discussed, and guidance is provided regarding strengths and limitations of the recommendations. Implementation of these recommendations may be enhanced by widespread dissemination and ease of access to measurement tools.


Asunto(s)
Dolor Crónico , Ensayos Clínicos como Asunto , Adolescente , Niño , Humanos , Dolor Crónico/diagnóstico , Dolor Crónico/terapia , Consenso , Técnica Delphi , Evaluación de Resultado en la Atención de Salud , Proyectos de Investigación , Resultado del Tratamiento
5.
BMC Musculoskelet Disord ; 24(1): 972, 2023 Dec 16.
Artículo en Inglés | MEDLINE | ID: mdl-38102656

RESUMEN

BACKGROUND: The Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway. METHODS: Participants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0-10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon. RESULTS: Overall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and - 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94. CONCLUSIONS: The magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years. TRIAL REGISTRATION: ISRCTN: 92,545,361.


Asunto(s)
Artroplastia de Reemplazo de Rodilla , Dolor Crónico , Humanos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Resultado del Tratamiento , Vías Clínicas , Estudios de Seguimiento , Dolor Crónico/diagnóstico , Dolor Crónico/etiología , Dolor Crónico/cirugía , Calidad de Vida , Medicina Estatal , Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de Vida
6.
Paediatr Neonatal Pain ; 5(3): 57-65, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37744281

RESUMEN

Long-term health conditions, whether mental or physical, often co-occur in adolescents. For instance, adolescents with chronic pain may experience co-occurring primary psychological disorders. In this scoping review, we determine the influence of co-occurring chronic pain and primary psychological disorders on adolescents' functioning. A systematic search of six databases was conducted to identify articles if they were: (1) peer-reviewed; (2) reported original findings; (3) included participants aged 11-19 years, who experienced chronic pain (i.e., pain lasting 3 months or more) and had a co-occurring diagnosis of a primary psychological disorder; and (4) assessed functioning. Searches returned 9864 articles after the removal of duplicates. A two-phase abstract and full-text screening process identified two eligible articles which compared emotional functioning (n = 1) and social functioning (n = 2) between groups of adolescents with co-occurring chronic pain and primary psychological disorders with adolescents only reporting chronic pain. Overall findings revealed no differences in social functioning, but adolescents with co-occurring chronic pain and a primary psychological disorder (depression and anxiety) reported worse emotional functioning compared with adolescents with chronic pain alone. This review confirms the limited research on the co-occurrence of primary psychological disorders and chronic pain in adolescents by only identifying two eligible articles exploring the co-occurrence of chronic pain with depression, anxiety, and/or attentional disorders.

