The design of studies testing the effectiveness of risk-guided care has many challenges: a scoping review addressing key considerations.

OBJECTIVES: Studies evaluating the effectiveness of care based on patients' risk of adverse outcomes (risk-guided care) use a variety of study designs. In this scoping review, using examples, we review characteristics of relevant studies and present key design features to optimize the trustworthiness of results. STUDY DESIGN AND SETTING: We searched five online databases for studies evaluating the effect of risk-guided care among adults on clinical outcomes, process, or cost. Pairs of reviewers independently performed screening and data abstraction. We descriptively summarized the study design and characteristics. RESULTS: Among 14,561 hits, we identified 116 eligible studies. Study designs included randomized controlled trials (RCTs), post hoc analysis of RCTs, and retrospective or prospective cohort studies. Challenges and sources of bias in the design included limited performance of predictive models, contamination, inadequacy to address the credibility of subgroup effects, absence of differences in care across risk strata, reporting only process measures as opposed to clinical outcomes, and failure to report benefits and harms. CONCLUSION: To assess the benefit of risk-guided care, RCTs provide the most trustworthy evidence. Observational studies offer an alternative but are hampered by confounding and other limitations. Reaching valid conclusions when testing risk-guided care requires addressing the challenges identified in our review.

Reported Outcomes and Outcome Measures in Proximal Interphalangeal Joint Arthroplasty: A Systematic Review.

Purpose: There is a lack of scientific consensus on the best arthroplasty implant option for proximal interphalangeal joint (PIPJ) arthritis, due to diversity in outcome reporting and measurement methods. The development of a standardized core outcome set (COS) and standard outcome measures could mitigate this issue. This study catalogs the reported outcomes and outcome measures found in PIPJ arthroplasty studies, which can be used in the first step of developing a COS. Methods: A database search of MEDLINE, EMBASE, and Web of Science (January 1, 2010, to March 10, 2021) was performed to retrieve studies that reported outcomes of the 3 most common primary PIPJ arthroplasty implants: silicone, pyrocarbon, and metal-polyethylene. The primary objectives of this study include reported outcomes and outcome measures. Secondary objectives include clinimetric properties of outcome measures, study design, and implant types. Results: Fifty articles met inclusion criteria. Of the included studies, 41 (82%) were case series, 8 (16%) were cohort studies, and 1 (2%) was a randomized control trial. Thirty-three unique outcomes were identified. Fifteen (46%) outcomes were clinician-reported and 26 (79%) were patient-reported. Eighteen unique outcome measures were identified. Of the outcome measures, 15 (83%) were patient-reported, 1 (6%) was clinician-reported, and 2 (11%) were reported by both patients and clinicians. Conclusions: Substantial heterogeneity was found in reported outcomes and outcome measures across studies evaluating PIPJ arthroplasty, impeding knowledge translation. The development of a COS for PIPJ arthroplasty is necessary to help compare and pool data across studies, and advance scientific knowledge.

Objectif: Il manque de consensus scientifique sur la meilleure option d'arthroplastie pour l'arthrite de l'articulation interphalangienne proximale (IPP) en raison de la diversité des résultats décrits et des méthodes de mesure. L'élaboration d'un ensemble standardisé de résultats de base et de mesures standardisées des résultats pourrait contribuer à limiter ce problème. Cette étude dresse un catalogue des résultats rapportés et des mesures de résultats trouvés dans les études sur l'arthroplastie des IPP; celui-ci peut servir de première étape à l'élaboration d'un ensemble standardisé de résultats de base. Méthodes: Une recherche a été menée dans les bases de données MEDLINE, EMBASE et Web of Science sur la période du 1er janvier 2010 au 10 mars 2021 pour extraire les études qui rapportaient des résultats avec les 3 implants pour arthroplastie des IPP les plus souvent utilisés : silicone, pyrocarbone et métal-polyéthylène. Les objectifs principaux de cette étude incluent les résultats rapportés et les mesures des résultats. Les objectifs secondaires sont, notamment, les propriétés clinimétriques des mesures des résultats, la conception des études et les types d'implants. Résultats: Cinquante articles satisfaisaient les critères d'inclusion. Parmi les études incluses, 41 (82%) étaient des séries de cas, 8 (16%) étaient des études de cohortes et 1 (2%) était un essai randomisé. Trente-trois résultats uniques ont été identifiés. Quinze résultats (46%) étaient rapportés par le clinicien et 26 (79%) ont été déclarés par les patients. Dix-huit mesures uniques de résultats ont été identifiées. Parmi les mesures de résultats, 15 (83%) ont été déclarées par les patients, 1 (6%) a été déclarée par un clinicien et 2 (11%) ont été déclarées à la fois par les patients et les cliniciens. Conclusions: Une hétérogénéité importante a été constatée dans les résultats rapportés et dans les mesures de résultats dans les études évaluant l'arthroplastie des IPP, entravant leur traduction en connaissances utiles. L'élaboration d'un ensemble standardisé de résultats de base s pour les IPP est nécessaire pour comparer et regrouper les données entre les études et donc pour faire avancer les connaissances scientifiques.