7.
Cochrane Database Syst Rev ; 8: CD013863, 2023 08 29.
Artículo en Inglés | MEDLINE | ID: mdl-37643992

RESUMEN

BACKGROUND: Chronic pain (pain lasting three months or more) is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Common types (excluding headache) include back pain, fibromyalgia, and neuropathic pain. Access to traditional face-to-face therapies can be restricted by healthcare resources, geography, and cost. Remote technology-based delivery of psychological therapies has the potential to overcome treatment barriers. However, their therapeutic effectiveness compared to traditional delivery methods requires further investigation. OBJECTIVES: To determine the benefits and harms of remotely-delivered psychological therapies compared to active control, waiting list, or treatment as usual for the management of chronic pain in adults. SEARCH METHODS: We searched for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, and PsycINFO to 29 June 2022. We also searched clinical trials registers and reference lists. We conducted a citation search of included trials to identify any further eligible trials. SELECTION CRITERIA: We included RCTs in adults (≥ 18 years old) with chronic pain. Interventions included psychological therapies with recognisable psychotherapeutic content or based on psychological theory. Trials had to have delivered therapy remote from the therapist (e.g. Internet, smartphone application) and involve no more than 30% contact time with a clinician. Comparators included treatment as usual (including waiting-list controls) and active controls (e.g. education). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. MAIN RESULTS: We included 32 trials (4924 participants) in the analyses. Twenty-five studies delivered cognitive behavioural therapy (CBT) to participants, and seven delivered acceptance and commitment therapy (ACT). Participants had back pain, musculoskeletal pain, opioid-treated chronic pain, mixed chronic pain, hip or knee osteoarthritis, spinal cord injury, fibromyalgia, provoked vestibulodynia, or rheumatoid arthritis. We assessed 25 studies as having an unclear or high risk of bias for selective reporting. However, across studies overall, risk of bias was generally low. We downgraded evidence certainty for primary outcomes for inconsistency, imprecision, and study limitations. Certainty of evidence ranged from moderate to very low. Adverse events were inadequately reported or recorded across studies. We report results only for studies in CBT here. Cognitive behavioural therapy (CBT) versus treatment as usual (TAU) Pain intensity Immediately after treatment, CBT likely demonstrates a small beneficial effect compared to TAU (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.39 to -0.16; 20 studies, 3206 participants; moderate-certainty evidence). Participants receiving CBT are probably more likely to achieve a 30% improvement in pain intensity compared to TAU (23% versus 11%; risk ratio (RR) 2.15, 95% CI 1.62 to 2.85; 5 studies, 1347 participants; moderate-certainty evidence). They may also be more likely to achieve a 50% improvement in pain intensity (6% versus 2%; RR 2.31, 95% CI 1.14 to 4.66; 4 studies, 1229 participants), but the evidence is of low certainty. At follow-up, there is likely little to no difference in pain intensity between CBT and TAU (SMD -0.04, 95% CI -0.17 to 0.09; 8 studies, 959 participants; moderate-certainty evidence). The evidence comparing CBT to TAU on achieving a 30% improvement in pain is very uncertain (40% versus 24%; RR 1.70, 95% CI 0.82 to 3.53; 1 study, 69 participants). No evidence was available regarding a 50% improvement in pain. Functional disability Immediately after treatment, CBT may demonstrate a small beneficial improvement compared to TAU (SMD -0.38, 95% CI -0.53 to -0.22; 14 studies, 2672 participants; low-certainty evidence). At follow-up, there is likely little to no difference between treatments (SMD -0.05, 95% CI -0.23 to 0.14; 3 studies, 461 participants; moderate-certainty evidence). Quality of life Immediately after treatment, CBT may not have resulted in a beneficial effect on quality of life compared to TAU, but the evidence is very uncertain (SMD -0.16, 95% CI -0.43 to 0.11; 7 studies, 1423 participants). There is likely little to no difference between CBT and TAU on quality of life at follow-up (SMD -0.16, 95% CI -0.37 to 0.05; 3 studies, 352 participants; moderate-certainty evidence). Adverse events Immediately after treatment, evidence about the number of people experiencing adverse events is very uncertain (34% in TAU versus 6% in CBT; RR 6.00, 95% CI 2.2 to 16.40; 1 study, 140 participants). No evidence was available at follow-up. Cognitive behavioural therapy (CBT) versus active control Pain intensity Immediately after treatment, CBT likely demonstrates a small beneficial effect compared to active control (SMD -0.28, 95% CI -0.52 to -0.04; 3 studies, 261 participants; moderate-certainty evidence). The evidence at follow-up is very uncertain (mean difference (MD) 0.50, 95% CI -0.30 to 1.30; 1 study, 127 participants). No evidence was available for a 30% or 50% pain intensity improvement. Functional disability Immediately after treatment, there may be little to no difference between CBT and active control on functional disability (SMD -0.26, 95% CI -0.55 to 0.02; 2 studies, 189 participants; low-certainty evidence). The evidence at follow-up is very uncertain (MD 3.40, 95% CI -1.15 to 7.95; 1 study, 127 participants). Quality of life Immediately after treatment, there is likely little to no difference in CBT and active control (SMD -0.22, 95% CI -1.11 to 0.66; 3 studies, 261 participants; moderate-certainty evidence). The evidence at follow-up is very uncertain (MD 0.00, 95% CI -0.06 to 0.06; 1 study, 127 participants). Adverse events Immediately after treatment, the evidence comparing CBT to active control is very uncertain (2% versus 0%; RR 3.23, 95% CI 0.13 to 77.84; 1 study, 135 participants). No evidence was available at follow-up. AUTHORS' CONCLUSIONS: Currently, evidence about remotely-delivered psychological therapies is largely limited to Internet-based delivery of CBT. We found evidence that remotely-delivered CBT has small benefits for pain intensity (moderate certainty) and functional disability (moderate to low certainty) in adults experiencing chronic pain. Benefits were not maintained at follow-up. Our appraisal of quality of life and adverse events outcomes post-treatment were limited by study numbers, evidence certainty, or both. We found limited research (mostly low to very low certainty) exploring other psychological therapies (i.e. ACT). More high-quality studies are needed to assess the broad translatability of psychological therapies to remote delivery, the different delivery technologies, treatment longevity, comparison with active control, and adverse events.