"Spin" in Observational Studies in Deep Inferior Epigastric Perforator Flap Breast Reconstruction: A Systematic Review.

The deep inferior epigastric artery perforator (DIEP) flap is widely used in autologous breast reconstruction. However, the technique relies heavily on nonrandomized observational research, which has been found to have high risk of bias. "Spin" can be used to inappropriately present study findings to exaggerate benefits or minimize harms. The primary objective was to assess the prevalence of spin in nonrandomized observational studies on DIEP reconstruction. The secondary objectives were to determine the prevalence of each spin category and strategy. Methods: MEDLINE and Embase databases were searched from January 1, 2015, to November 15, 2022. Spin was assessed in abstracts and full-texts of included studies according to criteria proposed by Lazarus et al. Results: There were 77 studies included for review. The overall prevalence of spin was 87.0%. Studies used a median of two spin strategies (interquartile range: 1-3). The most common strategies identified were causal language or claims (n = 41/77, 53.2%), inadequate extrapolation to larger population, intervention, or outcome (n = 27/77, 35.1%), inadequate implication for clinical practice (n = 25/77, 32.5%), use of linguistic spin (n = 22/77, 28.6%), and no consideration of the limitations (n = 21/77, 27.3%). There were no significant associations between selected study characteristics and the presence of spin. Conclusions: The prevalence of spin is high in nonrandomized observational studies on DIEP reconstruction. Causal language or claims are the most common strategy. Investigators, reviewers, and readers should familiarize themselves with spin strategies to avoid misinterpretation of research in DIEP reconstruction.

Routine Pathological Examination of Clinically Presumed Dupuytren Disease: Does It Add Value?

BACKGROUND: In surgery for Dupuytren disease (DD), palmar fascia specimens are routinely submitted for pathological evaluation. The purpose of this study was to determine the rate of discordant diagnosis and the value of, and costs associated with, routine pathological analysis of palmar fascia tissue extracted in surgery for clinically diagnosed DD. METHODS: All pathology reports for in-house palmar fascia specimens obtained in surgery for clinically diagnosed DD (time period: January 2001 to December 2020) were retrieved from one academic institution. All specimens were classified by a hierarchical free-text string matching algorithm (HFTSMA) and searched for evidence of malignancy. The primary outcome was percentage of concordant, discrepant, and discordant diagnoses. Secondary outcomes included anatomical location and costs. The HFTSMA was used to capture the anatomical location. Costs included professional, laboratory processing, and ancillary fees based on the Ontario Schedule of Benefits. RESULTS: The search retrieved 1323 pathology reports, with 1480 palmar fascia specimens, from 1078 individual patients. By diagnosis, 96.1% of specimens (1422/1480) were concordant (fibromatosis), 3.9% (58/1480) were discrepant (scarring/fibrosis, benign fascia/connective tissue, or other benign findings), and 0% (0/1480) were discordant. The most common location was ring finger (n = 381, 48.7%). Ancillary testing was minimal. The cost per palmar fascia specimen was estimated to be CAD $34.57. The institutional costs were approximately CAD $2558.18/year. CONCLUSIONS: Routine pathological examination of specimens in cases of clinically diagnosed DD does not yield additional clinically important findings and may not warrant their costs.

Outcomes in Facial Feminization Surgery: A Systematic Review.

Objective: Review literature on facial feminization surgery (FFS) for the transgender population and identify whether heterogeneity in reported outcomes and outcome measures exists across studies, as measured by a lack of consensus, and number of outcomes and outcome measures used. Evidence Review: A search of MEDLINE and EMBASE (database inception to January 20, 2021) was performed to retrieve FFS studies. Primary outcomes included number of reported outcomes and outcome measures; secondary outcomes included clinimetric properties of outcome measures and study characteristics. Findings: In total, 15 articles were included. Sixty-nine outcomes and 12 outcome measures were identified. Of those outcome measures, zero were found to be valid, reliable, and responsive in patients who had undergone FFS. A variety of FFS interventions were studied, with the three most common interventions being: rhinoplasty (n = 7, 46.7%), mandibuloplasty (n = 7, 46.7%), and chondrolaryngoplasty (n = 6, 40%). Conclusion and Relevance: Heterogeneity was evident in reported outcomes and outcome measures in FFS literature and there is currently no outcome measure commonly used for this patient population.

Methodologic and Reporting Quality of Economic Evaluations in Hand and Wrist Surgery: A Systematic Review.