Asunto(s)
Dolor Crónico , Fibromialgia , Adulto , Humanos , Adolescente , Dolor Crónico/terapia , Fibromialgia/terapia , Cefalea , Técnicos Medios en Salud , Analgésicos Opioides
8.
J Pain ; 24(12): 2103-2130, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37453533

RESUMEN

We previously conducted an exploration of the trustworthiness of a group of clinical trials of cognitive-behavioral therapy and exercise in spinal pain. We identified multiple concerns in 8 trials, judging them untrustworthy. In this study, we systematically explored the impact of these trials ("index trials") on results, conclusions, and recommendations of systematic reviews and clinical practice guidelines (CPGs). We conducted forward citation tracking using Google Scholar and the citationchaser tool, searched the Guidelines International Network library and National Institute of Health and Care Excellence archive to June 2022 to identify systematic reviews and CPGs. We explored how index trials impacted their findings. Where reviews presented meta-analyses, we extracted or conducted sensitivity analyses for the outcomes of pain and disability, to explore how the exclusion of index trials affected effect estimates. We developed and applied an 'Impact Index' to categorize the extent to which index studies impacted their results. We included 32 unique reviews and 10 CPGs. None directly raised concerns regarding the veracity of the trials. Across meta-analyses (55 comparisons), the removal of index trials reduced effect sizes by a median of 58% (Inter Quartlie Range (IQR) 40-74). 85% of comparisons were classified as highly, 3% as moderately, and 11% as minimally impacted. Nine out of 10 reviews conducting narrative synthesis drew positive conclusions regarding the intervention tested. Nine out of 10 CPGs made positive recommendations for the intervention(s) evaluated. This cohort of trials, with concerns regarding trustworthiness, has substantially impacted the results of systematic reviews and guideline recommendations. PERSPECTIVE: We found that a group of trials of CBT for spinal pain with concerns relating to their trustworthiness has had substantial impacts on the analyses and conclusions of systematic reviews and clinical practice guidelines. This highlights the need for a greater focus on the trustworthiness of studies in evidence appraisal. PRE-REGISTRATION: Our protocol was preregistered on the Open Science Framework: https://osf.io/m92ax/.


Asunto(s)
Ensayos Clínicos como Asunto , Dolor , Humanos , Revisiones Sistemáticas como Asunto , Metaanálisis como Asunto , Guías de Práctica Clínica como Asunto
10.
Pain ; 164(11): 2397-2404, 2023 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-37310441

RESUMEN

ABSTRACT: Retraction is a mechanism for correcting the scientific record and alerts readers when a study contains unreliable or flawed data. Such data may arise from error or research misconduct. Studies examining the landscape of retracted publications provide insight into the extent of unreliable data and its effect on a medical discipline. We aimed to explore the extent and characteristics of retracted publications in pain research. We searched the EMBASE, PubMed, CINAHL, PsycINFO, and Retraction Watch databases to December 31, 2022. We included retracted articles that (1) investigated mechanisms of painful conditions, (2) tested treatments that aimed to reduce pain, or (3) measured pain as an outcome. Descriptive statistics were used to summarise the included data. We included 389 pain articles published between 1993 and 2022 and retracted between 1996 and 2022. There was a significant upward trend in the number of retracted pain articles over time. Sixty-six percent of articles were retracted for reasons relating to misconduct. The median (interquartile range) time from article publication to retraction was 2 years (0.7-4.3). The time to retraction differed by reason for retraction, with data problems, comprising data falsification, duplication, and plagiarism, resulting in the longest interval (3 [1.2-5.2] years). Further investigations of retracted pain articles, including exploration of their fate postretraction, are necessary to determine the impact of unreliable data on pain research.

11.
Cochrane Database Syst Rev ; 5: CD014682, 2023 05 10.
Artículo en Inglés | MEDLINE | ID: mdl-37160297

RESUMEN

BACKGROUND: Chronic pain is common in adults, and often has a detrimental impact upon physical ability, well-being, and quality of life. Previous reviews have shown that certain antidepressants may be effective in reducing pain with some benefit in improving patients' global impression of change for certain chronic pain conditions. However, there has not been a network meta-analysis (NMA) examining all antidepressants across all chronic pain conditions. OBJECTIVES: To assess the comparative efficacy and safety of antidepressants for adults with chronic pain (except headache). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, AMED and PsycINFO databases, and clinical trials registries, for randomised controlled trials (RCTs) of antidepressants for chronic pain conditions in January 2022. SELECTION CRITERIA: We included RCTs that examined antidepressants for chronic pain against any comparator. If the comparator was placebo, another medication, another antidepressant, or the same antidepressant at different doses, then we required the study to be double-blind. We included RCTs with active comparators that were unable to be double-blinded (e.g. psychotherapy) but rated them as high risk of bias. We excluded RCTs where the follow-up was less than two weeks and those with fewer than 10 participants in each arm.  DATA COLLECTION AND ANALYSIS: Two review authors separately screened, data extracted, and judged risk of bias. We synthesised the data using Bayesian NMA and pairwise meta-analyses for each outcome and ranked the antidepressants in terms of their effectiveness using the surface under the cumulative ranking curve (SUCRA). We primarily used Confidence in Meta-Analysis (CINeMA) and Risk of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN) to assess the certainty of the evidence. Where it was not possible to use CINeMA and ROB-MEN due to the complexity of the networks, we used GRADE to assess the certainty of the evidence. Our primary outcomes were substantial (50%) pain relief, pain intensity, mood, and adverse events. Our secondary outcomes were moderate pain relief (30%), physical function, sleep, quality of life, Patient Global Impression of Change (PGIC), serious adverse events, and withdrawal. MAIN RESULTS: This review and NMA included 176 studies with a total of 28,664 participants. The majority of studies were placebo-controlled (83), and parallel-armed (141). The most common pain conditions examined were fibromyalgia (59 studies); neuropathic pain (49 studies) and musculoskeletal pain (40 studies). The average length of RCTs was 10 weeks. Seven studies provided no useable data and were omitted from the NMA. The majority of studies measured short-term outcomes only and excluded people with low mood and other mental health conditions. Across efficacy outcomes, duloxetine was consistently the highest-ranked antidepressant with moderate- to high-certainty evidence. In duloxetine studies, standard dose was equally efficacious as high dose for the majority of outcomes. Milnacipran was often ranked as the next most efficacious antidepressant, although the certainty of evidence was lower than that of duloxetine. There was insufficient evidence to draw robust conclusions for the efficacy and safety of any other antidepressant for chronic pain.  Primary efficacy outcomes Duloxetine standard dose (60 mg) showed a small to moderate effect for substantial pain relief (odds ratio (OR) 1.91, 95% confidence interval (CI) 1.69 to 2.17; 16 studies, 4490 participants; moderate-certainty evidence) and continuous pain intensity (standardised mean difference (SMD) -0.31, 95% CI -0.39 to -0.24; 18 studies, 4959 participants; moderate-certainty evidence). For pain intensity, milnacipran standard dose (100 mg) also showed a small effect (SMD -0.22, 95% CI -0.39 to 0.06; 4 studies, 1866 participants; moderate-certainty evidence). Mirtazapine (30 mg) had a moderate effect on mood (SMD -0.5, 95% CI -0.78 to -0.22; 1 study, 406 participants; low-certainty evidence), while duloxetine showed a small effect (SMD -0.16, 95% CI -0.22 to -0.1; 26 studies, 7952 participants; moderate-certainty evidence); however it is important to note that most studies excluded participants with mental health conditions, and so average anxiety and depression scores tended to be in the 'normal' or 'subclinical' ranges at baseline already. Secondary efficacy outcomes Across all secondary efficacy outcomes (moderate pain relief, physical function, sleep, quality of life, and PGIC), duloxetine and milnacipran were the highest-ranked antidepressants with moderate-certainty evidence, although effects were small. For both duloxetine and milnacipran, standard doses were as efficacious as high doses. Safety There was very low-certainty evidence for all safety outcomes (adverse events, serious adverse events, and withdrawal) across all antidepressants. We cannot draw any reliable conclusions from the NMAs for these outcomes. AUTHORS' CONCLUSIONS: Our review and NMAs show that despite studies investigating 25 different antidepressants, the only antidepressant we are certain about for the treatment of chronic pain is duloxetine. Duloxetine was moderately efficacious across all outcomes at standard dose. There is also promising evidence for milnacipran, although further high-quality research is needed to be confident in these conclusions. Evidence for all other antidepressants was low certainty. As RCTs excluded people with low mood, we were unable to establish the effects of antidepressants for people with chronic pain and depression. There is currently no reliable evidence for the long-term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point.