BACKGROUND: Economic evaluations can inform decision-making; however, previous publications have identified poor quality of economic evaluations in surgical specialties. METHODS: Study periods were from January 1, 2006, to April 20, 2020 (methodologic quality) and January 1, 2014, to April 20, 2020 (reporting quality). Primary outcomes were methodologic quality [Guidelines for Authors and Peer Reviewers of Economic Submissions to The BMJ (Drummond's checklist), 33 points; Quality of Health Economic Studies (QHES), 100 points; Consensus on Health Economic Criteria (CHEC), 19 points] and reporting quality (Consolidated Health Economic Evaluation Standards (CHEERS) statement, 24 points). RESULTS: Forty-seven hand economic evaluations were included. Partial economic analyses (i.e., cost analysis) were the most common (n = 34; 72 percent). Average scores of full economic evaluations (i.e., cost-utility analysis and cost-effectiveness analysis) were: Drummond's checklist, 27.08 of 33 (82.05 percent); QHES, 79.76 of 100 (79.76 percent); CHEC, 15.54 of 19 (81.78 percent); and CHEERS, 20.25 of 24 (84.38 percent). Cost utility analyses had the highest methodologic and reporting quality scores: Drummond's checklist, 28.89 of 35 (82.54 percent); QHES, 86.56 of 100 (86.56 percent); CHEC, 16.78 of 19 (88.30 percent); and CHEERS, 20.8 of 24 (86.67 percent). The association (multiple R) between CHEC and CHEERS was strongest: CHEC, 0.953; Drummond's checklist, 0.907; and QHES, 0.909. CONCLUSIONS: Partial economic evaluations in hand surgery are prevalent but not very useful. The Consensus on Health Economic Criteria and Consolidated Health Economic Evaluation Standards should be used in tandem when undertaking and evaluating economic evaluation in hand surgery.

Systematic review of reporting quality of economic evaluations in plastic surgery based on the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

BACKGROUND: Economic evaluations in healthcare are designed to inform decisions by the estimation of cost and effect trade-off of two or more interventions. This review identified and appraised the quality of reporting of economic evaluations in plastic surgery based on the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. METHODS: Electronic databases were searched: MEDLINE, EMBASE, The Cochrane Library, Ovid Health Star, and Business Source Complete from January 1, 2012 to November 30, 2019. Data extracted included: the type of economic evaluation (i.e., cost-utility analysis (CUA), cost-effectiveness analysis (CEA), cost-benefit analysis (CBA), cost-minimization analysis (CMA)), domain of plastic surgery, journal, year, and country of publication. The CHEERS checklist (with 24 items) was used to appraise the quality of reporting. RESULTS: Ninety-two economic evaluations were identified; CUA (10%), CEA (31%), CBA (4%), and CMA (50%). Breast surgery was the top domain (48%). Most were conducted in the USA (61%) and published in Plastic and Reconstructive Surgery journal (28%). One-third were published in the last two years. The average CHEERS checklist compliance score was 15 (63%). The average CHEERS checklist compliance score per type of evaluation was 19 (77%) for CUA, 17 (70%) for CEA, 13 (52%) for CBA, and 14 (57%) for CMA. The least reported CHEERS checklist items included: time horizon (15%), discount rate (18%), and assessment of heterogeneity (15%). Thirty-two percent of studies were inappropriately titled (i.e., methodologically incorrect). CONCLUSION: Quality of reporting of economic evaluations is suboptimal. The CHEERS checklist should be consulted when performing and reporting economic evaluations in plastic surgery.

Survey of occupational musculoskeletal pain and injury in Canadian ophthalmology.

OBJECTIVE: Surgeons and other physicians have reported occupational musculoskeletal (MSK) pain, and it has been recently raised as a growing issue by ophthalmologists and optometrists. What is most concerning is that it could be a serious threat to career longevity and performance. MSK pain and injury in Canadian ophthalmologists has not been quantified. Our goal was to estimate the prevalence of MSK issues, to determine the impact of MSK injuries to working hours and health, and to ascertain physician characteristics and practice patterns associated with MSK problems. DESIGN: Survey. PARTICIPANTS: One hundred sixty-nine ophthalmologists and 121 optometrists. METHODS: A voluntary internet-based (Survey Monkey) survey was conducted. All Canadian ophthalmologists and ophthalmology residents were contacted via the Canadian Ophthalmological Society, and all optometrists registered through the Canadian Association of Optometrists were contacted through their respective listserve email. RESULTS: One hundred sixty-nine ophthalmologists (response rate 17%) and 121 optometrists (2.4%) responded to a voluntary internet-based survey. Fifty percent of the ophthalmology respondents reported clinic-associated MSK pain in the preceding 12 months, compared to 61% of optometry respondents (p = 0.06). Of the ophthalmologists, 48.3% said they had experienced occupational MSK pain in the preceding 12 months, which they directly attributed to their operating room activities. Neck pain was reported in 46%, lower back in 36% and shoulder pain in 28% of ophthalmology respondents. This was compared to 34% (p = 0.04), 37% (p = 0.90) and 41% of optometrists (p= 0.02). Respondents in our survey listed "performing the same task over and over", "working in cramped or awkward positions" and "bending or twisting your neck" as the most common causes of MSK pain. CONCLUSION: Our survey identified that a large proportion of respondents reported MSK pain associated with clinical and surgical duties. Physician-led research is needed before industry and administrative partners can develop equipment and work-spaces that are better suited to the needs of physicians.