Asunto(s)
Dolor Crónico , Adulto , Humanos , Antidepresivos/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Clorhidrato de Duloxetina , Milnaciprán , Metaanálisis en Red , Manejo del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto
13.
14.
Br J Anaesth ; 130(3): 287-295, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36369016

RESUMEN

The randomised controlled trial is the foundation of clinical research; yet there is concern that many trials have flaws in design, conduct, and reporting that undermine trustworthiness. Common flaws in trials include high risk of bias, small size, outcomes irrelevant to clinical care and patient's experience, and inability to detect efficacy even if present. These flaws carry forward into systematic reviews, which can confer the label of 'high-quality evidence' on inadequate data. Trials can be futile because their flaws mean that they cannot deliver any meaningful result in that different results in a small number of patients would be sufficient to change conclusions. Some trials have been discovered to be fabricated, the number of which is growing. The fields of anaesthesia and pain have more fabricated trials than other clinical fields, possibly because of increased vigilance. This narrative review examines these themes in depth whilst acknowledging an inescapable conclusion: that much of our clinical evidence is in trouble, and special measures are needed to bolster quality and confidence.


Asunto(s)
Anestesia , Humanos , Dolor Postoperatorio
15.
Pain ; 164(1): 72-83, 2023 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-35470336

RESUMEN

ABSTRACT: Evidence-based medicine is replete with studies assessing quality and bias, but few evaluating research integrity or trustworthiness. A recent Cochrane review of psychological interventions for chronic pain identified trials with a shared lead author with highly divergent results. We sought to systematically identify all similar trials from this author to explore their risk of bias, governance procedures, and trustworthiness. We searched OVID MEDLINE, EMBASE, CENTRAL, and PEDro from 2010 to December 22, 2021 for trials. We contacted the authors requesting details of trial registration, ethical approval, protocol, and access to the trial data for verification. We used the Cochrane risk-of-bias tool and the Cochrane Pregnancy and Childbirth group's Trustworthiness Screening Tool to guide systematic exploration of trustworthiness. Ten trials were included: 9 compared cognitive behavioural therapy and physical exercise to usual care, exercise alone, or physiotherapy and 1 compared 2 brief cognitive behavioural therapy programmes. Eight trials reported results divergent from the evidence base. Assessment of risk of bias and participant characteristics identified no substantial concerns. Responses from the lead author did not satisfactorily explain this divergence. Trustworthiness screening identified concerns about research governance, data plausibility at baseline, the results, and apparent data duplication. We discuss the findings within the context of methods for establishing the trustworthiness of research findings generally. Important concerns regarding the trustworthiness of these trials reduce our confidence in them. They should probably not be used to inform the results and conclusions of systematic reviews, in clinical training, policy documents, or any relevant instruction regarding adult chronic pain management.


Asunto(s)
Dolor Crónico , Terapia Cognitivo-Conductual , Embarazo , Femenino , Adulto , Humanos , Dolor Crónico/terapia , Proyectos Piloto , Dolor de Cuello , Revisiones Sistemáticas como Asunto , Terapia Cognitivo-Conductual/métodos , Cognición
16.
Schmerz ; 37(1): 47-54, 2023 Feb.
Artículo en Alemán | MEDLINE | ID: mdl-35551473

RESUMEN

How to prevent the onset, maintenance, or exacerbation of pain is a major focus of clinical pain science. Pain prevention can be distinctly organised into primary, secondary, and tertiary prevention. Primary prevention describes avoiding hurt or pain, secondary prevention describes reducing pain when pain is unavoidable, and tertiary prevention describes preventing or reducing ongoing negative consequences such as high functional disability or distress due to chronic pain. Each poses separate challenges where unique psychological factors will play a role. In this short review article, we highlight psychological factors important to primary, secondary, and tertiary prevention and provide direction for the field. We present 2 case studies on secondary prevention in children and adolescents and tertiary prevention in adults with chronic pain. Finally, we provide research directions for progression in this field, highlighting the importance of clear theoretical direction, the identification of risk factors for those most likely to develop pain, and the importance of treatment.


Asunto(s)
Dolor Crónico , Terapia Cognitivo-Conductual , Niño , Adolescente , Adulto , Humanos , Dolor Crónico/terapia , Manejo del Dolor
17.
Paediatr Neonatal Pain ; 4(3): 110-124, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36188159

RESUMEN

The incidence of chronic and recurrent pain increases in adolescence. Prevalence of adolescent chronic pain is estimated to be 11%-44%, with approximately 5% adolescents experiencing moderate-to-severe chronic pain. Adolescents with chronic pain also report unwanted changes in emotional, social, and developmental functioning. Very little is known about how adolescents with chronic pain make sense of their development, the role of pain in that development, and how such developmental trajectories progress over time. A multi-methods qualitative study was designed to explore how adolescents make sense of their experience of chronic pain in the context of development. Nine adolescents (8 girls) aged 12-22 years old (Mean = 15.7, SD = 2.8) were recruited from a UK national pain service. Adolescents completed an interview on entering the service, and a follow-up interview 12 months later. They also completed monthly diaries in this 12-month period. Data comprised 18 interviews and 60 diary entries, which were analyzed using inductive reflexive thematic analysis. Analyses generated one overarching theme entitled "tug of war: push and pull," demonstrating developmental tension related to pain, and the cumulative impact these had over time. This overarching theme comprised two subthemes which capture these tensions across the developmental domains of peer relationships and autonomy. The first subtheme, "the shifting sands of peer relationships," explores the ever-changing closeness between self and peers. The second subtheme referred to "restricted choices" and how pain limited the participants' autonomy but that this, over time could push development forward. These results extend previous cross-sectional research on the developmental consequences of chronic pain, showing the dynamic fluctuations and alterations to developmental trajectories over time.

18.
BMC Musculoskelet Disord ; 23(1): 451, 2022 May 13.
Artículo en Inglés | MEDLINE | ID: mdl-35562815

RESUMEN

BACKGROUND: Approximately 20% of people experience chronic postsurgical pain after total knee replacement. The STAR randomised controlled trial (ISCRTN92545361) evaluated the clinical- and cost-effectiveness of a new multifaceted and personalised care pathway, compared with usual care, for people with pain at three months after total knee replacement. We report trial participants' experiences of postoperative pain and the acceptability of the STAR care pathway, which consisted of an assessment clinic at three months, and up to six follow-up telephone calls over 12 months. METHODS: Semi-structured interviews were conducted with 27 people (10 men, 17 women) between February 2018 and January 2020. Participants were sampled purposively from the care pathway intervention group and interviewed after completion of the final postoperative trial questionnaire at approximately 15 months after knee replacement. Interviews were audio-recorded, transcribed, anonymised and analysed using inductive thematic analysis. FINDINGS: Many participants were unprepared for the severity and impact of postoperative pain, which they described as extreme and constant and that tested their physical and mental endurance. Participants identified 'low points' during their recovery, triggered by stiffening, pain or swelling that caused feelings of anxiety, depression, and pain catastrophising. Participants described the STAR assessment clinic as something that seemed "perfectly normal" suggesting it was seamlessly integrated into NHS care. Even in the context of some ongoing pain, the STAR care pathway had provided a source of support and an opportunity to discuss concerns about their ongoing recovery. CONCLUSIONS: People who have knee replacement may be unprepared for the severity and impact of postoperative pain, and the hard work of recovery afterwards. This highlights the challenges of preparing patients for total knee replacement and suggests that clinical attention is needed if exercise and mobilising is painful beyond the three month postoperative period. The STAR care pathway is acceptable to people with pain after total knee replacement.


Asunto(s)
Artroplastia de Reemplazo de Rodilla , Artroplastia de Reemplazo de Rodilla/efectos adversos , Análisis Costo-Beneficio , Vías Clínicas , Femenino , Humanos , Masculino , Dolor Postoperatorio/diagnóstico , Dolor Postoperatorio/etiología , Modalidades de Fisioterapia , Investigación Cualitativa
19.
Pain ; 163(9): 1700-1715, 2022 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-35324507

RESUMEN

ABSTRACT: Adults with chronic low back pain, disability, moderate-to-severe pain, and high fear of movement and reinjury were recruited into a trial of a novel, automated, digital therapeutics, virtual reality, psychological intervention for pain (DTxP). We conducted a 3-arm, prospective, double-blind, pilot, randomized, controlled trial comparing DTxP with a sham placebo comparator and an open-label standard care. Participants were enrolled for 6 to 8 weeks, after which, the standard care control arm were rerandomized to receive either the DTxP or sham placebo. Forty-two participants completed assessments at baseline, immediately posttreatment (6-8 weeks), 9-week, and 5-month follow-up. We found that participants in the DTxP group reported greater reductions in fear of movement and better global impression of change when compared with sham placebo and standard care post treatment. No other group differences were noted at posttreatment or follow-up. When compared with baseline, participants in the DTxP group reported lower disability at 5-month follow-up, lower pain interference and fear of movement post treatment and follow-up, and lower pain intensity at posttreatment. The sham placebo group also reported lower disability and fear of movement at 5-month follow-up compared with baseline. Standard care did not report any significant changes. There were a number of adverse events, with one participant reporting a serious adverse event in the sham placebo, which was not related to treatment. No substantial changes in medications were noted, and participants in the DTxP group reported positive gaming experiences.


Asunto(s)
Dolor de la Región Lumbar , Terapia de Exposición Mediante Realidad Virtual , Realidad Virtual , Adulto , Humanos , Dolor de la Región Lumbar/terapia , Dimensión del Dolor , Estudios Prospectivos
20.
BMC Health Serv Res ; 22(1): 329, 2022 Mar 12.
Artículo en Inglés | MEDLINE | ID: mdl-35277160

RESUMEN

BACKGROUND: This consensus statement was developed because there are concerns about the appropriate use of opioids for acute pain management, with opposing views in the literature. Consensus statement on policies for system-level interventions may help inform organisations such as management structures, government agencies and funding bodies. METHODS: We conducted a multi-stakeholder survey using a modified Delphi methodology focusing on policies, at the system level, rather than at the prescriber or patient level. We aimed to provide consensus statements for current developments and priorities for future developments. RESULTS: Twenty-five experts from a variety of fields with experience in acute pain management were invited to join a review panel, of whom 23 completed a modified Delphi survey of policies designed to improve the safety and quality of opioids prescribing for acute pain in the secondary care setting. Strong agreement, defined as consistent among> 75% of panellists, was observed for ten statements. CONCLUSIONS: Using a modified Delphi study, we found agreement among a multidisciplinary panel, including patient representation, on prioritisation of policies for system-level interventions, to improve governance, pain management, patient/consumers care, safety and engagement.


Asunto(s)
Analgésicos Opioides , Trastornos Relacionados con Opioides , Analgésicos Opioides/uso terapéutico , Consenso , Técnica Delphi , Humanos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Políticas
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